Project description:Background and aimsBloodstream infection (BSI) of any cause may lead to device infection in cardiac implantable electronic device (CIED) patients. Aiming for a better understanding of the diagnostic approach, treatment, and outcome, patients with an implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy and defibrillator (CRT-D) hospitalized with BSI were investigated.MethodsThis is a single-centre, retrospective, cohort analysis including consecutive ICD/CRT-D patients implanted between 2012 and 2021. These patients were screened against a list of all hospitalized patients having positive blood cultures consistent with diagnosed infection in any department of a local public hospital.ResultsThe total cohort consisted of 515 patients. Over a median follow-up of 59 months (interquartile range 31-87 months), there were 47 BSI episodes in 36 patients. The majority of patients with BSI (92%) was admitted to non-cardiology units, and in 25 episodes (53%), no cardiac imaging was performed. Nearly all patients (85%) were treated with short-term antibiotics, whereas chronic antibiotic suppression therapy (n = 4) and system extraction (n = 3) were less frequent. Patients with BSI had a nearly seven-fold higher rate (hazard ratio 6.7, 95% confidence interval 3.9-11.2; P < .001) of all-cause mortality.ConclusionsDiagnostic workup of defibrillator patients with BSI admitted to a non-cardiology unit is often insufficient to characterize lead-related endocarditis. The high mortality rate in these patients with BSI may relate to underdiagnosis and consequently late/absence of system removal. Efforts to increase an interdisciplinary approach and greater use of cardiac imaging are necessary for timely diagnosis and adequate treatment.
Project description:The goal of this paper is to review some important issues occurring during the past year in Implantable devices.First cardiac implantable device was proposed to maintain an adequate heart rate, either because the heart's natural pacemaker is not fast enough, or there is a block in the heart's electrical conduction system. During the last forty years, pacemakers have evolved considerably and become programmable and allow to configure specific patient optimum pacing modes. Various technological aspects (electrodes, connectors, algorithms diagnosis, therapies, ...) have been progressed and cardiac implants address several clinical applications: management of arrhythmias, cardioversion / defibrillation and cardiac resynchronization therapy.Observed progress was the miniaturization of device, increased longevity, coupled with efficient pacing functions, multisite pacing modes, leadless pacing and also a better recognition of supraventricular or ventricular tachycardia's in order to deliver appropriate therapy. Subcutaneous implant, new modes of stimulation (leadless implant or ultrasound lead), quadripolar lead and new sensor or new algorithm for the hemodynamic management are introduced and briefly described. Each times, the main result occurring during the two past years are underlined and repositioned from the history, remaining limitations are also addressed.Some important technological improvements were described. Nevertheless, news trends for the future are also considered in a specific session such as the remote follow-up of the patient or the treatment of heart failure by neuromodulation.
Project description:The incidence of infection following implantation of cardiovascular implantable electronic devices (CIEDs) is increasing, as is the number of pulse generator replacements and upgrades. The rate of infections is rising faster than the rate of device implantation, mainly due to the increasing age and number of comorbidities of patients receiving the devices. Patients with a CIED infection usually require hospitalisation, multiple consultations, prolonged intravenous antibiotics and, in the majority of cases, CIED explantation and replacement. A significant proportion die of their infection. CIED infection therefore represents a substantial health and economic burden, and management of infections is critical. Numerous risk factors have been identified including host, procedure and device-related factors. Established strategies for preventing CIED infections include intravenous antibiotics and aseptic techniques. The TYRX™ Absorbable Antibacterial Envelope offers potential as an effective method to reduce CIED infections. Several studies have found a statistically significant association between antibacterial envelope use and reduced incidence of CIED infection in high-risk patients. A prospective, randomised trial to further evaluate this potentially important strategy for CIED infection prophylaxis is underway.
Project description:The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.
Project description:AimsIn patients with infections of cardiac implantable electronic devices (CIEDs), the identification of causative pathogens is complicated by biofilm formations and previous antibiotic therapy. In this work, the impact of an additional fluorescence in situ hybridization (FISH), in combination with polymerase chain reaction and sequencing (FISHseq) was investigated.Methods and resultsIn 36 patients with CIED infections, FISHseq of explanted devices was performed and compared with standard microbiological cultivation of preoperative and intraoperative samples. The mean age was 61.9 (±16.2) years; 25 (69.4%) were males. Most patients (62.9%) had heart failure with reduced ejection fraction. Infections occurred as endoplastits (n = 26), isolated local generator pocket infection (n = 8), or both (n = 2); CIED included cardiac resynchronization therapy defibrillator (n = 17), implantable cardioverter defibrillator (n = 11), and pacemaker (n = 8) devices. The overall positive FISHseq detection rate was 97%. Intraoperatively, pathogens were isolated in 42 vs. 53% in standard cultivation vs. FISHseq, respectively. In 16 of 17 FISHseq-negative patients, the nucleic acid strain DAPI (4',6-diamidino-2-phenylindole) indicated inactive microorganisms, which were partially organized in biofilms (n = 4) or microcolonies (n = 2). In 13 patients in whom no pathogen was identified preoperatively, standard cultivation and FISHseq identified pathogens in 3 (23%) vs. 8 (62%), respectively. For the confirmation of preoperatively known bacteria, a combined approach was most efficient.ConclusionFluorescence in situ hybridization sequencing is a valuable tool to detect causative microorganisms in CIED infections. The combination of FISHseq with preoperative cultivation showed the highest efficacy in detecting pathogens. Additional cultivation of intraoperative tissue samples or swabs yielded more confirmation of pathogens known from preoperative culture.
Project description:ImportanceCardiac implantable electronic device (CIED) infection is a potentially devastating complication with an estimated 12-month mortality of 15% to 30%. The association of the extent (localized or systemic) and timing of infection with all-cause mortality has not been established.ObjectiveTo evaluate the association of the extent and timing of CIED infection with all-cause mortality.Design, setting, and participantsThis prospective observational cohort study was conducted between December 1, 2012, and September 30, 2016, in 28 centers across Canada and the Netherlands. The study included 19 559 patients undergoing CIED procedures, 177 of whom developed an infection. Data were analyzed from April 5, 2021, to January 14, 2023.ExposuresProspectively identified CIED infections.Main outcomes and measuresTime-dependent analysis of the timing (early [≤3 months] or delayed [3-12 months]) and extent (localized or systemic) of infection was performed to determine the risk of all-cause mortality associated with CIED infections.ResultsOf 19 559 patients undergoing CIED procedures, 177 developed a CIED infection. The mean (SD) age was 68.7 (12.7) years, and 132 patients were male (74.6%). The cumulative incidence of infection was 0.6%, 0.7%, and 0.9% within 3, 6, and 12 months, respectively. Infection rates were highest in the first 3 months (0.21% per month), reducing significantly thereafter. Compared with patients who did not develop CIED infection, those with early localized infections were not at higher risk for all-cause mortality (no deaths at 30 days [0 of 74 patients]: adjusted hazard ratio [aHR], 0.64 [95% CI, 0.20-1.98]; P = .43). However, patients with early systemic and delayed localized infections had an approximately 3-fold increase in mortality (8.9% 30-day mortality [4 of 45 patients]: aHR, 2.88 [95% CI, 1.48-5.61]; P = .002; 8.8% 30-day mortality [3 of 34 patients]: aHR, 3.57 [95% CI, 1.33-9.57]; P = .01), increasing to a 9.3-fold risk of death for those with delayed systemic infections (21.7% 30-day mortality [5 of 23 patients]: aHR, 9.30 [95% CI, 3.82-22.65]; P < .001).Conclusions and relevanceFindings suggest that CIED infections are most common within 3 months after the procedure. Early systemic infections and delayed localized infections are associated with increased mortality, with the highest risk for patients with delayed systemic infections. Early detection and treatment of CIED infections may be important in reducing mortality associated with this complication.
Project description:BackgroundThere is limited data on the impact of comorbidity burden on clinical outcomes of patients undergoing cardiac implantable electronic devices (CIED) implantation.ObjectivesOur aim was to assess trends in CIED implantations and explore the relationship between comorbidity burden and outcomes in patients undergoing de novo implantations.MethodsUsing the National Inpatient Sample database from 2000 to 2014, we identified adults ⩾18 years undergoing de novo CIED procedures. Comorbidity burden was assessed by Charlson comorbidity Index (CCI), and patients were classified into 4 categories based on their CCI scores (CCI = 0, CCI = 1, CCI = 2, CCI ⩾3). Annual implantation trends were evaluated. Logistic regression was conducted to measure the association between categorized comorbidity burden and outcomes.ResultsA total of 3 103 796 de-novo CIED discharge records were identified from the NIS database. About 22.4% had a CCI score of 0, 28.2% had a CCI score of 1, 22% had a CCI score of 2, and 27.4 % had a CCI score ⩾3. Annual de-novo CIED implantations peaked in 2006 and declined steadily from 2010 to 2014. Compared to CCI 0, CCI ⩾3 was independently associated with increased odds of in-hospital mortality, bleeding, pericardial, and cardiac complications (all P < .05). Length of stay and hospital charges increased with increasing comorbidity burden.ConclusionsCCI is a significant predictor of adverse outcomes after CIED implantation. Therefore, comorbidity burden needs to be considered in the decision-making process for CIED implant candidates.
Project description:BackgroundAtrial high rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of stroke. However, the impact of AHRE on improving stroke risk stratification scheme remains uncertain.ObjectiveThe purpose of this study was to assess the impact of AHRE on prognosis in relation with cardiovascular events and risk stratification.MethodsA total of 856 consecutive patients who had dual-chamber CIEDs implanted were retrospectively analyzed. To detect AHREs, they were monitored for 6 months after CIEDs' implantation and were followed for a mean of 4.0 years for clinical outcomes such as thromboembolism or death.ResultsOverall, 125 (14.6%) of patients developed AHREs within the first 6 months (median age 72.0 years, 39.3% female). Patients with AHREs had a high rate of thromboembolism (2.6%/year) and mortality (3.0%/year). On multivariate analysis, AHRE was significantly associated with increased risk of thromboembolism [hazard ratio (HR) 3.40; 95% confidence interval (CI) 1.38-8.37, P = 0.01] and death (HR 3.47; 95% CI 1.51-7.95; P < 0.01). The predictive abilities of the CHADS2 and CHA2DS2-VASc scores were modest, with no significant improvements by adding AHRE to those scores. However, the integrated discrimination improvement and net reclassification improvement showed that the addition of AHRE to the CHADS2 and CHA2DS2-VASc scores statistically improved their predictive ability for the composite outcome.ConclusionsAHRE was an independent factor associated with increased risk of clinical outcomes. The addition of AHRE to the clinical risk scores significantly improved discrimination for thromboembolism or death.
Project description:Population aging and broader indications for the implant of cardiac implantable electronic devices (CIEDs) are the main reasons for the continuous increase in the use of pacemakers (PMs), implantable cardioverter-defibrillators (ICDs) and devices for cardiac resynchronization therapy (CRT-P, CRT-D). The growing burden of comorbidities in CIED patients, the greater complexity of the devices, and the increased duration of procedures have led to an augmented risk of infections, which is out of proportion to the increase in implantation rate. CIED infections are an ominous condition, which often implies the necessity of hospitalization and carries an augmented risk of in-hospital death. Their clinical presentation may be either at pocket or at endocardial level, but they can also manifest themselves with lone bacteremia. The management of these infections requires the complete removal of the device and subsequent, specific, antibiotic therapy. CIED failures are monitored by competent public authorities, that require physicians to alert them to any failures, and that suggest the opportune strategies for their management. Although the replacement of all potentially affected devices is often suggested, common practice indicates the replacement of only a minority of devices, as close follow-up of the patients involved may be a safer strategy. Implantation of a PM or an ICD may cause problems in the patients' psychosocial adaptation and quality of life, and may contribute to the development of affective disorders. Clinicians are usually unaware of the psychosocial impact of implanted PMs and ICDs. The main difference between PM and ICD patients is the latter's dramatic experience of receiving a shock. Technological improvements and new clinical evidences may help reduce the total burden of shocks. A specific supporting team, providing psychosocial help, may contribute to improving patient quality of life.
Project description:AimsTo evaluate whether patients with late complications of pacemakers or implantable cardioverter-defibrillators have hypersensitivity reactions to some of the materials used in generators or in electrodes, or to environmental metal burden.Methods and resultsThe cohort consisted of 20 men and 4 women (mean age: 62.3 ± 17.2 years) who had a history of late complications of implanted devices. The control group involved 25 men and 8 women (mean age: 64.6 ± 14.0 years) who had comparable devices, but no history of late complications. Lymphocyte transformation test was used to evaluate hypersensitivity to eight metal pollutants (antimony, manganese, mercury, molybdenum, nickel, platinum, tin, and titanium) selected by results of questionnaires on environmental burden, and by material analysis of generators and electrode surfaces. Exposures to metal pollutants were approximately the same in patients and in controls. Titanium alloy used in generators contained at least 99.32% of titanium and trace levels of other metals; higher levels of tin and platinum were detected in electrode surfaces. Hypersensitivity reactions to mercury and tin were significantly more frequent in patients than in controls (patients and controls: mercury: 68.2 and 31.1%, respectively; P = 0.022; tin: 25.0 and 3.2%, respectively; P = 0.035). In contrast, hypersensitivity to manganese was significantly more frequent in controls than in patients (patients and controls: 13.6 and 50.0%, respectively; P = 0.008).ConclusionOur findings suggest a possible relation between hypersensitivity to metals used in implantable devices or to environmental metal burden and the occurrence of their late complications.