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TAVR With Early- and New-Generation Devices in Bicuspid AS
Study Questions:
What are the clinical outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve stenosis (AS) with early- and new-generation devices?
Methods:
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.
Results:
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).
Conclusions:
The authors concluded that clinical outcomes of TAVR in patients with bicuspid AS were favorable.
Perspective:
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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