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To evaluate the feasibility and the mid-term results of subintimal angioplasty (SA) in the treatment of critical limb ischaemia (CLI) with tibial vessels occlusions.
Materials and methods
Between August 2000 and March 2005, we attempted to treat 46 patients (23 men, 23 women, median age of 75 years; range 35–92) and 50 limbs by SA of occluded tibial vessels. Twenty-one had gangrene, 25 ulcerations and 4 had rest pain. Thirty-nine occlusions (78%) were more than 10 cm in length, 28 (56%) involved popliteal and tibial artery and distal re-entry was at the ankle level in 18 cases (36%). Twenty-eight patients (61%) were diabetics.
Results
There were nine technical failures. Five of these patients were successfully treated medically (1), by conventional surgery (1) or by conventional angioplasty of another diseased tibial vessel (3). The four remaining patients had major amputation and 3 died within 3 months. There were 7 complications including 2 embolisms, 1 perforation and 4 haematomas. By intention to treat, one-year primary, secondary and clinical patency rates were 46%, 55% and 63%, respectively. One and two-year limb salvage rates were 87%. One and two-year survival rates were 74% and 64%, respectively.
Conclusions
SA of tibial vessel occlusions is a valuable treatment of CLI. Technical failures do not preclude conventional surgery when there is a valuable outflow. Complications may often be treated medically or by endovascular procedures. Results have to be confirmed by long-term follow up. Both techniques should be considered as complementary techniques in the management of CLI.
Critical limb ischaemia (CLI) with tibial vessels occlusions is a challenge for vascular surgeons. Surgery with great saphenous vein is still the gold standard with good results in terms of patency and limb salvage rates.
But CLI often affects elderly patients with severe co-morbidities who are poor candidates for this kind of surgery. Subintimal angioplasty described by A Bolia in 1987,
relies on the creation of a dissection in the arterial wall with a hydrophilic wire to create a “disease-free channel” to the distal patent artery. The aim of this report is to evaluate the feasibility and the mid-term results of subintimal angioplasty of tibial vessels occlusions in critical limb ischemia.
Patients and Methods
From August 2000 until March 2005 we attempted to treat 46 patients and 50 limbs with CLI and tibial vessel occlusions (Table 1). There were 23 men and 23 women aged 35–92 years (median 75 years). Twenty-one had gangrene (toe or extended necrosis treated by limited amputation to achieve healing), 25 had ulcerations and 4 had rest pain. Twenty-eight patients (61%) were diabetics, 33 (72%) had hypertension, 36 (78%) coronary artery disease, 7 (15%) had severe renal insufficiency with 3 on chronic haemodialysis. Four patients had a failed bypass in the affected leg. Thirty-nine occlusions (78%) were more than 10 cm in length, 28 (56%) involved popliteal and a tibial artery and distal re-entry was at the ankle level in 18 cases (36%) (Table 2). All procedures were performed by the author in the operating room under regional anaesthesia. Antegrade common femoral artery puncture was performed with a 5 or 6 French sheath. The subintimal dissection was performed with an angled 0.035″ hydrophilic guide wire (Terumo) and a 5F femorovertebral catheter (Terumo). After re-entry of the wire in the distal artery, 3500 to 4000 units of heparin were administrated and the guide wire was exchanged with stiffer wire with hydrophilic extremity (V 18 Boston Scientific). Angioplasty was then performed with a symmetry balloon (Boston Scientific) of 3 mm wide and 40 mm length with short (10 to 20 sec) and high pressure inflations (10 to 15 atm) from the distality to the proximal entry. No stents were used. Technical success was defined as good antegrade flow at the completion of the procedure and patency was confirmed by continuous doppler after the first 24 hours. During hospitalisation, patients were given low molecular weight Heparin, local application of 10 mg of Nitroglycerine once-daily (transdermal patch on the calf) and 160 mg Aspirin PO daily indefinitely. Follow-up was done at 1, 3, 6, 9, 12 and 18 months with clinical examination and duplex ultrasound.
Primary, secondary and clinical patency rates are reported by intention to treat, i.e. technical failures are considered as failures. Patency rates were analysed with the Kaplan-Meier method.
Results
There were 9 technical failures (18%). Five of these patients were successfully treated medically (1), by femorotibial bypass (1) or by conventional angioplasty of another diseased tibial vessel (3). The remaining four patients had major amputation despite surgical exploration or bypass (no run-off or very diseased distal vessels with early occlusion of the bypass). Three of these patients died within 3 months of the amputation. There was no operative mortality. There were 7 local complications including 2 embolisms (treated by thromboaspiration), 1 perforation (treated by surgical drainage) and 4 groins haematomas (2 treated by compressions and 2 by surgery).
There were 9 clinical failures (18%). Three late re-occlusions were successfully treated by conventional surgery at 5, 8 and 9 months. Two were treated by redo of SA at 2 and 3 months but re-occluded and were treated medically for 1 and by above the knee-amputation for the other. Four patients declined further treatment. Two of these patients died within 3 months after re-occlusion, the 2 remaining consulted another physician.
When last assessed at a median follow up of 15 months (range:2–53) 32 patients had clinical success (64%). 22 patients had a patent angioplasty site and no symptoms, 5 had asymptomatic late occlusion and 5 had symptomatic restenosis successfully treated by conventional angioplasty or SA.
Primary, secondary and clinical patency rates were 46%, 55% and 63% at one-year and 42%, 52% and 63% at two-years respectively. (Table 3)
Table 3Patency rates at 1, 12 and 24 months (standard error <10% at 24 months)
There were 5 major amputations including 4 in the technical failures group and 1 after late re-occlusion of the SA at 9 months. One and two-year limb salvage rates were 87%.
Sixteen of the 46 patients (35%) died in the follow-up period. Causes of death included cardiovascular disease in 10 and pulmonary disease in 6. One and two-year survival rates were 74% and 64% respectively. We also analysed the influence of diabetes, gender and type of clinical lesion (gangrene versus ulceration or rest pain) on technical success, secondary and clinical patency rates (Table 4). Female patients had improved results in term of secondary and clinical patency. The presence of diabetes and the location of the distal re-entry has no influence on outcome. The length of the occlusion and the requirement to extend treatment to the popliteal artery influenced the secondary and clinical patency rates.
Table 4Influence of factors on technical failures and one-year secondary and clinical patency rates
Conventional bypass with the great saphenous vein is still considered as the gold standard with good results in terms of patency and limb salvage rates.
only 14% of the patients had non-complicated vascular surgery with loss of the symptoms, healing of the wounds by first intention and no secondary intervention with a functional limb.
Conventional angioplasty allows the treatment of older patients with severe co-morbidities. Technical success is achieved in 70% to 96%,
confirmed the good results of SA of tibial vessels occlusions when surgery was not possible or considered high risk. Now we have changed our policy and treat CLI with tibial vessel disease by conventional angioplasty or SA as first choice. Exclusions from endovascular treatment include embolic or aneurysmal disease or very extensive disease in a debilitated patient.
Our technical failure rate was 18%, similar to other series,
and reflects our aggressive policy. Four of the 9 technical failures had secondary amputation despite surgical exploration. Three of these patients achieved limb salvage by other approaches.
During follow-up there was a high rate of late occlusions (19 or 46%). Only 6 of these patients had recurrence of symptoms. Five patients remained symptomatic on medical treatment and 1 had a major amputation. The others had asymptomatic occlusion (5) or could be treated successfully by conventional angioplasty, redo SA (5) or by conventional surgery (3). Our long term patency rates are lower than those obtained by bypass surgery and confirm that SA of tibial vessels is only indicated in CLI where temporary improvement of the vascularisation is enough to achieve the healing of the ulcer or amputation site. Healing probably reduces the oxygen demand of the extremity. Moreover in case of early or late occlusion, SA does not preclude conventional surgery. The use of Ticlopidine and Statins may improve the patency rates.
The overall cost of SA is quite low. The materials used are relatively simple and inexpensive (standard angiographic materials and a balloon catheter). The procedure is performed under local or regional anaesthesia,
there is no intensive care requirement in the majority of cases and the post operative stay is short unless the patient had complementary treatment like localised amputation or surgical debridment of extended ulcerations.
One other advantage of SA over surgery is the possibility to target the revascularisation to one infected or ulcerated area where surgery may be contra-indicated (Fig. 1, Fig. 2).
Fig. 1Extended necrosis of the foot in a 47 years-old diabetic patient: before surgery and angioplasty and final result.
Fig. 2Same patient: arteriogram at the ankle level: Tight stenosis of pedal artery (1) and occlusion of distal posterior tibial artery (2): after conventional angioplasty of pedal artery (3) and subintimal angioplasty of posterior tibial artery (4).
We perform recanalizations using “road mapping” and regional anaesthesia thereby minimising injection of contrast. The procedures are often performed with <100 ml of contrast and may be used in patients with renal impairment. Regional anesthesia also permits debridment of ulceration or localized amputation during the procedure and may reduce arterial spasm.
Our results suggest that SA of tibial vessel occlusions is a valuable alternative to surgery and the first line treatment in patients with CLI. We report a high technical and clinical success, low morbidity and mortality from tibial SA. Technical failure or late occlusion does not preclude later conventional surgery in the majority of the cases. The failure of tibial SA to be adopted widely may be due to the long learning curve required to achieve good results.
References
Morris G.E.
Raptis S.
Miller J.H.
Faris I.B.
Femorocrural grafting and regrafting: does polytetrafluoroethylene have a role?.
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