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使用新型Amplatzer肌部室间隔缺损封堵器经导管关闭梗死后室间隔缺损:美国注册研究结果

Transcatheter closure of postinfarction ventricular septal defects using the new Amplatzer muscular VSD occluder: Results of a U.S. Registry

Catheter Cardiovasc Interv · 2004 年 2 月 · Ralf Holzer, David Balzer, Zahid Amin 等 9 人

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新封堵器经导管关闭心梗后室间隔缺损,18例中16例成功。

梗死后室间隔缺损(心脏左右心室之间出现破口)是心肌梗死的严重并发症,发生率为0.2%,病死率极高。本研究前瞻性收集18例患者,使用新型Amplatzer梗死后肌部室间隔缺损封堵器(PIMVSD)经导管尝试封堵。18例中16例成功植入封堵器,30天死亡率为28%,11例存活者中位随访332天。结论为该装置安全有效,但需进一步试验与外科手术比较。

为什么推荐给您:新器械用于梗死后室间隔缺损的早期注册研究,属新适应证探索,值得关注。

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摘要Abstract

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The objective of this study was to assess the immediate and mid-term results of transcatheter closure of postinfarct muscular ventricular septal defects (VSDs) using the new Amplatzer postinfarct muscular VSD device (PIMVSD). Ventricular septal rupture occurs in 0.2% of myocardial infarcts and remains associated with very high morbidity and mortality. Data were prospectively collected for 18 patients who underwent attempted device closure of postinfarction VSDs between 2000 and 2003. Five patients underwent the closure in the acute phase (within 6 days from the infarct); the remaining patients underwent closure on day 14-95 after the diagnosis of the infarct. Outcome parameters included procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The procedure was successful in deploying a device across the VSD in 16 of 18 patients. The 30-day mortality was 28%. Eleven patients are still alive and have been followed up for a median of 332 days. Two patients required a second procedure to close a residual VSD. At the most recent outpatient follow-up, the VSD was completely closed in two patients, six patients had a trivial or small residual shunt, and two patients had a moderate residual shunt. We conclude that percutaneous device closure of postinfarction VSDs using the Amplatzer PIMVSD occluder appears to be safe and effective. Further trials are required to assess long-term efficacy and compare the results with those of surgical closure.

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