Volume 13, Issue 1 , Pages 20-24, January 2012
Antegrade approach for percutaneous interventions of ostial superficial femoral artery: outcomes from a prospective series of diabetic patients presenting with critical limb ischemia☆
Article Outline
- Abstract
- 1. Introduction
- 2. Material and methods
- 3. Results
- 4. Discussion
- 5. Study limitation
- 6. Conclusion
- References
- Copyright
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.
Keywords: Critical limb ischemia, Femoral artery, Angioplasty
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% [1], [2], [3], [4], [5], [6], [7], [8], [9]. 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 [4], [5], [9]. 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” [10]. 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 [5]. 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 [11], [12]. 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 [4] 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 [13]. The study was approved by the internal ethic committees, and signed informed consent was obtained from all patients.
Fig. 1.
Right femoral artery angiogram taken in ipsilateral oblique view displaying tight stenosis at the ostium of the SFA. This first angiogram obtained by injecting the contrast through a 19G needle located in the common femoral artery (CFA) indicates a short distance between the puncture site and the target lesion (A). Following needle removal and manual compression, a second higher puncture is performed in the CFA within the radiological marker represented by the midfemoral head (dotted line) (B). Final results after PTA and stent placement (Protegé Everflex 7.0×80 mm, ev3, Plymouth, MN, USA; expanded with 6.0-mm balloon at 12 atm, continuous line) in the proximal part of the SFA (C).
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.
3. Results
From January 2010 to June 2011, 530 patients admitted to our institution with CLI underwent a lower limb angiogram, and in 452 patients, PTA was performed. The remaining 78 patients underwent bypass surgery (66 patients) or were judged not suitable for any kind of revascularization (12 patients). In the PTA group, 64 patients had ostial SFA lesions. According to the prespecified criteria, the brachial (four patients) or contralateral femoral approach (15 patients) was used in 19/64 (30%) patients. Reasons for elective brachial or crossover approach are listed in Fig. 2. Among the 19 patients treated with brachial or contralateral approach, a second femoral puncture for antegrade approach was performed in three patients. In the remaining 45 patients, a bare 19G needle angiogram of the femoral bifurcation was performed. These patients constitute the study population. Their clinical characteristics are reported in Table 1. Table 2 shows the angiographic characteristics of the treated limbs of the study population. In 6/45 patients (13%), the first puncture was considered to close to the target lesion. A second higher puncture on the common femoral artery was performed in 4/45 (9%) patients, while in 2/45 patients (4%), a second higher puncture was not carried out because it would have been higher than the middle of the femoral bone head. In these two patients, the PTA was thereafter accomplished via the contralateral femoral route. Considering the consecutive series of 64 patients presenting with ostial SFA lesions, PTA was performed by the antegrade approach in 70% (45/64) of the patients. The percentage of procedures successfully performed antegradely according to the prespecified criteria was 95% (43/45). Technical success was achieved in 38/45 (84%) of patients and clinical success in 37/45 (82%) patients. One SAE was recorded during hospitalization: sudden vessel closure 6 h following the intervention requiring urgent bypass grafting. Procedural characteristics are shown in Table 3. No relevant groin hematoma was observed during hospital stay.
Fig. 2.
Flowchart showing the decision process for approach selection.
Table 1. Clinical characteristics of patients (n=45)
| Mean age (years) | 73.1±8.6 |
| Males/females (n) | 29/16 (63%/37%) |
| Insulin therapy/oral agents (n) | 31/14 (68%/32%) |
| Hypercholesterolemia (serum LDL>100 mg/dl) | 26/45 (59%) |
| Hypertension | 23/45 (52%) |
| Sensory motor neuropathy | 40/45 (91%) |
| Impaired real function (creatinine clearance≤60 mmol/dl) | 22/45 (50%) |
| Dialysis | 7/45 (12%) |
| History of coronary artery disease | 26/45 (59%) |
| Current smoker | 4/45 (9%) |
| Rutherford category [14] | |
 4 | 4/45 (9%) |
| 5 | 25/45 (55%) |
| 6 | 16/45 (36%) |
Table 2. Angiographic characteristics of the treated arteries (n=45)
| TASC II lesion classification [10] | |
| A | 0/45 |
| B | 1/45 (2%) |
| C | 27/45 (59%) |
| Mean SFA lesion length (cm) | 13.4±11.6 |
| SFA chronic total occlusions (%) | 12/45 (27%) |
| Previous angioplasty (%) | 6/45 (13%) |
| Previous stenting (%) | 4/45 (9%) |
| Number of diseased BTK arteries (lesions>50%) | 2.8±1.6 |
| Number of totally occluded BTK arteries | 1.8±1.3 |
Table 3. Procedural characteristics (n=45)
| PTA site | |
| SFA only | 6/45 (3%) |
| SFA and BTK | 38/45 (86%) |
| Mean number of treated BTK vessels | 1.5±0.9 |
| Max sheath size | |
| 4 Fr | 26/45 (59%) |
| 6 Fr | 18/45 (41%) |
| Number of stented limbs | 18/45 (41%) |
| Mean number of stents/limb | 1.2±0.9 |
| Mean stent length (mm) | 16.4±14.6 |
| Mean number of balloons | 2.4±1.6 |
| Mean number of wires | 2.4±2.1 |
| Mean contrast volume (ml) | 104±58 |
| Mean fluoro time (min) | 19±18 |
| Use of protamine sulphate | 16/45 (36%) |
4. Discussion
The main findings of the present study are as follows:
The treatment of patients with CLI often requires the simultaneous treatment of lesions located above and below the knee. In the presence of significant atherosclerotic disease close to the SFA ostium, the operator may perform the procedure via the contralateral femoral artery or brachial approach. The availability of dedicated balloons and stents with long shafts allows the treatment of crural vessels in many of these cases. However, following the treatment of the proximal portion of the SFA, a second antegrade puncture of the proximal femoral artery may be necessary to increase procedural success rates in the crural or in the foot vessels. On the other hand, in cases where the procedure is entirely performed by antegrade route, the operator should be aware to maintain an adequate distance between the arterial puncture site and the proximal target lesion, avoiding the risks of puncture above the inguinal ligament [11], [12]. In the present study, we report the outcome of our standardized algorithm to screen patients who are potential candidates for antegrade puncture. Patient selection is performed in different steps; nevertheless, it requires a short time and is not expensive. The first two steps are not invasive: a first line selection is performed by duplex scan analysis and by physical examination. These two tests identified about 30% of patients with ostial SFA lesions as being unsuitable for antegrade puncture. The final selection is performed following bare needle angiography. It is worth noting that, at this step, only 4% patients were excluded because of the presence of a high femoral bifurcation. The rarity of this anatomical abnormality is also confirmed by previous observations reporting that only in about 2% of patients was the bifurcation above the center of the femoral bone head [15]. One of the drawbacks of this approach can be the need of a second higher puncture in case the vessel entry site is too close to the proximal target lesion. However, it should be noted that a second puncture was performed in only 12% of patients, and in none of them did vascular complications occur. The minimal vessel trauma produced by the bare needle, the absence of heparin at the time of vessel puncture, and an adequate manual compression are essential in minimizing complications at this phase of the procedure.
The high success rate reported in the present study demonstrates the effectiveness of this approach in patients with diffuse peripheral arterial disease, requiring in the vast majority of the cases simultaneous interventions both on the SFA and at least a BTK artery. The antegrade femoral puncture is frequently used for percutaneous interventions in patients with CLI [4], [5], [9]. This approach allows direct femoral and infragenicular vessel visualization, provides high backup, and facilitates guidewire and balloon trackability. In case of chronic total occlusions, the strongest backup can be obtained manually holding the sheath while exerting a hard pressure on wires and catheters. In some retrospective studies, the overall risk of antegrade vascular access complications has been reported to be higher in comparison to the retrograde approach [16]. However, it must be noted that success rates and the incidence of complications largely differ according to operator's experience. The results from large series in which the antegrade approach was systematically adopted have showed rates of complications at the site of vessel puncture similar to those historically reported in similar populations treated with the retrograde contralateral approach [1], [2], [3], [4], [5], [6], [7], [8], [9].
5. Study limitation
There are some limitations of the present study. First, this is a single-arm study without a control group. Therefore, the rates of technical success and of vascular complications when routinely using the crossover approach were not assessed for comparison. Second, the results of the present study were derived from a single-center experience with a high work volume where the antegrade approach has been routinely adopted for many years as a first-choice approach. It is therefore likely that the selection of the antegrade versus crossover or brachial approach may differ largely from centers with historical preference for the contralateral route. Finally, in none of our patients was a baseline computed tomographic angiogram or a magnetic resonance angiogram performed before the intervention. An extensive use of these diagnostic tools might impact the decision process.
6. Conclusion
Ostial SFA lesions can be safely and effectively approached in an antegrade fashion if patients and lesions are correctly screened with duplex scan analysis and physical examination. The 19G bare needle angiogram of the femoral bifurcation correctly identifies an adequate puncture site in the vast majority of patients. The preference of antegrade puncture even in the case of ostial SFA lesions is justified by extremely frequent need of simultaneous treatment of above and below the knee arteries in diabetic patients presenting with CLI.
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☆ Conflict of interest: none.
PII: S1553-8389(11)00537-9
doi:10.1016/j.carrev.2011.10.003
© 2012 Elsevier Inc. All rights reserved.
Volume 13, Issue 1 , Pages 20-24, January 2012
