Robotic Techniques In Interventional Cardiology Giora Weisz MD

Robotic Techniques In Interventional Cardiology Giora Weisz, MD Director of Cardiovascular Clinical Research, Center for Interventional Vascular Therapy Columbia University Medical Center Cardiovascular Research Foundation New York, NY

Disclosures I have NO financial relationships related to this presentation or technology

The Past Of Interventional Cardiology

The Future Of Interventional Cardiology

Contemporary PCI Challenges that impede success • Limited precision and control • STLLR trial reported 47. 6% Longitudinal Geographical Miss • 10 -20% of patients require a second stent due to inaccurate placement or size of first stent • Wire and device slippage • High doses of contrast media - CIN!

Contemporary PCI Occupational hazards in the cath lab

Cataract p<0. 005 A dose dependent increased risk of posterior lens opacities Kleiman NJ, CCI 2010

Interventionalists Reported Spine Injury

The Robotic Solution ROBOT A mechanical device that sometimes resembles a human and is capable of performing a variety of often complex human tasks on command or by being programmed in advance.

The Three Laws of Robotics 1. A robot may not injure a human being or, through inaction, allow a human being to come to harm. 2. A robot must obey any orders given to it by human beings, except where such orders would conflict with the First Law. 3. A robot must protect its own existence as long as such protection does not conflict with the First or Second Law. Isaac Asimov. Runaround 1942

Cor. Path 200 Corindus Vascular Robotic System Operator Console Robotic Drive Single-use Cassette Interventional Cockpit

Cor. Path. TM 200 Vascular Robotic System Single-use Cassette Robotic Drive Control console

Single Use Cassette Wire Second Wire Stent Catheter

Guide Catheter Stability

Procedure Control Optimal Contrast usage

Wire Manipulation

Precise Measurements • Unrelated to angiographic view • Not affected by foreshortening The measurement feature may be useful for determining lesion length for stent selection or understanding the distance between 2 branch arteries.

Patient 003

Patient 007 Maverick 2. 5 mmx 9 mm Pre-Procedure Promus Stent 2. 5 x 16 mm BMW Wire Post-Procedure

First-in-Human Trial Juan F Granada & Giora Weisz Objectives: To evaluate the safety and technical efficacy of the Cor. Path system in delivery and manipulation of coronary devices for percutaneous coronary interventions (PCI) Inclusions: De novo lesion 2. 5 -4. 0 mm in diameter and ≤ 25 mm in length with >50% stenosis in patients with ischemia 10 Endpoint: < 30% final diameter stenosis after utilizing the Cor. Path system to deliver a wire/balloon/stent to target lesion, and successfully retracting the devices without the occurrence of any in-hospital MACE (JACC Intervention, In-press)

Patients Characteristics Cor. Path 200 n = 8 Mean Age, years Female Gender Hypertension Diabetes Mellitus 67. 8± 10. 7 62. 5% 75% 37. 5% Hyperlipidemia 75% Prior Myocardial Infarction 25% Prior PCI 25% Prior CABG Mean LVEF, % 0 59. 4± 8. 6

Devices • • 6 Fr Guide catheter 0. 014” Rx guidewire Pre-dilatation baloons 2. 5 -3. 5 mm Stents: DES or BMS 2. 5 -4. 5 X 12 -24 mm

Clinical Outcomes • CPK/MB ↑ 8, 16, 24 h 0% • MACE free @ 24 h 100% • Discharge @ 24 h 100% • MACE free @ 30 d 100%

Radiation Exposure (µGy) Table Operator Cor. Path Operator 97. 3 3. 78 41. 59 0 50. 5 0 12. 65 26. 91 Mean 97. 1% 3. 5 33. 33 3. 68 183. 0 0 47. 3 0 61. 57 ± 54. 95 1. 81 ± 1. 93

PRECISe Study Percutaneous Robotically-Enhanced Coronary Intervention Study • DESIGN: Prospective, nonrandomized, single-arm, multi-center clinical evaluation of the Cor. Path System. n=175 • OBJECTIVE: To evaluate the feasibility, safety, and performance of the Cor. Path system • PRINCIPAL INVESTIGATORS: Giora Weisz, MD Joseph Carrozza, MD

Primary Endpoints • Clinical Procedural Success defined as <30% residual stenosis in target lesion at the completion of the procedure, in the absence of MACE* at 48 -hrs post index procedure or at hospital discharge, whichever occurs first. • Device Procedural/Technical Success defined as successful advancement and retraction of the PCI devices using Cor. Path 200 without conversion to manual operation. * MACE is defined as – – Cardiac death, Q-wave or non Q-wave MI – Q wave defined as new pathologic Q waves in two or more contiguous ECG leads as determined by an ECG core laboratory or independent review of the CEC and elevation of cardiac enzymes above normal. In the absence of ECG data the CEC may adjudicate Q wave MI based on the clinical scenario and appropriate cardiac enzyme data. – Non Q-Wave defined as elevated CK ≥ 2 X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal) in the absence of new pathological Q waves. Clinically driven TVR by percutaneous or surgical means as adjudicated by the CEC.

Robotic Assisted PCI - 1 • Contemporary PCI is associated with longer and more complex procedures • Long procedures are associated with accumulating doses of radiation, distress the spine and results in occupational hazards • Remote-control PCI in a relaxed and ergonomic sitting position will reduce radiation exposure and spine injury, further resulting in better ability to concentrate on the patient treatment rather than operator’s discomfort

Robotic Assisted PCI - 2 • Contemporary PCI is not perfect and can be improved by increasing standardization, reproducibility, and accuracy • The controlled Cor. Path robotic system can improve guiding-catheter stability, guide-wire manipulation, manage contrast media injections, and improve visualization, and stent delivery with precise positioning • Perfection of PCI will translate to increased success rate and safety

Robotic Assisted PCI - 3 • First-In-Human experience with the Cor. Path system demonstrated the safety and feasibility of using robotic technology for PCI • Technical success of the system was 98. 6% and clinical success was 100% without complications • The operator exposure to radiation was 97% less than at the table position

Humans Are Irreplaceable

Robotic Techniques In Interventional Cardiology Giora Weisz, MD Director of Cardiovascular Clinical Research, Center for Interventional Vascular Therapy Columbia University Medical Center Cardiovascular Research Foundation New York, NY