The number of patients with CIED-related infections in the United States continues to increase out of proportion to the increase in implantation rates. Possible causes for this on-going epidemic include sicker patients with varying racial backgrounds, and more complex procedures. These insights may help improve our ability to best select patients for CIED implantation in "real-life" settings. (PACE 2010; 414-419).

To the Editor: Clinical indications for cardiac rhythm management devices (CRMDs) have expanded dramatically. The impact of this expansion upon rates of CRMD infection, a complication of device therapy that often requires system explantation (1), has not been clearly defined.We hypothesized that the current growth in implantable cardioverter defibrillator (ICD) utilization would impact rates of CRMD infection, both by expanding and changing the demographics of the population at risk. We analyzed a nationally representative database to compare trends in rates of new CRMD implants with rates of hospitalization for CRMD infection. We also sought to define the rates of in-hospital mortality associated with such events.We collected files from the National Hospital Discharge Survey (NHDS) from 1996 to 2003. Cases with a primary discharge diagnosis of pacemaker (PM) or ICD infection (International Classification of Diseases-9th Revision-Clinical Modification [ICD-9-CM] code 996.61) were identified. In addition, patients with device explantation (ICD-9-CM codes 37.77, 37.79, 37.89, or 37.99) and a primary discharge diagnosis of sepsis (ICD-9-CM code 038 or 785.59), bacteremia (ICD-9-CM code 790.7), endocarditis (ICD-9-CM codes 421.0, 421.9, or 424.90), cellulitis (ICD-9-CM code 682.9), or fever (ICD-9-CM code 780.6) were defined as having CRMD infection. New CRMD implantations were identified by ICD-9-CM procedural codes 377.0 to 377.6.In order to determine the clinical predictors for in-hospital mortality among patients with CRMD infection, a control group with previously implanted PM or ICD who did not have CRMD infection was identified. This much larger group included patients with PM or ICD in situ (ICD-9-CM codes V45.01 or V45.02, respectively) who were discharged with diagnoses other than CRMD infection. Demographic factors were recorded. Other characteristics were identified, including presence of diabetes (ICD-9-CM codes 250.00 to 250.02 or 250.70 to 250.72), renal failure (ICD-9-CM codes 585, 593.9, or V56.0), and hospital size.Univariate analysis was performed using 1-way analysis of variance for continuous variables and the chi-square test for categoric variables. Multivariate analysis using a binary logistic regression test was undertaken to determine the independent predictors of in-hospital mortality. Cases were weighed using the "weight" variable for derivation of national estimates according to

AimsPermanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker.Methods and resultsPatients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms.ConclusionEarly assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial.Clinical Trial RegistrationClinicalTrials.gov ID NCT02004873.

Predictors of complications after lead extraction procedures include a higher number of extracted leads and the presence of defibrillator as opposed to pacemaker leads. A new paradigm of the removal of all leads not connected to a device may, therefore, reduce the risk of complications from lead extraction procedures and deserves to be tested prospectively.