TAVR Outcomes for Bicuspid vs. Tricuspid Valves

Study Questions:

What are the procedural and clinical outcomes for transcatheter aortic valve replacement (TAVR) among patients with bicuspid versus tricuspid aortic stenosis (AS)?

Methods:

The Bicuspid AS TAVR registry is an international, multicenter, observational study that enrolled all consecutive patients with bicuspid AS undergoing TAVR at 33 centers in Europe, North America, and Asia-Pacific beginning in December 2013; data were collected retrospectively for cases performed before initiation, and prospectively thereafter. Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity-score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to VARC-2 criteria.

Results:

Compared to patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%, p = 0.006) and significantly lower device success rates (85.3% vs. 91.4%, p = 0.002). Early-generation devices (Sapien XT, CoreValve) were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices (Sapien 3, Lotus, Evolut R) were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%, p = 0.015) when undergoing implantation with the Sapien XT, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%, p = 0.02) when undergoing implantation with the CoreValve. Among patients with newer-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%, p = 0.28).

Conclusions:

Compared to tricuspid AS, TAVR among patients with bicuspid AS was associated with lower device success rates, but similar prognosis. Procedural differences were observed between bicuspid and tricuspid AS among patients treated with the early-generation devices, whereas no differences were observed with the newer-generation devices.

Perspective:

TAVR is being performed with increasing frequency among patients with bicuspid AS. Because deployment of both balloon-expandable and self-expanding valves relies on a relatively circular orifice, greater orifice/annular asymmetry in the setting of a bicuspid valve could lead to inferior outcomes. In this large, multicenter registry, the vast majority of patients with bicuspid AS had Sievers type 1 morphology (86%), with three sinuses of Valsalva; and only 13% of patients had Sievers type 0 morphology (with two relatively symmetrical sinuses of Valsalva). Take-home messages from this study probably should be that TAVR may be feasibly performed among some patients with bicuspid AS using newer-generation devices (Sapien 3, Lotus, Evolut R), with supporting data predominantly limited to patients with a Sievers type 1 bicuspid valve.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: ACC17, ACC Annual Scientific Session, Aortic Valve Stenosis, Bicuspid, Cardiac Surgical Procedures, Heart Valve Diseases, Mitral Valve, Outcome Assessment (Health Care), Prostheses and Implants, Transcatheter Aortic Valve Replacement, Tricuspid Valve Stenosis


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