AimsComplications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality.Methods and resultsPopulation-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3).ConclusionCIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment.
Manchester et al from Denver reported a series of 257 pregnancies which were complicated by suspected fetal abnormality on ultrasonography.' Thirty seven per cent of the infants born had additional anomalies not detected by prenatal ultrasonography, and the authors concluded that prenatal diagnoses based on ultrasonography were remarkably accurate but were insensitive to associated anomalies in individual cases. Our study confirms this, a revised diagnosis being made in 53 (40%) of such cases.We believe that examination of midtrimester fetuses by a clinical geneticist is a worthwhile service and improves diagnosis, which in turn benefits the diagnostic teams and parental counselling. It is best carried out by a clinician experienced in dysmorphology, used to normal variations in the appearance of fetuses at various stages in gestation, and familiar with rare dysmorphic syndromes. The collaboration of cytogeneticists and paediatric pathologists is important in defining the full extent of the anomalies in order to arrive at the final post-termination diagnosis, on which the parents will base their future reproductive decisions.We thank Dr T Andrews, regional cytogenetic servicc, anXr his staff and Dr A J Barson, department of pacdiltric pathology, University of Manchester, and his staff for their skilled work and cooperation.
AimsInfection is a serious complication of pacemaker (PM) systems. Although the rate of infection has been debated, the figures are largely unknown. We therefore studied the incidence of PM infection and its associated risk factors in the Danish population.Methods and resultsSince 1982, all PM implantation and removal procedures performed in Denmark have been prospectively recorded in the Danish Pacemaker Register. All patients (n = 46299) who underwent implantation between 1982 and 2007 were included. The total length of surveillance was 236 888 PM-years. The incidence of infection was calculated according to the total number of PM-years. The incidence of surgical site infection (≤365 days after PM implantation) was compared with later infection in first implant and replacement procedures. Multiple-record and multiple-event-per-subject proportional hazards analyses were used to identify the independent risk factors of PM infection. Surgical site infection occurred in 192 cases after first implantation (incidence rate 4.82/1000 PM-years), and in 133 cases after replacement (12.12/1000 PM-years). Infections occurring more than 365 days after the first implantation occurred in 153 cases (1.02/1000 PM-years), and in 118 cases after replacement (3.26/1000 PM-years). Independent factors associated with an increased risk of PM infection were a greater number of PM operations (including replacements), male sex, younger age, implantation during the earliest part of the study period, and absence of antibiotics (P< 0.001).ConclusionThe overall risk of infection after PM implantation was low. A greater number of operations augmented the risk of infection. This should be taken into account when considering revisions of PM systems.
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