Interventional procedure overview of superficial venous arterialisation and selective venous occlusion for chronic limb threatening ischaemia in people with no other option for revascularisation
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Summary of key evidence on superficial venous arterialisation and selective venous occlusion for chronic limb threatening ischaemia in people with no other option for revascularisation
Study 1 Djoric P (2012)
Study type | Cohort study (prospective) |
|---|---|
Country | Serbia (single centre) |
Recruitment period | 2009 to 2011 |
Study population and number | n=60 (distal venous arterialisation, n=30; antiaggregation therapy [100 mg aspirin per day], n=30) Patients with CLI |
Age and sex | Distal venous arterialisation: mean 65.37 years; 70% (21/30) male Antiaggregation therapy: mean 65.93 years; 57% (17/30) male |
Patient selection criteria | Inclusion criteria for distal venous arterialisation: patients with CLI but without the option for arterial reconstruction because of peripheral arterial occlusive disease with patent aortoiliac segment. Exclusion criteria for distal venous arterialisation: insufficient deep venous system and unsuitable GSV; extensive infective and/or necrotic process up to the metatarsal level; and poor prognosis of the patients. |
Technique | Distal venous arterialisation was done under regional anaesthesia with prophylactic antibiotics and intravenous heparin administration. After dissection of the median marginal vein of the foot and GSV, all tributaries were ligated caudally up to the ankle and lateroterminal anastomosis was created between the GSV and the inflow artery. Valvulotomy was done. |
Follow up | Distal venous arterialisation: mean 6.13±4.32 months Antiaggregation therapy: mean 6.74±0.5 months |
Conflict of interest/source of funding | This work was supported by the grant No. 175043 from the Ministry of Science and Technical Development of the Republic of Serbia. |
Analysis
Study design issues: This prospective randomised study assessed clinical efficiency and possible impact of distal venous arterialisation tissue damage by estimating oxidative status of patients with CLI treated with this procedure. The clinical outcomes included survival, limb salvage, pain relief and wound healing.
Of the included patients, 30 suitable patients were chosen for treatment with distal venous arterialisation. The remaining 30 patients were treated with the antiaggregation therapy (100 mg aspirin per day). Randomisation was done for sex, age, stage of disease, incidence of diabetes, hypertension, and smoking. All operations were done by a single surgeon.
Study population issues: Of the 60 patients, most had gangrene or unhealed painful ulceration of the foot. They had significant accompanying comorbidity. In both groups, one to two thirds of the patients had at least 1 of the following risk factors such as diabetes, hypertension and smoking. Around 30% to 40% of the patients had carotid and/or coronary artery disease. There were no statistically significant differences in age, sex, stage of disease, and comorbidity between groups. In the distal venous arterialisation group, reverse vein bypass graft with the position of a distal anastomosis on the junction of the dorsal venous arch and the superficial vein of the thumb was used in 6 patients. In this way arterial blood flow was made possible in 2 directions.
Key efficacy findings
Number of patients analysed: 60
Distal venous arterialisation (n=30) | Antiaggregation therapy (n=30) | p-value | |
|---|---|---|---|
Survival | 97% | 67% | <0.01 |
Limb salvage | 83% | 13% | <0.001 |
Pain relief | 83% | 7% | <0.001 |
Wound healing | 88% | 0% | <0.001 |
In 3 patients with a patent graft the gangrene process was not stopped, which needed an urgent high amputation of the extremities.
Preoperatively, there were no statistically significant differences in values of digital systolic pressure (30.67±7.512 mm Hg compared with 31.40±5.917 mm Hg, p=0.676) and digital-brachial index between the distal venous arterialisation and antiaggregation therapy groups (0.233±0.060 compared with 0.225±0.051, p=0.582). After distal venous arterialisation, a significant increase of digital systolic pressure values at 68.4±16.21 mm Hg (p<0.001) and digital-brachial index at 0.487±0.149 (p<0.001) was found.
Lactate level:
Immediately before procedure: 2.43±0.49 mmol/l
10 minutes after procedure: 1.143±0.329 mmol/l
P<0.001
Key safety findings
General complications of distal venous arterialisation:
Pneumonia: n=1
Cardiac decompensation: n=2 (with the fatal outcome in 1 patient)
Surgical complications of distal venous arterialisation (1 patient had simultaneous bleeding and early graft thrombosis):
Infection of operative incision: n=1
Bleeding: n=2
Graft thrombosis: n=6
Leg swelling: n=3
Most of the patients in the antiaggregation therapy group, 8 out of 10, died of the septic complications of the foot gangrene.
Study 2 Djoric P (2011)
Study type | Cohort study (prospective) |
|---|---|
Country | Serbia (single centre) |
Recruitment period | 2009 |
Study population and number | n=36 (distal venous arterialisation, n=12; conservative treatment [antiplatelet drugs], n=24) patients with CLI |
Age and sex | Distal venous arterialisation: mean 64.3 years; 59% (7/12) male Control: mean 67.1 years; 54% (13/24) male |
Patient selection criteria | Inclusion criteria for distal venous arterialisation: absence of any possibility for direct revascularisation as a result of extensive occlusive disease of crural and pedal arteries; sufficient deep venous system and usable GSV as a graft for in situ bypass surgery according to duplex scanning; localised infective and/or necrotic process up to the metatarsal level; and a satisfactory general patient condition. |
Technique | Distal venous arterialisation was done under spinal or epidural anaesthesia with prophylactic antibiotics. After exposing the median marginal vein of the foot and GSV cranially up to the suitable site for the anastomosis, all tributaries of the GSV were ligated caudally up to the ankle and leteroterminal anastomosis was created between GSV and the appropriate inflow artery. After intravenous heparin administration, valvulotomy was done. |
Follow up | Distal venous arterialisation: mean 4.8±3.9 months (range 1 to 14 months) Conservative treatment: mean 4.9±2.4 months (range 1 to 9 months) |
Conflict of interest/source of funding | Not reported |
Analysis
Study design issues: This prospective study estimated the validity of distal venous arterialisation as a limb salvage procedure. The primary outcomes included limb salvage, patient survival and clinical improvement as pain relief and wound healing. The secondary outcomes included early metabolic (serum lactate level) and haemodynamic changes (toe systolic pressure measurements) after reverse limb revascularisation. All procedures were done by a single surgeon.
Study population issues: At baseline, the 2 groups were well matched for age, sex, stage of disease, incidence of diabetes, hypertension and smoking. There were no statistically significant differences between groups in serum lip level, obesity and several comorbidity conditions such as coronary and carotid artery disease, renal failure and chronic pulmonary obstructive disease.
Key efficacy findings
Number of patients analysed: 36
Group | Distal venous arterialisation (n=12) | Conservative treatment (n=24) | P value |
|---|---|---|---|
Survival | 100% (12/12) | 67% (16/24) | 0.024 |
Limb salvage | 92% (11/12) | 13% (3/24) | 0.000 |
Pain relief | 75% (9/12) | 8% (2/24) | 0.000 |
Wound healing | 78% (7/9) | 0% (0/12) | 0.000 |
Distal venous arterialisation group (n=12)
Minor amputations: n=6
Graft patency: 83.3% (n=10)
Graft thromboses within 48 hours: 16.7% (n=2)
Haemodynamic parameters such as systolic digital pressure and digitobrachial systolic pressure index were increased after revascularisation using Student t test (p<0.001).
Key safety findings
Distal venous arterialisation group:
Intrahospital morbidity: 50% (including local surgical and general complications)
Wound infection: n=2 (infection was treated with antibiotics)
Haematoma: n=1 as a result of coagulopathy (haematoma evacuation with the swelling subsiding in 2 months)
Swelling of the foot: n=2
Pneumonia: n=1
Mortality: 0%
Conservative treatment group: mortality: 33.3% (n=8)
Of the 8 patients, 5 died from septic complications such as gangrene of the foot, and 2 died from myocardial infarction and pulmonary carcinoma.
Mortality between groups was statistically significantly different (p<0.05)
Study 3 Matzke J (1999)
Analysis
Study design issues: This retrospective cohort study assessed the outcomes of a series of patients who had arterialisation and compared them with patients who had conservative treatment. All arterialisations were done by the same vascular surgeon.
Study population issues: Between the 2 group, a match according to the match criteria was found for every patient except 1, whose age differed more than 10 years. In 1 patient femorodistal reconstruction was attempted prior to arterialisation.
Other issues: Because of the small sample, a type 2 statistically error may always bias the results in a comparison of 2 groups.
Key efficacy findings
Number of patients analysed: 28
Clinical outcome | Arterialisation | Conservative treatment |
|---|---|---|
Limb salvage | ||
1 month | 86% | 71% |
3 months | 64% | 71% |
6 months | 57% | 54% |
12 months | 57% | 54% |
Survival | ||
1 month | 100% | 100% |
3 months | 92% | 79% |
6 months | 92% | 64% |
12 months | 92% | 64% |
No difference in terms of leg salvage times could be detected.
According to the analysis with the Cox regression model, the survival times differed at the p=0.07 level. However, the Bonferroni-corrected p-value was 0.14.
50% of the amputations in the arterialisation group were done with a patent graft.
Key safety findings
Revascularisation: n=5 (4 patients in the arterialisation group and 1 in the conservative treatment group)
Study 4 Busato CR (2010)
Study type | Case series (retrospective) |
|---|---|
Country | Brazil (single centre) |
Recruitment period | Not reported |
Study population and number | n=18 patients with CLI without arterial runoff |
Age and sex | Not reported |
Patient selection criteria | Not reported |
Technique | After angiography and arterial duplex scan were done, an arteriovenous fistula was created and the GSV was then anastomosed end-to-side to the best donor vein. The arterial flow into the venous system progressed through the vein whose valves were destroyed using valvulotomy. All side branches of the GSV were ligated from the arterial anastomosis until the anterior perforating vein of the malleolus. |
Follow up | Mean 695.6 days (23 months; range 213 to 1,006 days) |
Conflict of interest/source of funding | None |
Analysis
Study design issues: This study described the technique and presented the results obtained after arterialisations of the venous arch of the foot with GSV maintained in situ.
Study population issues: Of the 18 patients, 11 had atherosclerosis obliterans, 6 had thromboangiitis obliterans and 1 had late presentation of popliteal artery aneurysm with distal thrombosis. Among the 11 patients with atherosclerosis obliterans, 6 had diabetes mellitus and, out of these, 2 had renal failure and depended on haemodialysis.
Key efficacy findings
Number of patients analysed: 18
Limb salvage: 55.6% (n=10, including 5 patients with atherosclerosis obliterans and 5 patients with thromboangiitis obliterans)
Healing of minor amputations: 33.3% (n=6, including 2 transmetatarsial, 2 finger and 2 phalanx amputations)
Major amputations: 38.9% (n=7, including 3 above the knee and 4 below the knee)
Of the 7 patients, 5 had atherosclerosis obliterans, 1 had thromboangiitis obliterans and 1 had popliteal artery aneurysm with distal thrombosis.
Key safety findings
Overall mortality: 17% (n=3)
Of the 3 patients, 1 patient with diabetes mellitus and chronic renal failure died (5.5%) after developing septicaemia by ascending infection, and 2 patients with atherosclerosis obliterans died because of comorbidities related to patent graft.
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