Endovascular Repair of Aortic Arch/Thoracic Aneurysms: Bolton RelayBranch Device Luis A. Sanchez MD Gregorio A. Sicard Distinguished Professor of Surgery & Radiology Chief, Section of Vascular Surgery
Disclosure Statement Consultant Cook Endologix Bolton Medical W. L. Gore
Extensive Arch aneurysms Option in 2018?
Open Total Arch Repair Technically demanding Complex circulatory management Hypothermic circulatory arrest (HCA) Morbidity and mortality significant in high risk patients
Total Arch Repair: Why endo? Increasing complexity of cases and high-risk patients
Thoracic Branched Endovascular Technology
Bolton RelayBranch Technology Based on Relay NBS Plus (Non-Bare Stent) platform Off-the-shelf (various proximal diameters, standard branch position and endograft length) Large single window for ease of cannulation of 2 internal tunnel(s) Innominate and LCCA Intended for Zone 0 deployment combined with extra-anatomic arch branch bypass as required
Relay NBS Plus Platform Technology used for RelayBranch Device Patented proximal capture technology Improved arch conformation and prevention of retroflex deployment Self-orienting pre-curved NiTi guidewire lumen Dual sheath design facilitates advancement into Zone 0
RelayBranch Early Feasibility Study STUDY DEFINITION /// Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects with Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery STUDY DESIGN /// Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study PRIMARY ENDPOINTS /// Primary Safety Endpoint: A Composite of the following MAEs occurring at 30 days after the procedure: 1. All-cause mortality 2. Stroke, excluding transient ischemic attack (TIA) 3. Paralysis, excluding paraparesis /// Primary Effectiveness Endpoint: Composite of the following criteria: 1. Technical success at 24 hours, defined as successful delivery and patency at 30 days 2. Patency of all endograft components at 30 days 3. Absence of type I and III endoleak, at 30 days # PATIENTS (Target n=10) /// Enrollment has been initiated, 2 patients have been treated
RelayBranch Early Feasibility Trial FOLLOW UP SCHEDULE /// Discharge /// 30 days post index procedure /// 6 months post index procedure /// One, two, three, four, and five years post index procedure MONITORING SUPPORT /// An independent Data Monitoring Committee (DMC) will review and adjudicate specific events. SITES /// 3 investigational sites in the United States: 1. Cleveland Clinic Foundation, Cleveland, Ohio CardioThoracic Surgery: Eric Roselli, MD Vascular Surgery: Federico Parodi, MD 2. Barnes Jewish Hospital-Washington University School of Medicine, St. Louis, Missouri CardioThoracic Surgery: Marc Moon, MD Vascular Surgery: Luis Sanchez, MD 3. University of Pennsylvania, Philadelphia, Pa. CardioThoracic Surgery: Wilson Szeto, MD Vascular Surgery: Ron Fairman, MD
Bolton RelayBranch Device LSA-LCCA Bypass Main Body Deployment BCT Branch Deployment LCCA Branch Deployment Super Stiff guidewire in the Left Ventricle Advancement of the main graft from femoro-iliac Complete deployment of the main body (under rapid pacing) Cannulation of the posterior tunnel from right carotid access Advancement of the BCT bridging stent from the right carotid access and deployment Cannulation of the anterior tunnel from left carotid access Advancement of the LCCA bridging stent from the left carotid access and deployment Balloon if necessary
Bolton RelayBranch Device Patient #1: Aortic arch aneurysm, poor surgical candidate 57 y.o. male with 64 mm aneurysm PMH/PSH: EVAR, FEVAR revision, CAD, MI, PCI x 15, CHF (EF 30-40%), AICD/PPM, DM, COPD, OSA, BMI 35, GERD Creatinine 0.9 ABI s > 1, no carotid disease
Bolton RelayBranch Device Patient #1: Underwent repair on 1/8/18 Left carotid subclavian bypass Open exposure left CFA, right CCA Right femoral temporary transvenous pacer placement AICD wires Temp Pacer
Bolton RelayBranch Device Patient #1: Underwent repair on 1/8/18 Left carotid subclavian bypass Open exposure left CFA, right CCA Right femoral temporary transvenous pacer placement Femoral access required a 26Fr sheath to access through the EVAR/FEVAR grafts Positioning and deployment of the Bolton Relay Branch Device
Bolton RelayBranch Device Window Distal Marker Window Proximal Marker Main Body Proximal Markers Window Markers Tunnels Proximal Markers Main Body Distal Markers
Bolton RelayBranch Device Patient #1: Underwent repair on 1/8/18 Left carotid subclavian bypass Open exposure left CFA, right CCA Right femoral temporary transvenous pacer placement Bolton Relay Branch Device Brachiocephalic branch placement Left carotid branch placement Left proximal subclavian embolization using 20 mm Amplatzer plug
Bolton RelayBranch Device
Bolton RelayBranch Device Patient #2: Aortic arch enlarging penetrating ulcer/aneurysm 71 y.o. female, poor surgical candidate PMH: HTN, severe COPD and emphysema, CKD, right common iliac occlusion, severe spinal osteoarthritis Creatinine: 1.3 ABI: 0.69/>1, no carotid disease
Bolton RelayBranch Device Patient #2: Underwent repair on 1/19/18 Left carotid subclavian bypass Open exposure left CFA, right CCA Right femoral temporary transvenous pacer placement Placement of Bolton Relay Branch Device Brachiocephalic branch placement Left carotid branch placement Left proximal subclavian embolization using 16 mm Amplatzer plug Ulcer
Bolton RelayBranch Device
Bolton RelayBranch Device Patient #1 Patient #2 LOS (days) 8 14 ICU stay (days) 2 6 Complications - Retinal artery occlusion - LLE weakness - Pulmonary insufficiency - UTI Operative time (min) 380 352 Fluoro time (min) 34.3 29.6 Radiation (mgy) 1367 860 Contract (cc) 66 80
Bolton RelayBranch Device World Wide Experience Single Branch: Patients treated via Custom Made Program 5 patients from initial feasibility experience (5 centers) Limited experience since the initiation of the Double Branch phase Double Branch (n=116 as of 1/1/18): Patients treated via Custom Made Program (25 centers)
Bolton RelayBranch Device Conclusion Initial experience with the Bolton Relay Branch Device in the US Feasibility Trial has been encouraging Fluoroscopy time and contrast use is limited for the complexity of the procedure performed
Bolton Relay Branch Device Under Feasibility Trial Evaluation in the US Started on 1/8/18 2 patients treated to date