التفاصيل البيبلوغرافية
| العنوان: |
The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up |
| المؤلفون: |
Mittal, S., Wilkoff, B. L., Kennergren, Charles, 1948, Poole, J. E., Corey, R., Bracke, F. A., Curnis, A., Addo, K., Martinez-Arraras, J., Issa, Ziad, Redpath, C., Moubarak, J., Khelae, S. K., Boersma, L. V. A., Korantzopoulos, P., Krueger, J., Lande, Jeff, Morss, G. M., Seshadri, S., Tarakji, K. G. |
| المصدر: |
Heart Rhythm. 17(7):1115-1122 |
| مصطلحات موضوعية: |
Cardiac and Cardiovascular Systems, Kardiologi, Cardiac resynchronization therapy, Complication, Generator replacement, Implantable cardioverter-defibrillator, Infection, Pacemaker, Replacement |
| الوصف: |
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. © 2020 The Authors |
| الوصول الحر: |
https://gup.ub.gu.se/publication/294753Test |
| قاعدة البيانات: |
SwePub |
