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Multicenter Registry (multicenter + registry)
Selected AbstractsImmediate and Midterm Complications of Sclerotherapy: Report of a Prospective Multicenter Registry of 12,173 Sclerotherapy SessionsDERMATOLOGIC SURGERY, Issue 2 2005FACPH, Jean-Jérôme Guex MD Background Growing interest in sclerotherapy has emphasized the need for complete knowledge of all aspects of this method. Objective To precisely delineate the actual incidence of immediate and delayed untoward events of daily sclerotherapy. Methods A multicenter prospective registry was established in 22 phlebology clinics to report their activity and complications. Results During the study period, 12,173 sessions of sclerotherapy were carried out, 5,434 with liquid, 6,395 with foam, and 344 using both. Four thousand eighty-eight (33.9%) sessions were carried out with ultrasound guidance. Forty-nine incidents or accidents (0.4%) occurred, of which 12 were with liquid and 37 with foam. These were reported during the time of the study and an additional 1-month follow-up. Most numerous were 20 cases of visual disturbances (in 19 cases, foam or air block was used); all resolved shortly, without any after-effects. A femoral vein thrombosis was the only severe adverse event in this study. Conclusions This study demonstrates that sclerotherapy is a safe technique. FUNDING FOR RESEARCH WAS PROVIDED BY THE FRENCH SOCIETY OF PHLEBOLOGY, A NONPROFIT ORGANIZATION. [source] Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical OverstressPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2001ROBERT G. HAUSER Hauser, R., et al.: Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybrid circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufacturers' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICDs following market release are inadequate. [source] Minimally Invasive Antral Membrane Balloon Elevation , Results of a Multicenter RegistryCLINICAL IMPLANT DENTISTRY AND RELATED RESEARCH, Issue 2009Efraim Kfir DMD ABSTRACT Background and Purpose: Frequently, the posterior maxilla lacks sufficient bone mass to support dental implants. This multiphysician registry assessed the feasibility and safety of minimally invasive antral membrane balloon elevation (MIAMBE), followed by bone augmentation and implant fixation. Materials and Methods: One hundred twelve consecutive patients were referred for MIAMBE. Following pre-procedural assessment and informed consent, patients underwent alveolar crest exposure, and 3 mm osteotomy followed by MIAMBE. Platelet-rich fibrin and bone substitutes were injected under the antral membrane; implant placement and primary closure were executed at the same sitting. Implant loading was carried out 6 to 9 months later. Results: One hundred nine (97.3%) patients successfully concluded the initial procedure. Three patients had membrane tear requiring procedure abortion. One case of infection was documented at 4 weeks. Procedure time was 58 ± 23 minutes. Incremental bone height consistently exceeded 10 mm, and implant survival of 95% was observed at 6 to 9 months. Conclusion: MIAMBE can be applied to all patients in need of posterior maxilla bone augmentation with high procedural success, low complication rate, and satisfactory bone augmentation and implant survival. As it is minimally invasive and associated with minimal discomfort, MIAMBE should be an alternative to the currently employed methods of maxillary bone augmentation. [source] Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution TrialJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2010ROBERT D. SAFIAN M.D. Purpose:,A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted during the 3-month period from March to May 2005. Methods:,Carotid artery stenting (CAS) was performed with the SpideRXÔ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration. Results:,The primary end-point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end-point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05). Conclusion:,CAS with distal embolic protection using the SpideRXÔ Embolic Protection System is a reasonable alternative for revascularization of some high-risk patients with severe carotid stenosis. (J Interven Cardiol 2010;23:491,498) [source] Predictors of Clinical Outcome Following NIR Stent Implantation for Coronary Artery Disease: Analysis of the Results of the First International New Intravascular Rigid-Flex Endovascular Stent Study (FINESS Trial)JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2002STEVEN FELD M.D. Background: Patient and procedural characteristics associated with major adverse cardiac events following balloon angioplasty have been identified. Factors predictive of angiographic restenosis following coronary stent implantation have been reported, although patient variables associated with adverse clinical outcome are not well defined. Hypothesis and Methods: To identify predictors of adverse clinical outcome following NIR stent implantation, clinical and angiographic characteristics of patients enrolled in the FINESS Trial were subjected to stepwise logistic regression analysis. From December 1995 through March 1996, NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter registry with broad entry criteria. Results: On stepwise logistic regression analysis, the presence of multivessel disease, diabetes, and the total length of the stented segment were predictive of major adverse cardiac events during 6-month follow-up. For every 1 mm increase in stent length, the risk for the combined end point of death or myocardial infarction increased by 3%. Lesion length was not predictive of clinical events on multivariate analysis. Conclusions: Our data raise the possibility that an attempt to use shorter stents to cover significant stenoses, but not adjacent areas of visible narrowing, may improve outcome. [source] Adjunctive use of the Rinspiration system for fluidic thrombectomy during primary angioplasty: The Rinspiration international registry,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2008Marco De Carlo MD Abstract Background: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously "rinses" the vessel with turbulent flow and aspirates thrombus. Methods: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was ,50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous elctrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). Results: Mean symptom-to-PCI time was 4.7 ± 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush ,2 in 78%. Rates of STR , 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. Conclusions: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit. © 2008 Wiley-Liss, Inc. [source] In-Hospital mortality of elderly patients with acute myocardial infarction: Data from the mitra (maximal individual therapy in acute myocardial infarction) registryCLINICAL CARDIOLOGY, Issue 11 2000K. K. Haase M.D. Abstract Background: Advanced age remains one of the principal determinants of mortality in patients with acute myocardial infarction (AMI). Hypothesis: The aim of this study was to determine the in-hospital outcome of elderly (>75 years) patients with AMI who were admitted to hospitals participating in the national MITRA (Maximal Individual Therapy in Acute Myocardial Infarction) registry. Methods: MITRA is a prospective, observational German multicenter registry investigating current treatment modalities for patients presenting with AMI. All patients with AMI admitted within 96 h of onset of symptoms were included in the MITRA registry. MITRA was started in June 1994 and ended in January 1997. This registry comprises 6,067 consecutive patients with a mean age of 65 ± 12 years, of whom 1,430 (17%) were aged > 75 years. Patients were compared with respect to patient characteristics, prehospital delays, early treatment strategies, and clinical outcome. Results: In the elderly patient population, the prehospital delay was 210 min, which was significantly longer than that for younger patients (155 min, p = 0.001). Although the incidence of potential contraindications for the initiation of thrombolysis was almost equally distributed between the two age groups (8.7 vs. 8.2%, p = NS), elderly patients (> 75 years) received reperfusion therapy less frequently (35.9 vs. 64.6%) than younger patients. Mortality increased with advanced age and was 26.4% for all patients aged > 75 years. If reperfusion therapy was initiated, in-hospital mortality was 21.8 versus 28.9% in patients aged > 75 years (p = 0.001) and 29.4 versus 38.5% in patients aged > 85 years (p = 0.001). Conclusion: In this registry, elderly patients with AMI had a much higher in-hospital mortality than that expected from randomized trials. In MITRA, the mortality reduction with reperfusion therapy was found to be highest in the very elderly patient population. [source] | ||||||||||