Between 2014 and 2020, there was a nearly 10-fold increase in transcatheter mitral valve procedural volumes in the U.S., with clinical outcomes generally improving too, according to a state-of-the-art review published Oct. 25 in the Journal of the American College of Cardiology.

Michael J. Mack, MD, MACC, et al., conducted a review of STS/ACC TVT Registry data from 37,475 patients who underwent a transcatheter mitral procedure between 2014 and March 31, 2020, including 33,878 transcatheter edge-to-edge repair with MitraClip (TEER) and 3,597 transcatheter mitral valve replacement (TMVR). The registry launched in 2011 and has three modules: TAVR, TEER and TMVR. The report focuses on the latter two modules.

Results showed that the number of TEER cases increased from 1,152 in 2014 to 10,460 in 2019, with a 50% increase seen between 2018 and 2019. The procedure was performed in 49 states, Washington, DC, and Puerto Rico at 403 sites. The MitraClip system remains the only U.S. Food and Drug Administration (FDA) approved technology for TEER, first approved in 2013 for patients with severe, symptomatic, primary mitral regurgitation (MR) who are at prohibitive surgical risk, with the indication expanded by the FDA in early 2019 to include patients with moderate-to-severe or severe secondary MR who have heart failure symptoms. The Centers for Medicare and Medicaid Services, however, did not issue a National Coverage Determination for this indication until early 2021. Results also showed that mortality rates for TEER at 30 days (5.6% to 4.1%) and one year (27.4% to 22.0%) have decreased.

Annual procedure volumes for TMVR have increased from 84 in 2014 to 1,120 in 2019 at 301 centers. Of these, 78.0% were mitral valve-in-valve procedures (MViV), 11.7% were valve-in-ring procedures after failed surgical annuloplasty (MViR), and 10.3% were procedures done in native mitral valves with severe mitral annular calcification (MviMAC). The number of TMVR cases nearly doubled from 2016 (n=360) to 2017 (n=643). Early off-label use data on TMVR in MViV led to FDA approval in 2017 of a balloon-expandable transcatheter heart valve system initially designed for TAVR. Overall 30-day mortality after TMVR was 7.8% (after excluding the 8.8% of patients with missing data). For MViV, 30-day mortality dropped from 8.8% in 2014 to 3.9% in 2019. Although 30-day mortality trended lower for all three TMVR categories, it remained substantial for MViMAC at 19.0% in 2019. One-year mortality after TMVR was 22.5% overall, with no discernable change over time.

According to the authors, both TEER and TMVR are performed mainly in patients who are judged to be high to prohibitive surgical risk. In addition, considering potential disparities in the use of these technologies, the researchers report that in this generally elderly patient population, the percentage of patients receiving TEER and TMVR who are Black approximates the overall U.S. population (10%) – by both disease incidence and percentage of U.S. population overall who are over 65 years of age.

“With patient-level data from over 30,000 procedures from 2014 through the first quarter of 2020, important insights can be discerned into the current state of transcatheter mitral valve therapies,” write Mack et al. “The STS/ACC TVT Registry will continue to gather and share this information with patients, clinicians, hospitals, regulatory agencies, and industry,” they write.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: National Cardiovascular Data Registries, STS/ACC TVT Registry, Heart Valve Prosthesis Implantation, Heart Failure, Registries, Cardiology, Tricuspid Valve, Heart Valve Diseases, Medicare, United States Food and Drug Administration, Transcatheter Aortic Valve Replacement, Mitral Valve Insufficiency, Mitral Valve

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