Establishing a Cardiac Implantable Electronic Device Lead Extraction Program in a Resource-Limited Setting.

Introduction

Background

There has been a steady increase in cardiac implantable electronic device (CIED) implantation procedures in Asia [ 1 , 2 ]. This is well reflected in the White Book of the Asia Pacific Heart Rhythm Society, which documents a steady rise in the volume of these procedures among all countries, including emerging economies such as the Philippines [ 2 ]. Contributing factors include an aging population and increased cardiovascular disease burden [ 3 ].

With this increase in the number of CIED procedures performed, there has been a corresponding increase in related infections as well as lead malfunctions. As these complications become more common—particularly infections—preparation for their management is crucial. For both issues, complete system extraction is considered a Class I recommendation according to guidelines from several specialty societies, including the European Heart Rhythm Association (EHRA) and the Heart Rhythm Society (HRS) [ 4 , 5 ].

The Philippines is an archipelago of more than 7000 islands, making healthcare delivery to rural and remote areas more difficult. As a result, access to these devices and procedures remains limited, particularly in rural areas. Most implants are performed in major urban centers, and the country's overall CIED implantation rate remains lower than in many Western nations [ 3 ]. In three of the country's leading electrophysiology (EP) training hospitals, 26 CIED infections were recorded from 2021 to 2024. This growing number highlights the need for proper management strategies, including lead extraction. Yet, lead extraction remains underutilized, primarily due to the lack of resources and logistical challenges. In many cases, infections are still managed conservatively, through lead abandonment and local debridement, rather than by definitive extraction [ 6 ]. This highlights the urgency of improving access to more definitive therapies like lead extraction.

The HRS and EHRA consensus statements highlight lead extraction as a key intervention for CIED‐related infections, lead dysfunction, and abandoned leads [ 4 , 5 ]. Both organizations agree that systemic infections—such as endocarditis or bacteremia—as well as localized infections with systemic involvement warrant prompt and complete system extraction [ 6 ]. Lead dysfunction, most often caused by fractures or insulation failure, is another primary indication for extraction [ 7 ]. Venous occlusion may also necessitate extraction to enable future lead implantation [ 8 ], while abandoned leads are often removed to minimize long‐term complications [ 9 , 10 ]. The EHRA guidelines specifically emphasize reducing the intravascular lead burden in cases involving multiple abandoned leads. Despite these recommendations, many institutions remain unequipped to perform lead extractions due to limited resources or inadequately trained personnel [ 4 ].

To address this challenge, the premier state university training hospital, the University of the Philippines‐Philippine General Hospital (UP‐PGH), launched the first lead extraction program in the country in September 2023.

Significance of the Study

This is the first lead extraction program in the Philippines. It permitted a systematic approach to managing CIED‐related infections and malfunction and solidified the workflow, including preoperative, intraoperative, and postoperative approaches to lead extraction cases. It allows the sharing of the initial experience of a lower‐middle‐income country to enable insight into other countries with similar economic backgrounds. It also highlights ongoing logistical issues that must be addressed to sustain such a program. Having a program improves patient outcomes, minimizes long‐term complications, optimizes the resources available, complies with international standards, and promotes research opportunities. This also aligns with the Asia Pacific Heart Rhythm Society (APHRS) committee's lead extraction goals, which aim to offer training and logistical support to enhance expertise, especially in low implant‐volume, developing countries. These efforts support the broader objective of expanding lead extraction capacity across the entire Asia‐Pacific region.

Objectives

General objective: To describe the establishment and early implementation of the UP‐PGH Lead Extraction Program.

Specific objectives: To detail the initial experience in forming the UP‐PGH Lead Extraction Program. To describe the clinical workflow developed from the initial experience and identify the resources required to establish the first lead extraction program in the Philippines.

Methodology

This descriptive study involved adult patients with CIED‐related infections, abandoned leads, or other clinical indications for lead extraction, based on EHRA and HRS guidelines. All adult patients at UP‐PGH identified from September 2023 to August 2024 meeting EHRA and HRS indications were included. Patients unable to undergo extraction due to comorbidities or who declined consent were excluded. The following data were collected: Preoperative data: Preoperative data included patient demographics, primary cardiac diagnosis, comorbidities, pacing dependency, extraction indications, and infection‐related data (blood cultures, transesophageal echo). Details on antibiotic therapy, lead characteristics (number, dwell time, status, and position), and prior extraction attempts were collected. Intraoperative data: Intraoperative data included the procedure venue, lead types, anesthesia approach, personnel involved, imaging modalities, specialized tools used, interventions, procedure duration, and immediate outcomes (e.g., intraoperative complications). Postoperative data: Post‐extraction data included hemodynamic parameters, rhythm management, and reimplantation timing. Other essential data consisted of hospitalization duration, long‐term complications, follow‐up data.

Results

Overview of Initial Experience

The program was officially launched on September 1, 2023, with all the elements outlined in the methodology in place. Within the first year, four cases were performed. Before the program's establishment, leads with an average dwell time of more than 2 years required surgical extraction by sternotomy. After program implementation, procedures were performed percutaneously in patients with median lead dwell time of 6.2 years, demonstrating the ability to manage chronically implanted leads less invasively.

The following elements were identified as essential to starting a lead extraction program: Training of personnel: Networking was done with lead extractors from the region. Engagements at international conferences and virtual meetings allowed coordination. Three electrophysiologists from the Philippines (GGG, JDL, and MJA) were identified as the lead extractors. They underwent a series of didactic lectures and hands‐on simulation training. Proctoring was done face‐to‐face and online for the first few cases. A multidisciplinary team composed of electrophysiologists, echocardiographers, thoracic and cardiovascular anesthesiologists (TCVA), surgeons (TCVS), and catheterization/operating room nurses was created. Procurement of equipment: The decision was to start with a system with locking stylets and cutting sheaths. Due to the absence of local a distributor of this equipment in the country, the team pursued and secured compassionate use approval from the regulatory body. The cutting sheaths could be sterilized if they are not heavily used during a case. Getting hospital support: The program was set up at the Division of Cardiovascular Medicine of the University of the Philippines‐Philippine General Hospital. Institutional backing was critical, with full support obtained from the hospital administration and all key stakeholders. Compassionate use approval granted by the Philippine Food and Drug Administration allowed for the use of the tools pending full registration. Charitable foundations were engaged to help procure the required equipment. Workflow development: A multidisciplinary team was tapped for the first four cases. A conference was held to assess risk, discuss the clinical strategy, and standardize the workflow. A unified workflow was reached among the team members, adapting from the EHRA Consensus statement on lead extraction. Setting up a lead extraction registry: This registry includes demographic, clinical, and outcome data of each case to allow monitoring and later publication. Forming multi‐hospital and international linkage: The team is actively working to build linkages with national and international partners, including the Philippine Heart Association and the Asia Pacific Heart Rhythm Society.

Preoperative Course

In the program's first year, four lead extraction cases were performed. All cases involved infected leads. Patient ages ranged from 51 to 71 years and all were male. One patient had ischemic cardiomyopathy. Three dual‐chamber pacemakers, and one a single‐chamber ICD. Antibiotic therapy was culture‐guided; vancomycin was used in three cases. Tansesophageal echocardiogram was performed in all cases and revealed no vegetation.

Each case was managed by a multidisciplinary team, led by electrophysiologists, with support from TCVS, TCVA, echocardiographers, and Infectious Disease specialists. This collaborative approach was essential to program success.

Intraoperative Course

All cases were performed in the cardiac catheterization laboratory or the cardiovascular operating room, under general anesthesia, mechanical ventilation, and continuous transesophageal echocardiogram monitoring. In all cases, femoral arterial and venous vascular access was secured for rapid cardiopulmonary bypass indication, if needed. The bypass team was on standby for possible vascular or cardiac injury. All cases but one utilized a locking stylet. The exception was a 16‐month‐old system, which was tied with sternal wires. Uniform and progressive traction was applied until extraction. A cutting sheath was required in only one case (the 20‐year‐old system). A snare was not required in any case. In the 20‐year‐old system, surgical cutdown and vascular repair at the subclavian vein entry site was performed. The EP‐led team successfully completed all extractions. No minor or major complications occurred. Cardiopulmonary bypass was not required in any case. Vasopressors or circulatory support were not required. No patient required prolonged intubation.

Postoperative Course

All patients were transferred to a monitored bed overnight. The first case was transferred to the referring hospital within 24 h after the extraction and underwent completion of antibiotics. The range of antibiotic therapy was 2–4 weeks (4 weeks in the two cases with positive blood culture and 2 weeks in those with negative blood culture). The mean length of hospital stay was 26 days, influenced mainly by the duration of antibiotic therapy. Device reimplantation was conducted 1 week after a negative blood culture for the three other cases. No long‐term complications were detected during the outpatient follow‐up of all four patients.

A summary table (Table 1 ) shows the baseline characteristics of the four cases who underwent transvenous lead extractions.

(1) Patient selection: Indications need to be reviewed against existing Clinical Practice Guidelines. Benefits versus risks need to be weighed and discussed within the team and between the team, the patient, and family. (2) Readiness of the multidisciplinary team: The team should be activated at the outset to ensure high success and reduced morbidity. (3) Choice of extraction approach: A decision must be made between percutaneous versus open approach. In general, we prefer a percutaneous approach with a surgical backup for complicated cases. (4) Preoperative preparation: A checklist is provided in the appendix, but key points include the performance of key diagnostic procedures, loading of IV antibiotics, and securing of tools for the procedure. (5) Intraoperative safety: This is the crux of the entire program, as all the preparatory steps come into play during the actual procedure. Hemodynamic and transesophageal monitoring is crucial to identify complications early and allow prompt surgical intervention, if needed. (6) Reimplantation strategy: The issue here is the timing of reimplantation, which depends on infection status and the availability of alternative pacing sites. Reimplantation should only be performed once cleared of infection since temporary pacemaker backup may be used in the interim. Other alternatives include the use of leadless and epicardial pacemakers. The American Heart Association Consensus statement offers a 3‐day window after negative blood cultures and a 2‐week window in cases of endocarditis. (7) Postoperative monitoring: Continuity of care is important to ensure a good long‐term outcome and detect late complications.

Discussion

The establishment of the UP‐PGH Lead Extraction Program represents a significant milestone in advancing cardiac care in the Philippines. It addresses the growing need for safe and effective lead extraction in patients with cardiac implantable electronic devices (CIED). The program was developed in response to the rising incidence of CIED infections and lead‐related complications accompanying the increased implant volumes, which, until recently, were managed conservatively, through lead abandonment and antibiotic therapy.

By aligning with international guidelines and leveraging multi‐disciplinary collaboration, the program has demonstrated that lead extraction can be performed safely and effectively in a resource‐limited setting, laying the foundation for similar initiatives in other developing countries.

Addressing the Need for a Lead Extraction Program

Across the Asia Pacific region, including the Philippines, cardiac implantable electronic device (CIED) implantations have risen, accompanied by a parallel increase in device‐related infections and mechanical failures. International guidelines from the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) advocate complete lead extraction in cases of systemic infections, endocarditis, or lead dysfunction.

Before program implementation lead extractions were rarely performed in the Philippines due to limited expertise, lack of specialized tools, and logistical constraints. As a result, patients were treated with suboptimal strategies carrying higher risks of long‐term complications. UP‐PGH addressed this gap through a structured, evidence‐based program, potentially setting a precedent for other centers in developing countries.

Program Implementation and Multidisciplinary Collaboration

A central factor in the program's success was the establishment of a structured workflow, ensuring a streamlined approach to patient evaluation, procedural planning, and postoperative management. The program adopted a multidisciplinary model, integrating electrophysiologists, thoracic and cardiovascular surgeons, anesthesiologists, and echocardiographers, and catheterization laboratory and operating room staff. This collaborative framework enabled comprehensive risk assessment, procedural safety, and effective complication management [ 11 ]. Additionally, close coordination with hospital administrators and industry partners facilitated equipment procurement and technical support, addressing one of the key challenges to performing lead extractions in low‐resource settings.

Comparison to International Standards

Although lead extraction remains underutilized in many parts of Asia, this program demonstrated encouraging outcomes, which eventually may be comparable to international benchmarks, such as those reported in the European Lead Extraction Controlled (ELECTRa) study and the Japanese Lead Extraction (J‐LEX) registry [ 12 , 13 , 14 , 15 , 16 ]. The procedural success rate, defined as the complete removal of all targeted leads, was consistent with international benchmarks, and no significant complications occurred in the initial cases. Key requirements availability of fluoroscopy, TEE, and emergency surgical backup‐ collectively increased operator confidence and enhanced procedural success. While these early results are promising, future studies with a larger cohort will help validate these findings, assess long‐term outcomes, and refine best practices for lead extraction in resource‐constrained environments.

Challenges and Sustainability

Despite early success, several challenges remain. The availability of lead extraction tools remains a limiting factor, as these specialized devices require significant financial investment and regulatory approval. Initial cases were performed under compassionate‐use exemptions; long‐term sustainability will depend on stable funding and negotiation for lower equipment costs. Ongoing training and skill development for extraction specialists are essential to maintain accessibility and safety for a growing patient population. Specific adaptive measures include: Lack of Tools: At time of program initiation, no local distributors for cutting sheaths and locking stylets were available in the Philippines. To address this, the team, through the hospital, applied for compassionate‐use approval from the Philippine Food and Drug Administration. Tools were used judiciously—some tools, for example, sheaths, were sterilized and reused if not heavily worn. This pragmatic approach maximized their utility without compromising safety. Insurance Reimbursement: Government insurance (PhilHealth) and most private insurers in the Philippines do not cover lead extraction procedures or the associated equipment. Thus, the four initial cases were funded through charitable foundations and donations. Proctor Fees: Proctorship was provided at no cost for the initial cases as part of an international collaboration. This was facilitated through relationships within the Asia Pacific Heart Rhythm Society network. Some proctoring was also conducted virtually, minimizing cost. These partnerships emphasized knowledge exchange over financial gain, supporting capacity‐building.

Sharing these adaptive strategies may offer a roadmap for other resource‐limited institutions. Institutional support, international collaboration, regulatory flexibility, and charitable funding cannot be overstated in making such complex programs possible and sustainable in low‐ and middle‐income countries.

Ethical Considerations and Policy Implications

Lead extraction is a high‐risk procedure requiring careful patient selection and informed consent. Given the life‐threatening nature of CIED infections, most patients had no alternative to extraction, making shared decision‐making integral. Integration to national healthcare policy is necessary to standardize lead extraction as guideline‐directed therapy and ensure broader access. Collaboration with professional societies, such as the Philippine Heart Association and the APHRS, will be crucial for policy advocacy and financial support from the public and private sectors.

Future Directions

The early experience of the UP‐PGH Lead Extraction Program highlights the feasibility and scalability of similar programs in other low‐ and middle‐income countries. To further strengthen the program, future efforts should expand electrophysiologist training opportunities, secure dedicated equipment funding, and develop a national registry to systematically track outcomes and complications. Increasing awareness among referring physicians about the extraction indications will, likewise, optimize patient selection and improve long‐term clinical outcomes.

Limitations

The clinical practice guidelines used in the program were adapted from Western countries and may not fully apply to different settings. The tools available in the Philippines may vary from those available to other countries. The regulatory procedures may likewise differ, limiting workflow applicability.

This report reflects the initial experience of a newly established lead extraction program in a developing country, with a small sample size. Although early outcomes were successful, the small sample size limits the generalizability of findings and precludes meaningful statistical analysis. Nevertheless, the program is expanding, and a prospective database is being developed to track future cases. Future directions include evaluating infection outcomes post‐extraction, assessing cost‐effectiveness of in‐country extractions versus overseas extractions, and measuring patient‐reported outcomes such as quality of life (QoL). These efforts will refine workflow, justify resource allocation, and contribute regional data for developing countries establishing similar programs.

Recommendations

To sustain the program, the logistical challenges need to be addressed consistently. A registry should be published to document results, support safety monitoring, and guide other countries setting up similar programs. Because lead extraction is a high‐risk procedure, all procedures should be performed within a multidisciplinary lead extraction program. Proctorship is recommended during the program's initial phase. Establishing a referral center and the forming of a local lead extraction core group, (e.g., through the Philippine Heart Rhythm Society) is recommended to strengthen the project and develop local guideline/consensus, including the recommendations for surgical backup in case of complications. For countries in the Asia‐Pacific region, coordination with the APHRS device and lead extraction subcommittees may potentially enhance the resources access and address logistical challenges.

Conclusions

In conclusion, the initial experience of the UP‐PGH lead extraction program demonstrated successful outcomes in all early cases. The establishment of a standardized lead extraction workflow illustrated the feasibility of setting up a CIED lead extraction program in a developing country. With appropriate training, institutional support, essential tools, a structured workflow, and multidisciplinary preparation, these complex cases were successfully performed by an EP‐led extraction team and resulting in favorable outcomes.

Ethics Statement

Ethical approval was obtained from the UP‐Manila Research Ethics Board (UPM‐REB).

Consent

Written Informed consent was obtained in accordance with the Declaration of Helsinki and Philippine National Ethical Guidelines for Health Research and Data Privacy Act of 2012.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Data S1: joa370163‐sup‐0001‐DataS1.docx.

Acknowledgments

We gratefully acknowledge the constant support of Dr. Pipin Kojodjojo, Professor Morio Shoda, Dr. Nobuhiro Nishii, Dr. Nigel Lever, Dr. Gerardo Legaspi (PGH Director), PGH Department of Medicine, PGH Division of Cardiovascular Medicine, PGH Division of Thoracic and Cardiovascular Surgery (TCVS), PGH Section of Thoracic and Cardiovascular Anesthesia, PGH Division of Pediatric Cardiology, and the Staff of Catheterization Laboratory and Cardiovascular Operating Room of the UP‐PGH.

Data Availability Statement

Data are available from the correspondong authors, upon reasonable request and in the article S1 .

References

1 J. H. Lee , S. R. Lee , E. K. Choi , et al., “ Temporal Trends of Cardiac Implantable Electronic Device Implantations: A Nationwide Population‐Based Study ,” Korean Circulation Journal 49 , no. 9 ( 2019 ): 841 – 852 . 31074230 10.4070/kcj.2018.0444 PMC6713826

2 Asia Pacific Heart Rhythm Society , White Book 2023: A Report of the Asia Pacific Heart Rhythm Society . S. Johar, P. Khmao, et al., country contributors ( APHRS , 2023 ).

3 G. G. Gervacio , N. S. Pestaño , B. A. Tumanan‐Mendoza , et al., “ Epidemiologic Burden of Hospitalization Among Adult Filipinos for Cardiac Arrhythmias Requiring Permanent Pacemaker Implantation ,” Philippine Journal of Cardiology 49 , no. 1 ( 2021 ): 21 – 29 .

4 F. M. Kusumoto , M. H. Schoenfeld , B. L. Wilkoff , et al., “ 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction ,” Heart Rhythm 14 , no. 12 ( 2017 ): e503 – e551 . 28919379 10.1016/j.hrthm.2017.09.001

5 M. G. Bongiorni , H. Burri , J. C. Deharo , et al., EHRA Expert Consensus Statement on Lead Extraction: Recommendations on Definitions, Endpoints, Research Trial Design, and Data Collection Requirements for Clinical Scientific Studies and Registries: Endorsed by APHRS/HRS/LAHRS , vol. 20 ( Oxford University Press , 2018 ), 1217 – 1217j . 10.1093/europace/euy050 29566158

6 D. R. Lakkireddy , D. S. Segar , A. Sood , et al., “ Early Lead Extraction for Infected Implanted Cardiac Electronic Devices ,” Journal of the American College of Cardiology 81 , no. 13 ( 2023 ): 1283 – 1295 . 36990548 10.1016/j.jacc.2023.01.038

7 A. Saeed , A. AlShafea , M. AlQthami , et al., “ A Systematic Review and Meta‐Analysis of the Prevalence and Risk Factors in Cardiac Implantable Electronic Device Malfunction ,” Journal of the Saudi Heart Association 35 , no. 4 ( 2023 ): 311 – 334 . 38179411 10.37616/2212-5043.1359 PMC10766167

8 S. Al‐Maisary , J. Kremer , G. Romano , M. Karck , and R. De Simone , “ Risk of Venous Occlusion After Lead Laser Extraction Preventing Future Lead Implantation ,” Journal of Cardiothoracic Surgery 16 , no. 1 ( 2021 ): 321 . 34717698 10.1186/s13019-021-01706-5 PMC8557546

9 S. Rijal , R. U. Shah , and S. Saba , “ Extracting Versus Abandoning Sterile Pacemaker and Defibrillator Leads ,” American Journal of Cardiology 115 , no. 8 ( 2015 ): 1107 – 1110 . 25697918 10.1016/j.amjcard.2015.01.537

10 M. Amelot , A. Foucault , P. Scanu , et al., “ Comparison of Outcomes in Patients With Abandoned Versus Extracted Implantable Cardioverter Defibrillator Leads ,” Archives of Cardiovascular Diseases 104 , no. 11 ( 2011 ): 572 – 577 . 22117909 10.1016/j.acvd.2011.08.004

11 K. Salib , L. Dardari , M. Taha , et al., “ Discussing the Prognosis and Complications of Transvenous Lead Extraction in Patients With Cardiac Implantable Electronic Devices (CIED): A Systematic Review ,” Cureus 15 ( 2023 ): e45048 . 37829955 10.7759/cureus.45048 PMC10565517

12 P. Salazar , A. Pérez‐Silva , A. Villablanca , et al., “ Feasibility and Safety of a Transvenous Lead Extraction Program Implementation in South America: Challenges, Early Outcomes, and Global Collaboration—A Single‐Center Experience ,” Heart Rhythm O2 3 , no. 6 ( 2022 ): 731 – 735 . 36589010 10.1016/j.hroo.2022.07.012 PMC9795241

13 M. G. Bongiorni , C. Kennergren , C. Butter , et al., “ The European Lead Extraction ConTRolled (ELECTRa) Study: A European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes ,” European Heart Journal 38 , no. 40 ( 2017 ): 2995 – 3005 . 28369414 10.1093/eurheartj/ehx080

14 M. Shoda , K. Kusano , M. Goya , et al., “ Japanese Lead EXtraction (J‐LEX) Registry: Annual Report 2019 ,” Journal of Arrhythmia 38 , no. 2 ( 2022 ): 187 – 191 . 35387141 10.1002/joa3.12678 PMC8977581

15 O. Wazni , L. M. Epstein , R. G. Carrillo , et al., “ Lead Extraction in the Contemporary Setting: The LExICon Study. An Observational Retrospective Study of Consecutive Laser Lead Extractions ,” Journal of the American College of Cardiology 55 , no. 6 ( 2010 ): 579 – 586 . 20152562 10.1016/j.jacc.2009.08.070

16 K. J. Williams , S. O'Keefe , and J. F. Légaré , “ Creation of the Sole Regional Laser Lead Extraction Program Serving Atlantic Canada: Initial Experience ,” Canadian Journal of Surgery 59 , no. 3 ( 2016 ): 180 – 187 . 10.1503/cjs.011115 PMC4982863 26999473