Early Results from the Intrepid Global Pilot Study for TMVR

Press Release, Wednesday, November 1, 2017 at 2:00pm CST

Early Experience of Transcatheter Mitral Valve Replacement: Results from the Intrepid Global Pilot Study

  • Intrepid Global Pilot Study examined the safety and function of the IntrepidTM TMVR System in patients with symptomatic mitral regurgitation that were deemed to be ineligible for conventional valve surgery.
  • Early conclusions are that TMVR with the IntrepidTM valve was feasible in a population at high-or extreme-risk for conventional mitral valve replacements.

Minneapolis, MN – November 1, 2017 – Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair, Valve Science Center of Minneapolis Heart Institute Foundation, presented today a first report investigation from the intrepid Global Pilot Study at the Transcatheter Cardiovascular Therapeutics conference in Denver, CO. Sorajja reported on investigators’ early experience with the IntrepidTM valve system.

With the successful implantation rate, short and reproducible procedure, and improvements in symptom status and quality-of-life in surviving patients, the IntrepidTM valve design was shown to be advantageous. Although the results of our initial feasibility trial demonstrate the promise of TMVR with the IntrepidTM valve system, further clinical investigations are required to define other patient populations with severe mitral regurgitation that may benefit from this procedure.

Fifty patients from 14 hospitals in Australia, Europe and United States were consecutively enrolled. Device implant was successful in 48 patients.  Median procedure time was 100 minutes. The median time for device deployment was 14 minutes. There were no incidences of device malfunction, device failure, nor conversions to open cardiac surgery. The 30-day mortality rate was 14% with no disabling strokes or repeat interventions. At latest follow-up, echocardiography confirmed mild or no residual mitral regurgitation.

“Patients with MR have few options for treatment, and many die within a few years from heart failure. TMVR represents a novel therapy that decreases the burden of MR and improves many people’s lives.” said Paul Sorajja, MD. “These findings are provocative and inform the need for further investigation into additional patient populations that could benefit from a less-invasive TMVR procedure.”

Mitral regurgitation (MR) is one of the most common types of valve disease. MR is leakage of blood backwards through the mitral valve each time the left ventricle contracts. Leakage can increase blood volume and pressure in the area. Increased blood pressure in the atrium can increase pressure in the veins leading from the lungs to the heart.

Mitral valve surgery remains the standard of care for patients with symptomatic severe MR. If valve repair is not feasible, then the valve is replaced with a mechanical or bioprosthetic heart valve. Transcatheter mitral valve replacement (TMVR) is an emerging therapy that may offer patients with severe symptomatic MR a less invasive alternative to open surgical treatment.

These findings were published in Journal of the American College of Cardiology.

About the Minneapolis Heart Institute Foundation® Valve Science Center

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.


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