The performances of implantable cardioverter defibrillators and leads are important issues for healthcare providers and patients. In 2007 Sprint Fidelis leads were found to be associated with an increased failure rate and so the purpose of the study was to evaluate long-term mortality and clinical outcomes in patients implanted with Sprint Fidelis leads compared with Sprint Quattro leads.
508 patients with Sprint Fidelis leads and 468 with Sprint Quattro leads were prospectively followed in 12 Italian cardiology centres.
Information on hospitalisations and other clinical events were collected during scheduled and unscheduled hospital visits. Deaths were identified from medical records or via phone contacts with patients’ family members or through the National Office of Vital Statistics.
Over a mean follow-up of 27±18 months 141 deaths occurred in the overall population. No death was observed in patients with diagnosed failing lead. Kaplan-Meier patient survival differed between the two lead groups (80±2% in Fidelis leads vs 70±4% in the Sprint Quattro leads at 4 years, p=0.002). Multivariate analyses showed that mortality was neither associated with lead type nor with diagnosed failed lead. The annual rate of lead failure was 1.8% patient-year for Fidelis leads and 0.2% for the Sprint Quattro leads.
In our multicentre research, the clinical outcomes of patients with Fidelis leads differed from those of patients with Sprint Quattro leads. Nevertheless, neither mortality nor the combined endpoint of mortality and heart failure hospitalisations was associated with the lead type.
To assess the cost-effectiveness of implantable loop recorders (ILRs) and tilt testing (TT) to direct pacing therapy in people with recurrent episodes of transient loss of consciousness that are adversely affecting their quality of life or represent a high risk of injury and are suspected to be vasovagal.
Decision analytical modelling was used to estimate the costs and benefits of diagnostic testing including the costs and benefits of treatment for several clinically important arrhythmias following diagnosis.
A UK National Health Service and personal social services perspective was taken.
People with recurrent episodes of transient loss of consciousness that are adversely affecting their quality of life or represent a high risk of injury and which are suspected to be vasovagal.
The diagnostic test strategies compared were TT alone, TT followed by ILR (if TT ‘negative’), ILR alone and no further testing.
Benefits measured using quality-adjusted life years and incremental cost-effectiveness ratios (ICER) are reported.
The ICERs for TT alone, ILR alone and TT followed by ILR were £5960, £24 620 and £19 110, respectively, compared with no testing. ILR alone was extendedly dominated by the other strategies, meaning that it is never the most cost-effective option. Sensitivity analysis found that the cost-effectiveness estimates were robust despite the areas of uncertainty identified in the evidence and assumptions used to inform the model.
TT alone is likely to be the most cost-effective strategy in this population.