Arrhythmias, Equipment Failure, Heart Failure, Prosthesis-Related Infections, Thrombosis
Conditions
Keywords
Cardiology, Device Removal, Pacemaker, Defibrillators, Catheterization, Laser Therapy, Cost-Benefit Analysis
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.
Interventions
DEVICELaser sheath
Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017
BEHAVIORALImplantable 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
Sponsors
University Hospital, Clermont-Ferrand
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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… |
| Investment cost for the hospital and damping | at day 1 | annual projections: medical device and supplies |
| 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 |
| percutaneous extraction | at day 1 | number of surgical transformation (sternotomy) |
Countries
France
Outcome results
None listed