Presentation is loading. Please wait.

Presentation is loading. Please wait.

VCU Pauley Heart Center:

Similar presentations


Presentation on theme: "VCU Pauley Heart Center:"— Presentation transcript:

1 VCU Pauley Heart Center:
A 2010 US News Top 50 Heart and Heart Surgery Hospital

2 PCI in Evolution: A Novel Approach Utilizing a Robotic Interventional System
George W. Vetrovec, MD. Kimmerling Professor of Cardiology VCU Pauley Heart Center Virginia Commonwealth University Richmond, Virginia

3 Disclosures Grants: Cordis, Merck, Corindus.
Consultant: Merck, Pfizer, Lilly, Roche. Speakers Bureau: Cordis, Lilly-Diiachi Sankyo, Gilead. I am an Interventional Cardiologist

4 Occupational hazards in the cath lab: Staff
Risks associated with high exposure to harmful x-ray radiation Cancer and cataracts High instance of spinal problems created from wearing lead aprons 50% of all ICs report chronic back pain vs. 27% of all adults1 15 pound lead apron can place pressures of up to 300 pounds per square inch of intravertebral discs2 Eye and neck repetitive strain injuries due to poor ergonomics of the cath lab

5 PCI Challenges Today: Patients
Challenges that impede success Limited precision and control Procedures not consistent or standardized Large inter-operator variability STLLR trial reports 47.6% Longitudinal Geographical Miss 10-20% of patients require a second stent due to inaccurate placement or size of first stent1 Wire and device slippage High doses of contrast media Geographical Miss Uncovered plaque Stent sizing Device placement

6 CorPath™ System Operator Console Single-use Cassette Robotic Drive
Interventional Cockpit Robotic Drive Single-use Cassette Operator Console Operator Console Single-use Cassette Robotic Drive Interventional Cockpit

7 CorPath Interventional Cockpit

8 CorPath Robotic Drive Articulated Arm Robotic Drive

9 CorPath System Controls
Fixate Advance Retract Rotate Measure

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

11 Guidewire Fixation No accidental wire movement
Wire locked during stent delivery Better support for bifurcations and complex lesions

12 Precise Stent Deployment
Optimal lesion coverage Avoid occluding side branches Exact stent placement for ostial lesions Accurate placement of overlapping stents Stent deployment from the cockpit

13 Complex Bifurcation Interventions

14 Preliminary Experience: Easy to Use
Easy installation – No construction Short physician learning curve Familiar procedure sequence Simple user interface Save time Simple to load cassette Efficient navigation Fast accurate measurement Open architecture You can select your wires and devices

15 Three-Vessel PCI in Swine: Robotic-Assisted with CorPath 200 System vs
Three-Vessel PCI in Swine: Robotic-Assisted with CorPath 200 System vs. Manual Intervention 19

16 Confidential Corindus Inc.
Objective The study was designed to assess and demonstrate safety and technical efficacy of the CorPath® 200 vascular robotics system in delivery and manipulation of coronary guidewires and stent and balloon systems for PCI and compare it with the standard manual delivery of the same devices in acute and 30-day chronic porcine model. Confidential Corindus Inc. 20

17 Confidential Corindus Inc.
Methods Twelve animals underwent 3-vessel (RCA, LCX and LAD) manual or CorPath-assisted PCI. The procedure involved every vessel balloon pre-dilated followed by two vessels stenting with either bare metal or drug eluting stents. The procedural characteristics – Procedure Time, X-Ray Time, Contrast Volume and Radiation exposure to the animal and the operator - were monitored in addition to clinical and histopathologic analysis of intervented vessels. Confidential Corindus Inc. 21

18 Confidential Corindus Inc.
Results All study devices were successfully deployed and all animals survived to their respective study endpoints. There were no early deaths. QCA demonstrated that angiographic results of deployment of stents or balloon catheters in porcine coronary arteries with the CorPath 200 System were not different from Manual deployment. Procedure Procedure Time (min) X-Ray Time (min) Contrast Volume (mL) Radiation Exposure Cumulative Dose(mGy) Operator (µGy) Manual 33.81 ±12.43 11.87± 4.97 154.2± 48.5 859.5 ±449.5 14.14 ±8.89 CorPath 200 ± 4.57 9.9 ± 2.27 108.3 ±34.2 792.7 ±339.9 4.30 ±7.23 Confidential Corindus Inc. 22

19 Confidential Corindus Inc.
Conclusions Robotic-assisted PCI was successful and comparable to the manual procedure in many categories: procedure time, X-Ray time and cumulative radiation exposure to the animal. There was significantly less radiation exposure to the operator as well as lower contrast volume in robotic-assisted PCI as compared to the manual procedure. Myocardial histopathology was not different between two procedures. Confidential Corindus Inc. 24

20 Confidential Corindus Inc.
CORBIC FIRST-IN-MAN Confidential Corindus Inc. 25

21 First-in-man Corbic Study
March-April, 2010 Location CORBIC Instituto Cardio-Neuro-Vascular Medellin, Colombia Investigators: Dr. Giora Weisz Dr. Juan Granada Study Objective To evaluate the safety and technical efficacy of the use of the CorPath system in delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI) Protocol: De novo lesion mm in diameter and ≤25 mm in length with >50% stenosis Primary Endpoint Achievement of a < 30% final diameter stenosis after utilizing the CorPath system to deliver a balloon/stent to target lesion, and successfully retracting the device without the occurrence of any In-Hospital MACE Confidential Corindus Inc. 26

22 FIM Corbic Overview Patients - 8
Clinical and Technical Considerations Symptomatic, positive stress test Significant CAD Wire, balloon and stent manipulated by the CorPath system Radiation Measurement 6 Fr Guide 0.014” Guide wire Pre-dilatation balloon mm Stent mm X mm

23 FIM Patient Characteristics Patients - 8
Factor N % Mean +/-SD Age 67.8+/-10.7 Male 3 37.5 Hyperlipidemia 6 75 Diabetes Smoking (Prior) Hypertension Prior MI 2 25 Unstable Angina 7 87.5

24 FIM Trial Baseline ANATOMY 8 Lesions N % RCA 3 37.6 LCx LAD 1 12.5 PDA
Target Lesion N % RCA LCx LAD PDA LVEF (%) 59.4+/-8.6 LESIONS 1 Length (mm) 11.4+/-6.1 RVD (mm) 3.0+/-7.4 MLD (mm) 2.4+/-3.1 Diam Sten 63.1+/-15% Thrombus 0 (0%) TIMI III 8 (100%) 1 % stenosis, lesion and vessel dimensions per QCA evaluation

25 CorPath Procedure Time (minutes) Total Fluoroscopy Time (minutes)
FIM Procedure Results CorPath Procedure Time (minutes) N (%) Mean  SD (N) 25.3 7.2 (8) Median (Range) 25 (12-35) Total Fluoroscopy Time (minutes) 11.53 3.7 (8) 12.0 ( )

26 % Diameter stenosis-post-procedure
FIM Procedure Results % Diameter stenosis-post-procedure Mean - 0.0% +/-0.0 +/-SD TIMI III Flow – 100% Free from MACE Discharge – 100% 30 Days % CKmb Rise post 8, 12, 24 Hrs. – 0% One late adverse event unrelated to procedure

27 FIM Results – Radiation (µGy)
Table Operator CorPath Operator 97.3 3.78 41.59 50.5 12.65 3.5 26.91 33.33 3.68 183. 47.3 Mean ± 54.95 1.81 ± 1.93 97.1% Confidential Corindus Inc.

28 Radiation Exposure No additional exposure to the patient
Corindus BOD meeting Radiation Exposure No additional exposure to the patient Control Data Corbic FIM Data Corindus data 50 % Age (y) 67.8 64 Height (cm) 160.2 169 Weight (Kg) 70.1 76 Flouro time (min) 12.3 11.7 Patient Radiation (Gy) 1.73 1.9 Physician radiation (Gy) N/A Contrast (ml) 158.7 250 Comparable radiation to the patient Comparable flouro time Significantly reduced physician radiation Significantly reduced contrast dose 36 December 19, 2007 36

29 CORBIC Study vs. Historic Data
Corindus BOD meeting CORBIC Study vs. Historic Data Lesions Treated (#) Stents (#) Fluoroscopy Time (min) Procedure Time (min) Nikolsky et al, 2007 All patients Fluoro time >23 min (2,408) Fluoro time ≤23 min (7,242) 1.87 ± 0.99 1.35 ± 0.65 1.88 ± 1.36 1.20 ± 0.83 18.3 ± 12.2 37.1 ± 29.3 12.7 ± 5.1 81.6 ± 60.6 119.6 ± 70.4 71.7 ± 53.5 CORBIC Study 1.0 11.5 ± 3.7 43.0 ± 18.61 1 CorPath Procedure time was 25.3±7.2 min The mean fluoro time from Corbic study compared favorably with the results of the reference study Even the longest fluoro time from Corbic study (15.5 min) fallen in the 50th percentile of fluoroscopy time in the referenced study (15.1 min) The mean procedure time in this study was significantly shorter than procedure time in the referenced study Confidential Corindus Inc. 37 December 19, 2007 37

30 CORPATH® PRECISE STUDY
Confidential Corindus Inc. 38

31 PRECISE Study Overall Objective:
To evaluate safety and effectiveness of CorPath 200 System in delivery and manipulation of coronary guidewires and stent/balloon catheters during CorPath-assisted PCI Corindus Inc. 40 40

32 Clinical Sites & Operators
Investigators NY-Presbyterian Hospital/Columbia University Medical Center New York, NY Giora Weisz, MD Jeffrey W. Moses, MD St. Elizabeth’s Medical Center Boston, MA Joseph P. Carrozza Jr, MD Lawrence A. Garcia, MD VCU Pauley Heart Center Richmond, VA George W. Vetrovec, MD Evelyne Goudreau, MD St. Joseph Hospital Syracuse, NY Ronald P. Caputo, MD Michael Fischi, MD Swedish Heart & Vascular Institute Seattle, WA Mark Reisman, MD Paul Huang, MD Confidential Corindus Inc. 41

33 PRECISE Study Study Design Sample Size Study Population:
This trial is a prospective, single-arm, multi-center, non-randomized study of the CorPath 200 System. Clinical data collected during the study will be compared to the Performance Goal derived from a meta-analysis of the studies using traditional stenting therapy Sample Size Up to 154 subjects shall be treated in the study at up to 8 clinical sites Study Population: Subjects with symptomatic, ischemic heart disease requiring PCI stenting for a single de novo native coronary artery lesion with reference vessel diameter 2.5–4.0 mm and lesion length <24.0 mm. Study Duration:  The anticipated enrollment period is 5 months/site with a 30-day follow-up period. The study completion is expected in 6-8 months Corindus Inc. 42 42

34 Co-Primary Endpoints PRECISE Study
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 CorPath 200 (i.e. without conversion to manual operation).

35 Potential Procedural Advantages
Precision Discrete, controlled linear movement and rotation Accurate length measurements Precise device placement Stability No unintended movements Y-connector is held in place Catheter and wire locked during device deployment Control Potential reduced fluoro and contrast Better visualization of angiography and vitals

36 Potential Patient Advantages
Procedure improvements translate to patient benefits More accurate device selection & placement Better visualization Shorter procedure duration Less contrast media Reduced radiation exposure


Download ppt "VCU Pauley Heart Center:"

Similar presentations


Ads by Google