Pacemaker and defibrillator lead extraction plays an important role in lead management strategy and complements novel technology, such as leadless pacing and subcutaneous implantable cardiac defibrillators. Indications and recommendations for lead extraction have been established.^1,2 Pediatric and adult congenital heart disease (CHD) centers may have lower case volumes than adult lead extraction centers. However, CHD adds anatomic complexity in a younger population of smaller patient size, where limited transvenous access, prior operations, and baffles and conduits may alter lead position. The 2014 PACES/HRS Consensus Statement recommends that device-based procedures be performed in a regional ACHD center laboratory with appropriate personnel and equipment, by an electrophysiologist with expertise in CHD.³ Guidelines have identified necessary components of a CHD lead extraction program, and we propose modifiers that demonstrate CHD expertise (Table 1). In experienced centers, procedural success remains high (~95%), with reported complication rates in the range of approximately 3-4%,^4-7 with no mortality – similar to adult series.^8,9 Due to anatomic complexity and potential for adverse outcomes which may be life threatening, centers performing these procedures should have a designated team familiar with the CHD management to maximize procedural success and safety.

Table 1: Suggested CHD Lead Extraction Operator Training/Expertise

	Guideline Recommendation	Suggestion
Lead extraction specialist	Electrophysiologist or CT surgeon Initial: 30 lead extractions Annual: 20 extractions	Primary operator: training in pediatric or adult congenital heart disease or Co-operator: training in pediatric electrophysiology
Cardiothoracic (CT) surgeon	Continuing education in surgical management of lead complications Immediately available for emergent sternotomy or thoracotomy within 5-10 minutes	Additional congenital heart disease training
Cardiovascular anesthesiologist	Procedures performed under general anesthesia in most centers which facilitates intraprocedural TEE, and eliminates urgent intubation	Additional congenital heart disease training
Tools	Simple manual traction Lead locking stylets Telescoping sheaths Femoral snares Mechanical cutters Laser sheaths	For leads that have been in place for a longer time ("dwell time"), the likelihood of requiring snares is higher
Intraoperative imaging	Strong recommendation for transesophageal echocardiogram (TEE) or intra-cardiac echocardiography (ICE) based on operator familiarity and comfort with image interpretation	ICE - less fluoroscopic interference; better right heart visualization; relies on the extractionist for interpretation. TEE - less costly upfront;  image interpretation independently performed by an echocardiographer.
Access	Some centers routinely place femoral arterial and venous sheaths for rapid cannulation if bypass is necessary	Venous occlusion and interrupted inferior vena cava with azygos continuation may limit maneuverability
Vascular tear preparation	Some centers include interventional radiologists or vascular surgeons to assist with percutaneous management of vascular tears	Routine preparation of tamponade balloon. Coordination with interventional cardiology (if use of covered stent  required).

Where and who is to perform lead extractions for anatomically complex cases need to be determined. Both the Heart Rhythm Society (HRS) and European Heart Rhythm Association (EHRA) suggest that competency is conferred with the performance of at least 30-40 lead extractions as the primary operator, requiring 20 lead extractions annually to maintain competency.^10,11 Large adult referral centers perform an average of 9-16 cases (17-29 leads) per month^12,13 compared to pediatric and adult centers that perform approximately 0.2-1 case (0.3-2.4 leads)/month, albeit with an anticipated volume increase due to an aging ACHD population. Though lead dwell time is similar (~6-7 years), CHD centers treat cases with more complex anatomy, including 23% who had undergone atrial switch operations for d-transposition of the great arteries.^4-7 These differences in volume and anatomic complexity make it challenging to train extraction experts to care for congenital heart disease patients.

Since the launch of our dedicated pediatric and congenital lead extraction program, we have identified strategies to assist with complex CHD (Table 2):

Table 2: Strategies to Assist with CHD Extraction and Lessons Learned

	Recommendation	Comments
Pre-procedural
Strategy	Aggressive lead management to remove dysfunctional leads and infected hardware	Institutional commitment to achieve this (e.g., equipment, staffing, operating room schedule, and surgical backup availability)
Case review	Multidisciplinary discussion between electrophysiologist, surgeon, and anesthesiologist	Review of prior imaging and past chest operations can assist with setup, access, approach, and surgical rescue planning
Protocols and simulation	Preparation for possible complications	Given rarity of emergencies, established routines and simulated practice may reduce mortality
Intraoperative
Anesthesia	General anesthesia for all cases	Reduces patient movement and discomfort in anticipation of prolonged procedures and optimizes hemodynamics
Access	Arterial access obtained in all cases Venous access obtained in all cases	Real time blood pressure monitoring in case of emergency Immediate availability for percutaneous cannulation and rapid infusion of volume or blood products if superior vena cava (SVC) flow is obstructed when the tamponade balloon is deployed
Tamponade balloon	Access with stiff guidewire across SVC and innominate veins and 12F peelaway sheath	Tamponade balloon equipment prepped and readily available for immediate use
Imaging	Real-time intracardiac or transesophageal echocardiogram	Immediate detection of pericardial effusion and intraoperative assessment of leads. ICE may be beneficial in evaluating prosthetic valve function (difficult to image prosthetic pulmonary valves with TEE in cases of endocarditis).14,15 TEE requires a separate echocardiographer for interpretation.
Pacing	Backup transvenous and transcutaneous pacing (in case of dislodgement) should be tested before extraction, if needed	Heart block without adequate escape rate may require additional venous access
Case differences
High percentage of atrial switch operations	Majority of extractions in Mustard and Senning patients require concurrent baffle interventions	Coordination with congenital interventional cardiologist to optimize procedural yield
Lead dysfunction rather than infection	More aggressive attempts to salvage functional leads to limit collateral damage	Familiarity with techniques and potential complications may result in improved salvaging of functional leads
More snare techniques utilized	Longer lead dwell time and patient youth (<40 years of age) are associated with more challenging extractions16	Familiarity with femoral snare techniques and steerable sheaths can assist with challenging cases. Minority of cases are successful with manual traction alone (readiness to escalate to advanced methods and powered sheaths).
Complications	Anatomic concerns, cumulative instrumentation (e.g., number of generator changes over a lifetime), infection risk, and anticoagulation	Outcome Transparency and measurement of key metrics; Regular Data review to promote quality initiatives and improve outcomes

Conclusion
Lead extraction can be performed successfully in CHD with comparable results as non-CHD patients. However, differences exist between most adult institutions and those that care for patients with CHD. Additional training and experience are necessary for anatomically complex and challenging cases. Multi-disciplinary collaboration with focused attention on the nuances related to CHD is critical to ensure procedural success and safety.

References

1. Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction.  Heart Rhythm 2017;14:e503-e551.
2. Bongiorni MG, Burri H, Deharo JC, et al. 2018 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. Europace 2018;20:1217a-1217j.
3. Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease: developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Heart Rhythm 2014;11:e102-65.
4. Gourraud JB, Chaix MA, Shohoudie A, et al. Transvenous lead extraction in adults with congenital heart disease: insights from a 20-year single-center experience. Circ Arrhythm Electrophysiol 2018;11:e005409.
5. Cecchin F, Atallah J, Walsh EP, Triedman JK, Alexander ME, Berul CI. Lead extraction in pediatric and congenital heart disease patients. Circ Arrhythm Electrophysiol 2010;3:437-44.
6. Fender EA, Killu AM, Cannon BC, et al. Lead extraction outcomes in patients with congenital heart disease. Europace 2017;19:441-46.
7. McCanta AC, Kong, MH, Carboni MP, Greenfield RA, Hranitzky PM, Kanter RJ. Laser lead extraction in congenital heart disease: a case-controlled study. PACE 2013;36:372-80.
8. Brunner MP, Cronin EM, Duarte VE, et al. Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions. Heart Rhythm 2014;11:799–805.
9. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol 2010;55:579–86.
10. Zipes DP, Calkins H, Daubert JP, et al. 2015 ACC/AHA/HRS advanced training statement on clinical cardiac electrophysiology (a revision of the ACC/AHA 2006 update of the clinical competence statement on invasive electrophysiology studies, catheter ablation, and cardioversion). J Am Coll Cardiol 2015;66:2767-2802.
11. Deharo JC, Bongiorni MG, Rozkovec A, et al. Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper. Europace 2012;14:124–34.
12. Tarakji KG, Saliba W, Markabawi D, et al. Unrecognized venous injuries after cardiac implantable electronic device transvenous lead extraction. Heart Rhythm 2018;15:318-25.
13. Tsang DC, Perez AA, Boyle TA, Carrillo RG. Effect of prior sternotomy on outcomes in transvenous lead extraction. Circ Arrhythm Electrophysiol 2019;12:e007278.
14. Sadek MM, Cooper JM, Frankel DS, et al. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm 2017;14:1779-85.
15. Østergaard L, Vejlstrup N, Køber L, Fosbøl EL, Søndergaard L, Ihlemann N. Diagnostic potential of intracardiac echocardiography in patients with suspected prosthetic valve endocarditis. J Am Soc Echocardiogr 2019;32:1558-64.
16. El-Chami MF, Sayegh MN, Patel A, et al. Outcomes of lead extraction in young adults. Heart Rhythm 2017;14:537-40.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Pericardial Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, CHD and Pediatrics and Quality Improvement, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: Heart Defects, Congenital, Vena Cava, Superior, Brachiocephalic Veins, Thoracotomy, Pericardial Effusion, Sternotomy, Traction, Benchmarking, Laboratories, Blood Pressure, Operating Rooms, Pulmonary Valve, Transposition of Great Vessels, Vena Cava, Inferior, Arteries, Pacemaker, Artificial, Catheterization, Surgeons, Heart Block, Endocarditis, Anesthesia, General, Stents, Education, Continuing, Referral and Consultation, Technology, Electrophysiology, Echocardiography, Anticoagulants, Defibrillators, Intubation, Intratracheal, Tomography, X-Ray Computed

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