Novel Wire-Assisted Mitral Commissurotomy Reduces Valve Crossing Time Compared to Inoue-Balloon Technique of Treating Mitral Stenosis, Randomized Controlled Trial (CROSSVal)

Abstract

Background: Percutaneous mitral commissurotomy (PMC) of mitral stenosis is routinely performed by the Inoue balloon technique (IBT) which may be challenging with respect to valvular crossing. Using a novel wire-assisted method (WAM) may improve feasibility and time efficiency. Aims: In a randomized clinical trial, we compared the feasibility and time consumption by WAM and IBT. Methods: Twenty mitral stenosis patients with a Wilkins score ≤10 were randomized 1:1 to IBT (n = 11) or WAM (n = 9). All procedures were performed under general anesthesia and optimized by in-field and transesophageal echocardiographic guiding. The IBT balloon catheter was inserted over the coiled wire, and the stylet was used to advance it to the mitral valve, while WAM was performed by advancing a commercially available balloon over a stiff coiled wire placed in the left ventricle. 1st endpoint was time from interatrial septal puncture to balloon inflation, and 2nd outcomes were failure to double mitral valve area or severe mitral regurgitation. Results: Mean ± SD age was 28 ± 7 years (80% women) with all in NYHA class II or III. Symptom duration was median (IQR) 7 (4.8) years, Wilkins score was 8.8 ± 0.9, and mitral inflow gradient was 15.6 ± 4.6 mmHg. Procedural time (1st endpoint) was 14.4 ± 3.4 min and 21.8 ± 8.3 min in WAM and IBT, respectively (p = 0.020). Three patients in each group did not double the valve area by PMC, and no procedure was complicated by severe mitral regurgitation. Conclusions: WAM significantly reduced the time from interatrial septal crossing to first balloon inflation during equally optimized PMC in severe mitral stenosis patients compared to IBT.