Limb salvage in high-risk patients with multisegmental disease.
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Is percutaneous iliac angioplasty before distal bypass a logical limb salvage option in a high-risk patient? A retrospective review of 113 iliac angioplasty procedures identified 10 patients in this situation. Angioplasty preceded femoropopliteal bypass (five), femorotibial bypass (three) and, in one case each, femorofemoral bypass or profundoplasty. There were no interventional deaths or complications. Ankle/brachial pressure index improvement followed intervention: 0.28 + 0.2 vs. 0.92 + 0.08, (p less than 0.0005). Limb salvage was 90% at one month, 80% at six months and 70% at one to three years by Life-Table analysis. Two patients with a patent bypass lost limbs from uncontrolled infection within two months. One patient required an amputation 311 days after the only failure of angioplasty and distal bypass. During this study period, 56% of the patients died. This review supports an angioplasty/bypass combined intervention as a valuable treatment option in high-risk patients facing limb loss.Keywords:
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Abstract. Background: The aim of this study was to determine the outcomes of primary bypass graft surgery (BGS) compared to BGS after failed angioplasty (PTA). Patients and methods: Between January 2007 and January 2014, we performed 136 BGSs exclusively for the treatment of critical limb ischaemia. Two cohorts were identified: 1) primary BGS (n = 102; group I), and 2) BGS after prior PTA (n = 34; group II). Data were analysed retrospectively and the primary endpoints were the rates of secondary patency, amputation-free survival, freedom from major adverse outcomes (graft occlusion, amputation, or death), and overall survival, which were assessed with the Kaplan-Meier method. Results: Both groups were comparable with a predominance of Rutherford’s category 5 ischaemic lesions (73.3 %). Most patients had extensive TASC D athe-rosclerotic disease (83.6 %), and the main conduit was the greater saphenous vein (58.1 %). The mean follow-up time was 36.2 months. The 3-year secondary patency rates were better for group I (64.3 % vs 49.6 %; P = 0.04). During the same period, the amputation-free survival rates were similar between the groups (77.4 % vs 74.5 %; P = 0.59). For multivariate Cox regression analysis, BGS after prior PTA was the only factor associated with re-intervention for limb salvage (hazard ratio = 2.39; CI 95 % = 1.19 - 4.80; P = 0.02). At the 3-year point, there were no differences in the overall survival rates (72.6 % vs 70 %; P = 0.97), but the proportion of patients without adverse outcomes was higher in group I (37.3 % vs 13.4 %; P = 0.007). Conclusions: Although secondary patency was better after primary BGS, the amputation-free and overall survival rates support the use of BGS after prior PTA.
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Purpose: To assess the role of percutaneous transluminal angioplasty (PTA) to treat critical limb ischemia (CLI) and to relate the changing experience with endovascular treatment of this condition in a major vascular unit. Methods: A prospective study was performed involving 110 consecutive patients (57 women; mean age 76 years, range 57–99) undergoing balloon angioplasty for critical limb ischemia in 133 limbs. Outcome at 1 year was examined by case note review or questionnaire to determine survival, amputation-free survival, limb salvage, and CLI recurrence. Results: Technical success was achieved in 105 (79%) of 133 limbs; the overall complication rate was 20% (3.8% major, 16.2% minor). The median follow-up was 15 months (minimum 12). The 12-month limb salvage rate by life-table analysis was 88%. Patients with an initially successful angioplasty had an extremely good outcome (95% 1-year limb salvage). In contrast, the 28 patients with failed angioplasty fared very poorly; a major amputation was required in 10, and death occurred in another 9, leaving only 9 survivors with limbs intact at 1 year. Conclusions: The results of this study justify the continuing use of PTA as first-line treatment for critical limb ischemia.
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Objective: To compare the results of percutaneous transluminal angioplasty (PTA) and bypass graft surgery (BGS) for the treatment of infrapopliteal lesions in individuals presenting with critical limb ischemia (CLI). Method: A total of 48 infrapopliteal PTAs and 50 infrapopliteal BGS were compared retrospectively. All grafts used nonreversed saphenous vein in a single length as a substitute. Results: Secondary patency and limb salvage rates in 24 months for the surgical group were 64.7% and 73.2%, respectively. For PTA group, these values were 63.7% and 68.2%, without differences between groups (log rank; P = .45 and .39, respectively). Bypass graft surgery presented better results of secondary patency (72.9% vs 57.1%) and limb salvage (83.5% vs 53.6%) than PTA for patients with Transatlantic Inter-Society Consensus (TASC) D lesions (P = .04 and P = .01, respectively). Conclusions: Both BGS and PTA provided similar results of patency and limb salvage for individuals with infrapopliteal atherosclerotic disease presenting with CLI. Bypass graft surgery had better results than PTA when TASC D lesions were present.
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In this issue of the journal Mendiz et al describe a large series of below knee angioplasty procedures in patients with critical limb ischemia (CLI) and reach the conclusion that this approach represents a safe and effective treatment option. Their technical results are good although there was no direct comparison with surgical bypass. In reality, there is very little level 1 evidence comparing endoarterial revascularization with bypass surgery for patients with severe lower limb ischemia. Consequently, there remains a lack of clarity as to how we should select treatment for individual patients. This issue is particularly important in diabetics where arteries proximal to the knee joint are often spared from occlusive disease and the majority of occlusions occur distal to the tibial bifurcation. Besides relieving pain and healing neuroischemic ulcers, the most important outcome in these patients is amputation-free survival. The BASIL trial randomized 452 patients to receive surgery first or angioplasty first to treat severe limb ischemia, and follow up finished when patients reached an endpoint: either the amputation of the trial leg above the ankle or death. The results showed that at 2 years, both strategies were associated with similar amputation-free and overall survival rates as well as no difference in improvements in health-related quality of life. However, for those patients who survived for at least 2 years after randomization, a bypass first strategy was associated with a significant increase in overall survival of about 7 months and a nonsignificant increase in amputation-free survival of about 6 months. This trial also demonstrated that vein bypass grafts performed significantly better than prosthetic bypass in terms of amputation-free survival but not overall survival. The authors concluded that patients who were expected to live less than 2 years should be offered balloon angioplasty first especially if the alternative was a prosthetic bypass. However, those expected to survive beyond this time, which was about 75% of the BASIL cohort, should be offered bypass first especially if a suitable vein was available. Essentially, the decision whether to perform bypass surgery or balloon angioplasty appears to depend upon life expectancy and availability of autologous vein. Of course, it may be argued that the technology associated with endovascular treatments is continually changing and improving. Drug-eluting stents have profoundly impacted coronary disease and the lower rate of in-stent restenosis associated with their use has significantly altered practice patterns. It is tempting to think that this success may be matched in small vessel disease encountered below the knee, improving patency rates and durability; however, this has not been proven as yet. Similarly, there is little level 1 evidence to support other innovative adjuncts to below the knee angioplasty such as cryotherapy and brachytherapy. Advances have undoubtedly been made in imaging and the technology required for treating the infrapopliteal arteries and to cross lesions. However, these technical advances cannot in themselves be taken to demonstrate a likelihood of a superior longer term outcome for the patient. We believe that multidisciplinary discussions are important in assessing these patients and prior to treating such lesions. Units treating patients with CLI should have the ability to offer both surgical and endovascular treatments and make sure that medical therapy is also optimized. Assessment of the availability of adequate autologous vein is paramount in the assessment for intervention and seems to vary widely between series and may depend on willingness to use contralateral veins, arm veins, as well as individual surgical experience. Mendiz and colleagues clearly recognize the limitations of their study. Further work is urgently needed to define more precisely the role of angioplasty over surgery in these difficult patients.
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In patients with critical limb ischaemia resulting from arterial occlusion, both percutaneous recanalisation and bypass surgery are potential therapeutic options to avoid amputation. The recently published Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial is the first randomised study to compare these techniques. The data from this trial show that patients eligible for balloon angioplasty or infra-inguinal bypass surgery fare equally well with percutaneous intervention. In the Netherlands, expertise with percutaneous intervention varies among hospitals. Consequently, the preferred strategy depends on the capabilities of the local hospital. Ideally, patients should be treated in hospitals with expertise in both techniques, because there is a trend towards fewer complications with percutaneous intervention. Moreover, there is a considerable difference in costs during the first year in favour of percutaneous intervention, mainly as a result of a shorter hospital stay.
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Background-Critical limb ischemia (CLI) is one of the most severe peripheral artery diseases. Angioplasty and bypass surgery are two major approaches for the treatment of CLI, however, it remains unclear which treatment has better benefit/risk ratio. In this paper, we performed a meta-analysis on the available clinical trials to compare these two approaches in terms of mortality, amputation-free survival, 5-year leg salvage, and freedom from surgical re-intervention. The results of this article will provide evidence based information for clinical treatment of CLI. Method-Randomized clinical trials comparing results between angioplasty and bypass surgery in CLI were identified by searching Pubmed (2000-2014) and EMBASE (2000-2014) using the search terms "angioplasty" or "bypass", "CLI" and "clinical trials". Primary outcome subjected to meta-analysis was amputation (of trial leg) free survival in 5 years. Secondary outcomes were 30-day mortality; mortality, re-interventions and leg salvage in 1, 3 and 5 years. Results-Seven clinical trials were selected for meta-analysis. No significant difference was found in the primary outcome-amputation free survival, between angioplasty and bypass surgery groups. The amputation free survival in 1, 3 and 5 years were 332/498 (66.7%), 169/346 (48.8%) and 21/60 (35%) in angioplasty group, versus 484/749 (64.6%), 250/494 (50.6%) and 46/132 (34.8%), in bypass group, respectively. The 30 days mortality rate was significantly higher in bypass treatment group [79/1304 (6.1%)] than in angioplasty group [30/918 (3.3%) [95% CI 0.55 [0.36, 0.86], P=0.008). However, there was no statistical significance in 1, 3 and 5 years mortality between these two groups. Two clinical trials showed that there was no difference in leg salvage between angioplasty and bypass surgery groups either. In addition, no difference was observed in re-vasculation between the two groups. Conclusion-Angioplasty is non-inferior to bypass surgery in regarding the amputation free survival, re-vasculation, leg amputation and overall mortality. However, angioplasty is safer, simple, and less invasive and less cost procedure. It should be considered as the first choice for feasible CLI patients.
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Abstract 137 consecutive patients with known ankle pressures and diabetic status had attempted femoro-popliteal dilatation for lower limb ischaemia in an English provincial teaching hospital. All except one were followed until failure or death to assess survival and amputation rates. Non-diabetic patients with critical limb ischaemia had a 5 year survival rate of 62.2% (SE 17.1) compared to 50.5% (SE 7.0) for claudicants, with no significant difference on logrank testing. Diabetics had a relative risk of amputation of 11.2 compared to non-diabetics. Patients with pre-treatment ankle pressures of 50 mm or less had a relative risk of amputation of 2.6 compared to those with higher resting pressures. It is concluded that angioplasty should be the treatment of first choice in critical lower limb ischaemia whenever it is technically possible. Including patients with rest pain in the critical ischaemia group does not significantly affect cumulative patency rates.
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