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

Heart Failure Clinical Trial

— GAINE LASER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03121183
• Other study ID #: CHU-318
• Status: Active, not recruiting
• Phase: N/A
• First received: April 14, 2017
• Last updated: July 31, 2017
• Start date: March 2015
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias
• Equipment Failure
• Heart Failure
• Prosthesis-Related Infections
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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