Clinical Outcomes with Transcatheter Mitral Valve Repair in the United States

The Valve Science Center at the Minneapolis Heart Institute Foundation® examined the acute, 30-day, and one-year clinical outcomes of commercial transcatheter mitral valve repair with MitraClip in the U.S.

Minneapolis, MN – March 18, 2017 – Researchers at the Valve Science Center at Minneapolis Heart Institute Foundation® examined the acute, 30-day, and one-year clinical outcomes of commercial transcatheter mitral valve (MV) repair with MitraClip for the treatment of mitral regurgitation (MR) in the U.S to ensure commercialized therapies are meeting expectations.

Paul Sorajja, MD, principal investigator at the Minneapolis Heart Institute Foundation notes, “Our findings demonstrate the acute effectiveness and safety of transcatheter MV repair performed in the U.S., and also highlight the importance of patient variables and MR reduction in relation to long-term clinical outcomes.”

Data from the Society of Thoracic Surgery (STS)/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with MitraClip were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. Data were linked to patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data for analyses.

The median age was 82 years (55.8% men), with a median STS predicted risk of mortality of 6.1% (3.7%, 9.9%) and 9.2% (6.0%, 14.1%) for mitral repair and replacement, respectively. Frailty was noted in 50.3%. Transcatheter MV repair was performed for degenerative disease in 85.9%; functional MR was described in 26.4% of patients. Overall, in-hospital mortality was 2.7% and stroke occurred in 0.4%. MR was acutely reduced to grade ≤2 in 91.8%. Mortality at 30-days and at 1-year was 5.2% and 25.8%, respectively. Repeat hospitalization for heart failure at 1-year occurred in 20.7%. The overall incidence of either death or repeat hospitalization for heart failure at 1-year was 37.9%. Variables associated with mortality and for re-hospitalization for heart failure were increasing age, lower left ventricular ejection fraction, post-procedural MR, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation.

For patients undergoing transcatheter MV repair in the U.S., acute procedural success is achieved in ~92%. At one-year, mortality occurred in ~25%, and death or repeat hospitalization for heart failure occurred in 38% of patients, and these outcomes vary according to baseline characteristics and procedural results.

This research was presented this month at the American College of Cardiology Annual Scientific Session & Expo.

 

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.