Analysis of Outcomes, Trends with SAPIEN 3 Transcatheter Heart Valve

Data from a new study examining use of the SAPIEN 3 transcatheter heart valve from Edward Lifesciences demonstrate the high rate of success seen with the device during transcatheter mitral valve-in-valve replacement procedures.

Using data from more than 1500 patients undergoing transseptal or transapical mitral valve-in-valve replacements, investigators assessed the technical success of procedures as well as provide an overview of temporary outcomes trends, including 30-day and 1-year mortality rates.

“Transcatheter mitral valve-in-valve using the SAPIEN 3 is associated with high technical success, a low complication rate, and 30-day mortality rates lower than predicted by the STS score. Most patients experienced significant improvement of symptoms and quality of life that were maintained at 1 year,” wrote investigators.

With increasing evidence regarding their safety and efficacy and an equal increase in popularity, a team of investigators led by Mayra Guerrero, MD, of the Mayo Clinic, designed a registry-based prospective cohort study to further the evidence base surrounding mitral valve-in-valve replacement procedures. Using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy Registry from June 2015-July 2019, investigators identified a total of 1529 patients for inclusion in the current study.

For inclusion in the study, patients needed to undergo a transseptal or transapical mitral valve-in-valve replacements between the aforementioned dates. Investigators pointed out 2144 patients were identified in their initial search, but patients undergoing mitral valve-in-ring, valve-in-mitral annular calcification, and transatrial mitral valve-in-valve implant procedures were excluded as well as those with insufficient data for classification.

The primary objective of the was to assess temporary outcomes of mitral valve-in-valve using the SAPIEN 3 transcatheter heart valve—with investigators using all-cause mortality at 1 -year as the primary efficacy end point and procedural technical success as per the Mitral Valve Academic Research Consortium as the primary safety end point.

Additionally, investigators included multiple secondary end points in their analysis. Specific secondary end points included procedural and in-hospital outcomes, New York Heart Association (NYHA) class, quality of life as defined by the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ), adverse events at 30 days and 1 year, and predictors of 1-year mortality.

Of the 1529 patients included in the study, 1326 underwent transseptal mitral valve-in-valve and 203 underwent transapical mitral valve-in-valve replacement procedures. For the overall study cohort, the mean age was 73.3 (SD, 11.84) years, 59.1% were women, and the mean STS predicted risk of mortality was 11.1% (SD, 8.7%).

Investigators determined the rate of procedural technical success was 96.8%, with success in 1480 of the 1529 patients included in the study. Results of the analysis indicated all0cause mortality among the overall study cohort was 5.4% at 30 days and 16.7% at 1 year. In analyses comparing outcomes and trends for transseptal and transapical procedures separately, investigators found transseptal access was associated with a lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P=.03).

Additionally, investigators found transcatheter mitral valve-in-valve replacement contributed to early, sustained, and clinically meaningful improvements in heart failure—specifically improvements in NYHA class. Of note, the mean mitral valve gradient of patients included in the cohort was 7 (2.89) mmHg.

“Transseptal MViV should be considered an option for most patients with failed surgical bioprosthesis who have favorable anatomy electing bioprosthetic valve replacement,” investigators wrote in their conclusion.

This study, “One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve,” was published in JAMA Cardiology.