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Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter Registry to Document Early QOL and time to return to work CASE REPORT FORMS www.smartsmsmarketing.com

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Page 1: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Patient Recovery After Robotic Assisted vs. Traditional CABG

1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery

2) Multicenter Registry to Document Early QOL and time to return to work

CASE REPORT FORMS

www.smartsmsmarketing.com

Page 2: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

CONTACT INFORMATION

Univ of Chicago Pranjal Desai

[email protected] Robert [email protected] 617-610-0126

Gary Balady

Univ of Toledo [email protected]; contract [email protected]

419-383-6915

Thomas [email protected]

419 383-5150 office860 841-8258 cell

Dr. [email protected]

Lennox Hill Joan [email protected]

Nirav [email protected]

Univ of Maryland Johannes [email protected]

.edu4438349124

Aldo [email protected]

Intuitive Cyprian OkaforLegal representative

Myriam Curet

Center for Clinical Trials (CCT)

U Maryland

D [email protected] [email protected]

Tessie Langreo billing analysis and budget, [email protected]

STUDY SITE STUDY COORDINATORS SURGEON-PI CPX TESTING MD

Page 3: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Site ID#Univ of Maryland: UMUniv of Toledo: UTLennox Hill: LHUniv of Chicago: UCSam Balkey: SBSt. Joseph’s: SJLankenau Hospital: LH

Patient ID#Univ of Toledo: numbers will range from 1-70

Univ of Maryland, Good Samaritan, Lennox Hill,Univ of Chicago: numbers for CPX study will range from 1-20

All registry participants: numbers will range from 1-100

Study subject ID: Site ID# - Patient ID# (e.g. UM-04)

Page 4: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*Zipcode very important to estimate income

Page 5: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 6: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 7: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 8: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 9: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 10: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 11: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 12: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 13: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 14: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 15: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 16: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 17: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 18: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 19: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 20: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 21: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 22: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 23: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 24: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For CPX studyData not part of the STS requirement

Page 25: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter
Page 26: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For CPX and registryBased on phone interview at 1 yearData not part of the STS requirement

Page 27: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

• For CPX and Registry• Data not part of the STS requirement

Page 28: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Collection of flow tracing

*CPX study and registry: Electonic file to be downloaded onlineData not part of the STS requirement

Page 29: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Collection of Cerebral Oximetry Tracings

*For CPX and Registry participants that use cerebral oximetryData not part of the STS requirement

Page 30: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Intubation billateral IMA harvesting LIMA to LAD grafting RIMA to OM grafting

Cerebral desaturation

Page 31: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For CPX study and registry: obtained by interview at 3 weeksData not part of the STS requirement

Page 32: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For CPX study and registry: obtained by interview at 3 weeksData not part of the STS requirement

Page 33: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For Registry and CPX Data not part of the STS requirement

Page 34: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For CPX study onlyData not part of the STS requirementBiomarker values will be entered by core lab – serum samples sent by study sites

Page 35: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

INTRAOPERATIVE GRAFT DATA CT SCAN results

Type of Conduit (LIMA, SVG…)

Coronary target (LAD, OM…)

Estimated Conduit Diameter(mm)

Estimated Target Diameter(mm)

Target Quality(Good/poor)

Regional WMA (y/n)

Graft Flow (cc/min) PI %DF

Patent at 1 Week (y/n/not done)

Patent at 6 Mo (y/n/not done)

*For CPX and registryData not part of the STS requirement

Page 36: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

*For CPX study onlyData not part of the STS requirement

Collection of perioperative serum samples

Page 37: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Copyright ©2009 American Heart Association

Myers, J. et al. Circulation 2009;119:3144-3161

Exercise Testing – Pre and Postop

Page 38: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Copyright ©2009 American Heart Association

Myers, J. et al. Circulation 2009;119:3144-3161

Page 39: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

Copyright ©2009 American Heart Association

Myers, J. et al. Circulation 2009;119:3144-3161

Page 40: Patient Recovery After Robotic Assisted vs. Traditional CABG 1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery 2) Multicenter

RIMA

LIMA

LAD OM1

Follow-up CT angiography – 6 months