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Registry-Based Medical-Device Safety Surveillance
Study Questions:
What is the utility of using an active clinical-data surveillance system (DELTA, Data Extraction and Longitudinal Trend Analysis) to identify device-related complications?
Methods:
The authors used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device compared with alternative approved vascular-closure devices, using data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication (a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention). Secondary safety endpoints were access-site bleeding requiring treatment and postprocedural blood transfusion. Contrast-induced acute kidney injury was used as an unrelated endpoint to assess for residual confounding.
Results:
The study cohort was comprised of 73,124 patients who received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. Compared with other closure devices, the Mynx device was associated with an increased risk of vascular complications (absolute risk, 1.2% vs. 0.8%; relative risk [RR], 1.59; 95% confidence interval [CI], 1.42-1.78; p < 0.001); access-site bleeding (absolute risk, 0.4% vs. 0.3%; RR, 1.34; 95% CI, 1.10-1.62; p = 0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; RR, 1.23; 95% CI, 1.13-1.34; p < 0.001). The initial alerts occurred within the first 12 months of monitoring. No significant difference in acute kidney injury was noted. All safety alerts were confirmed in an independent sample of 48,992 patients from April 2014 to September 2015.
Conclusions:
A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among patients treated with the Mynx device.
Perspective:
The ongoing evaluation of device safety is an important public health issue, but given the overall safety of contemporary devices and rarity of device complications, it has been difficult to reliably track low-frequency events. The authors report on a prospective registry-based surveillance that was able to identify an increased risk of complications with the Mynx device, suggesting the utility of using contemporary registries to monitor device safety.
Keywords: Acute Kidney Injury, Blood Transfusion, CathPCI Registry, Equipment Safety, Hematoma, Hemorrhage, Percutaneous Coronary Intervention, Public Health, Risk, Vascular Closure Devices
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