Iliocaval venous stenting is an established procedure used to improve clinical symptoms and quality of life in patients with deep venous disease, including those suffering from postthrombotic syndrome (PTS) and nonthrombotic iliac vein lesions. With the development of dedicated venous stents, the incidence of this procedure has increased.1, 2, 3, 4 It is generally considered a low-risk procedure, with adverse events occurring in 1.2% to 6.5% of cases5,6; however, the long-term outcomes of dedicated venous stents remain uncertain. Potential complications, including acute and chronic in-stent thrombosis (IST), as well as restenosis, highlight the need for further advancements in the treatment of complex venous lesions.
In addition to the current standard of care—comprising therapeutic anticoagulation, compression stockings, fibrinolytic therapies, venoplasty, and stent relining—there is a pressing need for novel devices. These devices could offer improved solutions for addressing complications such as stent occlusion and recurrent thrombus formation. Furthermore, specialists performing these procedures must be well-versed in the work-up for deep venous disease, intravascular imaging, and postoperative management, including anticoagulation and routine surveillance imaging.
In this issue of JSCAI, Abramowitz et al7 present the results of a multicenter retrospective study evaluating the safety and feasibility of the RevCore thrombectomy catheter (Inari Medical) for treating venous IST. The RevCore thrombectomy catheter is a minimally invasive, over-the-wire device designed to treat venous thromboembolism in both native vessels and within stents. Featuring a novel expandable coring element and a reinforced catheter shaft, the system allows for improved maneuverability and 360° vessel treatment.
The authors retrospectively reviewed 44 patients from 4 centers who had lower extremity venous IST treated with the RevCore device. The primary end point of the study was technical success, defined as a postprocedural effective stent diameter ≥50% measured via intravascular ultrasound. Safety end points included device-related serious adverse events (SAE) within 30 days, including mortality, readmissions, clinically significant pulmonary embolism, and vascular perforation.
The study analyzed 48 treated limbs with 6 different stent types. The median duration of IST symptoms was 8 weeks, ranging from 2 to 104 weeks. Of those treated, 24.4% had acute symptoms, 11.1% had subacute symptoms, and 64.4% had chronic symptoms. The majority of limbs (95.8%) had a prior history of deep vein thrombosis; only 2 patients had a stent placed for nonthrombotic iliac vein lesions. Interestingly, 25% of patients had previously undergone interventions for IST, such as venoplasty, catheter-directed thrombolysis, stent lining, and mechanical thrombectomy. Most of the treated patients had a Villalta score of 9, with a large proportion classified as clinical-etiology-anatomy-pathophysiology (CEAP) clinical class C3 (46.8%). The study found that all treated limbs met the primary end point, with an increase in the effective stent diameter from 21.1% ± 26.5% to 89.6% ± 10.1%. Additionally, there were no device-related SAE reported within 30 days of the procedure. At the 30-day follow-up, 32 of 34 limbs remained patent. Of the 6 limbs with CEAP scores of C6, 50% showed improvement to CEAP C5 after 3 months.
This small retrospective study demonstrates that the RevCore device is safe in the short term, with no significant device-related SAE, aside from 1 case of postprocedural stent fracture. Most patients showed mild improvement in their CEAP score (from C6 to C5), and there were no immediate issues with stent patency at the 30-day time point.
Long-term follow-up is needed to determine whether the RevCore device can reduce the incidence of recurrent venous thromboembolism, the need for additional therapies such as venoplasty or stent relining, and the development or worsening of PTS. In addition, randomized controlled trials are essential to compare the safety and efficacy of this novel device with current standard of care treatment, with both short- and long-term follow-up.
Venous stent occlusion management remains an area of ongoing debate. There is a clear need for more data on long-term outcomes, such as recurrent IST, the development of PTS, and improvements in CEAP classification. These studies should also investigate the economic and clinical benefits of novel devices and adjunctive therapies across various disease states and stages of chronicity. Differences in clinical scenarios and thrombus characteristics may require tailored treatment strategies and approaches.
Acknowledgments
Declaration of competing interest
The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.
Funding sources
This work was not supported by funding agencies in the public, commercial, or not-for-profit sectors.
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