Abstract
Background
Compared to traditional transvenous pacemakers, leadless pacemakers have the advantages of reducing risks of infection, minimal vascular access, and interactions with tricuspid apparatus. However, complications including device dislodgement can still occur and its management requires a comprehensive and innovative approach. We report a case of atrial leadless device dislodgement into pulmonary artery after implantation and intracardiac echocardiogram (ICE)-guided retrieval of the device. Venogram at the area confirmed that the device was lodged into a subbranch of the left pulmonary artery. A gooseneck snare tool was used to snare the device. With ICE guidance, pacemaker and snare device were adjusted to overcome valve entanglement and the system was retrieved. ICE imaging after retrieval showed moderate pulmonary regurgitation (PR) and small circumferential pericardial effusion. The patient tolerated the procedure well and was discharged a week later without any events. Follow-up transthoracic echocardiogram showed improved PR. In conclusion, device dislodgement is one of the complications after leadless pacemaker implantation. Intra-procedural ICE imaging is an efficient tool to guide device retrieval in order to avoid valve entanglement and damage.
Learning objective
The management and surveillance of device dislodgment after leadless pacemaker implantation requires an individualized approach. Intra-procedural intracardiac echocardiogram imaging is an efficient tool to guide device retrieval in order to avoid valve entanglement and damage.
Keywords: Leadless pacemaker, Device dislodgement, Intracardiac echocardiogram
Introduction
The efficacy and safety of leadless pacemakers have been investigated in multiple large-scale studies [1], [2], [3]. To date, Medtronic Micra (Minneapolis, MN, USA) and Abbott Aveir (Abbott Park, IL, USA) pacemaker systems have been approved by the US Food and Drug Administration. Compared to traditional transvenous pacemakers, leadless pacemakers have the advantages of reducing risks of infection, minimal vascular access, and interactions with tricuspid apparatus [4]. However, complications including device dislodgement can still occur and its management requires a comprehensive and innovative approach. We hereby report a case of atrial device dislodgement into pulmonary artery after implantation and the use of intracardiac echocardiogram (ICE) to guide its retrieval.
Case report
This is a case of an 81-year-old female with past medical history of persistent atrial fibrillation (Afib), hypertension, moderate aortic stenosis, end-stage renal disease (ESRD) on hemodialysis, and anemia who was admitted for Afib with rapid ventricular rate (Online Fig. 1). The patient initially underwent cardioversion. Afterwards the patient went back into Afib and also developed bradycardia with junctional rhythm. The initial strategy was to implant a dual chamber leadless pacemaker, followed by cardioversion and maintenance of sinus rhythm with amiodarone. She underwent implantation of a dual chamber leadless Aveir pacemaker for tachy-brady syndrome. Immediate post-procedural chest X-ray (CXR) showed that both the atrial and ventricular devices were in position (Fig. 1A). Post-procedural device interrogation showed normal parameters. However, on the day following the procedure, CXR showed that the right atrial device was dislodged (Fig. 1B). Subsequent fluoroscopy showed that the atrial device was stable in the left femoral vein. The patient had no symptoms or hemodynamic consequences. In this scenario, the decision was made to do the procedure in regular hours where more resources (for example, vascular cardiology, interventional radiology) were readily available. However, later on that day, she underwent hemodialysis. X-ray of the pelvis after dialysis showed that device was no longer visible in the femoral vein. During the whole post-procedural period, the ventricular device was seen to be in a good position and had good parameters with back-up VVI at 40 beats/min. Subsequently, she was taken to the electrophysiology laboratory and underwent fluoroscopy again, which showed that the atrial device was lodged into the left pulmonary artery (PA). Venogram at the area confirmed that the device was lodged into a subbranch of the left PA (Video 1). Dedicated extraction tools made by Abbott are difficult to navigate to the PA. An Impress® Diagnostic Peripheral Catheter (5Fr, 100 cm, Merit Medical Systems, South Jordan, UT, USA) was used to reach the PA. Then the catheter was exchanged over-the-wire to snare the delivery system. Tri-loop snare system (En Snare, 7Fr, 120 cm, Merit Medical Systems) was used to snare the device in the PA. The snare was used to capture the device at the level of the body to maximize stability (Fig. 2). After securing the device in the snare, the snare was pulled towards the bigger outer sheath. However, resistance was noticed around the pulmonary valve and pulling was temporarily paused. Manual minor adjustments were unsuccessful. In this scenario, a 10 Fr Acunav ICE (Siemens Healthineers, Erlangen, Germany) was advanced into the right ventricle from the left femoral vein to assess the issue. According to ICE imaging (Video 2), the pacemaker body was noted to be entangled at the area of the pulmonary valve. The pacemaker was snared and maneuvered to overcome the valve entanglement under ICE guidance. Then the whole system was pulled into the sheath to the groin. The outer sheath was removed from the atrial leadless pacemaker. ICE imaging afterwards showed moderate pulmonary regurgitation (PR) and small circumferential pericardial effusion. The ICE was removed. The patient tolerated the procedure well and was discharged without any events. Follow-up transthoracic echocardiogram showed improved PR. No additional pacemaker device was implanted considering the high risks of dislodgement of the atrial device and satisfactory device parameters with VVI mode during subsequent device interrogation.
Fig. 1.
(A) Immediate post-procedural chest X-ray showing normal position of the atrial lead (black circle). (B) Chest X-ray the day after the procedure showing missing atrial lead (black circle).
Fig. 2.
Fluoroscopy showing a gooseneck snare tool was used to snare the pacemaker body for extraction.
Discussion
Leadless pacemakers were developed with aims to minimize device-related infections, technical difficulties encountered during positioning, and lead-related tricuspid valve malfunction. Since the first leadless pacemaker trial LEADLESS in 2014 [5], leadless pacemakers have undergone multiple design enhancements to optimize fixation and stability. In particular, the evolution from single-chamber to dual-chamber pacing system further expanded its targeted patient population to patients requiring atrial pacing [6].
Although previous studies have demonstrated satisfying outcomes in terms of device safety and efficacy [7], [8], complications such as device dislodgement/embolization, ventricular/atrial wall perforation, and pericardial effusion have been reported. Bahbah et al. [9] investigated 5990 AVEIR VR implants over a 21-month period and found that 53 (0.88%) developed device dislodgment during or after the procedure. A meta-analysis including 18 studies and different types of leadless pacemakers also showed a similar dislodgment rate of 0.76% [10]. Device dislodgment could lead to severe complications such as embolization and stroke.
The retrieval of the dislodged device requires an individualized approach based on the location of the dislodged device and the anatomy of the patient, which can be determined using X-ray, fluoroscopy, and eventually confirmed with venogram. Afterwards, a snare system is advanced to the targeted location and captures the device. However, in this case, the retrieval process was met with resistance due to the location of the dislodged device. Although fluoroscopy and venogram provided visualization of the device and vascular anatomy, their ability to visualize valvular and intracardiac anatomies remains limited. In this case, the use of ICE allowed for accurate identification of anatomical markers, avoiding device entanglement and significant damage to the pulmonary valve and tricuspid valve while pulling back the sheath.
The reason for this complication is multifactorial including implantation techniques, anatomical characteristics, and device design. In particular, in patients with persistent Afib and ESRD, the atrial tissue characteristics may be altered, resulting in complicated anatomy. Further clinical practice and a higher procedural volume are needed to optimize the fixation techniques and protocols for post-procedural monitoring. An additional interesting finding in this particular case was that the device migrated from the left femoral vein to the left PA in less than 24 h. We presume the event occurred in between dialysis. This also necessitates the discussion about ‘routine’ care in between device dislodgement and removal, and timing of removal. An individualized protocol needs to be established in every institute performing this procedure.
In summary, we demonstrated a complex case of atrial leadless pacemaker dislodgment, which was complicated by further migration of the dislodged device in the PA possibly secondary to dialysis. This case underscores the importance of an individualized and multimodality approach when managing leadless pacemaker-related complications including ICE-guided retrieval techniques. This case report also raises the question of the protocols of performing post-procedural routine screening X-ray. In addition, this case report also demonstrates that the timing of removal of the dislodged device is critical, suggesting that early intervention is beneficial in terms of preventing further migration of the dislodged device.
Conclusions
Device dislodgement is one of the complications after leadless pacemaker implantation. Intra-procedural ICE imaging is an efficient tool to guide lead retrieval in order to avoid valve entanglement and damage.
Patient permission/consent statement
Informed consent regarding the procedures/treatments included in this case was obtained. No additional informed consent was obtained as this case report did not include any patient-identifying information. This case report is retrospective in nature, treatments/interventions are in adherence to guidelines and routine clinical practice.
Declaration of competing interest
Dr. Parikh is a consultant for Abbott. All other authors have no conflicts of interest or disclosures to report. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Footnotes
Funding: None
Supplementary data to this article can be found online at https://doi.org/10.1016/j.jccase.2026.03.001.
Appendix A. Supplementary data
Venogram at the area showing that the device was lodged into a subbranch of the pulmonary artery.
Intracardiac echocardiogram imaging during sheath retrieval. Intracardiac foreign body noted consistent with the atrial device.
Online Fig. 1.
Baseline electrocardiography showing atrial fibrillation with rapid ventricular response.
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Associated Data
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Supplementary Materials
Venogram at the area showing that the device was lodged into a subbranch of the pulmonary artery.
Intracardiac echocardiogram imaging during sheath retrieval. Intracardiac foreign body noted consistent with the atrial device.