Current Indications of Endovascular Management of Infra-inguinal CLI:

Cairo University Report

Amr Ahmed Gad, MD

Prof. of Vascular Surgery

Cairo University

The Consensus Document of the European Working Group Defined CLI as The Most Severe Clinical

Manifestation of PAD

• Persistent rest pain ( 74%) :Requiring analgesics for 2 weeksResting Ankle pressure < 50 mmHg Resting Toe pressure < 30 mmHg

OR

• Presence of gangrene (34%) orulcer (32%) of the foot / toes :With the same resting pressure

Prognosis of CLI is often Poor

1- One - year mortality is 25 % ( directly or indirectly )

[Balmer etal, 2002]

2- Quality of life indices (psychological testing) , similar to terminal phases of cancer

3- 150000 pat. require LL amputation in USA

4- Prognosis after amputation is worse

- Periop. mortality [ 5% -10% for BKA ][ 15%-20% for AKA]

- After amputation : - 2 years mortality 40%- Sec. amputation 30%- Full mobility 50% in BKA

25% in AKA[ Schainfeld & Inser (1999) CLI: Nothing to give at the office?]

Infra-inguinal CLI Common Femoral Artery Lesions

• Only 13.1% of CLI

• Surgery(Endarterectomy) Long term patency: 91% to 96%Sec. patency & Limb salvage: 100%Maintains the artery for endovascular access

( Schrijver , etal , 2010 )

• Endovascular treatment- PTA : poorer results (? 100% tech success)- Prim stent : Accepted midterm results

Limits future endovascular access Risk of fracture(Hip joint) very old & fragile pt Isolated lesionNo limit for subsequent surgery

[Stricker ,etal , 2004]

Infra-inguinal CLI Femoro-Popliteal Lesions

Approx 60% of CLI

Historically Surg. was primary strategy ,

NOW increasingly replaced by Endovascular treatment as 1st line therapy

The ideal bypass conduit is LSVFemoro-pop. Bypass - Primary 5-year patency rates (63-75%) - Secondary patency rates (80-83%) - Limb salvage rates (84-92%)

( Rutherford ,2000)

Femoro-Popliteal Lesions

BASIL Trial ( Bypass versus Angioplasty in Severe Ischaemia of the Leg )

-Stand as benchmark for current surgical practice -Reflects current results of limb salvage procedures

Conclusion :

Non-inferiority of Endovascular therapy compared to Surgery

. Identical rates of 2-year

amp. free survival

. Lower mortality rate

. Lower complication rate

. Lower cost

. Higher Reintervension rate

Femoro-Popliteal Lesion

Stent Implantation:May improve initial technical success1- Create homogenous tubular lumen by abolishing effect of :

- Obst. Dissections.

- Occluding intimal flaps.

- Residual stenosis.

2- Prevent elastic recoil & delayed constrictive remodeling

3- But increases the amount of myointimal hyperplasia

Endovascular Therapy in Infra-inguinal CLI Cairo university

Total No. : ( Jan. 2010 – June 2013 ) 262 Limb

Group (A) : Femoro-popliteal Disease 136 Limb

Group (B) : Infra-popliteal Disease 126 Limb

• 136 limbs• Males (67.64%)• Mean age : 62.5(50-75 Y)• Diabetics : 63.23%• TASC Class : A (0.00% )

B (22.05%)C (22.05%)D (55.9% )

PTA for Femoro-Popliteal Segment in CLI (Group A)

Cairo university

3 subgroups according to the length of the lesion

• < 5 cm : 16.17%

• 5 to 10 cm : 44.11 %

• > 10 cm : 39.7 %

PTA of Femoro-Popliteal Segment in CLI(Group A)(Cairo University )

• Technical success : 97.05 %• Prim. Patency at 1&2 Y : 79.41% & 67.64%• Sec. patency at 1&2 Y : 84.55% & 75.00%• Limb salvage rate at 1&2 Y

: 92.00% & 83.80%• Comp. 8.82%

PTA for Femoro-Popliteal Segment in CLI (Group A)

Cairo university

PTA for femoro-popliteal segment in CLI(Group A)Cairo University

Length of lesion 1ry patency 2ry patency

1 year 2 year 1 year 2 year

<5 cm 92.0% 85.3% 95.6% 88.23%

5-10 cm 80.88% 70.5% 83.8% 78.0%

>10 cm 55.00% 0.00% 62.5% 33.8%

Patency rates in relation to the length of the lesion

Infra-Popliteal DiseaseBTK

• About half of pt. with CLI(diabetic & aging population)

• Meta-analysis of studies (1992-1998) of distal bypass vein graft reported:

5 year graft prim patency ( 63 %)5 year graft sec. patency (70 %)5 year limb salvage rate (78 %)LSV 1st choice /any autologous veinPTFE is not recommended

(Singer & Baumgartner , CX , 2013)

• BASIL trial did not report subgroup data on distal revascularization

Infra-Popliteal DiseaseBTK

• Primary aim of PTA in BTK :

- Restore at least one straight line of blood flow to the ischaemic foot

- Maintain patency of treated A. for as long as possible or at least to allow:

- ulcer healing

- pain relief

- avoid rec. of CLI

(TASC I&II)

Infra-Popliteal DiseaseBTK

• Recently there is switch to :

- Maximal revascularization: “the more the better”= higher

chance to keep at least one

vessel patent over time

- Angiosome concept :

focus on wound related

artery rather than to

maximize the flow

Infra-Popliteal DiseaseBTK

• Due to evolution of techniques & availability of dedicated materials , The ENOVASCULAR 1st- line approach to BTK should be preferred over bypass for nearly all kinds of lesions

(Singer & Baumgartner, CX , 2013)

• It remains that case load & training are important factors for best possible outcome

PTA of BTK vessels in CLI(Group B)Cairo university

• 126 limbs

• Males : 72.2%

• Mean age : 62.5 (50-75 Y)

• Diabetics : 91.2%

• TASC Class A (9.50%) B (19.5%)C (38.1%) D (33.3%)

PTA of BTK vessels in CLI(Group B)Cairo university

-Technical success is 93.6 %

-Primary patency at 1 & 2year is 74.6 % & 63.4 %

-Secondary patency at 1 & 2year is 83.33% & 71.42 %

- Limb salvage rate at 1&2 yearis 91.27% & 82.53%

- Procedure comp. rate is 9.5%

Endovascular Management of CLI Group(A&B)

Cairo University

Multilevel occlusion

No. 53

% 20.23

Prim. Patency 75.47% ( 1Y) 50.94% (1Y)

Second. Patency

81.13% ( 2Y) 66.03% (2Y)

Outcome of endovascular treatment of Multilevel disease .

Endovascular Management of CLI Group(A&B)

Cairo University

No. of runoff Vessels

Frequency Percentage Limb salvage at 2 years

1 125 47.7% 80.00%

2 39 14.9% 85.22%

3 98 37.4% 100.00%

Runoff status as a prognostic factor in outcome of endovascular intervention:

Redo CasesFemoro-Pop. Segments

Redo fem. Pop. Bypass after stent occlusion

Current Indications in CLISummary

• CLI is the most severe clinical manifestation of PAD & associated with high M. & M.

• Revascularization has to be attempted as soon as possible

• Endovascular therapy should be the 1st line approach in the majority of pt. with CLI

• Bypass can be an alternative, but should primarily be considered in younger & healthier pt. if autologous vein is available

• Patency rates & limb salvage are sig. higher in short SFA lesions compared to long lesions > 10 cm

• Multilevel lesions have lower patency rates than single level lesions

• Runoff status is an important prognostic factor in the outcome of endovascular therapy

• Prevalence of diabetes is higher in group B (91.2%) than in group A (63.23%) , and infra-popliteal PTA showed satisfactory results

Current Indications in CLISummary

Recommendations

Technical Recommendations

1- Proximal lesions treated before more distal ones

2- Sequential revascularization

procedures are indicated in

tissue loss

3- Combination of a bypass & PTA may be employed

4- At least one run-off vessel in

the calf to serve as an outflow

Conclusions

• Stronger , randomized data has to be created , supporting the evidence for best endovascular treatment specifically for CLI pt.

• Research has to be focused & intensified on the development of specific peripheral arterial devices as anatomy & pathophysiology of the limb lesion differs significantly from Coronaries.

• Many extremities with CLI that would certainly have been amputated just a few years ago, can now be salvaged by a variety of techniques available to the trained vascular surgeon.

• Proper selection of the appropriate procedure requires a considerable degree of training , clinical experience and technical skills to achieve optimal results.

Conclusions

Thank You