Achieving Acute Success and Durable Results with Complete Total Occlusion?

1
Achieving Acute Success and Durable Results with
Complete Total Occlusion?
Christopher J. Kwolek, MD FACS Harvard Medical
School Division of Vascular and Endovascular
Surgery Massachusetts General Hospital
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Background

• Peripheral arterial occlusive disease (PAOD) is
  associated with substantial morbidity and health
  care expediture
• Operative series have consistently demonstrated 5
  year limb salvage rates of 80 or greater
• Complications may occur in up to 25 patients
  after peripheral arterial bypass surgery
• Morbidity may compromise functional outcomes as
  less than 50 patients report a return to
  normal by 6 months postoperatively

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Background

• Increasing application of endovascular therapy to
  all territories of the arterial tree
• Percutaneous endovascular infrainguinal
  interventions (PVI) have been proposed as first
  line therapy for PAOD
• PVI primary patency rates 12-90, but
  secondary interventions are non-surgical
• Enthusiasm for broadening PVI indications has
  continued to increase!
• Claudication?
• Limb Salvage?

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Peripheral Angioplasty

• 5 year patency
• Claudication 40
• Limb Salvage 28
• Stenosis 43
• Occlusion 32
• Good Runoff 47
• Poor Runoff 28

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THE FUTURE DEFINEDINFRAINGUINAL DISEASE

• SFA occlusions - Traditional wisdom The variety
  of endovascular interventions has produced poor
  results
• PTA vs. PTA/Stent Trial
• 221 patients, lt 7cm SFA lesion
• Angiographic failure at one year 40
• Patency _at_ 4 years ? 50 (Becquemin et
  al. SVS, June 02)

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Background

• Development of small diameter catheter systems
  (0.014/0.018)
• Flexible, self-expanding Nitinol stents

Studies with longer follow-up performed over
10-15 yrs outdated
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Mortality of patients with PVD

• 10 Yr Mortality
• Claudication 48
• Rest Pain 80
• Gangrene 95

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Cannulation of Contralateral Iliac Artery
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Torque Device
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Technique

• Contralateral access
• Placement of a working sheath 6Fr Raabe or Balkan
  in the CFA or SFA
• Use of an .035 angled/straight glidewire with an
  angled or straight 4Fr/5FR catheter
• Try to stay intraluminal but frequently end up
  subintimal using the loop of the distal wire to
  advance
• REENTRY
• Retrograde popliteal/tibial approach

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Frontrunner XP Peripheral CTO

• .039 distal tip size
• 2.3mm jaw opening
• 90 and 120cm lengths
• Responsive torque
• Shapeable distal tip
• Blunt micro-dissection technology

.039 XP compared to .035 guide wire
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Outback and Pioneer Catheter
Enables rapid, safe, and reproducible re-entry of
a guidewire from the subintimal space back into
the true lumen of a peripheral vessel
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Outback?LTD Re-Entry Catheter

• Deploy cannula in either T or L view
• Advance wire
• Retract needle
• Remove device

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Technique

• Once intraluminal access is regained will often
  switch to a low profile balloon .018 saavy or
  .014 coronary balloons
• Sequentially dilate up to 5 or 6 mm
• Self-expanding nitinol stents for significant
  recoil, dissection with flow limiting lesion
• Plavix load and then continue for at least 6
  weeks then switch to ASA alone
• Flexed views of the leg

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MGH Results

• 1) Mid-term results of femoropopliteal PTA
• 2) Contemporary series of patients
• 3) Influence of clinical variables on patency
  and limb salvage rates

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Methods

• Retrospective record review 1/02 7/04
• Native femoropopliteal disease
• Chronic LE ischemia
• Exclusion criteria Acute critical limb ischemia
• Functionally unsalvageable limb
• Threatened bypass graft
• Mechanical thrombectomy/ thrombolysis

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Methods
Demographic/ operative data Clinical presentation
(Rutherford classification) 1-3
Claudication 4 Rest Pain 5-6 Tissue
Loss Lesion Anatomy (TASC classification) A
single stenosis lt 3cm B single
stenosis/occlusion 3-5cm or multiple lt3cm C
single stenosis/occlusion gt5cm or multiple
3-5cm D Complete SFA/POP occlusion
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Demographic and Clinical Factors
Total Claud CLI p Value
Limbs 238 128 (54) 110 (46)
Male Gender 149 (63) 82 (64) 67 (61) 0.62
Average Age 72yrs 72yrs 72yrs 0.23
Hypertension 222 (93) 118 (92) 104 (95) 0.47
Heart Disease 141 (59) 72 (56) 69 (63) 0.31
Diabetes 115 (48) 40 (31) 75 (68) lt0.001
Renal Insufficiency 68 (29) 25 (20) 43 (39) 0.002
Dialysis 22 (9) 5 (4) 17 (15) 0.002
Current Smoker 32 (13) 18 (14) 14 (13) 0.76
Previous Smoker 163 (68) 91 (71) 72 (65) 0.35
Hyperlipidemia 163 (68) 89 (70) 74 (67) 0.71
CHF 44 (18) 15 (12) 29 (23) 0.004
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Anatomic/Treatment Features
Total Claud CLI p Value
Patients 238 128 (54) 110 (46)
TASC A 26 (11) 20 (16) 6 (5) 0.01
TASC B 102 (43) 54 (42) 48 (44) 0.82
TASC C 98 (41) 48 (37) 50 (46) 0.21
TASC D 12 (5) 6 (5) 6 (5) 0.79
Total Occlusion 91 (38) 41 (32) 50 (46) 0.03
Stent Placed 53 (22) 34 (27) 19 (17) 0.11
Angiographic success 230 (97) limbs
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Complications
No deaths related to PTA
6 Significant complications 2 groin hematomas
requiring transfusion 1 thromboembolus
thrombolysis 1 intubation from pulmonary
edema 1 SFA rupture FP bypass 1 device
malfunction FP bypass
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Primary Patency
p0.004
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Predictors of Primary Failure
Variable Hazard Ratio p Value
CHF 1.973 0.02
TASC C/D 1.959 0.02
Age lt65 1.259 0.49
Female Gender 1.190 0.49
Diabetes 1.296 0.32
Current Smoker 1.285 0.58
Hypertension 1.300 0.62
Dialysis 1.470 0.35
Critical Limb Ischemia 1.436 0.18
Occluded Lesion 1.344 0.29
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Assisted Patency
p0.31
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Limb Preservation
p0.007
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Predictors of Limb Loss
Variable Hazard Ratio p Value
CHF 6.656 0.02
TASC C/D 3.735 0.09
Age lt65 0.302 0.40
Female Gender 2.701 0.21
Diabetes 11.906 0.03
Current Smoker 1.998 0.62
Hypertension 0.437 0.35
Dialysis 1.700 0.66
Occluded Lesion 0.205 0.08
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TASC C/D Lesions
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Survival
plt0.0001
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Summary

• PTA of the femoropopliteal arterial segment can
  be performed with 97 technical success and a low
  peri-procedure morbidity
• Three year primary patency is 54, assisted
  patency is 92 and limb salvage is 89 in CLI

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Summary

• Predictors of primary patency failure include CHF
  and TASC C/D lesions
• Predictors of assisted patency failure include
  age lt 65 yrs, CHF and TASC C/D lesions
• Predictors of limb loss include Diabetes and CHF

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Conclusions

• Although primary patency rates remain low,
  excellent assisted patency and limb salvage can
  be achieved with close follow-up
• PTA should be considered as initial therapy
  regardless of Rutherford classification