Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
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Catheter Cardiovasc Interv · Nov 2006
Randomized Controlled Trial Multicenter StudyThe safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.
The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. ⋯ DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.
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Catheter Cardiovasc Interv · Nov 2006
Comparative StudyTranscatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke.
The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS). ⋯ PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy.
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Catheter Cardiovasc Interv · Nov 2006
Case ReportsLate migration of a Sideris buttoned device for occlusion of atrial septal defect.
We describe a 17-year-old patient with an atrial septal defect who underwent device closure with a second generation Sideris buttoned device at 4 years of age. She presented 13 years after the procedure with the acute onset of chest discomfort, at which time a chest radiograph showed migration of the wire of the right atrial counter-occluder to the lateral aspect of the right atrial wall, with an associated right atrial perforation. The patient underwent uneventful surgical device retrieval and atrial septal defect closure. Late migration of a portion of the Sideris buttoned device can occur, suggesting the need for continued follow up, and a high index of suspicion for device failure should a patient become symptomatic.
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Catheter Cardiovasc Interv · Nov 2006
Case ReportsFailure of cutting balloon angioplasty to prevent restenosis in childhood pulmonary venous stenosis.
We describe bilateral pulmonary vein stenosis in a 5-year-old boy. He initially presented with haemoptysis secondary to left upper lobe pulmonary vein atresia and left lower lobe stenosis and subsequently he underwent left-sided pneumonectomy. ⋯ Despite satisfactory initial results the pulmonary venous stenosis reoccurred as early as 2 months following balloon angioplasty. Although cutting balloon angioplasty has demonstrated effective immediate alleviation of pulmonary venous stenosis its utility in providing sustained improvement in pulmonary vein stenosis is limited.