Is there a role for robotics in PAE?

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Is there a role for robotics in PAE? S A N D E E P B A G L A, M D V A S C U L A R I N S T I T U T E O F V I R G I N I A W O O D B R I D G E V I R G I N I A U S A A D J U N C T C L I N I C A L A S S O C I A T E P R O F E S S O R U N C C H A P E L H I L L C H A P E L H I L L, N O R T H C A R O L I N A U S A

Sandeep Bagla, MD Consulting: Hansen, Boston Scientific, Medtronic, Dfine, Neuwave

Overview Challenges in PAE Robotic Systems are used in IR What are Endovascular Robotics Role for Current Technology Future Directions in Robotics & Embolization

Complicated Anatomy

What is the dirty little secret of IR?

Which specialty offers free cataract screening at its Annual Meeting? Neurosurgery Pediatrics Orthopedics Pathology Oncology Ophthalmology Interventional Radiology

Areas for Improvement in Embolization Radiation Reduction Staff and Patients Consistent Results Marketing Credentials/ Training Ablation, Angioplasty, Stenting Contrast Doses Radiation Exposure Variable Operator Experience & Comfort Uneven playing field for patients Reduction in Contrast Usage Marketing Consistency In Outcomes Variable Expertise Direct to Consumer Marketing (Cyberknife, DaVinci, Lap Band Commercials)

Robots are Everywhere! Robodoc First Surgical Robotic System. Orthopedic Surgery Active Epilepsy Surgery Amigo & Magellan Endovascular Cardiac and IR Freehand General Surgery Endoscope Davinci Prostate, Uterus, Lung

Robotics & Ablation/Biopsies

Results Technically Successful Reduction in Radiation To Staff & Patient Improved Accuracy Difficult to target lesions

Broad Applications

What is an Endovascular Robot?

21

I m an IR I can select that! (a) Note catheter tracking with manual catheterization in a bench top flow model. (b) Tracking data from robotically driven in the same model. (c) Catheter tracking software demonstrates tracking and wall contacts during arch and left carotid catheterization with manual technique. (Images courtesy of C. Riga, MD.)

Radiation Exposure 2 0 1 5 S I R A B S T R A C T P R E S E N T A T I O N S A N D E E P R A O, M D

Robot-assisted transarterial chemoembolization for hepatocellular carcinoma: Initial evaluation of safety, feasibility, success and outcomes using Magellan system S O C I E T Y O F I N T E R V E N T I O N A L R A D I O L O G Y A N N U A L M E E T I N G 2 M A R C H 2 0 1 5 A T L A N T A, G E O R G I A B Y S A N D E E P R A O M D M B A S I E R R A - P R O V I D E N C E H E A L T H N E T W O R K ( E L P A S O, T E X A S )

Results from TACE study SUCCESS: Overall technical success of DEB-TACE was 100%. Technical success of cannulating different vessels: Superior Mesenteric Artery: 100% Celiac trunk: 100% Common hepatic artery: 100% Right/left hepatic artery: 90% Subselective hepatic branches: 80% COMPLICATIONS No major or minor complications encountered. No access site complications Robot-related complications: 1 case (out of 10) of robotic system wire sensor failure, requiring reboot

Total procedural time Case 1: 3.5 hr Case 12: 38 min

Radiation exposure to operator Case 1: 109 mrem Case 10: 5.2 mrem

Radiation exposure to operator Independent workstation Case 1: 109 mrem Case 10: 5.2 mrem

Operator dose vs Control dose Bedside control Operator dose

Operator dose vs Control dose Bedside control Avg: 221.0 mrem Operator dose Independent Workstation Avg: 8.1 mrem

Operator dose vs Control dose Avg: 8.1 mrem Avg: 221.0 mrem Average radiation exposure to someone flying one way cross-country trip: avg 2-5 mrem* *US Environmental Protection Agency

Robotic versus manual Prostatic artery embolization: comparative analysis Retrospective 40 patients single center

100 90 80 70 60 50 40 30 20 10 0 Procedure Time (min) Procedure Time Fluoroscopy Time (min) Robotic Manual

30 AUA-SI 25 20 15 Robotic Manual 10 5 0 Baseline 1 month 3 month

6 QoL Score 5 4 3 Robotic Manual 2 1 0 Baseline 1 month 3 month

$5,000.00 $4,500.00 $4,000.00 $3,500.00 $3,000.00 $2,500.00 $2,000.00 $1,500.00 $1,000.00 $500.00 $0.00 Total Disposable Cost $4,350.21 $1,588.46 Robotic Manual

Case Examples

Acutely Angled Origins

+ One technical failure in the manual group Failed on the Right 1 st attempt with Manual Tech

Consistency: Proximal Support

Consistency: Proximal Support

Angulation: Better Results

Microcatheter driver (Off the Shelf) Any regular 110cm microcatheter Robotic guide wire controller Robotic guide catheter with distal tip steering

The future of Endovascular Robotics

EM sensor incorporated in the wall of the catheter EM SENSOR in WIRE IN CATHETER

Electromagnetic sensors integrated into wall of catheter EM Lab Setup Zeego fluoroscop y System 51 Live Virtual catheter displayed with 3D model or on 2D roadmap Electrical Box under table Window Field Generator

52

Do Robotics Help here? Credentials/ Training Radiation Exposure Marketing Variable Expertise Contrast Doses Consistency In Outcomes

Conclusions What we think we know Radiation exposure is less to us and patients (?) Advancements in technology has allowed for integration to many procedures Certain procedures with challenging anatomy may be best suited for robotics What we don t know Is this incremental cost worth it? Who s going to pay for it? Will this result in incremental improved outcomes Will the future pipeline further improve outcomes and safety

Thank you