Abstract
Background
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.
Aim
The aim of this study was to evaluate 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.
Results
Our study had male predominance (83.3%) 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.
Conclusion
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.
Keywords
Hybrid, revascularization, critical limb ischemia.
Introduction
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 associated with a high risk of loss of the affected limb. CLI is therefore undoubtedly responsible for increasing morbidity and mortality and consumes substantial social and healthcare resources.[1]
Successful treatment of patients with CLI has always been a challenge for the vascular surgeon, this can be attributed to the fact that atherosclerotic lesions usually involve multiple vascular beds, thus requiring extensive, multilevel revascularization procedure.[2]
Furthermore, CLI is frequently associated with several medical conditions, making these patients high risk for extensive open surgical procedures.[3]
With the widespread embracing of fixed imaging systems within the vascular operating room and the increasing 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 achieved 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 evident patency benefits of open vascular surgery with the advantages of less-invasive endovascular interventions to deliver a long-lasting and safe solution.[5]
Aim
The aims of this study were to evaluate 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.
Inclusion criteria:
• Patient with Critical Limb Ischemia presented with rest pain or tissue loss (Fontaine III-IV, Rutherford 4-6).
• 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.
Exclusion criteria:
• Patient with a significant contraindication to angiography:
i. Patient with renal impairment.
ii. Patient with hypersensitivity to the dye.
• 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.
Reconstruction of the common femoral artery and bifurcation was typically completed using a patch (autogenous saphenous vein or synthetic material).
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.
A guide wire and a catheter were directed to the intraluminal space of external iliac artery and the iliac artery is treated endovascularly.
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.
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.
Hemostasis was established by placing a Prolene suture at the puncture site. Final angiography was done to verify patency of the runoff arteries.
All patients were followed by clinical evaluation, ABI and colour duplex at 1, 6 and 12 months.
Technical success was defined as residual stenosis <30% on completion intraoperative arteriography.
Statistical analysis
Statistical analysis was performed using Windows version 20.0 (SPSS; SPSS Inc., Chicago, Illinois, USA). Categorical variables were reported as numbers with percentages. Continuous variables were reported as means with standard deviation. Chi-square test was used to compare qualitative data between different groups.
All P-values <0.05 were considered significant. The primary patency rate on an intention-to-treat basis of angioplastied vessels was calculated by the survival analysis techniques (Kaplan-Meier curve).
Results
The study included 25 (83.3%) males and 5 (16.67%) females with a mean age of 65 ± 10.28 years (range: 50- 85 years) (Table 1).
In our study 12 (40%) patients were suffering from CLI in right lower limb and 18 (60) patients were suffering from CLI in left lower limb.
The most frequent risk factor in the current study group was smoking where 18 (60%) patients were smokers followed by Diabetes in 16 (53.3%), hypertension in 14 (46.7%) and dyslipidemia in 12 (40%) of patients. Other risk factors in the current study were history of coronary artery diseases and stroke in 9 (30%) and 3 (10%) patients respectively (Table 2).
Table (1): Sex distribution in the study group
Sex Frequency (n (%))
Male
Female
Total 25 (83.3%)
5 (16.67%)
30 (100%)
Table (2): Risk factors
Risk factors Frequency (n (%))
Smoking
Diabetes Mellitus
Hypertension
Dyslipidemia
Coronary artery disease
History of stroke 18 (60%)
16 (53.3%)
14 (64.7%)
12 (40%)
9 (30%)
3 (10%)
Clinical presentation of the study group is shown at (Table 3). Digital gangrene (Rutherford category 6) was the most frequent presentation where it presented in 15 patients (50%) followed by lower limb ulcer (Rutherford category 5) in 10 patients (33.3%) and rest pain (Rutherford category 4) in 5 patients (16.7%).
Table (3): Clinical Presentations in the Current Study Group
Rutherford Category Clinical Description Frequency (n (%))
4
5
6 Ischemic rest Pain
Minor tissue loss (ulcer)
Major tissue loss (gangrene)) 5 (16.7%)
10 (33.3%)
15 (50%)
The CFA was involved with atherosclerosis in all cases (100%). It was associated with inflow disease involving the ipsilateral iliac artery in 8 cases (26.7%), with outflow disease (Femoropopliteal and leg vessels) in 8 cases (26.7%), and associated with both inflow and outflow disease in 14 cases (46.6 %).
Femoral endarterectomy was combined with both proximal and distal endovascular angioplasty interventions in 12 cases. In two cases femoral endarterctomy was combined with surgical bypass and distal endovascular intervention.
Femoral endarterectomy was combined with proximal endovascular angioplasty in eight cases, and with distal endovascular angioplasty in another eight cases (Table 4).
Table (4): Types of intervention in the current study Group
Intervention Frequency (n (%))
Femoral endarterectomy
+ proximal and distal PTA
+surgical bypass and distal PTA
+proximal PTA
+distal PTA
12 (40%)
2 (6.6%)
8 (26.7%)
8 (26.7%)
Technical success was achieved in 46 out of 48(95.8%) of procedures. In two patients, there was a failure to cross the SFA owing to the presence of a chronic long-segment occlusion. In these two cases, no intervention in addition to the CFA endarterectomy and iliac angioplasty was attempted, because both patients were treated for rest pain and the decision made was to assess the effect on each patient’s symptoms.
Hemodynamic and clinical success was achieved in all patients (100%) patients included in the study. The mean resting ABPI improved significantly, rising from 0.34 ± 0.053 preoperatively to 0.79 ± 0.121 after the intervention (P < 0.05).
Only 4 cases had postoperative complications that were managed successfully. These complications represent 13.3% of the whole study group, their frequency of occurrence and their management is shown in (Table 5). There was no postoperative 30 day mortality.
Table (5): Complications of Interventions of the Current Study Group:-
Complication Frequency (n (%)) Management
Arterial Thrombosis
Acute myocardial infarction on the 2nd postoperative day
persistent lymphorrhea 1(3.3%)
1(3.3%)
2(6.7%) Thrombectomy
remained in the coronary ICU for 3 days, and was discharged on the 15th day in good general condition
conservatively without need for
any intervention
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 as shown in figure (1).
Primary Patency rate Secondary Patency rate
Figure (1): Kaplan-Meier curve shows cumulative primary and secondary patency rates in limbs treated with hybrid procedures for critical limb ischemia
In our study limb-salvage rate at 1st, 6th and 12th months were 100%, 100 %, and 93.3% respectively as shown in figure (2).
Figure (2): Kaplan-Meier curve shows limb salvage rate in limbs treated with hybrid procedures for critical limb ischemia.
The 1-year patency rate was significantly lower in diabetic patients than among non- diabetic (P- value = 0.03).
The 1-year patency rate was significantly lower in patients presented with combined outflow& inflow disease than among patients with inflow or outflow disease only (P-value = 0.01).
The 1-year patency rate was significantly higher when vascular stents were placed than among non-stented arteries (P- value 0.03).