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Valve-in-Valve TAVR (PARTNER 2 Registry)
Study Questions:
What are the 30-day and 1-year outcomes among high-risk patients undergoing valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR)?
Methods:
The PARTNER 2 (Placement of Aortic Transcatheter Valves 2) trial was a prospective, multicenter study that enrolled patients with symptomatic aortic stenosis (AS); the study included a nested registry of patients with degenerated surgical aortic bioprostheses who were at high risk of complications during reoperation (≥50% major morbidity or mortality). Following the enrollment of a maximum of 100 patients in the nested registry, additional patients were enrolled in a continued access registry. Patients were treated with either a 23 mm or 26 mm Sapien XT transcatheter heart valve.
Results:
ViV procedures were performed in 365 patients (96 in the initial registry, 269 continued access patients). Mean age was 78.9 ± 10.2 years, with Society of Thoracic Surgeons predicted risk of mortality score 9.1 ± 4.7%. At 30 days, all-cause mortality was 2.7%, stroke 2.7%, major vascular complication 4.1%, conversion to surgery 0.6%, coronary occlusion 0.8%, and new pacemaker 1.9%. One-year all-cause mortality was 12.4%. Mortality fell from the initial registry to the subsequent continued access registry, both at 30 days (8.2% vs. 0.7%; p = 0.0001) and at 1 year (19.7% vs. 9.8%; p = 0.006). At 1 year, mean gradient was 17.6 mm Hg and effective orifice area was 1.16 cm2, with greater than mild paravalvular regurgitation in 1.9%. Left ventricular ejection fraction increased (50.6% to 54.2%) and mass index decreased (135.7 to 117.6 g/m2), with reduction in moderate or severe mitral regurgitation (34.9% vs. 12.7%) and tricuspid regurgitation (31.8% vs. 21.2%; all p < 0.0001). Kansas City Cardiomyopathy Questionnaire scores increased (mean 43.1 to 77.0) and 6-minute walk test distance increased (mean 163.6 to 252.3 meters; both p < 0.0001).
Conclusions:
The authors concluded that, among high-risk patients with degeneration of a bioprosthetic surgical aortic valve, ViV TAVR is associated with relatively low mortality and complication rates, improved hemodynamics, and excellent functional and quality-of-life outcomes at 1 year.
Perspective:
TAVR is gaining an increasingly important role in the treatment of symptomatic patients with severe AS. Among patients at high risk for complications during re-do surgical AVR, valve-in-valve (ViV) TAVR is an attractive alternative. This study reinforces the feasibility and generally favorable outcome associated with ViV TAVR. Along with the factors that affect the feasibility of TAVR in general, the utility of ViV TAVR also is affected by the size and design of the original surgical bioprosthesis. Use of a hemodynamically favorable aortic bioprosthesis at the time of the initial surgical AVR is of special importance, because this can affect the feasibility and outcomes of future ViV TAVR procedures.
Keywords: Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Coronary Occlusion, Geriatrics, Heart Valve Diseases, Mitral Valve Insufficiency, Reoperation, Stroke, Stroke Volume, Transcatheter Aortic Valve Replacement, Tricuspid Valve Insufficiency
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