用于治疗失败的主动脉外科生物瓣膜的自膨胀经导管心脏瓣膜的匹配比较：来自瓣中瓣国际数据注册库（VIVID）的见解
Matched Comparison of Self-Expanding Transcatheter Heart Valves for the Treatment of Failed Aortic Surgical Bioprosthesis: Insights From the Valve-in-Valve International Data Registry (VIVID).
作者信息
Alnasser Sami, Cheema Asim N, Simonato Matheus, Barbanti Marco, Edwards Jeremy, Kornowski Ran, Horlick Eric, Wijeysundera Harindra C, Testa Luca, Bedogni Francesco, Amrane Hafid, Walther Thomas, Pelletier Marc, Latib Azeem, Laborde Jean-Claude, Hildick-Smith David, Kim Won-Keun, Tchetche Didier, Agrifoglio Marco, Sinning Jan-Malte, van Boven Ad J, Kefer Joëlle, Frerker Christian, van Mieghem Nicolas M, Linke Axel, Worthley Stephen, Asgar Anita, Sgroi Carmelo, Aziz Mina, Danenberg Haim D, Labinaz Marino, Manoharan Ganesh, Cheung Anson, Webb John G, Dvir Danny
机构信息
From the St. Michael's Hospital, Toronto, Canada (S.A., A.N.C., J.E.); St. Paul's Hospital, Vancouver, Canada (M.S., M. Aziz, A.C., J.G.W., D.D.); Ferrarotto Hospital, University of Catania, Italy (M.B., C.S.); Rabin Medical Center, Tel Aviv, Israel (R.K.); Peter Munk Cardiac Center, Toronto, Canada (E.H.); Schulich Heart Centre, Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada (H.C.W.); Department of Cardiology, IRCCS Pol. S. Donato, Milan, Italy (L.T., F.B.); Medisch Centrum Leeuwarden, Netherlands (H.A., A.J.v.B.); Kerckhoff-Klinik Bad Nauheim, Germany (T.W., W.-K.K.); New Brunswick Heart Center, Saint John, Canada (M.P.); San Raffaele Scientific Institute, Milan, Italy (A. Latib); St. George's Hospital, London, England (J.-C.L.); Sussex Cardiac Centre, Brighton, England (D.H.-S.); Clinique Pasteur, Toulouse, France (D.T.); Centro Cardiologico Monzino, Milan, Italy (M. Agrifoglio); Heart Center, University Hospital Bonn, Germany (J.-M.S.); University Clinics Saint Luc, Brussels, Belgium (J.K.); Asklepios Klinik St. Georg Hospital, Hamburg, Germany (C.F.); Erasmus University Medical Center, Rotterdam, Netherlands (N.M.v.M.); Heart Center, University of Leipzig, Germany (A. Linke); Royal Adelaide Hospital, Australia (S.W.); Montreal Heart Institute, Canada (A.A.); Hadassah Hebrew University Medical Center, Jerusalem, Israel (H.D.D.); Ottawa Heart Institute, Canada (M.L.); and Royal Victoria Hospital, Belfast, United Kingdom (G.M.).
出版信息
Circ Cardiovasc Interv. 2017 Apr;10(4). doi: 10.1161/CIRCINTERVENTIONS.116.004392.
BACKGROUND
Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV).
METHODS AND RESULTS
Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm; =0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; =0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; =0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; =0.03).
CONCLUSIONS
In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.
背景
经导管瓣中瓣植入术是治疗外科主动脉生物瓣膜功能障碍的高危患者的一种成熟疗法。比较使用不同经导管心脏瓣膜（THV）进行瓣中瓣植入术的结果的数据有限。
方法与结果
纳入瓣膜内瓣膜国际数据注册研究（VIVID）并接受自膨胀THV装置治疗的患者，由对临床事件不知情的中央核心实验室进行分析。在倾向得分匹配后，以1:2的比例比较圣犹达医疗Portico瓣膜与美敦力CoreValve瓣膜。共有162例患者接受了基于Portico瓣膜（n = 54）和CoreValve瓣膜（n = 108）的瓣中瓣手术，构成研究人群，其基线特征无显著差异（年龄79±8.2岁；60%为女性；胸外科医师协会[STS]平均评分8.1±5.5%）。植入后，与Portico瓣膜相比，CoreValve瓣膜的有效瓣口面积更大（1.67对1.31平方厘米；P = 0.001），平均梯度更低（14±7.5对17±7.5毫米汞柱；P = 0.02），且核心实验室判定的中重度主动脉瓣关闭不全发生率更低（4.2%对13.7%；P = 0.04）。两组间包括THV位置不当、需要植入第二个THV或冠状动脉阻塞在内的手术并发症无显著差异。30天时的生存率和卒中率相似，但与CoreValve瓣膜治疗的患者相比，Portico瓣膜治疗的患者1年时的总体死亡率更高（22.6%对9.1%；P = 0.03）。
结论
在首次对用于瓣中瓣植入的THV进行的匹配比较中，Portico瓣膜和CoreValve瓣膜在术后血流动力学和长期临床结局方面存在差异。虽然这可能与THV设计特征有关，但不能排除其他手术因素的影响，需要进一步评估。
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