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Published on: December 11, 2017
Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and
G Michael Deeb1, Michael J Reardon2, Basel Ramlawi3
1Department of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, Michigan, USA.
Insights
Transcatheter aortic valve replacement (TAVR) shows similar 1-year clinical outcomes for patients with bicuspid aortic valves compared to tricuspid aortic valves. Bicuspid aortic stenosis patients experienced less paravalvular leak after TAVR.
Area of Science:
- Cardiology
- Interventional Cardiology
- Cardiac Surgery
Background:
- Pivotal transcatheter aortic valve replacement (TAVR) trials historically excluded patients with bicuspid aortic valves.
- The Low Risk Bicuspid Study reported a 30-day primary endpoint of death or disabling stroke at 1.3% in this population.
Purpose of the Study:
- To compare 1-year clinical and hemodynamic outcomes of TAVR in low surgical risk patients with bicuspid aortic stenosis versus those with tricuspid aortic stenosis.
Main Methods:
- A prospective, single-arm TAVR trial (Low Risk Bicuspid Study) enrolled 150 patients with bicuspid aortic valves.
- Patients were propensity matched (1:1) to 145 TAVR patients from the Evolut Low Risk Trial with tricuspid aortic valves.
- Outcomes were assessed at 1 year, including mortality, stroke, pacemaker implantation, and echocardiographic parameters.
Main Results:
- One-year all-cause mortality or disabling stroke occurred in 1.4% of bicuspid patients and 2.8% of tricuspid patients (P=0.413).
- Effective orifice area and mean gradient were similar between groups.
- Mild or worse paravalvular leak was significantly lower in the bicuspid group (21.3% vs 42.6%, P<0.001).
Conclusions:
- No significant differences in 1-year clinical or hemodynamic outcomes were observed between propensity-matched bicuspid and tricuspid aortic stenosis patients undergoing TAVR.
- TAVR is a viable option for low-risk patients with bicuspid aortic stenosis, with favorable short-term results and reduced paravalvular leak.
Objectives:
The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis.
Background:
The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%.
Methods:
The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs.
Results:
All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001).
Conclusions:
There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.
