Health Canada has issued an advisory to inform medical professionals about the potential risk of cardiac strangulation, a rare adverse event associated with epicardial pacemaker leads implanted in paediatric patients.
Health Canada has been made aware of rare Canadian cases of cardiac strangulation in paediatric patients implanted with epicardial pacemaker leads. Eight international cases of cardiac strangulation, including two fatalities, have been reported in the scientific literature. In some cases, cardiac strangulation was diagnosed early and the patients underwent successful revision surgery.
As the child's heart grows, the epicardial pacemaker leads can compress the heart and/or coronary arteries and cause cardiac strangulation which can result in a life-threatening condition or death. The placement and routing of the lead to the pacemaker appear to contribute to this potentially severe adverse event.
The clinical presentation of cardiac strangulation greatly varies among patients. Signs and symptoms associated with cardiac strangulation, that have been reported in the scientific literature, include chest pain, general fatigue, syncope, symptoms of myocardial infarction and heart failure and a new cardiac murmur.
Signs or symptoms of myocardial infarction or heart failure should prompt further clinical investigation and cardiac strangulation should be suspected in paediatric patients implanted with epicardial leads.
Particular attention should be taken for the appropriate placement and routing of the lead to the pacemaker in order to reduce the risk of cardiac strangulation.
For details, please refer to the Health Canada website: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/ prof/_2012/epicardial_leads_nth-aah-eng.php
Posted on 18 October 2012