Early Clinical and Echocardiographic Outcomes of Patients Undergoing Aortic Valve Replacement Using Sutureless Prosthesis in Small Annuli: Data Analysis of the Multicentric MANTRA Study

S. Shehada¹, S. Micovic², A. Nobre³, J. Choi⁴, F. Pollari⁵, C. Baeza⁶, E. Parrino⁷, M. Solinas^8
1Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University Hospital Essen, Essen, Nordrhein-Westfalen ²Dedinje Cardiovascular Institute, Belgrade, Vojvodina ³Hospital de Santa Maria Lisbon, Lisbon, Lisboa ⁴Seoul National University Hospital, Seoul, Seoul-t'ukpyolsi ⁵Klinikum Nürnberg, Nurnberg, Bayern ⁶University Hospitals Cleveland Medical Center, Cleveland, Ohio ⁷Ochsner Clinic Foundation, New Orleans, Louisiana ⁸Ospedale del Cuore di Massa, Massa, Toscana

Purpose: Treatment of patients with small annuli undergoing aortic valve replacement (AVR) is associated with prolonged operative times and high perioperative morbidities. Sutureless prosthesis, introduced 15-years ago, is associated with excellent hemodynamics and shorter operative times. Data addressing hemodynamic performance in small annuli are still limited[1]. This analysis investigates this aspect.

Methods: This is an ongoing prospective multicentric international study (MANTRA study NCT05002543) [2], investigating outcomes of patients undergoing AVR using a sutureless prosthesis. So far, a total of 255 patients (120, 47.1%, men, mean age at operation 72±6.3 years) from 27 centers over a two-year period (July/2021 through June/2023) are included. Clinical and hemodynamic outcomes were collected preoperatively, at discharge, at 30 day and at yearly follow up, while KCCQ-12 and EQ-5D-5L questionnaires were collected preoperatively, and at 30 days follow up visit. The present analysis focuses on the cohort of patients implanted with valve sizes covering aortic annuli from 19 to 23 mm (N= 142). Early (≤ 30 days) serious adverse events are assessed according to VARC-3 criteria [3]. 128 subjects reached the 30-day follow-up visit complete, 107 with available echocardiographic assessment. Severe patient prosthesis mismatch was defined as effective orifice area index (EOAi) < 0.65 [4].

Results: STS score was 2.7 ± 2.2%. 49 (34.5%) patients underwent a combined procedure (33 CABG, 6 ablation, 8 mitral/tricuspid valve surgery, 1 septal myectomy and 1 atrial septal defect repair). Surgical access was via full sternotomy in 77 (54.2%) or minimally invasive in 65 (45.8%) patients. Size S (covering annuli 19-21 mm) was implanted in 57 (40.1%) patients and Size M (21-23 mm) in 85 (59.9%) patients. Successful implantation was reported in all cases. Mean cross clamp and cardiopulmonary bypass times were 57.2±28 and 91.9±49.6 minutes. Thirty-day mortality was reported in one (0.7%) patient and no early failure requiring reintervention occurred. At 30-day echocardiographic control, mean pressure gradient was 11.4±4.1 mmHg, indexed effective orifice areas was 0.91±0.24 cm2/m2 and severe patient prosthesis mismatch was calculated in three (2.1%) patients without any symptoms (Table 1). None of the implanted valves developed severe paravalvular leakage nor central regurgitation. Clinical follow-up reported NYHA class I-II in 94.2% of patients (113 out of 120 available assessment). Quality of life significantly improved at 30 days compared to the preoperative values (KCCQ-12 summary score of 69.4±22.5 at 30 days versus 56±23.7 (P < 0.0001) at baseline, EQ-5D-5L VAS score 72.2±20 at 30 days versus 63±22.6 (P=0.0011) at baseline.

Conclusion: This analysis shows that sutureless valve simplifies aortic valve replacement in patients with small annuli without the need for root enlargement procedures and facilitates minimal invasive approaches. So far, echocardiographic outcomes confirm the efficacy of this prothesis in such patients with excellent hemodynamic performance and improved patients’ quality of life.

Identify the source of the funding for this research project: Corcym S.r.l (Saluggia, Italy).