Replace

REPLACE

Implantable Cardiac Pulse Generator Replacement Registry

Poole et al., Circulation 2010

Study Design

  • Prospective, multi-center study
  • Estimate the all-cause complication rates at 6-months for patients undergoing a pacemaker, ICD, CRT-P or CRT-D generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification
  • 1,744 subjects at 71 US sites

Key Result 1

Patients undergoing a straight forward CRM generator replacement (cohort 1), without plans to add or revise a lead, experienced a major complication rate of 4.0%, a major periprocedural event rate of 0.2%, a minor complication rate of 7.4%, and an infection rate of 1.4%.


Key Result 2

Patients undergoing a generator replacement with a plan to add or revise existing leads (cohort 2) experienced a major complication rate of 15.3%, a major periprocedure event rate of 2.4%, a minor complication rate of 7.6%, and an infection rate of 1.1%.


Key Result 3

In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%)


Clinical Relevance

  • REPLACE is the first prospective, multicenter trial to examine complications related to generator replacement.
  • The risk associated with upgrade procedures is concerning and favors performing indicated complex procedures before the development of advanced end-stage medical and cardiac disease, situations in which the risk may be prohibitive.
  • Results support the use and development of devices with long battery life to minimize the lifetime surgical risk for a patient.
  • Results provide insight into procedural outcomes for the next phase of life for patients who receive cardiac implantable electronic devices and a more robust analysis that can be used to establish a benchmark for comparative performance in this time of healthcare reform.

Reference no.
  • NCT00395447
Study Objective
  • To prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification (cohort 1) or with a planned system modification (cohort 2)
1° Endpoints
  • The all-cause complication rate for subjects undergoing generator replacement without system modification (cohort 1)
  • The all-cause complication rate for subjects undergoing generator replacement including a planned system modification (cohort 2)
2° Endpoints
  • Baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement without system modification (cohort 1)
  • Baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement including a planned system modification (cohort 2)
Clinical Sites
  • 71 sites in US
Sample Size
  • 1744 patients
Inclusion Criteria
  • Is able to give informed consent
  • Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer
  • Is clinically stable to tolerate the surgical procedure
  • Age 18 years or greater
  • Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit
Main Exclusion Criteria
  • Inability or unwillingness to give informed consent
  • Current system infection requiring generator explantation or lead extraction
  • Generator replacement requiring planned lead extraction
  • Participating in another cardiovascular investigational drug or device registry
  • A life expectancy of less than six months
  • Expected to receive a heart transplant within 6 months
  • All vulnerable subjects as defined by the FDA Office of Human Research Protection or the local IRB providing oversight
Devices
  • Any commercially available device (pacemaker, ICD, CRT-P, or CRT-D), per physician selection
  • Any commercially available RA, RV and LV leads, per physician selection
Follow-Up
  • Wound Check Visit, 3 month follow-up (telephone query/in-clinic), 6 month follow-up
Study Duration
  • July 2007 - June 2009
Principal Investigators
  • Jeane Poole, MD, University of Washington, USA

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