LimFlow Procedure · 1. Kum S, Tan YK, Schreve MA, Ferraresi R, Varcoe RL, Schmid A, et al. Midterm...
Transcript of LimFlow Procedure · 1. Kum S, Tan YK, Schreve MA, Ferraresi R, Varcoe RL, Schmid A, et al. Midterm...
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LimFlow Procedure
Steven Kum
FRCS CWSP
Director of Vascular Services
Changi General Hospital
Singapore
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Disclosure
• Workshop/Speaker Honourarium:
Medtronic, Abbott, Straub Medical, Boston Scientific, Bard, Biotronik
• Consultancy:
MdStart/LimFlow, Acelity, Abbott, Boston Scientific, Vascuros Medical, Orbus Neich
• Equity
LimFlow (patent)
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We are facing a Global CLI Pandemic
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Concept of Surgical Venous Arterialization
Courtesy Pramook
Deep Venous Bypass
VeinArtery
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Surgical DVA
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Failed Intervention +
No distal target for bypass
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Distal anastomosisis is difficult as vein is small and prone to twisting
Valves not easily
addressed
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Post DVAExtreme calcification
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Concept of Venous Arterialization
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Concept of LimFlow
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CADAVERIC ANGIOSCOPE
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Anatomy of a Valve
AnnulusLeaflet
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Cutting Balloon Vs Valvulotome
Cadaveric Angioscopewith Flow
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Case Examples
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Severe Calcium
Distal Foot Angioplasty Failed
LimFlow 15
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LimFlow 15Arterial Flow to
Venous Arch achieved
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Non healing for 6 months Almost fully healed in 2.5 month
LimFlow 15
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LimFlow 1380 Male
Severe Rest Pain & Toe Gangrene
Diabetic
Hypertensive
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Day 150Wound healed
85 yrs old Female
Severe Rest Pain & Toe Gangrene
Diabetic
Hypertensive
Poor Perfusion TcpO2 = 3mmHg
LimFlow 4
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LimFlow 1085 yrs old Female
Severe Rest Pain & Toe Gangrene
Diabetic
Hypertensive
Poor Perfusion TcpO2 = 16 mmHg
Day 194Wound healed
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LimFlow 9
62 yrs old Female
Heel Gangrene Failed Intervention to PT
Diabetic
Hypertensive
Poor Perfusion TcpO2 = 29 mmHg
Day 114Wound healed
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LimFlow 1272 yrs old Male
Severe Rest Pain & Toe Gangrene
Protein C/S Deficiency + Thrombocytosis
Multuple Interventions and Thrombolysis
Poor Perfusion TcpO2 = 4 mmHg
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CellutomeEpidermal Graft
Day 190Wound healed
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Some of the European & US cases..
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6.5 months
Antonius Ziekenhuis,Netherlands
Daniel Van den heuvelJean Paul DeVries LimFlow
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7 June 2017
Medical University of GrazGraz, Austria
Prof. Dr. Marianne Brodmann LimFlow
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27 July 2017
150mm Covered Stent 7F deliverable
now CE marked
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Kaiser Permanente Medical Center, Honolulu
Peter Schneider LimFlow
Peroneal feeds Tarsal Branch
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There is perfusion after the graft occludes…
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Singapore
No. 3
28 July 2014
7 months of primary patency
8 months for wound healing
Symptom Free
Persistent AVF signal even with graft occlusion
7 Oct 2015
TCPO2 = 24
TCPO2 > 50
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28 Aug 2014
3 months of primary patency
8 months of secondary patency
5 months for wound healing
22 Oct 2015 22 Oct 2015
TCPO2 = 75
TCPO2 = 19
Symptom Free
Persistent AVF signal even with graft occlusion
Singapore
No. 4
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Before LimFlowControl After LimFlow
Stent Occluded
Leipzig No. 3 Continued Perfusion despite Occlusion
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Collaterals after OccludedSurgical DVA
Courtesy FerraresiTCPO2 = 8mmHg TCPO2 = 65 mmHg
4 months
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May 2016
Aug 2016
Infected PTFE explanted
Strong “AVF-Like” Doppler despite
explantation
Singapore
No. 8
June 2017
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Graft explanted D77
TCPO2 remains high despite no DVA post explantation of
covered stent
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HYPOTHESIS
Courtesy Pramook
DVA ConduitPressurization of
Venous Bed allows collaterals to reach
CAPILLARY BED
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DCB Assisted Patency
15/09/14 07/01/16
564 Days of Patency from procedure date
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Pilot Study –7 “No-Option” CLI patients
1. Kum S, Tan YK, Schreve MA, Ferraresi R, Varcoe RL, Schmid A, et al. Midterm outcomes from a pilot study of percutaneous deep vein arterialization for the treatment of no-option critical limb ischemia. J Endovasc Ther. 2017 Jul 1:doi: 10.1177/1526602817719283 (epub ahead of print)
* Minor complications: two non-ST, non-procedure related elevated MIs; one patient developed spontaneous retroperitoneal bleeding 8 weeks’ post-procedure and was managed conservatively after cessation of anticoagulation.# three procedure unrelated deaths within 12 months: 2 patients died of pneumonia at 6 and 8 months, respectively; 1 patient had a fatal MI at 7 months following above-the-knee amputation.
Major Adverse Limb Events
SurvivalTechnicalSuccess
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Pilot Study – 12 months Endpoints
57%
86%
71% 71%
8
59
0
10
20
30
40
50
60
70
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Complete Wound Healing Limb Salvage Perfusion - TcPO2
TcP
O2 in m
mH
G
%
6 Months 12 months @ Baseline @ Wound Healing
p= 0.080
Median time to wound
healing = 145 days
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Summary of Experience –Objective Measurement of
Perfusion with TCPO2
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58%
37%
Rutherford classification
Class 4 Class 5 Class 6
• 43 “No option” patients
• Mean age 68 y.o. (range 36-94 y.o.)
• Majority of male patients (61% male, 39% female)
• 81% of the patients were diabetic
• As of today 22% of patients were on dialysis
OUS Clinical ExperiencePatient Demographics
Confidential and Proprietary
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Clinical Summary – all patients to date
Confidential and Proprietary
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 15 30 45 60 75 90 105 120 135 150 165 180
Death
AFS
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0
20
40
60
80
100
0 3 6 9 12
Am
pu
tati
on
-fre
e su
rviv
al (
%)
Months
312 260 238 221 213
AFS were 86±2%, 81±2%,77±3%, and 74±3% at 3, 6, 9,and 12 months, respectively.
Variables HR (95%CI) P value
BMI <18.5 2.22(1.23-4.01) 0.008
Statin administration 0.59(0.30-1.13) 0.11
Anemia 1.80(0.97-3.32) 0.06
Heat failure 1.73(1.02-2.91) 0.04
Wound infection 1.89(1.07-3.32) 0.02
Primary Endpoint: Amputation-free survival
Iida O, et al. Circ Cardiovasc Interv. 2013;6:68-76.
Independent predictors for AFS
BMI <18.5 Wound infectionHeat failure
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0
20
40
60
80
100
0 3 6 9 12
Pro
po
rtio
n o
f u
lcer
s h
eale
d (
%)
Months
119 58 32 22274
75% Rutherford 5 25% Rutherford 6
Secondary Endpoint: Time to wound healing
Median time requiring complete
wound healing was 97±10 days.
The proportion of not-healed patients was 54±3%, 29±3%, 18±3%, and 14±3% at 3, 6, 9, and 12 months, respectively.
Variables HR (95%CI) P value
BMI <18.5 0.54(0.31-0.96) 0.03
Hemodialysis 0.79(0.58-1.09) 0.15
Wound infection 0.60(0.36-0.98) 0.04
Factors predicting failure to achieve healing after 97 days
Iida O, et al. Circ Cardiovasc Interv. 2013;6:68-76.
BMI <18.5 Wound infection
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LimFlow pDVA Clinical Program
46
` PilotPre and Post
CE Mark
U.S.
Feasibility
OUS Post-
MarketU.S. Pivotal
# Patients 7 36 10 25 50 60 – 120
# Centers 1 9 3 6 10 20
Protocol
Single-center,
prospective,
open label
Multi-center,
prospective, open
label
Multi-center,
prospective,
single-arm
Multi-center,
prospective,
single-arm
Multi-center,
prospective, efficacy
and safety study
EnrollmentSep 2013-
Nov 2014
Mar 2015 – Mar
20172017 - 2018 2017 - 2018 2018 - 2019
Countries Singapore
France, Germany,
Italy, Netherlands,
Singapore
U.S. EU, Singapore U.S.
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Summary• Safe, effective but there is a learning curve
• A viable solution to treat patients with “No Option CLI” egDesert Foots, Renal Failure, Severe calcification
• In Combination with a Dedicated Wound Care Service, can yield acceptable Limb Salvage and Wound Healing in a complex group of patients
• Potentially applicable to any angiosome that cannot be opened via conventional techniques
• Sustained Perfusion after graft occlusion is surprising and has potential benefits
• FDA granted Expedited Access Pathway Oct 2017. Site selection on going focussing on ability to deliver quality wound care.
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LimFlow Procedure
Steven Kum
FRCS CWSP
Director of Vascular Services
Changi General Hospital
Singapore