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Archive for the ‘Peripheral Arterial Disease & Peripheral Vascular Surgery’ Category

 

Cardiovascular Research Foundation (CRF) Events – tctmd – The Source for Interventional Cardiovascular

 

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

http://www.tctmd.com/news.aspx

JOURNAL NEWS

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Monday, July 28, 2014 | Source: EuroIntervention

Proximal May Be Preferred Form of Embolic Protection in Carotid Stenting

By Kim Dalton
A proximal protection device can be successfully and safely used as the first choice for embolic protection during most carotid artery stenting…

Friday, July 25, 2014 | Source: The American Heart Journal

Meta-analysis: Patient Sex Affects Response to Routine Invasive Approach for NSTE-ACS

By Todd Neale
A routine invasive strategy—relative to a more selective approach—appears beneficial over the long term for men but not women with non-ST-segment elevation…

Thursday, July 24, 2014 | Source: American Journal of Cardiology

PCI for Stable CAD Drives Overall Decline in Use of Procedure Since 2009

By Yael L. Maxwell
National use of percutaneous coronary intervention (PCI) has decreased steadily since 2009, mostly driven by a reduction in procedures for patients…

Thursday, July 24, 2014 | Source: European Heart Journal

Pre-AMI Ischemia May Reduce Early Mortality

By Kim Dalton
Patients who report angina symptoms or are diagnosed with ischemia shortly before an acute myocardial infarction (AMI) are less likely to die within…

Wednesday, July 23, 2014 | Source: EuroIntervention

Bioresorbable Scaffold Performs Well, But Thrombosis Raises Concerns

By Todd Neale
Percutaneous coronary intervention (PCI) with an everolimus-eluting bioresorbable vascular scaffold (BVS) results in an “acceptable” rate of target…

Tuesday, July 22, 2014 | Source: Journal of the American College of Cardiology

New CMR-Identified Myocardial Injury Post-TAVR Linked With Decreased LV Function

By Yael L. Maxwell
New ischemic myocardial injury, presumably of embolic origin, is common after transcatheter aortic valve replacement (TAVR) and is associated with…

Tuesday, July 22, 2014 | Source: JAMA Internal Medicine

Catheter-Directed Thrombolysis for DVT Increases Bleeding Compared With Standard Anticoagulation

By L.A. McKeown
While catheter-directed thrombolysis and anticoagulation for deep vein thrombosis (DVT) does not appear to increase mortality over standard anticoagulation…

Monday, July 21, 2014 | Updated With New Commentary | Source: Lancet

HEAT-PPCI Published: Discrepant Finding of Heparin’s Superiority over Bivalirudin in Primary PCI Still Puzzles

By Yael L. Maxwell
The HEAT-PPCI trial, published July 5, 2014, ahead of print in the Lancet , reports better efficacy and comparable safety with bivalirudin than…

Monday, July 21, 2014 | Source: Journal of the American College of Cardiology

One-Time Platelet Testing Appears Insufficient to Guide Clopidogrel Therapy

By Kim Dalton
In many patients with stable coronary artery disease (CAD), platelet reactivity varies markedly over time despite an unchanged dose of clopidogrel,…

Friday, July 18, 2014 | Source: American Heart Journal

Hybrid Revascularization a Promising Option for Diabetic Patients

By L.A. McKeown
A hybrid procedure combining percutaneous revascularization with minimally invasive coronary artery grafting results in similar short-term and…

CONFERENCE NEWS

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Wednesday, May 28, 2014 | Source: EuroPCR 2014

EuroPCR 2014: Clinical Challenges, Novel Innovations Share the Limelight

By Caitlin E. Cox
PARIS, France—Research presented at EuroPCR 2014, held May 20 23, offered both new ways to improve on current therapies and fresh approaches to treating…

Friday, May 23, 2014 | Source: EuroPCR 2014

Studies Document Initial Steps Toward Percutaneous Mitral Valve Replacement

By Caitlin E. Cox
PARIS, France—Early data on 2 different catheter-based mitral valve therapies were presented in the same Hot Line session at EuroPCR on May 21, 2014.…

Friday, May 23, 2014 | Source: EuroPCR 2014

PERFUSE Registry: Diagnostic Accuracy Achieved with CT-Derived FFR Plus CT Perfusion Imaging

By Yael L. Maxwell
PARIS, France—A strategy combining fractional flow reserve (FFR) derived from computed tomography (CT) with CT perfusion imaging has demonstrated high…

Friday, May 23, 2014 | Source: EuroPCR 2014

Benefit of LAA Closure Becomes Most Evident After 1 Year

By Caitlin E. Cox
PARIS, France—Most of the stroke protection derived from percutaneous left atrial appendage (LAA) closure does not become apparent until 1 year after…

Friday, May 23, 2014 | Source: EuroPCR 2014

Nobori BES Demonstrates Good Long-term Outcomes with No Stent Thrombosis Beyond 3 Years

By Yael L. Maxwell
PARIS, France—A novel biolimus A9-eluting, biodegradable-polymer stent (BES) shows favorable long-term clinical outcomes and very low rates of device-related…

Friday, May 23, 2014 | Source: EuroPCR 2014

New Iteration of Sapien Device Associated with Low Rates of Early Mortality, Stroke

By L.A. McKeown
A new lower-profile valve and delivery system for transcatheter aortic valve replacement (TAVR) appears promising, with low mortality and stroke rates,…

Thursday, May 22, 2014 | Source: EuroPCR 2014

SYMPLICITY HTN-3: Predictors of Response Still Relevant After Trial’s Negative Findings

By Yael L. Maxwell
PARIS, France—Even though 6 month findings of the long awaited SYMPLICITY HTN 3 randomized trial demonstrated little effect of renal denervation on…

Thursday, May 22, 2014 | Source: EuroPCR 2014

UK Registry Finds Long-Term Survival After TAVR Depends on Patient Characteristics

By Caitlin E. Cox
PARIS, France—Nearly half of high-risk patients who undergo transcatheter aortic valve replacement (TAVR) for severe aortic stenosis live at least…

Thursday, May 22, 2014 | Source: EuroPCR 2014

Global SYMPLICITY Substudy Teases out Reasons for Non-response in Real-World Patients

By Yael L. Maxwell
PARIS, France—Renal denervation has spurred much controversy in recent months, with the sham-controlled SYMPLICITY HTN-3 trial demonstrating little…

Thursday, May 22, 2014 | Source: EuroPCR 2014

Early Data Show Novel Catheter-Implanted Device Benefits Patients with Left Heart Failure

By Caitlin E. Cox
PARIS, France—A first-in-man study presented Tuesday, May 20, at EuroPCR 2014 introduced a new percutaneous treatment for heart failure. Josep Rodés-Cabau,…

 

ACC NEWS

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Monday, June 24, 2013 | Source: ACC News Releases

Study Shows Heart Failure Survivors at Greater Risk for Cancer Trend toward more cancers and more deaths among heart failure patients

By ACC News Releases
WASHINGTON (June 25, 2013) – Heart failure patients are surviving more often with the heart condition but they are increasingly more likely to be diagnosed…

Tuesday, June 04, 2013 | Source: ACC News Releases

New Program to Help Heart Patients Navigate Care, Reduce Readmissions AstraZeneca sponsorship to help support patient-centered programs in 35 hospitals

By ACC News Releases
WASHINGTON (June 5, 2013) – The American College of Cardiology is developing a program with support from founding sponsor AstraZeneca to provide personalized…

Tuesday, June 04, 2013 | Source: ACC News Releases

ACC/AHA Update Guideline for Management of Heart Failure Update increases emphasis on quality of life, care coordination, palliative care

By ACC News Releases
WASHINGTON (June 5, 2013) – The American College of Cardiology and the American Heart Association today released an expanded clinical practice guideline…

Sunday, March 10, 2013 | Source: ACC News Releases

Study Shows On-Pump Bypass Comparable to Off-Pump at Year Mark

By ACC News Releases
30-day neurocognitive differences disappeared by one-year follow up Read More

Sunday, March 10, 2013 | Source: ACC News Releases

Screenings, Targeted Care Reduce Heart Failure in At-Risk Patients

By ACC News Releases
Study shows simple blood test may help patients with risks for heart disease Read More

Sunday, March 10, 2013 | Source: ACC News Releases

Digoxin Reduces Hospital Admissions in Older Patients with Chronic Heart Failure

By ACC News Releases
If replicated in heart failure patients discharged from hospital, drug may help hospitals avoid readmission penalties Read…

Monday, March 26, 2012 | Source: Clinical Trials

Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography

By Clinical Trials
The goal of the trial was to evaluate a strategy of cardiac computed tomography (CT) angiography compared with standard emergency department (ED)…

Monday, March 26, 2012 | Source: ACC News Releases

STUDY SUGGESTS BETTER SURVIVAL IN PATIENTS UNDERGOING BYPASS SURGERY COMPARED TO CORONARY ANGIOPLASTY

By ACC News Releases
Patients with coronary heart disease and their doctors have long been challenged by the decision of whether to pursue bypass surgery or opt for the…

Monday, March 26, 2012 | Source: ACC News Releases

CARDIAC CT IS FASTER, MORE EFFECTIVE FOR EVALUATING PATIENTS WITH SUSPECTED HEART ATTACK

By ACC News Releases
Cardiac computed tomography angiography scans (CT scans that look at the heart) can provide a virtually instant verdict on whether chest pain is…

Monday, March 26, 2012 | Source: Clinical Trials

EINSTEIN–Pulmonary Embolism (PE) Study

By Clinical Trials
The goal of the trial was to evaluate treatment of the oral direct factor Xa inhibitor, rivaroxaban, compared with standard therapy among patients…

 

 

 

Upcoming Meetings:
 CRF Podium Icon LAA Closure 
A Technique-Oriented Course
July 17-19, 2014
Chicago, IL
 CRF Podium Icon NYC Cineangiogram Case Review Dinner Series for Fellows
July 17, 2014
Opia Restaurant
(inside the Renaissance 57 Hotel)
130 East 57th St
New York, NY
 CRF Podium Icon BRS 
Bioresorbable Vascular Scaffolds: Transformational Technology for PCI
July 25-26, 2014
The Fairmont Copley Plaza
Boston, MA
 TCT Icon Transcatheter Cardiovascular Therapeutics (TCT) 2014
Sept. 13-17, 2014
Walter E. Washington Convention Center
Washington, DC
 CRF Podium Icon NYC Cineangiogram Case Review Dinner Series for Fellows
Sep 25, 2014
Opia Restaurant
(inside the Renaissance 57 Hotel)
130 East 57th St
New York, NY
 CRF Podium Icon The VEINS 
Venous Endovascular Interventional Strategies
Oct 9-11, 2014
The Swissotel Hotel
Chicago, IL
 CRF Podium Icon NYC Cineangiogram Case Review Dinner Series for Fellows
Nov 6, 2014
Opia Restaurant
(inside the Renaissance 57 Hotel)
130 East 57th St
New York, NY
 CRF Podium Icon Transradial Symposium 2014
November 8, 2014
W New York Union Square
New York, NY
 CRF Global Partner Events 
 CRF Podium Icon TCT India 
Advanced CardioVascular Solutions (ACVS) India 2014 with TCT
Aug 1-4, 2014
Hyderabad, India
 CRF Podium Icon TCT 2014 Highlights at GISE 
Oct 14-17, 2014
Genoa, Italy
 CRF Podium Icon ICI 
Innovations in Cardiovascular Interventional Cardiology
Dec 14-16, 2014
Tel-Aviv, Israel

SOURCE

http://www.tctmd.com/show.aspx?id=43158

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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

 

SOURCE

http://www.crbard.com/prlanding.aspx?releaseID=1939652

Circulatory System Devices Advisory Panel Provides a Unanimous Favorable Recommendation to FDA for the Lutonix® Drug Coated Balloon

Lutonix® DCB one step closer to becoming the first FDA-approved drug coated balloon for the treatment of patients with femoropopliteal occlusive disease

 

MURRAY HILL, N.J.–(BUSINESS WIRE)–Jun. 12, 2014– C. R. Bard, Inc. (NYSE:BCR) today announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix® Drug Coated Balloon PTA Catheter (DCB) in the U.S. The Lutonix® DCB is currently under review by FDA for improving luminal diameter and reducing the incidence of restenosis for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm. If approved, it is expected that the Lutonix® DCB will be the first and only FDA-approved DCB available in the U.S.

Data presented at today’s advisory committee meeting included one-year primary endpoint data from the LEVANT 2 pivotal study, which is a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol. LEVANT 2 investigators have submitted a manuscript for publication with a top-tier medical journal.

At one year, LEVANT 2 demonstrated superior primary patency of the target lesion with the Lutonix®DCB for the efficacy endpoint (73.5% vs. 56.8%, p<0.001 by Kaplan-Meier time-to-event analysis) and non-inferiority for the safety endpoint; both endpoints were compared to standard percutaneous transluminal balloon angioplasty (PTA).

The secondary efficacy endpoint results at one year for patients randomized to treatment with the Lutonix® DCB demonstrated superiority in binary restenosis (26.5% vs. 43.2%, p<0.001 by Kaplan-Meier time-to-event analysis at 365 days) when compared to uncoated balloons, and measurable but not statistically significant improvement in freedom from target lesion revascularization (TLR) (89.7% vs. 84.8%, p=0.1673 by Kaplan-Meier time-to-event analysis).

Comparing results to other trials can be challenging and misleading, as each study may have varying patient profiles, protocol structures and other criteria that may affect the reported outcomes. LEVANT 2 raises the bar for scientific rigor in superficial femoral artery (SFA) trials and was designed to reduce bias in the results in order to accurately and scientifically assess and compare the long-term performance of key clinical measures. Two key aspects of the study design differentiate this trial from recent SFA studies. First, unlike some other SFA trials, the LEVANT 2 clinical trial did not count bail-out stenting as a primary patency or TLR failure. Second, to reduce the potential introduction of bias into the subjective clinical decision for revascularization, the protocol required the clinical assessment to be performed by a physician who was blinded to the treatment group and the doppler patency measurement.

This methodology of blinding the evaluating physicians in SFA trials is unique to LEVANT 2. Published data suggest that trials with less rigorous blinding methodologies have shown physicians to intervene more often in the control arm than in the treatment arm, even when presented with similar objective results such as binary restenosis. This can have a significant impact on subjective results, such as TLR. For example, the blinding methodology in LEVANT 2 showed very similar rates of intervention when binary restenosis occurred in either arm of the trial. If instead the evaluating physicians in LEVANT 2 had intervened at the rates in unblinded DCB trials when binary restenosis occurred (as estimated from public data), the company estimates the comparable freedom from TLR for LEVANT 2 could have been approximately 94% in the treatment arm compared to approximately 78% in the control arm at one year.

PTA balloons are a well-established and accepted treatment for peripheral arterial disease (PAD) according to the American College of Cardiology and American Heart Association guidelines. The Lutonix® DCB is a standard angioplasty balloon that is coated with a low dose of the anti-restenotic agent, paclitaxel, and is designed as adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow. Successful treatment of PAD in the femoropopliteal arteries requires improved blood flow (patency) for longer periods of time. PTA is typically the first and preferred method to treat patients with PAD.

“The PAD patient population is growing and the variety of treatment needs for these challenging patients is increasing,” said Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and LEVANT 2 Co-Primary Investigator. “There is a need to improve upon the current well-established treatment modality and the Lutonix® DCB can be another tool to treat PAD in the difficult anatomy of the femoropopliteal artery without leaving an implant behind.”

The FDA will consider the positive recommendation of the advisory panel in its review of the PreMarket Approval (PMA) Application that was submitted by C. R. Bard in November 2013. Currently, the Lutonix® DCB is available commercially in Europe.

Timothy M. Ring, chairman and chief executive officer of C. R. Bard, commented, “We are hopeful that the unanimous positive recommendation for Lutonix® DCB is the next step in establishing a new standard of care for those patients in the U.S. confronted with femoropopliteal occlusive disease. Clinicians have been calling for a first-line alternative treatment to expand the therapy options for this painful, progressive and debilitating disease and we look forward to working closely with the FDA as it completes its review.”

About Peripheral Arterial Disease (PAD) and Treatment Options

PAD is a life-threatening condition that narrows arteries and reduces blood flow to limbs1 putting millions of people in danger of heart attack, stroke and potential lower-extremity amputation.2 The American Heart Association (AHA) estimates that PAD affects at least 8 million Americans with approximately 3 percent of people younger than 60 years and 20 percent of people older than 70 years affected by lower-extremity peripheral arterial disease.

There are both noninvasive and invasive SFA treatment options available, each of which has associated limitations. The most conservative approach is treatment with pharmacotherapy and/or exercise with risk factor modification; however, the effectiveness of these treatment options is often limited by patient intolerance to medication or lack of medication efficacy. Surgical bypass is at the other end of the spectrum. For most patients who fail conservative therapy alone, interventionalists and surgeons will typically offer percutaneous endovascular procedure as the initial treatment option, as a lower risk alternative to surgical bypass. PTA is the first-line, standard-of-care treatment for PAD, according to the American College of Cardiology and American Heart Association 2011 guideline; however, it is limited by its relative lack of long-term patency.

1 Why PAD Matters – American Heart Association Web site. Available at:http://www.heart.org/HEARTORG/Conditions/More/PeripheralArteryDisease/Why-PAD-Matters_UCM_301303_Article.jsp.

2 Peripheral Arterial Disease – NIH National Heart, Lung, and Blood Institute. Available at:https://www.nhlbi.nih.gov/health/health-topics/topics/pad/.

C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.

The FDA advisory panel vote should not be construed as an indication of the likelihood of the product gaining regulatory approval or being successful commercially. This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current expectations, the accuracy of which is necessarily subject to risks and uncertainties. These statements are not historical in nature and use words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “forecast”, “plan”, “believe”, and other words of similar meaning in connection with any discussion of future operating or financial performance. Many factors may cause actual results to differ materially from anticipated results including product developments, sales efforts, income tax matters, the outcomes of contingencies such as legal proceedings, and other economic, business, competitive and regulatory factors. The company undertakes no obligation to update its forward-looking statements. Please refer to the Cautionary Statement Regarding Forward-Looking Information in our March 31, 2014 Form 10-Q for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied.

 

Source: C. R. Bard, Inc.

C. R. Bard, Inc.
Investor Relations:
Todd W. Garner, 908-277-8065
Vice President, Investor Relations
or
Media Relations:
Scott T. Lowry, 908-277-8365
Vice President and Treasurer

 

 

SOURCE

http://www.crbard.com/prlanding.aspx?releaseID=1939652

 

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MedTech (Cardiac Imaging) and Medical Devices for Cardiovascular Repair – Curations, Co-Curations and Reporting by Aviva Lev-Ari, PhD, RN

MedTech (Cardiac Imaging) and Medical Devices for Cardiovascular Repair – Curations, Co-Curations and Reporting by Aviva Lev-Ari, PhD, RN

Cardiac Imaging and Cardiovascular Medical Devices in use for

Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

List of Publications updated on 8/13/2018

 

Single-Author Curation by Aviva Lev-Ari, PhD, RN

 

42c       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/

 

41c       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/

 

40c       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/

 

39c       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/

 

38c       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/

 

37c     MedTech & Medical Devices for Cardiovascular Repair – Curations by

Curator: Aviva Lev-Ari, PhD, RN

MedTech (Cardiac Imaging) and Medical Devices for Cardiovascular Repair – Curations, Co-Curations and Reporting by Aviva Lev-Ari, PhD, RN

 

36c     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/

 

35c       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/

 

34c       “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/

 

33c       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/

 

32c       Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

 

31c       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/

 

30c     Stenting for Proximal LAD Lesions

Curator: Aviva Lev-Ari, PhD, RN

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

 

29c       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/

 

28c       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/

 

27c       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/

 

26c       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/

 

25c       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/

 

24c       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/

 

23c       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/

 

22c       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/

 

21c       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/

 

20c       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/

 

19c       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/

 

18c       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/

 

17c       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/

 

16c       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/

 

15c       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/

 

14c       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/

13c       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/

 

12c       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/

 

11c       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/

 

10c       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/

 

9c         Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

Curator: Aviva Lev-Ari, PhD, RN

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

 

8c         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/

 

7c         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/

 

6c         DELETED, identical to 7r

 

5c         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/

 

4c         Global Supplier Strategy for Market Penetration &amp; Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology &amp; 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/

 

3c         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/

 

2c         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/

 

1c         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/

 

Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas.

Bouve College of Health Sciences, Northeastern University, Boston, MA 02115

 

Co-Curation Articles on MedTech and Cardiac Medical Devices by LPBI Group’s Team Members and Aviva Lev-Ari, PhD, RN

67co     ATP – the universal energy carrier in the living cell: Reflections on the discoveries and applications in Medicine

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/

66co     Eric Topol, M.D.

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

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

 

65co     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/

 

64co     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/

 

63co     Epilogue: Volume 4 – Translational, Post-Translational and Regenerative Medicine in Cardiology

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

Justin Pearlman, MD, PhD, FACC, 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/

 

62co     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/

 

61co     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/

60co     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/

 

59co     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/

 

58co     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/

 

57co     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/

 

56co     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/

 

55co     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/

 

54co     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/

 

53co     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/

 

52co     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/

51co     Orthotropic 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/

 

50co     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/

49co     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/

 

48co     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/

 

47co     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/

 

46co     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/

 

45co     DELETED, was identical to 47co

 

44co     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/

 

43co     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/

 

42co     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/

 

41co     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/

 

40co     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/

39co     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/

 

38co     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/

 

37co     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/

 

36co     On Devices and On Algorithms: Arrhythmia after Cardiac SurgeryPrediction 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/

 

35co     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/

 

34co     Drug Eluting Stents: On MIT‘s Edelman Lab’s Contributions to Vascular Biology and its Pioneering Research on DES

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

https://pharmaceuticalintelligence.com/2013/04/25/contributions-to-vascular-biology/

 

33co     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/

 

32co     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/

 

31co     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/

 

30co  DELETED identical to 58co

 

29co  DELETED identical to 58co

 

28co  DELETED identical to 57co

 

27co  DELETED identical to 47co

 

26co     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/

 

25co     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/

 

24co     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/

 

23co  DELETED identical to 24co

 

22co  DELETED identical to 49co

 

21co  DELETED identical to 52co

 

20co  DELETED identical to 50co

 

19co  DELETED identical to 57co

 

18co     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/

 

17co     Improved Results for Treatment of Persistent type 2 Endoleak after Endovascular Aneurysm Repair: Onyx Glue Embolization

Author & 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/

16co     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/

 

15co     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/

 

14co     First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices.

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

https://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

 

13co     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/

 

12co  DELETED identical to 40co

11co  DELETED identical to 38co

10co  DELETED identical to 39co

 

9co       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/

 

8co       DELETED identical to 37co

 

7co       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/

 

6co       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/

 

5co       DELETED identical to 36co

 

4co       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/

 

3co       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/

 

2co    DELETED identical to 35co

 

1co    DELETED identical to 34co

 

Single-Author Reporting on MedTech and Cardiac Medical Devices by

Aviva Lev-Ari, PhD, RN

 

162r 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/

 

161r 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/

 

160r 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/

159r Top 100 of 415 articles published on PubMed in 2018 on TAVR

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/08/14/top-100-of-415-articles-published-on-pubmed-in-2018-on-tavr/

158r Aortic Stenosis (AS): Managed Surgically by Transcatheter Aortic Valve Replacement (TAVR) – Search Results for “TAVR” on NIH.GOV website, Top 16 pages

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/08/14/aortic-stenosis-as-managed-surgically-by-transcatheter-aortic-valve-replacement-tavr-search-results-for-tavr-on-nih-gov-website-top-16-pages/

 

157r 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/

 

156r   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/

 

155r   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/

 

154r   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/

 

153r   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/

 

152r   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 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/

 

151r   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/

 

150r   What is the Role 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/

 

149r   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/

 

148r   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

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/

 

147r   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/

 

146r   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/

 

145r   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/

 

144r   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/

 

143r   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/

 

142r   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/

 

141r   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/

140r   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/

 

139r   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/

 

138r   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/

 

137r   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/

 

136r   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/

 

135r   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/

 

134r   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/

 

133r   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/

 

132r   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/

 

131r   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/

 

130r   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/

 

129r   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/

 

128r   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/

 

127r   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/

 

126r   Inferior Vena Cava 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/

 

125r   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/

 

124r   Clinical Trials for Transcatheter Mitral Valves 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/

 

123r   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

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/

 

122r   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/

 

121r   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/

 

120r   DELETED identical to 121r

 

119r   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/

 

118r   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/

 

117r   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/

 

116r   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/

 

115r   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/

 

114r   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/

 

113r 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/

 

112r   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/

 

111r   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/

 

110r   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/

 

109r   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/

 

108r   ‘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/

 

107r   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/

 

106r   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/

 

105r   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/

 

104r   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/

 

103r   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/

 

102r   DELETED, identical to 101r

 

101r   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/

 

100r   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/

 

99r     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/

 

98r     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/

 

 

97r     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/

 

96r     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/

95r     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/

 

94r     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/

 

93r     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/

 

92r     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/

 

91r     Fractional Flow Reserve–Guided PCI vs Drug Therapy for Stable Coronary Artery Disease

Reporter: Aviva Lev-Ari, PhD, RN

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

90r     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/

 

89r     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

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/

 

88r     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/

 

87r     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/

 

86r     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/

85r     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/

 

84r     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/

 

83r     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/

 

82r     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/

 

 

81r     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/

 

80r     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/

 

79r     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/

 

78r     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/

 

77r     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/

 

76r     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/

 

75r     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/

 

 

74r     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/

 

73r     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/

 

72r     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/

71r     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/

 

70r     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/

 

69r     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/

 

68r     “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/

 

67r     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/

 

66r     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/

 

65r     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/

 

64r     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/

 

63r     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/

 

62r     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/

 

61r     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/

 

60r     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/

 

59r     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/

 

58r   For Accomplishments in Cardiology and Cardiovascular Diseases: 2015 The Arrigo Recordati International Prize for Scientific Research

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/

 

57r   Dalio Institute of Cardiovascular Imaging @ NewYork-Presbyterian Hospital and Weill Cornell Medical College

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/

 

56r   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/

 

55r     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/

 

54r     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/

53r     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/

52r     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/

51r   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/

 

50r     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/

49r     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/

 

48r   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/

 

47r     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/

 

46r     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/

 

45r   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/

 

44r   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/

 

43r   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/

 

42r   Texas Heart Institute: 50 Years of Accomplishments

Reporter: Aviva Lev-Ari, PhD, RN

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

 

41r   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/

 

40r   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/

 

39r   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/

 

38r     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/

 

37r     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/

 

36r     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/

 

35r     DELETED, identical to 15c

 

34r     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/

 

33r     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/

 

32r     DELETED, identical to 14c

31r     DELETED, identical to 12c

 

30r     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/

 

29r     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/

 

28r     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/

 

27r     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/

 

26r     DELETED, identical to 11c

 

25r     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/

 

24r     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/

 

23r     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/

 

22r     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/

 

21r     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/

 

20r     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/

 

19r     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/

 

18r     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/

17r     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/

 

16r     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/

 

15r     DELETED, identical to 8c

 

14r     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/

 

13r     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/

 

12r   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/

 

11r     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/

 

10r     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/

 

9r      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/

 

8r      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/

 

7r      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/

 

6r      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/

 

5r      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/

 

4r      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/

 

3r      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/

 

2r     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/

 

1r     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/

 

 

 

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UPDATED on 1/13/2021

Medtronic CEO expects to submit renal denervation data to FDA this year, overcoming previous failures

Medtronic suffered a shocking setback back in 2014 when its Symplicity 3 pivotal trial failed to meet its primary endpoint of reducing blood pressure meaningfully. Now it is gearing up to present new data to the FDA.

“We are in the lead on realizing this multibillion-dollar opportunity to treat hypertension, which affects one-third of adults globally and is the single largest contributor to death,” Martha said on Monday. “We believe RDN can be a $1 billion market in 5 years and a $3 billion market by the end of the decade.”

There is a reason for his confidence. In June, Medtronic reported that new data from a global registry revealed that its Symplictity Denervation System meaningfully reduced blood pressure in patients who suffered uncontrolled hypertension even three years after the procedure. And this was independent of any changes to their medication, according to a company news release.

The number of patients at the very highest BP level – greater than 180 mmHg systolic at baseline – dropped by two-thirds at three years. Additionally, the number of patients who had reported office systolic BP less than 140 mmHg – a more controlled level of BP – increased from 13 percent at baseline to 39 percent at three years. The BP drops occurred while patients were prescribed an average of four or more anti-hypertensive medications, which remained unchanged over three years.

Earlier in the year, the company also showed positive data in its SPYRAL HTN-OFF MED trial. As the name of the trial suggests, Medtronic is testing the catheter-based procedure through a randomized, sham-controlled study by evaluating patients with uncontrolled blood pressure when they not taking prescribed medications to control their hypertension. The Dublin company is also testing patients in a separate trial called SPYRAL HTN-ON MED where it is testing the Symplicity Spyral Denervation system in the presence of prescribed anti-hypertensive medications.

“As the body of clinical evidence supporting renal denervation grows, we are encouraged by the outcomes observed in both controlled clinical trials and real-world practice,” said Dave Moeller, vice president and general manager of Medtronic’s Coronary and Renal Denervation business, in a statement in June.

The system is already approved in Europe and other countries but were the FDA to approve it, it would make for a real comeback story for Medtronic in the U.S. And perhaps be a final vindication for spending $800 million to buy Ardian back in 2010, although it had to take a significant writedown for the acquisition when the Symplicity 3 trial failed.

SOURCE

https://medcitynews.com/2021/01/medtronic-ceo-expects-to-submit-renal-denervation-data-to-fda-this-year-overcoming-previous-failures/

UPDATED on 1/14/2016

Renal Denervation: This Is Why Device Trials Need Sham Controls

Subtle biases are unavoidable in open-label studies, study suggests

http://www.medpagetoday.com/Cardiology/CardioBrief/55634

 

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

UPDATED on 5/27/2014

PARIS, FRANCE – No one could accuse EuroPCR 2014 of giving up on renal denervation following the negative results of the only large, randomized, sham-controlled trial of this cutting-edge technology.

In its plumpest program to date, this year’s EuroPCR meeting once again had a dedicated track focused on catheter-based interventions for hypertension (and heart failure), featuring more than 60 renal-denervation sessions. These included live cases, new data, how-to sessions, plus additional poster and oral abstract sessions. The two frontrunner companies in this space, Medtronic and St Jude Medical, even had conference rooms named for them, hosting training and information sessions for the duration of the meeting, funded by unrestricted grants.

And the sessions were packed. Without question, the sexiest technology of last year’s conference remained the hottest topic of 2014, with everyone seeking answers to the question: Why wasSYMPLICITY HTN-3 negative when so many preclinical studies, phase 1 and 2 studies, and mushrooming registry data point to beneficial effects of sympathetic modulation via denervation of the renal artery?

Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA), one of the steering committee members for SYMPLICITY HTN-3, acknowledged the unabated enthusiasm in Paris.

“At first glance I was surprised to see there was so much [renal denervation] in the 2014 program,” he admitted. But only by examining the randomized control trial data and other studies addressing procedural techniques and patient appropriateness will researchers learn more about why the SYMPLICITY HTN-3 results were so strikingly at odds with smaller, nonrandomized studies, he said. “So I think the organizers intentionally directed the program toward focusing more on the science of renal denervation and what the next steps are.”

More Insights From SYMPLICITY HTN-3

Kandzari presented a new analysis from SYMPLICITY HTN-3 focused on three variables that may have influenced efficacy in the trial: drug changes/drug adherence, patient population, and procedure-related factors.

For the first, he noted, patients in the study were required to be “stable” on their antihypertensive drug regimen for at least six weeks prior to trial enrollment. Yet during the trial, roughly two out of five participants required medication changes during the study, including 69% that were deemed “medically necessary.”

“This challenges the notion that patients were on their maximum tolerated drugs and that they can be maintained on stable drug regimens,” Kandzari said. Not only that, “it also highlights how different these trials are from clinical practice.” For example, in SYMPLICITY HTN-3, patients in both the intervention and sham arms had, on average, eight points of contact where blood pressure and medication were being closely scrutinized, he said—a factor that would have helped boost BP control in both arms.

Another important factor to emerge in these exploratory analyses was race, he said. Just under one-third of patients enrolled in SYMPLICTY HTN-3, by design, were African American (this was, after all, the pivotal trial designed in consultation with the FDA required for regulatory approval in the US). And, when non–African Americans were analyzed separately, renal-denervation–treated patients experienced drops in office systolic BP that were significantly greater than the sham-control group, something not seen in African American patients.

This finding was part of a larger discussion at EuroPCR circling around the fact that the pivotal phase 3 trial, which enrolled 535 patients in the US, was designed according to findings from SYMPLICITY  1and 2 . Those earlier trials were conducted in non-US patients whose distribution of risk factors and ethnic makeup is very different.

“I’ve been doing renal denervation since 2009, and I have never once seen an African American patient, or a black patient for that matter,” Dr Thomas Zeller (Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany) said in a Friday session.

Dr. Kulwant Raj|  Internal Medicine37 minutes ago

Amazing new technology for the benefit of treating surgeons, hospitals and for hardware manufacturing/ supplying companies. What is in it for the patient? Is there EVER meant to be anything for the patient? We, the “service providers” are the Gods for whom the patient sacrifices not only all his money but his life too. Hey, did I hear someone say “Gods or demons?” You are out of synch with the times my dear! These days Gods and demons are synonymous, as are “Healthcare” and “Sick-Care”

 

SOURCE

 

 

 UPDATED on 4/22/2014

Hopes Dashed by SYMPLICITY HTN-3

WATCH VIDEO

http://www.medscape.com/viewarticle/823774?nlid=55503_2562&src=wnl_edit_medp_card&uac=93761AJ&spon=2#1

Hi. This is Seth Bilazarian from theheart.org on Medscape, reporting from the American College of Cardiology (ACC) meeting in Washington, DC.

I want to make a few comments on the SYMPLICITY HTN-3 trial.[1,2] Briefly, SYMPLICITY is the name of a series of trials sponsored by the Medtronic company that are evaluating the efficacy and safety of therapy with a renal denervation catheter for a variety of problems, but most importantly for hypertension.

In the area of disclosure, I was a SYMPLICITY investigator. I was not compensated for my work and I am not an employee of the hospital where I performed the procedures, but for purposes of disclosure, I was quite an enthusiast about the potential for this technology, and I was quite disappointed [with the results].

The SYMPLICITY HTN-3 trial had 535 patients, with 2:1 randomization. Patients were blinded to the therapy. They were brought into the catheterization laboratory wearing blindfolds, and headphones with music playing. After having a sheath placed in the groin and an angiogram of the renal artery, patients were randomized to undergo either an actual procedure or a sham procedure in which we would pretend to do something, and then they would leave the room.

Patients were blinded for 6 months afterward, and at the end of 6 months they were unblinded, so the blinding was very effective during the study. The 2:1 randomization was designed to show effective blood pressure lowering. Previous studies in which there wasn’t randomization or sham procedures with blinding showed as much as a 30-mm Hg blood pressure reduction over the course of 12 years, which persisted for many years.

That was the great hope going into this, but the results of the SYMPLICITY HTN-3 trial[1] presented at the ACC Scientific Session showed only about a 2.4-mm Hg greater reduction in office blood pressure at 6 months compared with the sham arm. There was actually a 14-mm Hg blood pressure reduction from baseline to 6 months in the treatment group, but there was also a 12-mm Hg reduction in the sham arm.

These patients, just to be clear, had very significant hypertension. To be in the trial, patients had to have a systolic blood pressure higher than 160 mm Hg and had to be on 3 drugs, all at maximal doses, and 1 of them had to be a diuretic. They could be on more drugs, and many of my patients were on more than 3 drugs. These patients went through this procedure, and the average blood pressure at the end of the trial for all 535 patients in both arms was still higher than 160 mm Hg, so this is a very serious group of patients who are not yet well treated.

Renal Denervation in the Real World

Today, a second trial in the SYMPLICITY family of studies was presented: the Global SYMPLICITY Registry (GSR).[3] This included the first 1000 patients treated commercially outside of the United States where this device is available.

The GSR showed that for a variety of patients, renal denervation lowered blood pressure, as previously shown in nonrandomized trials. In the subset of patients with systolic blood pressures of 160 mm Hg (matching up with what was seen in the SYMPLICITY HTN-3 trial), they showed a 20-mm Hg blood pressure reduction in the registry vs 14 mm Hg in the randomized trial, which is not very different.

Why was this the case? There has been a lot of discussion about it, and many potential explanations have been offered. One is that patients seem to have a very robust decline in their blood pressure in the medical treatment group that is stable and not expected to change. This is a concern for me.

As an investigator, what actually happened to patients’ drug therapy over time is not reported, either in the manuscript or anywhere else that I can find. What happens from a practical standpoint for a community-based physician is that patients walking around with blood pressures of 170-180 mm Hg go to emergency rooms or see their primary care physicians, and their blood pressure medications are altered. That was said not to be the case, but it is not specifically reported, so was there a change?

For anyone who participates in clinical trials, the oversight of a clinical trial is such that the patients are very rigorously followed, and there is pill-counting and recommendations for strict compliance, all of which is very different from what happens with “optimal medical therapy” in real-world practice.

Furthermore, this was a renal denervation strategy with a particular device, so it could be that this particular device isn’t the best device for renal denervation.

A third practical question, which is unanswered, is whether we really achieved renal denervation. The animal and preclinical trials looked at how much energy was needed to create an injury that went from the renal artery lumen down to the renal nerves. Perhaps in this middle-aged group of patients with hypertension on a western diet, there is greater thickening of the renal vessel, which could actually cause problems in delivering the energy required to achieve effective renal denervation.

Uncontrolled Hypertension in the Balance

Those are some of the questions that have come up that may explain why we didn’t see the robust results we were hoping for. Although I don’t have to make the decision, if I were a senior executive at one of the companies involved, a decision to go forward would be very difficult in terms of investing corporate resources on the development of these devices.

As a clinician, however, we really need help, because there are 535 patients still walking around with systolic blood pressures higher than 160 mm Hg despite this therapy and being on 3 maximal-dose drugs. Many patients in our practices aren’t optimally controlled. Many patients can’t take optimal medical therapy because of adherence or intolerance of therapy issues, so a variety of patients would greatly benefit from another strategy.

There is no question that there will be great enthusiasm for a therapy that could deliver the promise of a 30-mm Hg blood pressure reduction that was safe, effective, and durable. Another question is whether it is even correct to compare such a strategy with optimal medical therapy. Wouldn’t it be valuable to show that this technique alone is equally good in terms of long-term clinical results compared with multiple drug therapy?

These questions are yet to be answered, and we may never get the answers because industry may choose not to invest in these programs going forward. Other questions, such as the potential for renal denervation as a therapy for such problems as left ventricular hypertrophy, congestive heart failure, or obstructive sleep apnea, have gone by the wayside at this point.

From my standpoint, I would enthusiastically want to participate as an investigator and talk to my patients, candidly disclosing the results of this trial, about enrolling in a new trial of renal denervation. There is great need for therapies that are effective for this patient population. The risks associated with blood pressure in this range (over 160 mm Hg) are well known, and strategies to treat these patients are greatly needed.

So, there are a lot of unanswered questions, as well as a great disappointment, both for the clinical practicing community as well as for patients. There has been a deflation in the device community about this innovation that has at least stalled progress and presents a hurdle going forward.

That is my quick update on renal denervation. Until next time, thank you, from the ACC in Washington.

SOURCE

 

 

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

On March 29, 2014 in NEJM Franz H. Messerli, M.D., and Sripal Bangalore, M.D. wrote:

  • the most likely explanation for the findings of the SYMPLICITY HTN-3 study is the inclusion of a sham-control group.
  • In clinical trials testing interventional procedures and medical devices, sham procedures are seminal, analogous to the use of a placebo in pharmaceutical trials. However, for ethical reasons sham procedures are frowned upon9;
  • neither the SYMPLICITY HTN-1 study nor the HTN-2 study had a sham-control cohort.
  • For this reason, placebo effects may well explain all or most of the blood-pressure differences noted in the first two trials.
  • Lack of efficacy could also be caused by incomplete or ineffective denervation.
  • No reliable markers of renal denervation are available, and questions remain as to
  • what exactly the procedure accomplishes. Nevertheless,
  • the ablation catheter used in the SYMPLICITY HTN-3 study was no different from that used in the SYMPLICITY HTN-1 and HTN-2 studies.
  • A decrease in systolic blood pressure was observed in both the renal-denervation group and the control group, a finding that is in marked contrast to the findings in previous trials.
  • At 6 months, the decrease in office systolic blood pressure from baseline in the renal-denervation group in the SYMPLICITY HTN-3 study was about half that observed in the corresponding group in the SYMPLICITY HTN-2 study, despite the fact that baseline blood pressures were similar in the two studies. This is puzzling, because
  • the degree of reduction in blood pressure is related to pretreatment blood-pressure levels (unpublished data). In addition,
  • there was a larger decrease in blood pressure in the control group of the SYMPLICITY HTN-3 study, as compared with the meager decrease in the SYMPLICITY HTN-2 study.
  • Is it conceivable that greater exposure to spironolactone in the SYMPLICITY HTN-3 study facilitated this decrease (and possibly contributed to a neutral outcome)?

Could we have predicted the outcome of the SYMPLICITY HTN-3 study?

  • The standard deviations of the change in office systolic blood pressure from baseline in both study groups in both trials were remarkably similar, indicating a wide variation in response.
  • In fact, in the SYMPLICITY HTN-2 study, the change in blood pressure from baseline in 95% of patients was between −78 mm Hg and 14 mm Hg in the renal-denervation group and
  • between −43 mm Hg and 41 mm Hg in the control group.
  • The mean blood-pressure reduction in the SYMPLICITY HTN-3 study is well within this range for both study groups.

Conclusion #1

The wide variability in response to renal denervation begs the question of whether this procedure could be more efficacious in selected patients with increased sympathetic drive only, such as those with heart failure. Regardless of this conjecture, the SYMPLICITY HTN-3 study certainly has raised the bar.

  • To be enrolled in a study, patients need to fulfill predefined blood-pressure criteria on a particular day. Patients whose blood pressure is above their usual average will preferentially be enrolled. Thus,
  • subsequent blood-pressure measurements are prone to be lower regardless of whether there was an intervention.
  • This phenomenon, although unlikely to fully explain the differences in blood-pressure decrease among various studies, occurs only when inclusion criteria require a certain blood-pressure level.
  • It should not be confused with regression to the mean or a placebo effect, both of which could also have contributed to the uneven blood-pressure response in the SYMPLICITY trials. Indeed,

Conclusion #2

  • regression to the mean was probably responsible for a less extreme decrease in office systolic blood pressure in the renal-denervation group and a more impressive decrease in the control group, as compared with changes observed in prior studies.

Conclusion #3

  • Exuberance about renal denervation has been widespread, as is illustrated by these statements: “The potential of renal denervation is enormous” and it “may be used not only to treat hypertension, but also . . . diseases that are characterized by high sympathetic activity such as diabetes and hyperinsulinemia, heart failure, arrhythmias, and chronic kidney disease.”10
  • These words, thoroughly referenced, tout the benefits of renal denervation in these metabolic or cardiovascular disorders.
  • In contrast, the conclusions of the SYMPLICITY HTN-3 study by one of the same authors now 6 months later soberingly state that “a significant effect on systolic blood pressure was not observed.

Conclusion #4

  • Further evaluation in rigorously designed clinical trials will be necessary . . . to confirm previously reported benefits of renal denervation in patients with resistant hypertension.
  • ” Should this statement indeed hold true, we will have to come to grips with two facts: the SYMPLICITY studies merely document the natural history of resistant hypertension in clinical trials, and the time has come to turn the page on renal denervation for hypertension but by all means, let’s not close the book.

 

SOURCE

Renal Denervation for Resistant Hypertension?  

Franz H. Messerli, M.D., and Sripal Bangalore, M.D.

March 29, 2014DOI: 10.1056/NEJMe1402388

 

RESULTS of Clinical Trials:

Trials such as the SYMPLICITY HTN-14 and HTN-25 studies

  • showed impressive decreases in blood pressure, seemingly attesting to the efficacy and safety of renal denervation.
  • Three-year follow-up of the SYMPLICITY HTN-1 study revealed a decrease in blood pressure of 32/14 mm Hg.6
  • These unprecedented results seemed to surpass what was achievable with drug therapy and continued to fan the flames of renal denervation.

The SYMPLICITY HTN-3 study, a blinded, sham-controlled study now reported in the Journal by Bhatt et al.,7 brings the renal-denervation train to a grinding halt.

  • After 6 months, office systolic blood pressure decreased from baseline to a similar extent in the renal-denervation and sham-procedure groups (P<0.001 for both comparisons of the change from baseline);
  • the difference in the change in blood pressure between the two groups was a paltry −2.39 mm Hg (Table 1TABLE 1: Selected Findings of the SYMPLICITY HTN-2 and HTN-3 Studies.

In addition, a prespecified difference in 24-hour ambulatory systolic pressure of only 2 mm Hg was not met.

  • Thus, in the SYMPLICITY HTN-3 study, renal denervation had no significant effect on office or 24-hour ambulatory systolic blood pressure,
  • findings that contradict most published data on renal denervation, although a recent trial even suggested inferiority of renal denervation, as compared with adjusted drug treatment.8

http://www.nejm.org/doi/full/10.1056/NEJMe1402388#t=article

 

For additional information of the subject and analysis of the Market impact, go to 

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

http://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/

Renal Denervation Safe in Real-World Setting: Preliminary results from the Global SYMPLICITY registry, 5/2013

UPDATED 5/29/2014

http://pharmaceuticalintelligence.com/2013/01/14/positive-effects-of-renal-denervation-ablation-for-hypertension-in-controlled-randomized-symplicity-htn-2-trial/

 

REFERENCES
1 Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med 2009;361:932-934
Free Full Text | Web of Science | Medline

2 Messerli FH, Bangalore S. Treatment-resistant hypertension: another Cinderella story. Eur Heart J 2013;34:1175-1177
CrossRef | Web of Science | Medline

3 Radio waves to kidneys lower persistent high blood pressure. Press release of the American Heart Association, Dallas, December 17, 2012.

4 Krum H, Schlaich M, Whitbourn R, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 2009;373:1275-1281
CrossRef | Web of Science | Medline

5 Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (the SYMPLICITY HTN-2 Trial): a randomised controlled trial. Lancet 2010;376:1903-1909
CrossRef | Web of Science | Medline

6 Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the SYMPLICITY HTN-1 study. Lancet 2014;383:622-629[Erratum, Lancet 2014;383:602.]
CrossRef | Web of Science | Medline

7 Bhatt DL, Kandzari DE, O’Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. DOI: 10.1056/NEJMoa1402670.

8 Elmula F, Hoffmann P, Larstorp AC, et al. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension 2014 March 3 (Epub ahead of print).

9 Gottlieb S. The FDA wants you for sham surgery: there are better ways to test medical devices than by having patients be placebos who get fake operations. Wall Street Journal. February 18, 2014.

10 Mahfoud F, Bhatt DL. Catheter-based renal denervation: the black box procedure. JACC Cardiovasc Interv 2013;6:1092-1094
CrossRef

 

Other Related Articles Published on this Open access Scientific Journal, include the following:

Renal Sympathetic Denervation: Updates on the State of Medicine

Aviva Lev-Ari, PhD, RN

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

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

Aviva Lev-Ari, PhD, RN

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

Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Aviva Lev-Ari, PhD, RN

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

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ATVB (Arteriosclerosis, Thrombosis and Vascular Biology) 2014 Conference  5/1 – 5/3/2014, Sheraton Centre Toronto – Toronto, Ontario

Reporter: Aviva Lev-Ari, PhD, RN

ATVB 2014 Early Registration closes TODAY!
Register NOW and get the BEST rates! 

ATVB 2014

Conference Dates/Location
Thursday, May 1 through Saturday,
May 3, 2014
Sheraton Centre Toronto – Toronto, Ontario

 


ATVB 2014 Scientific Sessions

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  Organized by the Arteriosclerosis, Thrombosis and Vascular Biology Council with participation by the Councils on Peripheral Vascular Disease and Functional Genomics and Translational Biology

 

Register Now to join your colleagues at the Sheraton Centre Toronto on May 1-3 for the ATVB 2014 Scientific Sessions. Meet and network with colleagues from around the world with wide-ranging common interests and expertise in arteriosclerosis, thrombosis, vascular biology, functional genomics, peripheral vascular disease, and vascular surgery research.

 

http://view.heartemail.org/?j=fe52107676610c79731d&m=fe6715707463057a7513&ls=fdbf1571746c01757614787262&l=fe8c1372706d057576&s=fded1576716c007d71137972&jb=ffcf14&ju=fe2917797565027b7d1170&r=0

ATVB 2014 Scientific Sessions

http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_451535.pdf

Join or renew your AHA/ASA Professional Membership by February 19 and save up to $300 on conference registration. Affiliate with one of these Councils:
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Endovascular Aortic Repair: A New Tool for Procedure Planning

Reporter: Aviva Lev-Ari, PhD, RN

 

Vascular surgeon – Humanitas Research Hospital, Milan (Italy) – EVARplanning developer

EVARplanning is a free, simple tool to help you plan the aortic endograft configuration once you know the sizes of the aneurysm. Here you can find the latest version of EVARplanning in a easy-share file. Just open EVARplanning online, or download

EVARplanning is a free, simple tool to help you plan the aortic endograft configuration once you know the sizes of the aneurysm. Here you can find the latest version of EVARplanning in a easy-share file. Just open EVARplanning online, or download the spreadsheet on your computer. As you enter the data of the aneurysm, the endografts configurations will automatically appear on the right. Select the graft type. You may want to use EVARplanning just to check your own planning or to help you think about the best solution by switching the main body access side or the intended iliac landing zones.

VIEW VIDEO

http://www.evarplanning.com/

SOURCE

http://www.evarplanning.com

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

Reporter: Aviva Lev-Ari, PhD, RN

VIEW VIDEO

Published on Jun 6, 2013

In this Mayo Clinic Grand Rounds video originally presented on November 30, 2012, cardiologists Rajiv Gulati, MD, PhD, and Sharonne Hayes, MD, discuss “Spontaneous Coronary Artery Dissection: New Insights and New Questions About This-Not-So-Rare Condition.”

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Genomics of Carotid-Femoral Pulse Wave Velocity and Excess Cardiovascular Disease Risk: Common Genetic Variation in the 3′-BCL11B Gene Desert

Reporter: Aviva Lev-Ari, PhD, RN

 

Common Genetic Variation in the 3′-BCL11B Gene Desert Is Associated With Carotid-Femoral Pulse Wave Velocity and Excess Cardiovascular Disease Risk – The AortaGen Consortium

Gary F. Mitchell, MD*Germaine C. Verwoert, MSc*Kirill V. Tarasov, MD, PhD*,Aaron Isaacs, PhD, Albert V. Smith, PhD, Yasmin, BSc, MA, PhD, Ernst R. Rietzschel, MD, PhD, Toshiko Tanaka, PhD, Yongmei Liu, MD, PhD, Afshin Parsa, MD, MPH,Samer S. Najjar, MD, Kevin M. O’Shaughnessy, MA, BM, DPhil, FRCP, Sigurdur Sigurdsson, MSc, Marc L. De Buyzere, MSc, Martin G. Larson, ScD, Mark P.S. Sie, MD, PhD, Jeanette S. Andrews, MS, Wendy S. Post, MD, MS, Francesco U.S. Mattace-Raso, MD, PhD, Carmel M. McEniery, BSc, PhD, Gudny Eiriksdottir, MSc, Patrick Segers, PhD, Ramachandran S. Vasan, MD, Marie Josee E. van Rijn, MD, PhD,Timothy D. Howard, PhD, Patrick F. McArdle, PhD, Abbas Dehghan, MD, PhD,Elizabeth S. Jewell, MS, Stephen J. Newhouse, MSc, PhD, Sofie Bekaert, PhD, Naomi M. Hamburg, MD, Anne B. Newman, MD, MPH, Albert Hofman, MD, PhD, Angelo Scuteri, MD, PhD, Dirk De Bacquer, PhD, Mohammad Arfan Ikram, MD, PhD†, Bruce M. Psaty, MD, PhD†, Christian Fuchsberger, PhD‡, Matthias Olden, PhD‡, Louise V. Wain, PhD§, Paul Elliott, MB, PhD§, Nicholas L. Smith, PhD‖, Janine F. Felix, MD, PhD‖, Jeanette Erdmann, PhD¶, Joseph A. Vita, MD, Kim Sutton-Tyrrell, PhD, Eric J.G. Sijbrands, MD, PhD, Serena Sanna, PhD, Lenore J. Launer, MS, PhD, Tim De Meyer, PhD, Andrew D. Johnson, MD, Anna F.C. Schut, MD, PhD, David M. Herrington, MD, MHS, Fernando Rivadeneira, MD, PhD, Manuela Uda, PhD, Ian B. Wilkinson, MA, BM, FRCP, Thor Aspelund, PhD, Thierry C. Gillebert, MD, PhD, Luc Van Bortel, MD, PhD, Emelia J. Benjamin, MD, MSc, Ben A. Oostra, PhD, Jingzhong Ding, MD, PhD, Quince Gibson, MBA, André G. Uitterlinden, PhD, Gonçalo R. Abecasis, PhD,John R. Cockcroft, BSc, MB, ChB, FRCP, Vilmundur Gudnason, MD, PhD, Guy G. De Backer, MD, PhD, Luigi Ferrucci, MD, Tamara B. Harris, MD, MS, Alan R. Shuldiner, MD, Cornelia M. van Duijn, PhD, Daniel Levy, MD*Edward G. Lakatta, MD* andJacqueline C.M. Witteman, PhD*

Correspondence to Gary F. Mitchell, MD, Cardiovascular Engineering, Inc, 1 Edgewater Dr, Suite 201A, Norwood, MA 02062. E-mailGaryFMitchell@mindspring.com

* These authors contributed equally.

Abstract

Background—Carotid-femoral pulse wave velocity (CFPWV) is a heritable measure of aortic stiffness that is strongly associated with increased risk for major cardiovascular disease events.

Methods and Results—We conducted a meta-analysis of genome-wide association data in 9 community-based European ancestry cohorts consisting of 20 634 participants. Results were replicated in 2 additional European ancestry cohorts involving 5306 participants. Based on a preliminary analysis of 6 cohorts, we identified a locus on chromosome 14 in the 3′-BCL11B gene desert that is associated with CFPWV (rs7152623, minor allele frequency=0.42, β=−0.075±0.012 SD/allele,P=2.8×10−10; replication β=−0.086±0.020 SD/allele, P=1.4×10−6). Combined results for rs7152623 from 11 cohorts gave β=−0.076±0.010 SD/allele,P=3.1×10−15. The association persisted when adjusted for mean arterial pressure (β=−0.060±0.009 SD/allele, P=1.0×10−11). Results were consistent in younger (<55 years, 6 cohorts, n=13 914, β=−0.081±0.014 SD/allele, P=2.3×10−9) and older (9 cohorts, n=12 026, β=−0.061±0.014 SD/allele, P=9.4×10−6) participants. In separate meta-analyses, the locus was associated with increased risk for coronary artery disease (hazard ratio=1.05; confidence interval=1.02–1.08; P=0.0013) and heart failure (hazard ratio=1.10, CI=1.03–1.16, P=0.004).

Conclusions—Common genetic variation in a locus in the BCL11B gene desert that is thought to harbor 1 or more gene enhancers is associated with higher CFPWV and increased risk for cardiovascular disease. Elucidation of the role this novel locus plays in aortic stiffness may facilitate development of therapeutic interventions that limit aortic stiffening and related cardiovascular disease events.

SOURCE:

Circulation: Cardiovascular Genetics.2012; 5: 81-90

Published online before print November 8, 2011,

doi: 10.1161/ CIRCGENETICS.111.959817

 

 

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

Reporter: Aviva Lev-Ari, PhD, RN

 

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

Tyler Duellman, BS, Christopher L. Warren, PhD, Peggy Peissig, PhD, Martha Wynn, MD and Jay Yang, MD, PhD

Author Affiliations

From the Molecular and Cellular Pharmacology Graduate Program (T.D., J.Y.) and Department of Anesthesiology (M.W., J.Y.), University of Wisconsin School of Medicine and Public Health, Madison; Illumavista Biosciences LLC, Madison, WI (C.L.W.); and Biomedical Informatics Research Center, Marshfield Clinics Research Foundation, Marshfield, WI (P.P.).

Correspondence to Jay Yang, MD, PhD, Department of Anesthesiology, University of Wisconsin SMPH, SMI 301, 1300 University Ave, Madison, WI 53706. E-mailJyang75@wisc.edu

Abstract

Background—Degradation of extracellular matrix support in the large abdominal arteries contribute to abnormal dilation of aorta, leading to abdominal aortic aneurysms, and matrix metalloproteinase-9 (MMP-9) is the predominant enzyme targeting elastin and collagen present in the walls of the abdominal aorta. Previous studies have suggested a potential association between MMP-9 genotype and abdominal aortic aneurysm, but these studies have been limited only to the p-1562 and (CA) dinucleotide repeat microsatellite polymorphisms in the promoter region of the MMP-9 gene. We determined the functional alterations caused by 15 MMP-9 single-nucleotide polymorphisms (SNPs) reported to be relatively abundant in the human genome through Western blots, gelatinase, and promoter–reporter assays and incorporated this information to perform a logistic-regression analysis of MMP-9 SNPs in 336 human abdominal aortic aneurysm cases and controls.

Methods and Results—Significant functional alterations were observed for 6 exon SNPs and 4 promoter SNPs. Genotype analysis of frequency-matched (age, sex, history of hypertension, hypercholesterolemia, and smoking) cases and controls revealed significant genetic heterogeneity exceeding 20% observed for 6 SNPs in our population of mostly white subjects from Northern Wisconsin. A step-wise logistic-regression analysis with 6 functional SNPs, where weakly contributing confounds were eliminated using Akaike information criteria, gave a final 2 SNP (D165N and p-2502) model with an overall odds ratio of 2.45 (95% confidence interval, 1.06–5.70).

Conclusions—The combined approach of direct experimental confirmation of the functional alterations of MMP-9 SNPs and logistic-regression analysis revealed significant association between MMP-9 genotype and abdominal aortic aneurysm.

SOURCE:

Circulation: Cardiovascular Genetics.2012; 5: 529-537

Published online before print August 31, 2012,

doi: 10.1161/ CIRCGENETICS.112.963082

 

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Aortic Aneurysm Pathogenesis: The Role of TGFβRIIb Mutations in  Altering Transforming Growth Factor β2 Signal Transduction

Reporter: Aviva Lev-Ari, PhD, RN

TGFβRIIb Mutations Trigger Aortic Aneurysm Pathogenesis by Altering Transforming Growth Factor β2 Signal Transduction

Katharine J. Bee, PhD, David C. Wilkes, PhD, Richard B. Devereux, MD, Craig T. Basson, MD, PhD and Cathy J. Hatcher, PhD

Author Affiliations

From the Center for Molecular Cardiology, Greenberg Division of Cardiology, Weill Cornell Medical College, New York, NY.

Correspondence to Cathy J. Hatcher, PhD, Greenberg Division of Cardiology, Weill Cornell Medical College, 525 E. 68th St, New York, NY 10065. E-mailcjhatche@med.cornell.edu

Abstract

Background—Thoracic aortic aneurysm (TAA) is a common progressive disorder involving gradual dilation of the ascending and/or descending thoracic aorta that eventually leads to dissection or rupture. Nonsydromic TAA can occur as a genetically triggered, familial disorder that is usually transmitted in a monogenic autosomal dominant fashion and is known as familial TAA. Genetic analyses of families affected with TAA have identified several chromosomal loci, and further mapping of familial TAA genes has highlighted disease-causing mutations in at least 4 genes: myosin heavy chain 11 (MYH11), α-smooth muscle actin (ACTA2), and transforming growth factor β receptors I and II (TGFβRI and TGFβRII).

Methods and Results—We evaluated 100 probands to determine the mutation frequency in MYH11ACTA2TGFβRI, and TGFβRII in an unbiased population of individuals with genetically mediated TAA. In this study, 9% of patients had a mutation in one of the genes analyzed, 3% of patients had mutations in ACTA2, 3% in MYH11, 1% in TGFβRII, and no mutations were found in TGFβRI. Additionally, we identified mutations in a 75 base pair alternatively spliced TGFβRII exon, exon 1a that produces the TGFβRIIb isoform and accounted for 2% of patients with mutations. Our in vitro analyses indicate that the TGFβRIIb activating mutations alter receptor function on TGFβ2 signaling.

Conclusions—We propose that TGFβRIIb expression is a regulatory mechanism for TGFβ2 signal transduction. Dysregulation of the TGFβ2 signaling pathway, as a consequence of TGFβRIIb mutations, results in aortic aneurysm pathogenesis.

SOURCE: 

Circulation: Cardiovascular Genetics.2012; 5: 621-629

Published online before print October 24, 2012,doi: 10.1161/ CIRCGENETICS.112.964064

 

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