Sutureless valves became an alternative to standard bioprostheses, allowing surgeons to significantly reduce cross-clamping and extracorporeal circulation times, with a potential positive impact on major postoperative complications. The aim of this European multicentre study was to evaluate the safety and efficacy of sutureless valves in patients with an intermediate-risk profile undergoing aortic valve replacement (AVR).
We investigated early and mid-term outcomes of 518 elderly patients with aortic stenosis at intermediate-risk profile (mean STS Score 6.1 ± 2%) undergoing AVR with sutureless aortic valve. Primary endpoints were 30-day mortality and freedom from all-cause death at follow-up. The secondary endpoint was survival freedom from MACCEs [all-cause death, stroke/transitory ischemic attack (TIA), bleeding, myocardial infarction, aortic regurgitation Grade II, endocarditis, reintervention and pacemaker implant; VARC 1–2 criteria].
Sutureless valve implantation was successfully performed in 508 patients, with a procedural success rate of 98.1% (508/518) as per VARC criteria. Concomitant myocardial revascularization [coronary artery bypass grafting (CABG)] was performed in 74 out of 518 patients (14.3%). In-hospital mortality was 1.9% (10/518). Postoperative complications included revision for bleeding (23/518; 4.4%), prolonged intubation more than 48h (4/518; 0.7%), acute renal failure (14/518; 2.7%), stroke/TIA (11/518; 2.1%), pacemaker implantation (26/518; 5.1%) and aortic regurgitation more than Grade II (7/518; 1.4%). At 48-month follow-up, Kaplan-Meier overall survival and freedom from MACCEs in patients receiving isolated AVR were 83.7% [95% confidence interval (95% CI): 81.1-86.3] and 78.4% (95% CI: 75.5-81.4), respectively, while in patients with concomitant CABG, Kaplan-Meier overall survival and freedom from MACCEs were 82.3% (95% CI: 73.3-91.3) and 79.1% (95% CI: 69.9-88.3), respectively.
The use of sutureless aortic valves in elderly patients with an intermediate-risk profile provided excellent early and mid-term outcomes, providing a reliable tool in patients undergoing surgical AVR in this specific subset of population. These preliminary data need to be investigated with a TAVI control-group in further studies.