Minimally Invasive Aortic Valve Replacement With Sutureless Valve: Results From An International Prospective Registry
Mattia Glauber1, Jose Cuenca2, Roberto Di Bartolomeo3, Max Baghai4, Daniela Zakova5, Theodor Fischlein6, Giovanni Troise7, Giorgio Viganò8, Marco Solinas9.
1Istituto Clinico Sant'Ambrogio, Milan, Italy, 2CHUAC Hospital Juan Canalejo, Coruna, Spain, 3Policlinico Sant'Orsola, Bologna, Italy, 4King's College Hospital, London, United Kingdom, 5CKTCH, Brno, Czech Republic, 6Klinikum, Nürnberg, Germany, 7Fondazione Poliambulanza, Brescia, Italy, 8UMCG, Groningen, Netherlands, 9Ospedale del Cuore G. Pasquinucci, Massa, Italy.
OBJECTIVE: To report the early and mid term results of patients who underwent minimally invasive (MICS) aortic valve replacement (AVR) with a sutureless prosthesis from an International prospective registry. METHODS: Between March 2011 and September 2018, among the 957 patients included in the prospective observational SURE-AVR registry a total of 480 patients underwent MICS AVR with self-expandable sutureless aortic bioprosthesis in 29 International institutions through either minithoracotomy (n = 266) or ministernotomy (n = 214). Preoperative, peri-procedural and follow-up clinical and echocardiographic parameters, as well as clinical outcomes, were analyzed for all patients. RESULTS: Patient age was 76.1 ± 7.1 years; 64.4% were female. Median logistic EuroSCORE II was 9.4%. The median cardiopulmonary bypass and cross-clamp time was 81 minutes (interquartile range, 64-100) and 51 minutes (interquartile range, 40-63). First successful implantation was achieved in 98.3% of the cases. Median intensive care unit stay was 1 day. Mean follow-up was 2.4 years (maximum follow-up 7 years). Two in-hospital deaths occurred one for non-cardiovascular causes and one following a disabling stroke. In the early (≤30 days) period disabling stroke occurred in 0.4%, while non-disabling stroke in 1% of the cases. Three early explants, two due to non-structural valve dysfunction and one for malpositioning were reported. A trans-catheter valve was implanted in one patient 6 days after surgery due to stent in-folding caused by inappropriate sizing. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) a pacemaker implantation was needed. In the late period (>30 days) 5 explants were reported, 3 due to endocarditis and 2 due to non-structural vale dysfunction. Rate of disabling and non-disabling stroke was 0.9% and 1.4%, respectively. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. The mean trans-valvular gradient at 2 year follow-up was 11.3 ± 5.4 mmHg. CONCLUSIONS: In this large prospective international registry MICS AVR with sutureless valve confirmed to be safe, reproducible and effective, even in a high risk population, providing satisfactory hemodynamic performance with excellent clinical recovery both in the early and at mid-term follow up, with low rate of definitive pacemaker and stroke.
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