Abstract
Objective
To demonstrate the safety and feasibility of the transpedal approach as an alternate arterial access site for iliac artery intervention.
Background
The common femoral artery is the traditional access site for the endovascular treatment of iliac artery stenoses. However, this approach is associated with complication rates as high as 2%, including retroperitoneal bleeding which carries high patient morbidity and mortality. Furthermore, the standard femoral approach is associated with longer recovery times and longer time to ambulation which are important considerations especially when performing procedures in an ambulatory setting.
Methods
Twelve patients were prospectively followed after treatment for symptomatic iliac artery stenosis via transpedal access. Under ultrasound guidance, one of the pedal arteries was visualized and accessed, and stenting of the iliac arteries were performed as per protocol. The patient was monitored immediately post procedure and clinical follow up was performed at one week and one month later.
Results
The average age of the patients was 71 years old. 58% were male. Most patients had Rutherford class III symptoms. Successful stent placement was achieved in all 12 patients via transpedal access. No conversion to femoral access was required. No complications immediately post procedure nor at any time period during follow up were noted. Lower extremity arterial duplex at one month showed patent stents and patent pedal access site vessels in all patients.
Conclusion
Transpedal arterial access may be a safe and feasible approach for iliac artery stenting. Given the possible benefits of avoiding femoral artery access, larger studies should be conducted directly comparing the different approaches.
1
Introduction
Peripheral arterial disease (PAD) is a common and debilitating disorder which affects more than 8 million people in the United States . The rising prevalence of PAD is not only the result of an aging population, but also due to the increased incidence of cardiovascular risk factors such as diabetes, hypertension, and dyslipidemia. The increased population awareness of PAD has also lead practitioners to focus clinically on identifying typical and atypical symptoms, and also utilize non-invasive testing, such as ankle–brachial indices, for screening purposes. Furthermore, the rapid improvement in endovascular techniques and equipment has expanded the treatment options for patients with severe PAD.
The common femoral artery (either anterograde or cross-over technique) is the traditional access site for the endovascular treatment of iliac artery stenoses. However, femoral access site complication rates have been reported to be as high as 2%, and certain complications, such as retroperitoneal bleeding, carry high morbidity and mortality . Furthermore, longer recovery times and increased time to ambulation associated with the femoral approach are important considerations especially when performing procedures in office based laboratories or ambulatory settings. The recent interest in the transpedal approach for the treatment of PAD has followed the miniaturization of sheaths and equipment used for transradial coronary artery interventions – with a hope that the pedal arteries can provide the same reduction in complication rates and increased patient comfort in the treatment of PAD that the transradial approach has shown to do for its coronary counterparts. A single case study of iliac artery stenting for the treatment of an iliac artery chronic total occlusion via a combined transpedal–transradial approach was recently reported . In this current study, we report our initial single-center experience in a consecutive series of patients utilizing a single retrograde transpedal approach for the percutaneous treatment of iliac artery stenoses.
2
Methods
From July 1, 2015 to December 31, 2015, 12 consecutive patients were treated for symptomatic iliac artery stenosis at our institution. Patient data were prospectively collected and entered into a database. All patients had a prior diagnostic angiogram performed, and patients with focal, non-calcified, unilateral iliac artery lesions less than 100 mm in length (and not involving the common iliac artery ostium or extending into the common femoral artery) were selected for the planned interventional procedure via transpedal access. Lesions with moderate to heavy calcification, tortuous arteries and aorto–iliac lesions were excluded from the study. Extensive duplex ultrasound evaluation of all the pedal vessels were performed prior to the procedure and patients with severe below the knee PAD (i.e. one vessel run off to the foot) were also excluded. Written informed consent was obtained from each patient prior to the procedure. Risks and benefits regarding the selection of an initial access site were explained to each patient, and a transpedal approach was chosen in each case. The study was approved by the local institutional review board.
2
Methods
From July 1, 2015 to December 31, 2015, 12 consecutive patients were treated for symptomatic iliac artery stenosis at our institution. Patient data were prospectively collected and entered into a database. All patients had a prior diagnostic angiogram performed, and patients with focal, non-calcified, unilateral iliac artery lesions less than 100 mm in length (and not involving the common iliac artery ostium or extending into the common femoral artery) were selected for the planned interventional procedure via transpedal access. Lesions with moderate to heavy calcification, tortuous arteries and aorto–iliac lesions were excluded from the study. Extensive duplex ultrasound evaluation of all the pedal vessels were performed prior to the procedure and patients with severe below the knee PAD (i.e. one vessel run off to the foot) were also excluded. Written informed consent was obtained from each patient prior to the procedure. Risks and benefits regarding the selection of an initial access site were explained to each patient, and a transpedal approach was chosen in each case. The study was approved by the local institutional review board.
3
Endovascular procedure
After review of the prior angiograms and non-invasive imaging of the pedal arteries, the patient was brought to the catheterization laboratory and draped in sterile fashion, preparing the pedal area on the ipsilateral side of the iliac artery lesion. The contralateral groin was also prepped in case a conversion to femoral access was necessary, or if an emergency bailout was needed for complications. After sterile preparation, the pedal arteries (mainly the anterior tibial and posterior tibial arteries) were visualized and flow confirmed by lower extremity arterial duplex ultrasound utilizing a 13–6 MHz transducer. Once an access site was chosen in a patent pedal artery, a 21 gauge micropuncture needle was used for arterial access under ultrasound guidance followed by placement of a 4Fr Glidesheath (Terumo Corporation, Tokyo, Japan). After confirming arterial flow, 5000 units of heparin was given intravenously and an antispasmodic cocktail of nitroglycerin 100 μg and verapamil 2.5 mg was administered into the sheath. Additional heparin was given if required, to maintain the activated clotting time (ACT) >300 s. Initial angiogram of the tibiopedal region was performed to assess the size and disease burden of the tibial vessel. Next, a 0.014˝ Runthrough® 300 cm (Terumo Corporation, Tokyo, Japan) guidewire and a 125 cm, 4 Fr Tempo Aqua hydrophilic coated vertebral catheter (Cordis Corporation, NJ, USA) was advanced through the pedal arteries into the superficial femoral artery then finally into the iliac arteries and a selective digital subtraction cineangiogram was taken ( Fig. 1 ). Orthogonal views were taken to assess the disease burden. Then, the 4 Fr sheath was upsized to a 6 Fr Glidesheath Slender (Terumo Corporation, Tokyo, Japan) which is an ultra-low profile sheath with an outer diameter of 2.4 mm (equivalent to a 5 Fr sheath, but with a large inner lumen of 2.2 mm) that can accommodate 6 Fr equipment. The Runthrough® wire was then exchanged for a 0.035″ Supra Core® wire (Abbott Vascular, MN, USA). Either pre-dilatation with an undersized balloon or direct stenting using self-expanding SMART nitinol stents (Cordis Corporation, NJ, USA) was performed. After stenting, the lesion was routinely post-dilated with a 0.035″ over the wire Cordis® Powerflex® Pro balloon that was one size smaller than the chosen stent diameter to facilitate stent expansion. Post interventional cineangiograms were obtained ( Fig. 2 ) in multiple and orthogonal views to ensure adequate stent expansion and apposition and, most importantly, to rule out perforation. Continuous invasive hemodynamic monitoring was performed throughout the procedure and subsequently post procedure with serial vitals check and close clinical follow up.
Modified patent hemostasis was achieved using a VasoStat™ (Forge Medical, NJ, USA) or TR Band™ (Terumo Corporation, Tokyo, Japan). In brief, the TR Band was inflated at the site of pedal puncture with about 15 cm 3 of air. The sheath was then removed. If bleeding was still present, additional air was injected in 1 cm 3 aliquots and the puncture site was closely observed to ensure no bleeding was present. Patency of the pedal vessel was verified with Doppler ultrasound. The patient was then transferred from the interventional suite to the holding area and observed with serial vital signs and continued Doppler examination of pedal vessels. The TR Band was then deflated in 1–2 cm 3 intervals beginning 1 h after the procedure and continuing every 10–15 min until the device could be removed without bleeding. The patient was discharged home with a small bandage over the access site.
If the VasoStat™ was chosen for the closure device, the adhesive pads on the base of the VasoStat™ device were aligned so that the central plunger would compress the skin over both the skin entry site and the underlying entry point into the pedal artery. The plunger of the device was then ratcheted through the base until sufficient compression was achieved to permit sheath removal. The sheath was then removed and if necessary, additional 1–3 ratchets were applied by the operator until no oozing occurred from the puncture site but with intact Doppler signal. After 1 hour of compression, the VasoStat device was released by disengaging the ratchet mechanism to reduce the compressive pressure. All patients were discharged within 2 hour of intervention.
Dual-antiplatelet therapy was prescribed to all patients for at least one month. Patients were discharged home 2 h after the intervention and completion of hemostasis. Clinical follow-up was performed at 1-week and 1-month post intervention. Routine surveillance lower extremity arterial duplex was performed at 1-month post intervention to establish patency of the intervened extremity including the access site.
4
Results
Patient baseline characteristics are shown in Table 1 . The average age was 71 years old, 58% were male, average BMI was 25.7, 42% had DM, and 58% were active smokers. The majority (83%) of patients presented with severe claudication (Rutherford Class III) while two patients presented with signs of critical limb ischemia (Rutherford Class IV–VI). The anterior tibial artery was accessed in 11 out of 12 patients and only one patient required posterior tibial artery access. Lesions were characterized with the Trans-Atlantic Inter-Society Consensus II (TASC II) classification system . Procedural characteristics are shown in Table 2 . Successful stent placement was achieved in 100% of patients. No conversion to femoral artery access, or other alternate access, was required. No complications, including hematoma, pseudoaneurysm, AV fistula, perforations, or blood transfusions immediately post procedure or at one month follow up was noted. Lower extremity arterial duplex at one month showed patent stents and patent access site vessels in all patients.
| Pt | Age | Sex | BMI | DM | HTN | HL | Smoking | CrCl | RC | PCI | CABG |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 86 | F | 28.3 | N | Y | N | N | 26.5 | III | Y | N |
| 2 | 80 | M | 27.8 | Y | Y | Y | Y | 66.9 | III | N | N |
| 3 | 63 | F | 25.9 | Y | Y | Y | Y | 116.2 | V | N | N |
| 4 | 66 | F | 24.9 | Y | Y | Y | Y | 73.2 | III | Y | N |
| 5 | 67 | F | 21.4 | Y | Y | Y | N | 51.7 | III | N | N |
| 6 | 78 | F | 22.3 | N | Y | Y | N | 56.2 | V | N | N |
| 7 | 85 | M | 27.1 | N | Y | Y | N | 81.1 | IV | Y | Y |
| 8 | 71 | M | 24.2 | Y | Y | Y | Y | 86.2 | III | Y | N |
| 9 | 56 | M | 30.8 | N | Y | Y | Y | 203 | III | Y | N |
| 10 | 62 | M | 27.4 | N | Y | Y | Y | 88.8 | III | Y | N |
| 11 | 69 | M | 24.6 | N | Y | N | Y | 76.9 | III | N | N |
| 12 | 69 | M | 24.6 | N | Y | Y | N | 75.6 | III | N | N |
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