Clinical trial NCT05775783: Effectiveness, Complications, and Mortality of TLE in Patients.
Official title: Effectiveness, Complications, and Mortality of Transvenous Lead Extraction in Patients With and Without Infections-Prospective Registry From a High-volume Center.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transvenous Lead Extraction
Keywords: Transvenous Lead Extraction
Cardiac Implantable Electronic Devices
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Wojciech Wańha
First posted: 2023-03-20
Enrollment: 504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 504 patients

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- no

Primary outcomes:
measure: Procedural success
timeFrame: 30 days
measure: Clinical success
timeFrame: 30 days
measure: Minor complications
timeFrame: 30 days
measure: All-cause death or occurrence of any major complication
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Krzysztof Gołba
Study officials:
References: