Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers (GAINE LASER)

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Prosthesis-Related Infections

Thrombosis

Equipment Failure

Arrhythmias

Heart Failure

Treatments

Device: Laser sheath

Behavioral: Implantable Cardiac Device lead extraction

Study type

Observational

Funder types

Other

Identifiers

NCT03121183

CHU-318

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria