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

NCT03121183 | Unknown

• 1 other identifier: CHU-318
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiology; Device Removal; Pacemaker; Defibrillators; Catheterization; Laser Therapy; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Investment cost for the hospital and damping

  at day 1

• Type of intervention

  at day 1

• Indication of the intervention

  at day 1

• Extracted leads characteristics

  at day 1

• Patient characteristics

  at day 1

Study Arms (1)

Patients who have undergone an extraction of implantable pace

Device: Laser sheath; Behavioral: Implantable Cardiac Device lead extraction

Interventions

Laser sheath DEVICE

Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017

Patients who have undergone an extraction of implantable pace

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

Patients who have undergone an extraction of implantable pace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017

You may not qualify if:

• \- None

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Prosthesis-Related Infections; Heart Failure; Arrhythmias, Cardiac; Thrombosis

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Vascular Diseases

Study Officials

• David BALAYSSAC

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 20, 2017
• Study Start: March 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 1, 2017

Record last verified: 2017-04

Locations

FR (1)