Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers (GAINE LASER)

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Thrombosis; Prosthesis-Related Infections; Arrhythmias; Equipment Failure
• Intervention / Treatment: Device: Laser sheath; Behavioral: Implantable Cardiac Device lead extraction

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who have undergone an extraction of implantable pace	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Cost-Benefit Analysis; Pacemaker; Cardiology; Laser Therapy; Catheterization; Defibrillators; Device Removal
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Postoperative Complications; Embolism and Thrombosis; Thrombosis; Prosthesis-Related Infections
• Other Study ID Numbers: CHU-318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No