Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system

Günther Laufer, Justus T Strauch, Kim A Terp, Marco Salinas, Jose M Arribas, Massimo Massetti, Martin Andreas, Christopher P Young, Günther Laufer, Justus T Strauch, Kim A Terp, Marco Salinas, Jose M Arribas, Massimo Massetti, Martin Andreas, Christopher P Young

Abstract

Objectives: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system.

Methods: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant.

Results: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively.

Conclusions: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery.

Name and registration of registry: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.

Keywords: Aortic valve replacement; Bioprosthesis; Haemodynamics; Heart valve; Rapid-deployment valve; Sutureless valve.

© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Figures

Figure 1:
Figure 1:
Valve size distribution. The bars show the proportion of patients implanted with each valve size.
Figure 2:
Figure 2:
Procedural outcomes. The bars show the mean ± standard deviation XCT and CPBT minutes. CPBT: cardiopulmonary bypass time; XCT: aortic cross-clamp time.
Figure 3:
Figure 3:
Mean systolic gradient, peak systolic gradient, aortic effective orifice area and left ventricular ejection fraction at preoperative baseline, discharge and after 6 months of follow-up. EOA: effective orifice area (in cm2); LVEF: left ventricular ejection fraction.
Figure 4:
Figure 4:
Changes in NYHA functional class from baseline during follow-up. The bars show the proportion of patients whose NYHA functional class improved, stayed the same and worsened at 1 and 6 months of follow-up. NYHA: New York Heart Association.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9631962/bin/ivac083f5.jpg

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Source: PubMed

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