Project description:Background. The optimum approach for infectious complication surveillance for cardiac implantable electronic device (CIED) procedures is unclear. We created an automated surveillance tool for infectious complications after CIED procedures. Methods. Adults having CIED procedures between January 1, 2005 and December 31, 2011 at Duke University Hospital were identified retrospectively using International Classification of Diseases, 9th revision (ICD-9) procedure codes. Potential infections were identified with combinations of ICD-9 diagnosis codes and microbiology data for 365 days postprocedure. All microbiology-identified and a subset of ICD-9 code-identified possible cases, as well as a subset of procedures without microbiology or ICD-9 codes, were reviewed. Test performance characteristics for specific queries were calculated. Results. Overall, 6097 patients had 7137 procedures. Of these, 1686 procedures with potential infectious complications were identified: 174 by both ICD-9 code and microbiology, 14 only by microbiology, and 1498 only by ICD-9 criteria. We reviewed 558 potential cases, including all 188 microbiology-identified cases, 250 randomly selected ICD-9 cases, and 120 with neither. Overall, 65 unique infections were identified, including 5 of 250 reviewed cases identified only by ICD-9 codes. Queries that included microbiology data and ICD-9 code 996.61 had good overall test performance, with sensitivities of approximately 90% and specificities of approximately 80%. Queries with ICD-9 codes alone had poor specificity. Extrapolation of reviewed infectious rates to nonreviewed cases yields an estimated rate of infection of 1.3%. Conclusions. Electronic queries with combinations of ICD-9 codes and microbiologic data can be created and have good test performance characteristics for identifying likely infectious complications of CIED procedures.
Project description:AimsCardiac implantable electronic devices (CIED) are important tools for managing arrhythmias, improving hemodynamics, and preventing sudden cardiac death. Device-related infections (DRI) remain a significant complication of CIED and are associated with major adverse outcomes. We aimed to assess the trend in CIED implantations, and the burden and morbidity associated with DRI.Methods and resultsThe 2011-2018 National Inpatient Sample database was searched for admissions for CIED implantation and DRI. A total of 1 604 173 admissions for CIED implantations and 71 007 (4.4%) admissions for DRI were reported. There was no significant change in annual admission rates for DRI (3.96-4.59%, P value for trend = 0.98). Those with DRI were more likely to be male (69.3 vs. 57%, P < 0.001) and have a Charlson comorbidity index score ≥3 (46.6 vs. 36.8%, P < 0.001). The prevalence of congestive heart failure (CHF) increased in those admitted with DRI over the observation period. Pulmonary embolism, deep vein thrombosis, and post-procedural hematoma were the most common complications in those with DRI (4.1, 3.6, and 2.90%, respectively). Annual in-hospital mortality for those with DRI ranged from 3.9 to 5.8% (mean 4.4%, P value for trend = 0.07). Multivariate analysis identified CHF [odds ratio (OR) = 1.67; 95% confidence interval (CI) = 1.35-2.07], end-stage renal disease (OR = 1.90; 95% CI = 1.46-2.48), coagulopathy (OR = 2.94; 95% CI = 2.40-3.61), and malnutrition (OR = 2.50; 95% CI = 1.99-3.15) as the predictors of in-hospital mortality for patients admitted with DRI.ConclusionDevice-related infection is relatively common and continues to be associated with high morbidity and mortality. The prevalence of DRI has not changed significantly despite technical and technological advances in cardiac devices and their implantation.
Project description:BackgroundThe purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente-Cardiac Device Registry.Methods and resultsThis is a cohort study of implantable cardioverter defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy (CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICDs, 33 519 PMs, 4472 CRTs, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% (ICD), 55.0% (PM), and 66.7% (CRT), with mean patient age 63.2 years (ICD), 75.2 (PM), and 67.2 (CRT). The 30-day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% (ICD), ≤0.6% (PM), and ≤0.4% (CRT). Device failures requiring revision occurred at a rate of 2.17% for ICDs, 0.85% for PMs, and 4.93% for CRTs, per 100 patient observation years. Superficial infection rates were <0.03% for all devices; deep infection rates were 0.6% (ICD), 0.5% (PM), and 1.0% (CRT). Results were used to monitor vendor-specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls.ConclusionsThe Kaiser Permanente-Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns.
Project description:The incidence of infection following implantation of cardiac implantable electronic devices (CIEDs) is increasing at a faster rate than that of device implantation. Patients with a CIED infection usually require hospitalisation and complete device and lead removal. A significant proportion die from their infection. Transvenous lead extraction (TLE) is associated with rare but serious complications including major vascular injury or cardiac perforation. Operator experience and advances in lead extraction methods, including laser technology and rotational sheaths, have resulted in procedures having a low risk of complication and mortality. Strategies for preventing CIED infections include intravenous antibiotics and aseptic surgical techniques. An additional method to reduce CIED infection may be the use of antibacterial TYRX™ envelope. Data from non-randomised cohort studies have indicated that antibacterial envelope use can reduce the incidence of CIED infection by more than 80 % in high-risk patients and a randomised clinical trial is ongoing.
Project description:AimsIn patients undergoing cardiac implantable electronic device (CIED) intervention, routine pre-procedure antibiotic prophylaxis is recommended. A more powerful antibiotic protocol has been suggested in patients at high risk of infection. Stratification of individual infective risk could guide the prophylaxis before CIED procedure.Methods and resultsPatients undergoing CIED surgery were stratified according to the Shariff score in low and high infective risk. Patients in the 'low-risk' group were treated with only two antibiotic administrations while patients in the 'high-risk' group were treated with a prolonged 9-day protocol, according to renal function and allergies. We followed-up patients for 250 days with clinical outpatient visit and electronic control of the CIED. As primary endpoint, we evaluated CIED-related infections. A total of 937 consecutive patients were enrolled, of whom 735 were stratified in the 'low-risk' group and 202 in the 'high-risk' group. Despite different risk profiles, CIED-related infection rate at 250 days was similar in the two groups (8/735 in 'low risk' vs. 4/202 in 'high risk', P = 0.32). At multivariate analysis, active neoplasia, haematoma, and reintervention were independently associated with CIED-related infection (HR 5.54, 10.77, and 12.15, respectively).ConclusionIn a large cohort of patients undergoing CIED procedure, an antibiotic prophylaxis based on individual stratification of infective risk resulted in similar rate of infection between groups at high and low risk of CIED-related infection.
Project description:BACKGROUND:Postcardiac injury syndrome (PCIS) is an inflammatory complication that derives from injury to the epicardium, myocardium, or endocardium. It occurs after trauma, myocardial infarction, percutaneous coronary intervention, cardiac surgery, intracardiac ablation, and implantation of cardiac implantable electronic device (CIED). In this study we assessed the incidence of PCIS after CIED implantation and its possible risk factors. MATERIAL AND METHODS:All patients who received CIED implantation at Heidelberg University Hospital between 2000 and 2014 were evaluated (n = 4989 patients). Clinical data including age, sex, underlying cardiac disease, type of implanted CIED, location of electrode implantation, clinical symptoms, time of symptom onset of PCIS, therapy, and outcome were extracted and analyzed. RESULTS:We identified 19 cases of PCIS in 4989 patients, yielding an incidence of 0.38%. The age of patients with PCIS ranged from 39 to 86 years. Dilated cardiomyopathy (DCM) as underlying cardiac disease and right atrial (RA) lead implantation had a significant association with occurrence of PCIS (p = 0.045 in DCM and p < 0.001 in RA lead implantation). Dyspnea, chest pain, dry cough, and fever were the most frequently reported symptoms in patients with PCIS. Pericardial and pleura effusion as well as elevated C‑reactive protein (CRP), increased erythrocyte sedimentation rate (ESR), and leukocytosis were the most common findings. CONCLUSION:To the best of our knowledge, this is the largest cohort evaluating the incidence of PCIS after CIED implantation. The data show that PCIS is a rare complication after CIED implantation and occurs more frequently in patients with DCM and those with RA lead implantation. Although rare and mostly benign, PCIS can lead to potentially lethal complications and physicians must be aware of its symptoms.
Project description:ObjectivesCardiac implantable electronic device (CIED)-induced metal artefacts possibly significantly diminish the diagnostic value of magnetic resonance imaging (MRI), particularly cardiac MR (CMR). Right-sided generator implantation, wideband late-gadolinium enhancement (LGE) technique and raising the ipsilateral arm to the generator during CMR scanning may reduce the CIED-induced image artefacts. We assessed the impact of generator location and the arm-raised imaging position on the CIED-induced artefacts in CMR.MethodsWe included all clinically indicated CMRs performed on patients with normal cardiac anatomy and a permanent CIED with endocardial pacing leads between November 2011 and October 2019 in our institution (n = 171). We analysed cine and LGE sequences using the American Heart Association 17-segment model for the presence of artefacts.ResultsRight-sided generator implantation and arm-raised imaging associated with a significantly increased number of artefact-free segments. In patients with a right-sided pacemaker, the median percentage of artefact-free segments in short-axis balanced steady-state free precession LGE was 93.8% (IQR 9.4%, n = 53) compared with 78.1% (IQR 20.3%, n = 58) for left-sided pacemaker (p < 0.001). In patients with a left-sided implantable cardioverter-defibrillator, the median percentage of artefact-free segments reached 87.5% (IQR 6.3%, n = 9) using arm-raised imaging, which fell to 62.5% (IQR 34.4%, n = 9) using arm-down imaging in spoiled gradient echo short-axis cine (p = 0.02).ConclusionsArm-raised imaging represents a straightforward method to reduce CMR artefacts in patients with left-sided generators and can be used alongside other image quality improvement methods. Right-sided generator implantation could be considered in CIED patients requiring subsequent CMR imaging to ensure sufficient image quality.Key points• Cardiac implantable electronic device (CIED)-induced metal artefacts may significantly diminish the diagnostic value of an MRI, particularly in cardiac MRIs. • Raising the ipsilateral arm relative to the CIED generator is a cost-free, straightforward method to significantly reduce CIED-induced artefacts on cardiac MRIs in patients with a left-sided generator. • Right-sided generator implantation reduces artefacts compared with left-sided implantation and could be considered in CIED patients requiring subsequent cardiac MRIs to ensure adequate image quality in the future.
Project description:BackgroundStudies investigating cardiac implantable electronic device infective endocarditis (CIED-IE) epidemiological changes and prognosis over long periods of time are lacking.MethodsRetrospective single cardiovascular surgery center cohort study of definite CIED-IE episodes between 1981-2020. A comparative analysis of two periods (1981-2000 vs 2001-2020) was conducted to analyze changes in epidemiology and outcome over time.ResultsOne-hundred and thirty-eight CIED-IE episodes were diagnosed: 25 (18%) first period and 113 (82%) second. CIED-IE was 4.5 times more frequent in the second period, especially in implantable cardiac defibrillators. Age (63 [53-70] vs 71 [63-76] years, P < .01), comorbidities (CCI 3.0 [2-4] vs 4.5 [3-6], P > .01), nosocomial infections (4% vs 15.9%, P = .02) and transfers from other centers (8% vs 41.6%, P < .01) were significantly more frequent in the second period, as were methicillin-resistant coagulase-negative staphylococcal (MR-CoNS) (0% vs 13.3%, P < .01) and Enterococcus spp. (0% vs 5.3%, P = .01) infections, pulmonary embolism (0% vs 10.6%, P < .01) and heart failure (12% vs 28.3%, p < .01). Second period surgery rates were lower (96% vs 87.6%, P = .09), and there were no differences in in-hospital (20% vs 11.5%, P = .11) and one-year mortalities (24% vs 15%, P = .33), or relapses (8% vs 5.3%, P = 0.65). Multivariate analysis showed Charlson index (hazard ratios [95% confidence intervals]; 1.5 [1.16-1.94]) and septic shock (23.09 [4.57-116.67]) were associated with a worse prognosis, whereas device removal (0.11 [.02-.57]), transfers (0.13 [.02-0.95]), and second-period diagnosis (0.13 [.02-.71]) were associated with better one-year outcomes.ConclusionsCIED-IE episodes increased more than four-fold during last 40 years. Despite CIED-IE involved an older population with more comorbidities, antibiotic-resistant MR-CoNS, and complex devices, one-year survival improved.
Project description:BACKGROUND:There are limited reports outlining the financial cost of treating cardiac implantable electronic device (CIED) infection outside the United States. This study aimed to determine the average treatment cost of CIED infection in a large UK tertiary referral centre and compared costs of different treatment pathways that are recognised in the management of CIED infection (early versus delayed re-implantation). METHODS:We retrospectively analysed cost and length of stay (LOS) data for consecutive patients undergoing infected CIED extraction with cardiac resynchronization therapy (CRT-D [with defibrillator], CRT-P [with pacemaker]), implantable cardioverter-defibrillators (ICDs) and permanent pacemakers (PPMs). RESULTS:Between January 2013 and March 2015, complete data was available for 84 patients (18 [21.4%] CRT-D, 24 [28.6%] ICDs and 42 [50.0%] PPMs). When all cases were considered the cost of infection ranged from £5,139 (PPM) to £24,318 (CRT-D). Considering different treatment strategies; 41 (48.8%) underwent CIED extraction and re-implantation during the same admission (early re-implant strategy (ER). 43 (51.2%) underwent extraction, but were then discharged home to be re-admitted for day-case re-implantation (delayed re-implant strategy (DR)). Median LOS was significantly shorter in DR compared to ER (5.0 vs. 18.0 days, p<0.001). The total cost of CIED infection episode was similar for both treatment strategies (median £14,241.48 vs. £14,741.70 including wearable defibrillator (Lifevest) and outpatient antibiotics costs, ER vs. DR; p = 0.491). CONCLUSION:CIED infections are expensive and associated with significant health-economic burden. When all device types were considered, a DR strategy is associated with reduced LOS without an increased cost penalty.
Project description:BackgroundThe relationship between the characteristics of cardiac implantable electronic device (CIED) leads and subclinical cardiac perforations remains unclear. This study aimed to evaluate the incidence of subclinical cardiac perforation among various CIED leads using cardiac computed tomography (CT).MethodsA total of 271 consecutive patients with 463 CIED leads, who underwent cardiac CT after CIED implantation, were included in this retrospective observational study. Cardiac CT images were reviewed by one radiologist and two cardiologists. Subclinical perforation was defined as traversal of the lead tip past the outer myocardial layer without symptoms and signs related to cardiac perforation. We compared the subclinical cardiac perforation rates of the available lead types.ResultsA total of 219, 49, and 3 patients had pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy, respectively. The total subclinical cardiac perforation rate was 5.6%. Subclinical cardiac perforation by screw-in ventricular leads was significantly more frequent than that caused by tined ventricular leads (13.3% vs 3.3%, respectively, p = 0.002). There were no significant differences in the incidence of cardiac perforation between atrial and ventricular leads, screw-in and tined atrial leads, pacing and defibrillator ventricular leads, nor between magnetic resonance (MR)-conditional and MR-unsafe screw-in ventricular leads. Screw-in ventricular leads were significantly associated with subclinical cardiac perforation [odds ratio, 4.554; 95% confidence interval, 1.587-13.065, p = 0.005]. There was no case subclinical cardiac perforation by septal ventricular leads.ConclusionsSubclinical cardiac perforation by screw-in ventricular leads is not rare. Septal pacing may be helpful in avoiding cardiac perforation.