Abstract
Objectives
This is a prospective evaluation of percutaneous interventions (PTAs) performed by the antegrade femoral approach in diabetic patients with critical limb ischemia (CLI) and ostial superficial femoral artery (SFA) lesions.
Methods
The puncture site was selected according to duplex scan analysis and physical examination (brachial, crossover, or antegrade). In cases of antegrade approach, a bare needle angiogram of the femoral bifurcation was performed in order to have an adequate distance (>2 cm) from the target lesion.
Results
Between January 2010 and August 2011, 64 diabetic patients underwent PTA for ostial SFA lesions.
Crossover or brachial approach was electively adopted in 19/64 (30%) patients. The antegrade bare needle angiogram was performed in the remaining 45/64 (70%) patients. In two patients, the vascular anatomy was considered not suitable for antegrade approach, and they were treated in crossover. Technical success was achieved in 38/45 (84%) of patients. During hospital stay, one patient had SFA stent thrombosis treated with urgent bypass grafting.
Conclusions
The antegrade approach can be safely performed in most patients presenting with CLI and ostial SFA lesions. The use of clinical and radiographic criteria correctly identifies patients with ostial SFA lesions suitable for an antegrade approach in 42/44 (95%) of cases.
1
Introduction
Percutaneous transluminal angioplasty is the mainstay in the management of critical limb ischemia (CLI) with rates of clinical and procedural success over 80% . The ipsilateral antegrade femoral access has been indicated by many authors as the first-choice approach for interventional procedures in cases of extensive atherosclerotic involvement of the infragenicular vessels . One of the conditions strongly discouraging the choice of the antegrade ipsilateral puncture is the presence of a severe stenosis or chronic total occlusion at the origin of the superficial femoral artery (SFA). In these cases, brachial and contralateral femoral approaches are usually preferred. However, when critical lesions or chronic total occlusions are simultaneously located above and below the knee, the recanalization of infragenicular vessels as well as of the pedal-plantar arch can be difficult in the absence of antegrade femoral access. The aim of the present study was to investigate the feasibility and efficacy of the treatment of ostial SFA lesions using the ipsilateral antegrade approach in patients presenting with CLI.
2
Material and methods
2.1
Study design and patient selection
This is a prospective evaluation of procedural and immediate clinical outcomes in a consecutive series of diabetic patients undergoing percutaneous transluminal angioplasty (PTA) for CLI with SFA lesions involving the vessel ostium. SFA lesions were defined as ostial if extending less than 1 cm from the origin of the vessel by visual estimation. Indication for peripheral angiography was taken according to “The Inter-Society Consensus; TASC II” . PTA was performed in the same session as the angiographic study. In patients in whom PTA was not attempted after the angiography or was unsuccessful, bypass surgery was considered. Patients in whom both PTA and bypass surgery were not feasible were treated medically, and above-the-ankle amputation was indicated in the case of persistent rest-pain or the presence of severe infection . All patients underwent a duplex scan analysis before the angiogram was performed. The first-choice approach for lower limb interventions was the ipsilateral antegrade puncture of the common femoral artery. The brachial or contralateral femoral approach was electively chosen if at least one of the following prespecified conditions was found: duplex scan evidence of iliac or common femoral artery stenosis >50%, severe obesity, high femoral bifurcation, previous stenting on the common femoral artery, recent intervention at the ipsilateral femoral groin with hematoma, suspected skin infection at the target groin. Patients with a failing bypass graft were excluded from the present analysis.
2.2
Procedure
At the beginning of the procedure, an angiogram of the femoral bifurcation was taken with a 19G bare needle (Cordis, Roden, the Netherlands). In all the cases, the needle was placed below a radiological marker represented by a transverse line across the middle of the femoral bone head . Baseline angiograms were taken in the ipsilateral oblique view (at least 30°) ( Fig. 1 ). The same vascular access was maintained if the SFA ostial lesion was at least 2 cm from the puncture site by visual estimation. In case of a minor distance, the needle was removed and replaced in the common femoral artery in a higher position. The second puncture was performed only if feasible below the above-mentioned radiological marker. Subsequently, a 0.035” wire (Starter, Boston Scientific Corporation, Natick, MA, USA) was introduced through the 19G needle into the SFA. In cases of SFA total occlusion, the wire was addressed toward the profunda femoral artery, and a 4-Fr, 11-cm sheath (Cordis, Roden, the Netherlands) was positioned into the common femoral artery. The engagement of the SFA ostium was then performed with a straight 0.035” wire (Starter, Boston Scientific Corporation) eventually addressed by a 4-Fr diagnostic catheter (BER I, BER II, MP A1, Cordis, Roden, the Netherlands). Percutaneous femoral angioplasty was subsequently performed according to the standard practice of our institution as described elsewhere by two operators experienced in antegrade femoral puncture (F.A., D.T.). PTA was considered indicated for angiographically documented stenosis >50% of the vessel lumen. A bolus of 70 IU/kg of unfractionated heparin was administered, eventually incremented in order to maintain an activated clotting time (ACT) >250 s. Procedures were performed with dedicated peripheral dilatation balloon with diameters ranging from 2.0 to 8.0 mm. Indication for stenting was left to the operator’s discretion in cases of residual stenosis or flow-limiting dissections persisting after prolonged inflations. At the end of the procedure, the sheath was manually removed following ACT measurement. In cases of ACT exceeding 150 s, the anticoagulant effect of heparin was reversed with protamine sulfate administration. Technical success was defined when at least one artery provided flow to the foot with no residual stenosis >50% along the in-line flow. Procedural success was defined as technical success without in-hospital serious adverse events (SAEs). Death, any life-threatening condition, and prolonged hospitalization were considered SAEs. Hematomas were considered relevant if requiring blood transfusion, prolonged hospitalization, or hemoglobin drop >3 g/dl . The study was approved by the internal ethic committees, and signed informed consent was obtained from all patients.
2.3
Statistical analysis
Statistical analyses were performed with the SPSS statistical program (version 15.0.1; SPSS, Chicago, IL, USA). Data were analyzed descriptively and reported with mean (S.D.) for continuous variables and with percentages for categorical variables.
2
Material and methods
2.1
Study design and patient selection
This is a prospective evaluation of procedural and immediate clinical outcomes in a consecutive series of diabetic patients undergoing percutaneous transluminal angioplasty (PTA) for CLI with SFA lesions involving the vessel ostium. SFA lesions were defined as ostial if extending less than 1 cm from the origin of the vessel by visual estimation. Indication for peripheral angiography was taken according to “The Inter-Society Consensus; TASC II” . PTA was performed in the same session as the angiographic study. In patients in whom PTA was not attempted after the angiography or was unsuccessful, bypass surgery was considered. Patients in whom both PTA and bypass surgery were not feasible were treated medically, and above-the-ankle amputation was indicated in the case of persistent rest-pain or the presence of severe infection . All patients underwent a duplex scan analysis before the angiogram was performed. The first-choice approach for lower limb interventions was the ipsilateral antegrade puncture of the common femoral artery. The brachial or contralateral femoral approach was electively chosen if at least one of the following prespecified conditions was found: duplex scan evidence of iliac or common femoral artery stenosis >50%, severe obesity, high femoral bifurcation, previous stenting on the common femoral artery, recent intervention at the ipsilateral femoral groin with hematoma, suspected skin infection at the target groin. Patients with a failing bypass graft were excluded from the present analysis.
2.2
Procedure
At the beginning of the procedure, an angiogram of the femoral bifurcation was taken with a 19G bare needle (Cordis, Roden, the Netherlands). In all the cases, the needle was placed below a radiological marker represented by a transverse line across the middle of the femoral bone head . Baseline angiograms were taken in the ipsilateral oblique view (at least 30°) ( Fig. 1 ). The same vascular access was maintained if the SFA ostial lesion was at least 2 cm from the puncture site by visual estimation. In case of a minor distance, the needle was removed and replaced in the common femoral artery in a higher position. The second puncture was performed only if feasible below the above-mentioned radiological marker. Subsequently, a 0.035” wire (Starter, Boston Scientific Corporation, Natick, MA, USA) was introduced through the 19G needle into the SFA. In cases of SFA total occlusion, the wire was addressed toward the profunda femoral artery, and a 4-Fr, 11-cm sheath (Cordis, Roden, the Netherlands) was positioned into the common femoral artery. The engagement of the SFA ostium was then performed with a straight 0.035” wire (Starter, Boston Scientific Corporation) eventually addressed by a 4-Fr diagnostic catheter (BER I, BER II, MP A1, Cordis, Roden, the Netherlands). Percutaneous femoral angioplasty was subsequently performed according to the standard practice of our institution as described elsewhere by two operators experienced in antegrade femoral puncture (F.A., D.T.). PTA was considered indicated for angiographically documented stenosis >50% of the vessel lumen. A bolus of 70 IU/kg of unfractionated heparin was administered, eventually incremented in order to maintain an activated clotting time (ACT) >250 s. Procedures were performed with dedicated peripheral dilatation balloon with diameters ranging from 2.0 to 8.0 mm. Indication for stenting was left to the operator’s discretion in cases of residual stenosis or flow-limiting dissections persisting after prolonged inflations. At the end of the procedure, the sheath was manually removed following ACT measurement. In cases of ACT exceeding 150 s, the anticoagulant effect of heparin was reversed with protamine sulfate administration. Technical success was defined when at least one artery provided flow to the foot with no residual stenosis >50% along the in-line flow. Procedural success was defined as technical success without in-hospital serious adverse events (SAEs). Death, any life-threatening condition, and prolonged hospitalization were considered SAEs. Hematomas were considered relevant if requiring blood transfusion, prolonged hospitalization, or hemoglobin drop >3 g/dl . The study was approved by the internal ethic committees, and signed informed consent was obtained from all patients.
