Complications of a Stepwise Approach for Transvenous Lead Extraction

Pacemaker Lead Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04306575
• Other study ID #: 01020031284
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: August 2021

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Mohamed A Abdelrady
• Phone: 0020102201284
• Email: mabolhassan10[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All consecutive patients referred for lead extraction with class I and IIa indications according to 2017 HRS expert consensus statement on CIED lead management and extraction.

Exclusion Criteria:

• Patients primarily requiring surgical extraction

Related Conditions & MeSH terms

• Pacemaker Lead Dysfunction

Intervention

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

Locations

Country	Name	City	State
Italy	Brescia university hospital	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bontempi L, Vassanelli F, Cerini M, Bisleri G, Repossini A, Giroletti L, Inama L, Salghetti F, Liberto D, Giacopelli D, Raweh A, Muneretto C, Curnis A. Hybrid Minimally Invasive Approach for Transvenous Lead Extraction: A Feasible Technique in High-Risk Patients. J Cardiovasc Electrophysiol. 2017 Apr;28(4):466-473. doi: 10.1111/jce.13164. Epub 2017 Feb 9. — View Citation

Curnis A, Bontempi L, Coppola G, Cerini M, Gennaro F, Vassanelli F, Lipari A, Ashofair N, Pagnoni C, Bisleri G, Munaretto C, Dei Cas L. Active-fixation coronary sinus pacing lead extraction: a hybrid approach. Int J Cardiol. 2012 May 3;156(3):e51-2. doi: 10.1016/j.ijcard.2011.08.016. Epub 2011 Sep 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural related major complications	Complications includes pericardial effusion/tamponade, arrhythmia, hypotension, pulmonary embolism and death	one year
Secondary	Clinical and radiological success	clinical success means that the procedure completed with no procedural complications, Radiological success means complete extraction of the whole lead or remaining of less than 3 cm	3 months