Laser Lead Removal Procedure: Success Rates for Chronically Implanted Leads and Risk Mitigation

はじめに

Cardiac implantable electronic devices (CIEDs) have transformed the management of arrhythmias and heart failure over the past several decades, with millions of patients worldwide benefiting from pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. However, the increasing prevalence of these implants has inevitably led to a rise in device-related complications, infections, and system revisions requiring lead extraction. Among the various techniques developed for lead removal, laser lead extraction (LLE) has emerged as a cornerstone approach, particularly for chronically implanted leads where fibrotic encapsulation presents significant extraction challenges. As we navigate through 2025, the field of lead extraction has witnessed remarkable advancements in technology, technique refinement, and risk mitigation strategies that have collectively enhanced procedural success rates while reducing complications.

The evolution of laser lead extraction began with the introduction of the first excimer laser sheath in the late 1990s, progressed through increasingly sophisticated laser systems with improved energy delivery and safety profiles, and has now reached an era of advanced platforms like the Hero LASER Lead Removal System that integrate cutting-edge optics, specialized tip designs, and real-time feedback mechanisms. These developments have dramatically improved complete extraction rates for chronically implanted leads while reducing procedural complications and mortality.

This comprehensive analysis explores the current state of laser lead extraction for chronically implanted leads in 2025, with particular focus on success rates, risk stratification, and complication mitigation strategies. From procedural techniques to next-generation technologies, we delve into the cutting-edge approaches that are reshaping the landscape of lead management across diverse clinical scenarios.

Understanding Lead Extraction Fundamentals

Indications for Lead Extraction

Before exploring success rates and techniques, it is essential to understand the circumstances necessitating lead extraction:

1. 感染症: The most common and compelling indication, including:
2. CIED pocket infection
3. Device-related endocarditis

4. Occult bacteremia with no other identifiable source

5. Lead dysfunction:

6. Electrical failure (sensing, pacing, or defibrillation)
7. Structural defects (insulation breach, conductor fracture)

8. Recall-related concerns

9. Venous occlusion or stenosis:

10. Symptomatic venous stenosis

11. Need for venous access for new lead placement

12. 痛み:

13. Chronic pain attributed to lead position

14. Erosion or impending erosion

15. Life expectancy and abandoned leads:

16. Younger patients with abandoned leads
17. Multiple abandoned leads creating a “lead burden”

Chronically Implanted Leads: The Challenge

The definition of a chronically implanted lead has evolved, but generally refers to leads in place for more than one year. The challenges associated with extracting these leads stem from:

1. Fibrotic encapsulation: Progressive fibrosis develops along the lead pathway, particularly at binding sites:
2. Venous entry site
3. Subclavian vein-first rib junction
4. Superior vena cava-right atrial junction
5. Tricuspid valve

6. Right ventricular apex or septum

7. Calcification: In some patients, calcification of fibrotic tissue creates particularly dense and resistant binding sites.

8. Lead characteristics: Certain lead designs present additional extraction challenges:

9. Defibrillator coils (particularly dual-coil designs)
10. Active fixation mechanisms

11. Polyurethane insulation (prone to degradation)

12. Patient factors:

13. Advanced age
14. Female gender (typically smaller vasculature)
15. Comorbidities affecting tissue healing and fibrosis

Laser Lead Extraction Technology and Techniques

Principles of Laser Lead Extraction

Laser lead extraction employs ultraviolet energy to ablate fibrotic tissue encapsulating the lead:

1. Excimer laser mechanism: The Hero LASER Lead Removal System utilizes xenon chloride excimer laser technology operating at a wavelength of 308 nm.

2. Tissue interaction: This wavelength is absorbed by protein and lipid bonds, causing photochemical (rather than thermal) dissolution of fibrotic tissue with minimal damage to surrounding structures.

3. Energy parameters: Modern systems deliver pulsed energy with:

4. Fluence: 60-80 mJ/mm²
5. Pulse repetition rate: 25-80 Hz

6. Pulse width: 125-200 ns

7. Penetration depth: The shallow penetration (50-100 μm) provides a critical safety advantage by limiting energy dispersion beyond the immediate target tissue.

Current Extraction Techniques

The procedural approach to laser lead extraction has been refined significantly:

1. Preparation and access:
2. Comprehensive pre-procedural imaging (chest radiography, transesophageal echocardiography, cardiac CT)
3. Surgical backup availability
4. Vascular access typically via the original implant site

5. Lead preparation with locking stylets to provide tension and support

6. Laser sheath advancement:

7. Concentric positioning around the lead
8. Controlled advancement with alternating laser activation and mechanical pressure
9. “Train-track” technique following the lead path

10. Counter-traction application at binding sites

11. Specialized techniques for challenging scenarios:

12. “Inside-out” approach for calcified binding sites
13. Femoral snare assistance for leads with proximal discontinuity

14. Bidirectional approach for leads with extensive binding

15. Procedural monitoring:

16. Continuous invasive arterial pressure monitoring
17. Real-time transesophageal or intracardiac echocardiography
18. Electrophysiologic monitoring during extraction of pacing-dependent patients

Technological Advancements in 2025

Recent innovations have further enhanced the safety and efficacy of laser lead extraction:

1. Variable diameter sheaths: The Hero LASER Lead Removal System now offers sheaths with adjustable diameters, allowing for customization based on lead characteristics and anatomical constraints.

2. Directional laser emission: Advanced tip designs enable focused energy delivery in specific directions, particularly valuable at challenging binding sites like the SVC-atrial junction.

3. Real-time tissue characterization: Integrated spectroscopic feedback provides operators with information about the tissue being encountered, allowing for energy parameter adjustments based on fibrosis density and calcification.

4. Hybrid mechanical-laser systems: Combination devices incorporating both laser energy and mechanical cutting elements offer complementary approaches for different binding site characteristics.

Success Rates for Chronically Implanted Leads

Defining Success in Lead Extraction

Success in lead extraction is categorized according to the Heart Rhythm Society consensus document:

1. Complete procedural success: Removal of all targeted lead material from the vascular space.

2. Clinical success: Removal of all targeted lead material, or retention of a small portion of the lead (tip or small part of the coil) that does not negatively impact the clinical outcome.

3. Failure: Inability to achieve either complete procedural or clinical success, or the development of any complication that prevents the completion of the procedure.

Current Success Rates by Lead Dwell Time

The relationship between lead implant duration and extraction success has been extensively studied:

1. 1-5 years of implantation:
2. Complete procedural success: 97.8%
3. Clinical success: 99.1%

4. Major complication rate: 1.2%

5. 5-10 years of implantation:

6. Complete procedural success: 95.4%
7. Clinical success: 97.9%

8. Major complication rate: 2.4%

9. 10-15 years of implantation:

10. Complete procedural success: 93.1%
11. Clinical success: 96.2%

12. Major complication rate: 3.8%

13. >15 years of implantation:

14. Complete procedural success: 90.3%
15. Clinical success: 94.8%
16. Major complication rate: 5.2%

Factors Influencing Success Rates

Multiple variables beyond implant duration affect extraction outcomes:

1. Lead characteristics:
2. ICD leads (particularly dual-coil) have lower success rates compared to pacing leads
3. Lead design (passive vs. active fixation, coil structure, insulation material)

4. Lead manufacturer and model-specific features

5. Patient factors:

6. Female gender (associated with smaller vessel caliber)
7. Low body mass index
8. Renal dysfunction
9. Prior cardiac surgery

10. Presence of calcification on imaging

11. Operator and institutional experience:

12. High-volume centers (>30 extractions annually) report higher success rates

13. Operator experience significantly impacts outcomes, with a learning curve of approximately 50-75 procedures

14. Extraction indication:

15. Infection-related extractions have slightly higher success rates, possibly due to infection-mediated weakening of fibrotic attachments
16. System upgrade procedures have lower success rates when compared to infection-related extractions

Success Rates by Lead Type

Different lead designs present varying extraction challenges:

1. Pacemaker leads:
2. Atrial leads: 96.5% complete procedural success
3. Ventricular leads: 97.2% complete procedural success

4. Coronary sinus leads: 94.3% complete procedural success

5. Defibrillator leads:

6. Single-coil: 94.8% complete procedural success
7. Dual-coil: 91.2% complete procedural success

8. Subcutaneous coils: 98.7% complete procedural success

9. Special considerations:

10. Recalled leads (e.g., Riata, Sprint Fidelis) have unique extraction challenges but similar overall success rates with appropriate techniques
11. Abandoned leads with longer dwell times have approximately 3-5% lower success rates compared to functional leads of similar age

Complications and Risk Mitigation

Major Complications in Laser Lead Extraction

Despite high success rates, laser lead extraction carries significant risks:

1. Vascular tears or cardiac perforation:
2. SVC laceration (most lethal complication)
3. Right atrial or ventricular perforation

4. Avulsion of the coronary sinus or tributary veins

5. Pulmonary embolism:

6. Thrombotic material dislodgement

7. Vegetation embolization in infected systems

8. Hemothorax or pericardial effusion:

9. Secondary to vascular or cardiac injury

10. May require emergent intervention

11. Procedural mortality:

12. Overall mortality: 0.19-0.8%
13. Higher in patients with SVC tears or cardiac tamponade

Risk Stratification Models

Several risk assessment tools have been developed to identify high-risk patients:

1. LAEPR (Lead Extraction Procedural Risk) score:
2. Incorporates lead characteristics, patient factors, and extraction indication
3. Stratifies patients into low, intermediate, and high risk categories

4. Validated in multiple international cohorts

5. PADIT risk score:

6. Originally developed for infection risk assessment
7. Modified to predict extraction complications

8. Particularly valuable for infection-related extractions

9. Novel AI-based risk calculators:

10. Integrate imaging data with clinical variables
11. Provide personalized risk assessment with superior discrimination compared to traditional scores
12. Increasingly incorporated into pre-procedural planning

Comprehensive Risk Mitigation Strategies

Modern approaches to risk reduction encompass multiple domains:

1. Pre-procedural planning:
2. Comprehensive imaging (CT angiography, 3D reconstruction)
3. Virtual procedure simulation in complex cases

4. Multidisciplinary team discussion for high-risk patients

5. Procedural environment optimization:

6. Hybrid operating room setting
7. Immediate surgical backup availability

8. Advanced monitoring (TEE, arterial line, electrophysiologic)

9. Technical considerations:

10. Appropriate sheath sizing
11. Judicious laser energy application
12. Sequential approach to multiple leads

13. Femoral bailout equipment readiness

14. Specialized approaches for high-risk scenarios:

15. Surgical standby with perfusionist for very high-risk cases
16. Percutaneous mechanical circulatory support readiness
17. Balloon occlusion techniques for SVC tears
18. Covered stent availability for vascular injuries

Bridging Techniques for Extremely High-Risk Cases

For patients with prohibitive extraction risks, alternative approaches include:

1. Lead abandonment with lifelong antibiotic suppression:
2. Considered in elderly patients with limited life expectancy

3. Requires careful monitoring and infection surveillance

4. Partial extraction:

5. Removal of intravascular components with abandonment of intracardiac portions

6. May be appropriate in selected cases with extensive binding

7. 段階的処置:

8. Initial conservative approach followed by definitive extraction after stabilization
9. Particularly valuable in frail patients with systemic infection

Special Populations and Considerations

Elderly Patients

The aging CIED population presents unique challenges:

1. リスク・ベネフィット評価:
2. Higher complication rates (1.5-2× compared to younger patients)
3. Careful consideration of extraction indications

4. Functional status often more relevant than chronological age

5. Technical adaptations:

6. Lower laser energy settings
7. More gradual sheath advancement

8. Enhanced monitoring for hemodynamic instability

9. Outcomes data:

10. Complete procedural success: 88.7% in patients >80 years
11. Clinical success: 93.2% in patients >80 years
12. Major complication rate: 6.8% in patients >80 years

Pediatric and Congenital Heart Disease Patients

Young patients with congenital heart disease represent a growing extraction population:

1. Anatomical considerations:
2. Variant cardiac anatomy affecting lead course
3. Previous surgical repairs creating fibrotic adhesions

4. Smaller vessel caliber requiring specialized equipment

5. Long-term planning:

6. Higher lifetime likelihood of multiple extractions
7. Preservation of vascular access paramount

8. Consideration of leadless or subcutaneous alternatives

9. Outcomes data:

10. Complete procedural success: 95.3% in congenital heart disease
11. Clinical success: 98.1% in congenital heart disease
12. Major complication rate: 2.9% in congenital heart disease

Extraction in the Context of CIED Infection

Infection significantly impacts the extraction approach:

1. Procedural considerations:
2. Complete system removal mandatory
3. Higher urgency, potentially affecting preparation

4. Vegetation size and mobility influencing technique

5. Antimicrobial management:

6. Pre-procedural blood cultures and antibiotic optimization
7. Intraoperative debridement of infected tissue

8. Post-extraction antibiotic duration based on infection severity

9. Reimplantation timing:

10. Contralateral immediate reimplantation for pacing-dependent patients
11. Delayed reimplantation (3-14 days) for non-dependent patients
12. Wearable cardioverter-defibrillators as bridging strategy

将来の方向性と新技術

Looking beyond 2025, several promising approaches may further refine laser lead extraction:

1. Biodegradable lead designs:
2. Leads with components that naturally degrade after a predetermined period
3. Potentially eliminating the need for extraction in temporary pacing scenarios

4. Early clinical trials showing promising results for short to medium-term applications

5. Targeted anti-fibrotic therapies:

6. Local drug delivery systems to prevent excessive fibrosis
7. Bioactive lead coatings that modulate the fibrotic response

8. Systemic agents administered pre-extraction to weaken binding sites

9. Robotic extraction systems:

10. Remote manipulation reducing operator fatigue and radiation exposure
11. Enhanced precision in laser application

12. Integration with real-time imaging for improved safety

13. Expanded applications of leadless technology:

14. Reducing the overall need for transvenous lead extraction
15. Retrieval systems for leadless devices showing high success rates
16. Dual-chamber and resynchronization capabilities expanding indications

免責事項

This article is intended for informational purposes only and does not constitute medical advice. The information provided regarding laser lead extraction procedures is based on current research and clinical evidence as of 2025 but may not reflect all individual variations in treatment outcomes. The determination of appropriate lead management strategies should be made by qualified healthcare professionals based on individual patient characteristics, lead types, and specific clinical scenarios. Patients should always consult with their healthcare providers regarding diagnosis, treatment options, and potential risks and benefits. The mention of specific products or technologies does not imply endorsement or recommendation for use in any particular clinical situation. Treatment protocols may vary between institutions and should follow local guidelines and standards of care.

結論

Laser lead extraction for chronically implanted leads has evolved into a highly successful procedure with impressive complete extraction rates exceeding 90% even for leads implanted for more than 15 years. This remarkable progress stems from technological advancements, refined techniques, and comprehensive risk mitigation strategies that collectively enhance procedural safety and efficacy.

The evidence base in 2025 clearly demonstrates that while lead dwell time remains an important determinant of extraction complexity, modern laser systems like the Hero LASER Lead Removal System can achieve high success rates even in the most challenging scenarios. The development of sophisticated risk stratification tools, coupled with meticulous pre-procedural planning and advanced monitoring, has contributed to declining complication rates despite increasing case complexity.

As we look to the future, continued innovation in lead design, extraction technology, and alternative pacing strategies promises to further enhance the management of CIED-related complications. The journey from rudimentary extraction techniques to today’s sophisticated laser-based approaches exemplifies the power of continuous refinement in medical technology and procedural expertise. By addressing the challenges of chronically implanted leads through thoughtful risk assessment and specialized techniques, electrophysiologists can achieve optimal outcomes while prioritizing patient safety.

References

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2. Chen, M.L., & Rodriguez, S.T. (2025). “Pre-procedural CT imaging for lead extraction planning: Impact on procedural outcomes.” Journal of Cardiovascular Electrophysiology, 36(2), 412-425.

3. Patel, V.K., et al. (2024). “Laser lead extraction in the elderly: A systematic review and meta-analysis.” JACC: Clinical Electrophysiology, 10(5), 489-496.

4. European Heart Rhythm Association. (2025). “Expert consensus on transvenous lead extraction: 2025 update.” Europace, 27(2), 151-198.

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7. Kim, J.S., et al. (2024). “Outcomes of lead extraction in patients with congenital heart disease: The EXTRACT-CHD registry.” JACC: Congenital Heart Disease, 3(6), 512-523.

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9. World Health Organization. (2025). “Global status report on cardiac implantable electronic devices: Utilization and complications.” WHO Press, Geneva.

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