*Corresponding author:Dr. Meera R. Boulos, Vascular and Endovascular Unit, Department of Surgery, Suez Canal University Hospital, Ismailia, Egypt
How to cite this article:Anubha B. Assessment of Clinical Outcomes of Pedal
Arteries Angioplasty for Patients with
Critical Lower Limb Ischemia in Suez Canal
University Hospital. Open Access J Surg. 2020; 12(1): 555830. DOI: 10.19080/OAJS.2020.12.555830.
Background: Patients with lower extremity peripheral artery disease (PAD) experience substantial functional disability due to claudication, rest pain, and minor or major tissue loss . Arterial revascularization is the optimal treatment to prevent limb loss. Several clinical trials have reported that the existence of pedal artery disease results in worse wound healing. Hence, adjunctive revascularization procedures for pedal artery disease might improve the rate of wound healing [2,3].
Aim of the study: To evaluate the clinical outcomes of pedal arteries angioplasty among patients with critical lower limb ischemia regarding severity of rest pain, duration and rate of wound healing.
Patients and methods: Between June 2017 and January 2019, this study was carried out as an interventional study on 30 consecutive CLI patients who underwent infra-genicular endovascular revascularization, using Planter Loop Technique then divided into 3 groups complete PAA, incomplete PAA, non-PAA. Study was conducted in Vascular Surgery unit, Department of Surgery Suez Canal University Hospital and to evaluate the clinical outcomes of pedal arteries angioplasty.
Results: On table post-procedural foot angiography showed 10 patients (33%) had successfully PAA, 12 patients (40%) had incomplete PAA and 8 patients (27%) had non-PAA. The mean (and standard deviation) of the ABPI raised from 0.53 (+/- 0.22) before the intervention to 0.926 (+/- 0.108) post procedural. Patients with PAA showed better relieve of rest pain, less duration and rapid rate of wound healing than the others.
Conclusion: Endovascular treatment is increasingly becoming the first-choice strategy for patients with CLI. Pedal-plantar arch angioplasty in situation with extensive arterial disease below the ankle in patients with CLI is an adjunctive technique that can help achieve tissue perfusion and subsequently accelerate the wound healing and relieve rest pain.
Patients with lower extremity peripheral artery occlusive disease (PAOD) experience substantial functional disability due to claudication, rest pain, and minor or major tissue loss . Critical limb ischemia is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels. The pedal arch describes the connection between the anterior and posterior circulation in the foot . An intact pedal arch has been associated with improved wound healing, as well as a higher patency rate for bypass grafting and percutaneous interventions for inflow disease [5-7]. Pedal arch intervention should therefore be considered in patients
with rest pain, ulcers, gangrene, major tissue loss, with a goal of restoring arterial flow to the tissues .
This was an interventional study took place in the Vascular Surgery Unit, Surgery department, Suez Canal University Hospital during the period from June 2017 till January 2019.
Inclusion criteria: included
i.Both sexes ages from 18 -80 years old.
ii. All patients with critical lower limb ischemia involving
the foot present with one or more of the following: Rest pain
not relieved for 2 weeks, Ulcer of toes or forefoot not healed for
6weeks and Gangrene of toes or forefoot.
iii. Patients with normal or non-significant stenosis at
common iliac artery, common femoral artery and upper superficial
femoral artery are suitable for antegrade trans-femoral pedal
Exclusion criteria: included
i. Patients refuse to be included in the study.
ii. All arterial lesions associated with A-V malformation
and aneurismal dilatation.
iii. Patients presented with proved vasculitis.
iv. Patients who are not fit for angioplasty as:
v. Patients with Chronic liver disease if there is prolonged
vi. Patients with Heart failure if the patient is orthopneic
and cannot lay on table for long time).
vii. Patients with impaired renal function.
Procedures and methods
i. Detailed history.
ii. Full vascular examinations.
iii. Imaging & investigations (CTA & Duplex).
i. Patients fasted for 4 hours pre-operative, then the
procedure was performed under local anesthetic (5-10 ml of 1%
ii. Site of arterial puncture: antegrade puncture of the IPSIlateral
iii. Every case was studied individually, the procedure was
done in operation room under complete aseptic technique, and
mobile C arm (Philips flat panel C arm 15 KW) with vascular
iv. Patients was placed supine. The ipsilateral common
femoral artery was punctured using a single-piece 18-gauge
needle. After selective wiring of the superficial femoral artery, an
11-cm-long, 6-F Terumo introducer sheath (Terumo Interventional
Systems, Somerset, NJ) was place. Heparin 50 IU/ kilo was given
IV, half of the dose was given when the procedure continued for
more than one hour.
v. Baseline angiography was performed to obtain pictures
of the femoropopliteal tract, as well as below the knee vessels
(BTK) and foot vessels.
vi. Regarding on table pre procedural angiography, all cases
had diseased infra-genicular vessels. According to Kawarada 
classification which described three types of pedal arch disease,
we found that all cases had absent pedal arch (APA); as they
had neither of the dorsalis pedis artery nor none of the plantar
arteries were patent and the circulation of the foot was established
through collateral vessels.
vii. Once baseline angiography is obtained, the
revascularization strategy was planned. The lesions may be
crossed trans-luminally or subintimal.
viii. A 0.018-inch (Boston Scientific, V-18 control wire,
0.018 x 300 cm) hydrophilic guide-wire was advanced into the
occluded pedal artery with the support of a microcatheter 0.018
in all presenting cases as our 1st choice. V-14 (Boston Scientific,
V-14 control wire, 0.014 x 300 cm) was tried after V-18 failure
ix. The use of appropriate x-ray equipment capable of
subtraction angiography and magnification is crucial to carefully
navigate the wire through the anastomotic connections between
the dorsalis pedis and plantar artery. A very useful trick is to
bring the balloon catheter to the distal dorsalis pedis or plantar
artery and then to inject contrast locally to assess a possible
road of connection. The availability of a low-profile, dedicated
balloon catheter is then very important to follow the wire through
tortuous vessels. Local injection through the balloon catheter can
also be used to confirm the correct intraluminal position before
x. Specifically, two approaches can be attempted in each
patient: (1) antegrade recanalization of the anterior tibial artery
and the dorsalis pedis followed by retrograde recanalization of
the plantar artery and then of the distal posterior tibial artery
or (2) antegrade recanalization of the posterior tibial artery and
the plantar artery followed by retrograde recanalization of the
dorsalis pedis and then of the distal anterior tibial artery.
xi. The inflation should last between 60 and 180 seconds.
The balloon size for foot vessels and plantar arch is usually 2.5
mm. The inflation pressure ranges between 7 and 10 atm, and the
anastomotic region is included in the target segment undergoing
dilatation. Associated femoral, popliteal and tibial vascular lesions
if found were treated as well.
xii. After inflation, the balloon was retrieved, while leaving
the guidewire in place, to perform digital subtraction angiography
and appraise post percutaneous transluminal angioplasty (PTA)
results. If angiographic success is apparent, the guidewire
was retrieved, and final control angiography was performed.
Otherwise, subsequent inflations at higher pressure or with larger
balloons was performed for any residual stenosis greater than
xiii. Routinely or If spasm occurred, 0.1–0.2 mg of
nitroglycerin was infused as an intra-arterial in bolus.
xiv. On table post-procedural angiography of the foot
was used to divide the patients into the following three groups
according to the post-procedural angiography status of the
pedal arch: complete pedal artery angioplasty (complete PAA),
incomplete pedal artery Angioplasty (incomplete PAA) group, and
non-pedal artery angioplasty (non PAA) group.
xv. After the procedure, homeostasis was achieved with
Manual compression of the accessed PA (7-10 minutes), followed
by a compressive bandage was performed in all procedures.
xvi. Technical success was defined as restored patency with
no stenosis greater than 30% as per reporting standards. A poor
result was defined as improvement in patency but with stenosis
greater than 30% whilst failure will be defined as no change in
patency or failure to cross the lesion.
xvii. Post procedural medication: All patients were medicated
on: LMWH (low molecular weight heparin) for 3 days and Dual
anti platelets for 3 months.
Follow-up for both groups
ABI, symptoms, pulses & duplex were assessed in these
intervals: Next day, After one week and Every month till 6 months
Between June 2017 and January 2019, 30 consecutive
CLI patients underwent infra-genicular endovascular
revascularization at our vascular unit in SCUH. The ratio of male
to female patients nearly equal; 16 men (53.3%) and 14 women
(46.7%) with a mean age of 61.63 ± 8.865 years. Regarding the
risk factors, 27 patients (90%) were diabetics, 20 patients (67%)
were hypertensive and 5 patients (17%) had ischemic heart
disease. Regarding the dyslipidemia, 27 out of the thirty patients
(90%) were positive. Only 5 patients were smokers and they were
all males, while only 5 of the females reported negative smoking,
as shown in Figure 1.
Regarding the presenting symptoms, 6 of the patients (20%)
presented with ischemic rest pain (Rutherford class 4) which
was of grade 7 according to pain scale, three patients among the
latter group had associated toes discoloration. We also found that
21 patients (70%) presented with minor tissue loss (Rutherford
class 5), while only 3 patients (10%) presented with superficial
heel gangrene (Rutherford class 6), as shown in Figure 2.
Concerning, Ankle brachial index pre-intervention: ABPI in
the presenting limb ranged between 0 and 0.8 with a mean of 0.53
(+/- 0.21), as shown in Table 1.
Regarding pre procedural Duplex and CTA; it showed that only
5 patients (16.6%) had significant distal SFA lesion associated
with tibial disease, as shown in Figure 3.
On table diagnostic angiography showed that all cases had
diseased infra-genicular vessels, diseased pedal vessels and
absent pedal arch. Angioplasty was carried on using planter-Loop
technique. Complete PAA was achieved in 10 cases, 8 patients
using V-18 and 2 patients using V-14 wires following V-18 trial.
Incomplete PAA was achieved in 12 cases, 7 patients using V-18
and 5 patients using V-14 wires following V-18 trial. Non PAA
was done in 8 cases despite both V-14 and V-18 trials, (p = 0.003,
significant), as shown in Figure 4.
In all patients with non PAA, we failed to cross the pedal arch
using 0.018 or 0.014-inch hydrophilic guide-wire, as shown in
In such cases, unfortunately we were not able to use retrograde
pedal and digital access techniques as they usually require an
adequate access site, which was very restricted due to ulcers and
infections. Five patients among 8 cases who had non-PAA (62.5%)
and 9 patients (75%) among 12 cases who had incomplete PAA
had associated foot wounds or infection obscuring distal access
site. Retrograde pedal and digital access techniques were not
feasible even in the remaining non wounded cases as they had
extensive pedal artery disease disturbing their original arterial
mapping, and the foot blood supply was depending mainly on
the patency of the newly developed collateral channels between
them. On table post-procedural angiography of the foot was used
to divide the patients according to the pedal arch status into the
following three groups; 10 patients (33%) had successfully PAA,
while 12 patients (40%) had incomplete PAA. Eight patients
(27%) had failed pedal artery angioplasty (non-PAA) and ended
up with tibial angioplasty only, as shown in Figure 6.
Average duration of the procedure, contrast used and
radiation exposure burden are shown in Table 2. All surgeons
working adherent to the operation table were wearing radiation
personal protective equipment. During the hospital stay, all 27
patients (90%) presented with tissue gangrene, foot wounds or
toes discoloration, underwent aggressive wound management.
Surgical treatment of the wound consisted of debridement
without bone resection in 4 cases (13.3%) while toe/ray
amputation was done in 13 cases (43.3%). On the other hand, 7
patients who presented with patches of dry gangrene (23.3%)
or those 3 patients who presented with toes discoloration (10%)
underwent conservative management with no further surgical
intervention post angioplasty as the gangrene shortly started to
slough and the discoloration disappeared later during their post
operative period, as shown in Figure 7.
Also, the mean (and standard deviation) of the ABPI raised
from 0.53 (+/- 0.22) to 0.9 (+/- 0.07) at by the end of 6th month
follow up period, as shown in Figure 8.
Regarding, during the 6 months follow-up period, all 6
patients with rest pain (grade 7) at presentation reported total
relieve of symptoms post procedural. Those who had incomplete
PAA reported more reported faster relieve of pain than those who
had non PAA, (p = 0.008, significant), as shown in Figure 9.
Concerning, During the follow-up, patients with PAA showed
more dramatic rapid wound healing more than the others, with
P=0.001, as shown in Table 3, and Figure 10.
During the follow-up, neither of the recovered patients
reported recurrence of symptoms nor loss of the previously
retrieved distal pulse. Only one patient started to develop infective
gangrene of the adjacent toe which was treated by surgical
debridement for the infective toes. None of the patients developed
neither extensive foot infection nor gangrene nor required
major limb amputation. The following are 2 case examples that
Case 1: Sixty years old female patient, diabetic. She presented
with dry gangrene over fore-foot and distal phalanx of RT big toe,
ischemic ulcer at dorsum of RT fore-foot. By clinical examination,
palpable femoral pulsation bilaterally, non-palpable pop nor Tibial
pulsations, Rt LL ABPI was over ATA and PTA 0.8. Duplex showed
that she has occluded PTA, distal peroneal a., DPA. Ballooning
Angioplasty of peroneal a., ATA, DPA and complete PAA was
achieved. First day post-op palpable ATA, PTA, ABI 1 over both
ATA, PTA. The patient showed similar results over her periodic
FU visits after one week up to 6 months. Fore-foot dry gangrene
sloughed, and ischemic ulcer healed within 2 months, as shown in
Figure 11 & 12.
Critical limb ischemia secondary to infra-genicular PAD is
associated with high amputation and low survival rates [9,10].
The re-establishment of pulsatile flow to the pedal and plantar
arches in below the knee region is a key factor to foot and limb
salvage [11,12]. The demographic data and risk factors of the
studied patients were as expected for this type of disease [13-15].
Although the sample size was small, but diabetes, hypertension
and hyperlipidemia all were prevalent among the studied group of
patients. Most of the patients in this study were diabetics (90%),
hypertensive (67%) and dyslipidemia (90%); which is similar
to Mohammed Ali et al.  study which is a similar research
conducted here at Egypt.
Regarding the presenting symptoms, a study conducted in
Japan by Tatsuya Nakama et al.  involving 275 patients showed
that most enrolled limbs, 200 limbs (77.8%) were classified as
Rutherford Class 5. Is spite of different sample sizes, our study
shows similar results as 21 cases out of 30 of the presenting
patients (70%) presented with minor tissue loss (Rutherford
class 5). Nakama et al.  also showed that 128 involved limbs
(49.8%) underwent surgical debridement or minor amputation
. Nevertheless, all 24 patients (80%) in our study presented
with tissue gangrene or foot wounds underwent aggressive
wound management as well. That implies that all patients involved
presented with critical limb ischemia.
This was associated with low mean ABPI (0.53 +/- 0.21)
in this study. This is common in similar studies in the same
community , which may reflect an awareness or financial
problems that prevent the patient from seeking medical advice in
early stage of this disease. This, most probably, should affect the
outcome of management for such cases, making the comparison
of interventional outcome with the international publications
difficult. Complete PAA was achieved in 10 cases; 8 patients
using V-18 and 2 patients using V-14 wires following V-18 trial.
Incomplete PAA was achieved in 12 cases; 7 patients using V-18
and 5 patients using V-14 wires following V-18 trial. Non PAA was
done in 8 cases in spite of both V-14 and V-18 trials. On the other
hand, several studies such as Nakama et al/ , Nicola et al/ 
and Manzi et al. [20,21] studies all showed that the procedure was
performed using 0.014-inch hydrophilic guide-wire as their 1st
choice mainly in all cases. Nakama et al.  reported successful
crossing of occluded pedal vessels using V-14 in 140 patients
(54%) who underwent PAA, while in the remaining 117 patients
(45.5%) failure to cross the pedal lesion occurred. However, Nicola
et al.  showed that they successfully achieved complete PAA in
42 patients (30.7%), incomplete PAA in 60 patients (43.8%), and
non-PAA in 35 patients (25.5%).
On the other hand, Mohamed Ali et al.  study that
was conducted in Egypt as well had the same 0.018-inch
hydrophilic guide-wire used in their procedure. By applying the
aforementioned protocol, they successfully managed to cross the
pedal-plantar arch lesions in 19 (90.5%) patients, and failed to
cross the pedal-plantar arch lesions in two (9.5%) patients and
unfortunately, they ended up in below-the-knee amputation owing
to an associated extensive tibial artery disease and aggressive
foot infection. That may imply that both wires have comparable
results regarding passing the pedal arch vascular lesions. We
used a low profile dedicated 2.5 mm balloon catheter in 22 cases.
Complete and incomplete PAA was achieved in 10 and 12 patients
consecutively. On the other hand, 3 mm balloon catheter was
used in all tibial angioplasty. These results are consistent with the
previous mentioned studies [16,17,19-21] as they used different
low-profile balloon catheters all ranged between 2-3 mm for same
range of inflation time.
In all patients with non PAA or incomplete PAA, we failed
to cross the pedal arch using 0.018 or 0.014-inch hydrophilic
guide-wire. In such cases, unfortunately we were not able to use
retrograde access techniques as they usually require an adequate
access site, which was very restricted due to ulcers, infections or
extensive pedal artery disease disturbing their original arterial
mapping, and the foot blood supply was depending mainly on
the patency arterial collaterals. These restrictions were found
and proved in other studies as well [11,22-24]. Some technical
solutions were introduced but still controversial. Angiosomeoriented
direct revascularization, which might improve the blood
supply toward target wounds, is a widespread strategy [8,25].
However, other studies showed that the effectiveness of the
angiosome concept is still controversial . Based on the fact
that in patients with pedal artery disease, original angiosome
mapping is already destroyed, and the blood supply toward the
target wounds depends on the patency of the newly developed
collateral channels . These results are consistent with those of
Azuma et al.  and Attinger et al.  as well. For example, our
study shows that regardless the angiosomal blood supply dilated
in the cases, all of them showed slowly progressive incomplete
wound healing by the end of our 6 months follow up period. Thus,
this support the argument that the angiosome theory is not totally
effective in patients with pedal artery disease.
Our study shows that patients who underwent PAA showed
a higher rate of complete wound healing and shorter time to
heal than patients without PAA. These results are similar to
Mohammed Ali et al.  study as 19 (90.5%) patients got their
wounds completely healed during 3 months duration. Utsunomiya
et al.  and Nakama et al.  showed similar results as well.
During 6 months follow-up period, neither of our patients
reported recurrence of symptoms. Only 3 patients (10%) started
to develop infective gangrene of the adjacent toe which was
treated by surgical debridement for the infective toes. None of the
patients developed neither extensive foot infection nor gangrene
nor required major limb amputation. On the contrary, Mohammed
Ali et al.  study showed that during the one year follow-up,
two patients underwent limb amputation owing to failed crossing
of the pedal-plantar arch and only one (6.25%) patient underwent
limb amputation after one year, while all the remaining patients
had complete wound healing within 6 months duration. Khalil
et al.  highlighted similar results where the major limb
amputation at one year was 4%.
i. Endovascular treatment is increasingly becoming the
first-choice strategy for patients with CLI. Pedal-plantar arch
angioplasty in situation with extensive arterial disease below the
ankle in patients with CLI is an adjunctive safe technique that can
help achieve tissue perfusion and subsequently accelerate the
wound healing and relieve rest pain. We recommend the following:
ii. Pedal arch angioplasty can improve the clinical outcomes
with accelerated wound healing in patients with CLI.s
iii. We successfully were able to pass pedal vessel lesions
using V-18 guide-wire in most cases whether they had complete
or incomplete PAA; therefore, it represents a fine 1st choice in CLI
cases with extensive pedal disease.
iv. The pedal plantar loop technique is a safe and feasible
technique and appears to provide a proper revascularization of
the foot arteries.
v. Further studies in this research area with larger sample
size, more equipment, and different techniques and longer follow
vi. Provide proper health education to all patients with
possible risk factors.