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      Treatment of bypass failure in patients with chronic limb threatening ischemia – open surgery vs. percutaneous mechanical thrombectomy

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          Summary: Background: Lower limb bypass occlusion in patients with chronic limb threating ischemia remains a challenge. We can choose between different treatment options: open surgery, local thrombolysis, thrombectomy/atherectomy devices. In this pilot study, we compare clinical outcomes and treatment costs between open surgery (OS) and percutaneous mechanical thrombectomy (pMTH). Patients and methods: This pilot study represents a retrospective analysis of hospital data of 48 occluded bypasses admitted from 2013 to 2018. Only patients presenting with severe ischemia and recrudescence of symptoms (Rutherford 4–6) were included in the current analysis. Two cohorts of patients were analysed: patients who underwent OS and patients that underwent pMTH. Primary clinical outcomes were one-year cumulative patency and limb salvage rates. Total cost was calculated as a sum of intra- and post-operative costs. To weigh clinical benefits against the economic consequences of OS versus pMTH a cost-effectiveness framework was adopted. Results: We analysed a series of 48 occluded bypasses 17 treated with open surgery and 31 with pMTH. Procedural success was 100% in both groups. When comparing one-year death rates ( p-value = .22) and re-occlusion rates ( p-value = .43), no statistically significant differences were observed between the two cohorts. Mean patency duration in the surgery cohort was significantly shorter ( p-value < .05). Primary patency (OS 41.2% vs. pMTH 48.4%) and limb salvage rate (OS 88.2% vs. pMTH 90.3%) at one year are similar in both groups. The total cost of surgery was substantially higher (OS 10,159€ vs. pMTH 8,401€) Conclusions: This pilot study, although limited to 48 occluded bypasses, demonstrates that endovascular treatment with pMTH is less invasive, less time consuming and less expensive, and produces greater health benefits than traditional OS.

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          Most cited references 30

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          A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators.

          Recent controlled trials suggest that thrombolytic therapy may be an effective initial treatment for acute arterial occlusion of the legs. A major potential benefit of initial thrombolytic therapy is that limb ischemia can be managed with less invasive interventions. In this randomized, multicenter trial conducted at 113 North American and European sites, we compared vascular surgery (e.g., thrombectomy or bypass surgery) with thrombolysis by catheter-directed intraarterial recombinant urokinase; all patients (272 per group) had had acute arterial obstruction of the legs for 14 days or less. Infusions were limited to a period of 48 hours (mean [+/-SE], 24.4+/-0.86), after which lesions were corrected by surgery or angioplasty if needed. The primary end point was the amputation-free survival rate at six months. Final angiograms, which were available for 246 patients treated with urokinase, revealed recanalization in 196 (79.7 percent) and complete dissolution of thrombus in 167 (67.9 percent). Both treatment groups had similar significant improvements in mean ankle-brachial blood-pressure index. Amputation-free survival rates in the urokinase group were 71.8 percent at six months and 65.0 percent at one year, as compared with respective rates of 74.8 percent and 69.9 percent in the surgery group; the 95 percent confidence intervals for the differences were -10.5 to 4.5 percentage points at six months (P=0.43) and -12.9 to 3.1 percentage points at one year (P=0.23). At six months the surgery group had undergone 551 open operative procedures (excluding amputations), as compared with 315 in the thrombolysis group. Major hemorrhage occurred in 32 patients in the urokinase group (12.5 percent) as compared with 14 patients in the surgery group (5.5 percent) (P= 0.005). There were four episodes of intracranial hemorrhage in the urokinase group (1.6 percent), one of which was fatal. By contrast, there were no episodes of intracranial hemorrhage in the surgery group. Despite its association with a higher frequency of hemorrhagic complications, intraarterial infusion of urokinase reduced the need for open surgical procedures, with no significantly increased risk of amputation or death.
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            Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy.

            A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to infrainguinal disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS).
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              Secondary Femoropopliteal Reconstruction


                Author and article information

                European Journal of Vascular Medicine
                Hogrefe AG, Bern
                June 26, 2020
                : 49
                : 5
                : 395-402
                [ 1 ]Vascular and Endovascular Unit, Department of Surgery, Pederzoli Hospital, Peschiera del Garda, Italy
                [ 2 ]Economics and Healthcare Management Division, Kozminski University, Poland
                [ 3 ]ZRx Outcomes Research Inc., Canada
                [ 4 ]Diabetic Foot Unit, Department of Surgery, Pederzoli Hospital, Peschiera del Garda, Italy
                Author notes
                Dr. Bruno Migliara, MD, PhD, Vascular and Endovascular Surgery, Pederzoli Hospital, Via Monte Baldo, 26, 37019 Peschiera del Garda, Italy, E-mail bruno.migliara@
                Self URI (journal page):
                Original communication


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