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Transcatheter Mitral Valve Replacement Outcomes
Study Questions:
What are the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses (valve-in-valve [ViV]), failed annuloplasty rings (valve-in-ring [ViR]), and severe mitral annular calcification (valve-in-mitral annular calcification [ViMAC])?
Methods:
The authors used the TMVR multicenter registry (began in November 2015 and includes 40 European and American centers) to review procedural and clinical outcomes of ViV, ViR, and ViMAC and compare them according to Mitral Valve Academic Research Consortium (MVARC) criteria. The primary endpoints were all-cause mortality at 30 days and 1 year; secondary endpoints were technical, device, and procedural success, and other major clinical endpoints.
Results:
A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0% (high risk for conventional MV surgery) underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Mean age was 73 years, 54% were female, and nearly 90% were New York Heart Association functional class III or IV. Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, over a median follow-up period of 160 days (interquartile range, 60–420 days), 117 patients died in the overall cohort (53 patients in the ViV group, 34 patients in the ViR group, and 30 patients in the ViMAC group). The 1-year all-cause and cardiovascular mortality were 23.5% and 20.2% in the entire cohort, respectively. Left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; p < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; p < 0.001). Accordingly, the technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; p < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥ moderate (18.4% vs. 13.8% vs. 5.6%; p < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; p = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank p < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank p < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR (ViR vs. ViV, hazard ratio [HR], 1.99; 95% confidence interval [CI], 1.27–3.12; p = 0.003 and ViMAC vs. ViV, HR, 5.29; 95% CI, 3.29–8.51; p < 0.001).
Conclusions:
The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
Perspective:
The observational study was performed in 40 centers in 521 patients. Center and physician experience, which was not defined other than ‘early and late experience,’ had a significant impact on outcome of each of the variables. Additional variables not available included surgical (SVMR) results in similar patients per center, rationale for device type and procedural access site, and patient variables such as frailty. The decision for TMVR versus SVMR versus continuing medical therapy for patients with ViMAC who have a 30-day 34.5% all-cause mortality and nearly 40% outflow tract obstruction with TMVR needs to be made by very experienced teams at experienced centers.
Keywords: Bioprosthesis, Cardiac Surgical Procedures, Frail Elderly, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Mitral Valve Annuloplasty, Mitral Valve Insufficiency, Outcome Assessment, Health Care
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