Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial

Abstract

Objectives: Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis.

Methods: A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory.

Results: Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm²; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027).

Conclusions: MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.

Keywords: Aortic valve replacement; Haemodynamics; Heart valve, Bioprosthesis; Minimally invasive.