Direct Comparison of the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves.

BACKGROUND

Rapid deployment aortic valve replacement (RDAVR) has emerged as an attractive alternative to conventional aortic valve replacement. This single-center study directly compared two commercially available rapid deployment valves with regard to clinical outcomes, valve-related complications, and hemodynamic performance.

METHODS

A total of consecutive 156 patients underwent RDAVR with the Intuity Elite (Edwards Lifesciences, Irvine, CA [Intuity group, n = 117] or the Perceval S (Sorin Group Italia Srl, Saluggia, Italy [Perceval group, n = 39]) between September 2012 and March 2016 at our institution. Perioperative data, including 30-day all-cause mortality, and echocardiographic measurements were assessed and retrospectively analyzed from our institutional database.

RESULTS

Preoperative variables, including mean age (77 ± 5 years), European System for Cardiac Operative Risk Evaluation (6.8 ± 2.1), and body mass index (27 ± 5 kg/m), did not differ between groups. More male patients (60% versus 15%) with a higher body surface area (1.9 ± 0.2 m versus 1.7 ± 0.2 m) and body weight (78 ± 13 kg versus 71 ± 15 kg) were in the Intuity group compared with the Perceval group, respectively (p < 0.05). Implanted RDAVR size (23.3 ± 1.8 mm versus 23.4 ± 1.5 mm), concomitant coronary artery bypass graft surgery (48% versus 33%), number of grafts, cardiopulmonary bypass, and aortic clamp time were comparable between the Intuity group and the Perceval group. Thirty-day mortality (Intuity 2.6% versus Perceval 5.1%) and valve-related complications (Intuity 12.0% versus Perceval 20.5%), including postoperative pacemaker implantation (Intuity 8.5% versus Perceval 12.8%), did not differ between groups. At discharge echocardiography, indexed effective orifice area was higher in the Intuity group, but peak or mean pressure gradients were comparable between groups.

CONCLUSIONS

Performing RDAVR with the Intuity and Perceval rapid deployment valves provides comparable good clinical outcomes and valve hemodynamics, with low valve-related complication rates. The rate of pacemaker implantation was comparable for both rapid deployment valves, ranging from 8% to 13%.