Transcatheter Mitral Valve Replacement for Mitral Regurgitation

Study Questions:

What is the effectiveness and safety of transcatheter mitral valve replacement (TMVR) using a self-expanding device among a cohort of patients with native valve mitral regurgitation (MR) at high risk for cardiac surgery?

Methods:

A cohort of 30 patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis (Tendyne Mitral Valve System [Tendyne Holdings, LLC; a subsidiary of Abbott Vascular; Roseville, MN]), and were examined in a prospective registry for short-term and 30-day outcomes.

Results:

A cohort of 30 patients (age 75.6 ± 9.2 years; 25 men) with grade 3+ or 4+ MR underwent TMVR. MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in one patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography revealed mild (1+) central MR in one patient, and no residual MR in the remaining 26 patients with valves in situ. Left ventricular (LV) end-diastolic volume index and LV end-systolic volume index both decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up, p = 0.0012; and 48.4 ± 19.7 ml/m2 at baseline vs. 43.1 ± 16.2 ml/m2 at follow-up, p = 0.18; respectively). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%.

Conclusions:

The authors concluded that TMVR is an effective and safe therapy for selected patients with symptomatic native MR, that further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted, and that this intervention may help address an unmet need in patients at high risk for surgery.

Perspective:

In an era in which transcatheter aortic valve replacement (TAVR) is re-defining intervention for severe symptomatic aortic stenosis, new devices are emerging for TMVR. This report describes early feasibility data for a self-expanding nitinol valve with a double-frame design (an outer frame with cuff rests against the anterior left atrial wall and aorta, and an inner frame houses the valve leaflets). Among a small cohort of 30 patients with predominantly but not exclusively secondary MR, feasibility and short-term (30-day) outcomes were good. Longer-term outcome data for this and other devices will be of interest.

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

Keywords: Cardiac Surgical Procedures, Echocardiography, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Mitral Valve Insufficiency, Transcatheter Aortic Valve Replacement


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