Findings Published From Global Feasibility Study of Abbott's Tendyne TMVR Device

March 26, 2019—The Minneapolis Heart Institute Foundation (MHIF) announced the publication of data from a global feasibility study of transcatheter mitral valve replacement (TMVR) with the investigational Tendyne valve technology (Abbott Structural Heart). Paul Sorajja, MD, et al published the findings in Journal of the American College of Cardiology (JACC; 2019;73:1250–1260). Dr. Sorajja is the Roger L. and Lynn C. Headrick Family Chair for Valve Science Research at MHIF in Minneapolis, Minnesota.

According to MHIF, the study examined outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the Tendyne device. Data showed that the TMVR procedure was highly effective in relieving mitral regurgitation (MR) and improving symptoms, with an acceptable safety profile.

As quoted in the MHIF announcement, Dr. Sorajja and colleagues highlighted the need for TMVR, stating, “The enthusiasm for TMVR among other transcatheter approaches is considerable due to the high prevalence of MR patients, their poor prognosis without therapy, and belief that MR correction improves not only symptoms of heart failure, but also survival. Importantly, the societal burden of patients with MR, which is an age-dependent disease, is only expected to grow with changing population demographics. Thus, there is hope that further TMVR development for native MR will help to address current and growing unmet clinical needs for these patients.”

The feasibility study evaluated the Tendyne TMVR technology in patients enrolled at 24 hospitals in the United States, Australia, and Europe who were symptomatic with grade 3 or 4 MR and were considered poor surgical candidates.

Clinical follow-up was performed at 1, 3, 6, and 12 months, and annually thereafter. New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and 6-minute walk distance were assessed at variable time points. Echocardiographic data were analyzed by a core laboratory, and clinical events were adjudicated by an independent clinical events committee.

The primary performance endpoint was intended performance of the device at 1-month postprocedure. The primary safety endpoint was a composite of device success and freedom from cardiovascular death, reintervention for valve-related dysfunction, disabling stroke, myocardial infarction, life-threatening bleeding, major vascular complications, renal failure requiring dialysis, or other device- or procedure-related serious adverse events at 30 days.

As summarized in JACC, there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction, and morbidities. There were no intraprocedural deaths, one instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively.

The investigators reported a 1-year survival free of all-cause mortality of 72.4% (95% confidence interval [CI], 62.1%–80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were NYHA function class I/II, improvements in 6-minute walk distance (P < .0001) and quality-of-life measurements were observed (P = .011), and 73.4% had an improvement in KCCQ score of ≥ 10 points.

Although further study to optimize the impact on long-term survival is needed, the Tendyne device was highly effective in relieving MR and improving symptoms, with an acceptable safety profile, concluded the investigators in JACC.