In short
A recent meeting of Cardiologists and St Jude Medical staff, convened to discuss the Implantable Cardioverter/Defibrillator lead externalisation problem (the so-called “Riata Summit”), concluded that more information was required in order to establish the best way forward. Now, in what looks like an initiative that will address the expressed need for more data, and to demonstrate that its newer iteration leads are performing to expectations, St Jude Medical has commissioned Population Health Research Institute (PHRI), an academic health science research institute to perform the task.
Background
In recent times we’ve found ourselves returning fairly frequently to the subject of Implantable Cardioverter/Defibrillator (ICD) leads. A recent meeting took place including Cardiologists and St. Jude Medical staff with the intention of reviewing the data pertaining to ICD lead “externalisation”, the condition under which potential risks of inappropriate or non-defibrillation were heightened by failure of the insulation covering the lead. According to one report of the meeting, covered on our pages here (among others), just about the only thing that all delegates could agree on was the fact that more data would inform better decisions. One of the more contentious discussion points related to St Jude’s assertion that its newer (current) product iteration, Durata, did not and would not suffer the same problem, despite one delegate demanding that the product be put “under the microscope”. Now the company has taken the reigns by outsourcing a data analysis project on its Riata™ ST Optim and Durata™ leads to Population Health Research Institute (PHRI), an academic health science research institute. This organisation will analyse data from three combined registries on the Riata™ ST Optim and Durata™ implantable cardioverter defibrillator (ICD) leads. The analysis will be entirely under the control of PHRI, who will complete a review of the performance of the leads.
Under the agreement, PHRI will receive the raw data, and independently design and perform analyses, from three ongoing prospective, actively monitored registries monitoring the performance of the Riata ST Optim and Durata leads; the OPTIMUM, SCORE and DF4 Post-Approval studies, all sponsored by St. Jude Medical. The combined data from these studies currently represents over 10,000 leads implanted at 292 sites, with over 24,000 patient-years of data collected over the more than five years that these leads have been on the market.
No stone unturned
PHRI will convene a committee of independent physicians chaired by Dr. John Cairns, an internationally recognized expert in cardiology clinical trials, professor of Medicine and former dean of Medicine at University of British Columbia, who has no affiliations with the cardiac rhythm management industry. Additional committee members include Dr. Stuart Connolly, professor and director of the Division of Cardiology at McMaster University, Dr. Jeff Healey, associate professor of Cardiology at McMaster University, Dr. Andrew Epstein, professor of Medicine at the University of Pennsylvania and chief of Cardiology at the Philadelphia Veterans Administration Medical Center, and Dr. Christopher Buller, professor of Medicine at The University of Toronto and director of Cardiac Catheterization and Intervention at St. Michael’s Hospital.
Independence assured
The committee will function independently of the company; meeting with the company to initiate the project, but conducting its work in private. The committee will meet on an ongoing basis for at least two years to review data as it is collected. Data analysis would be performed on an ongoing basis with accumulating data and the results would be published in St. Jude Medical biannual Product Performance Reports and made available on the St. Jude Medical website. The committee may also independently publish its findings.
Company comments
“We take our responsibilities as a leading manufacturer of cardiac rhythm management devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and that they function safely and properly,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “We are pleased to enlist PHRI to perform an independent analysis and validation of the Optim insulated defibrillation lead data from these three very large, long-term registries.”
Source: Marketwatch, Business Wire
published: March 26, 2012 in: Cardio, Clinical Studies/Trials, St Jude