Active and real-time is better, especially when assessing device safety in the general population. A Massachusetts-based hospital network analyzing the safety of PCI-related devices found that a real-time safety alert was able to change practices to improve patient safety and outcomes.
The study was aimed at creating a real-time safety alert system for devices already on the market and provide participant hospitals with prospective, active safety trend analysis.
The network tool, called the Data Extraction and Longitudinal Trend Analysis system (DELTA), was developed by Amit Kumar, MD, of the Lahey Hospital and Medical Center in Burlington, Mass., and colleagues.
Five hospitals in Massachusetts provided data relating to drug-eluting stents, embolic protection devices and vascular closure devices used in PCI procedures. Participating hospitals submitted data through the National Cardiovascular Data Registry CathPCI data collection instrument. Analyses were provided quarterly to participating hospitals.
The assessment found one device, Perclose Proglide vascular closure device (Abbott Medical), was being improperly used at one facility, leading to higher than normal risks for vascular complications. They found that the relative risk compared with alternative vascular closure devices for minor vascular complications was 4.14. There was also an increased relative risk of 2.06 for any vascular complication with Perclose over alternative vascular closure devices. They were able to ensure that the hospital in question provided more device training for physicians and implemented quality improvement initiatives to reduce risks.
They noted that the safety alert that was triggered was likely the result of operator training and/or patient selection rather than issues with the device itself. This made subanalysis of the data especially important, allowing those providing reports to not only determine quarterly performance on the devices, but also on how each hospital performed when using the device.
Similarly, they noted a data bump with the Mynx vascular closure device (Access Closure), although it didn’t rate a full alert as the trend toward any vascular complication was ultimately nonsignificant and use of the device declined after 2010.
Kumar et al noted that while at present the surveillance tool requires entry via a clinical registry, future efforts should extract data directly from EHR systems.
The study was published online Dec. 9 in Circulation: Cardiovascular Quality and Outcomes.