HRS 2017: Endovascular occlusion balloon inclusion during lead extraction reduces mortality

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Roger Carrillo

Patients who suffer superior vena cava tears (SVC) during lead extraction are more likely to survive when treatment includes an endovascular occlusion balloon, a late-breaking trial study presented at the Heart Rhythm Society’s 38th Annual Scientific Sessions (10‒13 May, Chicago, USA) found.

Lead investigator Roger Carrillo, from the University of Miami in Florida, USA, said: “Approximately 15,000 to 20,000 lead extractions are performed in the United States and the procedure is very safe and effective. However in 0.5% of cases, SVC tears may occur. An endovascular balloon has the potential to save lives during complications. The balloon requires the placement of a guidewire before the procedure from the femoral vein to the right internal jugular or the right subclavian vein. The balloon can be quickly deployed into position in less than two minutes.”

Central venous vascular tears constitute potentially the most lethal complication during cardiac implantable electronic lead device extraction. Historically, the fatality rate has been 50% due to exsanguination.

A compliant balloon (Bridge Occlusion Balloon, Spectranetics), specially devised for use in the SVC is designed to provide haemostasis and a clear surgical field for repair, significantly reducing the rate of blood loss, stabilising the patient, and allowing the physician more time to develop a plan of action. This study assessed the early impact of the compliant occlusion balloon on the management of SVC tears during lead extractions.

All FDA reports of adverse events due to medical devices involving Spectranetics extraction tools from 1 July 2016 to 31 Dec 2016 were reviewed independently by two physicians to identify instances of SVC tears. The cases were then analysed for patient demographics, repair strategies, and index hospital mortality. Inclusion criteria were surgically confirmed SVC tear by sternotomy or autopsy, between the innominate vein and right atrium. Exclusion criteria were unconfirmed SVC tears, non-SVC tears, and surgical repair not attempted.

During the study period, 68 adverse events were recorded and 35 instances of SVC tears were identified. In nine cases, the occlusion balloon was deployed, and all were discharged alive from hospital. The remaining 26 cases were managed with open surgery without endovascular occlusion, and 13 (50%) survived to discharge. SVC tears occurred in patients identified as high risk of complications. Balloon use significantly increased the likelihood of survival during the study period (p=0.013).

Limitations are small sample size due to the rare occurrence of SVC tears, and the study assumes compliance with federal reporting regulations. Researchers say future steps involve further characterisation of the demographics of patients not treated with the balloon, and more thorough analysis of the medical and surgical approaches.

Carrillo said the wire must remain in the vein during balloon deployment, and the introducer sheath be secured in the femoral vein. “We also learned that the balloon does not substitute surgical repair.” He said 20% of physicians had started to insert a guidewire and a sheath before they extract, and if all physicians followed suit it would make a significant difference to patients.

“This is a very simple change in the workflow of lead extraction. It is very simple for all of us to place a wire and a sheath and have a lifeline in case of complications. You do not need to locate the tear; you do not need to size the tear. The clinical presentation of an SVC tear is haemothorax or pericardial tamponade. So if [that happens], we can float the balloon. If it is coming from the SVC we will be able to temporise the injury. If the injury occurs in the right atrium or the right ventricle the balloon is not going to be effective. But those injuries are usually not as lethal as lacerations of the SVC…the worst complication you can have. Around 70 patients suffer an SVC tear in the United States, and 35 of them pass away. I would like to see zero, none of them passing away.”

The study was not funded and was independent.


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