Background
Superior vena cava (SVC) lacerations have been identified as the most lethal complication
encountered during cardiac implantable electronic device lead extraction. The case
fatality rate of these events approximates 50% due to rapid exsanguination. A novel,
compliant balloon specifically designed for use in the SVC may provide hemostasis
in the event of endovascular perforation. By temporarily occluding the compromised
vessel, the endovascular balloon should delay hemodynamic collapse, provide a more
controlled surgical field for repair, and thereby reduce the mortality of SVC tears
complicating transvenous lead extraction.
Objective
To assess the early impact of the compliant endovascular balloon on the management
of SVC tears and survival outcomes.
Methods
We searched a publicly available, United States Food and Drug Administration–maintained
database for adverse events from 1 manufacturer of lead extraction tools. Reports
from July 1, 2016, to December 31, 2016 were reviewed by 2 physicians to identify
instances of SVC tears. Extracting physicians were contacted for further case details.
Confirmed SVC tears were analyzed for patient demographics, repair strategies, and
index hospitalization mortality.
Results
Of the complications reported, 35 cases of surgically confirmed SVC tears were identified.
One hundred percent of patients (9/9) were discharged alive when the endovascular
balloon was properly utilized, compared to 50% of patients (13/26) when the device
was not used (P = .0131). Differences between all other variables analyzed were statistically insignificant.
Conclusion
During the study period, we observed a reduction in mortality in patients who suffered
SVC tears while undergoing lead extraction when treatment included an endovascular
balloon.
Keywords
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Article info
Publication history
Published online: May 12, 2017
Footnotes
Bruce L. Wilkoff has served on the physician advisory board for Spectranetics, Medtronic, and St. Jude Medical; and has received speaking fees from Convatec. Roger G. Carrillo has served as a consultant to Spectranetics and Sensormatic; has received a research grant from St. Jude Medical; and has served on the Speakers Bureau for Medtronic, St. Jude Medical, and the Sorin Group.
Identification
Copyright
© 2017 Heart Rhythm Society. All rights reserved.
