value of lsa branch devices in clinical practice early ... · value of lsa branch devices in...
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Value of LSA branch devices in clinical practice –
Early experience with the Valiant Mona LSA device
Jean M. Panneton, MD, FRCSC, FACS Professor of Surgery
Chief & Program Director Division of Vascular Surgery
Eastern Virginia Medical School Norfolk, Virginia, U.S.A.
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Disclosure
Speaker name:
Jean M Panneton, MD
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
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Valiant Mona LSA: Device Overview
Main Stent Graft (MSG)
• Flexible, conical-shaped cuff for BSG
– RO visualization proximal and distal
• Diameters: 30 – 46mm
• Nominal length: 15cm
Branch Stent Graft (BSG) • Nitinol helical stent with high radial force
• PE material with proximal flare
• Diameters: 10, 12, 14mm
• Length: 40mm
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Valiant Mona LSA: Delivery System
Delivery System • Two wire system
• Main/primary aortic tracking wire
• LSA cannulation wire
• Pre-cannulated LSA cuff
• Tip capture for precise MSG delivery
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Valiant MonaLSA Device
Main Stent Graft Deployment
Good wire separation
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Valiant MonaLSA Device
Branch Stent Graft Deployment
Retrograde
angiogram for BSG
positioning
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Valiant MonaLSA Device
Completion angiogram
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Valiant MonaLSA Device
Post-op 3D CTA and Extracted device
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1 Month 6 Month 1 Year
Valiant MonaLSA Device
Sequential 3D CTAs
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1 Month
6 Months
1 Year
Valiant MonaLSA Device
Sequential Overlays
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Valiant Mona LSA Early Feasibility Trial
1-Year Outcomes
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Baseline Demographics and Clinical Characteristics
• 9 patients in total, 7 US and 2 UK
• Mean age: 73 years (63-87)
• 67% female
• Mean Maximum Aneurysm Diameter: 53.7 mm (42-76)
• Mean LSA Diameter: Ostium – 10.3mm (8-13) , Distal – 9.6mm (8-10)
Fusiform4 Saccular
5
Aneurysm Morphology Comorbidities
Hypertension
Hyperlipidemia
Arrhythmia*
COPD
Cancer
TIA
8
7
5
4
4
2
*All subjects presented with Cardiac Disease
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Procedural Characteristics
• 100% successful delivery and deployment of MSGs and BSGs
• Duration of procedure: 125 min. (60-227)
• General anesthesia used in all 9 cases
Surgical 7
Perc 2
Main Stent Graft Access
Brachial 7
Axillary 2
Branch Stent Graft Access
• 7 patients received distal Valiant device to extend coverage
• Mean hospital procedure stay: 5.9 days (5-8)
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Primary Endpoints
• Treatment Success1: 100%
• Technical Success: 100%
1 Treatment success is defined as technical success, which is the successful delivery and deployment of the stent graft
and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.
Composite Safety Endpoints through 1-Year
• All-Cause Mortality: 0 patients
• Aneurysm-Related Mortality: 0 patients
• Stroke: 3 patients, all within 30d
• Minor, non-disabling neurological events
• All regained full functional status; all still alive
• Paraplegia: 0 patients
• Left Arm/Hand Ischemia: 0 patients
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Key Secondary Endpoints through 1-Year
• Secondary Endovascular Procedures: 0 patients
• Conversion to Surgical Procedure: 0 patients
• Surgical Revasc of the LSA: 0 patients
• Paraparesis: 0 patients
• Rupture: 0 patients
• 100% Stent Graft Integrity and Patency
• No kinking, twisting, separation, migration, fracture or
occlusion of Main or Branch Stent Grafts
• Endoleaks at 12 month visit: 1 Type II and 1 Type III
• Junctional Type III between MSG/BSG since discharge. TAA
stable. Continuing to monitor.
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Early Feasibility 1-Year Summary
• The Valiant Mona LSA stent graft system has
performed as planned through 1-year follow-up
• Patients will continue to be followed through 5 years
Valiant Mona LSA Feasibility Study – currently enrolling
• 7 sites in the US and 24 additional patients
First patient in: April 2015
• 10 patients enrolled to date
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CT Slice Parameters
Slice increment 0.4 mm (z)
Slice thickness 0.5 mm (z)
Pixel size 0.518 mm (x,y) 00034-001-J-D; 50 Yr, Male, Pre Op Scan May 8, 2015
Pan view for LSA takeoff: RAO 2°, CRAN 8°
Best angle to view the LSA ostium
Pan view for arch: LAO 3°, CRAN 8°
Best angle to view the landing zone between the
LCC and LSA
Valiant MonaLSA Device
Case planning
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CT Slice Parameters
Slice increment 0.4 mm (z)
Slice thickness 0.5 mm (z)
Pixel size 0.518 mm (x,y) 00034-001-J-D; 50 Yr, Male, Pre Op Scan May 8, 2015
Obtainable barrel view for LSA takeoff: RAO 50°, CAUD 1°
Valiant MonaLSA Device
Case planning
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Valiant MonaLSA Device
Summary
The Valiant Mona LSA Device is a valuable addition to zone 2 TEVAR
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Value of LSA branch devices in clinical practice –
Early experience with the Valiant Mona LSA device
Jean M. Panneton, MD, FRCSC, FACS Professor of Surgery
Chief & Program Director Division of Vascular Surgery
Eastern Virginia Medical School Norfolk, Virginia, U.S.A.