Mi-Eye device for in-office arthroscopy Results of a feasibility Study

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1 Mi-Eye device for in-office arthroscopy Results of a feasibility Study Sam Akhavan, MD Director, Orthopaedic Sports Medicine Fellowship Director of Orthopaedic Research Allegheny Sports Medicine Assistant Professor, Temple University Team Physician, USA Rugby Team Physician, Pittsburgh Pirates Team Physician, Pittsburgh Riverhounds Team Physician, Pittsburgh Harlequins

2 Disclosure VITAL grant Highmark Financial Feasibility of the Mi-Eye device for in office use in 1. Diagnosis of Meniscal Tears» Closed 2. Determination of Uni-Compartmental vs Total Knee Arthroplasty» Ongoing

3 Background MiEye Device designed for in-office arthroscopy Retractable needle 0 degree scope Local anesthesia Performed dry with flush Saline Anesthesic

4 Potential advantage Background Quick, same-day, in-office diagnosis Save cost/time associated with an MRI Quicker time-to-surgery Quicker return to every day activity

5 Background Dermegian et al AJO 2018 Demonstrated good success in diagnosis 106 patients All with MRI diagnosis of MMT Correlated findings with Mi EYE in operating room at time of surgery» PATIENT ASLEEP 92% sensitive and 100% specific in diagnosis

6 Background Proposed VITAL grant Determine the feasibility of use Accuracy of diagnosis Patient tolerance in an office setting Financial Viability of use Direct Comparison with MRI» Is it worth reimbursement?

7 Proposed Study Determine Feasibility in two clinical situation 1. Diagnosis of meniscal tears (Quality Improvement) 50 patients proposed Clinical diagnosis of possible meniscal tear Mi Eye performed in office» If definitive diagnosis made» No MRI Surgery» If diagnosis questionable or negative» MRI performed» If Meniscus torn Surgery

8 Proposed Study Determine Feasibility in two clinical situation 2. Determination of need for UKA vs TKA (RESEARCH) 50 patients proposed X-ray: Potential UKA candidate» Patient Consented for study Mi-Eye performed in the office» Determination made of UKA vs TKA» Amount of degeneration of non-involved compartments

9 Proposed Study Determine Feasibility in two clinical situation 2. Determination of need for UKA vs TKA (RESEARCH) 50 patients proposed MRI performed in all patients» Correlation with Mi-EYE findings Surgery based on surgeon s determinations» Final correlation made at time of surgery

10 Proposed Meniscus Study Financial Viability of use Would Mi-EYE device be Financially Viable? Cost of Individual modalities (*Research Costs) Mi-Eye Device: ~$300*» * Actual device cost $400-$500 In-Office Arthroscopy charge: ~$500 MRI: ~$850 Office visit: ~$150

11 Meniscus Study Financial Viability of use Expected Cost SAVINGS Cost Comparison If Only MRI obtained» Expected Cost: ~$1000/ patient If only Mi-Eye obtained» Expected Cost: ~$800/ patient Mi-Eye would result in ~20% savings» $10,000 for study

12 Results of Study Meniscal Study

13 Meniscal Study 11 patients recruited In-Office arthroscopy performed and completed in all 10 same day 1 separate day

14 Definitive diagnosis Meniscal Study Meniscal tear diagnosed in 4 patients (39%) NO MRI Patient #1 Patient #2 Patient #3

15 Definitive diagnosis Meniscal Study Meniscal tear diagnosed in 4 patients (39%) Surgery All had correlation of the tear found with Mi-EYE device

16 Definitive diagnosis Meniscal Study Meniscal tear diagnosed in 4 patients (39%) Surgery 2 out of 4» Significant arthritis seen at the time of surgery» Would not have been good candidates for surgery

17 Questionable diagnosis Meniscal Study 6 out of 11 patients had a questionable diagnosis MRI Meniscal tear in 4 out of 6 4 out of 6 had surgery 3 patients Could not tolerate the procedure and had to stop 2 refused further treatment

18 Meniscal Study Negative Diagnosis One patient with a negative diagnosis on mi-eye MRI Obtained Undersurface tear of the meniscus» Not identified on Mi-Eye due to inability to lift meniscus

19 Meniscus study Patient Tolerance Average rating 5.6 (Range 2-9) Patient s willingness to under go again Average Rating 6.5 (Range 1-10) Patient s willingness to recommend Average Rating 6.8 (Range 1-10) Other Two patients left physician due to intolerance 3 patients required aspiration of knee following procedure

20 Meniscus Study Correlation with MRI In Positive Mi-Eye 100% correlation of meniscus tear to tear seen on Mi-Eye Did not pick up other pathology well Degree of other OA in other compartments» Patient s intolerance limited ability to check other compartments In Negative Mi-Eye (N=1) Did not correlate with MRI

21 Meniscus Study Financial Viability of use Expect Cost SAVINGS Cost Comparison If Only MRI obtained» Expected Cost: ~$1000/ patient If only Mi-Eye obtained» Expected Cost: ~$800/ patient Mi-Eye would result in ~20% savings» $10,000 for study

22 Meniscus Study Financial Viability of use Within numbers suggested for the study Mi-Eye was not financially viable After 11 Patients 4 patients: Mi-EYE correctly diagnosed meniscus tear» $200 Savings/Patient =$800 Savings 6 patients: Incurred both costs» Extra $800/patients = Extra $4800 One Innacurate diagnosis:incurred both cost (Appropriately)» Extra $800 After 11 patients Mi-Eye increased cost by $4800 over MRI alone» 48% Increase cost

23 Meniscus Study Financial Viability of use Within numbers suggested for the study Mi-Eye was not financially viable 40% increase in cost to date To be equivalent with an MRI 36 of next 40 patients would need positive diagnosis with Mi- Eye If all 40 patients did not require MRI Study would result in $80 saving per patient» 8%

24 Discussion Dermegian et al AJO 2018 Demonstrated good success in diagnosis 106 patients All with MRI diagnosis of MMT Correlated findings with Mi EYE in operating room at time of surgery Study BIAS Done in OR, in patients already asleep Done with diagnosis already established (MRI done preop) Current study did not know diagnosis until after Mi-EYE Live patients in clinic While procedure well tolerated by some Poorly tolerated by 4/11 patients

25 Conclusion Within the current study Mi-EYE was not financially viable Increased cost by 40% Compared to MRI Diagnosis of meniscal tears in office Study closed early due to failure of primary objective Excellent + predictive value If meniscal tear seen, will be present at surgery?poor predictive value (N=1) False seen In 55% of cases, diagnosis was uncertain Required an MRI Affects cost saving of device

26 Conclusions Potential is present Patients who are unable to get an MRI Prevent radiation of CT scan Injections Intra-articular At particular structure

27 Thank You