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TAVR Led to Encouraging Clinical Outcomes in Bicuspid Aortic Valve Disease
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Transcatheter aortic valve replacement yielded encouraging clinical outcomes at 30 days and 1 year in a cohort of patients with bicuspid aortic valve disease.
Researchers conducted a retrospective analysis of the TAV-in-BAV Registry to assess clinical outcomes after TAVR in 139 elderly patients with bicuspid aortic valve disease. The mean age of the patients was 78 years and the mean Society of Thoracic Surgeons predicted risk of mortality score was 4.9%. The researchers collected baseline and procedural data along with follow-up results from patients who underwent TAVR at 12 centers in Europe and Canada from April 2005 to January 2014. The balloon-expandable transcatheter heart valve (Sapien XT, Edwards Lifesciences) was used in 48 patients and the self-expandable transcatheter heart valve (CoreValve, Medtronic) was used in 91 patients.
Bicuspid aortic valve stenosis was reported in 65.5% of patients, mixed disease in 33.8% and regurgitation in 0.7%, according to the results. Among those with a confirmed bicuspid aortic valve type, 68.3% were type 1, 26.7% were type 0 and 5% were type 2.
Sixty-three percent of patients had multislice CT-based transcatheter aortic valve sizing; this approach was utilized in 77.1% of patients who received the balloon-expandable transcatheter heart valve and 56% who received the self-expandable transcatheter heart valve (P=.02).
Procedure-associated mortality was 3.6%. Transcatheter aortic valve embolization occurred in 2.2%. Conversion to surgery was required by 2.2% of patients.
Postprocedural echocardiography findings demonstrated a decrease in mean aortic gradient of 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (P<.0001). Post-implantation aortic regurgitation grade ≥2 was reported in 28.4% of patients overall (92% paravalvular), with 19.6% in the balloon-expandable transcatheter heart valve group and 32.2% in the self-expandable transcatheter heart valve group (P=.11). Aortic regurgitation grade ≥2 outcome was prevalent in just 17.4% of patients who underwent multislice CT-based transcatheter aortic valve sizing (16.7% in the balloon-expandable transcatheter heart valve group and 17.6% in the self-expandable transcatheter heart valve group; P=.99). Multivariate analysis indicated an association between multislice CT-based transcatheter aortic valve sizing and reduced aortic regurgitation (OR=0.19; 95% CI, 0.08-0.45).
“A high incidence of post-implantation aortic regurgitation is observed following [TAVR in patients with bicuspid valve disease]. The incidence of post-implantation paravalvular leak is moderated by [multislice CT-based transcatheter aortic valve sizing], which should be considered mandatory for [TAVR in patients with bicuspid valve disease],” the researchers wrote.
At 30 days, device safety was reported in 79.1% of patients, device success in 89.9% and device efficacy in 84.9%. At 1 year, the mortality rate was 17.5%. The researchers observed an association between major vascular complications and increased mortality at 1 year (OR=5.66; 95% CI, 1.21-26.43).
“Longer-term follow-up of a larger cohort of patients is required to more completely assess the efficacy and durability of [TAVR] in patients with bicuspid disease,” the researchers wrote.
Disclosure: Some researchers report associations with companies that include Biotronik, Boston Scientific, DirectFlow, Edwards Lifesciences, General Electric and Medtronic.
Perspective
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Samir Kapadia, MD
This study is a very important first look at the data that can help us answer the burning questions about in which kinds of anatomies can we put transcatheter aortic valves, and whether the bicuspid aortic valve be treated safely with TAVR. Since the success of TAVR and recognition that a fair number of older patients do have bicuspid aortic valves, and there are bicuspid valve patients with comorbidities resulting in high surgical risk, the feasibility of TAVR in these patients is a very relevant question. I think the conclusion is kind of sobering. I would caution that the TAVR team has to be more experienced, to be deliberate and to understand the anatomy very well before deciding to perform TAVR for bicuspid aortic valve patients.
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