Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
• Abbott Vascular: medical advisory board, speakers bureau, education
• Boston Scientific: medical advisory board
• Edwards Lifesciences: proctoring
• Medtronic: speakers bureau
• Terumo: speakers bureau, education
We will be discussing off-label uses of FDA approved devices.
• 83 y/o M, CAD, CHF EF 45%, DM2, HTN
• Lives independently with wife
• 3 months of R foot ulcer and osteomyelitis
• ABI noncompressible
• Aggressive wound care, iv abx
• Angiogram by vascular surgeon
A Case…
Angiogram
Procedure Note:
“Right LE Angiography
reveals patent arteries to
the right foot, with severe
small-vessel disease.
There is no option for
intervention.”
Occluded R tibioperoneal trunk
Subtotal occlusion R anterior tibial
• 3 months later, sees me for followup
• Wants any option to save his leg
A Case…
Angiogram
0.014” Command Wire 4x20mm Angiosculpt balloon
Angiogram
Final Images
• Ulcer heals 2-3 weeks later
• ABI at one month: 0.9 (mildly abnormal)
One Wire, One Balloon
• Common
• Systemic disease with high risk of
cardiovascular mortality and morbidity
• Requires systemic therapy
• Modern peripheral vascular interventions are
safe and effective
• There is no such thing as “small vessel
disease”
Peripheral Arterial Disease
0% 5% 10% 15% 20% 25% 30% 35%
29%PARTNERS5
Age >70, or between 50-69 with diabetes or smoking
11.7%San Diego2
Mean Age=66
19.8%Diehm4
Age ≥65
19.1%Rotterdam3
Age >55
14.5%NHANES1
Age ≥70
4.3%
Documented Presence of PAD
When common risk factors were included, the prevalence of PAD was ~1/3 of patients
1. Selvin E, Erlinger TP. NHANES. Circulation. 2004;110:738-743.2. Criqui MH, et al. Circulation. 1985;71:510-515.3. Diehm C, et al. Atherosclerosis. 2004;172:95–105. 4. Meijer WT, et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192. 5. Hirsch AT, et al. JAMA. 2001;286:1317-1324.
NHANES1
Age >40
0
20
40
60
55-59 60-64 65-69 70-74 75-79 80-84 85-89
Rotterdam Study (ABI <0.9) San Diego Study (PAD by noninvasive tests)
Prevalence of PAD Increases With Age
Figure adapted from Creager M, ed. Management of Peripheral Arterial Disease. Medical, Surgical and Interventional Aspects. 2000.
Pati
en
ts w
ith
PA
D (
%)
Age Group (y)
Vascular Disease is a Systemic Disease
Bhatt DL, et al. REACH Investigation. Presented at: American College of Cardiology Annual Scientific Session; March 8, 2005; Orlando, FL. Abstract 1127-96.
PAD
36.9%
9.5%
39.4%
14.2%
CVD
CAD
N=7013
Natural History of PAD:
5-year Outcomes
Stable Claudication
70-80%
Worsening Claudication
10-20%
Critical Limb Ischemia
1-2 %
Limb MorbidityLimb Morbidity
Non-CV Causes 25%
CV Causes 75%
Mortality 15-30%
Nonfatal CV Events 15-30%
Cardiovascular Morbidity and Mortality
Weitz et al.
PAD Survival Curve
Criqui MH, et al. N Engl J Med. 1992;326:381–386.
Normal Subjects
Asymptomatic PAD
Symptomatic PAD
Severe Symptomatic PAD
100
75
50
25
0 2 4 6 8 10 12
Surv
ival (%
)
Year
Critical Limb Ischemia (CLI): Fate of Patients After Initial Treatment
Dormandy JA, et al. J Vasc Surg. 2000;31:S1-S296.
Summary of 19 studies on 6-month outcomes
tients After Initial Treatment
Summar6-m
Sumon 6-m
Dead
20%
Alive Without Amputation
45%
Alive with Amputation
35%
• History
• Physical exam
• Non-invasive assessments
• Invasive angiography
Establishing the diagnosis
of PAD
• Asymptomatic
• Intermittent claudication
– Discomfort, ache, cramping in leg with exercise
– Resolves with rest
• Critical limb ischemia
– Rest pain
• Pain or paresthesias in foot or toes, worsened by leg elevation and improved by dependency
– Ischemic ulceration and gangrene
Clinical Manifestations of
PAD
Elevation Pallor
Dependent Rubor
Critical Limb Ischemia (CLI)
Non-invasive assessments of CAD and PAD are similar
Peripheral Arterial Disease
- ABI
- PVR, Segmental Pressures
- Treadmill Test
- Duplex US, CTA, MRA
Coronary Artery Disease
- EKG
- Echo
- Stress Test
- Angiography
The Ankle-Brachial Index (EKG)
• Simple, painless, accurate, highly reproducible
• Clinical utility
–Diagnosis of PAD
–Prognosis: predictor of MACE
ACC/AHA 2006 PAD Management Guidelines Diagnostic Methods: Ankle-Brachial Index (ABI)
The resting ABI should be used to establish the lower extremity PAD
diagnosis in patients with suspected lower extremity PAD, defined as
individuals:
• with exertional leg symptoms,
• with nonhealing wounds,
• who are 70 years and older,
• or who are 50 years and older with a history of smoking or diabetes.
I IIa IIb III
C
Adapted from Hirsch AT, et al. J Am Coll Cardiol. 2006:47:1239-1312.
Ankle systolic pressure
Brachial systolic pressure
ABI =
• Ankle and brachial systolic pressures taken using a hand-held Doppler instrument
• The ABI is 95% sensitive, 99% specific for PAD
The Ankle-Brachial Index
Normal 0.90 -1.30
PAD < 0.90
Pain/Ulceration < 0.40
Non-Compressible > 1.30
ABI Limitations
• ABI may be elevated in patients with
noncompressible arteries, such as those who
are elderly or have diabetes
• Resting ABI is insensitive to mild aortoiliac
occlusive disease
• Some symptomatic patients have normal
resting ABI (like an EKG)
Diagnostic Algorithm for PAD
History, Physical Examination Suggestive of PAD?
No!Search for Alternate Diagnosis
Yes?
<0.9
PAD
>0.9
Still Suspicious?
>1.30
Vascular Lab Referral •segmental pressures, PVR •graded treadmill test
Anatomic Assessment: DUS, CTA, MRA
Ankle-Brachial Index
Therapies for PAD
Preventing Death, MI, Stroke
• Antiplatelets
• Cholesterol lowering – statins
• ACE Inhibitors
Pre
•••
Reducing Claudication Symptoms
• Exercise
• Cilostazol
• Endovascular interventions
• Surgery
Saving Limbs in CLI
• Endovascular interventions
• Surgery
Therapies for PAD
Preventing Death, MI, Stroke
• Antiplatelets
• Cholesterol lowering – statins
• ACE Inhibitors
Pre
•••
Risk of Occlusive Vascular Events in High-Risk Patients: Antithrombotic Trialists’ Collaboration
Meta-Analysis of Open versus Endovascular Approach to CLI
Hinchliffe RJ et al., Diabetes/Metabolism Research and Reviews 2012
0%
25%
50%
75%
100%
Limb Salvage at 1 Year
78%85%
Open Endovascular
49 Reports, 1980-2010
Comparison of Open Versus Endovascular Approach in CLI Patients: 5 Year Followup
Garg K et al., JVS 2014
0%
25%
50%
75%
100%
Mortality Repeat Procedures Limb Salvage
85%
55%
42%
83%
68%
48%
Open Endovascular
Trends in Revascularization 1996-2011
Goodney PP et al., JAMA Surgery 2015
Trends in Amputation 1996-2011
Goodney PP et al., JAMA Surgery 2015
How Do We Achieve Success in CLI?
Revascularization
Wound Care Medical Therapy
• What is the safest way of achieving a good result for this anatomy in this patient?
• Which vessels need to be opened?
• How durable of a result is needed?
• If different options: safest, least invasive approach first
• Don’t burn bridges to future options
CLI Management in Practice
Modern Limb Salvage Intervention
Angiosome Guided 0.014” and 0.018” Wires
Tibial/pedal Access
CTO and Re-Entry Devices
Angiosomes of the Foot and Ankle
Attinger, et al. Plast Reconstr Surg. 2006;117 (suppl): 261S–293S. Images courtesy of Dr. Mehdi H. Shishehbor
• Retrospective analysis, 203 limbs (177 patients) with ischemic ulcerations who underwent endovascular therapy
• Patients were classified into direct and indirect revascularization based on the angiosome concept
• Limb salvage was 86% when patients were directly revascularized versus 69% when indirectly revascularized (P = 0.03) for up to 4 years post-procedure
Occluded Anterior Tibial and Posterior Tibial Arteries
Antegrade R Leg Angiogram
CTO Crossing with Avinger KittyCat
Final
Baseline
Final Angiography:
After AT and PT CTO Crossing and Angioplasty
Re-Entry Devices
OffRoad™ Re-Entry ntryntryCatheter
Pioneer™ LTD Catheter
Outback™ Catheter
Enteer™ Catheter
Case: SFA Occlusive Disease
• Antegrade L femoral artery
stick
• Mid SFA total occlusion
with reconstitution in
popliteal
• Two vessel runoff
Subintimal Tracking and Re-entry (STAR)
Crossed the occluded segment, but difficulty re-entering lumen
Potential Solution:
Re-enter true lumen by utilizing a re-entry device
Scenario: Guidewire enters
subintimal space but subisubintimntimal spacepace but fails to re-enter true
lumen
Pioneer Used to Facilitate Reentry Into Distal Lumen
True lumen with Chroma Flo feature
Needle trajectory indicator
Pioneer catheter tip in subintimal space
Intima
Adventitia
> Enhanced ImagingIVUS transducer
> PositioningDual-wire system
> TargetingCurved-needle housing
> AccuracyAdjustable needle depth (1–7)
> ControlDouble-braided shaft
Pioneer adjacent toreconstituted vessel
Wire into true lumen of reconstituted vessel
Intervention with PTA/Stent
True lumen2-vessel runoff
Angioplasty5x150mm balloon
2 overlapping SE stents6x150mm x2
Final Angiography
Baseline Final
Options for CTO Access
The Front Door (antegrade)
The Side Door (subintimal & collateral)
The Back Door (retrograde)
Extensive Collateral Network
Balloon From Above, Withdraw Loop
Final Images, after PTA and Supera Stent
• Ultrasound or fluoro guidance
• Distal 1/3 of leg
• Access to tibials is easier than peroneal
• Start with micropuncture kit
• 0.014” or 0.018” wire
• Remove access as soon as feasible
• Nitro 100-300mcg per sheath
Tibial/Pedal Access
Technical Success and Safety
of Tibiopedal Access
Bazan H et al., JVS 2014; Mustapha JA et al., CCI 2014
Technic
al S
uccess
0%
25%
50%
75%
100%
Bazan H et al., 2014 Mustapha JA et al., 2014
95%
69%
13 Patients
23 Patients
No Major Access Complications
Fluoro Access
Works well with
• Suboptimal ultrasound images
• Calcified lesions
• Disease near entry site
Spectranetics Quick-Access Needle Holder
Ultrasound
Access
No radiation
Easy to distinguish arteries
from veins
Learning curve
Mustapha JA, et al, EV Today 2014
4F Cook Micropuncture
+/- Tuohy
Wire crossing
4F Terumo
Pinnacle Precision
Supportive wire crossing
Intervention: 0.014” balloon
1.25mm Diamondback
Not Sheathless!
Draping
Hemostasis: External
Courtesy of of Dr. J. Wang
Hemostasis: Internal
Courtesy of of Dr. J. Wang
Balloon inflation
3-5 minutes
Techniques for Retrograde Crossing and ConnectingRetrograde CART Reverse CART Double Balloon
FacilitatedReentry
Occluded Anterior Tibial, Posterior Tibial, and Peroneal Arteries
Crossover R Leg Angiogram: 83 y/o M with Ulcers
CTO Crossing from Posterior Tibial Retrograde Access
Angioplasty of Posterior Tibial
• Vascutrak 3x250mm scoring balloon
FinalBaseline
Final Angiography
Reverse CART Technique
Long SFA Total Occlusion Reverse CARTFinal ImagesPost Stents
85 y/o F
Not diabetic
R foot ulcer x 2y
Retrograde AT access
Unable to pass into Unable to pass into
popliteal true lumen
Double Balloon:
5x20mm and
4x30mm Fox SV
Wired from above
with Steelcore
4.5 x 60mm Supera stent in popliteal
4 x 40mm Chocolate in popliteal-AT 4 x 40mm Chocolate in popliteal-AT
3 x 40mm Armada 0.014” PTA in AT
Heavily Calcified SFA Complex Lesion
Subintimal with Wire…
Subintimal with Wire…Outback Re-entry…Failed…
Retrograde AT Access, Unable to Connect Wires
Retrograde PTA to Facilitate Outback Re-entry
Antegrade PTA and Supera Stent
Final Angiogram
Modern Limb Salvage Intervention: ATK Treatment
Atherectomy
Drug Coated Balloons
Newer SFA Stents
Specialty Balloons
Atherectomy Devices
Silverhawk
Jetstream
Diamondback
LASER
12-Month Primary Patency (K-M) for Superficial Femoral Artery Endovascular Therapies
Modern Limb Salvage Intervention: BTK Treatment
Long 0.014” Balloons/Long Inflation Times
Atherectomy
Coronary DES (as Bailout)
Specialty Balloons
Atherectomy
93 y/o F
R foot ulcer x 4 mos
Not diabetic
ABI non-comp
Orbital Atherectomy
1.25mm solid crown
Adjunctive PTA
Angiosculpt Balloon: Recalcitrant Lesions
Chocolate Balloon: Popliteal
Modern Limb Salvage Intervention: Treatment
Specialty BalloonsSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecialtialtialtialtialtialtialtialtialty Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Balloolloolloolloolloolloolloolloolloolloolloolloolloonsnsnsnsns