Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT trial analysis.

Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention Trial) study, but its effectiveness in the presence of hematoma is not well understood.The purpose of this study was to evaluate the incidence and infectious consequences of hematoma and the association between envelope use, hematomas, and major CIED infection among WRAP-IT patients.All 6800 study patients were included in this analysis (control 3429; envelope 3371). Hematomas occurring within 30 days postprocedure (acute) were characterized and grouped by study treatment and evaluated for subsequent infection risk. Data were analyzed using Cox proportional hazard regression modeling.Acute hematoma incidence was 2.2% at 30 days, with no significant difference between treatment groups (envelope vs control hazard ratio [HR] 1.15; 95% confidence interval [CI] 0.84-1.58; P = .39). Through all follow-up, the risk of major infection was significantly higher among control patients with hematoma vs those without (13.1% vs 1.6%; HR 11.3; 95% CI 5.5-23.2; P.001). The risk of major infection was significantly lower in the envelope vs control patients with hematoma (2.5% vs 13.1%; HR 0.18; 95% CI 0.04-0.85; P = .03).The risk of hematoma was 2.2% among WRAP-IT patients. Among control patients, hematoma carried a11-fold risk of developing a major CIED infection. This risk was significantly mitigated with antibacterial envelope use, with an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control

Risk Factors for CIED Infection After Secondary Procedures

OBJECTIVES This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures. BACKGROUND Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy of an antibacterial envelope for CIED infection reduction, offers insight into procedural details and infection prevention strategies. METHODS This analysis included 2,803 control patients from the WRAP-IT trial who received standard preoperative antibiotics but not the envelope (44 patients with major infections through all follow-up). A multivariate least absolute shrinkage and selection operator machine learning model, controlling for patient characteristics and procedural variables, was used for risk factor selection and identification. Risk factors consistently retaining predictive value in the model (appeared >10 times) across 100 iterations of imputed data were deemed significant. RESULTS Of the 81 variables screened, 17 were identified as risk factors with 6 being patient/device-related (nonmodifiable) and 11 begin procedure-related (potentially modifiable). Patient/device-related factors included higher number of previous CIED procedures, history of atrial arrhythmia, geography (outside North America and Europe), device type, and lower body mass index. Procedural factors associated with increased risk included longer procedure time, implant location (non-left pectoral subcutaneous), perioperative glycopeptide antibiotic versus nonglycopeptide, anticoagulant, and/or antiplatelet use, and capsulectomy. Factors associated with decreased risk of infection included chlorhexidine skin preparation and antibiotic pocket wash. CONCLUSIONS In WRAP-IT patients, we observed that several procedural risk factors correlated with infection risk. These results can help guide infection prevention strategies to minimize infections associated with secondary CIED procedures. (J Am Coll Cardiol EP 2022;8:101-111) (c) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Superior Vena Cava Defibrillator Coils Make Transvenous Lead Extraction More Challenging and Riskier

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the world wide randomized antibiotic envelope infection prevention wrap it trial long term follow up

Abstract Background The WRAP-IT trial reported a 40% reduction in major CIED infection within 12 months of the procedure with the antibacterial-eluting envelope (TYRX). Objective This report describes the longer-term (>12 months) envelope effects on infection reduction and complications. Methods All trial patients that underwent CIED replacement, upgrade, revision, or initial CRT-D implant received standard-of-care infection prophylaxis and were randomized 1:1 to receive the envelope or not. CIED infection incidence, and procedure and system-related complications were characterized through all follow-up (36 months) using Cox proportional hazard regression modeling. Results In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up 21.0±8.3 months). Major CIED-related infection occurred in 32 envelope patients and 51 control patients (KM estimate, 1.3% vs. 1.9%; HR: 0.64, 95% CI: 0.41-0.99; P=0.046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate, 2.1% vs. 2.8%; HR: 0.69, 95% CI: 0.49-0.97; P=0.030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate, 8.0% vs. 8.2%; HR, 0.95, 95% CI: 0.79-1.13; P Conclusions The effects of the TYRX envelope in reducing the risk of CIED infection are sustained beyond the first year post-procedure, without increased risk of complication

2018 EHRA expert consensus statement on lead extraction: Recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: Endorsed by APHRS/HRS/LAHRS

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A Case of Pacemaker Endocarditis Caused by Aerococcus urinae

Background: Aerococcus urinae has lately been acknowledged as a cause of infective endocarditis (IE) especially in older males with underlying urinary tract disorders. In this population, cardiac implanted electronical devices (CIED) are not uncommon, but despite the capacity of A. urinae to form biofilm in vitro, no cases of aerococcal CIED infections have been reported to date.Case Presentation: An 84-year-old male with pacemaker was admitted with dysuria one month after a transurethral procedure for urinary bladder cancer. A. urinae was isolated from urine and blood. Transesophageal echocardiography (TEE) was without signs of vegetation on valves or pacing cables. The patient was treated with a twelve-day course of β-lactam antibiotics. Forty days after the initial admission, the patient was readmitted due to malaise, general pain of the joints, chills, and renewed blood cultures grew A. urinae. TEE demonstrated a 10 × 5 mm vegetation on either the tricuspid valve or one of the pacing cables. The pacemaker system was completely removed and demonstrated macroscopic signs of infection. A temporary system was implanted, and after 14 days of penicillin G treatment, a new system permanent system was implanted. Total treatment time was 40 days. Recovery was uneventful.Conclusion: This report demonstrates that A. urinae can cause CIED infection. In patients with A. urinae bacteremia and a CIED, this risk must be considered, especially if bacteremia reoccurs

Percutaneous occlusion balloon as a bridge to surgery in a swine model of superior vena cava perforation

Superior vena cava (SVC) perforation is a rare but potentially fatal complication of transvenous lead removal. The aim of this study was to evaluate the feasibility of hemodynamic stabilization using an occlusion balloon during SVC tear in a porcine model. A surgically induced SVC perforation was created in Yorkshire cross swine (n = 7). Three animals were used to develop and test surgical repair methods. Four animals were used to evaluate hemodynamic, behavioral, and neurological effects up to 5 days after SVC tear and repair. An occlusion balloon (Bridge Occlusion Balloon, Spectranetics Corporation, Colorado Springs, CO) was percutaneously delivered through the femoral vein to the location of the injury and inflated. Once hemodynamic control was achieved, the perforation was surgically repaired. After SVC perforation and clamp release, the rate of blood loss was 7.0 ± 0.8 mL/s. Mean time from SVC tear to occlusion balloon deployment was 55 ± 12 seconds, during which mean arterial pressure decreased from 56 ± 2 to 25 ± 3 mm Hg and heart rate decreased from 76 ± 7 to 62 ± 7 beats/min. After the deployment of the occlusion balloon, the rate of blood loss decreased by 90%, to 0.7 ± 0.2 mL/s. The mean time of balloon occlusion of the SVC was 16 ± 4 minutes and hemodynamic measures returned to baseline levels during this time. Study animals experienced no major complications, demonstrated stable recovery, and exhibited normal neurological function at each postoperative assessment. Endovascular temporary balloon occlusion may be a feasible option to reduce blood loss, maintain hemodynamic control, and provide a bridge to surgery after SVC injury