Abstract 15682: A Novel Antibiotic Delivery Approach Enhances Salvage of Infected Cardiovascular-implantable Electronic Devices

Introduction: Infection of cardiovascular-implantable electronic devices (CIED) is a serious complication. Systemic antibiotic therapy is considered ineffective, justifying the current guidelines proposing total CEID and lead extraction. Objective: To evaluate the safety and efficacy of continuous in-situ-targeted, ultra-high concentration of antibiotics (CITA) in CIED infections limited to the subcutaneous pocket. Methods: Infected CIED were treated with CITA, delivered to the CIED pocket following minimally invasive surgery (MIS). The CIED were submerged in a 10 2 -10 3 minimal inhibition concentration (MIC) solution of vancomycin and/or gentamicin as per daily conventional dosing. Serum antibiotic levels were regulated by adjusting the concentration and flow of pocket irrigation. CIED salvage rate was assessed. Results: A total of 937 and 481serum assays of vancomycin and gentamicin, respectively, from 83 infected CIED was evaluated (Figure). Target antibiotic serum levels were obtained at 12-48 hours. Median treatment was 8 days (IQR 5,12). Parallel intravenous (IV) vancomycin treatment was applied in 6 (7%) infections. Vancomycin serum levels exceeded a trough limit of 20μg/ml in 20 (2.1%) assays, of which 19/20 received parallel IV treatment. No peak gentamicin levels were recorded. Gentamicin exceeded trough serum level reaching 2-3μg/ml in 80 (16.6%), reached potentially toxic levels of 3-5μg/ml in 33 (6.9%), and exceeded 5μg/ml in 10 (2.1%) assays. CITA resulted in a 1-year salvage of 71 (86%) CIED. Treatment failed in 12 infections, resulting in 8 uneventful total CIED extractions. The 30-day mortality rate was 2.4%. Conclusions: CITA provided ultra-high pocket antibiotic levels, with its safety confirmed by systemic level assays. CITA combined with MIS enabled salvage of 86% of infected CIED. The CITA-MIS approach may serve as an initial therapeutic option prior to the extraction of locally infected CIED, especially in high-risk patients.

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EFFICACY AND FEASIBILITY OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES LEAD EXTRACTION IN ELDERLY PATIENTS

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(12)60710-4 ◽

2012 ◽

Vol 59 (13) ◽

pp. E709

Author(s):

Michio Nagashima ◽

Yoshimori An ◽

Kenji Ando ◽

Yoshimitsu Soga ◽

Masakiyo Nobuyoshi

Keyword(s):

Elderly Patients ◽

Electronic Devices ◽

Lead Extraction ◽

Cardiovascular Implantable Electronic Devices

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Anesthetic Management of Laser Lead Extraction for Cardiovascular Implantable Electronic Devices

Seminars in Cardiothoracic and Vascular Anesthesia ◽

10.1177/1089253217728581 ◽

2017 ◽

Vol 21 (4) ◽

pp. 302-311 ◽

Cited By ~ 1

Author(s):

Meena Bhatia ◽

Payam Safavi-Naeini ◽

Mehdi Razavi ◽

Charles D. Collard ◽

Daniel A. Tolpin ◽

...

Keyword(s):

Anesthetic Management ◽

Electronic Devices ◽

Cardiac Resynchronization ◽

Lead Extraction ◽

Lead Removal ◽

Implantable Cardioverter Defibrillators ◽

Cardiovascular Implantable Electronic Devices ◽

Number Of Patients ◽

Cardioverter Defibrillators

Cardiovascular implantable electronic devices (CIEDs) play a significant role in the modern management of cardiovascular disease. CIEDs include implantable pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. These devices improve the quality of life of their recipients and help reduce the incidence of sudden cardiac death. Traditionally, CIEDs have been reliant on the use of transvenous endocardial leads to directly connect with the heart. Over time, these endovascular leads may become endothelialized rendering removal extremely difficult. As the indications for CIEDs expands and with the continuing evolution of these devices, the number of patients requiring explantation for device recall, malfunction, and infection continues to increase. In this manuscript, we review the most common CIEDs, the indications and process of lead removal/device explantation, potential complications associated with the procedure and the anesthetic management of these patients.

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Management of Cardiovascular Implantable Electronic Devices Infections in High-Risk Patients

Arrhythmia & Electrophysiology Review ◽

10.15420/aer.2015.4.1.53 ◽

2015 ◽

Vol 4 (1) ◽

pp. 53 ◽

Cited By ~ 3

Author(s):

Charles Kennergren ◽

Keyword(s):

High Risk ◽

Pulse Generator ◽

Electronic Devices ◽

Randomised Trial ◽

Significant Proportion ◽

Infection Prophylaxis ◽

High Risk Patients ◽

Cardiovascular Implantable Electronic Devices ◽

Intravenous Antibiotics ◽

Risk Patients

The incidence of infection following implantation of cardiovascular implantable electronic devices (CIEDs) is increasing, as is the number of pulse generator replacements and upgrades. The rate of infections is rising faster than the rate of device implantation, mainly due to the increasing age and number of comorbidities of patients receiving the devices. Patients with a CIED infection usually require hospitalisation, multiple consultations, prolonged intravenous antibiotics and, in the majority of cases, CIED explantation and replacement. A significant proportion die of their infection. CIED infection therefore represents a substantial health and economic burden, and management of infections is critical. Numerous risk factors have been identified including host, procedure and device-related factors. Established strategies for preventing CIED infections include intravenous antibiotics and aseptic techniques. The TYRX™ Absorbable Antibacterial Envelope offers potential as an effective method to reduce CIED infections. Several studies have found a statistically significant association between antibacterial envelope use and reduced incidence of CIED infection in high-risk patients. A prospective, randomised trial to further evaluate this potentially important strategy for CIED infection prophylaxis is underway.

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Transvenous Lead Extraction of Cardiac Implantable Electronic Devices Indications, Complications and Outcome: An Egyptian Two Years' Experience

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2019.415 ◽

2019 ◽

Vol 7 (15) ◽

pp. 2447-2451

Author(s):

Ibrahim El-Zoghby ◽

Amr Nawar ◽

Mohamed Soliman ◽

Mahmoud Kenawy ◽

Khaled Hussien ◽

...

Keyword(s):

Electronic Devices ◽

Lead Extraction ◽

Extraction Techniques ◽

Factors Associated ◽

Cardiac Implantable Electronic Devices ◽

Cardiovascular Implantable Electronic Devices ◽

Permanent Pace ◽

Pace Maker ◽

Locking Stylet ◽

Manual Traction

BACKGROUND: The growing needs to extract cardiovascular implantable electronic devices warrants the need to improve the outcome and prevent complications. AIM: This study aims to analyse the findings and identify factors associated with complications of Percutaneous Transvenous Lead Extraction in the Critical Care Department, Cairo University. METHODS: We studied 52 candidates for Percutaneous Transvenous Lead extraction of a Permanent Pace Maker (PPM) regarding extraction indications, comorbidities, device type, complications and outcome. Extraction was first attempted by simple manual traction using regular non-locking stylet and if failed, locking stylet, and evolution dilator sheath were used. RESULTS: We extracted 110 leads with a mean lead age of 4.67 ± 3.6 years. The most common extraction indication was an infection (71.15%). Indications correlated significantly with comorbidities (p = 0.024), the most common being Diabetes Mellitus (40.38%). Simple traction was successful in 31 % of the leads, while 69% were extracted using locking stylet and evolution dilator sheath. The method of lead extraction correlated significantly with lead age (P ≤ 0.001). Complications were significantly higher with extraction by evolution dilator sheaths than by simple traction (P = 0.003) and in older patients (P = 0.008). Complications also correlated significantly with extractions indications (p = 0.012), type of PPM (P = 0.037), number of extracted leads (P = 0.041), and lead age (p= 0.011). CONCLUSION: Among the studied variables, extraction indications particularly infection, was the only preventable factor significantly associated with complications. While focusing on preventable factors, improving, implantation and extraction techniques should also be addressed.

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A Novel Video-Assisted Approach to Excimer Laser-Guided Cardiac Implantable Electronic Devices Lead Extraction

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery ◽

10.1097/imi.0000000000000277 ◽

2016 ◽

Vol 11 (3) ◽

pp. 210-213

Author(s):

Patrick Zardo ◽

Henning Busk ◽

Johannes Hadem ◽

Hassina Baraki ◽

George Kensah ◽

...

Keyword(s):

High Risk ◽

Real Time ◽

Laser Sheet ◽

Electronic Devices ◽

Lead Extraction ◽

Clinical Value ◽

High Risk Patients ◽

Video Assisted ◽

Cardiac Implantable Electronic Devices ◽

Risk Patients

Objective Even though roughly 90% of all implanted cardiac implantable electronic devices leads can be removed through conventional techniques, presence of large vegetations or thrombi, fractured leads, previous failed extraction, or long duration from implantation often impede classical transvenous extraction. In these cases, laser-assisted procedures represent a highly successful alternative and have a low procedural complication rate with major adverse events in less than 2% of cases. Unfortunately, most encountered complications are potentially fatal, which prompted us to develop a novel approach that adds additional safety measures by allowing for real-time intrathoracic visualization and intervention. Methods Five consecutive patients classified as high-risk patients received concomitant laser sheet extraction and right-sided uniportal video-assisted thoracic surgery for real-time intrathoracic visualization. Results Complete extraction was achieved in all cases without observing major intraoperative events, and on-table extubation was feasible in all cases. No chest tube-associated or incision-related complications were encountered. Conclusions Concomitant laser sheet extraction and video-assisted thoracoscopy are feasible and may offer benefits in high-risk patients. Further studies to document the actual safety and clinical value of our procedure are warranted.

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