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MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes
Quick Takes
- Transseptal MViV in selected patients at high surgical risk was associated with a 100% technical success rate, a low complication rate, and a low mortality rate (3.3%) at 1 year.
- Based on these preliminary data, transseptal MViV may be considered for selected high-risk patients with degenerated mitral bioprosthesis who have favorable anatomy.
- Additional prospective randomized controlled studies are needed to validate these results and to assess the durability of THV performance.
Study Questions:
What are the 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial?
Methods:
The investigators prospectively enrolled high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprosthesis. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). A Kaplan-Meier curve was generated for all-cause mortality and for the composite endpoint of all-cause mortality and hospitalization for heart failure.
Results:
Thirty patients were enrolled between July 2016 and October 2017 (median age, 77.5 years; interquartile range [IQR], 70.3-82.8 years; 63.3% women; median Society of Thoracic Surgeons score 9.4% [IQR, 5.8%-12.0%], 80% in New York Heart Association [NYHA] functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in NYHA functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range, 5.5-8.9 mm Hg), and all patients had MR grade ≤1+.
Conclusions:
The authors concluded that transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year.
Perspective:
This feasibility trial reports that transseptal MViV in selected patients at high surgical risk was associated with a 100% technical success rate, a low complication rate, and a low mortality rate (3.3%) at 1 year. Furthermore, transseptal MViV was associated with alleviation of symptoms, improvement in 6-minute walk distance, improvement in quality-of-life scores, and performance remained stable at 1 year. Based on these preliminary data, transseptal MViV may be considered for selected high-risk patients with degenerated mitral bioprosthesis who have favorable anatomy. Since the current study was neither randomized nor controlled, the results cannot provide definitive evidence that MViV in high-risk patients with failed surgical bioprosthesis is superior to repeat standard MV surgery. Additional prospective randomized controlled studies are needed to validate these results and to assess the durability of THV performance.
Clinical Topics: Cardiac Surgery, 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: Bioprosthesis, Cardiac Surgical Procedures, Geriatrics, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Mitral Valve Stenosis, Quality of Life, Risk, Secondary Prevention, Transcatheter Aortic Valve Replacement
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