Prospective Single-Arm Trial of Endovascular Mechanical Debulking as Initial Therapy in Patients With Acute and Subacute Lower Limb Ischemia: One-Year Outcomes

Abstract

Purpose: To report the results of a prospective, single-arm study to establish whether the initial treatment of acute or subacute limb ischemia (ALI and SLI, respectively) can be accomplished successfully using endovascular mechanical debulking of the target vessels to avoid the risks associated with thrombolysis and/or open surgery. Materials and Methods: From April 2009 to April 2015, 316 consecutive patients (mean age 70.9±12 years; 184 men) with ALI (202, 63.9%) or SLI (114, 36.1%) were enrolled; the only exclusion criterion was irreversible ischemia. The ALI group included 146 (72.3%) participants with category IIb ischemia and 56 (27.7%) with category IIa. Critical limb ischemia was diagnosed in 74 (64.9%) of the 114 patients with SLI. Target occlusions of thrombotic (n=256) or embolic (n=60) origin were located in the femoropopliteal segment (n=231), prosthetic or venous femoropopliteal bypass grafts (n=75), and the aortoiliac segment (n=35). The mean occlusion length was 22.9±14.8 cm. Results: The overall technical success (residual stenosis ≤30%) was 100% after debulking and adjunctive techniques (aspiration, dilation, stenting) at the level of the target lesions. No open surgical or thrombolytic modalities were necessary to bypass or recanalize the target vessels, and no death occurred in association with target occlusion therapy. Additional infrapopliteal interventions were performed in 195 (61.7%) patients (adjunctive thrombolysis in 29) to treat acute, subacute, and chronic lesions. Minor complications directly related to the debulking procedure occurred in 26 (8.2%) patients. Serious complications occurred in 11 (3.5%) patients, including hemorrhage in 8 (2.5%) patients (associated with infrapopliteal thrombolysis in 5). At 30 days, primary and secondary patency rates were 94.3% and 97.2%, respectively; mortality was 0.3% (1 fatal intracranial hemorrhage after adjunctive thrombolysis). Of 229 patients eligible for 1-year follow-up, amputation-free survival was estimated to be 87.4% in 199 patients with available data. Conclusion: In this all-comers study, mechanical debulking with the Rotarex alone or with adjunctive techniques is feasible as a primary therapy for occluded supratibial vessels in patients with ALI or SLI.

Percutaneous Rotational Mechanical Atherectomy Plus Thrombectomy Using Rotarex S Device in Patients With Acute and Subacute Lower Limb Ischemia: A Review of Safety, Efficacy, and Outcomes

“…Furthermore, there is also no need for hospitalization in intensive care unit after Rotarex S MATH. Hospital stay after Rotarex S MATH is also shorter (23). There is only one exception when lytic therapy cannot be replaced by Rotarex S MATH, in the case of below-the-knee arteries involvement, due to the catheter size.…”

“…Main data regarding the utility of MATH using the Rotarex S device in the management of acute and subacute lower limb occlusive disease and its potential contribution in prolonging the durability of endovascular revascularization are coming mainly from retrospective studies ( Table 1) (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). Looking at the literature, we identified 16 clinical studies, which evaluated MATH using the Rotarex S device as a primary treatment during revascularization interventions in patients with peripheral arterial occlusive disease in iliac, femoral, and/or popliteal arteries.…”

“…The majority were retrospective cohorts with a total number of 1,844 patients having had Rotarex S MATH as part of their treatment. Out of 16 studies, 8 studies investigated the role of Rotarex S MATH for native vessel occlusion (12)(13)(14)(15)(16)(17)(18)(19), 3 studies used Rotarex S MATH for in-stent restenosis/occlusion (6, 20, 21), 2 studies tested Rotarex S MATH for bypass thrombosis (1,10), and 3 studies evaluated Rotarex S MATH for mixed populations combining the three previous indications (11,22,23).…”

“…Bulvas et al, the largest prospective study, reported 1-year outcomes of Rotarex S MATH as initial therapy in 316 patients (184 men; mean age 70.9 ± 12 years) with acute (202 patients, 63.9%) and subacute (114 patients, 36.1%) lower limb ischemia in native vessel, stent grafts, and bypass grafts (23) In most cases of these studies, the use of Rotarex S MATH was capable of precluding and replacing thrombolysis, and reducing the rate of stenting, showing to be an efficient and safe option for treating acute and subacute thrombus-containing occlusive lesions in lower limb vessels, with excellent immediate and satisfactory long-term outcomes, whatever the age of the thrombus and the type of vessel, even at the proximal iliac level and for long lesions.…”

“…Last, even if cost-effective analyses in favor of the adjunctive use of Rotarex S MATH do not exist, this approach allows to decrease the rate of complications in lower limb occlusions (23)(24)(25). On the other hand, no data were available on the use of protective filter devices when using the Rotarex S system.…”