Evaluation of Ipsilateral Antegrade Techniques for Endovascular Treatment of Ostial Superficial Femoral Artery Lesions

INTRODUCTION

Peripheral arterial disease (PAD) is a term used to describe the gradual narrowing and blockage of peripheral arteries, particularly those in the lower limbs. Smoking, diabetes mellitus (DM), end-stage renal disease (ESRD), obesity, high blood pressure, high cholesterol, ageing, and a family history of PAD, heart disease, or stroke are all risk factors for PAD. Diabetes is a significant risk factor for PAD.¹.

Although accessing the contralateral common femoral artery (CFA) is the standard treatment route, an ipsilateral, antegrade CFA approach offers certain benefits. The main benefit is the shorter access-to-lesion distance, which increases the mechanical advantage and responsiveness of the instruments employed in the intervention.²

Endovascular revascularization of a flush blockage involving the ostium of the superficial femoral artery (SFA) provides a unique difficulty, requiring advanced methods such as retrograde recanalization from the popliteal artery.³

Owing to a lack of working length distal to the tip of the access sheath, the ipsilateral CFA cannot be used as an access due to ostial lesions of the superficial femoral artery (SFA). The most popular alternate techniques are retrograde contralateral CFA and trans-brachial CFA. In the presence of iliac artery excess tortuosity, blockage, or stent, the former is problematic.⁴

In the case of SFA ostial lesions, operators who use the antegrade ipsilateral approach usually only implant the last few centimetres of the sheath into the CFA. As a consequence, the sheath is often unstable in this posture. This method of insertion commonly abuts the ostial SFA lesion during insertion. When trying to bridge an Obstruction, the force is conveyed to the partly implanted sheath, which might get dislodged from the artery, resulting in bleeding and access loss.⁵

In this situation, keeping a wire in the profunda femoris artery (PFA) throughout the process and allowing a buddy wire to pick the SFA is one option for maintaining access. If accessibility is mistakenly lost, the sheath may be reinserted over the profunda wire. ⁵

For flush SFA ostial occlusions, however, ipsilateral CFA access is difficult. This is due in part to the CFA's short length, which doesn't provide enough "working room" for sheath landing and stability, as well as catheter manipulation. To address this shortcoming, a double-wire approach called the "profunda anchor" was devised to enable ipsilateral antegrade intervention in situations with flush SFA blockage.⁶

Even if there is PFA stenosis, using a steerable microwire at entrance enables for the selection of PFA branches that are ideal for sheath implantation. In addition, if there is substantial PFA disease, endovascular "profundoplasty" might be done at the completion of the operation..⁵

Another procedure reported is inserting 2 to 3 cm of the sheath into the common femoral artery and leaving the rest of the sheath in a fashioned sub-cutaneous tunnel of the lower most abdomen, securing and shielding the sheath against unintended dislodgement.⁷

Except for the necessity for careful identification of both radiological and anatomical landmarks, the technical demands are similar to those for performing established antegrade punctures. Furthermore, the procedure does not need the use of any extra instruments. Limitations to using the suggested procedure include the PFA's inability to be cannulated and/or the CFA's high bifurcation.⁷

Aim of the work was to assess the feasibility, adequacy, safety, as well as complications of an ipsilateral antegrade procedure in patients with persistent lower limb ischemia who had superficial femoral artery ostial lesions.

PATIENTS AND METHODS

Between August 2019 and August 2021, 30 patients with peripheral arterial occlusive disease were included in this prospective cohort research at Al-Azhar University Hospitals (Al-Hussain and Bab-Alsheryah) (affecting ostium of the superficial femoral artery).

Inclusion criteria:

The study included patients with critical lower limb ischemia with Computerized Topographic Angiography (CTA) evidence of significant ostial lesion of femoral vessels with or without tibial lesions and presenting with the following: (1) Patient with previous angioplasty of aortic, ipsilateral iliac, contralateral iliac and CFAs lesions. (2) Thin and average built patients. (3) Patients with generally adequate state of cardiac, respiratory and renal conditions that allow the procedure. (4) Clinically, patients have: Disabling claudication or Ischemic rest pain, and tissue loss (as nonhealing foot ulcers or focal gangrene).

Exclusion criteria:

(1) Morbid obesity and pendulous abdomen. (2) A high bifurcation or occlusion of the CFA. (3) Aneurysmal disease and AVF at femoral region. (4) Patients with creatinine > 1.5 mg/dl have a known intolerance to study medicines or contrast agents. (5) Poor general condition (decompensated heart failure, stroke, bed ridden). (6) Clinically, patients have: Inevitable Above knee amputation, acute on top of chronic ischemia, and capacitating claudication.

All patients were subjected to: Pre-procedural assessment, history and Examination, ankle brachial pressure index measurement, routine laboratory investigations, plain X-ray of the foot (if ulcer or infection was present),duplex scanning, and CTA done to assess the infra-inguinal arterial system and to describe the femoral artery lesion characteristics (stenosis/occlusion), and length.

Equipment:

Duplex Ultrasound and C-arm (angiographic apparatus).

Materials:

Seldinger’s needle. A 0.018-inch microwire. 6 or 7 French caliber sheaths & their dilators. Hydrophilic coated Terumo® guidewire 0.035 French “J tipped” of 180 cm length. A 200-cm-long V18 (Boston Scientific, Natick, MA), for distal lesions. For procedure after passing lesion: 4 or 5 French Bernstein catheter. Balloon catheters (5-6 mm in diameter for femoral dilatation) with or without stent, and inflation device. Medications as xylocaine 2%, non-ionic contrast material, heparin, and nitroglycerine (Tridil).

Access Techniques:

Profunda Ancor technique:

Fig 1: Double wire technique and engaging the ostial cap.

Tunneled novel technique:

Fig 2: Tunnel creation after 2^nd puncture site.

Fig 3: Sheath stability after tunneling.

Fig 4: 1st puncture site suturing.

Procedure out comes:

The procedure was considered to be successful depending on the following:

Technical success; when PFA accessed firstly, then engagement of ostial lesion of SFA.

Post-operative success; no complication occurs as extravasation, hematoma, losing profunda access or pseudo aneurysm.

Clinical success; as improvements should include symptomatic improvement and change of at least one category according to TASC classification.

Operative follow-up:

Intraoperative:

Procedure-related complications occurred in 4 cases. Vessel perforation and extravasation in 1 patient and the perforations occurred at the proximal SFA during the attempt to cross the lesion whish treated only by balloon tamponade without surgical intervention, Residual stenosis in another case , Dissection in mid SFA and treated by stenting and puncture site hematoma whish resolved spontaneously by compression. However, none of our cases suffered Intraoperative thrombosis, pseudoaneurysm or arteriovenous fistula. And Finally, No life threatening complications or retroperitoneal hematoma occurred in any patient

Post-operative:

At 1, 6 & 12 months"

One patient was lost to follow-up throughout the follow-up period, which lasted from one to twelve months. In addition, two patients died for other reasons at this time. Claudication severity, rest pain, and toe ulcers all enhanced considerably during a 10.5 month ±1.5 follow-up period. The pulse of the distal arteries could be felt, as well as the filling of the veins. At one year following intervention, the ankle-brachial index increased from 0.48± 0.17 to 0.84 ±0.11 (P<.001), and patency rates were 95 percent, 72 percent, and 41 percent, respectively, at 1, 6, and 12 months.

Minor amputation on occurred in three cases after 6 months and and major amputation occurred in one case.

Restenosis occurred in 5 cases after 1 year duo to neglection of treatment and remaining of risk factors specially smoking.

Statistical analysis:

SPSS version 28 was used for data administration and statistical analysis (IBM, Armonk, New York, United States). The sole numerical variable was age, which was represented by the average and standard deviations. Numbers and percentages were used to summarize categorical data. The age of individuals who had technical success was compared using an independent t-test, while categorical data was compared using Fisher's exact test. To calculate the time to occurrence, the Kaplan Meier curve was utilized. To compute the difference between two or more sets of qualitative variables, use the Chi square test (χ2). P values of less than 0.05 were deemed relevant.

RESULTS

The median age of the studied patients was 56 ±8 years. There was a male predominance (70%). Rutherford Category was four in 30%, five in 40%, and six in 30%. About three quarters had hypertension (70%), and most patients had diabetes (86.7%). Smoking was reported in about two-thirds (63.3%). Ischemic heart disease was reported in 43.3%, while dyslipidemia was reported in 53.3% (Table 1).

The most frequent extension of the lesion was SFA CTO total length till the adductor canal (36.7%), followed by proximal 1/3 SFA tight stenosis extending into middle 1/3 of SFA (26.7%), proximal SFA CTO extending into middle 1/3 of SFA (20%), and proximal 1/3 SFA tight stenosis (16.7%). Most patients showed technical success (80%), and most of them (79.2%) had endo-luminal wire passage. The most frequent type of passage in failure cases was contralateral antegrade (50%), followed by transbrachial antegrade (33.3%) and popliteal ipsilateral retrograde (16.7%) (Table 2).

Most patients showed no complications (86.7%). Only four patients reported dissection in mid-SFA (one patient), puncture site hematoma (one patient), residual stenosis (one patient), and vessel perforation and extravasation (one patient) (Table 3).

All patients showed clinical improvement at one month. At six months, minor and major amputations were reported in three patients and one patient, respectively. Also, one patient lost follow-up, and one patient died. At one year, one patient had restenosis (20.8%), and one died (Table 4).

There was no significant variances were reported between those with and without technical success regarding age (P = 0.796), gender (P = 1.0), rutherford Category (P = 0.616), hypertension (P = 1.0), diabetes (P = 1.0), smoking (P = 1.0), ischemic heart disease (P = 0.672), and dyslipidemia (P = 1.0) (Table 5).

Kaplan Meier curve was done to estimate time to event (any) in the studied patients. At six months, the improvement rate declined to 83.3%, and at one year, it declined to 62.5% (Figure 5).

Table 1: General characteristics of the studied patients.

* The proportions are based on a total of 24 patients that had technical success.

** The proportions are based on a total six patients without technical success

Table 2: Extension of the lesion and procedure characteristics in the studied patients.

Table 3: Procedure complications in the studied patients.

* Percentages were calculated based on 24 patents

Table 4: Follow up findings in the studied patients.

Table 5: Patients’ characteristics according to technical success.