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经股动脉入路主动脉瓣置换术在有和无心脏外科手术部的医院的结局:来自前瞻性德国主动脉瓣置换质量保证登记(AQUA)在 17919 例患者中的研究结果。

Outcomes of transfemoral transcatheter aortic valve implantation at hospitals with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17 919 patients.

机构信息

Cardioangiological Center Bethanien (CCB) and AGAPLESION Bethanien Hospital, Frankfurt, Germany

ProMedCon GmbH, Ebenhausen, Germany.

出版信息

Eur Heart J. 2016 Jul 21;37(28):2240-8. doi: 10.1093/eurheartj/ehw190. Epub 2016 May 17.

DOI:10.1093/eurheartj/ehw190
PMID:27190093
Abstract

AIMS

Performing transcatheter aortic valve implantation (TAVI) at hospitals with only cardiology department but no cardiac surgery (CS) on-site is at great odds with current Guidelines.

METHODS AND RESULTS

We analysed data from the official, prospective German Quality Assurance Registry on Aortic Valve Replacement to compare characteristics and in-hospital outcomes of patients undergoing transfemoral TAVI at hospitals with (n = 75) and without CS departments (n = 22). An interdisciplinary Heart Team was established at all centres (internal staff physicians at hospitals with on-site CS; in-house cardiologists and visiting cardiac surgical teams from collaborating hospitals at non-CS hospitals). In 2013 and 2014, 17 919 patients (81.2 ± 6.1 years, 55% females, German aortic valve (GAV) score 2.0 5.6 ± 5.8%, logistic EuroSCORE I 21.1 ± 15.4%) underwent transfemoral TAVI in Germany: 1332 (7.4%) at hospitals without on-site CS department. Patients in non-CS hospitals were older (82.1 ± 5.8 vs. 81.1 ± 6.1 years, P < 0.001), with more frequent co-morbidities. Predicted mortality risks per GAV-score 2.0 (6.1 + 5.5 vs. 5.5 ± 5.9%, P < 0.001) and logEuroSCORE I (23.2 ± 15.8 vs. 21.0 ± 15.4%, P < 0.001) were higher in patients at non-CS sites. Complications, including strokes (2.6 vs. 2.3%, P = 0.452) and in-hospital mortality (3.8 vs. 4.2%, P = 0.396), were similar in both groups. Matched-pair analysis of 555 patients in each group with identical GAV-score confirmed similar rates of intraprocedural complications (9.2 vs. 10.3%, P = 0.543), strokes (3.2% for both groups, P = 1.00), and in-hospital mortality (1.8 vs. 2.9%, P = 0.234).

CONCLUSION

Although patients undergoing TAVI at hospitals without on-site CS department were older and at higher predicted perioperative death risk, major complications, and in-hospital mortality were not statistically different, suggesting the feasibility and safety of Heart Team-based TAVI at non-CS sites. These findings need confirmation in future randomized study.

摘要

目的

在仅有心脏病科而无心脏外科的医院进行经导管主动脉瓣置换术(TAVI)与当前指南相矛盾。

方法和结果

我们分析了德国主动脉瓣置换术官方、前瞻性质量保证登记处的数据,以比较在有(n=75)和无(n=22)心脏外科部门的医院行经股 TAVI 的患者的特征和住院期间结局。所有中心都成立了跨学科心脏团队(有现场心脏外科的医院内部工作人员医生;非心脏外科医院的内部心脏病专家和来访的心脏外科团队)。2013 年和 2014 年,德国有 17919 例患者(81.2±6.1 岁,55%为女性,德国主动脉瓣(GAV)评分 2.05.6±5.8%,逻辑 EuroSCORE I 21.1±15.4%)接受经股 TAVI:1332 例(7.4%)在无现场心脏外科部门的医院。非心脏外科医院的患者年龄更大(82.1±5.8 岁 vs. 81.1±6.1 岁,P<0.001),合并症更频繁。按 GAV 评分 2.0 预测的死亡率(6.1+5.5 岁 vs. 5.5+5.9%,P<0.001)和 logEuroSCORE I(23.2+15.8 岁 vs. 21.0+15.4%,P<0.001)在非心脏外科部位的患者中更高。两组的并发症包括中风(2.6% vs. 2.3%,P=0.452)和住院死亡率(3.8% vs. 4.2%,P=0.396)相似。每组 555 例具有相同 GAV 评分的匹配对分析证实,术中并发症(9.2% vs. 10.3%,P=0.543)、中风(两组均为 3.2%,P=1.00)和住院死亡率(1.8% vs. 2.9%,P=0.234)相似。

结论

尽管在无现场心脏外科部门的医院接受 TAVI 的患者年龄更大,围手术期死亡风险更高,但主要并发症和住院死亡率无统计学差异,表明心脏团队为基础的非心脏外科部位 TAVI 的可行性和安全性。这些发现需要在未来的随机研究中得到证实。

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