Future Applications Ryan D. Madder, MD Section Chief, - PowerPoint PPT Presentation

Progress of f Telerobotics & & Future Applications Ryan D. Madder, MD Section Chief, Interventional Cardiology Medical Director, Cardiac Cath Lab Frederik Meijer Heart & Vascular Institute Spectrum Health Grand Rapids, Michigan

Disclosures • Research Support: Corindus Vascular Robotics • Advisory Board: Corindus Vascular Robotics

Addressing Unmet Needs with Telerobotics The Problem The Strategy Reduce time to treatment for Emergent procedures: Time to ! emergent procedures such as STEMI treatment is critical and stroke Access to expertise & treatment is Increase access to care globally geographically limited Expand intervention- & Shortage of skilled specialists thrombectomy-capable facilities Enable tele-proctoring & scale tele- Incidence of STEMI & stroke on the rise diagnostic capabilities to tele-treatment due to aging patient population

Evolution of Remote Intervention Remote capabilities across vascular interventions Same Hospital Same Hospital Different Hospital Same Hospital Control Room Multiple Room Control Remote Site Procedure Room Connection Hardwired Hardwired Fiber WiFi/Fiber 8’ from Patient 30’ from Patient 200’ from Patient 20 Miles from Patient

Telestenting: Defining the Concept Physician in Location “A” Patient in Location “B” The performance of PCI, using a combination of robotics and telecommunications, by an operator who is in a separate geographic location than the patient

The Problem: Disparities in PCI Access Dark Areas: <60-min Drive to PCI Hospital % of Population Within 60-mins of PCI • Total US: 80% • California: 90.9% • Delaware: 91.7% • Florida: 91.2% • West Virginia:45.6% • Alaska: 40.0% • Wyoming: 30.5% Concannon et al. Circ Cardiovasc Qual Outcomes 2012;5:14-20

Rates of Primary PCI in US 2003 - 2010 100 Primary PCI CABG Medical Therapy 90 Treatment 80 N = 1,990,486 70 of STEMI 60 in the 50 % United 40 States 2003- 30 20 2010 10 0 Northeast Midwest South West Kolte et al. Clin Cardiol 2014;37:204-212.

Endovascular Thrombectomy vs Medical Therapy in Acute Stroke: Results of Meta-analysis Compared to medical therapy, endovascular thrombectomy was associated with significantly less disability at 90 days OR 2.49 [95% CI 1.76 – 3.53], p<0.001 NNT to reduce disability by ≥1 point on modified Rankin scale was 2.6 Goyal et al. Lancet 2016; 387: 1723 – 31

Shortage of Comprehensive Stroke Centers in US 212 Comprehensive Stroke Centers in US = 3.8% Holmes & Hopkins J Am Coll Cardiol. 2019;73:1483-90 Total US Hospitals = 5,534

Telerobotics Technology Development: Achievements and Planned Milestones

Telestenting: The REMOTE-PCI Study Is it feasible for a physician to perform PCI from outside the procedure room housing the patient? Madder et al. EuroIntervention 2017;12:1569-1576

Telestenting: The REMOTE-PCI Study Conventional configuration REMOTE-PCI configuration

REMOTE-PCI: Primary Endpoints 95 100 Pre-specified primary endpoints: 86.4 90 1) Technical success 80 • successful intracoronary advancement and 70 retraction of guidewires, angioplasty balloons, 60 and stents by the robotic system without 50 (%) conversion to manual operation 40 2) Procedural success 30 • <30% residual stenosis upon completion of the 20 procedure in the absence of death or repeat 10 revascularisation prior to hospital discharge 0 Technical Procedural Madder et al. EuroIntervention 2017;12:1569-1576. Success Success

Feasibility of Robotic Telestenting Over Long Geographic Distances: A pre-clinical ex vivo and in vivo study PCI Simulator Distance = 4.6 miles Ex Vivo Spectrum Health internal network Live Pigs Distance = 4.1 miles In Vivo Relied on commodity internet Live Pigs Distance = 103 miles Madder et al. In EuroIntervention 2019; Vivo Relied on commodity internet DOI: 10.4244/EIJ-D-19-00106

Madder et al. Ex Vivo Telestenting Model EuroIntervention 2019; DOI: 10.4244/EIJ-D-19-00106 Medical Office Building Cardiovascular Simulation Center

Madder et al. EuroIntervention 2019; Ex Vivo Telestenting Model DOI: 10.4244/EIJ-D-19-00106 Robotic arm Simulator mannequin

Madder et al. EuroIntervention 2019; In Vivo Telestenting Model DOI: 10.4244/EIJ-D-19-00106 Medical Office Building Animal Laboratory 4.1 Miles

In Vivo Telestent Model Madder et al. EuroIntervention 2019; DOI: 10.4244/EIJ-D-19-00106

Experimental Telestenting Models: The patient site Cardiology Fellow & Scrub Tech • Obtained vascular access • Seated guide catheter • Performed contrast injections • Loaded devices onto robot • Performed balloon inflations Madder et al. Ex Vivo Simulator Model In Vivo Porcine Model EuroIntervention 2019; DOI: 10.4244/EIJ-D-19-00106

Experimental Telestenting Models: The interventional cardiologist site Live fluoroscopy images Live tele-communications Live hemodynamics Robotic controls

Case # Target Vessel Added Latency (ms) Stent Size (mm) Procedural Success Feasibility of Ex Vivo Cases Performed Over a Distance of 4.6 Miles Robotic Ex vivo lesion #1 LAD 0 3.0 x 20 Yes Ex vivo lesion #2 RCA 0 4.0 x 16 Yes Telestenting Ex vivo lesion #3 RCA 0 3.5 x 12 Yes Over Long In Vivo Cases Performed Over a Distance of 4.1 Miles In vivo lesion #1 Circ 0 4.0 x 12 Yes Geographic In vivo lesion #2 LAD 600 4.0 x 24 Yes Distances: In vivo lesion #3 LAD 0 4.0 x 38 Yes In vivo lesion #4 Circ 1000 4.0 x 8 Yes A pre-clinical ex In Vivo Cases Performed Over a Distance of 103 Miles vivo and in vivo In vivo lesion #5 Circ 0 4.0 x 12 Yes study In vivo lesion #6 LAD 600 4.0 x 28 Yes In vivo lesion #7 RCA 1000 4.0 x 28 Yes In vivo lesion #8 RCA 2000 5.0 x 24 Yes

Feasibility of Telestenting in Humans Dr. Tejas Patel performed 1 st long-distance telestenting in humans: 5 patients over a distance of 20 miles in India in December 2018

First-in-Human Clinical Overview & Outcomes Co CorPath GRX POP Stu tudy Purp rpose To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures. CorPath GRX POP Enrollment Co CorPath GRX POP Stu Co tudy • • Subjects with coronary artery disease and with a clinical indication for PCI; All 5 subjects completed the study; − Discharge or 48 hours post-procedure; whichever occurs first • Sample Size: up to 5 subjects; • • Clinical Site: Apex Heart Institute , Ahmedabad-380054, Gujarat, INDIA All Type A lesions • • Remote Site: Swaminarayan Akshardham in Gandhinagar, Gujarat, INDIA All procedures completed robotically as planned • All procedures completed robotically in an average of 21.2 minutes; No serious adverse events or clinical events noted Pati Pa tient 1 Day Day Age Age Acce Ac cess Lesion Pre-Stenosis Pre Post-Stenosis Po Pr Proce cedure Time 2 1 1 54 RFA Robotically treated mid LAD (2.5 x 12mm) 95% 0% 12 min 2 1 53 LAR Robotically treated mid LAD (3.0 x 15mm) 90% 0% 18 min First 34 min 3 3 2 52 RRA Robotically treated mid LAD (2.75 x 18mm) 90% 0% Live Case 4 2 84 RRA Robotically treated mid CFX (3.5 x 10mm) 99% 0% 27 min 5 2 55 LRA Robotically treated R-PDA (2.5 x 9mm) 90% 0% 15 min 1. All patients indicated with chronic stable angina 2. RoR enabled on all cases 3. Active narration of first live case resulted in an extended procedure time

Telestenting: Barriers to Utilization • Need for second operator – vascular access, engage the guide catheter, perform angiography • Managing complications - perforation, tamponade, abrupt vessel closure, dissections, vascular access complications, etc. • Licensure? Credentialing? Liability? • Network performance – internet traffic, security, signal latency

Will 5G Wireless Technology Enable Wireless Telestenting? 5G – The 5 th Generation of Mobile Communication Impact for Tele-Robotics • High-Speed, Low-Latency Access Networks 5G can help provide high-quality connections to locations without fiber, helping extend interventional • Faster Speed care with robotics 20x the speed of 4G 1 • Shorter Delays Less than 10 milliseconds in fully operationalized Control Location Patient Location conditions 1 (interventional cardiologist) (simulated patient) • Increased Bandwidth More data and more devices can communicate at the same time 1 https://www.verizon.com/about/our-company/5g/what-5g

Conclusions • There is currently geographic disparity in access to PCI. Telestenting is being explored as a potential means to improve PCI access. • Telestenting has been successfully demonstrated in animals over distance of 103 miles and in humans over distance 20 miles. • Considerable research is needed to determine optimal network performance needed to support telestenting in clinical care. • Several barriers exist to further development – we need creative people to come up with creative solutions to overcome these barriers • Potential exists to adapt telestenting technology to provide remote endovascular treatment of acute stroke and PAD