589955

research-article2015

JETXXX10.1177/1526602815589955Journal of Endovascular TherapyGandini et al

Technical Note

Foot Embolization During Limb Salvage Procedures in Critical Limb Ischemia Patients Successfully Managed With Mechanical Thromboaspiration: A Technical Note

Journal of Endovascular Therapy 2015, Vol. 22(4) 558­–563 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1526602815589955 www.jevt.org

Roberto Gandini, MD1, Stefano Merolla, MD1, Fabrizio Chegai, MD1, Costantino Del Giudice, MD2, Matteo Stefanini, MD1, and Enrico Pampana, MD1

Abstract Purpose: To illustrate the use of a mechanical thromboaspiration device originally designed for clot retrieval in acute stroke in the treatment of acute distal embolism occurring during percutaneous revascularization of the femoropopliteal and below-the-knee arterial segments. Technique: The Penumbra system was adapted for aspiration of thrombus in the distal foot arteries as a standalone device. The 2 over-the-wire, tapered lumen catheters have long working lengths (139 cm for the 4MAX to 153 cm for the 3MAX) that allow advancement below the ankle even with a retrograde contralateral approach. Once the occluded arterial segment is reached, the catheters are connected to the dedicated pump for continuous vacuum aspiration. The use of the device is illustrated in 3 diabetic patients (1 woman and 2 men; ages 88, 70, and 73 years, respectively) undergoing limb salvage procedures who experienced distal embolization that would have seriously jeopardized the foot circulation. The lumens of the occluded arteries were restored without complication. Conclusion: While further evaluation in a larger cohort of patients is needed, this initial experience using the Penumbra system in the peripheral vasculature suggests that this is a rapid, effective approach to address intraprocedural foot embolization and avoid possible grave clinical sequelae. Keywords critical limb ischemia, endovascular revascularization, distal embolization, mechanical thrombectomy, thromboaspiration, limb salvage, acute ischemia, foot arteries

Introduction Intraprocedural acute distal embolism of particulate debris or thrombi detached from an atheromatous plaque is a complication that may occur during percutaneous recanalization of the femoropopliteal and below-the-knee arterial segments. The incidence of distal embolization, as determined by angiographic or clinical manifestations, has been estimated to range from 1% to 5% for peripheral interventions,1–3 with worse outcomes in diabetic patients with critical limb ischemia and chronic renal failure.4 Distal emboli may occlude the distal runoff vessels, causing worsening ischemia and limb loss even if a successful recanalization of the main lesion is obtained. Although many techniques are available to extract or lyse emboli, currently a gold standard treatment does not yet exist.

Percutaneous catheter thromboaspiration and catheterdirected thrombolysis, with or without additional catheter thromboaspiration, are techniques used to address this complication when it occurs in the femoropopliteal segment,5,6 but they have some general and specific drawbacks. 1

Department of Diagnostic Imaging, Interventional Radiology, Radiotherapy, and Nuclear Medicine, IRCCS Fondazione Policlinico di Tor Vergata, Rome, Italy 2 Hôpital Européen Georges-Pompidou, Université Paris V René Descartes, Paris, France Corresponding Author: Stefano Merolla, Department of Diagnostic Imaging, Interventional Radiology, Radiotherapy, and Nuclear Medicine, IRCCS Policlinico di Tor Vergata, Viale Oxford 81, 00133 Rome, Italy. Email: [email protected]

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Gandini et al Table 1.  Clinical and Procedure Data. Patient Sex/ Age, y

Comorbidities

TWC/Wound Site

Runoff Score

Treated Segment

1. F/88

DM, RF, CLI

III B/calcaneus

1/3

SFA

2. M/70

DM, DYS, CLI

II B/forefoot

1/3

FP and TPT CTO

3. M/73

DM, DYS, HTN, CLI III D/forefoot, toes 4,5a

1/3

Pop and ATA

TE Site Lateral calcaneal artery + lateral PA Distal PTA and lateral PA Dorsalis pedis

Thrombectomy Device 3MAX 4MAX 3MAX

Abbreviations: ATA, anterior tibial artery; CLI, critical limb ischemia; DM, diabetes mellitus; DYS, dyslipidemia; FP, femoropopliteal; HTN, hypertension; PA, plantar artery; PTA, posterior tibial artery; RF, renal failure; SFA, superficial femoral artery; TE, thromboembolization; TPT, tibioperoneal trunk; TWC, Texas wound class. a At the site of a previous minor amputation.

Catheter-directed thrombolysis is a time-consuming procedure, sometimes contraindicated owing to the patient's bleeding risk and ineffective against hard and highly organized embolic debris. Often, neither may be effective in the below-the-ankle vessels due to reduced trackability of these devices in distal foot arteries. Rheological thrombolysis is another technique that could be effectively used to face this embolic complication, but it may itself cause further distal thrombosis3,4 and often is not adequate as a standalone therapy.7 In this note, an antegrade mechanical thrombectomy device designed for clot removal in the setting of acute ischemic stroke is demonstrated in the treatment of distal embolization during limb salvage procedures.

Technique Based on our experience in neurointerventional procedures,8 the Penumbra 3MAX or 4MAX (Penumbra Inc, Alameda, CA, USA) was adapted for aspiration of thrombus in the distal foot arteries as a standalone device. These over-the-wire catheters (0.014- or 0.035-inch guidewire platform) have long working lengths ranging from 139 cm for the 4MAX to 153 cm for the 3MAX, which allow them to be advanced below the ankle even with a retrograde contralateral approach. The coil reinforcement of the distal atraumatic tip permits navigation in tortuous vessels with high pushability and trackability. Moreover, the lumen has a large proximal diameter that tapers to a smaller distal diameter, which greatly improves aspiration power (4MAX: 6-F proximal to 4.3-F; 3MAX: 4.7-F proximal to 3.8-F). Once the occluded arterial segment is reached, the catheters are then connected to the dedicated Penumbra pump for continuous vacuum aspiration for the duration of the procedure. The use of the device is illustrated in 3 patients (1 woman and 2 men; ages 88, 70, and 73 years, respectively) undergoing limb salvage procedures who experienced distal embolization that would have seriously jeopardized the foot circulation (Figures 1–3). All patients were diabetic and had

non-healing foot ulcers (Table 1) of varying severity according to the Texas wound classification system. Notably, all patients had single-vessel runoff. The patients were begun on dual antiplatelet therapy (acetylsalicylic acid 100 mg/d and clopidogrel 75 mg/d) 3 days prior to the procedure. Access was via an antegrade 6-F femoral sheath that was flushed with heparinized saline solution during the entire procedure to prevent clotting. Heparin was administered during the procedure to maintain the activated clotting time >250 seconds. In each of case, distal embolization occurred during the procedure owing to the challenging nature of the disease. Antegrade mechanical thromboaspiration was performed using the Penumbra system 3MAX or 4MAX catheters, which were advanced through the tortuous anatomy to the occluded vessel. The dedicated continuous aspiration pump was engaged, which resulted in rapid removal of the long thrombotic debris. The lumens of the occluded arteries were restored with direct flow through the main lesion in each case. The ulcers all healed in 3 to 6 months, and the patients were symptom-free at 12-month follow-up.

Discussion Distal embolization is a severe complication during limb salvage procedures that may jeopardize foot revascularization, leading to amputation despite a successful recanalization of inflow lesions. The use of antiplatelet therapy associated with antithrombotic therapy during the procedure9 and continuous heparinized saline flushing of the introducer sheath are sufficient to obtain a rate of peripheral embolization