Early Clinical Results with the Valiant Mona LSA Branch Stent-Graft
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1 Early Clinical Results with the Valiant Mona LSA Branch Stent-Graft Frank R. Arko III, MD Professor of Cardiovascular Surgery Director, Endovascular Surgery Co-Director, Aortic Institute Carolinas Medical Center
2 Disclosure Speaker name: Frank R. Arko III, 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
3 Valiant Mona LSA: Device Overview Main Stent Graft (MSG) Flexible cuff volcano for BSG 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
4 Valiant Mona LSA: Delivery System Delivery System Two wire system Main/primary aortic tracking wire Pre-cannulated LSA cuff wire Tip capture for precise MSG delivery
5 Carolinas Medical Center Valiant Mona LSA Clinical Experience
6 Trial Patient 1: 81 y/o female, DTA 5.7cm Measurements Proximal Seal zone Between LSA and LCC: 35.7mm Beginning of Proximal Neck: 37.5mm Distal Seal zone: 41.6mm LSA: mm Planned Treatment with: 46mm MSG (15cm length) 10mm BSG (4cm length) 46mm Distal Extension to diaphragm
7 Pre-Op 3D CT
8 Distal device placed first Pre and Post Angios
9 1 Month Follow Up
10 1 Month Post-Op 6 Month Post-Op 1 Year Post-Op
11 1 Year Post-Op 3D CT
12 Emergent Patient: 84 y/o female, TAA in Arch Considerable arch thrombus Conservatively managed for 2 years post-diagnosis Presented symptomatically with worsening upper back/scapular pain CTA indicated rapidly expanding TAA with asymmetric expansion of anterior wall Bovine Arch with patent LSA Marginal access ( mm)
13 3D Reconstruction
14 Proximal Target Landing Zone Diameter 40mm Length 13.5mm
15 Deployment of 46 x 150 Valiant Mona LSA
16 Placement of LSA Branch Positioning of 10x40 LSA Branch Graft Ballooning of 10x40 LSA Branch Graft
17 Final Angiogram
18 Post-op Patency and Exclusion LSA Branch Patent Complete Exclusion
19 Post-Op 3-D Fly-Through
20 Valiant Mona LSA Early Feasibility Trial Acute Clinical Outcomes
21 Valiant Mona LSA Early Feasibility Trial Prospective, non-randomized, 3-center, pre-market clinical study 9 patients (7 US, 2 OUS) Goal: Validate procedure Assess acute safety and performance Collect imaging data to augment current understanding Principle Investigators: Eric E. Roselli, MD Cleveland Clinic Cleveland, OH, USA Frank R. Arko III, MD Carolinas Medical Center Charlotte, NC, USA Matt Thompson, MD St. George s Institute London, UK
22 Baseline Demographics and Clinical Characteristics 9 patients in total, 7 US and 2 UK Mean Age: 73 years (63-87) 67% female Aneurysm Morphology Comorbidities Hypertension 8 Hyperlipidemia 7 Saccula r 5 Fusifor m4 Arrhythmia* COPD Cancer TIA 2 *All subjects presented with Cardiac Disease Mean Maximum Aneurysm Diameter: 53.7 mm (42-76) Mean LSA Diameter: Ostium 10.3mm (8-13), Distal 9.6mm (8-10)
23 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 Main Stent Graft Access Perc 2 Branch Stent Graft Access Axillary 2 Surgical 7 Brachial 7 7 patients received distal Valiant device to extend coverage Mean hospital procedure stay: 5.9 days (5-8)
24 Primary Endpoints through 30-day Visit Treatment Success 1 : 100% Technical Success: 100% Composite Safety Endpoints Aneurysm-Related Mortality: 0 patients Stroke: 3 patients Minor, non-disabling neurological events All subjects regained full functional status Paraplegia: 0 patients Left Arm/Hand Ischemia: 0 patients 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.
25 Key Secondary Endpoints through 30-day Visit Secondary Endovascular Procedures: 0 patients Conversion to Surgical Procedure: 0 patients Surgical Revasc of the LSA: 0 patients Paraparesis: 0 patients Rupture: 0 patients Stent Graft Integrity: 100% Stent Graft Patency: 100% No technical issues with Main or Branch stent grafts Endoleaks at 30-day visit: 1 Type II and 1 Undetermined
26 Summary of Principle Findings through 30- days Primary effectiveness objective achieved at 30 days 100% Treatment Success, 100% Technical Success No deaths, major strokes, paraplegia or left arm/hand ischemia No evidence device migration, infolding or fractures 100% stent graft integrity and patency
27 Conclusions The Valiant Mona LSA stent graft system has performed as planned in the short term Patients will continue to be followed through 5 years Expansion of Feasibility Trial planned for 2015: 7 sites Up to 24 additional patients
28 Thank You Frank R. Arko III, MD Professor of Cardiovascular Surgery Director, Endovascular Surgery Co-Director, Aortic Institute Carolinas Medical Center
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