Becker's Spine Review

17 Executive Briefing Sponsored by: T he number of surgical cases performed in the ASC has steadily risen over the past 10-plus years, and spine care is no exception to the trend, according to data from L.E.K. Consulting. In 2015, the same year CMS added nine new codes for spine surgery to the ASC-payable list, 40 percent of outpatient spine procedures were performed in an ASC. In 2017, L.E.K. Consulting reported half of outpatient spine cases would be performed in the ASC by 2020. That projection was made before CMS dropped several additional spine codes from the inpatient-only list, and before the COVID-19 pandemic stoked concerns about infection risks at inpatient facilities. Now, several leading spine surgeons expect outpatient settings to become even more appealing amid apprehension about long hospital stays. "COVID has really shone a light on some of this," said Gurvinder Deol, MD, an orthopedic spine surgeon and medical director at Wake Orthopaedics in Raleigh, N.C. "People generally seem to think, 'I'd much rather stay away from a hospital, and I'm much safer in a surgery center.'" As migration to outpatient alternatives continues — and even accelerates, to accommodate anxious patients — spine surgeons will be called to determine which protocols, clinical methods and devices will set them up for success. The outpatient framework Spine surgeons at the forefront of outpatient migration have developed a playbook for other specialists considering the move. These surgeons and their organizations should focus on selecting the appropriate case types and patients. According to Dr. Deol, whose surgery center has been offering anterior cervical discectomy and fusion for many years, minimally invasive lumbar fusions and cervical fusions are the primary cases migrating to outpatient spaces. More invasive multi-level reconstructions, on the other hand, are staying in the hospital. Also better served by inpatient facilities are patients with risk factors such as cardiac issues or obesity, said Neill Wright, MD, a St. Louis-based neurosurgeon. He explained that the amount of pain that a surgery entails can influence the proper care setting and whether a surgeon should maintain access to additional resources during a case. Posterior cervical or open lumbar approaches, which involve more muscle retraction, by extension involve more pain. Additionally, with anterior cervical discectomy and fusion, the historical standard is using bone from the patient's iliac crest, which can cause significant discomfort. "If we're going to do the ACDF in an outpatient [center], we're really moving more toward substitutes for that historical standard of autograft to allow for faster surgery and faster recovery," Dr. Wright said. Finding an evidence-based alternative The St. Louis-based neurosurgeon isn't alone in recognizing that the increasing prevalence of spine cases in outpatient settings requires a corresponding change in clinical approach. An entire industry around spinal bone grafting has sprung up to help surgeons decrease patients' pain, and to in turn shorten hospital stays, lower medical costs and improve healthcare efficiencies. The need for such solutions spurred rapid commercial growth of demineralized bone matrix, or allograft bone where the inorganic mineral has been removed to expose cell-differentiating growth factors. The market for these products was valued at $620 million in 2018, with an anticipated compound annual growth rate of 5.4 percent from 2019-25, according to The Market Reports. Although there are hundreds on the market, "the problem with DBMs was that there wasn't a lot of clinical data to substantiate using them," Dr. Deol said. Plus, in practice, DBMs didn't facilitate the kind of healing he wanted to see, which elevated the risk of non-unions and subsequent reoperations. A group of growth factors known as bone morphogenetic proteins then came along, and they indeed delivered a powerful method for helping bone fuse and heal, Dr. Deol said. But as with many innovations, there were downsides: namely, the high price tag and the inflammatory side effects such as neck swelling, swallowing trouble and hematoma when used in the cervical spine. These issues put surgeons like Dr. Deol back at square one, using DBMs that largely relied on retrospective cohort studies. Like Dr. Deol, Dr. Wright wanted to veer away from using allograft for ACDF after a nationwide product recall in 2005. He had to notify dozens of patients they'd been potentially exposed to a communicable disease. "I did not want to use a human-sourced bone graft from that point forward," he said. "I moved to synthetics, which were the main option at the time." Though he was satisfied with the synthetic bone graft he historically used, it didn't have extensive human data or prospective studies to back it up. So, when Cerapedics came to him with exactly that kind of robust data — showing i-FACTOR®'s Bone Graft's superiority to autograft in overall A bone graft substitute that works in outpatients — with the data to prove it

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