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Major Stroke (major + stroke)
Selected AbstractsImmediate Clinical Outcome after Prolonged Periods of Brain Protection: Retrospective Comparison of Hypothermic Circulatory Arrest, Retrograde, and Antegrade PerfusionJOURNAL OF CARDIAC SURGERY, Issue 5 2009Anil Z. Apaydin M.D. Methods: Between 1993 and 2006, 339 patients underwent proximal aortic operations using a period of cerebral protection. Among these, 161 patients (mean age of 55 ± 12 years) who required cerebral protection longer than 25 minutes were included in the analysis. Ascending aorta with or without root was replaced in all patients. In addition, total arch replacement was performed in 36 patients. All patients were cooled to rectal temperature of 16 °C. Hypothermic circulatory arrest without adjunctive perfusion was used in 48 patients. Retrograde or antegrade cerebral perfusion was added in 94 and 19 patients, respectively. The mean duration of total cerebral protection was 42 ± 17 minutes. Results: Overall mortality was 15.5% (25/161) and did not differ among the perfusion groups. There was no difference in the incidence of overall neurological events, temporary neurological dysfunction, or major stroke among the groups. Multivariate analysis revealed that transfusion of >3 units of blood (p < 0.03) was an incremental risk factor for mortality. History of hypertension (p < 0.03), coexisting systemic diseases (p < 0.005), and transfusion of >3 units of blood (p < 0.04) were predictors of temporary neurological dysfunction. Conclusion: In proximal aortic operations requiring prolonged periods of cerebral protection, the mortality and neurological morbidity are not determined by the type of cerebral protection method only. Factors like hypertension and diabetes may play a role in the development of temporary neurological dysfunction. [source] European Carotid PROCAR Trial: Prospective Multicenter Trial to Evaluate the Safety and Performance of the ev3 ProtégéÔ Stent in the Treatment of Carotid Artery Stenosis,1- and 6-Month Follow-UpJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2006JENNIFER SUGITA Background: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. Method: The Protégé® GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018, (6,9 mm stent) or 7 Fr 0.035, (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. Results: In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. Conclusions: The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA). [source] Long-term Management of an Implantable Left Ventricular Assist Device Using Low Molecular Weight Heparin and Antiplatelet Therapy: A Possible Alternative to Oral AnticoagulantsARTIFICIAL ORGANS, Issue 5 2007Bart Meuris Abstract:, Between January 2004 and December 2005, out of 14 patients with decompensated heart failure who were treated with an INCOR left ventricular assist device (Berlin Heart AG, Berlin, Germany), 10 patients were kept on a long-term regime of low molecular weight heparin (LMWH) and antiplatelet therapy. The treatment objective was bridge-to-transplantation. All patients received LMWH in therapeutic doses according to body weight, in combination with daily aspirin 160 mg, clopidogrel 75 mg, and three times dipyridamole 75 mg. Effectiveness of the low molecular weight regime was monitored through measurement of antifactor Xa activity (base and peak levels). Antiplatelet therapy was monitored through weekly platelet function tests. Within this group of 10 patients, six patients successfully received transplants and four patients died, the latest death after 405 days of INCOR support. Causes of death were sepsis, intestinal hemorrhage, acute right ventricular failure, and one major stroke. Long-term management of INCOR assist devices using a combination of LMWH and antiplatelet therapy is feasible. This treatment strategy can serve as an alternative to oral anticoagulants. [source] Carotid angioplasty and stenting in octogenarians: Is it safe?CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2008M. Henry MD Abstract Purpose: Elderly patients have a higher risk of complications in carotid endarterectomy. The aim of the study was to evaluate whether carotid artery stenting (CAS) performed in octogenarians also increases the procedure related risk. Methods: 870 patients (male 626) mean age 70.9 ± 9.3 years underwent 930 CAS for de novo lesions (n = 851) restenoses (n = 54) post radiation (n = 14) inflammatory arteritis (n = 9) post trauma aneurysms (n = 2). Indications for treatment: symptomatic carotid stenosis , 70% (n = 577) or asymptomatic stenosis , 80%. Patients were separated into two age groups: <80 years (749 patients, 806 CAS) and >80 years (121 patients, 124 CAS). 187 CAS performed without protection (N.P,) 6 patients >80 years, 743 with protection (NP+) (occlusion balloon: 334, filters: 404, reversal flow: 6) 118 patients >80 years. Data analysis included neurological complications, death and myocardial infarction (MI) rate at 30 days, anatomical particularities. Technical points will be described depending on the age of the patient. Results: Technical success 804/806 in patients <80 years, 123/124 in patients >80 years (NS). 30 days outcomes: in the patient group <80 years we observed 9 TIA (1.1%) 3 without NP (1.7%) 6 with NP (0.9%), 5 minor strokes (0.6%) 2 without NP (1.1%) 3 with NP (0.5%), 3 major strokes: 2 without NP (1.1%) 1 with NP (0.2%), 5 deaths (0.6%) 2 without NP (1.1%) 3 with NP (0.5%). Death/stroke/MI: 14 (1.8%) 6 without NP (3.3%), 8 with NP (1.3%). In the group >80 years, we observed 2 TIA (1.7%) 1 without NP 1 with NP (0.92%) 1 minor stroke without NP (17%) no major stroke, no death. Death/stroke/MI 1 without NP (17%). Conclusion: CAS can be performed in elderly patients without higher risk than in younger patients. But good indications, a meticulous technique, protection devices are mandatory and some technical points must be pointed out to avoid neurological complications and failures. © 2008 Wiley-Liss, Inc. [source] European Carotid PROCAR Trial: Prospective Multicenter Trial to Evaluate the Safety and Performance of the ev3 ProtégéÔ Stent in the Treatment of Carotid Artery Stenosis,1- and 6-Month Follow-UpJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2006JENNIFER SUGITA Background: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. Method: The Protégé® GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018, (6,9 mm stent) or 7 Fr 0.035, (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. Results: In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. Conclusions: The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA). [source] Flow-Reversal Device for Cerebral Protection During Carotid Artery Stenting,Acute and Long-Term ResultsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2006KASJA RABE M.D. Objective: Several types of cerebral (embolic) protection devices have been used in patients undergoing carotid stenting. This study assessed results achieved with a flow-reversal system. Method: Carotid stenting was performed in 56 patients (mean age, 68 ± 9 years). The mean percentage of stenosis was 77%± 10%. During the procedure, cerebral protection was achieved by means of balloon occlusion of the common and external carotid artery with use of a Parodi Anti-Emboli System. The patients' neurologic status was assessed during the intervention; at discharge; 1, 6, and 12 months after the procedure; and yearly thereafter. Results: The procedure was technically successful in all cases. One patient had a minor stroke 6 hours after the intervention. No major strokes, deaths, or myocardial infarctions occurred. During long-term follow-up (to 40 months), 2 patients died of a secondary complication after intracerebral bleeding and stroke and 1 died as a result of ventricular fibrillation. Restenosis did not exceed 50% of vessel diameter in any patient. Conclusions: The acute results indicate that proximal occlusion and flow reversal for cerebral protection during carotid stenting is a safe and effective method. The low restenosis and complication rate during long-term follow-up is in accordance with other series of carotid angioplasty and shows that the occlusion balloons do not cause any long-term side effects. [source] Carotid artery stenting in high surgical risk patients using the FiberNet® embolic protection system: The EPIC trial results,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2010FACC, Subbarao Myla MD Abstract Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Background: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet® Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). © 2009 Wiley-Liss, Inc. [source] Carotid angioplasty and stenting in octogenarians: Is it safe?CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2008M. Henry MD Abstract Purpose: Elderly patients have a higher risk of complications in carotid endarterectomy. The aim of the study was to evaluate whether carotid artery stenting (CAS) performed in octogenarians also increases the procedure related risk. Methods: 870 patients (male 626) mean age 70.9 ± 9.3 years underwent 930 CAS for de novo lesions (n = 851) restenoses (n = 54) post radiation (n = 14) inflammatory arteritis (n = 9) post trauma aneurysms (n = 2). Indications for treatment: symptomatic carotid stenosis , 70% (n = 577) or asymptomatic stenosis , 80%. Patients were separated into two age groups: <80 years (749 patients, 806 CAS) and >80 years (121 patients, 124 CAS). 187 CAS performed without protection (N.P,) 6 patients >80 years, 743 with protection (NP+) (occlusion balloon: 334, filters: 404, reversal flow: 6) 118 patients >80 years. Data analysis included neurological complications, death and myocardial infarction (MI) rate at 30 days, anatomical particularities. Technical points will be described depending on the age of the patient. Results: Technical success 804/806 in patients <80 years, 123/124 in patients >80 years (NS). 30 days outcomes: in the patient group <80 years we observed 9 TIA (1.1%) 3 without NP (1.7%) 6 with NP (0.9%), 5 minor strokes (0.6%) 2 without NP (1.1%) 3 with NP (0.5%), 3 major strokes: 2 without NP (1.1%) 1 with NP (0.2%), 5 deaths (0.6%) 2 without NP (1.1%) 3 with NP (0.5%). Death/stroke/MI: 14 (1.8%) 6 without NP (3.3%), 8 with NP (1.3%). In the group >80 years, we observed 2 TIA (1.7%) 1 without NP 1 with NP (0.92%) 1 minor stroke without NP (17%) no major stroke, no death. Death/stroke/MI 1 without NP (17%). Conclusion: CAS can be performed in elderly patients without higher risk than in younger patients. But good indications, a meticulous technique, protection devices are mandatory and some technical points must be pointed out to avoid neurological complications and failures. © 2008 Wiley-Liss, Inc. [source] |