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C A R D I O L O G Y G R A N D R O U N D S Presentation: Fenestrated and Branched Endografts for the treatment

of Complex Aortic Aneurysms: An Update Speaker: Jesse M. Manunga, Jr., MD

Vascular & Endovascular Surgeon Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: Monday, April 6, 2015, 7:00 – 8:00 AM

Location: ANW Education Building, Watson Room OBJECTIVES At the completion of this activity, the participants should be able to:

1. Outline surgical options for the management of complex aortic aneurysms: a. Juxtarenal, pararenal, suprarenal and paravisceral aneurysms b. Arch aneurysms c. Iliac artery aneurysms

2. Identify currently available devices used to endovascularly treat patients with complex aortic aneurysms. 3. Extrapolate one year of results and outcomes of the ANW hospital fenestrated stent graft program.

ACCREDITATION Physicians: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians.

Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurses: This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.

Others: Individuals representing other professional disciplines may submit course materials to their respective professional associations for 1.0 hours of continuing education credit. DISCLOSURE STATEMENTS Speaker(s): Dr. Manunga has declared the following relationship; Consultant: Cook Medical, Inc.

Planning Committee: Dr. Michael Miedema, and Eva Zewdie have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationships - stockholder: Cardiomind, Interface Biologics, Aritech, DSI/Transoma, InstyMeds, Intervalve, Medtronic, Osprey Medical, Stout Medical, Tricardia LLC, CoAptus Inc, Augustine Biomedical; scientific advisory board: Abbott Laboratories, Boston Scientific, MEDRAD Inc, Thomas, McNerney & Partners, Cardiomind, Interface Biologics; options: BackBeat Medical, BioHeart, CHF Solutions; speakers bureau: Vital Images; consultant: Edwards LifeSciences.

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Fenestrated & Branched Endografts for the Treatment of Complex Aortic Aneurysm: An Update

Jesse Manunga, MDVascular & Endovascular Surgeon

MINNEAPOLS HEART INSTITUTEG R O U N D R O U N D SA P R I L 6 T H , 2 0 1 5

Disclosure

C lt t f C k M di l IConsultant for Cook Medical, Inc.

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Outline• Define Complex Aortic Aneurysm

• Outline surgical options for the management of Outline surgical options for the management of complex aortic aneurysms– Juxtarenal, Pararenal, Suprarenal and Paravisceral and

Thoracoabdominal Aneurysms– Arch aneurysms

• Review currently available devices for the endovascular treatment of patients with complex aortic aneurysms

• Review 1 year outcome of the ANW Hospital fenestrated stent graft program

• Discuss the future

Endovascular aortic repairAdvantages over open repair

Less:

- Operative deaths- Operative time- Blood loss and transfusion requirements- Mechanical ventilation

ICU and hospital stay- ICU and hospital stay

DREAM trial. N Eng J Med 2004;351:1607-18

EVAR-1 trial. Lancet 2005; 365: 2179-86

OVER trial. JAMA 2009

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Thoracic aneurysms: Si l ?

Arch Aneurysms:complex

Thoracic aneurys,in

Simple?

I f l AAA Si l

Complex aneurysms

Infrarenal AAA: Simple

Iliac aneurysms: Complex

Complex AAsDefining complexity

- Dissection, clamp site, visceral ischemia, extent of reconstruction (for open repair) - Extent of coverage, number of vessels requiring incorporation, adverse vessel anatomy due to tortuosity, occlusive disease (for endo repair)

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Complex AAs

Short, angulated Complex AAAs

20-40%

necks Complex AAAs

Short neckinfrarenal

Juxtarenal Pararenal Paravisceral TAAA

Suprarenal

Making A Case for Fenestrated a g Case o e est atedStent Graft as a Valid Treatment Option for Patients With Complex Aortic Aneurysms

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North American Complex Abdominal Aortic Debranching Registry NACAAD registry participants

Center Investigators

Mayo ClinicGustavo S. Oderich MDPeter Gloviczki MDStephen Cha MS

208 patients from 14 centersUniversity of North Carolina Mark Farber MD

UCLAWilliam Quinones‐BaldrichMD

Juan Carlos Jimenez MD

Cleveland ClinicRoy Greenberg MD

Dan Clair MDSean Lyden MD

University of MichiganGuillermo A. Escobar MD

Jonathan L. EliasonHimanshu J. Patel MD

University of Virginia Gilbert Upchurch Jr.

UT SouthWestern DallasCarlos Timaran MD Patrick Clagett MD

14 centers

Mount Sinai Hospital New York Sharif Ellozy MD

University of PennsylvaniaEdward Woo MDRon FairmanMD

University of Rochester Michael Singh MD

Dartmouth University Mark Fillinger MD

Stanford University Jason Lee MD

Johns Hopkins Hospital James Black MD

SUNY Buffalo New YorkPurandahl Lall MDH DoghousluMD

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NACAAD registryEarly mortality and SVS comorbidity scores

34%n = 20/59n = 20/59

17%n = 7/42

3%n = 3/107

SVS score (sum 0‐30)

n = 3/107

p < 0.001

SVS, Society for Vascular Surgery comorbidity scores (0 to 33 points)Early death, 30‐day and/or in‐hospital

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Endovascular repair of complex aortic aneurysms

Failing to plan is planning to fail!

3D Lab interpretationComplex geometric correlations

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Proximal aortic neckThe quest for ‘normal aorta’

Diameter Diameter Length Angulation Thrombus Calcification

Length Angulation Thrombus Calcification

Parallel aortic wall

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Fenestrated Stent GraftsAnatomic Criteria

Proximal Neck CriteriaProximal Neck CriteriaTotal length > 20mmTotal length > 20mm

32 mm max32 mm max

Fixation stentFixation stentAxisAxis

< 45º< 45º32 mm max32 mm maxDiameter < 31mmDiameter < 31mm

Sealing StentSealing StentAxisAxis

Renal Artery IssuesRenal Artery Issues

Other Neck IssuesOther Neck IssuesCalcificationCalcificationThrombusThrombusAngulationAngulation

Renal Artery IssuesRenal Artery IssuesSmall size (< 4 mmSmall size (< 4 mm

StenosisStenosisEarly bifurcationEarly bifurcation

MultipleMultipleAngulationsAngulations

Celiac 125 mmCeliac 125 mmProximal Proximal landing landing

zonezone

Centerline of flowAccurate estimates of lengths

SMA 147 mmSMA 147 mm

L renal 166 mmL renal 166 mm

R renal 169 mmR renal 169 mm

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Axial vessel location

Inner Aortic Diameter 32mmSt t G ft Di t 28 Inner Aortic Diameter 22mmStent Graft Diameter 28mm Inner Aortic Diameter 22mm

Stent Graft Diameter 28mm

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AngulationImplications for planning

AngulationImplications for planning

Suprarenal axisSuprarenal axis

Neck angulation < 45-60˚

Infrarenal axisInfrarenal axis Aneurysm axisAneurysm axis

Angulated landing zoneAngulated landing zone

Main body side Main body side

C id tiC id tiConsiderations1. Vessel diameter vs

sheath diameter2. Avoid tortuosity for fenestrated component

Considerations1. Vessel diameter vs

sheath diameter2. Avoid tortuosity for fenestrated component

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LARGE FENESTRATION88 12mm diameter12mm diameter

Fenestrated and Branched Stent GraftsDesign and Planning

SCALLOP10mm Wide10mm Wide

66 12mm Length12mm Length

88--12mm diameter12mm diameter>10mm from edge>10mm from edge

66--12mm Length12mm Length

SMALL FENESTRATION6mm wide6mm wide

88--10mm height10mm height>15mm from edge>15mm from edge

• Sizing for fenestrated endografts

• Centerline of flow – Blinded independent

investigator

Type I Type II

endografts • 2‐cm proximal seal

investigator– Standardized sizing

for fenestrated endograft

– 2-cm proximal sealing zone

1 Fenestration ± 1 scallop 2 Fenestrations ± 1 scallop

Type III Type IV

3 Fenestrations ± 1 scallop 4 Fenestrations

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Available/in Trial Devices:Aortic Arch

W.L. Gore Device Cook MedicalMedtronic

Arch Fenestrated Stent Graft

INNOMINATE

L SUBCLAVIANTX2 36 x 157 mm

PLZ

DLZ

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Available/in Trial Devices: Aortic Arch

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Available/in Trial Devices: Aortic Arch

Total Aortic Arch Devices

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Total Aortic Arch Devices

Available/in Trial DevicesW.L. Gore Device Cook MedicalMedtronic

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Tambi: W.L. Gore Device

Available/in Trial Devices

Currently Available/In Trial DevicesMedtronic  device

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Currently Available/In Trial DevicesMedtronic  device

Aortic side branch incorporationCook Fenestrated and branched stent grafts

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ENDOLOGIX

• Concept 1: Fairly consistent anatomical relationship between pthe renals and SMA

• SMA @11-1 O’clock

• RRA @ 9-11 O’clock

• LRA @ 1-4 O’clock

• Concept 2: Device with pararenal flexibility (fenestrated and branched) will accommodate over 70% of ptswith pararenal and suprarenal aneurysms

Endovascular Interventions

P- Branch Device

• Based on review of 350 CTA

• Relatively consistent branch relationship

• Treat 80% of patients

Resch TA et al. Eur J Vasc Endovasc Surg 2012

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Off-The-Shelf Devices

P-Branch Device- Based on Zenith Fenestrated platformFenestrated platform

- 2 “pivot” renal fenestration, an SMA fenestration, and a

celiac Scallop

- Preloaded fenestrated wires

- “Self-retrieving” top cap

- Spiral constraining wire- Double diameter-reducing

ties

P-Branch DeviceDeployment sequence

- Ipsilateral fenestrated, preloaded devicedevice

- Contraleteral 12 Fr sheath (pigtail and 7 Fr sheath for the SMA

- Catheterization of the renals via preloaded 6 Fr sheaths (4 Fr

catheters)- Position renal sheaths post

removal of preloaded wires- Deploy the device & retrieve top ep oy t e de ce & et e e top

cap- Deployment of all branch stents

- Placement of bifurcated endograft

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Fenestrated Stent Graft: ANW Hospital ExperienceANW Hospital Experience

12/17/2013 to present/ / p

Demographics• 28 pts. treated with fenestrated stent graft

• Gender:• Men: 22 (>78%)• Men: 22 (>78%)

• Female: 6 (>20%)

• Mean age: 77 years (67 – 92)• Mean max aneurysm diameter: 56 (54 – 78 mm)

• SVS/AAVS comorbidity severity score: 17.3 (10-23)

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Technical aspects • Number of visceral arteries incorporated: 80

• 66 (82.5%) stented

• Renal arteries: 54 • 52/54 (94.4%) stented

• Unable to stent 2 (3.7%)

• SMA: 26 (32.5%)• 59.3% stented

Technical aspects • Technical success: 100%

• Vessels lost:• Intraoperative: • Renal: 1 (1.8%)

• SMA: 0• Post operative:• Renal: 1 (1.8%)

• SMA: 0SMA: 0• Total vessel lost:

• Renal: 2 (3.7%)• SMA: 0

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Intraoperative

• Fluoro time: 73 minutes (37 – 183 minutes) • Fluoro: 1,161 mGy (984 -6028 mGy)

• Contrast: 76 cc (40 – 206 cc)

• 4 type IA/III endoleaks:• 3 still present at 8 wks on CTA

• 3 resolved at reintervention• 1 still present

Complications

• 1 SMA dissection ( at reintervention for type IA/III endoleak)

• 1 CFA occlusion requiring intervention• 1 RLE compartment syndrome -> fasciotomy-

>renal failure -> dialysis• 1 LLE sensory deficit -> resolved on POD # 2

• 1 Paraplegia -> death (3.5%)• Expected Mortality based on SVS/AAVS

comorbidity score 34%

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Result -Summary

# pts Mean age # visceral vessels incorporated

Technical Success

patency Targetvessel lost

Death(%) Dialysis HLOS

28 77 80 100% 97.5% 2 (2.5%) 1 (3.5%) 1 (3.5%) 2.7 dRenal SMA

54 26

Result -Summary

# pts Mean age

# visceralvessels

Technical Success(%)

Patency(%)

Targetvessel lost

Death(%) Dialysis (%)

Paralysis/death

Stroke

ANW 28 77 80 100 97.5 2 (2.5) 1 (3.5) 1 (3.5) 1 (3.5) 0

Post approval

(14 centers)

57 73 120 100 97.5 3 (2.5) 1 (1.8) 1 (1.8) 1(1.8) 1 (1.8)

centers)

J Vasc Surg 2014; 60:295-300

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Fenestrated and branched stent grafts

Juxta/Pararenal aneurysm n30-day mortality

(%) (2)1-year survival

Greenberg 227 1.8 82%

Naoki Unno 5 0 91%

ANW Hospital 28 3.5 96.4%

Greenberg RK et al. JTCVS 2011

Branch patency

l ll

primary patency in 518 Renal Arteries 95±8%

Author Vessel patency (%)

Follow up(months)

Semmens et al 91 17O’Neill et al 91 19Muhs et al 92 46Ziegler et al 92 72

Mastracci et al. Perspec Vasc Endovasc Ther

Scurr et al 97 24Kristmundsson et al 96 25Haulon et al 100 11ANW Hospital 97.5% 12

Mohabbat W et al. J Vasc Surg 2009;49;827-37

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7676--yearyear--old female with old female with enlarging enlarging 5.75.7--cm cm AAAAAA

COPD (2 L home O2)COPD (2 L home O2)Positive cardiac stress testPositive cardiac stress testHigh calcium score (1 1885 8 High calcium score (1 1885 8 High calcium score (1,1885.8 High calcium score (1,1885.8 Left main)Left main)

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Complex endovascular repairIntra- & perioperative considerationsSupraSupra‐‐aortic branchesaortic branchesUE access & monitoringUE access & monitoringEmbolization riskEmbolization risk

Aortic arch curvatureAortic arch curvatureLack of stent appositionLack of stent apposition“Birds peak” effect“Birds peak” effectStent collapse or kinksStent collapse or kinksE d l kE d l k

Aortic valve, coronaries & heartAortic valve, coronaries & heartAV/ MV regurgitationAV/ MV regurgitationDissection/ traumaDissection/ traumaPerforation/ Perforation/ tamponadetamponadeArrhythmiasArrhythmias

Aortic forcesAortic forcesControlled hypotension Controlled hypotension due todue to““windwind‐‐socket effectsocket effect””

EndoleaksEndoleaks

Critical Critical intercostalsintercostals (T6 to L1) (T6 to L1) Spinal drainageSpinal drainagePermissive hypertension MAPs Permissive hypertension MAPs 90 to 100 mmHg90 to 100 mmHgBranch incorporationBranch incorporationIschemia & Ischemia & atheroembolizationatheroembolizationACTs > 300ACTs > 300 secssecsArrhythmiasArrhythmias ACTs > 300 ACTs > 300 secssecsRenal function declineRenal function declineInflammatory responseInflammatory responseHypogastricHypogastric preservationpreservation

Pelvic ischemiaPelvic ischemiaParaplegiaParaplegiaLE ischemiaLE ischemia

Access issuesAccess issuesInadvertent ruptureInadvertent ruptureOcclusive sheathOcclusive sheath

Endovascular repair of complex aneurysms � Improvements in stent grafts

- Smaller delivery system- More conformational

� Improvements in stent grafts - Smaller delivery system- More conformational- More conformational- Smaller profile side branches

� Improvements in pipeline- ‘Off-the-shelf’ branched/ fenestrated- In situ fenestrated techniques- Homemade’ “kits” for urgent repair

- More conformational- Smaller profile side branches

� Improvements in pipeline- ‘Off-the-shelf’ branched/ fenestrated- In situ fenestrated techniques- Homemade’ “kits” for urgent repair

� Current challenges- Regulatory approval- Dissemination of technique- Cost/ reimbursement

� Current challenges- Regulatory approval- Dissemination of technique- Cost/ reimbursement

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Fusion CT technology

Less mortality Less reinterventions

Open vs endo complex aneurysm repair Assumptions

Less mortalityLess morbidity

Shorter hospital stayFaster convalescence

Less reinterventionsLess imaging FU

No radiation

Renal deterioration?

ENDOENDO OPENOPEN

Spinal cord injury?Long-term survival?

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ANW Hospital Vascular Team

ANW Hospital Vascular Team

Thank You

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Aortoiliac aneurysms