Independent analysis shows positive results for Durata and Riata leads at five years

88

At the Heart Rhythm Society (HRS) meeting, John Cairns, on behalf of the Population Health Research Institute (PHRI), presented five-year follow-up results from an independent analysis of over 10,000 Durata and Riata ST Optim implantable cardioverter defibrillator leads (St Jude Medical) studied in three ongoing registries at 293 sites.

PHRI analysed data from three actively monitored registries; the OPTIMUM, SCORE and SJ4 post-Approval registries (all sponsored by St Jude Medical).

The findings from PHRI’s initial analysis of the combined Optim-insulated lead registries, for data collected through 28 Feb 2013, showed, at five years, a 99.9% rate of freedom from all-cause insulation abrasion (includes all types of abrasion and other mechanical types of insulation damage). Also, at five years, it demonstrated a 99.4% rate of freedom from all-cause mechanical failure (includes any insulation abrasion, conductor fracture, failure of a crimp, weld, or bond, or other mechanical failure).


“Data from St Jude Medical’s prospective, actively-monitored Optim lead registries have been thoroughly analysed by PHRI and continue to demonstrate very low rates of insulation abrasion and mechanical failure,” said Cairns, professor of Medicine and former dean of Medicine at University of British Columbia in Vancouver. “These prospective registries are well designed with pre-specified definitions for adverse events and a centralised reporting structure. They have now been independently adjudicated by PHRI.”


PHRI convened a committee of independent physicians chaired by Cairns, an internationally recognised expert in cardiology clinical trials who has no affiliations with the cardiac rhythm management device industry, to perform the analysis.


Additional committee members include Stuart Connolly, professor and director of the Division of Cardiology at McMaster University, Jeff Healey, associate professor of Cardiology at McMaster University, Andrew Epstein, professor of Medicine at the University of Pennsylvania and chief of Cardiology at the Philadelphia Veterans Administration Medical Center, and Christopher Buller, professor of Medicine at The University of Toronto and director of Cardiac Catheterization and Intervention at St Michael’s Hospital.