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临床试验/NCT03121183
NCT03121183Unknown不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Direct medical cost

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Direct medical cost

时间窗: 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

次要结局

  • percutaneous extraction(at day 1)
  • 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)
  • Number and type of complications(at day 1)
  • Duration of hospitalization(at day 1)
  • Duration of extraction procedure and fluoroscopy(at day 1)
  • quotation ranking of each patient for revenue valuation(at day 1)
  • Number of rehospitalization(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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