TAVR in patients with bicuspid aortic valves (BAV) is more challenging compared to individuals with trileaflet aortic valves (TAV). BAV have been excluded from the large randomized clinical trials assessing transcatheter aortic valve replacements (TAVR) and has been considered as a relative contraindication to TAVR.
To report the outcomes of TAVR in BAV and compare them to TAV in the National Inpatient Sample (NIS).
TAVR procedures were identified between 2011 and 2014 in the NIS dataset. Endpoints assessed included in-hospital mortality, periprocedural complications, length of stay and cost.
Of 40,604 identified TAVR procedures, 407(1%) were BAV and the 40,197 (99%) were TAV. Patients with BAV were younger and had a lower comorbidity burden. In hospital mortality (4.89% vs 4.17%, OR: 1.71, 95%CI: 0.57-5.12, P=0.21), AMI (3.49% vs 3.58%, OR: 1.12, 95%CI: 0.36-3.54, P=0.85), stroke and TIA (2.49% vs 3.55%, OR: 0.75, 95%CI: 0.18-3.16, P=0.70), vascular complications (2.39% vs 5.58%, OR:0.47, 95%CI: 0.11-1.93, P=0.29), major bleeding (16.96% vs 23.50%, OR: 0.63, 95%CI: 0.34-1.17, P=0.15) and rates of permanent pacemaker (PPM) (9.88% vs 10.88%, OR: 1.19, 95%CI: 0.57-2.51, P=0.64) were similar in both cohorts.
Conclusions: With multimodality imaging and further improvement in technology, our study demonstrates off-label TAVR should not be considered prohibitive and can be successfully performed for BAV with similar peri-procedural outcomes compared to those with TAV. However, there is a need for robust large prospective studies.