The alternative of hybrid revascularization surgery combines the well-established patency benefits of open vascular surgery with the advantages of less-invasive endovascular interventions to provide a durable and safe solution for critical limb ischemia.
The aim of this study was to evaluate of the feasibility and efficacy of hybrid therapy in patients with complex multifocal steno-obstructive vascular disease and report short and midterm outcomes through assessment of patency and salvage rates.
Patients and methods
This study was conducted prospectively on thirty patients who presented to the Department of Vascular Surgery of Assiut University Hospital with critical limb ischemia due to multilevel peripheral arterial disease involving CFA from November 2015 to November 2016. All patients underwent detailed history taking, and data were collected on age, sex and risk factors. Patients were further evaluated using clinical examination, measurement of the ankle brachial index (ABI), duplex ultrasound, and Computed Tomography Angiography if needed.
Our study had male (83.3%) predominance with a mean age of 65 years. The most frequent risk factor was smoking in 18/30 (60%). According to Rutherford classification, the majority of patients (50%) were treated for digital gangrene, followed by minor tissue loss (33.3%) and rest pain (16.7%). Femoral endarterectomy was done in all cases, combined with both proximal and distal endoluminal procedures in 40% of patients, with proximal endoluminal procedures only in 26.7 % and with distal endoluminal procedures in 26.7%. Technical success was achieved in 95.8% of procedures. The primary patency rate at 1st, 6th and 12th months were 96.7%, 90% and 80% respectively. Secondary patency rates at 1st, 6th and 12th months were 100 %, 83.3% and 67% respectively while limb-salvage rate at 1st, 6th and 12th months were 100%, 100 %, and 93.3% respectively. Diabetes has been found to reduce 1- year patency rate with statistically significant difference.
Hybrid lower extremity revascularization procedures can be used to treat CLI with low perioperative morbidity and mortality and good immediate and midterm patency and limb salvage.
Hybrid, revascularization, critical limb ischemia, Assiut.
Critical limb ischemia (CLI) is a condition in which patient presents a clinical status of pain at rest or at night and presence of tissue loss (ulceration, gangrene), and it is linked with a high risk of loss of the affected limb. CLI is therefore clearly responsible for increasing morbidity and mortality and consumes considerable social and healthcare resources.1
Successful treatment of patients with CLI has always been a challenge for the vascular surgeon, as atherosclerotic lesions usually involve multiple vascular beds, requiring extensive, multilevel revascularization procedure.2
Moreover, CLI is frequently associated with multiple medical comorbidities, making these patients high risk for extensive open surgical procedures.3
With the widespread adoption of fixed imaging systems within the vascular operating room and the developing endovascular skills of the vascular surgeon, patients now benefit from all-in-one procedures that are part open vascular surgery and part catheter-based intervention, so-called hybrid surgery. These procedures are often performed by a single vascular specialist under a single anesthetic in a single location, with clear patient benefits and cost savings of almost 50% compared to staged procedures in different locations.4
The alternative of hybrid revascularization surgery combines the well-established patency benefits of open vascular surgery with the advantages of less-invasive endovascular interventions to provide a durable and safe solution.5
The aims of this study were to evaluate of the feasibility and efficacy of hybrid surgical and endovascular therapy in patients with complex multifocal steno-obstructive vascular disease, report short and midterm outcomes through assessment of patency and salvage rates, evaluate safety of hybrid procedure, and report complications and need for re-intervention.
Patients and methods
This study was conducted prospectively on thirty patients (30 limbs) who presented to the Department of Vascular Surgery of Assiut University Hospital with critical limb ischemia due to multilevel peripheral arterial disease involving CFA from November 2015 to November 2016. The study was approved by the ethical committee of our institution. Patients or relatives of patients provided written consent for study participation.
1) Patient with Critical Limb Ischemia presented with rest pain or tissue loss (Fontaine III-IV, Rutherford 4-6).
2) Obstructive arterial disease in the femoral bifurcation segment (including the common femoral artery, femoris profunda, or the origin of the superficial femoral artery), and at least one level among the iliac, femoropopliteal and infragenicular arteries.
1) Patient with a significant contraindication to angiography:
i. Patient with renal impairment.
ii. Patient with hypersensitivity to the dye.
2) Patients presented with extensive necrosis or infective gangrene requiring primary major amputation.
All patients underwent detailed history taking, and data were collected on age, sex, cardiovascular risk factors such as smoking, diabetes mellitus (DM) and hypertension.
Patients were further evaluated using clinical examination, measurement of the ankle brachial index (ABI) using Doppler, duplex ultrasound, and multi-detector Computed Tomography Angiography if needed.
The Rutherford classification for limb ischemia was used to determine the clinical severity at the time of presentation as specified by the Society for Vascular Surgery (SVS) reporting standards.6
All patients underwent CFA endarterectomy in combination with endovascular repair of inflow and/or outflow lesions in the same surgical setting. CFA endarterectomy was performed using the standard technique under an ipsilateral common femoral bifurcation exposure through a longitudinal groin incision. During endarterectomy, adequate profunda femoral artery (PFA) outflow was always preserved or restored.7
Reconstruction of the common femoral artery and bifurcation was typically completed using a patch (autogenous saphenous vein or synthetic material).7
We then proceed to the endovascular part of the procedure; a standard 6 French sheath was inserted by puncture to distal part of the patch. The sheath was introduced only a short distance inside the artery to avoid subintimal placement.8
A guide wire and a catheter were directed to the intraluminal space of external iliac artery and the iliac artery is treated endovascularly.8
In the case of an iliac occlusion, the retrograde approach is the first choice, and the antegrade approach via the left brachial artery was adopted only if retrograde approach failed.8
For patients with critical ischemia and infrainguinal multilevel arterial disease, open femoral endarterectomy and distal intervention can be done simultaneously.The sheath is then placed in an antegrade fashion to treat femoropopliteal or tibial lesions.7
Hemostasis was estabilished by placing a Prolene suture at the puncture site. Final angiography was done to verify patency of the runoff arteries.7
All patients were followed by clinical evaluation, ABI and colour duplex at 1, 6 and 12 months.
Technical success was defined as residual stenosis