Objective: The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement.
Methods: Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation.
Results and Recommendations: Seventeen randomized studies published in 23 articles involving 1317 patients, and 14 nonrandomized trial published in 18 articles involving 2485 patients were included in the meta-analysis and consensus conference. All randomized trials inserted the stentless bioprosthetic valves in the subcoronary configuration. The consensus panel agreed upon the following statements and recommendations in patients undergoing aortic valve replacement:
1. Stentless and stented valves both provide an excellent valve substitute for aortic valve disease (class I, level A).
2. In certain situations, the early superior hemodynamic performance of stentless bioprosthesis offers advantages over stented valves (class IIa, level A).
Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:
1. In the absence of aortic root disease and with an annulus greater than or equal to 21 mm, either stentless or stented valves are acceptable alternatives for the majority of patients when a current (second or third) generation bioprosthesis is indicated (class I, level C).
2. In the presence of an aortic annulus <21 mm, the use of a freestanding bioprosthetic root can be considered as an alternative to enhanced diameter stented bioprosthesis or a root enlargement procedure (class I, level C).
From the *Department of Cardiothoracic Surgery, Imperial College, Royal Brompton Hospital, London, UK; †Department of Anesthesia and Perioperative Medicine, Evidence-Based Perioperative Clinical Outcomes Research Group (EPiCOR), London Health Sciences Centre, The University of Western Ontario, London, ON, Canada; ‡St. Mary’s Hospital, London, UK; §Division of Thoracic and Cardiovascular Surgery, The Lankenau Hospital, Wynnewood, PA USA; ¶St. Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada; ∥Department of Cardiothoracic Surgery, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY USA; **Golden Jubilee National Hospital, Clydebank, UK; ††Department of Surgery, Siena University School of Medicine, Siena, Italy; and ‡‡High Impact Technology Evaluation Centre, London Health Sciences Centre, London, ON, Canada.
Accepted for publication February 15, 2009.
Support for the meta-analysis and a consensus conference was provided by the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), which has received unrestricted educational grants from industries that produce surgical technologies.
Address correspondence and reprint requests to: John R. Pepper, FRCS, Department of Cardiothoracic Surgery, Imperial College, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK. E-mail: J.Pepper@rbht.nhs.uk.
Disclosure: Geoffrey A. Berg, FRCS, Consultant for Vascutek Ltd.
Francis D. Ferdinand, MD, Investigator for Sorin Group, St. Jude Medical, Edwards Lifesciences.
WR Eric Jamieson, FRCSC, Consultant for Sorin, St. Jude Medical, Medtronic; Speakers Bureau/Honoraria for Edwards Lifesciences, Sorin Group, On-X Life Technologies, St. Jude Medical; Principal Investigator for St. Jude Medical, Edwards Lifesciences, On-X Life Technologies, Medicure Inc, Rib-X Pharmaceuticals, Sorin Group, Medtronic, CIHR; Randomized Controlled Trials for On-X, St. Jude Medical.