Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices.
BACKGROUND
Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.


OBJECTIVE
To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices.


METHODS
Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts.


METHODS
Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered.


RESULTS
We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device.


CONCLUSIONS
Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.
BrighamandWomen’s Hospital and Harvard Medical School, Boston, Massachusetts 02115, USA. fresnic@partners.org
Frederic S
FS
Resnic
Thomas P
TP
Gross
Danica
D
Marinac-Dabic
Nilsa
N
Loyo-Berrios
Sharon
S
Donnelly
Sharon-Lise T
SL
Normand
Michael E
ME
Matheny
D000328:Adult; D000368:Aged; D001331:Automation; D002318:Cardiovascular Diseases / Q000628:therapy*; D004869:Equipment Safety; D005260:Female; D006801:Humans; D008297:Male; D008404:Massachusetts; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects* / Q000592:standards; D012042:Registries; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration