NCT04306575

Complications of a Stepwise Approach for Transvenous Lead Extraction

Challenges and Complications of a Stepwise Approach for Transvenous Lead Extraction, Single High-Volume Center Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Pacemaker Lead Dysfunction

Interventions

Type	Name	Description
OTHER	Trans-venous lead extraction	Patients with a dysfunction or infection of a cardiac pacemaker or a defibrillator are indicated for extraction of these devices, so lead extraction is done transvenously to remove these leads

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-03-01
• Completion: 2021-08-01
• First posted: 2020-03-13
• Last updated: 2020-03-13

Locations

1 site across 1 country: Italy