UC SF The Short Neck: What is the Role of Anchors, Chimneys, - - PDF document

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UC SF The Short Neck: What is the Role of Anchors, Chimneys, Z-Fen? Jade S. Hiramoto, MD, MAS UCSF Vascular Symposium April 4, 2019 VASCULAR SURGERY UC SAN FRANCISCO 1 UC SF Disclosures Research support and royalties from Cook,

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

The Short Neck: What is the Role

  • f Anchors, Chimneys, Z-Fen?

Jade S. Hiramoto, MD, MAS UCSF Vascular Symposium April 4, 2019

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Disclosures

  • Research support and royalties

from Cook, Inc.

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

EVAR: The Short Neck

  • Unfavorable proximal aortic neck:

increased risk of failure after EVAR

  • Short neck
  • Highly angulated
  • Conical (reverse taper morphology)
  • Thrombus/calcium
  • Currently marketed endografts IFU

require neck length of 10-15 mm

  • Increased risk of endoleak and migration

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

EVAR: The Short Neck

  • Augment the neck
  • Endoanchors
  • Raise the neck
  • Chimney grafts
  • Fenestrated devices

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VASCULAR SURGERY • UC SAN FRANCISCO

EndoAnchors

  • Heli-FX EndoAnchor system (Medtronic,

Santa Rosa, CA)

  • Designed as adjunct to EVAR
  • Enhance fixation and sealing of endograft

within proximal aortic neck

  • May be helpful in cases of highly angulated
  • r short neck
  • Contraindicated if mural thrombus or calcium

present at site of intended deployment

  • Prohibit penetration of EndoAnchor into aortic wall

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VASCULAR SURGERY • UC SAN FRANCISCO

EndoAnchors

  • Advantages
  • Improve fixation/sealing of endograft to

proximal aortic neck

  • “Mimics” surgical sutured anastomosis
  • Disadvantages
  • Subsequent open surgery may be harder

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Augmenting the Neck: EndoAnchors

Jordan et al; J Vasc Surg 2014;60:885-92

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

ANCHOR Prospective Multicenter Registry

  • 2/2012-12/2013: 319 patients from 43 sites in the

US/Europe

  • Asymptomatic, symptomatic, or ruptured AAA
  • Primary arm:
  • EndoAnchor implantation at same time as initial EVAR

procedure

  • High risk anatomy for future proximal neck complication,

based on opinion of investigator

  • Treated for prophylaxis of endoleak or migration
  • Type IA EL at initial EVAR procedure
  • Secondary arm:
  • Prior EVAR with type IA EL or endograft migration

Jordan et al; J Vasc Surg 2014;60:885-92

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VASCULAR SURGERY • UC SAN FRANCISCO

ANCHOR Prospective Multicenter Registry

Jordan et al; J Vasc Surg 2014;60:885-92

(n=242) (n=77) (n=319)

  • Procedural success=technical success without type IA EL

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VASCULAR SURGERY • UC SAN FRANCISCO

ANCHOR Prospective Multicenter Registry

  • During mean follow-up of 9.3 ± 4.7 months, no

new type 1A EL or endograft migration after index procedure

  • Single center study of 51 patients: 87% 2 year

freedom from type IA EL (Goudeketting et al; JEVT 2019; 26(1):90-100)

Jordan et al; J Vasc Surg 2014;60:885-92

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VASCULAR SURGERY • UC SAN FRANCISCO

Raising the Neck:Chimney Grafts

  • Placement of stent into branch vessel with proximal part of

stent extending above proximal edge of aortic stent graft

  • Allows more proximal placement of aortic stent graft in

short-necked AAAs while maintaining perfusion to viscera and kidneys

Hiramoto et al; J Vasc Surg 2009;49:1100-6

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Raising the Neck:Chimney Grafts

  • Chimney grafts from brachial/axillary arteries
  • Aortic stent-graft deployed from femoral arteries
  • Main stent-graft ballooned simultaneously with branch vessel

stents

Yammine H et al; Tech Vasc Interventional Rad 2018;21:165-174

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VASCULAR SURGERY • UC SAN FRANCISCO

Raising the Neck:Chimney Grafts

  • Advantages:
  • Standard, off-the shelf components
  • May be less technically challenging

than fenestrated device

  • Disadvantages:
  • Gutters: blood flow through

channels between main body of aortic endograft and chimney grafts

  • Chimney stents may become

kinked, compressed, or occluded

  • Stroke risk (upper extremity access)

Yammine H et al; Tech Vasc Interventional Rad 2018;21:165-174

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VASCULAR SURGERY • UC SAN FRANCISCO

PERICLES Registry: Collected World Experience

  • Largest collection of ch-EVAR

procedures

  • 517 patients treated from 2008-2014
  • “Real world” clinical practice
  • 20% cases symptomatic, rapid

expansion, ruptured

  • Aneurysm classification:
  • Juxtarenal AAA n=360 (70%)
  • Suprarenal AAA n=129 (25%)
  • Type IV TAAA n=28 (5%)

Donas et al; Ann Surg 2015;262:546-553

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VASCULAR SURGERY • UC SAN FRANCISCO

PERICLES Registry: Collected World Experience

  • Type IA intraoperative EL in 41

patients (8%)

  • 15 patients (3%) with persistent EL

despite corrective measures

  • Technical success 502/517 cases (97%)
  • 30 day mortality: 5%
  • Four procedural-related deaths
  • Mean follow-up 17.1 months (range

1-70 months)

  • Primary chimney patency 94%
  • No difference if balloon-expandable or

self-expanding stent used

Donas et al; Ann Surg 2015;262:546-553

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

PERICLES Registry: Collected World Experience

  • What is the optimal device

combination for ch-EVAR?

  • Unclear
  • No difference in chimney occlusion

rates between aortic device types with BECS

  • Trend toward higher occlusion

rate with BECS in Group C

Group A=nitinol/polyester Group B=stainless steel/polyester Group C=nitinol/PTFE BECS=balloon-expandable covered stent Occlusion-free survival of balloon expandable chimneys

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

PERICLES Registry

  • Significant occlusion-free

survival advantage in those with lower number of chimney stents

  • 1.8 fold-increased risk of
  • cclusion for each additional

chimney stent

  • Use of bare metal “endolining”

stent doubled occlusion hazard risk

Scali et al; JVS 2018;68:24-35

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VASCULAR SURGERY • UC SAN FRANCISCO

Raising the Neck: Fenestrated Devices (FEVAR)

  • Advantages:
  • FDA-approved indication for

juxtarenal AAA repair

  • No gutters
  • Disadvantages:
  • Manufacturing delay
  • Technically challenging
  • Costs

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VASCULAR SURGERY • UC SAN FRANCISCO

Zenith FEVAR

Oderich et al; JVS 2014;60:1420-8

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VASCULAR SURGERY • UC SAN FRANCISCO

Zenith FEVAR U.S. Multicenter Trial

  • First prospective multicenter analysis of FEVAR

to treat juxtarenal AAA

  • 67 patients enrolled in 14 US centers from

2005-2012

  • Custom-made fenestrated stent-grafts with one

to three fenestrations

  • Renal alignment with balloon-expandable stents
  • Covered and uncovered stents

Oderich et al; JVS 2014;60:1420-8

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VASCULAR SURGERY • UC SAN FRANCISCO

Zenith FEVAR U.S. Multicenter Trial: Results

Oderich et al; JVS 2014;60:1420-8

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Systematic Review of FEVAR

  • 763 patients and 2040 target vessels
  • 93% technical success
  • 30 day mortality 1.7% (range 0-4%)
  • 74 target vessels occluded (3.6%)
  • 9 intraoperative
  • 65 during follow-up
  • 90% freedom from re-intervention at 1 year

Ou et al; Ann Vasc Surg 2015;29:1680-88

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FEVAR vs ch-EVAR: How Do They Compare?

  • Systematic review/meta-analysis of 42

studies with 2264 patients undergoing FEVAR and ch-EVAR

  • 25 studies of FEVAR
  • 13 studies of ch-EVAR
  • 4 studies containing both
  • 4413 target vessels

Yaoguo et al; Vascular 2017;25(1):92-100

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VASCULAR SURGERY • UC SAN FRANCISCO

FEVAR vs ch-EVAR: How Do They Compare?

Yaoguo et al; Vascular 2017;25(1):92-100

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VASCULAR SURGERY • UC SAN FRANCISCO

FEVAR vs ch-EVAR: How Do They Compare?

Yaoguo et al; Vascular 2017;25(1):92-100

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Complex EVAR: VQI

O’Donnell et al; JVS 2019;1-12

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VASCULAR SURGERY • UC SAN FRANCISCO

Complex EVAR: VQI

  • Perioperative death (p=0.13)
  • 3.4% FEVAR
  • 2.7% PMEG
  • 6.1% ch-EVAR
  • Overall survival 91% at 1 year

and 88% at 3 years

  • No difference between repair types
  • Ch-EVAR cases:
  • More arm/neck access
  • Longer procedural times
  • Used more contrast material
  • Increased risk of stroke, MI, MACE

O’Donnell et al; JVS 2019;1-12 Adjusted Odds Ratios for Outcomes

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VASCULAR SURGERY • UC SAN FRANCISCO

FEVAR/ch-EVAR vs Open Repair

  • National Surgical Quality Initiative Program

(NSQIP) Database 2012-2016

  • Examined 30 day outcomes of FEVAR, ch-

EVAR and open repair for juxta, para, and suprarenal AAA

  • 1191 patients underwent AAA repair
  • 72% open repair
  • 14% FEVAR
  • 14% chEVAR

Locham S et al; Vasc Endovasc Surg 2019; 53(3):189-198

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VASCULAR SURGERY • UC SAN FRANCISCO

NSQIP Data:30 Day Outcomes

Locham S et al; Vasc Endovasc Surg 2019; 53(3):189-198

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VASCULAR SURGERY • UC SAN FRANCISCO Locham S et al; Vasc Endovasc Surg 2019; 53(3):189-198

NSQIP Data:30 Day Outcomes

Open AAA repair associated with 2 to 5-fold increase in mortality, renal, and cardiopulmonary complications

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FEVAR vs Open Repair: VQI Database 2012-2018

  • 2125 complex open AAA vs 877 FEVAR
  • Patients undergoing FEVAR were older, with

larger aneurysms, and more comorbidities

  • Propensity weighted perioperative mortality

similar between open repair and FEVAR

  • 4.7& vs 3.3%, p=0.17
  • Open repair with higher rates of:
  • Myocardial infarction (5% vs 3%, p=0.03)
  • Acute kidney injury (25% vs 16%, p<0.001)
  • New dialysis (4.3% vs 2.1%, p=0.003)
  • Propensity weighted long term mortality higher

following FEVAR

O’Donnell et al; Ann Surg 2018

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VASCULAR SURGERY • UC SAN FRANCISCO

Conclusions: EVAR For The Short Neck

  • Urgent or emergent case
  • Endoanchors
  • Chimney grafts
  • Thrombus/calcified aortic neck -raise the neck
  • Chimney grafts
  • FEVAR
  • Elective case
  • Dealer’s choice, depending on comfort level
  • No randomized data
  • Variable follow-up times

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