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First 100 Patients With Transcatheter Mitral Prosthesis
Study Questions:
What are the outcomes with expanded follow-up for the first 100 patients who underwent transcatheter mitral valve replacement (TMVR) with the Tendyne prosthesis?
Methods:
The investigators enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study with the Tendyne prosthesis. Clinical outcomes through last clinical follow-up were adjudicated independently. The primary performance endpoint for the investigation was reduction of MR to ≤2+ at 1 month post-procedure. The primary safety endpoint was evaluated at 30 days and 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. The Kaplan-Meier method was used to generate survival estimates for freedom from all-cause mortality.
Results:
In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). 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 1-year survival free of all-cause mortality was 72.4% (95% confidence interval, 62.1%-80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association functional class I/II, and improvements in 6-minute walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points.
Conclusions:
The authors concluded that in this study of TMVR, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile.
Perspective:
This study of high-risk patients with symptomatic MR reports that TMVR with the Tendyne prosthesis demonstrated favorable early safety and effectiveness, with no intraprocedural deaths, no conversions to cardiac surgery or need for cardiopulmonary bypass, a low rate of major apical bleeding, elimination of MR in 98% of patients treated, and symptom improvement in the majority. The present investigation suggests the potential for TMVR to effectively treat high-risk MR without cardiopulmonary bypass, with a reasonable safety profile, and improve symptoms and quality of life in patients with heart failure. Larger prospective studies are indicated to confirm the outcomes of TMVR using this technique and to compare with other therapeutic options for symptomatic MR who are at high surgical risk.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Cardiopulmonary Bypass, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Mitral Valve Insufficiency, Myocardial Infarction, Prostheses and Implants, Quality of Life, Renal Dialysis, Renal Insufficiency, Secondary Prevention, Stroke, Stroke Volume, Vascular Diseases
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