Post on 02-Jun-2015
description
Michael Knizhnik
Belinson Hospital, Rabin MC, Petah-Tiqva, Israel
"
Almaty 4 July 2014
66% of PAD patients may have stable symptoms. Up to 5% will eventually
require amputation.
However, cardiovascular mortality in patients with PAD is sharply increased
with a significantly higher overall death rate. JVIR 2013
A diagnosis of PAD is critical evidence of more atherothrombotic, with
high risksof subsequent CVS events and death. Cardiovasc Dis.2005
• Within 3 months of presentation:
– death in 9%
– MI in 1%
– stroke in 1%
– amputation in 12%
– persistent CLI in 18%
• 1-year mortality: 21.0%
• 2-year mortality: 31.6%
interventional radiologist
vascular surgeon
orthopaedist
podiatr cardiologist
endocrinologist
?
plastic surgeon
Recommendation 24. Optimal treatment for patients with critical limb ischemia (CLI)
Revascularization is the optimal treatment for patients with CLI
Which kind of revascularization?
F3.2 Endovascular treatment of infrapopliteal occlusive disease Endovascular procedures below the popliteal artery are usually indicated for limb salvage and there are no data comparing endovascular procedures to bypass surgery for intermittent claudication in this region. Angioplasty of a short anterior or posterior tibial artery stenosis may be performed in conjunction with popliteal or femoral angioplasty. Use of this technique is usually not indicated in patients with intermittent claudication. There is increasing evidence to support a recommendation for angioplasty in patients with CLI and infrapopliteal artery occlusion where in-line flow to the foot can be re-established and where there is medical co-morbidity. In the case of infrapopliteal angioplasty, technical success may approach 90% with resultant clinical success of approximately 70% in some series of patients with CLI. Salvage rates are reported as being slightly higher.
Röntgen 1895 X-ray imaging Heuser 1919 Venography in man Moniz 1927 Arteriography Forssmann 1929 basilic vein cath. to the heart* Dos Santos 1929 tranlumbar aortography Farinas 1941 transfemoral aortography Seldinger 1951 arterial access Fogarty 1963 embolectomy catheter Dotter 1964 arterial dilation w rigid catheters Gruntzig 1974 balloon angioplasty Palmaz 1985 balloon expandable stent Parodi 1991 stent graft
S.Seldinger
1953 a method of percutaneous insertion of a catheter into a blood vessel or space.
A needle is used to puncture the structure and a guide wire is threaded through the needle; when the needle is withdrawn, a catheter is threaded over the wire; the wire is then withdrawn, leaving the catheter in place.
Ch. Dotter M. Judkins
Described angioplasty in 1964, jugular veinthrough the liver biopsyalso developed
A. Gruentzig
1974 - Peripheral angioplasty
1984 the original nitinol stent, which was the first in the world implanted into vessels,
biliary tracts, the esophagus, and other hollow organs.
I.Rabkin
Foot arteries anatomy & angiosomes
•IN NORMAL SUBJECTS, FOOT CIRCULATION IS ANASTOMOTIC
LOTS OF ARTERIAL-ARTERIAL BRANCHES = COLLATERALS
In Diabetic Patients Collaterals Formation is Reduced or Absent
Circulation, 1999;99:2239-2242; Cardiovasc Res. 2001 Feb 16;49(3):554-60; Circulation, 2004;2343-2348
IN DIABETIC SUBJECTS, FOOT CIRCULATION BECOMES
BECAUSE OF LACK OF COLLATERALS FUNCTIONALLY TERMINAL
THIS IS THE REASON WHY WE NEED TO IMPROVE THE
FLOW TO THE WOUNDED AREA MOST DIRECT
THE SAME REASON WHY WE NEED TO LOOK AT THE WOUND,STUDY THE VASCULAR ANATOMICAL
SITUATION, IDENTIFY THE RELATED ARTERY AND TREAT IT WHEN POSSIBLE
Angiosome: Anterior Tibial
Angiosome: Peroneal Calcanear Branch
Angiosome: Posterior Tibial
M. Manzi, MD
Contralateral femoral (retrograde)
Ipsilateral femoral (antegrade)
Ipsilateral popliteal (retrograde)
Pedal
HEALING VARIABLES
•Number of vasc. levels involved
•Plantar arch patency
•Amount of tissue destruction
•Presence of infection
•Need of debridement or skin graft
•Available conduit for bypass
•Comorbidity
•Nutritional status
• Complete vessel treatment
- pressure wire
• Restenosis less of an issue
• Clinical follow-up and team
approach more important
- wound clinic
01-2014 JB5799
In high risk patients, choosing Visipaque can help optimise
outcomes and minimise costs6,12
Visipaque reduces the likelihood of cardiac and renal
complications in high risk patients6-10
Visipaque helps minimise discomfort for patients undergoing
intra-arterial procedures11
In patients at high risk of contrast-related adverse events,
choice of contrast agent is critical1-4
Visipaque is the only X-ray contrast agent for intravascular use
with an osmolality similar to blood at all iodine concentrations5
01-2014 JB5799
In patients at high risk of contrast-related adverse events, choice of contrast agent is critical.
01-2014 JB5799
An increasing number of patients are at high risk of contrast-related adverse events
Increased
risk of13 Cardio-renal
syndrome15-17
Increased
risk of14
e.g. with diabetes, renal
impairment, proteinuria,
hypertension, gout, recent
nephrotoxic treatment1,2
CM volume and
osmolality should
be limited2
Risk factors for CM-related adverse events1,2,13-17
Ageing
patients
CVD
CKD
Intra-
arterial
procedures
Other
vulnerable
adult patients
Paediatric
patients
There are many interacting risk factors for CM-related adverse events, including age, CKD, CVD and interventional cardiology procedures1,2,13-17
– As the population ages, the number of patients at high risk of CM-related adverse
events increases
CKD: chronic kidney disease
CM: contrast media
CVD: cardiovascular disease
01-2014 JB5799
Patients with multiple risk factors are more likely to experience adverse events such as contrast-induced acute kidney injury18
CKD is the most significant risk factor for CI-AKI, which is the 3rd most common cause of hospital-acquired acute renal failure19
Formal risk scoring in the cardiac angiography setting shows that the presence
of multiple risk factors increases the likelihood of CI-AKI further18
* SCr >1.5 mg/dl score =4 or eGFR score =2 (40–60 ml/min/1.73 m2), 4 (20–40 ml/min/1.73 m2), or 6 (<20 ml/min/1.73 m2) † SBP <80 mmHg ** NYHA class III/IV± pulmonary oedema †† baseline haematocrit <39% for men and <36% for women
CI-AKI risk increases as the number of risk factors increases
(n=8,357)18
Renal impairment* 2–6
Hypotension† 5
Intra-aortic balloon pump 5
Congestive heart failure** 5
Age >75 years 4
Anaemia†† 3
Diabetes mellitus 3
CM volume 1 per 100
ml3
Risk factors Score
≤5
6-10
11-15
≥16
7.5%
14.0%
26.1%
57.3%
Total score Risk level Incidence of CI-
AKI
Low
Moderate
Hig
h
Very
high
Adapted from Mehran 200418
CKD: chronic kidney disease
CM: contrast media
CI-AKI: contrast-induced acute kidney injury
eGFR: estimated glomerular filtration rate
NYHA: New York Heart Association
SBP: systolic blood pressure SCr: serum creatinine
01-2014 JB5799
In patients undergoing interventional procedures, contrast-induced
acute kidney injury increases the risk of further cardiovascular
events20,21
Cardio-renal syndrome can be exacerbated by CI-AKI, which increases the risk of death, CV events
and associated hospital stays in patients undergoing percutaneous coronary intervention20-25
CI-AKI: contrast-induced acute kidney injury
CM: contrast media
CV: cardiovascular MACE: major adverse cardiac events
PCI: percutaneous coronary intervention
% p
atie
nts
16
12
8
4
0
13.8%
Outcome: Mortality In-hospital MACE In-hospital stroke Vascular complications
Adapted from Iakovou 200220
Card
iovascula
r events
No CI-AKI
CI-AKI
p<0.0001
5.3%
p=0.001
7.9% 2.9% 4.7% 1.4%
p=0.0008
4.7% 0.9%
p=0.0003
CI-AKI increases the risk of CV events in patients receiving CM for PCI (n=8,268)20
01-2014 JB5799
Even transient contrast-induced acute kidney injury results in increased hospitalisation, morbidity and mortality for cardiovascular events
Both transient and persistent CI-AKI are prognostically significant for hospitalisation, morbidity and mortality during extended follow-up26,27
Physicians may disregard mild or transient increases in SCr after CM procedures, even though they lead to worse short- and long-term outcomes26
* CI-AKI defined as a >25% increase or >0.5 mg/dl (>44.2 mmol/l) increase in SCr within two days of intravascular administration
of iodinated CM when no other major kidney insult was identified
CI-AKI* increases the risk of hospital admission for CV events
(incuding myocardial infarction, heart failure, stroke and target
vessel revascularisation) dialysis and death26
Cum
ula
tive e
vent
rate
for
com
posite e
ndpoin
t
0 12
24
36
0.6
0.4
0.2
0.0
Follow-up (months)
Persistent CI-AKI
Transient CI-AKI
No CI-AKI
p=0.021
p=0.035
Hospital adm
issio
n, dia
lysis
and d
eath
Adapted from Wi 201126
CI-AKI: contrast-induced acute kidney injury
CM: contrast media
CV: cardiovascular
SCr: serum creatinine
01-2014 JB5799
Patients at higher risk of contrast-induced acute kidney injury are more likely to incur the considerable long-term costs associated with it
When adjusted by risk level, the average cost of managing CI-AKI per PCI performed is higher in high risk patients, since they are more likely to develop it28
– The largest cost driver is the increased length of stay associated with the
initial hospitalisation28
*Risk levels taken from the risk scoring system developed by Mehran et al (2004)18
Average 1-year cost per CI-AKI event28
Average 1-year cost per PCI procedure28
12,000
8,000
4,000
0
Cost $
Cost $
Patient CI-AKI risk level*
CI-AKI event Lo
w
Hig
h
Very
high
Moderat
e
Dialysis
MACE
In-hospital
Adapted from Subramanian 200728
CI-AKI: contrast-induced acute kidney injury
MACE: major adverse cardiac events
PCI: percutaneous coronary intervention
9,000
6,000
3,000
0
01-2014 JB5799
Choice of contrast agent is critical to minimise the
likelihood of contrast-related events in high risk patients1-4
Hyperosmolality has long been recognised by international guidelines as one of the key determinants of CM-related adverse events, particularly in high risk patients1-4
ACR: American College of Radiology
CI-AKI: contrast-induced acute kidney injury
CKD: chronic kidney disease
CM: contrast media
CV: cardiovascular
KDIGO: Kidney Disease Improving Global Outcomes
MACE: major adverse cardiac events
Increased
risk of6
Increased
risk of2,3
Increased
risk of29
CV
effects
and
MACE
Patient
discomfort
Hyperosmolality as a factor in CM-related adverse events1-3,6
CI-AKI
The KDIGO Clinical Practice Guideline states that
wherever possible isosmolar agents should be used
in people with CKD at high risk for CI-AKI4
ACR guidelines suggest that for intra-arterial injections, isosmolar CM are associated with the least amount
of discomfort2 2013
2013
ACR guidelines state attention should be paid to limiting osmolality in patients with CV disease2
2013 Hyper-
osmolality
01-2014 JB5799
Visipaque is the only X-ray contrast agent for
intravascular use with an osmolality similar to
blood at all iodine concentrations5
Visipaque reduces the likelihood of contrast-related
cardiac and renal complications in high risk patients6-10
Visipaque helps minimise discomfort for patients
undergoing intra-arterial procedures11
01-2014 JB5799
Examining the rate of contrast-induced acute kidney injury with Visipaque compared with low osmolar agents in high risk patients
A recent comprehensive meta-analysis investigated the incidence of CI-AKI in comparative studies of isosmolar Visipaque and LOCM6
A broad range of publications were considered6
The baseline SCr across all included studies was ≥1.6 mg/dl and average
GFR was ≤50 ml/min/1.73 m2, indicating that patients had, on average, moderately impaired renal function6
CI-AKI: contrast-induced acute kidney injury
GFR: glomerular filtration rate
LOCM: low osmolar contrast media
SCr: serum creatinine
-Strict inclusion criteria were applied6 - studies needed to be randomised, prospective,
head-to-head comparisons of Visipaque and a LOCM
- they needed to have CI-AKI as a primary and/or
secondary endpoint
- they needed to be of high methodological quality
(with a Jadad score ≥2)
25 were included
in the meta-analysis
145 potential articles
were identified
01-2014 JB5799
Visipaque is associated with a lower risk of contrast-induced acute kidney injury than low osmolar agents in high risk patients6
Intra-arterial use of isosmolar Visipaque significantly reduced the risk of CI-AKI* compared to LOCM† in the interventional cardiology setting (RR=0.46; CI: 0.27–0.79; p=0.004)6
*CI-AKI defined as SCr increase of ≥0.5 mg/dl from baseline measured up to 3 days after contrast media exposure †Pool of LOCM (iohexol, iomeprol, iopamidol, iopromide, ioversol and ioxaglate)
CI-AKI risk is lower with intra-arterial Visipaque than with LOCM (n=4,769)6
0.01 0.1 10 1
Study
100
Aspelin (NEPHRIC) 03
Hill 94
Sinha 04
Wessely 09
Hardiek 08
Laskey 09
Solomon (CARE) 07
Juergens 09
Li 08
Nie 08
Han 10
Hernández 08
Rudnick (VALOR) 08
Jo (RECOVER) 06
Mehran (ICON) 09
Favours Visipaque Favours LOCM
Adapted from McCullough 20116
CI: confidence interval
CI-AKI: contrast-induced acute kidney injury
LOCM: low osmolar contrast media
RR: relative risk
01-2014 JB5799
Visipaque has minimal cardiovascular effects, which is critical when managing patients at risk of contrast-related adverse events
Fluid shift as CM flows through coronary arteries may lead to adverse CV effects, resulting in heightened cardiac risk31
Potential CV effects of CM Benefits of Visipaque
Changes in electrophysiological parameters
(e.g. QT-interval, QRS vector difference)32-35
Less impact on electrophysiological parameters than
ioxaglate and iohexol32-35
Haemodynamic changes can induce
myocardial ischaemia during coronary
procedures35,36
Minimal change in left ventricular systolic pressure
(compared to a significant fall with iopromide)35
Minimal changes in haemodynamic parameters
(left ventricular end diastolic pressure, aortic pressure)
compared with iohexol36
Reduced contractility and lowered cardiac
output, resulting in the heart beating faster
in order to compensate35
Lower impact on heart rate variability than
iopromide, ioxaglate or iomeprol in clinical trials35,37-39
Electrical
activity
Mechanical
performance
Heart rate
variability
CM: contrast media
CV: cardiovascular
01-2014 JB5799
Visipaque is associated with fewer major adverse cardiac events than low osmolar agents in the interventional cardiology setting8-10
Visipaque was associated with fewer MACE than LOCM in the interventional cardiology setting8-10
Several large prospective clinical trials have shown that Visipaque is associated with significantly fewer MACE (such as cardiac death, stroke and coronary artery bypass graft) than LOCM8-10
*In-hospital included cardiac death, emergency recatheterisation for ischaemia, repeat revascularisation, CABG, subacute thrombosis,
stroke/TIA, non-fatal MI, abrupt closure of target vessel, systemic arterial thromboembolic event, and unplanned coronary artery bypass
surgery
% p
atie
nts
MACE criteria*
p<0.025
In-hospital8 (n=1,276)
In-hospital9
(n=856)
≤30 days post-discharge10 (n=208)
p=0.003
p=0.027
iopamidol ioxaglate iopromide Visipaqu
e
Visipaqu
e
Visipaqu
e
1.9% 5.4% 4.8% 8.8% 9.5% 9.0%
12
10
8
6
4
2
0
Majo
r advers
e c
ard
iac e
vents
Adapted from Harrison 20048, Davidson 20009 and Nie 200810
CABG: coronary artery bypass graft
LOCM: low osmolar contrast media
MACE: major adverse cardiac events
MI: myocardial infarction
TIA: transient ischaemic attack
01-2014 JB5799
In high risk patients, choosing Visipaque can help
optimise outcomes and minimise costs6,12
01-2014 JB5799
In high risk patients, choosing Visipaque can help optimise
outcomes and minimise costs6,12
Visipaque reduces the likelihood of cardiac and renal
complications in high risk patients6-10
Visipaque helps minimise discomfort for patients undergoing
intra-arterial procedures11
In patients at high risk of contrast-related adverse events,
choice of contrast agent is critical1-4
Visipaque is the only X-ray contrast agent for intravascular use
with an osmolality similar to blood at all iodine concentrations5
• Major amputation was required more often in those with fewer patent arteries (P < 0.001).
When is a technically successful peripheral angioplasty effective in preventing above-the-ankle amputation
in diabetic patients with critical limb ischaemia?
Faglia E et all. Diabetic Medicine 2007; 24: 823-829
Crural patent arteries after PTA
N. patients no requiring amputation (n=398)
N. patients requiring amputation (n=22)
3
2
1
0
67
143
179
9
0
0
7 (4%)
15 (62%)
• 159 TMA/153 patients
• 159 limbs revascularized: bypass (15.2%) and by endovascular procedure (84.8%).
• Predictive factors for healing: - number of vessels open at ankle level (OR: 7.42)
Effect of revascularization on transmetatarsal amputation healing in diabetic ischemic foot
Dalla Paola et al. VII meeting of the DFSG, 2008
N. open vessels Time of healing (days)
0 160.0 ± 155.6
1 125.9 ± 113.7
2 95.0 ± 79.5
3 88.6 ± 108.5 By-pass =78+/-52 days
p=0,0
4
p=0.03
n.s.s.
“In diabetic ischaemic foot TMA outcome is influenced to kind of revascularization. Every vessel open at ankle level reduces about of 31 days the time of healing. Data from this study indicate that efforts should be done during revascularization to open the most number of vessels to reduce time of healing.”
BTK PTA…Yesterday
For limb salvage only;
At least one direct vessel to the foot (ankle level);
For wounds healing too;
For deambulation salvage;
Two or three vessels to the foot (inflow);
Foot vessels revascularization (outflow).
BTK PTA… TODAY
≠ Treating angiographic images
= Treating patients’ complaints
Restoring outflow
1 artery straight-line flow to foot
= PRIMARY GOAL OF ANY TREATMENT
EXC : Diabetics poor collateralisation
PRE POST
Single spot lesions A rare example
Pre-op Post-op
Occlusion all 3 BTK vessels
Which vessel to treat?
Pre-op Post-op Pre-op (distal)
Occlusion at distal popliteal: which vessel to treat?
Pre-op Post-op Pre-op Post-op
Length dependent strategy decision Short lesion
Focal PTA technique
+ Balloon expandable stents
+ Nitinol stents
Intermediate lesion Nitinol stents
Long lesion Long low pressure balloons
with or without additional focal stenting
Lesion passage
Stiff 0.014 – 0.018” hydrophilic wire
Extra support with 4-5F multipurpose glide cath
Tandem lesion on ATA
Pre Post
Pre-op Post-op
Distal lesion
Stabilizer+
Cordis 0.014”
Ultrasoft SV
BSCI 2x30
Ultrasoft SV (BSCI) – short occlusion distal ATA
After suboptimal PTA Flow-limiting dissection
Residual stenosis
Coronary stents
Dedicated BTK stents Bare
Passive coating
Active coating
Bioabsorbable
Pro-kinetic Explorer (Biotronik)
PRE POST PRE POST
Cypher (Cordis) – Distal P3-segment high grade stenosis
3.0/28
Cypher stent
Pre-op
Cypher (Cordis) – proximal lesion
Pre-op
3.5/33
Cypher
stent
Guidewire
passage
and PTA
Post-op
PTA
Cypher (Cordis) – Occlusion TFT
Pre-op
Post-op
2x Cypher stent
Magic Explorer (Biotronik) – Bifurcation lesion
Pre Post
Disadvantages Crushability
Limited flexibility
Stent damage
Disturbed flow dynamics
Dedicated design for small vessels Do not place a large vessel stent in smaller diameters!
Metal overload
Impaired flow dynamics
4x40 Astron Pulsar
Dilation popliteal lesion
Passeo baloon
3x80
Courtesy of O. D’Archambeau – J Hendriks
Dilatation ATA lesion
baloon3x20
Resulting in dissection
Courtesy of O. D’Archambeau – J Hendriks
Stenting
4x80
Courtesy of O. D’Archambeau – J Hendriks
Post dilation
3x80
Courtesy of O. D’Archambeau – J Hendriks
Courtesy of O. D’Archambeau – J Hendriks
PRE POST
Knee straight
POST
Knee bend
FINAL FLOW
Low pressure balloons L 8-17 cm
Ø 2.5-3.5mm
Improve outcome with spot stenting Achieving dynamic flow
into foot is goal
Dilation Pre-op Post-op
Passeo-18 (Biotronik)
Diffusely diseased PTA
Pre-op Post-op
Revascularization existing feeding collateral
Additional focal stenting on areas of low success
pre-op
Dissection
after PTA
Multi-link
Vision
post-op
Dilation ATA
2.5x170
2 times
Resulting in distal flow
limiting dissection
cases of Dr . M.Manzi
Why and when endoluminal
atherectomy? M.Manzi, 2009
•Young patients •Popliteal tract •SFA intrastent reocclusion
In order to avoid stent !
• BTK high risk for PTA segments (bi-trifurcations)
•PTA restenosis •Light calcified distal plaques
Alternative to balloon
PTA
M.Manzi, 2009
ischemic rest pain, ulcers or Chronicgangrene attributable to objectively
proven arterial occlusive disease
and is to chronicityThe term CLI implies be distinguished from acute limb
ischemia
Ankle pressure
< 50 mm Hg
Toe pressure
< 30 mm Hg
TcpO2
< 30 mm Hg
Norgren et al. TASC II, Eur J Vasc Endovasc Surg 33, 2007
diabetes
neuropathy
trauma,
deformity
ulcer
lack of healing
infection
gangrene
1 million one mil. major amputations ww p/y
54% mortality, 46% amputation at 1y for untreated CLI
•www.iwgdf.org -International Working Group of Diabetic Foot
•Lepäntalo et al: EJVES 1996;11 (2): 153-157
Revascularization + extra-Vascular care
Rogers LC, Armstrong DL: Podiatry Care, Chapter 113, Rutherford's Vascular Surgery, 7th
Edition, Cronenwett JL, Johnston KW, editors, Elsevier Inc, 2010
• Healing and Perfusion: non linear correlation
• Probability of healing:
– Suboptimal with suboptimal perfusion
– Maximized with optimal wound care and perfusion
– Best preserved in presence of optimal and durable perfusion
• Makes healing faster and better
O.Iida et al. angiographic restenosis and its clinical impact after infrapopliteal
angioplasty. Europ J of Vasc and Endovasc Surgery 2012
Reiber, et al. Diabetes Care, Vol 22, Number 1, January 1999
External Triggers of Ulceration
.1Durable perfusion is an insurance policy against the casual occurrence of new ulcers
.2Scarce Perfusion makes foot vulnerable to recrudescence and recurrencies
optimal Perfusion: F.Vermassen 2010
sub-optimal Perfusion:
Frequency and magnitude of reinterventions in CLI have a known bad implication on patient’s survival and QoL [1]
.1Conte M.S Suggested objective performance goals and clinical trial design for evaluating catheter-
based treatment of critical limb ischemia. JVS 2009;50:1462-1473
Ouriel K, Lancet 2001, data of ‘60
Limb Salvage correlates poorly with Primary Patency, less poorly with Secondary Patency
•Primary Patency reduces TLR, adds life and QoL to CLI Patients
T.Kudo et al. The effectiveness of percutaneous transluminal angioplasty for the treatment of
critical limb ischemia: A 10-year experience. J Vasc Surg 2005;41:423-35.)
Patency clinically relevant when WRA is involved [1-2]
.1Neville et al. Revascularization of a Specific Angiosome for Limb Salvage: Does the Target Artery Matter? Ann Vasc Surg 2009; 23: 367-373
.2Iida O. et al. Importance of the Angiosome Concept for Endovascular Therapy in Patients with Critical Limb Ischemia - Catheterization and
Cardiovascular Interventions 75:830–836 (2010)
[1] [2]
M.Manzi et al. 2009
• Improved functional outcome following re-establishment of the plantar arch due to suboptimal results of tibial revascularization
135 of 1331 CLI patients treated at Abano Terme Clinic (Italy) from 2007 to 2008) by pedal-
plantar-loop technique due to sub-optimal ATA revascularization and/or risk of amputation
Below-the-ankle run-off reduce MALE [1]
O.Iida et al. Anatomical Predictors of Major Adverse Limb Events after Infrapopliteal Angioplasty for Patients with Critical Limb
Ischaemia due to Pure Isolated Infrapopliteal Lesions. European Journal of Vascular and Endovascular Surgery 44 (2012) 318e324
Microcirculation to the wound related territory increase limb salvage
Utsunomiya M et al. Impact of wound blush as an angiographic end point of endovascular therapy for patients with critical limb
ischemia. J Vasc Surg 2012;55:113-21
Patency necessary but not sufficient for functional limb preservation (extravascular care = key therapy component)
Restenosis becomes clinically relevant
when involves the wound related artery
when occurs during the healing process
as new ulceration occur within the target angiosome, triggered by external factors
Prolonged better than short-term, Primary Patency better than Secondary Patency
Technically best fitting the extensive, multivessel, long diffuse BTK disease of real world CLI Patients
• 74% of all lesions in BTK
• 66% occlusions
• 50% occlusions >10 cm
• Tissue loss associated with significant worse, BTK concentrated disease [2-3]
• Arterial Disease extension and distribution in CLI and Diabetes [1]
.1Graziani L et al. Vascular Involvement in Diabetic Subjects with Ischemic
Foot Ulcer: a New Morphologic Categorization of Disease Severity Eur J
Vasc Endovasc Surg 33, 453 460 (2007)
.2Diehm N et al. Association of Cardiovascular Risk Factors with Pattern of
Lower Limb Atherosclerosis in 2659 Patients Undergoing Angioplasty. Eur J
Vasc Endovasc Surg 31, 59–63 (2006)
.3A.Bradbury et al. Bypass versus Angioplasty in Severe Ischaemia of the
Leg (BASIL) trial: A description of the severity and extent of disease using
the Bollinger angiogram scoring method and the TransAtlantic Inter-Society
Consensus II classification JVS 2010
.1D.Scheinert, J Am Coll Cardiol 2012;60:2290–5)
.2H.K.Soder, J Vasc Interv Radiol 2000; 11:1021–1031
.3F. Baumann, J Vasc Interv Radiol 2011; 22:1665–1673
.4F.Fanelli, J Endovasc Ther. 2012;19:571–580
.5F.Liistro, TCT 2012 oral presentation
.6A.Schmidt, Catheter Cardiovasc Interv. 2010 Dec 1;76(7):1047-54
101 Patients
12m Angio
PTA arm PTA arm
60 Patients
10m Angio
33 Patients
6m Angio
11 Patients
12m Angio
67 Patients
12m Angio
58 Patients
3m Angio
PTA arm
A.Schmidt LINC 2013
• Single Center Registry
• IN.PACT Amphirion
• Long BTK lesions > 80 cm
• 104 Patients
• Primary Endpoint: 3-month binary Restenosis rate
A.Schmidt JACC 2011
First DEB-BTK Experience in complex, real world BTK
lesions
IN.PACT (angio subgroup)
# patients / limbs 74 / 79
Male gender 51 (68.9%)
mean age (y) 73.5 ± 9.3
diabetics 54 (73%)
Renal insuff. 34 (45.9%)
RC 3 16 (20.3%)
RC 4 14 (17.7%)
RC 5 49 (62%)
RC 6 0 (0%)
avg lesion length 173±87 mm
Tot occlusions 61.9%
IN.PACT (angio subgroup)
3m Ang. FU
Restenosis (>50%) 27.4%
Full-segm. Resten. 10%
Restenosis Length 64 mm
12m Clinical
FU
Deaths 16.3%
Limb Salvage 95.6%
Clinical Improv. (1) 91.2% (2)
Compl. wound heal. 74.2%
TLR 17.3%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain
IN.PACT (angio subgroup)
PTA* (histor. group)
3m Angiographic FU
Restenosis (>50%) 27.4% 69%
Full-segm. Resten. 10% 56%
Restenosis Length 64 mm 155 mm
Clinical FU
12-month 15-month
Deaths 16.3% 10.5%
Limb Salvage 95.6% 100%
Clinical Improv. (1) 91.2% 76.5%
Compl. wound heal. 74.2% 78.6%
TLR 17.3% 50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain
vs historical PTA cohort (A.Schmidt et al. CCI 2010)
IN.PACT (angio subgroup)
PTA* (histor. group)
# patients / limbs 74 / 79 58 / 62
Male gender 51 (68.9%) 38 (65.5%)
mean age (y) 73.5 ± 9.3 70.5 ± 8.08
diabetics 54 (73%) 52 (89.7%)
Renal insuff. 34 (45.9%) 30 (51.7%)
RC 3 16 (20.3%) 0 (0%)
RC 4 14 (17.7%) 16 (25.8%)
RC 5 49 (62%) 46 (74.2%)
RC 6 0 (0%) 0 (0%)
avg lesion length 173±87 mm 183±75 mm
Tot occlusions 61.9% 64.9%
Compared to matched historical PTA cohorts, IN.PACT DEB
shows a remarkable (>60%) decrease in angiographic restenosis
at 3-month and TLR-rate at 12-15 months (65%) in the treatment
of long / complex BTK lesions
IN.PACT restenosis pattern presents more frequently focal
Single Center Randomized (1:1)
CLI, Diabetic patients
IN.PACT Amphirion vs. std PTA
Primary Endpoint: 12-month (>50%) Angiographic RR
F.Liistro LINC 2013
CLI + Diabetes
150 (Tibial) Lesions
DEB
(75 lesions)
Std PTA
(75 lesions)
12m Angio / Clinical FU
Aspirin + Clopidogrel (1 month)
24 m Duplex / Clinical FU
random (1:1)
First Randomized trial to assess DEB vs. PTA in a complex CLI–Diabetic population with 12-
month angiographic endpoint
DEB PTA p
Patients Nr 65 67
Mean age 74±9.4 y 75±9.6 y 0.7
Male gender 54 (83.1%) 52 (77.6%) 0.5
Diabetes 65 (100%) 67 (100%) 1
Hypertension 46 (70.8%) 52 (77.6%) 0.4
Smoking 13 (20.0%) 7 (10.4%) 0.1
Hypercholesterol. 23 (35.4%) 16 (23.9%) 0.1
Prev. PAD diagnosis 25 (38.4%) 23 (34.3%) 0.4
Serum creatinine 2.18±0.25 2.25±0.25 0.9
Dialysis 7 (10.8%) 7 (10.4%) 1
Obesity 23 (35.3%) 26 (38.8%) 0.5
Cor. Artery Disease 12 (18.5%) 10 (14.9%) 0.6
Cerebrov. disease 5 (7.7%) 7 (10.4%) 0.7
Limbs Nr 71 72 0.9
ABI 0.31±0.8 0.29±1.0 0.6
Concom. Fempop PTA 32 (49.2%) 35 (52.2%) 0.8
DEB PTA p
Lesions Nr 80 78
Tot Occlusions 62 (77.5%) 64 (82.1%) 0.5
Mean Length (mm±SD) 128±83 130±79 0.9
Severe Calcification 20 (25.0%) 22 (28.2%) 0.5
RVD (mm) 2.91±0.27 2.87±0.29 0.7
MLD (mm) 0.06±0.14 0.05±0.14 0.6
DS(%±SD) 97.2±7.7% 97.1±8.0% 0.9
DEB PTA p
IC 1 (1.4%) 3 (4.2%) 0.5
IIC 3 (4.2%) 5 (6.9%)
ID 7 (9.9%) 9 (12.5%)
IID 34 (47.9%) 32 (44.4%)
IIID 26 (36.6%) 23 (31.9%)
Texas Wound Class
DEB PTA p
Lesions Nr 80 78
pre-Dilatation 80 (100.0%) -
Subintimal Recanalization 17 (21.3%) 17 (21.8%) 0.8
Antegrade Recanalization 78 (97.5%) 75 (96.2%) 0.7
Retrograde Recanalization 2 (2.5%) 3 (3.8%) 0.7
Balloon Inflation Time (sec±SD) 142±38 140±50
0.5
Balloon Diameter (mm±SD) 2.90±0.39 2.85±0.36
0.4
Mean Balloon length (mm±SD) 148±83
140±79 0.5
Bailout Stenting 1 (1.3%) 1 (1.3%) 0.9
Technical Success [1] 80 (100%) 78 (100%) 1
Procedural Success [2] 65 (100%) 67 (100%) 1
.1Achievement of <30% residual stenosis by visual estimate
.2Achievement of Technical Success without procedural complications
DEB PTA p
Nr assessed Lesions 74 (92.5%) 74 (94.9%)
Lesion Assessment: ANGIO 67 (90.5%) 68 (91.9%) 0.8
DUPLEX 7 (10.0%) 6 (8.1%) 0.8
Restenosis (>50%) 20 (27.0%) 55 (74.3%) <0.001
Occlusion 13 (17.6%) 41 (55.4%) <0.001
Occlusion length (mm) 87±88 128±75 <0.001
12-month occl./baseline occl. %±SD 52±40 87±88 <0.001
Death 5(7.7%) 3(4.5%) 0.4
Major Amputation 0(0.0%) 1 (1.5%) 0.9
CVA 2 (3.1%) 3 (4.5%) 0.9
AMI 3 (4.6%) 3 (4.5%) 0.9
PCI 4 (6.2%) 3 (4.5%) 0.7
CLI recurrency 20(30.8%) 30(44.8%) 0.1
TLR 12 (18.5%) 29 (43.3%) 0.003
Non TLR 16 (24.6%) 23 (34.3%) 0.2
Cumulative MAE 19 (29.2%) 31 (46.3%) 0.05
Restenosis and Occlusion Rates TLR
Complete Wound Healing
12-month TLR
DEB vs. PTA:
18.5% vs. 43.3%
(p=0.003)
Major Adverse Events
.1F.Fanelli et al. J Endovasc Ther 2012;19:571–580
.2A.Cioppa – EuroPCR 2012
.3F.Liistro – TCT 2012
.4K.Suzuki – LINC Asia Pacific 2012
.5A.Schmidt et al. J Am Coll Cardiol 2011;58:1105–9 2011
10 Patients
12m Angio
75 Patients
12m Angio
65 Patients
12m Angio
20 Patients
4m Angio
74 Patients
3m Angio
A.Schmidt LINC 2013
Sustained Primary Patency should be the goal of modern revascularization therapies for CLI
Balloon-based technologies remain the most versatile solution to address the extent and burden of BTK arterial disease in CLI
IN.PACT DEB clinical evidence in complex, long BTK lesions shows significantly lower restenosis rate and burden, reduced TLR and improved wound healing vs. PTA
Patient #1
M, 32y/o,
17 y with DM type 1,
s/p kidney transplantation,
necrotic wound on the lt. foot
PRE
PRE
PTA with Balloonn 2.5X170 mm
END OF PROCEDURE
F, 81 y.o.
DM, type 2, 34 y.
HTN, IHD
Rest pain
necrotic wound on the lt. foot
Lt TFA antegrade admittance
PRE
Treatment
Treatment
Treatment
End of the
procedure
0-3 m
(89 patients)
0-6 m
(90 patients)
0-12 m
(92 patients)
Death
Amputation
TLR
1 (1.1%)
0%
1 (1.1%)
1 (1.1%)
0%
4 (4.5%)
2 (2.2%)
0%
8 (8.7%)
12M Survival from TLR, Occlusion, >50% Restenosis
83.7% Primary Patency (PSVR < 2.5)
PSVR ± SD
3,1
1,1 1,1 1,1 1,2
0
0,5
1
1,5
2
2,5
3
3,5
4
4,5
5
baseline discharge 3m 6m 12m
P < 0.0001
P = NS
Micari et al. Euro-PCR 2011 Micari et al. JACC Cardiovasc Intervent 2012
Sample case of restenosis following DEB administration
•CTO with significant calcium burden
•Efforts were made to avoid bail-out stenting, despite sub-
optimal acute results
•Further progression at later time points, especially around calcified segment
Angiograms Courtesy of Gunnar Tepe, MD
Background of Atherectomy
…Problem = recoil/ restenosis
…Problem = dissection
…Problem = vessel stretch
causes injury
…Problem = Intima Hyperplasia
usually after 3 - 9 months in
the SFA
…Problem = relative
contraindication in vessel
segments with high external
forces (knee)
…no dilatation - avoids
barotrauma and recoil
…smoothens the lumen
…reduces the need of stents
Angioplasty contemporarily
shifts the plaque…
Stenting permanently shifts
… the plaque
DCA removes the plaque…
Zeller et al. JACC 2006;48:1573-1578
Krankenberg et al. Circulation 2007
84
6168
0
10
20
30
40
50
60
70
80
90
1-yr patency
Silverhawk
POBA
stent
[%]
De novo lesions, 4.5mm length
Atherectomized Plaque
PHOTOPAC: Laseratherectomy & DCB
vs. DCB in instent-restenosis
PIs: Scheinert / Zeller
DEFINITIVE AR: DCA & DCB vs. DCB in native
vessels PIs: Tepe / Zeller
Entire cohort PTA DCB P
Primary patency @ 12 months [n/%/] 48/86 (55) 27/62 (43) 21/24 (88) <0.001*
TLR @ 12 months [n/%] 31/86 (36%) 29/62
(47%)
2/24 (8%) 0.001*
Restenosis@ 12 months [n/%] 39/86 (45%) 36/62
(58%)
3/24
(13%)
<0.001*
Secondary patency @ 12 months [n/%] 61/86 (71%) 39/62
(63%)
22/24
(92%)
0.015*
*: p<0.05; TLR: Target Lesion Revascularisation;
Sixt et al. JVS under revision
1. Hydrolyser
2. Oasis™ Thrombectomy System
3. Angiojet®
4. Amplatz Clot Buster (ATD)™
5. Trerotola Device
6. PMT™ Device
Mechanical Thrombectomy Local Thrombosis Straub-Rotarex (8F)
Micro Catheter
0.014” Guidewire
Dilatable Tip
FDA Cleared
CE approved
The Intraluminal Approach
The size and unique design of the Voletek™ peripheral
crossing system enables it to cross
in micro-channels
57y white male; 45mm total occlusion >9 months;
CiTop™ succeeded after standard GW failed; followed by x1 stent.
Crossing time: 3 min
Occlusion of the Rt. popliteal
FIM Peripheral Randomized Study
Operator: Dr. Alexander Belenky
DIRECTIONAL ATHERECTOMY
Endovascular Intervention offers a low risk
1-st choice therapy.
Surgery should be reserved for
– Diffuse severe vascular Calcification
– Failed endovascular intervention with
freq. restenosis
– Extensive gangrene with very prolonged healing