Self-Expanding Intra-Annular Transcatheter Aortic Valve Replacement System in Patients With Severely Calcified Aortic...

Outcomes of patients with severe aortic valve calcification (AVC) undergoing transcatheter aortic valve replacement (TAVR) with self-expanding intra-annular transcatheter heart valves (THVs) remain uncertain. The aim of this study is to assess the impact of AVC severity on procedural and clinical outcomes following TAVR with self-expanding intra-annular THVs.

This retrospective, multicentre study included patients treated with Portico or Navitor THVs (Abbott Cardiovascular, Santa Clara, CA). Patients were stratified by AVC burden (severe ≥ 3000 Agatston unit (AU) vs nonsevere < 3000 AU). The primary endpoint was 30-day device success.

Among the 371 patients included (64% female; median Society of Thoracic Surgeons [STS] 3.7%), 86 (23.1%) had AVC ≥ 3000 AU. This group presented higher AVC density (9.0 AU/mm² [0.8-25.3] vs 4.2 AU/mm² [0.8-8.8]; P < 0.001) and echocardiographic mean transvalvular gradient (47 mm Hg [13-103] vs 44 mm Hg [15-95]; P < 0.001) compared with the nonsevere AVC group. Thirty-day device success was similar between groups (89.7% vs 89.6%; P = 0.988). Technical success occurred in 93.8% of patients. Severe AVC was associated with higher rates of procedural predilation (98.8% vs 93.3%; P = 0.048). A higher permanent pacemaker implantation rate was observed in the severe AVC group (30.2% vs 20.3%; P = 0.055). Despite comparable valve performance, 12-month heart failure-related hospitalizations were higher in the severe AVC group (13.8% vs 3.8%; P = 0.001). Finally, Portico THV was associated with a 3-fold increase risk of device failure (odds ratio [OR], 2.96; P = 0.011) compared with Navitor THV.

The use of self-expanding intra-annular THVs seems to be an effective and safe strategy also for patients with severe AVC, achieving comparable outcomes with those with lower calcification burden.