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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.
The study will compare the strategies of percutaneous extraction to surgical extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who have undergone an extraction of implantable pace |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser sheath | Device | Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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- Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017
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| Name | Affiliation | Role |
|---|---|---|
| David BALAYSSAC | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| Implantable Cardiac Device lead extraction | Behavioral | Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017 |
|
| 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 |
| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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