The role of parallel grafts and endovascular aortic sealing (EVAS) … · 2017. 12. 11. · EVAS...
Transcript of The role of parallel grafts and endovascular aortic sealing (EVAS) … · 2017. 12. 11. · EVAS...
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IML MAC 2017
The role of parallel grafts and endovascular
aortic sealing (EVAS) - do they fill a gap?
Ian Loftus
St Georges Vascular Institute, London, UK
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IML MAC 2017
Disclosures
• Endologix: Consultancy, Proctor, Speaker
• Gore: Consultancy, Speaker
• Medtronic: Consultancy, Speaker, Research
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IML MAC 2017
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IML MAC 2017
Endovascular Treatment Complex AAA
• CMD ‘gold-standard’ but temporal, cost and
manufacturing constraints
• Significant ‘turndown’ rate
• Defined reintervention and failure rates
• ‘Off the shelf’ f-EVR limited by applicability and
durability
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IML MAC 2017
Parallel Grafts and EVAR/EVAS
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IML MAC 2017
Chimney-EVAS
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IML MAC 2017
Where Does Ch-EVAS “Fit A Gap’?
• Pararenal AAA (<10mm neck)
• Aortic neck >28mm
• Severe angulation (>75%)
• Conical necks (>10%)
• Anatomically unsuitable for FEVAR
• Unfit for OR (or patient preference)
• Urgent cases
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IML MAC 2017
Type 3B Endoleak Repair
Renu
Type 1A Endoleak Repair
Excluder Anaconda
Type 3A Endoleak Repair
Talent
Courtesy of Francesco Torella, MDLiverpool, UK
Courtesy of JP de Vries, MD, PhDNieuwegein, NL
Courtesy of Rob Fischer, MDLiverpool, UK
Courtesy of Michel Reijnen, MD, PhDArnhem, NL
EVAS for Failing EVAR
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IML MAC 2017
S P SPositionSelection Seal
EVAS ProcedureEvolved and Improved
Patient SelectionProper Positioning of the Nellix Device
Establishment of a Durable Seal
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IML MAC 2017
Optimum Seal: Plan For 15mm Neck
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IML MAC 2017
• July 2013 – October 2016.
• Single centre study, n=69
• Cases unsuitable for F-EVAR, B-EVAR or OSR.
• Mean follow up > 1 year
• Mean no of chimneys 1.64
Parallel Grafts and EVAS – St Georges
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IML MAC 2017
Adverse event Number Re-intervention
30 day mortality 1 N/A
Late mortality 5 N/A
Type 1 endoleak 5 Embolisation x3 successful
Limb occlusion
4
Iliac stent x2
Iliac-fem crossover x1
Asymptomatic
Stroke 2 N/A
Acute kidney injury 1 Angioplasty of right renal stent
Parallel Grafts and EVAS – Outcomes
Parallel graft patency 98.3%
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IML MAC 2017
• Post-market registry of Ch-EVAS
• Open-label, single-arm, no prospective screening
• 200 patients, 10 international centers, 5y F/U
• Endpoints typical of EVAR in complex AAA
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IML MAC 2017
De Novo Procedures (154)
Insert
Single
40.3%
Double
35.1%
Triple
17.5%
Quadruple
7.1%
N=62
LRA = 33, RRA = 27
SMA = 1
Not Specified = 1
N=54
Both RA = 49
RA and SMA = 4
Not Specified = 1
N=27
Both RA, SMA = 24
RA, SMA, CA = 2
Not Specified = 1
N=11
Both RA, SMA, CA
Image
Here
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IML MAC 2017
Outcomes at 30days
n %
Mortality 4/154 2.6%
Stroke 4/154 2.6%
Renal Failure 2/154 1.3%
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IML MAC 2017
Freedom from Mortality
30d 1 yr
ARM 97.2% 94.3%
ACM 97.2% 89.8%
ARM
ACM
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IML MAC 2017
All Endoleak
Total Type Ia Type Ib Type II Type III
Early
(154)
1.9% (3) 0.6% (1) 1.3% (2) 0% 0%
Late
(136)
2.9% (4) 2.9% (4) 0% 0% 0%
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IML MAC 2017
Freedom from Secondary Intervention
30d 1 yr
94% 89%
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IML MAC 2017
Aneurysm Morphology
ASCEND
(n=154)
PERICLES
(n=517)
SINGLE 11%
70%
(Juxtarenal)
DOUBLE 58%
TRIPLE/QUADRUPLE 31%30%
(Suprarenal)
PERSISTENT
TYPE I ENDOLEAK0% 2.9%
TARGET VESSEL PATENCY 98% - 100% 92%
FREEDOM FROM ACM 90% 85%
ChEVAS and ChEVAR
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IML MAC 2017
• Ch-EVAS does fit a gap
• Theoretical advantages over Ch-EVAR
• Both need a healthy neck
• Careful planning is the key
• Early results acceptable
• Long term results and durability vital
Conclusions