Effectiveness, Complications, and Mortality of TLE in Patients. (EXTRACT)

Effectiveness, Complications, and Mortality of Transvenous Lead Extraction in Patients With and Without Infections-Prospective Registry From a High-volume Center.

The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. The Achilles' heel of cardiac implantable electronic devices (CIEDs) is the risk of infections and lead failure, which, when untreated, can be the cause of poor outcomes and a high mortality rate. Abandoned leads predict serious adverse events, such as lead infections, death, electrical interference, or potential problems during future TLE procedures. Therefore, it is crucial to extract them, presuming the decision is warranted based on a patient's individual risk. TLE is a standard treatment for device-related complications, and while TLE procedures are relatively rare in comparison to the number of CIEDs that are implanted, the need for TLE has grown in recent years due to the aging population, an increasing number of upgrades of pacing systems, and a related rise in infection rates. According to the European Lead Extraction ConTRolled Registry (ELECTRa), the most frequent indication for TLE is CIED infection, with the majority of them being local infections. The second most common reason for TLE is lead dysfunction, which is observed in 38.1% of cases. In such cases, the treatment must be fast and effective. TLE is the first-line treatment for those patients and prevents further serious or even lethal complications. However, the goal of TLEis often to remove leads and also maintain access in the occluded vein by moving the sheath over the lead to the lead myocardial interface. TLE technology has recently shown substantial progress in improving the safety and effectiveness of the procedure. As a rule, single traction is the primary method of treatment, followed by more aggressive techniques such as locking stylet, mechanical sheaths, powered extraction sheaths, and femoral snares.

Data obtained in previous studies. indicated that identifying predictors of such undesirable adverse events appeared essential for optimizing the procedural technique. Another vital element to address were patients deemed at high risk of stricter follow-up and stronger secondary prevention strategies; notably, infected TLE patients have unique characteristics. The analysis of independent predictor outcomes could, thus, allow clinicians to better identify high-risk TLE patients. In light of this, the current registry aimed to investigate the composite short-term outcomes for infected and non-infected patients in real-world populations.

Study Overview

• Status: Completed
• Conditions: Transvenous Lead Extraction
• Intervention / Treatment: Procedure: Transvenous lead extraction

• Study Type: Observational
• Enrollment (Actual): 702

Contacts and Locations

Study Locations

• Poland
  • Katowice, Poland
    • Krzysztof Gołba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

702 patients

Description

Inclusion Criteria:

Consecutive patients who underwent TLE between 2016 and 2025 entered the EXTRACT Registry.

Exclusion Criteria:

- no

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consecutive patients with CIEDs, treated with TLE (infections)	Procedure: Transvenous lead extraction; Each TLE procedure was started using the single traction method. If this attempt was not sufficient to extract the lead, then the following methods were used: mechanical extraction sheaths (Byrd, Cook Vascular Inc., Leechburg, PA, USA), locking and nonlocking stylets (Liberator® Beacon® Tip Locking Stylet, Cook® Medical, Leechburg, PA, USA), powered extraction sheaths (Evolution or Evolution II Mechanical Dilator Sheath, Cook® Medical, Leechburg, PA, USA). A side retrieval snare loop (Needle's Eye Snare, Cook® Medical, Leechburg, PA, USA) was used for the femoral approach when the subclavian-only approach was insufficient.
Consecutive patients with CIEDs, treated with TLE (no-infections)	Procedure: Transvenous lead extraction; Each TLE procedure was started using the single traction method. If this attempt was not sufficient to extract the lead, then the following methods were used: mechanical extraction sheaths (Byrd, Cook Vascular Inc., Leechburg, PA, USA), locking and nonlocking stylets (Liberator® Beacon® Tip Locking Stylet, Cook® Medical, Leechburg, PA, USA), powered extraction sheaths (Evolution or Evolution II Mechanical Dilator Sheath, Cook® Medical, Leechburg, PA, USA). A side retrieval snare loop (Needle's Eye Snare, Cook® Medical, Leechburg, PA, USA) was used for the femoral approach when the subclavian-only approach was insufficient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Removing all targeted leads and their component parts without causing any permanently disabling complication or procedure-related death.	30 days
Clinical success	Removing all targeted leads and their component parts from the cardiovascular system or leaving a small part of the lead (<4cm) that did not adversely affect the objectives of the procedure or cause procedural-related death	30 days
Minor complications	Complications that did not require surgical intervention or involved minor surgical interventions that did not affect the patient's functionality.	30 days
All-cause death or occurrence of any major complication		30 days

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Collaborators: Wojciech Wańha

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Implantable Electronic Devices; Transvenous Lead Extraction
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Device Removal; Device Lead Extraction
• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No