Summary Safety Review - Percutaneous radiofrequency ablation catheters - Assessing the potential risk of an abnormal connection between the heart and digestive tract (atrioesophageal fistula)

April 16, 2018

Product

Percutaneous radiofrequency (RF) ablation catheters

Potential Safety Issue

Risk of an abnormal connection between the heart and digestive tract (atrioesophageal fistula, AEF)

Key Messages

  • Percutaneous RF ablation catheters are medical devices authorized for sale in Canada. They are used in heart procedures to treat patients with irregular heartbeats (i.e., arrhythmias).
  • Health Canada reviewed the potential risk of an abnormal connection forming between the heart and the digestive tract known as an atrioesophageal fistula (AEF) after receiving rare Canadian reports related to the use of these catheters.
  • Health Canada’s review concluded that there is a potential link between the use of these catheters and the development of AEF. This risk is not specific to any one device or manufacturer.
  • Health Canada will work with the manufacturers of these catheters to update the Instructions for Use to warn about this risk. A Health Product InfoWatch notice will be issued once the updates are completed. Health Canada will also issue a Health Product Risk Communication to healthcare professionals to inform them of this safety information.

Overview

Health Canada reviewed the potential risk of AEF after receiving Canadian reports related to the use of percutaneous RF ablation catheters that are used in heart procedures to treat patients with irregular heartbeats. This risk is not specific to any one device or manufacturer. While rare, AEF can be life-threatening. The Instructions for Use for some of these devices do not mention the potential risk.

Use in Canada

  • Percutaneous RF ablation catheters are medical devices authorized for sale in Canada to treat patients with irregular heartbeats (i.e. arrhythmias) when treatment with drugs has failed. The catheters are flexible tubes put into the heart to give heat to certain parts of the heart muscles, to treat the abnormal electrical signals that cause an irregular heartbeat.
  • There are 31 licensed percutaneous RF ablation catheters currently sold in Canada by 5 different manufacturers.

Safety Review Findings

  • At the time of the review, Health Canada had received 4 Canadian cases of AEF related to the use of these catheters for heart procedures. A strong link between the use of the catheter and the AEF was found in 2 cases. The link was considered possible in the remaining 2 cases. Death occurred in 3 of these patients, with the cause of death probably due to the catheter use in only 1 case.
  • Another 4 Canadian patient reports of AEF including 3 deaths were found in the published literature. Considering the limited information provided, the reports could not be assessed to determine if there was a link between the use of the catheter and the AEF.
  • A review of the medical literature found that an important risk factor for developing AEF is the close distance between the heart and digestive tract. It has been proposed that the heat made by the catheter to treat the heart may damage the area between the heart and digestive tract. This could create an abnormal opening between these 2 organs. This distance may be shorter in patients with ongoing irregular heartbeats that may have an enlarged heart (i.e., an enlarged left atrium) and in patients with low body weight. Other factors that may increase the risk of AEF include a history of acid reflux (i.e. gastroesophageal reflux), use of higher power settings with the device during the treatment, and potential injury to the digestive tract related to general anaesthesia.
  • The review showed that the AEF may not be found in a timely fashion as it may develop several days to weeks following the procedure and the symptoms are not specific to AEF. It also showed that timely management of this potentially life-threatening condition may improve the patient outcome.

Conclusions and Actions

  • Health Canada’s review concluded that there is a potential link between the use of the percutaneous RF ablation catheters and the development of AEF. This risk is not specific to any one device or manufacturer.
  • Health Canada will work with the manufacturers of these catheters to update the Instructions for Use to warn about this risk. A Health Product InfoWatch notice will be issued once the updates are completed. Health Canada will also issue a Health Product Risk Communication to healthcare professionals to inform them of this safety information.
  • Health Canada will continue to monitor safety information involving these catheters, as it does for all health products on the Canadian market, to identify and assess potential harms, and take appropriate and timely action if any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of these devices both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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