Safety and efficacy of Accura Balloon for Percutaneous balloon pulmonary valvuloplasty (PBPV).

Background
Balloon pulmonary valvuloplasty (BPV) is treatment of choice for significant pulmonary stenosis (PS). Currently, Tyshak balloon is preferred but water melon seeding effect is frequently seen with it resulting into multiple dilatation. Advantage of Accura balloon (Vascular Concept, UK) over is attributed to its self-positioning configuration, variable diameter, rapid inflation-deflation sequence and performance metrics.

Methods
It was prospective, non-randomized study of BPV using Accura balloon at our institute from March 2012 to May 2018. BPV was performed using standard technique but balloon was slenderized by removing metallic straightener when it reached into right atrium to facilitate its delivery across pulmonary valve. Patients were followed-up by 2D echo at 24 hours, 6 month and at 1year.

Results
Successful BPV was done in 19 patients (age: 29±13 years; 11 males and 8 females) among which 3 patients had dysplastic valve as they had Noonan syndrome. Mean diameter of annulas was 16±2 mm. Right ventricular systolic pressure was >75% of systemic pressure in all patients. 17 patients had immediate hemodynamic improvement as peak systolic gradient reduced from 109±18 to 28±18 mmHg (P<0.005) while 2 patients had <50% reduction of resting gradient. Infundibular spasm might have been a contributory factor as significant reduction of gradient at 6 month was observed in these patients. Fluoroscopy and procedural time were 6.3±3.1 min and 22.9±2.5 min respectively. Major complications (death, cardiac perforation, tamponade, tricuspid regurgitation) were none. Minor complications were seen in 4 patients (transient hypotension-1, no-sustained ventricular tachycardia-2, transient bradycardia-1) which resolved spontaneously. Accura balloon being bulky was delivered over left atrial and superstiff Amplatz wire in 16 and 3 patients respectively.

Conclusions
BPV using Accura Balloon is safe and effective for both stenosed and dysplastic valves where full effect sometimes may take little long among few patients (6 months).