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Sankt Pölten, Austria

Wollmann C.G.,Universitatsklinikum St Polten Lilienfeld | Wollmann C.G.,Institute of Cardiovascular Research
Herzschrittmachertherapie und Elektrophysiologie | Year: 2014

This is the first case report about a patient implanted with a DF4 lead suffering from reel syndrome. The reel syndrome may occur due to a ratchet mechanism where the device generator creates torque on a lead fixed at the fixation sleeve. Theoretically, this is less likely to occur in DF4 connectors due to their higher stiffness. © 2014, Springer-Verlag Berlin Heidelberg. Source

Cleland J.G.F.,University of Hull | Calvert M.,University of Birmingham | Freemantle N.,University of Birmingham | Arrow Y.,University of Hull | And 6 more authors.
European Journal of Heart Failure | Year: 2011

Aims Revascularization is frequently advocated to improve ventricular function and prognosis for patients with heart failure due to coronary artery disease, especially when there is evidence of extensive myocardial viability. Methods and resultsPatients with heart failure, coronary artery disease, and a left ventricular (LV) ejection fraction ≤35, who had a substantial volume of viable myocardium with contractile dysfunction assessed by any standard imaging technique, were randomly assigned to a strategy of conservative management vs. angiography with the intent of percutaneous or surgical revascularization. Patients requiring revascularization for angina or too frail for surgery were excluded. Only 138 of the planned 800 patients were enrolled because of withdrawal of funding due to slow recruitment. Also, a larger trial (The Surgical Treatment for Ischemic Heart Failure Trial) addressing a similar question became available, which investigators were encouraged to join. Of 69 patients assigned to the invasive strategy, 6 refused angiography, 2 died as a result of the diagnostic procedure, 14 were considered unsuitable for revascularization, 2 refused surgery, and 45 had revascularization. After a median follow-up of 59 (inter-quartile range: 33-63) months, there were 51 (37%) deaths; 25 (37%) in those assigned to the conservative strategy, and 26 (38%) in those assigned to the invasive strategy, 13 (29%) of whom had been revascularized. Conclusion A conservative management strategy may not be inferior to one of coronary arteriography with the intent to revascularize in patients with heart failure, LV systolic dysfunction, and extensive myocardial viability. However, this study was underpowered and, further, larger trials are required to settle this issue.Clinical trials Registration No: ISRCTN86284615. © 2010 The Author. Source

Belch J.,Institute of Cardiovascular Research | Hiatt W.R.,Aurora University | Hiatt W.R.,CPC Clinical Research | Baumgartner I.,University of Bern | And 3 more authors.
The Lancet | Year: 2011

Patients with critical limb ischaemia have a high rate of amputation and mortality. We tested the hypothesis that non-viral 1 fibroblast growth factor (NV1FGF) would improve amputation-free survival. In this phase 3 trial (EFC6145/TAMARIS), 525 patients with critical limb ischaemia unsuitable for revascularisation were enrolled from 171 sites in 30 countries. All had ischaemic ulcer in legs or minor skin gangrene and met haemodynamic criteria (ankle pressure <70 mm Hg or a toe pressure <50 mm Hg, or both, or a transcutaneous oxygen pressure <30 mm Hg on the treated leg). Patients were randomly assigned to either NV1FGF at 0·2 mg/mL or matching placebo (visually identical) in a 1:1 ratio. Randomisation was done with a central interactive voice response system by block size 4 and was stratified by diabetes status and country. Investigators, patients, and study teams were masked to treatment. Patients received eight intramuscular injections of their assigned treatment in the index leg on days 1, 15, 29, and 43. The primary endpoint was time to major amputation or death at 1 year analysed by intention to treat with a log-rank test using a multivariate Cox proportional hazard model. This trial is registered with ClinicalTrials.gov, number NCT00566657. 259 patients were assigned to NV1FGF and 266 to placebo. All 525 patients were analysed. The mean age was 70 years (range 50-92), 365 (70) were men, 280 (53) had diabetes, and 248 (47) had a history of coronary artery disease. The primary endpoint or components of the primary did not differ between treatment groups, with major amputation or death in 86 patients (33) in the placebo group, and 96 (36) in the active group (hazard ratio 1·11, 95 CI 0·83-1·49; p=0·48). No significant safety issues were recorded. TAMARIS provided no evidence that NV1FGF is effective in reduction of amputation or death in patients with critical limb ischaemia. Thus, this group of patients remains a major therapeutic challenge for the clinician. Sanofi-Aventis, Paris, France. © 2011 Elsevier Ltd. Source

Belch J.J.F.,Institute of Cardiovascular Research | Dormandy J.,St. Georges Hospital
Journal of Vascular Surgery | Year: 2010

Objective: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting. Methods: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD) were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100 mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite of index-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safety endpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries [GUSTO] classification). Results: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151 of 426 patients in the placebo (plus ASA) group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.78-1.23). In a prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR, 0.65; 95% CI, 0.45-0.95; P = .025) but not in venous graft patients (HR, 1.25; 95% CI, 0.94-1.67, not significant [NS]). A significant statistical interaction between treatment effect and graft type was observed (Pinteraction = .008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the rates of severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1% vs 1.2%). Conclusion: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk. © 2010 Society for Vascular Surgery. Source

Wollmann C.G.,Clinical Medicine III | Wollmann C.G.,Institute of Cardiovascular Research
Minerva Cardioangiologica | Year: 2011

Twiddler's Syndrome and Reel Syndrome are potentially harmful lead-related complications in patients with implantable defibrillators and pacemakers. Twiddler's Syndrome is caused by device rotations around the devices long axis. A ratchet mechanism, possibly involving lead fixation sleeves and not device rotations around the transverse axis is suggested to be responsible for the Reel Syndrome. No detailed information about the underlying mechanisms of the Reel Syndrome is available. A case of a patient with a CRT-D and Reel Syndrome is reported; the mechanisms making the Reel Syndrome possible are illustrated and discussed. Source

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