Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation

Balloon aortic valvuloplasty (BAV) is routinely performed preceding transcatheter aortic valve implantation (TAVI). Among risks inherent in BAV is low cardiac output due to rapid ventricular pacing (RVP), especially in patients with severely impaired left ventricular function. We herein report early experience utilizing a non-occlusive balloon for BAV (TrueFlow™, BARD, Peripheral Vascular, Tempe, AZ, US), which does not require RVP.

Between 11/2016 and 10/2017, 27 consecutive patients received TAVI using a non-occlusive balloon valvuloplasty catheter for predilatation and a self-expandable transcatheter heart valve (77.8% female, 81.7 ± 6.6 years, logEuroSCORE I 15.8 ± 10.3%, STS Prom Score 2.5 ± 0.5%). Hemodynamic measurements and acute outcome data were analyzed according to updated Valve Academic Research Consortium definitions.

Procedure time, fluoroscopy time and amount of contrast agent were 74.5 ± 17.4 min, 16.7 ± 6.9 min and 156.9 ± 92.7 ml. Device success and early combined safety were 100% and 92.6% (25/27). Effective BAV without RVP after the first inflation was achieved in 92.6% of the patients (25/27). Continuous recording of hemodynamics documented no relevant systemic pressure drop during BAV. Postdilatation with a regular balloon was required in 10/27 patients. No death was observed during 30-day follow-up. Resultant mean transvalvular gradient was 6.0 ± 3.5 mm Hg. In one patient a moderate paravalvular leakage was seen.

In this series of TAVI utilizing a novel non-occlusive balloon, safety and efficacy were demonstrated. Adequate predilatation was achieved in all cases without need for RVP and with stable hemodynamics. These results will have to be confirmed in larger patient cohorts.