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The World-wide Rand...
The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up
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Mittal, S. (author)
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Wilkoff, B. L. (author)
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- Kennergren, Charles, 1948 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
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Poole, J. E. (author)
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Corey, R. (author)
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Bracke, F. A. (author)
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Curnis, A. (author)
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Addo, K. (author)
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Martinez-Arraras, J. (author)
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Issa, Ziad (author)
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Redpath, C. (author)
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Moubarak, J. (author)
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Khelae, S. K. (author)
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Boersma, L. V. A. (author)
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Korantzopoulos, P. (author)
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Krueger, J. (author)
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Lande, Jeff (author)
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Morss, G. M. (author)
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Seshadri, S. (author)
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Tarakji, K. G. (author)
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(creator_code:org_t)
- Elsevier BV, 2020
- 2020
- English.
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In: Heart Rhythm. - : Elsevier BV. - 1547-5271. ; 17:7, s. 1115-1122
- Related links:
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http://www.heartrhyt...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
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- 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
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Cardiac resynchronization therapy
- Complication
- Generator replacement
- Implantable cardioverter-defibrillator
- Infection
- Pacemaker
- Replacement
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Mittal, S.
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Wilkoff, B. L.
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Kennergren, Char ...
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Poole, J. E.
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Corey, R.
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Bracke, F. A.
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show more...
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Curnis, A.
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Addo, K.
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Martinez-Arraras ...
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Issa, Ziad
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Redpath, C.
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Moubarak, J.
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Khelae, S. K.
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Boersma, L. V. A ...
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Korantzopoulos, ...
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Krueger, J.
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Lande, Jeff
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Morss, G. M.
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Seshadri, S.
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Tarakji, K. G.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Heart Rhythm
- By the university
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University of Gothenburg