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Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category

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

 

Reporter: Aviva Lev-Ari, PhD, RN

 

ANNOUNCEMENT

Leaders in Pharmaceutical Business Intelligence (LPBI) Group will cover the event in REAL TIME

Aviva Lev-Ari, PhD, RN will be streaming live from the floor of the Westin Hotel in Boston on May 1-3, 2017

@pharma_BI

@AVIVA1950

 

Biggest Voices in Cardiovascular Care

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

 

UPDATED on 3/29/2017

Partners Media Contact: Rich Copp

617-278-1031 rcopp@partners.org

REINVENTING CARDIOVASCULAR AND CARDIOMETABOLIC CARE FOCUS OF GLOBAL GATHERING

BOSTON — March 29, 2017 — Partners HealthCare, the nation’s largest academic research enterprise, today announced the third annual World Medical Innovation Forum, which will bring together nearly 1,000 international cardiovascular innovation decision-makers from industry, investment, clinical and research communities from May 1 to May 3, 2017 in Boston.

The focus of the Forum is the new technologies and systems that are transforming the largest market in healthcare. Keynoters include the CEOs of Amgen, Boston Scientific, Medtronic, Philips, Cardinal Health, Abiomed, Alnylam, Bard, Edwards, Medicines Company, Moderna, MyoKardia, Yumanity, Zoll, Boehringer Ingelheim, American Heart Association, GE Healthcare, Siemens Healthcare, and GE Ventures. They will be joined by top investors, the head of National Heart Lung and Blood Institute, Gary Gibbons, MD, the former FDA commissioner, Robert Califf, MD, and key leaders from the Centers for Medicare and Medicaid Services. There will be more than 120 speakers in total—all experts from industry, government, the investment community and Harvard Medical School. World Forum attendees include senior executives, investors, entrepreneurs, clinicians and scientists.

“The Forum will highlight the remarkable convergence occurring across different industries around the redesign of cardiovascular care,” says Calum MacRae, MD, PhD, Chief of Cardiovascular Medicine at Brigham and Women’s Hospital and Associate Professor of Medicine at Harvard Medical School. “The outcomes of this cooperation between academia and industry will impact the lives of millions of patients worldwide.”

Over three days, the Forum will review in detail the emerging cardiovascular therapies, ’omics, digital diagnostics, education and engagement with new delivery platforms to that will become the model of care for cardiovascular and related metabolic diseases.

The Forum is co-chaired by MacRae and Anthony Rosenzweig, MD, Chief, Cardiology Division at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. Academic speakers will include dozens of senior Harvard Medical School-appointed clinicians and investigators from Brigham and Women’s Hospital, Massachusetts General Hospital and Newton-Wellesley Hospital including the Presidents of all three hospitals.

“The changing spectrum of heart disease has produced new clinical needs, and marshaling an effective response will require cooperation among a diverse array of stakeholders. Technology, patient insights and clinical management have been combined to propel diagnosis, treatment and long term care into a new era,” said Anthony Rosenzweig, MD. “This global gathering of top cardiovascular leaders will catalyze new connections, conversations and thinking around these opportunities.”

Among the many features of the Forum is announcement of the “Disruptive Dozen,” the technologies likely to have the greatest impact on cardiovascular and cardiometabolic care in the next decade.

The Forum will kick off with 10-minute rapid-fire presentations by BWH and MGH early career Harvard faculty leaders describing the clinical potential of their work. Discovery Café workshops will follow, led by senior Harvard faculty addressing cutting-edge cardiovascular challenges.

The World Medical Innovation Forum is organized by Partners HealthCare Innovation, a division of Partners HealthCare dedicated to advancing the commercial application of the unique capabilities of Partners’ Harvard faculty.

Sponsors of the Forum include Boston Scientific, Amgen, Lilly, GE, Pfizer, AstraZeneca, Bayer, Bard, Edwards Lifesciences, Mintz Levin, Medtronic and Novo Nordisk.

About the World Medical Innovation Forum

The World Medical Innovation Forum is a global gathering of senior corporate, investor and academic leaders. It was established to respond to the intensifying transformation of health care and its impact on innovation. The Forum is rooted in the belief that no matter the magnitude of that change, the center of health care needs to be a shared, fundamental commitment to collaborative innovation—industry and academia working together and its ability to improve patient lives.

For more information or to register, please go to www.worldmedicalinnovation.org.

About Partners HealthCare

Partners HealthCare is an integrated health system founded by Brigham and Women’s Hospital and Massachusetts General Hospital. The Partners system includes academic, community and specialty hospitals, a managed care organization, community health centers, a physician network, home health and long-term care services, and other health-related entities. Partners HealthCare is one of the nation’s leading biomedical research organizations and a principal teaching affiliate of Harvard Medical School. Partners HealthCare is a non-profit organization.

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Monday, May 1, 2017

 

7:00 am – 8:00 am
8:00 am – 11:30 am
First Look: The Next Wave of Cardiology Breakthroughs

Harvard Medical School investigators describe their most promising work in rapid fire presentations highlighting commercial opportunities in cardiovascular and cardiometabolic care. Twenty rising stars from Brigham and Women’s Hospital and Massachusetts General Hospital will present in 10-minute sessions.

11:45 am – 1:15 pm
Concurrent Discovery Cafés Breakout Sessions: Sharing Perspectives

Top Cardiology faculty from Brigham and Women’s Hospital and Massachusetts General Hospital address compelling topics in clinical research and implementation of care.

Topics to be covered include:

  • Cardiac Replacement Therapy: The Next Ten Years
  • Heart Failure: Back in The Game through New Pathways
  • Payment Models: Provider’s Perspective
  • Microbiome: Implications for Cardiovascular and Metabolic Disease
  • Molecular Imaging: New Biological Endpoints – Function Over Structure
  • Technology: Enhancing Translational Medicine

 

1:15 pm – 1:30 pm
1:30 pm – 1:40 pm
Opening Remarks
Introduction by: Anne Klibanski, MD
  • Chief Academic Officer, Partners HealthCare
  • Laurie Carrol Guthart Professor of Medicine, Academic Dean for Partners, Harvard Medical School
  • CEO, Partners HealthCare
1:40 pm – 2:15 pm
Reinventing Cardiac Care

Two renowned clinical leaders provide an overview of the medical and economic challenges that cardiovascular and cardiometabolic disorders present.

They will highlight strategic direction in cardiac research and clinical care at Partners, and address how recent trends in investment, regulation, and policy may be dovetailed with efforts at Partners.

The experts also spotlight for attendees the various therapies, diagnostics, devices, and critical issues that will be discussed throughout the upcoming 2.5 days of the World Medical Innovation Forum.

  • CEO, Southern Cross Biotech Consulting
  • Chief of Cardiovascular Medicinem Brigham and Women’s Hospital
  • Associate Professor of Medicine, Harvard Medical School
  • Chief, Cardiology Division, Massachusetts General Hospital
  • Professor of Medicine, Harvard Medical School
2:15 pm – 3:05 pm
CEO Roundtable: Today’s Learning, Tomorrow’s Opportunities

Discussion on contribution of technology innovation to the treatment of cardiovascular disease reflecting on lessons and how they shape investment decisions.

Moderator: Benjamin Pless
  • Executive in Residence, Partners HealthCare Innovation
  • EVP Medical Affairs and CMO, UnitedHealth Group
  • CEO, Abiomed
  • CEO, Edwards Lifesciences
  • CEO, Bard
3:05 pm – 3:55 pm
Tackling the AFib Epidemic

Evolving trends in diagnosis, prevention, and treatment of atrial fibrillation. Factors that will influence patient care over the next 5 years are considered, including risk stratification, procedure and technology options, and potential implications of CMS policies, such as bundling.

 

  • Associate Chief, Cardiology Division, Massachusetts General Hospital Heart Center
  • Professor of Medicine, Harvard Medical School
  • Director, Cardiac Arrhythmia Service, Massachusetts General Hospital
  • Associate Professor, Harvard Medical School
  • VP, GM, AF Solutions, Medtronic
  • President, Cardiovascular and Neuromodulation, Abbott
  • VP US Medical Affairs, CVMD TA, AstraZeneca
3:55 pm – 4:45 pm
Heart Failure’s Therapeutic Mandate

One million patients are hospitalized annually for HF—80% of total US cost of HF management. After discharge from HF hospitalization, 24% are rehospitalized within 30 days, greater than 50% within 6 months. Perspective on disease management, addressing the issues of hospital readmission and optimizing therapies.

 

  • VP and Medical Director, Abbott
  • CEO, MyoKardia
  • SVP, CMO, Global Health Policy, Rhythm Management, Boston Scientific
4:45 pm – 5:50 pm
CLINICAL HIGHLIGHT: A New Chapter of PAD

PAD is the most challenging atherosclerotic syndrome, largely due to the technological challenges of managing peripheral artery disease through minimally invasive strategies. Top physician, governmental, and industry leaders in the field discuss the potential for new breakthroughs including novel implantable devices, pharmacologic approaches, and reductions in associated cardiovascular morbidity and mortality.

The panel will also discuss, Below The Knee: The Persisting Unmet Need

 

Moderator: Michael Jaff, DO
  • President, Newton-Wellesley Hospital, Partners Healthcare
  • Professor of Medicine, Harvard Medical School
  • Director, Coverage and Analysis Group, CMS
  • Chief, Peripheral Interventional Devices Branch, Food and Drug Administration
  • CMO, Cardinal Health
  • Co-Director, Endovascular Surgery, Brigham and Women’s Hospital
  • Assistant Professor, Harvard Medical School
  • SVP and President, Peripheral Interventions, Boston Scientific
6:00 pm – 6:45 pm

Tuesday, May 2, 2017

 

7:00 am – 7:45 am
7:00 am – 7:45 am
FOCUS SESSION: Japan Today: Advancing Cardiometabolic Therapies

Discussion on unique aspects of cardiometabolic market in Japan, its projected trend over the next 5 years and explore transformative models of open innovation to accelerate development of new therapeutic options.

  • Yoshiro Miwa Associate Chair and Founding Director, Center for Interdisciplinary Cardiovascular Sciences, Brigham and Women’s Hospital
7:00 am – 7:10 am
Opening
  • Chief Innovation Officer, Partners HealthCare
8:00 am – 8:50 am
Pricing to Enable Affordability and Innovation

Balancing acceptable answers to high and escalating drug prices in the United States while making strides in medical innovation. Leaders in innovation, policy, care delivery, academia, and insurance discuss potential collaborative solutions.

 

Moderator: Peter Slavin, MD
  • President, Massachusetts General Hospital
  • CEO, Cardinal Health
  • CEO, Boehringer Ingelheim USA
8:50 am – 9:40 am
CLINICAL HIGHLIGHT: Emerging Devices for Complex Structural Heart Disease

Evolution of mitral disease management, current practice and impact of new technologies on both repair and replacement, implications of a heterogeneous patient population, triage, timing of intervention.

  • CVP, Advanced Technology, CSO, Edwards Lifesciences
  • SVP and President, Coronary & Structural Heart, Medtronic
9:40 am – 10:10 am
1:1 Fireside Chat: John Lechleiter, Chairman, Eli Lilly
Moderator: Susan Dentzer
  • CEO, Network for Excellence in Health Innovation
  • Chairman, Eli Lilly and Company
10:10 am – 10:25 am
10:25 am – 11:15 am
Personal Monitoring for Disease Management

Considering the evolving trends in viability and utilization and the opportunities wearables may present for real-world clinical decision making.

 

Moderator: Joe Kvedar, MD
  • VP, Connected Health, Partners HealthCare
  • Associate Professor of Dermatology, Harvard Medical School
  • CEO, GE Healthcare
  • CEO, Philips
  • CEO, Siemens Healthcare
  • CEO, Zoll Medical
11:15 am – 11:45 am
1:1 Fireside Chat: Omar Ishrak, CEO, Medtronic
Moderator: Paul LaViolette
  • Managing Partner & COO, SV Life Sciences Advisers
  • CEO, Medtronic
12:00 pm – 12:30 pm
12:15 pm – 12:30 pm
1:00 pm – 1:10 pm
1:10 pm – 2:00 pm
Global Clinical Trials: Next Generation Design and Scalability

Cardiovascular trials currently account for 10 percent of all clinical trial participants. Discussion on design and implementation of clinical studies globally, considering strategies for patient access, regulatory implications, cost containment and management of relationships with global service providers.

 

  • Chairman, TIMI Study Group, Lewis Dexter, MD Distinguished Chair in Cardiovascular Medicine, Brigham and Women’s Hospital
  • VP, Cardiovascular & Metabolic Disease Head, Global Medicines Development, AstraZeneca
  • VP Cardiovascular Medicine, Covance
  • Vice President, Global Development, Amgen
2:00 pm – 2:50 pm
Precision Cardiovascular Medicine: What is Different This Time

Explore how precision medicine is changing the face of cardiovascular medicine specifically. The session will examine the impact of combined phenotypic and genotypic characterization on optimizing response to therapeutics, trial design, improving outcomes, and redefining reimbursement.

  • CEO, GE Ventures & healthymagination
2:50 pm – 3:40 pm
CV Investing in the Next Decade

View on investing landscape, opportunities in the CV/metabolic marketplace, the drugs, devices and diagnostics currently in pipelines and notable positive trends.

  • Partner, Atlas Venture
  • VP, Venture, Partners HealthCare
  • Managing General Partner, Frazier Healthcare Partners
3:40 pm – 4:30 pm
CLINICAL HIGHLIGHT: Optimizing Care for the 51%: New Market Opportunities

Introduction: Cathy Minehan, Chair, MGH Corporation

Address implications of gender as a key biological factor for personalized medicine. Stroke is likely to be the first cardiovascular event, tied to AF and secondarily to hypertension. Opportunities for medication utilization and optimization in context of, manifestation of disease and understanding the biology, complications, strategies to collect relevant clinical evidence, and treatment response.

  • CEO, American Heart Association
  • Medical Director, Boston Scientific
4:30 pm – 5:20 pm
Disruptive Therapeutic Platforms: New Tools, New Outcomes

Recent advances of biological drugs have broadened the scope of therapeutic targets for a variety of human diseases. This holds true for dozens of RNA-based therapeutics currently under clinical investigation for diseases including heart failure. These emerging drugs could be considered in context of genomic/germ line screening, family history and epigenetics.

Moderator: Tony Coles, MD
  • CEO, Yumanity Therapeutics
  • Founder, AnGes
5:20 pm – 6:00 pm

Wednesday, May 3, 2017

 

7:30 am – 7:55 am
1:1 Fireside Chat: Robert Califf, Commissioner (former), Food and Drug Administration
  • Chairman, Department of Medicine, Physician-in-Chief, Brigham and Women’s Hospital
  • Hersey Professor of the Theory and Practice of Medicine, Soma Weiss, MD Distinguished Chair in Medicine, Harvard Medical School
  • Commissioner (former), Food and Drug Administration
7:55 am – 8:45 am
Innovation in Translational Trials

CV/metabolic disorders comprise aggregates of many niche diseases that may be targeted with therapies against specific molecular alterations, yet the final potential markets are much larger. This model creates challenges for both drug development and patient care with implications for initial indication selection and design and execution of clinical trials – from first-in-human through post marketing studies.

 

  • SVP, Global Head of Regenerative Medicine Unit, Head of Scientific Affairs, Japan, Takeda
  • CEO, Mirna Therapeutics
  • SVP, R&D Pipeline, GlaxoSmithKline
  • CMO, Verily
  • Senior Vice President & CSO, PAREXEL International
9:15 am – 10:05 am
New Targets in Coronary Artery Disease

Cardiovascular trials have a proud history of providing some of the most robust data in evidence-based medicine. However the growing size and complexity of these trials imperils their future. This panel will discuss the design and implementation of clinical studies globally, considering strategies for patient access, leveraging electronic health records and mobile device data, personalized medicine, regulatory implications, cost containment and management of relationships with global service providers.

  • Director, Center for Human Genetic Research, Massachusetts General Hospital
  • Associate Professor of Medicine, Harvard Medical School
  • VP Research, Cardiometabolic Disorders Therapeutic Area Head, Site Head Amgen San Francisco, Amgen
  • Director, Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital
  • Eugene Braunwald Professor of Medicine, Harvard Medical School
10:05 am – 10:25 am
10:25 am – 10:55 am
1:1 Fireside Chat: Gary Gibbons, NHLBI
Moderator: Betsy Nabel, MD
  • President, Brigham and Women’s Hospital
  • Director, NHLBI
10:55 am – 11:45 am
The Skinny on Fat: Therapeutic Opportunities

Explore the evolving role of adipose tissue as an active endocrine organ and discuss the possibilities to discover novel signaling pathways relevant to cardiovascular health and viable druggable targets.

  • SVP and US Medical Leader, Eli Lilly and Company
  • SVP and CSO, CVMET, Pfizer
  • CEO, Zafgen
  • VP, Therapy Area, Cardiovascular & Metabolism, AstraZeneca
11:45 am – 12:45 pm
Disruptive Dozen: 12 Technologies that will reinvent Cardiovascular Care
  • Chief of Cardiovascular Medicinem Brigham and Women’s Hospital
  • Associate Professor of Medicine, Harvard Medical School

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Listen to some of the top CEOs in the cardiovascular industry discuss their latest innovations.

Forum keynoters will include the CEOs of Eli Lilly, Boston Scientific, Medtronic, Boehringer Ingelheim, Cardinal Health, Edwards Life Sciences, Abiomed, Bard, American Heart Association, GE Healthcare, Siemens Healthcare, the FDA Commissioner and dozens of top investors, emerging company CEOs, and senior Harvard faculty. Be part of the new urgency to redefine cardiovascular and cardiometabolic care – the largest market in healthcare – through new therapies, digital diagnostics, ‘omics, platforms and engagement.

To join fellow decision makers at the World Medical Innovation Forum, please follow the link to register: worldmedicalinnovation.org

 

 

John Lechleiter, PhD

CEO, Eli Lilly and Company

George Barrett

CEO, Cardinal Health

Robert Califf, MD

Commissioner, Food and Drug Administration

Michael Mussallem

CEO, Edwards LifeSciences

Tony Coles, MD

CEO, Yumanity Therapeutics

Nancy Brown

CEO, American Heart Association

Frans van Houten

CEO, Philips

Bernd Montag, PhD

CEO, Siemens Healthcare

Michael Minogue

CEO, Abiomed

Tamara Syrek Jensen

Director, Coverage and Analysis Group, CMS

Betsy Nabel, MD

President, Brigham and Women’s Hospital

Richard Migliori, MD

EVP Medical Affairs and CMO, UnitedHealth Group

Jean-François Formela, MD

Partner, Atlas Venture

Patrick Vallance, MD, PhD

R&D President, GlaxoSmithKline

Tassos Gianakakos

CEO, MyoKardia

 

Michael Mahoney

CEO, Boston Scientific

Omar Ishrak, PhD

CEO, Medtronic

John Flannery

CEO, GE Healthcare

Timothy Ring

CEO, Bard

Jessica Mega, MD

CMO, Verily

Gary Gibbons, MD

Director, NHLBI

Sue Siegel

CEO, GE Ventures & healthymagination

Jonathan Rennert

CEO, ZOLL Medical

Paul Lammers, MD

CEO, Mirna Therapeutics

André-Michel Ballester, PhD

CEO, LivaNova

Paul Fonteyne

CEO, Boehringer Ingelheim USA

Paul LaViolette

Managing Partner and COO, SV Life Sciences Advisers

Ora Pescovitz, MD

SVP and US Medical Leader, Eli Lilly and Company

Jeff Mirviss

SVP and President, Peripheral Interventions, Boston Scientific

Fouzia Laghrissi-Thode, MD

VP, Therapy Area, Cardiovascular & Metabolism, AstraZeneca

 

 

Atherosclerosis

  • New Targets in Coronary Artery Disease
  • PAD: Improving Outcomes

Clinical Evidence & Care Pathway

  • Gender and Cardiovascular Disease
  • Global Clinical Trials: Next Generation Design and Scalability
  • Innovations in Cardiac Delivery
  • Innovation in Translational Trials

Innovation and Policy

  • Cardiovascular Innovation: Triumphs, Challenges, Opportunities
  • Pricing to Enable Affordability and Innovation
  • Regulatory Priorities: FDA Commissioner (invited)
  • Technology, Populations and Disease: CV Investing in the Next Decade

 

Heart Failure

  • Heart Failure: Back in the Game Through New Pathways

Metabolic Syndrome

  • Cardioprotective Effects of Metabolic Drugs
  • The Skinny on Fat: Therapeutic Opportunities

Modalities

  • Disruptive Therapeutic Platforms: From Nucleic Acid to Proteins
  • Personal Monitoring for Disease Management
  • Precision Cardiovascular Medicine: What is Different This Time?

Rhythm Disorders

  • A Cure for AFib: Drugs, Ablation or Lifestyle?

Structural Heart

  • Emerging Devices for Complex Structural Heart Disease

 

 

 

The 2017 World Medical Innovation Forum, May 1-3, 2017, will be held at the Westin Copley Place in Boston, Massachusetts.

Register Today.

Early bird discounts apply.

Sign up before December 31.

worldmedicalinnovation.org

For more information contact:

Chris Coburn

Chief Innovation Officer

Partners HealthCare

 

 

 

Partners HealthCare Innovation

Partners HealthCare

Add to Calendar

Contact Us

 

SOURCE

From: Partners HealthCare Innovation <innovations@partners.org>

Date: Wednesday, December 14, 2016 at 9:47 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Cardiovascular’s next chapter of innovation begins now.

Read Full Post »

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

Reporter: Aviva Lev-Ari, PhD, RN

 

 

July 15, 2016
Authors:

Rajiv Tayal, MD, MPH1,2;  Mihir Barvalia, MD, MHA1;  Zeshan Rana, MD2;  Benjamin LeSar, MD1;  Humayun Iftikhar, MD1;  Spas Kotev, MD1;  Marc Cohen, MD1;  Najam Wasty, MD1

Abstract: Traditionally, brachial and common femoral arteries have served as access sites of choice, with many operators recently converting to radial artery access for coronary angiography and percutaneous intervention due to literature suggesting reduced bleeding risk, better patient outcomes, and lower hospital-associated costs. However, radial access has limitations when percutaneous procedures requiring larger sheath sizes are performed. Six Fr sheaths are considered the limit for safe use with the radial artery given that the typical luminal diameter of the vessel is approximately 2 mm, while peripheral artery disease (PAD) may often limit use of the common femoral artery, particularly in patients with multiple co-morbid risk factors. Similarly, the brachial artery has fallen out of favor due to both thrombotic and bleeding risks, while also not safely and reliably accommodating sheaths larger than 7 Fr. Here we describe 3 cases of a new entirely percutaneous technique utilizing the axillary artery for delivery of Impella 2.5 (13.5 Fr) and CP (14 Fr) cardiac-assist devices for protected percutaneous coronary intervention in the setting of prohibitive PAD.

J INVASIVE CARDIOL 2016;28(9):374-380. 2016 July 15 (Epub ahead of print)

Key words: axillary artery, percutaneous access, high-risk PCI

 

SOURCE

http://amptheclimeeting.com/ampcentral/articles/totally-percutaneous-insertion-and-removal-impella-device-using-axillary-artery-setting

Read Full Post »

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

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 4/8/2017

BVS Stent Pulled From European Market – Bioresorbable stent will still be available in a clinical registry setting

by Larry Husten, CardioBrief, April 06, 2017

Abbott Laboratories sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.”

The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from the ABSORB II trial uncovered a significantly higher rate of target vessel MI. More recently, 2-year results from the pivotal ABSORB III trial confirmed those findings, showing a significant increase in target lesion failure. At the same time the FDA said that it was investigating the stent.

http://www.medpagetoday.com/cardiology/cardiobrief/64391

 

 

Robotic Radial Bifurcation Bioresorbable Vascular Scaffold (BVS) PCI placement of Abbott Vascular’s Absorb GT1

A remote-controlled robotic system was designed to address some of the procedural challenges and occupational hazards associated with traditional percutaneous coronary intervention (PCI) in addition to enhancing the degree of precision and control for the interventional procedure. We report the first large-scale, multicenter study evaluating the safety and efficacy of a novel robotic system for PCI.

 

It demonstrates the capabilities of the technology including double-wire intervention, successful BVS delivery, and the ability to re-cross through a scaffold-strut for branch vessel ostium dilatation. More experience with this technology will potentially add to its utilization in more complex lesions.

Safety and Feasibility of Robotic Percutaneous Coronary Intervention PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study

Author + information

Abstract

Objectives The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted percutaneous coronary intervention.

Background Robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice.

Methods Patients with coronary artery disease and clinical indications for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using the robotic system only.

Results A total of 164 patients were enrolled at 9 sites. Percutaneous coronary intervention was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%), whereas 4 (2.4%) had periprocedural non–Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position.

Conclusions This pivotal multicenter study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator. (Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions [PCI] [PRECISE]; NCT01275092)

Reference

1. Weisz G, Metzger DC, Caputo RP, et al. Safety and feasibility of robotic percutaneous coronary intervention. J Am Coll Cardiol 2013;61:1596–1600.

 

SOURCES

J Am Coll Cardiol 2013;61:1596–1600.

http://www.invasivecardiology.com/files/Corindus%20Clinical%20Case%20Update%20-%20October%202016.pdf

http://www.invasivecardiology.com/files/Corindus%20Clinical%20Case%20Update%20-%20December%202016.pdf?inter_email=Zlk4YUF5VU9UQzE5ckNwTUJnRFd0LzJnNnJXRXZSYSt3Q2t1N1ovSmZYWT0=&inter_date=UHUvalFXSTVmSEJvTTR1L1dobWxyQT09

http://2015.icimeeting.com/wp-content/uploads/2015/12/1858-Mahmud-Hall-I-mon.pdf

Read Full Post »

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

Reporter: Aviva Lev-Ari, PhD, RN

Original Article in NEJM

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1610227

Based on

Stents, Bypass Surgery Equally Safe and Effective for Many with Left Main Heart Disease – Stents offer less-invasive option for many patients with left main coronary artery disease

Findings from the EXCEL (Evaluation of Xience versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were published this morning online in the New England Journal of Medicine and presented at the annual Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. The trial research team included interventional cardiologists and cardiac surgeons from 126 centers in 17 countries.

Coronary artery bypass graft (CABG) surgery has long been considered the definitive treatment for patients with left main coronary artery disease (LMCAD), in which the artery that supplies oxygen-rich blood to most of the heart muscle is clogged with atherosclerotic plaque. About two-thirds of all LMCAD patients have mild to moderate disease in the remainder of the coronary arteries.

“Our study has shown that many patients with left main coronary artery disease who prefer a minimally invasive approach can now rest assured that a stent is as effective as bypass surgery for at least three years, and is initially safer, with fewer complications from the procedure,” said first author Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia.

Stents, which are placed into the diseased artery via a catheter that is inserted through a small opening in a blood vessel in the groin, arm or neck, are a less-invasive treatment option for many people with coronary artery disease. However, CABG has long been considered the definitive treatment for patients with LMCAD, which affects a large portion of the heart muscle.

http://www.dicardiology.com/article/stents-bypass-surgery-equally-safe-and-effective-many-left-main-heart-disease

WATCH VIDEO

http://www.dicardiology.com/videos/stents-bypass-surgery-have-equal-outcomes-excel-trial/5201737825001?eid=333021707&bid=1601993

  • Patients treated with percutaneous coronary intervention (PCI) rather than CABG had fewer MIs, and less bleeding, infections, arrhythmias and renal failure within 30 days, although more repeat revascularization procedures at three years. Fewer patients developed definite stent thrombosis after PCI than symptomatic graft occlusion after PCI at 30 days and three years.
  • “Our study establishes stents as an acceptable or preferred alternative for patients with LMCAD and low or moderate disease complexity in the other three coronary arteries — about two-thirds of all LMCAD patients,” said Stone. “While bypass is still considered a more durable repair, patients and doctors may prefer a percutaneous treatment approach, which is associated with better upfront results, fewer complications, and quicker recovery.”
  •  The researchers reported that bypass surgery should still be considered standard therapy for those with LMCAD and extensive blockages in the remainder of the heart arteries, although the study did not include patients with severe disease.

Read Full Post »

Advances and Future Directions for Transcatheter Valves – Mitral and tricuspid valve repair technologies now in development

Reporter: Aviva Lev-Ari, PhD, RN

 

Based on

http://www.dicardiology.com/article/advances-and-future-directions-transcatheter-valves

 

Read the article “First TAVR Device Receives European Approval to Treat Intermediate Risk Patients”from August 2016.

Watch the video “The Evolution of TAVR Technology.” Interview with Juan Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation, at the Transcatheter Valve Therapies 2015 meeting.

 

Watch the video “TAVR Beats Surgery — Top News From ACC.16.” Dr. Vinod Thourani, professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine and a co-investigator for the PARTNER II Trial, discusses the biggest news item from ACC.16 — the Sapien 3 TAVR device performed better that surgical aortic valve replacement.

Watch the video “CoreValve Trumps Surgical Valve Replacement — TVT 2015.” Interview with Michael Reardon, M.D., professor of cardiothoracic surgery at DeBakey Heart and Vascular Center, and chairman of the patient screening committee, CoreValve U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.

 

Read the article “FDA Clears Sapien XT for Valve-In-Valve Procedures.”

Read the article “FDA Expands Use of CoreValve for Aortic Valve-in-Valve Replacement.”

Transcatheter Mitral Valves are the Next Frontier

Most interventional and cardiac surgical experts say TMVR will be the next frontier in minimally invasive structural heart interventions. With the success and rapid growth of TAVR, there is an immense anticipation that TMVR will have an even greater impact in cardiology. This has translated into more than $2.5 billion being spent in the past year by vendors purchasing start-up TMVR companies, while less than 50 patients have actually been treated using these technologies, said Michael Mack, M.D., medical director, cardiovascular surgery, Baylor Health Care System and chairman of The Heart Hospital Baylor Plano Research Center.

However, the mitral valve involves much more complex anatomy than the aortic valve, so the devices, imaging for procedural planning and guidance will be much more sophisticated than what is used for TAVR. Among the challenges are: fixation of a device to the very small landing zone of the mitral annulus; avoiding the left ventricular outflow tract (LVOT); avoiding compression of the atrioventricular (AV) node; avoiding the papillary muscle and chordae tendineae; ensuring the device seals properly to avoid paravalvular regurgitation; and the device needs to be able to adapt to remodeling of the anatomy. There are more than 20 TMVR devices in development. The majority of these valves utilize a self-expanding nitinol frame that engages both sides of the native mitral valve annulus for fixation, similar to Amplatzer septal closure devices.

The companies with first-in-human TMVR implants include Tendyne, Neovasc and Edwards Lifesciences’ Fortis and Sapien XT devices. The Neovasc Tiara, Tendyne Bioprosthetic Mitral Valve and CardiAQ Valve Technologies TMVR system all have been granted FDA conditional investigational device exemption (IDE) studies.

Watch the video “Transcatheter Mitral Valve Therapies in Development.” 

Watch the video “Transcatheter Mitral Valve Repair Technologies.” An interview with Ted Feldman, M.D., FACC, MSCAI, FESC, cardiac cath lab director, Evanston Hospital, North Shore Health System, and principle investigator, Everest II MitraClip U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.

 

Advancements in TAVR and TMVR Technologies at TCT 2016 

Watch the video VIDEO “Transcatheter Valve Technology Advancements at TCT 2016.” This is an interview Torsten Vahl, M.D., about advancements in transcatheter valve repair technology, including new devices for the aortic, mitral and tricuspid valves. Vahl is director of experimental and translational research and assistant professor of medicine, Columbia University Medical Center, Center for Interventional Vascular Therapy.

Watch the video “VIDEO: Transcatheter Mitral Valve Technology, Anatomical Challenges.” A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 annual meeting. Granada is executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation.

SOURCE

FEATURE | HEART VALVE TECHNOLOGY | NOVEMBER 12, 2015| DAVE FORNELL

Advances and Future Directions for Transcatheter Valves – Mitral and tricuspid valve repair technologies now in development

http://www.dicardiology.com/article/advances-and-future-directions-transcatheter-valves

 

Other related articles published in this Open Access Online Journal include the following:

 

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

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

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

 

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Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

 

WEDNESDAY, NOV 30 2016

“Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves.”

The Hadassah Medical Organization has opened Israel’s first Heart Valve Disease Clinic, which is geared toward detecting and treating the most complicated cases of heart valve disease–a growing problem in an aging population.

Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves. Currently, these invasive procedures are often superseded by less invasive cardiac catheterizations. In any case, however, efficiently treating valve disease and minimizing life-threatening risk factors such as heart attack remains an ongoing struggle for cardiovascular specialists.

As Prof. Ronen Beeri, head of Hadassah’s Cardiovascular Research Center, explains: “A ‘cardio team’ is needed to treat a patient suffering from heart valve disease. The time from referral to our Heart Institute to receive treatment from the relevant specialist can sometimes take months. Generally, patients with complex issues cannot afford to wait that long. The multidisciplinary cardio team solution at our new Clinic will help streamline the process so that a patient will receive all the necessary echocardiograms and other exams needed to diagnose and begin treatment within a week’s time.”

SOURCE

http://www.hadassah.org/news-stories/heart-valve-disease.html

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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

 

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The new method was developed by researchers at the National, Heart, Lung and Blood Institute (NHLBI) and tested in a trial on 100 patients at 20 hospitals across the United States. Researchers said it proved successful in 99 of the patients.

“This is a seminal study,” said the lead author, cardiologist Adam B. Greenbaum, M.D., co-director of the Henry Ford Hospital Center for Structural Heart Disease, Detroit. “It challenged conventional wisdom, which objected to the idea of safe passage between the vena cava and the aorta. More important, it is the first of many non-surgical minimally-invasive tissue-crossing, or so-called transmural catheter procedures developed at NIH that can be applied to diverse fields of medicine.”

Robert J. Lederman, M.D., a senior investigator in NHLBI’s Division of Intramural Research who led the study, said researchers developed the method to address a specific clinical need, even though they knew it would be a challenging proposition for most surgeons and physicians to accept. The proposed and counterintuitive mechanism of action is that bleeding from the aorta spontaneously decompresses into a corresponding hole the physician makes in the vein, because the surrounding area behind the peritoneum has higher pressure than the vein.

The results of the research, which were independently confirmed by a committee of outside cardiologists, show the procedure not only has a high success rate, but also an acceptable rate of bleeding and vascular complications, particularly in the high risk patients studied. The study builds on the access technique that Lederman’s NHLBI team developed and first tested in animals in 2012 and first applied with Henry Ford physicians to help patients in 2013. NHLBI and its collaborators are now working to find ways to train more specialists to perform the procedure.

The study will also be presented on Monday, October 31 at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. Co-authors include researchers from

  • Henry Ford Hospital;
  • Emory University, Atlanta;
  • Oklahoma Heart Institute, Tulsa;
  • Lexington Medical Center, West Columbia, South Carolina; and
  • Oschner Medical Center, New Orleans.

Researchers at the National Institutes of Health have developed a new, less invasive way to perform transcatheter aortic valve replacement (TAVR), a procedure widely used to treat aortic valve stenosis, a lethal heart condition. The new approach, called transcaval access, will make TAVR more available to high risk patients, especially women, whose femoral arteries are too small or diseased to withstand the standard procedure. The Journal of the American College of Cardiology published the findings.

Aortic valve stenosis involves the narrowing of the heart’s aortic valve which reduces blood flow through the heart. For about 85 percent of patients with this condition, doctors typically perform TAVR through the femoral artery in the leg. But for the other 15 percent, doctors must find a different access route. The most common alternative routes are through the chest, which requires surgery and are associated with significantly more complications.

Transcaval access, which can be performed in awake patients, involves electrifying a small wire so that it crosses between neighboring blood vessels in the abdomen. The technique calls for making large holes in both the abdominal aorta and the inferior vena cava, which physicians previously considered dangerous because of the risk of fatal bleeding.

SOURCE

https://www.nih.gov/news-events/news-releases/new-method-performing-aortic-valve-replacement-proves-successful-high-risk-patients

http://www.medscape.com/viewarticle/871196?nlid=110314_3866&src=WNL_mdplsfeat_161101_mscpedit_card&uac=93761AJ&spon=2&impID=1226378&faf=1

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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

 

Robot in the cath lab takes surgeons out of radiation’s way

October 3, 2016 By Abigail Esposito Leave a Comment

The system consists of a bedside unit and an interventional cockpit. Developer Corindus Vascular Robotics says the radiation-shielded cockpit features a control console with simple-to-use controls for the precise positioning of guidewires, balloons and stent catheters.

An interventional cardiologist loads the single use cassette and later manually introduces the guiding catheter into the coronaries. At that time, the physician can remove their lead covers and sit behind the Interventional Cockpit to perform the remainder of their procedure.

Harmful Exposures in the Cath Lab:

  • One study of self-reported brain tumors in interventionists showed that 86% of the tumors were left-brain—the side of the head most often exposed to radiation during procedures.
  • There’s also the risk of orthopedic injuries from wearing the heavy, leaded equipment used to block radiation (interventionists practicing over 21 years suffer a 60% incidence of spine issues) and
  • Cataracts, another effect of radiation exposure in interventionists. In a RELID study (Retrospective Evaluation of Lens Injuries and Dose), 50% of interventional cardiologists had posterior subcapsular lens changes (precursors to cataracts) caused by radiation exposure, versus less than 10% in the control group.

Benefits of CorPath Vascular Robotic System

One trial (Percutaneous Robotically-Enhanced Coronary Intervention Study) showed a

  • 95.2% reduction in radiation exposure for the primary operator,
  • 98.8% device success and
  • 97.6% clinical success with no device-related complications. What’s more, the trial saw a
  • 9% reduction in stent use as compared to historical data.

http://www.medicaldesignandoutsourcing.com/robot-in-the-cath-lab-takes-surgeons-out-of-radiations-way/?spMailingID=9704333&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1021334606&spReportId=MTAyMTMzNDYwNgS2

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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

Northwestern Medicine First in Illinois to Implant New FDA-Approved Aortic Valve

Second in the United States to implant Edwards Intuity Elite valve with newly designed deployment system

Northwestern Medicine, Edwards Lifesciences, Intuity Elite suturless aortic valve, first in Illinois

Edwards Intuity valve image courtesy of Northwestern Medicine

October 7, 2016 — A Northwestern Medicine cardiac surgeon was recently the first in Illinois and second in the United States to implant the Edwards Intuity Elite sutureless aortic valve in a patient with coronary artery disease. The device was implanted through the newly U.S. Food and Drug Administration (FDA)-approved, minimally invasive delivery system.

Patrick McCarthy, M.D., executive director of Northwestern Medicine Bluhm Cardiovascular Institute and chief of cardiac surgery at Northwestern Memorial Hospital, led the team that implanted the aortic valve in Robert Kurinsky, a 74-year-old retiree from Oak Brook, Ill. Kurinsky had been treating his slowly deteriorating heart valve since 2012 primarily through medication.

“Using this newly approved valve system helped replace Mr. Kurinsky’s valve in only 12 minutes, which means less trauma to the body and a quicker recovery time,” said McCarthy, who is also the Heller-Sacks Professor of Medicine at Northwestern University Feinberg School of Medicine. “The valve opening is slightly larger than a standard valve, a positive feature for heart function in the coming years. We are always looking to find the safest and most effective means of treating our patients, and I was pleased we could offer this option to Mr. Kurinsky days after the FDA approved it.”

Traditionally, open-heart surgery is the preferred method for valve replacement but increasingly cardiologists and cardiac surgeons are turning to minimally invasive approaches, a critical sea change in the field of cardiac care. McCarthy led the clinical trial at Northwestern Medicine Feinberg School of Medicine for the new valve prior to its approval by the FDA.

The FDA approved, in August 2016, the advanced Edwards Intuity Elite valve system, a deployment device that incorporates some elements of transcatheter aortic valve replacement (TAVR), a minimally invasive valve replacement system.

Kurinsky said he was thrilled to learn of a less invasive option to replace his aortic valve just days before his scheduled surgery. His wife Carol Kurinsky said she could not believe when he picked up the phone in the intensive care unit and said hello the morning after the surgery. She had left him late the night before and he was on a breathing tube.

“I was told my aortic valve was closing, and we came to Northwestern for a second opinion,” said Kurinsky, who works part-time as a golf starter and is an avid international traveler, two avocations he plans to return to soon. “Coming to Northwestern and Dr. McCarthy was the best decision we made.”

For more information: www.edwards.com

SOURCE

http://www.dicardiology.com/content/northwestern-medicine-first-illinois-implant-new-fda-approved-aortic-valve?eid=333021707&bid=1554809

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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

 

UPDATED on 7/17/2018

VIEW VIDEO

https://www.dicardiology.com/videos/video-tricuspid-valve-imaging-and-interventions-developing-hand-hand-0?eid=333021707&bid=2175978

Rebecca Hahn, M.D., professor of medicine and director of interventional echocardiography, Columbia University Medical Center, New York, explains that techniques for imaging the tricuspid valve, the  advanced study of its disease etiology and the rapid development of transcatheter devices to treat tricuspid valve disease are all developing together. She spoke on these topics during sessions at both the American Society of Echocardiography (ASE) 2018 meeting and at the Transcatheter Valve Therapies (TVT) conference in June.

Related Transcatheter Tricuspid Valve Content:
Recent Advances in Transcatheter Valve Technology

VIDEO: Mitral and Tricuspid Valve Repair Technologies — interview with Azeem Latib, M.D.

VIDEO: Transcatheter Tricuspid Valve Repair and Replacement Technologies — interview with Rebecca Hahn, M.D.

Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial

Positive, Sustained Improvement at One Year in SCOUT I Transcatheter Tricuspid Repair Trial

Gate Bioprosthesis Used in Canada’s First Transcatheter Valve Replacement for Tricuspid Regurgitation

SOURCE

https://www.dicardiology.com/videos/video-tricuspid-valve-imaging-and-interventions-developing-hand-hand-0?eid=333021707&bid=2175978

University Hospital Zurich Heart Team First to Perform Tricuspid Valve Repair with Cardioband

Device has traditionally been used for mitral valve repairs

Cardioband, first tricuspid valve repair, University Hospital Zurich, Francesco Maisano

October 10, 2016 — Francesco Maisano, clinic director at the University Hospital Zurich, recently led a team of cardiac surgeons and cardiologists in for the first time repairing a leaky tricuspid valve using a new catheter technology.

Maisano, who is also director of the Clinic for Cardiovascular Surgery at USZ, co-director of the University Heart Center and professor at the University of Zurich, began using the Cardioband in Switzerland for repair of the mitral valve. Now he and his team have succeeded in an application at a leaky tricuspid a 75-year-old patient. The patient is doing well.

The device has been used previously as a patient-friendly method of repairing a leaking mitral valve in the left heart. It is the minimally invasive alternative to open-heart surgery. Maisano was instrumental in the development of Cardioband, which can be gathered with the help of the leaky valve ring and contracted. For this, the band is placed using a catheter around the valve ring (annulus), and is fixed there by small screws and contracted with a wire, so that the flap closes again tightly.

The tricuspid valve separates the right atrium from the right chamber of the heart. A tricuspid regurgitation, i.e. an insufficient performance of the door, can cause serious symptoms. The backflow of blood into the ventricle and in the veins occur and can cause elevated pressure. This can result in problems in the legs and in the abdomen and liver damage. Also, atrial fibrillation may be associated with the consequences of tricuspid regurgitation. The current treatment of insufficiency of the tricuspid valve consisted of a surgical open-heart surgery using a heart-lung machine.

Maisano explained the advantages of the new Cardioband method: “Since the insufficiency of this heart valve is often created as the result of mitral valve disease, open-heart surgery is often risky surgery. The use of the Cardioband minimally invasive therapy without the use of cardiopulmonary bypass protects the patient and reduces the risk.”

For more information: www.valtechcardio.com

SOURCE

http://www.dicardiology.com/content/university-hospital-zurich-heart-team-first-perform-tricuspid-valve-repair-cardioband?eid=333021707&bid=1554809

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