In this feature interview, we speak with Roger Carrillo, MD, Chief of Surgical Electrophysiology at University of Miami Hospital, about his experience with Bridge™ Occlusion Balloon (Spectranetics) for lead extraction.
Tell us about your medical background. Were there areas of particular interest in your training?
I’m a heart surgeon by training and in practice. Since very early in my career, I have had a particular interest in implantable devices such as pacemakers and defibrillators.
Describe Bridge™ Occlusion Balloon and its role in perforations of the superior vena cava (SVC) that may occur in lead extraction procedures. What is the rarity of SVC tears?
I think Bridge is a very important advancement in lead extraction safety, because it’s the first technology developed specifically to stop bleeding when an SVC tear occurs. SVC tears are rare, occurring in less than 0.2% to 0.3% of cases, but when they do occur, they can be catastrophic. Even if a surgeon is present during the event, there is still a mortality rate of 50%. Bridge is a game changer, controlling the bleeding so that a surgeon like me can go in and repair the injury. When you have to stop the bleeding, every second counts. A patient can lose as much as one-half liter of blood every minute, so it’s very important to react quickly. Bridge stops the bleeding and maintains acceptable hemostasis for 30 minutes, giving surgeons the time they need to give the appropriate therapy.
What about Bridge makes it designed specifically for SVC tears? Is there special sizing or material properties that make Bridge well-suited for use in SVC tears?
First, the shape of Bridge is cylindrical, similar to the shape of the superior vena cava. It’s also the proper length. It will cover the entire internal span of the SVC in at least 90% of patients. Additionally, it’s made of a very soft and pliable material, which results in a very compliant balloon that conforms to the vessel to occlude an injury. Radiopaque markers aid the physician in quick and accurate deployment.
Tell us about Bridge’s ability to achieve occlusion with leads in place.
We have been looking at that at our institution, and in patients with leads in place, the balloon can occlude the SVC without any problems.
Describe your clinical experience, including deployment and ease of use, with Bridge.
We have been using Bridge in some of our patients here at the University of Miami Hospital, and it has met our expectations for ease of use as well as quick deployment, taking less than two minutes.
What have been the clinical experiences of other physicians (e.g., extractors, surgeons, EPs) with Bridge in emergent situations, including impact to survival?
To my knowledge, there have been four instances in which Bridge has been deployed in the SVC after a tear occurred, and it has performed very well. In two of the four cases, they were able to complete the surgical repair off bypass, which is incredible. In all four cases, the patients did very well, surviving the procedure and being discharged from the hospital. Some physicians have insisted to me that they will not undertake extraction procedures without the availability of the Bridge balloon going forward.
As I said, the mortality rate when an SVC tear occurs can be 50%; 100% of these four patients were saved. I cannot overstate that this is a tool that saves lives. Today there are patients living their lives and enjoying their families because they survived a potentially lethal complication.
Does Bridge technology have the ability to change perceptions about lead extraction?
Experienced extractors know that with the technology available to us today, lead extraction is safe and effective, with a much higher success rate and a much lower complication rate than many of the other procedures that we do. However, there is a disproportionate perception of risk associated with lead extraction. I believe Bridge makes the procedure safer and, therefore, can overcome barriers to patients getting appropriate care.
How do other balloon technologies designed for SVC occlusion compare to Bridge?
Bridge is the only technology that is approved by the FDA for vascular tears in the superior vena cava. The other products are not designed or approved for this particular application. Technically speaking, the other balloons tend to be much shorter and more spherical, meaning they do not provide the same degree of vascular coverage and may not be able to accommodate obstacles such as device leads.
How should physicians prepare before a case so that Bridge could be deployed in the event of a tear?
The physicians and their teams should be familiar with the use of this lifesaving tool, because once they’re familiar with it, they can deploy it in a hurry. If you’re not very familiar and you have to deploy a tool in a hurry, you may fumble. So I would advise physicians to be familiar with the balloon beforehand, so if they have an emergency, they can deploy appropriately.
Do you recommend a stiff wire be in place before procedures? What about use of an introducer sheath, or other preparations?
Yes, in order to deploy the balloon very easily, a stiff wire has to be placed through an introducer. You need to have an introducer and wire for the balloon to glide into position. If you don’t have the wire at the beginning of the case, it will take time to get the wire there where you want it. Also, if you have a laceration, you may accidently put the wire through the laceration and not be able to be achieve access. So it’s important to have the wire in position before you start the procedure. Once you start a procedure, you can expeditiously deploy the balloon if you have any issues.
What other considerations should be taken into account for prophylactic use of Bridge in high-risk cases?
If you have a difficult case and you anticipate that the patient has the possibility of having an injury or tear in the SVC, I would be ahead of the game and try to have the balloon somewhere very close by in order to be able to deploy the balloon as quickly as possible. It just makes sense.
What does the future of lead management look like?
Lead management is only going to become more important. For example, even patients with functioning leads may need upgrades to MRI-compatible technology. Extraction is a procedure that is growing, and the safer that we can make the procedure, the better it’s going to be for our patients. When the procedure is safer, both the extractor and team are more confident approaching lead management.
I’m very happy about the development of this lifesaving tool, and I’m very confident it’s going to make a big difference in how physicians practice. It has certainly changed the way I practice and the way I deal with patients, and I hope it will do the same for other physicians.
Disclosure: The author has no conflicts of interest to report regarding the content herein.