Acute coronary syndromes: considerations for improved acceptance and implementation of management guidelines.
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in Expert Review of Cardiovascular Therapy (2012), 10(4), 489-503
The management of acute coronary syndrome in Europe is covered by various European Society of Cardiology guidelines, which although valuable, are complex and may not always provide clear guidance in ... [more ▼]
The management of acute coronary syndrome in Europe is covered by various European Society of Cardiology guidelines, which although valuable, are complex and may not always provide clear guidance in everyday clinical practice. Consequently, implementation of the guideline recommendations is frequently suboptimal. To complicate matters further, a wealth of new data from large trials examining novel anti-thrombotic agents will become or are already available, necessitating guideline updates. This article summarizes the gaps between current guideline-recommended treatment of acute coronary syndrome and daily practice as dictated by the evidence base, including recent trials. Reasons for the suboptimal implementation of the current European Society of Cardiology guidelines and possible solutions to making these more practice oriented are presented. [less ▲]Detailed reference viewed: 18 (3 ULg)
Final results of a phase IIa, randomised, open-label trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: the SEISMIC trial.
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in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (2011), 6(7), 805-12
AIMS: The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure patients with implanted cardioverter ... [more ▼]
AIMS: The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure patients with implanted cardioverter-defibrillators (ICD). METHODS AND RESULTS: Patients were randomised 2:1 to autologous skeletal myoblast therapy vs. optimal medical treatment. The primary safety end-point was defined as the incidence of procedural and device related serious adverse events, whereas the efficacy endpoints were defined as the change in global LVEF by MUGA scan, change in NYHA classification of heart failure and in the distance achieved during a six-minute walk test (6MW) at 6-month follow-up. Forty subjects were randomised to the treatment arm (n=26), or to the control arm (n=14). There were 12 sustained arrhythmic events and one death after episodes of ventricular tachycardia (VT) in the treatment group and 14 events in the control group (P=ns). At 6-month follow-up, 6MW distance improved by 60.3+/-54.1?meters in the treated group as compared to no improvement in the control group (0.4+/-185.7?meters; P=ns). In the control group, 28.6% experienced worsening of heart failure status (4/14), while 14.3% experienced an improvement in NYHA classification (2/14). In the myoblast-treatment arm, one patient experienced a deterioration in NYHA classification (8.0%), whereas five patients improved one or two classes (20.0%; P=0.06). However, therapy did not improve global LVEF measured by MUGA at 6-month follow-up. CONCLUSIONS: These data indicate that implantation of myoblasts in patients with HF is feasible, appears to be safe and may provide symptomatic relief, though no significant effect was detected on global LVEF. [less ▲]Detailed reference viewed: 96 (0 ULg)