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In most cases EVAR substituted
conventional repair for ruptured AAA
Why?
Antalya, 27/30-10-2011 Medical School Twente
EVAR team Medisch SpectrumTwente
Enschede, the Netherlands
Why think of EVAR?
• Gut feeling: great difference rEVAR vs open*
• Reduced peri-operative mortality in elective AAA
repair
- EVAR 1: EVAR 1.7% vs open 4.7%
- EVAR 2: 9% for unfit patients
• Less blood loss
• Less use of ICU
• Shorter length of hospital stay
• Less major morbidity
• Shorter recovery time
Antalya, 27/30-10-2011 Medical School Twente
Influence of EVAR on (r)AAA outcome
0
5
10
15
20
25
30
35
%
In hospital mortality per vascular area per year
(R)AAA
aortic-iliac oblit
fem-distal oblit
cerebrovasc oblit
6194 arterial interventions MST 1997-2007
Medical School TwenteAntalya, 27/30-10-2011
Why think of EVAR?
• Gut feeling: great difference rEVAR vs open
• Reduced peri-operative mortality in elective AAA
repair
- EVAR 1: EVAR 1.7% vs open 4.7%
- EVAR 2: 9% for unfit patients
• Less blood loss
• Less use of ICU
• Shorter length of hospital stay
• Less major morbidity
• Shorter recovery time
Antalya, 27/30-10-2011 Medical School Twente
Advantages of rEVAR
• Less invasive
- No laparotomy required
- No retroperitoneal dissection
- Local anaesthesia
• Intact vascular resistance and muscular tone abdominal wall
- Reduced blood loss
- Less hemodynamic disturbance
– No aortic cross clamping required
• Less ischemia and reperfusion of lower body and visceral organs
- Reduced inflammatory response,  cytokines →  MOF
Antalya, 27/30-10-2011 Medical School Twente
Advantages of rEVAR
• Less effect on
- Cardial function
- Respiratory function
- Renal function
• Fewer systemic complications
• Faster recovery
Antalya, 27/30-10-2011 Medical School Twente
Ruptured AAA: Evidence
• > 400 papers mentioning rEVAR
– Open vs rEVAR minimum of 5 patients in each group
• 17 single center studies
• 1 multicentre study
• 1 single center RCT
• 2 database analysis
Antalya, 27/30-10-2011 Medical School Twente
Ruptured AAA: Evidence
• Analysis
– Heterogenicity of studies
– Lack of standardized reporting
– Small numbers
– Small percentage treated with rEVAR (15-50%)
– Devices: AUI vs Bifurcation vs Tube
– Percentage unstable patients rEVAR 33-73% vs open 35-68%
• Definition of “unstable” varied
– Local anaesthesia 0-97%
• Mean short term mortality 25% rEVAR vs 42% open
Antalya, 27/30-10-2011 Medical School Twente
Ruptured AAA: Evidence
• Cochrane review 2008
– No RCT
– Heterogenicity studies
– Reduction mortality rate, ICU stay and blood loss
encouraging
Antalya, 27/30-10-2011 Medical School Twente
Ruptured AAA: MST experience
• No treatment
• Open procedure (MST 30% 30-day mortality)
• rEVAR?
Antalya, 27/30-10-2011 Medical School Twente
Ruptured AAA
rEVAR
• Aortic Unilateral device
+ Straight forward procedure
+ Small stockage
– Fem-fem needed
– On long term proximal migration and
type 1 endoleak
• Bifurcated devices
– Enormeous stockage on the shelves needed
– Contralateral access unpredictable
ntalya, 27/30-10-2011 Medical School Twente
ANACONDA
 Contralateral access facilitated by magnet system
 Body repositionable
 Device also applicable in complex anatomy
Ruptured AAA
TAAR (TransAbdominal Aneurysm Repair)
• Mortality and morbidity high and
unchanged last decades (40-90%)
EVAR
• Aortic Unilateral device
– Straight forward procedure
– Small stockage
– Fem-fem needed
– On long term angulation, proximal migration
and type 1 endoleak are not negligible
• Bifurcated devices
– Enormeous stockage on the shelves needed
– Contralateral access unpredictable
Antalya, 27/30-10-2011 Medical School Twente
Ruptured Aortic Aneurysm Study
with the Anaconda
• Feasibility study
• Single center
• Prospective
• Intension to treat
• From April 2006 until April 2010
• Consecutive patients
Antalya, 27/30-10-2011 Medical School Twente
Ruptured AAA MST
9%
61%
3%
1%
24%
162 ruptured infrarenal aneurysms
31 not treated
89 open procedures
4 Talent AUI
4 Endurant (1 AUI)
34 Anaconda
Antalya, 27/30-10-2011 Medical School Twente
RASA (N= 34)
Patient characteristics
Gender
Male
Female
30
4
Age
Mean (range) 73 (58-87) years
Follow up
Mean (range) 25 (7-55) months
Lost to follow up 0
Antalya, 27/30-10-2011 Medical School Twente
RASA (N= 34)
Highlights anatomy
Antalya, 27/30-10-2011 Medical School Twente
Mean range
Diameter infrarenal neck D2a (mm)
D2b (mm)
D2c (mm)
22
23
23
16-31
17-28
16-30
Body size
Oversizing %
29
24
21-34
14-47
Neckshape Parallel ||
Conical  /
Rev.-conical / 
Bell ( )
28
2
3
1
Length infrarenal neck mm 25 9-55
Circumferential thrombus % <10 0-25
Circumferential calcification % <10 0-50
Angulation neck  aneurysm degrees 41 0-100
Aneurysm diameter (D3) mm 76 33-125
OR-time
X-ray time
146 min (70-300 min)
12 min (3-50 min)
Contrast
Packed cells
140 cc (25-360 cc)
5 (0-21)
Endoleak at “end” operation 1xType I? (conversion, re-relap, prox inlay)
7xType II, at discharge 2, 30-day onward 0
Occlusion renal artery 2 times intentional
(accessory renal artery)
IC-hospitalisation 3 days (0-15)
17x < 24 hours
Conversion 3x
RASA (N=34)
Peri-operative results
Antalya, 27/30-10-2011 Medical School Twente
Conversions
 free rupture during procedure †
 free rupture, balloon, thrombosis aorta †
 ongoing instable patient, missed type I endoleak?
final angio: no endoleak
clamp infrarenal “on prosthesis”
conventional suturing proximal
 2 x decompression abdomen
RASA (N=34)
Intra-operative techniques
Antalya, 27/30-10-2011 Medical School Twente
Cannulation contralateral gate
-straight forward
-with tricks
-not cannulated
28x
4x
2x*
Body repositioning 5x
Renal stents 1x, renal arteries in valleys of body
Local anaesthesia 30x
*Cannulation not possible?
 free rupture during cannulation procedure
 free rupture, balloon, no time for cannulation
procedure, to introduce balloon body needed to be
released, thrombosis aorta
RASA (N=34)
Intra-operative techniques
Antalya, 27/30-10-2011 Medical School Twente
Cannulation contralateral gate
-straight forward
-with tricks
-cannulation not possible
28x
4x
2x*
Body repositioning 5x
Renal stents 1x, renal arteries in valleys of body
Local anaesthesia 30x
Antalya, 27/30-10-2011 Medical School Twente
D3 98mm
Severe iliac angulation
Body repositioning
Antalya, 27/30-10-2011 Medical School Twente
Antalya, 27/30-10-2011 Medical School Twente
Magnet system “downstream”
Repositioning mainbody
RASA (N=34)
Mortality
Antalya, 27/30-10-2011 Medical School Twente
period cause total
Intra-operative 2 1x cardiac arrest
1x thrombosis aorta and
visceral arteries
2
In hospital 3 mof, cardial, pneumonia 5 (15%)
30-day mortality 1 cardial 6 (17%)
6-months mortality 1 cardial 7
Study mortality 4 cardial 2x, malignancy,CVA 11
Aneurysm related 3
Device related 0
RASA (N=25)
Re-interventions
Antalya, 27/30-10-2011 Medical School Twente
nr reason
In hospital (8) 2
2
1
1
2
After conversion to aorto-bi-fem, hemicolectomy (bowel
ischemia) and later rupture anastomosis left groin
Sigmoid resection (ischemia) and later closure abdomen
Stents renal arteries
Occluded leg, thrombectomy and stent flowsplitter
Decompression abdomen, later suturing proximal
anastomosis (type I endoleak?)
30-day (1) 1 Occluded leg, thrombectomy and kissing PTA flowsplitter
6-months 0
Study 1 After 4 yrs rupture type Ib left -> extended with leg
Conclusion RASA
• Treating a ruptured aneurysm with the
Anaconda is feasible
– Succesfull exclusion rAAA in 31 of 34 patients
• 91% success
– 2x free rupture during operating procedure
– Possible type I endoleak, converted (suturing prox. anastomosis)
– 30 day mortality = 17%
– Tricks needed, not straight forward
Antalya, 27/30-10-2011 Medical School Twente
In most cases EVAR substituted
conventional repair for ruptured AAA
Why?
Antalya, 27/30-10-2011 Medical School Twente
• Feasible
• Growing evidence
• Many heterogeneous studies
• Lower mortality rates
• Future:
• Multiple periscope and chimney grafts
for type IV TAAA or AAA
Randomised controlled trials
AJAX
IMPROVE
ECAR

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In most cases evar substituted conventional repaire for ruptured aaa why

  • 1. In most cases EVAR substituted conventional repair for ruptured AAA Why? Antalya, 27/30-10-2011 Medical School Twente EVAR team Medisch SpectrumTwente Enschede, the Netherlands
  • 2. Why think of EVAR? • Gut feeling: great difference rEVAR vs open* • Reduced peri-operative mortality in elective AAA repair - EVAR 1: EVAR 1.7% vs open 4.7% - EVAR 2: 9% for unfit patients • Less blood loss • Less use of ICU • Shorter length of hospital stay • Less major morbidity • Shorter recovery time Antalya, 27/30-10-2011 Medical School Twente
  • 3. Influence of EVAR on (r)AAA outcome 0 5 10 15 20 25 30 35 % In hospital mortality per vascular area per year (R)AAA aortic-iliac oblit fem-distal oblit cerebrovasc oblit 6194 arterial interventions MST 1997-2007 Medical School TwenteAntalya, 27/30-10-2011
  • 4. Why think of EVAR? • Gut feeling: great difference rEVAR vs open • Reduced peri-operative mortality in elective AAA repair - EVAR 1: EVAR 1.7% vs open 4.7% - EVAR 2: 9% for unfit patients • Less blood loss • Less use of ICU • Shorter length of hospital stay • Less major morbidity • Shorter recovery time Antalya, 27/30-10-2011 Medical School Twente
  • 5. Advantages of rEVAR • Less invasive - No laparotomy required - No retroperitoneal dissection - Local anaesthesia • Intact vascular resistance and muscular tone abdominal wall - Reduced blood loss - Less hemodynamic disturbance – No aortic cross clamping required • Less ischemia and reperfusion of lower body and visceral organs - Reduced inflammatory response,  cytokines →  MOF Antalya, 27/30-10-2011 Medical School Twente
  • 6. Advantages of rEVAR • Less effect on - Cardial function - Respiratory function - Renal function • Fewer systemic complications • Faster recovery Antalya, 27/30-10-2011 Medical School Twente
  • 7. Ruptured AAA: Evidence • > 400 papers mentioning rEVAR – Open vs rEVAR minimum of 5 patients in each group • 17 single center studies • 1 multicentre study • 1 single center RCT • 2 database analysis Antalya, 27/30-10-2011 Medical School Twente
  • 8. Ruptured AAA: Evidence • Analysis – Heterogenicity of studies – Lack of standardized reporting – Small numbers – Small percentage treated with rEVAR (15-50%) – Devices: AUI vs Bifurcation vs Tube – Percentage unstable patients rEVAR 33-73% vs open 35-68% • Definition of “unstable” varied – Local anaesthesia 0-97% • Mean short term mortality 25% rEVAR vs 42% open Antalya, 27/30-10-2011 Medical School Twente
  • 9. Ruptured AAA: Evidence • Cochrane review 2008 – No RCT – Heterogenicity studies – Reduction mortality rate, ICU stay and blood loss encouraging Antalya, 27/30-10-2011 Medical School Twente
  • 10. Ruptured AAA: MST experience • No treatment • Open procedure (MST 30% 30-day mortality) • rEVAR? Antalya, 27/30-10-2011 Medical School Twente
  • 11. Ruptured AAA rEVAR • Aortic Unilateral device + Straight forward procedure + Small stockage – Fem-fem needed – On long term proximal migration and type 1 endoleak • Bifurcated devices – Enormeous stockage on the shelves needed – Contralateral access unpredictable ntalya, 27/30-10-2011 Medical School Twente ANACONDA  Contralateral access facilitated by magnet system  Body repositionable  Device also applicable in complex anatomy
  • 12. Ruptured AAA TAAR (TransAbdominal Aneurysm Repair) • Mortality and morbidity high and unchanged last decades (40-90%) EVAR • Aortic Unilateral device – Straight forward procedure – Small stockage – Fem-fem needed – On long term angulation, proximal migration and type 1 endoleak are not negligible • Bifurcated devices – Enormeous stockage on the shelves needed – Contralateral access unpredictable Antalya, 27/30-10-2011 Medical School Twente
  • 13. Ruptured Aortic Aneurysm Study with the Anaconda • Feasibility study • Single center • Prospective • Intension to treat • From April 2006 until April 2010 • Consecutive patients Antalya, 27/30-10-2011 Medical School Twente
  • 14. Ruptured AAA MST 9% 61% 3% 1% 24% 162 ruptured infrarenal aneurysms 31 not treated 89 open procedures 4 Talent AUI 4 Endurant (1 AUI) 34 Anaconda Antalya, 27/30-10-2011 Medical School Twente
  • 15. RASA (N= 34) Patient characteristics Gender Male Female 30 4 Age Mean (range) 73 (58-87) years Follow up Mean (range) 25 (7-55) months Lost to follow up 0 Antalya, 27/30-10-2011 Medical School Twente
  • 16. RASA (N= 34) Highlights anatomy Antalya, 27/30-10-2011 Medical School Twente Mean range Diameter infrarenal neck D2a (mm) D2b (mm) D2c (mm) 22 23 23 16-31 17-28 16-30 Body size Oversizing % 29 24 21-34 14-47 Neckshape Parallel || Conical / Rev.-conical / Bell ( ) 28 2 3 1 Length infrarenal neck mm 25 9-55 Circumferential thrombus % <10 0-25 Circumferential calcification % <10 0-50 Angulation neck  aneurysm degrees 41 0-100 Aneurysm diameter (D3) mm 76 33-125
  • 17. OR-time X-ray time 146 min (70-300 min) 12 min (3-50 min) Contrast Packed cells 140 cc (25-360 cc) 5 (0-21) Endoleak at “end” operation 1xType I? (conversion, re-relap, prox inlay) 7xType II, at discharge 2, 30-day onward 0 Occlusion renal artery 2 times intentional (accessory renal artery) IC-hospitalisation 3 days (0-15) 17x < 24 hours Conversion 3x RASA (N=34) Peri-operative results Antalya, 27/30-10-2011 Medical School Twente Conversions  free rupture during procedure †  free rupture, balloon, thrombosis aorta †  ongoing instable patient, missed type I endoleak? final angio: no endoleak clamp infrarenal “on prosthesis” conventional suturing proximal  2 x decompression abdomen
  • 18. RASA (N=34) Intra-operative techniques Antalya, 27/30-10-2011 Medical School Twente Cannulation contralateral gate -straight forward -with tricks -not cannulated 28x 4x 2x* Body repositioning 5x Renal stents 1x, renal arteries in valleys of body Local anaesthesia 30x *Cannulation not possible?  free rupture during cannulation procedure  free rupture, balloon, no time for cannulation procedure, to introduce balloon body needed to be released, thrombosis aorta
  • 19. RASA (N=34) Intra-operative techniques Antalya, 27/30-10-2011 Medical School Twente Cannulation contralateral gate -straight forward -with tricks -cannulation not possible 28x 4x 2x* Body repositioning 5x Renal stents 1x, renal arteries in valleys of body Local anaesthesia 30x
  • 20. Antalya, 27/30-10-2011 Medical School Twente D3 98mm Severe iliac angulation Body repositioning
  • 22. Antalya, 27/30-10-2011 Medical School Twente Magnet system “downstream” Repositioning mainbody
  • 23. RASA (N=34) Mortality Antalya, 27/30-10-2011 Medical School Twente period cause total Intra-operative 2 1x cardiac arrest 1x thrombosis aorta and visceral arteries 2 In hospital 3 mof, cardial, pneumonia 5 (15%) 30-day mortality 1 cardial 6 (17%) 6-months mortality 1 cardial 7 Study mortality 4 cardial 2x, malignancy,CVA 11 Aneurysm related 3 Device related 0
  • 24. RASA (N=25) Re-interventions Antalya, 27/30-10-2011 Medical School Twente nr reason In hospital (8) 2 2 1 1 2 After conversion to aorto-bi-fem, hemicolectomy (bowel ischemia) and later rupture anastomosis left groin Sigmoid resection (ischemia) and later closure abdomen Stents renal arteries Occluded leg, thrombectomy and stent flowsplitter Decompression abdomen, later suturing proximal anastomosis (type I endoleak?) 30-day (1) 1 Occluded leg, thrombectomy and kissing PTA flowsplitter 6-months 0 Study 1 After 4 yrs rupture type Ib left -> extended with leg
  • 25. Conclusion RASA • Treating a ruptured aneurysm with the Anaconda is feasible – Succesfull exclusion rAAA in 31 of 34 patients • 91% success – 2x free rupture during operating procedure – Possible type I endoleak, converted (suturing prox. anastomosis) – 30 day mortality = 17% – Tricks needed, not straight forward Antalya, 27/30-10-2011 Medical School Twente
  • 26. In most cases EVAR substituted conventional repair for ruptured AAA Why? Antalya, 27/30-10-2011 Medical School Twente • Feasible • Growing evidence • Many heterogeneous studies • Lower mortality rates • Future: • Multiple periscope and chimney grafts for type IV TAAA or AAA Randomised controlled trials AJAX IMPROVE ECAR