A recent analysis of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry shows that transcatheter mitral valve-in-valve (MViV) with the transseptal SAPIEN 3 valve (Edwards Lifesciences) was associated with rare procedural complications and low mortality.
These results, which were published online Wednesday in JAMA Cardiology, demonstrate that MViV should be considered an option for most patients with failed surgical bioprosthetic mitral valves.
Bioprosthetic mitral valves are commonly implanted, and with increased frequency recently with an aging population. However; like most bioprosthetic valves, they inevitably degenerate. When a bioprosthetic mitral valve degenerates, it can lead to heart failure.
Transcatheter MViV using a balloon-expandable transcatheter valve has emerged as an alternative for high-surgical-risk patients. Brian Whisenant, MD, of Intermountain Medical Center, Salt Lake City, and colleagues assessed contemporary outcomes of SAPIEN 3 MViV. The authors analyzed 1,529 patients (mean age, 73.3 years; 904 women [59.1%]) who underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019 identified in the TVT Registry. The mean STS predicted mortality risk was 11.1%.
The authors’ analysis shows that procedural technical success was 96.8%. All-cause mortality was 5.4% at 20 days and 16.7% at 1 year. Also, transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs. 21.7%; p=0.03). The mean mitral valve gradient at 1 year was 7±2.89 mmHg. A secondary analysis highlighted that MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure, 87.1% at baseline vs. 9.7% at 1 year).
The study does have some limitations, mostly inherent limitations of an observational study with limited independent adjudication of adverse events and potential underreporting of adverse events. Also, there was no independent echocardiographic core laboratory, and the STS/ACC TVT Registry database does not include a standard definition of left ventricular outflow tract obstruction.
Despite these limitations, this important observation demonstrates that transcatheter MViV using the SAPIEN 3 transcatheter heart valve, especially from the transseptal approach, is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance, the authors conclude.
In an accompanying editorial, Anita W. Asgar, MD, MSc, of Montreal Heart Institute, said the data presented by Whisenant and colleagues are compelling and that MViV should be considered an “option, certainly, but one that requires careful deliberation since many questions remain.”
She pointed out that 1-year follow-up was not complete in 54% of patients in this analysis, either because the follow-up visit was not yet due or the data were unavailable. However, she also noted that the quality of life for patients whose data were available at 1 year, as measured by their responses to the Kansas City Cardiomyopathy Questionnaire showed sustained improvement.
Whisenant B, Kapadia SR, Eleid MF, et al. One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve. JAMA Cardiol 2020 Jul 29. doi:10.1001/jamacardio.2020.2974
Asgar AW. Transcatheter Mitral Valve-in-Valve—A Plausible Option but Questions Remain. JAMA Cardiol 2020 Jul 29. doi:10.1001/jamacardio.2020.2993