Παρουσίαση του powerpoint · 1,2 0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0 endoavf surgical...
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Παναγιώτης Μ. Κίτρου MD, MSc, PhD, EBIRΕπικ. Καθηγητής Επεμβατικής Ακτινολογίας
Π.Γ.Ν. Πατρών
EndoAVF
0030 69 46 68 67 [email protected] @pkitrouPanos Kitrou Panagiotis M. Kitrouorcid.org/0000-0001-7631-2068
Χειρουργική Δημιουργία. Gold standard αλλά..
~1-2 Interventions
needed to maintain a
working AVF in the EU
15 - 46%Do Not Mature
and are unusable for
hemodialysis in the EU
~30%Patients
refuse surgical
AVF creation
10 - 23%Thrombose
within 3 months
in the EU 1. Voormolen et al. JVS 2009;49:1325-1336.2. Field M, et al. JVA 2011;12(4):325-330.
3. Bashar K, et al. PLoS ONE 2015;10(3).4. Huijbregts HJT, et al. CJASN 2008;3:714-719.
5. Ferring M, et al. CJASN 2010;5:2236-2244.6. Harper SJF, et al. EJVES 2008;36:237-241.
7. Casey JR, et al. AJKD 2014
Συστήματα ενδαγγειακής δημιουργίας
Τα βασικά
Δύο φλεβικά δίκτυα: Επιπολής και εν τω βάθει
Ένα αρτηριακό δίκτυο
Εν τω βάθει +Αρτηριακό (2:1)
AV V
Επιπολής: Βασιλική και Κεφαλική φλέβα
Μεσόστεος α + φλ
Βασιλική φλέβα
Κεφαλική Φλέβα
Διατιτρώσα
Κερκιδικά Αγγεία
Ωλένια Αγγεία
Βαραχιόνια Αγγεία
Τι είδους φίστουλα δημιουργείται με το WavelinQ;
Φίστουλα με το εν τω βάθει φλεβικό δίκτυο
Κερκιδο-κερκιδική
Ωλενιο-Ωλένια
Ωλένια Φίστουλα
Κερκιδική Φίστουλα
WavelinQδύο επιπλέον επιλογές για δημιουργία φίστουλας
ForearmRadiocephalic
Upper ArmBrachiocephalic Upper Arm
Transposed Brachiobasilic
WavelinQUlnar-Ulnar
Proximal Radial
Σχεδιασμός
Case Planning
Ø > 2.5 mm
Ø > 2.0 mm
Ø > 2.0 mm
Ø > 2.0 mmConfirm outflow vessels1
Confirm perforator2
Select creation site3
Select access/navigation4
Ø > 2.0 mm
Ulnar Access Options
BA/BV
UA
MC / Basilic
UV
Cephalic
Radial Access Options
BA/BV
MC/Basilic
RA/RV
Cephalic
Distal Arterial Access - Screening
Calcification may inhibit electrode cutting.Avoid locating the fistula in areas of apparent calcification (DUS/fluoroscopy)
A partial fistula, if experienced, may be improved with angioplasty
Calcification
WavelinQSystem
Venous Catheter
Arterial Catheter
4 Fr catheter profileCompatible with 5 Fr or 4/5 slender sheath with a .014” guidewire RX
Hydrophilic coating: distal 23 cm Working length from hub to electrode: 40 cm
ElectrodeIndicatorDistal
MagnetsTipProximal Magnets
Valve crossing sleeve
Venous Catheter
Electrode is a flexible, atraumatic leaf spring
Electrode compresses as needed during delivery and navigation and extends as tissue is removed during activation
Venous Catheter
Arterial Catheter
Ceramic backstop designed to receive cutting electrode
Arterial Catheter
When correctly aligned,the arc of the electrode falls into the “saddle” of the ceramic backstop
Peaks of “saddle” control the fistula length
Catheter Interaction
Devices are Bi-directionally Compatible
Device Symmetry
Rotational IndicatorDistal magnet array
(square cross section)0.014” compatible RX guidewire lumen
Rapid Exchange Catheter (a.k.a. Monorail)
Insert catheter tip1
Insert valve crosser2
Introduce catheter through valve crosser3
Spasmolytic Cocktail
References: 1. Patel’s Atlas of Transradial Intervention, The Basics and Beyond. © 2012 by Tejas Patel, pages 8-17. 2. Rao SV, Tremmel JA, Gilchrist IC, et al. Best practices for transradial angiography and intervention: a consensus statement from the Society for Cardiovascular Angiography and interventions’ transradial working group. Catheter Cardiovasc Interv. 2014;83:228-236
Following arterial sheath insertion:
Consider “spasmolytic cocktail” to mitigate arterial spasm1: • 200 - 400 mcg of Nitroglycerin1
• 2.5 – 5 mg of Verapamil1 (diluted with patients blood)
Consider NTG for venous spasm if evident
Anticoagulant typically delivered IA at this time. Target ACT = 220
The Procedure
Sometimes….
Sometimes….The dominant network is the deep one
Obstruction and thrombosis of the deep veins with coils
Brachial V. 2
Brachial V. 1
Collaterals
Cephalic V.7
wee
ks la
ter
9 w
eeks
late
r
Data
Oxidative Stress
Hypoxia
Vascular AccessCreation
Dramatic & TraumaticEvent
End StageRenal Disease
InflammationEndothelialDysfunction
VenousNeo-IntimalHyperplasia
Needle Puncture for HD
Characteristics of AV access stenosis
Multiple Clinical Studies on WavelinQ
Pilot Study
Expanded Population
Expanded
Population
Next Generation
Device
FLEX StudyFeasibility and safety of using
the everlinQ endoAVF system
Design• Single-center, multi-
operator, prospective study
• 33 patients, 4 sequential
cohorts
• 6 month follow-up
Completed in 2014JVIR 2015; 26:484–490.
NEAT StudySafety and effectiveness of
using the everlinQ endoAVF
system
Design• Multicenter, prospective in
Canada, Australia and New
Zealand
• 60 patients (+20 roll-in),
single arm
• 12 month follow-up
Completed in 2016J Vasc Access 2017;28;18
(Suppl. 2):8-14.
Am J Kidney Dis. 2017 Jun 9. pii:
S0272-6386(17)30692-3.
EASE StudySafety and efficacy of
using the everlinQ 4 (4Fr)
System
Design• Single center,
prospective study
• 32 patients
• 6 month follow-up
Preliminary results
endoAVF Study
EU Post-Market
Study“Real world” multi-center study
designed to continue building
clinical evidence with everlinQ
endoAVF
Design• Multicenter, prospective study
• ~120 patients, single arm
• 12 month follow-up
• Includes radiocephalic AVF
candidates
Study initiated in 2016
Surgical Fistula: Meta-analysis Results
50%
0%
71%
60%
±95% C.I.
▪ 46 publications
▪ 62 unique cohorts
▪ n = 12,383
100%
Primary Patency: Time from successful endoAVF creation to the first intervention designed to address thrombosis or stenosis, assist in maturation or cannulation of endoAVF, or endoAVF abandonment.
Secondary Patency: Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
68.6%
83.5%
Lok et al. Am J Kidney Dis. 2017 Jun 9. pii: S0272-6386(17)30692-3.
NEAT Results (everlinQ)*
*Data collected on endoAVFs created by the 6 Fr System
Am J Kidney Dis, 63: 464-478, 2014.
0,5
1,8
0,1
0,4
0,02
1,2
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
endoAVF Surgical AVF
Inte
rven
tion
rate
(per
pa
tien
t-year) Procedure
Matched Surgical AVF N=60
Event rate (per pt-yr)
endoAVF N=60
Event rate (per pt-yr)
Angioplasty 0.93 0.04Thrombolysis 0.00 0.02Thrombectomy 0.20 0.04Stent placement 0.00 0.00Embolization/ligation 0.10 0.13DRIL 0.00 0.02Thrombin injection 0.00 0.04Surgical AVF or transposition 0.30 0.11Revision 0.17 0.04AVG placement 0.07 0.02Catheter placement 0.43 0.11Vascular access related infection (outpatient)*
0.97 0.00
Vascular access related infection (inpatient)*
0.27 0.02
Total Intervention Rate 3.4 0.6
Few Interventions Required Relative to Surgery
* Includes infection due to CVC while AVF maturingAVF intervention
CVC placement
Infection treatment
Propensity-score matched comparison using a 5% CMS sample of claims data for surgical AVF cohort
Yang S, JVA 2017; 18(Suppl. 2): 8 – 14.
Η εμπειρία της Πάτρας
Patras ExperienceNumber of Cases: 18
Men: 18/18 (100%) (Women have smaller vessels)
Dialysis Status:
8 Pre-Dialysis
10 Dialysis
Technical Success: 18/18 (100%)
Types of Fistula:
17/18 radial-radial (94.4%)
1/18 ulnar-ulnar (5.6%)
Patras ExperienceType of Access:
16/18 radial (88.9%)
1/18 ulnar (5.6%)
1/18 brachial (5.6%)
Successful Dialysis: 16/18 (88.9%)
Immediate Coiling of a Brachial Vein: 6/18 (33.3%)
Secondary Procedures: 7/18 (38.5%)
Coiling: 3
Angioplasty: 2
Angioplasty/Coil: 1
Declotting: 1 (angio+coil)
Coil11/1573.3%
Patras Experience
Mean Time From Procedure to Cannulation
116 days (56-303 days)
Mean Time From Cannulation until Today (Follow Up)
185 days (30-456 days)
Road to a successful MDM
What do you need?
Open Surgery Creation
EndoAVF creation
Dialysis Access Maintenance
Referring Physicians
What are the disciplines?
Surgeon
Interventional Radiologist
Nephrologist
Radial access: Talk to your Interventional Cardiologist!!!
Η επιτυχία της Πάτρας
Συμμετοχή όλων των ειδικοτήτων
Νεφρολόγοι
Αγγειοχειρουργοί
Επεμβατικοί Ακτινολόγοι
Τίποτα από αυτά δεν θα ήταν εφικτό χωρίς την συμμετοχή όλων
Σύνοψη
Το WavelinQ™ 4Fr EndoAVF έχει μικρή και γρήγορη καμπύλη εκμάθησης
Η χρήση του συστήματος 4Fr παρέχει επιπλέον επιλογές πρόσβασης και δυνατότητες για τη
δημιουργία ενδαγγειακής φίστουλας
Πολλαπλές μελέτς αλλά και η εμπειρία του τμήματός μας αναδεικνύουν την ασφάλεια και την
αποτελεσματικότητα της μεθόδου
Το WavelinQ™ 4F EndoAVF System παρέχει δύο επιπλέον ανατομικές επιλογές για τη
δημιουργία αυτόλογης αγγειακής πρόσβασης αιμοκάθαρσης για τον αιμοκαθαρόμενο ασθενή
1.Rajan et al. J Vasc Interv Radiol 2015; 26:484–490.2.Yang et al. J Vasc Access 2017;28;18 (Suppl. 2):8-14.
3.Arnold et al. JVIR 2018 (in press)4.Lok et al. Am J Kidney Dis. 2017; 70(4): 486-497
Ευχαριστώ!Παναγιώτης Μ. Κίτρου MD, MSc, PhD, EBIR
Επικ. Καθηγητής Επεμβατικής Ακτινολογίας
Π.Γ.Ν. Πατρών