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.
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
Barbanti, Marco;
2025-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
