Borut Gersak1, Theodor Fischlein2, Thierry A Folliguet3, Bart Meuris4, Kevin H T Teoh5, Simon C Moten6, Marco Solinas7, Antonio Miceli8, Peter J Oberwalder9, Manfredo Rambaldini10, Gopal Bhatnagar11, Michael A Borger12, Denis Bouchard13, Olivier Bouchot14, Stephen C Clark15, Otto E Dapunt9, Matteo Ferrarini16, Guenther Laufer17, Carmelo Mignosa18, Russell Millner19, Philippe Noirhomme20, Steffen Pfeiffer2, Xavier Ruyra-Baliarda21, Malakh Shrestha22, Rakesh M Suri23, Giovanni Troise24, Anno Diegeler25, Francois Laborde26, Marc Laskar27, Hani K Najm28, Mattia Glauber16. 1. University of Ljubljana School of Medicine and University Medical Center Ljubljana, Ljubljana, Slovenia bgersak@maat.si. 2. Klinikum Nuernberg, Paracelsus Medical University, Nuremberg, Germany. 3. Centre Hospitalo-Universitaire Brabois, Université de Lorraine, Vandoeuvre les Nancy, France. 4. U.Z. Gasthuisberg, Leuven, Belgium. 5. McMaster University, Hamilton, ON, Canada. 6. Austin Health and Royal Melbourne Hospital, Melbourne, Australia. 7. Ospedale del Cuore G. Pasquinucci, Fondazione Toscana G. Monasterio, Massa, Italy. 8. Istituto Clinico Humanitas, Milan, Italy. 9. Medical School Graz, Graz, Austria. 10. Ospedale di Mantova, Mantua, Italy. 11. Trillium Cardiovascular Associates, Mississauga, ON, Canada. 12. Columbia University Medical Center, New York, NY, USA. 13. University of Montreal, Montreal, QC, Canada. 14. CHU le Bocage, Dijon, France. 15. Freeman Hospital, Newcastle, UK. 16. Istituto Clinico Sant' Ambrogio, Milan, Italy. 17. Medizinische Universitaet Wien, Vienna, Austria. 18. Ospedale Ferrarotto, Catania, Italy. 19. Blackpool Victoria Hospital, Blackpool, UK. 20. Cliniques Universitaires St-Luc, Brussels, Belgium. 21. Hospital University Germans Trias I Pujol, Barcelona, Spain. 22. Medizinischen Hochschule Hannover, Hannover, Germany. 23. Mayo Clinic, Rochester, MN, USA. 24. Fondazione Poliambulanza, Brescia, Italy. 25. Herz- und Gefäß-Klinik Bad Neustadt, Bad Neustadt an der Saale, Germany. 26. Institut Mutualiste Montsouris, Paris, France. 27. University Hospital Dupuytren, Limoges, France. 28. King Fahad National Guard Hospital, Riyadh, Saudi Arabia.
Abstract
OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.
OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.
Authors: Sami Kueri; Fabian A Kari; Rafael Ayala Fuentes; Hans-Hinrich Sievers; Friedhelm Beyersdorf; Wolfgang Bothe Journal: Dtsch Arztebl Int Date: 2019-06-21 Impact factor: 5.594
Authors: Michael L Williams; Campbell D Flynn; Andrew A Mamo; David H Tian; Utz Kappert; Manuel Wilbring; Thierry Folliguet; Antonio Fiore; Antonio Miceli; Augusto D'Onofrio; Giorgia Cibin; Gino Gerosa; Mattia Glauber; Theodor Fischlein; Francesco Pollari Journal: Ann Cardiothorac Surg Date: 2020-07
Authors: Antonio Miceli; Paolo Berretta; Antonio Fiore; Martin Andreas; Marco Solinas; Giuseppe Santarpino; Utz Kappert; Martin Misfeld; Carlo Savini; Alberto Albertini; Emmanuel Villa; Kevin Phan; Theodor Fischlein; Bart Meuris; Gianluca Martinelli; Kevin Teoh; Carmelo Mignosa; Malakh Shrestha; Thierry P Carrel; Tristan D Yan; Mattia Glauber; Marco Di Eusanio Journal: Ann Cardiothorac Surg Date: 2020-07
Authors: Muhammet Onur Hanedan; Mehmet Ali Yuruk; Ali Ihsan Parlar; Ugur Ziyrek; Ali Kemal Arslan; Ufuk Sayar; Ilker Mataraci Journal: Tex Heart Inst J Date: 2018-02-01
Authors: Anna Olasińska-Wiśniewska; Piotr Buczkowski; Bartłomiej Perek; Mateusz Puślecki; Michał Bociański; Sebastian Stefaniak; Tomasz Urbanowicz; Marek Grygier; Maciej Lesiak; Marek Jemielity Journal: Cardiol J Date: 2021-12-13 Impact factor: 3.487
Authors: Bijan Abar; Alejandro Alonso-Calleja; Alexander Kelly; Cambre Kelly; Ken Gall; Jennifer L West Journal: J Biomed Mater Res A Date: 2020-07-02 Impact factor: 4.396
Authors: Alina Zubarevich; Marcin Szczechowicz; Konstantin Zhigalov; Anja Osswald; Jef Van den Eynde; Arian Arjomandi Rad; Robert Vardanyan; Daniel Wendt; Bastian Schmack; Arjang Ruhparwar; Alexander Weymann Journal: J Thorac Dis Date: 2021-06 Impact factor: 2.895