Background <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p> Trial registration <p>Study number 587/2015.</p>

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

  • Giuseppe Santarpino,
  • Roberto Lorusso,
  • Giovanni Concistrè,
  • Josè Cuenca Castillo,
  • Vincenzo Argano,
  • Alistair Royse,
  • Angelo Lucas Nobre,
  • Patrick Parrino,
  • Gianluigi Bisleri,
  • Max Baghai,
  • Theodor Fischlein,
  • Giovanni Troise,
  • Generoso Mastrogiovanni,
  • Raphael Fontaine,
  • Davide Pacini,
  • Giuseppe Minniti,
  • Aniello Pappalardo,
  • George Chad Hughes,
  • Philippe Noirhomme,
  • Jean-Philippe Grimaud,
  • Maximilian Scherner,
  • Ignacio Muñoz,
  • George Asimakopoulos,
  • Antony Walker,
  • Daniela Zakova,
  • Michele Torella,
  • Giorgio Vigano,
  • Mark Connolly,
  • Christian Dinges,
  • Pierre Corbi,
  • Loris Salvador,
  • Mauro Rinaldi,
  • Luis Maroto,
  • David Heimansohn,
  • Basel Ramlawi,
  • Mattia Glauber,
  • Jlenia D’Agnano,
  • Valeria Cosco,
  • Veronica D’Anna,
  • Marco Solinas

摘要

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.