Can you tell us about your lab and practice?
I am an interventional cardiologist practicing at the Arkansas Heart Hospital and have been in practice for a little over 8 years. I do both coronary and peripheral cases. My peripheral volume is about 60-70% of my practice. Arkansas Heart Hospital has four labs and we do over 1500 peripheral interventions a year. We use multiple technologies, including specialty balloons, atherectomy, and stents. We treat iliac disease, as well as infrainguinal/superficial femoral artery (SFA) disease and critical limb ischemia (CLI).
Can you tell us about any new devices you’re using?
The newest device that we have been able to use has been the 220 mm length version of the Lutonix 035 drug-coated balloon (BD/Bard). We have used this product since it launched in August and have done six cases thus far, all with great results. I am very excited about this device, because about 80% of my patients have lesions longer than 150 mm, and now we can treat them with one drug-coated balloon instead of two or more.
Prior to the launch of the 220 mm Lutonix 035, how were you treating patients with longer lesions?
We have traditionally used Lutonix because of its strong safety profile, but we like that it has the most sizes compared to other drug-coated balloons, and that it is all 5 French (Fr), even up to 7 mm diameters. However, the longest length previously available for any DCB was 150 mm, so in the past, we used at least two drug-coated balloons to treat a long SFA lesion. Using two balloons instead of one significantly increased costs to the lab, not to mention the procedure time and radiation exposure to the patient and cath lab staff. Even the time required to inflate multiple balloons made it more cumbersome to do these procedures. Moreover, we were always concerned about the risk of dissecting the part of the lesion that ended up getting re-dilated because it fell within the overlapped treated area. Having the 220 mm lengths of Lutonix available has allowed us to treat longer lesions, in addition to those that fall within the 220 mm range, with a single balloon. Lastly, due to the low, 5 Fr profile of these new lengths, we have been able to deliver the 220 mm balloons as smoothly and as easily as we delivered the shorter lengths. Other long length balloons are not always as easy to maneuver as their shorter counterparts, so it was a nice surprise to see how well engineered the new Lutonix lengths were.
Can you talk about the time saved with the use of a single balloon?
For each drug-coated balloon, a 2-minute inflation time is recommended. We used to have to wait for the first balloon to inflate for those 2 minutes and then deflate, then remove that balloon and load a second balloon, which adds additional time to the procedure. Then, we had to inflate the second balloon and wait another 2 minutes, deflate again and remove it. Considering those factors alone, we have been able to decrease our procedure time substantially just by using one balloon instead of two, not to mention the headache and risks involved with multiple inflations.
What about fluoroscopy time?
We do save on fluoroscopy time. We typically use fluoroscopy when positioning the balloon and ensuring we have appropriate wall apposition, and obviously, the ability to use one balloon instead of two shortens the procedure and subsequent fluoroscopy time. However, one other nice benefit specific to Lutonix and the other Bard/BD catheters is the GeoAlign Marking System, which really helps us minimize our fluoroscopy use during positioning. The GeoAlign Marking System is an easy-to-use non-radiopaque ruler on the catheter shaft. Using the same marking system across all these lines of products just makes a ton of sense. It all visually looks the same and provides a reference point, so you can have confidence in what you are ballooning and where you are delivering your device. So between the GeoAlign Marking System and using a single balloon instead of two or more, we have been able to decrease the resultant fluoroscopy radiation exposure to our team and patient considerably.
What about staying low profile?
One of the key reasons we like the Lutonix DCB line is that it has a really low profile of 5 Fr across all its sizes. It is the only drug-coated balloon available with such a low profile. The fact that we can deliver Lutonix through a 5 Fr sheath means increased patient safety compared to using a larger sheath. In our practice, we often encounter more hematomas and more pseudoaneurysms when larger sheath sizes are used. Therefore, smaller groin access sheaths as well as alternative access sites like radial and pedal are utilized in our practice. This has been very beneficial in complex cases where alternative access was needed in order to appropriately treat the patient. After being able to use a full suite of 5 Fr products in my peripheral arterial cases, it almost seems archaic to upsize my sheath in these procedures.
Could you describe a recent case?
We had an 88-year-old female in whom I had previously treated an SFA chronic total occlusion (CTO) conservatively with PTA and was able to open up that CTO. She experienced a recurrence of some disease in the distal SFA and popliteal, and was having claudication. She also had a left great toe wound that was healing slowly, but given the fact that she had claudication symptoms as well as some minor tissue loss (Rutherford 5), we elected to intervene again. We found an 80% stenotic, moderately calcified lesion in the distal SFA/popliteal extending about 200 mm in length (Figures 1-2). We first used an UltraScore Focused Force balloon (BD/Bard) to appropriately dilate the lesion and crack the calcium. Subsequent imaging showed no dissections and an excellent angiographic result after one low pressure inflation. In order to maintain long-term patency, we delivered an anti-restenotic therapy through angioplasty with the 220 mm Lutonix 035 balloon. In the past, this treatment would have required using both a 150 mm and a 60 mm balloon, but now we were able to treat the lesion with a single drug-coated balloon. Again, we did this all through a 5 Fr sheath and with a great result (Figures 3-4). The patient’s age and size put her at risk for having an access site complication, so we were especially grateful to be able to stay low profile. The results showed little to no residual stenosis and brisk flow down to the tibial vessels. Since the procedure was done in August, her wound has continued to heal adequately and her symptoms of claudication have resolved. The benefits are clear: for the patient, we were able to avoid any groin complications by staying 5 French, and for the hospital, we were able to decrease the procedural cost by only using one drug-coated balloon instead of two drug-coated balloons. And everyone benefited from our ability to decrease the procedure time and radiation exposure.
How do you see the 220 mm Lutonix balloon changing your practice?
Especially since most patients have lesions that are longer than 150 mm, being able to use one balloon as opposed to multiple balloons is advantageous for these patients. It allows us to treat longer lesions with a single device rather than having to use two or more devices. There are also advantages in being able to stay lower profile and especially in the ability to deliver the Lutonix through an alternative access sites. The ability to stay lower profile, especially in alternative access, allows for a safer procedure overall. Having a longer length balloon has definitely transformed the way I treat these patients — I could not go back to being limited to 150 mm length drug-coated balloons.
This article is supported by BD Interventional.
Disclosure: Dr. Ian Cawich reports he is a consultant to Bard.
Dr. Ian Cawich can be contacted at firstname.lastname@example.org.
The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes.
The LUTONIX® 035 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
The LUTONIX® Catheter is contraindicated for use in: 1) Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy. 2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in nursing infants from paclitaxel exposure. 3) Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
Potential adverse events which may be associated with a peripheral balloon dilatation procedure include: Additional intervention ∙ Allergic reaction to drugs, excipients, or contrast medium ∙ Amputation/loss of limb ∙ Aneurysm or pseudoaneurysm ∙ Arrhythmias ∙ Embolization ∙ Hematoma ∙ Hemorrhage, including bleeding at the puncture site ∙ Hypotension/hypertension ∙ Inflammation ∙ Occlusion ∙ Pain or tenderness ∙ Pneumothorax or hemothorax ∙ Sepsis/infection ∙ Shock ∙ Stroke ∙ Thrombosis ∙ Vessel dissection, perforation, rupture, or spasm Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events, not described in the above source, which may be unique to the paclitaxel drug coating include: Allergic/immunologic reaction to the drug coating (paclitaxel) ∙ Alopecia ∙ Anemia ∙ Blood product transfusion ∙ Gastrointestinal symptoms ∙ Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) ∙ Hepatic enzyme changes ∙ Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis ∙ Myalgia/ Arthralgia ∙ Myelosuppression ∙ Peripheral neuropathy
Please consult package insert for more detailed safety information and instructions for use.
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