A novel generation balloon-expandable versus supra-annular self-expanding trans-catheter heart valve in patients with severe aortic stenosis and calcified left ventricle outflow tract.

INTRODUCTION

Severe left ventricular outflow tract (LVOT) calcification remains a challenging anatomy for transcatheter aortic valve replacement (TAVR), with increased risk of paravalvular leak (PVL), annular injury, and conduction disturbances. Evidence on the performance of new-generation balloon-expandable (BE) valves in this setting is limited.

METHODS

An international, multicenter, cohort analysis comparing outcomes of patients with severe LVOT calcification treated with the novel Octacor BE versus two self-expanding (SE) transcatheter heart valves (THVs: Acurate Neo2 and Evolut Pro/Pro+). The primary endpoint was Valve Academic Research Consortium-3 (VARC-3) technical success. Secondary endpoints were: overall mortality, overall stroke, moderate-to-severe paravalvular leak (PVL), permanent pacemaker implantation (PPI), annulus rupture and major bleeding rates at 30 days.

RESULTS

A total of 257 patients were analyzed of whom 35 in the BE group while 222 in the SE group. VARC-3 technical success was 100 % in the BE versus 94.6 % in the SE group (p = 0.127). No significant differences were reported between BE and SEs in terms of VARC-3 device success (82.9 % vs. 77 %; p = 0.3), all-cause mortality (0 % vs. 1.6 %; p = 0.4) and stroke (0 % vs. 2.7 %; p = 0.2) rates. Moderate-to-severe PVL was significantly lower in the BE versus SE group (0 % vs. 9.9 %; p = 0.03). At sub-group analysis Octacor showed a significantly lower moderate-to-severe PVL compared to Evolut Pro/Pro+ (0 % vs. 11.2 %; p = 0.03) while no significant difference versus Neo2 (0 % vs. 6.6 %, p = 0.1). In a prespecified sub-analysis excluding Acurate Neo2, Octacor remained associated with lower post-dilatation and PVL compared with Evolut. These results were consistent after annulus-adjusted sensitivity analysis.

CONCLUSIONS

In patients with severe AS and significant LVOT calcifications undergoing TAVR, novel generation BE and SE THVs demonstrated favorable safety and efficacy outcomes at 30-day.