Via Research Recognition Day 2024 VCOM-Carolinas

Clinical Case-Based Reports

A Case Series Evaluating the Safety and Efficacy of Leadless Pacemaker Extractions and Reimplantation Alexis Howarth, OMS-II a ; Fergie Losiniecki, MD b ; Jose Lopez, MD c ; Justin Mark, MD d ; Sanford Zeigler, MD e ; Anne Kroman, DO, PhD b a Edward Via College of Osteopathic Medicine, Spartanburg, SC; b Medical University of South Carolina, Dept. of Cardiac Electrophysiology, Charleston, SC; c University of Miami Miller School of Medicine, Dept. of Cardiovascular Disease, Atlantis, FL; d University of Miami Miller School of Medicine, Dept. of Internal Medicine, Fort Lauderdale, FL; e Medical University of South Carolina, Dept. of Cardiothoracic Surgery, Charleston, SC; Introduction Case Presentation (cont.) Discussion

Patient 2 An active and previously healthy 20-year-old female, received a LP to manage multiple syncopal events, associated with activity, and inappropriate symptomatic sinus bradycardia. After discharge, patient initially felt well but within two days developed marked dizziness with exertion, thus prompting readmission to the hospital for evaluation of the LP device. Investigation indicated an increased pacing threshold in the LP device from 1 mV to 4.5 mV resulting <1% utilization. Radiological assessments, including a chest XR and CT scan, confirmed the device was in the correct placement. No other abnormalities were identified other than the change in device threshold. Discussion of replacement of the LP with a transvenous pacemaker was discussed but the patient opted to undergo extraction of the Micra TM device followed by reimplantation with an Aveir TM LP device. Similar to patient one, the LP was removed and replaced using the 23 French Aveir TM retrieval sheath and snare system. Confirmation of the placement of the device Patient two experienced complete symptomatic resolution following replacement of the device.

Case Presentation Leadless pacemakers (LP) have only recently been introduced into clinical practice as an alternative to traditional transvenous pacemakers (TVP) for the management of brady and tachy-arrhythmias. The two devices available include the Micra TM (Medtronic, Minneapolis, MN) and the Aveir TM (previously Nanostim TM , Abbott, Abbott Park, IL) systems. LP have gained notoriety due to their minimally invasive implantation methods and leadless design decreasing long-term lead failures seen in TVP. Despite the advantages of LP, there is still hesitancy in using this device due to the lack of literature showing the safety and efficacy of the device, specifically when it comes to device failure and subsequent removal and reimplantation. LP do not come without risk, more commonly these risks are device malfunction or infection. Thus, repositioning or extraction may still be necessary. Some studies have successfully shown that extraction is safe and feasible for LP 1 , but there is currently paucity of data regarding appropriate techniques and best practices for safe extraction. Herein, presented is two cases of successful Micra TM extraction using a retrieval sheath and triple snare system, followed by immediate reimplantation with Aveir TM . This case series adds meaningful real-world clinical information supporting the safety and feasibility of LP extraction via a femoral snaring approach and subsequent reimplantation of a different LP. Patient 1 A 64-year-old female with tachycardia-bradycardia syndrome, presented to the hospital with symptoms of dizziness. Clinical examination revealed bradycardia with a heart rate of 30 beats per minute, accompanied by hypotension. Correction of the bradycardia and hypotension was achieved through administration of two 1 mg intravenous doses of atropine. Subsequent diagnostic assessments, including echocardiography, identified a large pericardial effusion, further confirmed by a computed tomography (CT) scan, which revealed a superior displacement of the LP device and a perforation in the anterior right ventricular free wall. After multidisciplinary discussion, the decision was made to proceed with extraction of the Micra TM with immediate reimplantation of a leadless Aveir TM pacemaker as the patient’s clinical status would pose a higher risk of complication with a traditional system. Femoral venous access was obtained under ultrasound guidance and a 25 French Aveir TM retrieval sheath and triple snare system were advanced over a wire into the mid-right atrium, followed by successful retrieval of the Micra TM device into the retrieval catheter sheath (Figure 1). The perforation was then corrected to ensure hemostasis, followed by implantation of the Aveir TM device in the right ventricle septal myocardium using the same retrieval sheath used for removal. A transesophageal echocardiogram post-procedure showed normal systolic function and a chest x-ray (XR) showed proper positioning of the device (Figure 2). The patient experienced complete symptom resolution and was subsequently discharged on day four of admission.

The presented case series highlights crucial insights into the safety and feasibility of Micra TM system extraction, with an additional focus on two instances of successful immediate, complication-free replacement using the Aveir TM system. The clinical information contributes to affirming the safety and feasibility of Micra TM extraction. LPs have transformed the management of bradyarrhythmia’s and high degree AV blocks, as these devices have begun to replace traditional TVP for patients requiring single chamber ventricular pacing and sensing for permanent atrial fibrillation with bradycardia, bradycardia-tachycardia syndrome, or sinus bradycardia. 2 LPs offer distinct clinical advantages, as they are less invasive, carrying significantly less lead-related post-operative restrictions and failures and infection risk with increased battery life. The need for transvenous lead extraction is prevalent but remains technically difficult in comparison to LP extraction (due to formation of scar tissue around the generator and leads). Additionally, TLE carries an increased rate of major complications. Similarly, LP extraction may be indicated for infectious complications, device dislocations, malfunctioning, or perforations but carries a much lesser complication rate. 3

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Conclusion

In conclusion, LP extraction is safe, feasible and less technically challenging than TVP extractions. Similarly, our two reported patients underwent successful LP extraction via femoral snaring. The presence of the protective sheath successfully protected against the tearing of the veins as the device was being removed.

Figure 1. (a) Fluoroscopic view showing the snare catheter successfully latched to the Micra device. (b) Micra pacemaker attached to the snare catheter.

References

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Figure 2. (a) Antero-posterior chest XR showing proper positioning of Aveir LP. (b) Lateral chest XRshowing proper positioning of Aveir LP. (c) Illustration of device placement in the right ventricle septal myocardium.

The patients provided informed consent to use data in a case report.

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2024 Research Recognition Day