The Cook Fenestrated Platform: Experiences and

Oncoming Technology

Krassi Ivancev

Department of Vascular & Endovascular Surgery, Royal Free London NHS Foundation Trust,

London, United Kingdom

Disclosure

• Cook Medical Inc. - Patent licenses/Royalties - Research funds - Travel expenses

Cook Zenith Fenestrated Device Indication: Infrarenal Neck >4mm

Patient-Specific Fenestrations

Scallop Scallops along the graft’s proximal edge are 10 mm wide and 6-12 mm high.

Precision Design

Small Fenestration Small fenestrations are 6 mm wide and 6 or 8 mm high.

Large Fenestration Large fenestrations range from 8-12 mm in diameter.

Indications for fenestrated stentgraft

  Juxtarenal aneurysm –  Short neck –  Conical neck –  Thrombus-lined neck

•  15-20% of AAA will

have inadequate neck for standard infrarenal SG

Open vs F-EVAR vs Ch-EVAR Cumulative Results for JAA

Study Design

•  Systematic PubMed search

•  English articles (January 2001-July 2012)

•  JAA Management (Open surgery, F-EVAR, Ch-EVAR)

•  Studies with ≥10 pts included

Study Cohorts

  OPEN Surgery: 20 studies,1725 pts

  F-EVAR: 10 studies, 931 pts

  Ch-EVAR: 5 studies, 94 pts

Outcomes Comparison

Target Vessel Preservation

Excellent rates for F-EVAR, Ch-EVAR Under-reported for Open

30-Day Mortality

30-Day Mortality (1)

→ F-EVAR ↓ Mortality vs Open but NS However... F-EVAR: ↑ Risk pts & Learning curve

30-Day Mortality (2)

→ Reasonable due to acute cases in Ch-EVAR But even with acute cases excluded… Ch-EVAR: 5.1% F-EVAR: 2.4%

Perioperative Complications

F-EVAR ↓ complications vs Open

Ch-EVAR ↓ pulmonary complications (only) vs Open

Operative Data

F-EVAR & Ch-EVAR : ↓ EBL, ICU & Hospital LOS vs Open

Proximal Type I Endoleak

Ch-EVAR: 5-31%, Cumulative 10%

F-EVAR: 0-5.9%, Cumulative 4.3%, (p=0.002)

TM Mastracci, MD, RK Greenberg, MD, MJ Eagleton et al, Durability of branches in branched and fenestrated endografts, J Vasc Surg 2013;57:926-33

SMA Reintervention N=26 (4%)

50% Endoleak

50% Stenosis

9 Urgent

3 related deaths

Celiac Reintervention N=4 (0.6%)

LRA N=30 (5%) 32% Diagnostic

48% Endoleak

19% Stenosis RRA N=41 (6%)

Device Migration N=7 5 req intervention,

4 branch related Time to any branch

stent intervention 237 days (SD 354 days)

Secondary Interventions: CCF Data

TM Mastracci, MD, RK Greenberg, MD, MJ Eagleton et al, Durability of branches in branched and fenestrated endografts, J Vasc Surg 2013;57:926-33

Freedom From Secondary Intervention All Endo-Juxtarenal and TAAA Repairs

TM Mastracci, MD, RK Greenberg, MD, MJ Eagleton et al, Durability of branches in branched and fenestrated endografts, J Vasc Surg 2013;57:926-33

Options in “short/no” Neck AAA Conclusions

  Open Surgery in short/no necks: good risk pts

  Fenestrated EVAR: alternative to open, especially in high risk patients

  Chimney techniques: to be proven, therefore only as bail-out and in acute patients

Problems with current technology

 Planning – Margin of Error

 Production – 6-8 weeks

 Bilateral Access – LE perfusion – Compromised access

 Precision of graft in vivo

Not for symptomatic/very large AAA?

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10

20

30

40

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60 0 2 4 6 8 10 12

Dis

tanc

e to

SM

A

Clock Position

RRA LRA

Off The Shelf

6 8 10 12 2 4 6

•  Retrospective analysis of 353 patients

•  Methods/Assumptions •  Align SMA fenestration •  Device fits if renals are

within outer ring (15 mm diameter)

•  Results

•  80% coverage possible

J. Sobocinski, G. d’Utra, N. O’Brien et al. Off-the-Shelf Fenestrated Endografts: A Realistic Option for More Than 70% of Patients With Juxtarenal Aneurysms ENDOVASC THER 2012;19:165–172

P-Branch device

Zenith® Preloaded Delivery System

Not available for sale.

6mm

15mm

Not available for sale.

Current Status

 CE marking trial on-going – 4 sites (1 Europe, 3 US) – 48 patients enrolled

» 6 ruptures » 1 symptomatic

A Kitagawa, RK Greenberg, MJ Eagleton, TM Mastracci: Zenith pivot branch device (p-branch) standard endovascular graft: Early experience on an innovative standard fenestrated endograft for juxtarenal abdominal aortic aneurysm J Vasc Surg 2013;-:1-10

Current Status

  32 patients: •  2 renal artery stents occluded – succesfully

recanalized •  1acute patient – SMA and renal artery stent

compression – succesfully re-stented •  No type 1 and 3 endoleaks •  30-day mortality = 0

P-Branch Limitations

  Results of imperfect fit?? •  Stress/strain on mating stents? •  Fenestrations more mobile?

  New ancillary equipment •  Longer mating stents •  Longer sheaths/catheters

  Balance of 3 vs. 2 target vessels

P-Branch Strengths

  Base Technology works –  Based on Zenith Fenestrated Platform

  Use for juxta, para and suprarenal AAA –  SMA fenestration

  Unilateral Sheath   Preloaded Fenestrations

 2 designs fit 70-80%

P Branch Conclusions

 Feasibility  Valuable addition to current

technology – No complete replacement for CMD

 Use for wide range of paravisceral AA