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Outcomes of Valve-in-Valve Transcatheter Mitral Valve Replacement
Quick Takes
- Using data from the STS/ACC TVT Registry, the procedural technical success of valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR) was 96.8%.
- The 30-day and 1-year all-cause mortality after ViV TMVR were 5.5% and 16.7%, respectively.
- Transseptal access was associated with lower 1-year all-cause mortality compared to transapical access.
Study Questions:
What are the 1-year outcomes associated with valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR) in the setting of a degenerated bioprosthetic mitral valve using the SAPIEN 3 balloon-expandable device?
Methods:
The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry database was used to identify and retrieve data regarding patients who underwent ViV TMVR from June 2015 to July 2019. US Centers for Medicare and Medicaid data were used to ensure that the collection of death and stroke data were comprehensive. The primary safety endpoint was procedural technical success, defined by the Mitral Valve Academic Research Consortium criteria. The primary efficacy endpoint was 1-year mortality. Secondary endpoints included 30-day mortality, New York Heart Association (NYHA)-defined heart failure, and mitral valve performance.
Results:
A total of 1,529 patients (mean age 73.3 ± 11.84 years; 904 women [59.1%]) underwent transseptal or transapical ViV TMVR at 295 hospitals between June 2015 and July 2019. The mean STS predicted risk of mortality was 11.1% ± 8.7%. Procedural technical success was achieved for 1,480 of 1,529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs. 21.7%; p = 0.03). ViV TMVR led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV NYHA heart failure of 87.1% at baseline vs. 9.7% at 1 year). The mean mitral valve gradient at 1 year was 7.0 ± 2.9 mm Hg.
Conclusions:
ViV TMVR using the SAPIEN 3 transcatheter heart valve was associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance at 1 year. The authors concluded that transseptal ViV TMVR should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.
Perspective:
Bioprosthetic mitral valve replacement (MVR) has an advantage of avoiding the requirement for life-long anticoagulation with warfarin associated with mechanical MVR. However, mitral bioprostheses have a limited durability, potentially leading to serial interventions. In the setting of structural valve degeneration of a surgically implanted mitral bioprosthesis, treatment traditionally required re-do surgical MVR. ViV TMVR offers an alternative treatment that is less invasive than re-do surgical valve replacement. These data from the STS/ACC TVT Registry reinforce the feasibility and favorable short-term (30-day and 1-year) outcomes associated with ViV TMVR for the treatment of bioprosthetic MVR structural deterioration. All-cause and cardiovascular mortality was lower in this study than in some other published registries, possibly related to the greater use of a transseptal approach. Still undefined are the long-term durability of ViV TMVR, and how many serial ViV procedures can be accomplished without compromising hemodynamics. However, in appropriate candidates, ViV TMR appears to be a reasonable alternative to re-do surgical MVR.
Clinical Topics: Anticoagulation Management, 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: Anticoagulants, Bioprosthesis, Cardiac Surgical Procedures, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Mitral Valve Insufficiency, Stroke, Transcatheter Aortic Valve Replacement, Treatment Outcome
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