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Clinical TrialSeptember 2019

JOURNAL：JACC Cardiovasc Interv. Article Link

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

B Faurie, G Souteyrand, the EASY TAVI investigators. Keywords: left-ventricular stimulation; left-ventricular pacing; transcatheter aortic valve implantation; transcatheter aortic valve replacement

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.

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