The 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 clinical outcome in a controlled trial — “it was a very easy next step to take,” Dr. Wright said.
i-FACTOR Bone Graft was also compelling to Dr. Wright because of how it worked. Combining an osteogenic cell binding peptide (P-15) with a proven carrier to promote bone growth struck him as “a powerful intellectual idea,” free of the safety concerns linked to other growth-factor products. Its unique mechanism of action attracts osteogenic cells in the surrounding tissues, which then attach via cellular surface receptor integrins to the P-15 Peptide, similar to a lock and key. The mechanical attachment activates (unlocks) multiple molecular processes that drive bone formation.
Comparing fusion rates, safety The kind of evidence Cerapedics furnished for i-FACTOR Bone Graft isn’t easy to obtain. In the absence of high-level regulatory requirements around bone graft substitutes, most manufacturers don’t go beyond demonstrating safety in a lab environment with animal long bone, Dr. Deol and Dr. Wright said. “There’s not a lot of products out there [that] have this level of data. That’s why I chose Cerapedics; I think that’s the strength of the product,” Dr. Wright said.
Cerapedics followed a stringent investigational device exemption pathway to make i-FACTOR Bone Graft the only other drug-device combination in the same regulatory class as BMP — which the FDA issued a public health warning against its use in the cervical spine, after surgeons reported complications of respiratory distress, reintubation and death in anterior cervical spine cases.
A fair comparison to other bone graft substitutes, however, isn’t so simple, considering the wide variation in mechanisms of action, levels of approval, side effect profiles and more. To address the lack of clarity as to how the devices stack up against one another, in January 2019, the International Society for the Advancement of Spine Surgery proposed six major categorizations of bone graft substitutes: nonstructural allograft, demineralized bone grafts, cellular allografts, synthetic bone grafts, autologous cellular grafts, and Class III drug-device combination products.
“Bone grafting is an essential part of spinal surgery and an ever-evolving science,” ISASS said. “With each new advance, one needs to understand the characteristics of the material, its mechanism of action, the regulatory pathway by which it came to market, and the preclinical and human clinical evidence available on which to base a clinical use decision.”
Landing in the Class III grouping further underscored i-FACTOR Bone Graft’s advantages, according to Dr. Wright. According to Dr. Wright, i-FACTOR has a well-established safety profile based on Level 1 data. “If you really believe that human spine data is the most important criterion for selecting a spine product … [i-FACTOR Bone Graft] is the only product that meets that criteria with an outstanding safety record,” he said.
The claims hold up in practice
In the 325 cases where Dr. Wright has used i-FACTOR Bone Graft, two benefits have stood out to him the most. “One, it works,” he said. “The fusion rates are better than I have seen previously with just a synthetic substitute. Two, the safety profile is absolutely exemplary. I haven’t had a single complication of swelling, unintended bone growth or any other complication with i-FACTOR Bone Graft.”
Due to these results — and despite countless pitches from other vendors — Dr. Wright has finally reached a point where he’s not on the hunt for any other products or the “next
generation.”
Moreover, he said, i-FACTOR Bone Graft is a viable option for outpatient facilities where ACDF procedures are increasingly performed. Whereas some bone graft substitutes have to be harvested, soaked or otherwise prepared, i-FACTOR Bone Graft takes no time to set up.
“For ease-of-use for that ASC, to do those rapid, efficient cases, it hits all the boxes,” Dr. Wright said. Despite Cerapedics’ investment in the expensive IDE pathway, i-FACTOR Bone Graft provides a lower-cost alternative to growth factors. More importantly, the product’s good fusion rates help curtail future costs — which is especially important for facilities participating in bundled payment contracts.
“The largest economic impact would be having to redo a fusion,” Dr. Deol said. “Downstream, if that inexpensive bone graft doesn’t ultimately work, then you just doubled the cost.”
With Advisory Board projecting that U.S. healthcare spending will surpass $4 trillion in 2020 — and climb to more than $6 trillion by 2028 — managing costs is just one aspect of a surgeon’s responsibility, but it’s an increasingly pressing one. If such massive figures can be boiled down to one imperative, it’s this: identifying the right setting, product and clinical approach for every patient.
“We have an obligation, as users or surgeons, to help the healthcare systems decide which products should be paid for, and which are maybe not worth the amount that’s been charged,” Dr. Wright said. “Even though those other products don’t have the same proven efficacy and safety, i-FACTOR Bone Graft has that — and is economically more suitable for an ASC setting.”
This article is sponsored by Cerapedics.