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Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease | Journal Scan
Study Questions:
Is transcatheter aortic valve replacement (TAVR) safe and effective in patients with bicuspid aortic valve disease?
Methods:
This registry examined 139 patients at 12 centers with bicuspid aortic valve disease undergoing TAVR using a balloon-expandable (n = 48) or self-expanding (n = 91) device. The TAVR team at the individual centers in Europe and Canada decided on patient selection. Endpoints included procedural success and clinical events including mortality.
Results:
Mean age was 78.0 ± 8.9 years, and the Society of Thoracic Surgeons mortality risk was 4.9 ± 3.4%. Indications for TAVR included stenosis (65.5%), isolated regurgitation (0.7%), and mixed disease (33.8%). Procedural complications included device malposition (6.5%), device embolization (2.2%), implantation of a second device (3.6%), cardiac tamponade (3.6%), and aortic root rupture (0.7%). Overall device success was 89.9%. Post-TAVR regurgitation grade was ≥2 in 28.4% and ≥3 in 6.0%. Overall mortality was 5.0% at 30 days and 17.5% at 1 year. At 30 days, the combined safety endpoint was met in 79.1%, and the combined efficacy endpoint was met in 84.9%. On multivariable analysis, the only significant predictor of mortality at 1 year was major vascular complications (odds ratio [OR], 5.7; 95% confidence interval [CI], 1.2-26.4; p = 0.03). Multivariable predictors of regurgitation grade ≥2 were male gender (OR, 4.3; 95% CI, 1.6-10.8; p = 0.003) and use of CT for device sizing (OR, 0.2; 95% CI, 0.1-0.5; p < 0.001).
Conclusions:
The use of TAVR in patients with bicuspid aortic valve disease is feasible and has good intermediate-term outcomes, although it is associated with a high rate of significant regurgitation. The use of CT for device sizing markedly lowers the risk of postprocedural regurgitation.
Perspective:
Patients with bicuspid aortic valve disease were excluded from the major TAVR trials, as there were concerns about the effectiveness and safety of the devices in patients with altered valve geometry. This study describes the experiences of 12 sites that implanted TAVR devices in bicuspid aortic valves, and reports generally good outcomes. While the rate of aortic regurgitation was high, CT was only used for prosthesis sizing in 63% of cases, and its use was associated with a large reduction in significant regurgitation. These results demonstrate the benefit of 3-D methods for prosthesis sizing in bicuspid valves, as has been seen with tricuspid valves. It is important to recognize that these were highly experienced sites that would be expected to be adept at difficult implants. Furthermore, there was no common methodology for selecting patients, and each site followed an individual approach to selecting potential cases. Therefore, it remains unclear if sites were skilled at selecting bicuspid patients more likely to benefit from TAVR, or if these results would be similar in a more general cohort of patients with bicuspid valves. These results are encouraging and should prompt further study.
Keywords: Aortic Valve Insufficiency, Canada, Cardiac Tamponade, Constriction, Pathologic, Europe, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Registries, Tricuspid Valve, Mitral Valve
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