Fenestrated Anaconda™: Experience in 101 cases in the UK

Robin WilliamsFreeman Hospital

Newcastle-upon-Tyne

Frances E Colgan a

Michael J Clarke a

Peter M Bungay b

John W Quarmby b

Nicholas Burfitt c

Alun H Davies c

Mike Jenkinsc

Andrew Hatrick d

David Gerrard d

a Freeman Hospital, Newcastle-upon-Tyne

b Royal Derby Hospital, Derby

c Imperial College, London

d Frimley Park Hospital, Frimley

Disclosure

Speaker name: Robin Williams

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

x

Predictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Repair

Andres Schanzer, MD Roy K. Greenberg, MD et al

Circulation 2011 jun 21;123(24) :2848-55

10228 patients

42% of patients had anatomy that met the most conservative definition of device instructions for use

69% met the most liberal definition of device instructions for use.

5-year post-EVAR rate of AAA sac enlargement was 41%

Independent predictors of AAA sac enlargement

endoleak, age ≥80 years, aortic neck diameter ≥28 mmaortic neck angle >60°

common iliac artery diameter >20 mm

Supra-renal OR mortality >10% in England

NVD & HES data

Elective open suprarenal aneurysm repair in England from 2000 to 2010 an

observational study of hospital episode statistics.Karthikesalingam A1, Holt PJ, Patterson BO, Vidal-Diez A, Sollazzo G, Poloniecki JD, Hinchliffe RJ, Thompson MM.

PLoS One. 2013 May 23;8(5):e64163. doi: 10.1371/journal.pone.0064163. Print 2013.

Anaconda Fenestrated Range

UK

Germany

Austria74

228

300

France 67

Netherlands

Italy 46

64

Canada 45

Spain 41

Belgium 35

Australia 11

Brazil 9

Switzerland 7

Monaco

Chile 2

6

Hungary 2

Sweden 2

Poland 1

Implanted Devices to Date

…by Country

1727 Cases

• Four UK centres

– Royal Derby Hospital, Derby

– Imperial College/St Mary’s Hospital, London

– Frimley Park Hospital, Surrey

– Freeman Hospital, Newcastle

– All completed >20 cases• learning curves included,

much like Globalstar

UK four centre study

First 101 devices (prospective, consecutive series, unfunded)

Juxta renal, para-visceral, type IV TAAAno previous EVAR - cuffs and re-lines excluded

2010- 2014 Q1

- includes the first Anaconda fEVAR

data from the individual centres

Demographics

– 85% male

– median age 76 years (range 56-89 years)

– 52% described as “not fit for open repair”

Co-morbidity Number (n=101)

Diabetes 13 (13%)

Hypertension 72 (72%)

Ischaemic heart disease 53 (53%)

Congestive cardiac failure 5 (5%)

Chronic renal impairment 39 (39%)

Cerebrovascular disease 10 (10%)

Prior aortic surgery 2 (2%)

ASA grade Number of

patients (n=101)

1 0

2 21

3 67

4 10

5 0

Not stated 3

Graft type

4%

49%36%

11%

Number of fenestrations

1

2

3

4

30 day outcomes

• Technical success: 97%

– Aneurysm excluded (no type I or type III endoleak)

Procedural Endoleaks

Procedural 30 day

Type I 11% 2%

Type II 15% 22%

Type III 4% 1%

Type IV 1%

U/C 1%

30 day outcomes

• Type I/III endoleaks

– 9/11 type I endoleaks sealed spontaneously within 30 days

• one type Ib treated with angioplasty

• one considered for APTUS but had resolved by the time the patient attended for treatment (after 30 days)

– 3/4 type III endoleaks sealed spontaneously within 30 days

• left renal fenestration impossible to cannulate due to graft twist.

• 2nd attempt failed

• artery occluded with plug (after 30 days)

Target vessel patency – 30 day

• All vessel (incl valleys) 99.6%

• Stented vessels 247/251 = 98.4%

• coeliac artery occluded pre-op

• failed catheterisation of renal artery due to graft twist

– silent renal artery occlusion

– SMA delayed dissection with vessel occlusion

• Secondary Interventions: 5%

– SMA stent for dissection

– Retroperitoneal bleeding, NAD on catheter angio

– Second attempt to cannulate renal artery

– Redilatation of renal artery stent

– SMA stent due to valley encroachment

30 day outcomes

• Mortality: 3%

– SMA dissection, failed endovascular salvage, patient died

– Peri-operative perforated gastric ulcer and multi-organ failure

– Stent graft thrombosis (infra-renal); ax-fem bypass

MOF

1 yr – Mortality (all cause) – 9%

• 3 deaths within 30 days

• 6 further deaths within 1 yr– 85 days post fEVAR, 1 day post CFA thrombectomy

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

1 2 3 4 5 6 7 8 9 10 11 12 13

Survival

TVP (88 pts – 4 pts had US follow-up)

• 30 days 99.6%

• 1yr 99.1% (silent renal artery occlusion)

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0 1 2 3 4 5 6 7 8 9 10 11 12

• Migration (>5mm) 0%

• Type I/III endoleak 0%

• Renal function (>25%) 0%

• Freedom from secondary interventions – 90%

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

0.90

1.00

Sac size pre-op vs 1 yr

median change -11mm

decreased 67 76%stable 20 23%

99%

increased (>5mm) 1 1%

30

40

50

60

70

80

90

100

110

mm

• Highly effective to 1 yr

–30 day Mortality 3%

–1 yr TVP 99.1%

–Limb occlusion 0%

• 3 year data

• 2 centres only…

• 52/101 patients

Early results of fenestrated endovascular repair of juxtarenal aortic aneurysms in

the United Kingdom.British Society for Endovascular Therapy and the Global Collaborators on Advanced Stent-Graft Techniques for Aneurysm Repair

(GLOBALSTAR) Registry..

Circulation. 2012 Jun 5;125(22):2707-15. doi: 10.1161/CIRCULATIONAHA.111.070334.

Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-

up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised

controlled trial.Patel R, Sweeting MJ, Powell JT, Greenhalgh RM; EVAR trial investigators..

Lancet. 2016 Nov 12;388(10058):2366-2374. doi: 10.1016/S0140-6736(16)31135-7.

3 years - all cause mortality – 18%1 aneurysm related death

Elective open suprarenal aneurysm repair in England from 2000 to 2010 an

observational study of hospital episode statistics.Karthikesalingam A1, Holt PJ, Patterson BO, Vidal-Diez A, Sollazzo G, Poloniecki JD, Hinchliffe RJ, Thompson MM.

PLoS One. 2013 May 23;8(5):e64163. doi: 10.1371/journal.pone.0064163. Print 2013.

Median AAA sac size (mm)

0

10

20

30

40

50

60

70

1m 12m 24m 36m

3 yrs

0.00

0.20

0.40

0.60

0.80

1.00

Procedure 6 months 12 months 18 months 24 months 30 months 36 months

93% Freedom from AAA expansion

3 yearRe-interventionsTVP

SMA stent fracture

graft twist at primary implant

T2EL embolisation

1 TV lost

SMA

Conclusion

In a wide range of anatomy

52% not considered for OR

Many unsuitable for other fEVAR devices

Safe to implant 3% mortality

99.2% TVP

Effective to 1 year (& 3 years)

Low mortality

AAAs continue to shrink (better than conventional EVAR)

Low TV loss

Fenestrated Anaconda™: Experience in 101 cases in the UK

Robin WilliamsFreeman Hospital

Newcastle-upon-Tyne

Frances E Colgan a

Michael J Clarke a

Peter M Bungay b

John W Quarmby b

Nicholas Burfitt c

Alun H Davies c

Mike Jenkinsc

Andrew Hatrick d

David Gerrard d

a Freeman Hospital, Newcastle-upon-Tyne

b Royal Derby Hospital, Derby

c Imperial College, London

d Frimley Park Hospital, Frimley