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基于导管的肥厚性梗阻性心肌病治疗。德国TASH注册研究的首次院内结局分析。

Catheter-based therapy for hypertrophic obstructive cardiomyopathy. First in-hospital outcome analysis of the German TASH Registry.

作者信息

Kuhn H, Seggewiss H, Gietzen F H, Boekstegers P, Neuhaus L, Seipel L

机构信息

Klinikum Bielefeld-Mitte, Klinik für Kardiologie und Internistische Intensivmedizin, 33604 Bielefeld, Germany.

出版信息

Z Kardiol. 2004 Jan;93(1):23-31. doi: 10.1007/s00392-004-1028-6.

Abstract

BACKGROUND

Registry results of the new catheter-based method in the treatment for HOCM are missing so far. In 1997, the Transcoronary Ablation of Septal Hypertrophy Registry (TASH Registry) was established by the German Cardiac Society (GCS) as a multicenter, national registry of patients with HOCM undergoing the new catheter interventional therapy. This is the report of the in-hospital outcome of patients who underwent the procedure during the first two years of data collection in the registry.

METHODS AND RESULTS

Information was based on three standard forms for each patient, with a total of 86 variables. Information was collected on an "intention to treat" basis. The TASH Registry includes the establishment of a data base in the data collecting center. Ten centers participated. Enrollment forms were received for 264 patients out of 279 patients registered up to January 2000. There was a history of medical treatment of 3.6+/-3.9 years. The vast majority of patients (91%) were treated in three centers. The Vasalva maneuver and the exercise Doppler echocardiography were used for noninvasive stress testing. Exercise Doppler echocardiography induced a significantly higher augmentation of the baseline gradient (70.1% vs 133.4%; p<0.01). The echo-contrast guided technique was used for the intervention in 50.8% and the pressure angiography guided technique in 49.2%. On the average 2.8+/-1.3 ml of alcohol were injected. Before the procedure, the gradient measured by catheterization was 60.4+/-38.6 mmHg at baseline and 142.7+/-46.2 mmHg following the extrasystolic beat. At the end of the session it was reduced significantly by 75% and 67%. The peak phosphocreatine kinase activity was 482.5+/-246.4 U/L. Major complications occurred in 15.6% including a mortality rate of 1.2% and a permanent pacemaker implantation rate because of total heart block in 9.6%. There was an early in-hospital improvement of dyspnoe corresponding to a significant decrease of NYHA functional class from 2.8+/-0.7 to 1.8+/-0.6 (p<0.001). Similar hemodynamic and clinical benefit was found in patients with and without resting gradient at baseline.

CONCLUSION

This analysis for the first time gives a comprehensive overview of clinical characteristics, technique, procedural data, in-hospital outcome and complications in a large number of patients with HOCM who were treated by the new catheter-based method and prospectively enrolled in a registry. The results contribute considerably to critical evaluation and validation of the new technique. This analysis supports the catheter-based method to constitute a new therapeutic option for very symptomatic patients, to be effective both in patients with and without intraventricular pressure gradient at rest and to be an alternative to surgical treatment, as has been stated recently.

摘要

背景

迄今为止,基于导管的新方法治疗肥厚型梗阻性心肌病(HOCM)的注册研究结果尚缺。1997年,德国心脏病学会(GCS)设立了经冠状动脉室间隔肥厚消融注册研究(TASH注册研究),作为对接受新型导管介入治疗的HOCM患者进行多中心、全国性注册的研究。本文报告了在该注册研究数据收集的头两年接受该手术患者的院内结局。

方法与结果

信息基于每位患者的三种标准表格,共86个变量。信息收集基于“意向性治疗”原则。TASH注册研究包括在数据收集中心建立数据库。有10个中心参与。截至2000年1月,在登记的279例患者中收到了264例患者的登记表。患者有3.6±3.9年的药物治疗史。绝大多数患者(91%)在三个中心接受治疗。采用Valsalva动作和运动多普勒超声心动图进行无创负荷试验。运动多普勒超声心动图引起的基线压差增幅显著更高(70.1%对133.4%;p<0.01)。50.8%的患者采用超声造影引导技术进行干预,49.

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