La valvuloplastica aortica percutanea eseguita con o senza stimolazione ventricolare rapida: risultati dello studio randomizzato PNP (Pacing vs No Pacing)

Objective To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). Background BAV technique is poorly standardized. Methods One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. Results There were fifty-one patients in the BAV group performed with RP, forty-nine in the BAV group without RP (no-RP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1% respectively (p=0.16). Fewer people in the no-RP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the no-RP group compared to 20/51 in the RP (42.9% vs 39.2%; p=0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ?3 (8.2% no-RP vs 13.7%; p=0.53). The no-RP group required fewer bailout temporary pacemakers (p=0.048) and had a lower incidence of mild renal function worsening (4.1% vs 17.6%; p=0.052). The calculation of the population sample for a large randomized study, in relation to a composite outcome of the net rate of positive/negative events occurred in the two arms of this pilot study, led to consider the future enrollment of 343 patients in each group. Conclusions Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse.