PICCs With Magnetized Tip Linked to Serious Allergic Reactions

Tara Haelle

October 10, 2019

Anaphylactic or anaphylactoid reactions occurred more often in patients overall — and 10 to 20 times more frequently in patients with cystic fibrosis (CF) — when a specific brand of peripherally inserted central catheters (PICCs) was inserted, compared with another PICC, found a study published online October 8 in Infection Control & Hospital Epidemiology.

The models associated with the reactions were the PowerPICC SOLO catheter and Groshong PICC, both used with the Sherlock TLS, a magnetized tip that guides insertion, all manufactured by Bard Access Systems.

"Given the disproportionate rate of anaphylactic or anaphylactic-like reactions following PICC insertion observed in CF patients, our observations suggest the need for additional clinical vigilance in the CF population," Christina S. Thornton, PhD, MD, of the University of Calgary and Alberta Health Services in Canada, and colleagues write.

They caution, however, that their study could not show causation. "Furthermore, these findings suggest that disease-specific reports of adverse reactions associated with medical devices may be important in identifying their biologic basis."

The researchers launched their study after noting an increase in adverse events resembling allergic reactions following the adoption of the PowerPICC SOLO catheter and Groshong PICC with the Sherlock TLS in Calgary Health Zone hospitals in early 2010.

They therefore began monitoring patients receiving PICCs with the Sherlock TLS and tracked adverse events from October 2010 to November 2014 at two tertiary-care hospitals. They compared these adverse events with those of patients at a new hospital in Calgary and at The Ottawa Hospital in Ottawa that both used PICCs that did not contain the Sherlock TLS.

All the hospital sites "used identical skin preparations, buffered lidocaine, flushes, and similar dressings," the authors report. "No apparent deviations in aseptic technique were identified at any of the sites and type of infusion between sites was similar."

The researchers defined anaphylaxis and anaphylactoid reactions one of three ways:

  • Requiring signs or symptoms from at least two body systems within 60 minutes after insertion, with at least one sign/symptom being hypotension, vasodilation, or respiratory difficulty.

  • Either a clinical diagnosis of anaphylactic or anaphylactoid reaction or signs of allergic process with respiratory difficulty and/or cardiovascular symptoms, all occurring within minutes to hours without any other apparent cause.

  • Either (1) an acute reaction involving the skin and/or mucosal tissue along with respiratory compromise and/or reduced blood pressure or symptoms of end-organ dysfunction; or (2) rapid onset after a likely allergen exposure of at least two of these: skin/mucosal tissue involvement, "respiratory compromise, reduced blood pressure or related symptoms and/or persistent gastrointestinal symptoms"; or (3) reduced blood pressure after a known allergen exposure.

At the two hospitals using the Sherlock TLS, 37 potential reactions occurred among 8257 PICC insertions (0.45%), compared with no reactions among the 491 PICC insertions at the Calgary hospital and 7889 PICC insertions at the Ottawa hospital that did not use the Sherlock TLS. The reactions all occurred within minutes of insertion, but reaction rates varied between the two hospitals using the Sherlock TLS: the site with 5957 insertions had 0.54% reactions, and the site with 2300 insertions had 0.22% reactions.

The four patients with CF who experienced these reactions represented 10.8% of all patients with CF receiving the PICCs using the Sherlock TLS, resulting in a substantially higher rate of reactions than any other patient populations.

Among the patients with adverse events, 91.9% met the criteria for anaphylaxis or an anaphylactoid reaction using the first definition, 81.8% met the criteria for the second definition, and 54.1% met the criteria using the third definition. All four patients with CF met the criteria for all three definitions, and two had a reaction serious enough to requires a "code blue" and intensive care admission.

For all definitions of anaphylactic or anaphylactoid reactions, the association was significant for the PowerPICC SOLO and Groshong PICC (P < .0001). No significant difference in reactions appeared between these two PICC models.

Among the patients with adverse events, most were female (79.5%) with a median age of 46 years. For two thirds (67.6%) of them, indication for PICC insertion was receipt of long-term intravenous antibiotics. Venous access was the indication for 21.6% of them, and one patient required parenteral nutrition while another needed a PICC for chemotherapy.

More than half (56.8%) of the patients experiencing reactions had a history of environmental or drug allergies, and about a third (35.2%) had multiple allergic responses.

The authors say the reasons why patients with CF seem to be affected much more often are unclear, and they are aware of no other reports of this in the scientific literature. Their centers have since stopped using PICCs with a magnetized stylet.

"Given the high rates of antibiotic allergy in the CF population compared to the general population, there may be an element of IgE-mediated immediate anaphylaxis," they write. They suggest the reactions could be related to the materials in some components of the devices, such as neodymium, silver, or gold.

"The reporting of very similar reactions using the PowerPICC SOLO or Groshong PICC with the Sherlock TLS within the US FDA Center for Devices and Radiological Health Medical Product Safety Network (MedSun) and the Canadian Medical Devices Sentinel Network — Health Canada Reporting Project provides supportive evidence for our observations," they write.

"Notably, the manufacturer was advised of the concerns and responded by updating its labeling to indicate that anaphylactic or anaphylactic-like reactions occur in a small percentage of the population during placement, positioning, flushing of CVCs or cleaning of the catheter exit site."

The authors recommended that clinicians be aware of the variety of PICC models and manufacturers since "findings pertaining to a particular type of product may not translate to others." They also acknowledge that the explanation for their findings could be multifactorial.

The authors have disclosed no relevant financial relationships.

Infect Control Hosp Epidemiol. Published online October 8, 2019. Abstract

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