Effectiveness, Complications, and Mortality of TLE in Patients.

NCT05775783 | Completed

• 1 other identifier: 0001
• Study Type: observational
• Target: 702
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transvenous Lead Extraction

Keywords

Transvenous Lead Extraction; Cardiac Implantable Electronic Devices

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Consecutive patients with CIEDs, treated with TLE (infections)

Procedure: Transvenous lead extraction

Consecutive patients with CIEDs, treated with TLE (no-infections)

Procedure: Transvenous lead extraction

Interventions

Transvenous lead extraction PROCEDURE

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 (infections); Consecutive patients with CIEDs, treated with TLE (no-infections)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

702 patients

You may qualify if:

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

You may not qualify if:

• \- no

Sponsors & Collaborators

• Wojciech Wańha: collaborator
• Medical University of Silesia: lead

Study Sites (1)

Krzysztof Gołba

Katowice, Poland

Location

MeSH Terms

Interventions

Device Lead Extraction

Intervention Hierarchy (Ancestors)

Device Removal; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 20, 2023
• Study Start: January 1, 2016
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

PL (1)