John D Puskas1, Joseph E Bavaria2, Lars G Svensson3, Eugene H Blackstone4, Bartley Griffith5, James S Gammie6, David A Heimansohn7, Jerzy Sadowski8, Krzysztof Bartus8, Douglas R Johnston4, Jacek Rozanski9, Todd Rosengart10, Leonard N Girardi11, Charles T Klodell12, Mubashir A Mumtaz13, Hiroo Takayama14, Michael Halkos15, Vaughn Starnes16, Percy Boateng17, Tomasz A Timek18, William Ryan19, Shuab Omer20, Craig R Smith21. 1. Department of Cardiovascular Surgery, Mount Sinai Saint Luke's, New York, NY, USA. 2. Department of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. 3. Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. 4. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, OH, USA. 5. Department of Thoracic and Cardiovascular Surgery, University of Maryland, Baltimore, MD, USA. 6. Department of Surgery, University of Maryland Medical Center, Baltimore, MD, USA. 7. Department of Cardiothoracic Surgery, St Vincent Heart Center, Indianapolis, IN, USA. 8. Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital, Krakow, Poland. 9. National Institute of Cardiology, Warsaw, Poland. 10. Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA. 11. Department of Cardiothoracic Surgery, New York Presbyterian Hospital, New York, NY, USA. 12. Department of Surgery, University of Florida, Gainesville, FL, USA. 13. Department of Cardiovascular and Thoracic Surgery, Pinnacle Health, Harrisburg, PA, USA. 14. Division of Cardiothoracic and Vascular Surgery, Department of Surgery, Columbia University-New York Presbyterian Hospital, New York, NY, USA. 15. Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, GA, USA. 16. Department of Surgery, University of Southern California, Los Angeles, CA, USA. 17. Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY, USA. 18. Division of Cardiothoracic Surgery, Spectrum Health Medical Group, Grand Rapids, MI, USA. 19. Department of Cardiovascular Surgery, Heart Hospital Baylor, Plano, TX, USA. 20. Department of Cardiovascular Surgery, Michael E DeBakey VA Medical Center, Houston, TX, USA. 21. Department of Surgery, Columbia Presbyterian Medical Center, New York, NY, USA.
Abstract
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01757665.
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01757665.
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