World’s first minimally invasive deep venous ‘stent cleaner’ shows real-world promise
Key takeaways:
- A surgeon completed the world’s first deep venous stent thrombectomies for chronic stent occlusion via a minimally invasive catheter.
- Procedural success was achieved; all patients noted symptomatic improvement.
In March, Steven Abramowitz, MD, a surgeon at MedStar Washington Hospital Center, completed the world’s first procedures to treat deep venous stent thrombosis using a novel minimally invasive thrombectomy catheter.
The thrombectomy catheter (RevCore, Inari), colloquially referred to as a deep venous “stent cleaner,” previously received 510(k) clearance from the FDA in March and was officially launched in June, according to company press releases.
Since the first procedures in March, Abramowitz, who is a vascular surgeon at MedStar Washington Hospital Center and chairman of vascular surgery at MedStar Health, has treated nearly 20 patients with deep venous stent thrombosis with 100% procedural success.
Abramowitz spoke with Healio about the importance of treating deep venous stent thrombosis as well as his initial experiences using the minimally invasive catheter.
Healio: What is the prevalence of stent thrombosis among patients who receive a venous stent, and how long does it typically take to develop?
Abramowitz: The prevalence of deep venous stent occlusion varies depending upon the original pathology for which the deep venous stent was placed. For patients who have what we call NIVLs, or nonthrombotic iliac vein lesions, typically we see stent thrombosis rates of about 3% to 5% in the first 2 to 5 years, depending upon the stent trial. However, for patients with acute DVT or postthrombotic syndrome, the rate can be as high as 40% at 2 to 5 years.
Stent occlusion can occur after a few weeks, or it can occur after a few years, and usually it’s a result of platelet aggregation and thrombus formation that relines the stent as the body tries to maintain laminar flow. And so, that’s generally the prevalence and when it occurs.
Healio: Can you provide some background on the RevCore catheter and its development?
Abramowitz: For patients who have deep venous stent occlusion, there were very few effective options for clearing out and debulking the material from within the stent, specifically due to the caliber of the stent and the nature of the occlusive material. These stents tend to be anywhere from 12 mm to 18 mm in diameter, and the material that recurs is not atherosclerotic plaque or neointimal hyperplasia. Rather, it’s a highly collagen dense scar-like tissue that occurs within the stent itself.
The RevCore device was designed to be something that can expand to variable diameters and debulk the material within the stent to regain the lumen. It was designed to address large-diameter stents with dense material seen specifically in venous disease.
Healio: What has your experience been using this device and how have the outcomes been so far?
Abramowitz: We've seen about seven to 10 patients in 1 month follow-up after the procedure. So far, the patency rates have been 100% at follow up and the patients report symptomatic improvement. For those patients with wounds, we've seen ulcer healing. The patient experience has been very positive. We have not yet had any device-related complications, although it's still early to make overarching statements about device safety. But we can say that it's been very efficacious. We've had 100% technical results in terms of procedural success.
The great thing about the device is it’s easy to use with wonderful haptic feedback, and so as you’re using the device, you are able to feel as it’s spinning within the stent, as the RevCore system interacts with the stent wall or as the device encounters resistance within the vessel of itself.
It can be efficacious in the hands of many operators who are treating this type of deep venous pathophysiology.
Healio: Do you foresee a learning curve for new operators of this device?
Abramowitz: I don't see a steep learning curve for new operators of the device; however, we may see that there's a learning curve in terms of crossing chronically occluded venous stents to utilize the device. The device is going to make it much easier for people to treat chronically occluded venous stents. I think a lot of people shied away from intervening on or crossing these stent occlusions earlier on because there weren't great tools for treating the disease once the lesion crossed.
Healio: Which patients are the best candidates for this procedure?
Abramowitz: The device is an excellent tool for maintaining primary assisted or secondary patency. Patients who've had a deep venous stent placed who find that their symptoms are recurring or who on surveillance imaging show in-stent thrombosis, narrowing or occlusion are candidates for intervention.
Healio: How long until we see wider use of this device?
Abramowitz: The device is now commercially available, so anybody can use it. As people become more comfortable in addressing chronically occluded or failing venous stents, this is going to become a larger part of their armamentarium. If somebody has a patient now, the device is available to them.
For more information:
Steven Abramowitz, MD, can be reached at steven.d.abramowitz@medstar.net.
References:
- Inari Medical announces commercial launch of RevCore and Triever16 Curve, two new purpose-built products for addressing venous stent thrombosis and venous thromboembolism. ir.inarimedical.com/news-releases/news-release-details/inari-medical-announces-commercial-launch-revcoretm-and. Published June 8, 2023. Accessed July 7, 2023.
- MedStar Washington Hospital Center performs the world’s first RevCore stent cleaning procedure for deep vein thrombosis. www.medstarhealth.org/news-and-publications/news/first-revcore-stent-cleaning-procedure-for-deep-vein-thrombosis. Published July 5, 2023. Accessed July 7, 2023.
- RevCore Thrombectomy Catheter. www.accessdata.fda.gov/cdrh_docs/pdf22/K223609.pdf. Published March 14, 2023. Accessed July 7, 2023.
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