Antibiotic-impregnated envelopes reduce the rate of surgical site infection in deep brain stimulation pulse generators: a comparative study.

BACKGROUND AND PURPOSE: Deep brain stimulation (DBS) is a surgical procedure that has been used to treat a variety of neurological disorders including Parkinson's disease, essential tremor, and dystonia. While DBS is generally considered safe and effective, surgical site infections (SSIs) are a potential complication that can lead to significant morbidity and mortality. Our objective was to investigate the use of antibiotic-impregnated envelopes (AIEs) encasing implantable pulse generators (IPGs) to reduce the rate of infection at IPG sites and the costs. METHODS: We conducted a retrospective analysis at a single center encompassing all procedures involving the placement of Implantable Pulse Generators (IPG), including both initial insertions and replacement surgeries. The study period spanned from January 2017 to May 2024. Starting in 2020, the routine utilization of AIE became standard practice at our institute for both primary DBS implantation and IPG replacements. Surgical techniques remained consistent, pre- and post-operative antibiotic protocols were standardized throughout the study period and all cases were undertaken by a single surgeon. RESULTS: 178 patients were included and the overall incidence of IPG SSIs was found to be 1.7% (1 infection in 58 patients; 20 primary IPG/38 IPG replacements) among those who received an AIE compared to 5% (6 infections in 120 patients; 36 primary IPG/84 replacement IPG) in patients where no AIE was utilized. This resulted in an odds ratio for infection that was 2.9 times higher in the absence of AIE. The decrease in infection rates was observed in both primary and replacement IPG implants. Notably, over 80% of patients with IPG infection required surgical intervention. The use of AIE further resulted in significant cost savings. CONCLUSION: To our knowledge, this is the largest series reporting the efficacy of Antibiotic impregnated envelope (AIE) in modifying infection rates associated with both initial and replacement Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs). The implementation of AIEs led to a decrease in the occurrence of IPG-related infections, observed across both primary implantations and replacement surgeries, with associated economic benefits.

Efficacy of the antibacterial envelope to prevent cardiac implantable electronic device infection in a high-risk population.

AIMS: Infection is a serious complication of cardiac implantable electronic device (CIED) therapy. An antibiotic-eluting absorbable envelope has been developed to reduce the infection rate, but studies investigating the efficacy and a reasonable number needed to treat in high-risk populations for infections are limited. METHODS AND RESULTS: One hundred and forty-four patients undergoing CIED implantation who received the antibacterial envelope were compared with a matched cohort of 382 CIED patients from our institution. The primary outcome was the occurrence of local infection, and secondary outcomes were any CIED-related local or systemic infections, including endocarditis, and all-cause mortality. The results were stratified by a risk score for CIED infection, PADIT. The envelope group had a higher PADIT score, 5.9 ± 3.1 vs. 3.9 ± 3.0 (P < 0.0001). For the primary endpoint, no local infections occurred in the envelope group, compared with 2.6% in the control group (P = 0.04), with a more pronounced difference in the stratum with a high (>7 points) PADIT score, 0 vs. 9.9% (P = 0.01). The total CIED-related infections were similar between groups, 6.3% compared with 5.0% (P = 0.567). Mortality after 1600 days of follow-up did not differ between groups, 22.9 vs. 26.4%, P = 0.475. CONCLUSION: Our study confirms the clinical efficacy of an antibacterial envelope in the prevention of local CIED infection in patients with a higher risk according to the PADIT score. In an effort to improve cost-benefit ratios, ration of use guided by the PADIT score is advocated. Further prospective randomized studies in high-risk populations are called for.

Differences between cardiac implantable electronic device envelopes evaluated in an animal model.

INTRODUCTION: Cardiac implantable electronic device (CIED) pocket related problems such as infection, hematoma, and device erosion cause significant morbidity and the clinical consequences are substantial. Bioabsorbable materials have been developed to assist in the prevention of these complications but there has not been any direct comparison of these adjunctive devices to reduce these complications. We sought to directly compare the TYRX absorbable antibacterial and CanGaroo extracellular matrix (ECM) envelopes in an animal model susceptible to these specific CIED-related complications (i.e., skin erosion and infection). METHODS AND RESULTS: Sixteen mice undergoing implantation with biopotential transmitters were divided into three groups (no envelope = 4, TYRX = 5, and CanGaroo = 7) and monitored for device-related complications. Following 12 weeks of implantation, gross and histological analysis of the remaining capsules was performed. Three animals in the CanGaroo group (43%) had device erosion compared to none in the TYRX group. The remaining capsules excised at 12 weeks were qualitatively thicker following CanGaroo compared to TYRX and no envelope and histological evaluation demonstrated increased connective tissue with CanGaroo. CONCLUSION: CanGaroo ECM envelopes did not reduce the incidence of device erosion and were associated with qualitatively thicker capsules and connective tissue staining at 12 weeks compared to no envelope or TYRX. Further studies regarding the use of these envelopes to prevent device erosion and their subsequent impact on capsule formation are warranted.

Real-world data on the effectiveness of TYRX and TauroPace for preventing CIED infections.

BACKGROUND: The implantation of cardiac implantable electronic devices (CIEDs) carries a known risk of infection. Two devices (TYRX and TauroPace) have been proposed to reduce this risk. METHODS: The aim of our study was to compare the effectiveness of TauroPace and TYRX. Real-world comparative studies were included. Data analysis was based on reconstruction of individual patient data from Kaplan-Meier curves using an artificial intelligence algorithm. The endpoint was CIED infection or systemic infection. Statistical tests included heterogeneity assessment, superiority testing, and non-inferiority testing. The primary outcome measure was the hazard ratio (HR) with confidence interval (CI). RESULTS: Our literature search identified two real-world studies suitable for our analysis. Follow-up was 12 months for TauroPace (654 patients) and 60 months for TYRX (872 patients), with a total of 2,083 controls. There was no heterogeneity among controls. Compared to the pooled control group, patients treated with TYRX or TauroPace had fewer CIED infections (HR, 0.3892; 95% CI, 0.2042-0.7419; P=0.00414; HR, 0.3313; 95% CI, 0.1005-1.0925; P=0.06958, respectively). When testing for non-inferiority of TauroPace vs. TYRX, the comparison yielded a HR of 0.8494 (in favor of TYRX) with a 90% CI of 0.27-2.63; this CI of TauroPace did not meet the non-inferiority criterion set at HR>0.75 (i.e., relative difference ≤25%). CONCLUSIONS: Both treatments had some important drawbacks. Regarding TYRX, more selective use in higher-risk patients should be advocated to improve its cost-effectiveness, but robust evidence is still lacking. Regarding TauroPace, our analysis testing for a non-inferiority margin of ≤25% did not meet this demonstration.

Preclinical evaluation of a third-generation absorbable antibacterial envelope.

BACKGROUND: The TYRX (Medtronic) absorbable antibacterial envelope has been shown to stabilize implantable cardiac devices and reduce infection. A third-generation envelope was developed to reduce surface roughness with a redesigned multifilament mesh and enhanced form factor but identical polymer coating and antibiotic concentrations as the currently available second-generation envelope. OBJECTIVE: The purpose of this study was to compare drug elution, bacterial challenge efficacy, stabilization, and absorption of second- vs third-generation envelopes. METHODS: Antibiotic elution was assessed in vitro and in vivo. For efficacy against gram-positive/gram-negative bacteria, 40 rabbits underwent device insertions with or without third-generation envelopes. For stabilization (migration, rotation), 5 sheep were implanted with 6 devices each in second- or third-generation envelopes. Prespecified acceptance criteria were <83-mm migration and <90° rotation. Absorption was assessed via gross pathology. RESULTS: Elution curves were equivalent (similarity factors ≥50 per Food and Drug Administration guidance). Third-generation envelopes eluted antibiotics above minimal inhibitory concentration (MIC) in vivo at 2 hours postimplant through 7 days, consistent with second-generation envelopes. Bacterial challenge showed reductions (P <.05) in infection with second- and third-generation envelopes. Device migration was 5.5 ± 3.5 mm (third-generation) vs 9. 9 ±7.9 mm (second-generation) (P <.05). Device rotation was 18.9° ± 11.4° (third-generation) vs 17.6° ± 15.1° (second-generation) and did not differ (P = .79). Gross pathology confirmed the absence of luminal mesh remainders and no differences in peridevice fibrosis at 9 or 12 weeks. CONCLUSION: The third-generation TYRX absorbable antibacterial envelope demonstrated equivalent preclinical performance to the second-generation envelope. Antibiotic elution curves were similar, elution was above MIC for 7 days, infections were reduced compared to no envelope, and acceptance criteria for migration, rotation, and absorption were met.

Combined Use of S-ICD and Absorbable Antibacterial Envelopes: A Proof-of-concept Study.

BACKGROUND: Absorbable antibacterial envelopes (AAEs) are currently recommended in patients undergoing a transvenous ICD implantation in cases at high risk of infection, who are now preferably implanted with a subcutaneous ICD (S-ICD). Nevertheless, experiences using a combined approach with S-ICD and AAE have not been reported. The aim of our study was to evaluate this strategy in patients at very high risk of infection. METHODS: Twenty-five patients were implanted with the S-ICD+AAE using our combined approach, restricted to patients who would fit our decisional flow algorithm identifying very high-risk patients. Patients were followed up 1 month after discharge and every 6 months thereafter. Complications were defined as device-related events requiring medical or surgical intervention for resolution and/or device reprogramming. RESULTS: Twenty-five patients (92% males, mean age 58.5±14.1 years) were implanted with the S-ICD device and the AAE using our combined approach. The most common high-infective risk factors were diabetes requiring insulin treatment (80%) and CKD requiring hemodialysis (48%), with 7 (28%) patients presenting with more than 2 risk factors. A single mild early post-operative hematoma was observed that was managed conservatively with a spontaneous resolution. Despite a very high-risk cohort, only a single late pocket infection was detected and solved conservatively with antibiotic therapy. CONCLUSIONS: The preliminary data of this proof-of-concept study show how a combined deployment of AAE and S-ICD in selected patients at very high risk of infection is a safe and feasible technique and may offer a reliable treatment option in specific and selected clinical settings.

Cardiac resynchronization therapy defibrillator: a de novo implant in a COVID-19 patient by an echo-guided axillary venous approach.

The COVID-19 pandemic has seriously revolutionized the management of patients who need an implanted cardiac implantable electronic device. We report, for the first time, a successful cardiac resynchronization therapy defibrillator implantation procedure in an 82-year-old man affected by COVID-19, recent myocardial infarction, second-degree 2:1 atrioventricular block and left bundle branch block.

Antibiotic envelope is associated with reduction in cardiac implantable electronic devices infections especially for high-power device-Systematic review and meta-analysis.

BACKGROUND: Infections after cardiac implantable electronic device (CIED) placement are associated with significant morbidity and mortality. The incidence of CIED is increasing overtime despite the optimal use of antimicrobial agents. This systematic review and meta-analysis will address the latest evidence on the use of AE to mitigate the risk of CIED infection, and which subset of patients will they benefit the most. METHODS: We performed a comprehensive search on topics that assesses antibiotic envelope and implantable cardiac electronic device up until August 2019. RESULTS: There were a total of 32,329 subjects from six studies. Antibiotic envelope was associated with a lower risk of major infection with OR 0.42 [0.19, 0.97], P = .04; I2: 58% and HR 0.52 [0.32, 0.85], P = .009; I2: 80%. Upon sensitivity analysis by removing a study, the OR became 0.40 [0.27, 0.59], P < .001; I2: 46%. Subgroup analysis for 12 months' infection was OR 0.65 [0.43, 0.99], P = .04; I2: 49%. Meta-analysis of propensity-matched cohort showed a reduced risk of infection with AE (OR of 0.14 [0.05, 0.41], P < .001; I2:0%). Mortality was similar in both AE and control groups. Antibiotic envelope reduced the incidence of infection in patients receiving high-power device (OR 0.44 [0.27, 0.73], P = .001; I2:0%) but not low-power device. CONCLUSION: Antibiotic envelope (TYRX) was found to be safe and effective in reducing the risk of major infections in high-risk patients receiving CIED implantation, especially in those receiving high-power CIED.

Economic impact of introducing TYRX amongst patients with heart failure and reduced ejection fraction undergoing implanted cardiac device procedures: a retrospective model based cost analysis.

BACKGROUND AND AIMS: Infection is a serious and expensive complication of Cardiac Implantable Electronic Device (CIED) procedures. A retrospective based cost analysis was performed to estimate Trust level savings of using the TYRX antibacterial envelope as a primary prevention measure against infection in a tertiary referral centre in South London, UK. METHODS: A retrospective cohort of heart failure patients with reduced ejection fraction undergoing Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) procedures were evaluated. Decision-analytic modelling was performed to determine economic savings of using the envelope during CIED procedure vs CIED procedure alone. RESULTS: Over a 12 month follow-up period following CIED procedure, the observed infection rate was 3.14% (n = 5/159). The average cost of a CIED infection inpatient admission was £41,820 and, further to economic analysis, the additional costs attributable to infection was calculated at £62,213.94. A cost saving of £624 per patient by using TYRX during CIED procedure as a primary preventative measure against infection was estimated. CONCLUSIONS: TYRX would be a cost-saving treatment option amongst heart failure patients undergoing ICD and CRT device procedures based on analysis in the local geographical area of South London. If upscaled to the UK population, we estimate potential cost savings for the National Health Service (NHS).

A meta-analysis of antibacterial envelope use in prevention of cardiovascular implantable electronic device infection.

OBJECTIVES: Cardiac implantable electronic device (CIED) infection has been a major clinical problem in addition to being a major financial burden. In spite of antimicrobial prophylaxis, CIED infection rates have been increasing disproportionately. We therefore conducted this meta-analysis to assess the role of TYRX antibiotic envelope for the prevention of CIED infection. METHODS: Using extensive online search, we conducted a meta-analysis of studies reporting CIED infections with versus without the use of TYRX antibiotic envelope. A random-effect model was used, and between studies heterogeneity was estimated with I2. All analyses were performed with RevMan (version 5.0.20). RESULTS: Five cohort studies were included in this meta-analysis. The pooled odds ratio (OR) of included studies was 0.29 [95% confidence interval (CI): 0.09-0.94; p < 0.004]. There was evidence of heterogeneity with I2 of 58%. There was also evidence of publication bias on funnel plot analysis. On sensitivity analysis, no statistically significant difference was noted when stratified by study design or duration of follow-up. CONCLUSION: The results of our study demonstrate a significant beneficial effect of TYRX antibiotic envelope for the prevention of CIED infections.