Recommendations for Prosthetic Valve Regurgitation

CORLOERecommendationsComment/Rationale
IBSurgery is recommended for operable patients with mechanical heart valves with intractable hemolysis or HF due to severe prosthetic or paraprosthetic regurgitation (250,251).2014 recommendation remains current.
IIaC-LDSurgery is reasonable for asymptomatic patients with severe bioprosthetic regurgitation if operative risk is acceptable (241).MODIFIED: LOE updated from C to C-LD. A specific indication for surgery is the presence of severe bioprosthetic regurgitation in a patient with acceptable operative risk. With the new recommendation for valve-in-valve therapy, indications for intervention need to account for patients who would benefit from surgery versus those who would benefit from transcatheter therapy, determined by type of valve, symptomatic status, and risk of reoperation.
See Online Data Supplement 23 (Updated From 2014 VHD Guideline)
Bioprosthetic valve degeneration can result in regurgitation due to leaflet calcification and noncoaptation or leaflet degeneration with a tear or perforation. Even in asymptomatic patients with severe bioprosthetic regurgitation, valve replacement is reasonable because of the risk of sudden clinical deterioration if further leaflet tearing occurs (241). The increased risk of a repeat operation must always be taken into consideration. The type of valve prosthesis and method of replacement selected for a patient undergoing reoperation depend on the same factors as those for patients undergoing a first valve replacement.
IIaBPercutaneous repair of paravalvular regurgitation is reasonable in patients with prosthetic heart valves and intractable hemolysis or NYHA class III/IV HF who are at high risk for surgery and have anatomic features suitable for catheter-based therapy when performed in centers with expertise in the procedure (252–254).2014 recommendation remains current.
IIaB-NRFor severely symptomatic patients with bioprosthetic aortic valve regurgitation judged by the heart team to be at high or prohibitive risk for surgical therapy, in whom improvement in hemodynamics is anticipated, a transcatheter valve-in-valve procedure is reasonable (154,247,248).NEW: Registries and case series of patients have reported on the short-term outcomes and complication rates for patients with bioprosthetic aortic regurgitation who have undergone transcatheter valve-in-valve replacement.
See Online Data Supplement 9.
The VIVID (Valve-In-Valve International Data) Registry is the largest registry to date examining outcomes of the transcatheter valve-in-valve procedure in 459 patients, of whom 30% had severe prosthetic valve regurgitation and 30% had combined regurgitation and stenosis (154). Within 1 month after the valve-in-valve procedure, 7.6% of patients died, 1.7% had a major stroke, and 93% of survivors experienced good functional status (NYHA class I/II). The overall 1-year survival rate was 83.2% (154). In nonrandomized studies and a systematic review comparing outcomes and safety of the transcatheter valve-in-valve procedure with repeat surgical AVR, the valve-in-valve procedure was found to have similar hemodynamic outcomes, lower stroke risk, and reduced bleeding risk as compared with repeat surgery (248). No data are available yet on the durability and long-term outcomes after transcatheter valve-in-valve procedures. There are also unique clinical and anatomic challenges requiring experienced operators with an understanding of the structural and fluoroscopic characteristics of the failed bioprosthetic valve. The use of transcatheter valve-in-valve procedures to treat bioprosthetic valve regurgitation should be applied only to patients with larger-sized prostheses for whom hemodynamic improvement is anticipated. The transcatheter aortic valve-in-valve procedure is not currently approved to treat paraprosthetic valve regurgitation or failed/degenerated transcatheter heart valves, and it is contraindicated in patients with IE. Transcatheter valve-in-valve implantation has also been successfully performed for failed surgical bioprostheses in the mitral, pulmonic, and tricuspid positions.