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Multicenter Study
. 2025 Jul 25;20(1):313.
doi: 10.1186/s13019-025-03558-9.

Prognostic impact of small size sutureless prostheses: results for 241 patients from an international registry

Giuseppe Santarpino  1   2   3 , Roberto Lorusso  4 , Giovanni Concistrè  5 , Josè Cuenca Castillo  6 , Vincenzo Argano  7 , Alistair Royse  8 , Angelo Lucas Nobre  9 , Patrick Parrino  10 , Gianluigi Bisleri  11 , Max Baghai  12 , Theodor Fischlein  13 , Giovanni Troise  14 , Generoso Mastrogiovanni  15 , Raphael Fontaine  16 , Davide Pacini  17 , Giuseppe Minniti  18 , Aniello Pappalardo  19 , George Chad Hughes  20 , Philippe Noirhomme  21 , Jean-Philippe Grimaud  22 , Maximilian Scherner  23 , Ignacio Muñoz  24 , George Asimakopoulos  25 , Antony Walker  26 , Daniela Zakova  27 , Michele Torella  28 , Giorgio Vigano  29 , Mark Connolly  30 , Christian Dinges  31 , Pierre Corbi  32 , Loris Salvador  33 , Mauro Rinaldi  34 , Luis Maroto  35 , David Heimansohn  36 , Basel Ramlawi  37 , Mattia Glauber  38 , Jlenia D'Agnano  39 , Valeria Cosco  39 , Veronica D'Anna  39 , Marco Solinas  5
Affiliations
Multicenter Study

Prognostic impact of small size sutureless prostheses: results for 241 patients from an international registry

Giuseppe Santarpino et al. J Cardiothorac Surg. .

Abstract

Background: The treatment of aortic valve disease in small annuli remains a debated topic in terms of prosthetic choice - biological or mechanical - and risk of patient prosthesis mismatch.

Methods: The clinical data of the 241 patients who received a small size sutureless prosthesis from the Sorin Universal REgistry on Aortic Valve Replacement (SURE-AVR) (NCT02679404) were analysed at 30 days and at follow-up. The mean age was 75.5 ± 7.8 years (89.2% female); the mean Society of Thoracic Surgeons (STS) score was 4.2 ± 3.2%, and the preoperative NYHA class II or III score was 83.8%. A minimally invasive approach was performed in 52.7% of patients; concomitant procedures were performed in 27.8% of patients. Similar aortic clamping and cardiopulmonary bypass times were observed in the overall isolated cohort and the isolated minimally invasive cohort. The mean intensive care unit (ICU) stay was 2.4 ± 2.0 days and the total length of stay was 10.3 ± 6.1 days.

Results: Three deaths were recorded at 30 days (1.2%), 2 for noncardiac causes. One patient experienced a myocardial infarction (0.4%) and 2 a nondisabling stroke (0.8%). 2 patients showed intraprosthetic leakage ≥ 2 and one patient para-prosthetic leakage ≥ 2; of these, one patient required reoperation with prosthesis removal. 4.1% of patients required a pacemaker implant. At a maximum follow-up of 8.1 years, 10 cardiovascular deaths, 4 valve related reinterventions (3 structural valve deterioration (SVD) requiring TAVI Valve-in-Valve, 1 endocarditis) occurred.

Conclusions: With their good clinical outcomes, sutureless prostheses represent a good alternative for patients with small annuli, who are at high risk for annular enlargement and anticoagulant therapy.

Trial registration: Study number 587/2015.

Keywords: Biological heart prosthesis; Follow-up outcome; Patient‒prosthesis mismatch; Sutureless aortic valve.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Comitato Etico Sperimentazione Clinica Ceavno (Area Vasta Nord-Ovest Toscana). Reference number: Study N° 587/2015. All patients provided written informed consent to participate. Consent for publication: All authors have read and approved the final manuscript and consent to its publication in The Journal of Cardiothoracic Surgery. Competing interests: The authors declare no competing interests. Disclosure of relationships and activities: Angelo Lucas Nobre, Patrick Gene Parrino, Max Baghai, Giovanni Troise, George Asimakopoulos, Basel Ramlawi and Mattia Glauber are consultants for CORCYM. Disclaimers: The statements, opinions and data contained in the publication are solely those of the individual author(s) and contributor(s) and not an official position of the institution or funder.

Figures

Fig. 1
Fig. 1
Kaplan-Meier Curves: (a) Freedom from death; (b) Freedom from reintervention; (c) Freedom from reintervention due to SVD
See this image and copyright information in PMC

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