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Novel endovascular balloon may decrease mortality in superior vena cava tears
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CHICAGO — A novel compliant endovascular balloon may have the potential to save lives in patients who experience superior vena cava tears during transvenous lead extraction, researchers reported at the Heart Rhythm Society Annual Scientific Sessions.
Superior vena cava tears during lead extractions are extremely rare, study researcher Roger G. Carrillo, MD, MBA, FHRS, CCDS, from the University of Miami, said during a press conference. Only about 0.46% of lead extractions involve superior vena cava tears, but mortality among those who do experience tears is disproportionately high.
In a recent study, Carrillo and colleagues found that all nine patients who experienced superior vena cava tears while undergoing lead extraction survived when the compliant endovascular balloon (Bridge Occlusion Balloon, Spectranetics) was properly utilized, as compared with 13 of 26 patients when the device was not used (100% vs. 50%; P = .0131).
“The balloon is a bridge from a damaged vascular laceration in the superior vena cava, which bleeds profusely and can lead to death if you can’t stop the bleeding before you can open the chest and close the laceration,” study researcher Bruce L. Wilkoff, MD, FHRS, CCDS, from Cleveland Clinic and a Cardiology Today Editorial Board member, said in an interview.
“The compliant balloon, which is very soft, can be put in over a wire that goes from the atrium to the top of the superior vena cava. When inflated, it fills the whole superior vena cava, and because it’s so soft, it can ooze out into the branches, so we don’t have to know where the tear is,” he said. “The device allows you to stop the blood loss, provide for control and allow the surgeon to open the chest, find the tear and repair it.”
For the study, the researchers searched the FDA’s Manufacturer and User Facility Device Experience database for adverse events from one manufacturer of lead extraction tools and reviewed reports from July to December 2016 to identify instances of superior vena cava tears. They then contacted physicians involved in these reported events for further details and collected clinical data on patient demographics, repair strategies and index hospitalization mortality.
The researchers divided the study patients into two groups: patients with superior vena cava tears in whom the device was used properly and patients with superior vena cava tears in whom the device was not used or was not properly used.
In the balloon use cohort, a stiff guidewire was prepositioned from the right femoral vein to the right internal jugular or right subclavian vein before extraction, and the wire remained in the vein during balloon deployment. In the non-balloon use cohort, the balloon was not used at all or the stiff guidewire was not in the vein during balloon deployment.
In addition to increased survival in the balloon use cohort, the researchers found that superior vena cava tears occurred more often in patients at higher risk for complications, including women (54.3%), those with implantable cardioverter defibrillators (65.7%) and older leads (9.62 years).
The researchers also gleaned information about how the balloon should be used, according to Carrillo.
“We learned that in order for the balloon to be deployed, we need a guidewire and a sheath, which creates a change in the workflow. Therefore, the extraction teams have to be familiar with the procedure and prepare themselves to be able to deploy this device in an emergency,” he said.
Wilkoff also noted that the researchers discuss principles of use in their study, which was recently published online in Heart Rhythm, that will help improve use of the device. – by Melissa Foster
Reference s :
Carrillo RG, et al. LBCT03-03. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 10-13, 2017; Chicago.
Azarrafiy R, et al. Heart Rhythm. 2017;doi: 10.1016/j.hrthm.2017.05.005.
Disclosure : Carrillo reports consulting for Sensormatic and Spectranetics; receiving a research grant from St. Jude Medical; and serving on the speakers’ bureau for Medtronic, St. Jude Medical and the Sorin Group. Wilkoff reports serving on an advisory board for Medtronic, Spectranetics and St. Jude Medical and receiving speaking fees from ConvaTec.