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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03121183

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prosthesis-Related Infections Equipment Failure Heart Failure Arrhythmias Thrombosis	Device: Laser sheath Behavioral: Implantable Cardiac Device lead extraction

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 Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers: a Retrospective Observational Study

Actual Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients who have undergone an extraction of implantable pace	Device: Laser sheath Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017 Behavioral: Implantable Cardiac Device lead extraction Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017

Arm

Intervention/Treatment

Patients who have undergone an extraction of implantable pace

Device: Laser sheath

Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017

Behavioral: Implantable Cardiac Device lead extraction

Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017

Outcome Measures

Primary Outcome Measures

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

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