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Monday, January 4, 2021

Rotational Thrombectomy and Drug-Coated Balloon for Femoropopliteal Artery Nonembolic Occlusion

Combination of Percutaneous Rotational Thrombectomy and Drug-Coated Balloon for Treatment of Femoropopliteal Artery Nonembolic Occlusion: 12-Month Follow-up


Clinical question
Is mechanical thrombectomy (using the Rotarex catheter) combined with drug-coated balloon angioplasty safe and effective for treatment of femoropopliteal occlusive disease?

Take-away point
The combination of mechanical thrombectomy with Rotarex and DCB is effective for femoropopliteal occlusions; however, a significant number of patients required bailout stenting.

Reference
Wang, Qi, et al. Combination of Percutaneous Rotational Thrombectomy and Drug-Coated Balloon for Treatment of Femoropopliteal Artery Nonembolic Occlusion: 12-Month Follow-up. J Vasc Interv Radiol. 2020;31(10):1661-1667.

Click here for abstract

Study design
Retrospective cohort study

Funding source
Self-funded or unfunded

Setting
Two academic centers, Beijing China




Figure 1. Total occlusion of the superficial femoral artery treated by mechanical thrombectomy with the Rotarex catheter and DCB. (a) Digital subtraction angiograph shows occlusion of the superficial femoral artery (arrow). (b) Recanalization of superficial femoral artery after second crossing with 6-F Rotarex catheter (arrow). (c) DCB angioplasty of the superficial femoral artery (asterisk). (d) Final angiography after DCB dilation.

Summary


This article aimed to evaluate the safety and efficacy of percutaneous mechanical thrombectomy in combination with a drug-coated balloon angioplasty for treatment of acute and subacute femoropopliteal artery occlusive disease.

The current standard of care for femoropopliteal arterial occlusive disease is open surgical intervention or catheter directed thrombolysis. Balloon catheter thrombectomy or surgical bypass possess significant morbidity and mortality related to both the procedure and general anesthesia. Catheter directed thrombolysis presents with risk of hemodynamically or neurologically significant hemorrhage. For a patient population typically presenting with multiple comorbidities and advanced age, a minimally invasive, safer alternative is desirable for treatment of femoropopliteal arterial occlusive disease.

Consecutive treatment with the Rotarex catheter and a paclitaxel coated balloon catheter was retrospectively reviewed over approximately a 2 year period, which included a total of 81 patients with acute to subacute femoropopliteal artery occlusive disease diagnosed by color Doppler ultrasound or CT angiography. Included patients were generally considered poor surgical candidates. Two passes with the Rotarex catheter were performed, predilation of the recanalized vessel with an uncoated balloon, followed by subsequent percutaneous transluminal drug coated angioplasty. Additional stent placement with self-expanding nitinol bare stents were used to treat significant dissections of residual stenosis greater than 30%, and additional thrombolysis was administered via a Unifuse infusion catheter if significant remaining clot burden was present. Dual antiplatelet therapy was continued for a minimum of 6 months following the procedure, followed by clopidogrel alone.

Vessel recanalization was achieved in 70.3% of patients (57/81) with percutaneous mechanical thrombectomy alone, 17.3% (14/81) with percutaneous mechanical thrombectomy and bailout stent placement, and 12.3% (10/81) had residual thrombus and required additional thrombolysis. No major adverse events were encountered. 11 minor procedure-related complications occurred, including flow limiting dissection (5/81), distal embolism (4/81), and artery perforation during thrombectomy (2/81), all of which were successfully treated when encountered. 71 patients completed the 12-month followup; primary patency rate was 87.3% (62/71), 9.9% of patients required target lesion revascularization (7/71), and 3% of patient had restenosis with mild symptoms which were managed conservatively (2/71). During the follow-up period, the ABI significantly (P < .01) improved after treatment, improving from 0.46 ± 0.15 before treatment to 0.77 ± 0.14 at 12 months.

Commentary


The authors emphasize the superiority of their results with Rotarex catheter in complication with drug coated balloon angioplasty, compared to rotational thrombectomy in combination with an uncoated balloon, which had significantly higher restenosis rates. The authors acknowledge some limitations to their study, including the retrospective nature of the study, small number of patients, no control group, limited follow up to only 1 year, and selection bias consisting of mostly poor surgical candidates. It seems that the authors downplay the technical skill necessary to use the Rotarex catheter safely and effectively, which was only touched on briefly in the procedural details when referring to “slow back-and forth movements” and “repeated retraction” of the catheter. It would seem the use of this device is more technically demanding than thrombolysis, and use in the hands of a less familiar operator could vary. Overall, the authors present a compelling argument for further investigation of rotational thrombectomy in combination with drug coated balloon angioplasty in the treatment of acute and subacute thrombus-containing femoropopliteal artery atherosclerotic occlusions. Larger prospective randomized controlled trials will need to further evaluate the growing variety and combinations of minimally invasive techniques with the current surgical standard of care.


Post Author
Greg Rufener, MD
Radiology Resident (PGY-3)
Department of Radiology
Oregon Health and Science University, Portland, Oregon
@gregoryrufener

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