Valiant ThoracoAbdominal Aortic Aneurysm Stent Graft · PDF fileValiant ThoracoAbdominal...
Transcript of Valiant ThoracoAbdominal Aortic Aneurysm Stent Graft · PDF fileValiant ThoracoAbdominal...
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Valiant ThoracoAbdominal
Aortic Aneurysm
Stent Graft System
Patrick W. Kelly,
MD, FACS
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Disclosure
• The Devices and Technology presented
here has been licensed to Medtronic
Corporation
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Paradigm Shift For Repair Of
Complex Aneurysm
• Proximal Deployment
• Endo-Bypasses
• Delayed Distal Seal
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Proximal Deployment
Placement of the Thoracic Bifurcated Graft and the
Visceral Manifold above the “visceral vessels.”
Allows for continued perfusion throughout the procedure.
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Endo-Bypass
Each of the branch vessels are stented individually from a position more proximally.
These bridging stents are slightly longer, but the favorable flow characteristics and conformability to anatomic variations mirror many of the lessons we’ve learned from open bypass.
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Delayed Distal Seal
Once flow has been secured to each of the
involved branches, then the open limb of the
proximal compartmentalizing graft can be extended
distally, excluding the diseased segment of vessel.
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Partnering With Industry To
Solve This Problem
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The Valiant ThoracoAbdominal
Aortic Aneurysm
Stent Graft System
By Medtronic
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VTAAA
Device
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Thoracic
Bifurcated Graft
TBG
Valiant Main Component
Diameter Size Match
Endurant Extension
20mm Limb
16mm Limb
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Visceral Manifold
(VM)
24mm Main Body
14mm Proximal Limbs
8mm Individual Limbs
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Assembled
System
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Outflow Conditions of Each Configuration
Under Steady State
Fenestrated Antegrade branch Investigational retrograde
branch
Investigational Manifold Investigational Unitary
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Fenestrated Antegrade branch Investigational retrograde
branch
Investigational Manifold Investigational Unitary
Velocity Streamlines (steady-state condition)
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Clinical Results of ThoracoaAbdominal Aortic AneurysmRepair First 36 Patients
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Clinical Results of 36
Visceral Manifold Patients
Gender22 Males
14 Females
Mean Age72.3 (58-89)
Previous Aortic Surgery14/36
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Clinical Results of 36
Visceral Manifold Patients
• 36 TAAA• 28 Non Emergent
• 5 TAB
• 3 Emergent Leaking• 1 TBG/VM
• 2 Modified Configuration
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Clinical Results of 36
Visceral Manifold Patients
Intra Op (All 36 Patients)
ASA Score 4 or greater 18/36
Length of Surgery 450 min (184-870)
Fluoro Time 116 min (49-300)
Total Contrast Used 166 ml (23-357)
Target Vessels Debranched 132/135* 98%
*3 vessels were unsuccessfully debranched secondary to previously placed suprarenal fixated stent grafts
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In Hospital Post Op Results (VM)
Mortality Rate 1/36
MI 1/36
Renal Failure 3/36
CVA 0/36
Paraplegia 3/36
LOS 9.6 Days (3-26)
Discharged to Home 20/36 w/ LOS 6.6 Days
Clinical Results of 36 Visceral
Manifold Patients
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Clinical 1 yr Summary
In Hospital Mortality 1/36
30 Day Mortality 1/36
One Year Device Related Mortality 0/36
Aneurysm Related Mortality 2/36
1yr All Cause Mortality 10/36
Renal Failure 4/36
Paraplegia 3/36
Patency Rates 65/67 97% +> 1yr
Secondary Interventions 1/132 EndoBypasses
Type 3 EndoLeaks 2
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I & II13/36
5.1-8.6 cm
III12/36
5.2-9.6 cm
IV10/36
5.0-12.1 cm
V1/36
5.3 cm
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I & II13/36
5.1-8.6 cm
III12/36
5.2-9.6 cm
IV10/36
5.1-12.1 cm
V1/36
5.3cm
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Applying To Type IV and
ParaVisceral Aneurysm
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IDE
Unitary
Graft
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Unitary Stent Graft System (PMEG)
Fixation
25-36 mm Diameter Main Body
6-8 mm Visceral Limbs
13-14 mm InfraRenal Extension
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Unitary (PMEG)
6-8mm Visceral Limbs
13-14mm InfraRenal Extension
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Clinical Results of First 6
Patients Under IDE (PMEG)
Gender: 5 males
1 female
Mean Age: 69.8 (57-80)
Previous Aortic Surgery: 3/6
Patients: 5 – non-emergent1 - emergent
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Clinical Results of First 6
Patients Under IDE (PMEG)
Intra-Op
• ASA Score 4 or greater 5/6
• Length of Surgery 282 min (185-512)
• Implant Time (n=5) 163 min (136-231)
• Fluoro Time 78.5 min (57-112)
• Total Contrast Used 88 ml (37-133)
• Target Vessels Debranched 23/23 (100%)
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• Mortality rate 0/6
• MI 0/6
• Renal Failure 0/6
• CVA 0/6
• Paraplegia 0/6
• LOS 8.6 days (5-18)
• Discharged to Home 5/6 w/ LOS 6.8 days
Clinical Results of First 6
Patients Under IDE (PMEG)
In Hospital Post-Op Results (Unitary)
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Aneurysm Related Deaths 0
30 Day All Cause Mortality 0
Device Related Death 0
Renal Failure 0
Paraplegia 0 new cases
EndoLeaks 2 - Type 2
No Evidence of Graft Migration
Secondary Interventions 2/23
EndoBypasses on 1 subject
Branch Graft Patency 22/23 96%
Clinical Results of First 6
Patients Under IDE (PMEG)
30-Day Follow-up (Unitary)
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Conclusions
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By Approaching This Problem From
A Non-Anatomical Standpoint
Of
Proximal Deployment
Endo-Bypass
Delayed Distal Seal
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Minimizing Aortic Coverage
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We’ve Been Able To Perform
In-Situ Customized
Aneurysm Repairs
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Handling Virtually Any Anatomy
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With Very Reasonable Results
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Thank You