Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Implantation

Abstract Background Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve implantation (TAVI). Objectives We investigated whether left ventricular (LV)-stimulation via a guidewire reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV)-stimulation. Methods This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVI with a Sapien valve (Edwards Lifesciences) were allocated to LV- or RV-stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. This trial is registered at clinicaltrials.gov (NCT02781896). Results Between May 2017 and May 2018, 307 patients were randomised but 4 were excluded because they did not receive the intended treatment: 303 patients were analysed in the LV- (n=151) or RV-stimulation (n=152) groups. Mean procedure duration was significantly shorter in the LV-stimulation group (48.4±16.9 vs. 55.6±26.9 min, p=0.0013), with a difference of -0.12 (95% CI -0.20 to -0.05) in the log transformed procedure duration (p=0.0012). Effective stimulation was similar in the LV- and RV-stimulation groups: 124 (84.9%) vs. 128 (87.1%), p=0.60. Safety of stimulation was also similar in the LV- and RV-stimulation groups: procedural success occurred in 151 (100%) vs. 151 (99.3%) patients (p=0.99); 30-day MACE-TAVI occurred in 21 (13.9%) vs. 26 (17.1%) patients (p=0.44); fluoroscopy time was lower in the LV-stimulation group (13.48±5.98 vs. 14.60±5.59, p=0.02) as was cost (€18,807±1,318 vs. €19,437±2,318, p=0.001). Conclusions Compared with RV-stimulation, LV-stimulation during TAVI was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety.