New Study Assesses Efficacy and Safety of TAVR in BAV Disease

The use of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) disease may be feasible with encouraging short- and intermediate-term clinical outcomes, according to a study published Dec. 1 in the Journal of the American College of Cardiology. Though the study also observed a high incidence of post-implantation aortic regurgitation (AR) post-procedure, results of the study showed it can be mitigated by multislice computed tomography (MSCT)-based transcatheter aortic valve (TAV) sizing.

With a prevalence estimated between 0.5 percent and 2 percent, BAV disease is the most common congenital cardiac defect. Given that there is a portion of patients within this population who are suitable and at high-risk for surgical intervention, Darren Mylotte, MB, MD, University Hospital, Galway, Ireland, and his team of researchers sought to evaluate whether TAVR could serve as a potential alternative, assessing the safety and efficacy of the procedure in a large group of patients.

Collecting data on 139 patients treated with TAVR in 12 centers over nine years, results showed that BAV stenosis occurred in 65.5 percent, regurgitation in 0.7 percent and mixed disease in 33.8 percent. Overall, procedural mortality was 3.6 percent, with TAV embolization in 2.2 percent, and conversion to surgery in 2.2 percent. The mean aortic gradient was found to decrease from 48.7 ± 16.5 to 11.4 ± 9.9 mmHg (p<0.0001).  Incidences of post-implantation AR ≥ grade 2 occurred in 28.4 percent (19.6 percent balloon-expandable transcatheter heart valve versus 32.2 self-expandable transcatheter heart valve, P=0.11), but was prevalent in only 17.4 percent MSCT-based TAV sizing was performed (16.7 balloon-expandable transcatheter heart valve versus 17.6 self-expandable transcatheter heart valve, P=0.99).  MSCT-sizing was associated with reduced AR on multivariable analysis (odds ratios [OR] 0.19, 95 percent confidence intervals [CI]: 0.08-0.45, p<0.0001).  While 30-day device safety, success, and efficacy were observed in 79.1 percent, 89.9 percent and 84.9 percent of patients, respectively, and one-year mortality was 17.5 percent. Major vascular complications were associated with an increased 1-year mortality (OR 5.66, 95 percent CI: 1.21-26.429, p=0.03).

The authors conclude that “given the suboptimal echocardiographic results, further study is required to evaluate the long-term efficacy.”

In a corresponding editorial, Antonio Colombo, MD, FACC, and Azeem Latib, MD, FACC, write, “Unless next-generation transcatheter valves show better performance regarding prevention of residual aortic regurgitation, the incidence of significant aortic regurgitation following first-generation transcatheter valves implantation – even with full MSCT evaluation – is too high to extend TAVR to BAV unless the patient is truly inoperable or has an unacceptably high surgical risk. However, the current study does set a benchmark for next-generation TAVR devices and does demonstrate the feasibility of TAVR in BAV.” They add that the present study, “gives us a realistic perspective of TAVR in BAV and defines areas of improvement if the goal is to continue to treat more patients in a less invasive way.”

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Constriction, Pathologic, Equipment Safety, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Hospitals, University, Ireland, Multidetector Computed Tomography

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