Extravascular ICD as a Viable Solution after CIED Lead Extraction: a case report.

Post-implant infections of pacemakers or defibrillators represent a significant complication, impacting patient morbidity and mortality. This case report describes a 75-year-old man with multiple comorbidities who developed pocket erosion of a previously implanted biventricular defibrillator, complicated by Staphylococcus Haemolyticus infection. Following device extraction and targeted antibiotic therapy, an extravascular implantable cardioverter defibrillator (EV-ICD) Aurora EV-ICD™ was implanted. The procedure was successfully performed, with a two-month follow-up showing no signs of infection or device displacement. EV-ICD emerges as a safe and effective alternative in high-risk patients, minimizing complications associated with vascular access and endocardial lead implantation.

Pacemaker or defibrillator post-implantation infections remain one of the most relevant complications, with an annual probability of around 1.3% and a significant impact on patient morbidity and mortality. [1-3] Although antibiotic prophylaxis and antibiotic-impregnated sheaths have been shown to reduce the incidence of such events, these measures do not eliminate the risk. [4] When an infection occurs, complete extraction of the cardiac implantable electronic device (CIED) is strongly recommended [2]. During reimplantation, it is crucial to use a new access site and a different location for the CIED device [5]. In this context, the new extravascular implantable cardiac defibrillator (EV-ICD) represents a viable and safe alternative to reimplanting traditional pacemakers or transvenous implantable cardioverter defibrillators (ICD). not-yet-known not-yet-known not-yet-known unknown 1 CASE REPORT This clinical case concerns a 75-year-old man suffering from hypertension, dyslipidemia, obesity, type 2 diabetes mellitus, hyperuricemia and non-dilated left ventricular cardiomyopathy without coronary artery disease. Despite optimized medical therapy, he exhibited global hypokinesia and a left ventricular ejection fraction of 35%,. In 2019, he underwent the implantation of a biventricular defibrillator for primary prevention. In December 2024, lead extraction was performed without complications due to pocket erosion with ICD case exposure. A biopsy of the pectoral pocket and microbiological exam of the lead tips revealed the presence of Staphylococcus Haemolyticus, prompting an antibiogram. Antibiotic therapy with linezolid was initiated and later replaced with Clindamycin due to an allergic reaction. Given the need for ICD reimplantation, the absence of pacing requirements, and the high risk of infection, the patient underwent implantation of an extravascular ICD (Aurora EV-ICD™, Medtronic, Inc) two weeks later, with the assistance of the cardiothoracic surgery team. 1 CASE REPORT not-yet-known not-yet-known not-yet-known unknown 1 PROCEDURE The patient was placed under general anesthesia and intubated for the entire procedure. In the operating room, fluoroscopy was used to identify and mark key anatomical landmarks on the skin, including the xiphoid process, the lower margin of the last ribs, the mid-sternal line, the left sternal margin, the silhouette of the upper portion of the heart, and the implant pocket (Fig. 1). After preparing the sterile surgical field, a 3 cm incision was made between the projection of the xiphoid process and the left lower costal margin. Dissection proceeded to the fascia of the rectus abdominis muscle, and the diaphragm muscle was traversed to the left of the xiphoid process to access the retrosternal portion of the anterior mediastinum through manual dissection (Fig. 2). Two nonabsorbable braided synthetic sutures were placed on the fascia of the rectus abdominis muscle to anchor the electrocatheter sleeve. The sternal tunneling tool was then introduced, ensuring continuous adherence to the posterior portion of the sternum (Fig. 3). Under fluoroscopic guidance, using anteroposterior and latero-lateral projections, the tunneling rod was advanced to the upper margin of the cardiac shadow. It was then removed, and the electrocatheter was introduced through the previously positioned introducer in the retrosternal space (Fig. 4). The introducer was carefully peeled under radioscopic guidance, revealing the typical epsilon shape of the electrocatheter. The sleeve was fixed to the pre-placed anchoring points, and the electrocatheter was secured to the sleeve with an additional suture using a constrictor knot. The subcutaneous pocket for the generator was created. The subxiphoid breach was connected to the implant pocket using a second tunneling tool. The electrocatheter was attached to the sternal end of the tunneling rod and guided into the implant pocket. The generator was placed inside the pocket and connected to the electrocatheter via a connector. The generator was secured to the pocket with a non-absorbable suture. Finally, the surgical wounds were closed using a continuous suture with absorbable thread. The procedure concluded with a successful ventricular fibrillation induction test, verification of arrhythmia recognition, and effectively discharging 30 J from the extravascular defibrillator. The wound check 8 days post-surgery was satisfactory. The patient was monitored for over two months without signs of infections or erosion, maintaining stable electrical parameters. 1 PROCEDURE not-yet-known not-yet-known not-yet-known unknown 1 DISCUSSION In ICD implantation, the careful selection of the device is essential, prioritizing, whenever possible, extravascular defibrillators that, due to their configuration and position outside the cardiac chambers, can reduce the risk of post-implantation systemic infections and related complications. Moreover, the extravascular approach may be particularly indicated in patients undergoing extraction due to the complexity and risks associated with the procedure and the possible difficulty of vascular access, which could make the subsequent reimplantation of a traditional device very challenging. [1-2] In this case, the patient presented multiple risk factors for infection, including diabetes, obesity, and reduced ejection fraction. [6] After the extraction of the leads and the dual-chamber ICD due to pocket erosion and a Staphylococcus Haemolyticus infection, an EV-ICD was chosen for reimplantation, given the absence of pacing needs and the high infection risk. Although the use of EV-ICD in patients who have previously undergone extraction has not been standardised yet, there is a solid clinical and pathophysiological rationale supporting its use. Indeed, in recent years, the subcutaneous defibrillator (S-ICD), i.e., a non-transvenous device with suprasternal lead, has been extensively employed in this specific patient population. Similarly, leadless pacemakers, which provide cardiac pacing without the need for transvenous leads, are increasingly being implanted in patients at high risk of infection and/or with difficult vascular access, such as those who have already undergone extraction [7-9]. The extravascular defibrillator Aurora EV-ICD combines the functionalities of transvenous devices with its innovative features. The device can perform anti-tachycardia pacing (ATP) and provide backup pacing and post-shock pacing (up to 40 bpm for a maximum of 30 seconds). The battery has an estimated lifespan of approximately 11.7 years, and the dimensions are comparable to those of transvenous single-chamber devices, allowing for implantation in a subcutaneous pocket. The system has four electrodes—two coils and two rings—that allow for three different pacing options and three sensing options [10]. The safety and effectiveness of this device were demonstrated in the Pivotal study [11], where it successfully passed 98.7% of defibrillation tests at implantation. The study protocol required ventricular arrhythmia termination using a shock energy of ≤30J, despite the device’s maximum deliverable energy of 40J. The shock was effective in 100% of the spontaneous episodes during the 3-year follow-up. Furthermore, the effectiveness of ATP therapies was verified, which successfully terminated 77% of episodes [11], a percentage similar to that reported in various studies on transvenous defibrillators. [12] The Pivotal study reported no major intraprocedural complications. However, 9.7% of patients experienced inappropriate shocks, mainly due to P-wave over-sensing. This issue decreased over the course of the study as operators gained experience [11]. The subxiphoid position of the extravascular defibrillator can reduce complications related to vascular access and those arising from lead manipulation within the heart. Moreover, unlike traditional transvenous devices, the eventual extraction of the system is less risky, as it can be performed relatively simply, using only manual traction and/or mechanical devices for extraction without compromising the thoracic organs. This case highlights the efficacy and safety of extravascular devices in high-risk patients, confirming their role in preventing/management post-implantation infectious complications. 1 DISCUSSION not-yet-known not-yet-known not-yet-known unknown

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Authors Metrics & Citations Metrics Article Usage 206views 124downloads Citations Download citation Giuseppe Coppola, Salvatore Torre, L. D’Amico, et al. Extravascular ICD as a Viable Solution after CIED Lead Extraction: a case report.. Authorea. 08 March 2025. DOI: https://doi.org/10.22541/au.174144604.45132510/v1 DOI: https://doi.org/10.22541/au.174144604.45132510/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu.