Endoscopy and implantable electronic devices.
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ABSTRACT:
SUBMITTER: Corbett GD
PROVIDER: S-EPMC5517255 | biostudies-other | 2012 Apr
REPOSITORIES: biostudies-other
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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.
| S-EPMC10834167 | biostudies-literature
Project description:AimsRemote management of heart failure using implantable electronic devices (REM-HF) aimed to assess the clinical and cost-effectiveness of remote monitoring (RM) of heart failure in patients with cardiac implanted electronic devices (CIEDs).Methods and resultsBetween 29 September 2011 and 31 March 2014, we randomly assigned 1650 patients with heart failure and a CIED to active RM or usual care (UC). The active RM pathway included formalized remote follow-up protocols, and UC was standard practice in nine recruiting centres in England. The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, death from cardiovascular reasons, death from cardiovascular reasons and unplanned cardiovascular hospitalization, unplanned cardiovascular hospitalization, and unplanned hospitalization. REM-HF is registered with ISRCTN (96536028). The mean age of the population was 70 years (range 23-98); 86% were male. Patients were followed for a median of 2.8 years (range 0-4.3 years) completing on 31 January 2016. Patient adherence was high with a drop out of 4.3% over the course of the study. The incidence of the primary endpoint did not differ significantly between active RM and UC groups, which occurred in 42.4 and 40.8% of patients, respectively [hazard ratio 1.01; 95% confidence interval (CI) 0.87-1.18; P = 0.87]. There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components.ConclusionAmong patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes.
| S-EPMC5837548 | biostudies-literature
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.
| S-EPMC10998729 | biostudies-literature
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.
| S-EPMC9247999 | biostudies-literature
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.
| S-EPMC3417886 | biostudies-other
Project description:Parylene-C (poly-chloro-p-xylylene) is an appropriate material for use in an implantable, microfabricated device. It is hydrophobic, conformally deposited, has a low dielectric constant, and superb biocompatibility. Yet for many bioelectrical applications, its poor wet adhesion may be an impassable shortcoming. This research contrasts parylene-C and poly(p-xylylene) functionalized with reactive group X (PPX-X) layers using long-term electrical soak and adhesion tests. The reactive parylene was made of complementary derivatives having aldehyde and aminomethyl side groups (PPX-CHO and PPX-CH2NH2 respectively). These functional groups have previously been shown to covalently react together after heating. Electrical testing was conducted in saline at 37 degrees C on interdigitated electrodes with either parylene-C or reactive parylene as the metal layer interface. Results showed that reactive parylene devices maintained the highest impedance. Heat-treated PPX-X device impedance was 800% greater at 10kHz and 70% greater at 1Hz relative to heated parylene-C controls after 60 days. Heat treatment proved to be critical for maintaining high impedance of both parylene-C and the reactive parylene. Adhesion measurements showed improved wet metal adhesion for PPX-X, which corresponds well with its excellent high frequency performance.
| S-EPMC2748105 | biostudies-literature
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.
| S-EPMC4711570 | biostudies-literature
Project description: Not available
| S-EPMC8221045 | biostudies-literature
Project description:BackgroundPermanent cardiac implantable electronic devices (CIEDs) are traditionally implanted with the assistance of fluoroscopy. While clinically effective, this technique exposes both patients and providers to radiation which is associated with adverse health effects and represents an occupational hazard. In this study, we investigate the safety and feasibility of permanent CIED placement under the guidance of transthoracic echocardiography (TTE). There is also increasing interest in use of non-fluoroscopic options for noninvasive cardiac electrophysiologic procedures.MethodsFifteen patients consecutively consented for initial implant of CIEDs, specifically dual chamber pacemakers (DCPM) and dual chamber implantable cardioverter defibrillators (DCICDs). Patients were excluded if they had previous implants, abandoned leads, or anatomic anomalies including congenital and known persistent left superior vena cava (PLSVC). We used TTE to guide and implant atrial and ventricular leads.ResultsEleven patients received DCPMs and four patients received DCICDs. The procedure duration was 49.3 min for DCICD and 52.3 min for DCPM, p = .807. The average number of right atrial lead attempts was 1.6 for DCPMs and 1.8 for DCICD, p = .860. The average number of right ventricular lead attempts for DCPMs was 2.2 and 1.0 attempt for DCICDs, p = .044. There were no complications at 90-day follow-up.ConclusionWe demonstrate the feasibility of TTE-guided DCPM/DCICD implantation without use of fluoroscopy. We present this method as a safe alternative for permanent CIED placement that may reduce risk of radiation exposure and cost while maintaining safety and efficacy. No operators wore lead aprons during the procedure.
| S-EPMC8457189 | biostudies-literature
Project description:BackgroundRemote monitoring of cardiac implantable electronic devices (CIEDs) has demonstrated substantial benefits. Treatment guidelines have therefore endorsed its use and is being increasingly adopted in the clinical setting, but the level of satisfaction they convey remains still unknown. We developed and validated a questionnaire to measure patient satisfaction with remote monitoring using Medtronic CareLink® Network and assessed its internal reliability and dimensional validity.MethodsAfter a thorough literature review, cognitive debriefing of 18 patients, and an expert panel discussion, a 30-item instrument was proposed and grouped into 5 dimensions (items): 1- Information on cardiac condition (3), 2- Device convenience (3), 3- Transmission process (6), 4- Satisfaction with medical monitoring (8), and 5- General opinions (10). Correlation with the visual analog scale (VAS), overall health related quality of life (HRQoL) measured by the EuroQoL-5D accompanied by the VAS as well as with the Medical Outcomes Study (MOS) SF-36 were assessed. Psychometric properties, exploratory factor analysis and a second order confirmatory factor analysis (a hierarchical CFA with a general common factor explaining the relations between the first order common factors, See Figure 1) were estimated. Models were assessed based on item loading size, sign and statistical significance, and goodness-of-fit statistics.ResultsA total of 186 patients (77% male) with a mean age of 66.03 (SD = 13.94) years were assessed. 48% had implantable cardioverter-defibrillators, 24% had pacemakers, and 29% had cardiac resynchronization therapy devices. An overall Cronbach's α = 0.893 was achieved, with acceptable reliabilities for isolated dimensions. Correlations with corresponding VAS scales were meaningful and significant (p < 0.01). The second order factor solution yielded good goodness-of-fit indexes (χ2/df = 1.44, CFI = 0.96, TLI = 0.95, RMSEA = 0.05). Satisfaction with remote monitoring was not related to HRQoL (r < 0.05), except for the correlation between the SF-36 mental component and the information on cardiac condition dimension (r = 0.263, p < 0.001).ConclusionsThe 30-item questionnaire showed good reliability and validity to assess satisfaction with remote monitoring in patients with CIEDs.
| S-EPMC7183665 | biostudies-literature