Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers

• Conditions: Heart Failure; Equipment Failure; Arrhythmias; Thrombosis; Prosthesis-Related Infections
• Interventions: Device: Laser sheath; Behavioral: Implantable Cardiac Device lead extraction

• Registration Number: NCT03121183
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Removal can be performed according to transvenous or surgical procedures. Transvenous lead removal (TLR) must be done by experimented cardiologists and respecting current consensus. TLR can be done with conventional techniques involving inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. These conventional procedures have a success rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate until \>95%. However, the TLR from chronically implanted CIEDs still carries a significant risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels and cardiac structures, even when performed by experienced operators. Even if the transvenous extraction using laser sheath seems to be more effective, this strategy would be more expensive.

Considering the availability of several strategies for TLR and the cost heterogeneity of procedures, a cost assessment in real life of these therapeutic strategies is essential for an optimal choice of therapeutic strategies.

Detailed Description

The study will compare the strategies of percutaneous extraction to surgical extraction.

* Mechanical percutaneous extraction is the conventional technique using locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue.

* Laser-assisted lead extraction is most often used in complex procedures and dissolves rather than tear the scar tissue.

* Sternotomy is the surgical procedure used when leads cannot be removed by percutaneous extraction. It is rarely employed.

Study Timeline

• Study Start: 2015-03
• Status Verified: 2017-04
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-20
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01
• Primary Completion: 2018-04
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• • Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017

Exclusion Criteria

• • None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have undergone an extraction of implantable pace	Laser sheath	-
Patients who have undergone an extraction of implantable pace	Implantable Cardiac Device lead extraction	-

Primary Outcome Measures

Name	Time	Method
Direct medical cost	at day 1	Overall cost of care according to the hospital perspective: drug treatment, medical device, catheterization lab occupancy, operating room occupancy, medical and nursing staff time, hospitalization

Secondary Outcome Measures

Name	Time	Method
Investment cost for the hospital and damping	at day 1	annual projections: medical device and supplies
Type of intervention	at day 1	mechanical percutaneous extraction, laser percutaneous extraction, surgical extraction
Indication of the intervention	at day 1	infectious, technical failure or other
Extracted leads characteristics	at day 1	number, type, age, failure
Patient characteristics	at day 1	age, sex, origin (general hospital, university hospital, other)
Number and type of complications	at day 1	tamponade, vascular rupture, haemothorax, equipment breakage, death...
percutaneous extraction	at day 1	number of surgical transformation (sternotomy)
Duration of hospitalization	at day 1	pre and post-extraction
Duration of extraction procedure and fluoroscopy	at day 1	for percutaneous extraction
quotation ranking of each patient for revenue valuation	at day 1	quotation ranking of each patient for revenue valuation
Number of rehospitalization	at day 1	duration, cause and service

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France