Leadless Pacemaker Retrieval: Clinical Feasibility and Experience

Leadless pacemakers have transformed the landscape of bradycardia therapy since their commercial introduction over a decade ago. By eliminating the subcutaneous pocket and transvenous leads, these capsule-sized devices reduce complications such as pneumothorax, lead fracture, and pocket infection that have long plagued conventional transvenous systems. In Australia, adoption has grown steadily across major cardiac centres in Sydney, Melbourne, Brisbane, Perth, and Adelaide, supported by Therapeutic Goods Administration approval and reimbursement through the Medicare Benefits Schedule for appropriate indications.

As implant volumes climb, the cardiology community faces a practical question that early adopters rarely had to confront: what happens when a leadless pacemaker reaches end-of-service, develops an infection, or needs to be replaced with a different system? Initially conceived as permanent implants, these devices are now being retrieved with increasing confidence. Operators worldwide have published case series and registry analyses demonstrating that extraction is technically achievable in the majority of patients, provided the procedure is performed in centres with appropriate expertise and equipment.

The shift in mindset has been gradual, influenced by longer follow-up data and the realisation that many patients will outlive their first device. Battery longevity for contemporary leadless pacemakers typically ranges from 8 to 15 years depending on pacing burden, meaning younger recipients will almost certainly require a management strategy decades after their initial implant. Without retrieval options, abandoned devices accumulate in the right ventricle, with uncertain consequences for venous patency, tricuspid valve function, and future imaging compatibility.

Australian electrophysiologists have contributed to this evolving evidence base, participating in international registries and reporting local outcomes from high-volume centres. The country's mix of metropolitan teaching hospitals and regional referral pathways creates unique considerations for device management, particularly for patients in rural and remote areas who travel significant distances for specialist care. Remote monitoring capabilities, supported by Australian telehealth frameworks, help clinicians track device parameters between in-person reviews and flag retrieval candidates well before clinical deterioration occurs.

The rise of leadless pacing and the retrieval question

The first leadless pacemaker systems entered clinical practice with the explicit understanding that retrieval was not part of routine workflow. Devices were engineered for permanent deployment, and operators were trained primarily on implantation technique. However, registry data and post-market surveillance soon revealed scenarios where removal became clinically desirable: infection at a remote site with haematogenous seeding, device upgrade to a system with cardiac resynchronisation capability, or simply the need to replace a depleted generator in a younger patient.

In Australian practice, the decision to retrieve rather than abandon is increasingly discussed at multidisciplinary device rounds. Operators at Royal Prince Alfred Hospital in Sydney, The Royal Melbourne Hospital, and the Princess Alexandra Hospital in Brisbane have been among those documenting successful percutaneous retrieval using dedicated snares, retrieval catheters, and occasionally femoral or internal jugular approaches when standard techniques fail. The learning curve appears steep but manageable, with success rates in experienced hands exceeding 80% in published series.

Technical feasibility and procedural considerations

Retrieval of a leadless pacemaker is fundamentally different from extraction of a transvenous system. There are no anchoring sleeves or binding sites to disrupt; instead, the operator must engage the device header or body and withdraw it through the venous system, often with the aid of a snare or dedicated retrieval tool. The procedure is typically performed via the femoral vein using a large-bore sheath, and operators must be prepared for the possibility of converting to an open surgical approach if the device is firmly endothelialised.

Procedural planning involves careful review of implant location, time since implantation, and device orientation on fluoroscopy. Devices implanted within the past 2–3 years are generally easier to retrieve than those in place for longer periods, as encapsulation by fibrous tissue increases the risk of avulsion injury to the myocardium or tricuspid valve apparatus. Several Australian operators have described techniques for managing difficult cases, including the use of steerable sheaths, buddy wires, and hybrid approaches involving cardiothoracic surgical backup.

Contemporary series report successful retrieval in approximately 85–90% of attempted cases, with major complications occurring in fewer than 3% of procedures. These figures compare favourably with historical outcomes for transvenous lead extraction, although direct comparisons are complicated by differences in patient population, indication, and operator experience. Notably, the absence of indwelling leads means there is no risk of superior vena cava laceration or retained lead fragments, which has been a source of morbidity in conventional extraction practice.

Clinical outcomes from multicenter series

Multicenter data on leadless pacemaker retrieval have matured substantially over the past five years. A pooled analysis of more than 600 retrieval attempts published in 2024 reported an overall procedural success rate of 88%, with a major adverse event rate of 2.1%. These outcomes have been replicated in subsequent series from European, North American, and Asia-Pacific centres, lending external validity to the earlier single-centre reports that first suggested retrieval was feasible.

Australian centres have contributed patient cohorts to several of these collaborative analyses. Local operators have emphasised the importance of pre-procedural planning, particularly for devices implanted more than three years prior or in patients with significant comorbidities. In one Melbourne-based series, retrieval was attempted in 42 patients over a four-year period, with successful removal achieved in 38 (90.5%) and no procedural deaths. Two patients required surgical backup for devices that could not be disengaged percutaneously, both of whom recovered without long-term sequelae.

The outcomes contrast somewhat with those reported for abandoned devices. While short-term follow-up suggests that leaving a depleted leadless pacemaker in situ is generally well tolerated, concerns remain about long-term effects on right ventricular function, tricuspid regurgitation, and the potential for the device to interfere with future transcatheter tricuspid interventions. These uncertainties have strengthened the argument for retrieval whenever technically feasible and clinically appropriate.

Patient selection, indications, and long-term management

Identifying which patients should undergo retrieval rather than abandonment requires careful clinical judgement. Clear indications include device-related infection, the need for upgrade to a system incompatible with the existing leadless device (such as cardiac resynchronisation therapy), and patient preference after thorough counselling. Relative indications include younger age at implant, anticipated need for magnetic resonance imaging under specific conditions, and participation in occupations or activities where device interference could pose safety risks.

The Australian context introduces some unique considerations. The country's vast geography means that many patients live far from specialist retrieval centres, making pre-emptive retrieval at the time of battery depletion a less attractive proposition than scheduling the procedure around an elective replacement. Conversely, the widespread availability of remote monitoring through platforms supported by Medicare-funded telehealth item numbers allows clinicians to identify devices approaching end-of-service well in advance, facilitating planned retrieval rather than urgent intervention.

For patients with complex arrhythmia substrates, decisions about device selection at the time of initial implant can have downstream implications. Cardiologists managing atrial fibrillation alongside structural heart disease or congenital anomalies must weigh the merits of leadless pacing against alternatives that allow for atrial lead placement or combined defibrillator therapy. Approaches to AF management in PFO often require coordinated input from electrophysiologists, structural interventionalists, and imaging specialists, with device choices made in the context of the broader treatment strategy rather than in isolation.

Future directions and registry insights

The next generation of leadless pacemakers is being designed with retrieval in mind. Manufacturers have introduced features such as proximal retrieval buttons, radiopaque alignment markers, and docking mechanisms that simplify engagement at the time of removal. Early experience with these devices suggests that retrieval success rates may exceed 95%, although longer-term follow-up is needed to confirm these promising initial results.

Registry initiatives are critical to refining best practice. The Asia Pacific Heart Rhythm Society, which jointly publishes the Journal of Arrhythmia, has supported collaborative data collection across the region, and Australian centres contribute to several ongoing studies. Real-world registries capture outcomes that randomised trials cannot, including rare complications, device performance over time, and procedural learning curves across diverse healthcare settings. Engagement with national and international registries helps ensure that the evidence base continues to mature in step with technological advances.

Looking ahead, the integration of leadless pacing with other device therapies will require careful attention to programming and interaction. While leadless pacemakers function independently of subcutaneous defibrillators, patients receiving both systems need coordinated follow-up to avoid inappropriate sensing or interaction. Attention to optimal S-ICD programming becomes particularly relevant when patients transition between devices or require upgrades, highlighting the need for electrophysiologists to remain current with programming recommendations across the full range of contemporary cardiac devices.

For clinicians and researchers interested in contributing to this evolving field, the Journal of Arrhythmia welcomes original research, review articles, and case reports that advance understanding of leadless pacemaker retrieval and related device management questions. Submissions undergo rigorous peer review through the journal's editorial workflow, and accepted manuscripts are published open access to maximise reach across the Asia Pacific region and beyond. Practising electrophysiologists, trainees, and research teams are encouraged to share their experience through the journal's online submission system, helping to build the evidence base that will guide clinical practice for years to come.