Dr. Christopher R. Good Virginia Spine Institute

Transcription

1 Dr. Christopher R. Good Virginia Spine Institute College University of Rochester Medical School University of Rochester School of Medicine Residency in Orthpaedic Surgery Cornell University Medical Center Hospital for Special Surgery (New York, NY) Fellowship in Adult and Pediatric Spine Surgery Washington University School of Medicine Dual Board Certification American Board of Orthopaedic Surgery American Board of Spine Surgery Affiliations Fellow, American College of Surgeons American Academy of Orthopaedic Surgeons North American Spine Society Scoliosis Research Society Barnes Jewish Hospital St. Louis Children s Hospital Shriners Hospital for Children mazorrobotics.com 1

2 Complications and revision rates in robotic-guided vs. fluoro-guided minimally invasive spinal fusions REPORT FROM MIS ReFRESH PROSPECTIVE COMPARATIVE STUDY Good CR 1, Schroerlucke SR 2, Zahrawi F 3, Wang MY 4, Cannestra A 5, Lim JY 6, Hsu VW 7, Villalobos HJ 3,8, Ramirez PM 3,8, Sweeney T 9 1. Virginia Spine Institute, Reston, VA 2. Department of Orthopaedic Surgery, St. Francis Hospital, Memphis, TN 3. Department of Orthopaedic Surgery, Florida Hospital, Celebration, FL 4. Department of Neurological Surgery, University of Miami Hospital, Miami, FL 5. Department of Neurological Surgery, Baptist Medical Center Jacksonville, Jacksonville, FL 6. Department of Neurological Surgery, Reston Hospital Center, Reston, VA 7. Department of Orthopaedic Surgery, Abington Hospital, Abington, PA 8. Department of Orthopaedic Surgery, Osceola Regional Medical Center, Osceola, FL 9. Department of Orthopaedic Surgery, Doctors Hospital of Sarasota, Sarasota, FL

3 Benefits of Minimally Invasive Surgery (MIS) Clinical and Economic Minimized surgical collateral damage Reduced pain Reduced length of stay and downtime Reduced rate of infection and scarring (skin + soft tissues) Economic ramifications Surgeon Longevity

4 Benefits of Minimally Invasive Surgery (MIS) MIS Traditional Open

5 MIS using 2D fluoro-guided vs. robotic-guided Reports of higher accuracy with robotics vs. freehand Paucity of prospective, controlled data Almost no outcomes data

6 Objectives Adults undergoing short lumbar fusions via MIS technique Compare Robotic-guided versus fluoro-guided (freehand) Assess differences in: Surgical complication rates New neuro deficits Implant-related durotomy Infection requiring return to surgery Hardware failure requiring removal Vertebral body fracture requiring revision Intra-operative radiation exposure

7 Surgical Technique - Robotic Arm 1. Pre-operative planning on CT 2. Attachment of bone-mounted platform 3. Automatic 3D registration 2 fluoros (AP + oblique)

8 Surgical Technique Fluoro Arm 1. One of two fluoro images in OR 2. Guide needles / wires into pedicles

9 Results Robotic arm (n=287) Fluoro arm (n=92) Mean STD Mean STD P Value* Age Gender (F) 62.0% 57.4% BMI <0.001 Charlson Comorbidity Index Total Skin-to-Skin (minutes) Skin-to-Skin per screw Number executed screws <0.001 Fluoro instrumentation (seconds) <0.001 Fluoro instrumentation per screw < % Fluoro total case <0.001 *T-test or Fisher 9

10 Cox Regression: Fluoro vs. Robot Significant Reduction in Complications and Revisions At 1 year Robot-Guided Fluoro-Guided Complications 5.9% (17) 27.2% (25) Revisions 1.4% (4) 4.3% (4) Logistic (Cox) Regression - 1 yr 95% Confidence Interval P value Relative Risk Lower Upper Complications (Fluoro vs. Robot) < BMI Logistic (Cox) Regression - 1 yr 95% Confidence Interval P value Relative Risk Lower Upper Revisions (Fluoro vs. Robot) BMI

11 % Complication Free Kaplan-Meier Curve Complication Free Survival Robotic-guided p<0.001 Fluoro-guided Guided Fluoro- Robotic- Guided Days Proportion Proportion 90 79% 98% % 95% Days 11

12 Conclusions Significantly fewer complications in robotic arm Compared to fluoro-guided, robotic-guided surgeries were at 5.3 times LOWER risk for a complication Significantly fewer revisions in robotic arm Compared to fluoro-guided, robotic-guided surgeries were at 7.1 times LOWER risk for a revision 78% less fluoro time/screw in robotic arm Caveats: Interim report only 92 control patients Only 2 surgeons in control arm 6-month average follow-up High event rate in fluoro-guided arm

13 Explaining Reduction in Complications and Revisions Mazor Core Clinical Value Beyond Instrumentation Accuracy Surgical Planning Suite Anatomy Recognition Engine Patient Connection Platform Cross Modality Registration

14 Explaining Reduction in Complications and Revisions Surgical Planning Suite BEFORE SURGERY Optimization of implant size and trajectory to anatomy Increases surgeon familiarity with anatomy/fewer intra-op surprises Accounts for anatomic variables / deficiencies

15 Example of Value of Pre-op Planning Screw Cadence Facilitates Rod Placement

16 Explaining Reduction in Complications and Revisions Anatomy Recognition Engine BEFORE SURGERY Recognizes critical anatomy base on advanced algorithms Assists in surgical planning Accounts for anatomic variables / deficiancies

17 Explaining Reduction in Complications and Revisions Patient Connection Platform During Surgery Rigidly fix the robotic system to the patient during surgery - PRECISION Maintains patient-machine unity during the operation - ACCURACY

18 Explaining Reduction in Complications and Revisions Cross-modality Registration During Surgery Matches images of different types Each separate vertebra is registered independently

19 Explaining Reduction in Complications and Revisions Cross-modality Registration During Surgery Matches images of different types Each separate vertebra is registered independently???

20 Explaining Reduction in Complications and Revisions Cross-modality Registration During Surgery Matches images of different types Each separate vertebra is registered independently

21 Translating Reduced Complications and Revisions to $ What does a complication cost? What does a revision cost? How does Mazor Core impact health economics? 21

22 What Does a Complication Cost? Wide Range of Reports in Literature Complex question depends on: Type of complication (e.g. medical, surgical, mechanical) Severity / Duration / Permanency Cost to patient, to surgeon, to society, to hospital, to healthcare system. NOT well defined or understood 22

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27 Cost of Surgical Site Infections (SSI): $15-29, patients (5.6%) experienced an SSI with a mean direct cost of $15,817 per SSI. McGirt et al. J Neurosurg Spine 2011;14: The mean hospital cost associated with the treatment of SSI following TLIF was $29,110 * Parker et al. Minim Invasive Neurosurg. 2011;54(1):33-7 *Based on 6 cases 27

28 What does a complication cost? Complex question depends on: Type of complication (e.g. medical, surgical, mechanical) Severity 28

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30 Hellsten et al.: Cost of Complications by Severity Adverse Event (AE): any event caused by medical or surgical management and not by underlying disease process or injury, which leads to patient harm or requires additional monitoring or treatment. Adverse Event (AE) severity grades 1. Results in no or minimal treatment E.g., urinary tract infection 2. Requires treatment 6 months E.g., acute postoperative wound infection 3. Requires treatment >6 months E.g., significant nerve root injury or myocardial infarction 4. Death 30

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32 Ong et al., Neurosurgical Focus 2014 N = 1,672 Average age = 71.4 years 3 months 1 year 2 years Revisions 10.9% 13.3% 16.9% Readmissions for complications 11.1% 17.5% 24.9% Average Medicare payment $36,230 ± $17,020 $46,840 ± $31,350 $61,610 ± $46, % of patients had either undergone a reoperation and/or received an epidural injection by 2 years postoperatively. 32

33 What Does a Complication Cost? Wide Range of Reports in Literature Hellsten et al.: $4, ,000 (Canadian dollars) Culler et al.: $5,500 30,000 (Medicare costs) Use Culler s $9,000 average 33

34 What does a revision cost?

35 Modelling Mazor Core impact on health economics Assumptions 100 cases per year, per surgeon Change from Fluoro-guided MIS cases to Mazor Core MIS Complication rate of 27% in first year post-op (MIS ReFRESH) Revision rate of 4% in first year post-op (MIS ReFRESH) Cost of a complication = $9,000* (Culler et al. 2016) Cost of a revision = $28,000* (Adogwa et al. 2013) * Based on Medicare costs 35

36 How does Mazor Core impact health economics? If a surgeon changes 100 Fluoro-guided MIS cases to Mazor Core MIS per year: Event type Baseline Relative Anticipated Reduction in Cost of Reduced number of Risk* number of number of event** costs events* events* events* Complications $9K $200K $198K Revisions $28K $84K Total speculated savings /100 surgeries/year $282K *Based on MIS ReFRESH data **Based on Medicare costs (From Culler 2013 & Adogwa 2016) 36

37 mazorrobotics.com 37