Outcomes of infrapopliteal angioplasty in patients with critical limb ischemia

Outcomes of infrapopliteal angioplasty in patients with critical limb ischemia

Wagih Fawzy, MD; Ayman A Hassan, MD; Ahmed Abou Elnaga, MD;

Ahmed Kamal, MD

Department of Vascular Surgery, Ain Shams University, Cairo, Egypt.

Abstract

Background: Critical limb ischemia is the natural endstage in many patients with atherosclerotic chronic lower limb ischemia. Most of these patients are risky for major surgical revascularization procedures. Infrapopliteal angioplasty can represent an alternative procedure to the popliteal to distal bypasses in such group  of patients.

Aim of the study:  To evaluate the efficacy ofinfrapopliteal angioplasty in management of patients with critical  limb ischemia.

Patients and methods: 48 limbs  in 47 patients with  critical limb ischemia, secondary to atherosclerosis involving the tibial vessels, underwent treatment with tibial angioplasty.Immediate technical success, sustained clinical improvement based on Rutherford upward categorical shift, and limb salvage rates were assessed and recorded.

Results:  75% of involved  patients belonged to category 4-6 of Rutherford  classification. 63%

had pure tibial disease and 37% had a concurrentfemoropopliteal multilevel disease. 92% of tibia/lesions were classified as TASC D lesions. Immediate technical success was recorded  in

44 limbs  (91.6%). Sustained clinical improvement and  limbs salvage rates were 100%, 92%,

84% and  77% at 1, 3, 6 and 12 months, respectively.

Conclusion: Infrapopliteal angioplasty represents an effective method  in treating patients with critical/ower limb ischemia.

Introduction:

Patients with critical limb ischemia  (cLn

represent the most advanced stage of chronic

ischemia. These patients  often have diffuse disease affecting multiple levels including the infrapopliteal vessels.l

A substantial portion  of these  patients, requiring arterial revascularization, do not have adequate saphenous vein, and the alternative conduits have inferior patency and limb salvage rates.2

CLI  also reflects  an advanced, systemic form of atherosclerotic disease that renders the patients  at high risk for complications after open surgical revascularization.3

Aim of the study:

Was to evaluate the efficacy and safety of infrapopliteal angioplasty in the management of patients with CLI.

Patients and methods:

A prospective  study involved 48 limbs in

47 patients was done in Ain Shams University hospitals and Al-Ahssa Hospital, Saudi Arabia, during the period between March 2008 and March 2010  analyzing the  outcomes of infrapopliteal angioplasty.

All patients enrolled in this study had one

of the presentations of CLI that was defined by the European  consensus  document as the presence of ischemic rest pain requiring opiate analgesia for at least 2 weeks, ankle systolic pressure lower  than  50 mmHg  and/or toe systolic pressure lower than 30 mmHg or the presence of ischemic ulcer or foot gangrene.4

The expected underlying pathology  was atherosclerosis and the involved vessels were either the tibial vessels alone or in concurrent with femoropopliteallesions.

Any patient had one of the following criteria was excluded from the study:

1-  Patients not  fulfilling criteria of  CLI.

2- Patients  with functionally unsalvageable limbs.

3-   Underlying  pathology  rather  than

atherosclerosis  e.g.  Burger's disease.

4- Patients with no runoff.

5- Patients with chronic renal impairment with S.creatinine>1.5 mg% (contraindication for usage of contrast).

All patients were submitted to a thorough

physical examination with special care to the pulse deficits, Doppler evaluation  and ankle brachial index (ABI).

The  tibial  disease was  evaluated using multislice CT angiography or digital subtraction angiography.

The  lesion anatomy (presented in  the angiography) was assessed according  to the Trans-Atlantic Inter-Society Consensus II (TASC  II) criteria5  as shown  in Table(l).

Table (1): TASC II classification for infrapopliteallesions.

The lesions were classified according to the target vessel to be treated which was the most likely to provide an inline flow down to the foot. In case of the presence of simualtneous stenotic and occlusive lesions or two lesions of the same type but with varying lengths, we classified the lesion  according to the most severe lesion type.

Periprocedure medications:

All  patients were  given  clopidogril 75 mg/day one week before the procedure. If it was not possible to start clopidogril before the procedure,  it was given as a loading dose of

300 mg once at the morning of the procedure. Clopidogril was maintained as 75 mg daily for

3 months combined  in the first week with a weight based dose of low molecular  weight heparin  (LMWH) in  therapeutic doses.

After 3 months all patients were maintained

on aspirin 1OOmg daily for life.

Procedure:

An arterial access was obtained using a 6F sheath through an  antegrade ipsilateral approach. Retrograde contralateral access was used;  if  there  was  a concurrent proximal

superficial femoral artery (SFA) lesion.

Lesions  were  crossed  with a 0.035  inch hydrophilic wire.  A 0.014  or 0.018  inch platinum tipped wires were used if the 0.035 wire could not be navigated through the lesion.

Subintimal procedures Figure(l) were used

only  if  the  transluminal approach failed

Figure(2).

All  patients were  anticoagulated with systemic heparin during the  procedure.

Angioplasty was performed using a balloon

diameter of 2-3 mm, whereas 4 mm balloon diameter was used in the tibioperoneal  trunk. Long balloons (10-22 em) were used to prevent arterial injury or dissection.

The development of flow limiting dissection or persistence of> 30% residual stenosis were the indications for using nitinol self-expandable stents (at level  of tibioperoneal trunk) or coronary balloon mounted stents (distally at tibial vessels).

Defmitions used:

-Technical success:No or residual stenosis of

< 30% with an inline flow in at least one tibial vessel down to the foot.

-Multilevel intervention: Femoropopliteal

interventions in conjunction with tibial interventions.

-Multivessel intervention: Intervention in more

than one tibial vessel.

-Clinical success: Improvement of rest pain or progressive healing  of  the   wounds.

Postoperative follow up:

All patients were followed up for one year. Failure of primary patency was considered if symptoms recurred in the face of worsening ABI  due  to  recurrence of  the  lesions.6

Patients with recurrent symptoms secondary to progression of the disease  in the iliac  or femoropopliteal segments were considered as clinical failures but not failure of primary patency.

Table (2): Demographic data of the patients.

Also, patency was considered to be failed if surgical bypass was needed to save the limb or post procedure major  amputation was needed.

Statistical method used:

Kaplan-Meier methodology was used to assess the  outcomes  of  the   procedure.

Results:

In this study, the tibial angioplasty was used to treat 48 limbs in 47  patients. The demographic and clinical data of these patients are summarized in Table(2).

Clinical stratification of the patients enrolled in  our   study, according to  Rutherford categories,? showed 2 patients (4%) enrolled as category 4 (rest pain), 10 patients (21%) as category 5 (minor tissue loss) and 36 patients (75%)  as  category 6  (major  tissue loss).

30 patients (63%) had pure tibial disease and  18  patients (37%) had  a  concurrent femeropopliteal multilevel disease. The anterior

tibial artery was the most commonly  treated artery with a 64% predominance, the posterior tibial artery was our target vessel in 54% of treated limbs and the peroneal artery in 56% of the cases.

Table(3)   summarizes  the    lesion

characteristics and the procedures done in the treated 48 limbs.

Table (3): Lesion characteristics and procedures done.

We achieved an immediate technical success in 44 limbs (91.6%) with only 4 failures. In these failures, the tibial vessels were totally occluded and calcified that can't be crossed by

the wires. Two of these patients underwent surgical bypass while the other two patients had primary amputations.

(A)                                 (B)                                  (C)                                    (D)

Figure (1): (A) Anterior tibial artery occlusion just distal to the origin, (B) Guide wire loop in the subintimal space, (C) Successful  anterior tibial artery re-canalization, failed attempt for posterior tibial artery canalization, wire loop in the subintimal space (D) Patent dorsalis pedis artery, (E) Gangrenous third toe (before re-canalization), (F) Minor amputation of the second and   third  toes,  arrest  of   gangrenous process with  proximal limb  salvage.

(A)                                          (B)                                        (C)

(D)                                                                          (E)

Figure (2): (A) Left posterior tibial artery showing significant stenosis (1em) at lower 1/3 and complete occlusion (3cm) distally. (B) Balloon dilatation. (C) Successful regaining of straight­ line blood flow through the stenotic and occluded segments. (D) Left transmetatarsal amputation one   day   after  PTA. (E)   Complete healing  of   the   stump  3  months after  PTA.

Clinical improvement was observed in 35 limbs based on Rutherford upward categorical shift  with absence of rest pain and/or progressive tissue healing  together with improved ABI.

Sustained clinical improvement based on

Rutherford upward categorical shift  is represented by  the  Kaplan-Meier curve Figure(3) which shows a sustained clinical improvement of 100%, 92%, 84% and 77% at

1,  3,  6  and   12  months, respectively.

% of sustain ed cllnciallmprov

10

80

60

40

20

0

3                 6                12  Month!

Figure (3): Kaplan-Meier curve showing sustained clinical improvement.

Follow  up of the haemo-dynamic outcome showed an improvement  in 95%, 85%, 71% and 42% of patients at 1, 3, 6, and 12 months, respectively.

The  limb   salvage rate   in  technically

Table (4): End points of the study.

successful  cases  was 100%,  92%, 84% and

77% at 1, 3, 6 and 12 months, respectively.

Table(4) shows the end points of the study and their incidence.

Complications:

The overall mortality was 7(15%), however the deaths were  due to progression of concurrent comorbidities as cardiac and pulmonary diseases. No cases developed large

Discussion:

Bypass surgery using the outflow vessels in the distal ankle and foot was considered the standard line  of treating patients  with CLI secondary to tibial disease.8 However, it needs good vein conduit and is associated with 0.9% perioperative mortality, 3% cardiac morbidities and 6.6% graft thrombosis.9

For these reasons, in:frapopliteal angioplasty is currently proposed as the primary line of treatment of patients with CLI.lO

This  study  was conducted on a selected patient population with  CLI secondary to infragenicular arterial disease in  order  to precisely  evaluate  the clinical  outcomes of angioplasty in tibial vessels.

Our studied population consisted of a very homogenous group  of predominantly male patients with a mean age of 65 years and or remarkable  association  of diabetes mellitus, hypertension and ischemic heart disease with in:fragenicular diffuse multiple occlusive lesions rather than focal stenotic lesions.

The limb salvage  rate at one year in this

study was higher than that of the patency rate. This  can  be  explained as the  temporarily recanalized vessels increase the blood flow to the foot that had a positive effect in eradicating infection and healing ulcers. The healed foot has a lower oxygen demand, so less blood flow

groin hematoma. Contrast nephropathy occurred  in 4(8%) patients  and non of them required dialysis.

is generally required to maintain tissue integrity and  keep  the    limb  asymptomatic.ll The results  obtained  by a study  done by Soder et al.ll on 72 limbs showed an initial technical success rate of 61% and 18 months patency  and limb salvage of 48% and 80%,

respectively.

Similarly, Vraux et al.,12reported a technical success rate of 78% and a one-year  primary patency rate of 58%.

In our study, the initial success was 91.6%

which was higher than the previous trials.This may be explained by the advances in the wire's and balloon's technology nowadays which was not present in previous trials that were done on year 2000.

Our results were similar to that obtained by

a large trial done on 443 patients by Boisers et ai.,lO who reported a one-year  patency of

74% and limb salvage rate of 96%. These results led them to predict that tibial angioplasty would become the first line therapy for CLI.

Conclusion:

Angioplasty  of the infragenicular vessels represents an effective method in treatment of CLI and should be the first treatment option in those  patients  who would, otherwise, be offered distal bypass surgery or amputation,