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Interact CardioVasc Thorac Surg 2009;9:191-194. doi:10.1510/icvts.2009.204867 © 2009 European Association of Cardio-Thoracic Surgery
Combined infrainguinal reconstruction and infrapopliteal intraluminal angioplasty for limb salvage in critical limb ischemia
a Department of Transplant Surgery, Institute of Clinical and Experimental Medicine, Víde Received 11 February 2009; received in revised form 1 May 2009; accepted 5 May 2009
*Corresponding author. Tel.: +420 26136 5026.
The aim of this retrospective study was to assess the success rates of limb salvage, and the primary and secondary patency rates of reconstructions of critical limb ischemia (CLI) patients undergoing combined infrainguinal reconstruction and intraluminal angioplasty of crural arteries. In 2000–2005, infrainguinal reconstruction with concomitant intraluminal angioplasty of crural arteries was performed in 30 patients with CLI, mean age was 63 years (S.D.=10); according to the Fontaine classification, 28 (93%) patients had stage IV and 2 (7%) stage III ischemia. During mean follow-up of 12.9 (S.D.=16.9) months, primary 1-year patency of vascular reconstruction was seen in 16 (52.6%) patients of our group. Secondary 1-year patency over the same follow-up period was documented in 17 (56.2%) patients and 1-year limb salvage was obtained in 25 (82.6%) patients. Based on this finding, we consider a combined surgical and endovascular procedure to be the method of choice in limb salvage in patients with CLI not allowing for an isolated endovascular procedure.
Key Words: Critical limb ischemia; Limb salvage; Combined procedure; Hybrid procedure
Critical limb ischemia (CLI) is characterized by resting pain refractory to analgesics, or by ulceration and gangrene of the leg or toes, and defined as stages III and IV according to the Fontaine classification, and Rutherford categories 4–6. The incidence of CLI is 50–100 cases per 100,000 population per year [1]. Only 66% of CLI patients undergo revascularization, and 16% of patients have primary above-knee amputation [1]. In a study by Bertele et al. comprising a group of 1560 CLI patients with concomitant diabetes and treated non-invasively, 50% of patients required above-knee amputation at 1 year [2]. The 1-year and 5-year mortality rates of this patient population are expected to be 12–20% and over 50%, respectively [3]. Atherosclerotic lesions in CLI are diffuse and multilevel with marked involvement of the infrapopliteal arterial bed [4]. Possible therapeutic options in CLI with multilevel arterial disease include percutaneous endovascular intervention (percutaneous transluminal angioplasty, PTA), surgical revascularization, or a combination of both [5–7]. The aim of our retrospective study was to assess the success rates of limb salvage, and the primary and secondary patency rates of reconstructions of CLI patients undergoing combined infrainguinal reconstruction and intraluminal angioplasty of crural arteries.
2.1. Group of patients In 2000–2005, infrainguinal reconstruction with concomitant intraluminal angioplasty of crural arteries was performed in 30 patients with CLI in our department. Their mean age was 63 years (S.D.=10); the group included 21 men and 9 women. Co-morbidities included diabetes present in 21 (70%) individuals, coronary artery disease in 16 (53%), hypertension in 19 (63%), and active smoking in 4 (13%) patients. Clinical features of CLI included gangrene involving one or more toes in 12 (40%), tissue defects of the foot or crura in 15 (50%), resting limb pain in 2 (7%) patients, and interdigital phlegmona in 1 (3%) patient. Using the Fontaine classification, 28 (93%) patients had stage IV and 2 (7%) stage III ischemia. Each patient had angiography from the common femoral artery (CFA) of the involved limb using the Seldinger's technique. In the infrainguinal region, 29 (97%) patients had significant multiple stenosis (>50%, TASC C), or occlusion of the superficial femoral artery (SFA), TASC classification D, whereas 5 (17%) patients were diagnosed to have significant stenosis of the CFA or origin of the profound femoral artery (PFA), TASC classification D. One patient (3%) had isolated significant stenoses in the CFA and PFA, TASC classification D. Findings in the infrapopliteal region included three crural artery multiple stenoses, TASC classification B–C, in 18 (60%) patients, and involvement of two crural arteries in 10 (33%) patients, and single crural artery in 2 (7%) patients. 2.2. Intraluminal balloon angioplasty and surgical intervention In 23 patients, sheath was surgically advanced into popliteal artery (PA) in the operating theater, then the patients were transferred to an angiographic laboratory for intraluminal angioplasty of the infrapopliteal arteries. Subsequently, the patients were transferred back to the operating theater for surgical revascularization. In four patients percutaneous intraluminal angioplasty was performed before surgical revascularization and in three patients intraluminal angioplasty was performed via surgical reconstruction.Intraluminal balloon angioplasty (balloon catheter 1.5–5 mm, balloon length 2–10 cm) was performed in three crural arteries in 9 (30%) patients, two crural arteries in 8 (27%), and one crural artery in 13 (43%) patients. A self-expandable nitinol stent was implanted into four crural arteries of 4 (13%) patients. Surgical revascularization passed under general heparinization (100 UI/kg), a femoropopliteal proximal venous bypass was performed in 15 (50%) patients and a femoropopliteal distal venous bypass in 6 (20%) patients, using the great saphenous vein harvested from the ipsilateral or contralateral limb. In 6 (20%) patients the femoropopliteal proximal prosthetic bypass was undertaken. One patient (3%) had endarterectomy of the CFA and profundoplasty using a prosthetic patch, another one (3%) had femoro-ATA venous bypass, and still another one (3%) had femoro-ATP venous bypass. The procedure was followed by long-term antiplatelet therapy with 100 mg acetylsalicylic acid and 3-month administration of 75 mg clopidogrel daily. Mean follow-up was 12.9 months (S.D.=16.9). In all patients, infrainguinal reconstruction patency was assessed by clinical examination, palpation at two different sites and audio Doppler examination. In cases with an unclear clinical finding, puncture angiography or CT angiography was indicated. Limb salvage was defined as toe amputation or transmetatarsal amputation at most in the postoperative period. Statistical methods used are descriptive (means, S.D. and relative frequencies). Survival curves were constructed by Kaplan–Meier method (product limit estimator). All calculations were done by statistical software SYSTAT® 10.
Postoperative complications in infrainguinal reconstructions were classified as early if occurring within three months and as late if developing after three months since surgery. Overall, there were 5 (17%) early and 8 (27%) late surgical complications. Patients with femoropopliteal proximal venous bypass had four episodes of bleeding from the reconstruction (on postoperative days 0, 1, 10, and 30), requiring surgical revision. Five patients developed occlusion of the reconstruction secondary to outflow tract stenosis. Three patients had surgical thrombectomy with simultaneous intraluminal re-angioplasty of the infrapopliteal arteries (on postoperative day 6, and at postoperative 10 and 15 months). Two had femoropopliteal bypass reconstruction using an allogeneic venous graft combined with crural artery re-angioplasty (at postoperative 4 and 11 months). 3.3. Stenosis of the proximal anastomosis We noted two cases of reconstruction occlusion because of proximal anastomosis stenosis (at 6 and 11 postoperative months); the condition was managed by surgical plasty of anastomosis. The patient undergoing endarterectomy of the CFA and profundoplasty had femoropopliteal distal venous bypass (at 17 postoperative months) because of restenosis in the reconstruction and progression of the clinical finding. In our group, infectious complications occurred only in one patient with crural bypass; the bypass was extracted (at 1 postoperative month). Transluminal infrapopliteal angioplasty was followed by non-occlusive crural artery dissection in seven cases, with self-expandable nitinol stent implantation in four cases, while the remaining three were left untreated because of their insignificancy.No other immediate complications of the procedure or early intra-operative death occurred in our group. During mean follow-up of 12.9 months, primary 1-year patency of vascular reconstruction was seen in 16 (52.6%) patients of our group (Fig. 1). Secondary 1-year patency over the same follow-up period was documented in 17 (56.2%) patients. In our retrospectively assessed group, 1-year limb salvage was obtained in 25 (82.6%) patients (Fig. 2).
CLI characterized by rest pain, gangrene or ulceration of the leg or toes is a frequent problem encountered by the vascular surgeon. According to the TASC, the term CLI should be used for all patients with chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease. The term CLI implies chronicity and is to be distinguished from acute limb ischemia. In CLI, multi-level disease is frequently encountered. Adequate inflow must be established prior to improvement in the outflow. Treatment of CLI for the limb salvage consists of endovascular therapy, vascular revascularization, or a combination of both. The first combined procedure was reported by Porter and Dotter in 1973, who were the first to undertake pelvic artery dilatation and femorofemoral bypass [8]. However, it was not until 1977, with the technical improvement of the balloon catheter by Gruntzig, that combined procedures came into widespread clinical use [9]. In general, the outcomes of revascularization depend upon the extent of the disease in the subjacent arterial tree (inflow, outflow and the size and length of the diseased segment), the degree of systemic disease and the type of procedure performed. According to TASC recommendation, in a situation where endovascular revascularization and open repair/bypass of a specific lesion causing symptoms of peripheral arterial disease give equivalent short-term and long-term symptomatic improvement, endovascular techniques should be used first. The only valid study, the BASIL trial, was able to compare the outcomes of bypass surgery and angioplasty in individuals with severe limb-threatening ischemia who were suitable for either treatment. In this multicenter trial that involved 27 UK hospitals, 452 patients were recruited with CLI. The BASIL study showed no significant difference in 30-day mortality, and 1-year survival with intact leg was 68% and 71% after angioplasty or after surgery, respectively [5]. Experience with infrapopliteal artery PTA in salvaging limbs with CLI is encouraging. Preventional amputation and salvage of a functioning limb reported results for infrapopliteal PTA usually focus on these outcomes and report limb salvage rates of 59–91% [10, 11]. The salvage rate of limbs treated by infrapopliteal artery PTA is 83% over a mean follow-up of 12 months [12]. It should be noted that, should intraluminal angioplasty fail, the procedure can be repeated several times. Similarly, good experience has been reported with infrapopliteal PTA through infrainguinal reconstruction performed previously [13]. An important aspect in the treatment of CLI with infrainguinal and infrapopliteal vascular bed involvement is played by pedal bypass. In a study by Pomposeli with 10-year follow-up of 1032 pedal bypasses, primary patency was 56.8%, secondary patency 62.7%, and successful limb salvage rate 78.2% at 5 years; the respective figures at 10 years were 37.7%, 41.7%, and 57.7% [14]. In a study of 54 pedal bypasses for CLI, Staffa et al. reported a limb salvage rate of 81% over a follow-up period of 54 months [15]. Another alternative modality of treatment of patients with CLI manifesting as multilevel arterial involvement is a combined procedure. The present retrospective study includes patients with CLI treated by a combination of infrainguinal reconstruction and infrapopliteal intraluminal angioplasty. After the mean follow-up of 12.9 (S.D.=16.9) months, primary 1-year patency of vascular reconstructions amounted to 52.6% (16 patients). Secondary 1-year patency over the same follow-up period was 56.2% (17 patients) and 1-year limb salvage was achieved in 25 (82.6%) patients. Based on this finding, we consider a combined surgical and endovascular procedure the method of choice in limb salvage in patients with CLI, not allowing for an isolated endovascular procedure. In cases where there is a choice, or where it is possible to perform pedal bypass or a combined procedure, our clear preference are combined procedures given the lower technical demands associated with infrainguinal reconstruction compared with pedal bypasses. Combined procedures are also our option in cases where lower limb defects make it impossible to perform pedal bypass. Last, but not least, infrapopliteal intraluminal angioplasty can be repeated through the vascular reconstruction in the postoperative period. The combined approach seems to be a valuable alternative to totally open or totally endovascular procedure. However, the final decision of the choice of the treatment of CLI depends on the size and length of the diseased segment, the degree of ischemia, status of systemic disease, quality of autologous conduit and on surgeon's own experience in treatment of CLI.
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Abstract
1. Introduction
