Feasibility and Safety of Transthoracic Echocardiography-Guided Transcatheter Closure of Atrial Septal Defects with Deficient Superior-Anterior Rims

Although previous studies showed that transthoracic echocardiography (TTE) can be used to guide transcatheter closure of atrial septal defect (ASD), whether TTE can be used to guide transcatheter closure of secundum ASD with a deficient superior-anterior rim is unknown and this critical issue was addressed in the present study. A total of 280 patients with secundum ASD who underwent transcatheter ASD closure were recruited and divided into groups A and B depending on ASD superior-anterior rim>4 mm (n = 118) or ≤4 mm (n = 162). TTE was used to guide Amplatzer-type septal occluder (ASO) positioning and assess residual shunt. Procedure success was defined as no, trivial and small residual shunt immediately after the procedure as assessed by color Doppler flow imaging. Group A and group B did not differ in complication rate (8.55% vs.7.55%), procedure success rate (98.3% vs. 95.0%) or complete closure rate immediately after the procedure (89.7% vs. 89.3%) or at 6-month follow-up (98.3% vs. 96.8%). The mean procedure and fluoroscopy time in group B were much longer than those in group A. In conclusion, the absence of a sufficient superior-anterior rim in patients undergoing percutaneous closure of secundum-type ASDs using fluoroscopic and TTE guidance is associated with slightly greater device malposition and migration as well as increased procedural and fluoroscopic times, but the overall complication rate did not differ with TTE guidance when compared to historical controls that used TEE guidance.     

国产房缺封堵器治疗多孔型房缺

目的：评估国产封堵器治疗多孔型房缺的可行性及安全性。方法：在X线及超声引导下对19例多孔型房缺植入国产房缺封堵器,术后常规进行心电图及经胸心脏超声随访半年。结果：所有患者均成功进行了房缺封堵,其中5例放置1枚国产普通型房缺封堵器,7例放置2枚国产普通型房缺封堵器,另7例则分别放置1枚细腰大边型房缺封堵器,术后即刻超声检查1例仍有少许分流,术后1月时随访分流消失,所有患者随访半年未出现明显并发症。结论：国产房缺封堵器可安全应用于多孔型房缺患者的封堵治疗,在经验丰富的先心病介入治疗专科中心,封堵治疗可做为部分多孔型房缺患者的首选治疗。     

国产房缺封堵器治疗多孔型房缺

目的:评估国产封堵器治疗多孔型房缺的可行性及安全性。方法:在X线及超声引导下对19例多孔型房缺植入国产房缺封堵器,术后常规进行心电图及经胸心脏超声随访半年。结果:所有患者均成功进行了房缺封堵,其中5例放置1枚国产普通型房缺封堵器,7例放置2枚国产普通型房缺封堵器,另7例则分别放置1枚细腰大边型房缺封堵器,术后即刻超声检查1例仍有少许分流,术后1月时随访分流消失,所有患者随访半年未出现明显并发症。结论:国产房缺封堵器可安全应用于多孔型房缺患者的封堵治疗,在经验丰富的先心病介入治疗专科中心,封堵治疗可做为部分多孔型房缺患者的首选治疗。     

Cost-Effectiveness of Procedures for Treatment of Ostium Secundum Atrial Septal Defects Occlusion Comparing Conventional Surgery and Septal Percutaneous Implant

ObjectivesThe study performs a cost-effectiveness analysis of procedures for atrial septal defects occlusion, comparing conventional surgery to septal percutaneous implant.MethodsA model of analytical decision was structured with symmetric branches to estimate cost-effectiveness ratio between the procedures. The decision tree model was based on evidences gathered through meta-analysis of literature, and validated by a panel of specialists. The lower number of surgical procedures performed for atrial septal defects occlusion at each branch was considered as the effectiveness outcome. Direct medical costs and probabilities for each event were inserted in the model using data available from Brazilian public sector database system and information extracted from the literature review, using micro-costing technique. Sensitivity analysis included price variations of percutaneous implant.ResultsThe results obtained from the decision model demonstrated that the percutaneous implant was more cost effective in cost-effectiveness analysis at a cost of US$8,936.34 with a reduction in the probability of surgery occurrence in 93% of the cases. Probability of atrial septal communication occlusion and cost of the implant are the determinant factors of cost-effectiveness ratio.ConclusionsThe proposal of a decision model seeks to fill a void in the academic literature. The decision model proposed includes the outcomes that present major impact in relation to the overall costs of the procedure. The atrial septal defects occlusion using percutaneous implant reduces the physical and psychological distress to the patients in relation to the conventional surgery, which represent intangible costs in the context of economic evaluation.     

Atrial Septal Defect in Infancy

The case histories of seven infants with atrial septal defect are presented to draw attention to certain features and possible dangers of this defect in infancy. Four infants were asymptomatic but one failed to thrive and two died suddenly. Five had ejection murmurs and two, with pulmonary hypertension, had loud pan-systolic murmurs with a thrill. In two infants murmurs were noted at birth, but in five they were first heard between the ages of 1 and 6 months. The second pulmonary sound was initially narrowly split in all, but became widely split between the ages of 12 and 20 months. Electrocardiograms and chest roentgenograms were of little help at the outset but later showed findings characteristic of the defect after one year. All infants were catheterized; a left-to-right atrial shunt was detected in each instance. Pulmonary hypertension was present in two infants, one of whom died.     

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting an estimated 6 million people in the United States ¹. Since AF affects primarily elderly people, its prevalence increases parallel with age. As such, it is expected that 15.9 million Americans will be affected by the year 2050 ². Ischemic stroke occurs in 5% of non-anticoagulated AF patients each year. Current treatments for AF include rate control, rhythm control and prevention of stroke ³.The American College of Cardiology, American Heart Association, and European Society of Cardiology currently recommended rate control as the first course of therapy for AF ³. Rate control is achieved by administration of pharmacological agents, such as β-blockers, that lower the heart rate until it reaches a less symptomatic state ³. Rhythm control aims to return the heart to its normal sinus rhythm and is typically achieved through administration of antiarrhythmic drugs such as amiodarone, electrical cardioversion or ablation therapy. Rhythm control methods, however, have not been demonstrated to be superior to rate-control methods ^4-6. In fact, certain antiarrhythmic drugs have been shown to be associated with higher hospitalization rates, serious adverse effects ³, or even increases in mortality in patients with structural heart defects ⁷. Thus, treatment with antiarrhythmics is more often used when rate-control drugs are ineffective or contraindicated. Rate-control and antiarrhythmic agents relieve the symptoms of AF, including palpitations, shortness of breath, and fatigue ⁸, but don''t reliably prevent thromboembolic events ⁶.Treatment with the anticoagulant drug warfarin significantly reduces the rate of stroke or embolism ^9,10. However, because of problems associated with its use, fewer than 50% of patients are treated with it. The therapeutic dose is affected by drug, dietary, and metabolic interactions, and thus requires detailed monitoring. In addition, warfarin has the potential to cause severe, sometimes lethal, bleeding ². As an alternative, aspirin is commonly prescribed. While aspirin is typically well tolerated, it is far less effective at preventing stroke ¹⁰. Other alternatives to warfarin, such as dabigatran ¹¹ or rivaroxaban ¹² demonstrate non-inferiority to warfarin with respect to thromboembolic events (in fact, dabigatran given as a high dose of 150 mg twice a day has shown superiority). While these drugs have the advantage of eliminating dietary concerns and eliminating the need for regular blood monitoring, major bleeding and associated complications, while somewhat less so than with warfarin, remain an issue ^13-15.Since 90% of AF-associated strokes result from emboli that arise from the left atrial appendage (LAA) ², one alternative approach to warfarin therapy has been to exclude the LAA using an implanted device to trap blood clots before they exit. Here, we demonstrate a procedure for implanting the WATCHMAN Left Atrial Appendage Closure Device. A transseptal cannula is inserted through the femoral vein, and under fluoroscopic guidance, inter-atrial septum is crossed. Once access to the left atrium has been achieved, a guidewire is placed in the upper pulmonary vein and the WATCHMAN Access Sheath and dilator are advanced over the wire into the left atrium. The guidewire is removed, and the access sheath is carefully advanced into the distal portion of the LAA over a pigtail catheter. The WATCHMAN Delivery System is prepped, inserted into the access sheath, and slowly advanced. The WATCHMAN device is then deployed into the LAA. The device release criteria are confirmed via fluoroscopy and transesophageal echocardiography (TEE) and the device is released.     

Atrioventricular Block Subsequent to Intraoperative Device Closure Atrial Septal Defect with Transthoracic Minimal Invasion; A Rare and Serious Complication

Objectives

Atrioventricular block (AVB) is a infrequent and serious complication after percutaneous ASD closure. In this study, we report on the incidence of AVB associated with intraoperative device closure of the ASD with transthoracic minimal invasion, and the outcomes of this complication in our center.

Methods

Between May 2006 and January 2011, a total of 213 secundum-type ASD patients were accepted in our hospital for intraoperative and transthoracic device closure with a domestic occluder. All patients were assessed by real-time transthoracic echocardiography (TTE) and electrocardiograph (ECG).

Results

All patients were occluded successfully under this approach. Immediate postprocedure third-degree AVB was observed in two patients. Since heart rates were in the range of about 50 to 55 beats per minute, no intervention was needed except for close observation for one patient. Another patient who recovered sinus rhythm intermittently during the operation was fitted with a temporary pacemaker. Approximately one week following glucocorticoid treatment, the AVB resolved spontaneously in these two patients. Mobitz type II AVB occurred in three patients during the procedure. Two patients developed post-operative cardiac arrest and were rescued successfully with cardiopulmonary resuscitation. One other patient changed to Mobitz type I AVB after three days. During the follow-up period, which ranged from six months to five years, no further occurrence of AVB was found.

Conclusions

Intraoperative and transthoracic device closure of secundum ASDs with domestic occluder resulted in excellent closure rate. AVB is an infrequent but serious complication during and after device closure of a secundum ASD. AVB is a complication that warrants greater attention and long-term follow-up.     

Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting millions of individuals worldwide ^1-3. The rapid, irregular, and disordered electrical activity in the atria gives rise to palpitations, fatigue, dyspnea, chest pain and dizziness with or without syncope ^{4, 5}. Patients with AF have a five-fold higher risk of stroke ⁶.Oral anticoagulation (OAC) with warfarin is commonly used for stroke prevention in patients with AF and has been shown to reduce the risk of stroke by 64% ⁷. Warfarin therapy has several major disadvantages, however, including bleeding, non-tolerance, interactions with other medications and foods, non-compliance and a narrow therapeutic range ^8-11. These issues, together with poor appreciation of the risk-benefit ratio, unawareness of guidelines, or absence of an OAC monitoring outpatient clinic may explain why only 30-60% of patients with AF are prescribed this drug ⁸.The problems associated with warfarin, combined with the limited efficacy and/or serious side effects associated with other medications used for AF ^12,13, highlight the need for effective non-pharmacological approaches to treatment. One such approach is catheter ablation (CA), a procedure in which a radiofrequency electrical current is applied to regions of the heart to create small ablation lesions that electrically isolate potential AF triggers ⁴. CA is a well-established treatment for AF symptoms ^{14, 15}, that may also decrease the risk of stroke. Recent data showed a significant decrease in the relative risk of stroke and transient ischemic attack events among patients who underwent ablation compared with those undergoing antiarrhythmic drug therapy ¹⁶.Since the left atrial appendage (LAA) is the source of thrombi in more than 90% of patients with non-valvular atrial fibrillation ¹⁷, another approach to stroke prevention is to physically block clots from exiting the LAA. One method for occluding the LAA is via percutaneous placement of the WATCHMAN LAA closure device. The WATCHMAN device resembles a small parachute. It consists of a nitinol frame covered by fabric polyethyl terephthalate that prevents emboli, but not blood, from exiting during the healing process. Fixation anchors around the perimeter secure the device in the LAA (Figure 1). To date, the WATCHMAN is the only implanted percutaneous device for which a randomized clinical trial has been reported. In this study, implantation of the WATCHMAN was found to be at least as effective as warfarin in preventing stroke (all-causes) and death (all-causes) ¹⁸. This device received the Conformité Européenne (CE) mark for use in the European Union for warfarin eligible patients and in those who have a contraindication to anticoagulation therapy ¹⁹.Given the proven effectiveness of CA to alleviate AF symptoms and the promising data with regard to reduction of thromboembolic events with both CA and WATCHMAN implantation, combining the two procedures is hoped to further reduce the incidence of stroke in high-risk patients while simultaneously relieving symptoms. The combined procedure may eventually enable patients to undergo implantation of the WATCHMAN device without subsequent warfarin treatment, since the CA procedure itself reduces thromboembolic events. This would present an avenue of treatment previously unavailable to patients ineligible for warfarin treatment because of recurrent bleeding ²⁰ or other warfarin-associated problems.The combined procedure is performed under general anesthesia with biplane fluoroscopy and TEE guidance. Catheter ablation is followed by implantation of the WATCHMAN LAA closure device. Data from a non-randomized trial with 10 patients demonstrates that this procedure can be safely performed in patients with a CHADS₂ score of greater than 1 ²¹. Further studies to examine the effectiveness of the combined procedure in reducing symptoms from AF and associated stroke are therefore warranted.     

房间隔缺损闭合器组织相容性研究

目的:采用GB/T16175-1997和ISO10993-6:2007标准中植入后局部反应试验的结果判定方法,评价房间隔缺损闭合器植入体内后的组织相容性,探讨两种方法在组织相容性评价中的作用.方法:采用试验动物家兔皮下植入试验,将试验样品植入家兔背部皮下组织,分别于植入后1周、4周和12周后处死动物,取材,常规制片,HE染色,组织学观察采用炎症和纤维囊腔分级法及半定量记分法.结果:样品皮下植入后随着时间的延长,其周围组织的反应程度呈加重趋势.植入后12周,组织学反应未达到稳态.两种方法的组织学观察结果是一致的.结论:两种方法在组织学评价中均有其局限性,实际中可将两种方法结合来评价医疗器械的组织相容性,建议继续观察该样品植入后26周的局部反应,以减少临床使用的风险.