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Primary Endpoint (primary + endpoint)
Selected AbstractsLatent-Model Robustness in Joint Models for a Primary Endpoint and a Longitudinal ProcessBIOMETRICS, Issue 3 2009Xianzheng Huang Summary Joint modeling of a primary response and a longitudinal process via shared random effects is widely used in many areas of application. Likelihood-based inference on joint models requires model specification of the random effects. Inappropriate model specification of random effects can compromise inference. We present methods to diagnose random effect model misspecification of the type that leads to biased inference on joint models. The methods are illustrated via application to simulated data, and by application to data from a study of bone mineral density in perimenopausal women and data from an HIV clinical trial. [source] Plasma urocortin in acute myocardial infarction patientsEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 10 2010Arintaya Phrommintikul Eur J Clin Invest 2010; 40 (10): 874,882 Abstract Background, Despite its proposed cardioprotective effect, the role of plasma urocortin in acute myocardial infarction (AMI) remains unknown. We investigated plasma profile of urocortin in AMI patients and evaluated its long-term prognostic performance. Material and methods, Sixty-six AMI patients and 21 healthy subjects were included in this study. Blood samples for urocortin were collected on days 0 (onset), 1, 3 and 5 and at 3 and 6 months. Primary endpoint was mortality within 1 year of follow-up. Secondary endpoint was combined death and nonfatal adverse cardiac events (i.e. myocardial reinfarction, urgent revascularization or hospitalization due to heart failure) within 1 year. Results, During follow-up at 1 year, 38 (57·6%) patients were alive without cardiac events, nine (13·6%) had nonfatal cardiac events and 17 (25·8%) died. Plasma urocortin in AMI patients were increased on days 0, 1, 3 and 5 (P < 0·05 vs. control). The receiver-operating characteristic curve showed an area under curve (AUC) of day 0 urocortin to be 0·750 with 95% confidence interval (CI) of 0·619,0·881 (P = 0·004), whereas AUC of NT-proBNP was 0·857 (95% CI, 0·722,0·992; P = 0·003). Sensitivity values for predicting the mortality of urocortin NT-proBNP and a combined urocortin and NT-proBNP were 0·81 (95% CI, 0·54,0·95), 0·86 (95% CI, 0·42,0·99) and 1·0 (95% CI, 0·56,1·0), respectively. Conclusions, Plasma urocortin level is elevated in AMI patients for 5 days from onset. High plasma urocortin within 24 h after the onset is associated with increased mortality. Combined urocortin and NT-proBNP enhance prognostic performance in AMI patients. [source] Effects of peer-assisted training during the neurology clerkship: a randomized controlled studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2008J. G. Heckmann Objective:, To determine the efficacy of peer-assisted clinical skills training for students during their neurology clerkship. Methods:, Students (n = 122) were randomized to get clinical skills training from either student (peer) instructors (experimental group) or from experienced clinical staff (control group). The remaining schedule during the clerkship did not differ between both groups. Primary endpoint was students' practical skills and knowledge tested at the end of the course by a written test and objective structured clinical examination (OSCE). Secondary endpoints were evaluation of the practical training and self-estimated gain in theoretical and practical competence. Results:, In the written test, the peer-trained group (n = 66) scored 69.5 ± 10.2 (95% CI 67,72) points of 100 and the postgraduates-trained group (n = 56) 66.7 ± 11.4 (95% CI 63.6,69.8) (P = 0.15). In the OSCE the peer-trained group scored 93.7 ± 6.3 (95% CI 92.1 to 95.2) points of 100 and the postgraduates-trained group 92 ± 5.1 (95% CI 90.6 to 93.4) (P = 0.11). In the evaluation and self-assessment items, there was no significant difference between the two groups except for the postgraduates' higher competence (P = 0.004). Conclusion:, Peer-trained students pass written exam and OSCE as efficient as postgraduates-trained students. Self-assessed learning success is equally rated in both groups. [source] Eradication of Helicobacter pylori Does Not Reduce the Incidence of Gastroduodenal Ulcers in Patients on Long-term NSAID Treatment: Double-Blind, Randomized, Placebo-Controlled TrialHELICOBACTER, Issue 5 2007Helena T.J.I. De Leest Abstract Background:,,Helicobacter pylori and nonsteroidal antiinflammatory drugs (NSAIDs) are the major causes of gastroduodenal ulcers. Studies on the benefit of eradication of H. pylori in NSAID users yielded conflicting results. Objective:, To investigate whether H. pylori eradication in patients on long-term NSAIDs reduces the incidence of gastroduodenal ulcers. Methods:, Patients on long-term NSAID treatment and who are H. pylori positive on serologic testing, were randomly assigned to either H. pylori eradication (omeprazole, amoxicillin, and clarithromycin) or placebo. Primary endpoint was the presence of endoscopic gastric or duodenal ulcers 3 months after randomization. Results:, One hundred sixty-five (48%) of a total of 347 patients were on gastroprotective medication. At endoscopy, gastroduodenal ulcers were diagnosed in 6 (4%) and 8 (5%) patients in the eradication and placebo group, respectively (p = .65). During follow-up of 12 months, no symptomatic ulcers or ulcer complications developed. No significant differences were found in the development of gastroduodenal erosions, dyspepsia, or in quality of life. Conclusion:,H. pylori eradication therapy in patients on long-term NSAID treatment had no beneficial effect on the occurrence of ulcers, erosions, or dyspepsia. Ulcer rates in both study arms are remarkably low, in both patients with and without gastroprotective therapy. [source] Efficacy of Spironolactone on Survival in Dogs with Naturally Occurring Mitral Regurgitation Caused by Myxomatous Mitral Valve DiseaseJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 2 2010F. Bernay Background: Spironolactone, an aldosterone antagonist, has been demonstrated to decrease mortality in human patients when added to other cardiac therapies. Hypothesis: Spironolactone in addition to conventional therapy increases survival compared with conventional therapy in dogs with naturally occurring myxomatous mitral valve disease (MMVD). Animals: Between February 2003 and March 2005, 221 dogs were recruited in Europe. Nine dogs were excluded from analysis, leaving 212 dogs with moderate to severe mitral regurgitation (MR) caused by MMVD (International Small Animal Cardiac Health Council classification classes II [n = 190] and III [n = 21]). Methods: Double-blinded, field study conducted with dogs randomized to receive either spironolactone (2 mg/kg once a day) or placebo in addition to conventional therapy (angiotensin converting enzyme inhibitor, plus furosemide and digoxin if needed). Primary endpoint was a composite of cardiac-related death, euthanasia, or severe worsening of MR. Results: Primary endpoint reached by 11/102 dogs (10.8%) in the spironolactone group (6 deaths, 5 worsening) versus 28/110 (25.5%) in control group (14 deaths, 8 euthanasia, 6 worsening). Risk of reaching the composite endpoint significantly decreased by 55% (hazard ratio [HR] = 0.45; 95% confidence limits [CL], 0.22,0.90; log rank test, P= .017). Risk of cardiac- related death or euthanasia significantly reduced by 69% (HR = 0.31; 95% CL, 0.13,0.76; P= .0071). Number of dogs not completing the study for cardiac and other miscellaneous reasons similar in spironolactone (67/102) and control groups (66/110). Conclusion and Clinical Importance: Spironolactone added to conventional cardiac therapy decreases the risk of reaching the primary endpoint (ie, cardiac-related death, euthanasia, or severe worsening) in dogs with moderate to severe MR caused by MMVD. [source] Desloratadine relieves nasal congestion and improves quality-of-life in persistent allergic rhinitisALLERGY, Issue 11 2009K. Holmberg Background:, Symptoms of allergic rhinitis (AR), particularly nasal congestion, can impair quality-of-life (QoL). However, only a modest correlation exists between these symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, suggesting that both be evaluated for a complete assessment of health. Methods:, Subjects with a ,2-year history of moderate-to-severe AR to dust mite or cat dander were randomized to desloratadine 5 mg/day (n = 293) or placebo/day (n = 291) for 28 days. Primary endpoint was change from baseline in a.m./p.m. nasal congestion score. Secondary outcomes included change from baseline in total nasal symptom score, individual symptom scores and RQLQ scores (completed on days 1, 7, and 28). Results:, The Allergic Rhinitis and its Impact on Asthma criteria for persistent allergic rhinitis (PER) were fulfilled by 99% of subjects in the placebo arm. Between-treatment difference in a.m./p.m. nasal congestion score, observed from day 8 onward, significantly favored desloratadine (P = 0.0003). Desloratadine significantly improved a.m./p.m. nasal congestion and RQLQ scores after 1 week and at treatment end (P < 0.05). Improvements in 5 of 7 RQLQ domain scores exceeded the minimal important difference. On days 7 and 28, desloratadine was also significantly superior to placebo in mean change from baseline in a.m./p.m. total nasal symptom score and rhinorrhea score (both P , 0.01). Symptomatic benefit was primarily driven by improvement in nasal congestion and rhinorrhea. Conclusions:, Desloratadine 5 mg/day significantly improved symptoms associated with PER, including nasal congestion, and provided significant improvement in QoL after 1 week of treatment. [source] Darbepoetin alfa 300 or 500 ,g once every 3 weeks with or without intravenous Iron in patients with chemotherapy-induced anemia,AMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2010Michael Auerbach This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 ,g with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double-blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 ,g (n = 62), darbepoetin alfa 300 ,g plus IV iron (n = 60), darbepoetin alfa 500 ,g (n = 60), or darbepoetin alfa 500 ,g plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ,10 g dL,1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (,11 g dL,1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT-F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 ,g achieved target hemoglobin (75 and 78%, respectively); Kaplan,Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 ,g Q3W and 500 ,g Q3W showed similar benefit, while added IV iron improved treatment response in these patients. Am. J. Hematol., 2010. © 2010 Wiley-Liss, Inc. [source] Phase II trial of weekly bortezomib in combination with rituximab in untreated patients with Waldenström MacroglobulinemiaAMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2010Irene M. Ghobrial This study aimed to determine the activity and safety of weekly bortezomib and rituximab in patients with untreated Waldenström Macroglobulinemia (WM). Patients with no prior therapy and symptomatic disease were eligible. Patients received bortezomib IV weekly at 1.6 mg/m2 on days 1, 8, 15, q 28 days × 6 cycles, and rituximab 375 mg/m2 weekly on cycles 1 and 4. Primary endpoint was the percent of patients with at least a minor response (MR). Twenty-six patients were treated. At least MR was observed in 23/26 patients (88%) (95% CI: 70,98%) with 1 complete response (4%), 1 near-complete response (4%), 15 partial remission (58%), and 6 MR (23%). Using IgM response evaluated by nephlometry, all 26 patients (100%) achieved at least MR or better. The median time to progression has not been reached, with an estimated 1-year event free rate of 79% (95% CI: 53, 91%). Common grade 3 and 4 therapy related adverse events included reversible neutropenia in 12%, anemia in 8%, and thrombocytopenia in 8%. No grade 3 or 4 neuropathy occurred. The combination of weekly bortezomib and rituximab exhibited significant activity and minimal neurological toxicity in patients with untreated WM. Am. J. Hematol., 2010. © 2010 Wiley-Liss, Inc. [source] The Effect of Metformin in Overweight Patients with Type 1 Diabetes and Poor Metabolic ControlBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2009Iben Brock Jacobsen Double-blinded intervention with 2000 mg metformin or placebo daily in 24 type 1 diabetic patients as adjunct to intensive insulin therapy. Primary endpoint was HbA1c, while secondary endpoints were body weight, frequency of hypoglycaemia, blood pressure, lipids, insulin dosage and self-monitored blood glucose profiles were measured. After 24 weeks, no difference in HbA1c was seen between the metformin and placebo groups (,0.5 ± 0.3 vs. ,0.2 ± 0.2%, P = 0.26. , mean ± S.E.M). Mean diurnal blood glucose profiles showed no statistical significant difference between the groups. The total daily insulin dose (IU) was significantly reduced in the metformin group compared to placebo after 24 weeks (,5.9 ± 2.2 vs. 2.9 ± 1.7, P = 0.004. , mean ± S.E.M). An increase in the frequency of hypoglycaemia was seen in the metformin group (0.7 ± 0.9 vs. 0.3 ± 0.5 events patient,1 week,1, P = 0.005), and a reduction in body weight was found using metformin compared to placebo (,3.0 ± 1.0 vs. 0.8 ± 1.1, P = 0.02. , mean ± S.E.M). Lipids and blood pressure did not differ significantly after intervention. Metformin, as adjunct to intensive insulin therapy, was associated with a reduction in the total daily insulin dose and a significant weight loss in patients with type 1 diabetes mellitus. [source] Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion,BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2007NJ Secher Objective, To evaluate the effect of double cerclage compared with a single cerclage. Design, Randomised, controlled multicentre trial. Setting, Ten different countries are participating with both secondary and tertiary centres. The countries participating are Denmark, Sweden, Germany, United Kingdom, Spain, South Africa, Australia and India. This gives both a broad spectrum of diversity global and local. We expect a total of 242 women enrolled per year. Population, Prophylactic study: 1History of cervical incompetence/insufficiency. (Delivery 15 to <36 weeks.) 2Congenital short cervix (secondary to maternal administration of diethyl stilbestrol) or traumatic/surgical damage rendering the vaginal approach difficult (e.g. conisation). 3Cervical suture applied in previous pregnancy, successful outcome. 4Previous failed cerclage. Therapeutic study: 5Secondary cerclage: Short cervix, without the membranes being exposed to the vagina. 6Tertiary cerclage: Short cervix, membranes exposed to the vagina. Observational study: Eligible women who refuse to be randomised will participate in an observational study. 7Repeat/requested cervical occlusion. Methods, The women will be randomised between a single (vaginal or abdominal) and a double cerclage. The cervical cerclage (McDonald or Shirodkar) as well as the abdominal suture will be performed with the same material and technique normally used by the participating department. Those randomised to the double cerclage will have their external os closed with a continuous nylon 2-0/3-0 suture, in addition to the standard single cerclage. Local guidelines concerning antibiotics, Heparin, bed rest, tocolytics etc. are followed and recorded in the follow-up form. Main outcome measures, Primary endpoint is take home baby rate. The secondary endpoints are gestational age at delivery, incidence of preterm birth (<34+0 days) and number of days in neonatal unit. [source] Treatment of instent restenosis following stent-supported renal artery angioplastyCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2007Thomas Zeller MD Abstract Objectives: We prospectively studied the long-term outcome of endovascular treatment of instent renal artery stenosis (IRAS). Background: Restenosis is a considerable drawback of stent-supported angioplasty of renal artery stenosis especially in small vessel diameters. The appropriate treatment strategy is not yet defined. Patients and Methods: During a 10-year period 56 consecutive patients (65 lesions) with their first IRAS were included in a prospective follow-up program (mean follow-up 53 ± 25 months, range 6,102). Primary endpoint of the study was the reoccurrence of IRAS (, 70%) after primarily successful treatment of the first IRAS determined by duplex ultrasound. Results: Primary success rate was 100%, no major complication occurred. Nineteen lesions were treated with plain balloon angioplasty (group 1, 30%), 42 lesions with stent-in-stent placement (group 2, 65%) using various bare metal balloon expandable stents, and 4 lesions with drug-eluting stent angioplasty (group 3, 6%). During follow-up, overall 21 lesions (32%) developed reoccurrence of IRAS: n = 7/19 in group 1 (37%), n = 14/42 in group 2 (33%), and n = 0/4 in group 3 (0%; P = 0.573). Reoccurrence of IRAS was more likely to occur in smaller vessel diameters than in larger ones [3,4mm: 4/7 (57%); 5 mm: 11/26 (42%); 6 mm: 5/25 (20%); 7 mm: 1/7 (14%), P = 0.088]. Multivariable analysis found bilateral IRAS and IRAS of both renal arteries of the same side in case of multiple ipsilateral renal arteries as independent predictors for reoccurrence of IRAS. Conclusion: Treatment of IRAS is feasible and safe. The data demonstrate a nonsignificant trend towards lower restenosis with restenting of IRAS versus balloon angioplasty of IRAS. Individual factors influence the likelihood of reoccurrence of IRAS. © 2007 Wiley-Liss, Inc. [source] Stem Cells Improve Left Ventricular Function in Acute Myocardial InfarctionCLINICAL CARDIOLOGY, Issue 4 2009Sarabjeet Singh MD Background Animal studies have suggested dramatic improvement in cardiac function after acute myocardial infarction (AMI) through regeneration of the myocardium or neovascularization by transfer of cells derived from bone marrow (BMC) generated clinical studies. Recently published small sized studies have yielded mixed results, leaving the question unanswered. Hypothesis We analyzed data from these studies in a meta-analysis to investigate if intracoronary stem cell therapy was effective in improving cardiac function. Methods A total of 7 randomized controlled trials meeting the inclusion criteria were identified by a systematic literature search. Primary endpoint was change in global left ventricular ejection fraction (LVEF) baseline to follow-up (ranging between 3 to 6 months). The meta-analysis consisted of 516 patients (BMC group, 256; control group, 260). A 2-sided , error of less than .05 was considered to be statistically significant (P<.05). Results There were no significant differences in patient characteristics between the BMC treatment and control groups at baseline. Compared to the control group, patients in the BMC treatment group had significantly greater increase in LVEF from baseline to follow-up (mean difference: 6.108%; SE: 1.753%; 95% confidence interval [CI]: 2.672%, 9.543%; P<.001). Conclusions The present meta-analysis suggests that intracoronary bone marrow stem cell infusion may be effective in improving left ventricular systolic function in patients after acute myocardial infarction. Copyright © 2009 Wiley Periodicals, Inc. [source] Influence of needle size on metabolic control and patient acceptanceEUROPEAN DIABETES NURSING, Issue 2 2007G Kreugel RN, MSc Clinical Nurse Specialist in Diabetes Abstract Aim: To investigate whether the length of the needle used for intermittent subcutaneous insulin administration affects metabolic control, injection-related side effects and patient preference. Method: In a crossover study, 68 patients with type 1 and type 2 diabetes, body mass index , 18 kg/m2, were randomised into two groups; 52 patients completed the trial. Patients in group A used a 5 mm needle for their insulin injections over a period of 13 weeks, then switched to a longer needle (8 or 12 mm). Patients in group B used the needles in reverse order. Patients were re-assessed at 26 weeks. Primary endpoints were insulin doses, and frequency and severity of hypoglycaemic events. Secondary endpoints were patient preference and frequency of injection-related bruising, bleeding, insulin leakage and pain. Results: A total of 52 patients completed the study. No change in the mean glycosylated haemoglobin (HbA1c) level was found in group B (baseline, 7.41%; 13 weeks, 7.38%; 26 weeks, 7.34%), whereas a small but significant rise in mean HbA1c level was observed in group A after returning to the longer needle (baseline, 7.67%; 13 weeks, 7.65%; 26 weeks, 7.87%: p<0.05). There were no significant changes in the amount of insulin injected, frequency or severity of hypoglycaemic events or insulin leakage in either group. The 5 mm needle was associated with a significant decrease in bleeding, bruising and pain (p<0.05). Most patients (86%) showed a preference for the 5 mm needle (p<0.05).Conclusion: For insulin injection, a 5 mm needle length is associated with unchanged HbA1c levels, unchanged frequency or severity of hypoglycaemic events and less discomfort for patients compared with 8 or 12 mm needles. The use of 5 mm needles is as safe as 8 or 12 mm needles. Further research is advisable involving thin and obese patients using 5 mm needles, in order for shorter needles to be recommended as standard practice. Copyright © 2007 FEND [source] Efficacy and Safety of a Once-Yearly Intravenous Zoledronic Acid 5 mg for Fracture Prevention in Elderly Postmenopausal Women with Osteoporosis Aged 75 and OlderJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 2 2010Steven Boonen MD OBJECTIVES: To determine the efficacy of once-yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double-blind, placebo-controlled trials. PARTICIPANTS: Postmenopausal women (aged ,75) with documented osteoporosis (T -score ,,2.5 at femoral neck or ,1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54,0.78, P<.001; HR=0.34, 95% CI=0.21,0.55, P<.001; and HR=0.73, 95% CI=0.60,0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once-yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis. [source] Comparison of Cool Tip Versus 8-mm Tip Catheter in Achieving Electrical Isolation of Pulmonary Veins for Long-Term Control of Atrial Fibrillation: A Prospective Randomized Pilot StudyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2006SANJAY DIXIT M.D. Objective: To compare safety and efficacy of 8-mm versus cooled tip catheter in achieving electrical isolation (EI) of pulmonary veins (PV) for long-term control of atrial fibrillation (AF). Background: There is paucity of studies comparing safety/efficacy of 8-mm and cooled tip catheters in patients undergoing AF ablation. Methods and Results: This was a randomized and patient-blinded study. Subjects were followed by clinic visits (at 6 weeks and 6 months) and transtelephonic monitoring (3-week duration) done around each visit. Primary endpoints were: (1) long-term AF control (complete freedom and/or >90% reduction in AF burden on or off antiarrhythmic drugs at 6 months after a single ablation), and (2) occurrence of serious adverse events (cardiac tamponade, stroke, LA-esophageal fistula, and/or death). Eighty-two patients (age 56 ± 9 years, 60 males, paroxysmal AF = 59) were randomized (42 patients to 8-mm tip and 40 patients to cooled tip). EI of PVs was achieved in shorter time by the 8-mm tip as compared with cooled tip catheter (40 ± 23 minutes vs 50 ± 30 minutes; P < 0.05) but long-term AF control was not different between the two (32 patients [78%] vs 28 patients [70%], respectively; P = NS). One serious adverse event occurred in each group (LA-esophageal fistula and stroke, respectively) and no significant PV stenosis was observed in either. Conclusion: EI of PVs using either 8-mm or cooled tip catheter results in long-term AF control in the majority after a single ablation procedure, with comparable efficacy and safety. [source] Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2009N. EJSKJAER Summary Background, TZP-101 is a synthetic, selective ghrelin agonist in development for gastroparesis. Aim, To assess safety and effects of TZP-101 in diabetes patients with symptomatic gastroparesis. Methods, Adults with type 1 or type 2 diabetes mellitus received placebo and TZP-101 (80, 160, 320 or 600 ,g/kg) infusions in a cross-over manner following a radiolabelled meal. Blood glucose levels were stabilized using a hyperinsulinemic-euglycemic clamp. Primary endpoints were gastric half emptying and latency times. Secondary measures included assessment of gastroparesis symptoms and endocrine responses. Results, Ten patients with type 1 (n = 7) or 2 (n = 3) diabetes, moderate-to-severe gastroparesis symptoms and ,29% retention 4 h after a radiolabelled solid meal were enrolled. TZP-101 produced significant reductions in solid meal half-emptying (20%, P = 0.043) and latency (34%, P = 0.037) times vs. placebo. Reductions in overall postmeal symptom intensity (24%) and postprandial fullness (37%) following TZP-101 infusion were not statistically significant. Most adverse events were mild and self-limiting and there were no identifiable differences in numbers or types of adverse events between TZP-101 and placebo. Conclusions, This proof-of-concept study demonstrates that the ghrelin agonist TZP-101 is well-tolerated in diabetes patients with moderate-to-severe chronic gastroparesis and shows statistically significant improvements in gastric emptying. [source] Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer,BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 9 2009T. Yoshikawa Background: Locally advanced gastric cancer with extensive lymph node metastasis is usually considered unresectable and so treated by chemotherapy. This trial explored the safety and efficacy of preoperative chemotherapy followed by extended surgery in the management of locally advanced gastric adenocarcinoma. Methods: Patients with gastric cancer with extensive lymph node metastasis received two or three 28-day cycles of induction chemotherapy with irinotecan (70 mg/m2 on days 1 and 15) and cisplatin (80 mg/m2 on day 1), and then underwent gastrectomy with curative intent with D2 plus para-aortic lymphadenectomy. Primary endpoints were 3-year overall survival and incidence of treatment-related death. Results: The study was terminated because of three treatment-related deaths when 55 patients had been enrolled (mortality rate above 5 per cent). Two deaths were due to myelosuppression and one to postoperative complications. Clinical response and R0 resection rates were 55 and 65 per cent respectively. The pathological response rate was 15 per cent. Median overall survival was 14·6 months and the 3-year survival rate 27 per cent. Conclusion: This multimodal treatment of locally advanced gastric cancer provides reasonable 3-year survival compared with historical data, but at a considerable cost in terms of morbidity and mortality. Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Clinical prognostic scoring system to aid decision-making in gastro-oesophageal cancerBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 12 2007D. A. C. Deans Background: Accurate prediction of prognosis in gastro-oesophageal cancer remains challenging. The aim of this study was to develop a robust model for outcome prediction. Methods: The study included 220 patients with gastric or oesophageal cancer newly diagnosed over a 2-year period. Patients were staged and underwent treatment following discussion at a multidisciplinary team (MDT) meeting. Clinical and investigative variables were collected, including performance and nutritional status, and serum C-reactive protein (CRP) level. Primary endpoints were death within 12 and 24 months. Results: Overall median survival was 13 months. Advanced clinical stage (P < 0·001), reduced performance score (P < 0·001), weight loss exceeding 2·75 per cent per month (P = 0·026) and serum CRP concentration above 5 mg/l (P = 0·031) were identified as independent prognostic indicators in multivariable analysis. A prognostic score was constructed using these four variables to estimate a probability of death. Applying the model gave an area under the receiver,operator characteristic curve of 0·84 and 0·85 for prediction of death at 12 and 24 months respectively (both P < 0·001). Conclusion: This model accurately estimated the probability of death within 12 and 24 months. This may aid the MDT decision-making process. Copyright © 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Low recurrence rate after surgery for dermatofibrosarcoma protuberansCANCER, Issue 5 2004A multidisciplinary approach from a single institution Abstract BACKGROUND Dermatofibrosarcoma protuberans (DFSP) is a rare sarcoma with a propensity for local recurrence. Treatments with wide excision, Mohs surgery, and other approaches have been reported with widely variable local control rates. The objective of this study was to review the experience with a multidisciplinary approach employing wide excision and Mohs surgery selectively in the treatment of patients with DFSP at a single academic institution over the past 10 years. METHODS The records of 62 patients with 63 DFSP tumors who underwent wide excision, Mohs surgery, or a multidisciplinary combination approach from January 1991 to December 2000 were reviewed retrospectively. Primary endpoints included the ability to extirpate the DFSP lesion completely, the tumor recurrence rate, and the need for skin grafts or local tissue flaps. Additional objectives included defining surgical practice patterns at the authors' institution. RESULTS Sixty-three DFSP lesions were removed from 62 patients. At a median follow-up of 4.4 years, no local or distant recurrences were detected in any patient. Forty-three lesions were treated with wide local excision, 11 lesions were treated with Mohs surgery, and 9 lesions were treated with a combination approach. Ninety-five percent of lesions that were approached initially with wide local excision were cleared histologically. Two patients (5%) received postoperative radiation for positive margins after undergoing maximal excision. Eighty-five percent of lesions that were approached initially with Mohs surgery were cleared histologically. The remaining 15% of lesions subsequently were cleared surgically with a wide excision. DFSP lesions that were approached initially with Mohs surgery tended to be smaller. Patients with head and neck lesions most often underwent Mohs surgery or were treated with a multidisciplinary combination approach (87%). CONCLUSIONS Wide local excision with careful pathologic analysis of margins was found to have a very low recurrence rate and was used for the majority of patients with DFSP lesions at the authors' institution. Wide local excision, Mohs surgery, and a multidisciplinary combination approach, selected based on both tumor and patient factors, were capable of achieving very high local control rates in the treatment of DFSP. The evolution of a multidisciplinary approach has provided a level of expertise that no single individual could achieve for the treatment of the full spectrum of DFSP lesions at the authors' institution. Cancer 2004;100:1008,16. © 2004 American Cancer Society. [source] An Alternative Hemostatic Dressing: Comparison of CELOX, HemCon, and QuikClotACADEMIC EMERGENCY MEDICINE, Issue 1 2008Buddy G. Kozen MD Abstract Objectives:, Uncontrolled hemorrhage remains a leading cause of traumatic death. Several topical adjunct agents have been shown to be effective in controlling hemorrhage, and two, chitosan wafer dressing (HemCon [HC]) and zeolite powder dressing (QuikClot [QC]), are being utilized regularly on the battlefield. However, recent literature reviews have concluded that no ideal topical agent exists. The authors compared a new chitosan granule dressing (CELOX [CX]) to HC, QC and standard dressing in a lethal hemorrhagic groin injury. Methods:, A complex groin injury with transection of the femoral vessels and 3 minutes of uncontrolled hemorrhage was created in 48 swine. The animals were then randomized to four treatment groups (12 animals each). Group 1 included standard gauze dressing (SD); Group 2, CX; Group 3, HC; and Group 4, QC. Each agent was applied with 5 minutes of manual pressure followed by a standard field compression dressing. Hetastarch (500 mL) was infused over 30 minutes. Hemodynamic parameters were recorded over 180 minutes. Primary endpoints included rebleed and death. Results:, CX reduced rebleeding to 0% (p < 0.001), HC to 33% (95% CI = 19.7% to 46.3%, p = 0.038), and QC to 8% (95% CI = 3.3% to 15.7%, p = 0.001), compared to 83% (95% CI = 72.4% to 93.6%) for SD. CX improved survival to 100% compared to SD at 50% (95% CI = 35.9% to 64.2%, p = 0.018). Survival for HC (67%) (95% CI = 53.7% to 80.3%) and QC (92%; 95% CI = 84.3% to 99.7%) did not differ from SD. Conclusions:, In this porcine model of uncontrolled hemorrhage, CX improved hemorrhage control and survival. CELOX is a viable alternative for the treatment of severe hemorrhage. [source] Persistent effects of a pedagogical device targeted at prevention of severe hypoglycaemia: A randomized, controlled studyACTA PAEDIATRICA, Issue 10 2005Sam Nordfeldt Abstract Aim: To study the long-term use of self-study material in type 1 diabetes patient education targeted at the prevention of severe hypoglycaemia. Methods: Randomized 1,1,1 control study in three local hospitals. We studied 332 type 1 diabetes patients from the geographic population, aged 2.6,18.9 y at entry. The intervention group received a videotape and brochure in which interviewed patients, parents and medical experts reviewed in detail practical skills for self-control and treatment, with the aim of preventing severe hypoglycaemia. There were two control groups: one received a videotape and brochure with general diabetes information and the other only traditional treatment. Primary endpoints were severe hypoglycaemia needing assistance by another person and HbA1c. Dissemination, reading/viewing level, patients' attitudes and extra contact with caregivers were also investigated. At 24 mo, 249 subjects provided data. Results: The yearly incidence of severe hypoglycaemia decreased at 24 mo from 42% to 25% (difference 17%, 95% CI 3,31, p=0.0241) in the intervention group, but not in controls. HbA1c remained unchanged. Video use during months 13,24 was higher in the intervention group than in controls (p=0.0477), ranging from 1,15 (median 2) times, among 37% of patients (months 1,12, 100%). Higher future use was anticipated for intervention material (p=0.0003). Extra caregiver contact was related to severe hypoglycaemia (p=0.0009). The cost of the material was Thiazolidinediones: effects on the development and progression of type 2 diabetes and associated vascular complicationsDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 2 2009Andrew Krentz Abstract In addition to reducing hyperglycaemia, the metabolic actions of TZDs (pioglitazone and rosiglitazone) in theory might improve the prognosis of patients with type 2 diabetes. However, it appears from recent data that pioglitazone and rosiglitazone have different cardiovascular risk profiles. The scope of this paper is to examine the benefits and risks of pioglitazone and rosiglitazone. Three large clinical studies (DREAM, and ADOPT with rosiglitazone; PROactive with pioglitazone) have recently been reported. A lower annual rate of decline of ß-cell function observed with rosiglitazone in the ADOPT study, compared with metformin and glyburide (glibenclamide), along with a reduced progression to insulin use seen with pioglitazone in the PROactive study, provides evidence that TZDs are effective in treating progressive hyperglycaemia. In PROactive, although the primary endpoint was not met, pioglitazone was associated with a reduction in a secondary composite endpoint of clinical cardiovascular events in high-risk patients with existing macrovascular disease who were already receiving other glycaemic and cardiovascular medications. Further evidence supporting an anti-atherogenic effect of pioglitazone was gained from the PERISCOPE study of carotid intima-media thickness. Recent controversy concerning a possible increased risk of myocardial infarction associated with rosiglitazone has fuelled uncertainty about the risk,benefit profile of this agent. In 2008, an update of an American Diabetes Association,European Association for the Study of Diabetes consensus statement on initiation and adjustment of therapy in patients with type 2 diabetes advised clinicians against using rosiglitazone. Skeletal fractures have recently emerged as a side effect of both TZDs. Available data suggest that cardiovascular benefits observed with pioglitazone might not be a class effect of TZDs. Copyright © 2009 John Wiley & Sons, Ltd. [source] Cardiac function and antiepileptic drug treatment in the elderly: A comparison between lamotrigine and sustained-release carbamazepineEPILEPSIA, Issue 8 2009Erik Saetre Summary Purpose:, To investigate the comparative effects of carbamazepine (CBZ) and lamotrigine (LTG) on electrocardiography (ECG) parameters in elderly patients with newly diagnosed epilepsy. Methods:,, The study was conducted in the Norwegian subcohort (n = 108) of an international randomized double-blind 40-week trial, which compared the efficacy and tolerability of LTG and sustained-release CBZ in patients aged 65 and older with newly diagnosed epilepsy. Target maintenance doses were 400 mg/day for CBZ and 100 mg/day for LTG, with adjustments based on clinical response. Patients with significant unpaced atrioventricular (AV) conduction defect were excluded. Resting 12-lead ECG recordings were made under standardized conditions at pretreatment (baseline) and at the 40-week study visit (treatment visit). Changes in QRS interval (primary endpoint), heart rate (HR), PQ, and QTc (HR-corrected QT) intervals were assessed and compared between groups. Results:, Of the 108 patients randomized, 33 discontinued prematurely because of adverse events (n = 24, none of which was cardiac) or other reasons (n = 9), and 15 were nonevaluable due to incomplete ECG data. None of the assessed ECG parameters differed significantly between groups at baseline. No significant ECG changes were recorded between baseline and treatment visit for QRS duration and QTc intervals, whereas HR fell and PQ intervals increased slightly on both treatments. However, there were no differences between groups in changes from baseline to treatment visit. There were no significant relationships between individual ECG changes and serum drug concentrations, except for QTc intervals, which decreased slightly with increasing CBZ concentrations. The proportion of patients with ECG parameters outside the normal range at treatment visit was similar to that recorded at baseline. Discussion:, Clinically significant ECG changes are not common during treatment with CBZ or LTG in elderly patients with no preexisting significant AV conduction defects. [source] Electrical optimization of cardiac resynchronization in chronic heart failure is associated with improved clinical long-term outcomeEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 8 2010Christopher Adlbrecht Eur J Clin Invest 2010; 40 (8): 678,684 Abstract Background, Cardiac resynchronization therapy (CRT) is an established treatment option for symptomatic chronic heart failure (CHF) patients with pharmacological baseline therapy, but not all patients benefit from device therapy. One reason for this may be inadequate device settings. In real-world practice, echocardiographic evaluation of atrioventricular (AV) delay is not performed in a high proportion of patients, as the effect of electrical optimization of CRT is an issue open for investigation. Materials and methods, We performed a retrospective observational study analysing the effect of AV-interval evaluation with echocardiography on long-term [32 (23?43) months] clinical outcome in 205 CHF patients. A stepwise Cox regression model including a co-morbidity score, failed AV-interval evaluation, satisfactory device function after the first implantation attempt, failure to reach 100% of the recommended renin-angiotensin system inhibitor and beta-blocker dose at follow-up and CRT device implantation compared with CRT in combination with an implanted cardioverter defibrillator (ICD) was applied. Results, In the total study cohort, 124 (60·5%) patients had reached the primary combined endpoint death or cardiac hospitalization and 59 (28·8%) had died. Cox regression analysis revealed that failed AV-interval evaluation [HR = 1·72 (1·19,2·49), P = 0·004] non-optimized CHF pharmacotherapy dosages [HR = 2·12 (1·32,3·42), P = 0·002], the presence of a CRT/ICD combination device [HR = 1·87 (1·28,2·71), P = 0·001] and satisfactory device function after the first implantation attempt [HR = 0·44 (0·25,0·77), P = 0·004] were associated with the primary endpoint. Conclusion, Echocardiographic evaluation of the AV-interval in patients with CRT was independently associated with improved clinical outcome, impacting on daily clinical practice of HF patient care. [source] The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: Results of a double-blind, randomized, placebo-controlled trial,,HEPATOLOGY, Issue 4 2010Edith M. M. Kuiper Colesevelam is an anion-exchange resin with a 7-fold higher bile acid,binding capacity and fewer side effects than cholestyramine, the current first-line treatment option for cholestatic pruritus. The aim of this trial was to compare the effects of colesevelam and a placebo in patients with cholestatic pruritus. In a randomized, double-blind, investigator-initiated, multicenter trial, patients with cholestatic pruritus, both treatment-naive and previously treated, received 1875 mg of colesevelam or an identical placebo twice daily for 3 weeks. The effect on pruritus was assessed with daily visual analogue scales, quality-of-life scores, and evaluations of cutaneous scratch lesions. The predefined primary endpoint was the proportion of patients with at least a 40% reduction in pruritus visual analogue scale scores. Thirty-eight patients were included, and 35 were evaluable: 17 took colesevelam, 18 took the placebo, 22 were female, 8 were treatment-naive, 14 had primary biliary cirrhosis, and 14 had primary sclerosing cholangitis. The mean serum bile acid levels were comparable between the groups before treatment (P = 0.74), but they were significantly different after treatment (P = 0.01) in favor of patients treated with colesevelam. Thirty-six percent of patients in the colesevelam group reached the primary endpoint versus 35% in the placebo group (P = 1.0). There were no significant differences between the groups with respect to pruritus scores, quality-of-life scores, and severity of cutaneous scratch lesions. Mild side effects occurred in one colesevelam-treated patient and four placebo-treated patients. Conclusion: Although colesevelam significantly decreased serum bile acid levels, this trial was unable to demonstrate that it was more effective than a placebo in alleviating the severity of pruritus of cholestasis. (HEPATOLOGY 2010) [source] Effectiveness of antipsychotic polypharmacy for patients with treatment refractory schizophrenia: an open-label trial of olanzapine plus risperidone for those who failed to respond to a sequential treatment with olanzapine, quetiapine and risperidoneHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2008Takefumi Suzuki Abstract Objective To evaluate the effectiveness of antipsychotic polypharmacy in a methodologically sound manner. Methods In this open-label study, 17 patients with treatment-refractory schizophrenia, who failed to respond to a sequential monotherapy with olanzapine, quetiapine and risperidone, were subsequently treated with a combination therapy with olanzapine plus risperidone for at least 8 weeks. Results Seven responded according to the primary endpoint defined as the post-treatment Brief Psychiatric Rating Scale being less than 70% of the pretreatment values, and they were classified as such an average of 10 weeks after the initiation of polypharmacy. Two of them were successful in a later conversion to monotherapy. None dropped out prematurely. Four (out of 13 inpatients) got better enough to be discharged from the hospital, while six patients did not show any response. The Global Assessment of Functioning score improved from 37.1 to 53.0 in responders (mean maximum dose: olanzapine 12.9,mg; risperidone 3.14,mg), while it showed non-significant changes among others (mean maximum dose: olanzapine 14.5,mg; risperidone 5.50,mg). Body weight, prolactin, and total cholesterol increased significantly. Conclusions Antipsychotic polypharmacy might be sometimes helpful for difficult populations but at the cost of adverse effects. More studies of antipsychotic combination therapy versus clozapine, augmentation strategies or tenacious longer- term monotherapy are warranted for refractory schizophrenia. Copyright © 2008 John Wiley & Sons, Ltd. [source] The collaborative atorvastatin diabetes study: preliminary results,INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2005Olwen Glynn Owen Summary The Collaborative AtoRvastatin Diabetes Study (CARDS) is the first large primary prevention study to focus specifically on the role of a statin in patients aged 40,75 years with type 2 diabetes, but no signs or symptoms of pre-existing vascular disease and who had only average or below average cholesterol levels. The trial was a prospective double-blind randomised trial with 2383 type 2 diabetic subjects randomised to either 10-mg atorvastatin daily or placebo. Originally designed to run for 5 years, the trial was terminated over a year early in June 2003 on account of a clear benefit demonstrated for the intervention group. Over half of patients had a low-density lipoprotein cholesterol (LDL-C) below 3.3 mmol/l at entry and a quarter had an LDL-C <2.6 mmol/l. Atorvastatin 10 mg reduced LDL-C by 40% (1.2 mmol/l) on average. Results at 4 years showed a 37% relative risk reduction (p < 0.001) for atorvastatin 10 mg in the primary endpoint (acute coronary heart disease death, fatal or non-fatal myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, coronary revascularisation procedures and stroke). Among the secondary endpoints, total mortality was reduced by 27% (p = 0.05), acute coronary events by 36%, coronary revascularisation by 31% and stroke by 48%. The same magnitude of benefit was observed among patients with LDL-C above or below 3 mmol/l. Results observed were against a background where 9% of placebo patients had been permitted to start statin therapy after enrolment and 15% of patients on active treatment had discontinued atorvastatin. The true benefit of the intervention is therefore probably around 25% greater than the intention to treat analysis reports. [source] Safety of Deferring the Reimplantation of Pacing Systems After Their Removal for Infectious Complications in Selected Patients: A 1-Year Follow-Up StudyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2010ELOI MARIJON M.D. Introduction: Recent expert consensus guidelines mention that one of the principles for infected device replacement following removal is to "reevaluate carefully if there is a continued need for a new cardiac device replacement." This is a Class I recommendation, which nevertheless suffers from a very low level of evidence (level of evidence C), since no study has revisited the systematic practice of reimplanting the same device based on a meticulous clinical reassessment. In the present paper, we examined the safety of withholding the implantation of pacing systems in selected patients. Methods and Results: Between January 2005 and December 2007, 188 consecutive patients underwent extractions of infected pacing systems at 2 medical centers. "Low-risk" patients were identified by (1) a spontaneous heart rate >45 bpm, (2) no symptomatic asystole during monitoring, (3) QRS duration <120 ms when history of AV block was noted, (4) no high-degree AV block during continuous monitoring. They remained device-free, unless an adverse clinical event occurred mandating the reimplantation. The primary study endpoint was rate of sudden death and syncope after a 12-month follow-up. Among the 74 (39.4%) "low-risk" patients, a single patient suffered a bradycardia-related syncopal event corresponding to a 1.3% (95% CI, 0.0,3.9) rate of primary endpoint. Pacing systems were also reimplanted in 24 patients (32.4%) for syncope (n = 1), nonsevere bradycardia-reated symptoms (n = 17), cardiac resynchronization (n = 2), and for reassurance in 4 asymptomatic patients. Conclusion: After removal of infected pacing systems, these preliminary data demonstrated that a strategy of nonsystematic device reimplantation associated with close surveillance was safe in "low-risk" patients, allowing the administration of antimicrobials in a device-free state. (J Cardiovasc Electrophysiol, Vol. 21, pp. 540-544, May 2010) [source] Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device Interrogations in Clinic: Results from a Randomized Pilot Clinical TrialJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2010M.H.S., SANA M. AL-KHATIB M.D. ICD: Remote Monitoring Versus Clinic Interrogations.,Introduction: Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic. Methods and Results: In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months. Conclusion: We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial. (J Cardiovasc Electrophysiol, Vol. 21, pp. 545-550, May 2010) [source] Left Ventricular Lead Proximity to an Akinetic Segment and Impact on Outcome of Cardiac Resynchronization TherapyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 6 2006DANIEL ARZOLA-CASTANER M.D. Background: Previous studies report that the optimal pacing site for cardiac resynchronization therapy (CRT) is along the left ventricular (LV) lateral and postero-lateral (PL) wall. However, little is known regarding whether pacing over an akinetic site impacts the contractile response and long-term outcome from CRT. Methods and Results: A total of 38 patients with ischemic cardiomyopathy were studied for their acute hemodynamic and 12-month clinical response to CRT. The intraindividual percentage change in dP/dt (%,dP/dt), over baseline, was derived from the mitral regurgitation (MR) Doppler profile with CRT on versus off. Two-dimensional echocardiography was used for myocardial segmentation and determinination of akinetic sites. LV lead implant site was determined using angiographic and radiographic data and categorized as being "on" (group 1) or "off" (group 2) an akinetic site. Long-term response was measured as a combined endpoint of hospitalization for heart failure and/or all cause mortality at 12 months. Time to primary endpoint was estimated by the Kaplan-Meier method. Clinical characteristics and acute hemodynamic response was similar in both (group 1 [n = 14]; %,dP/dt 48.8 ± 67.4% vs group 2 [n = 24]; %,dP/dt 32.2 ± 40.1%, P = 0.92). No difference in long-term outcome was observed (P = 0.59). In contrast, lead placement in PL or mid-lateral (ML) positions was associated with a better acute hemodynamic response when compared to antero-lateral (AL) positions (PL, %,dP/dt 45.7 ± 50.7% and ML, %,dP/dt 45.1 ± 58.8% vs AL, %,dP/dt 2.9 ± 30.9%, respectively, P = 0.014). Conclusion: LV lead proximity to an akinetic segment does not impact acute hemodynamic or 12-month clinical response to CRT. [source]
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