Outcomes of a Rapid Deployment Aortic Valve versus its Conventional Counterpart

Abstract

Objective

The aim of this study was to compare outcomes after rapid-deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies.

Methods

Patients who underwent RDAVR (INTUITY valve) in the prospective, 5-year, single-arm multicenter TRITON study, or conventional AVR (Perimount Magna Ease valve) in the prospective Perimount Magna Ease postmarket study, were propensity score matched and compared for procedural, hemodynamic, safety, and clinical outcomes.

Results

Matched RDAVR (n = 106) and conventional AVR (n = 106) patients had similar baseline characteristics (mean ± SD age, 72.8 ± 7.6 vs 72.5 ± 7.4 years; male 59.4% vs 61.3%) and procedures (concomitant procedures: 41.5% vs 50.9%). Mean ± SD aortic cross-clamp time was significantly shorter in RDAVR than AVR patients (51.8 ± 20.9 vs 73.9 ± 33.2 minutes; P < 0.001), as was mean cardiopulmonary bypass time (82.8 ± 34.2 vs 102.4 ± 41.7 minutes; P < 0.001). At 1 year, RDAVR patients showed significantly lower mean ± SD and peak aortic valve gradients (9.0 ± 3.4 and 17.0 ± 6.2 mm Hg, respectively) than conventional AVR patients (13.4 ± 5.5 and 24.2 ± 10.8 mm Hg, respectively; all P < 0.001). Patient-prosthesis mismatch was significantly less common with RDAVR than with AVR [overall: 16/66 (24.2%) vs 46/76 (60.5%); P = 0.007; severe: 2/66 (3.0%) vs 13/76 (17.1%)]. There were no significant differences between the RDAVR and AVR groups regarding 30-day safety endpoints. Survival rates in the RDAVR and conventional AVR groups were, respectively, 99.1% and 100.0% at 30 days, 97.1% and 95.1% at 1 year, and 93.3% and 94.1% at 3 years (P = nonsignificant).

Conclusions

In this retrospective study with matched populations, the RDAVR with the INTUITY valve system provided superior procedural and hemodynamic outcomes than a standard bioprosthesis without compromising safety.