The data included 156 patients (median age 40 years) with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. Almost all patients had significant TR, TS, or both, and the majority (71%) were in New York Heart Association class III/IV before TVIV.
Implantation was successful in 150/152 (Melody=94) and Sapien (n=58). TV inflow gradient and tricuspid regurgitation improved significantly. There were few serious procedural complications, including two device embolizations. Both were retrieved with one successful second attempt with a new device, and the second case was referred for surgery five months later.
Acute outcomes showed four patients (2 receiving Melody, 2 receiving Sapien) had important residual TV dysfunction consisting of moderate TR in 2 patients and significant TS in 2. One patient had a moderate paravalvular leak around the implanted TVIV, and 7 had trivial/mild leaks.
At follow-up (median, 13.3 months), 22 patients died, five within 30 days (2 who underwent TVIV as compassionate cases). One of the deaths was considered procedure-related (hemopericardium and tamponade). 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). There were 10 TV reinterventions, and three other patients had significant recurrent TV dysfunction.
Factors associated with worse survival include age ≥60 years, NYHA class IV, and preimplantation renal insufficiency.
Outcomes did not differ according to surgical valve size or TVIV valve type. TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve sizes.
Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for the treatment of failing TV bioprostheses.
All editors: Frank F. Ing, MD, MSCAI
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