News in brief: ICD battery malfunction warning; Statins may save Tasmanian Devil; Deprescribe aspirin in DOAC users

Tuesday, 20 Apr 2021

ICD and CRT-D battery malfunction warning

Users of some Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy (CRT-Ds) are being advised of the potential for unexpected and rapid decrease in battery life.

According to an FDA advisory statement, the decrease in battery life is caused by a short circuit and will cause some devices to produce a “Recommended Replacement Time (RRT)” (first warning that the battery is low) earlier than expected. Some devices may progress to full battery depletion within as little as one day and the device may stop functioning.

A spokesperson for the TGA said similar advice was being provided by Medtronic to Australian users via an updated product notification.

Users are advised by the FDA to be vigilant for audible alerts for low battery voltage and to seek prompt replacement of the device if unexpected RRT is observed.

“The TGA can also confirm that Medtronic has commenced similar corrective action in Australia (as that outlined on the USFDA website), which will be published shortly on the TGA website (on the System of Australian Recall Actions (SARA) database),” it said.

A spokesperson for Medtronic told the limbic that the company recently began communicating with physicians about a potential issue for a subset of ICDs and CRT-Ds.

“Medtronic has identified that a small percentage of these devices, from a well-defined subset, may experience a shortened interval between the Recommended Replacement Time (RRT) notification to End of Service (EOS) notification,” they said.

“Medtronic cardiac implantable electronic devices are designed to have a three-month interval between RRT and EOS. Due to this issue, the time interval may be shorter between a device battery detecting it is low to the battery needing to be replaced. We have received no reports of permanent harm to patients as a result of this issue.”

According to Medtronic, the identified subset of ICDs and CRT-Ds were last implanted in February 2019 and manufactured with a specific battery design that is no longer being distributed.

“In consultation with its Independent Physician Quality Panel, Medtronic is providing detailed patient management recommendations to physicians. Medtronic medical staff in consultation with the physician panel recommends against prophylactic replacement due to the low rate of occurrence and low potential for permanent harm when prompt device replacement occurs in response to an unexpected RRT.”

Patients and clinicians may determine if a specific device is affected by looking up the serial number on Medtronic’s Product Performance website:

Statins may save Tasmanian Devil

Stains could be the key to tackling the aggressive and fatal devil facial tumour disease (DFTD) that has led to an 80% drop in the number of Tasmanian devil since the 1990s.

Research led by scientists from QIMR Berghofer, Brisbane has shown that the lipid-lowering drugs inhibit tumour growth by disrupting cholesterol synthesis within the cells that transmit devil facial tumour disease.

with the emergence of The fatal, very aggressive form of transmissible cancer is spread through the transfer of living cancer cells when Tasmanian devils bite each other. and Spain suggests cholesterol-lowering drugs could help delay the spread of the devil facial tumour disease and may help protect the endangered Australian marsupials from extinction.

Lead researcher Dr Manuel A. Fernández-Rojo said that identifying the impact of manipulating the cholesterol content in DFTD cells led them to look at cholesterol lowering drugs as potential treatments.

“Our laboratory experiments showed devil facial tumour disease cells grew and spread more, using glucose as a source of energy, if they were stimulated with drugs that activated the nuclear receptor LXR (Liver-X-receptor). LXR is involved in regulating cellular cholesterol levels,” he said.

“We found statins reduced the growth of the devil facial tumours in the laboratory and we believe more research should now be undertaken to see whether these cholesterol-lowering drugs could be used to inhibit, or at least slow, the growth of DFTD and hopefully help protect the species.”

Co-researcher Dr Maria Ikonomopoulou said the research findings might also have implications for malignant and highly aggressive cancers in humans.

“We know statins work on tumour cells in lab experiments, so we now want to expand our study of the drugs in stopping the spread of cancer tumours,” she said.

According to Zoos Victoria, there are fewer than 15,000 Tasmanian devils left in the wild.

The research findings are published in Cell Reports website.

Deprescribe aspirin in DOAC users

Many patients using DOAC therapy for atrial fibrillation or VTE prevention are taking aspirin at the same time, putting them at increased bleeding risk without a significant reduction in thrombotic outcomes, new research.

A US registry based cohort study of 3280 patients taking DOACs found that one third (33.8%) were taking aspirin despite having no clear indication such as recent MI or valve replacement. After follow up of almost two years there was no difference in thrombosis rates between these patients and a propensity matched control group. However the patients taking DOAC and aspirin experienced more bleeding events compared with DOAC monotherapy (26.0 vs 31.6 bleeds per 100 patient years, P = .01).

“Efforts should be made to help clinicians identify and deprescribe [aspirin] for patients taking a DOAC without an indication for aspirin,” the investigators said in JAMA Internal Medicine.

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