Percutaneous Radiofrequency Ablation Catheter and the Potential Risk of Atrioesophageal Fistula

Starting date:
April 16, 2018
Posting date:
April 16, 2018
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices, New safety information
Audience:
Hospitals
Identification number:
RA-66492

Audiences

Healthcare professionals in hospitals, including hospital chief of medical staff, departments of emergency medicine, family medicine, electrophysiology, infectious disease, neurology, intensive care unit, and other relevant departments.

Key messages

  • Health Canada is aware of the rare but serious risk of atrioesophageal fistula (AEF) associated with percutaneous radiofrequency (RF) ablation catheters that are used for the treatment of atrial fibrillation (AF).
  • AEF usually occurs within 1 to 6 weeks following an AF ablation procedure using these catheters. While rare, AEF is associated with high morbidity and mortality.
  • Early symptoms of AEF are usually non-specific and may include fever, chest pain, dyspnea, dysphagia, odynophagia, nausea, vomiting and hematemesis. Late presentation may involve altered mental status, seizures and coma secondary to endocarditis and septic emboli.
  • Healthcare professionals are advised to watch for early signs/symptoms of AEF in patients with a recent history of AF ablation. When AEF is suspected, prompt diagnosis and timely management may contribute to optimal patients’ outcomes.
  • Health Canada is working with relevant medical device manufacturers to update the labelling for the RF ablation catheters
    to include this safety information.

      

Issue

Cases of AEF, including death associated with the use of percutaneous RF ablation catheters for the treatment of AF, have been reported in Canada and internationally.

Products affected
Manufacturer/Canadian distributor Device Name CF-sensing
Biotronik ALCATH/ALCATH FLUX MAPPING AND ABLATION CATHETERS No
Boston Scientific STINGER ABLATION CATHETER No
CHILL II COOLED ABLATION CATHETER No
BLAZER OPEN-IRRIGATED ABLATION CATHETER No
INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER No
INTELLANAV OPEN-IRRIGATED ABLATION CATHETER No
BLAZER CARDIAC ABLATION CATHETERS No
BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS No
INTELLANAV TEMPERATURE ABLATION CATHETERS No
Johnson & Johnson Medical Products THERMOCOOL SMARTTOUCH DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER Yes
NAVI-STAR DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER No
NON-NAVIGATIONAL CATHETERS No
NAVIGATIONAL BI-DIRECTIONAL CATHETERS No
RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER No
DIAGNOSTIC/ ABLATION ELECTROPHYSIOLOGY CATHETERS No
CELSIUS RMT DIAGNOSTIC/ ABLATION STEERABLE TIP CATHETER No
Abbott Laboratories TACTICATH QUARTZ Yes
SAFIRE BIDIRECTIONAL ABLATION CATHETER No
FLEXABILITY ABLATION CATHETER, SENSOR ENABLED No
LIVEWIRE TC(TM) ABLATION CATHETERS No
THERAPY COOL PATH ABLATION CATHETER No
SAFIRE DUO ABLATION CATHETER MEDIGUIDE ENABLED No
COOLPATH DUO ABLATION CATHETER MEDIGUIDE ENABLED No
SAFIRE BLU No
THERAPY ABLATION CATHETERS No
FLEXABILITY ABLATION CATHETER No
THERAPY COOL FLEX No
Medtronic PULMONARY VEIN ABLATION CATHETER GOLD No
RF ENHANCR II STEERABLE ELECTRODE CATHETER FOR INTRACARDIAC ABLATION No
RF MARINR STEERABLE ELECTRODE CATHETER FOR INTRACARDIAC ABLATION No
RF CONTACTR STEERABLE ELECTRODE CATHETER FOR INTRACARDIAC ABLATION No

Background information

The percutaneous ablation catheters are single use devices used for the treatment of symptomatic arrhythmia, most commonly AF, which do not respond to drug therapies. They are designed to facilitate electrophysiological mapping, pacing (some brands) of the heart chambers, and when used in conjunction with a compatible RF generator, to transmit RF energy to the cardiac tissues in order to block the erratic electrical signals.

When RF ablation catheters are used to treat AF, an AEF may develop as a result of esophageal injury due to the close anatomic relationship between the esophagus and the heart. A diagnosis of AEF may not be considered in a timely fashion due to delayed and non-specific clinical presentation potentially occurring in the majority of cases. The risk is low, but AEF is associated with high mortality, reported as being between 67% and 100% of cases.1

Clinical observations of delayed onset of AEF support theories of either a direct thermal injury to the esophagus, or heat damage to the anterior esophageal arteries, causing ischemia, ulceration and fistulisation.1,2 Predictors of AEF may include anatomical factors such as an enlarged left atrium occasionally seen in patients with persistent AF and the shorter distance between the heart and the digestive tract seen in patients with a low body weight, a history of gastroesophageal reflux, higher RF power setting, and potential injury to the esophagus related to general anesthesia and the use of a nasogastric tube during anesthesia.    

Health Canada is aware of rare Canadian and international cases of AEF resulting from the use of percutaneous RF catheters for AF ablation.3,4,5,6

Among the four Canadian cases of AEF that were reported to Health Canada, the complication was identified at any time between days and weeks following the RF ablation procedures. Health Canada’s assessment of these four cases concluded a strong causal link between the use of the catheter and the AEF in two cases, and a possible causal link in the remaining two cases. Three of these four cases resulted in a fatal outcome and cause of death was probably due to the catheter use in only one case. Another four Canadian reports of AEF including three fatalities were found in the published literature. However, given the lack of sufficient information, causal link for these cases was not assessed by Health Canada.

Several preventative measures have been suggested in the literature. These may include determining the location of the esophagus and avoiding making a lesion near it, reduction of RF power and shortening application time and mechanical displacement of the esophagus.7 Each of these preventative measures has advantages and disadvantages and clinical evidence does not appear to be always consistent. Clinical studies have shown that despite preventative measures taken during the procedure, esophageal thermal injuries may still happen.6,8

Health Canada recognizes that AEF may occur following AF ablation with other technologies including cryoablation or high-intensity focused ultrasound.

Who is affected

Information for consumers

Percutaneous RF ablation catheters are medical devices used in a heart procedure to treat patients with an irregular heartbeat when treatment with drugs has failed. The catheters are flexible tubes put into the heart to deliver heat in certain parts of the heart muscles, which disrupt or stop the abnormal electrical signals that cause an irregular heartbeat. 

There have been rare Canadian and international reports of AEF, which is an abnormal connection between the heart and the digestive tract, associated with these catheters.

Mild chest pain following this heart procedure is normal and the symptom will disappear within a couple of weeks. However, patients should immediately contact their healthcare professionals or go to the emergency department if they develop fever with temperature above 38 °C, severe chest pain, difficult and/or painful swallowing, nausea, vomiting, passing blood, difficulty speaking and weakness or numbness of a limb.

Information for healthcare professionals

Rare cases of delayed onset of AEF in association with percutaneous RF catheters following AF ablation procedures have been reported from post-market experience. While rare, this complication is associated with significant morbidity and mortality.

AEF usually occurs within 1 to 6 weeks following an AF ablation procedure. Diagnosis of AEF may be challenging as the initial symptoms may be subtle and non-specific. The initial symptoms may include fever (usually above 38°C), chest pain, dysphagia, odynophagia, hematemesis, nausea, vomiting, melena and dyspnea. Late presentation may involve altered mental status, seizures and coma secondary to endocarditis and septic emboli. As such, healthcare professionals should have a high index of suspicion in symptomatic patients with a recent history of AF ablation. Prompt diagnosis and timely management of AEF may contribute to optimal patients’ outcomes.

Action taken by Health Canada

Health Canada is working with medical device manufacturers to update the safety information (labelling) for all affected catheters to include details about this potential risk. Health Canada is also communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website. This communication will be further distributed through the MedEffect™ e-Notice email notification system.

Health Canada will continue to monitor safety information involving percutaneous RF ablation catheters, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of atrioesophageal fistula or other serious or unexpected side effects in patients treated with percutaneous RF ablation catheters should be reported to the device manufacturer or Health Canada.

Any suspected adverse incident can be reported to:

Regulatory Operations and Regions Branch
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675

The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

References

  1. Nair KK, Danon A, Valaparambil A, Koruth JS, Singh SM. Atrioesophageal Fistula: A Review. J Atr Fibrillation. 2015 Oct 31;8(3):1331. doi: 10.4022/jafib.1331. eCollection 2015 Oct-Nov.

  2. Nair GM, Nery PB, Redpath CJ, Lam BK, Birnie DH. Atrioesophageal fistula in the era of atrial fibrillation ablation: a review. Can J Cardiol. 2014 Apr;30(4):388-95. doi: 10.1016/j.cjca.2013.12.012. Epub 2013 Dec 20.

  3. Gitenay E, O' Hara GE, Sarrazin JF, Nault I, Philippon F, Sadron Blaye-Felice M, Laaouaj J, Champagne J. Contact-Force Catheters: Efficacy Versus Safety? Case Report of 2 Atrioesophageal Fistulae. J Cardiovasc Electrophysiol. 2016 Dec;27(12):1483-1487. doi: 10.1111/jce.13079. Epub 2016 Oct 13.

  4. Trisha Mackle, Kevin Pistawka. ATRIOESOPHAGEAL FISTULA AFTER ABLATION FOR ATRIAL FIBRILLATION. The Journal of Emergency Medicine, Vol. 53, No. 1, pp. e1–e4, 2017.

  5. Rajapaksha WR, Cunningham KS, Rose TH. A fatal case of atrioesophageal fistula following radiofrequency ablation of left atrium and pulmonary veins for atrial fibrillation. Cardiovasc Pathol. 2014 Jul-Aug;23(4):238-40. doi: 10.1016/j.carpath.2014.02.004. Epub 2014 Mar 6.

  6. Black-Maier E, Pokorney SD, Barnett AS, Zeitler EP, Sun AY, Jackson KP, Bahnson TD, Daubert JP, Piccini JP. Risk of Atrioesophageal Fistula Formation with Contact-Force Sensing Catheters. Heart Rhythm. 2017 Apr 14. pii: S1547-5271(17)30452-6. doi: 10.1016/j.hrthm.2017.04.024.

  7. Nair KK, Shurrab M, Skanes A, Danon A, Birnie D, Morillo C, Chauhan V, Mangat I, Ayala-Paredes F, Champagne J, Nault I, Tang A, Verma A, Lashevsky I, Singh SM, Crystal E. The prevalence and risk factors for atrioesophageal fistula after percutaneous radiofrequency catheter ablation for atrial fibrillation: the Canadian experience. J Interv Card Electrophysiol. 2014 Mar;39(2):139-44. doi: 10.1007/s10840-013-9853-z. Epub 2013 Dec 7.

  8. Mohanty S, Santangeli P, Mohanty P, Di Biase L, Trivedi C, Bai R, Horton R, Burkhardt JD, Sanchez JE, Zagrodzky J, Bailey S, Gallinghouse JG, Hranitzky PM, Sun AY, Hongo R, Beheiry S, Natale A. Outcomes of atrioesophageal fistula following catheter ablation of atrial fibrillation treated with surgical repair versus esophageal stenting. J Cardiovasc Electrophysiol. 2014 Jun;25(6):579-84.