Clinical trial NCT03121183: Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers
Official title: Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthesis-Related Infections
Equipment Failure
Heart Failure
Arrhythmias
Thrombosis
Keywords: Cardiology
Device Removal
Pacemaker
Defibrillators
Catheterization
Laser Therapy
Cost-Benefit Analysis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017

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.

Eligibility criteria: 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

Primary outcomes:
measure: Direct medical cost
timeFrame: at day 1
Secondary outcomes:
measure: Investment cost for the hospital and damping
timeFrame: at day 1
measure: Type of intervention
timeFrame: at day 1
measure: Indication of the intervention
timeFrame: at day 1
measure: Extracted leads characteristics
timeFrame: at day 1
measure: Patient characteristics
timeFrame: at day 1
measure: Number and type of complications
timeFrame: at day 1
measure: percutaneous extraction
timeFrame: at day 1
measure: Duration of hospitalization
timeFrame: at day 1
measure: Duration of extraction procedure and fluoroscopy
timeFrame: at day 1
measure: quotation ranking of each patient for revenue valuation
timeFrame: at day 1
measure: Number of rehospitalization
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: David BALAYSSAC
role: PRINCIPAL_INVESTIGATOR
References: