Suneet Mittal1, Bruce L Wilkoff2, Charles Kennergren3, Jeanne E Poole4, Ralph Corey5, Frank A Bracke6, Antonio Curnis7, Kamel Addo8, Joaquin Martinez-Arraras9, Ziad F Issa10, Calum Redpath11, Jean Moubarak12, Surinder Kaur Khelae13, Lucas V A Boersma14, Panagiotis Korantzopoulos15, Jo Krueger16, Jeff D Lande16, Gina M Morss16, Swathi Seshadri16, Khaldoun G Tarakji2. 1. Department of Cardiology, Valley Health System, Ridgewood New Jersey. Electronic address: MITTSU@Valleyhealth.com. 2. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio. 3. Sahlgrenska Medical Faculty, University of Göteborg, Göteborg, Sweden. 4. Division of Cardiology, University of Washington School of Medicine, Seattle, Washington. 5. Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina. 6. Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands. 7. Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. 8. Cardiology Division, Mount Carmel Health System, Columbus, Ohio. 9. Department of Cardiology, Amarillo Heart Clinical Research Institute, Amarillo, Texas. 10. Department of Cardiology, Prairie Education & Research Cooperative, Springfield, Illinois. 11. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 12. Division of Cardiology, UPMC, Hamot Medical Center, Erie, Pennsylvania. 13. Department of Electrophysiology, Institute Jantung Negara, Kuala Lumpur, Malaysia. 14. Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands; Amsterdam University Medical Centers, Amsterdam, The Netherlands. 15. First Department of Cardiology, University of Ioannina Medical School, Ioannina, Greece. 16. Cardiac Rhythm and Heart Failure (CRHF) Clinical, Medtronic, Mounds View, Minnesota.
Abstract
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 cardiacresynchronization 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.
RCT Entities:
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.