Data from Largest Clinical Experience with Transcatheter Mitral Valve Replacement Published in Journal of the American College of Cardiology
Global feasibility study enrolled symptomatic patients with primary or secondary mitral regurgitation
MINNEAPOLIS / March 26, 2019 – The Minneapolis Heart Institute Foundation® (MHIF) today announced the publication of data from a global feasibility study, which is the largest experience to date, with transcatheter mitral valve replacement (TMVR) in the March 26, 2019 edition of the Journal of the American College of Cardiology. The study examined outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the investigational Tendyne valve technology (manufactured by Abbott). Data showed the TMVR procedure was highly effective in relieving mitral regurgitation and improving symptoms, with an acceptable safety profile. Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair for Valve Science Research at the Minneapolis Heart Institute Foundation® was the lead author in the study.
In an editorial also published in the same edition of the journal, Dr. Sorajja and Minneapolis Heart Institute® colleagues, João Cavalcante, MD, and Mario Gossl, MD, highlighted the need for TMVR. “The enthusiasm for TMVR among other transcatheter approaches is considerable due to the high prevalence of mitral regurgitation (MR) patients, their poor prognosis without therapy, and belief that MR correction improves not only symptoms of heart failure, but also survival. Importantly, the societal burden of patients with MR, which is an age-dependent disease, is only expected to grow with changing population demographics. Thus, there is hope that further TMVR development for native MR will help to address current and growing unmet clinical needs for these patients.”
Patients enrolled at 24 hospitals in the United States, Australia and Europe to receive the Tendyne TMVR technology were symptomatic with grade 3 or 4 MR and were considered poor surgical candidates. Seventeen patients were enrolled in the study through MHIF at Abbott Northwestern Hospital. Clinical follow-up was performed at one, three, six, and 12 months, and annually thereafter. NYHA functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and six-min walk distance were assessed at variable time points. Echocardiographic data were analyzed by a core laboratory, and clinical events were adjudicated by an independent clinical events committee. The primary performance endpoint for the investigation was intended performance of the device at one month post-procedure. The primary safety endpoint was evaluated at 30 days and was a composite of device success and freedom from cardiovascular death, reintervention for valve-related dysfunction, disabling stroke, myocardial infarction, life-threatening bleeding, major vascular complications, renal failure requiring dialysis, or other device- or procedure-related serious adverse events.
About Cardiac Valve Disease
Most patients with cardiac valve disease are not receiving adequate care. Given that valve disease is associated with aging, patients often receive conservative therapy. Unfortunately, a paradox emerges as valve disease progresses and patients become too sick for an interventional procedure to either repair or replace the diseased or dysfunctional valve. Essentially, most patients miss their window of opportunity to receive treatment. As a result, the prevalence of severe, high-risk, valve disease has grown substantially. In the United States alone, there are 3.2 million people affected, and 5.6 million people will be affected by 2030.
Mitral regurgitation (MR) is the most common valvular disease. Surgery, consisting of either valve repair or chordal-sparing valve replacement, is the most effective means for relief of MR, and can be life-saving in selected patients. Transcatheter mitral valve repair is a new, less-invasive option for appropriate patients involving the delivery of the valve replacement device through a vein in the leg. Currently, a substantial number of patients with MR do not undergo surgery due to advanced age, procedural risk, or a perception of a low likelihood of clinical benefit.
The Tendyne™ TMVR technology is currently being studied in clinical trial and is not approved for sale in the United States or Europe.
About the Minneapolis Heart Institute Foundation® Valve Science Center
MHIF is a world leader in cardiac valve disease research and has been among the first in the world to utilize new transcatheter technologies. The studies of new transcatheter valve replacement technologies are part of MHIF’s mission to advance care and outcomes for patients through innovative research and education.
Established in 2016, the mission of the MHIF Valve Science Center is to eliminate the morbidity and mortality of valvular heart disease. Through its commitment to leading research and education, in partnership with physicians at the Minneapolis Heart Institute®, the Center is addressing the root causes of currently poor outcomes by studying barriers to care, advancing public education and disease state awareness, innovation in medical technology, and introducing novel patient care pathways to improve outcomes. MHIF actively participates in major clinical trials and conducts many investigator-initiated research studies focused on disease mechanisms, clinical care effectiveness and applying new treatment, diagnosis or monitoring methods. MHIF’s valve team has authored hundreds of papers and presents frequently at national conferences, such as American Heart Association, Transcatheter Cardiovascular Therapeutics and American College of Cardiology.
About the Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
- Scientific Innovation and Research — MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 175 peer-reviewed abstracts. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
- Education and Outreach — MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and supports research initiatives of Minneapolis Heart Institute® at Abbott Northwestern Hospital. Minneapolis Heart Institute® physicians provide care for patients at Abbott Northwestern Hospital in Minneapolis and at 38 community sites across Minnesota and western Wisconsin. More information can be found at http://www.mplsheart.org