Comparison of safety and efficiency of aortic balloon valvuloplasty performed in a free-standing catheterization laboratory and one with cardiac surgery backup.

Introduction: Balloon aortic valvuloplasty (BAV) is typically performed in hybrid theaters or hospitals with cardiosurgery wards. Due to limited access to these facilities, BAV may also be conducted in standalone catheterization laboratories (ASC). Aim: This study compared the safety and efficiency of BAV in ASC versus cardiac surgery-backed units (CSBU). Material and methods: This multicenter (7 sites) retrospective registry included 514 symptomatic patients with severe aortic stenosis who underwent BAV. Of these, 376 procedures were performed in CSBU and 138 in ASC. Results: Baseline characteristics were similar, except for a higher prevalence of CAD (ASC 63% vs. CSBU 45%, p = 0.001) and anemia (ASC 47.1% vs. CSBU 11.7%, p = 0.001) in the ASC group. No differences were observed between groups: in-hospital death (ASC 0.72% (n = 1) vs. CSBU 2.93% (n = 11) p = 0.14), tamponades (ASC 0.72% (n = 1) vs. CSBU 1.33% (n = 5) p = 0.57), significant bleeding which required transfusion (ASC 4.34% (n = 6) vs. CSBU 1.86% (n = 7) p = 0.57), pseudoaneurysm (ASC 1.44% (n = 2) vs. CSBU 0.52% (n = 2) p = 0.29) and implanting pacemakers (ASC 4.34% (n = 6) vs. CSBU 1.86% (n = 7) p = 0.57). Balloon dilatation with 18-24 mm diameter balloon catheters reduced the transvalvular gradient in both groups significantly (ASC: 49.6 ±8.2 mm Hg to 34.4 ±5.2 mm Hg, p = 0.01, and CSBU: 50.2 ±7.3 mm Hg to 36.5 ±4.3 mm Hg). There were no significant differences in transvalvular gradient after the procedure. Conclusions: The safety and efficiency of BAV performed in standalone catheterization laboratories are comparable to those performed in cardiology wards with cardiac surgery backup.