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TAVR in bicuspid aortic stenosis more effective with newer-generation devices
WASHINGTON — Treatment of bicuspid aortic stenosis with transcatheter aortic valve replacement was comparable to transcatheter aortic valve replacement in tricuspid aortic stenosis, but the procedure was more successful with newer-generation systems, according to data presented at the American College of Cardiology Scientific Session.
Patients with bicuspid aortic stenosis have been excluded from randomized controlled trials of TAVR systems, and there are few data comparing clinical outcomes of TAVR in bicuspid vs. tricuspid aortic stenosis, Sung-Han Yoon, MD, from the department of interventional cardiology at Cedars-Sinai Heart Institute, said during a presentation.
“The indication of TAVR is expanding into younger and lower-risk [patients],” Yoon said. “According to previous studies, the prevalence of bicuspid aortic valve stenosis is higher in the younger population. Therefore, these patients have been coming for TAVR more frequently. Due to younger age and fewer comorbidities in bicuspid aortic stenosis, it is possible that outcomes of TAVR for bicuspid could differ from tricuspid aortic stenosis.”
Yoon and colleagues compared outcomes in 561 patients with bicuspid aortic stenosis who underwent TAVR and were included in the Bicuspid AS TAVR registry of 33 centers around the world with those in 4,546 patients with tricuspid aortic stenosis who underwent TAVR during the same period at 12 centers.
The primary outcome was all-cause mortality at 2 years. The results were simultaneously published in the Journal of the American College of Cardiology.
Compared with the tricuspid group, the bicuspid group was more often converted to surgery (2% vs. 0.2%; P = .006) and had a lower rate of device success, defined as absence of procedure-related death, correct positioning of the artificial valve into the proper location, no patient-prosthesis mismatch, mean aortic gradient < 20 mm Hg or peak velocity < 3 m/s and no moderate or severe paravalvular leak (85.3% vs. 91.4%; P = .002).
In an analysis of those who received early-generation TAVR devices (Sapien XT, Edwards Lifesciences; CoreValve, Medtronic) vs. those who received later-generation ones (Sapien 3, Edwards Lifesciences; Lotus, Boston Scientific; CoreValve Evolut R, Medtronic), there were no differences in procedural outcomes between those with bicuspid and those with tricuspid aortic stenosis in the later-generation devices, Yoon said.
However, he said, among those who received the Sapien XT, those with bicuspid aortic stenosis had more aortic root injury (4.5% vs. 0%; P = .015) than those with tricuspid aortic stenosis. Among those who received the CoreValve, those with bicuspid aortic stenosis had more moderate to severe paravalvular leak (19.4% vs. 10.5%; P = .02) vs. those with tricuspid aortic stenosis.
All-cause mortality was 17.2% in those with bicuspid aortic stenosis and 19.4% in those with tricuspid aortic stenosis at 2 years (P = .28), according to the researchers. – by Erik Swain
References:
Yoon SH, et al. Featured Clinical Research II: Interventional. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Yoon SH, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2017.03.017.
Disclosure: Yoon reports no relevant financial disclosures.Perspective
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Yoon and colleagues present a thorough and well-executed observational study investigating the safety and efficacy of TAVR in patients with symptomatic severe bicuspid aortic stenosis as compared to those with tricuspid aortic stenosis. The study represents the largest analysis to date evaluating TAVR in bicuspid aortic stenosis, draws from a large number of experienced international sites, and employs propensity-score matching in an attempt to adjust for measured confounders. In addition, within subgroup analyses, the study evaluates and compares the performance of older vs. new-generation transcatheter valve prostheses for bicuspid aortic stenosis.
This is the first study to evaluate and systematically compare TAVR performance in bicuspid aortic stenosis to that in tricuspid aortic stenosis. While the authors confirm prior concerns that TAVR in bicuspid aortic stenosis is associated with lower rates of device success, higher rates of conversion to surgery, and higher rates of moderate to severe paravalvular aortic regurgitation and aortic root injury, subgroup analyses suggest that these differential results do not impact newer-generation transcatheter valves. Moreover, cumulative 2-year mortality did not differ between bicuspid and tricuspid aortic stenosis groups, further supporting the safety of TAVR in patients with bicuspid aortic stenosis.
The results of this study support the safety and efficacy of TAVR in patients with bicuspid aortic stenosis; however, it remains concerning that TAVR for bicuspid aortic stenosis is associated with more frequent procedural complications, reduced device success and greater paravalvular aortic regurgitation. While such results may be acceptable for high- or extreme-risk patients with limited alternative therapeutic options, greater safety is needed before the widespread application of TAVR for bicuspid aortic stenosis can be endorsed in healthier patients. The more favorable outcomes observed with newer-generation TAVR valves are certainly encouraging and warrant further investigation and confirmation.
Two primary factors must be considered when evaluating treatment options for patients with bicuspid aortic stenosis. No. 1 is patient risk. Until greater device success and safety can be consistently attained with TAVR, surgical AVR should remain the treatment of choice for low- and intermediate-risk patients with bicuspid aortic stenosis. No. 2, the presence of an associated aortopathy should strongly favor surgery unless the predicted risk of mortality is felt to be too great.