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Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.中危患者的外科手术或经导管主动脉瓣置换术。
N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
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JACC Cardiovasc Interv. 2017 Feb 13;10(3):276-282. doi: 10.1016/j.jcin.2016.11.025.
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Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study.新型自膨式生物瓣经导管主动脉瓣置换术治疗重度主动脉瓣狭窄且不适合手术患者的早期临床转归:Evolut R 美国研究结果。
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SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve.SOURCE 3 注册研究:新一代 SAPIEN 3 经导管主动脉瓣的欧洲上市后注册研究的设计和 30 天结果。
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2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.2016 年胸外科医师学会/美国心脏病学会经导管瓣膜治疗注册中心年度报告。
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退伍军人事务部经导管主动脉瓣置换项目的发展:首批100例患者

Evolution of Veterans Affairs Transcatheter Aortic Valve Replacement Program: The First 100 Patients.

作者信息

Yang Joseph, Zimmet Jeffrey M, Ponna Vimala M, Ma Frank, Wozniak Curtis J, Ge Liang, Shunk Kendrick A, Tseng Elaine E

机构信息

Division of Cardiology, Department of Medicine, University of California San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.

Division of Cardiothoracic Surgery, Department of Surgery, University of California San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.

出版信息

J Heart Valve Dis. 2018 Jan;27(1):24-31.

PMID:30560596
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8590872/
Abstract

BACKGROUND

Transcatheter aortic valve replacement (TAVR) is a widely established alternative to surgery in intermediate- and high-risk patients. TAVR program development within the Veterans Affairs (VA) system has been previously described. However, national TAVR registries do not capture VA outcomes data, and few data have been reported regarding TAVR outcomes at lower-volume federal institutions. The study aim was to demonstrate the evolution of a successful VA TAVR program.

METHODS

A retrospective analysis was performed of the first 100 TAVR patients at San Francisco VA Medical Center. Mortality and major complications were evaluated.

RESULTS

Between 25th November 2013 and 31st August 2016, a total of 100 TAVR procedures was performed at the authors' institution. The mean patient age was 79.7 ± 8.7 years. Patients underwent TAVR via percutaneous-transfemoral (n = 90), surgical cutdown-transfemoral (n = 8), or transapical (n = 2) approaches. The valve systems employed were Edwards SAPIEN (n = 16), SAPIEN XT (n = 31), SAPIEN 3 (n = 23), and Medtronic CoreValve (n = 16) and CoreValve Evolut R (n = 14). The overall device success was 96%. TAVR-in-TAVR was required in the remaining 4% of patients, and was successful. All-cause procedural mortality was 1%. Complications included tamponade (1%), stroke (2%), temporary hemodialysis (1%), vascular injuries requiring intervention (4%), and permanent pacemaker implantation (14%). There were no conversions to surgical aortic valve replacement. Twenty-two (22%) patients had mild, two (2%) had moderate, and none (0%) had severe paravalvular leakage. The post-procedure aortic valve gradient by echocardiography was 8.6 ± 4.5 mmHg. Follow up was 100% complete and survival was 99%, 93%, and 89% at one, six, and 12 months, respectively.

CONCLUSIONS

Successful outcomes were demonstrated for a VA TAVR program that compared favorably with benchmarks established by the National Transcatheter Valve Therapies Registry. These results provide a necessary transparency of TAVR outcomes at a federal institution.

摘要

背景

经导管主动脉瓣置换术(TAVR)是中高危患者广泛采用的手术替代方案。退伍军人事务部(VA)系统内TAVR项目的发展情况此前已有描述。然而,国家TAVR登记处未收录VA的结局数据,关于联邦机构中较低手术量的TAVR结局报告的数据也很少。本研究的目的是展示一个成功的VA TAVR项目的发展历程。

方法

对旧金山VA医疗中心的首批100例TAVR患者进行回顾性分析。评估死亡率和主要并发症。

结果

2013年11月25日至2016年8月31日期间,作者所在机构共进行了100例TAVR手术。患者平均年龄为79.7±8.7岁。患者通过经皮股动脉途径(n = 90)、手术切开股动脉途径(n = 8)或经心尖途径(n = 2)接受TAVR。使用的瓣膜系统为爱德华兹SAPIEN(n = 16)、SAPIEN XT(n = 31)、SAPIEN 3(n = 23)、美敦力CoreValve(n = 16)和CoreValve Evolut R(n = 14)。总体器械成功率为96%。其余4%的患者需要进行TAVR-in-TAVR,且手术成功。全因手术死亡率为1%。并发症包括心包填塞(1%)、中风(2%)、临时血液透析(1%)、需要干预的血管损伤(4%)和永久性起搏器植入(14%)。无一例转为外科主动脉瓣置换术。22例(22%)患者有轻度瓣周漏,2例(2%)有中度瓣周漏,无(0%)有重度瓣周漏。术后经超声心动图测得的主动脉瓣压差为8.6±4.5 mmHg。随访完成率为100%,1个月、6个月和12个月时的生存率分别为99%、93%和89%。

结论

VA TAVR项目取得了成功的结果,与国家经导管瓣膜治疗登记处设定的基准相比具有优势。这些结果为联邦机构的TAVR结局提供了必要的透明度。