RESUMEN
We present a case of percutaneous closure of main pulmonary artery pseudoaneurysm using an atrial septal occluder device in a seven-month-old infant. The infant had tetralogy of Fallot repair followed by transcatheter left pulmonary artery stenting. The occlusion of the wide neck of the pseudoaneurysm was performed successfully using the atrial septal occluder with no detected complications in his six-month follow-up post-catheterisation.
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Aneurisma Falso , Fibrilación Atrial , Defectos del Tabique Interatrial , Dispositivo Oclusor Septal , Humanos , Lactante , Arteria Pulmonar/diagnóstico por imagen , Arteria Pulmonar/cirugía , Cateterismo Cardíaco , Aneurisma Falso/cirugía , Resultado del Tratamiento , Defectos del Tabique Interatrial/cirugíaRESUMEN
PURPOSE: Routinely collected administrative data is widely used for population-based research. However, although clinically very different, atrial septal defects (ASD) and patent foramen ovale (PFO) share a single diagnostic code (ICD-9: 745.5, ICD-10: Q21.1). Using machine-learning based approaches, we developed and validated an algorithm to differentiate between PFO and ASD patient populations within healthcare administrative data. METHODS: Using data housed at ICES, we identified patients who underwent transcatheter closure in Ontario between October 2002 and December 2017 using a Canadian Classification of Interventions code (1HN80GPFL, N = 4680). A novel random forest model was developed using demographic and clinical information to differentiate those who underwent transcatheter closure for PFO or ASD. Those patients who had undergone transcatheter closure and had records in the CorHealth Ontario cardiac procedure registry (N = 1482) were used as the reference standard. Several algorithms were tested and evaluated for accuracy, sensitivity, and specificity. Variable importance was examined via mean decrease in Gini index. RESULTS: We tested 7 models in total. The final model included 24 variables, including demographic, comorbidity, and procedural information. After hyperparameter tuning, the final model achieved 0.76 accuracy, 0.76 sensitivity, and 0.75 specificity. Patient age group had the greatest influence on node impurity, and thus ranked highest in variable importance. CONCLUSIONS: Our random forest classification method achieved reasonable accuracy in identifying PFO and ASD closure in administrative data. The algorithm can now be applied to evaluate long term PFO and ASD closure outcomes in Ontario, pending future external validation studies to further test the algorithm.
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Foramen Oval Permeable , Algoritmos , Cateterismo Cardíaco/métodos , Foramen Oval Permeable/diagnóstico , Foramen Oval Permeable/epidemiología , Humanos , Ontario/epidemiología , Resultado del TratamientoRESUMEN
BACKGROUND: Atrial septal defects (ASD) following endovascular mitral valve clipping are potentially hemodynamically relevant complications. Immediate closure with an occluder can represent a safe and effective treatment. An 81-year-old female patient suffering from severe dyspnea due to previously known severe mitral valve regurgitation was scheduled for elective mitral valve clipping. The clip was successfully implanted. Removal of the transseptal cannula resulted in a sudden drop in oxygen saturation and systolic blood pressure as well as an immediate increase in central venous pressure. An iatrogenic left-right shunt was observed at the atrial level with a relevant shunt volume. Immediate closure using an atrial septal occluder successfully restored the oxygen saturation and hemodynamic parameters. CONCLUSION: An increase in central venous pressure, reduction of systolic blood pressure or oxygen saturation after withdrawal of the transseptal cannula during mitral valve clipping should always be further investigated regarding a possible ASD.
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Insuficiencia de la Válvula Mitral , Válvula Mitral , Anciano de 80 o más Años , Presión Sanguínea , Cateterismo Cardíaco , Presión Venosa Central , Femenino , Humanos , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Saturación de OxígenoRESUMEN
INTRODUCTION: Secundum atrial septal defect is one of the most common congenital heart defects. Previous paediatric studies have mainly addressed echocardiographic and few clinical factors among children associated with adverse events. The aim of this study was to identify neonatal and other clinical risk factors associated with adverse events up to one year after closure of atrial septal defect. METHODS: This retrospective case-control study includes children born in Sweden between 2000 and 2014 that were treated surgically or percutaneously for an atrial septal defect. Conditional logistic regression was used to evaluate the association between major and minor adverse events and potential risk factors, adjusting for confounding factors including prematurity, neonatal sepsis, neonatal general ventilatory support, symptomatic atrial septal defects, and pulmonary hypertension. RESULTS: Overall, 396 children with 400 atrial septal defect closures were included. The median body weight at closure was 14.5 (3.5-110) kg, and the median age was 3.0 (0.1-17.8) years. Overall, 110 minor adverse events and 68 major events were recorded in 87 and 49 children, respectively. Only symptomatic atrial septal defects were associated with both minor (odds ratio (OR) = 2.18, confidence interval (CI) 95% 1.05-8.06) and major (OR = 2.80 CI 95% 1.23-6.37) adverse events. CONCLUSION: There was no association between the investigated neonatal comorbidities and major or minor events after atrial septal defect closure. Patients with symptomatic atrial septal defects had a two to four times increased risk of having a major event, suggesting careful management and follow-up of these children prior to and after closure.
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Cateterismo Cardíaco/efectos adversos , Defectos del Tabique Interatrial/cirugía , Complicaciones Posoperatorias/epidemiología , Nacimiento Prematuro/epidemiología , Dispositivo Oclusor Septal/efectos adversos , Adolescente , Niño , Preescolar , Comorbilidad , Femenino , Estudios de Seguimiento , Humanos , Lactante , Modelos Logísticos , Masculino , Estudios Retrospectivos , Factores de Riesgo , Suecia/epidemiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
We report a case of Figulla-II Occlutech septal occluder malposition with residual shunt at posteriosuperior margin of an atrial septal defect. Improvising its bioptome type delivery cable, same system was used to recapture the device and redeploy it successfully. This report highlights a potential malfunction of Figulla-II Occlutech disc and the advantage of its delivery system for retrieval of the device.
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Cateterismo Cardíaco/instrumentación , Defectos del Tabique Interatrial/terapia , Falla de Prótesis , Dispositivo Oclusor Septal , Adolescente , Ecocardiografía Transesofágica , Defectos del Tabique Interatrial/diagnóstico por imagen , Humanos , Masculino , Diseño de Prótesis , Resultado del TratamientoAsunto(s)
Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Apéndice Atrial/fisiopatología , Apéndice Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Humanos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/fisiopatología , Accidente Cerebrovascular/prevención & controlRESUMEN
Objective: To investigate the safety and efficacy of percutaneous intervention of children with combined congenital heart abnormality solely guided by transthoracic echocardiography (TTE) . Methods: From September 2015 to June 2017, 21 children with combined congenital heart abnormality undergoing percutaneous interventional guided by TTE in Fuwai hospital were enrolled in our study, and the clinical data were retrospective analyzed. The atrial septal defect(ASD) closure, ventricular septal defect(VSD) closure, patent ductus arteriosus(PDA) closure or balloon pulmonary valvuloplasty were performed under the guidance of TTE. The procedural effect was evaluated by TTE after operation. The patients were followed up after discharged from the hospital. Results: The age was (37.3±11.6) months, and there were 9 male and 12 female patients. There were 4 cases with ASD and VSD, 6 cases with VSD and PDA, 6 cases with ASD and PDA, 2 cases with VSD and pulmonary stenosis, 3 cases with ASD and pulmonary stenosis. The operations were successfully performed in all patients. No one required extra X ray guidance or open heart surgery. The operation time was (44.6±7.5)min. All patients did not require blood transfusion, inotropic support, and analgesia. There were no complications such as peripheral vascular injury and pericardialeffusion after the operation. The length of hospital stay time was (3.5±0.6) days. All patients were recovered well. The follow-up was (17.6±5.2) months, and post-procedural conduction disturbances, residual shunts, occlude fall off, thrombosis, and new onset of valvular regurgitation were not observed in these patients. Conclusion: Percutaneous interventional of children with combined congenital heart abnormality solely guided by TTE is safe and effective, and the procedure can avoid the potential injuries of X ray and contrast agent.
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Cateterismo Cardíaco , Ecocardiografía , Defectos del Tabique Interatrial , Niño , Femenino , Cardiopatías Congénitas , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/terapia , Humanos , Masculino , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: An Amplatzer Vascular Plug (AVP), which was designed as a permanent occluding device derived from the Amplatzer Septal Occluder and Amplatzer Duct Occluder, is a useful embolic device that can be precisely deployed in medium to large vessels with high resistance to migration. However, migration of these Amplatzer devices has been reported as a relatively rare but major complication. CASE REPORT: A 59-year-old woman was referred for the treatment of advanced pancreatic body cancer; after systemic chemotherapy, distal pancreatectomy with en bloc celiac axis resection (DP-CAR) was planned as curative treatment. Therefore, preoperative embolisation of the common hepatic artery (CHA) for arterial redistribution was performed. Although a 6-mm AVP II was deployed at the mid-portion of the CHA, the AVP migrated to the proper hepatic artery. Although migrated AVP retrieval using a goose neck snare was attempted, it was impossible to retrieve it into the 5-F guiding sheath. Therefore, the AVP was delivered to the splenic artery, which was planned to be resected in DP-CAR. Finally, a 10-mm AVP II was redeployed at the proximal portion of the CHA, and complete occlusion was achieved. CONCLUSIONS: When AVP retrieval is not possible, delivery to the other arteries having lesser influence might be an alternate technique.
RESUMEN
OBJECTIVES: To develop a novel delivery technique to overcome vascular size limitations for device closure of a secundum ASD in the young patient. BACKGROUND: The efficacy, clinical utility, and safety of transcatheter closure in comparison to surgical closure are well established; however, access vessel size remains a potential limitation to device selection in the young patient. METHODS: A retrospective medical record review of all cases of secundum ASD closure between April 2015 and April 2016 utilizing a novel delivery method described herein at two separate academic institutions. The device is disassembled allowing the delivery sheath to serve as the introducer. It is advanced to the RA with re-introduction of the device allowing for deployment in the standard fashion. RESULTS: Overall, 10 patients underwent secundum ASD closure via this novel delivery technique. There were six females (60%) and the average age at time of the procedure was 4.2 years ± 1.6 years (range 2-6 years). The majority of patients had an isolated secundum ASD (70%) with the primary indication for closure being right ventricular volume overload (90%). All patients had successful placement of a GORE® CARDIOFORM® Septal Occluder (GCSO) with no or trivial residual shunt. No patients had vascular complications related to the procedure. CONCLUSIONS: We describe a novel technique for ASD closure using the GCSO delivery sheath as the access sheath, which reduces the vascular access size requirement by 25%, thus addressing one common limitation for percutaneous device closure of a secundum ASD in young patients. © 2016 Wiley Periodicals, Inc.
Asunto(s)
Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/métodos , Defectos del Tabique Interatrial/terapia , Dispositivo Oclusor Septal , Factores de Edad , Cateterismo Cardíaco/efectos adversos , Niño , Preescolar , Femenino , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/fisiopatología , Humanos , Masculino , Registros Médicos , Minnesota , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , San Francisco , Factores de Tiempo , Resultado del TratamientoRESUMEN
We report a case of late infective endocarditis in an 8-year-old boy 3 years after transcatheter closure of an atrial septal defect with the Amplatzer Atrial Septal Occluder Device. Echocardiography showed a very thick pannus lining the left atrial disc of the prosthesis, with some mobile elements. MRI showed several cerebral microemboli. The patient had dental caries and blood cultures found Staphylococcus aureus. Patient was treated with gentamicin and oxacillin before surgical removal of the prosthesis. Twenty-one cases of infective endocarditis after atrial defect device closure have been reported in the literature (13 ostium secundum ASD and 8 patent foramen ovale). Seven pediatric cases were reported. S. aureus was the most frequent bacterium. Antibiotics were administered in all cases and most patients (n = 18) underwent surgical removal of the device. Incomplete endothelialization of the prosthesis was a suggested mechanism. Two patients died after surgery. © 2016 Wiley Periodicals, Inc.
Asunto(s)
Cateterismo Cardíaco/efectos adversos , Endocarditis Bacteriana/microbiología , Defectos del Tabique Interatrial/terapia , Infecciones Relacionadas con Prótesis/microbiología , Dispositivo Oclusor Septal/efectos adversos , Infecciones Estafilocócicas/microbiología , Staphylococcus aureus/aislamiento & purificación , Antibacterianos/uso terapéutico , Cateterismo Cardíaco/instrumentación , Niño , Remoción de Dispositivos , Ecocardiografía , Endocarditis Bacteriana/diagnóstico , Endocarditis Bacteriana/cirugía , Defectos del Tabique Interatrial/diagnóstico por imagen , Humanos , Imagen por Resonancia Magnética , Masculino , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/cirugía , Factores de Riesgo , Infecciones Estafilocócicas/diagnóstico , Infecciones Estafilocócicas/cirugía , Factores de Tiempo , Resultado del TratamientoRESUMEN
Objective: To compare the efficacy and safety of percutaneous ventricular septal defect (VSD) closure under solely guidance of echocardiography and fluoroscopy. Methods: The retrospective study was conducted at Fuwai Hospital, between February 2014 and February 2015. The patients were divided into two groups. VSD closure was conducted in 42 patients under solely guidance of echocardiography, and 100 patients who were treated with percutaneous catheter closure under fluoroscopy guidance were selected as a control group. The baseline characteristics, procedural time and complications were recorded and assessed. Results: There were no significant differences in terms of age, gender and pre-operative echocardiographic characteristics (all P>0.05). Percutaneous VSD closure under traditional fluoroscopy guidance was successful in 95 patients (95%). The procedural time was (54.7±12.5) minutes. The symmetrical occluders diameter was (6.9±1.8) mm. Four patients had postoperative residual shunt, one patient developed left bundle branch block, and 6 patients developed new tricuspid regurgitation. Percutaneous VSD closure under only transthoracic echocardiography (TTE) guidance was successful in 39 patients (93%). Because of delivery catheter passage failure through the defect, one case required conversion to perventricular closure via a small transthoracic incision under transesophageal echocardiography (TEE) guidance. The other two cases underwent surgical repair because of residual shunt with more than 2 mm after closure. The procedural time was (40.3±13.2) minutes. The symmetrical occluders diameter was (6.5±1.2) mm. Four patients had postoperative residual shunt that disappeared after 1 month follow-up, and one patient developed right bundle branch block which disappeared 3 days later. During (9.3±3.6) months follow-up, there were no other complications, such as pericardial effusion, occluder malposition, atrioventricular block, aortic valve regurgitation, and aggravating tricuspid regurgitation in each group. However, the total operation time, diameter of VSD occluder, total mild complications, and the equipment cost in the study group were less than that in the control group (P<0.05). Conclusion: Percutaneous VSD closure can be successfully performed under sole guidance of echocardiography with outcomes similar to those achieved with fluoroscopy guidance.
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Cateterismo Cardíaco , Ecocardiografía Transesofágica , Defectos del Tabique Interventricular/cirugía , Ecocardiografía , Estudios de Seguimiento , Humanos , Derrame Pericárdico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Objective: To investigate the feasibility of trans-catheter closure of multiple atrial septal defects (ASD) monitored by trans-thoracic echocardiography (TTE) under the guidance of 3D printing heart model. Methods: Between April and August 2016, a total of 21 patients (8 male and 13 female) with multiple ASD in Fuwai Hospital of Chinese Academy of Medical Sciences underwent CT scan and 3-dimensional echocardiography for heart disease model produced by 3D printing technique. The best occlusion program was determined through the simulation test on the model. Percutaneous device closure of multiple ASD was performed follow the predetermined program guided by TTE. Clinical follow-up including electrocardiogram and TTE was arranged at 1 month after the procedure. Results: The trans-catheter procedure was successful in all 21 patients using a single atrial septal occluder. Mild residual shunt was found in 5 patient in the immediate postoperative period, 3 of them were disappeared during postoperative follow-up. There was no death, vascular damage, arrhythmia, device migration, thromboembolism, valvular dysfunction during the follow-up period. Conclusion: The use of 3D printing heart model provides a useful reference for transcatheter device closure of multiple ASD achieving through ultrasound-guided intervention technique, which appears to be safe and feasible with good outcomes of short-term follow-up.
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Cateterismo Cardíaco , Defectos del Tabique Interatrial/cirugía , Impresión Tridimensional , Dispositivo Oclusor Septal , Ecocardiografía , Ecocardiografía Transesofágica , Femenino , Humanos , Masculino , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
Objective: To compare the efficacy and safety of Cardi-O-fix patent foramen ovale (PFO) occluder and Amplatzer PFO occluder for the treatment of patients with PFO. Methods: A total of 246 consecutive patients (105 males and 141 females) with PFO were prospectively enrolled from May 30, 2013 to March 30, 2015 in our hospital. PFO interventional closure was applied according to the anatomical structure of the disease and patients' wishes.Cardi-O-fix PFO occluder was used in 180 cases (COF group), Amplatzer PFO occluder was used in the remaining 66 cases (Amp group). Post-procedure safety including recurrent stroke, transient ischemic attack, death, and complete closure rate, and efficacy including procedure related complications of different devices were compared during the 12 months follow-up. Results: (1) Rate of transient ischemic attack was similar between COF group and Amp group at 12 months after procedure(1.1%(2/180) vs. 1.5%(1/66), P=1.000). There was no recurrent stroke and death during the 12 months follow-up period.Complete closure rate was similar between COF group and Amp group at 12 months after the procedure(90.6%(163/180)vs. 86.4%(57/66), P=0.355). (2) Three cases(1.7%) of paroxysmal atrial fibrillation were observed in COF group during the 12 months follow-up period, 1 patient converted spontaneously to sinus rhythm and 2 patients received successful pharmacologic conversion and converted to sinus rhythm. One patient(1.5%)developed paroxysmal atrial fibrillation and was pharmacologically converted to sinus rhythm in the Amp group. There was no significant difference in rate of paroxysmal atrial fibrillation between the two groups(P=1.000). There was no complications such as occluder translocation, erosion, pericardial effusion and puncture site bleeding in the 2 groups during the 12 months follow-up. Conclusion: Efficacy and safety are similar for PFO treatment with Cardi-O-fix PFO occluder or Amplatzer PFO occluder in this patient cohort.
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Foramen Oval Permeable/terapia , Dispositivo Oclusor Septal , Fibrilación Atrial , Cateterismo Cardíaco , Femenino , Humanos , Masculino , Seguridad , Resultado del TratamientoRESUMEN
Platypnoea-orthodeoxia is a rare, but under-diagnosed clinical entity, characterised by postural hypoxia and breathlessness. Underlying pathology is inter-atrial shunt or pulmonary vascular malformation, but what anatomical distortion / physiological alterations initiates right to left shunt, usually against the pressure gradient remains unknown.
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Hipoxia , Trasplante de Pulmón/efectos adversos , Complicaciones Posoperatorias/fisiopatología , Femenino , Humanos , Hipoxia/etiología , Hipoxia/fisiopatología , Persona de Mediana EdadRESUMEN
Embolization of the occlusion device after percutaneous closure of atrial septal defect (ASD) is a potential disastrous complication. The usual site of embolization is the right side of the heart including pulmonary artery, but the device embolization to the extracardiac aorta is extremely rare. Here, we report a successful percutaneous retrieval case of the embolized Amplatzer Septal Occluder (ASO) to the descending thoracic aorta after the successful deployment of two ASO devices in a patient with double ASD. Competition between the two devices to obtain a stable position may be an explanation for the migration of ASO.
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Remoción de Dispositivos/métodos , Embolia/etiología , Embolia/cirugía , Defectos del Tabique Interatrial/complicaciones , Dispositivo Oclusor Septal/efectos adversos , Adulto , Defectos del Tabique Interatrial/cirugía , Humanos , Masculino , Resultado del TratamientoRESUMEN
Patent foramen ovale (PFO) is a flaplike opening in the fossa ovalis; between the septum primum and secundum. It is highly prevalent with approximately 25% of the population having a PFO. It is usually asymptomatic but can rarely cause paradoxical embolism leading to stroke and/or significant right to left shunting causing hypoxia. The complications of PFO closure with a percutaneous device include embolization, cardiac perforation, and thrombosis. These are all early complications. We describe the case of a patient with a history of PFO closure who had device thrombosis 3 years after implantation. Management includes anticoagulation with warfarin. Repeat cardiac imaging to document the resolution of thrombosis is recommended.
RESUMEN
Atrial septal abnormalities are common congenital lesions that remain asymptomatic in many patients until adulthood. Adults with atrial septal defects (ASD) most commonly have ostium secundum ASD. Transcatheter closure has become increasingly popular in recent years as a successful alternative method to surgery for treating ASD and patent foramen ovale (PFO). The overall rate of ASD transcatheter closure device embolization has been reported to be less than 1%; however, retrieving the device via surgery or by trans-catheter route can be necessary. The current manuscript describes a systematic review of the techniques used to retrieve ASD closure devices, as well as their success rates, complications, and limitations. A comprehensive search was performed covering various databases including PubMed, MEDLINE, SCOPUS, Google Scholar, and Cochrane Library from inception until April 2022 for English-published case reports, case series, and experimental studies investigating the indications, safety, and limitations of ASD closure and ASD device retrieval by trans-catheter approaches. Finally, 20 studies were included in our review. Our findings showed that most of the studies used a single snare technique; of these, all but one reported 100% success. Double tool retrieval methods (snare plus snare, snare plus bioptome, or snare plus forceps) and the gooseneck snare technique yielded 100% success. One study that used the lasso technique reported unsuccessful retrieval and the need for surgical intervention. More recently, the novel "coronary wire trap technique" was introduced, which provides a simpler method for embolized device removal by trapping the device for retrieval using coronary wire.
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Cateterismo Cardíaco , Remoción de Dispositivos , Foramen Oval Permeable , Defectos del Tabique Interatrial , Dispositivo Oclusor Septal , Humanos , Defectos del Tabique Interatrial/cirugía , Defectos del Tabique Interatrial/diagnóstico , Cateterismo Cardíaco/métodos , Foramen Oval Permeable/cirugía , Foramen Oval Permeable/terapia , Remoción de Dispositivos/métodosRESUMEN
INTRODUCTION: Surgical ligation of the left atrial appendage is considered standard of care in patients who undergo mitral valve surgery or as an adjunct to a surgical Maze procedure for treatment of atrial fibrillation (AF). However, several studies have demonstrated that this can result in incompletely surgically ligated left atrial appendage (ISLL) in a significant number of patients. It is believed that ISLL may in turn promote thrombus formation and lead to clinically relevant thromboembolic events. A novel approach for percutaneous endocardial occlusion of ISLL is described. METHODS AND RESULTS: Seven patients with AF and ISLL following prior open-chest, surgical suture ligation in the absence of rheumatic heart disease, underwent percutaneous endocardial ISLL occlusion using an Amplatzer Septal Occluder device guided by fluoroscopy and transesophageal echocardiography through a novel approach. Three patients were diagnosed in the setting of acute embolic stroke, 2 at the time of cardiac arrhythmia ablation and 2 by elective precardioversion transesophageal echocardiography. All patients were treated with oral anticoagulation therapy. Acute and long-term ISLL occlusion was successfully achieved in 6 patients, in whom oral anticoagulation was eventually discontinued without any embolic events during 10 ± 2 months of follow-up. CONCLUSION: Percutaneous endocardial occlusion of ISLL is feasible using an Amplatzer Septal Occluder device. Additional studies are required to evaluate the long-term safety and efficacy of this therapeutic treatment strategy in patients with ISLL.
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Apéndice Atrial/cirugía , Cateterismo Cardíaco/métodos , Endocardio/cirugía , Dispositivo Oclusor Septal , Adulto , Anciano , Anciano de 80 o más Años , Apéndice Atrial/patología , Estudios de Cohortes , Endocardio/patología , Femenino , Estudios de Seguimiento , Humanos , Ligadura , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVES: We sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing percutaneous patent-foramen-ovale (PFO) closure with medical therapy for preventing recurrent thromboembolic events after cryptogenic stroke. BACKGROUND: Observational studies suggested that transcatheter PFO closure decreases recurrent events after cryptogenic stroke; however, three recent RCTs failed to demonstrate such benefit. METHODS: Trials were identified from the PubMed and Cochrane databases. Primary endpoint was the composite of transient ischemic attack (TIA) and ischemic cerebrovascular events (CVA). Both intention-to-treat (ITT) and as-treated analyses (AT) were performed. RESULTS: Three RCTs met inclusion criteria. The pooled data provided 2,303 patients, of which 1,150 were in the PFO closure group and 1,153 in the medical therapy group. In the ITT analysis, there were 43 events (3.7%) of the composite end point in the closure group compared with 61 events (5.3%) in the medical therapy group, with a trend in favor of the PFO closure (OR = 0.70; 95% CI, 0.47-1.05, P = 0.08). The incidences of TIA, ischemic CVA, and bleeding were not statistically different between the groups. There was a trend for the more frequent occurrence of atrial fibrillation in the PFO closure group (OR = 3.29; 95% CI, 0.86-12.60, P = 0.08). In the AT analysis, the composite end point was significantly less frequent in the PFO closure group (OR = 0.62; 95% CI, 0.41-0.94, P = 0.02). CONCLUSIONS: In this meta-analysis of contemporary RCTs, successful transcatheter closure of PFO might be more effective than medical therapy alone for the prevention of recurrent thromboembolic events.