TAVR With Early- and New-Generation Devices in Bicuspid AS
What are the clinical outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve stenosis (AS) with early- and new-generation devices?
The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Kaplan-Meier survival analysis and the log-rank test were used for comparisons across the group. The entire follow-up was used to analyze time-to-event outcomes and patients were censored at the time of death or last available follow-up. Univariate Cox regression models were used to evaluate potential predictors of all-cause mortality.
Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, CA]: n = 87; CoreValve [Medtronic, Minneapolis, MN]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, MA]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2-3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99).
The authors concluded that clinical outcomes of TAVR in patients with bicuspid AS were favorable.
This study reports that overall clinical outcomes of TAVR in bicuspid AS are comparable to those of reported studies and new-generation devices are associated with less paravalvular leak, and consequently, a higher device success rate than early-generation devices. However, these improved procedural outcomes did not translate into a significant reduction in 30-day mortality or other major clinical endpoints. Future studies should evaluate long-term outcomes of TAVR in patients with stenotic bicuspid valves.
Keywords: Aortic Valve Stenosis, Acute Kidney Injury, Cardiac Surgical Procedures, Bicuspid, Heart Valve Diseases, Hemorrhage, Outcome Assessment (Health Care), Stroke, Survival Analysis, Transcatheter Aortic Valve Replacement, Vascular Diseases
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