Study Evaluates Balloon Postdilation in CoreValve TAVR Trials

February 3, 2017—A study of the impact of balloon postdilation (BPD) on outcomes in the United States clinical trials for the CoreValve transcatheter aortic valve replacement (TAVR) system (Medtronic) were published by J. Kevin Harrison, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:168–175). 

The investigators concluded that BPD of the self-expanding bioprosthesis was performed in 22% of patients in the CoreValve United States clinical trials, most commonly to reduce the degree of residual aortic regurgitation (AR). BPD was also effective in acutely improving valve performance without an associated increase in neurologic events.

As summarized in JACC: Cardiovascular Interventions, procedural details of 3,532 patients were examined to determine whether BPD was performed after self-expanding TAVR. The investigators noted that best practice guidelines recommended BPD for the treatment of suboptimal intraprocedural valve function, primarily manifested by moderate or severe residual AR.

The investigators found that procedural BPD was performed in 782 patients (22%). The most common indication was greater than or equal to moderate AR after valve deployment (58.1%). Greater baseline aortic valve gradients (P < .001), higher grades of baseline AR (P < .001), larger annular diameters (P < .001), and lower device to annular ratios (P < .001) were more common in patients who underwent BPD.

The study showed that BPD was performed less often with the 26-mm valve compared with the 31-mm valve (17.9% vs 38.1%; P < .05). BPD reduced moderate or severe AR by 75.6% (from 58.1% to 14.2%). 

Thirty-day and 1-year clinical events were similar in the two groups, although acute kidney injury was more common in patients undergoing BPD (P = .026). In-hospital major adverse cardiovascular and cerebrovascular event rates were 9.3% in the BPD group versus 7.5% for others (P = NS). There was no increase in neurological events, reported the investigators in JACC: Cardiovascular Interventions.