The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up
| Autor: | Antonio Curnis, Surinder Kaur Khelae, Panagiotis Korantzopoulos, Ralph Corey, Jo Krueger, Calum J. Redpath, Khaldoun G. Tarakji, Suneet Mittal, Swathi Seshadri, Lucas V.A. Boersma, Frank A. Bracke, Jeff D. Lande, Kamel Addo, Ziad F. Issa, Gina M. Morss, Jeanne E. Poole, Joaquin Martinez-Arraras, Charles Kennergren, Bruce L. Wilkoff, Jean B. Moubarak |
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| Přispěvatelé: | Cardiology, ACS - Heart failure & arrhythmias |
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Prosthesis-Related Infections Time Factors medicine.drug_class medicine.medical_treatment Antibiotics Replacement Cardiac resynchronization therapy 030204 cardiovascular system & hematology Implantable cardioverter-defibrillator 03 medical and health sciences Generator replacement 0302 clinical medicine Risk Factors Physiology (medical) medicine Infection control Humans Single-Blind Method 030212 general & internal medicine Prospective Studies Aged business.industry Incidence (epidemiology) Incidence Hazard ratio Antibiotic Prophylaxis Confidence interval Surgery Anti-Bacterial Agents Defibrillators Implantable Pacemaker Female Cardiology and Cardiovascular Medicine Complication business Infection Follow-Up Studies |
| Zdroj: | Heart rhythm, 17(7), 1115-1122. Elsevier |
| ISSN: | 1556-3871 1547-5271 |
| Popis: | Background: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN). Objective: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications. Methods: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy – defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling. Results: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41–0.99; P = .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 = .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 < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics). Conclusion: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications. |
| Databáze: | OpenAIRE |
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