Evidence - Transfemoral Fogarty balloon catheter embolectomy in embolic occlusion of the left external iliac artery—Vascular Surgery

  1. Literature summary

    Treatment options in acute limb ischemia (ALI) include:

    1. Open surgical procedures

    • Fogarty arterial catheter thrombectomy/embolectomy
    • Thromboendarterectomy (TEA) with patchplasty
    • Various bypass procedures

    2. Endovascular procedures

    • Local direct and pharmacomechanical thrombolysis
    • Thrombus aspiration
    • Mechanical thrombectomy
    • Balloon and stent angioplasty

    Open surgical and endovascular revascularization – outcomes of systemic reviews

    A Cochrane review from 2013 with a total of 1283 patients investigated whether open surgical procedures or thrombolysis should be the preferred treatment modality in ALI.[1] No significant differences in limb preservation or death were found at 30 days, 6 months, or 1 year between the groups. Strokes were more frequent in the thrombolysis group than in the surgical group at 30 days (1.3% vs. 0%). The same was true for bleeding complications (8.8% vs. 3.3%) and distal embolization (12.4% vs. 0%). However, these risks would have to be weighed against the individual surgical risk in each case. The authors therefore concluded that a generally valid recommendation for open surgery or thrombolysis cannot be made.

    A later review of 1773 patients enrolled in 6 studies reached similar conclusions regarding short-term outcomes and mortality, amputation rates, and recurrent ischemia at 12 months.[2]  However, since endovascular procedures were associated with lower morbidity, this analysis corroborated an endovascular first-line strategy in ALI.

    In a third review from 2016 based on 4 prospective randomized trials as well as 5 other trials, the authors also recommended an endovascular first-line strategy in ALI because of equivalent short-term outcomes and lower perioperative morbidity and mortality.[3] Still, the authors pointed out the greater need for additional interventions with this strategy: In some cases, once ALI has been repaired by endovascular means, patients are more likely to be candidates for definitive surgical revascularization with a better long-term outcome.

    Additional studies

    Taha et al. presented a retrospective comparison of endovascular (154 limbs) and open (326 limbs) surgical revascularization in lower limb ALI.[4]  In the surgical group, 293 thromboembolectomies were performed in addition to 107 bypasses, 67 endarterectomies, and 56 hybrid procedures; the endovascular group underwent 83 catheter-based thrombolyses, 15 pharmacomechanical thrombolyses, and 56 hybrid procedures combining catheter-based and pharmacomechanical thrombolysis.

    Outcomes:

    Merkmal

    Open surgery

    Endovascular

    Technical success rate

    88.0%

    81.0%

    Wound infection

    9.0%

    0.7%

    Repeat thrombosis

    14.7%

    1.3%

    Amputation rate at 30 days

    13.5%

    6.5%

    Amputation rate at 1 year

    19.6%

    13.0%

    Amputation rate at 30 days

    13.2%

    5.4%

    Mortality at 1 year

    33.8%

    12.9%

    Mortality at 2 years

    40.5%

    18.7%

    Primary patency rate at 1 year

    57.0%

    51.0%

    Primary patency rate at 2 years

    48.0%

    38%

    • When interpreting the outcomes, it is important to note that the surgical group included more patients with advanced stages of ischemia in ALI. In these cases, open surgical revascularization was superior to endovascular techniques in terms of technical success rate, especially when the ischemia was due to underlying stent or bypass failure.

    Casillas-Berumen et al. used the NSQIP database to draw conclusions about morbidity and mortality after embolectomy.[5]  The database included 1749 embolectomies performed between 2005 and 2012. The mean age of the patients was 68 years, and almost 48% were men.  Iliofemoral-popliteal embolectomies were performed in 1231 (70.4%) patients, popliteo-tibioperoneal embolectomies in 303 (17.3%) patients, and embolectomies at both levels in 215 (12.3%) patients. Fasciotomy was performed concurrently with embolectomy in 308 patients (17.6%). Postoperative complications included: myocardial infarction/cardiac arrest in 4.7%, pulmonary complications in 16.0%, and wound complications in 8.2% of cases. Twenty-five percent of patients had to undergo repeat surgery within 30 days. Postoperative 30-day mortality was 13.9%.

    In an analysis, the authors developed a prognostic model for perioperative mortality. Risk factors included age > 70 years, male sex, functional dependence, COPD, heart failure, recent myocardial infarction/angina pectoris, chronic renal failure, and steroid therapy. The need for risk stratification is prudent for several reasons, as half of the deceased patients were completely physically dependent,and thus surgical revascularization must be weighed against palliative care at the end of life. On the other hand, the prognostic model can serve to risk-stratify those patients scheduled for surgical embolectomy but who may better profit from percutaneous embolectomy devices and catheter-based thrombolysis.

  2. Ongoing trials on this topic

  3. Literature on this topic

    1. Berridge DC, Kessel DO, Robertson I (2013) Surgery versus thrombolysis for initial management of acute limb ischaemia. Cochrane Database Syst Rev (6):CD002784

    2. Enezate TH, Omran J, Mahmud E, Patel M, Abu-Fadel MS, White CJ, Al-Dadah AS (2017) Endovascular versus surgical treatment for acute limb ischemia: a systematic review and meta-analysis of clinical trials. Cardiovasc Diagn Ther 7:264–271

    3. Wang JC, Kim AH, Kashyap VS (2016) Open surgical or endovascular revascularization for acute limb ischemia. J Vasc Surg 63:270–278

    4. Taha AG, Byrne RM, Avgerinos ED, Marone LK, Makaroun MS, Chaer RA (2015) Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg 61:147–154

    5. Casillas-Berumen S, Sadri L, Farber A, Eslami MH, Kalish JA, Rybin D, Doros G, Siracuse JJ (2017) Morbidity and mortality after emergency lower extremity embolectomy. J Vasc Surg 65:754–759

Reviews

1. Branco BC, Montero-Baker MF, Mills JL Sr. The pros and cons of endovascular and open surgical tr

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