Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results From the Global Valve-in-Valve Registry

Study Questions:

What are the clinical results of transcatheter aortic valve-in-valve (VIV) implantation using a large, worldwide registry?

Methods:

The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (age 77.7 ± 10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n = 85, 42%), regurgitation (n = 68, 34%), or combined stenosis and regurgitation (n = 49, 24%). Implanted devices included CoreValve (n = 124) and Edwards SAPIEN (n = 78).

Results:

Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases, and ostial coronary obstruction in 3.5%. Post-procedure, valve maximum/mean gradients were 28.4 ± 14.1 mm Hg/15.9 ± 8.6 mm Hg, and 95% of patients had ≤ +1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 83.7% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients.

Conclusions:

The authors concluded that the VIV procedure is clinically effective in the vast majority of patients with degenerated stenotic or regurgitant bioprosthetic valves.

Perspective:

This pilot evaluation of the transcatheter approach for failed surgically-inserted aortic bioprostheses suggests that in high-risk patients having degenerated bioprosthetic valves, the VIV approach is clinically effective in most cases. While short- and intermediate-term results following these procedures are favorable, safety and efficacy concerns include device malposition, ostial coronary obstruction, and high post-procedural gradients. A larger trial with longer-term follow-up is indicated to further assess this novel technology.

Clinical Topics: Cardiac Surgery

Keywords: Heart Valve Prosthesis, Registries, Surgical Instruments, Follow-Up Studies, Bioprosthesis, New York, Postoperative Period


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