Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study

Abstract

Purpose To evaluate the safety and efficacy of rotational thrombectomy (RT) in a large single-center real-world cohort for total vascular occlusions of the lower extremity.

Materials and Methods The clinical records and images of all patients between 2010 and 2020 treated via RT (Rotarex, BD) were assessed. Patient demographics, clinical data, procedural characteristics, and outcome parameters were documented. In total, 397 procedures in 293 patients were included (mean age 69.8 ± 12.0 years; 64.8 % male). Occlusions were acute (47.5 %), subacute and acute-on-chronic (22.2 %), and chronic (30.3 %). The target lesions were the iliac artery (7.1 %), iliac/femoropopliteal (5.0 %), femoropopliteal (59.4 %), femoropopliteal/below-the-knee (27.0 %), below-the-knee (1.5 %), and after bypass surgery (14.9 %). Lesion length was > 20 cm in 61.5 % of cases.

Results Clinically successful revascularization was achieved in 90.4 % of cases. Additional thrombolysis was necessary for 32.0 % of procedures. The arithmetic mean ankle-brachial index increased from 0.33 ± 0.29 to 0.81 ± 0.25 (p < 0.0001). Bypass grafts were less likely to be fully treatable and required additional lysis (p < 0.001). The overall primary patency (no clinically driven target lesion revascularization) was 93.2 %, 88.8 %, 79.1 %, and 72.4 % at 1, 3, 6, and 12 months, respectively. Adverse events occurred in 46.1 % of cases, of which peripheral embolization (22.4 %) was most frequent, requiring interventional treatment in 67.4 % of cases. RT was directly associated with 7.1 % (n = 28) of complications, which consisted of perforations 2.8 %, arteriovenous fistula 1.3 %, and dissections 2.0 %.

Conclusion Rotational thrombectomy is a safe and efficient method for the treatment of occlusions of the arterial circulation of the lower extremity with bypass occlusions having a higher propensity for residual thrombi requiring further lysis therapy.

Key Points: 

• Rotational thrombectomy was safe and efficacious for treating occlusions of the lower extremities.

• Rotational thrombectomy was associated with 7.1 % of complications.

• Distal embolization occurred in 22.4 % of cases with 67.4 % requiring interventional treatment.

• Primary patency was 93.2 %, 88.8 %, 79.1 %, 72.4 % after 1, 3, 6, and 12 months, respectively.

Citation Format

• Artzner C, Martin I, Hefferman G et al. Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study. Fortschr Röntgenstr 2023; 195: 406 – 415

Zusammenfassung

Hintergrund Evaluierung der Sicherheit und Wirksamkeit der Rotationsthrombektomie (RT) in einer großen realen Kohorte eines einzelnen Zentrums bei totalen Gefäßverschlüssen der unteren Extremitäten.

Material und Methoden Die klinischen Aufzeichnungen und Bilder aller zwischen 2010 und 2020 mittels RT (Rotarex, BD) behandelten Patienten wurden ausgewertet. Es wurden demografische Daten der Patienten, klinische Daten, Verfahrensmerkmale und Ergebnisparameter dokumentiert. Insgesamt wurden 397 Eingriffe bei 293 Patienten eingeschlossen (Durchschnittsalter 69,8 ± 12,0 Jahre; 64,8 % Männer). Die Verschlüsse waren akut (47,5 %), subakut und akut-chronisch (22,2 %) und chronisch (30,3 %). Bei den Zielläsionen handelte es sich um die Arteria iliaca (7,1 %), die Arteria iliaca/femoropoplitea (5,0 %), die Arteria femoropoplitea (59,4 %), die Arteria femoroplitea/unter dem Knie (27,0 %), die Arteria femoroplitea unter dem Knie (1,5 %) und nach einer Bypassoperation (14,9 %). Die Läsionslänge betrug in 61,5 % der Fälle mehr als 20 cm.

Ergebnisse Eine klinisch erfolgreiche Revaskularisierung wurde in 90,4 % der Fälle erreicht. Eine zusätzliche Thrombolyse war in 32,0 % der Fälle erforderlich. Der arithmetische mittlere Knöchel-Arm-Index stieg von 0,33 ± 0,29 auf 0,81 ± 0,25 (p < 0,0001). Bei Bypasstransplantaten war die Wahrscheinlichkeit geringer, dass sie vollständig behandelbar waren und eine zusätzliche Lyse erforderlich wurde (p < 0,001). Die primäre Offenheit (keine klinisch bedingte Zielläsionsrevaskularisation) betrug 93,2 %, 88,8 %, 79,1 % und 72,4 % nach 1, 3, 6 bzw. 12 Monaten. Unerwünschte Ereignisse traten in 46,1 % der Fälle auf, wobei die periphere Embolie (22,4 %) am häufigsten war und in 67,4 % der Fälle eine interventionelle Behandlung erforderlich machte. Die RT stand in direktem Zusammenhang mit 7,1 % (n = 28) der Komplikationen, bei denen es sich um Perforationen (2,8 %), arteriovenöse Fisteln (1,3 %) und Dissektionen (2,0 %) handelte.

Schlussfolgerung Die Rotationsthrombektomie ist eine sichere und effiziente Methode zur Behandlung von Verschlüssen des arteriellen Kreislaufs der unteren Extremität, wobei Bypassverschlüsse eine höhere Neigung zu Restthromben aufweisen, die eine weitere Lysetherapie erfordern.

Wichtige Punkte: 

• Rotationsthrombektomien waren sichere und wirksame Behandlungsmethoden von Verschlüssen der unteren Extremitäten.

• Rotationsthrombektomien waren mit 7,1 % der Komplikationen verbunden.

• 22,4 % der Fälle zeigten distale Embolien, hiervon erforderten 67,4 % eine interventionelle Therapie.

• Die primäre Offenheit betrug 93,2 %/88,8 %/79,1 %/72,4 % nach jeweils 1/3/6/12 Monaten.

Key words

mechanical thrombectomy - obstruction/occlusion - vascular - rotarex - interventional procedures - arteries

Publication History

Received: 05 September 2022

Accepted: 21 September 2022

Article published online:
19 October 2022

• References

• 1 Lawall H, Huppert P, Rümenapf G. S3-Leitlinie zur Diagnostik, Therapie und Nachsorge der peripheren arteriellen Verschlusskrankheit. Vasa 2016; 45: 11-82
• 2 Song P, Rudan D, Zhu Y. et al. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. The Lancet Global Health 2019; 7: e1020-e1030
• 3 Fowkes FGR, Rudan D, Rudan I. et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. The lancet 2013; 382: 1329-1340
• 4 Heller S, Lubanda J-C, Varejka P. et al. Percutaneous mechanical thrombectomy using Rotarex® S device in acute limb ischemia in infrainguinal occlusions. BioMed research international 2017; 2017: 2362769
• 5 Liao C-j, Song S-h, Li T. et al. Combination of rotarex thrombectomy and drug-coated balloon for the treatment of femoropopliteal artery in-stent restenosis. Annals of vascular surgery 2019; 60: 301-307
• 6 Fluck F, Augustin AM, Bley T. et al. Current Treatment Options in Acute Limb Ischemia. Fortschr Röntgenstr 2020; 192: 319-326
• 7 Rusch R, Trentmann J, Hummitzsch L. et al. Effectiveness and Safety of Percutaneous Thrombectomy Devices: Comparison of Rotarex and Angiojet in a Physiological Circulation Model. Eur J Vasc Endovasc Surg 2020; 59: 983-989
• 8 Katsanos K, Spiliopoulos S, Reppas L. et al. Debulking atherectomy in the peripheral arteries: is there a role and what is the evidence?. Cardiovascular and interventional radiology 2017; 40: 964-977
• 9 Bulvas M. Endovascular Mechanical Atherothrombectomy (MATH): Using the Rotarex Catheter for Initial Therapy of Acute Lower Limb Ischemia. Archives of Clinical and Medical Case Reports 2019; 3: 660-669
• 10 Freitas B, Steiner S, Bausback Y. et al. Rotarex mechanical debulking in acute and subacute arterial lesions: single-center experience with 525 patients. Angiology 2017; 68: 233-241
• 11 Lichtenberg M, Stahlhoff W, Boese D. et al. Twelve months outcome after percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion. Cardiovascular intervention and therapeutics 2013; 28: 178-183
• 12 Wang Q, Zhu R-M, Ren H-L. et al. Combination of percutaneous rotational thrombectomy and drug-coated balloon for treatment of femoropopliteal artery nonembolic occlusion: 12-month follow-up. Journal of Vascular and Interventional Radiology 2020; 31: 1661-1667
• 13 Filippiadis D, Binkert C, Pellerin O. et al. Cirse quality assurance document and standards for classification of complications: the cirse classification system. Cardiovascular and interventional radiology 2017; 40: 1141-1146
• 14 Laganà D, Carrafiello G, Lumia D. et al. Recanalisation of thrombotic arterial occlusions with rotational thrombectomy. La radiologia medica 2011; 116: 932-944
• 15 Bulvas M, Sommerová Z, Vaněk I. et al. Prospective single-arm trial of endovascular mechanical debulking as initial therapy in patients with acute and subacute lower limb ischemia: one-year outcomes. Journal of Endovascular Therapy 2019; 26: 291-301
• 16 Stanek F, Ouhrabkova R, Prochazka D. Percutaneous mechanical thrombectomy in the treatment of acute and subacute occlusions of the peripheral arteries and bypasses. Vasa 2016; 45: 49-56
• 17 Lawall H, Huppert P, Rümenapf G. S3-Leitlinie zur Diagnostik, Therapie und Nachsorge der peripheren arteriellen Verschlusskrankheit. Deutsche Gesellschaft für Angiologie und Deutsche Gesellschaft für Gefäßmedizin 2015. https://www.awmf.org/uploads/tx_szleitlinien/065-003l_S3_PAVK_periphere_arterielle_Verschlusskrankheit_2020-05.pdf (Zugriff 11.10.2022)
• 18 Stahlberg E, Anton S, Sieren M. et al. Mechanical rotational thrombectomy in long femoropopliteal artery and bypass occlusions: risk factors for periprocedural peripheral embolization. Diagnostic and Interventional Radiology 2021; 27: 249
• 19 Loffroy R, Falvo N, Galland C. et al. 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. Frontiers in Cardiovascular Medicine 2020; 7: 207
• 20 Latacz P, Simka M, Brzegowy P. et al. Mechanical rotational thrombectomy with Rotarex system augmented with drug-eluting balloon angioplasty versus stenting for the treatment of acute thrombotic and critical limb ischaemia in the femoropopliteal segment. Wideochir Inne Tech Maloinwazyjne 2019; 14: 311-319
• 21 Lichtenberg MK, Stahlhoff WF. Endovascular-first strategy for acute and subacute limb ischaemia: Potenzial benefits of a pure mechanical thrombectomy approach Comment on Stanek et al. Vasa 2016; 45: 7-9
• 22 Rusch R, Trentmann J, Hummitzsch L. et al. Effectiveness and safety of percutaneous thrombectomy devices: comparison of Rotarex and Angiojet in a physiological circulation model. European Journal of Vascular and Endovascular Surgery 2020; 59: 983-989
• 23 Lichtenberg M, Stahlhoff F-W, Boese D. Endovascular treatment of acute limb ischemia and proximal deep vein thrombosis using rotational thrombectomy: a review of published literature. Cardiovascular Revascularization Medicine 2013; 14: 343-348
• 24 Giannini D, Balbarini A. Thrombolytic therapy in peripheral arterial disease. Current Drug Targets-Cardiovascular & Hematological Disorders 2004; 4: 249-258