CENTER VALLEY, Pa., April 12, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the publication of “Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up” in Spine.1 This is another significant milestone in Aesculap’s commitment to enhancing patient access to lumbar total disc replacement as a gold standard of care.
The post-hoc analysis, which used all available radiographic data from the activL® Artificial Disc Investigative Device Exemption (IDE) study, examined the rate at which radiographic adjacent-level degeneration (ALD) occurred five years following lumbar total disc replacement (LTDR) with either the activL Artificial Disc (Aesculap AG, Tuttlingen, Germany) or the ProDisc-L (Centinel Spine, West Chester, PA) control arm. The authors found an extremely low incidence rate of radiographic adjacent level deterioration at five years (only 9.7% of patients) compared to previous reports of deterioration at levels superior to fusion (28% of patients) and an even lower rate of clinically-significant ALD that resulted in additional surgery (in just 2.29% of patients).
These newly published outcomes from the activL Study show that, in a select patient population, LTDR is more effective at slowing the adjacent segment degenerative cascade than fusion, which is consistent with previously reported LTDR ALD rates from both the U.S. and Europe (9.2%-10.7%).2,3
As part of the analysis, the authors also sought to answer the question of whether patients with asymptomatic x-ray findings of adjacent level degeneration at the time of the index procedure experienced a clinically-relevant progression of this ALD at five years follow-up.
According to author Jack Zigler, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), “Spine surgeons who believe in motion preservation are often frustrated by U.S. payers whose medical policies state that the written reporting of even the smallest trace of anatomic deterioration at an adjacent but clinically-asymptomatic level will exclude their coverage of a lumbar TDR at the symptomatic level. Our analysis found that no patients who exhibited asymptomatic radiographic ALD changes at the time of preoperative assessment required any additional surgery at those levels at five years. In other words, even five years later, the implantation of a LTDR did not accelerate radiographic, non-pain-generating ALD to the point of requiring surgical treatment. This data shows how important it is to educate health plan decision makers about the medical necessity of allowing treatment with LTDR to treat single-level chronic degenerative disc disease.”
While the overall LTDR five-year rate of ALD was 9.7%, there was a statistically-significant difference in ALD rates between patient groups. The activL patients experienced an 8.8% ALD progression at five years, while ProDisc-L patients experienced a 19% progression (p=0.05).4 The authors hypothesized that these differences in progression rates between earlier versus later generation ProDisc-L discs may be related to the protective effect of improved of range of motion on ALD. The activL Disc, which has been shown to have a higher rate of motion preservation at five years than ProDisc-L (6.2° vs. 4.0°, p=0.004)5 also had a lower rate of ALD.
The activL Artificial Disc and ProDisc-L are currently the only commercially available lumbar artificial disc devices that have undergone the rigor of biomechanical and clinical studies to satisfy the safety and efficacy requirements for Food and Drug Administration approval and the only devices that have been evaluated for ALD rates. The activL Disc was approved in 2015.
In the interest of improving the evidence base for LTDR, Aesculap has sponsored Open Access to this landmark publication. The full text can be found on the Spine website. https://journals.lww.com/spinejournal/Abstract/publishahead/Progression _of_Adjacent_level_
“It is evidence like this that will hopefully move the needle with health plans in favor of a procedure that is less costly in the short- and long-term,” said coauthor Scott Blumenthal, MD (Center for Disc Replacement at Texas Back Institute, Plano, TX), who performed the first lumbar disc replacement eighteen years ago. “It is time we acknowledge the strength of the current evidence base for this life-improving procedure.”
Over the last eighteen months, U.S. commercial payers have begun to adopt coverage of lumbar total disc replacement due largely in part to the availability of long-term evidence such as the data presented in this publication.
Last year, major health care insurance carriers such as Humana, BlueCross BlueShield of Louisiana and Highmark BlueCross BlueShield established positive coverage policies for LTDR. Aesculap offers a patient advocacy platform, the Patient Assistance Line, to patients who are candidates for single-level LTDR with the activL disc to help them overcome commercial payer hurdles for those plans still denying access to this proven procedure.
In 2017, a panel of surgeons at the North American Spine Society Annual Meeting (Orlando, FL) concluded that the evidence now supports that lumbar artificial disc replacement is a standard of care for a subset of degenerative disc disease patients.
The full dataset of five-year safety and efficacy outcomes from the activL Artificial Disc IDE study are currently in submission to Spine.
About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.
- Zigler JE, Blumenthal SL, Guyer RD, Ohnmeiss DD, Patel L. Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up. Spine 2018: published online ahead of print, March 21, 2018.
- Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. Journal of Neurosurgery. Spine 2012;17:504-11.
- Aghayev E, Etter C, Barlocher C, et al. Five-year results of lumbar disc prostheses in the SWISSspine registry.
Eur Spine J 2014;23:2114-26.
- Blumenthal, SL et al. Adjacent Segment Degeneration After Lumbar Total Disc Replacement: 5-Year Results of a Multicenter, Prospective, Randomized Study with Independent Radiographic Assessment. In NASS 32nd Annual Meeting Proceedings NASS, The Spine Journal 17 (2017) S111–S165.
- Yue JJ, Garcia R, Jr. Five-Year Results of a Randomized Controlled Trial for Lumbar Artificial
Discs in Single-Level Degenerative Disc Disease. Spine; in submission.
SOURCE Aesculap Implant Systems, LLC