Acute and Subacute Ischemia of Lower Limb Can Mechanical Debulking Replace Surgery and Thrombolysis?
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1 Acute and Subacute Ischemia of Lower Limb Can Mechanical Debulking Replace Surgery and Thrombolysis? Miroslav Bulvas King s Vineyards Hospital 3 rd School of Medicine, Charles University, Prague
2 Disclosure Speaker name: Miroslav Bulvas Potential conflicts of interest to report: Proctoring for Straub Medical AG
3 ACUTE LIMB ISCHEMIA threatens patient s limb and life
4 CURRENT GUIDELINES OPEN SURGERY (OS) preferred in IIB THROMBOLYSIS (TL) in milder symptoms (IIA, I) PERCUTANEOUS MECHANICAL DEVICES as useful adjunctive techniques to accelerate TL or when OS and TL are not feasible
5 Open surgery preferred: AMERICAN COLLEGE OF CHEST PHYSICIANS 2012
6 ALI + SLI, consecutive, , initial therapy: ROTAREX DEBULKING CATHETER n=316, 184 m; mean age 71 (23-96) yrs 100% 90% 80% SLI 114 (36%) 70% 60% 50% 40% ALI IIA 56 (18%) SLI IIA IIB 30% 20% 10% ALI IIB 146 (46%) 0%
7 Target occlusion origin Target arteries (n=316, mean length 23 cm) % Thrombosis Embolism % % Femoropopl. segm. Bypasses Aortoiliac segm. Abd. aortic stntgr. % Concomitant lesions Patent calf vessels % Deep fem. a. Infrapopl. vessels % % ALI SLI Embol Thromb
8 RISK PROFILE: ALI +SLI (N=316) 80 % Hypert Smoking Cardiac dis Hyperlipid Diabetes Arrhythmias Cerebrovasc Renal insuff Malignancy %
9 TYPICAL FEATURES OF A PATIENT WITH ALI (in real life setting) Elderly, at high surgical risk, serious concomitant disease Multisegmental arterial disease Long supratibial target occlusion (artery, bypass) Thrombotic origin with underlying lesion(s): adjunctive therapy Severe tibioperoneal disease (poor candidate for surgery) Immediately threatened extremity Critical time to reperfusion (poor candidate for thrombolysis) Critical limb ischemia in SLI patients
10 Randomized Studies: Surgery vs. Thrombolysis (meta-analysis, 1283 pts) SURGERY THROMBOLYSIS 30-day mortality 8.2% ( ) 4.6% (0-12.3) 30-day limb salvage 87% (56-98) 88% (36-91) Major haemorrhage 3.3% (0-5.1) 8.8% (0-11.8) Stroke 0 1.3% (0-1.8) No overall difference in limb salvage or death at 30 days, six months or one year (patients with milder symptoms) Berridge DC et al. 2013, Cochrane Database
11 SURGERY: CURRENT DATA 30d mortality 13 18% Intrahospital major adverse events 20% 30d 90d amputation: % 1 year mortality 21% 1 year limb loss 24% Taha AG et al (296 pts) Baril DT et al 2013 (323 pts) Kempe K et al (170 pts)
12 MAJOR LIMITATIONS OPEN SURGERY: invasiveness, serious cardiopulmonary complications, technical limitations THROMBOLYSIS: serious hemorrhage, brain attack, slow therapeutic effect
13 CAN WE AVOID THROMBOLYSIS? AngioJet (Boston Sci): rheolytic thrombectomy, no atherectomy potential, adjunctive usage of CDT: 37%-64% (Ansel G, 2002; Kasirajan K, 2001; Leung DA, 2015; Spiliopoulos S, 2012) Direct administration of thrombolytics during rheolytic procedure: 67% (Leung DA, 2015) Mortality: 0-9.3%; technical success: %; amputation rate 30d: % Antiembolic filter recommended (Spiliopoulos S, 2012) whenever technically feasible
14 CAN WE AVOID THROMBOLYSIS? ROTAREX (Straub Medical): combines thrombectomy + atherectomy potential Thrombolysis: 0-14 % Open surgery: % 30 days mortality rate : 0-1 %
15 ROTAREX IN THERAPY OF ACUTE AND SUBACUTE ISCHEMIA OF LOWER LIMBS Technical success: % Amputation rate: 0-34% infra-aortic arteries : Zeller T 2003 fem-pop. arterial segments: Due SR 2005; Wissgott C 2008 Staněk F 2013; Freitas B 2017 Bérczi V 2002 fem-pop. bypasses: Lichtenberg M 2012; Wissgott C 2013
16 MECHANICAL DEBULKING ADVANTAGE Low invasiveness Prompt reperfusion Immediate treatment of concomitant lesions Low rate of serious hemorrhage No need to place the patient in an intensive care unit No contraindications
17 SUMMARY Mechanical debulking cannot fully replace open surgery and thrombolysis in the therapy of acute and subacute ischemia of lower limbs. Used as an initial treatment, it can substatially decrease mortality rate in ALI + SLI patients with therapeutic efficacy comparable to thrombolysis and surgery. Mechanical debulking can shift open surgery and thrombolysis into the category of adjunctive techniques.
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