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Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry
M. Glauber, L. Di Bacco, J. Cuenca, R. Di Bartolomeo, M. Baghai, D. Zakova, T. Fischlein, G. Troise, G. Viganò, M. Solinas
Language English Country United States
Document type Journal Article, Multicenter Study, Observational Study
- MeSH
- Aortic Valve Stenosis surgery MeSH
- Sutureless Surgical Procedures methods statistics & numerical data MeSH
- Bioprosthesis MeSH
- Heart Valve Prosthesis Implantation methods statistics & numerical data MeSH
- Echocardiography methods MeSH
- Cardiac Surgical Procedures methods MeSH
- Cardiopulmonary Bypass statistics & numerical data MeSH
- Humans MeSH
- Minimally Invasive Surgical Procedures methods MeSH
- Prospective Studies MeSH
- Prosthesis Design trends MeSH
- Registries MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Heart Valve Prosthesis MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
OBJECTIVE: To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. METHODS: Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy (n = 266) or ministernotomy (n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. RESULTS: Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. CONCLUSIONS: In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.
CHUAC Complexo Hospital Universitario A Coruña Coruna Spain
Fondazione Poliambulanza Brescia Italy
Istituto Clinico Sant'Ambrogio Milan Italy
King's College Hospital London UK
Klinikum Nürnberg Paracelsus Medical University Nuremberg Germany
Ospedale del Cuore G Pasquinucci Massa Italy
References provided by Crossref.org
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- $a OBJECTIVE: To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. METHODS: Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy (n = 266) or ministernotomy (n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. RESULTS: Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. CONCLUSIONS: In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.
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