Balloon Mitral Valvotomy With the Accura Double-Lumen Balloon Catheter: Immediate and One-Year Clinical Outcomes

Objective Despite the decline in the incidence of rheumatic heart disease in developed countries, the disease still remains endemic among individuals of low socioeconomic status. The aim of the study is to assess immediate and one-year outcomes of balloon mitral valvotomy using the double-lumen Accura balloon (Vascular Innovations Co., Nonthaburi, Thailand) in patients with mitral valve stenosis. Methods This was a single-centre, observational, investigator-initiated retrospective study. All consecutive patients undergoing balloon mitral valvotomy with the Accura balloon between January 2015 and June 2020 were included. The primary endpoint was procedural success defined as an increase in mitral valve area (MVA) ≥50% from basal valve area or final valve area of ≥1.5 cm(2), in the absence of mitral regurgitation grade >2. Clinical, echocardiographic, and haemodynamic parameters were assessed at the one-year follow-up. Results A total of 62 patients underwent balloon mitral valvotomy. The mean age was 34.9 ± 8.0 years, and 54 (87.1%) patients were female. Mean Wilkins' echo score was 7.5 ± 0.5. Procedural success was achieved in 59 (96.7%) patients. Mean MVA increased from 0.75 ± 0.14 cm(2) to 1.64 ± 0.21 cm(2), and mean mitral valve gradient decreased from 24.9 ± 5.5 mmHg to 7.30 ± 1.40 mmHg. Atrial fibrillation, mitral valve replacement, and moderate to severe mitral regurgitation occurred in 36 (59.0%), two (3.3%), and two (3.3%) patients, respectively. No death, cerebrovascular accidents, restenosis, or redo procedures occurred. Conclusion Balloon mitral valvotomy using the double-lumen Accura balloon is safe in patients with mitral valve stenosis.