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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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.

Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Direct medical cost [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: April 14, 2017
Date Started: March 2015
Date Completion: June 2018
Last Updated: April 19, 2017
Last Verified: April 2017