Pepper John, Cheng Davy, Stanbridge Rex, Ferdinand Francis D, Jamieson W R Eric, Stelzer Paul, Berg Geoffrey, Sani Guido, Martin Janet
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.
Innovations (Phila). 2009 Mar;4(2):49-60. doi: 10.1097/IMI.0b013e3181a34872.
: 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.
: 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.
: 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:Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:
本次共识会议的目的是确定在接受主动脉瓣置换术的患者中,无支架生物瓣膜与有支架瓣膜相比是否能改善临床和资源相关结局,并概述在成人主动脉瓣置换术中使用无支架和有支架生物瓣膜的循证推荐。
在共识会议之前,对现有最佳证据进行了回顾,其中系统评价、随机试验和非随机试验按照有效性和重要性从高到低的顺序进行考量。在共识会议上,制定了循证声明,并采用共识流程来确定后续推荐。使用美国心脏协会/美国心脏病学会系统对证据水平和推荐类别进行标注。
纳入荟萃分析和共识会议的有23篇文章中发表的17项随机研究(涉及1317例患者)以及18篇文章中发表的14项非随机试验(涉及2485例患者)。所有随机试验均将无支架生物瓣膜以冠状动脉下构型植入。共识小组就接受主动脉瓣置换术患者的以下声明和推荐达成一致:由于尚无比较冠状动脉下无支架人工瓣膜与根部置换的随机对照试验,以下推荐源自专家意见: