Leaders in Pharmaceutical Business Intelligence (LPBI) Group

 

 

 

 

 

Series A: e-Books on Cardiovascular Diseases

https://www.amazon.com/dp/B07MKHDBHF

Volume Authors, Curators and Co-Editors:

 

Justin D. Pearlman, MD, PhD, FACC:

Editorials and Clinical Pearls, Author

Larry H. Bernstein, MD, FCAP

Author, Curator and Co-Editor

and

Aviva Lev-Ari, PhD, RN

Author, Curator and Volume Co-Editor

]

 

Aviva Lev-Ari, PhD, RN

Editor-in-Chief BioMed e-Series of e-Books

Leaders in Pharmaceutical Business Intelligence, Boston

avivalev-ari@alum.berkeley.edu

 

Other e-Books in the BioMedicine e-Series

Series A: e-Books on Cardiovascular Diseases

Content Consultant: Justin D Pearlman, MD, PhD, FACC

 

• Volume One: Perspectives on Nitric Oxide

Sr. Editor: Larry Bernstein, MD, FCAP, Editor: Aviral Vatsa, PhD and Content Consultant: Stephen J Williams, PhD

Available on Kindle Store @ Amazon.com

http://www.amazon.com/dp/B00DINFFYC

• Volume Two: Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation

Curators: Justin D Pearlman, MD, PhD, FACC, Larry H Bernstein, MD, FCAP and

Aviva Lev-Ari, PhD, RN

• Causes
• Risks and Biomarkers
• Therapeutic Implication

Available on Kindle Store @ Amazon.com

http://www.amazon.com/dp/B018Q5MCN8

• Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics

Curators: Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

• Causes
• Risks and Biomarkers
• Therapeutic Implications

Available on Kindle Store @ Amazon.com

http://www.amazon.com/dp/B018PNHJ84

• Volume Four: Regenerative and Translational Medicine: The Therapeutics Promise for Cardiovascular Diseases

Curators: Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

• Causes
• Risks and Biomarkers
• Therapeutic Implications

Available on Kindle Store @ Amazon.com

http://www.amazon.com/dp/B019UM909A

 

• Volume Five: Pharmaco-Therapies of Cardiovascular Diseases

Volume Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

This is Volume Five, to be published in 2018

• Volume Six: Interventional Cardiology and Cardiac Surgery for Disease Diagnosis and Guidance of Treatment  

Volume Curators: Justin D Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

This is Volume Five, to be published in 2018

Other e-Books in the BioMed e-Series included the following 13 e-Books on Amazon.com

This e-Book is a comprehensive review of recent Original Research on Interventional Cardiology and Cardiac Surgery for Disease Diagnosis and Guidance of Treatment and related opportunities for Surgical and Interventional Procedures written by Experts, Authors, Writers. The results of Original Research gain value added for the e-Reader by the Methodology of Curation which adds expert commentary, synthesis and guidance. The e-Book’s articles have been published on the Open Access Online Scientific Journal, since April 2012.  All new articles on this subject, will continue to be incorporated, as published with periodical updates.

Open Access Online Journal

http://www.pharmaceuticalIntelligence.com

is a scientific, medical and business, multi-expert authoring environment for information syndication in several domains of Life Sciences, Medicine, Pharmaceutical and Healthcare Industries, BioMedicine, Medical Technologies & Devices. Scientific critical interpretations and original articles are written by PhDs, MDs, MD/PhDs, PharmDs, Technical MBAs as Experts, Authors, Writers (EAWs) on an Equity Sharing basis.

Our DOMAINS in Scientific Media

I.   Pharmaceutical: Biologics, Small Molecules, Diagnostics

II.  Life Sciences: Genomics and Cancer Biology

III.  Patient-centered Medicine: Focus on #1: Cardiovascular, #2: Cancer, #3: Physiology: Metabolomics, Immunology

IV.  Biomedicine, BioTech, and MedTech (Medical Devices)

V.   HealthCare: Patient-centered Medicine and Personalized/Precision Medicine

List of Videos

 

New cardiovascular innovations in these videos from other conferences over the past year:

VIDEO: Editor’s Choice of the Most Innovative New Technology at TCT 2018

VIDEO: Editor’s Choice of the Most Innovative Echo Technology at ASE 2018

VIDEO: Trends and Advances in Cardiac CT Technology

VIDEO: Editor’s Choice of Most Innovative New Cardiac Technology at ACC 2018

VIDEO: Editor’s Choice of the Most Innovative New Imaging Technology at RSNA 2017

https://www.dicardiology.com/videos/video-editors-choice-most-innovative-new-cardiac-technology-aha-2018

 

List of Contributors

Contributors’ Biographies

• Co-Editor, Series A Content Consultant, Author of Preface, Introduction and Summary to Part One and Part two, Epilogue, Author of Articles and Clinical Pearls: 

Justin D. Pearlman MD ME PhD MA FACC

• Co-Editor, Author and Curator

Larry H Bernstein, MD, FCAP 

• Co-Editor, Author and Curator, Editor-in-Chief, BioMed e-Series, 16 Volumes, Curator of Series A, Volumes 5 & Volume 6 electronic Table of Contents (eTOCs), Articles Curator and Lead Scientific Reporter 

Aviva Lev-Ari, PhD, RN

 

ArticleID by Authors, Curators and Scientific Reporters

• • 154 authored and curated articles

• • 194 Scientific reports

In Total,  348 articleIDs

 

• Guest Authors & Live Link to Biographies: N = 9 articles

Ed Kislauskis, PhD N = 1	1.3.9
Demet Sag, PhD. et al. N = 3	6.1.1, 6.1.2, 6.1.3
Stephen J. Williams, PhD N = 1	6.2.2
Aviral Vatsa, PhD, MBBS N = 1	7.4.1
Dror Nir, PhD N = 1	8.1.2
Tilda Barliya, PhD N = 2	11.2.5, 14.4.1

 

• Lead Authors and Curators: N = 145 articles

• Lead Scientific Reporter: N = 194 articles

 

Author & Curator: Justin D. Pearlman, MD, PhD, FACC N = 3		4.1.2, 4.1.3, 8.1.1
Author and Curator: Larry H Bernstein, MD, FCAP N = 32		1.1.1, 1.1.2, 1.1.3, 1.2.4, 1.3.3, 2.4, 3.2.1, 3.3.4.1, 3.3.5.4, 5.1.1, 5.1.2, 5.1.9, 5.2.1, 5.2.2, 5.2.5, 6.2.1, 6.2.4, 6.2.5, 6.2.11, 7.3.2, 9.1, 9.6.1, 9.6.2, 9.6.5, 10.3.2.1, 10.3.2.4, 12.4.2.5, 14.1.1, 14.1.2, 14.2.5, 14.2.7, 14.3.1
Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN N = 35		1.2.3, 1.3.6, 3.3.5.1, 3.3.5.2, 3.3.5.3, 4.4.2, 6.2.8, 6.2.9, 7.2.3, 7.2.6, 9.4.1, 9.6.4, 9.6.6, 10.1.1, 10.1.6, 10.1,7, 10.1.8, 10.1.9, 10.1.11, 10.1.14, 10.2.1.3, 11.1.2, 11.1.3, 11.2.6, 12.3.1.2, 12.3.4.2, 12.3.4.3, 12.3.4.5, 12.4.1.1, 12.4.2.1, 13.2.12, 13.2.13, 13.4.1, 14.3.2, 14.3.5
Author: Justin Pearlman, MD, PhD, FACC,  Author and Curator:  Larry H Bernstein, MD, FCAP, and Curator: Aviva Lev-Ari, PhD, RN N = 1		2.6
Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN N = 13		2.7, 4.1.4, 4.1.5, 8.4.2, 8.4.4, 8.4.5, 8.5.1, 8.5.2, 8.7.4, 8.8.1, 10.1.10, 11.1.7, 13.3.2
Co-Editor: Larry H Bernstein, MD, FCAP, and Co-Editor: Justin Pearlman, MD, PhD, FACC N = 2		2.8, 7.2.2
Curators: Aviva Lev-Ari, PhD, RN and Larry H. Bernstein, MD, FCAP N = 1		9.4.5
Authors: Larry H Bernstein, MD, FCAP, Justin Pearlman, MD, PhD, FACC,  and Curator: Aviva Lev-Ari, PhD, RN N = 2		3.3.5.5, 10.1.4
Aviva Lev-Ari, PhD, RN   Curations:  N = 56 Scientific Reports: N = 194 ArticleIDs in Series A, Volume 6: N = 250		Curations N = 56   1.3.2, 2.1, 3.1.1, 3.1.2, 3.1.3, 3.1.4, 3.2.4, 3.2.6, 3.3.2.8, 3.3.2.12, 3.3.2.13, 3.3.3.2, 3.3.4.2, 3.3.5.6, 4.1.6, 4.3.2, 5.1.3, 5.1.4, 5.1.5, 6.2.7, 7.1.1, 7.2.4, 8.1.3, 8.1.6, 8.1.17, 8.4.1, 8.6.5, 8.9.2, 9.4.9, 9.5.1, 10.1.3, 10.1.5, 10.2.2.1, 10.2.2.3, 10.2.2.5, 10.3.1.5, 11.1.1, 11.1.5, 11.1.6, 11.2.2, 11.2.3, 11.2.4, 11.2.7, 11.3.1, 11.3.7, 11.3.10, 11.3.11, 12.1, 12.3.1.1. 12.3.2.2, 12.3.2.3, 12.3.4.7, 12.4.1.3, 13.1.8, 13.3.5, 14.6.1
Aviva Lev-Ari, PhD, RN   Curations: N = 56   Scientific Reports: N = 194 ArticleIDs in Series A, Volume 6: N = 250	Scientific Reporting N = 194 1.1.4, 1.2.1, 1.2.2, 1.3.1, 1.3.4, 1.3.5, 1.3.7, 1.3.8, 1.3.10, 2.2, 2.3, 2.5, 2.9, 2.10, 2.11, 3.1.5, 3.2.2, 3.2.3, 3.2.5, 3.3.1.1, 3.3.1.2, 3.3.1.3, 3.3.2.1, 3.3.2.2, 3.3.2.3, 3.3.2.4, 3.3.2.5, 3.3.2.6, 3.3.2.7, 3.3.2.9, 3.3.2.10, 3.3.2.11, 3.3.2.14, 3.3.3.1, 4.1.1, 4.1.7, 4.2.1, 4.2.2, 4.3.1, 4.4.1, 4.4.3, 5.1.6, 5.1.7, 5.1.8, 5.1.10, 5.1.11, 5.1.12, 5.1.13, 5.2.3, 5.2.4, 6.2.3, 6.2.6, 6.2.10, 6.3.1, 6.3.2, 6.3.3, 7.1.2, 7.1.3, 7.2.1, 7.2.5, 7.3.1, 8.1.4, 8.1.5, 8.1.7, 8.1.8, 8.1.9, 8.1.10, 8.1.11, 8.1.12, 8.1.13, 8.1.14, 8.1.15, 8.1.16, 8.2.1, 8.2.2, 8.2.3, 8.2.4, 8.2.5, 8.3.1, 8.3.2, 8.3.3, 8.3.4, 8.3.5, 8.3.6, 8.4.3, 8.4.6, 8.4.7, 8.6.1, 8.6.2, 8.6.3, 8.6.4, 8.7.1, 8.7.2, 8.7.3, 8.7.5, 8.9.1, 8.10.1, 8.11.1, 9.2, 9.3, 9.4.2, 9.4.3, 9.4.4, 9.4.6, 9.4.7, 9.4.8, 9.6.3, 10.1.2, 10.1.12, 10.1.13, 10.2.1.1, 10.2.1.2, 10.2.1.4, 10.2.2.2, 10.2.2.4, 10.2.2.6, 10.2.2.7, 10.3.1.2, 10.3.1.3, 10.3.1.4, 10.3.2.2, 10.3.2.3, 11.1.4, 11.1.8, 11.1.9, 11.1.10, 11.2.1, 11.2.8, 11.2.9, 11.2.10, 11.3.2, 11.3.3, 11.3.4, 11.3.5, 11.3.6, 11.3.8, 11.3.9, 12.2, 12.3.1.3, 12.3.1.4, 12.3.2.1, 12.3.3.1, 12.3.3.2, 12.3.4.1, 12.3.4.4, 12.3.4.6, 12.4.1.2, 12.4.2.2,12.4.2.3, 12.4.2.4, 12.4.2.6, 12.4.2.7, 12.4.2.8, 13.1.1, 13.1.2, 13.1.3, 13.1.4, 13.1.5, 13.1.6, 13.1.7, 13.1.9, 13.2.1, 13.2.2, 13.2.3, 13.2.4, 13.2.5, 13.2.6, 13.2.7, 13.2.8, 13.2.9, 13.2.10, 13.2.11, 13.2.14, 13.2.15, 13.2.16, 13.2.17, 13.2.18, 13.3.1, 13.3.3, 13.3.4, 13.3.6, 13.3.7, 13.5.1, 13.5.2, 13.6.1, 14.2.1, 14.2.2, 14.2.3, 14.2.4, 14.2.6, 14.3.3, 14.3.4, 14.5.1, 14.5.2

PREFACE by Justin D. Pearlman MD ME PhD MA FACC

Volume Six addresses Interventional Cardiology, Cardiac Imaging and Cardiac Surgery.

In lay terms, all patient interactions might be considered interventions, but in medicine, that term is reserved for procedures that directly produce physical changes. Surgical interventions for cardiovascular diseases include heart or heart and lung transplant, implantation of cardiac assist devices, shock devices and pacemakers, bypass grafts for coronary or other arteries, valve repairs or replacement, removal of plaque (endarterectomy), removal of tumors, and repair or palliation of injuries or of congenital anomalies. All of these interventions are continually studied and improved, with a major effort at minimizing the risk, reducing recovery time and reducing the size of entry scar, for example by use of video scopes instead of direct visualization, and mechanical devices and robotics instead of direct manual access. Interventional Cardiology refers to an often competing non-surgical approach in which access is limited to entry by vein or artery (catheterization). The two teams have joined forces  to achieve a major success in replacing aortic valves by femoral artery access without opening the chest at all (TAVR), with on-going progress towards a similar approach to mitral valve replacement.

Book Introduction by Justin D. Pearlman MD ME PhD MA FACC 

Volume Six: Interventional Cardiology and Cardiac Surgery for Disease Diagnosis and Guidance of Treatment addresses disease prevalence, personalized patient and doctor experiences with Cardiac Surgery, the role of transfusion, status of the MedTech market, and a review of major accomplishments from pathology, anesthesiology, radiology, cardiology and surgery. The contributions of specific groups, such as the Texas Heart Institute, the Dalio Institute at New York Presbyterian/Weill Cornell, the Cleveland Clinic, and the Scripps Institute are reviewed. Individual contributions from Eric Topol, Arthur Moss, Paul Zoll, Tim Wu, and Earl E. Bakken (Medtronic co-founder) are included. Discoveries in relevant biology, including ATP (the metabolic paycheck) and plasma metabolomics, and novel technologies such as tethered-liquid perfluorocabon surface biocoating to prevent clotting are further subjects of curation. Additional curations present views of cardiothoracic surgeons, of cath lab “jockeys”, and engineering of replacement body parts.  An aside presents poetic views expressed in a discussion between Dr. John M. Mandrola and Dr. Abraham Verghese. Business aspects are addressed by review of costs, prevalence, payment methods, prevention impact and business models.  Decision support tools are also reviewed, and changes in guidelines.

Overall, there were 2.2 million hospitalizations nationwide for cardiovascular events in 2016, resulting in $32.7 billion in costs and 415,480 deaths.

Data from sources including Healthcare Cost and Utilization Project databases and the National Vital Statistics System show that as many as 805,000 of the 2016 hospitalizations and 75,245 deaths occurred among adults under age 65 years.

“Many of these cardiovascular events are happening to middle-aged adults — who we wouldn’t normally consider to be at risk,” Schuchat said. “Most of these events can be prevented through daily actions to help lower risk and better manage medical conditions.”

The highest morality rates were seen among non-Hispanic blacks (211.6 per 100,000), and men had the highest hospitalization rates (989.6 per 100,000), with mortality rates of 172.3 per 100,000, and the rates increased with age.

The study also provides state-level data on nonfatal cardiovascular events — and showed surprisingly substantial variations in numerous measures: Rates of emergency department visits for cardiovascular events in 2016, for instance, per 100,000, ranged from 56.4 in Connecticut to as high as 274.8 in Kentucky; hospitalizations, per 100,000, ranged from 484.0 in Wyoming to 1670.3 in Washington, DC; and mortality, per 100,000, ranged from 11.2 in Vermont to 267.3 in Mississippi.

“This is one of the first studies to demonstrate striking state-level variation in nonfatal cardiovascular event rates and hospitaliza­tion costs using data collected among adults of all ages and across all payer types, including the uninsured,” the authors said.

SOURCE

Cardiovascular Event Rates High in Middle Age: CDC by Nancy A. Melville, September 11, 2018

https://www.medscape.com/viewarticle/901809?nlid=124992_4622&src=WNL_mdplsnews_180914_mscpedit_nurs&uac=93761AJ&spon=24&impID=1739205&faf=1

 

We start this book by sharing with the e-Reader three case studies on Cardiac Patient experience with Open Heart Surgery

https://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/2014-the-patients-voice-personal-experience-with-invasive-medical-procedures/

The Voice of Open Heart Surgery Survivors

• A Patient’s Perspective: On Open Heart Surgery from Diagnosis and Intervention to Recovery – A New Day, a New Lease and Unfolding Questions!
• Triple-bypass operation at age 69 – Ralph’s Story: An Entertainer at Heart
• A Fantastic Vessel-Clearing Innovation on The vessel-clearing device, U.S. Patent No. 8,663,209

 

These three articles are in Chapter 8: Cardiac Surgery, in

The VOICES of Patients, Hospitals CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures, 2017.

On Amazon.com since 10/16/2017

https://www.amazon.com/dp/B076HGB6MZ

 

We proceed by sharing with the e-Reader the expertise our members of the Team has in Cardiovascular Diseases and all the other aspects of Medicine that are dealing with co-morbidities causing cardiac maladaptations and dysfunctions. We express that expertise by a series of commentaries created to highlight the frontiers of Cardiology and of biological sciences as we have organized in a Series of 16 volumes in BioMedicine. Our focus is to demonstrate how each of the books is contributing to education of Patients and of medical stuff is the complexities of cardiovascular diseases. We demonstrate and analyze the context in which the Cardiovascular and Cardiac fields has been developed and what are the breakthrough innovations emerging in these interrelated fields.

Please start by reviewing the following articles for broader edification with our approach to this e-Book subject matter:

• Commentaries on each Volume’s Contribution to Medical Education by L.H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN – BioMedical e-Books e-Series: Multiple Volumes in Five e-Series

Author: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/biomed-e-books/commentaries-on-each-volumes-contribution-to-medical-education-by-l-h-bernstein-md-fcap-and-aviva-lev-ari-phd-rn-biomedical-e-books-e-series-multiple-volumes-in-five-e-series/

• Mapping the Universe of Pharmaceutical Business Intelligence: The Model developed by LPBI and the Model of Best Practices LLC

Author and Curator of Model A: Aviva Lev-Ari, PhD, RN and Reporter on Model B: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/13/mapping-the-universe-of-pharmaceutical-business-intelligence-the-model-developed-by-lpbi-and-the-model-of-best-practices-llc/

• An Overview of the Heart Surgery Specialty: heart transplant, lung transplant, heart-lung transplantation, aortic valve surgery, bypass surgery, minimally invasive cardiac surgery, heart valve surgery, removal of cardiac tumors, reoperation valve surgery

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/07/11/the-heart-surgery-specialty-heart-transplant-lung-transplant-heart-lung-transplantation-aortic-valve-surgery-bypass-surgery-minimally-invasive-cardiac-surgery-heart-valve-surgery-removal-of-ca/

• No evidence to change current transfusion practices for adults undergoing complex cardiac surgery: RECESS evaluated 1,098 cardiac surgery patients received red blood cell units stored for short or long periods

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/04/08/no-evidence-to-change-current-transfusion-practices-for-adults-undergoing-complex-cardiac-surgery-recess-evaluated-1098-cardiac-surgery-patients-received-red-blood-cell-units-stored-for-short-or-lon/

 

Team Collaborations on this book include:

https://pharmaceuticalintelligence.com/founder/medtech-medical-devices-for-cardiovascular-repair-curations/

• Editor-in-Chief’s Commissions and Investigator-initiated Articles on MedTech and Cardiovascular Medical Devices Published by LPBI Group’s Team Members
• Co-Curation Articles on MedTech and Cardiovascular Medical Devices by LPBI Group’s Team Members and Aviva Lev-Ari, PhD, RN
• Single-Author Curations by Aviva Lev-Ari, PhD, RN on MedTech (Cardiac Imaging) and Cardiac and Cardiovascular Medical Devices
• Single-Author Reporting on MedTech and Cardiac Medical Devices by Aviva Lev-Ari, PhD, RN

 

Repository of Sources

MedTech & Medical Devices for Cardiovascular Repair – Curations, Co-Curations and Reporting by Aviva Lev-Ari, PhD, RN

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/17/medtech-medical-devices-for-cardiovascular-repair-curation-by-aviva-lev-ari-phd-rn/

I.   Core important issues of Medical Policy in Cardiology, Technologies in Cardiac Surgery and Outcome monitoring in Care Delivery

 

2017 American Heart Association Annual Meeting: Sunday’s Science at #AHA17 – Presidential Address

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/11/13/2017-american-heart-association-annual-meeting-sundays-science-at-aha17-presidential-address/

2017 World Medical Innovation Forum: Cardiovascular, May 1-3, 2017, Partners HealthCare, Boston, at the Westin Hotel, Boston

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/14/2017-world-medical-innovation-forum-cardiovascular-may-1-3-2017-partners-healthcare-boston-at-the-westin-hotel-boston/

 

II.  The Marketplace for MedTech and Devices in Cardiovascular Medicine

 

Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/22/competition-in-the-ecosystem-of-medical-devices-in-cardiac-and-vascular-repair-heart-valves-stents-catheterization-tools-and-kits-for-open-heart-and-minimally-invasive-surgery-mis/

 

Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

 

III.  The book represents the Frontier in Technologies for Cardiac Imaging and Cardiac Repair – Part Two, below

Example of a novel technology

Tethered–Liquid Perfluorocarbon surface (TLP): Biocoating Prevents Blood from Clotting on Implantables

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/13/tethered-liquid-perfluorocarbon-surface-tlp-biocoating-prevents-blood-from-clotting-on-implantables/

Claimer:

• Some articles mentioned above as Repository of Sources, received an articleID and were sorted among the various Chapters in the e-Book since they provide a unique perspective and context for the content of the e-Book itself.
• One articles, 3.3.2.8 is identical to 10.2.2.5. In Chapter 3, this article represents a case for the process that a Medical Device is subjected to for being granted FDA Clearance. In Chapter 10, this article represent a technology used to treat refractory hypertension and the function of the cardiac-renal axis play in treatment for this condition by renal denervation.  
• All Videos references in this e-Book are courtesy of Youtube.com
• Cardiac Imaging for diagnosis is a large part of this e-Book. We acknowledge the expertise of e-Book Co-Editor, Justin D. Pearlman MD ME PhD MA FACC in Cardiac Imaging.
• This is the only e-Book in existence that covers in depth Cardiac Surgery, Interventional Cardiology and Cardiac Imaging. These three practitioners are affiliated to three different professional societies.
• This is the only e-Book in existence that covers in depth Cardiac Repair Medical Devices and Cardiac Surgery, Interventional Cardiology and Cardiac Imaging in ONE volume.
• We decided to include in addition to all modalities of Cardiac Repair also Vascular Repair, which represents a fourth surgical specialty using endovascular interventions and stent insertion in the systemic vasculature of the Brain, Head and Neck and the entire human body (Abdomen and Extremities), excluding the Heart which is under the care of Cardiac Surgeons (Cardio-thoracic Surgery Specialty) and Interventional Cardiologists. Interventional Radiologists deal with the systemic vasculature and work in tandem with Vascular surgeons.

Abbreviated eTOCs

 

PREFACE by Justin D. Pearlman MD ME PhD MA FACC

The scope of the following addresses interventional cardiology and cardiac surgery from many aspects, including the personal experience from patients and interventionalists, plus medical, societal and business aspects, including major biotechnical advances.

Part One: Trends in Intervention Cardiology and Cardiac Surgery

Introduction by Justin D. Pearlman MD ME PhD MA FACC

A review of contributions to the current state of the art from institutions and individuals personalizes a tour of the current capabilities and points to avenues for further advances. Business aspects and FDA are also covered.

Chapter 1: Lessons from the Past – Recognition of Pioneering Contributors to the Study of the Human Heart

Chapter 2: Cardiovascular Healthcare: Value and Cost Burden

Chapter 3: Clinical Trials and FDA Approval of Medical Devices

Summary by Justin D. Pearlman MD ME PhD MA FACC

Take home messages from the above include sharing the personal impact of having or treating a life-threatening cardiovascular condition, the vital importance of innovations to change the outcomes, and the trials and tribulations of both the patient, the caretaker, and the medical innovators. The burden of cardiovascular disease was reviewed, as well as the opportunities, hurdles and protections in the path of disseminating solutions.   

Part Two: Cardiovascular Diseases – Etiology, Diagnostics and Treatment Options

Introduction by Justin D. Pearlman MD ME PhD MA FACC

The following chapters focus on the causes and mechanisms of cardiovascular diseases, information crucial to identifying opportunities for prevention and amelioration. Understanding the genetic underpinnings (the templates for all proteins involved) not only clarifies the fine-tuning of biofeedback regulation, but also provides “biomarkers” (blood tests) that clarify patient status and responses to treatments. Three large topics – coronary disease, blood clots, and heart failure, receive particular attention by the process of curation (expert guided tour linked to original source materials). The topics covered are:

• I. Cardiovascular Diseases – Etiology 

Chapter 4: Coronary Arteries Disease and Interventions

Chapter 5: Genomics and Biomarkers of Cardiovascular Diseases

Chapter 6: Circulation, Coagulation and Thrombosis

Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical

• II. Cardiovascular Diseases – Diagnostics for Emergent Cardiac Events

Chapter 8: Cardiac Imaging and Cardinal Modalities of Cardiovascular Diagnostics

Chapter 9: Emergent Cardiac Events 

• III. Cardiovascular Diseases – Diagnostics and Management of Chronic Cardiovascular Disorders 

Chapter 10: Chronic Cardiovascular Disorders

• IV. Cardiovascular Diseases – Treatment Options

Chapter 11: Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

Chapter 12: Technologies to sustain Circulation: Enlargement of a Narrowing Artery by Stenting and Scaffolding 

Chapter 13: Valve Replacement, Valve Implantation and Valve Repair

Chapter 14: Modification of Heart Original Anatomy – Revolution in Technologies and Methods

Summary by Justin D. Pearlman MD ME PhD MA FACC

The material above presented a curation – a linkage to original material coupled with expert guidance – covering causes of cardiovascular diseases, opportunities and successes in diagnosis and treatment, and means to track the impact (biomarkers). The treatments continue to evolve, so the above emphasized the process as a guide to tracking that evolution.  The material covered personal impact, societal impact, mechanisms of disease, opportunities for prevention and treatment, and a tour of successes and challenges. There are competing strategies which present current challenges to decision making.

If you have or are advising someone burdened by coronary artery disease,

• should they focus on medical management, stenting, enhanced extracorporeal counter pulsation (EECP) or bypass surgery?
• If they have a valve problem, has medical management been optimized?
• Should they consider classic surgery, minimally invasive robotics, or transcutaneous intervention?
• What are the consequences?
• What is the risk of getting blood clots as a consequence?
• As the treatments evolve, so do the answers, so stay tuned.

EPILOGUE by Justin D. Pearlman MD ME PhD MA FACC

Thank you for joining us on a journey through the numerous facets of cardiovascular disease and its impact. If you are or become a patient, or a patient advocate, you will face important decisions. We hope the presentation of the state of the art in competing options will help you make the best decision at the time.

• If you are an innovator, we hope the presentation by examples plus business and regulation aspects helps you contribute further improvements to the management of the prevalent burden of cardiovascular diseases.
• If you are a politician or policy maker, we likewise hope this journey helps you form significant contributions. The electronic format enables continual updates, so come back and read more in the future, not just for review, but to keep up to date.
• If you are a Cardiologist in the Community or a Fellow in Cardiology, a Resident in Cardiology or a medical student – for you this volume is INVALUABLE on every topic that it covers.

 

Electronic Contents of Volume Six

 

PREFACE

by Justin D. Pearlman MD ME PhD MA FACC

Trends in interventional cardiology and cardiac surgery presents a curation, or guided tour, of original updates on the state of the art and the pathways linking past-present-future for structural changes by catheter or knife to address cardiovascular impairments.  It begins with a personal touch, heart-felt views from patient and doctor. That is followed by a tour through major contributions from centers and individuals. Many of the solutions involve devices, so a survey of companies, products, market share, and company focuses is covered, as well as clinical trial and FDA approval issues. Opportunities are addressed by presenting updates on the mechanisms of disease, intervention, and response monitoring, along with innovations and discoveries pointing a path for the future.

 

Part One

Trends in Intervention Cardiology and Cardiac Surgery

 

Introduction

Justin D. Pearlman MD ME PhD MA FACC

Atul Gawande authored “Complications: A Surgeon’s Notes on an Imperfect Science” as he completed his residency in cardiothoracic surgery. It presents a lively, prescient and candid first hand experience, trials and tribulations, in the cardiothoracic surgeon’s view of patient care. Dick Cheney co-authored with Jonathan Reiner M.D.  Heart: An American Medical Odyssey, which reviews his struggles with multiple heart attacks and near death experiences from heart failure, treated with an assist device and then transplantation. These two perspectives personalize major issues extant in Cardiology, and lay a strong foundation for delving deeply into the state of the art which is covered subsequently by curation of numerous relevant topics from individual and institutional contributions, ground breaking discoveries and advances.

Dick Cheney, the former vice president, had the first of five heart attacks in 1978, when he was 37 years old and running in his first political campaign, to become a Republican in the House of Representatives in Wyoming.  As consequences of multiple heart attacks, he became pacemaker dependent and then mechanical assist device dependent. He lived with the fear that enemies of the state might try to use RF reprogramming to kill him by reprogramming his pacemaker, so he had his doctors disable that feature. In 2010 the former vice president was within hours of dying from heart failure <http://www.usatoday.com/story/news/politics/2013/10/20/cheney-head–and-heart-strong/3107049/#>, when he was saved by urgent surgery to implant a left ventricular assist device with an external battery that kept him alive while he waited for a heart transplant. He received the call that he reached the top of the recipient list and a donor heart available for him 20 months later. “As I think about the future, I’m back where most people live their lives,” he told USA TODAY in an extended interview about Heart: An American Medical Odyssey, a new book he co-authored with cardiologist Jonathan Reiner. “Which is death is not imminent, and that’s different.”

 

Chapter 1: Lessons from the Past – Recognition of Pioneering Contributors to the Study of the Human Heart

 

1.1     In Service by the Cardiology Profession

1.1.1 Outstanding Achievement in Pathology

The Olympus microscope company created an award for unsung heroes in pathology. Dr. Tracey Corey Handy was recognized for her contributions as medical examiner for child abuse, by probing deeply into causes of child mortality, adding routine screening for metabolic defects apparent in conditions otherwise attributed to Sudden Infant Death Syndrome (SIDS). Dr. Matthew Zarka was recognized for his OB/GYN outreach work on behalf of extremely poor Mexican-Indian population in the remote mountain regions of Oaxaca, Mexico.  The contributions of Steven L. Gonias, M.D., Ph.D. apply to the heart in the more direct sense for  identifying and characterizing novel pathways of proteases and their cell-surface receptors. The laboratory of  David A. Herold, M.D., Ph.D. improved mass spectrometry applications to clinical diagnostics, including for prostaglandins, trace metal and steroids, in particular testosterone. The laboratory of David Cheresh Ph.D. has identified a series of critical microRNAs that regulate the growth of blood vessels (angiogenesis).  

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/09/26/outstanding-achievement-in-pathology/

 

1.1.2 Outstanding Achievement in Anesthesiology

Dr. Arthur Bert is a cardiac anesthesiologist for children and adults who participated in a research team growing tissue-engineered heart valves.  Dr. Henrik Kehlet, M.D., Ph.D. was recognized for advances in pain prevention (pre-emptive analgesia) and speedy recovery from surgery (fast track enhanced recovery after surgery). 

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/09/26/outstanding-achievement-in-anesthesiology/

 

1.1.3 Outstanding Achievements in Radiology or Radiotherapy

Curator: Larry H Bernstein, MD, FCAP

Radiation oncologists Dr. Lawrence Marks, Julian Rosenman and Joel Tepper are among 22 UNC-affiliated oncologists honored by Newsweek magazine. Dr. Timothy Zagar received ASTRO research award for assessing risk benefit of radiation versus alternative therapies. John C. Baumann, M.D. was honored for his quality rating as the chief of radiation oncology at the Walter Reed Medical Center. 

https://pharmaceuticalintelligence.com/2015/09/26/outstanding-achievements-in-radiology-or-radiotherapy/

1.1.4 American College of Cardiology 2015 Annual Meeting: Simon Dack Lecture: “I Carry Your Heart” by Abraham Verghese, MD

Dr. Abraham Verghese introduced a session of the American College of Cardiology (ACC) Scientific Sessions with an E.E> Cumings poem about heart: “I Carry Your Heart with Me,” which focuses on the power and unity of love, and how love connects not just two individuals but also the world at large.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/04/08/american-college-of-cardiology-2015-annual-meeting-simon-dack-lecture-i-carry-your-heart-by-abraham-verghese-md/

1.2     Basic Science Discoveries and Discoverers

1.2.1 Texas Heart Institute: 50 Years of Accomplishments

The Texas Heart Institute has passed its 50 year milestone, having performed more than 100,000 open heart operations, 200,000 cardiac catheterizations, and 1,000 heart transplants, with 20 consecutive years ranked as one of the top 10 heart centers in America (“America’s Best Hospitals,” U.S. News & World Report). This curation reviews its structure, history, and accomplishments.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/04/texas-heart-institute-50-years-of-accomplishments/

1.2.2 Dalio Institute of Cardiovascular Imaging @ NewYork-Presbyterian Hospital and Weill Cornell Medical College

The Dalio Institute for Cardiovascular Imaging , a joint venture from New York-Presbyterian Hospital and Weill Cornell Medicine, has focused on improvements in cardiac imaging and risk assessment, including a focus on vulnerable plaque. Vulnerable plaque is a major as yet unsolved issue due to the observation that while half of heart attacks occur as consequences of observable and stress test detectable blockages or “significant stenosis,” the other half of patients who had recent prior coronary imaging did not have flow limiting blockages, but rather had lesions minor in degree of obstruction that proved major in their consequences. Thus prevention for that category needs to identify and remedy “unstable plaque,” consisting of lesions that are not currently severe but are prone to fracture, plaque hemorrhage, and thrombogenesis, as causes of heart attacks.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/12/dalio-institute-of-cardiovascular-imaging-newyork-presbyterian-hospital-and-weill-cornell-medical-college/

1.2.3 ATP – the universal energy carrier in the living cell: Reflections on the discoveries and applications in Medicine

This curation tracks the discoveries that identified and elucidated the roles of ATP as the biologic paycheck for energizing cell activities, including enabling the beating of the heart.

Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/27/atp-the-universal-energy-carrier-in-the-living-cell-reflections-on-the-discoveries-and-applications-in-medicine/

1.2.4 A Future for Plasma Metabolomics in Cardiovascular Disease Assessment

In a search for early markers of heart attacks, peripheral plasma from Non ST Segment Elevation Acute Coronary Syndrome patients and healthy controls were analyzed by gas chromatography – mass spectrometry which identified 15 metabolites with statistical differences (p<0.05) between experimental groups.

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/09/09/a-future-for-plasma-metabolomics-in-cardiovascular-disease-assessment/

 

1.3     Leadership in Cardiology and in Design of Medical Devices

 

1.3.1 For Accomplishments in Cardiology and Cardiovascular Diseases: 2015 The Arrigo Recordati International Prize for Scientific Research

The Arrigo Recordati International Prize for Scientific Research (in memory of the Italian pharmaceutical entrepreneur) awarded 100,000 Euros to Professor John Joseph Valentine McMurray of Glasgow, Scotland, UK and Professor Salim Yusuf, of Hamilton, Canada for their contributions to population research into cardiovascular risk reduction.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/22/for-accomplishments-in-cardiology-and-cardiovascular-diseases-the-arrigo-recordati-international-prize-for-scientific-research/

 

1.3.2 Becoming a Cardiothoracic Surgeon: An Emerging Profile in the Surgery Theater and through Scientific Publications 

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/08/becoming-a-cardiothoracic-surgeon-an-emerging-profile-in-the-surgery-theater-and-through-scientific-publications/

 

1.3.3 Life-work in Engineering of Improved Heart Valve

Curator and Reporter: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/07/15/life-work-in-engineering-of-improved-heart-valve/

1.3.4 2017 American Heart Association Annual Meeting: Sunday’s Science at #AHA17 – Presidential Address

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/11/13/2017-american-heart-association-annual-meeting-sundays-science-at-aha17-presidential-address/

1.3.5 Cleveland Clinic: Change at the Top, Tomislav “Tom” Mihaljevic, M.D., as its next CEO and President to succeed Toby Cosgrove, M.D., effective Jan. 1, 2018

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/09/01/cleveland-clinic-change-at-the-top-tomislay-tom-mihaljevic-m-d-as-its-next-ceo-and-president-to-succeed-toby-cosgrove-m-d-effective-jan-1-2018/

1.3.6 Eric Topol, M.D., Gary & Mary West Endowed Chair of Innovative Medicine, Scripps Research, Executive VP, Scripps Research, Ex-Chairman of cardiovascular medicine at Cleveland Clinic and founder of the Cleveland Clinic Lerner College of Medicine

Curators: Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/09/22/eric-topol-m-d/

1.3.7 Renowned Electrophysiologist Dr. Arthur Moss Died on February 14, 2018 at 86

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/02/27/renowned-electrophysiologist-dr-arthur-moss-died-on-february-14-2018-at-86/

1.3.8 Paul Zoll, MD: Originator of Modern Electrocardiac Therapy – A Biography by Stafford Cohen, MD, BIDMC

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/16/paul-zoll-md-originator-of-modern-electrocardiac-therapy-a-biography-by-stafford-cohen-md-bidmc/

1.3.9 Introducing Dr. Tim Wu – Interventional Cardiologist, Inventor and Entrepreneur

Author: Ed Kislauskis, PhD

https://pharmaceuticalintelligence.com/2013/01/14/introducing-dr-tim-wu-interventional-cardiologist-inventor-and-entrepreneur/

1.3.10 Cardiac Medical Devices Pioneer, Earl E. Bakken, Medtronic Co-founder, the developer of the first external, battery-powered, transistorized pacemaker, died at 94 on 10/21/2018 in Hawaii

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/10/22/cardiac-medical-devices-pioneer-earl-e-bakken-medtronic-co-founder-the-developer-of-the-first-external-battery-powered-transistorized-pacemaker-died-at-94-on-10-21-2018-in-hawaii/

 

Chapter 2: Cardiovascular Healthcare: Value and Cost Burden

2.1     Mapping the Universe of Pharmaceutical Business Intelligence: The Model developed by LPBI and the Model of Best Practices LLC

Author and Curator of Model A: Aviva Lev-Ari, PhD, RN and Reporter on Model B: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/13/mapping-the-universe-of-pharmaceutical-business-intelligence-the-model-developed-by-lpbi-and-the-model-of-best-practices-llc/

2.2     An Overview of the Heart Surgery Specialty: heart transplant, lung transplant, heart-lung transplantation, aortic valve surgery, bypass surgery, minimally invasive cardiac surgery, heart valve surgery, removal of cardiac tumors, reoperation valve surgery

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/07/11/the-heart-surgery-specialty-heart-transplant-lung-transplant-heart-lung-transplantation-aortic-valve-surgery-bypass-surgery-minimally-invasive-cardiac-surgery-heart-valve-surgery-removal-of-ca/

2.3   Economic Toll of Heart Failure in the US: Forecasting the Impact of Heart Failure in the United States – A Policy Statement From the American Heart Association

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/economic-toll-of-heart-failure-in-the-us-forecasting-the-impact-of-heart-failure-in-the-united-states-a-policy-statement-from-the-american-heart-association/

2.4     The Cost to Value Conundrum in Cardiovascular Healthcare Provision

Author: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/01/01/the-cost-to-value-conundrum-in-cardiovascular-healthcare-provision/

2.5     PCI, CABG, CHF, AMI – An Overview Methods: Bundled payments (hospitalization costs, up to 90 days of post-acute care, nursing home care, complications, and rehospitalizations) vs Diagnosis-related groupings cover only what happens in the hospital.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/07/10/pci-cabg-chf-ami-two-payment-methods-bundled-payments-hospitalization-costs-up-to-90-days-of-post-acute-care-nursing-home-care-complications-and-rehospitalizations-vs-diagnosis-related-gro/

2.6     Treatment, Prevention and Cost of Cardiovascular Disease: Current & Predicted Cost of Care and the Potential for Improved Individualized Care Using Clinical Decision Support Systems

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC, Author and Curator: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/

2.7     Cardiovascular Diseases: Decision Support Systems for Disease Management Decision Making

Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/04/cardiovascular-diseases-decision-support-systems-for-disease-management-decision-making/

2.8     AHA, ACC Change in Requirement for Surgical Support: Class IIb -> Class III, Level of Evidence A: Supports Non-emergent PCI without Surgical Backup (Change of class IIb, Level of Evidence B).

Author, Curator, Volumes 1,2,3,4,5,6 Co-Editor: Larry H Bernstein, MD, FCAP, and

Author, Volume 2 & 5, Co-Editor and Content Consultant to Six-Volume e-SERIES A: Cardiovascular Diseases, Justin Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/07/17/aha-acc-change-in-requirement-for-surgical-support-class-iib-class-iia-level-of-evidence-a-support-nonemergent-pci-without-surgical-backup-change-of-class-iib-level-of-evidence-b/

The Voice of Justin D Pearlman, MD, PhD, FACC

Minimally invasive x-ray imaging of coronary artery disease (computed tomography instead of arterial catheterization cinefluoroscopy) provides lower quality images at similar or higher radiation and similar or higher contrast agent load without the opportunity for concurrent intervention. However, it does provide 3D data, does not require arterial catheterization with risks of vessel damage, is faster and easier, and there is progress reducing the radiation hazard. Recent advances add the ability to analyze intensity versus time to get prefusion data analogous to “flow reserve.”

2.9   CT Angiography (CCTA) Reduced Medical Resource Utilization compared to Standard Care reported in JACC

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/16/ct-angiography-ccta-reduced-medical-resource-utilization-compared-to-standard-care-reported-in-jacc/

2.10   Chest Radiation Therapy causes Collateral Damage to the Human Heart

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/08/28/chest-radiation-therapy-causes-collateral-damage-to-the-human-heart/

2.11 National Trends, 2005 – 2011: Adverse-event Rates Declined among Patients Hospitalized for Acute Myocardial Infarction or Congestive Heart Failure

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/02/04/national-trends-2005-2011-adverse-event-rates-declined-among-patients-hospitalized-for-acute-myocardial-infarction-or-congestive-heart-failure/

 

Chapter 3: Clinical Trials and FDA Approval of Medial Devices

3.1     Perspectives of the Regulatory Process & Market Aspects of the Medical Devices Technology Sector

 

3.1.1 MedTech & Medical Devices for Cardiovascular Repair – Curations, Co-Curations and Reporting by Aviva Lev-Ari, PhD, RN

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/17/medtech-medical-devices-for-cardiovascular-repair-curation-by-aviva-lev-ari-phd-rn/

3.1.2  Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

3.1.3  Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/22/competition-in-the-ecosystem-of-medical-devices-in-cardiac-and-vascular-repair-heart-valves-stents-catheterization-tools-and-kits-for-open-heart-and-minimally-invasive-surgery-mis/

3.1.4  Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

3.1.5 Expected New Trends in Cardiology and Cardiovascular Medical Devices

Reported: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2012/08/17/expected-new-trends-in-cardiology-and-cardiovascular-medical-devices/

3.2     USPTO – Issues in Patenting Innovations

3.2.1 USPTO Guidance On Patentable Subject Matter

Curator and Reporter: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/07/03/uspto-guidance-on-patentable-subject-matter/

3.2.2 Patent Dispute over Heart Defect Repair Technology: Appeals court Upholds Gore win over St. Jude Medical – Helex septal occluder competes with the Amplatzer device made by AGA/St. Jude

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/12/patent-dispute-over-heart-defect-repair-technology-appeals-court-upholds-gore-win-over-st-jude-medical-helex-septal-occluder-competes-with-the-amplatzer-device-made-by-agast-jude/

3.2.3 CardioMEMS sold to St. Jude Medical: Boston Millennia Partners announced that St. Jude Medical (NYSE: STJ) is acquiring the remaining 81 percent of CardioMEMS, Inc. it does not own for $375 million

Reporter: Aviva Lev-Ari,  PhD, RN

https://pharmaceuticalintelligence.com/2014/06/02/implantable-device-cardiomems-hf-system-for-heart-failure-patients-fda-approved/

3.2.4 Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/transcatheter-valve-competition-in-the-united-states-medtronic-corevalve-infringes-on-edwards-lifesciences-corp-transcatheter-device-patents/

3.2.5 Settled Heart Valve Lawsuit: Medtronic to Pay Edwards: Edwards Lifesciences’ Sapien XT beat out Medtronic’s CoreValve

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/16/first-head-to-head-trial-finds-edwards-tavr-superior-to-medtronics/

3.2.6 Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Reporter and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/06/28/spectranetics-a-technology-leader-in-medical-devices-for-coronary-intervention-peripheral-intervention-lead-management-to-be-acquired-by-philips-for-1-9-billion-euros/

3.3     FDA – Issues in Clinical Trials and Approval of Medical Devices

3.3.1  Policy Issues

3.3.1.1 FDA on Medical Devices: Part 1 – User Fee Act (MDUFA) III and Part 2 – Expedited Access Program for Medical Devices that Address Unmet Medical Needs

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/28/fda-on-medical-devices-part-1-user-fee-act-mdufa-iii-and-part-2-expedited-access-program-for-medical-devices-that-address-unmet-medical-needs/

3.3.1.2 Boston Scientific implant designed to occlude the heart’s left atrial appendage implicated with embolization – Device Sales in Europe halts

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/05/boston-scientific-implant-designed-to-occlude-the-hearts-left-atrial-appendage-implicated-with-embolization-device-sales-in-europe-halts/

3.3.1.3 Steps to minimise replacement of cardiac implantable electronic devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/02/04/steps-to-minimise-replacement-of-cardiac-implantable-electronic-devices/

3.3.2 Medical Devices: The 510(k) Clearance Process

3.3.2.1 Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/31/gaps-tensions-and-conflicts-in-the-fda-approval-process-implications-for-clinical-practice/

3.3.2.2 Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/02/27/expanded-stroke-thrombectomy-guidelines-fda-expands-treatment-window-for-use-up-to-24-hours-post-stroke-of-clot-retrieval-devices-strykers-trevo-stent-in-certain-stroke-patients/

3.3.2.3 Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/11/13/medical-devices-early-feasibility-fdas-pathway-accelerated-recruitment-for-randomized-clinical-trials-replacement-and-repair-of-mitral-valves/

3.3.2.4 Clinical Trials for Feasibility FDA’s Pathway Annulus Repairs and TAVR: CT Structural Software for Procedural Planning and Anatomical Assessments

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/08/15/clinical-trials-for-transcatheter-mitral-valves-annulus-repairs-and-tavr-ct-structural-software-for-procedural-planning-and-anatomical-assessments/

3.3.2.5 Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/10/13/abbotts-bioabsorbable-stent-met-its-primary-endpoint-in-a-u-s-clinical-trial-applications-for-fda-approval-follows/

3.3.2.6 New Era for PAD as FDA approval in the US of 1st Drug-coated Balloon (DCB) for PDA – CAD Indication for DCB will follow

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/15/new-era-for-pad-as-fda-approval-in-the-us-of-1st-drug-coated-balloon-dcb-for-pda-cad-indication-for-dcb-will-follow/

3.3.2.7 An FDA advisory committee unanimously recommended approval of the Lutonix drug-coated balloon PTA catheter for the treatment of patients with femoropopliteal occlusive disease.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/16/an-fda-advisory-committee-unanimously-recommended-approval-of-the-lutonix-drug-coated-balloon-pta-catheter-for-the-treatment-of-patients-with-femoropopliteal-occlusive-disease/

3.3.2.8 Market Impact on Global Suppliers of Renal Denervation Systems by Pivotal US Trial: Metronics’ Symplicity Renal Denervation System FAILURE at Efficacy Endpoint

Curator and Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/09/market-impact-on-global-suppliers-of-renal-denervation-systems-by-pivotal-us-trial-metronics-symplicity-renal-denervation-system-failure-at-efficacy-endpoint/

3.3.2.9 Hybrid Cath Lab/OR Suite’s da Vinci Surgical Robot of Intuitive Surgical gets FDA Warning Letter on Robot Track Record

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/hybrid-cath-labor-suites-da-vinci-surgical-robot-of-intuitive-surgical-gets-fda-warning-letter-on-robot-track-record/

3.3.2.10 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

3.3.2.11 FDA Approval for Under-Skin Defibrillator goes to Boston Scientific Corporation

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/10/01/fda-approval-for-under-skin-defibrillator-goes-to-boston-scientific-corporation/

3.3.2.12 FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/01/28/fda-pending-510k-for-the-latest-cardiovascular-imaging-technology/

3.3.2.13 Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/03/21/minimally-invasive-structural-cvd-repairs-fda-grants-510k-to-philips-echonavigator-x-ray-and-3-d-ultrasound-image-fused/

3.3.2.14 FDA: Strengthening Our National System for Medical Device Post-market Surveillance

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/07/fda-strengthening-our-national-system-for-medical-device-post-market-surveillance/

3.3.3  Transcatheter Aortic Valve Replacement (TAVR)

3.3.3.1 Transcatheter Aortic Valve Implantation (TAVI): FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/02/transcatheter-aortic-valve-implantation-tavi-risky-and-costly/

3.3.3.2 Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

3.3.4  Novel Chemical Entities (NCE)

3.3.4.1 Why did this occur? The matter of Individual Actions Undermining Trust, The Patent Dilemma and The Value of a Clinical Trials

Reporter and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/07/18/why-did-this-occur/

3.3.4.2 Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/10/19/clinical-trials-results-for-endothelin-system-pathophysiological-role-in-chronic-heart-failure-acute-coronary-syndromes-and-mi-marker-of-disease-severity-or-genetic-determination/

3.3.5  From Lab to Bedside: Translational, Post-Translational and Regenerative Medicine in Cardiology

3.3.5.1 Introduction to Translational Medicine (TM) – Part 1: Translational Medicine

Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2014/04/25/introduction-to-translational-medicine-tm-part-1/

3.3.5.2 Summary of Translational Medicine – e-Series A: Cardiovascular Diseases, Volume Four – Part 1

Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/28/summary-of-translational-medicine-cardiovascular-diseases-part-1/

3.3.5.3 Introduction to e-Series A: Cardiovascular Diseases, Volume Four Part 2: Regenerative Medicine

Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/27/larryhbernintroduction_to_cardiovascular_diseases-translational_medicine-part_2/

3.3.5.4 Summary – Volume 4, Part 2: Regenerative Medicine in Cardiovascular Diseases

Author and Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/05/10/summary-part-2-volume-4-translational-medicine-in-cardiovascular-diseases/

3.3.5.5 Epilogue: Volume 4 – Translational, Post-Translational and Regenerative Medicine in Cardiology

Larry H Bernstein, MD, FCAP, Author and Curator, Content Consultant for Series B,C,D,E

Justin Pearlman, MD, PhD, FACC, Author and Curator, Content Consultant for Series A: Cardiovascular Diseases

Aviva Lev-Ari, PhD, RN, Co-Editor and Editor-in-Chief, BioMed e-Series

https://pharmaceuticalintelligence.com/2014/05/12/epilogue-volume-4-post-translational-and-transformative-cardiology/

3.3.5.6 Stem Cells and Cardiac Repair: Scientific Reporting by Aviva Lev-Ari, PhD, RN

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/17/stem-cells-and-cardiac-repair-content-curation-scientific-reporting-aviva-lev-ari-phd-rn/

Summary by Justin D. Pearlman MD ME PhD MA FACC

Curated updates in cardiovascular disease and interventions by catheter or knife presented expert guided tours of literature addressing current treatments, new treatments available only at specialized centers, and pathways to upcoming improvements. The use of stem cells to repair previously permanent injuries from heart attacks is a particularly exciting arena. Reduced risk and recovery time by catheter-based aortic valve replacement is becoming a mainstream offering, initially for just patients who were deemed excessive risk for open surgery, but now becoming a desired alternative for patients not requiring concurrent surgery, e.g., for coronary artery bypasses (CABG). Trans-catheter repair of mitral regurgitation (MITRA) on the other hand has so far been less compelling due to less that stellar outcomes. The materials presented include companies, market shares, FDA and trial hurdles, and opportunities. The electronic format enables periodic updates, so return here not only to review, but to track progress and guides to further opportunities.

 

Part Two

Cardiovascular Diseases – Etiology, Diagnostics and Treatment Options

 

Introduction

Justin D. Pearlman MD ME PhD MA FACC

Curation of the topics addressing causes, diagnoses and treatment options starts with the cause of heart attacks – arterial plaques, and also covers hypertension, the two most common causes of heart failure. Subtopics include medication versus catheter intervention, endovascular intervention, tissue engineering, genomics and gene therapies. The understanding of disease mechanisms, treatments and opportunities to define status and response to interventions continuously evolves. Wise investment, further innovation, and decision making benefits from a mastery of every level of the curated data presented.

Chapter 4: Coronary Arteries Disease and Interventions

4.1     Thought Leadership on CAD

 

4.1.1. 2017 World Medical Innovation Forum: Cardiovascular, May 1-3, 2017, Partners HealthCare, Boston, at the Westin Hotel, Boston

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/14/2017-world-medical-innovation-forum-cardiovascular-may-1-3-2017-partners-healthcare-boston-at-the-westin-hotel-boston/

4.1.2 Unstable Arterial Plaques

Curator & Author: Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2014/06/08/unstable-arterial-plaques/

4.1.3 Coronary Artery Interventions: balloon, stent, drug-eluting and antiplatelet demand

Curator: Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2018/08/05/coronary-artery-interventions-balloon-stent-drug-eluting-stent-and-antiplatelet-demand/

4.1.4 State of Cardiology on Wall Stress, Ventricular Workload and Myocardial Contractile Reserve: Aspects of Translational Medicine (TM)

Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/09/30/state-of-cardiology-on-wall-stress-ventricular-workload-and-myocardial-contractile-reserve-aspects-of-translational-medicine/

4.1.5 Hypertension and Vascular Compliance: 2013 Thought Frontier – An Arterial Elasticity Focus

Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/11/arterial-elasticity-in-quest-for-a-drug-stabilizer-isolated-systolic-hypertension-caused-by-arterial-stiffening-ineffectively-treated-by-vasodilatation-antihypertensives/

4.1.6 Coronary artery disease in symptomatic patients referred for coronary angiography: Predicted by Serum Protein Profiles

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/12/29/coronary-artery-disease-in-symptomatic-patients-referred-for-coronary-angiography-predicted-by-serum-protein-profiles/

4.1.7 Cardiovascular Biology  – A Bibliography of Research @Technion

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/27/cardiovascular-biology-a-bibliography-of-research-technion/

4.2     Drug Therapy vs Angioplasty

4.2.1 Ischemic Stable CAD: Medical Therapy and PCI no difference in End Point: Meta-Analysis of Contemporary Randomized Clinical Trials

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/03/ischemic-stable-cad-ffr-in-5000-patients-medical-therapy-and-pci-no-difference-in-end-point-meta-analysis-of-contemporary-randomized-clinical-trials/

4.2.2 Fractional Flow Reserve–Guided PCI vs Drug Therapy for Stable Coronary Artery Disease

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/04/fractional-flow-reserve-guided-pci-vs-drug-therapy-for-stable-coronary-artery-disease/

 

4.3     In Search for CAD Causes 

4.3.1 Females and Non-Atherosclerotic Plaque: Spontaneous Coronary Artery Dissection – New Insights from Research and DNA Ongoing Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/12/female-and-non-atherosclerotic-plaque-spontaneous-coronary-artery-dissection-new-insights-from-research-and-dna-ongoing-study/

4.3.2 Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/10/19/clinical-trials-results-for-endothelin-system-pathophysiological-role-in-chronic-heart-failure-acute-coronary-syndromes-and-mi-marker-of-disease-severity-or-genetic-determination/

4.4     Milestones in CAD Therapy: Vascular Repair and Devices

4.4.1 Endovascular Aortic Repair: A New Tool for Procedure Planning

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/25/endovascular-aortic-repair-a-new-tool-for-procedure-planning/

4.4.2 Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization

Author and Curator: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/05/bioengineering-of-vascular-and-tissue-models/

4.4.3 Advanced Peripheral Artery Disease (PAD): Axillary Artery PCI for Insertion and Removal of Impella Device

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/13/advanced-peripheral-artery-disease-pad-axillary-pci-for-insertion-and-removal-of-impella-device/

Chapter 5: Genomics and Biomarkers of Cardiovascular Diseases

5.1 Genomics as a Determinant and Gene Therapy Potential

 

5.1.1 Summary of Genomics and Medicine: Role in Cardiovascular Diseases

Author: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/01/06/summary-of-genomics-and-medicine-role-in-cardiovascular-diseases/

5.1.2 Gene-Silencing and Gene-Disabling in Pharmaceutical Development

Curator: Larry H. Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2015/11/19/gene-silencing-and-gene-disabling-in-pharmaceutical-development/

5.1.3 Synthetic Biology: On Advanced Genome Interpretation for Gene Variants and Pathways: What is the Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/17/synthetic-biology-on-advanced-genome-interpretation-for-gene-variants-and-pathways-what-is-the-genetic-base-of-atherosclerosis-and-loss-of-arterial-elasticity-with-aging/

5.1.4 “Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/10/sudden-cardiac-death-sudd-is-in-ferrer-incodes-suite-of-cardiovascular-genetic-tests-to-be-commercialized-in-the-us/

5.1.5 Calcium Cycling (ATPase Pump) in Cardiac Gene Therapy: Inhalable Gene Therapy for Pulmonary Arterial Hypertension and Percutaneous Intra-coronary Artery Infusion for Heart Failure: Contributions by Roger J. Hajjar, MD

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/01/calcium-molecule-in-cardiac-gene-therapy-inhalable-gene-therapy-for-pulmonary-arterial-hypertension-and-percutaneous-intra-coronary-artery-infusion-for-heart-failure-contributions-by-roger-j-hajjar/

5.1.6 Genetics of Aortic and Carotid Calcification: The Role of Serum Lipids

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/12/genetics-of-aortic-and-carotid-calcification-the-role-of-serum-lipids/

5.1.7 Transposon-mediated Gene Therapy improves Pulmonary Hemodynamics and attenuates Right Ventricular Hypertrophy: eNOS gene therapy reduces Pulmonary vascular remodeling and Arterial wall hyperplasia

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/31/transposon-mediated-gene-therapy-improves-pulmonary-hemodynamics-and-attenuates-right-ventricular-hypertrophy-enos-gene-therapy-reduces-pulmonary-vascular-remodeling-and-arterial-wall-hyperplasia/

5.1.8 Lysyl Oxidase (LOX) gene mis-sense mutation causes Thoracic Aortic Aneurysm and Dissection (TAAD) in Humans because of inadequate cross-linking of collagen and elastin in the aortic wall. Mutation carriers may be predisposed to vascular diseases because of weakened vessel walls under stress conditions

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/19/lysyl-oxidase-lox-gene-missense-mutation-causes-thoracic-aortic-aneurysm-and-dissection-taad-in-humans-because-of-inadequate-cross-linking-of-collagen-and-elastin-in-the-aortic-wall/

5.1.9 The Implications of a Newly Discovered CYP2J2 Gene Polymorphism Associated with Coronary Vascular Disease in the Uygur Chinese Population

Author, Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/05/24/the-implications-of-a-newly-discovered-cyp2j2-gene-polymorphism-associated-with-coronary-vascular-disease-in-the-uygur-chinese-population/

5.1.10 Elastin Arteriopathy: The Genetics of Supravalvular Aortic Stenosis

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/30/elastin-arteriopathy-the-genetics-of-supravalvular-aortic-stenosis/

 

5.1.11 Abdominal Aortic Aneurysm: Matrix Metalloproteinase-9 Genotype as a Potential Genetic Marker

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/30/abdominal-aortic-aneurysm-matrix-metalloproteinase-9-genotype-as-a-potential-genetic-marker/

5.1.12 Gene, Meis1, Regulates the Heart’s Ability to Regenerate after Injuries

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/03/gene-meis1-regulates-the-hearts-ability-to-regenerate-after-injuries/

 

5.1.13 CT Angiography & TrueVision™ Metabolomics (Genomic Phenotyping) for new Therapeutic Targets to Atherosclerosis

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/11/15/ct-angiography-truevision-metabolomics-genomic-phenotyping-for-new-therapeutic-targets-to-atherosclerosis/

5.2     Role of Cardiac Biomarkers in Disease Diagnosis

 

5.2.1 Diagnostic Value of Cardiac Biomarkers

Author and Curator: Larry H Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2014/01/04/diagnostic-value-of-cardiac-biomarkers/

5.2.2 Assessing Cardiovascular Disease with Biomarker

Author and Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2012/12/25/assessing-cardiovascular-disease-with-biomarkers/

 

5.2.3 Cardiovascular Risk Inflammatory Marker: Risk Assessment for Coronary Heart Disease and Ischemic Stroke – Atherosclerosis

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/10/30/cardiovascular-risk-inflammatory-marker-risk-assessment-for-coronary-heart-disease-and-ischemic-stroke-atherosclerosis/

 

Serum Pentraxin 3 Levels, a newly identified inflammatory marker, indicate the complexity and severity of Coronary Artery Disease (CAD), for patients with stable angina

5.2.4 15 Novel Risk Loci for Coronary Artery Disease: found by International Consortium

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/12/03/15-novel-risk-loci-for-coronary-artery-disease-found-by-international-consortium/

5.2.5 Identification of Biomarkers that are Related to the Actin Cytoskeleton

Curator and Writer: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2012/12/10/identification-of-biomarkers-that-are-related-to-the-actin-cytoskeleton/

Chapter 6: Circulation, Coagulation, Stroke, Thrombosis and Thrombectomy

6.1 Basic Research

 

6.1.1 The Effects of Bovine Thrombin on HUVEC and AoSMC

Authors: Demet Sağ,^1,*and Jeffrey Harold Lawson^1,2

https://pharmaceuticalintelligence.com/2013/07/20/the-effects-of-bovine-thrombin-on-huvec-and-aosmc/

 

6.1.2 Topical Bovine Thrombin Induces Vascular Cell Proliferation

Authors: Demet Sağ, Kamran Baig*, Steven Hanish*, Jeffrey Lawson

https://pharmaceuticalintelligence.com/2013/07/20/topical-bovine-thrombin-induces-vascular-cell-proliferation/

6.1.3 The Effects of Aprotinin on Endothelial Cell Coagulant Biology

Authors: Demet Sag, PhD*†, Kamran Baig, MBBS, MRCS; James Jaggers, MD, Jeffrey H. Lawson, MD, PhD

https://pharmaceuticalintelligence.com/2013/07/20/the-effects-of-aprotinin-on-endothelial-cell-coagulant-biology/

 

6.2     Coagulation and Circulatory Disorders: Determinants of Thrombotic Risk

 

Artery walls use a simple molecule, nitric oxide, as a signal to adjust the diameter of each vessel appropriately for the variable demands of blood delivery.

6.2.1 Biochemistry of the Coagulation Cascade and Platelet Aggregation: Nitric Oxide: Platelets, Circulatory Disorders, and Coagulation Effects

Curator/Editor/Author: Larry H. Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2012/11/26/biochemistry-of-the-coagulation-cascade-and-platelet-aggregation/

6.2.2 Telling NO to Cardiac Risk, DDAH Says NO to ADMA(1); The DDAH/ADMA/NOS Pathway(2)

Author-Writer-Reporter: Stephen J. Williams, PhD

https://pharmaceuticalintelligence.com/2012/12/10/telling-no-to-cardiac-risk/

6.2.3 ATVB (Arteriosclerosis, Thrombosis and Vascular Biology)

2014 Conference  5/1 – 5/3/2014, Sheraton Centre Toronto – Toronto, Ontario

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/03/05/atvb-arteriosclerosis-thrombosis-and-vascular-biology-2014-conference-51-532014-sheraton-centre-toronto-toronto-ontario/

 

6.2.4 Hyperhomocysteinemia interaction with Protein C and Increased Thrombotic Risk

Reporter and Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/12/03/hyperhomocysteinemia-interaction-with-protein-c-and-increased-thrombotic-risk/

6.2.5 Triggering of Plaque Disruption and Arterial Thrombosis

Curator and Reporter: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/10/13/triggering-of-plaque-disruption-and-arterial-thrombosis/

6.2.6  Is Pharmacogenetic-based Dosing of Warfarin Superior for Anticoagulation Control?

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/02/04/is-pharmacogenetic-based-dosing-of-warfarin-superior-for-anticoagulation-control/

6.2.7 Cardiovascular Risk: C-Reactive Protein BioMarker and Plasma Fibrinogen

Curator & Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/01/24/cardiovascular-risk-c-reactive-protein-biomarker-and-plasma-fibrinogen/

6.2.8 What is the Role of Plasma Viscosity in Hemostasis and Vascular Disease Risk?

Author: Larry H Bernstein, MD and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/11/28/what-is-the-role-of-plasma-viscosity-in-hemostasis-and-vascular-disease-risk/

 

6.2.9 Special Considerations in Blood Lipoproteins, Viscosity, Assessment and Treatment

Author: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/11/28/special-considerations-in-blood-lipoproteins-viscosity-assessment-and-treatment/

 

The cardiovascular system is spread over a larger territory – the entire body. Coordination of functions requires signals be sent by either the nervous system or in the blood. A very small molecule, nitric oxide, controls dilation or contraction of muscular blood vessels, to adjust flow impedance, blood pressure, target tissue perfusion, and workload on the heart.

6.2.10 Prostacyclin and Nitric Oxide: Adventures in vascular biology –  a tale of two mediators

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/30/prostacyclin-and-nitric-oxide-adventures-in-vascular-biology-a-tale-of-two-mediators/

6.2.11 Coagulation: Transition from a familiar model tied to Laboratory Testing, and the New Cellular-driven Model

Curator: Larry H. Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2012/11/10/coagulation-transition-from-a-familiar-model-tied-to-laboratory-testing-and-the-new-cellular-driven-model/

6.3     Thrombus Aspiration and Filters

6.3.1 Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/02/27/expanded-stroke-thrombectomy-guidelines-fda-expands-treatment-window-for-use-up-to-24-hours-post-stroke-of-clot-retrieval-devices-strykers-trevo-stent-in-certain-stroke-patients/

6.3.2 Thrombectomy Guidelines Filters: Device for Prevention of Pulmonary Embolism and Thrombosis

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/04/vena-caval-filters-device-for-prevention-of-pulmonary-embolism-and-thrombosis/

6.3.3 Thrombus Aspiration for Myocardial Infarction: What are the Outcomes One Year After

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/04/thrombus-aspiration-for-myocardial-infarction-what-are-the-outcomes-one-year-after/

Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical

7.1     Trends in the Industry

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

In addition to minimally invasive treatments for coronary disease and valve disease, there are minimally invasive alternatives to heart transplant for the dangerously weak heart (extreme heart failure) which can otherwise result in Cardiogenic Shock. These involve various means to augment or complement the pumping function of the heart, such as a Ventricular Assist Device (VAD) .

With respect to the performance of Mitral Valve Replacement, the current practice favors bioprosthetic valves over mechanical valve replacement for most patients, initially just used for elderly to avoid need for coumadin, but now used at younger ages due to improvements in longevity of the bioprosthetic valves, plus less damage to red cells.

7.1.1 Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Reporter and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/06/28/spectranetics-a-technology-leader-in-medical-devices-for-coronary-intervention-peripheral-intervention-lead-management-to-be-acquired-by-philips-for-1-9-billion-euros/

7.1.2 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

7.1.3 Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/11/implantable-synchronized-cardiac-assist-device-designed-for-heart-remodeling-abiomeds-symphony/

7.2     Left Ventricular Failure

7.2.1 Entire Family of Impella Abiomed Impella® Therapy Left Side Heart Pumps: FDA Approved To Enable Heart Recovery

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/06/entire-family-of-impella-abiomed-impella-therapy-left-side-heart-pumps-fda-approved-to-enable-heart-recovery/

7.2.2 Treatment Options for Left Ventricular Failure – Temporary Circulatory Support: Intra-aortic balloon pump (IABP) – Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical)

Author: Larry H Bernstein, MD, FCAP And Curator: Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/07/17/treatment-options-for-left-ventricular-failure-temporary-circulatory-support-intra-aortic-balloon-pump-iabp-impella-recover-ldlp-5-0-and-2-5-pump-catheters-non-surgical-vs-bridge-therapy/

7.2.3 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

 

7.2.4 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction

Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/05/09/experimental-therapy-left-inter-atrial-shunt-implant-device-for-heart-failure-expert-opinion-on-a-preliminary-study-on-heart-failure-with-preserved-ejection-fraction/

 

7.2.5 CELLWAVE Randomized Clinical Trial: Modest improvement in LVEF at 4 months – “Shock wave–facilitated intracoronary administration of BMCs” vs “Shock wave treatment alone”

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/23/cellwave-randomized-clinical-trial-modest-improvement-in-lvef-at-4-months-shock-wave-facilitated-intracoronary-administration-of-bmcs-vs-shock-wave-treatment-alone/

7.2.6 Three-Dimensional Fibroblast Matrix Improves Left Ventricular Function post MI

Curators: Larry H. Bernstein, MD. FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/02/three-dimensional-fibroblast-matrix-improves-left-ventricular-function/

7.3     Right Ventricular Failure

7.3.1 Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/03/10/dilated-cardiomyopathy-decisions-on-implantable-cardioverter-defibrillators-icds-using-left-ventricular-ejection-fraction-lvef-and-midwall-fibrosis-decisions-on-replacement-using-late-gadolinium/

Amyloidosis and Right Ventricular Hypertrophy

Amyloidosis inserts abnormal proteins into tissues – in the heart, that results in an insidious decline cardiac function marked by increased stiffness (requiring high filling pressures that wet the lungs) and decreased contractility  or inotropy (pumping ability). resulting in poor circulation of nutrients to tissues and organs. Amyoloidosis is suspected when imaging shows thickened heart muscle and thickened valves with reduced function, but thickened muscle also occurs as a reaction to incomplete control of elevated blood pressures, as well as by other infiltrative disorders.

7.3.2 Amyloidosis with Cardiomyopathy

Author: Larry H Bernstein, MD, FACP

https://pharmaceuticalintelligence.com/2013/03/31/amyloidosis-with-cardiomyopathy/

Protein malnutrition lowers the oncotic (partical) pressure that keeps fluid in circulation, resulting in edema unrelated to heart failure. Transthyretin (pre-albumin) is used as a biomarker because its rapid clearance increases the significance of its concentration. However, it is also an “acute phase reactant” which means acute illness can temporary spoil its value as a biomarker of chronic states.

7.4 Implantable Cardioverter Defibrillator (ICD)

7.4.1 Reduction in Inappropriate Therapy and Mortality through ICD Programming

Reporter: Dr Aviral Vatsa, PhD, MBBS

https://pharmaceuticalintelligence.com/2013/01/04/reduction-in-inappropriate-therapy-and-mortality-through-icd-programming/

 

• II. Cardiovascular Diseases – Diagnostics for Emergent Cardiac Events

 

Chapter 8: Cardiac Imaging Diagnostic Modalities for Cardiovascular Disease Diagnosis

 

The FDA announced a partnership with a new nonprofit organization—the Medical Device Innovation Consortium (MDIC) —to advance regulatory science in the medical technology arena, e.g., promoting advanced cardiovascular imaging.

The Voice of Justin D. Pearlman, MD, PhD, FACC

Decisions about management of cardiovascular disease can get complex, and computer models may be useful. The following article discusses cost-benefit analysis, decision trees, and computer decision support systems, with specific examples.

Clinical Decision Support Systems for Management Decision Making of Cardiovascular Diseases

 

8.1     Diagnosis with Medical Imaging

 

8.1.1 Cardiovascular Imaging

Author: Justin D. Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/02/04/cardiovascular-imaging/

 

8.1.2 The Role of Medical Imaging in Personalized Medicine

Author & Reporter: Dror Nir, PhD

https://pharmaceuticalintelligence.com/2014/01/13/the-roll-of-medical-imaging-in-personalized-medicine/

8.1.3 Risks for Patients’ and Physician’s Health in the Cath Lab

Reporter and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/10/17/risks-for-patients-contrast-induced-nephropathy-and-physicians-health-radiation-exposure-in-the-cath-lab/

8.1.4 Among those 26 exams deemed low-value, 12 involve medical imaging, in tests that range from preoperative chest radiography to carotid artery screening for asymptomatic patients, imaging for back pain, and CT for headache and rhinosinusitis (JAMA Internal Medicine, May 12, 2014)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/13/among-26-exams-deemed-low-value-12-involve-medical-imaging-preoperative-chest-radiography-carotid-artery-screening-imaging-for-back-pain-and-ct-for-headache-and-rhinosinusitis-jama-im-may-12-2/

8.1.5 Echocardiogram Quantification: Quest for Reproducibility and Dependability

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/10/12/echocardiogram-quantification-quest-for-reproducibility-and-dependability/

8.1.6 CVD Prevention and Evaluation of Cardiovascular Imaging Modalities: Coronary Calcium Score by CT Scan Screening to justify or not the Use of Statin

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/03/03/cvd-prevention-and-evaluation-of-cardiovascular-imaging-modalities-coronary-calcium-score-by-ct-scan-screening-to-justify-or-not-the-use-of-statin/

8.1.7 Sudden Cardiac Death invisible at Autopsy: Forensic Power of Postmortem MRI

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/18/sudden-cardiac-death-invisible-at-autopsy-forensic-power-of-postmortem-mri/

8.1.8 “Medicine Meets Virtual Reality” – NextMed-MMVR21 Conference 2/19 – 2/22/2014, Manhattan Beach Marriott, Manhattan Beach, CA

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/09/medicine-meets-virtual-reality-nextmed-mmvr21-conference-219-2222014-manhattan-beach-marriott-manhattan-beach-ca/

8.1.9 Maladaptive Vascular Remodeling found by four-dimensional (4D) flow MRI: Outflow Patterns, Wall Shear Stress, and Expression of Aortopathy are caused by Congenital bicuspid aortic valve (BAV) Cusp Fusion

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/12/maladaptive-vascular-remodeling-found-by-four-dimensional-4d-flow-mri-outflow-patterns-wall-shear-stress-and-expression-of-aortopathy-are-caused-by-congenital-bicuspid-aortic-valve-bav-cusp-fus/

8.1.10 Echo vs Cardiac Magnetic Resonance Imaging (CMRI): CMRI may be a useful adjunct in Hypertrophic Cardiomyopathy (HCM) family screening in higher risk

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/20/echo-vs-cardiac-magnetic-resonance-imaging-cmri-cmri-may-be-a-useful-adjunct-in-hypertrophic-cardiomyopathy-hcm-family-screening-in-higher-risk/

 

Stiffness of the left ventricle, aorta, and ventricular-arterial coupling can be estimated from blood pressure, stroke volume and ejection fraction

8.1.11 iElastance: Calculates Ventricular Elastance, Arterial Elastance and Ventricular-Arterial Coupling using Echocardiographic derived values in a single beat determination

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/19/ielastance-calculates-ventricular-elastance-arterial-elastance-and-ventricular-arterial-coupling-using-echocardiographic-derived-values-in-a-single-beat-determination/

8.1.12 Cardiac Perfusion Exam, Rapid Heart Scanner, CT, MRI and PET imaging – Innovations in Radiology @ Beth Israel Deaconess Medical Center

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/12/cardiac-perfusion-exam-rapid-heart-scanner-ct-mri-and-pet-imaging-innovations-in-radiology-beth-israel-deaconess-medical-center/

8.1.13 Preserved vs Reduced Ejection Fraction: Available and Needed Therapies

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/03/preserved-vs-reduced-ejection-fraction-available-and-needed-therapies/

8.1.14 Myocardial Strain and Segmental Synchrony: Age and Gender in Speckle-tracking-based Echocardiographic Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/05/myocardial-strain-and-segmental-synchrony-age-and-gender-in-speckle-tracking-based-echocardiographic-study/

8.1.15 Comparison of four methods in diagnosing acute myocarditis: The diagnostic performance of native T1, T2, ECV to LLC

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/08/08/comparison-of-four-methods-in-diagnosing-acute-myocarditis-the-diagnostic-performance-of-native-t1-t2-ecv-to-llc/

8.1.16 Computationally designed “self”-peptide could be used to better target drugs to tumors, to ensure pacemakers are not rejected, and to enhance medical imaging technologies

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/12/08/computationally-designed-self-peptide-could-be-used-to-better-target-drugs-to-tumors-to-ensure-pacemakers-are-not-rejected-and-to-enhance-medical-imaging-technologies/

8.1.17 Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

8.2     Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI

8.2.1 What is the Atheroma (TCFA) of Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI?

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/02/27/what-is-the-role-of-noninvasive-diagnostic-fractional-flow-reserve-ffr-ct-vs-invasive-ffr-for-pci/

8.2.2 Fractional Flow Reserve vs. Angiography in Non-ST-segment Elevation Myocardial Infarction

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/02/24/fractional-flow-reserve-vs-angiography-in-non-st-segment-elevation-myocardial-infarction/

8.2.3 Fractional Flow Reserve–Guided PCI vs Drug Therapy for Stable Coronary Artery Disease

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/04/fractional-flow-reserve-guided-pci-vs-drug-therapy-for-stable-coronary-artery-disease/

8.2.4 Asymptomatic Patients After Percutaneous Coronary Intervention: Low Yield of Stress Imaging – Population-Based Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/27/asymptomatic-patients-after-percutaneous-coronary-intervention-low-yield-of-stress-imaging-population-based-study/

8.2.5 Females and Non-Atherosclerotic Plaque: Spontaneous Coronary Artery Dissection – New Insights from Research and DNA Ongoing Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/12/female-and-non-atherosclerotic-plaque-spontaneous-coronary-artery-dissection-new-insights-from-research-and-dna-ongoing-study/

8.3     Imaging Modeling for Preliminary Evaluation of CAD

 

8.3.1 Chest Pain: Cardiac MRI provides the Picture of MI

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/03/chest-pain-cardiac-mri-provides-the-picture-of-mi/

8.3.2 Stanford University researchers have developed a scanner that unites optical, radioluminescence, and photoacoustic imaging to evaluate for Thin-Cap Fibro Atheroma (TCFA)

Reporter: Aviva Lev-Ari, RN

https://pharmaceuticalintelligence.com/2018/07/23/stanford-university-researchers-have-developed-a-scanner-that-unites-optical-radioluminescence-and-photoacoustic-imaging-to-evaluate-for-thin-cap-fibro-atheroma-tcfa/

8.3.3 Hybrid Imaging 3D Model of a Human Heart by Cardiac Imaging Techniques: CT and Echocardiography

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/08/03/hybrid-imaging-3d-model-of-a-human-heart-by-cardiac-imaging-techniques-ct-and-echocardiography/

8.3.4 Low-dose and High-resolution Cardiac Imaging with Revolution™ CT

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/08/23/low-dose-and-high-resolution-cardiac-imaging-with-revolution-ct/

8.3.5 Coronary CT Angiography versus Standard Evaluation in Acute Chest Pain

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/09/coronary-ct-angiography-versus-standard-evaluation-in-acute-chest-pain/

8.3.6 ‘Mammogram for the heart’ can predict heart attack by Dr. James Min, Director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian Hospital and Weill Cornell Medical College

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/07/07/mammogram-for-the-heart-can-predict-heart-attack-by-dr-james-min-director-of-the-dalio-institute-of-cardiovascular-imaging-at-new-york-presbyterian-hospital-and-weill-cornell-medic/

 

8.4     Assessment and Detection of Plaque by Combined Imaging Methods

8.4.1 CVD Prevention and Evaluation of Cardiovascular Imaging Modalities: Coronary Calcium Score by CT Scan Screening to justify or not the Use of Statin

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/03/03/cvd-prevention-and-evaluation-of-cardiovascular-imaging-modalities-coronary-calcium-score-by-ct-scan-screening-to-justify-or-not-the-use-of-statin/

8.4.2 Coronary Circulation Combined Assessment: Optical Coherence Tomography (OCT), Near-Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) – Detection of Lipid-Rich Plaque and Prevention of Acute Coronary Syndrome (ACS)

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/25/coronary-circulation-combined-assessment-optical-coherence-tomography-oct-near-infrared-spectroscopy-nirs-and-intravascular-ultrasound-ivus-detection-of-lipid-rich-plaque-and-prevention-of-a/

The Voice of Justin D Pearlman, MD, PhD, FACC

Therapeutic endpoints for treatment of atherosclerosis have relied on lipid blood tests, but benefits of statins occur in patients with normal “target” levels prior to therapy. Some have argued the benefits relate not only to changes in blood lipids but also anti-inflammatory effects of statins. Carotid intimal thickness by high frequency ultrasound has been offered as an alternative method to guide success of halting and/or reversing plaque build up in arteries. The following article aims to offer another method which can be applied to coronary arteries, the aorta, and other vessels not reachable by surface high frequency ultrasound.

8.4.3 Advanced CT Reconstruction: Plaque Estimation Algorithm for Fewer Errors and Semiautomation

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/18/advanced-ct-reconstruction-plaque-estimation-algorithm-for-fewer-errors-and-semiautomation/

8.4.4 Normal and Anomalous Coronary Arteries: Dual Source CT in Cardiothoracic Imaging

Reporters: Justin D Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/18/normal-and-anomalous-coronary-arteries-dual-source-ct-in-cardiothoracic-imaging/

The Voice of Justin D. Pearlman, MD, PhD, FACC

The adequacy of coronary arteries (blood supply to the heart) to adapt to challenges is measured as fractional flow reserve. That measurement use to require catheterization, but now that can be computed from CT imaging. That method helps identify if a lesion is “Flow Limiting” rather than rely only on anatomic stenosis severity.

8.4.5 Emerging Clinical Applications for Cardiac CT: Plaque Characterization, SPECT Functionality, Angiogram’s and Non-Invasive FFR

Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/17/emerging-clinical-applications-for-cardiac-ct-plaque-characterization-spect-functionality-angiograms-and-non-invasive-ffr/

8.4.6 Coronary CT Angiography versus Standard Evaluation in Acute Chest Pain

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/09/coronary-ct-angiography-versus-standard-evaluation-in-acute-chest-pain/

8.4.7 Carotid Ultrasound more sensitive for Detecting Subclinical Atherosclerosis in patients with rheumatoid arthritis (RA) than CT with calculation of Coronary Artery Calcification Scores

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/10/09/carotid-ultrasound-more-sensitive-for-detecting-subclinical-atherosclerosis-in-patients-with-rheumatoid-arthritis-ra-than-ct-with-calculation-of-coronary-artery-calcification-scores/

8.5     Measurement of Myocardial Perfusion Viability and Ischemic Assessment

8.5.1 Acute and Chronic Myocardial Infarction: Quantification of Myocardial Perfusion Viability – FDG-PET/MRI vs. MRI or PET alone

Justin Pearlman, MD, PhD and Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2013/05/22/acute-and-chronic-myocardial-infarction-quantification-of-myocardial-viability-fdg-petmri-vs-mri-or-pet-alone/

8.5.2 Fractional Flow Reserve (FFR) & Instantaneous wave-free ratio (iFR): An Evaluation of Catheterization Lab Tools (Software Validation) for Ischemic Assessment (Diagnostics) – Change in Paradigm: The RIGHT vessel not ALL vessels

Reporters: Justin D Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/04/fractional-flow-reserve-ffr-instantaneous-wave-free-rario-ifr-an-evaluation-of-catheterization-lab-tools-for-ischemic-assessment/

8.6     Aortic Aneurysm: Ascending and Descending

8.6.1 Abdominal Aortic Aneurysms (AAA): Albert Einstein’s Operation by Dr. Nissen

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/11/abdominal-aortic-aneurysms-aaa-albert-einsteins-operation-by-dr-nissen/

8.6.2 Endovascular Aortic Repair: A New Tool for Procedure Planning

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/25/endovascular-aortic-repair-a-new-tool-for-procedure-planning/

8.6.3 First-of-Its-Kind FDA Approval for ‘AUI’ Device with Endurant II AAA Stent Graft: Medtronic Expands in Endovascular Aortic Repair in the United States

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/30/first-of-its-kind-fda-approval-for-aui-device-with-endurant-ii-aaa-stent-graft-medtronic-expands-in-endovascular-aortic-repair-in-the-united-states/

8.6.4 Abdominal Aortic Aneurysm: Endovascular repair and open repair resulted in similar long-term survival

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/12/03/abdominal-aortic-aneurysm-endovascular-repair-and-open-repair-resulted-in-similar-long-term-survival/

8.6.5 No Early Symptoms – An Aortic Aneurysm Before It Ruptures – Is There A Way To Know If I Have it?

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/10/no-early-symptoms-an-aortic-aneurysm-before-it-ruptures-is-there-a-way-to-know-if-i-have-it/

8.7     Cardiovascular Imaging for Detection of Atrial Fibrillation Onset

Screening for Atrial Fibrillation With Electrocardiography, US Preventive Services Task Force Recommendation Statement, US Preventive Services Task Force

Article Information

JAMA. 2018;320(5):478-484. doi:10.1001/jama.2018.10321

Audio Interview(16:50)

USPSTF Recommendation: Screening for Atrial Fibrillation With Electrocardiography

Abstract

Importance  Atrial fibrillation is the most common type of cardiac arrhythmia (irregular heartbeat), and its prevalence increases with age, affecting about 3% of men and 2% of women aged 65 to 69 years and about 10% of adults 85 years and older. Atrial fibrillation is a major risk factor for ischemic stroke, increasing risk of stroke by as much as 5-fold. Approximately 20% of patients who have a stroke associated with atrial fibrillation are first diagnosed with atrial fibrillation at the time of stroke or shortly thereafter.

Objective  To issue a new US Preventive Services Task Force (USPSTF) recommendation on screening for atrial fibrillation with electrocardiography (ECG).

Evidence Review The USPSTF reviewed the evidence on the benefits and harms of screening for atrial fibrillation with ECG in adults 65 years and older, the effectiveness of screening with ECG for detecting previously undiagnosed atrial fibrillation compared with usual care, and the benefits and harms of anticoagulant or antiplatelet therapy for the treatment of screen-detected atrial fibrillation in older adults.

Findings  Most older adults with previously undiagnosed atrial fibrillation have a stroke risk above the threshold for anticoagulant therapy and would be eligible for treatment. Anticoagulant therapy is effective for stroke prevention in symptomatic persons with atrial fibrillation and high stroke risk. However, the USPSTF found inadequate evidence to determine whether screening with ECG and subsequent treatment in asymptomatic adults is more effective than usual care. At the same time, the harms of diagnostic follow-up and treatment prompted by abnormal ECG results are well established and include misdiagnosis and invasive testing. Given these uncertainties, it is not possible to determine the net benefit of screening with ECG.

Conclusions and Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for atrial fibrillation with ECG. (I statement)

SOURCE

https://jamanetwork.com/journals/jama/fullarticle/2695678

 

8.7.1 Atrial Fibrillation Surgery Market worth $1.73 Billion by 2020

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/12/15/atrial-fibrillation-surgery-market-worth-1-73-billion-by-2020/

8.7.2 Convergent Procedure addresses the progressive nature of A-Fib

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/29/convergent-procedure-addresses-the-progressive-nature-of-a-fib/

8.7.3 Arrhythmias Detection: Speeding Diagnosis and Treatment – New deep learning algorithm can diagnose 14 types of heart rhythm defects by sifting through hours of ECG data generated by some REMOTELY iRhythm’s wearable monitors

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/07/10/arrhythmias-detection-speeding-diagnosis-and-treatment-new-deep-learning-algorithm-can-diagnose-14-types-of-heart-rhythm-defects-by-sifting-through-hours-of-ecg-data-generated-by-some-remotely-irhy/

8.7.4 On Devices and On Algorithms: Arrhythmia after Cardiac Surgery Prediction and ECG Prediction of Paroxysmal Atrial Fibrillation Onset

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/07/on-devices-and-on-algorithms-arrhythmia-after-cardiac-surgery-prediction-and-ecg-prediction-of-paroxysmal-atrial-fibrillation-onset/

8.7.5 Surgical Options for Left Atrial Appendage (LAA) Removal for A-Fib Patients without Indication for Anticoagulant Therapy

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/15/surgical-options-for-left-atrial-appendage-laa-removal-for-a-fib-patients-without-indication-for-anticoagulant-therapy/

8.8     Measurement of Hypertension and Hypercholesterolemia

8.8.1 Imaging Biomarker for Arterial Stiffness: Pathways in Pharmacotherapy for Hypertension and Hypercholesterolemia Management

Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/24/imaging-biomarker-for-arterial-stiffness-pathways-in-pharmacotherapy-for-hypertension-and-hypercholesterolemia-management/

8.9     Lower-extremity Revascularization

 

8.9.1 An FDA advisory committee unanimously recommended approval of the Lutonix drug-coated balloon PTA catheter for the treatment of patients with femoropopliteal occlusive disease.

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/16/an-fda-advisory-committee-unanimously-recommended-approval-of-the-lutonix-drug-coated-balloon-pta-catheter-for-the-treatment-of-patients-with-femoropopliteal-occlusive-disease/

 

8.9.2 Fractional Flow Reserve (FFR) & Instantaneous wave-free ratio (iFR): An Evaluation of Catheterization Lab Tools (Software Validation) for Endovascular Lower-extremity Revascularization Effectiveness: Vascular Surgeons (VSs), Interventional Cardiologists (ICs) and Interventional Radiologists (IRs)

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/01/endovascular-lower-extremity-revascularization-effectiveness-vascular-surgeons-vss-interventional-cardiologists-ics-and-interventional-radiologists-irs/

8.10     CT Role in Valve Replacement

 

8.10.1 Left ventricular outflow tract (LVOT) obstruction (LVOTO): The Role of CT in TAVR and in TMVR

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/07/25/left-ventricular-outflow-tract-lvot-obstruction-lvoto-the-role-of-ct-in-tavr-and-in-tmvr/

8.11   The Septal Occluder Device

8.11.1 Patent Dispute over Heart Defect Repair Technology: Appeals court Upholds Gore win over St. Jude Medical – Helex septal occluder competes with the Amplatzer device made by AGA/St. Jude

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/12/patent-dispute-over-heart-defect-repair-technology-appeals-court-upholds-gore-win-over-st-jude-medical-helex-septal-occluder-competes-with-the-amplatzer-device-made-by-agast-jude/

Chapter 9: Emergent Cardiac Events – Unstable Angina, Acute Myocardial Infarction (AMI), Asystole (cardiac arrest rhythm), Acute Coronary Syndrome

What is the treatment for Asystole? – “Sudden Cardiac Death,” SudD

The advanced cardiac life support (ACLS) 2010 guidelines allow vasopressin 40 IU IV as a 1-time dose treatment option in VF and asystole. This treatment can be given either before epinephrine or after the first dose of epinephrine. Dec 26, 2015

9.1     Accurate Identification and Treatment of Emergent Cardiac Events

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/03/15/accurate-identification-and-treatment-of-emergent-cardiac-events/

9.2     Protein Clue to Sudden Cardiac Death: Research @Oxford University

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/02/19/protein-clue-to-sudden-cardiac-death-research-oxford-university/

9.3     Evidence for Overturning the Guidelines in Cardiogenic Shock

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/03/evidence-for-overturning-the-guidelines-in-cardiogenic-shock/

9.4     Acute Myocardial Infarction

 

9.4.1 Previously undiscerned value of hs-troponin

Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/06/18/previously-undiscerned-value-of-hs-troponin/

 

9.4.2 What is the history of STEMI? What is the current treatment for Cardiogenic Shock? The Case Study of Detroit Cardiogenic Shock Initiative

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/05/07/what-is-the-history-of-stemi-what-is-the-current-treatment-for-cardiogenic-shock-the-case-study-of-detroit-cardiogenic-shock-initiative/

 

9.4.3 Thrombus Aspiration for Myocardial Infarction: What are the Outcomes One Year After

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/04/thrombus-aspiration-for-myocardial-infarction-what-are-the-outcomes-one-year-after/

 

9.4.4 On-Hours vs Off-Hours: Presentation to ER with Acute Myocardial Infarction – Lower Survival Rate if Off-Hours

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/22/on-hours-vs-off-hours-presentation-to-er-with-acute-myocardial-infarction-lower-survival-rate-if-off-hours/

 

9.4.5 Acute Myocardial Infarction: Curations of Cardiovascular Original Research A Bibliography

Curators: Aviva Lev-Ari, PhD, RN and Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/01/22/acute-myocardial-infarction-curations-of-cardiovascular-original-research-a-bibliography/

9.4.6 Culprit-Lesion Over Multivessel PCI in STEMI Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/11/07/culprit-lesion-over-multivessel-pci-in-stemi-patients/

9.4.7 Myocardial Infarction: The New Definition After Revascularization

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/10/15/myocardial-infarction-the-new-definition-after-revascularization/

9.4.8 New Definition of MI Unveiled, Fractional Flow Reserve (FFR) CT for Tagging Ischemia

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/27/new-definition-of-mi-unveiled-fractional-flow-reserve-ffrct-for-tagging-ischemia/

 

A novel approach uses micoscopic gold particles to impart electric signal to the heart of MI patients.

9.4.9 MIT’s Promise for the MI Patient: A new cardiac patch uses Gold Nanowires to enhance Electrical Signaling between heart cells

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/25/mits-promise-for-the-mi-patient-a-new-cardiac-patch-uses-gold-nanowires-to-enhance-electrical-signaling-between-heart-cells/

9.5     The Warning Symptoms for a Diagnosis in Suspect

 

9.5.1 Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

9.6     The Biomarker Troponin

 

9.6.1 Recent Insights into the High Sensitivity Troponins for Acute Coronary Syndromes

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/09/08/recent-insights-into-the-high-sensitivity-troponins-for-acute-coronary-syndromes/

9.6.2 More on the Performance of High Sensitivity Troponin T and with Amino Terminal Pro BNP in Diabetes

Writer and Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/01/20/more-on-the-performance-of-high-sensitivity-troponin-t-and-with-amino-terminal-pro-bnp-in-diabetes/

9.6.3 Atherosclerosis Risk and Highly Sensitive Cardiac Troponin-T Levels in European Americans and Blacks: Genome-Wide Variation Association Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/12/atherosclerosis-risk-and-highly-sensitive-cardiac-troponin-t-levels-in-european-americans-and-blacks-gemone-wide-variation-association-study/

9.6.4 Troponin I in acute decompensated heart failure: insights from the ASCEND-HF study

Writer and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/troponin-i-in-acute-decompensated-heart-failure/

9.6.5 Preparing the United States for High-Sensitivity Cardiac Troponin Assays

Curator: Larry Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/06/13/high-sensitivity-cardiac-troponin-assays/

9.6.6 Dealing with the Use of the High Sensitivity Troponin (hs cTn) Assays: Preparing the United States for High-Sensitivity Cardiac Troponin Assays

Author and Curator: Larry H Bernstein, MD, FCAP and Author and Curator: Aviva Lev-Ari, PhD, RD

https://pharmaceuticalintelligence.com/2013/05/18/dealing-with-the-use-of-the-hs-ctn-assays/

 

 

• III. Cardiovascular Diseases – Diagnostics and Management of Chronic Cardiovascular Disorders

 

Chapter 10: Management of Chronic Cardiovascular Disorders: Heart Failure (HF), CHF, Need for Heart Transplant (HT)

10.1   End-stage Heart Failure: The Heart Transplant Process, Devices and Survival post implantation

 

Heart & Heart-Lung Transplant: Voices of Larry H Benstein, MD, FCAP and Justin Pearlman MD, PhD, FACC

While heart surgery is the primary means to improve quality and quantity of life from severe valve disease and/or heart failure, there is a momentum building for less invasive competition, with newer options analogous to the alternatives to surgery achieved by the  catheter approach to coronary artery disease. There are a growing number of mechanical means of supporting a failing heart that can delay or possibly serve as an alternative to transplantation.

This section presents examples of achievements relating to preparation for or performance of heart or heart lung transplants lead by centers of excellence in cardiothoracic and vascular surgery, without any intention of ranking or subjugating the numerous other centers of excellence. For example, the Mayo Clinic in Rochester Minnesota has fame for excellence, but it also has very strong competition from Rush Medical Center in Chicago, the University of Michigan, Ann Arbor, the Henry Ford Hospital and the William Beaumont Hospital in Oakland, Michigan, to name a few other centers of excellence in the region. Similarly, Centers of Excellence in San Diego have regional competition from UCLA, Cedars-Sinai, Stanford and UC San Francisco. The Cleveland Clinic is now developing an educational venture with the outstanding Western-Reserve Medical School, a short distance away, in Cleveland, Ohio.

10.1.1 Heart Transplantation: NHLBI’s Ten year Strategic Research Plan to Achieving Evidence-based Outcomes

Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/heart-transplantation-research-in-the-next-decade-a-goal-to-achieving-evidence-based-outcomes/

10.1.2 Of the Cardiac-specific Deaths, Deaths from Heart Attack and Sudden Heart Rhythm Disturbances declined steeply, no decline in Deaths from Heart Failure in a 20,000 PCI patients Study @ Mayo Clinic

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/12/of-the-cardiac-specific-deaths-deaths-from-heart-attack-and-sudden-heart-rhythm-disturbances-declined-steeply-but-there-was-no-decline-in-deaths-from-heart-failure-in-a-20000-pci-patients-study/

10.1.3 Heart Transplant (HT) Indication for Heart Failure (HF): Procedure Outcomes and Research on HF, HT @ Two Nation’s Leading HF & HT Centers

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/09/research-programs-george-m-linda-h-kaufman-center-for-heart-failure-cleveland-clinic/

10.1.4 Alternative Designs for the Human Artificial Heart: Patients in Heart Failure – Outcomes of Transplant (donor) / Implantation (artificial) and Monitoring Technologies for the Transplant/Implant Patient in the Community

Authors and Curators: Larry H Bernstein, MD, FCAP and Justin D Pearlman, MD, PhD, FACC and Article Curator and Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/05/alternative-designs-for-the-human-artificial-heart-the-patients-in-heart-failure-outcomes-of-transplant-donorimplantation-artificial-and-monitoring-technologies-for-the-transplantimplant-pat/

10.1.5 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with Preserved Ejection Fraction

Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/05/09/experimental-therapy-left-inter-atrial-shunt-implant-device-for-heart-failure-expert-opinion-on-a-preliminary-study-on-heart-failure-with-preserved-ejection-fraction/

10.1.6 Orthotopic Heart Transplant (OHT): Effects of Autonomic Innervation / Denervation on Atrial Fibrillation (AF) Genesis and Maintenance

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/decreased-postoperative-atrial-fibrillation-following-cardiac-transplantation/

10.1.7 Pre-operative Risk Factors and Clinical Outcomes Associated with Vasoplegia in Recipients of Orthotopic Heart Transplantation in the Contemporary Era

Writer and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/vasoplegia-in-orthotopic-heart-transplants/

10.1.8 Mechanical Circulatory Assist Devices as a Bridge to Heart Transplantation or as “Destination Therapy“: Options for Patients in Advanced Heart Failure

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/advanced-heart-failure/

The Voice of Larry H. Bernstein, MD, FCAP on Immune suppression and Heart Transplants

Heart transplants (and heart lung transplants) require immune suppression so that the body defenses against foreign cell activities such as infection, cancer or transplants to not succeed in rejecting the transplant. Thus transplant patients have risks not only of organ rejection (autoimmune attack) but also serious infections and cancers. Replacing the original organ with one from a donor (orthotopic transplant) comes with serious complications. In addition to transplant rejection, infection, cancer, accelerated atherosclerosis, also vasoplegia is a serious problem of increased vascular resistance thought to be due to dysregulation of endothelial homeostasis and subsequent endothelial dysfunction secondary to direct and indirect effects of multiple inflammatory mediators. Vasoplegia has been observed in all age groups and in other clinical settings besides transplants; vasoplegia has also been associated with protamine reaction, other anaphylaxis, sepsis, hemorrhagic shock, or hemodialysis and cardiac surgery.

10.1.9 After Cardiac Transplantation: Sirolimus acts as immunosuppressant Attenuates Allograft Vasculopathy

Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2013/06/30/sirolimus-as-primary-immunosuppression-attenuates-allograft-vasculopathy/

The Voice of Justin D. Pearlman, MD, PhD, FACC on Electric System of the Heart: Pacemakers & Implantable Cardiac Defibrillators (ICD)

The electric system of the heart communicates when each portion of the heart should contract (beat). An enlarged failing heart has longer and slower pathways often with the complication of asynchronous contraction (poorly timed electric activation of muscle movement), so different parts activate staggered over time instead of as a coordinated effort, resulting in a relatively uncoordinated wobble rather than a maximally effective beat.  Cardiac Resynchronization consists of inserting a plurality of pacemaker wires designed and adjusted to compensate for bad timing so that the contraction effort is more synchronized. If the electrical activation is asynchronous, then assuming that the axis of maximal difference in timing is parallel to one of the electrocardiogram (ECG) lead views, then the ECG will show wide activation in at least one lead (QRS duration > 120 msec). Both MRI and Echo imaging have been applied to identify the axis of maximal difference in timing to help guide placement of lead wires in the heart and timing offsets between the lead wire stimulations of regional heart contraction (a topic studied by Dr. Pearlman using MRI and TEE). Unfortunately, remedy is limited – if leads are placed by catheter, the location choices are limited to the apex of the right ventricle, and a left ventricular branch of the coronary sinus. At surgery, there is greater freedom to place epicardial leads at favorable locations in viable myocardium. If the heart is prone to dangerous dysrhythmias such as ventricular tachycardia or ventricular fibrillation, pacing can sometimes help, but the surest method is delivery of an electric shock to stop the bad rhythm, and resynchronize preparation for a better rhythm. The decision of when to burst pace and when to shock is computed by an implantable computer chip as part of an implantable cardiac defibrillator (ICD). Patients with irreversible heart failure with ejection fraction remaining <35% after >3 months of optimized triple therapy (beta blocker, angiotensin-converting-enzyme inhibitor, aldosterone inhibitor) are prone to death from arrhythmia, and may live considerably longer with an ICD.

10.1.10 Cardiac Resynchronization Therapy (CRT) to Arrhythmias: Pacemaker/Implantable Cardioverter Defibrillator (ICD) Insertion

Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/22/cardiac-resynchronization-therapy-crt-to-arrhythmias-pacemakerimplantable-cardioverter-defibrillator-icd-insertion/

The Voice of Justin D. Pearlman, MD, PhD, FACC

Patients with heart failure develop abnormal breathing patterns mediated by the phrenic nerve which controls diaphragm contractions. Nerve stimulators enable computer control to change such patterns. In particular, there is an abnormal pattern of breathing called Cheyne-Stokes Respiration characterized by progressively deeper and/or  faster breathing followed by a decrease leading to a brief stoppage of breathing. Investigators have looked at taking control of the phrenic nerve to alleviate the Cheyne-Stokes abnormal respiration pattern.

10.1.11 Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/20/phrenic-nerve-stimulation-in-patients-with-cheyne-stokes-respiration-and-congestive-heart-failure/

10.1.12 Premature Ventricular Contraction percentage predicts new Systolic Dysfunction and clinically diagnosed CHF and overall Mortality

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/07/14/premature-ventricular-contraction-percentage-predicts-new-systolic-dysfunction-and-clinically-diagnosed-chf-and-overall-mortality/

10.1.13 Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/10/03/rhythm-management-device-hardware-dual-chamber-pacemaker-coupled-with-backbeats-cardiac-neuromodulation-therapy-cnt-bioelectronic-therapy-for-lowering-systolic-blood-pressure-for-patients-w/

10.1.14 Prognostic Marker Importance of Troponin I in Acute Decompensated Heart Failure (ADHF)

Curators: Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/troponin-i-in-acute-decompensated-heart-failure/

10.2   Kidney and Heart

10.2.1 Cardio-Renal Syndrome in Heart Failure

 

10.2.1.1 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

10.2.1.2 Intravascular Stimulation of Autonomics: A Letter from Dr. Michael Scherlag

Letter received by Aviva Lev-Ari, PhD, RN on September 1, 2012

https://pharmaceuticalintelligence.com/2012/09/02/intravascular-stimulation-of-autonomics-a-letter-from-dr-michael-scherlag/

10.2.1.3 The Cardiorenal Syndrome in Heart Failure: Cardiac? Renal? syndrome?

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2013/06/30/the-cardiorenal-syndrome-in-heart-failure/

 

Predicting Outcomes: Collecting data on death rates and prior lab values can identify associations. It is important to consider the biologic plausibility

10.2.1.4 Long-Term Mortality in Treated Hypertensive Patients: Serum Uric Acid Level, Longitudinal Blood Pressure and Renal Function

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/20/long-term-mortality-in-treated-hypertensive-patients-serum-uric-acid-level-longitudinal-blood-pressure-and-renal-function/

 

10.2.2 Refractory Hypertension, Renal Artery Denervation Procedures and Alternatives in Device/Tool Design – Industry Trends

10.2.2.1 Renal Sympathetic Denervation: Updates on the State of Medicine

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/12/31/renal-sympathetic-denervation-updates-on-the-state-of-medicine/

10.2.2.2 PAD and Resistance Hypertension: Renal Artery Intervention using Stenting

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/02/pad-and-resistance-hypertension-renal-artery-intervention-using-stenting/

10.2.2.3 Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/13/treatment-of-refractory-hypertension-via-percutaneous-renal-denervation/

10.2.2.4 Potential Explanation to Lack of Efficacy Results of SYMPLICITY HTN-3 Study that Contradict Most Published Data on Renal Denervation

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/03/31/potential-explanation-to-lack-of-efficacy-results-of-symplicity-htn-3-study-that-contradict-most-published-data-on-renal-denervation/

10.2.2.5 Market Impact on Global Suppliers of Renal Denervation Systems by Pivotal US Trial: Metronics’ Symplicity Renal Denervation System FAILURE at Efficacy Endpoint

Curator and Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/09/market-impact-on-global-suppliers-of-renal-denervation-systems-by-pivotal-us-trial-metronics-symplicity-renal-denervation-system-failure-at-efficacy-endpoint/

10.2.2.6  St. Jude’s CEO is still betting on EnligHTN IV Study Renal Denervation System, despite Medtronic’s setback related to SYMPLICITY Phase IV

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/10/renal-denervation-enlightn-iv-study-called-off-and-potential-novel-indications-diastolic-heart-failure/

10.2.2.7 Renal Denervation Technology of Vessix Vascular, Inc. been acquired by Boston Scientific Corporation (BSX) to pay up to $425 Million

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/11/08/renal-denervation-technology-of-vessix-vascular-inc-been-acquired-by-boston-scientific-corporation-bsx-to-pay-up-to-425-million/

10.3   Lung and Heart

 

10.3.1 Pulmonary Arterial Hypertension

 

10.3.1.2 riociguat (Adempas, Bayer) for the treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) – Approved by FDA 10/2013

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/29/riociguat-adempas-bayer-for-the-treatment-of-chronic-thromboembolic-pulmonary-hypertension-cteph-and-pulmonary-arterial-hypertension-pah-approved-by-fda-102013/

10.3.1.3 Endothelial Cell Dysfunction plays a role in the Pathogenesis of Alzheimer’s Disease, Atherosclerosis, Diabetes, and Pulmonary Hypertension: New Research @Cleveland Clinic

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/02/endothelial-cell-dysfunction-plays-a-role-in-the-pathogenesis-of-alzheimers-disease-atherosclerosis-diabetes-and-pulmonary-hypertension-new-research-cleveland-clinic/

10.3.1.4 Clinical Effects and Cardiac Complications of Recreational Drug Use: Blood pressure changes, Myocardial ischemia and infarction, Aortic dissection, Valvular damage, and Endocarditis, Cardiomyopathy, Pulmonary edema and Pulmonary hypertension, Arrhythmias, Pneumothorax and Pneumopericardium

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/30/clinical-effects-and-cardiac-complications-of-recreational-drug-use-blood-pressure-changes-myocardial-ischemia-and-infarction-aortic-dissection-valvular-damage-and-endocarditis-cardiomyopathy-p/

 

10.3.1.5 Calcium Cycling (ATPase Pump) in Cardiac Gene Therapy: Inhalable Gene Therapy for Pulmonary Arterial Hypertension and Percutaneous Intra-coronary Artery Infusion for Heart Failure: Contributions by Roger J. Hajjar, MD

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/01/calcium-molecule-in-cardiac-gene-therapy-inhalable-gene-therapy-for-pulmonary-arterial-hypertension-and-percutaneous-intra-coronary-artery-infusion-for-heart-failure-contributions-by-roger-j-hajjar/

 

10.3.2 Hypertrophic Cardiomyopathy – Genetics and Genomics Aspects

10.3.2.1 Amyloidosis with Cardiomyopathy

Author: Larry H Bernstein, MD, FACP

https://pharmaceuticalintelligence.com/2013/03/31/amyloidosis-with-cardiomyopathy/

10.3.2.2 Implications of Inheritance for Clinical Management: Common Cardiovascular Disorders When There Is a Family History

Reporter: Aviva Lev- Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/12/implications-of-inheritance-for-clinical-management-common-cardiovascular-disorders-when-there-is-a-family-history/

10.3.2.3 North Americans With Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy: Genomics of Ventricular arrhythmias, A-Fib, Right Ventricular Dysplasia, Cardiomyopathy – Comprehensive Desmosome Mutation Analysis

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/18/north-americans-with-arrhythmogenic-right-ventricular-dysplasiacardiomyopathy-genomics-of-ventricular-arrhythmias-a-fib-right-ventricular-dysplasia-cardiomyopathy-comprehensive-desmosom/

10.3.2.4 MYBPC3 gene and the heart

Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/11/05/mybpc3-gene-and-the-heart/

 

• IV. Cardiovascular Diseases – Treatment Options

 

Introduction to Invasive Procedures by Surgery versus Catheterization

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

Coronary artery disease (blockages in blood supply) causes heart attacks by two methods: (1) severe narrowing that provides insufficient nutrition and oxygen to a region of heart muscle compared to its needs (hence the tissue commits a form of hara-kari called apoptosis), or (2) unstable plaque that can crack, cause localized hemorrhage into the wall of a coronary artery, and clot, suddenly stopping blood supply to a region of heart muscle, also triggering apoptosis and cell death with replacement of heart muscle by scar tissue. As little as ten minutes of stopped blood supply can trigger cell death (myocardial infarction), hence the phrase “time is muscle” with urgency to relieve problems by nitrates and catheterization. The blood supply to the heart consists of the left main (LM, a short vessel that promptly branches to the left anterior descending (LAD), and the left circumflex (LCX)), and the right coronary (RCA) which often gives rise to the posterior descending artery (PDA) (10% of patients get PDA blood supply as an extension of the LCX). Based on the normal branching pattern of blood supply to the heart, lesions causing blockage may cause heart attacks affecting different regions:

SOURCE for FIGURES

Robin Smithuis and Tineke Wilems
Radiology department of the Rijnland Hospital Leiderdorp and the University Medical Centre Groningen, the Netherlands.
http://rad.desk.nl/en/48275120e2ed5 

• septum (anterior 2/3 of the interventricular septum, LAD),
• apex (distal LAD),
• anterior (mid LAD),
• pan-anterior (proximal LAD or LM),
• lateral (LCX),
• inferior wall (PDA, RCA or LCX) and
• right ventricle (RCA).

As one in four people eventually get a heart attack (myocardial infarction, death of heart muscle), and a third die from that, there have been great efforts at prevention. Heart attacks can be prevented by

(1) not smoking,

(2) small waist (<35 inches for women, <40 inches for men),

(3) prevent or control of diabetes,

(4) control of lipids/cholesterol.

(5) control of inflammation (limited data favors keeping hs-CRP below 2.0)

Additional benefits have been demonstrated from fish oil (controversy about inconsistent association with prostate cancer not withstanding), alcohol (1/2 to 2 drinks daily elevates apoproteins and HDL which reverses lipid deposits in arterial walls), and statins even if LDL is not high, and possibly red wine or grape congeners, and possibly an anti-inflammatory biologic (canakinumab – but the FDA declined allowing that benefit label). All of these aim to prevent the development of blockages. Once blockages do develop, one may consider balloon angioplasty to open the obstruction, bare metal stent to keep it propped open, drug-eluting stent to inhibit reactive tissue growth, or bypass surgery.

While heart surgery is the primary means to improve quality and quantity of life from severe valve disease, there is a momentum building for less invasive competition analogous to the catheter approach to coronary artery disease.

Introduction to Cardiothoracic Surgery

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

VIEW VIDEOS  – Courtesy of YouTube as well as the individual sponsors of the links cited below.

• VIDEO: Cardiac Surgery Simulation – Graphics Hardware meets Congenital Heart Disease
• VIDEO: SPY Imaging: Quality in Heart Bypass Surgery

The major cardiovascular surgeries include (1) coronary artery bypass grafting (CABG), (2) heart valve repair or replacement, (3) repair of a defect in the heart or a blood vessel, (4) reconstructions to compensate for a congenital defect, (5) insertion of a device to modify electric, pump or blood pressure control activities. Surgery on blood vessels outside the chest constitutes a separate specialty distinct from cardiothorasic .

The word bypass in relation to CABG has two meanings: (1) a bypass route to delivery blood around a narrow or obstructed segment, and (2) use of a bypass pump that circumvents the pumping role of the heart and the oxygenation role of the lungs so that the heart may be stopped for several hours with minimal interruption of delivery of oxygenated blood to the brain and the rest of the body (the brain does not tolerate >5-10 minutes interruption unless it is chilled). Venous blood is diverted to the bypass pump which oxygenates the blood

 

Cardiothoracic Surgery at Tertiary Academic Hospitals in the US

The Voice of Co-Editor of LPBI Group’s 16-Volume BioMed e-Series,  Larry H Bernstein, MD, FCAP

The following articles are a review of a decade of cardiovascular surgery and interventional cardiology at the Presbyterian Hospital, Columbia University Medical Center and Weill Cornell Medical Center.

This section includes analysis of  morbidity and mortality, including 10 year survival rates for coronary artery bypass grafts (CABG heart surgery) versus percutaneous catheter interventions (PCI), presented along with discussion of deficiencies inherent in such studies, and conclusions.  The first major comparison addresses CABG vs Plain Old Balloon Angioplasty (POBA), showing similar survival rates at 10 years for patients qualifying for either procedure.   The high rate ofrestenosis observed in PCI, requiring a second procedure, declined substantially in the time since the initial comparisons as a result of technological innovations instent design and in diameter of insertion device.  The comparisons involve moving targets, as drug-eluting stents (DES) continue to improve.  These studies involve 10,000 matched patients.

Mortality rates were adjusted using Cox proportional hazards method, adjusting for

• severity of disease
• comorbidity
• LAD only
• multiple vessel disease

As most patients are presented the options of catheter interventions versus bypass surgery, the results impact patient shared decision-making. An early study of CABG versus medical therapy was biased in favor of medical therapy, achieved by stringent exclusion criteria eliminating large percentage of patients with left main CAD and an ejection fraction of < 0.40.  Many of these patient would have crossed over to CABG.   The study was done prior to advances in medical therapy, as well as advances in imaging, myocardial protection, anesthesia, and LIMA.

The important findings are as follows:

1. The long-term survival rates of CABG and PCI are comparable, if we compare a patient cohort that qualifies for both procedures.
2. The Achille’s heel of PCI has been restenosis, but the risk of restenosishas declined with improved devices.
3. The risk-adjusted  in-hospital mortality for CABG vs stentwas found to be comparable.  There is an advantage to stenting,  when:
   • Patient is > 65 years
   • Not an insulin-dependent diabetic
   • Patient also has significant non-coronary vascular disease.

There is no intermediate-term survival advantage of CABG over stenting in patients with normal ejection fraction who have multivessel disease that can be treated percutaneously.

Randomized clinical trials established advantages of CABG over medical therapyin patients with

• triple-vessel CAD
• left main coronary artery stenosis
• double-vessel CAD with proximal left anterior descending (LAD) coronary artery stenosis
• left ventricular dysfunction
• insulin dependent diabetics

The Duke database study showed better survival rates with PTCA than with CABG in patients with single-vessel CAD, whereas CABG produced better survival than did PTCA in patients with severe, triple-vessel CAD.  There are important considerations when reviewing these trials:

• stents were not used in the PTCA patients
• operative mortality rates for the CABG groups were higher than the rates currently found in the Society of Thoracic Surgeons (STS) database
•  the inclusion/exclusion criteria of these studies eliminated a high percentage of those patients who might have benefited more from CABG than from PTCA

Chapter 11: Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

11.1   Hybrid Cath Lab/OR Suite

VIEW VIDEOS:

• The New Hyrid Operating Room. Westchester Medical Ceneter
• Hybrid Operating Room Installation. Maquet

https://www.youtube.com/watch?v=Se_NpFTCFRc The Corpus Christi-Medical Center, TX

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

In an uncommon reversal of opinion, the combined forces of the American Heart Association (AHA) and the American College of Cardiology (ACC) reviewed compelling data and reversed a prior assessment on the need for an on-site cardiovascular surgery support for sites offering interventional cardiac catheterization. The data show that sites offering the intervention without a surgeon achieve better results that sites that ship patients out for the interventions, and that the risk without on-site thoracic surgery backup is negligible.

AHA, ACC Change in requirement for surgical support:  Class IIb -> Class IIa Level of Evidence A: Supports Nonemergent PCI without Surgical Backup (Change of class IIb, level of Evidence B).

Larry H Bernstein, MD, FCAP and Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/07/17/aha-acc-change-in-requirement-for-surgical-support-class-iib-class-iia-level-of-evidence-a-support-nonemergent-pci-without-surgical-backup-change-of-class-iib-level-of-evidence-b/

11.1.1 3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

11.1.2 Coronary Reperfusion Therapies: CABG vs PCI – Mayo Clinic preprocedure Risk Score (MCRS) for Prediction of in-Hospital Mortality after CABG or PCI

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/mayo-risk-score-for-percutaneous-coronary-intervention/

11.1.3 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

Curators: Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

11.1.4 Left Main Coronary Artery Disease (LMCAD): Stents vs CABG – The less-invasive option is Equally Safe and Effective

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/left-main-coronary-artery-disease-lmcad-stents-vs-cabg-the-less-invasive-option-is-equally-safe-and-effective/

11.1.5 Revascularization: PCI, Prior History of PCI vs CABG

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/revascularization-pci-prior-history-of-pci-vs-cabg/

11.1.6 Patients with Heart Failure & Left Ventricular Dysfunction: Life Expectancy Increased by coronary artery bypass graft (CABG) surgery: Medical Therapy alone and had Poor Outcomes

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/04/patients-with-heart-failure-left-ventricular-dysfunction-life-expectancy-increased-by-coronary-artery-bypass-graft-cabg-surgery/

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

As minimally interventional techniques improve, patients are offered a choice of invasive surgical remedies or less invasive procedures (video assisted, robotic, or percutaneous). The decision should not rest on the size of the scar or even the up front risk and discomfort, but rather should weigh all aspects of the risks and benefits. In addition to the risks and benefits for the current problem, one should also consider why the problem occurred and its likelihood of recurrence. Open chest surgery has a clear disadvantage when it comes to recurrences, as the scars from first surgery interfere with second surgery. Opening the chest (sternotomy) for a second or third time poses elevated risks analyzed herein. This article reviews data from major centers addressing the risks from repeat sternotomy and from minimally invasive cardiovascular surgeries. Any invasion of the body elevates risk of infection, which can lead to sepsis and possible death, so that risk is also addressed.

11.1.7 Cardiovascular Complications: Death from Reoperative Sternotomy after prior CABG, MVR, AVR, or Radiation; Complications of PCI; Sepsis from Cardiovascular Interventions

Author, Introduction and Summary: Justin D Pearlman, MD, PhD, FACC, and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/23/cardiovascular-complications-of-multiple-etiologies-repeat-sternotomy-post-cabg-or-avr-post-pci-pad-endoscopy-andor-resultant-of-systemic-sepsis/

11.1.8 Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/01/08/cardiac-surgery-theatre-in-china-vs-in-the-us-cardiac-repair-procedures-medical-devices-in-use-technology-in-hospitals-surgeons-training-and-cardiac-disease-severity/

 

11.1.9 Ablation Devices Market to 2016 – Global Market Forecast and Trends Analysis by Technology, Devices & Applications

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/12/23/ablation-devices-market-to-2016-global-market-forecast-and-trends-analysis-by-technology-devices-applications/

11.1.10 No evidence to change current transfusion practices for adults undergoing complex cardiac surgery: RECESS evaluated 1,098 cardiac surgery patients received red blood cell units stored for short or long periods

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/04/08/no-evidence-to-change-current-transfusion-practices-for-adults-undergoing-complex-cardiac-surgery-recess-evaluated-1098-cardiac-surgery-patients-received-red-blood-cell-units-stored-for-short-or-lon/

11.2   Cardiothoracic Surgery: Open Heart Surgery for Coronary Artery Bypass Grafting (CABG) and/or Valve replacement

 

11.2.1 ACC/AHA Guidelines for Coronary Artery Bypass Graft Surgery

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/05/accaha-guidelines-for-coronary-artery-bypass-graft-surgery/

 

11.2.2 Patients with Heart Failure & Left Ventricular Dysfunction: Life Expectancy Increased by coronary artery bypass graft (CABG) surgery: Poor Outcomes on Medical Therapy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/04/patients-with-heart-failure-left-ventricular-dysfunction-life-expectancy-increased-by-coronary-artery-bypass-graft-cabg-surgery/

 

11.2.3 Moderate Ischemic Mitral Regurgitation: Outcomes of Surgical Treatment during CABG vs CABG without Mitral Valve Repair

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/04/moderate-ischemic-mitral-regurgitation-outcomes-of-surgical-treatment-during-cabg-vs-cabg-without-mitral-valve-repair/

 

11.2.4 Call for the abandonment of the Off-pump CABG surgery (OPCAB) in the On-pump / Off-pump Debate, +100 Research Studies

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/31/call-for-the-abandonment-of-the-off-pump-cabg-surgery-opcab-in-the-on-pump-off-pump-debate-100-research-studies/

11.2.5 Nitric Oxide and it’s impact on Cardiothoracic Surgery

Author, curator: Tilda Barliya PhD

https://pharmaceuticalintelligence.com/2012/12/15/nitric-oxide-and-its-impact-on-cardiothoracic-surgery/

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

Comparison of the 10-year and 15-year survivals after CABG demonstrated benefit from a change in graft sources used at the Mayo Clinic and widely adapted by others: vascular grafts from the left internal mammary artery (LIMA) instead of just leg veins, for multiple grafts (up to 3), LIMA-to-LAD plus grafts using LIMA or radial artery vs LIMA/saphenous vein (SV).

11.2.6 CABG Survival in Multivessel Disease Patients: Comparison of Arterial Bypass Grafts vs Saphenous Venous Grafts

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2013/06/30/multiple-arterial-grafts-improve-late-survival-of-patients-with-multivessel-disease/

11.2.7 CABG or PCI: Patients with Diabetes – CABG Rein Supreme

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/11/05/cabg-or-pci-patients-with-diabetes-cabg-rein-supreme/

11.2.8 CABG: a Superior Revascularization Modality to PCI in Patients with poor LVF, Multivessel disease and Diabetes, Similar Risk of Stroke between 31 days and 5 years, post intervention

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/07/25/cabg-a-superior-revascularization-modality-to-pci-in-patients-with-poor-lvf-multivessel-disease-and-diabetes-similar-risk-of-stroke-between-31-days-and-5-years-post-intervention/

11.2.9 Expected New Trends in Cardiology and Cardiovascular Medical Devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/17/expected-new-trends-in-cardiology-and-cardiovascular-medical-devices/

11.2.10 Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/09/patient-access-to-medical-devices-a-comparison-of-u-s-and-european-review-processes/

 

11.3   Coronary Angioplasty: Percutaneous Coronary Intervention (PCI)

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

Arterial access typically starts by passing a needle through skin into an access artery, such as the femoral artery in the groin, or the radial artery at the wrist or brachial artery at the inside of the elbow. A wire is passed through the needle (Seldinger technique) to serve as a guide wire conducting hollow items into the artery. Once the wire is in place the needle is pulled off over the wire while the wire remains threaded into the artery, then the needle is replaced by plastic tubing, called an introducer, threaded over the guide wire. Large diameter tubing may require surgical cut down into the artery, and subsequent arterial repair (there are mechanical inserts that facilitate artery wall closure and repair). What occurs next depends on the target of treatment. To diagnose coronary artery obstructions, there are different designs of catheters consisting of long hollow tubing pre-shaped to catch the entrance of the left or right coronary arteries. To place a balloon across a lesion within a coronary artery is more challenging, so a longer thin guide wire is threaded down the catheter through the lesion, and a new catheter is threaded over that wire to place a balloon, and later a balloon with a stent on it, centered in the lesion, for deployment.

For percutaneous access (path starting by skin penetration into a blood vessel) to replace the aortic valve, the path is very similar to that for coronary arteries: femoral artery, up the aorta, around the arch of the aorta, to the aortic root. In theory, the mitral valve could be reached by passing through the aortic valve across the left ventricle, to the mitral valve, but the submitral apparatus would be hard to navigate. Alternatively, one may use venous access: femoral vein to inferior vena cava to right atrium, then pass through the foramen ovale (a trap door between right and left atria, normally closed after birth) into the left atrium, to the mitral valve, with no interference from the submitral (left ventrcular) apparatus of chordae and papilllary muscles.

Once the catheter is in place, it can be used to perform a number of procedures including

• coronary angiography
• flow reserve measurement
• balloon angioplasty (dilation and cracking of obstructions)
• stent placement
• balloon septostomy (creating an opening in the interatrial septum, to modify circulation impeded by congenital abnormalities)
• embolization to occlude a vessel or to inject alcohol to kill obstructive musle
• localize delivery of a thrombolytic or anti-spasm medication or angiogenesis or vasculogenesis or stem cell therapies
• percutaneous closure of a septal defect
• electrophysiology study
• ablation of dysfunctional electro-conductive pathways or arrhythmia riggers
• valvuloplasty
• valve placement
• aneurysm repair tube graft

The decision to intervene on a vascular lesion considers:

• length of the abnormal segment
• flow reserve (physiologic impact)
• patient age and co-morbidities (ailments)
• extent of calcification
• renal function
• pathway to the lesion
• branch anatomy that may be affected by the planned intervention

There has been considerable controversy about the role of catheterization (percutaneous catheter intervention or PCI) as an alternative to coronary artery bypass surgery (CABG). PCI has clearly been vital when applied within the first hour of a discrete coronary occlusion (heart attack) and may be as valuable even out to 12 or more hours, particularly with incomplete injuries (“stuttering heart attack”). Both PCI and CABG relieve chest pain due to impaired blood supply to the heart (ischemia). CABG provides alternate routes for blood delivery competing with the diseased segments, while PCI repairs (recanulates) selected obstructed segments of coronary arteries. PCI is faster and may be repeated far more often in the future. Benefits on life expectancy have been more challenging to demonstrate. While early comparisons demonstrated advantage of surgery for diabetics and patients with 3 vessel obstruction or left main obstruction or equivalent, the continual changes in technique for both surgery and PCI require updated comparisons. PCI has evolved from plain old balloon angioplasty (POBA), which lead to early restenosis (recurrence of narrowing in the arterial channel) and/or thrombosis (clot formation), requiring repeated interventions often within 6 months. Stents (wire cages to keep the vessels open) addressed the early restenosis problem, but reaction to the metal results in another mechanism for early failure: endotherial tissue in-growth (in-stent stenosis) as well as more frequent thrombosis. Use of stronger antiplatelet medications (e.g., aspirin plus clopidogrel) reduced the thrombosis issue, and addition of medications in the stent to block endothelial growth (drug-eluting stents, DES) reduced the problem with in-stent stenosis but prolonged the problem with thrombosis.

As a general clinical rule, the aspirin and clopidogrel interfere with platelet function sufficient to put off any surgeries – the anti-platelet treatment after stent is deemed uninterruptable for 1-2 months after a bare metal stent, and 6-12 months after a drug-eluting stent, with fading benefit thereafter over 2 years (then aspirin alone can suffice). Genetic studies identified that some patients are not protected by clopidogrel plus aspirin, so further studies investigate alternatives such as prasugrel and ticagrelor. Clopidogrel is a thienopyridine which selectively and irreversibly inhibits the platelet adenosine 5’-diphosphate (ADP) P2Y12 receptor, further inhibiting platelet aggregation (the “white” component of blood clots) over aspirin alone. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial, randomly assigned 12,562 patients with acute coronary syndrome (ACS) to receive clopidogrel (300 mg loading followed by 75 mg once daily) or placebo in addition to aspirin for 3 to 12 months; after an average follow-up of 9 months, the major adverse cardiovascular event rate (MACE= death from cardiovascular causes, myocardial infarction or stroke) occurred in 9.3% vs 11.4%, respectively (P < 0.001), due to fewer myocardial infarctions in those treated with clopidogrel (5.2% vs 6.7%, P < 0.001). Prasugrel is a thienopyridine ADP receptor inhibitor, which irreversibly binds to the P2Y12 receptor. In comparison to clopidogrel, prasugrel acts more quickly, more consistently, and more potently, and its value was examined in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-TRITON-TIMI 38. Analysis of 13,608 patients treated with Prasugrel 60 mg loading dose and a 10 mg daily maintenance dose versus clopidogrel 300 mg loading dose and a 75 mg daily maintenance dose showed prasugrel more was effective than clopidogrel in reducing MACE (9.9% vs 12.1%, P < 0.001), due to fewer myocardial infarctions (7.3% vs 9.5%, P < 0.001), but at the cost of increased major bleeds (2.5% of those treated with prasugrel vs 1.7% of those treated with clopidogrel, P = 0.001, with CABG-related major bleeding 0.4% vs 0.1%, P = 0.001). Ticagrelor is a reversible inhibitor of platelet P2Y12-subtype ADP receptor, which means a switch of plans to CABG need not be delayed for the 9 days it takes permanent platelet inhibition to wear off.

The Platelet Inhibition and Patient Outcomes (PLATO) studyrandomized 18,624 patients with ACS to 180 mg loading dose, then 90 mg twice dailyof ticagrelor vs 300-600 mg loading dose, then 75 mg daily of clopidogrel for 12 months. The risk of MACE was reduced by ticagrelor (9.8% vs 11.7%, P < 0.001), due to reduced death from all causes (4.5% vs 5.9%, P < 0.001), death from vascular causes (4.0% vs 5.1%, P = 0.001), myocardial infarction (5.8% vs 6.9%, P = 0.005), and stent thrombosis (1.3% vs 1.9%,P = 0.009), at a cost of increased major bleeding (2.8% vs 2.2%, P = 0.030).

VIEW VIDEOS  – Courtesy of YouTube as well as the individual sponsors of the links cited below.

VIDEO: Coronary artery stents in Atherosclerosis

11.3.1 Risks for Patients’ and Physician’s Health in the Cath Lab

Reporter and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/10/17/risks-for-patients-contrast-induced-nephropathy-and-physicians-health-radiation-exposure-in-the-cath-lab/

11.3.2 CorPath robotic system for bifurcation lesions with placement of the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) (Abbott Vascular)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/07/corpath-robotic-system-for-bifurcation-lesions-with-placement-of-the-absorb-gt1-bioresorbable-vascular-scaffold-bvs-abbott-vascular/

11.3.3 Robot-assisted coronary intervention program @MGH – The first CorPath Vascular Robotic System, lets Interventional Cardiologists position the right stent in the right place at reduces radiation exposure by 95%

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/17/robot-assisted-coronary-intervention-program-mgh-the-first-corpath-vascular-robotic-system-lets-interventional-cardiologists-position-the-right-stent-in-the-right-place-at-reduces-radiation-exposu/

11.3.4 FDA approved Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), Everolimus releasing and Absorbed by the body in 3 years

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/05/fda-approved-absorb-gt1-bioresorbable-vascular-scaffold-system-bvs-everolimus-releasing-and-absorbed-by-the-body-in-3-years/

11.3.5 Transradial PCI Bests Transfemoral PCI in UK Analysis, regardless of Patient’s Age

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/02/24/transradial-pci-bests-transfemoral-pci-in-uk-analysis-regardless-of-patients-age/

11.3.6 Asymptomatic Patients After Percutaneous Coronary Intervention: Low Yield of Stress Imaging – Population-Based Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/27/asymptomatic-patients-after-percutaneous-coronary-intervention-low-yield-of-stress-imaging-population-based-study/

 

11.3.7 Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

 

11.3.8 PCI Outcomes, Increased Ischemic Risk associated with Elevated Plasma Fibrinogen not Platelet Reactivity

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/01/10/pci-outcomes-increased-ischemic-risk-associated-with-elevated-plasma-fibrinogen-not-platelet-reactivity/

 

11.3.9 Ischemic Stable CAD: Medical Therapy and PCI no difference in End Point: Meta-Analysis of Contemporary Randomized Clinical Trials

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/03/ischemic-stable-cad-ffr-in-5000-patients-medical-therapy-and-pci-no-difference-in-end-point-meta-analysis-of-contemporary-randomized-clinical-trials/

 

11.3.10 The ACUITY-PCI score: Will it Replace Four Established Risk Scores — TIMI, GRACE, SYNTAX, and Clinical SYNTAX

Curator: Aviva Lev-Ari, PhD, RN  

https://pharmaceuticalintelligence.com/2013/01/03/the-acuity-pci-score-will-it-replace-four-established-risk-scores-timi-grace-syntax-and-clinical-syntax/

11.3.11 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

 

Chapter 12: Technologies to sustain Circulation: Enlargement of a Narrowing Artery by Stenting and Scaffolding

Improvements in Stenting Technologies

• DES stents have decreased the rate of acute and subacute periprocedural thrombosis

• the RAVEL trial excluded patients with lesions longer than 18 mm, ostial targets, calcified or thrombosed targets, or target arteries less than 2.5 mm in diameter.

The lesion and patient characteristics that lead to the failure of PCI are multifactorial, but more patients with unfavorable features are being treated with PCI. Despite an increasingly older and sicker patient population, CABG outcomes continue to improve, and operative mortality rates have decreased because advances in preoperative evaluation, including

• more precise coronary artery targeting and
• myocardial imaging and
• diagnostic techniques,

have allowed more appropriate patient selection and surgical planning.

12.1 Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

12.2 To Stent or Not? A Critical Decision

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/10/23/to-stent-or-not-a-critical-decision/

12.3   Atherosclerosis

12.3.1 Carotid Artery

 

12.3.1.1 Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/14/vascular-surgery-position-statement-in-2013-and-contributions-of-a-vascular-surgeon-at-peak-career-richard-paul-cambria-md-chief-division-of-vascular-and-endovascular-surgery-co-director-thoracic/

 

12.3.1.2 Carotid Endarterectomy (CEA) vs. Carotid Artery Stenting (CAS): Comparison of CMMS high-risk criteria on the Outcomes after Surgery:  Analysis of the Society for Vascular Surgery (SVS) Vascular Registry Data

Writer and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/28/effect-on-endovascular-carotid-artery-repair-outcomes-of-the-cmms-high-risk-criteria/

12.3.1.3 Right Internal Carotid Artery Clot Aspiration: 4.5 Minute Thrombectomy Using the ADAPT-FAST Technique and the ACE68 Catheter

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/05/17/right-internal-carotid-artery-clot-aspiration-4-5-minute-thrombectomy-using-the-adapt-fast-technique-and-the-ace68-catheter/

12.3.1.4 Carotid Stenting: Vascular surgeons have pointed to more minor strokes in the stenting group and cardiologists to more myocardial infarctions in the CEA cohort

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/21/carotid-stenting-vascular-surgeons-have-pointed-to-more-minor-strokes-in-the-stenting-group-and-cardiologists-to-more-myocardial-infarctions-in-the-cea-cohort/

 

12.3.2 Coronary Artery

12.3.2.1 Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/29/absorb-bioresorbable-vascular-scaffold-an-international-launch-by-abbott-laboratories/

 

12.3.2.2 Stenting for Proximal LAD Lesions

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/18/stenting-for-proximal-lad-lesions/

 

12.3.2.3 Stent Design and Thrombosis:  Bifurcation Intervention, Drug Eluting Stents (DES) and Biodegrable Stents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/06/stent-design-and-thrombosis-bifurcation-intervention-drug-eluting-stents-des-and-biodegrable-stents/

 

12.3.3 Intracranial Vascular Stenosis

12.3.3.1 Intracranial Vascular Stenosis: Comparison of Clinical Trials: Percutaneous Transluminal Angioplasty and Stenting (PTAS) vs. Clot-inhibiting Drugs: Aspirin and Clopidogrel (dual antiplatelet therapy) – more Strokes if Stenting

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/15/intracranial-vascular-stenosis-comparison-of-clinical-trials-percutaneous-transluminal-angioplasty-and-stenting-ptas-vs-clot-inhibiting-drugs-aspirin-and-clopidogrel-dual-antiplatelet-therapy/

12.3.3.2 Percutaneous Transluminal Angioplasty and Stenting (PTAS) – Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/05/percutaneous-transluminal-angioplasty-and-stenting-ptas-stenting-versus-aggressive-medical-therapy-for-intracranial-arterial-stenosis/

 

12.3.4 Vascular & Peripheral Artery Disease

 

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

Peripheral Vascular Disease commonly refers to problems with branch vessels from the aorta to the head and limbs, but often is extended to include problems in the aorta such as excessive regional dilation (aneurysm). While less widely distributed than coronary artery treatment centers, there are numerous centers with varied offerings to treat peripheral vascular disease. The examples cited are with no intended prejudice regarding other quality centers.

As with catheter intervention versus bypass surgery, left ventricular assist devices (LVAD) versus heart transplant, percutaneous valve replacement versus heart valve surgery, so too,  there are advances in less invasive treatment of blocked arteries to the brain or to the limbs. The use of stents to revascularize the arteries to the brain raised grave concerns about emboli (blood born debris) but results have been quite good.

We have seen in the evolution of endovascular surgery mirroring the advances applied to coronary artery stenosis treatments, starting with balloon dilation, then stents (wire cages to keep the vessel open) then drug-eluting stents (DES) to suppress problems from tissue reaction to stents. Peripheral arteries have larger diameter than coronary arteries so there are problems with insertion and post-insertion restenosis.  The stent diameters require a wide range to fit the need.

Onyx glue has been successful for sealing leaks after endovascular repair.

The Voice of Larry H Bernstein, MD, FCAP on Peripheral Vascular Disease and Vascular Surgery

There are many famous centers focused on the treatment of vascular disease. The clear benefit of completing revascularization within one hour of onset of a heart attack has promoted dissemination of catheter interventions and cardiac surgery throughout the country. There are fewer centers of excellence for peripheral vascular disease.  Without prejudice, we discuss details of the offerings at specific centers.

This series depicts the scientific and medical contributions of the Vascular Surgery Section at Massachusetts General Hospital, including carotid artery, thoracic aorta and abdominal aortic aneurysm, under Dr. Richard Cambria. The published work ranges from standards definition related to the type of procedure and complexity based on comorbidities and surgical volume to special problems encountered in endovascular surgery of thoracic aorta, abdomenal aorta, carotid artery, and vessels of the lower extremities. These are topics discussed:
1.  Impact of hospital volume and type on outcomes of open and endovascular repair of descending thoracic aneurysms in the United States Medicare population.
2.  Why calls for more routine carotid stenting are currently inappropriate: an international, multispecialty, expert review and position statement;   Predictors of clamp-induced electroencephalographic changes during carotid endarterectomies; Centers for Medicare and Medicaid Services conducts a medical evidence development and coverage advisory committee meeting on carotid atherosclerosis.  Centers for Medicare and Medicaid Services conducts a medical evidence development and coverage advisory committee meeting on carotid atherosclerosis: executive summary.
3.  Commentary regarding “lower-extremity endovascular interventions for Medicare beneficiaries: comparative effectiveness as a function of provider specialty” by Zafar et al. J Vasc Interv Radiol 2012; 23:3-9.
4.  Impact of chronic kidney disease on outcomes after abdominal aortic aneurysm repair.
5.  Improved results using Onyx glue for the treatment of persistent type 2 endoleak after endovascular aneurysm repair.

There are key points to be learned in this material offered.  Hospitals that have volumes are not only less restrictive in the procedures they handle, but also they have a staff that can handle the most difficult cases.  The special problems of carotid stenting are made clear, and special problems of endovascular surgery on the aorta near the origin of the renal arteries are discussed.

The characteristics of a peripheral target artery that influence graft patency include:

•  the diameter of the target artery
•  the presence or absence of diffuse disease within the artery
•  whether or not the artery requires endarterectomy

12.3.4.1 Resistance Hypertension: Renal Artery Intervention using Stenting

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/12/02/pad-and-resistance-hypertension-renal-artery-intervention-using-stenting/

 

12.3.4.2 Effect of Hospital Characteristics on Outcomes of Endovascular Repair of Descending Aortic Aneurysms in US Medicare Population

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/27/effect-of-hospital-characteristics-on-outcomes-of-endovascular-repair-of-descending-aortic-aneurysms-in-us-medicare-population/

 

Similarly, catheter-based interventions offer less invasive alternatives to open surgery for the abdominal aorta Aneurysm repair.

12.3.4.3 Open Abdominal Aortic Aneurysm (AAA) repair (OAR) vs. Endovascular AAA Repair (EVAR) in Chronic Kidney Disease (CKD) Patients – Comparison of Surgery Outcomes

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2013/06/28/the-effect-of-chronic-kidney-disease-on-outcomes-after-abdominal-aortic-aneurysm-repair/

 

The Voice of Justin D. Pearlman, MD, PhD, FACC

Minimally invasive repair of the aorta: Whereas atherosclerosis offers potentially somewhat protective stiffening of the arterial wall, it can promote clots, athero-emboli, and failure of the remodeling can lead to an outward ballooning, or aneurysm, that promotes both clot formation and wall or lining tears or rupture (a cause of sudden death). Passage of a needle, then wire, then catheter, then stent delivery system, can offer repair without surgery.

12.3.4.4 First-of-Its-Kind FDA Approval for ‘AUI’ Device with Endurant II AAA Stent Graft: Medtronic Expands in Endovascular Aortic Repair in the United States

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/30/first-of-its-kind-fda-approval-for-aui-device-with-endurant-ii-aaa-stent-graft-medtronic-expands-in-endovascular-aortic-repair-in-the-united-states/

 

12.3.4.5 Improved Results for Treatment of Persistent type 2 Endoleak after Endovascular Aneurysm Repair: Onyx Glue Embolization

Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN 

https://pharmaceuticalintelligence.com/2013/06/28/onyx-glue-for-the-treatment-of-persistent-type-2-endoleak/

12.3.4.6 New Era for PAD as FDA approval in the US of 1st Drug-coated Balloon (DCB) for PDA – CAD Indication for DCB will follow

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/15/new-era-for-pad-as-fda-approval-in-the-us-of-1st-drug-coated-balloon-dcb-for-pda-cad-indication-for-dcb-will-follow/

12.3.4.7 Endovascular Lower-extremity Revascularization Effectiveness: Invasive Intervention performed by

• Vascular Surgeons (VSs),
• Interventional Cardiologists (ICs) and
• Interventional Radiologists (IRs) 

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/01/endovascular-lower-extremity-revascularization-effectiveness-vascular-surgeons-vss-interventional-cardiologists-ics-and-interventional-radiologists-irs/

12.4   Stent Technology

12.4.1 Drug-eluting Stents

12.4.1.1 Drug Eluting Stents: On MIT‘s Edelman Lab’s Contributions to Vascular Biology and its Pioneering Research on DES

A stent is basically fencing material to keep lipids back into the arterial wall after they are pushed out of the way by inflation of a balloon, so the lipid (cholesterol ester) pile up does not obstruct blood flow. A drug eluting stent adds “weed killer” to the fence, to prevent tissue reaction from growing through the fence, to help prevent a future blockage. A small layer of tissue growth counters the risk of blood clot activation from the foreign body material in the stent, so drug eluting stents decrease early closure from tissue reaction but increase the risk of local clotting, which is countered by taking anti-platelet medication.

Author: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/contributions-to-vascular-biology/

12.4.1.2 Svelte Medical Systems’ Drug-Eluting Stent: 0% Clinically-Driven Events Through 12-Months in First-In-Man Study

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/28/svelte-medical-systems-drug-eluting-stent-0-clinically-driven-events-through-12-months-in-first-in-man-study/

12.4.1.3 New Drug-Eluting Stent Works Well in STEMI

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/08/22/new-drug-eluting-stent-works-well-in-stemi/

12.4.2 Bioactive Stents

 

12.4.2.1 Vascular Repair: Stents and Biologically Active Implants

Author and Curator: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/04/stents-biologically-active-implants-and-vascular-repair/

12.4.2.2 ACC 2017, 3/30/2017 – Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/04/02/acc-2017-3302017-poor-outcomes-for-bioresorbable-stents-in-small-coronary-arteries/

12.4.2.3 FDA approved Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), Everolimus releasing and Absorbed by the body in 3 years

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/05/fda-approved-absorb-gt1-bioresorbable-vascular-scaffold-system-bvs-everolimus-releasing-and-absorbed-by-the-body-in-3-years/

12.4.2.4 Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/10/13/abbotts-bioabsorbable-stent-met-its-primary-endpoint-in-a-u-s-clinical-trial-applications-for-fda-approval-follows/

12.4.2.5 Titanium-nitric-oxide-coated bioactive stents in acute coronary syndrome

Reporter: Larry Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2014/08/10/titanium-nitric-oxide-coated-bioactive-stents-in-acute-coronary-syndrome/

12.4.2.6 Bioabsorbable Drug Coating Scaffolds, Stents and Dual Antiplatelet Therapy

Reporter: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2013/05/29/bioabsorbable-drug-coating-scaffolds-stents-and-dual-antiplatelet-therapy/

12.4.2.7 Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/29/absorb-bioresorbable-vascular-scaffold-an-international-launch-by-abbott-laboratories/

12.4.2.8 Tethered–Liquid Perfluorocarbon surface (TLP): Biocoating Prevents Blood from Clotting on Implantables

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/13/tethered-liquid-perfluorocarbon-surface-tlp-biocoating-prevents-blood-from-clotting-on-implantables/

 

Chapter 13: Valve Replacement, Valve Implantation and Valve Repair

 

The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

As catheter techniques evolved to compete with bypass surgery they progressed from balloon cracking of obstructive lesions (POBA=plain old balloon angioplasty) to placement of stents (wire fences). Surgeons sometimes use in-stent valves, and now devices analogous to in-stent valves can be placed by catheter for valve replacement in patients with too much co-morbidity to go through heart surgery. Aortic valve replacement by stent (TAVR) has had sufficient success to be considered for all patients who have sufficient impairment to merit intervention. The diameter is large, so a vascular surgeon participates in the arterial access and repair of the access site.

13.1   Policies and Industry Trends

 

2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sep 21, 2018 – Sep 25, 2018, San Diego

by Nicole Lou, Contributing Writer, MedPage, 9/19/2018

Other highlights of what investigators are serving up, Sept. 21-25 in San Diego include:

• REDUCE-FMR, a sham-controlled trial looking at the Carillon Mitral Contour System for the reduction of mitral regurgitation
  • Second Chance for MitraClip in Functional Mitral Regurgitation? COAPT takes the spotlight in San Diego
• SOLVE-TAVI, a 2×2 trial comparing self-expanding versus balloon-expandable valves and anesthesia versus more mild conscious sedation in transcatheter aortic valve replacement
• Large imaging studies ULTIMATE (intravascular ultrasound to guide drug-eluting stent [DES] placement) and LRP (near-infrared spectroscopy for vulnerable plaque)
• Head-to-head studies on newer-generation DES
• More bioresorbable vascular scaffold data from ABSORB IV and ABSORB COMPARE

“We’re expecting tremendous science,” said Gregg Stone, MD, of Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation (CRF) in New York City at a media briefing, teasing the 15 late-breaking trials and 12 late-breaking clinical science presentations that will be presented at TCT.

One change to the meeting this year is the addition of a large, hands-on “training destination” where physicians and allied health personnel can learn new skills in pavilions featuring simulators and cadaver hearts. Some of these activities are industry-sponsored, whereas others originated with CRF, Stone noted.

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75181?xid=nl_mpt_ACC_Reporter_2018-09-20&eun=g5099207d2r

13.1.1 Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2017

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/12/08/mitral-valve-repair-global-leader-edwards-lifesciences-acquired-harpoon-medical-for-250-in-12-2017-followed-by-690-million-buyout-of-valtech-cardio-1-2017-and-400-million-acquisitio/

13.1.2 Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/01/25/edwards-lifesciences-closes-690m-a-buy-of-valtech-cardio-and-most-of-the-heart-valve-repair-technologies-its-developing/

13.1.3 Issue with Delivery System Deployment Process: MitraClip Clip Recalled by Abbott Vascular

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/03/21/issue-with-delivery-system-deployment-process-mitraclip-clip-recalled-by-abbott-vascular/

 

13.1.4 CEO of PolyNova: The Paradigm Shift in Heart Valve

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/16/ceo-of-polynova-the-paradigm-shift-in-heart-valve/

13.1.5 Are TAVR volume requirements limiting rural and minority access to this life-saving procedure, or are they still necessary for patient safety?

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/09/20/are-tavr-volume-requirements-limiting-rural-and-minority-access-to-this-life-saving-procedure-or-are-they-still-necessary-for-patient-safety/

13.1.6 Minimally Invasive Valve Therapy Programs: Recommendations by SCAI, AATS, ACC, STS

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/19/minimally-invasive-valve-therapy-programs-recommendations-by-scai-aats-acc-sts/

13.1.7 Settled Heart Valve Lawsuit: Medtronic to Pay Edwards: Edwards Lifesciences’ Sapien XT beat out Medtronic’s CoreValve

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/16/first-head-to-head-trial-finds-edwards-tavr-superior-to-medtronics/

13.1.8 Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/transcatheter-valve-competition-in-the-united-states-medtronic-corevalve-infringes-on-edwards-lifesciences-corp-transcatheter-device-patents/

13.1.9 Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/01/29/direct-flow-medical-wins-european-clearance-for-catheter-delivered-aortic-valve/

13.2   Aortic Valve

13.2.1 New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/31/new-method-for-performing-aortic-valve-replacement-transmural-catheter-procedure-developed-at-nih-minimally-invasive-tissue-crossing-transcaval-access-abdominal-aorta-and-the-inferior-vena-cava/

13.2.2 Second in the United States to implant Edwards Newly FDA-Approved Aortic Valve “Intuity Elite” Sutureless Valve at Northwestern Medicine

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/13/second-in-the-united-states-to-implant-edwards-newly-fda-approved-aortic-valve-intuity-elite-sutureless-valve-at-northwestern-medicine/

13.2.3 Medtronic’s CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/15/medtronics-corevalve-system-sustains-positive-outcomes-through-two-years-in-extreme-risk-patients/

13.2.4 Surgical Aortic Valve Replacement (SAVR) vs Transcatheter Aortic Valve Implantation (TAVI): Results Comparison for Prosthesis-Patient Mismatch (PPM) – adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/10/09/surgical-aortic-valve-replacement-savr-vs-transcatheter-aortic-valve-implantation-tavi-results-comparison-for-prosthesis-patient-mismatch-ppm-adjusted-outcomes-including-mortality-heart-fai/

13.2.5 Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

13.2.6 Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/06/22/off-label-tavr-procedures-1-in-10-associated-with-higher-in-hospital-30-day-mortality-1-year-mortality-was-similar-in-the-off-lavel-and-the-on-label-groups/

13.2.7 First U.S. TAVR Patients Treated With Temporary Pacing Lead (Tempo Lead)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/21/first-u-s-tavr-patients-treated-with-temporary-pacing-lead-tempo-lead/

13.2.8 SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis: One-Year Clinical Outcomes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/14/sapien-3-transcatheter-aortic-valve-replacement-in-high-risk-and-inoperable-patients-with-severe-aortic-stenosis-one-year-clinical-outcomes/

13.2.9 TAVR with Sapien 3: combined all-cause death & disabling stroke rate was 8.4% and 16.6% for the surgery arm

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/05/tavr-with-sapien-3-combined-all-cause-death-disabling-stroke-rate-was-8-4-and-16-6-for-the-surgery-arm/

13.2.10 Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/hadassah-opens-israels-first-heart-valve-disease-clinic/

13.2.11 One year Post-Intervention Mortality Rate: TAVR and AVR – Aortic Valve Procedures 6.7% in AVR, 11.0% in AVR with CABG, 20.7 in Transvascular (TV-TAVR) and 28.0% in Transapical (TA-TAVR) Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/08/04/one-year-post-intervention-mortality-rate-tavr-and-avr-aortic-valve-procedures-6-7-in-avr-11-0-in-avr-with-cabg-20-7-in-transvascular-tv-tavt-and-28-0-in-transapical-ta-tavr-patients/

13.2.12 Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/

13.2.13 Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/

13.2.14 Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/03/transcatheter-aortic-valve-replacement-for-inoperable-severe-aortic-stenosis/

13.2.15 Updated Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

Reporter: Aviva Lev-Ari, PhD,RN

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

13.2.16 The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

13.2.17 Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

13.2.18 Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

13.3   Mitral Valve

13.3.1 Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/19/transcatheter-mitral-valve-tmv-procedures-centers-for-medicare-medicaid-services-cms-proposes-to-cover-transcatheter-mitral-valve-repair-tmvr/

13.3.2 Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/04/mitral-valve-repair-who-is-a-candidate-for-a-non-ablative-fully-non-invasive-procedure/

13.3.3 Replacement of the Mitral Valve: Using the Edwards’ Sapien Aortic Valve Device

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/10/replacement-of-the-mitral-valve-using-the-edwards-sapien-aortic-valve-device/

13.3.4 Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/05/17/less-is-more-minimalist-mitral-valve-repair-expert-opinion-of-prem-s-shekar-md-chief-division-of-cardiac-surgery-bwh-7-2017-disruptive-dozen-at-wmif17/

13.3.5 Moderate Ischemic Mitral Regurgitation: Outcomes of Surgical Treatment during CABG vs CABG without Mitral Valve Repair

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/04/moderate-ischemic-mitral-regurgitation-outcomes-of-surgical-treatment-during-cabg-vs-cabg-without-mitral-valve-repair/

13.3.6 Prospects for First-in-man Implantation of Transcatheter Mitral Valve by Direct Flow Medical

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/03/03/prospects-for-first-in-man-implantation-of-transcatheter-mitral-valve-by-direct-flow-medical/

13.3.7 Abbott’s percutaneous MitraClip mitral valve repair device SUPERIOR to Pacemaker or Implantable Cardioverter Defibrillator (ICD) for reduction of Ventricular Tachyarrhythmia (VT) episodes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/05/19/abbotts-percutaneous-mitraclip-mitral-valve-repair-device-superior-to-pacemaker-or-implantable-cardioverter-defibrillator-for-reduction-of-ventricular-tachyarrhythmia-vt-episodes/

13.4   Valve-in-Valve (Aortic and Mitral) Replacements

13.4.1 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices

Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

13.5   Tricuspid Valve

13.5.1 First-in-Man Mitral Valve Repairs Device used for Tricuspid Valve Repair: Cardioband used by University Hospital Zurich Heart Team

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/13/first-in-man-mitral-valve-repairs-device-used-for-tricuspid-valve-repair-cardioband-used-by-university-hospital-zurich-heart-team/

13.5.2 Advances and Future Directions for Transcatheter Valves – Mitral and Tricuspid valve repair technologies now in development

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/advances-and-future-directions-for-transcatheter-valves-mitral-and-tricuspid-valve-repair-technologies-now-in-development/

13.6   Pulmonary Artery Valve

 

13.6.1 Pulmonary Valve Replacement and Repair: Valvuloplasty Device – Tissue (bioprosthetic) or mechanical valve;  Surgery type – Transcatheter Pulmonary Valve Replacement (TPVR) vs Open Heart, Valve Repair – Commissurotomy, Valve-ring Annuloplasty

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/09/30/pulmonary-valve-replacement-and-repair-valvuloplasty-device-tissue-bioprosthetic-or-mechanical-valve-surgery-type-transcatheter-pulmonary-valve-replacement-tpvr-vs-open-heart-valve-re/

 

 

Chapter 14: Revolution in Technologies and Methods for Modification of the Original Anatomy of the Heart

 

14.1   The Technological Frontier Harnessed for Heart Health

14.1.1 Kurzweill Reports in Medical Science I

Kurzweill reports cover myriad topics ranging from E Coli resistance to brain development, scan down to find material relevant to heart health.

Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/11/21/kurzweill-reports-in-medical-science-i/

14.1.2 Control Heartbeats using Light

Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/10/25/control-heartbeats-using-light/

14.2   Treatment of the Heart Pathophysiology

14.2.1 Boston Scientific implant designed to occlude the heart’s left atrial appendage implicated with embolization – Device Sales in Europe halts

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/05/boston-scientific-implant-designed-to-occlude-the-hearts-left-atrial-appendage-implicated-with-embolization-device-sales-in-europe-halts/

14.2.2 Cardiovascular Biology  – A Bibliography of Research @Technion

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/27/cardiovascular-biology-a-bibliography-of-research-technion/

14.2.3 Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

14.2.4 Comparison of four methods in diagnosing acute myocarditis: The diagnostic performance of native T1, T2, ECV to LLC

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/08/08/comparison-of-four-methods-in-diagnosing-acute-myocarditis-the-diagnostic-performance-of-native-t1-t2-ecv-to-llc/

14.2.5 Treatment for Infective Endocarditis

Curator: Larry H Bernstein, MD, FACP

https://pharmaceuticalintelligence.com/2013/03/30/treatment-for-infective-endocarditis/

14.2.6 Early Surgery May Benefit Some With Heart Infection

Reporter: Aviva Lev-Ari, RN

https://pharmaceuticalintelligence.com/2012/08/02/early-surgery-may-benefit-some-with-heart-infection/

14.2.7 Interaction of Nitric Oxide and Prostacyclin in Vascular Endothelium

Author: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2012/09/14/interaction-of-nitric-oxide-and-prostacyclin-in-vascular-endothelium/

14.3 Tissue Engineering

14.3.1 3D revolution and tissue repair

Curator: Larry H. Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2016/04/11/3d-revolution-and-tissue-repair/

14.3.2 Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization

Author and Curator: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/05/bioengineering-of-vascular-and-tissue-models/

14.3.3 Stem-Cell Therapy for Ischemic Heart Failure: Clinical Trial MSC Demonstrates Efficacy

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/08/stem-cell-therapy-for-ischemic-heart-failure-clinical-trial-msc-demonstrates-efficacy/

14.3.4 Heart Renewal by pre-existing Cardiomyocytes: Source of New Heart Cell Growth Discovered

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2012/12/23/heart-renewal-by-pre-existing-cardiomyocytes-source-of-new-heart-cell-growth-discovered/

14.3.5 Source of Stem Cells to Ameliorate Damaged Myocardium (Part 2)

Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/10/29/source-of-stem-cells-to-ameliorate-damaged-myocardium/

14.4   NanoTechnology and Cardiology

14.4.1 Nanotechnology and Heart Disease

Author and Curator:  Tilda Barliya PhD

https://pharmaceuticalintelligence.com/2013/03/04/nanotechnology-and-heart-disease/

14.5   Organ 3D Printing

 

14.5.1  3-D BioPrinting in use to create Cardiac Living Tissue: Print Your Heart Out

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/03/16/3-d-bioprinting-in-use-to-create-cardiac-living-tissue-print-your-heart-out/

 

14.5.2 Capillaries: A Mapping Geometrical Method using Organ 3D Printing

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/08/22/capillaries-a-mapping-geometrical-method-using-organ-3d-printing/

14.6   Stem Cell Function in Angiogenesis

14.6.1 Stem Cells and Cardiac Repair: Scientific Reporting by Aviva Lev-Ari, PhD, RN

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/17/stem-cells-and-cardiac-repair-content-curation-scientific-reporting-aviva-lev-ari-phd-rn/

Summary by Justin D. Pearlman MD ME PhD MA FACC

Chapters 4-6 addressed clinical trial data in coronary disease, biomarkers of cardiovascular disorders, coagulation including top roles of nitric oxide, C-reative protein, protein C, aprotinin and thrombin). Chapters 7-8 covered amyloidosis, atherosclerosis, valve disease, flow reserve, atrial fibrillation and roles for advanced imaging. Chapters 9-10 covered unstable angina, transplants, and ventricular assist devices. Chapters 11-14 span interventions on the aorta, peripheral arteries, and coronary arteries, valve surgery and percutaneous valve repair or replacement, plus the growing role of prosthetics and repair by stem cells and tissue engineering. 

EPILOGUE by Justin D. Pearlman MD ME PhD MA FACC

Thank you for joining us in coverage of basic and advanced status analysis, methods, outcomes, and future opportunities in cardiovascular disease diagnosis, mechanisms, impact and opportunities. Coverage includes trends in societal impact, and the basis for improvement in adverse events. 

We use the present tense, because these are electronic documents that update periodically to stay fresh, so you can come back not only for review but also for updates.

National Trends, 2005 – 2011: Adverse-event Rates Declined among Patients Hospitalized for Acute Myocardial Infarction or Congestive Heart Failure

Reporter: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/02/04/national-trends-2005-2011-adverse-event-rates-declined-among-patients-hospitalized-for-acute-myocardial-infarction-or-congestive-heart-failure/