Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection

Kay, Gemma L.; Eby, E.; Brown, Breanna; Lyon, J A; Eggington, Simon; Kumar, G.; Fenwick, Elisabeth; Sohail, M. Rizwan; Wright, David J.

doi:10.1080/13696998.2017.1409227

Cited by 45 publications

(46 citation statements)

References 17 publications

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“…Cardiac implantable electronic device (CIED) infection is a rare but serious complication that can lead to significant morbidity, mortality, and cost. [1][2][3][4][5] Management typically involves extraction of the implanted system (device and lead[s]), which can result in the need for prolonged hospitalization. Other than the use of a sterile, adequate surgical technique and the administration of intravenous preoperative antibiotics, 6 there has been a lack of evidence on other prophylactic strategies to prevent CIED infections.…”

Section: Introductionmentioning

confidence: 99%

The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up

Mittal

Wilkoff

Kennergren³

et al. 2020

Heart Rhythm

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BACKGROUND The Worldwide 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 longerterm (.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 6 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 5 .046). Any CIED-related infection This work was supported by Medtronic.

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Section: Introductionmentioning

confidence: 99%

The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up

Mittal

Wilkoff

Kennergren³

et al. 2020

Heart Rhythm

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“…Database search yielded 66 studies, of which seven studies were included, six observational and one RCT, summing to a total of 14 859 procedures …”

Section: Resultsmentioning

confidence: 99%

“…The use of an antibiotic envelope is associated with several deterrents. One must consider the cost associated with prophylactic antibiotic envelop use . Also, the effect of antibiotic envelops on hard clinical endpoints like death is not well established .…”

Section: Discussionmentioning

confidence: 99%

Role of antibiotic envelopes in preventing cardiac implantable electronic device infection: A meta‐analysis of 14 859 procedures

Kumar

Doshi

Shariff

2019

Journal of Arrhythmia

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Introduction:We conducted an updated meta-analysis assessing the role of antibiotic envelopes in preventing Cardiac implantable electronic devices (CIED)-related infections as compared to standard infection prevention strategies. Methods:A systematic search was conducted on Medline/PubMed and EMBASE/ Ovid database. We used Mantel-Haenszel method with fixed-effect model to compute risk ratio (RR) with 95% confidence interval (CI). We also performed subgroup and trial sequential analysis on the data. Results: Antibiotic envelope reduced the risk of both all infections [RR: 0.41, CI: 0.31-0.54, P < .05, I 2 = 75%, χ 2 P < .05] and major infections [RR: 0.48, CI: 0.32-0.70, P < .05, I 2 = 60%, χ 2 P = .04]. Conclusion: Prophylactic use of antibiotic envelopes as an adjuvant therapy to standard infection prevention strategies, helps in reducing the risk of CIED infections. K E Y W O R D S antibiotic envelope, cardiac implantable electronic devices R E FE R E N C E S How to cite this article: Kumar A, Doshi R, Shariff M. Role of antibiotic envelopes in preventing cardiac implantable electronic device infection: A meta-analysis of 14 859 procedures. J Arrhythmia. 2020;36:176-179. https ://doi.

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“…Serious infections can lead to lethal complications such as urosepsis, wound dehiscence, and erosion at the pocket site. An FDA‐approved antibacterial envelope—a poly(propylene) mesh that releases antimicrobial agents including rifampin and minocycline (TYRX, Medtronic Inc., USA)—has shown significant efficacy in reducing the risk of infection ( Figure a) …”

Section: Soft Bioelectronics–assisted Therapymentioning

confidence: 99%

Wearable and Implantable Devices for Cardiovascular Healthcare: from Monitoring to Therapy Based on Flexible and Stretchable Electronics

Hong

Jeong

Cho

et al. 2019

Adv Funct Materials

400

271

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Cardiovascular disease is the leading cause of death and has dramatically increased in recent years. Continuous cardiac monitoring is particularly important for early diagnosis and prevention, and flexible and stretchable electronic devices have emerged as effective tools for this purpose. Their thin, soft, and deformable features allow intimate and long-term integration with biotissues, which enables continuous, high-fidelity, and sometimes large-area cardiac monitoring on the skin and/or heart surface. In addition to monitoring, intimate contact is also crucial for high-precision therapies. Combined with tissue engineering, soft bioelectronics have also demonstrated the capability to repair damaged cardiac tissues. This review highlights the recent advances in wearable and implantable devices based on flexible and stretchable electronics for cardiovascular monitoring and therapy. First, wearable/implantable soft bioelectronics for cardiovascular monitoring (e.g., the electrocardiogram, blood pressure, and oxygen saturation level) are reviewed. Then, advances in cardiovascular therapy based on soft bioelectronics (e.g., mesh pacing, ablation, robotic sleeves, and electronic stents) are discussed. Finally, device-assisted tissue engineering therapy (e.g., functional electronic scaffolds and in vitro cardiac platforms) is discussed.

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Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection

Cited by 45 publications

References 17 publications

The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up

The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up

Role of antibiotic envelopes in preventing cardiac implantable electronic device infection: A meta‐analysis of 14 859 procedures

Wearable and Implantable Devices for Cardiovascular Healthcare: from Monitoring to Therapy Based on Flexible and Stretchable Electronics

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