No-reflow protection and long-term efficacy for acute myocardial infarction with Tongxinluo: a randomized double-blind placebo-controlled multicenter clinical trial (ENLEAT Trial).

BACKGROUND: No-reflow after emergency percutaneous coronary intervention (PCI) for acute ST segment elevation myocardial infarction (STEMI) is related to the severe prognosis. The aim of this study was to evaluate the efficacy of Tongxinluo, a traditional Chinese medicine, on no-reflow and the infarction area after emergency PCI for STEMI. METHODS: A total of 219 patients (female 31, 14%) undergoing emergency PCI for STEMI from nine clinical centers were consecutively enrolled in this randomized, double-blind, placebo-controlled, multicenter clinical trial from January 2007 to May 2009. All patients were randomly divided into Tongxinluo group (n = 108) and control group (n = 111), given Tongxinluo or placebo in loading dose 2.08 g respectively before emergency PCI with aspirin 300 mg and clopidogrel 300 mg together, then 1.04 g three times daily for six months after PCI. The ST segment elevation was recorded by electrocardiogram at hospitalization and 1, 2, 6, 12, 24 hours after coronary balloon dilation to evaluate the myocardial no-flow; myocardial perfusion scores of 17 segments were evaluated on day 7 and day 180 after STEMI with static single-photon emission computed tomography (SPECT) to determine the infarct area. RESULTS: There was no statistical significance in sex, age, past history, chest pain, onset-to-reperfusion time, Killip classification, TIMI flow grade just before and after PCI, either in the medication treatment during the follow up such as statin, ß-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) between two groups. There was significant ST segment restoration in Tongxinluo group compared to the control group at 6 hours ((-0.22 ± 0.18) mV vs. (-0.18 ± 0.16) mV, P = 0.0394), 12 hours ((-0.24 ± 0.18) mV vs. (-0.18 ± 0.15) mV, P = 0.0158) and 24 hours ((-0.27 ± 0.16) mV vs. (-0.20 ± 0.16) mV, P = 0.0021) reperfusion; and the incidence of myocardial no-reflow was also reduced significantly at 24-hour reperfusion (34.3% vs. 54.1%, P = 0.0031). The myocardial perfusion scores of 17 segments evaluated by static SPECT was improved significantly on day 7 and day 180 after STEMI in Tongxinluo group compared to the control group (0.61 ± 0.40 vs. 0.76 ± 0.42, P = 0.0109 and 0.51 ± 0.42 vs. 0.66 ± 0.43, P = 0.0115, respectively). There was no significant difference in severe adverse events between two groups. CONCLUSION: Tongxinluo as a kind of traditional Chinese medicine could reduce myocardial no-reflow and infarction area significantly after emergency PCI for STEMI with conventional medicine therapy.

Off-pump pulmonary valve implantation of a valved stent with an anchoring mechanism.

PURPOSE: The purpose of this study was to evaluate the longitudinal performance and anti-migration effect of a bovine valved stent equipped with an anchoring mechanism implanted off-pump in the pulmonary position. DESCRIPTION: Through a delivery system, the bell-shaped pulmonary valved stents were implanted off-pump in the pulmonary valve position into six sheep by the transventricular approach. Hemodynamic, angiographic, and echocardiographic evaluations were carried out before, immediately after, and 2 months after implantation. Macroscopic and radiographic examination were performed for evaluation. EVALUATION: The valved stents were all successfully implanted off-pump in the pulmonary position on six sheep. Early and late angiographic, echocardiographic, hemodynamic, and macroscopic studies confirmed firm anchoring and good positions of the stents. All valved stents were potent, except one mild stenosis with a 24 mm Hg transvalvular pressure gradient that developed and one mild insufficiency that were discovered at the end of the study. CONCLUSIONS: Transventricular implantation of the bell-shaped pulmonary valved stents was evaluated during a 2-month period in the sheep in the present study and showed a good structural and functional outcome with no migration.

Transcatheter occlusion of the ruptured sinus of Valsalva aneurysm with an Amplatzer duct occluder.

BACKGROUND: Ruptured sinus of Valsalva aneurysm (RSVA) can be associated with ventricular septal defects or isolated lesions. Percutaneous transcatheter closure of RSVA has been an alternative strategy to surgery. The results of transcatheter closure of the RSVA in 10 patients were presented. METHODS: From January 2000 to May 2006, 10 patients (4 males, 6 females) aged from 7 years to 69 years (mean ages 37+/-18.8 years) were involved in the present report. The diagnosis of RSVA was made based on a combination of several imaging modalities. Of them, 9 patients were identified as congenital cause and one did as acquired RSVA. Two-dimensional and color Doppler echocardiography revealed the rupture of right coronary sinus into right ventricle in 5 cases and into right atrium in 3 cases, while non-coronary sinus ruptured into right atrium in 2 cases. Aortogram showed that the estimated size of the defect was 6.2+/-2.3 mm (2-10 mm). After the establishment of the arterio-venous wire loop, Amplatzer duct occluder (ADO) was deployed by antegrade venous approach in all patients. RESULTS: ADO with 1-3mm larger than the defect was used. All defects were successfully occluded without any complications. On the follow-up, echocardiography showed neither residual shunt nor aortic regurgitation, and there was also no device embolization, infective endocarditis in any of the patients. CONCLUSIONS: Transcatheter closure is a feasible and effective alternative for both congenital and acquired RSVA. However, long-term follow-up is mandatory.

[Transcatheter closure of ruptured sinus of valsalva aneurysm using Amplatzer duct occluder].

OBJECTIVE: The present study was conducted to investigate the feasibility and efficacy of transcatheter closure of ruptured sinus of Valsalva aneurysm (RSVA). METHODS: Four patients (3 females) aged 7-57 years with RSVA (3 congenital RSVA and 1 post-surgery RSVA) were involved in the present study. Two-dimensional and color Doppler echocardiography revealed the ruptures of right coronary sinus into right ventricle in all cases. The echo estimated size of the defect was 2-10 mm. After the establishment of the arterio-venous wire loop, Amplatzer Duct Occluder (ADO) was successfully deployed by antegrade venous approach in all patients. The diameter of the occluder was chosen to be at least 1 to 2 mm larger than defect. RESULTS: The defects were successfully occluded without any complications. On the follow-up 3 months after operation, there was no device embolization, infective endocarditis and aortic regurgitation. CONCLUSION: Transcatheter closure is a feasible and effective modality for RSVA without other anomalies.