Popliteal-to-distal (PD) bypass versus infragenicular percutaneous transfemoral angioplasty (PTA) to treat limb threatening ischemia

Popliteal-to-distal (PD) bypass versus infragenicular percutaneous transfemoral angioplasty (PTA) to treat limb threatening ischemia

Mohamed E. El Sherbeni, MD; Wael Elshimy, MD; Abdelrahman M. Gameel,  MD;Medhat El-Leboudy,  MD; Ahmad M. Tawfik MD

Vascular Surgery Unit, Zagazig University, Egypt.

Objectives:  The purpose  of this study is to compare the results of revascularization  in a critically ischaemic limb due to infragenicular arterial diseases, using either the conventional bypass operations or endovascular revascularization.

Methods: Over a period from December 2010 and May 2012,  forty patients suffering  from limb-threateningischaemia wereincluded in this study; all of the patientshad peripheral arterial disease  falling into  Fontaine  III  & IV categories.  All patients had  extensive infrapopliteal disease (TASC type C&D). All patients had a good run off at the posterior tibial, anterior tibial or dorsalis pedis. The patients  were divided into group A treated by PD bypass surgery and group B treated by endovascular management.

Results:  The primary patency rate of group A at 6 months and one year was 77% and 65% respectively,  with limb  salvage rate 80% after one year  follow up. In group  B the primary patency rate at 6 months and one year was 65% and 60% respectively,  with limb salvage rate

75% after one year follow up.

Conclusions: PD bypass has primary success rate and limb salvage rates higher than infragenicular PTA that might be due to our still growing experience in PTA.

Keywords:  Infragenicular  angioplasty;  popliteal  to distal bypass;  pedal bypass;  critical limb ischaemia.

Introduction:

Patients with limb-threatening ischemia from severe occlusive disease of the infrapopliteal arteries with reconstitution of a patent distal crural or pedal artery are excellent candidates for distal arterial revascularization. The source of inflow is usually the common femoral artery (CFA), but in selected patients, generally those with diabetes in whom obstructive disease is preferentially  in the popliteal and tibioperoneal  segments, the inflow site can be the popliteal artery.l

The  theoretical   drawbacks   of   using   a

distal  inflow  source   include  the  presence of haemodynamically significant proximal occlusive disease (especially in the superficial femoral  artery) and progression  of occlusive disease in the postoperative period.2

Although   surgical   bypass  still  plays   a

key   role   in   revascularization    of   critical limb ischemia (CLI),3 increasing clinical experience over the past two decades shows encouraging results for primary endovascular strategies, with acceptable feasibility, low complication rates,4-6 and high limb salvage rates comparable with surgery.

Diabetic patient, with systemic atherosclerosis, neuroischemic limb ulcers, gangrene, and sepsis (the so-called "diabetic foot syndrome") is prone to a higher rate of periprocedural    surgical   complications.3,4,7

Therefore,    endovascular   techniques    may have many applications  in this field because of their low invasiveness, absence of scarring, and  lack  of  need  for  venous  conduits.4,8,9

These strategies seem to have the advantages of enabling simultaneous multiple vessel recanalization   with  high  reproducibility   if

Am-Shams] Surg 2014; 7(15):1-10

necessary,S,9    resulting   in   shorter   hospital stays and health care expenditure.

The TransAtlantic Inter-Society Consensus

(TASC)lO working  group  developed  an alternative   classification,  in  which  surgery was advised  in cases with TASC type C&D lesions.

This  study  aims  at  comparing  the  two

modalities  of  treatment  (PD  bypasses  and PTA)  in  TASC C&D  infrapopliteal  lesions and to define the role of tibial PTA in infragenicular lesions as alternative modality of treatment in our unit.

Patients and methods:

This   study   was   conducted   during   the period  between  December  2010  and  May

2012 at Zagazig university hospitals. Forty patients suffering from critical limb ischemia were included in this study.

Clinical assessment in the form of complete history taking, full vascular examinations of lower limbs including measurement of Ankle/ Brachial index (ABI) and Duplex ultrasounds as  well as arteriography  were performed  in all patients. Particular attention was paid to proper visualization  of distal run off vessels and the appropriate inflow vessel.

Inclusion criteria: (1) Patients that had rest

pain or ischaemic  ulceration or gangrene (2) preoperative angiographic evidence of severe infrapopliteal disease; either TASC C or D infrapopliteallesions; (3) Adequate ipsilateral or contralateral saphenous vein ( vein greater than 3 mm in diameter at preoperative duplex scanning); and (5) no contraindications  to anticoagulation therapy.

Exclusion criteria were: (1) patients who were elderly or had poor medical conditions, with  life expectancy  estimated  at  less than

2 years. (2) Any stenotic narrowing of the arterial lumen by 25%to 40% were considered hemodynamically  insignificant, (3) patients with non salvageable feet.

The  patients   were   classified   into  two groups; A which included 20 patients in whom revascularization was done by using popliteo­ distal bypass and group B which included 20 patients in whom revascularization  was done

by infragenicular  angioplasty.  Open surgery

was excluded in case of presence of infection near the site of distal anastomosis in 4 cases, poor general condition in 7cases or patient preference in 9 cases.

In group (A) a short popliteo-distal bypass

was  done  with  use  of  regional  anesthesia, either epidural or spinal. Inflow was the popliteal  artery  above  the  knee.  Vein graft was used in all cases. The reversed technique was used in 15 cases, while the non-reversed translocated technique was used in 5 cases, where there was a size mismatch.

In  group  (B)  percutaneous  transluminal

angioplasty (PTA) was done (only local anesthesia  was  used  in  most  cases). Ipsilateral   antegrade   femoral   access   was used. A 6 F sheath was used for delivery of various devices. Terumo guide wire was used for passage across the lesion. The balloon dimensions were chosen according to the size ofthe artery and the length ofthe lesion. No stents were used in any ofthe cases.

In all patients with tissue loss debridement

and drainage of any infection was done.

Postoperative management: Postoperative antithrombotic    therapy   consisted   initially of platelet inhibitors (Clopidogrel) and vasodilators (Cilostazol) with intravenous heparin application for one week then the patient was switched to oral anticoagulants depending upon the individual surgeon preference.   Graft   patency,   ABI   and   the clinical status of the patient, according to Rutherford's  (1997)11 guidelines,  were recorded postoperatively daily during the hospital stay period. After discharge the patients   was  followed   up  weekly   in  the first month then monthly for the first year. During these follow up visits wound healing was observed, pulses were felt regularly, Doppler study of the graft and distal arteries were done, and ankle/Brachial indices were performed. Duplex study was routinely done at  3,  6,  9  and  12  months  postoperatively. CT angiography was not done except when complications were suspected.

End points of the study were primary and

secondary patency, limb salvage rates, and death.  An ABI decrease  of  more than  0.15

compared  with the  initial postoperative  ABI

in-   ams     urg       ;

Figure {1): Pre-operative angiography.

Figure {2): Postoperative angiography showing popliteo anterior tibial bypass.

Figure {3): Postoperative angiography showing popliteo anterior tibial bypass.

100

90

>-       so

c:         70

cCIS.          60

50

c:

Gu>              40

'-

G>

---GroupB

--Group A

Q.         30

20

10

0

0   1   2        3        4    5   6   7   8   9  10  11   12

Months

Figure {4): Primary patency in both groups.

100

90

>-    80

0

c:

Q)

!IS

.....          60

0

--·Group B

-Group A

c:

Q)

0...

Q)

Q.       20

10

0

0   1   2   3   4  5   6   7   8   9   10 11  12

Months

Figure {5): Secondary patency in both groups.

Table (1): The associated conditions in both groups of patients.

MI= myocru·dial mfru·ct:J.on; CABG= coronru·y rutety bypass grafting; AP= angina pectons;

TIA= t:J.·ansient ischemic attack, Ns = p>0.05.

Table (2): Indications of surgery for patients in both groups.

was considered to indicate a failing graft.

Statistical analysis: In the statistical analysis,   fi:equencies and  categorical   data of the two groups  were compru·ed using the chi-squru·e test (:XZ). A p value < 0.05  was

considered to be statistically significant. Primru·y and  secondruy  patency  rates  and limb salvage rates for both groups were assessed with the Kaplan-Meier life table analysis method.

Table (3): Ankle/ Brachial  Index (Pre and Postoperatively).

Table (4): Preoperative and postoperative foot care procedures.

Table (5): Early (30 day) morbidity  and mortality in Group A and Group B after surgery.

Patients may have developed more than one complication

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Table (6): Primary patency rate in group A using "Life table" analysis.

Table (7): Secondary patency rate in group A using "Life table" analysis.

Table (8): Primary patency rate group Busing "Life table" analysis.

in-   ams     urg       ;

Results:

This study included 40 patients; 20 in group A and 20 in group B. In group A the mean age was 53.2 years. They were 15 males and 5 females. 15 patients were diabetics. While in group B the mean age of the patients was 57.8 years. They were 16 males and 4 females 14 ofthem were diabetics.

Indication for revascularization in both groups  is shown  in Table (2). According  to the TASC types all patients in group A were TASC C&D lesions, while in group B all lesions were type C only.

According  to the site  of runoff  in group A cases, 14 popliteo - posterior tibial and 6 popliteo-anterior  tibial bypasses  were  done. In  15  bypasses  a  reversed  saphenous  graft was used, while in the other 5 translocated saphenous graft was used.

In group B arterial duplex and/or angiography  revealed  that the  lesions  were:

7  anterior  tibial,  16  posterior  tibial  and  9

tibio-peroneal.

In the first two weeks postoperatively  in group A two patients died, one from cardiac and the other patient died from hypoglycemic attack. Another one died 3 months after the operation with massive myocardial infarction. There  were  four  patients  withdrawn  from the study  as one  of them underwent  above knee amputation, while the other three cases

were  missed  from  the follow  up  schedule.

Seven  grafts  were  occluded  in  our  study; two at the same day of operation, to which thrombectomy   of  the  graft  was  done  and the  flow regained  successfully.  Another patient came to us around 3 months of the operation   with   no  distal   doppler   signals, duplex study showed thrombosis ofthe entire graft, angiography was done and revealed significant stenosis of the external iliac artery (EIA), thrombectomy  was done successfully with  dilatation  and  stenting  of the  EIA.  In the other four occluded grafts no further surgical  interference   was  done  as  two  of them had unsalvageable feet with infection reaching the site of distal anastomosis and underwent  above knee amputation.  Another one presented to us 8 months postoperatively with occluded graft and healed ulcer and was treated  medically.  The  last  case  occluded after   10  months  postoperatively   and   the patient  presented  with  aggressive  infection and unsalvageable foot and underwent above knee amputation.

In  the  first  two  weeks  postoperatively one patient died of massive myocardial infarction.  Another  patient  died  at  the  18 weeks postoperatively in car accident, and another  one  died  10  weeks  postoperatively and the suggestive cause was unknown. There were four patients withdrawn from the study as two of them underwent major amputation.

The other two  cases  were missed  from  the

Am-Shams] Surg 2014; 7(15):1-10

follow up schedule.

As  regard  group  B, 8  procedures  failed in our study; one at the same time of the procedure due to arterial perforation and the patient was transferred to surgery and the flow was  regained  successfully  by  interposition graft in posterior tibial  artery. The 2nd case developed huge puncture site hematoma compressing  CFA, surgical exploration  24 hours after the angioplasty was done with evacuation of hematoma and thrombectomy was done with restoration of blood flow. The third and fourth patients showed lost palpable pulsation on the 4th week and 3rd month respectively with ischaemic stump of toes amputations, CT angiography was done and showed  restenosis in 3rd case and occlusion in the 4th, redilatation was performed to the yd and PD bypass to the 4th case.

The fifth patient came to us after 4 months of  the  procedure   with  recurrence   of  rest pain, duplex study showed restenosis  of the artery  but  no  further  surgical  interference was  done  as there  was  unsalvageable  feet and underwent major amputation. The sixth patient came to us 6 months postoperatively at the time of routine follow up duplex where there was restenosis with still good perfusion of the  limb and  was treated  medically.  The last two patients came to us at one year with occluded artery and neglected ischemic limb and underwent above knee amputation.

Four cases of Group A underwent major amputations, three of them showed occlusion of the bypass graft. The fourth patient was diabetic  female  patient  complaining  of forefoot gangrene and underwent posterior tibial  bypass  then  after  four  months  there was  ascending  infection  reaching  the  level of malleoli with still pulsating graft so below knee amputation was done to the patient. After

10 days we noticed  infection  in the stump,

drainage with repeated dressing was tried but lastly decision of above knee amputation was taken.

Five cases  in Group  B underwent  major

amputations; three ofthem showed occlusion of  the  procedure  with  neglected  ischemic limb  while  the  other  two  cases  underwent

amputations due to extension of infection and

unsalvageable foot lesions.

Discussion:

Occlusive disease ofthe popliteal artery and its trifurcation with sparing ofthe superficial femoral artery is a pattern of atherosclerosis, which is often seen in patients with diabetes. These patients with single-level occlusive disease may have limb-threatening ischemia. We tested in this study the available treatment options for such patients: open surgery and PTA. Ballotta et all stated that infrapopliteal revascularization  originating  from  the  SFA or popliteal and tibial arteries can be carried out with patency and limb salvage rates statistically not different from those achieved with revascularization arising from the CFA.

In  this   study   group   A  patients   were offered popliteo-distal bypass in which 14 popliteo - posterior tibial and 6 popliteo­ anterior  tibial  bypasses  were  done,  where the posterior tibial and anterior tibial arteries provided a straight line flow to the foot. The peroneal and dorsalis pedis arteries were not used as an outflow in any case of this study. Albers et all2 stated in a meta-analysis of 31 studies that when a dorsal pedal bypass and a peroneal bypass are both applicable,  some surgeons prefer the dorsal pedal bypass to obtain more complete foot revascularization and avoid major amputation  in the presence of a patent graft.l3 A properly indicated tibial or  peroneal  bypass  is possibly  as  effective as a longer pedal bypass for limb salvage.l4

The GSV was used as a conduit in all patients of group A. Many studies followed the same principle.l5-17

Fifteen  patients  in this  study  had a reversed saphenous conduit while 5 patients had  non   reversed   translocated   saphenous graft  used due  to  size  mismatch  especially at the  distal  anastomoses.  Most  studies  on PD grafts have shown a preference for the reversed configuration. IS One study used the non-reversed translocated GSV in 15% ofthe cases until 1989 and in 31% thereafter. The non-reversed translocated GSV is sometimes particularly suitable for infrapopliteal revascularization.l9

Primary  success  was  achieved  in  13/20

in-   ams     urg       ;

patients of group A in this study (65%). Primary        success   rates   of   other   studies concerned with short bypasses worldwide showed   a   wide  range   between   60%   (in

patients  with  severe  calcifications),20  74%

(in patients with no calcification)  and up to

93% in a meta-analysis  of 31 studies.l2 The differences   between   studies   are  probably related to technical experience, and selection criteria  of  patients  and  differences  in  the quality of the run off.  Limb salvage  rate in group A was 80% (16/20) patients). This was

comparable to other studies as Albers et al 12

88%, Ballotta et all 95%, Chung et ai21 85%, and Hughes et ai22 75%, Sayed et ai23 85%.

Group     B     patients      were     offered     a

percutaneous transluminal angioplasty to revascularize    their   infrapopliteal    disease. The site of the lesion to be dilated was 7 anterior  tibial,   16  posterior   tibial,  and  9 tibia-peroneal.   The  aim  of  the  procedure was to obtain a straight-line flow to the foot. Beyssen  et  ai24 stressed  the  importance  of obtaining a straight-line flow to the foot and treating all the significant stenoses and short occlusions that impair distal vascularization. Primary  success was achieved  in  12/20 patients of group A 60%. Bosiers et al25 reported similar  results: 68%, also Sayed et ai23 reported similar results 64%. But Sigala et ai26 reported better results: 94%, but this is explained by the fact that their patients were not restricted to TASC C&D disease, so, patients with milder lesions (TASC group A

It is worth noting that 4 patients in group B had their limbs saved inspite of occlusion of their arteries. This can be explained by the fact  that  once healing  has  occurred,  should the artery restenose or occlude, collateral flow can be sufficient to preserve tissue integrity if there is no further injury.

Patients  with  critical  limb  ischemia  are

typically elderly with multiple co-morbidities and limited life expectancy and therefore, a procedure, which is minimally invasive with reduced morbidity and mortality but lesser longterm patency, may be more appropriate than a more invasive procedure with better long-term  patency.27 Amato et al reported similarly the particular suitability  of PTA for the elderly patients.28

No stents were used in this study, because the  experience  in their  use  in infrapopliteal disease is still evolving and currently insufficient to justify their primary use, subinitimal   technique    was   not   used   in this study, but Bolia reported in 2005 that recanalization oflongtibial occlusions and the possibility  of  reconstituting  the  trifurcation has proved to be most useful in the treatment of patients with critical limb ischemia.29

Conclusion:

Although   infragenicular   PTA  still  has less primary  success  rate  and limb  salvage rates than PD bypass, it is a very promising technique in our institute  owing to its lower

rate   of   perioperative   morbidity   plus   our

& B) had better results.

Limb salvage rate in patients of group B was

growm0

g expen0  ence.

75% (15/20patients). It was higher in Sayed et ai23 78%, and also higher in Bosiers et ai25

96.7% and Sigala et ai26 92%, but again these

higher values are explained  by the presence of lesions  of all categories  in these  studies. In fact,  Sigala  et  ai26 reported  significantly higher  amputation  rates  in  patients  falling into TASC group  C. In addition,  our study selected  patients  with  a contraindication  to open  surgery,  as  spreading  infection   near the site of run off, to do PTA. one of these patients had a BKA done due to the infection, in spite, of patent artery, which reduced the

limb salvage rate.

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