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. 2023 Jun 1;36(6):ivad103.
doi: 10.1093/icvts/ivad103.

Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry

Giovanni Concistré  1 , Max Baghai  2 , Giuseppe Santarpino  3 , Alistair Royse  4 , Maximilian Scherner  5 , Giovanni Troise  6 , Mattia Glauber  7 , Marco Solinas  1
Affiliations

Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry

Giovanni Concistré et al. Interdiscip Cardiovasc Thorac Surg. .

Abstract

Objectives: Perceval sutureless valve has been in clinical use for >15 years. The aim of this study is to report the real-word clinical and haemodynamic performance from the SURE-aortic valve replacement international prospective registry in patients who underwent aortic valve replacement with Perceval valve.

Methods: From 2011 to 2021, patients from 55 institutions received a Perceval valve. Postoperative, follow-up, and echocardiographic outcomes were analysed.

Results: A total of 1652 patients were included; mean age was 75.3 ± 7.0 years (53.9% female); mean EuroSCORE II was 4.1 ± 6.3. Minimally invasive approach was performed in 45.3% of patients; concomitant procedures were done in 35.9% of cases. Within 30 days, 0.3 and 0.7% valve-related reinterventions were reported. Transient ischaemic attack, disabling and non-disabling strokes were limited (0.4%, 0.4% and 0.7%, respectively). Pacemaker implant was required in 5.7% of patients. Intra-prosthetic regurgitation ≥2 was present in 0.2% of cases, while paravalvular leak ≥2 in only 0.1%. At a maximum follow-up of 8 years, 1.9% of cardiovascular deaths and 0.8% of valve-related reintervention occurred. Among the 10 cases of structural valve deterioration (mean 5.6 ± 1.4 years after implant; range: 2.6-7.3 years), 9 were treated with a transcatheter vale-in-valve implantation and 1 with explant. Mean pressure gradient decreased from 45.8 ± 16.5 mmHg preoperatively to 13.3 ± 5.2 mmHg at discharge and remained stable during follow-up.

Conclusions: This experience represents the largest prospective real-world cohort of patients treated with Perceval showing that Perceval is a safe and effective alternative to conventional surgical aortic valve replacement, providing favourable clinical and haemodynamic results also at mid-term follow-up.

Keywords: Aortic stenosis; Aortic valve replacement; Real-world evidence; Sutureless valves.

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Figures

Figure 1:
Figure 1:
Kaplan–Meier curve for overall survival.
Figure 2:
Figure 2:
Kaplan–Meier curve for valve-related major adverse events (death, reintervention, stroke, and/or transient ischaemic attack).
None
See this image and copyright information in PMC

References

    1. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA. et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines 2014. AHA/ACC Guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438–88. - PubMed
    1. Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H. et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2012;42:S1–44. - PubMed
    1. Goodney PP, O'Connor GT, Wennberg DE, Birkmeyer JD.. Do hospitals with low mortality rates in coronary artery bypass also perform well in valve replacement? Ann Thorac Surg 2003;76:1131–6; discussion 1136–7. - PubMed
    1. Brown JM, O'Brien SM, Wu C, Sikora JAH, Griffith BP, Gammie JS.. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg 2009;137:82–90. - PubMed
    1. Magovern GJ, Cromie HW.. Sutureless prosthetic heart valves. J Thorac Cardiovasc Surg 1963;46:726–36. - PubMed

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