Recommendations for Prosthetic Valve Stenosis

CORLOERecommendationsComment/Rationale
ICRepeat valve replacement is indicated for severe symptomatic prosthetic valve stenosis (239–241).2014 recommendation remains current.
IIaC-LDIn patients with suspected or confirmed bioprosthetic valve thrombosis who are hemodynamically stable and have no contraindications to anticoagulation, initial treatment with a VKA is reasonable (203,242–246).NEW: Case series of patients presenting with bioprosthetic valve stenosis have suggested improvement in hemodynamics with VKA treatment because of resolution of thrombus on the valve leaflets.
See Online Data Supplement 8.
There are no medical therapies known to prevent or treat bioprosthetic valve degeneration. However, bioprosthetic valve thrombosis may present with slowly progressive stenosis months to years after implantation. Small, nonrandomized studies support the use of VKAs to treat patients with bioprosthetic valve thrombosis after both surgical AVR and TAVR (203,242–246). In a retrospective single-center report of 31 patients with bioprosthetic valve thrombosis who were initially treated with either a VKA or surgery/thrombolysis, VKA-treated patients had 87% thrombus resolution and experienced hemodynamic and clinical improvement comparable to surgery/thrombolysis, with no complications (244). Notably, in that case series, the peak incidence of bioprosthetic valve thrombosis occurred 13 to 24 months after implantation, with the longest interval being 6.5 years (244). Surgery or thrombolysis may still be needed for patients who are hemodynamically unstable or have advanced and refractory HF, large mobile thrombus, or high risk of embolism. At present, the DOACs have not been adequately studied, nor has the U.S. Food and Drug Administration approved them for prophylaxis or treatment of prosthetic valve thrombosis.
IIaB-NRFor severely symptomatic patients with bioprosthetic aortic valve stenosis judged by the heart team to be at high or prohibitive risk of reoperation, and in whom improvement in hemodynamics is anticipated, a transcatheter valve-in-valve procedure is reasonable (154,247,248).NEW: Registries and case series have reported on the short-term outcomes and complication rates in patients with bioprosthetic AS who have undergone transcatheter valve-in-valve therapy.
See Online 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 about 40% had isolated stenosis 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. An anticipated hemodynamic improvement from the transcatheter valve-in-valve procedure occurs only in patients with larger-sized prostheses, because a smaller-sized valve will always be placed within a failing bioprosthesis. In 2015, the U.S. Food and Drug Administration approved the transcatheter heart valve-in-valve procedure for patients with symptomatic heart disease due to stenosis of a surgical bioprosthetic aortic valve who are at high or greater risk for open surgical therapy (as judged by a heart team, including a cardiac surgeon) (249). The transcatheter aortic valve-in-valve procedure is not currently approved to treat para-prosthetic valve regurgitation or for 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.