Παναγιώτης Μ. Κίτρου MD, MSc, PhD, EBIRΕπικ. Καθηγητής Επεμβατικής Ακτινολογίας

Π.Γ.Ν. Πατρών

EndoAVF

0030 69 46 68 67 66panoskitrou@gmail.com @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