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Marek EHRLICH MD

Director Aneurysm Program

Dept. Cardiac Surgery

Univ. of Vienna

Austria

1HOUSTON 2017

Larry Fortensky

2HOUSTON 2017

Spectrum Total Arch

Conventional Debranching Total EndovascularFET

3HOUSTON 2017

HistoryHistory: Single: Single BBranchedranched DDeviceevice

• Based on Relay NBS (Non-Bare Stent)• Based on Relay NBS (Non-Bare Stent)

Plus platform

• Internal tunnel and window – bridging• Internal tunnel and window – bridging

graft to be deployed under ostium of

target vessel

• Intended for Zone 0 deployment

combined with preceded double

debranching

HOUSTON 2017

Second anterior tunnel for LCA

HOUSTON 2017

Arch Graft System (Bolton) is a Custom Made Device Arch Graft System (Bolton) is a Custom Made Devicea nd only re com m e nde d force rta inpa tie nts

Im pla nta tion is now re se rve d for ca re fully se le cte d Im pla nta tion is now re se rve d for ca re fully se le cte dce nte rs worldwide with long te rm e xpe rie nce inTEVA Rtre a tm e nttre a tm e nt

A im is toim ple m e nta com m e rcia lly a va ila ble “A rch Ste ntde vice ”de vice ”

HOUSTON 2017

Individual Graft Design – Overview

DE

A BF

C

A = 32-48m mA = 32-48m mB = 22-48m m (50m m forcustom )C = 255 m m (for45m m D )

270 m m (for60m m D )C ustom m inim um le ngth

D = 45 or60m mE = 50mm ONLY FIXED DISTANCE

F = 26m m ifA :32-34m mC ustom m inim um le ngth150 (forD a t45m m )160 (forD a t60m m )

F = 26m m ifA :32-34m mF: 32m m ifA :36-42m mF: 38m m ifA :44-48m m

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

Graft Design – Tunnel Length and Diameter

G

D

G

H

G :Poste riortunne l forB C TH :A nte riortunne l forL C A

H

Tunnel LengthTunnel Length

LengthD

LengthG

LengthH

60 m m 40 mm 35 mm

45 m m 35 mm 30 mm

C O N FID EN TIA L –B oltonM e dica l inte rna l use only

8

HOUSTON 2017

Bridging Stents Design

B /D :70-80-90-100-120-140 m m

C /E:8-9-10-11-12-13-14-16-18-20-22-24 m m

B D

C /E:8-9-10-11-12-13-14-16-18-20-22-24 m m

C E

C O N FID EN TIA L –B oltonM e dica l inte rna l use only

E

HOUSTON 2017

RelayBranch Design: Lock-Stent

• Tunnels feature Lock-Stent technology that prevents branch disjunction• Tunnels feature Lock-Stent technology that prevents branch disjunction

Lock-StentLock-Stent

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

Goal - Device of the Shelf

D E

A BF

C

A :proxim a l e nd (9 siz e s)B :dista l e nd (14 siz e s)C :tota l cove re d le ngth(2 siz e s)

D :frontportion(2 options)E:fe ne stra tion’s le ngth(fixe d)F:fe ne stra tion’s width(fixe d)

Aim - Catalogue of 25 – 30 modules

C :tota l cove re d le ngth(2 siz e s) F:fe ne stra tion’s width(fixe d)

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

# Code Center Country Investigators1 392 O spe da le G .B rotz u -C a glia ri Ita ly dr.S.C a m pa rini

2 811 O sa k a U nive rsity H ospita l Ja pa n dr.T.Kura ta ni

3 331 H opita l R a ngue il -Toulouse Fra nce prof.H .R ousse a u

4 391 O spe da le Sa nC a m illo-R om a Ita ly prof.P.G .C a o

5 333 H opita l G e orge Pom pidou -Pa ris Fra nce dr.J.M .A lsa c

6 441 St.M a ry's H ospita l -L ondon U nite d Kingdom dr.M .H a m a dy

7 461 L ink ö ping U nive rsity H ospita l -L ink ö ping Swe de n dr.C .Forsse ll

8 341 H ospita l U C A de O vie do Spa in dr.M .A lonso

9 311 U tre chtU nive rsity H ospita l -U tre cht N e the rla ndsprof.F.M oll,dr.J.Va nH e rwa a rde n

10 491 M a inz H ospita l G e rm a ny dr.E.W e iga ng

11 492 U nive rsitätk linik um Fre iburg -Fre iburg G e rm a ny dr.B .R ylsk i

12 493 U nive rsitätsk linik um G ie ß e n G e rm a ny dr.A .Koshtov

13 495 U nive rsitätsk linik W ie n A ustria dr.Funovics,Ehrlich13 495 U nive rsitätsk linik W ie n A ustria dr.Funovics,Ehrlich

HOUSTON 2017

Patient Clinical Requirements

Patient treated with the branched devices have to meet the following

conditions:conditions:

• suitable for positioning the guidewire and the tip of the main device into

the Left Ventricle (no mechanical aortic valve)

• suitable for maneuvers to manage the blood pressure with rapid pacing

• subject must have :

• aortic inner diameter of 43 mm or less and a healthy proximal neck

length of 30mm

• 60mm as minimum required distance between sinotubular junction• 60mm as minimum required distance between sinotubular junction

and innominate artery

• femoro-iliac axes compatible with the profile of the system (24 Fr)

C O N FID EN TIA L –B oltonM e dica l inte rna l use only

• femoro-iliac axes compatible with the profile of the system (24 Fr)

HOUSTON 2017

Aortic diameters of reference

ZERO point 50m m

1:a ortic dia m e te r a t 45m m or60m m (whe n a pplica ble )from60m m (whe n a pplica ble )fromthe Z e roPoint

2: a ortic dia m e te r a t the Z e roPoint

5** to10 m m

23

5

4

Point

3: a ortic dia m e te r 50m m fromthe Z e roPoint

4:a ortic dia m e te r 130m m from

15 4:a ortic dia m e te r 130m m from

the Z e roPoint

5:a ortic dia m e te r 210m m fromthe Z e roPoint

6the Z e roPoint

6: a ortic dia m e te r a t dista lla nding z one (EXTR A G R A FT)

Aortic diameters of reference

7

87:B C T dia m e te rrightbe fore thebifurca tion

9ZERO point

9’8 bifurca tion

8:B C T dia m e te r1cm a bove theosthium

9: L C A dia m e te r in a stra ight9: L C A dia m e te r in a stra ighta re a a t le a st 3cm a bove theostium

9’: L C A dia m e te r in a nothe r9’: L C A dia m e te r in a nothe rloca tion of it to confirm them e a sure m e nt

HOUSTON 2017

ACCESS SITES

• Left or Right Femoral access for main

device (1or 2) and angio catheter

• RCA access for branch graft (3)

• LCA access for branch graft (4)

• Brachial access (right) for angiographic

catheter (5) or as needed to inject in

innominate bifurcationinnominate bifurcation

• Venous access for pacing leads

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

TU N N EL G R A FTPL A C EM EN TPL A C EM EN T

M A R KER S

Proxim a l m a rk e rs gra ft

M a rk e rofbe ginning ofpock e t

M a rk e rofe nd ofpock e t

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

MAIN BODY GRAFT PLACEMENT

Advance secondary sheath to

proximal landing zoneproximal landing zone

Position the graft to align the tunnel

pocket with the ostium of the BCTpocket with the ostium of the BCT

and LCA artery. Align the tunnel

marker 5-10 mm proximal to the

BCT (0 point)

Deploy the tunnel graft under rapid

pacing

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

BRANCH GRAFT FOR BCT and LCA ARTERYCANNULATION OF BOTH TUNNELSCANNULATION OF BOTH TUNNELS

Turn C-arm between LAOTurn C-arm between LAO

and RAO to visualize

anterior and posterior

tunnelstunnels

Cannulate the posterior

and anterior tunnel usingand anterior tunnel using

a guide wire

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

Am I inside and which tunnel ?

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

The important thing is to be able to recognize

the tunnelsthe tunnels

PO STER IO R TU N N EL(B C T)

A N TER IO R TU N N EL(L C A )(B C T) (L C A )

• It’s approximately 5mm longer than theanterior

• It’s approximately 5mm shorter than theanterioranterior

• It runs “on the left” ofthe middle marker ofthe fenestration

anterior

• It runs “on the right”of the middle markerof the fenestrationthe fenestration of the fenestration

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

Is Cannulation ok? Which tunnel?

Two ways to check thatthe wire is in the tunnel:the wire is in the tunnel:

-Angiogram

-PTA Balloon-PTA Balloon

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

3 pa tie nts ,m e a na ge 74 a

Indications:Indications:

a) Penetrating ulcer in the aortic arch after st. p. IMH in

ascending aorta – AA graft replacementascending aorta – AA graft replacement

b) Penetrating Ulcer in the aortic arch

c) St. p. Type B with TEVAR, 1a Endoleak – 7 cm arch aneurysmc) St. p. Type B with TEVAR, 1a Endoleak – 7 cm arch aneurysm

2 patients needed subclavian - left carotid bypass before the2 patients needed subclavian - left carotid bypass before the

procedure

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

Comorbidites:Comorbidites:

Patient 1:St.p.IM H a nd A sce nding R e pla ce m e nt,st.p.la rynge a l

ca nce rwithne ck disse ctiona nd ra dia tion,st.p.Strok e 2008,

C O PD G old III

Patient 2:St.p.A A A withEVA R A ptus,C O PD III.st.p.prosta te

ca nce r,st.p.strok e 2010,st.p.colonca nce r2000,St.p.fe m .pop

bypa ss,St.p.bulle k tom y a nd ple ure ce tom y le ftlung

Patient 3: St.p.type B disse ctionwithTEVA R ,st.p.tonguePatient 3: St.p.type B disse ctionwithTEVA R ,st.p.tongue

ca nce rwithne ck disse ctiona nd ra dia tion1996,G old II

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

Clinical Data ViennaClinical Data Vienna ––PostinterventionalPostinterventionalPostinterventionalPostinterventional

Mortality 0 %, Neurological Compl. –

ICU Stay – mean 4.6 days, 3-10 days

1 PRIND (Pt. 2) - Remission after 4th day

ICU Stay – mean 4.6 days, 3-10 days

2 pts – 6 months follow up – no Endoleak

1 pt – done last week – no prim. Endoleak

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017

The B olton”A rchD e vice ”offe rs inthis firststa ge custom m a deThe B olton”A rchD e vice ”offe rs inthis firststa ge custom m a depe riod a via ble optionforse le cte d pa tie nts

Pre lim ina ry re sults look prom ising withPre lim ina ry re sults look prom ising withlow m orta lity a nd m orbidity ra te s

Itcould be com e a ne ffe ctive a nd sa fe ofthe she lftool forItcould be com e a ne ffe ctive a nd sa fe ofthe she lftool forpa tie nts witha ortic a rchpa thologie s

M ore shorta nd m id-te rm da ta is ne e de d toconfirm the be ne fitM ore shorta nd m id-te rm da ta is ne e de d toconfirm the be ne fitofthis de vice

HOUSTON 2017