Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement

Henrikson, Charles A.; Sohail, M. Rizwan; Acosta, Helbert; Johnson, Eric E.; Rosenthal, Lawrence; Pachulski, Roman; Dan, Dan; Paladino, Walter; Khairallah, Farhat; Gleed, Kent; Hanna, Ibrahim R.; Cheng, Alan; Lexcen, Daniel R.; Simons, Grant R.

doi:10.1016/j.jacep.2017.02.016

Cited by 53 publications

(33 citation statements)

References 27 publications

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“…Longer battery longevity, less ICD lead revisions due to lead failure and conservative management of device recalls should reduce the revision rate and consecutively the infection rate. Other forms like the use of antibacterial envelope might further reduce the infection rate …”

Section: Discussionmentioning

confidence: 99%

Contemporary benefit‐harm profile over two decades in primary prophylactic ICD‐therapy

Kleemann

Strauss

Kouraki

et al. 2019

Clinical Cardiology

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Background Implantable cardioverter defibrillator (ICD) was implemented into clinical routine more than 20 years ago. Since then, ICD therapy became standard therapy for primary and secondary prevention of sudden cardiac death in clinical practice. Objectives Aim of the study was to evaluate the benefit‐harm profile of contemporary primary prophylactic ICD therapy. Methods A total of 1222 consecutive patients of a prospective single‐center ICD‐registry were analyzed who underwent primary prophylactic ICD implantation between 2000 and 2017. Patients were divided into two groups according to the implantation year: 2010‐2017 (group 1, n = 579) and 2000‐2009 (group 2, n = 643). Results The rate of estimated appropriate ICD therapy after 8 years was 51% in the 2000s and 42% in the 2010s (P < .001). The complication rate changed slightly from 53% to 47% (P = .005). This decline was mainly driven by the reduction of inappropriate ICD shocks (30% vs 14%, P < .001) whereas the rate of ICD shock lead malfunction and device/ lead infection remained unchanged over time. Nonischemic cardiomyopathy was an independent predictor for ICD complications without benefit of ICD therapy (HR 1.37, 95% CI 1.07‐1.77). Conclusion The ICD therapy rate for ventricular arrhythmias in patients with primary prophylactic ICD implantation is decreasing over the last two decades. Complication rate remains high due to an unchanged rate of ICD shock malfunctions and device infections. Nonischemic cardiomyopathy is an independent predictor for ICD complications without benefit of ICD therapy in primary prophylactic ICD‐therapy.

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Section: Discussionmentioning

confidence: 99%

Contemporary benefit‐harm profile over two decades in primary prophylactic ICD‐therapy

Kleemann

Strauss

Kouraki

et al. 2019

Clinical Cardiology

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“…Results from the recently published Citadel study showed a significantly lower CIED infection rate with use of an envelope compared to a previously reported rates without an envelope (0.4% vs. 2.2%, P = 0.0023) . Although these data were not included in our analysis due to the use of only a benchmark control infection rate being used as a control, the results support the findings of our meta‐analysis.…”

Section: Discussionmentioning

confidence: 99%

Use of antibiotic envelopes to prevent cardiac implantable electronic device infections: A meta‐analysis

Koerber

Turagam

Winterfield

et al. 2018

Cardiovasc electrophysiol

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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

395

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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Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement

Abstract: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [Centurion]; NCT01043861/NCT01043705).

Cited by 53 publications

References 27 publications

Contemporary benefit‐harm profile over two decades in primary prophylactic ICD‐therapy

Contemporary benefit‐harm profile over two decades in primary prophylactic ICD‐therapy

Use of antibiotic envelopes to prevent cardiac implantable electronic device infections: A meta‐analysis

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

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