Balloon rupture during aortic valvuloplasty with compliant balloon: predictors and outcomes.

Objectives of the study were the prevalence and clinical consequences of balloon rupture with compliant balloons in balloon aortic valvuloplasty (BAV). Compliant low-profile balloons have been developed to reduce access site complications. Made by thinner materials, these balloons are more prone to rupture. This is a single-center retrospective analysis (2016-2018) of patients undergoing BAV with compliant balloons. Baseline echocardiography and computed tomography (CT) were analyzed. Best cutoff point for calcium score was assessed. Long-term mortality was analyzed with Kaplan-Maier. In vitro test was performed. Rupture occurred in 30/90 (33%) of BAVs independent of risk factors, surgical risk and frailty scores. Patients experiencing rupture had increased mean gradient [53.5 (44-64) vs 44 (35-49) mmHg, p < 0.05] and reduced aortic valve area [0.61 (0.46-0.76) vs 0.76 (0.64-0.83) mm, p < 0.05]. Valve calcium score on CT > 2686 AU was more frequent in the rupture group (41% vs 10%, p < 0.05) and more patients in the third tertile of calcium score experienced rupture (75% vs 23% vs 41% for second and first tertile, p < 0.05). Median gradient reduction from baseline was similar among groups [30 (20-50) vs 30 (17-39) mmHg]. No patient with rupture had any complication. One-month and long-term mortality were similar (rupture 0% vs 3.5% no rupture from 1 month). In vitro test required more volume and strength to rupture the balloon than used in BAV. Balloon rupture is frequent in BAV using compliant balloons, occurs with more severe aortic stenosis, does not affect BAV efficacy and does not impair outcomes.