Max Baghai1, Mattia Glauber2, Raphael Fontaine3, Jose Cuenca Castillo4, Antony H Walker5, Ugolino Livi6, José Montiel7, Alistair Royse8, Gianluigi Bisleri9, Davide Pacini10, Vincenzo Argano11, Aurelien Roumy12, George Asimakopoulos13, Marco Solinas14. 1. Department of Cardiovascular Medicine, King's College Hospital, Brixton, London, SE5 9RS, UK. mbaghai@nhs.net. 2. U.O. Cardiochirurgia Mininvasiva, Istituto Clinico Sant'Ambrogio, Milan, Italy. 3. Chirurgie Cardiaque CHR Namur, Namur, Belgium. 4. Cirugía Cardiaca, Hospital Juan Canalejo, A Coruña, Spain. 5. Cardiothoracic Surgery, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK. 6. Cardiochirurgia, Az. Osp. Univ. S. Maria della Misericordia, Udine, Italy. 7. Cirurgia Cardiaca, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 8. Cardiovascular department, The University of Melbourne, Melbourne, Australia. 9. Division of Cardiac Surgery, University of Toronto, Toronto, Canada. 10. Cardiochiurgia, Policlinico Sant'Orsola, Bologna, Italy. 11. U.O.C. Cardiochirurgia, AOU Policlinico "Paolo Giaccone", Palermo, Italy. 12. Service de chirurgie cardio-vasculaire, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. 13. Heart Surgery, Royal Brompton Hospital, London, UK. 14. U.O.C Cardiochirurgia Adulti, Ospedale del Cuore G. Pasquinucci, Fondazione Toscana Fabriele Monasterio, Massa, Italy.
Abstract
BACKGROUND: Early treatment of aortic valve stenosis is recommended in eligible symptomatic patients with severe aortic valve stenosis who would otherwise have a poor prognosis. The sutureless aortic valve bioprosthesis offers an alternative to standard aortic valve replacement with a sutured valve, but limited data are available in patients who have undergone multiple valve procedures involving the new, sutureless technology. We sought to investigate outcomes in high operative risk patients with previous or concomitant valve surgery who were implanted with a sutureless valve. METHODS: SURE-AVR is an ongoing, prospective, multinational registry of patients undergoing aortic valve replacement. In-hospital and post-discharge outcomes up to 5 years were collected. RESULTS: The study population comprised 78 patients (mean ± SD: age 73.6 ± 7.6 years, logistic EuroSCORE 18.0 ± 17.5) enrolled at 13 sites who presented for concomitant or previous mitral valve repair (n = 45) or replacement (n = 33), with or without additional concomitant procedures, and were implanted with a sutureless valve. Mean ± SD overall aortic cross-clamp time was 109 ± 41 min and cardiopulmonary bypass time was 152 ± 49 min. Mean ± SD aortic pressure gradients decreased from 37.6 ± 17.7 mmHg preoperatively to 13.0 ± 5.7 mmHg at hospital discharge, and peak aortic pressure gradient from 61.5 ± 28.7 to 23.4 ± 10.6 mmHg. Early events included 1 death, 1 transient ischaemic attack, and 1 bleed (all 1.3%); a permanent pacemaker implantation was required in 6 patients (7.7%), and 2 reoperations (not valve related) (2.6%) took place. Over a median follow-up of 55.5 months (Q1 13.4, Q3 68.6), 12 patients died (6 cardiovascular and 6 non-cardiovascular, both 2.1% per patient-year). Five-year survival was 81.3%. Late paravalvular leak occurred in 2 patients (0.7% per patient-year) and permanent pacemaker implantation was required in 3 patients (0.1% per patient-year). There was no apparent rise in mean or peak aortic pressure gradient over the study. CONCLUSIONS: These results suggest that the sutureless implant is a technically feasible procedure during mitral surgery and is associated with good clinical outcomes.
BACKGROUND: Early treatment of aortic valve stenosis is recommended in eligible symptomatic patients with severe aortic valve stenosis who would otherwise have a poor prognosis. The sutureless aortic valve bioprosthesis offers an alternative to standard aortic valve replacement with a sutured valve, but limited data are available in patients who have undergone multiple valve procedures involving the new, sutureless technology. We sought to investigate outcomes in high operative risk patients with previous or concomitant valve surgery who were implanted with a sutureless valve. METHODS: SURE-AVR is an ongoing, prospective, multinational registry of patients undergoing aortic valve replacement. In-hospital and post-discharge outcomes up to 5 years were collected. RESULTS: The study population comprised 78 patients (mean ± SD: age 73.6 ± 7.6 years, logistic EuroSCORE 18.0 ± 17.5) enrolled at 13 sites who presented for concomitant or previous mitral valve repair (n = 45) or replacement (n = 33), with or without additional concomitant procedures, and were implanted with a sutureless valve. Mean ± SD overall aortic cross-clamp time was 109 ± 41 min and cardiopulmonary bypass time was 152 ± 49 min. Mean ± SD aortic pressure gradients decreased from 37.6 ± 17.7 mmHg preoperatively to 13.0 ± 5.7 mmHg at hospital discharge, and peak aortic pressure gradient from 61.5 ± 28.7 to 23.4 ± 10.6 mmHg. Early events included 1 death, 1 transient ischaemic attack, and 1 bleed (all 1.3%); a permanent pacemaker implantation was required in 6 patients (7.7%), and 2 reoperations (not valve related) (2.6%) took place. Over a median follow-up of 55.5 months (Q1 13.4, Q3 68.6), 12 patientsdied (6 cardiovascular and 6 non-cardiovascular, both 2.1% per patient-year). Five-year survival was 81.3%. Late paravalvular leak occurred in 2 patients (0.7% per patient-year) and permanent pacemaker implantation was required in 3 patients (0.1% per patient-year). There was no apparent rise in mean or peak aortic pressure gradient over the study. CONCLUSIONS: These results suggest that the sutureless implant is a technically feasible procedure during mitral surgery and is associated with good clinical outcomes.
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