Effectiveness, Complications, and Mortality of TLE in Patients.

Completed

• Conditions: Transvenous Lead Extraction
• Interventions: Procedure: Transvenous lead extraction

• Registration Number: NCT05775783
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Study First Submitted: 2023-02-25
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

Consecutive patients who underwent TLE between 2016 and 2022 entered the EXTRACT Registry.

Exclusion Criteria

• no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive patients with CIEDs, treated with TLE (infections)	Transvenous lead extraction	-
Consecutive patients with CIEDs, treated with TLE (no-infections)	Transvenous lead extraction	-

Primary Outcome Measures

Name	Time	Method
Procedural success	30 days	Removing all targeted leads and their component parts without causing any permanently disabling complication or procedure-related death.
Clinical success	30 days	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
Minor complications	30 days	Complications that did not require surgical intervention or involved minor surgical interventions that did not affect the patient's functionality.
All-cause death or occurrence of any major complication	30 days

Trial Locations

Locations (1)

Krzysztof Gołba; 🇵🇱 Katowice, Poland