More than 7 million patients worldwide live with pacemakers or implantable cardioverter defibrillators (ICDs). These devices are connected to the heart through leads. In some cases, such as lead infection, failure, or recall, it becomes necessary to extract the leads and replace them with new ones. At this time, 15,000 to 20,000 lead extractions are performed annually in the United States. Although this procedure is relatively safe, superior vena cava (SVC) tears remain one of the most dangerous complications and dissuade some physicians and patients from pursuing this treatment. SVC tears occur in only about 0.5 percent of cases, but when they do occur, the mortality rate nears 50 percent.

Spectranetics is a Colorado-based company that is currently a pioneer in cardiac lead management. Spectranetics aspires to mitigate the high mortality rate associated with SVC tears during lead extraction with its new product, Bridge Occlusion Balloon.

Spectranetics launched Bridge Occlusion Balloon last year. The device requires a stiff guide wire that is inserted through the right femoral vein and threaded up to the right internal jugular vein prior to initiating the lead extraction procedure. If a SVC tear occurs, the balloon can be deployed in less than two minutes to temporarily halt bleeding from the tear by obstructing blood flow through the superior vena cava. Of course, the balloon does not substitute surgical repair, but it acts to stabilize the patient long enough for the cardiac surgeon to open the patient’s chest and repair the tear.

During the Heart Rhythm Society 2017 Scientific Sessions in Chicago, Dr. Roger Carrillo of the University of Miami presented a new study on how the compliant Bridge Occlusion Balloon reduces lethality of SVC tears during lead extractions. The study reviewed all reports between July 1, 2016, and December 31, 2016, that were recorded in the MAUDE database, an FDA-maintained, mandatory registry of adverse events related to medical devices. Within the study period, there were 35 confirmed SVC tears during transvenous lead extractions. In 9 cases the Bridge Occlusion Balloon was deployed, and all 9 patients (100 percent) survived. The remaining 26 cases were managed without the balloon, and only 13 patients (50% percent) survived. Patients with SVC tears were more likely to survive when treatment included an endovascular occlusion balloon.

Dr. Roger Carrillo stated, “During our study there was something very apparent. Physicians, who where able to use the balloon and rescue their patients, reported a feeling of relief and success. On the other hand, physicians, who did not have the balloon and encountered this complication, reported a feeling of despair and frustration. Even though this procedure [lead extraction] is safe, I do believe that the wire and sheath should be placed on every patient going through lead extraction.”

During Heart Rhythm Society 2017 Scientific Sessions in Chicago, we at Medgadget had the opportunity to observe a live demonstration of the Bridge Occlusion Balloon by Dr. Carrillo. During the demonstration, the Bridge Occlusion Balloon is used to stop bleeding from an SVC tear. You can see the device working around 40 seconds into the video. Check it out:

Product page: Bridge Occlusion Balloon…