DepartmenFrance.

CorrespondVascular SurgRue Pierre D�echu-nice.fr

Ann Vasc Surhttp://dx.doi.or� 2013 Elsevi

Manuscript rec

11, 2013.

894

Percutaneous Angioplasty of Long TibialOcclusions in Critical Limb Ischemia

Nirvana Sadaghianloo, Elix�ene Jean-Baptiste, Serge Declemy, Aur�elien Mousnier,

Sophie Brizzi, and R�eda Hassen-Khodja, Nice, France

Background: The aim of this study was to assess the midterm results of percutaneousangioplasty in patients with critical limb ischemia (CLI) and long tibial occlusions.Methods: Between January and September 2011, 34 consecutive patients with patent femoro-popliteal artery and 49 segmental tibial occlusions >8 cm were included in our prospective,single-center cohort study. Clinical success (defined as wound healing and survival withoutmajor amputation), patency, and freedom from target vessel revascularization (TVR) wereexamined.Results: The median age of the patients was 75 (53e89) years, 74% were diabetic, and 89%of the limbs studied were Rutherford 5 and 6. Median follow-up was 12.5 (1e15) months. The1-year clinical success rate was 65%, higher among patients with technical success (76% vs.25%, P ¼ 0.01) and patients with 2 or 3 patent tibial arteries after the procedure (90% vs.41% in patients with only 1 patent artery, P ¼ 0.003). At 1 year, primary and secondary patencyrates were 13% and 32%, respectively (24% and 58% without technical failures). The 1-yearfreedom-from-TVR rate was 34%.Conclusions: Despite high technical failure rates and the need for repeat procedures,percutaneous angioplasty of long tibial occlusions enhances wound healing, especially whenintegrated into a maximal revascularization approach.

INTRODUCTION

In the recent European guidelines for critical limb

ischemia (CLI), percutaneous angioplasty has been

recognized as a reasonable first-line therapeutic

modality for patients with CLI and infrapopliteal

lesion, in the majority of cases.1 Distal surgical

bypass is a well-acknowledged therapeutic modality

and must be considered for more complex anatomic

lesions of tibial arteries or in cases of endovascular

failure and persisting clinical symptoms of CLI.1,2

However, without a specific classification of infra-

popliteal arterial disease, the role of endovascular

t of Vascular Surgery, University Hospital of Nice, Nice,

ence to: R�eda Hassen-Khodja, MD, Department ofery, University Hospital of Nice, Hopital Saint Roch, 5voluy, 06000 Nice, France; E-mail: hassen-khodja.r@

g 2013; 27: 894–903g/10.1016/j.avsg.2013.02.008er Inc. All rights reserved.

eived: December 8, 2012; manuscript accepted: February

treatment in complex anatomic lesions remains

unclear. Recent studies have shown high technical

success rates and better limb-salvage rates in

patients undergoing angioplasty of heterogeneous

infrapopliteal lesions, with however, an inconstant

proportion of long tibial occlusions and various defi-

nitions of success.3,4 The objective of our single-

center study was to prospectively assess the 1-year

clinical and patency results of percutaneous angio-

plasty in a specific cohort of patients with CLI and

long tibial occlusions.

METHODS

Between January and September 2011, all consecu-

tive patients admitted to our vascular surgery

department with CLI and infrapopliteal arterial

disease were assessed for revascularization. Defini-

tion of CLI followed the current consensus: presence

of ischemic rest pain for >2 weeks (Fontaine stage

III, Rutherford class 4) or ischemic tissue loss associ-

ated with an absolute ankle pressure of <50 mm Hg

Vol. 27, No. 7, October 2013 Angioplasty in tibial occlusions 895

or great toe pressure of <30 mm Hg (Fontaine stage

IV, Rutherford class 5 or 6).

Endovascular treatmentwas thefirst-line strategy

for all patients whenever technically achievable.

Patients who underwent primary major amputa-

tion owing to irreversible ischemic damage were

primarily excluded from our database. In nonambu-

latory patients with limited life expectancy, CLI

was managed conservatively by the best medical

treatment, including analgesic, antibiotic, statin,

and antiplatelet therapy, and their data were also

excluded from analyses.

Patients with patent femoropopliteal arteries and

segmental tibial occlusions >8 cm, diagnosed by

angiography and eligible for endovascular treat-

ment,were included in our prospective cohort study.

Exclusion criteria were acute limb ischemia,

recent (<6 months) ipsilateral revascularization,

concomitant open vascular surgery, endovascular

treatment of venous bypasses, isolated nonocclusive

stenoses and short occlusions (<8 cm) of tibial

arteries, long occlusions without distal vessel visu-

alization, and isolated below-the-ankle arterial

occlusions.

The study was conducted according to the Decla-

ration of Helsinki, and the institutional ethics

committee of our hospital approved this protocol.

Patients gave informed consent before inclusion in

the study.

Treatment Protocol

Before the intervention, a nephron-protection

protocol was commenced in all patients with creat-

inine clearance <30 mL/min: a 3-mL/kg/hr sodium

bicarbonate infusion 1 hr before and 1 mL/kg/hr for

6 hours after the procedure.

All procedures were performed in the operating

room by an experienced vascular surgeon, under

local, regional, or general anesthesia, according to

patient’s age and comorbidities.

After anterograde puncture of the ipsilateral

common femoral artery, we attempted to recanalize

all selected long occlusions via a 5F sheath by a trans-

luminal or subintimal approach, using dedicated

0.014-in. below-the-knee wires (Pilot 200 and

Winn 200T; Abbott Vascular, Abbott Park, IL).

Angioplasty was performed using dedicated low-

profile balloons (Armada 0.14 [Abbott Vascular]

and Advance 0.14 [Cook Medical, Inc., Blooming-

ton, IL]). In successfully recanalized arteries,

stenting (Xpert; Abbott Vascular) was only used in

the case of a flow-limiting dissection that was not

resolved by 5-min balloon inflation.

At the beginning of the procedure, 3500e5000 IU

of heparin was administered based on the patient’s

weight. At the end of the procedure, the access site

was closed using a percutaneous suture device

(StarClose SE; Abbott Vascular). Surgical treatment

to remove necrotic tissue and drain the abscess

was performed at the end of the interventional

procedure when necessary, and this was always

accompanied by broad-spectrum antibiotic therapy.

After the intervention, all patients received

75 mg/d of aspirin for life, with an additional

75mg/d of clopidogrel for 1month. Optimalmedical

treatment for vascular risk factors and additional

wound care were given to all patients.

Assessment of the peripheral circulation was

systematically performed by a duplex scan during

follow-up at 1, 3, and 6 months, or more frequently

depending on individual clinical needs; repeated

angiography was limited to patients with symp-

tomatic recurrent stenosis/occlusion or additional

arterial lesions that were suspected clinically.

Outcome Measures and Definitions

Revascularization of at least one of the 3 leg arteries

with reestablishment of a direct arterial flow to the

foot was considered a technical success. The main

outcome measure was the clinical success rate.

Clinical success was defined as complete tissue loss

healingwithoutmajor amputation (Rutherford class

5 and 6 patients) or upward shift of at least 2 clinical

symptom categories according to the Rutherford

classification (Rutherford class 4 patients).

Secondary outcome measures were patency and

freedom from target vessel revascularization (TVR).

Primary patency was defined as uninterrupted

patency with no additional procedures performed

on or at the margins of the treated segment. Assisted

primary patency was used when patency was not

lost but maintained by prophylactic intervention.

Secondary patency concerns any patent revascular-

ization, even after a reintervention.5

Statistical Method

Statistical analysis was performed with StatView

software, version 5.0 (SAS Institute, Inc., Cary,

NC). Nominal variables were expressed as a number

and a percentage of patients. Differences of categor-

ical variables were assessed by the 2-tailed Fisher’s

exact test. Continuous variables were expressed

as the mean standard deviation or the range for

non-Gaussian distributions. Differences between

continuous variables were assessed by 2-tailed

unpaired t-test. Differences with a value of P <0.10 were statistically controlled by logistic

Fig. 1. Initial treatment of patients with critical limb ischemia.

Table I. Population characteristics

Number of patients 34

Male 23 68%

Female 11 32%

Risk factors

Hypertension 25 74%

Diabetes 25 74%

Current smoking (<3 years) 6 18%

Hyperlipidemia 17 50%

Comorbid diseases

Severe renal insufficiency 9 27%

ESRD on dialysis 4 12%

BMI >30 7 21%

COPD 3 9%

Coronary artery disease 16 47%

Cerebrovascular disease 5 15%

Medication

Antiplatelet 32 94%

Statin 29 85%

Beta-blocker 20 59%

ACE inhibitor 12 35%

Oral glucose-lowering medication 15 44%

Insulin therapy 15 44%

Mode of presentation (37 limbs)

Rutherford 4 4 11%

Rutherford 5 30 81%

Rutherford 6 3 8%

ACE, angiotensin-converting enzyme; BMI, body mass index;

COPD, chronic obstructive pulmonary disease; ESRD, end-

stage renal disease.

Fig. 2. (A) Long occlusion of both anterior and posterior

tibial artery. (B) Successful recanalization of anterior

tibial artery. The posterior tibial artery was not attempted

(no distal vessel visualization).

896 Sadaghianloo et al. Annals of Vascular Surgery

regression analysis. The KaplaneMeier life-table

method was used to calculate patency curves. Bivar-

iate assessment of interdependency of gender and

patency was performed by applying log-rank tests.

Table II. Predictive factors of technical failure:

Univariate analysis of 49 recanalization attempts

Success Failure

Pn % n %

Total (N ¼ 49) 27 55% 22 45% dGender

Male 15 47% 17 53% 0.14

Female 12 71% 5 29%

Age (years) 71.5 ± 10.5 75.8 ± 10.1 0.15

Comorbid diseases

Hypertension 21 58% 15 42% 0.52

Diabetes 24 65% 13 35% 0.02

Severe renal

insufficiency

9 69% 4 31% 0.33

Fontaine stage

III 1 20% 4 80% 0.15

IV 26 59% 18 41%

Rutherford

classification

4 1 20% 4 80%

5 23 58% 17 42% 0.20

6 3 67% 1 33%

Occlusion

length (cm)

14.7 ± 5.8 18.3 ± 4.2 0.01

Table III. Predictive factors of clinical success:

Univariate analysis of 37 limbs

Success Failure

Pn % n %

Total (N ¼ 37) 24 65% 13 35% dGender

Male 14 56% 11 44% 0.14

Female 10 83% 2 17%

Age (years) 73 ± 11.1 76.5 ± 9.3 0.33

Comorbid diseases

Hypertension 19 70% 8 30% 0.27

Diabetes 19 70% 8 30% 0.27

Severe renal

insufficiency

8 80% 2 20% 0.43

Coronary artery

disease

14 78% 4 22% 0.17

Medication

Antiplatelet 23 66% 12 34% >0.99

Statin 21 68% 10 32% 0.64

Beta-blocker 15 71% 6 29% 0.48

ACE inhibitor 9 69% 4 31% 0.73

Oral glucose-lowering

medication

9 60% 6 40% 0.73

Insulin therapy 14 82% 3 18% 0.38

Occlusion length (cm) 15.2 ± 6.8 18.1 ± 6.7 0.13

Technical success

(29 of 37)

22 76% 7 24% 0.01

ACE, angiotensin-converting enzyme.

Table IV. Predictive factors of clinical success

Vol. 27, No. 7, October 2013 Angioplasty in tibial occlusions 897

The Cox proportional hazards regression model was

used to control potentially confounding factors for

censored variables. Differences are expressed

as hazard ratio (HR) with 95% confidence interval

(CI). P< 0.05was considered statistically significant.

among Fontaine stage IV limbs (N ¼ 33)

Success Failure

Pn % n %

Number of patent arteries

at end of procedure

1 5 35% 9 65% 0.006

2 15 88% 2 12%

2 15 88% 2 12% >0.99

3 2 100% 0 0%

Patency of angiosome

arteries

At least 1 artery 16 73% 6 27% 0.43

No artery 6 55% 5 43%

RESULTS

Between January and September 2011, 153 consec-

utive patients were admitted to our vascular surgery

department with CLI and infrapopliteal arterial

disease. Thirty patients were excluded from our

study: 22 with irreversible ischemic tissue loss who

underwent primary major amputation, and 8 with

limited life expectancy who were managed conser-

vatively. Treatment concerning the remaining 123

patients with CLI and eligible for revascularization

are summarized in Figure 1.

According to our selected criteria, 34 patients

presenting with 37 CLI and long tibial occlusion

(Fontaine stage IV, Rutherford class 5 and 6)

(89%) were included in our cohort study (Fig. 1).

The median age was 75 (range 53e89) years, and

23 (68%) of the patients were men. Patients’ demo-

graphic data, mode of presentation, risk factors for

arteriosclerosis, and comorbidities are summarized

in Table I.

Forty-nine occluded tibial arteries with a mean

length of 16.2 ± 5.9 cm were considered for either

transluminal or subintimal angioplasty (Fig. 2)

among the 34 patients. Twenty-two artery recanali-

zation attempts failed, owing to the inability to cross

or dilate highly calcified lesions (n¼ 17), an absence

of tibial blood flow at the time of final angiography

(n ¼ 4), or tibial artery rupture (n ¼ 1). In the

univariate analysis (Table II), the length of the

lesion was significantly higher in the failed

Fig. 3. Clinical evolution of patients with ischemic tissue loss.

898 Sadaghianloo et al. Annals of Vascular Surgery

recanalization attempts group (16.3 ± 6.1 cm vs.

11 ± 3 cm; P ¼ 0.02 [t-test]). Technical failures

were also more common in nondiabetic patients

than in diabetic ones (75% vs. 35%; P ¼ 0.01).

Multivariate logistic regression analysis showed

that lesion length (odds ratio [OR] ¼ 1.19; 95%

confidence interval [CI] 1.03e1.38; P ¼ 0.01)

and nondiabetic patients (OR ¼ 8.02; 95% CI

1.61e39.89; P ¼ 0.01) were independent predictors

of technical failure. Of note, the length of the lesion

was similar in diabetic and nondiabetic patients

(16.5 ± 4 cm vs. 15.7 ± 5.8 cm; P ¼ 0.63 [t-test]).

Further clinical characterization of this nondiabetic

subgroup could not be achieved because of the

small sample size and insufficient data collection.

With respect to the number of limbs treated,

the technical success rate was 78% (29 of 37)

(Table III). Five stents were implanted in this series

because of residual stenosis (n ¼ 3) or vessel dissec-

tion (n ¼ 2). The final angiography showed no

improvement in 8 limbs, despite revascularization

attempts on at least 1 occluded artery.

The 30-day complication rate was 9% (1 retro-

peritoneal hematoma, 1 calf hematoma after arterial

perforation, and 1 myocardial infarction). No death

occurred during this period.

Median follow-up was 12.5 (range 1e15)

months. One patient was unavailable for follow-

up. Patient survival rate was 91% at 12 months.

Four patients (12%) died within the follow-up

period (1 multiorgan failure, 1 respiratory failure,

1 heart failure, 1 mesenteric infarction).

The clinical success rate at 1 year, defined as

wound healing without major amputation, was

65%. Clinical success was higher among patients

with 2 patent tibial arteries after the first procedure

(88%) versus patients with only 1 patent artery

(35%) (P ¼ 0.006 by Fisher’s exact test). Given

that there were only 2 patients with 3 patent tibial

arteries, comparison between patients with 2 vs.

3 patent arteries was not significant (P < 0.99

by Fisher’s exact test) (Table IV). The clinical evolu-

tion of patients with ischemic tissue loss showed

improvement within the first 3 months, and

progressive wound healing within 6 months

(Fig. 3).

Primary patency rates at 6 months and 1 year

were 27% and 13%, assisted primary patency rates

were 41% and 28%, and secondary patency rates

were 47% and 32%, respectively. When consid-

ering only those patients with an initial technical

success, primary patency rates at 6 months and 1

year were 48% and 24%, assisted primary patency

rates were 74% and 52%, and secondary patency

rates were 85% and 58%, respectively (Fig. 4).

During follow-up, 14 TVRs were performed on 10

patients (12 limbs) with delayed healing. Seven

patients who healed in spite of restenosis did not

undergo any further revascularization procedures.

Freedom from TVR was 34% at 1 year.

The occlusion lengthwas associatedwith resteno-

sis or thrombosis in the univariate analysis (16.3 ±

6.1 cm vs. 11 ± 3 cm; P ¼ 0.02 [Fisher’s exact test])

(Table V), but not in the multivariate analysis

(hazard ratio [HR] ¼ 1.06; 95% CI 0.98e1.14;

P ¼ 0.11 [Cox model]). In both the univariate and

multivariate analyses, male gender was an indepen-

dent predictor of higher primary patency

(HR ¼ 0.32; 95% CI 0.12e0.87; P ¼ 0.02 [Cox

model]) (Fig. 5). Gender-related outcome was no

longer significant in secondary patency rates (HR ¼0.46; 95% CI 0.18e1.22; P ¼ 0.11 [Cox model]).

Fig. 4. (A) KaplaneMeier analysis of patency. (B) KaplaneMeier analysis of patency (without primary technical

failures).

Vol. 27, No. 7, October 2013 Angioplasty in tibial occlusions 899

DISCUSSION

In this cohort of patients with CLI and long tibial

occlusions, the technical success rate of angioplasty

was 78%. To the best of our knowledge, this is the

first series dealing with CLI and long tibial artery

occlusion simultaneously. Other series have either

excluded long tibial occlusions, contained cases

with mixed short and long tibial occlusions, or

Table V. Predictive factors of patency loss:

Univariate analysis of 27 recanalized arteries

Patency loss Patent arteries

Pn % n %

Total (N ¼ 27) 19 70% 8 30% dGender

Male 8 53% 7 47% 0.04

Female 11 92% 1 8%

Age (years) 73.8 ± 9.6 66 ± 11.3 0.07

Comorbid diseases

Hypertension 16 76% 5 24% 0.31

Diabetes 16 67% 8 33% 0.53

Severe renal

insufficiency

8 100% 0 0% 0.06

Medication

Antiplatelet 19 70% 8 30% dStatin 14 64% 8 36% 0.27

Beta-blocker 13 81% 3 19% 0.20

ACE inhibitor 9 90% 1 10% 0.18

Oral glucose-lowering

medication

7 58% 5 42% 0.39

Insulin therapy 9 60% 6 40% 0.23

Occlusion length (cm) 16.3 ± 6.1 11 ± 3 0.02

ACE, angiotensin-converting enzyme.

900 Sadaghianloo et al. Annals of Vascular Surgery

included many patients with tibial stenosis.6e13 In

a previous meta-analysis, Romiti et al. reported

a mean technical success rate of 84% in heteroge-

neous series with tibial occlusions and stenoses.3

In our series, limited to tibial occlusions, we failed

to recanalize 22 of 49 occluded tibial arteries

(45%), which seems to be a poor result; however,

this is comparable to findings reported by Ferraresi

et al., who had a technical success rate of 48%

when treating 281 stenosed or occluded tibial

arteries.10 The length of the lesion was predictive

of technical failure in our series. Vraux et al.

reported similar results with occlusions >10 cm.6

Postoperative and long-term complications were

similar to previously published data.14 Only 1 death

occurred within the first 6 months of follow-up.

Therefore, endovascular treatment of long tibial

occlusions may not increase morbidity and

mortality.

Limb salvage and amputation-free-survival rates

are often considered as primary end-points in

similar studies.15,16 However, focusing on wound

healing is at least as important to evaluate midterm

results of a revascularization technique in patients

with ischemic tissue loss. Considering the high rate

of primary technical failure in long tibial occlusions,

the clinical success rate in our series seems discor-

dant, although similar, to some published literature

findings (55e80%).6,7,17e19 Our analysis of clinical

success predictors shows that the number of patent

tibial arteries at the end of the procedure may be

of paramount importance in wound healing. Two

patent tibial arteries will lead to a higher rate of clin-

ical success than only 1 patent tibial artery

(P¼ 0.006). Iida et al. reported quite similar findings

when evaluating the angiosome concept in CLI.16

Considering the positive wound-healing outcome

and the infrequency of postoperative complications,

we may advocate, when possible, the revasculariza-

tion of at least 2 tibial arteries, instead of limiting

attempts to 1 artery.

In our series, specific direct revascularization of

the angiosome did not prove efficient in terms of

wound healing (Table III). Iida et al. reported a 4-

year amputation-free survival rate of 49% in a direct

revascularization group compared with 29% in an

indirect group (P ¼ 0.0002).20 However, the angio-

some theory remains controversial.21e23 in CLI

because one given wound often covers several

angiosomes. Therefore, direct revascularization of

all supplying arteries is probably the best approach

for the patient.

In addition to these findings, we found that the

length of the occlusion was predictive of restenosis.

Lazaris et al. demonstrated that the length of occlu-

sion and the number of run-off vessels were the

main determinants of patency after subintimal

angioplasty of infrainguinal arteries, but they

included only 6 isolated infrapopliteal angioplasties

in their cohort.24

Patency was assessed by duplex scan in all recan-

alized arteries of our series, and even by angiog-

raphy for some patients (61%). Our patency rates

are low, mostly due to a high primary technical

failure, and comparison of our patency rates with

those of previously published heterogeneous

cohorts remains difficult. Interestingly, 74% of our

patients are diabetic and in the recent European

guidelines for CLI, Dick et al. noted that, in diabetic

patients, primary patency rates are quite poor, but

with close follow-up and reinterventions one can

attain acceptable secondary patency and

amputation-free survival rates.25 Our results are

consistent with this statement.

In our study, we have shown female gender to be

predictive of poor primary patency. Gender-related

outcome in peripheral occlusive vascular disease

has already been described after carotid and femoro-

popliteal artery surgery26e29 Pomposelli et al. also

found that 5-year vein graft patency after a dorsalis

pedis bypass was worse in women.2 Although our

study was not designed primarily with this aim in

Fig. 5. (A) Log-rank analysis of gender-related primary patency. (B) Log-rank analysis of gender-related secondary

patency.

Vol. 27, No. 7, October 2013 Angioplasty in tibial occlusions 901

902 Sadaghianloo et al. Annals of Vascular Surgery

mind, we suggest closer follow-up after angioplasty

of long tibial occlusions in women.

Study Limitations

This prospective, non-randomized, single-center

study has several limitations. We assessed a small

number of patients, which makes statistical

interpretation difficult. However, our restrictive

inclusion criteria allowed us to assess outcomes

for a specific type of lesion.

Another limitation was that patency was deter-

mined by conventional angiography in only 61%

of cases during follow-up. Our personal experience

and some recent literature have shown that Duplex

ultrasound only has a limited value for the investi-

gation of infrapopliteal lesions.30 However, the use

of a noninvasive technique seemed preferable in

our high-risk population.

In conclusion, despite high technical failure rates

and the need for repeated procedures, endovascular

treatment of long tibial occlusions does enhance

wound healing. Our data also suggest that patients

with 2 patent tibial arteries have higher clinical

success rates than patients with only 1 patent artery.

In our specific subset of patients, female gender was

predictive of patency loss. Although described in

previous studies on other arteries, gender-related

outcome in infrapopliteal arteries should be assessed

further in a larger study population.

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