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

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

Feb 18, 2023 44 likes •312 views

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

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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

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SLIDE 2

Disclosures

  • Research Support: Corindus Vascular Robotics
  • Advisory Board: Corindus Vascular Robotics
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Addressing Unmet Needs with Telerobotics

The Strategy The Problem

Access to expertise & treatment is geographically limited Shortage of skilled specialists Incidence of STEMI & stroke on the rise due to aging patient population

!

Emergent procedures: Time to treatment is critical

Reduce time to treatment for emergent procedures such as STEMI and stroke

Increase access to care globally Expand intervention- & thrombectomy-capable facilities Enable tele-proctoring & scale tele- diagnostic capabilities to tele-treatment

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Evolution of Remote Intervention

Remote capabilities across vascular interventions

Same Hospital Procedure Room Same Hospital Control Room Same Hospital Multiple Room Control Different Hospital Remote Site Connection Hardwired 8’ from Patient Hardwired 30’ from Patient Fiber 200’ from Patient WiFi/Fiber 20 Miles from Patient

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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

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The Problem: Disparities in PCI Access

% 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 Dark Areas: <60-min Drive to PCI Hospital

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SLIDE 7

Rates of Primary PCI in US 2003 - 2010

10 20 30 40 50 60 70 80 90 100 Northeast Midwest South West Primary PCI CABG Medical Therapy

N = 1,990,486

%

Kolte et al. Clin Cardiol 2014;37:204-212.

Treatment

  • f STEMI

in the United States 2003- 2010

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Endovascular Thrombectomy vs Medical Therapy in Acute Stroke: Results of Meta-analysis

Goyal et al. Lancet 2016; 387: 1723–31

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

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SLIDE 9

Shortage of Comprehensive Stroke Centers in US

212 Comprehensive Stroke Centers in US = 3.8% Total US Hospitals = 5,534

Holmes & Hopkins J Am Coll Cardiol. 2019;73:1483-90

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Telerobotics Technology Development:

Achievements and Planned Milestones

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Telestenting: The REMOTE-PCI Study

Madder et al. EuroIntervention 2017;12:1569-1576

Is it feasible for a physician to perform PCI from outside the procedure room housing the patient?

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Telestenting: The REMOTE-PCI Study

Conventional configuration REMOTE-PCI configuration

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REMOTE-PCI: Primary Endpoints

Pre-specified primary endpoints: 1) Technical success

  • successful intracoronary advancement and

retraction of guidewires, angioplasty balloons, and stents by the robotic system without conversion to manual operation

2) Procedural success

  • <30% residual stenosis upon completion of the

procedure in the absence of death or repeat revascularisation prior to hospital discharge 86.4 95 10 20 30 40 50 60 70 80 90 100 Technical Success Procedural Success

Madder et al. EuroIntervention 2017;12:1569-1576.

(%)

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Feasibility of Robotic Telestenting Over Long Geographic Distances:

A pre-clinical ex vivo and in vivo study

Madder et al. EuroIntervention 2019; DOI: 10.4244/EIJ-D-19-00106 Ex Vivo In Vivo In Vivo PCI Simulator Live Pigs Live Pigs Distance = 4.6 miles Spectrum Health internal network Distance = 4.1 miles Relied on commodity internet Relied on commodity internet Distance = 103 miles

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Ex Vivo Telestenting Model

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

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Ex Vivo Telestenting Model

Simulator mannequin Robotic arm

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

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In Vivo Telestenting Model

Medical Office Building Animal Laboratory

4.1 Miles

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

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In Vivo Telestent Model

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

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Experimental Telestenting Models:

The patient site

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

Ex Vivo Simulator Model In Vivo Porcine Model

Cardiology Fellow & Scrub Tech

  • Obtained vascular

access

  • Seated guide

catheter

  • Performed contrast

injections

  • Loaded devices onto

robot

  • Performed balloon

inflations

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Experimental Telestenting Models:

The interventional cardiologist site

Robotic controls Live fluoroscopy images Live hemodynamics Live tele-communications

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Feasibility of Robotic Telestenting Over Long Geographic Distances:

A pre-clinical ex vivo and in vivo study

Case # Target Vessel Added Latency (ms) Stent Size (mm) Procedural Success

Ex Vivo Cases Performed Over a Distance of 4.6 Miles Ex vivo lesion #1 LAD 3.0 x 20 Yes Ex vivo lesion #2 RCA 4.0 x 16 Yes Ex vivo lesion #3 RCA 3.5 x 12 Yes In Vivo Cases Performed Over a Distance of 4.1 Miles In vivo lesion #1 Circ 4.0 x 12 Yes In vivo lesion #2 LAD 600 4.0 x 24 Yes In vivo lesion #3 LAD 4.0 x 38 Yes In vivo lesion #4 Circ 1000 4.0 x 8 Yes In Vivo Cases Performed Over a Distance of 103 Miles In vivo lesion #5 Circ 4.0 x 12 Yes 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

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Feasibility of Telestenting in Humans

  • Dr. Tejas Patel

performed 1st long-distance telestenting in humans: 5 patients over a distance

  • f 20 miles in India in

December 2018

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First-in-Human Clinical Overview & Outcomes

Pa Pati tient1 Day Day Age Age Ac Acce cess Lesion Pre Pre-Stenosis Po Post-Stenosis Pr Proce cedure Time2

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 3 2 52 RRA Robotically treated mid LAD (2.75 x 18mm) 90% 0% 34 min3 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

First Live Case

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

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.

Co CorPath GRX POP Stu tudy

  • All 5 subjects completed the study;

− Discharge or 48 hours post-procedure; whichever occurs first

  • All Type A lesions
  • 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

Co CorPath GRX POP Enrollment

  • Subjects with coronary artery disease and with a clinical indication for PCI;
  • Sample Size: up to 5 subjects;
  • Clinical Site: Apex Heart Institute, Ahmedabad-380054, Gujarat, INDIA
  • Remote Site: Swaminarayan Akshardham in Gandhinagar, Gujarat, INDIA
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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
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Will 5G Wireless Technology Enable Wireless Telestenting?

5G – The 5th Generation of Mobile Communication Networks

  • Faster Speed

20x the speed of 4G1

  • Shorter Delays

Less than 10 milliseconds in fully operationalized conditions1

  • Increased Bandwidth

More data and more devices can communicate at the same time

Impact for Tele-Robotics

  • High-Speed, Low-Latency Access

5G can help provide high-quality connections to locations without fiber, helping extend interventional care with robotics

Control Location (interventional cardiologist) Patient Location (simulated patient)

1https://www.verizon.com/about/our-company/5g/what-5g

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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
  • vercome these barriers
  • Potential exists to adapt telestenting technology to provide remote endovascular treatment of acute stroke and PAD