Bury My Heart at SAS
Wikimedia Commons If a paper falls in the forest, will healthcare providers hear it? Last week a super abundance of Level One clinical papers covering spine technologies and cost data was presented—to a half-empty hall at SAS’s annual meeting in New Orleans. So if researchers present high-level comparative effectiveness, MIS and arthroplasty data will the Centers for Medicare and Medicaid Services (CMS) and the private payers notice?
This was probably the best SAS meeting as measured by the quality of the podium presentations and overall program (thank you Todd Albert and Jeff Goldstein). As a scientific society, SAS solicited, organized and delivered relevant and rigorous data to spine surgeons. As a surgeon society could SAS be winning the battle but losing the overall war?
U.S. surgeons may agree that good scientific evidence exists for arthroplasty or MIS or biologic treatments and that the benefits of these FDA approved technologies substantially outweighs the potential risks. If no payer reimburses it, however, then discussing these technologies with eligible patients is an exercise in either futility or altruism.
It is a testament to the commitment of spine surgeons to improving patient outcome that 650 attended to hear these podium presentations—despite payment issues.
The data (see below) is clearly pointing to improved outcomes with motion preserving implants and MIS procedures. SAS made a concerted effort this year to attack the issue of Level One data for cervical disc arthroplasty, lumbar disc arthroplasty, MIS, biologics and other new technologies and procedures for treating spine disease. They succeeded to an impressive extent.
Ranking the Quality of Evidence
Probably the most widely used system of ranking the quality of clinical evidence is the U.S. Preventative Services Task Force ranking. Here is that ranking:
Level I: Evidence obtained from at least one properly designed randomized controlled trial.
Level II-1: Evidence obtained from well-designed controlled trials without randomization.
Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
What SAS Presented
In a quick-read and summary form, here is are some of the clinical study highlights CMS, FDA, United Healthcare, the Blues, Aetna and Cigna may have missed.
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Abstract: 132: Lumbar Disc Arthroplasty versus Anterior Lumbar Interbody Fusion: Five-year Outcomes for Patients in the Maverick Disc IDE Study M.F. Gornet1, J.K. Burkus2, R.F. Dryer3, J.H. Peloza4 | |
Prospective, Randomized (2:1), controlled, 31 centers. 5-year follow up. | 577 patients |
Conclusions: Consistent with the two-year IDE study outcomes, treatment of single-level lumbar degenerative disease with the MAVERICK Disc resulted in outstanding clinical outcomes at five years after surgery, including Oswestry and SF-36 PCS, resulting in improved physical function, reduced pain, and greater patient satisfaction. | |
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Abstract: 90: 5-year Results of the Prospective, Randomized, Multicenter FDA Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement versus Circumferential Fusion for the Treatment of 2-level Degenerative Disc Disease R. Delamarter1, J.E. Zigler2, R.A. Balderston3, J.M. Spivak4, R.J. Linovitz5, J.F. Zucherman6, J.J. Yue7, T.T. Haider8, S.H. Kitchel9, F.P. Cammisa10, G.O. Danielson, III11, D. Geiger12, R. Watkins13, H. Yuan14, J.E. Sherman15, H.N. Herkowitz16, M.A. Kropf1, J.A. Goldstein4 | |
Prospective, randomized (2:1), 16 centers, 5-year follow up. | 237 patients |
Conclusions: The data shows that significant clinical improvement was achieved and maintained in the ProDisc-L patients out to 60 months; in properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion at two levels by multiple clinical outcomes. | |
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Abstract: 219: Preliminary Observations from a Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating Anular Repair after Lumbar Discectomy A. Bailey1, G. Amundson1, S. Blumenthal2, M. Chedid3, R. Guyer2, J.S. Gerdes4, J. Messer5, S.L. Griffith5 | |
Prospective, randomized (2:1), 34 sites 2.5-year follow up. | 750 patients |
Conclusions: Similar clinical outcomes were noted in the two groups with similar occurrence rates of adverse events. Based on current data available, there was a trend toward a 1.75 times greater risk over time of re-herniation in the control group requiring a second surgery and an overall 57% reduction in the risk of re-herniation with the device. As the number of enrolled patients per surgeon increased, the beneficial treatment effect of annular repair to reduce reoperation due to recurrent herniation increased. | |
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Abstract: 106: 5-year Results of the Prospective, Randomized, Multicenter FDA Investigational Device Exemption ProDisc-C Clinical Trial R.Delamarter1, D. Murrey2, M. Janssen3, J.A. Goldstein4, J. Zigler5, B.K.-B. Tay6, B. Darden II2 | |
Prospective, randomized (1:1), 13 sites 5-year follow up. | 236 patients |
Conclusions: NDI, VAS and SF-36 scores of ProDisc-C patients improved more than those of ACDF patients at five years, though not significantly. There was a greater difference in VAS satisfaction improvement in ProDisc-C compared to ACDF patients was seen. At 24 months, 84.4% of ProDisc-C patients achieved ≥4 degrees of motion or maintained functional motion (relative to baseline) at the operated level, remaining consistent to 60 months. Within 60 months, the number of secondary surgeries differed significantly; 0.2% of ProDisc-C compared to 8.8% of ACDF patients (P = 0.006) needed a re-operation, revision, or supplemental fixation. | |
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Abstract: 74: Prospective, Randomized Study Comparing Cervical Total Disc Replacement to Anterior Cervical Fusion. Lauryssen1, D. Coric2, R.D. Guyer3, C. Gordon4, P. Nunley5, C. Carmody6, T.A. Dimmig7, W. Taylor8, R. Buckley9, J. Donner10, J. Rhee11, P.C. Gerszten12, P.J. Tortolani13, J. Rappaport14, R.Q. Knight15, G. Dix16, K.T. Foley17, F.D. Bitan18, R. Bains19, H.N. Herkowitz | |
Prospective, randomized (1:1), 21 sites 2-year follow up | 269 patients |
Conclusions: Mean blood loss, operative time, and length of hospital stay were not significantly different in the two surgical groups and hospital stays averaged approximately two days in both groups. The mean NDI scores improved significantly in both groups by six-week follow-up and remained improved throughout 24-month follow-up. There were no significant differences between groups at any visit. The VAS pan scores followed a similar pattern, improving significantly in both groups with no significant differences between groups. | |
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Abstract: 107: Prospective, Controlled Results of Patients Treated with Expanded Indications for ProDisc-C M.E. Janssen1, R. Delamarter2 | |
Prospective, randomized, 14 sites, 1 level TDR adjacent to fusion, 2 level TDR and 3 level TDR 2-year follow up | 55 patients |
Conclusions: NDI and SF-36 scores were significantly less compared to pre-surgery scores at all follow-up visits for all indications. Overall neurological success was achieved by about 90% of patients at all time points. VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up time points compared to pre-operative levels for all indication treatments. Radiological evaluation showed no evidence of device migration, device subsidence, or decrease in disc height. Results show that at 24 months post-operatively, greater than 80% of ProDisc-C patients achieved ≥ 4 degrees of motion or maintained motion relative to pre-operative baseline at each operated level. 82% of patients at each time point responded "yes" to having the same surgery again. | |
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Abstract: 352: SECURE-C Cervical Artificial Disc IDE: Two Year Clinical Outcomes J. McConnell1, J. Marzluff2, J. Highsmith2, C.R. Tomaras3, T.J. Morrison3, I. Volcan4, A. Goodrich4, P. Asdourian | |
Prospective, randomized (1:1), 5 sites 2-year follow up | 188 patients |
Conclusions: 188 patients were treated at five sites: 108 patients received the investigational SECURE-C device and 80 received the control ACDF. 143 patients reached two-year follow-up: SECURE-C patients demonstrated significant improvement in average NDI from 51.9 preoperatively to 10.6 at two years, as compared to control patients improving from 54.5 pre-op to 14.9 at two years. Both groups also demonstrated statistically significant improvement in VAS neck and arm pain at two years compared to preoperative values. Differences between NDI and VAS outcomes for SECURE-C and ACDF treatment groups are not statistically significant. At 24-months post-op, patient satisfaction was 92% for the SECURE-C group and 86% for the ACDF group. | |
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Abstract: 504: Cost-effectiveness of Lumbar Total Disc Replacement versus Lumbar Fusion A. Tuschel1, M. Meissl1, M. Ogon1 | |
Methods: Model treatment and associated direct costs (surgery, inpatient stays, outpatient visits, GP and orthopaedic consultations, x-ray, medication, rehabilitation and physiotherapy) over a 18-months time horizon. Outcomes measured by ODI and SF-36 at one-year follow-up and costs. Costs were derived from standard Austrian price lists and from hospital‘s cost unit accounting. | |
Conclusions: Disc arthroplasty patients had outcome-scores at 1.5-year follow-up comparable to fusion but had lower costs than lumbar fusion: Costs per improved ODI-point were €954 in the fusion group and €645 in patients treated with lumbar disc arthroplasty. Costs for one gained SF36-point were €1645 after fusion and €954 after disc arthroplasty. | |
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Abstract: 56: Cost Comparison of Total Disc Replacement vs. Fusion in Patients with Insurance Denial for Disc Replacement D.D. Ohnmeiss1, C.S. Hume1, R.D. Guyer2, J.E. Zigler2, S.L. Blumentha | |
Methods: Eight TDR who were denied insurance coverage and had fusion. These were matched with 8 patients who received TDR re level(s) operated (exact match), date of surgery (< 25 days between matched procedures), and all at performed at the same hospital. Both groups had five single-level cases and three two-level cases. Seven fusions were combined anterior/posterior procedures. Cost data included total billed and total actually received. Costs were further subclassified and compared by category. | |
Conclusions: The total cost billed as well as the categories of hospital room, pharmacy, sterile supplies, operating room, and anesthesia costs were significantly greater for fusion compared to TDR (P< 0.05). There were trends for the total actually paid, intravenous supplies and implants and related supplies to be greater in the fusion group. The only cost significantly greater in the TDR group compared to fusion was radiology services. Costs were similar in the two surgery groups for nonsterile supplies and recovery room. Both the total amount billed and amount actually paid for fusion were approximately 50% greater than TDR. | |
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There were approximately another 200 studies presented including many, many more Level One studies. Please contact SAS for a copy of the meeting abstract book.
