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Major Adverse Events (major + adverse_event)
Selected AbstractsExtended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist DeviceCONGESTIVE HEART FAILURE, Issue 2 2010Scott Harris DO Background LVAD therapy is an established treatment modality for patients with advanced heart failure. Pulsatile LVADs have limitations in design precluding their use for extended support. Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism. Methods In a prospective multicenter study, 281 patients urgently listed (United Network for Organ Sharing status 1A or 1B) for heart transplant underwent implant of a continuous-flow LVAD. Survival and transplant rates were assessed at 18 months. Patients were assessed for adverse events throughout the study and for quality of life, functional status, and organ function for 6 months. Results Of 281 patients, 222 (79%) underwent transplant or LVAD removal for cardiac recovery or had ongoing LVAD support at 18-month follow-up. Actuarial survival on support was 72% (95% confidence interval, 65%,79%) at 18 months. At 6 months, there were significant improvements in functional status and 6-minute walk test results (from 0% to 83% of patients in New York Heart Association functional class I or II and from 13% to 89% of patients completing a 6-minute walk test) and in quality of life (mean values improved 41% with Minnesota Living With Heart Failure and 75% with Kansas City Cardiomyopathy questionnaires). Major adverse events included bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in 4 patients. Conclusions A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplant, with improved functional status and quality of life. [source] Major adverse events, pretransplant assessment and outcome predictionJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 11 2009Hui-Chun Huang Abstract Liver cirrhosis and portal hypertension pose enormous loss of lives and resources throughout the world, especially in endemic areas of chronic viral hepatitis. Although the pathophysiology of cirrhosis is not completely understood, the accumulating evidence has paved the way for better control of the complications, including gastroesophageal variceal bleeding, hepatic encephalopathy, ascites, hepatorenal syndrome, hepatopulmonary syndrome and portopulmonary hypertension. Modern pharmacological and interventional therapies have been designed to treat these complications. However, liver transplantation (LT) is the only definite treatment for patients with preterminal end-stage liver disease. To pursue successful LT, the meticulous evaluation of potential recipients and donors is pivotal, especially for living donor transplantation. The critical shortage of cadaveric donor livers is another concern. In many Asian countries, cultural and religious concerns further limit the number of the donors, which lags far behind that of the recipients. The model for end-stage liver disease (MELD) scoring system has recently become the prevailing criterion for organ allocation. Initial results showed clear benefits of moving from the Child,Turcotte,Pugh-based system toward the MELD-based organ allocation system. In addition to the MELD, serum sodium is another important prognostic predictor in patients with advanced cirrhosis. The incorporation of serum sodium into the MELD could enhance the performance of the MELD and could become an indispensable strategy in refining the priority for LT. However, the feasibility of the MELD in combination with sodium in predicting the outcome for patients on transplant waiting list awaits actual outcome data before this becomes standard practice in the Asia,Pacific region. [source] High-frequency vibration for the recanalization of guidewire refractory chronic total coronary occlusions,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2008Klaus Tiroch MD Abstract Background: Recanalization of coronary chronic total occlusions (CTOs) remains a clinical challenge, particularly when standard guidewire attempts fail. Objectives: We sought to determine the safety and efficacy of a novel method that used high-frequency (20 kHz) vibration to fragment occlusive fibrous tissue and facilitate guidewire crossing into the distal vessel. Methods: A total of 125 patients with CTO, who failed at attempts of conventional guidewire recanalization after more than 5 min of fluoroscopy time, were enrolled in the study. The primary efficacy endpoint was the advancement of the CROSSERÔ catheter through the occlusion and attainment of coronary guidewire positioning in the distal coronary lumen. The primary safety endpoint was the occurrence of death, myocardial infarction, clinical perforation, or target vessel revascularization within the first 30 days. Results: The average fluoroscopy time while delivering the CROSSER catheter was 12.4 min. CROSSER-assisted guidewire recanalization was achieved in 76 (60.8%) procedures and a final diameter stenosis <50% was obtained in 68 (54.4%) of cases. Major adverse events occurred in 11 (8.8%) patients, lower than the predefined objective performance criteria. Angina frequency and quality of life were improved in patients with successful guidewire recanalization. Conclusions: We conclude that high-frequency vibration using the CROSSER catheter is a safe and effective therapy for patients with CTO, which are refractory to standard guidewire recanalization. © 2008 Wiley-Liss, Inc. [source] Atrial septal interventions in patients with hypoplastic left heart syndrome,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2008Ralf J. Holzer MD Abstract Objectives: To report an institutional experience performing percutaneous atrial septal interventions in patients with hypoplastic left heart syndrome (HLHS). Background: The success of the Hybrid approach in palliating patients with HLHS is crucially dependant on relieving any significant interatrial restriction. Data on transcatheter interventions to relieve atrial septal restrictions in patients with HLHS are limited. Methods: We retrospectively reviewed 67 transcatheter atrial septal interventions that were performed between July 2002 and September 2007 in 56 patients with HLHS. The median weight was 3.35 kg. About 10.7% of patients had an intact atrial septum. Balloon atrial septostomy (BAS) was used in 77.6% of procedures, additional techniques in 35.8% of procedures. Patients were divided into those with standard atrial septal anatomy (group A, n = 33) and those with complex atrial septal anatomy (group B, n = 23). Results: The mean trans-septal gradient was reduced significantly from 7 mm Hg to 1 mm Hg with the median time to discharge being 3.5 days. Major adverse events were seen in 8.9% of procedures, whereas minor adverse events occurred in 26.8% of procedures. Adverse events were significantly less common in patients with standard atrial septal anatomy, compared to those with complex atrial septal anatomy (25.6% versus 50.0%). About 19.6% patients required repeated atrial septal interventions. Survival up to and including Comprehensive stage II palliation was 73% group A, and 57% in group B. Conclusions: With utilization of appropriate techniques and equipment, atrial septal interventions in HLHS can be performed successfully in virtually all patients. Complex atrial septal anatomy is technically challenging and has a higher incidence of procedural adverse events. In the majority of patients, standard BAS can be performed safely, and is usually the only intervention required to achieve adequate relief of atrial septal restriction until Comprehensive stage II palliation. © 2008 Wiley-Liss, Inc. [source] Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 20081-Year results in the CABERNET trial Abstract Objective: The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent® plus FilterWire EX®/EZÔ Emboli Protection System. Background: For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). Methods: The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography ,50% for symptomatic patients and ,60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31,365 days) ipsilateral stroke. Results: Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. Conclusions: The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls. © 2008 Wiley-Liss, Inc. [source] Etomidate for Pediatric Sedation Prior to Fracture ReductionACADEMIC EMERGENCY MEDICINE, Issue 1 2001Richard Dickinson MD Abstract. Objective: While etomidate is reported as a procedural sedative in adults, its use in children has not been extensively reported. The authors describe their experience with etomidate for procedural sedation in children with extremity fractures and major joint dislocations. Methods: This was a retrospective descriptive chart review. The setting was a university-based emergency department (ED) that follows national guidelines for procedural sedation. Subjects were children less than 18 years old who received etomidate prior to fracture reduction or major joint dislocations. Standardized data were abstracted from the medical records, including patient demographics, diagnosis, weight, types and doses of sedative and analgesic agents used, number of boluses of etomidate, attempts at reduction, complications encountered, vitals signs before, during, and after the reduction, disposition, and the time from procedure to discharge. Descriptive statistics calculated included means and proportions with 95% confidence intervals. Results: Fifty-three children received etomidate for fracture reduction. Their mean age was 9.7; 41.5% were females. Indications for reduction included forearm fractures (38), ankle fractures (12), upper arm fractures (2), and hip dislocations (1). In most cases (83%) reduction was successful after one attempt only. The mean initial and total doses of etomidate were 0.20 mg/kg (range, 0.1 to 0.4) and 0.24 mg/kg (range, 0.13 to 0.52), respectively. Thirteen patients required a second bolus of etomidate or midazolam. Thirty-four patients (64%) were discharged from the ED after a mean observation of 94 minutes (range, 35 to 255). There were no major adverse events (95% CI = 0% to 5.7%). One patient reported nausea and one required a fluid bolus for hypotension. One patient receiving multiple sedatives and opioid analgesics was admitted for observation due to prolonged sedation. No patient required assisted ventilation or intubation. Conclusions: These results suggest that etomidate is a safe and effective agent for procedural sedation in children requiring fracture and major joint reductions. [source] Ward reduction of gastroschisis in a single stage without general anaesthesia may increase the risk of short-term morbidities: Results of a retrospective auditJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 6 2009Shripada C Rao Background: Ward reduction of gastroschisis in a single stage without the need for general inhalational anaesthesia (ward reduction) has been reported by some authors to be effective and safe. We introduced this practice to our neonatal unit 2 years ago. Aim: To compare the short-term outcomes of this new practice with the standard procedure of reduction under general anaesthesia (GA). Methods: Retrospective case series of all infants with gastroschisis between January 2004 and January 2008. Results: Twenty-seven infants were managed with the traditional approach and 11 infants underwent ward reduction without GA. Infants in the ward reduction group had an increased frequency for all the three major adverse events (ischemic necrosis of bowel: 27.3% vs. 3.7%, odds ratio (OR) 10.72, 95% confidence interval (CI): 0.72, 159.6; need for total parenteral nutrition (TPN) more than 60 days: 18% vs. 3.7%, OR 4.13, 95% CI: 0.28, 61.55; and unplanned return to theatre: 27.3% vs. 7.4%, OR 3.88, 95% CI: 0.44, 34.08), although none of these events reached statistical significance. There were no significant differences between the groups for the outcomes of time to reach full feeds, duration of hospital stay and number of days on antibiotics. Conclusions: These results raise concerns over the role of ward reduction of gastroschisis in a single sitting without the use of GA. Randomised trials with appropriate design and sample size are needed before embracing this method as a standard practice. [source] The Residual Platelet Aggregation after Deployment of Intracoronary Stent (PREDICT) scoreJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 1 2008T. GEISLER Summary.,Background:,Recent studies suggest a high interindividual variability of response to clopidogrel associated with adverse cardiovascular outcome. Different clinical factors are considered to influence a persistent residual platelet aggregation (RPA) despite conventional antiplatelet therapy. Objectives:,To investigate clinical factors that affect RPA after 600-mg clopidogrel loading in a large unselected cohort of patients with symptomatic CAD. Methods:,The study population included a consecutive cohort of 1092 patients treated with coronary stenting for stable angina and acute coronary syndromes (ACS). Residual platelet activity was assessed by ADP (20 ,mol L,1)-induced platelet aggregation , 6 h after LD. Eleven clinical factors were included in the primary analysis. Results:,In multivariate regression analysis increased RPA was significantly influenced by ACS, reduced LV-function, diabetes mellitus, renal failure (creatinine > 1.5 mg dL,1), and age > 65 years. In a factor-weighed model the risk for high RPA increased with higher score levels (OR for patients with a score of 1,3, 1.21, 95% CI 0.7,2.1; score 4,6, OR 2.0, 95% CI 1.17,3.5; P = 0.01; score 7,9, OR 3.3, 95% CI 1.8,6.0). During a 30-day follow-up the incidence of major adverse events was higher in patients with RPA in the upper tertile (4.8% vs. 2.5% in the 2nd and 1.5% in the 1st tertile; P < 0.05). Conclusions:,The PREDICT score provides a good tool to estimate residual platelet activity after clopidogrel LD by easily available patient details. Additionally, we demonstrate its association with short-term outcome. Thus, patients with a high score may benefit from intensified antiplatelet therapy by improved platelet inhibition and risk reduction for thromboischemic events. [source] Treatment of chronic hepatitis C in polytransfused thalassaemic patients: a meta-analysisJOURNAL OF VIRAL HEPATITIS, Issue 4 2010S.-M. Alavian Summary., Hepatitis C virus (HCV) infection is a major cause of liver-related morbidity and mortality among thalassaemic patients. In order to analyse the effect of the current anti-HCV treatment in this subset of HCV-infected patients, we conducted a systematic review with meta-analysis of the available literature. The outcome was sustained viral response. Both comparative [odds ratio (OR)] and non-comparative indeces (success rate) were used to run the meta-analytical procedure. Data encompassing 429 thalassaemic HCV-infected patients treated with conventional or pegylated interferon monotherapy or combination therapy with ribavirin were collected from 13 articles (10 prospective cohort studies, 1 randomized-controlled trial and 2 controlled trials). Pooled sustained viralogical response (SVR) was 44.7% (34.6,54.9). Pooled ORs of SVR for Genotype 1 vs non-Genotype 1 infected thalassaemic patients were 0.46 (95% CI: 0.22,0.95) in IFN monotherapy and 1.7 (95% CI: 0.46,6.04) in ribavirin combination therapy. Our meta-analysis shows that thalassaemic patients with Genotype 1 infection significantly benefit from the addition of ribavirin to their therapeutic regimen. It seems that using ribavirin in thalassaemic patients increases transfusion need by a median of 30,40%, but does not increase major adverse events or treatment withdrawal. Current literature is lacking sufficient evidence about the use of PEG-IFN as monotherapy or in combination with ribavirin in thalassaemic patients. [source] Clinical trial: comparison of ibuprofen-phosphatidylcholine and ibuprofen on the gastrointestinal safety and analgesic efficacy in osteoarthritic patientsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2008F. L. LANZA Summary Background, Chronic use of NSAIDs is associated with gastrointestinal (GI) toxicity that increases with age. Aim, To evaluate the GI safety and therapeutic efficacy of ibuprofen chemically associated with phosphatidylcholine (PC) in osteoarthritic (OA) patients. Methods, A randomized, double-blind trial of 125 patients was performed. A dose of 2400 mg/day of ibuprofen or an equivalent dose of ibuprofen-PC was administered for 6 weeks. GI safety was assessed by endoscopy. Efficacy was assessed by scores of analgesia and anti-inflammatory activity. Bioavailability of ibuprofen was pharmacokinetically assessed. Results, Ibuprofen-PC and ibuprofen provided similar bioavailability/therapeutic efficacy. In the evaluable subjects, a trend for improved GI safety in the ibuprofen-PC group compared with ibuprofen that did not reach statistical significance was observed. However, in patients aged >55 years, a statistically significant advantage for ibuprofen-PC treatment vs. ibuprofen in the prevention of NSAID-induced gut injury was observed with increases in both mean Lanza scores and the risk of developing >2 erosions or an ulcer. Ibuprofen-PC was well tolerated with no major adverse events observed. Conclusion, Ibuprofen-PC is an effective osteoarthritic agent with an improved GI safety profile compared with ibuprofen in older OA patients, who are most susceptible to NSAID-induced gastroduodenal injury. [source] Pilot clinical study of a novel minimally invasive bipolar microneedle radiofrequency device,LASERS IN SURGERY AND MEDICINE, Issue 2 2009Basil M. Hantash MD Abstract Background and Objectives Noninvasive bipolar and monopolar radiofrequency (RF) deep dermal heating devices have previously been described. A novel minimally invasive RF device employing a bipolar microneedle electrode system is introduced and its resultant thermal effects on human skin in vivo were characterized for the first time. Study Design/Materials and Methods An investigational 35 W RF device was configured to operate in bipolar mode delivering energy directly within the dermis using 5 microneedle electrode pairs with real-time feedback of tissue temperature for treatment control. Superficial cooling was achieved using a Peltier device. A range of pulse durations between 1 and 25 seconds, and lesion temperatures between 60 and 80°C were tested in vivo on 15 human subjects. Thermal effects were assessed histologically using either hematoxylin & eosin (H&E) or nitroblue-tetrazoliumchloride (NBTC) staining. Treatment effects and adverse events were also monitored clinically. Results The investigational bipolar RF device delivered controlled heating within dermal tissue. Histological staining with H&E revealed the presence of zones of denatured collagen within the reticular dermis. Lesions were generated at preselected temperatures between 60 and 80°C. Fractional lesions separated by zones of sparing as well as contiguous lesion patterns were demonstrated. Histological staining with H&E and NBTC revealed sparing of adnexal structures and adipose tissue. No major adverse events were observed. Conclusions A novel fractional RF device utilizing a minimally invasive bipolar microneedle delivery system for the treatment of human tissue was developed. Treatment of 15 human subjects illustrated the controlled creation of dermally located thermal coagulation zones, herein known as radiofrequency thermal zones. We discovered that varying the pulse length allowed for fractional sparing of dermal tissue. To our knowledge, this is the first report to describe use of a direct real-time temperature and impedance feedback system to control energy delivery during deep dermal heating. Lasers Surg. Med. 41:87,95, 2009. © 2009 Wiley-Liss, Inc. [source] Propofol or propofol,alfentanil anesthesia for painful procedures in the pediatric oncology wardPEDIATRIC ANESTHESIA, Issue 8 2004Margareta von Heijne MD PhD Summary Background :,For children with cancer receiving curative treatment, the pain of diagnostic and therapeutic procedures is often worse than that of the disease itself. In order to evaluate if light propofol anesthesia in the pediatric oncology ward (POW) could improve the management of procedure pain and anxiety, a questionnaire was developed. Methods :,After prolonged EMLA application, 65 propofol anesthetics were performed successfully in 28 children during lumbar puncture and/or bone marrow aspiration in the POW, with short recovery time and without major adverse events. The questionnaire was mailed to the parents of the 28 children who were included in the survey. Results :,The return of questionnaire compliance was 89% (25 of 28), 12 females and 13 males, mean age was 7 years (range 2,16). Among those who replied, the diagnoses were acute lymphatic leukemia in 21, lymphoma in two and tumor in the other two. In the questionnaire, all parents/patients reported advantages with anesthesia in the POW compared with the operating room. In the list of stated advantages, 88% marked ,familiar nurses and doctors', 84%,familiar environment', 80%,closer to own room', 68%,the child more calm', 72%,shorter waiting-time', 60%,faster recovery', 44%,shorter fasting-time' and 44%,parents more calm', as benefits. For future procedures requiring anesthesia to reduce pain, discomfort and/or anxiety, 92% of the parents/patients preferred anesthesia in the POW. Conclusions :,If anesthesia is chosen for invasive procedures, this study suggest that propofol anesthesia in the POW is preferred by parents and children. [source] Animal Model Development for the Penn State Pediatric Ventricular Assist DeviceARTIFICIAL ORGANS, Issue 11 2009Elizabeth L. Carney Abstract:, In March 2004, the National Heart, Lung, and Blood Institute awarded five contracts to develop devices providing circulatory support for infants and small children with congenital and acquired cardiac disease. Since 2004, the team at Penn State College of Medicine has developed a pneumatically actuated ventricular assist device (VAD) with mechanical tilting disk valves. To date, hemodynamic performance, thrombogenesis, and hemolysis have been chronically evaluated in 16 animals, including 4 pygmy goats and 12 sheep. Major complications, mainly respiratory failure, have been encountered and resolved by a multi-disciplinary team. Multi-modal analgesia, appropriate antibiotic therapy, and attentive animal care have contributed to successful outcomes. Time after implant has ranged from 0 to 40 days. Most recently, a sheep implanted with Version 3 Infant VAD was electively terminated at 35 days postimplant, with no major adverse events. This report describes a successful in vivo model for evaluating a pediatric VAD. [source] Mechanical embolectomy for large vessel ischemic strokes: A cardiologist's experience,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2010Dr. Mark Abelson FCP (Cardiology) Abstract Introduction: Large vessel acute ischemic stroke has a poor outcome. Intravenous (IV) thrombolysis is often contra-indicated and if given, usually ineffective. Mechanical embolectomy is an option in these patients and may be performed by an interventional cardiologist experienced in carotid interventions. Method: Consecutive stroke patients were assessed by the stroke physician and, if eligible, referred for possible mechanical embolectomy using the Merci retriever. All procedures were done by a single cardiologist. Patient information, procedural characteristics and clinical outcomes at 90 days were collected by retrospective chart review. Results: A total of 22 patients were referred for emergency cerebral angiography with 17 undergoing mechanical embolectomy. The mean National Institute of Health Stroke Scale (NIHSS) score was 20.1 and the mean stroke duration was 284 min. Recanalization was successful in 15 (88%) patients. Ten patients (59%) had a good outcome (modified Rankin Score ,2 at 90 days) and four died (mortality 23%). Three patients had significant intra-cerebral hemorrhage. There were no other major adverse events. Conclusions: For patients with large vessel occlusion strokes where IV thrombolysis was either contra-indicated or had failed, mechanical embolectomy performed by an interventional cardiologist had a high recanalization rate with an acceptable clinical outcome and safety profile. © 2010 Wiley-Liss, Inc. [source] Transcatheter closure of high-risk muscular ventricular septal defects with the CardioSEAL occluder: Initial report from the CardioSEAL VSD RegistryCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2007D. Scott Lim MD Abstract Objectives: The CardioSEAL VSD registry was created to track safety of the device to close high-risk Ventricular Septal Defect (VSD). Background: This is the first report from the multi-centered CardioSEAL VSD registry reviewing demographics and initial results. Methods: Centers recruited patients with VSD who were high-risk for surgery due to medical condition or anatomic features. Results: 18 centers contributed data on 55 high-risk patients who had 61 VSD-occlusion procedures, with age of range of 5 days to 65 years and using one to six devices. Implantation approach was transvenous in 48, perventricular in five, and by combined approach in two patients. Ninety-two percent of intended VSD device implants were judged successful. Twenty-two patients had single VSD closed by single device in 18 and by two devices in four patients. All patients <8 kg underwent perventricular device implantation. Thirty-three patients had multiple VSDs which were closed by a single device in 23, and multiple devices in 10. At discharge echocardiography showed total residual flow through all VSDs in which devices were used was classified as "Small" or less in 74%, "More than small" in 11%, and "Uncertain" in 15%. Eight major adverse events occurred in 5/61 cases (8% event rate), with 3/81 devices embolized (4% embolization rate), 5/81 devices surgically explanted (6% explant rate), and no deaths judged to be procedure-related. Conclusion: This initial report from the multi-centered CardioSEAL VSD registry demonstrates the safety of the device to close high-risk VSDs. © 2007 Wiley-Liss, Inc. [source] | ||||||||||||||||||||||