瑞士经导管主动脉瓣植入术的手术结果和临床结局：一项关于Sapien 3与Sapien XT经导管心脏瓣膜的观察性队列研究
Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves.
作者信息
Binder Ronald K, Stortecky Stefan, Heg Dik, Tueller David, Jeger Raban, Toggweiler Stefan, Pedrazzini Giovanni, Amann Franz W, Ferrari Enrico, Noble Stephane, Nietlispach Fabian, Maisano Francesco, Räber Lorenz, Roffi Marco, Grünenfelder Jürg, Jüni Peter, Huber Christoph, Windecker Stephan, Wenaweser Peter
机构信息
From the Department of Cardiology and Department of Cardiovascular Surgery, University Heart Centre Zurich, University Hospital Zurich, Zurich, Switzerland (R.K.B., F.N., F.M.); Department of Cardiology and Department of Cardiovascular Surgery, Swiss Cardiovascular Centre, Bern University Hospital, Bern, Switzerland (S.S., L.R., C.H., S.W., P.W.); Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Triemli Hospital Zurich, Zurich, Switzerland (D.T.); Department of Cardiology and Department of Cardiovascular Surgery, Basel University Hospital, University of Basel, Basel, Switzerland (R.J.); Cantonal Hospital Lucerne, Lucerne, Switzerland (S.T.); Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland (G.P.); Department of Cardiology, Klinik im Park, Hirslanden Clinic Zurich, Zurich, Switzerland (F.W.A.); Department of Cardiothoracic Surgery, Lausanne University Hospital, Lausanne, Switzerland (E.F.); Department of Cardiology, Geneva University Hospital, Geneva, Switzerland (S.N., M.R.); and Heart Clinic Hirslanden, Hirslanden Clinic Zurich, Zurich, Switzerland (J.G.).
出版信息
Circ Cardiovasc Interv. 2015 Oct;8(10). doi: 10.1161/CIRCINTERVENTIONS.115.002653.
BACKGROUND
New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation.
METHODS AND RESULTS
In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27).
CONCLUSIONS
The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.
背景
新一代经导管心脏瓣膜（THV）可能会改善经导管主动脉瓣植入术的临床疗效。
方法与结果
在一项全国性、前瞻性、多中心队列研究（瑞士经导管主动脉瓣植入注册研究，NCT01368250）中，对连续接受经股动脉经导管主动脉瓣植入术且分别使用Sapien 3 THV（S3）和Sapien XT THV（XT）治疗的患者的结局进行了研究。共将153例连续的S3患者与445例连续的XT患者进行了比较。S3组和XT组患者术后平均跨瓣压差分别为（6.5±3.0对7.8±6.3 mmHg，P = 0.17），无差异。S3组患者中，中重度以上瓣周反流发生率（1.3%对5.3%，P = 0.04）和血管并发症发生率（5.3%对16.9%，P<0.01）显著更低。接受S3瓣膜的患者中，新的永久性起搏器植入率更高（17.0%对11.0%，P = 0.01）。致残性卒中（S3组1.3%对XT组3.1%，P = 0.29）和全因死亡率（S3组3.3%对XT组4.5%，P = 0.27）无显著差异。
结论
与XT相比，使用新一代球囊扩张式S3 THV可降低中重度以上瓣周反流和血管并发症的风险，但与永久性起搏器植入率增加有关。使用最新一代球囊扩张式THV进行经导管主动脉瓣植入术的卒中风险较低且临床结局良好。
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