Individuals undergoing TAVR for bicuspid aortic valve (BAV) stenosis, compared with tricuspid aortic valve (TAV) stenosis, had similar device success and one-year survival, but a higher risk of complications, according to a study published Oct. 4 in JACC: Cardiovascular Interventions.

Claudio Montalto, MD, et al., conducted a systematic review and meta-analysis that included 17 studies – all nonrandomized, observational – and 181,433 patients undergoing TAVR. From these, 6,669 (0.27%) had BAV. In a secondary analysis, they propensity matched 7,071 individuals with similar baseline characteristics.

Baseline data from the unmatched cohorts showed that BAV patients were significantly younger (76.1 years vs. 80.3 years; p<0.0001), had lower left ventricular ejection fractions (52.7% vs. 55.5%; p=0.03), and were more frequently in NYHA class III or IV heart failure (78% vs. 65%; p=0.02).

Results show device success rates of 97% and 94% for BAV and TAV patients, respectively (p=0.55), and one-year survival rates of 91.3% and 90.8%, respectively (p=0.22). In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in the main analysis (risk ratio [RR], 1.12; 95% confidence interval [CI], 0.99-1.27; p=0.07). However, in the propensity-matched analysis, this trend was not seen (RR, 1.00; 95% CI, 0.81-1.24; p=0.99). The risk for moderate to severe paravalvular leak (PVL) was higher in subjects with BAV both in the main analysis and in the matched populations (RRs, 1.42 [p<0.0001] and 1.53 [p<0.002], respectively). The incidence rates of stroke or transient ischemic attack (2.4% vs. 1.6%; p=0.015), annular rupture (0.27 vs. 0.02; p=0.014), and conversion to surgery 1.2% vs. 0.35%; p=0.018), were all significantly higher in BAV than TAV in matched patients.

In a subgroup analysis, periprocedural complications were significantly higher with BAV when newer-generation devices and balloon-expandable valves were used. PVL was also more common when balloon-expandable devices were used, irrespective of device generation.

Acknowledging some limitations of the data, the authors note that there was heterogeneity in reported outcomes, requiring caution in interpretation of findings. Also, the BAV cohort consists of patients deemed unsuitable for surgical aortic valve replacement, which may introduce a selection bias that is not accounted for by the statistical analysis.

Montalto, et al., conclude, “…although BAV should not be a contraindication to TAVR and can be used safely in selected subjects with bicuspid anatomy with comparable long-term survival, the higher rates of periprocedural complications and of individual complication endpoint, such as cerebral ischemic events and annular rupture, warrant expert operators at high-volume centers who can manage them promptly.” The authors further suggest that randomized controlled trials are required to ascertain if TAVR is preferable over surgery to treat patients with bicuspid anatomy.

This study represents a “highly selected” group of BAV patients, note editorial comment writers, Didier Tchetche, MD, and Saifullah Siddiqui, MD, with only 0.27% of patients who underwent TAVR having a bicuspid valve. In another recent report, the incidence of BAV in consecutive patients with aortic stenosis was reported at 17%.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Interventions, CHD and Pediatrics and Quality Improvement, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Patient Reported Outcome Measures, Contraindications, Heart Failure, Stroke, Aortic Valve Stenosis, Ventricular Function, Left, Confidence Intervals, Constriction, Pathologic, Mitral Valve, Ischemic Attack, Transient, Transcatheter Aortic Valve Replacement, Heart Valve Prosthesis, Aortic Valve, Stroke Volume, Bicuspid Aortic Valve Disease

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