Role of Retrograde Trans-Popliteal Access for Surgical High-Risk Patients with TASC II-D Femoro-Popliteal Occlusive Disease: A Single Center Experience

Roleof Retrograde Trans-Popliteal Access for Surgical High-Risk Patients with TASC II-D Femoro-Popliteal Occlusive Disease: A Single Center Experience

Mohamed Mahmoud Zaki, Amr Nabil Kamel, Amr Abdelghaffar Hanfy Mahmoud

Department of Vascular Surgery, Faculty of Medicine, Ain Shams University, Egypt

Objectives: To compare the safety and efficacy of retrograde trans-popliteal access in total Superficial Femoral Artery (SFA) occlusions (TASK II-D) in surgical high-risk patients, in the presence of a patent popliteal artery, after unsuccessful antegrade lesion crossing attempts.

Patients and methods: This is a retrospective study including 58 surgical high-risk patients with TASC II D femoro-popliteal occlusive diseases. After failure of antegrade access to cross the occlusion in 9 patients, medial retrograde trans-popliteal access was successfully achieved, followed by snaring of the retrograde wire through rendezvous technique. Perioperative complications and technical success were compared between different access groups.

Results: 58 patients were included in the study; 15 men (25.9%) and 43 women (74.1%). 42 patients (72.4%) underwent contralateral retrograde access at Common Femoral Artery (CFA), 7 patients (12.1 %) ipsilateral antegrade access at CFA, 9 patients (15.5%) ipsilateral retrograde access at popliteal artery. All patients were ASA grade 4. Technical success was highest with contralateral retrograde entailing 40 cases (95.2%), followed by ipsilateral ante-grade access (6 cases - 85.7%) and lowest with ipsilateral retrograde (7 cases-77.8%).

Conclusion: Transpopliteal retrograde approach can be utilized safely and efficiently using a medial infracondylar retrograde popliteal puncture, with the patient in the supine position. Furthermore, this retrograde popliteal approach can be considered a valid alternative for SFA or proximal PA recanalization after a failed antegrade approach, especially in high risk surgical patients (ASA 4).

Keywords:Endovascular  management  of  femoral  artery  complex  total  occlusion,  TASC  II  D  Femoro-popliteal

occlusive Disease, Retrograde popliteal access, Trans-popliteal access.

Conflicts of interest: There are no conflicts of interest or sources of funding that any of the authors receive to

disclose.

Type of Research: Single center, non-randomized Cohort study.

Key Findings: 58 TASC II D femoropopliteal angioplasty procedures were done. Technical success was highest with contralateral retrograde (40 cases - 95.2%), followed by ipsilateral ante-grade access (6 cases - 85.7%) and lowest with ipsilateral retrograde (7 cases-77.8%).

Take home message: Retrograde popliteal approach can be considered a safe, effective, and valid alternative for Superficial Femoral Artery, or proximal popliteal recanalization after a failed antegrade approach.

Summary

Retrograde approach showed comparable technical success and no perioperative complications in this retrospective assessment of 58 patients with femoropopliteal occlusions. The authors conclude that retrograde approach is a safe and reliable alternative to contralateral retrograde or ipsilateral antegrade access after failure of TASK IID femoro- popliteal occlusion antegrade crossing attempts.

Introduction

Peripheral arterial disease (PAD) is usually caused by atherosclerosis that leads to stenosis (narrowing) or blockage in the major vessels supplying the lower extremities. Approximately 10% of the worldwide population have PAD.1  The vast majority of people with PAD are either asymptomatic or do not have any  functional  limitation.2  Many  people  with  PAD, however, have limited walking ability and therefore reduced quality of life. Besides the limited walking ability, people with advanced PAD/critical limb ischemia are at risk of limb loss. In addition to affecting the limbs, PAD is a “manifestation of systemic atherosclerosis that involves other major circulation, such as the cerebral and coronary arteries”.3 Patients diagnosed with PAD are at a two- to three-fold increased risk of mortality, myocardial infarction (MI) and stroke compared to age- and sex-matched population without PAD.4

Endovascular treatment is an attractive alternative to  open  surgical  procedures  for  peripheral arterial disease (PAD) due to the less associated periprocedural risk. Various therapeutic strategies can be planned to treat long femoro-popliteal (FP) lesions, such as self-expandable stent, drug eluting balloon or stent, or covered stent.5

BASIL trial reported that up to 2 years, there was no statistically significant difference in overall survival or amputation-free survival by intention-to-treat assignment between surgery and angioplasty in severe limb ischemia.6  However, post hoc analysis demonstrated that beyond 2 years, patients initially randomized to open bypass surgery had superior clinical outcomes.7   Consequently, in patients who are not at high risk for surgery, bypass surgery is indicated for long (i.e. >_25 cm) SFA lesions when an autologous vein is available and life expectancy is > 2 years.7  

Endovascular treatment for chronic total occlusion of the femoro-popliteal artery is usually managed from an antegrade ipsilateral common femoral artery approach, or via a retrograde contralateral approach in absence of a sufficient working distance in the SFA. Manipulation and pushability through the  retrograde  contralateral  approach  may  be very challenging, especially in patients with high iliac tortuosity and previous aorto-bi-iliac bypass for aorto-iliac occlusive or aneurysmal disease. Moreover, retrograde contralateral access may be difficult or contraindicated in flush occlusions of the SFA without a proximal stump, obesity, surgical scars in the groin, and lesions involving CFA.

In these situations, when antegrade access fails, retrograde trans-popliteal approach may be an efficient alternative, especially in high risk surgical patients. A medial supra or infra-genicular approach to  popliteal  artery  access  was  first  described by   Tonnessen   and   his   colleagues  in   1988;8 however, an antero-lateral approach has been recently gaining popularity with overcoming the obstacle of post-intervention puncture site sealing through initial sheathless access till rendezvous, sphygmomanometer cuff inflation, low pressure ballooning and fibrin blood injection at the access site.9.10

Objective

This is a retrospective analysis of data collected from patients with high risk for surgery (ASA 4), and TASK II D femoro-popliteal occlusive disease. This study aims at detecting the safety and efficacy of retrograde popliteal access after failure of antegrade crossing of total SFA arterial occlusions in  endovascular  management  for  surgical  high- risk patients with TASC II D femoro-popliteal occlusive disease. Primary end point is limb salvage, secondary end points include technical success and perioperative access related complications.

Methodology

From May 2015 till May 2018, we treated 58 patients  included  in  this  study  with  history  of critical limb ischemia as defined by Rutherford classification; rest pain (Category 4), ischemic ulceration not exceeding ulcer of the digits of the foot (Category 5) & severe ischemic ulcers or frank gangrene (Rutherford category 6). All patients had high risk for anesethia ASA 4, and all patients had intact femoral pulsation with patent iliac arteries. Radiologically, all patients had TASC II D femoro- popliteal arterial lesions detected by duplex or CT angiography (Chronic total occlusions of SFA >20cm) or popliteal artery occlusion. Physical examinations, baseline investigations and ABPI measurement were performed to all patients according to our hospital’s protocol.

With patients in the supine position, access to the SFA  lesion  was  achieved  from  the  contralateral or ipsilateral femoral artery. After the sheath placement, 5000 units of heparin were administered. In all cases, antegrade recanalization was initially attempted from the retrograde contralateral femoral artery or through an antegrade ipsilateral approach. However,  in  8  cases,  recanalization  proved  to be impossible owing to inability to re-enter the true lumen distal to the occlusion. Therefore, a refined medial retrograde popliteal access at the infracondylar plane was adopted.

All procedures were performed with patients receiving local anesthesia. After a preoperative multislice contrast enhanced CT angiography– (Figure 1), standard aortogram and bilateral runoff were done using a biplane conventional angiogram with at least two views 60 degrees apart to evaluate the lesion inflow disease (obstruction or stenosis in the iliac arteries), and the runoff (number of patent tibio-peroneal vessels).

Fig 1. Standard Multislice CT Angiography showing task II-D femoropoplitral lesion.

This was followed by insertion of a standard angle tipped hydrophilic 0.035 guide wire in all cases, stiff hydrophilic 0.035 guide wire was used in 4/58 patients (6.9%), standard hydrophilic 0.018 in 13/58 patients (22.4%) and standard hydrophilic 0.014 in 2 patients only (3.4%). All cases with contralateral CFA  retrograde  access  needed  contra  catheter 6 French (Cook ®) and guiding Rim catheter. 48 patients needed guiding catheter to manipulate the wire to gain its access in the target vessel (82.75%) (Bern, Boston Scientific®), while 10 patients need supporting catheter to increase pushability of GW (17.2%) e.g. (Rubicon, Boston Scientific®), (CXI, Cook®). Sheath size 6 French was used in (15/58;25.9%) and 8-French in (43/5; 74.1%).

In case  of  failure of antegrade crossing of the CTO lesion, duplex guided retrograde access was performed  using  18G  needle  and  0.018  guide wire followed by a 6 French sheath introduction through the popliteal artery via a medial approach. Snaring of the guidewire is then performed using the antegrade sheath, then the antegrade wire crosses the lesion and the procedure is completed (Figures 2,3).  For  achieving  post-procedural hemostasis,    direct    manual    compression    of the puncture site was performed for 15 minutes followed by direct angiography. In case of further extravasation, prolonged low-pressure balloon inflation was performed. Complete hemostasis was achieved in all cases.

Fig  2.  Sharing  of  retrograde  wire  throgh  the antegrade sheath.

Fig 3. Long 6×300 mm ballon dilatitation of the SFA.

Statistical Analysis

Statistical  analysis  was  conducted  using  SPSS x7 (SPSS, IBM, Chicago, IL, USA). P-values was considered significant if <0.05. The continuous variables were presented in the form of mean and standard deviation. The categorical variables were presented as percentages. The demographic data and the comorbidities of the patients were related to the number of patients, whereas the patency data were calculated according to the number of limbs. Chi square tests were used to explore the association between different categorical variables and access groups, ANOVA was used to compare means of non-categorical variables among access site groups, and paired t-test was used to compare mean values of ABPI pre and post intervention.

Results

58 patients were included: 15 men (25.9%) and 43 women (74.1%) range of age is between 35-87 years with mean of 62 (SD; 10.226). Cardiovascular risk factors included Smoking (32/58; 55.2%) the duration of smoking was between 5 to 50 years with mean of 21.47 (SD;11.02), Hypertension (41/54; 75.9%), obesity (16/58; 27.6), Diabetes Mellitus (50/58; 86.2%) in which Insulin dependent DM (25/50; 50%), hypertension (45/58; 77.6%), dyslipidemia (26/58; 44.8%), and coronary heart disease (27/58; 46.6%), cerebrovascular accident (4/58; 6.9%), and renal impairment (1/58; 1.7%) (Table 1).  

Table 1: Association and comparing means of patients’ demography and pre-existing medical condition with

different access group

Access Site

P-value

Gender

Famale

Male

0.34*

Smoking

No

Yes

0.23*

Obesity

No

Yes

0.48*

No

DM

Yes

0.74%

Type of DM

IDDM

NIDDM

0.04*

HTN

No

Yes

0.06*

Dyslipidemia

No

Yes

0.99*

Ischemic heart

Disease

No

Yes

0.11*

Congestive heart failure

No

Yes

0.41*

Cerebrovascular

insufficiency

No

Yes

0.54*

Renal impairment

No

Yes

0.11*

Table 1: Continued

Ispilateral

Mean           Std. Deviation           F Value                P-value

antegrade             74.00                  8.446

Age

Contralateral retrograde

Ispilateral

59.71                 9.689

7.196                  0.002**

retrograde             63.00                  7.483

Ispilateral

antegrade              17.50                  5.000

Cigaretts per day

Contralateral retrograde

Ispilateral

24.46                10.483

1.114                   0.34**

During of smoking in years

Time of major

retrograde              27.50                  9.574

Ispilateral

antegrade              27.50                  8.660

Contralateral

retrograde             20.46                 11.504

Ispilateral

retrograde             26.67                 10.328

Ispilateral

1.278                   0.29**

amputation in days

antegrade               8.00                     0                       0.552                   0.59**

*P-value calculated using Likelihood ratio. **P-value calculated using ANOVA.

We detected 55/58 patients with intact distal run off (94.8%), while 3/58 patients with absent distal run off (3.4%). The lesion site was chronic total occlusion of the Superficial Femoral artery (48/58; 82.8%), popliteal artery (2/58; 3.4%), or both (4/58; 6.9%).

Length of lesion was 20.7 +/- 10 cm (SD; 3.457). The duration of procedure was between 30 to 210 Min with     mean     108.79     Min     (SD;     41.93). (Tables 3,4).

Table 3: Association and comparing means value of lesion characterristics among different ccess group

Access Site

Ispilateral antegrade

Contralateral retrograde

Ispilateral

retrograde              P-value

Site of the lesion

Lesion lengh

Distal run off

SFA

Sfa and Poplital Poplital Category 2

Category 3

Category 4

Absent

Present

4                       39                         5

57.1%                 92.9%                  100.0%

1                        3                          0

14.3%                 7.1%                     0.0%

2                        0                          0

28.6                  0.0%                     0.0%

1                       18                         1

14.3%                42.9%                  12.5%

0                        8                          2

0.0%                 19.0%                  25.0%

6                       16                         5

85.7%                38.1%                  62.5%

0                        2                          0

0.0%                  4.9%                     0.0%

7                       39                         9

100.0%               95.1%                  100.0%

0.03*

0.06*

0.5*

Mean           Std. Deviation            F Value                 P-value

Ispilateral

antegrade              22.29                  6.945

Lesion lengh

Contralateral retrograde

Ispilateral

20.45                 2.804

0.841                   0.43**

Dutation of precedure

retrograde             20.60                  0.548

Ispilateral

antegrade             102.86                48.550

Contralateral

retrograde             106.43                38.750

Ispilateral

retrograde             124.44                52.228

0.757                   0.47**

Table 4: Association and comparing means value of intra-operative findings among differnt ccess group

Access Site

Ispilateral antegrade

Contralateral retrograde

Ispilateral

retrograde              P-value

Ballon diameter

Ballon type

Dub

Stent placement

4 mm

5 mm

6 mm

7 mm

Standard

High pressure

Drug eluting ballon

No Yes No

Yes

1                        1                          0

14.3%                 2.5%                    0.0%

6                       34                          5

85.7%                85.0%                   71.4%

0                        4                          2

0.0%                 10.0%                   28.6%

0                        1                          0

0.0%                  2.5%                    0.0%

5                       29                          6

71.4%                72.5%                   85.7%

0                        3                          0

0.0%                  7.5%                    0.0%

2                        8                          1

28.6%                20.0%                   14.3%

5                       32                          6

71.4%                80.0%                   85.7%

2                        8                          1

28.6%                20.0%                   14.3%

6                       17                          4

85.7%                40.5%                   44.4%

1                       25                          5

14.3%                59.5%                   55.6%

0.47*

0.68*

0.88*

0.07*

Ispilateral

Mean           Std. Deviation           F Value                P-value

antegrade            22.29%                6.945

Lesion lengh

Contralateral retrograde

Ispilateral

20.45                 2.804

0.841                   0.43**

Dutation of precedure

retrograde             20.60                  0.548

Ispilateral

antegrade             102.86                48.550

Contralateral

retrograd              106.43                38.750

Ispilateral

retrograde             124.44                52.228

Contralateral

retrograd              41.44                 40.768

Ispilateral

retrograde              9.67                  15.885

0.757                   0.47**

Interventions were performed percutaneously via the Common Femoral Artery (CFA) by an antegrade access (7/58; 12.1%) or an over the-bifurcation approach contralateral CFA access (42/58; 72.4%) or  ipsilateral retrograde  through popliteal arteryaccess (9/58; 15.5%). Technical success was highest with contralateral retrograde entailing 40 cases (95.2%), followed by ipsilateral ante-grade access (6 cases - 85.7%) and lowest with ipsilateral retrograde (7 cases-77.8%) (Figure 4, Table 5).

Fig 4: Bar chart showing technical sucess among differnt access groups.

Table 5: Association and comparing means value of outcome parameters among different access group

Access Site

P-value

Procedure related adverse events

No

Yes

0.51*

Technical success

No

Yes

0.26*

Asymptomatic

Postoperative Rutherford Classification

Mild claudication Iscemic ucler 0.19* Gangrene 

Sustain Clinical

Improvement

NO

Yes

0054*

Binary Restenosis

BS

No

Yes

0.15*

Target Lesion Revascularization TLR

No

Yes

0.53*

Target Extremity Revascularization TLR

Immediate Haemodynamic Improvement

No

No

Yes

-

0.42*

Sustai Haemodynamic Improvement

No

Yes

0.94*

Major Ampulation

No

Yes

0.72*

Table 5: Continued

Limb Salvage

No

Yes

0                        1                          0

0.0%                  2.4%                     0.0%

7                       40                         9

100.0%               97.6%                  100.0%

0.72*

Mean           Std. Deviation            F Value                 P-value

Post-operative Right

ABPI

Post-operative Left

ABPI

Ispilateral

antegrade             0.6671               0.07088

Contralateral

retrograde             0.6902               0.25156

Ispilateral

retrograde             0.7088               0.23703

Ispilateral

antegrade             0.7143               0.13138

Contralateral

retrograde             0.7283               0.17452

Ispilateral

retrograde             0.7750               0.12550

0.058                   0.94**

0.252                   0.77**

Time to

Target Lesion

Ispilateral antegrade

Contralateral

1.00                     0

1.251                   0.31**

Revascularization weeks

retrograde              41.44                 40.768

Ispilateral

retrograde              9.67                  15.885

* P-value calculated using Likeihood ratio ** P-value calculated using ANOVA

Mean pre-intervention ABPI was 0.54 (SD 0.19) and 0.57 (SD 0.22), and the post-intervention ABPI was 0.69 (SD 0.23) and 0.73 (SD 0.16) for the right and left limbs respectively, which was statistically significant with a p-value of <0.0001 (Figure 5, Table 6). 

Fig 5: Boxplot representation of both pre intervention ABPI measurement.

Table 6: Comparing mean values of pre-intervention and post-intervention ABPIs

Mean                         Std. Deviation                       P-value

Pre-operative Right ABPI                             0.54                                  0.19

Post-operative Right ABPI                            0.69                                  0.23

Pre-operative Left ABPI                               0.57                                  0.22

Post-operative Left ABPI                              0.73                                 0.16

* P-value calculated using paired sample t-test <0.0001 <0.0001

Endovascular treatment for chronic total occlusion of the femoro-popliteal artery is usually managed from an antegrade ipsilateral common femoral artery (CFA) approach or via retrograde contralateral CFA. Manipulation from the contralateral CFA may become difficult in patients with tortuous iliac arteries  or  an  aorto-bifemoral  Y-prosthesis  used to treat a previous abdominal aortic aneurysm. Compared to the contralateral retrograde approach, the ipsilateral antegrade provides better pushability. However, there are a plethora of circumstances in which an ipsilateral CFA access would be difficult or contraindicated, such as a flush SFA occlusion without proximal stump, obesity, surgical scars in the groin, and lesions involving the CFA. When antegrade recanalization fails, a retrograde transpopliteal approach can be used as an alternative.

The retrograde popliteal approach requires that the patient be turned to a prone position. However, with the patient prone, the maneuvers from the femoral access are difficult for the interventionist and often prolong the procedure. Furthermore, patients in the prone position are apt to feel fatigue, especially those who are obese or have impaired respiratory function.11 In addition, a subintimal revascularization with a planned combined subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) can be adopted to improve the success rate and avoid damage to important collaterals.12

Conclusion

Trans-popliteal retrograde approach can be accomplished safely and efficiently using a medial infracondylar retrograde  popliteal puncture, with the patient in the supine position. Furthermore, this retrograde popliteal approach can be considered a valid alternative for Superficial Femoral Artery, or proximal popliteal recanalization after a failed antegrade approach.

References

1.   Peach G, Griffin M, Jones KG, Thompson MM, Hinchcliffe RJ: Diagnosis and management of peripheral arterial disease. BMJ. 2012; 345:520-528.

2.   McDermott  M,  Greenland  P,  Liu  K,  Guralnik J, Criqui M, Dolan N et al: Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional   impairment. JAMA.  2001; 286(13): 1599–606.

3.  Hiatt WR, Fowkes FG, Heizer G, Berger JS, Baumgartner I, Held P, Katona BG, Mahaffey KW, Norgren L, Jones WS, Blomster J, Millegard M, Reist C, Patel MR: Ticagrelor versus clopidogrel in symptomatic peripheral artery disease. N Engl J Med. 2017; 376: 32–40.

4.   Norgren  L,  Pande  RL,  Preux  PM,  Stoffers HE:   Treat-Jacobson   D.   Measurement   and interpretation of the ankle-brachial index: A scientific statement from the American Heart Association.         Circulation.  2012;  126:  2890–2909. 

5.  Bosiers M, Peeters P, Tessarek J, Deloose K, Strickler S: The Zilver PTX Single-Arm Study Investigators. The Zilver_ PTX_ Single Arm Study: 12-month results from the TASC C/D lesion  subgroup.  J  Cardiovasc  Surg  (Torino). 2013; 54: 115–122.

6.   Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF: Bypass versus angioplasty in severe ischaemia of the leg (BASIL): Multicenter, randomized controlled trial. Lancet 2005; 366:1925-1934.

7.    Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FGR, Gillespie I, et al: Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty- first  revascularization  strategy.  J  Vasc  Surg.2010; 51(Suppl 10): 5S-17S.

8.   Tonnesen  KH,  Sager  P,  Karle  A,  Henrisen L, Jorgensen B: Percutaneous transluminal angioplasty  of  the  superficial femoral  artery by retrograde catheterization via the popliteal artery. Cardiovasc Intervent Radiol.  1988; 11:127-31.