Femoropoplital bypass versus endovascular treatment for long superficial femoral artery occlusion

Femoropoplital bypass versus endovascular treatment for long superficial femoral artery occlusion

HeshamAbu  Greda, MD; Nehad Zaid, MD

Vascular Surgical Unit, Menoufiya University Hospitals, Menojj;a, Egypt.

Aim: To evaluate the effectiveness of angioplasty and stenting versus above-knee bypass in the treatment of symptomatic long segment superficial femoral artery lesions.

Patients  & methods:  60 patients with symptoms of superficial femoral artery lesions P- 10

em long) were enrolled into the study. Thirty patients were randomly assigned to percutaneous transluminal angioplasty (PTA) and primary stenting. Another 30 patients underwent bypass surgery. All  patients in both groups  were followed  up at 1, 3, 6 and 12 months after either procedure.

Results:  Patients who underwent endovascular treatment have got a primary patency rate

71.4% and a secondary patency rate 89.2%. Patients who underwentfem-pop bypass have got a primary patency rate 77. 7% and a secondary patency rate 81.4% at 12 months follow up. The primary & secondary patency rates among both groups were not significantly different (P

= 0.754 & 0.451 respectively).

Conclusion: Endovascular  treatment is an  effective  procedure  as bypass  surgery in the treatment of long superficial femoral artery lesions. It holds the advantages of short hospital stay and avoidances of surgery-related wound infection especially in diabetics.

Key words: Angioplasty, patency & bypass surgery.

Introduction:

Management of symptoms of superficial femoral   artery  long  lesions  SFA  poses  a unique challenge for vascular surgeons world­ wide. This is owing to the complex interplay of various factors including: the underlying pathology,  anatomic  defect,  degree  of ischemia, co-morbid conditions, functional status, previous ambulation and suitability of anatomy for successful revascularization.

There are two widely available treatment

options   for   lower   limb   revascularization (1) bypass surgery and (2) endovascular treatment. The goals of both modalities are relieving   pain,  promoting   wound  healing, and preserving the  best limb function,  with the least cardiovascular risks.

Bypass  surgery  had  been  the  treatment

of  choice  for  long  SFA  lesions  but  with recent advances in endovascular tools many controversies  had been aroused about which

of the two modalities should be the first line

for treatment of these lesions)

Patients and methods:

This   prospective   study   was  conducted on 60 patients suffering from symptomatic chronic lower limb ischemia due to :::> 10 em long  superficial  femoral  artery  lesions. Patients were randomized  into 2 treatment groups. The first group; included patients who underwent fern-pop bypass graft. The second group; included patients who underwent PTA with primary stenting for the SFA lesions.

All  patients  underwent  duplex  scanning

and  CT  angiography.  All  angiograms  had been reviewed by a vascular surgeon and an interventional radiologist. All patients who participated  in  the  study  had  at  least  one patent  crural  artery.  Ankle  brachial  index was  recorded.   Also  laboratory   tests  were done including the kidney & liver functions, coagulation   profiles   and   complete   blood

picture.

Am-ShamsJSurg2014;7(2):375-382

The bypass procedure was achieved using an ePTFE (expanded polytetrafluoroethylene) graft 6-8 mm according to size of the native artery. Postoperative low molecular weight heparin and intravenous antibiotic was maintained for three days.

Patients in the endovascular  group: were

accessed percutaneously in the contralateral common femoral artery via standard Seldinger technique  and were fully anticoagulated with heparin (100 units/kg) during the procedure. Transluminal or subintimal  plan was used to cross occlusive lesions with pre-dilatation angioplasty  of the lesion to be treated. Stent deployment was accomplished with self­ expandable nitinol stents sized according to vessel lumen. Following stent placement; patients were immediately started on aspirin (150 mg/day) and clopidogrel (75 mg/day) for a minimum of3 months then were maintained on aspirin only.

After discharge, all patients in both groups

were  followed   up  on  out-patient  basis  at

1,  3, 6  and  12 months.  Patient  assessment was   essentially   focused   on:   lower   limb clinical examination,  determination of Ankle Brachial Index (ABI) and color flow Doppler ultrasound.

Statistical analysis:

Continuous    variables    were    presented as mean and standard deviation; Categoric variables were presented as counts and percentages.  Differences  of  categoric variables were assessed by the two-tailed Fisher Exact test. Differences between continuous  variables  were assessed  by two­ tailed unpaired t-test. Primary patency rates were compared  between the surgical bypass and endovascular  treatment  groups by using the log-rank test and are presented as Kaplan­ Meiercurves. AP-value <0.05 was considered statistically significant.

Results:

Between January 2013 and January 2014,

30 patients were treated percutaneously  with angioplasty and primary stenting and 30 patients were treated surgically with femoral to above-knee popliteal artery bypass.

The  analysis  was  based  on  60  patients

consisting  of  17 females  & 43  males  with mean age 55.6 ± 9 y (range from 40-71 years). The gender and age differences between both groups were not significant. These data are shown in Table (1).

The    distal   perfusion    in   both    groups

presented  with ABI  was 0.45  ± 0.12  in the bypass   group   versus   0.50   ± 0.13   in  the endovascular group. The differences in pretreatment clinical presentation and average ABI in both groups was not significant. This is shown in Table (2).

By following the TASC II grading system

for  femoral-popliteal   lesions,  each  limb  in both treatment  groups was assigned a TASC II classification as shown in Table (3). There was no significant difference in TASC II classification between the two treatment groups.  The demography  of arterial  lesions and number of patent crural arteries in both groups is shown in Table (4).

Above knee femora-popliteal bypass, using

ePTFE  graft was successfully  performed  in all treated limbs in the surgical bypass group. The mean diameter of the used grafts was 6.6 mm (range 6 to 8 mm). The mean duration of the operation was 190 ± 29.3 minutes.

In the endovascular treatment  group, contralateral femoral artery puncture was successfully performed in all patients. Transluminal crossing of target lesion was performed in 17 patients while subintimal crossing was performed in 13 patients. Stents were  successfully  deployed  in  all  patients. The mean duration of the procedure  was 56

± 13.9 minutes.

Length of hospital stay was analyzed for both groups, the mean hospital stay was 3.1

± 1.21  days for  the  endovascular  treatment group,  and  9.8 ± 3.45  days for the surgical bypass group, This difference proved to be significant (P = 0.001).

Marked improvement of the pain free walking distance and relief of rest pain was recorded in the early postoperative period. Average ankle brachial index was improved by 0.37 ± 0.08 in bypass group and by 0.34

± 0.07 in endovascular group. This difference

between the two groups  was not significant

(P = 0.12).

m-      ams      ur;g _      4;    _  :         -    _

Figure (1): Superfacialfemoral artery.                    Figure (2): Occlusion stent placement.

Figure (3): Refilling after stent placement.

Mean follow-up duration was 18 months (range fi:om 12-24 months) for both treatment groups. Complete foot wound healing was achieved after 55.3 ± 12.6 (range: 35-75 days) in bypass group  versus  60.6  ± 14.1 (range:

40-95 days) in the endovascular group. However; this difference was not significant (P = 0.13).

In the surgical  bypass group;  early  non­

tlu·ombotic complications  were observed  in

- Surglbypass group

- Endovascular group

20                                                                                                         LogrankP;0.656

0

0--2--4--6-

180--12

Follow up period (monlhs)

Figure (4): Primary patency rates in both groups.

Table 1. Patients characteristics in both treatment groups.

Table 2. Clinical features in both groups.

Table 3. TASC II grading of each limb in both treatment groups.

8/30 patients (26.7%). Surgical site infection and wound dehiscence were managed non­ operatively except in two patients where secondruy  suture  was done  few days  later.

In  the  endovasculru· group;  immediate procedure-related   and  eru·ly post-operative, non-tluombotic complications were observed in  4/30  (13%)   patients.   In  two  patients,

Table 4: Arterial lesions and number  of patent crural arteries.

Table 5: Patency rates between the two groups.

arterial wall dissection did occur in the SFA during  passage  of  a  guide-wire  where  the stent was used to exclude the dissection along with the atherosclerotic lesion. Another two patients  had  a  small  groin  hematoma  that were managed conservatively.

In the bypass group; 30 days mortality rate

was 6.66  % (2/30  patients),  another  patient died during the follow up period. In the endovascular  group,  30  days mortality  was

0  %,  but two  patients  mortality  was faced

during  follow   up  period.   Mortality  faced in both groups was diagnosed as massive myocardial infarction in 4 cases and cerebral stroke in one case. All deaths were unrelated to the procedure performed.

In the surgical bypass group; two patients underwent   above  knee  amputation   of  the target limb owing to progressive  tissue loss due  to  graft  thrombosis   within  6  months after the operation. In the endovascular treatment  group,  there  was no  major target limb   amputation,   with   significance   level (P = 0.23).

Cumulative  primary  patency  rates calculated  at  follow-up  at  1, 3,  6  and  12 months in surgical bypass group were 100%,

92.8%,    82.1%   and   77.7%   respectively;

and  in  the   endovascular   treatment   group it were 100%, 96.6%, 86.2% and 71.4% respectively.  Secondary  patency  rate  at the

12-month follow-up was 81.4% in surgical bypass group and 89.2% in the endovascular treatment  group. The differences  in primary and  secondary   patency  rates  between   the two treatment groups and their significance level are shown in Table (5) and presented by Figure (1).

Discussion:

The choice of treatment of long SFA occlusion is a matter of controversy over the last  couple  of  decades  especially  with  the great advances of endovascular techniques & resources.

In the present study; we did try to evaluate the effectiveness of endovascular treatment versus  the  convention   surgical  bypass  for long SFA occlusion.  The main  goal  of our study was focused on the patency of either treatment modality.

The  primary  patency  rate  calculated  at

12-month  follow-up  was  better  in  bypass graft  patients  than   those  in  endovascular group   (77.7%   versus   71.4%).   However; the  difference  in  the  primary  patency  rate

Am-ShamsJSurg2014;7(2):375-382

between  either  groups  was  not  significant. On  the  other  hand;  the  secondary  patency rate at 12-month follow-up was better in endovascular   patients   than   those   in  the bypass graft one (89.6% versus 81.4%). Also; the difference between either groups was not significant. These findings did not come in agreement  with the findings of patency rates disagree with many previous studies that had compared bypass to angioplasty and stenting in long SFA lesions. 2,3

Stephen and Albert in 2003, have reported that treatment of long SFA lesions with angioplasty   and  primary   stenting   resulted in  lower  long-term  patency  rate than  those with surgery, and it might be an acceptable alternative in selected patients with critical ischemia  but  bypass  remains  the  procedure of choice.2 Also; Yllmaz et al. in 2003 have reported that despite recent advances in endovascular treatment and even with the use of subintimal angioplasty, femoropopliteal bypass  surgery  still  offers the  best  patency in the management  of long SFA occlusions. 3

Furthermore;  Schlager  et  al.  in  2005  have also reported that long segment stenting has a high rate of re-stenosis with 12-months primary patency of 54% and recommended it for only poor surgical patients with significant cardiovascular comorbidity.4

These  differences   in  the  patency  rates

between the present study and the previously mentioned  studies may  be explained  by the absence  of  randomization  in  these  studies or  the  advances  in  the  endovascular  tools as the use of nitinol stents which had higher patency and lower complication rate than stainless steel stents. This sight has reported by Nakagawa  et al. in 2009; who compared the  use  of  two  stents  in  the  management of long SFA lesions.5 Similar believe was achieved earlier by Ihnat et al.in 2008.6 They have reported that early experiences with stainless-steel  stents showed no benefit over angioplasty alone but comparing superficial femoral artery angioplasty alone with nitinol stenting have shown a reduced incidence of restenosis with primary stenting.

Most   of  surgeons   believe   that   bypass

surgery  is the  best treatment  for  long  SFA

lesions  and their  decisions  are based on the TASC II guidelines which had recommended bypass surgery for these lesions, because percutaneous treatments are considered less effective.7 However, since the release of these guidelines till now many studies had been conducted to re-evaluate the effectiveness of both modalities in long SFA lesions.

Many  studies  have  compared  bypass surgery with endovascular treatment and concluded results similar to our study, Dosluoglu   et   al.,  had   compared   stenting versus above knee polytetrafluoroethylene bypass for long SFA lesions and had reported that the  12- and  24-month  primary  patency was 83% and 80% for stenting group; versus

81% and 75% for the bypass group, and they had reported that secondary patency was significantly better in stenting group than bypass group.8

In addition, McQuade et al., had reported that the stent group demonstrated  a primary patency  of  72%  and  secondary  patency  of

83% at 12 months while the surgical group demonstrated   a  primary  patency  77%  and a secondary  patency  of 86%  at  12 months with  no  statistical   difference   between  the two groups with respect to primary or secondary  patency.9 Similar results were reported by Scali et al., who had concluded that equivalent outcomes of endovascular and open surgical revascularization  of the SFA could be achieved regardless of indication or TASC classification.lO

Many authors have evaluated the use of angioplasty  and stenting  in the treatment  of long SFA lesions, Ferreira et al. in 2007 have reported that primary and primary-assisted patency rates at 1, 2 & 3 years were 90%,78%,

74%; and 96%, 90%, 90%, respectively and considered  it as a good outcome considering length of lesions.ll  In addition, Bosiers et al., had reported  that  long  segment  stenting  of SFA had a low incidence of more than 50% restenosis and low fracture rate at 12 months and suggested that nitinol stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.l2

Taneja et al., had reported that bare nitinol

m-      ams      ur;g _      4;    _  :         -    _

stent enabled recanalization  of long segment lesions of superficial femoral artery with favorable midterm outcome and acceptable limb salvage rates but repeated interventions

were required.13 Hu et al., had also concluded

that nitinol self-expanding stent implantation seems to be a good choice for patients with long SFA occlusions with good short and mid­ term patency results, but more observations are needed to assess its long-term efficiency.l4

Similar results were reported  by Connors et al., who had concluded that percutaneous treatment  of  long  femoral   artery  stenoses and occlusions could achieve high long-term patency rates and recommended out-patient surveillance andre-intervention for recurrent symptoms and restenosis for the durability of long lesions.l5

Furthermore;  other studies considered the use  of covered  stents instead  of bare stents in the treatment of long SFA lesions, Kedora et al., & Farraj et al., had concluded that percutaneous treatment with a stent graft in long SFA lesions had primary and primary assisted  patency rates  at 1 year comparable to above knee femora-popliteal bypass using PTFE grafts.l6,17 McQuade  et al.,  also had reported that management of superficial femoral artery occlusive disease with percutaneous stent-grafts exhibits similar primary  patency  at  24-month  follow-up when compared with conventional femoral­ popliteal artery bypass grafting with synthetic conduit even in long SFA lesions.l8

Beside patency rates in either treatment modality we did observe the procedure time consuming, the hospital stay and the wound complications. In all these observations endovascular procedures was superior to the bypass surgery.

In     the     present     study,    both     bypass

surgery   and   the   endovascular   procedure had comparable results with no significant difference regarding improvement of clinical presentation, improvement of average ankle brachial index, wound healing, mortality and patency rates. Although all patients in this study were fit for surgery and endovascular procedure,  the  later  can  be  used  also  m

treatment of poor surgical candidates.

Surgical site infection and wound complication are morbidities associating surgery  and  their  absence  gives  advantage to endovascular procedures. Endovascular interventions  also  have  the  advantages  of being minimal invasive procedures, can be performed under local anesthetic, repeatable, can be performed safely in fragile patients having  high  cardiovascular  risks  and  they do not interfere with any bypass surgery if indicated later on. Therefore, endovascular treatment should be the first choice for management    of   long   superficial   femoral artery occlusive disease and bypass surgery could be considered only after failure of endovascular interventions.

Conclusion:

Endovascular treatment has similar results with regard to wound healing, mortality and patency rates when compared with bypass surgery  in  lower  limb  ischemia  secondary to long superficial femoral  artery lesions. It also has a shorter procedure time and hospital stay than surgery with lower incidence of complications so endovascular treatment should be the first choice for management of these lesions.

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