Pacemaker Lead Dysfunction Clinical Trial
Official title:
Challenges and Complications of a Stepwise Approach for Transvenous Lead Extraction, Single High-Volume Center Study
It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had a dysfunction or infection so needed to be extracted.
The number of cardiac implantable electronic device (CIED) implantations has increased over
recent years (1) with approximately 1.2-1.4 million CIEDs are being implanted annually
worldwide.(2) Consequently this has been associated with increasing rates of infection and
lead malfunctions, affecting approximately 1-2% of all CIED cases.(3)
Recently, it is estimated that between 10 000 and 15 000 leads are extracted worldwide each
year.(4) Over the past few decades, transvenous lead extraction (TLE) has evolved as the
preferred method for leads removal being less invasive compared to surgical removal by open
heart surgery which is now reserved for cases with high risk procedures or a very large
vegetation.
Most frequent indications for TLE are infection (accounting for 52.8%) and lead dysfunction
(accounting for 38.1%) of all cases of TLE. (5)
There have been different approaches (superior and inferior approaches) and techniques for
TLE. Current techniques employ mechanical and/or laser equipment with variable success rates.
The locking stylet has been the principal tool in these techniques, while the telescoping
(powered or non-powered) mechanical or laser sheaths serve as the most important ancillary
tools.
Despite being a safe procedure with minor complications ranging from 0.06 to 6.2%, but
serious complications may still arise in 0.2-1.8 % of cases in even the most experienced
hands with mortality rates in several large registries amounting 0.2 - 1.2 %.(6) Although
many studies have tried to identify risk factors for complications including patient/lead
profile and centre/operator experience, major studies still have conflicting results.
Recently, the hybrid approach, with mini-thoracotomy or thoracoscopy, has been introduced and
supposed to be associated with increased safety in challenging TLE procedures. (7, 8)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04055740 -
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
|
N/A | |
| Active, not recruiting |
NCT05037474 -
Contemporary Transvenous Lead Extraction Outcomes
|