Reports question adequacy of cardiac device safety surveillance system
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Failures of cardiac implantable devices leading to recalls can confer adverse outcomes in patients, and improvements in safety surveillance systems are needed to better protect patients, according to reports released in JAMA Internal Medicine.
“Progress on medical device safety will not be possible in the United States unless the FDA makes data collection and data transparency priorities and takes prompt and commensurate regulatory actions when safety issues are identified,” James W. Salazar, MD, MAS, resident at the University of California, San Francisco, and Cardiology Today Editorial Board Member Rita Redberg, MD, professor of medicine at University of California, San Francisco, and editor-in-chief of JAMA Internal Medicine, wrote in an editorial accompanying the reports.
CRT-P report
In one report, Jay Sengupta, MD, researcher at the Minneapolis Heart Institute Foundation, clinical cardiac electrophysiologist at Minneapolis Heart Institute at Abbott Northwestern Hospital and director of the Minneapolis Heart Institute Pacemaker Department, and colleagues analyzed 90 patients (mean age, 71 years; 41% men) implanted with a cardiac resynchronization therapy pacemaker (InSync III, Medtronic), which was recalled in 2015 due to high internal battery impedance, as well as reports on the device submitted to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database.
Among the 90 patients, all of whom were treated at the Minneapolis Heart Institute, five had syncope due to device battery failure or wire connection problems before the recall, the researchers wrote.
Among the patients analyzed in the MAUDE database reports, battery failures before the recall were tied to one death, one case of cardiac arrest, five cases of syncope and six cases of HF exacerbation, according to the researchers. In addition, they wrote, three cases of syncope were caused by wire connection problems.
“The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing,” Sengupta and colleagues wrote. “The FDA classified the recall as
class II rather than the more critical class I. This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.”
ICD lead report
In another report, Gustav Arnar Davidsson, BSc, from the faculty of medicine at the University of Iceland, Reykjavik, and colleagues analyzed 52 patients (median age, 55 years; 77% men) from the National University Hospital of Iceland who were affected by a recall of a defective implantable cardioverter defibrillator lead (Riata, St. Jude Medical). They used 50 patients (median age, 56 years; 72% men) treated with other ICDs as controls.
In the recall group, 36.5% of patients had lead failure (electrical dysfunction, 13.5%; externalization of the conductor, 3.8%; electrical dysfunction and externalization of the conductor, 13.5%; lead fracture, 5.7%), according to the researchers, who noted that one patient died from ventricular tachycardia after the ICD did not deliver therapy.
In the control group, 8% had lead failure (P < .01), including 2% with electrical dysfunction and 6% with lead fractures, the researchers wrote.
During 8 years of follow-up, the rate of unexpected lead failure was 4.41 per 100 patient-years in the recall group and 1.13 per 100 patient-years in the control group, according to the researchers.
After adjustment, the recall group had higher risk for lead failure (HR = 4.67; 95% CI, 1.18-18.5) but lower risk for death (HR = 0.25; 95% CI, 0.07-0.87), Davidsson and colleagues wrote.
Inappropriate shocks did not differ between the groups (P = .87).
“While patients with the recalled leads did not receive more inappropriate shocks, the cumulative incidence of serious lead problems was high, with more than one-third experiencing significant consequence,” the researchers wrote. “The lead failures among patients who had the recalled leads occurred over the course of the follow-up time, indicating that leads should be monitored for the full dwell time. While there is still no clear consensus about the root cause of the Riata lead failure, we conclude that development of more durable ICD leads with regards to biomaterials and engineering design is warranted.”
In their editorial, Salazar and Redberg wrote that “the current medical device surveillance system, which is based on the voluntary reporting of adverse events, requires substantial improvement to prevent avoidable serious illnesses and deaths. Patients deserve a robust medical device surveillance system that invariably puts patient safety first.” – by Erik Swain
References:
Davidsson GA, et al. JAMA Intern Med. 2019;doi:10.1001/jamainternmed.2019.4717.
Salazar JW, et al. JAMA Intern Med. 2019;doi:10.1001/jamainternmed.2019.5170.
Sengupta J, et al. JAMA Intern Med. 2019;doi:10.1001/jamainternmed.2019.5171.