Cardiac Implantable Electronic Device Infection Research Articles

The role of an antibiotic envelope in the prevention of major cardiac implantable electronic device infections: A systematic review and meta-analysis.

Background:Over the past decade, rates of cardiac implantable electronic device (CIED) related infections have increased and been associated with increased morbidity, mortality and financial burden on healthcare systems.Methods:To examine the effect of an antibacterial envelope in reducing major CIED related infections, we performed a systematic review and meta-analysis by searching PubMed/MEDLINE, CENTRAL, Google scholar and Clinicaltrials.gov for studies that examined the effect of an antibiotic envelope in reducing major related CIED infections, comprising of device-related endocarditis, systemic infection requiring systemic antibiotics and or device extraction, compared to control up till February 15th, 2020. A random-effects meta-analysis was conducted by calculating risk ratios (RR) and respective 95% confidence intervals (CI).Results:We include 6 studies that comprise of 11,897 patients, of which 5844 received an antibiotic envelope and 6053 did not. Compared with control, utilization of an antibiotic envelope at the time of procedure was associated with a significant 74% relative risk reduction in major CIED related infections among patients at high risk for infection (RR: 0.26 [95% CI, 0.08–0.85]; P = .03), while no significant reduction was observed among patients enrolled from studies with any risk for infection (RR: 0.53 [95% CI, 0.06–4.52]; P = .56). Additionally, no reduction in mortality among patients that received an envelope compared to control was observed (RR: 1.15 [95% CI, 0.53–2.50]; P = .72).Conclusion:The utilization of an antibiotic envelope at the time of device implantation or upgrade reduces major CIED infections, especially if used in patients perceived to be at higher risk for infection.

Single Photon Emission Tomography in the Diagnostic Assessment of Cardiac and Vascular Infectious Diseases.

Cardiac and vascular infection is an arising cause of mortality and morbidity in the adult population. Diagnosis based on culture and anatomic imaging are frequently inconclusive. Radiolabeled leucocyte scintigraphy plays a useful role in the diagnosis and management of these serious infectious conditions. In this paper, we present an update on the diagnostic performance of single- photon emission tomographic (SPECT) techniques using different radionuclides in the management of patients with cardiac and vascular infections. We performed a thorough search of recent literature on the topic. We present a discussion on the clinical utility of different SPECT tracers in cardiac and vascular infections, including infective endocarditis, cardiac implantable electronic device (CIED) infections, left ventricular assist device infection, and vascular graft infection. Radionuclide technique using SPECT tracers is a useful imaging modality in the diagnosis of cardiac infection. Among the different SPECT tracers for infection imaging, radiolabeled leucocyte scintigraphy is currently the most useful tool in the diagnosis and management of patients with suspected cardiac and vascular infection. Radiolabeled leucocyte scintigraphy has a high specificity, a result of the ability of the leucocytes to accumulate as sites of pyogenic infection but not at sites of sterile inflammation such as seen in the early post-operative period or in response to the presence of a prosthetic cardiac or vascular material. Limited experience with radiotracers for in vivo labelling of leucocytes such as 99mTc-sulesomab and 99mTc-besilesomab show acceptable diagnostic performance without the need for the tedious process of ex-vivo labeling. 67Ga scintigraphy used to be popular for cardiac and vascular infection imaging. Its use has run out of favor following the availability of more effective molecular imaging methods. SPECT techniques with radiolabeled leucocyte scintigraphy has a high diagnostic performance in the evaluation of patients with suspected cardiac or vascular infection. It is able to confirm or reject the presence of infection when results of anatomic imaging or culture remain inconclusive. Its diagnostic performance is not compromised by sterile inflammation occurring in the early post-operative period or in response to implanted prosthetic materials.

Hyaluronic acid-based antibacterial hydrogels constructed by a hybrid crosslinking strategy for pacemaker pocket infection prevention

In this study, we developed an injectable antibacterial hydrogel based on hyaluronic acid (HA) and chlorhexidine (CHX) for cardiovascular implantable electronic device (CIED) infection treatment. To balance stability and moldability, the HA scaffold was pre-crosslinked by 1,4-butanediol diglycidyl ether (BDDE) and then ground to form an HA microgel (CHA). Then, the antibacterial agent CHX was further crosslinked in the CHA microgel through electrostatic interactions between CHA and CHX to obtain hybrid crosslinked hydrogels (CHA/CHX). These hydrogels exhibited shear-thinning/self-recovery behavior, allowing easy injection into the CIED pocket and good matching with the pocket shape without extra space requirements, which represents an improvement on previously reported methods. In vitro and in vivo antibacterial tests showed that the CHA/CHX hydrogels had both good biocompatibility and very effective antibacterial action. The above results indicated that the CHA/CHX hydrogels would be an excellent candidate for CIED pocket infection treatment.

P549CIED infection risk score validation using US health claims data

Abstract Funding Acknowledgements This work was supported by Medtronic Background/Introduction: The increasing number of cardiac implantable electronic device (CIED) infections has led to increased interest in the identification of patients who may benefit from additional infection prevention measures. Purpose The purpose of this evaluation was to validate the predictive value of the Prevention of Arrhythmia Device Infection Trial (PADIT) risk score to identify patients at increased risk of CIED infection using a U.S. health claims data set. Methods A retrospective analysis using the Optum® Clinformatics® claims database was conducted to create a dataset of index procedures which either did or did not result in an infection. The study population included both commercial and Medicare Advantage patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014. Major CIED infections, defined as an infection associated with system removal, invasive procedure without system removal, or death attributable to infection, were identified through diagnosis and procedure codes. The dataset was randomized (stratified by PADIT score, which included prior procedures, age, depressed renal function, immunocompromised, and procedure type) into a Development Dataset (60%) and a Validation dataset (40%). A frailty model allowing multiple procedures per patient was fit using the Development Dataset, with PADIT score as the only predictor, excluding patients with prior infection. Prior CIED infection, which was not available in the original PADIT data, was examined for additional predictive value. Results The data extraction resulted in a dataset of 53,554 index procedures among 51,583 patients, with 30,950 patients randomized to the Development Dataset. The distribution of procedures was pacemakers (52%), ICD (20%), CRT (12%), and Revision/Upgrade (16%), while prior procedures were none (62%), 1 (37%), and 2 (1%). Among patients with no history of prior CIED infection, the frailty model showed that a 1 unit increase in the PADIT score predicts higher infection risk (20%) in the U.S. claims data set (Table 1). Prior CIED infection was associated with strong additional predictive value (HR 4.77, p < 0.0001) after adjusting for PADIT score. Conclusion In the largest external validation of a CIED risk score, the PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that can benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection brings additional predictive value to the PADIT score.

1261Geographical variations in the incidence of CIED infection and infection prevention strategies: Update from the global WRAP-IT study

Abstract Funding Acknowledgements Medtronic, Inc. Introduction Cardiac Implantable Electronic Device (CIED) infections lead to significant morbidity, mortality, and use of health care resources. There is variation in infection prevention strategies among centers, and it is not clear whether there is also variation in infection rates across different geographies. Recently, WRAP-IT, the largest global randomized trial to evaluate an infection reduction strategy, randomized 6,983 patients to receive an antibacterial envelope (treatment) vs. no envelope (control). The results demonstrated a significant reduction in major CIED infection with the TYRX antibiotic envelope (12-mo infection rate for envelope vs. control 0.7% and 1.2%, respectively; HR, 0.60; 95% [CI], 0.36 to 0.98; P = 0.04). The purpose of this analysis is to assess geographical variations in patient characteristics, procedural routines, and infection rates. Methods The WRAP-IT study enrolled patients undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator and randomized them to receive the envelope or not, in addition to mandated pre-procedure intravenous antibiotic prophylaxis. To assess geographical variations in infection rates, the control group (per protocol) baseline demographics and procedural characteristics were identified. Major infection was defined as CIED infections resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death. Results A total of 3429 control patients were evaluated and followed for a mean of 20.9 ± 8.3 months; 2530 patients from 123 centers in North America, 777 patients from 46 centers in Europe, and 122 patients from 11 centers in Asia/South America. The 24-month Kaplan-Meier major infection rates were 1.2% in North America (30 pts), 2.5% in Europe (16 pts), and 4.3% Asia/South America (5 pts) (see Figure). These geographical variations in the incidence of major CIED infections were significant (overall P = 0.008, univariate). There were differences in baseline patient characteristics, including age, sex, medication use, NYHA Class, and number of previous devices across geographies. Differences also included procedural characteristics, such as device type, use of pocket wash, skin preparation, pre-operative antibiotic drug use, and procedure time. Conclusion Major CIED infection rates vary significantly across geographies. The effect of patient demographics and procedural characteristics on these findings will be assessed and presented at EHRA. Insights into geographical variability of CIED infections is important to mitigate infection risk, reduce morbidity and cost. Abstract Figure. Major CIED Infection Rate by Geography

P1506Prolonged and recurrent hospital admissions predict risk of cardiac implantable electronic device infections in hospitalized patients with bacteriaemia

Abstract Background As the use of Cardiac Implantable Electronic Devices (CIED) is expanding, the burden of device-related infections, particularly infectious endocarditis, is also increasing. Furthermore, with the increase in life expectancy, these devices are being implanted in patients who are older, with more serious co-morbidities and who are frequently hospitalized. Purpose To assess incidence and predisposing factors for infective endocarditis (IE) in hospitalized patients with CIED and nosocomial bacteraemia. Methods We performed a retrospective analysis of all hospitalized patients with CIED and positive blood cultures admitted to the Cardiology department between January 2012 and February 2019. Endocarditis was defined according to modified Duke criteria. We analyzed clinical parameters, device- and procedure-related characteristics, length of hospital stay and hospitalizations in the previous year. Results 25 patients had positive blood cultures, 4 patients (16.0%) were diagnosed with infective endocarditis (median age 59.25 years, 75.0% male). Patients characteristics are displayed in the Table. In univariable analysis, the number and presence of hospitalizations in the previous year and the length of hospital stay was significantly associated with the possibility of endocarditis (respectively, OR 3.411, 95% CI 1.164-9.998, p-value 0.025; OR 18.000, 95% CI 1.375-235.686, p-value 0.028; and OR 1.047, 95% IC 1.001-1.096, p-value 0.046). Conclusion In this group of patients with positive blood cultures during hospitalization, the possibility of CIED infection was predicted by the length of hospital stay and the presence and number of hospitalizations in the previous year. With CIED-IE Without CIED-IE p-value Age in years, median (IQR) 63 (16) 76 (16) 0.002 Heart failure, n (%) 4 (100%) 10 (47.6%) 0.105 LVEF in %, median (IQR) 21 (9) 51 (30) 0.008 LV dilation, n (%) 4 (100%) 8 (38.1%) 0.039 Device revision/upgrade/substitution, n (%) 2 (50.0%) 6 (28.57%) 0.570 LOS in days, median (IQR) 58.5 (83) 20 (15) 0.004 Hospital admissions in the previous year, n (%) 3 (75.0%) 3 (14.3%) 0.031 No. of hospital admissions in the previous year, mean (standard deviation) 1.67 (1.528) 0.29 (0.784) 0.005 Use of central venous access, n (%) 4 (100%) 4 (19.05%) 0.008 LOS – Length of Stay; LV – Left Ventricle; LVEF – Left Ventricle Ejection Fraction

P1188Oral antibiotic treatment for local cardiac implantable electronic device infections: our 6-year experience

Abstract INTRODUCTION Cardiac implantable electronic device (CIED) infection is a severe disease with an increasing incidence due to the rise in the number of CIEDs implanted world-wide. Complete hardware removal is the treatment of choice, but there is little clinical data about the best antimicrobial strategy, such as the best choice of antibiotics, treatment duration and when to switch to oral administration in cases of local CIED infections. PURPOSE In 2013, we designed a new protocol for CIED infection management, by which local infections were treated with complete hardware removal followed by empiric parenteral antibiotic during the first 72h, which was replaced to an oral agent (in case of negative blood cultures) and continued for 10 days. The oral antibiotic was selected according to the local cultures when positive, or to Clindamicin, Levofloxacin or Cotrimoxazole when no germ was identified. Our purpose is to describe our experience and results after the implementation of this strategy. METHODS We retrospectively reviewed all consecutive local CIED infection cases from the implementation of the protocol until September 2019, and evaluated the population characteristics, type of infection, rate of positive cultures and outcomes. RESULTS We identified 74 cases of CIED infection, of which 46 (62%) were local. The average age of this population was 75.3 ± 13.2 yo and 65% (30) were male. The predominant comorbidities were diabetes (41%), congestive heart failure (30%), and malignancies (22%). Eighteen patients (39%) had previous local infection treated medically without hardware removal. Mean number of previous procedures was 2.65 ± 1.8, and 34 (74%) of the devices were pacemakers (single and dual chamber), 5 (11%) ICDs, 6 (13%)CRT-P and 1 (2%) CRT-D. Blood cultures were negative in all cases, whereas local cultures (exudate or intraoperative tissue) were positive in 32 (70%). The most frequent microorganisms were Staphylococcus epidermidis in 18 (56%) and Staphylococcus aureus in 8 (25%), including 1 case of meticillin-resistance. Intravenous Vancomycin was administered in all cases during 72 h, followed by oral antibiotics for a mean duration of 8.8 ± 3.3 days. Hardware removal was intended in all cases, with complete or clinical success in 42 and 3 cases respectively (global success rate 97.8%), and in one case (2.2%) an epicardial lead was not removed. During a mean follow-up of 30 months, 1 infection-related death occurred (2%) due to a side effect of intravenous antibiotic therapy, and there was 1 infection relapse (2%) in the only patient without complete hardware removal, related to the remnant epicardial lead. CONCLUSIONS Oral antimicrobial treatment with good bioavailability agents, associated with complete hardware removal is an effective strategy for the management of local CIED infections, with a low recurrence rate, and avoiding long hospitalizations and potential side effects of intravenous antibiotic therapy.

Antibiotic eluting poly(ester urea) films for control of a model cardiac implantable electronic device infection

Cardiac implantable electronic device (CIED) infections acquired during or after surgical procedures are a major complication that are challenging to treat therapeutically, resulting in chronic and sometimes fatal infections. Localized delivery of antibiotics at the surgical site could be used to supplement traditional systemic administration as a preventative measure. Herein, we investigate a cefazolin-eluting l-valine poly(ester urea) (PEU) films as a model system for localized antibiotic delivery for CIEDs. Poly(1-VAL-8) PEU was used to fabricate a series of antibiotic-loaded films with varied loading concentrations (2%, 5%, 10% wt/wt) and thicknesses (40 µm, 80 µm, 140 µm). In vitro release measurements show thickness and loading concentration influence the amount and rate of cefazolin release. Group 10%-140 µm (load-thickness) showed 22.5% release of active pharmaceutical ingredient (API) in the first 24 h and 81.2% of cumulative percent release through day 14 and was found most effective in bacterial clearance in vitro. This group was also effective in clearing a bacterial infection in a model in vivo rat study while eliciting a limited inflammatory response. Our results suggest the feasibility of cefazolin-loaded PEU films as an effective sustained release matrix for localized delivery of antibiotics. Significance StatementImplant-associated infections acquired during surgical procedures are a major complication that have proven a challenge to treat clinically, resulting in chronic and sometimes fatal infections. In this manuscript, we investigate an antibiotic-eluting L-valine poly(ester urea) (PEU) films as a model system for localized delivery of cefazolin. Significantly, we demonstrate a wide variation in temporal delivery and dosing within this family of PEUs and show that the delivery can be extended by varying the film thickness. The in vivo results show efficacy in an infected wound model and suggest antibiotic loaded PEU films function as an effective sustained release matrix for localized delivery of antibiotics across a number of clinical indications.

Abstract 103: A Meta Analysis of Antibiotic Envelope Use to Prevent Cardiac Implantable Electronic Device Infections

Introduction: Cardiac Implantable Electronic Device (CIED) infections are a major source of morbidity, mortality and increased healthcare cost. There are several well established risk factors associated with increased infection. An antibiotic coated envelope has been developed as an infection prevention intervention. Hypothesis: Whether antibiotic coated envelope is an effective preventive strategy against Cardiac Implantable Electronic Device Infections. Methods: 6 trials comparing use of antibiotic envelope to control, including 1 randomized trial and 5 cohort studies were selected using PubMed and Embase data bases through May 2019. The efficacy end point was prevention of CIED Infection. Outcomes were combined using random effects model and estimated by odds ratio with 95% confidence intervals (CI). Results: In our analysis of total 12,024 patients undergoing CIED implantation, 5,844 patients received antibiotic envelope while 6,180 patients were included in the control group. Antibiotic envelope was superior to control in reducing the risk of device infection (OR 0.40 CI [0.17-0.95], p=0.04). Conclusions: The use of antibiotic envelope in Cardiac Implantable Electronic Devices (CIED) is associated with reduced incidence of CIED infection.

Lead Extraction for Cardiovascular Implantable Electronic Device Infection in Patients With Left Ventricular Assist Devices.

The goal of this study was to assess the utility of transvenous lead extraction for cardiovascular implantable electronic device (CIED) infection in patients with a left ventricular assist device (LVAD). The use of transvenous lead extraction for the management CIED infection in patients with a durable LVAD has not been well described. Clinical and outcomes data were collected retrospectively among patients who underwent lead extraction for CIED infection after LVAD implantation at Duke University Hospital. Overall, 27 patients (n=6 HVAD; n=15 HeartMate II; n=6 Heartmate III) underwent lead extraction for infection. Median (interquartile range) time from LVAD implantation to infection was 6.1 (2.5 to 14.9) months. Indications included endocarditis (n=16), bacteremia (n=9), and pocket infection (n=2). Common pathogens were Staphylococcus aureus (n=10), coagulase-negative staphylococci (n=7), and Enterococcus faecalis (n=3). Sixty-eight leads were removed, with a median lead implant time of 5.7 (3.6 to 9.2) years. Laser sheaths were used in all procedures, with a median laser time of 35.0 s (17.5 to 85.5s). Mechanical cutting tools were required in 11 (40.7%) and femoral snaring in 4 (14.8%). Complete procedural success was achieved in 25 (93.6%) patients and clinical success in 27 (100%). No procedural failures or major adverse events occurred. Twenty-one patients (77.8%) were alive without persistent endovascular infection 1 year after lead extraction. Most were treated with oral suppressive antibiotics after extraction (n=23 [82.5%]). Persistent infection after extraction occurred in 4 patients and was associated with 50% 1-year mortality. Transvenous lead extraction for LVAD-associated CIED infection can be performed safely with low rates of persistent infection and 1-year mortality.

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Aims: Cardiac device infections (CDIs) are serious adverse events associated with morbidity and mortality, significant costs and increased healthcare utilization. The objective of the current study was to characterize the CDI rate by device type, risk factors for infection and healthcare costs from a large U.S. health insurer perspective.Materials and Methods: A retrospective analysis of a large U.S. health insurer database identified commercial and Medicare Advantage with Part D (MAPD) members ≥18 years with ≥1 claim for a cardiac implantable electronic device (CIED) procedure between 01 October 2011 and 31 October 2015. CIEDs included pacemakers (IPG), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy – pacemakers without (CRT-P) and with defibrillation (CRT-D). Probabilities of CDI through one-year post implant were estimated using the Kaplan–Meier method. A regression model with stepwise variable selection was used to select risk factors associated with CDIs.Results: A total of 63,406 patients were included with an overall CDI rate of 1.28% (1.0% de novo and 1.74% replacement devices), varying by device type: IPG = 0.91%; ICD = 1.63%; CRT-p = 1.50%; CRT-D = 2.22%. The average adjusted annual medical costs were 2.4 times greater [95% confidence interval (CI) = 2.1–2.7] for those with an infection compared to those without, and the incremental cost difference was estimated to be $57,322 [95% CI $46,572–$70,484]. Observed risk factors of CDIs included prior device infection [Odds ratio (OR) = 11.356; 95% CI = 7.923–16.276], undergoing a CIED replacement procedure (OR = 1.644; 95% CI = 1.361–1.987), implantation of a high-power device (OR = 1.354; 95% CI = 1.115–1.643), and younger age (age < 65) (OR = 1.607; 95% CI = 1.307–1.976).Conclusions: The CDI rate at one year ranged from 0.91%–2.22% depending on device type. Management of CDIs among commercial and MAPD members is associated with high healthcare expenditures.

Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.

Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system. This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets. Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P<0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P=0.004). Quality of life was reduced (P=0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage. This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

Cardiac Implantable Electronic Device Infections in Patients with Left Ventricular Assist Devices

Cardiac implantable electronic device infections (CIED) reflect life threatening complication for LVAD patients. Despite antibiotic treatment removal or exchange of all foreign surfaces may be required for cure. However, there is limited published data and we here present to our knowledge the largest case series of CIED removal in LVAD patients. Since 2011, 161 patients underwent LVAD Implantation at our institution. We identified 7 patients who underwent infection related CIED removal and report outcome. Patient and infection characteristics, management strategy, and clinical outcomes are described. Of the 7 patients one was female; mean age was 54 years (range 42-64). Three of 7 patients had an ischemic cardiomyopathy, and 2 of 7 patients had a continuous flow LVAD placed as destination therapy. All patients presented with clinical signs of infection, lead-related endocarditis and vegetations. In one patient additional pocket infection was present. Causative pathogens included staphylococcus aureus (1), staphylococcus epidermidis (1), enterococcus faecalis (1), candida albicans (2), and culture negative (2). All patients underwent laser assisted complete CIED removal along with antimicrobial therapy. The mean implanted age of the removed leads was 5 years (2-10 years), and 3 of the 7 patients experienced a procedural complication (pocket hematoma) from CIED removal. Infection was successfully treated in all patients, except one. No re-occurrence of endocarditis was observed and no LVAD exchange was needed. One patient died within 30 days after CIED explantation due to multi organ failure and persistent sepsis. Five patients remained alive at latest follow-up with a median duration of 15 months (0.1-55 months) from the time of CIED explantation. Complete CIED removal combined with optimal antimicrobial therapy may be an effective and safe therapy for CIED infections in LVAD patients.

A study on pacemaker pocket infection

<strong>Objective:</strong> Cardiac implantable electronic device (CIED) infections now constitute ∼ 10% of all endocarditis cases. The incidence of CIED infection is usually < 2%. Our objective was to study pacemaker pocket infection rate and different risk factors in our institution.

Efficacy of antibacterial envelope in prevention of cardiovascular implantable electronic device infections in high-risk patients: A systematic review and meta-analysis

BackgroundLimited evidence is available to determine the efficacy of an antibacterial enveloped (AE) cardiovascular implantable electronic device (CIED). ObjectiveTo assess if the use of antibacterial enveloped devices in high-risk patients are associated with lower chances of major CIED infections and mortality compared to non-enveloped devices. MethodsA comprehensive literature search on multiple databases was performed. The relative odds ratio (OR) of major CIED infection and mortality was calculated using a random-effect model. ResultsA total of six studies consisting of 11,897 patients, were included; 5844 with an AE-CIED and 6053 with conventional CIED. In the pooled cohort, patients with AE-CIED had a 66% lower odds of major CIED infection (OR 0.34, 0.13, 0.86, CI 95%, p = 0.02) compared to CIED. Propensity matched analysis showed a 71% lower odds of major infection in the AE-CIED group (OR 0.29, 95% CI 0.10–0.82, p = 0.02). Stratified analysis based on the type of study (retrospective vs. prospective) and duration of follow up (6 months vs. greater than six months) also showed numerically lower infection odds in the AE-CIED. Similarly, the relative odds of mortality were lower in patients with AE-CIED (OR 0.55, 95% CI 0.16–1.91, p = 0.34) compared to CIED patients; however, this difference was statistically non-significant. ConclusionIn high-risk patients, AE-CIED might offer lower odds of CIED infections. It has numerically lower (45%) but statistically non-significant odds of mortality if used in conjunction with the standard infection prevention protocol. More large scale studies and long-term follow-ups are required to validate our findings.

Reply "Role of antibiotic envelopes in preventing cardiac implantable electronic device infection: A meta-analysis of 14859 procedures".

Reply "Role of antibiotic envelopes in preventing cardiac implantable electronic device infection: A meta-analysis of 14859 procedures".

Predictors of short-term mortality in patients undergoing a successful uncomplicated extraction procedure.

The prognosis of patients with untreated cardiac implantable electronic device (CIED) infection is poor. Whether removal of all leads by a successful transvenous lead extraction (TLE) procedure changes the prognosis is unclear. To identify predictors of mortality in patients with CIED infection despite successful TLE. Retrospective single-center analysis of prospectively collected database from consecutive patients undergoing TLE at our center. Predictors for mortality were identified and a score predicting high mortality rate was calculated. A total of 371 consecutive patients underwent TLE, of whom 337 (90.8%) had complete hardware removal. Most were extracted due to infectious causes (81.3%). Approximately one-third (35%) died during a mean follow-up of 1056 ± 868 days. There was significantly higher mortality observed in the infectious group. Multivariate logistic regression models for infectious group only identified creatinine and albumin measurements as risk markers for 30 days mortality (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.19-2.38; P = .003 and OR, 0.4; 95% CI, 0.16-0.97; P = .039, respectively). A risk score was created based on cutoff values of creatinine ≥2md/dL (1 point) and albumin ≤3.5 g/dL (1 point). A value of 2 points predicted a 50% chance of 30-day mortality and a 75% chance of 1-year mortality (P < .0001 for both). Creatinine and albumin can be used as a combined risk score to successfully identify patients at risk of death despite undergoing a successful TLE procedure for infectious reasons. This score could help decision making when contemplating on conservative antibiotic treatment vs TLE.

Cardiac implantable electronic device infection: Does the device need to be extracted?

BackgroundCardiac implantable electronic devices (CIED) have become a common treatment modality in clinical practice. The increase in utilization of these devices has been associated with an increase in infection rates. Published guidelines define when a device is deemed infected (CDI); recommendations for the work‐up of CDI and criteria for extraction. Few data exist as to adherence to these guidelines.ObjectiveWe wanted to o evaluate whether devices diagnosed as CDI fit guidelines, whether clinicians followed work‐up recommendation of CDI, and whether CIED was extracted according to the guidelines criteria in our hospital.MethodsA retrospective review was performed in our hospital between 2008 and 2017. Adult patients (pts) 18 years and older who had their device extracted (DE) with a diagnosis of CDI were included. A total of 95 pts were identified.ResultsWe included 95 pts who were diagnosed as having CDI and who had their DE. Work‐up of patients with a diagnosis of CDI was inconsistently followed. Blood cultures, Echocardiogram, lead cultures (LC), and device pocket cultures (PC) were done in 100%, 90.5%, 75.6%, and 49.3%, respectively. Thirty out of 90 pts. (33%) did not meet guidelines criteria for extraction.ConclusionsIn our institution, a one third of the pts diagnosed with CDI who had DE had no indication for DE per guidelines recommendations. Clinicians did not follow recommendations for work‐up of CDI consistently. Low adherence was seen in obtaining LC and PC. CIED extraction guidelines should be followed to prevent unnecessary complications and cost.

USE OF ANTIBIOTIC ENVELOPES TO PREVENT CARDIAC IMPLANTABLE ELECTRONIC DEVICE RELATED INFECTIONS: A META-ANALYSIS

Cardiac implantable electronic devices (CIED) have shown survival benefit in certain patient populations and as these devices continue to gain popularity, complications remain a concern, in particular CIED infection. An absorbable mesh envelope (TYRX, Medtronic), coated with absorbable polymer mixed

CLEANING UP THE MESS: ANGIOVAC DEBULKING IN ENDOCARDITIS PATIENT WITH LARGE, DEVICE-RELATED VEGETATIONS

Despite improvements in cardiovascular implantable electronic device (CIED) design and functionality, the risk of device infection is on the rise. Complete removal of the device is recommended following CIED infection. However, the optimal management of large lead vegetations (> 2 cm) remains