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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Prosthesis-Related Infections, Equipment Failure, Arrhythmias, Thrombosis

Intervention / Treatment
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* Device: Laser sheath
* Behavioral: Implantable Cardiac Device lead extraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct medical cost | 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 | at day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiology, Device Removal, Pacemaker, Defibrillators, Catheterization, Laser Therapy, Cost-Benefit Analysis