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Technical Pearls and Results of Technical Pearls and Results of Endovascular Therapy for Critical Limb Endovascular Therapy for Critical Limb Dorros-Feuer Interventional Ischemia Ischemia Cardiovascular Disease Foundation, Ltd Gerald

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SLIDE 1

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Technical Pearls and Results of Endovascular Therapy for Critical Limb Ischemia Technical Pearls and Results of Endovascular Therapy for Critical Limb Ischemia

Gerald Dorros MD, ScD (Yeshiva), MA (ex officio Colby ’02), ScD (Colby),

FACC, FESC, FASCI, FACP, FSVMB, FCCP, FACA Clinical Professor of Medicine, Columbia University, NYC Adjunct Professor of Medicine, State University of New York, Buffalo (NY) Dorros-Feuer Interventional Cardiovascular Disease Foundation Jackson Hole ( WY), Grafton (WI), and Phoenix (AZ)

Gerald Dorros MD, ScD (Yeshiva), MA (ex officio Colby ’02), ScD (Colby),

FACC, FESC, FASCI, FACP, FSVMB, FCCP, FACA Clinical Professor of Medicine, Columbia University, NYC Adjunct Professor of Medicine, State University of New York, Buffalo (NY) Dorros-Feuer Interventional Cardiovascular Disease Foundation Jackson Hole ( WY), Grafton (WI), and Phoenix (AZ)

TCT Washington D.C. 8.2003

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SLIDE 2

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Classification

Claudicants Class I-II Limb Salvage Class III-IV Ulcers/non--healing wound/gangrene Class IV Rest Pain Class III

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SLIDE 3

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Technical Pearls: Preferred approaches Technical Pearls: Preferred approaches

  • 1. Contralateral with sheath: 6F coronary multipurpose guide,

coronary wires, balloons, and stents

  • 2. Antegrade puncture
  • 3. Staged procedure for SFA flush occlusion: popliteal, then

contralateral or even antegrade

  • 4. Left brachial with long sheath (125cm) and coronary

equipment (150cm) for situations with fem-fem graft.

  • 5. DP/AT cutdown for flush occlusions of the TPV.
  • 6. AVOID Complications: COMPARTMENT SYNDROME

(carefully open occlusions and avoid bleeding), stents for tears, distal embolization, prolonged balloon inflation for tears, avoid compressing ipsilateral side to maintain antegrade flow.

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SLIDE 4

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI 80M

[L.subclavian

  • ccl. (80M)]: L.

brachial approach stent recanalization

CLI 80M

[L.subclavian

  • ccl. (80M)]: L.

brachial approach stent recanalization

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SLIDE 5

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Ischemic petechia: recognition and

recanalization (RA 80M)

Ischemic petechia: recognition and

recanalization (RA 80M)

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SLIDE 6

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Popliteal Approach used for recanalization of SFA

  • cclusion for CLI, was

complication by popliteal fossa hemorrhage1 (6/92 MC 60F) Popliteal Approach used for recanalization of SFA

  • cclusion for CLI, was

complication by popliteal fossa hemorrhage1 (6/92 MC 60F)

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SLIDE 7

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Healing of right foot occurs2 (6/93) Healing of right foot occurs2 (6/93)

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SLIDE 8

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Patient returns with right leg claudication3 (5/94) Patient returns with right leg claudication3 (5/94)

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SLIDE 9

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Bilateral popliteal occlusions1

(78F with severe COPD, Class IV angina; 8/90)

Bilateral popliteal occlusions1

(78F with severe COPD, Class IV angina; 8/90)

Bilateral balloon PTA, 8/80

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SLIDE 10

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Bilateral popliteal occlusions1: 2.5 yrs. latter

(81F with severe COPD, Class IV angina; 1st PTA in 8/90)

Bilateral popliteal occlusions1: 2.5 yrs. latter

(81F with severe COPD, Class IV angina; 1st PTA in 8/90)

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SLIDE 11

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI: Resolution of long standing ischemic ulcer

with TPV PTA

CLI: Resolution of long standing ischemic ulcer

with TPV PTA

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SLIDE 12

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

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SLIDE 13

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

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SLIDE 14

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI: using coronary techniques

to solve a peripheral problem of left posterior tibial artery (66M)

CLI: using coronary techniques

to solve a peripheral problem of left posterior tibial artery (66M)

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SLIDE 15

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Dorsalis pedis cannulation: cutdown to expose

artery; similarly can be done for posterior tibial artery

Dorsalis pedis cannulation: cutdown to expose

artery; similarly can be done for posterior tibial artery

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SLIDE 16

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Results and Resource Implications of Treating End-stage Limb Ischemia: Holdsworth* Results and Resource Implications of Treating End-stage Limb Ischemia: Holdsworth*

235 limbs (86%) procedure to improve blood supply 19 limbs (7%) primary amputation 21 limbs (8%) treated conservatively 228 Pts 275 severely ischemic limbs

Holdsworth et al. Eur J Vasc Endovasc Surg 1997; 13:164-173

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SLIDE 17

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Results and Resource Implications of Treating End-stage Limb Ischemia Results and Resource Implications of Treating End-stage Limb Ischemia

216 (76%) primary 51(18%) secondary 17(6%) supplemental Individual grafts 31 (10%) revisions 28 (10%) thrombectomy Additional Procedure 284 grafts

Holdsworth et al. Eur J Vasc Endovasc Surg 1997; 13:164-173

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SLIDE 18

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Results and Resource Implications of Treating End-stage Limb Ischemia Results and Resource Implications of Treating End-stage Limb Ischemia

0.2 0.4 0.6 0.8 1 percent limb salvage 1 0.83 0.73 0.68 0.65 survival 1 0.69 0.58 0.48 0.41 1yr 2yr 3yr 4yr

Holdsworth et al. Eur J Vasc Endovasc Surg 1997; 13:164-173

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SLIDE 19

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Results and Resource Implications of Treating End-stage Limb Ischemia Results and Resource Implications of Treating End-stage Limb Ischemia “An acceptable limb-salvage rate can be

achieved although there is a high initial

  • mortality. In view of the poor overall survival,

any benefit for these patients should be viewed as relatively short-term objectives.”

Holdsworth, vascular surgeon, Stirling Royal Infirmary, Stirling, UK Holdsworth et al. Eur J Vasc Endovasc Surg 1997; 13:164-173

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SLIDE 20

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Demographics

Class I-III Class IV Class V PTS. 77 134 101

Male 22 (29%) 39 (29%) 34 (34%) Female 55 (71%) 95 (71%) 67 (66%)

Cases 133 166 118 Age 65 + 11 (32-88) 67 + 8 (46-83) 67 + 10 (40-86) #Dilation Sites 359 450 319

TPV 208 258 191 Other 151 192 128

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SLIDE 21

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV: Demographics

Class I-III Class IV Class V

NYHA CI 3-4 4 (3%) 17 (10%) 1 (1%) CHF, prior 12 (9%) 7 (4%) 28 (24%) Prior MI 41 (31%) 36 (22%) 43 (36%) Prior CABG 44 (33%) 57 (35%) 38 (32%) Prior PV Surg 52 (39%) 63 (38%) 48 (41%) Diabetes 55 (41%) 63 (38%) 83 (70%) CRF 30 (23%) 29 (17%) 48 (41%) Hypertension 72 (54%) 103 (62%) 77 (65%) CVA 12 (9%) 14 (8%) 14 (12%) TIA 5 (4%) 13 (8%) 7 (6%)

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Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Success 2

Class I-III Class IV Class V Stents 1/ 1 1/ 1 5/ 5 Other Sites Femoral 75/ 75 97/ 99 46/ 46 Iliac 9/ 10 5/ 5 6/ 6 Popliteal 59/ 59 81/ 83 68/ 71 Renal 5/ 5 4/ 4 4/ 4 Subclavian 1/ 1 1/ 1

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SLIDE 23

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Success 1

20 40 60 80 100 Class I-III Class IV Class V TPV Stenosis Occlusion

% Success

197 148 49 240 197 43 168 116 52

  • 208 151 57 258 198 60 191 120 71
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Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Complications 1

Class I-II Class III Class IV Death Related

  • 1 (1%)

Spasm 7 (5%) 2 (1%) 4 (4%) Distal Emboli 2 (1%) 5 (3%) 1 (1%) Dissection 11 (8%) 2 (1%) 9 (8%) Occlusion 2 (1%)

  • 1 (1%)

Em Vasc Surg 2 (1%) 2 (1 %) 1 (1%)

Fem./Brach. Repair 2 (1%) 2 (1%)

  • Bypass
  • -*

Amputation

  • 1 (1%)

* bypass followed by amputation

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SLIDE 25

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Complications 2

Class I-II Class III Class IV Compartment Syndrome

  • 1 (1%)

ARF 3 (2%) 5 (3%) 15 (13%) Transfusion

  • 6 (4%)

8 (5%) Major Infection

  • 1 (1%)
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SLIDE 26

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

TPV-PTA: Discharge Data (no outliers > 30 days)

Class I-II Class III Class IV Hospital Days 5.6 + 5.0 (2-30) 4.8 + 3.9 (2-26) 8.1 + 6.5 (1-29) Proc-dischg 4.1 + 3.9 (1-25) 3.5 + 3.5 (1-25) 5.9 + 5.0 (1-25) Clinical Status Improved 130 (98%) 165 (99%) 105 (89%) Unchanged 1 (<1%) 1 8 (7%) Worse 1 (<1%)

  • 3 (3%)

Deceased 1 (<1%)

  • 2 (2%)

Related

  • 1 (1%)
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SLIDE 27

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ clinical follow-up

All Pts Class III Class IV PTS. 215 128 87 Cases 266 160 106 Age 67+9 (37-86) 68+8 (46-83) 67+10 (37-86) mean f/u (mos) 34+33

39+34 30+30 Adverse Events* Bypass 21 (8%) 4 (3%) 17 (16%) AKA 5 (2%) 1 (1%) 4 (4%) BKA 18 (7%) 5 (3%) 13 (12%) Metatarsal 23 (9%) 1 (1%) 22 (21%)

*not mutually exclusive

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SLIDE 28

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

215 CLI Patients’ Survival 215 CLI Patients’ Survival

0.2 0.4 0.6 0.8 1 1yr 2yr 3yr 4yr 5yr

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SLIDE 29

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ Survival:

Fontaine Class 3 and Class 4

CLI Patients’ Survival:

Fontaine Class 3 and Class 4

100

Class 3 Class 4

80 20 40 60

% Survival

12 12 24 36 48 60

Time (Months)

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SLIDE 30

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ Survival: PTA in comparison to

surgical revascularization:

Dorros (PTA) vs Holdsworth (Surgery)

CLI Patients’ Survival: PTA in comparison to

surgical revascularization:

Dorros (PTA) vs Holdsworth (Surgery)

0.2 0.4 0.6 0.8 1

Surgery 1 0.69 0.58 0.48 0.41 PTA 1 0.9 0.86 0.78 0.63 0.56 1yr 2yr 3yr 4yr 5yr

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SLIDE 31

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ Survival: PTA in comparison

to surgical revascularization

CLI Patients’ Survival: PTA in comparison

to surgical revascularization

0.2 0.4 0.6 0.8 1 1yr 2yr 3yr 4yr 5yr

215 CLI Pts

0.2 0.4 0.6 0.8 1 1yr 2yr 3yr 4yr limb salvage survival

Holdsworth et al. Eur J Vasc Endovasc Surg 1997; 13:164-173 Dorros’ CLI-PTA series

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SLIDE 32

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ clinical follow-up:

conclusions

At 60 month follow-up (mean: 34 mos): Survival was 56%: (Cl.3: 69% vs Cl.4: 37%) Incidence of surgical intervention: Bypass was 8% (Cl.3: 3% vs Cl.4: 16%) AKA was 2 % (Cl.3: 31% vs Cl.4: 4%) BKA was 7% (Cl.3: 3% vs Cl.4: 12%) Transmetatarsal amputation was 9% (Cl.3: <1% vs Cl.4: 21%)

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SLIDE 33

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Critical Limb Ischemia:

Conclusions using balloon angioplasty and surgical revascularization observational series

Angioplasty Surgery Success 95%

  • Mortality

0.4% 6-20% Primary/secondary amputation 0.4% 12-22% Limb salvage 99% 78-88% LOS 11+10 (1-25) Approx.25

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SLIDE 34

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Critical Limb Ischemia:

Conclusions using balloon angioplasty and surgical revascularization observational series

Critical Limb Ischemia:

Conclusions using balloon angioplasty and surgical revascularization observational series Fontaine Class/PTA

Class III Class IV Surgery

Success

99% 89% ?

Mortality

1% 6-20%

Primary/secondary

amputation

1% 12-22% Limb salvage 100% 89% 78-88% LOS 5+4 8+7 16

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SLIDE 35

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

Critical Limb Ischemia:

PTA and surgical observational series:

4 yr survival

PTA: 63% Class III 89% Class IV 37% Surgery: 1. reconstruction 54% amputation 40% sympathectomy 53%

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SLIDE 36

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ clinical follow-up:

conclusions

Co-morbidities adversely impact survival Subsequent surgical bypass after PTA was 8% ( 3% Class III; 16% Class IV Pts) Subsequent (AKA/BKA) amputation occurred in <9%

  • f PTA Pts

(4% Class III, 16% Class IV)

[limb salvage rate was 57% at 4 years in surgical series

(Holdsworth)]

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SLIDE 37

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ clinical follow-up:

conclusions

Transmetatarsal amputation occurred in 9% of Pts 1% Class III, 21% Class 4 cohort (very acceptable, since presence of foot or heal enabled Pt to ambulate and stand)

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SLIDE 38

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

CLI Patients’ clinical follow-up:

conclusions These data are compelling, and despite being

  • bservational, indicate

Angioplasty is the primary therapy for critical limb ischemia,patients with infra- popliteal disease Future areas of interest will involve the use of stents with/without eluting drugs, and adjunctive drug therapies.

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SLIDE 39

Jan-04

Dorros-Feuer Interventional Cardiovascular Disease Foundation, Ltd

You See Only What You Look For, You Recognize Only What You Know.