Medtronic’s Chameleon PTA Balloon Catheter Studied for Single-Device Thrombectomy Interventions

June 23, 2021—Online in The Journal of Vascular Access (JVA), Ari Kramer, MD; John Ross, MD; and Antonios P. Gasparis, MD, reported findings from a novel technique using a single device, the Chameleon percutaneous transluminal angioplasty (PTA) balloon catheter (Medtronic), to safely and efficiently perform percutaneous thrombectomy interventions.

The investigators noted that the Chameleon PTA balloon provides imaging, thrombectomy, and angioplasty in one device. Placement of an introducer sheath is not required because of the imaging capabilities of the device, the catheter profile, and the rewrapping of the balloon after deflation.

In the case reported in JVA, the investigators used lysis-assisted balloon thrombectomy to treat a thrombosed bovine arteriovenous graft (AVG) in a 74-year-old left-handed female patient with end-stage renal disease (ESRD) caused by diabetes mellitus. The patient was dialyzing via a left upper extremity, nonaneurysmal, brachial-basilic, bovine, straight 6-mm graft placed in November 2017.

As noted by the investigators in JVA, techniques for performing thrombectomy in AVG range from open surgical procedures to percutaneous procedures. They noted that within the category of percutaneous thrombectomies, techniques range from chemical to mechanical and various combinations in between and that most of these techniques are elaborate and time consuming.

An advantages of this technique, stated the investigators, was a significantly shorter time compared to previously described techniques. They cited a study by Donald Schon, MD, et al in Seminars in Dialysis that looked at 368 thrombolytic events in both AV fistula and AVG accesses with an average procedural time of 66.05 minutes (2013; 26:344–348). The technique described within the recent JVA case report demonstrated an average procedure time of 21.1 minutes. There was also a direct cost difference reported due to eliminating the need for introducer sheaths, as well as performing thrombectomy using a PTA balloon compared to using the wide variety of mechanical thrombectomy devices currently available on the market.

Furthermore, the technique outlined in this case report facilitates performance of a direct arteriogram that is essential to ensure patency of the distal arteries after a thrombectomy. In JVA, the investigators outlined the reasons for this observation: “(1) a direct angiogram is less likely to embolize residual thrombus than a retrograde occlusive, (2) the higher pressure of a retrograde occlusive may hide residual lesions, and (3) the higher pressure of a retrograde occlusive may lead to vessel dissection postangioplasty.”

Additionally, the investigators noted in JVA that keeping a wire in the central vasculature while performing a pullback venogram saves additional time while ensuring that the operator does not need to traverse the lesion twice in difficult-to-cross lesions. They also explained that the presence of the injection port at the site of the lesion can reduce the doses of contrast and fluoroscopy to the patient, which is particularly important in this setting where kidney damage due to the contrast agent can be common for ESRD patients who have residual renal function.

Discussing the findings with Endovascular Today, Dr. Kramer commented, “This novel technique for performing a sheathless thrombectomy is only possible by the unique features of the Chameleon PTA balloon. We were not only able to save our patients approximately 40 minutes of procedure time and get them back to their daily lives faster, but most importantly, we also had a technical success rate of 100% while saving the hospital considerable secondary costs in the process.”

Dr. Kramer, the study’s Principal Investigator, continued, “My hope is that more dialysis access clinicians will consider adopting some version of this method for thrombectomy, or at the very least try it, given the efficacy, safety, and technical cost-efficiency.”

As reported in January 2021, findings from a study of the Chameleon device were published online in JVA by Joel Crawford, MD, et al. The investigators compared the performance of the Chameleon balloon catheter for fistula and graft maintenance procedures versus a standard PTA balloon.