Cardiac Implantable Electronic Device Placement Research Articles

Postcardiac Injury Syndrome After Cardiac Surgery: An Evidence-Based Review.

Postcardiac injury syndrome (PCIS) serves as a comprehensive term encompassing a spectrum of conditions, namely postpericardiotomy syndrome, postmyocardial infarction (MI) related pericarditis (Dressler syndrome), and post-traumatic pericarditis stemming from procedures like percutaneous coronary intervention or cardiac implantable electronic device placement. These conditions collectively give rise to PCIS, triggered by cardiac injury affecting pericardial or pleural mesothelial cells, leading to subsequent inflammation syndromes spanning from uncomplicated pericarditis to substantial pleural effusion. A thorough literature search conducted on MEDLINE/PubMed utilizing search terms including "postacute cardiac injury syndrome," "postcardiac injury syndrome," "postcardiotomy syndrome," "postpericardiotomy syndrome," and "post-MI pericarditis" was instrumental in collating pertinent studies. To encapsulate the amassed evidence, relevant full-text materials were meticulously selected and amalgamated narratively. The pathophysiology of PCIS is proposed to manifest through an autoimmune-mediated process, particularly in predisposed individuals. This process involves the development of anti-actin and antimyosin antibodies after a cascade of cardiac injuries in diverse forms. Treatment strategies aimed at preventing recurrent PCIS episodes have shown efficacy, with colchicine and nonsteroidal anti-inflammatory drugs, including ibuprofen, demonstrating positive outcomes. Conversely, corticosteroids have exhibited no discernible benefit concerning prognosis or recurrence rates for this ailment. In summary, PCIS serves as a unifying term encompassing a spectrum of cardiac injury-related syndromes. A comprehensive review of relevant literature underscores the autoimmune-mediated pathophysiology in susceptible individuals. The therapeutic landscape involves the proficient use of colchicine and Nonsteroidal anti-inflammatory drugs to deter recurrent PCIS episodes, while corticosteroids do not appear to contribute to improved prognosis or reduced recurrence rates. This nuanced understanding contributes to an enhanced comprehension of PCIS and its multifaceted clinical manifestations, potentially refining its diagnosis and management.

Factors of mortality in patients with cardiac implantable electronic device: 5-year experience.

The use of cardiac implantable electronic devices has increased in recent years. It has also brought some issues. Among these, the complications of cardiac implantable electronic devices infection and pocket hematoma are difficult to manage. It can be fatal with the contribution of patient-related risk factors. In this study, we aimed to find mortality rates in patients who developed cardiac implantable electronic devices infection and pocket hematoma over 5 years. We also investigated the risk factors affecting mortality in patients with cardiac implantable electronic devices. A total of 288 cardiac implantable electronic devices patients were evaluated. Demographic details, history, and clinical data of all patients were recorded. Cardiac implantable electronic devices infection was defined according to the modified Duke criteria. The national registry was used to ascertain the mortality status of the patients. The patients were divided into two groups (exitus and survival groups). In addition, the pocket hematoma was defined as significant bleeding at the pocket site after cardiac implantable electronic devices placement. The cardiac implantable electronic devices infection was similar in both groups (p=0.919), and the pocket hematoma was higher in the exitus group (p=0.019). The exitus group had higher usage of P2Y12 inhibitors (p≤0.001) and novel oral anticoagulants (p=0.031). The Cox regression analysis, including mortality-related factors, revealed that renal failure is the most significant risk factor for mortality. Renal failure was linked to a 2.78-fold higher risk of death. No correlation was observed between cardiac implantable electronic devices infection and mortality, whereas pocket hematoma was associated with mortality. Furthermore, renal failure was the cause of the highest mortality rate in patients with cardiac implantable electronic devices.

Abstract 13046: Bleeding Complications During Cardiac Electronic Device Implantation With Novel Oral Anticoagulants versus Vitamin K Antagonist : A Systematic Review and Meta-Analysis

Introduction: Pocket hematoma is a feared complication of cardiac implantable electronic device (CIED) placement. About half the patients undergoing the procedure are on anticoagulation with consequent increased frequency of device-pocket hematoma. The risk of hematoma is variable based on the type of anticoagulation therapy. The purpose of this study was to compare the risk of device-hematoma in patients on interrupted novel oral anticoagulants (NOAC) versus uninterrupted vitamin K antagonists (VKA) during the peri-operative period. Methods: We performed a meta-analysis using electronic literature search to retrieve studies with CIED surgery on uninterrupted VKA versus interrupted NOAC (range 12-96 hours). Primary outcome of interest was pocket-hematoma. Outcomes were pooled under random-effects meta-analyses and reported as risk ratios (RRs) and 95% CIs. 5 studies with low heterogeneity (I 2 =14%), 4 observational and 1 post-hoc analysis of a randomized trial, were included. 1002 patients NOAC group=376 and VKA group=626 were followed for 4-6 weeks. Results: Baseline characteristics were similar, mean age 71 years and 71% male across both groups. There was no significant difference in endpoints: pocket hematoma (major and minor) {RR 0.74 (0.43-1.29), P=0.29}; major hematoma {RR 0.53 (0.24-1.19), P=0.13}; hematomas with new implants {RR 0.82 (0.46-1.48), P=0.51}; hematomas with generator changes {RR 1.90 (0.84-4.31), P=0.12}; hematomas with device-upgrade {RR 0.41 (0.15-1.07), P=0.07}; major bleed {RR 0.18 (0.03-1.09), P=0.06}; pericardial effusion {RR 1.01 (0.13-8.19), P=0.67}(Fig 1). One study reported peri-implantation infection (n=4/311 NOAC, n=2/467 VKA). One patient out of all 5 studies had systemic thromboembolism in each group (1/837 NOAC, 1/1000 VKA). Conclusion: Interrupted NOAC use is not associated with a higher risk of pocket hematoma compared to uninterrupted VKA after CIED placement.

Abstract 15148: Contemporary Trends of Antibacterial Envelope Use to Prevent Cardiac Implantable Device Infection: Insights From the National Readmission Database

Introduction: Local antibiotic delivery using an antibacterial envelope (AE) was shown to reduce major cardiac implantable electronic devices (CIEDs) infections in a controlled trial. We sought to assess the effect of AE use on CIED infection rates in subsequent clinical practice in the U.S. Methods: Using the Nationwide Readmissions Database and ICD 9/10-PCS codes, we identified patients who had a CIED implanted between 2010 and 2018. Patients were stratified according to the use of an AE. Outcomes were CIED infection rates as well as trends and predictors of AE use. Results: A total of 866,245 patients underwent CIED implantation between 2010 and 2018, with 8489 (1.0%) having an AE implanted during the same index admission. AE use showed an increasing pattern from 0.2% in 2012 up to 3.3% in 2018, p<0.001. After excluding the last 6 months of each calendar year to allow for 6 months of follow-up data, a total 438,299 patients had a CIED implanted with 3938 (0.9%) receiving an AE. The rate of CIED related infection during 6-months post-implantation was lower among patients who had an AE (1.2% vs. 2.2, P<0.001), and this difference persisted after adjustment using a multivariable regression model (OR, 0.53; 95% CI: 0.39-0.71, P<0.001). Some patient factors (hypertension, heart failure, chronic kidney disease, atrial fibrillation and obesity), and hospital characteristics were independent predictors of increased likelihood of AE use during CIED placement (Table 1). Conclusions: There is an up-trending pattern of AE use during CIED implantation. The use of these envelopes is associated with a lower risk of CIED related infection.

How to perform extrathoracic venous access for cardiac implantable electronic device placement: Detailed description of techniques

Venous access is needed for implantation of cardiac implantable electronic devices (CIEDs) with endocardial leads. Extrathoracic venous access in the prepectoral region has become the standard of care for CIED implantation because of lower risks for pneumothorax and likely less lead malfunction due to subclavian crush syndrome. The most common extrathoracic venous access sites in the pectoral region are extrathoracic subclavian vein access, axillary vein access, and cephalic vein access. This review provides a detailed description of the anatomy, technical considerations, and relative advantages and disadvantages of each of these extrathoracic venous access sites.

Tricuspid insufficiency after cardiac-implantable electronic device placement

ABSTRACT Objective Device-related estimates of incidence and significance of tricuspid regurgitation (TR) is mainly based on case reports and small observational studies. We sought to determine whether right-heart device implantation increased the risk of TR in this interventional study. Methods All patients who underwent permanent pacemaker (PPM) or other device implantation were assessed for degree of TR at one year. The data collected was analyzed on IBM SPSS version 26. Descriptive statistics were applied for qualitative variables. Mean and standard deviation were applied for quantitative variables. Regression analysis and paired t-tests were applied for the degree of change and predictors of TR. Results Out of 165 participants, 73.94% were male. The mean age of the participants was 59.86 ± 12.03 years. Dual-chamber pacemaker (DDDR) was the most common device implanted (78.18%) causing significant TR and drop in left ventricular ejection fraction as compared to other devices (p-value < 0.05). The paired t-test for changes in ejection fraction (LVEF) and TR were also significant (p-value < 0.05). A regression model predicted significant TR to depend on baseline LVEF (p-value < 0.05). Conclusion Device-related worsening of TR is related to mechanical mechanisms. It is significantly associated with DDDR pacemakers after a 1-year follow-up.

Evidence-Based Strategies to Promote Long-Term Cardiac Implant Site Health: Review of the Literature.

Cardiac implantable electronic devices (CIEDs) are commonly used nowadays. The association between CIED placement and infections is responsible for the high mortality and device explantation rate. Since CIED placement has increased in the past decade, CIED-related complications have risen. In order to reduce the CIED-related complications rate, the prevention of device infection represents the main goal. Over time, many different studies have proven the importance of the measures to prevent CIED-related infections. This review aims to collect the actual recommendations for CIED infection prevention, providing an overview of the main evidence-based strategies.

Baseline incision characteristics and early scar maturation indices following cardiac device implantation.

AimsDermatologic evaluation for cardiac implantable electronic devices (CIEDs) has not been established. We sought to ascertain baseline wound scar features using quantifiable surgical tools and scar scales on post‐CIED patients.MethodsA single‐center, prospective observational case‐control study was performed where 92 study subjects (40 healthy volunteers and 52 post‐CIED patients) completed the study. Durometer was used to quantify skin pliability before CIED placement, postprocedure, and 2 weeks postprocedure. Higher durometer readings signified reduced skin pliability. Durometer readings were compared to the patients’ contralateral pectoral skin and to a healthy volunteer's cohort skin within the prepectoral region. Patient wounds were observed and graded using the Patient Observer Scar Assessment Scale (POSAS) and Manchester Scar Scale (MSS).ResultsBaseline pectoral skin pliability readings were similar in healthy volunteers and CIED patient population. In comparison to preprocedural measurements, surgical site skin pliability decreased in postprocedural and 2 weeks follow‐up time points (P‐value .004 and <.001, respectively). The increases in durometer readings were higher in the older population (age >75 over time, P = .008). POSAS evaluations showed on average a thin painless hypopigmented scar with moderate stiffness. MSS scar evaluation showed a palpable scar with slight contour differences and color mismatch and appeared to be slightly better in the African American population. There was no difference in scar characteristics with preprocedural use of antiplatelet or anticoagulation or staple closure or gender.ConclusionsSerial measurements could be of value for development of new strategies for cosmesis and improved wound healing.

Complications of cardiac implantable electronic device placement in public and private hospitals.

Few safety data exist comparing clinical outcomes in Australian public and private hospitals. We hypothesised that differences could exist between public and private hospitals due to differences in acuity and patient-level co-morbidities. To report comparative complications of cardiac implantable electronic device (CIED) placement in public and private hospitals. We conducted an observational cohort study of outcomes of patients aged >18 years from 2010 to 2015 undergoing a new permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy pacemaker or defibrillator (CRT-D/P) implant in NSW and Queensland public and private hospitals. The primary endpoint was major CIED-related complications occurring in-hospital or within 90 days of discharge. The independent effect of hospital sector was determined using multiple logistic regression, adjusting for covariates, including age, sex, co-morbidities and procedural acuity. A total of 32 364 new CIED implants (PPM 23 845, ICD 5361 and CRT-D/P 3158) were included (49% in private hospitals). Overall, 8.0% of private hospital procedures and 9.6% public hospital procedures experienced at least one complication. After adjustment, the overall risk of CIED complications was similar in private and public hospitals (OR: 0.92, 95% CI: 0.84-1.00, P = 0.06). In analysis of individual complications, adjusted all-cause in-hospital mortality was higher in private hospitals, (OR: 1.49, 95% CI: 1.03-2.16, P = 0.036) primarily driven by an excess mortality in acute cases. The adjusted risk of in-hospital generator operation (OR: 0.53, 95% CI: 0.30-0.94, P = 0.03) and post-discharge infection (OR: 0.61, 95% CI: 0.46-0.81, P < 0.001) was lower in private hospitals. These data identify important similarities and differences in safety outcomes of CIED implantation between Australian public and private hospitals.

Prevention of Cardiac Implantable Electronic Device-Related Infection in Patients With Cancer: The Role of a Comprehensive Prophylactic Bundle Approach That Includes the Antimicrobial Mesh.

BackgroundOncological patients have several additional risk factors for developing a cardiac implantable electronic device (CIED)–related infection. Therefore, we evaluated the clinical impact of our comprehensive bundle approach that includes the novel minocycline and rifampin antimicrobial mesh (TYRX) for the prevention of CIED infections in patients living with cancer.MethodsWe retrospectively reviewed all consecutive patients who had a CIED placement at our institution during 2012–2017 who received preoperative vancomycin, intraoperative pocket irrigation with bacitracin and polymyxin B, plus TYRX antimicrobial mesh, followed by postoperative oral minocycline.ResultsA total of 154 patients had a CIED, with 97 permanent pacemakers (PPMs), 23 implantable cardioverter defibrillators (ICDs), and 34 cardiac resynchronization therapy (CRT) devices. An underlying solid cancer was present in 62% of patients, while 38% had a hematologic malignancy. Apart from a higher proportion of surgical interventions in the PPM group than in the ICD and CRT groups (P = .007), no other oncologic variables were statistically significantly different between groups. Despite an extensive median follow-up period (interquartile range) of 21.9 (6.7–33.8) months, 16 patients (10%) had a mechanical complication, while only 2 patients (1.3%) developed a CIED infection, requiring the device to be explanted.ConclusionsOur comprehensive prophylactic bundle approach using TYRX antimicrobial mesh in an oncologic population at high risk for infections was revealed upon extensive follow-up to be both safe and effective in maintaining the rate of CIED infection at 1.3%, well within published averages in the broader population of CIED recipients.

Cardiac implantable electronic device placement following alcohol septal ablation for hypertrophic cardiomyopathy in the United States.

Cardiac implantable electronic devices (CIED) are sometimes required after alcohol septal ablation (ASA) for hypertrophic cardiomyopathy (HCM). The primary objectives of this study were to characterize the incidence, timing, and predictors of CIED placement after ASA for HCM. Patients were identified from the 2010-2015 Nationwide Readmissions Databases. Incidence, timing and independent predictors of CIED placement, as well as 30-day readmission rates were examined. There were 1296 patients (national estimate = 2864) with HCM who underwent ASA. CIED were implanted in 322 (25% overall; 14% permanent pacemaker, 11% implantable cardioverter defibrillator) during the index hospitalization. Of these, 21%, 23%, 21%, and 18% occurred on postprocedure day 0, 1, 2, and 3, respectively. Only 17 (1.3%) patients underwent CIED implantation between discharge and 30-day follow up. Independent predictors of index hospitalization CIED implantation included older age, diabetes, heart failure, nonelective index hospital admission and hospitalization at a privately owned hospital. Nonelective 30-day readmission rates among those who did and did not undergo CIED placement during their index hospitalization, were 6.8% and 7.9%, respectively (p = .53); median time to readmission was also similar between groups. One in four HCM patients undergoing ASA underwent CIED implantation during their index hospitalization; nearly 2/3rd during the first 48 hpostprocedure. Private hospital ownership independently predicted CIED placement. More data are needed to better understand the unexpectedly high rates of CIED placement, earlier than anticipated timing of implantation and differential rates by hospital ownership.

Postoperative Antibiotic Prophylaxis Following Cardiac Implantable Electronic Device Placement.

Infections related to cardiac implantable electronic device (CIED) placement are associated with poor clinical outcomes. As such, preprocedural prophylactic antibiotic therapy is indicated for all patients prior to device insertion. However, the available data are less clear on the impact of postprocedural antibiotic therapy on rates of CIED infection when used in addition to preprocedural therapy. This is single-center, retrospective cohort study of 913 patients who underwent CIED-related procedures between October 2010 and August 2014 sought to compare the rate of CIED infections in patients receiving only preprocedural antibiotics with those receiving both preprocedural and postprocedural antibiotics. Univariate analysis was used to detect independent risk factors for CIED infection. After excluding patients receiving concomitant antibiotics for other conditions, those undergoing CIED extraction alone, and those with a lack of follow-up data and/or adequate documentation of clinical encounters, 569 patients were identified for inclusion in the final analysis. The majority of patients who received postprocedural antibiotics received three to five days of therapy, with the most common antibiotic used being cephalexin. There was no statistically significant difference in the incidence of infection between patients who did and did not receive postoperative antibiotics (4.5% versus 6.1%; p = 0.398). In a multivariate analysis, the use of postprocedural antibiotic therapy was not a significant risk factor for infection (adjusted odds ratio: 0.692; 95% confidence interval: 0.314–1.525; p = 0.361). It is therefore reasonable to withhold prescribing postoperative antibiotics in patients following CIED implantation. Individualized risk factor evaluation of patient comorbidities and procedural characteristics may be needed to aid in determining whether postoperative antibiotics are reasonable in different patients. The validity of these findings is contingent on further confirmation via a prospective, randomized clinical trial.

Impact of transvenous cardiac implantable electronic devices in chronic hemodialysis patients: a single-center, observational comparative study

BackgroundWe investigated the impact of a transvenous cardiac implantable electronic device (CIED) placement on outcomes and arteriovenous vascular access (VA) patency among chronic hemodialysis patients.MethodsThis is a single-center, observational comparative study between chronic hemodialysis patients with ipsilateral and contralateral CIED and VA. Forty-two consecutive patients who underwent both CIED placement and upper-extremity VA for hemodialysis, regardless of the sequence and time interval between these 2 procedures, were identified between January 2001 and December 2017. Patients with ipsilateral (n = 22, 52%, the ipsilateral group) and contralateral (n = 20, 48%, the contralateral group) CIED and VA were compared retrospectively; the primary outcome was any-cause mortality and cardiac mortality or the composite of any systemic complications, defined as central venous stenosis or occlusion, any device infections or tricuspid regurgitation; the secondary outcome was CIED or VA malfunction.ResultsDuring the median follow-up period of 101 months, primary outcome incidence was significantly higher in the ipsilateral group than the contralateral group (73% vs 40%, P = 0.03), although the incidences of any-cause mortality (P = 0.28) and cardiac mortality (P > 0.99) were similar between the groups. Secondary outcome incidence did not differ significantly between the 2 groups (55% vs 30%, P = 0.36). Kaplan–Meier survival analysis revealed similar primary and secondary VA patency rates in both groups. On subgroup analysis, patients with upper arm VA had similar primary and secondary patency to those with forearm VA.ConclusionsDespite some notable limitations of the study, the retrospective study design and small sample size, we found that the any-cause mortality incidence and VA patency did not differ between the 2 groups, but primary outcome incidence was significantly higher among patients with ipsilateral CIED and VA.

Infection and readmission rate of cardiac implantable electronic device insertions: An observational single center study

Infection is one of the most serious complications following surgical placement of cardiac implantable electronic devices (CIEDs). Infection prevention efforts are necessary in reducing CIED infectious outcomes. These devices, however, are commonly inserted in higher risk patients, which may explain the ongoing risk of surgical site infection (SSI) in this population. The rates of CIED infection and utilization vary widely in the literature. The definitions of infection may also vary between clinical definitions and the National Healthcare Safety Network (NHSN) criteria. The primary objective of this study was to review patient data to identify risk factors for infection and readmission after CIED placement at an academic medical center. The secondary objectives were to compare the rates of SSI identified by NHSN criteria compared to that obtained by applying clinical infection definitions. The overall rate of infection (SSI) was 1.9%, which was identical in both the clinical definition and NHSN reported data. The 30 day readmission rate and the 90 day readmission rate were 12.7% and 25.6% respectively with the most readmissions related to the patients' underlying medical conditions. A lower ejection fraction (EF) was identified as an independent risk factor for readmission, inpatient procedures, smoking and device infection were also significantly associated with readmission after CIED insertion.

Spontaneous subclavian venous occlusion before electronic device implantation

Subclavian venous occlusion sometimes precludes the ability to insert leads during placement of a cardiac implantable electronic device. This study was performed to identify the risk factors for spontaneous subclavian venous occlusion prior to placement of an implantable electronic device. We studied 446 patients who underwent axillary-subclavian venography to assess for occlusion and/or anomaly of the subclavian vein or associated veins before electronic device implantation. Six (1.3%) patients had venous occlusion (left subclavian vein in 5, left innominate vein in 1). There was a significantly higher incidence of previous cancer in the occlusion group than in the nonocclusion group (11.5% vs. 50%, p = 0.03). Subclavian venous occlusion may be present before cardiac implantable electronic device placement. A history of cancer represents a risk factor subclavian venous occlusion, and patients with this risk factor should undergo subclavian venography prior to electronic device placement.

Outcomes of Lead Revision for Myocardial Perforation After Cardiac Implantable Electronic Device Placement

Cardiac perforation is an infrequent but potentially life-threatening complication associated with placement of a cardiac implantable electronic device (CIED). The objective of this study was to determine the outcomes of percutaneous lead revision in patients who had lead perforation of the myocardium after CIED placement. We reviewed records of 1,458 patients who underwent CIED lead extraction or repositioning. Of these, 31 (2.1%) had the procedure performed for lead perforation as a complication of CIED placement. Demographic, clinical, and follow-up characteristics of the patients were analyzed. Mean (SD) patient age was 65 (23) years. Cardiac perforation was detected within 24 hours after implantation in 9 patients, within 1 month in 17, and greater than 1 month in 5. Pericardiocentesis was performed with a pigtail drainage catheter in place before the lead revision in 17 patients (55%) who had pericardial effusion, with or without hemodynamic compromise. All culprit leads were successfully managed with percutaneous lead removal (n = 3 [10%]), new lead placement (n = 12 [38%]), or lead repositioning (n = 16 [52%]). Of the 17 patients with pericardiocentesis before the reoperation, none had tamponade develop; in contrast, 3 of the remaining 14 patients had tamponade develop and required urgent pericardiocentesis. All patients survived without requiring open chest surgery. Percutaneous removal or repositioning of the perforating lead is feasible and appears effective. Placement of a prophylactic pericardial drain catheter may reduce the incidence of urgent pericardiocentesis during or after a procedure.

Rib Perforation From a Right Ventricular Pacemaker Lead

A 50-year-old man was admitted to a community hospital for high fever. Seven years earlier, he had been in a motor vehicle accident and a cervical spine injury had resulted in quadriplegia and ventilator dependence. During that hospitalization, he was noted to have long sinus pauses that were thought to be vagally mediated, and a single-chamber pacemaker was implanted to hasten his recovery, with an active fixation pacing lead placed at the right ventricular apex (Figure 1A through 1C). His bradycardia spells subsequently disappeared, and minimal pacing was needed. Figure 1. Serial chest radiographs showing the pacemaker lead position at the time of implantation (A), at initial hospital discharge (B), 7 months after implantation (C), and at the current admission (D). The position of the lead tip is designated by an arrow, and the lead tip is clearly located outside the rib cage (D). Because of spiking fevers, leukocytosis, and methicillin-resistent Staphylococcus aureus growing from blood cultures; a …