Temporal Trends in Transcatheter Aortic Valve Replacement in France FRANCE 2 to FRANCE TAVI
Temporal Trends in Transcatheter Aortic Valve Replacement in France FRANCE 2 to FRANCE TAVI
复制标题
法国经导管主动脉瓣置换术的时间趋势 FRANCE 2 至 FRANCE TAVI
DOI：
10.1016/j.jacc.2017.04.053
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发表时间：
2017-07-04
影响因子：
24
通讯作者：
Le Breton, Herve
中科院分区：
文献类型：
--
作者：
Auffret, Vincent;Lefevre, Thierry;Le Breton, Herve
背景经导管主动脉瓣置换术（TAVR）是手术风险高的重度主动脉瓣狭窄患者的标准治疗。然而，关于手术特征和临床结局的国家数据随着时间的推移是有限的。结论本研究的目的是评估全国范围内的性能趋势和临床结局的TAVR在6年periods.METHODS TAVR在48个中心在法国之间的2013年1月和2015年12月进行了前瞻性纳入法国TAVI（法国经导管主动脉瓣植入）注册。将结果与FRANCE 2（法国主动脉国家CoreValve和Edwards 2）登记研究报告的结果进行进一步比较，该登记研究收集了2010年1月至2012年1月在34个中心进行的所有TAVR。结果：共有12，804例来自FRANCE TAVI的患者和4，165例来自FRANCE 2的患者纳入本分析。患者的中位年龄为84.6岁，49.7%为男性。法国TAVI参与者年龄较大，但手术风险较低（欧洲心脏手术风险评估系统[EuroSCORE]的中位数：15.0% vs. 18.4%; p < 0.001）。法国TAVI中超过80%的患者接受了经股动脉TAVR。经食管超声心动图引导的病例从60.7%下降到32.3%，而最近的手术越来越多地在混合手术室进行（15.8% vs. 35.7%）。瓣膜学术研究联盟定义的器械成功率从法国2的95.3%增加到法国TAVI的96.8%（p < 0.001）。法国TAVI的住院和30天死亡率分别为4.4%和5.4%，而法国2的住院和30天死亡率分别为8.2%和10.1%（两者p < 0.001）。中风和潜在的危及生命的并发症，如瓣环破裂或主动脉夹层，保持稳定，随着时间的推移，而心脏填塞和起搏器植入率显着increasing.CONCLUSIONS法国TAVI注册提供可靠的数据，TAVR性能的趋势，在全国范围内的所有来港人士的人口。尽管如此，考虑到TAVR适应症可能扩展到手术风险较低的患者，仍然存在关于潜在危及生命的并发症和起搏器植入的担忧。（导管建立的主动脉瓣生物瓣膜登记研究[FRANCE TAVI]; NCT 01777828）（C）2017年，美国心脏病学会基金会。
BACKGROUND Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited.OBJECTIVES The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.METHODS TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.RESULTS A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.CONCLUSIONS The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828) (C) 2017 by the American College of Cardiology Foundation.