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- Herausgeber: Bentham Science Publishers
- Kategorie: Fachliteratur
- Serie: Contemporary Endoscopic Spine Surgery
- Sprache: Englisch
Contemporary Endoscopic Spine Surgery brings the reader the most up-to-date information on the endoscopy of the spine. Key opinion leaders from around the world have come together to present the clinical evidence behind their competitive endoscopic spinal surgery protocols. Chapters in the series cover a range of aspects of spine surgery including spinal pain generators, preoperative workup with modern independent predictors of favorable clinical outcomes with endoscopy, anesthesia in an outpatient setting, management of complications, and a fresh look at technology advances in a historical context. The reader will have a first-row seat during the illustrative discussions of expanded surgical indications from herniated disc to more complex clinical problems, including stenosis, instability, and deformity in patients with advanced degenerative disease of the human spine. Contemporary Endoscopic Spine Surgery is divided into three volumes: Cervical Spine, Lumbar Spine, and Advanced Technologies to capture an accurate snapshot in time of this fast-moving field. It is intended as a comprehensive go-to reference text for surgeons in graduate residency and postgraduate fellowship training programs and for practicing spine surgeons interested in looking for the scientific foundation for expanding their clinical practice towards endoscopic surgery. This volume (Advanced Technologies) covers the following endoscopic spine surgery topics in 19 detailed chapters: endoscopic intradiscal therapy and foraminoplasty, evidence based medicine in spine surgery, artificial intelligence for spine surgery, postoperative management, transforaminal lumbar endoscopy and associated complications, laser applications in full endoscopy of the spine, high frequency surgery for the treatment of herniated discs, lumbar MRI, cost and maintenance management of endoscopic spine systems, regenerative medicine, interbody fusion, endoscopic intravertebral canal decompression after spinal fracture, treatment of lumbar tuberculosis, treatment of degenerative scoliosis, treatment of thoracic meningioma with spinal canal decompression, and cervical endoscopic unilateral laminotomy for bilateral decompression (CE-ULBD).
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Seitenzahl: 568
Veröffentlichungsjahr: 2002
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PREFACE
Spinal endoscopy is a technology-driven subspecialty of spinal surgery. The increased clinical traction and acceptance of minimally invasive endoscopic spinal surgery techniques result in successful technology transfers from other industries. Image quality in endoscopy is perceived by magnification, depth of field, resolution, color truth, and high image contrast, as well as low distortion and homogeneous illumination up to the edge of the image. The introduction of HD technology in 2005 to the general consumer market forced endoscope manufacturers to develop endoscopes that provided optimized image quality for the HD Video chain. Some of these technological advancements in 2000 coincided with the introduction of the endoscope into transforaminal spinal surgery. Newer clinical indications for endoscopic spine surgery are aimed to replace traditional translaminar surgeries. This expansion of the endoscopic spinal surgery platform is fueled by technology transfers from the space-, military- or consumer sector developments in the area of illumination, image quality, and high-definition video quality. It also hinges on the development of more durable and stress-resistant spinal endoscopes requiring continued expert surgeon input. Illustrating the application of these technological advancements in endoscopic spine surgery is at the heart of the third volume of the Bentham Series entitled “Contemporary Endoscopic Spine Surgery.”
The editors have come together to develop a multi-authored and clinically focused medical monograph entitled Contemporary Endoscopic Spine Surgery: Advanced Technologies to give the reader a most up-to-date snapshot of the current and future technology advances in spinal endoscopy. The publication is intended for Orthopedic Spine & Neurosurgeons interested in treating common painful conditions of the spine with minimally invasive endoscopic techniques. A wide array of highly timely and clinically relevant topics have been assembled for this purpose. They range from the historical review of intradiscal therapies and foraminoplasty techniques, the discussion of the disruptive approach to personalized pain generator-oriented spine care versus population-based evidenced-based treatment strategies in context with modern clinical classification systems, the application of lasers, radiofrequency, and regenerative medicine strategies, the use of artificial intelligence and decision algorithms employed in the interpretation of advanced imaging studies to more accurately identify pain generators and their management with denervation and surgical strategies, the management of postoperative sequelae and complications, the indications for efficacious use of interspinous implants and fusion techniques, to the cost of implementing and maintaining a clinical endoscopic spine care program and advanced endoscopic technique for the most challenging clinical problems.
Future advances in clinical protocols will likely be driven by higher image quality standards that may provide the basis for artificial intelligence applications in image recognition, robotics, integration and automatization of surgical processes. Contemporary Endoscopic Spine Surgery: Adavanced Technologies was written with these trends in mind. The editors hope that the readers will find it an informative knowledge resource they will continue to revert to when implementing a lumbar endoscopic spinal surgery program in their practice setting.
List of Contributors
The History and Future Value of Endoscopic Intradiscal Therapy and Foraminoplasty
Anthony Yeung1,Kai-Uwe Lewandrowski2,3,4Abstract
The utilization of spinal endoscopic surgery techniques is on the rise in routine clinical practice and treating painful annular tears, herniated disc, and spinal stenosis. Over the past ten years, we have witnessed an increasing number of surgeons recognizing spinal endoscopy's value. Many of them had difficulty finding access to adequate training while facing reimbursement and acceptance problems. In this chapter, the authors describe the implementation issues at play that they perceive as relevant in the discussion between the healthcare equation's stakeholders. Included in this chapter on the forward-looking perspective of spinal endoscopy is the first author's involvement in the role and value of laser and electrothermal therapy, which is still pertinent but has evolved with advancements in technology and endoscopes and instrumentation.
INTRODUCTION
Surgeons and surgically trained non-surgeons will advance the future success of endoscopic spinal surgery. The number of endoscopic and minimally invasive spinal surgeries has been predicted to increase the spine surgery market at a compound annual growth rate of 7.57 percent between 2016 and 2020 in North America and Europe alone [1]. The explosion of endoscopic spine surgeries in
Asia has been recently illustrated by analyzing the country of residence of the authors of scholarly articles published in peer-reviewed SCI(E) journals within the last five years [2]. Authors from China, South Korea, the USA, Germany, and Japan have published the vast majority of papers. The most prolific authors came from a few number of well-recognized institutions, including the Wooridul Spine Hospital in Seoul, South Korea, The Tongji University and the Third Military Medical University in China, the University of Witten/Herdecke in Germany, Brown University, The Center For Advanced Spine Care of Southern Arizona, and from the Desert Institute of Spine Care, Phoenix, in the USA. Endoscopic spinal surgery is expected to become more mainstream globally by increasingly augmenting or replacing traditional open spinal surgeries with less aggressive procedures that are less invasive but equally, if not more beneficial to the patient.
The expanding number of indications that surgeons now identify as appropriate for endoscopic treatment of the spine's common degenerative conditions suggest that there is more to it than merely miniaturizing incisions and performing surgery under local anesthesia sedation. The direct visualization of the intradiscal pathology, pathology in the epidural space, and neural elements in the axilla allow for the diagnosis of pain generators that previously have not been visualized and recognized as treatable conditions. Even more relevant is the ability to correlate the pathophysiology of pain with visualized pathoanatomy with the endoscope. Examples include toxic and painful annular tears, epidural adhesions, scar tissue, and inflammatory granulomas. Other pain inducing patho-anatomy include superior foraminal ligament and facet impingement, facet joint cysts and impaction, tethering of the nerve roots to the pars interarticularis, the pedicles or the intertransverse membrane. Inflammatory irritation of the annulus, posterior longitudinal ligament, lateral and shoulder osteophytes (Tables 1 and 2), and a myriad of endoscopically visualized intradiscal conditions ranging from fissuring, delamination of the endplates, to gaseous degeneration of the intervertebral disc leaving it hollow, and void of any functional tissues round out the myriad of patho-anatomy documented with the endoscope (Fig. 1) [3].
With current diagnostic tools, including radiographs, computed tomography (CT), and magnetic resonance imaging (MRI), these conditions are difficult to establish before surgery. These pain generators may be insufficiently imaged with routine preoperative studies or just not included in imaging reporting by the radiologist, hence, leaving a large portion of patients that by new measures are considered either “too young,” or “too old” or having too much surgical morbidity without surgical treatment of their painful conditions. However, it will be in this grey area where highly qualified and experienced providers will use the endoscope to correlate the pathophysiology of the patients' symptoms with intraoperatively visualized pathoanatomy that can be decompressed, ablated, thermally modulated, and irrigated to provide pain relief from chemical as well as mechanical irritation and structural defects.
Fig. (1)) Illustration of 9 common, and 19 endoscopically documented painful conditions and their anatomic locations in the foramen.This endoscopic surgical platform's success depends on the practitioner's cumulative clinical and intraoperative experiences, validated by the direct correlation of a responsive patient under modern monitored anesthesia care (MAC), and recorded response to the endoscopic surgery [4]. Rather than relying on a surgical plan that is deducted mainly from preoperative imaging studies, which by definition limit the list of plausible pain generators virtually only to instability and neural impingement, the clinical approach to employing spinal endoscopy relies on the personalized and individualized diagnostic workup of each patient with much greater attention to detail of the relevant patho-anatomy and its pathophysiological role in the patient's pain syndrome.
Invariably, this not only leads to less aggressive but also to earlier, staged, interventions. Rather than waiting for the advanced clinical end-stage of the degenerative condition to develop, treating pain generators in the early stages of the degeneration of the lumbar motion segment, in the authors’ opinion, will be the largest area of expansion of endoscopic spinal surgery. The senior author with 29 years of experience, and early clinical involvement in chymopapain and laser clinical research, has demonstrated his approach to identifying pain generators intraoperatively by interactive feedback with the patient along with surgical case examples with recorded audio and video feedback available for viewing on youtube.com and his website (www.sciatica.com). The viewer will follow the authors' editorialized opinions on performing endoscopic surgery on the sedated yet awake patient's relevant pain generators in these videos. In this chapter, a historical review on the evolution and value of the various intradiscal therapies, including laser and electrothermal technologies and foraminoplasty, is provided as experienced first-hand by the first author.
THE POLITICS, BUSINESS, AND REIMBURSEMENT FOR ENDOSCOPIC SPINE SURGERY
Internationally, spinal endoscopy is already accepted and practiced extensively in Asia. However, its recognition as a mainstream method to treat common degenerative conditions of the spine lags in North America and Europe. A recent opinion survey amongst 430 spine surgeons the world over corroborated this statement [5-7]. Surgeons in Asia reported fewer hurdles to implementation, less concern with the cost of capital equipment and disposables, fewer problems with health insurance authorization, and fewer problems with rejection by the medical establishment in their respective countries [8]. Surgeons in North America, and Europe on the other hand, were not only by far fewer, but they were also chiefly concerned with low reimbursement and fear of being called out for operating outside the norms established by the coverage and treatment guidelines of their national professional societies, the health insurance industry, and local governing bodies [5, 7, 8]. Some of these concerns were also echoed by surgeons from Latin America who reported better overall acceptance of endoscopic spinal surgery into the mainstream than surgeons from North America and Europe [5]. These responding surgeons from the Americas and Europe were keenly aware of their advanced endoscopic spinal surgery program colliding with established treatment guidelines by challenging the necessity of aggressive and extensive open spinal surgeries which they are seeking to replace with small targeted endoscopic interventions. This dynamic creates a conflict of opinions and conflict between the stakeholders of this ongoing debate. They represent various economic and political agendas in the healthcare industry as a whole. It is the makeup of the politics of medicine. The high responsiveness of surgeons to the surveys cited herein clearly shows how keenly aware spine surgeons seeking to innovate their clinical practice are of this debate [5-8].
The three elephants in the room silently partaking in this ongoing discussion whether spinal endoscopy is “too experimental, too costly, and unproven” on the one hand, or “cutting edge, cost saver, and advanced medicine” on the other hand are the stakeholders in the health insurance, hospital, and medical device industry. All three may have a competing economic interest in the revenue cycle of medicine, which ultimately impacts the surgeon innovator's ability to justify the cost of implementation. The burden of proof of its economic viability is typically placed on the practitioner in the context of clinical superiority. While it is easy to understand that medical device companies are looking to grow sales with innovative products and directly or indirectly contribute to the rise in healthcare costs, even if the individual products and services may help outcomes and make accepted procedures achieve better outcomes, health insurance companies are held to a higher moral standard as they are expected to operate as a real business but should do it to benefit their insured in an economically viable manner. Therefore, most health insurance companies have formulated extensive medical coverage guidelines and implemented a vigorous preauthorization of service bureaucracy to facilitate appropriate utilization without abuse. These coverage guidelines are typically based on a comprehensive review of the evidence-based literature, which is often graded by its quality as level I – high-quality randomized trial or prospective study (RCT), level II - lesser quality RCT; prospective comparative study; retrospective study; untreated controls from an RCT; lesser quality prospective study; development of diagnostic criteria on consecutive patients; sensible costs and alternatives and meta-analysis, level III - case-control study (therapeutic and prognostic studies); retrospective comparative study, level IV - Case series; case-control study (diagnostic studies); poor reference standard; analyses with no sensitivity analyses, and level V – personal opinion. By definition, evidence-based medicine analyzes the effectiveness of various protocols in managing disease in a population as a whole. Simultaneously, such an approach to determine the medical necessity of an intervention or surgery of the spine is at odds with the personalized approach to spine care with endoscopy. All accepted levels of evidence begin with level 5 expertise. Therefore, the evidence-based medicine approach, which may be appropriate for determining drug-based therapies' effectiveness, seems rather ill-fitted for modern personalized spine care that does not fit the double-blind level 1 and 2 trials criteria. Furthermore, contrary to its intent, it may increase the cost by mandating rigid sequential care protocols with ineffective services before definitive care with endoscopic surgery is deemed indicated. To this author's surprise, this dilemma was even recognized by the SPORT trial authors who recently accepted the need for more patient-specific, individualized tools for presenting clinical evidence on treatment outcomes [9] after their initial studies suffered from a high percentage of patient crossover [10, 11].
It is evident that the current debate suffers from intersectional barriers between the stakeholders with business illiteracy on the surgeons' side, and a lag of medical accolades on the commercial and regulatory side where the parties involved simply do not have sufficient knowledge of each other's expertise to the extent that innovation could be vetted more expeditiously and implemented if proven safe, efficacious, and cost-effective regardless of the health care market dynamics in an individual country. This dynamic has played out in Asia, where private reimbursement is not as critical, and there is government-provided health care. Acceptance of spinal endoscopy into the mainstream in North America and Europe will depend on how this debate will be steered by payer systems and by the traditional open surgery-oriented spine surgeons skeptical of percutaneous and endoscopic procedures that they are not trained to perform and are competing with their successful traditional techniques [12].
It is clear though that the U.S. Department of Health and Human Services via its Centers for Medicare & Medicaid Services (CMS) is incentivizing institutions and surgeons alike to move simple spinal decompressions from being performed as an inpatient to an outpatient ambulatory surgery center (ASC) to provide more cost-effective, high-value spine care. New current procedural terminology (CPT) codes have been allowed to perform many spinal surgeries in ASC [13]. In 2017, The American Medical Association (AMA) for the first time included a new spinal endoscopy CPT code (62380) [14]. The new code covers endoscopic decompression of the spinal cord, nerve root, including laminotomy, partial facetectomy, foraminotomy, discectomy, and excision of a herniated intervertebral disc, one lumbar interspace [15]. However, CMS did not assign a final value to CPT 62380 in its final 2017 ruling instead of assigning contractor pricing. Effectively, this means that each Medicare Administrative Contractor (MAC) will set reimbursement determination [16]. As a result, it remains to be seen how this endoscopic CPT role plays out in each healthcare market with sufficient reimbursement for the facility- and professional fee being of concern for ASCs and surgeons. Ultimately, spinal endoscopy is intended to replace more costly open inpatient spinal surgeries. However, financial disincentives may come to bear mainly if the actual reimbursement of endoscopic procedures is lower than the procedures it replaces, and if capital equipment and disposable cost are insufficiently covered. The authors expect that this transition from open to endoscopic procedures will not be swift. Slow embracement of spinal endoscopy by mainstream spinal surgeons in North America and Europe coupled with low reimbursement and lack of formal inclusion into coverage and treatment guidelines will leave the field by default to a smaller group of endoscopic surgeons and multidisciplinary pain management and rehabilitation physicians who do not have nor accept the need for additional surgery training. The latter is simply needed and required for the procedure to be mainstream. Endoscopic spinal surgeons must demonstrate that the procedures they adopt remain safe, efficient, and practical or more effective than the current contemporary techniques they are trying to replace [17].
THE REASON WHY ENDOSCOPIC SPINE SURGERY SHOULD REQUIRE HIGH STANDARDS
U.S. regulatory approval is not needed for physicians to perform endoscopic spinal surgery since physicians are licensed and are overseen by their medical boards, and not the Food and Drug Administration (FDA) who does not regulate the practice of medicine. Credentialing of core privileges at hospitals and surgery centers typically requires that the surgeon presents evidence of having had training in the surgeries she or he is intending to perform. Examples of this include kyphoplasty and fusion surgeries. Kyphoplasty became popular in the United States 20 years ago and gained significant traction 15 years ago. Fusion surgeries have seen a similar rise in utilization within the same time frame. While it is understandable that hospitals require training in more complex and riskier fusion surgeries, having to show evidence of training in kyphoplasty as a by far less aggressive procedure may not seem evident to surgeons. Spinal endoscopy may fall in a similar category where surgery through a small incision may be considered as a smaller, less risky surgery that can be carried out by nearly anyone who had some postgraduate residency or fellowship training in neuro- or orthopedic spinal surgery. This is not the case in endoscopic spine surgery. The casual approach to training future expert surgeons capable of executing endoscopic spinal surgeries in a highly reliable and consistent manner is inappropriate. Many KOLs have published results of their clinical series after many years of trial and error practice to hone in their skills in mastering this demanding procedure that by many is recognized to have a steep learning curve and may not be for everyone [17]. Integration of formal spinal endoscopy training into the core curriculum of neurosurgical and orthopedic residency program should be not just considered but required, and will most likely remain part of the debate.
Besides the complex technical aspects of spinal endoscopy, there is the issue of understanding its indications and surgical principles of best clinical practice. There is no doubt that spinal endoscopy is not merely replacing existing surgeries and their standard clinical indications to the authors. The intradiscal and epiduroscopic visualization during spinal endoscopy has and will continue to recognize pain generators either hitherto unknown or ignored because of the lack of adequate diagnostic and treatment protocols (Fig. 2) [17]. In other words, it is a new world distinctly different from traditional spine surgery that is simply focused on relieving neural element compression in consideration of instability and deformity; a new world that requires any practitioner embarking on the spinal endoscopy voyage to think differently, and to become familiar with the in's and out's of a successful endoscopic spine practice. At its core, a successful endoscopic spine practice requires close investigative interaction with the patient to treat the pain generator causing the disability [17].
Fig. (2))a) Epidurogram of paracentral HNP demonstrating blockage of the traversing nerve b) epidural gram and incidental discogram. The leakage of contrast identifies and extruded HNP. A therapeutic injection providing good relief provides a good prognosis for endoscopic decompression.In that sense, the endoscopic spine technology's successful application employs new concepts that are “disruptive” to traditional degenerative spine surgery concepts. In the authors’ opinion, open surgery for many of the degenerative conditions of the spine are appropriate, but has the propensity to be more surgically aggressive than required and may be associated with greater collateral damage from associated muscle de-innervation and the destabilizing effects of the decompression. Ultimately, postoperative adjacent segment disease and epidural fibrosis may add to additional disability and more follow-up surgeries, which in the patients' minds seems outdated and creates apprehensions before spine surgery [18]. The patients demand us to do better by modernizing the approach to managing their sciatica-type low back- and leg pain or their cervical and thoracic pain syndromes. Patient demand, coupled with a push by government and payers to develop more reliable, less complicated, and “less costly” ways to manage the socioeconomic impact of spine-related pain syndrome. Pain management, however, is NOT a minimally invasive subspecialty of surgical pain care.
In current practice, authorization for health insurance coverage of surgical indications is primarily dependent on interpreting the CT and MRI imaging by the reading radiologist [19]. When the radiologist's report “on paper” does not support the treatment requested by the surgeon, denial for a preauthorization insurance company for surgery is often the consequence. This disconnect between these traditional protocols run by payers and governmental review boards and protocols used by the “disruptive” spine surgeon has the potential to lead to significant undertreatment. This has recently been corroborated in a study that found that up to 30% of patients who underwent successful endoscopic decompression for a lumbar herniated disc and spinal stenosis were classified as MRI false negative [19]. These MRI false-negative patients underwent successful surgery with a resolution of symptoms despite the MRI report suggesting that stenosis was not present at the surgical level. Therefore, the Interventional Pain Management Surgery approach will require the definition and validation of more useful clinical prognosticators of a successful outcome after endoscopic spinal surgery [19].
THE ROLE OF INJECTIONS AS PROGNOSTICATORS OF OUTCOME
The interpretation of preoperative advanced imaging studies may be further validated and documented by discography, transforaminal epidurography, and transforaminal therapeutic epidural steroid injections (TESI) containing a local anesthetic, or transforaminal foraminal nerve root blocks by injecting just a local anesthetic to identify the pain generator (Fig. 2). Diagnostic transforaminal injections containing a local anesthetic are an excellent prognosticator of favorable outcomes after a lumbar transforaminal decompression procedure. The concepts of developing new prognosticators of successful surgical outcomes lie in the pathophysiology's correlation with the intraoperative endoscopic visualization of the patho-anatomy responsible for the patient's pain. Correlation between the patient's response to a preoperative interventional work with lidocaine containing TESI has been conclusively demonstrated in a recent study carried out over nine years [20]. Of the 1839 patients, 1750 had intraoperatively visualized stenosis in the lateral recess at the surgical level, and 89 patients did not. The analysis showed true positive (1578); false negative (172), as compared with TESI responses in patients without visualized compressive pathology: false positive (26); and true negative (63). The sensitivity (90.17%), specificity (70.79%), and the positive predictive value (98.38%) of preoperative lidocaine containing TESI concerning the successful clinical outcome of the subsequent endoscopic decompression surgery were calculated. This study demonstrated that diagnostic lidocaine containing transforaminal epidural steroid injection – if it produces more than fifty percent VAS pain score reduction – is a valuable diagnostic tool in predicting improved clinical outcomes after lumbar endoscopic transforaminal decompression.
The only person able to validate this correlation intraoperatively in close interaction with the sedate yet awake patient is the surgeon. The surgeon's evaluation and validation of the preoperative prognosticators, whether imaging studies or diagnostic injections, during surgery cannot be replaced by any other technological prognosticator. Since pain relief relies on the correlation between the pathophysiology and the intraoperatively visualized patho-anatomy for each patient's specific condition, a successful outcome depends on this critical patient surgeon interaction. It cannot be replaced by a rule book of medical necessity criteria or by rigid adherence to advanced imaging reporting discounting the importance of the interaction between the patient and the surgeon [21, 22].
THE ROLE OF IMPROVED ENDOSCOPES AND INSTRUMENTATION
Historically, companies marketing spinal endoscopes, endoscopic- devices, and instruments had to budget significant money for training to stimulate their sales. Advances in endoscopes and surgical equipment will also help the development and adoption of endoscopic surgery [23, 24]. The development of endoscopic implants for the spine may further galvanize the push towards endoscopic spine surgery, particularly if viable reimbursement is associated with these procedures. The feasibility of a stand-alone lumbar interbody fusion cage being placed entirely using an endoscope and instruments adopted for the percutaneous endoscopic transforaminal placement of the cage into the spine has recently been demonstrated [25]. It is evident that creating sustainable revenue cycles for physicians and facilities is needed to retool clinical practices from traditional open to minimally invasive endoscopic spinal surgeries.
The Role Of Physician and Certification
For a surgeon to achieve success in the future subspeciality of Endoscopic Surgical Pain Care employing the “disruptive” techniques of correlating patho-anatomy and pathophysiology of pain generators, providers who embrace these spinal endoscopy principles should have surgical training. They should also:
1. Continue research and development of the endoscopic platform. Examples of future impactful developments include intraoperative robotic mechanical and image recognition guidance.
2. Continue to develop endoscopic designs and instrumentation to improve surgeon effectiveness and competence.
3. Support commercially viable manufacturing, marketing, distribution, and training operations to facilitate the expansion of spinal endoscopy to be incorporated into mainstream postgraduate training at a contemporary level.
All physicians who employ spinal endoscopy must be adequately and formally trained. Ideally, surgeon training moves away from weekend cadaver courses run by vendors. It should be included in the core curriculum of neurosurgical and orthopedic residency programs and, at a minimum, be taught in MIS spine fellowship programs. The most effective way to formalize training in spinal endoscopy is to establish standards for certification. The formalization of such minimum required standards for certification and skill level in spinal endoscopy may be challenging to define. It will most likely continue to be at the center of the debate. Despite this perceived difficulty, it is essential and will be demanded by licensing and neurosurgical and orthopedic governing boards for them to be able to endorse it.
THE PATIENT’S POINT OF VIEW & PLACEMENT OF SPINAL ENDOSCOPY
Patients who can seek the best surgeons and are often willing to pay cash and supplement what is not covered by insurance, for not just the best endoscopic surgeons, but surgeons with a known track record for safety and excellent clinical results [26]. Such surgeons will be sought out, similar to recruiting the best professional athletes. Cultural biases may also influence patients in their quest to search out the most appropriate way to treat spine pain. Asians, for example, have accepted specific methods of non-traditional medicine for thousands of years. One can only speculate whether the higher acceptance of alternative medicine in Asia has made it easier for spinal endoscopy in Asian countries to be adopted widely. Every culture has its own biases toward ethnic methods such as Asian alternative medicine methods, including acupuncture, exercise, massage, stretching techniques, reflexology, and naturopathic medicine [27]. Hence, other ethnic groups may have their level of acceptance and methodologies.
In the authors' opinion, the verdict is straightforward: Innovation in medicine in general, besides many other factors, requires money. Therefore, acceptance of endoscopic procedures and technologies as a “surgical” procedure or minimally invasive spinal surgical technique rather than interventional pain management is the most appropriate way to place a fair monetary value on its application, implementation, and expansion into day-to-day clinical practice. Adoption by the majority of surgeons and their respective professional governing boards and specialty societies will depend upon its continued safety, low complication rates, and effectiveness with ongoing innovation. These three factors will always heavily depend on each physician's skills [27, 28].
CONCLUSION
Spinal endoscopy will likely become more mainstream in the years to come. Formalized postgraduate training programs are expected to improve training, helping surgeons to master the learning curve. The substantiation of clinical guidelines should follow to formalize payment schedules that provide adequate reimbursement to build viable endoscopic spinal surgery programs capable of replacing traditional open spinal surgery protocols.
CONSENT FOR PUBLICATION
Not applicable.
CONFLICT OF INTEREST
The authors declare no conflict of interest, financial or otherwise.
ACKNOWLEDGEMENT
Declared none.
REFERENCES
[1]Adam Schrag. 20 things to know about minimally invasive spine surgery. 2017. https://www.beckersspine.com/mis/item/35569-20-things-to-know-about-minimally-invasive- spine-surgery.html[2]Kim JS. A bibliometric study in the field of percutaneous full-endoscopic spine surgery since 1997. Annual NASS Meeting 2018, Los Angeles After Hours: Endoscopic Spine Surgery: Current Trends & Evidence of Spinal Endoscopic Procedures2018.[3]Pan F, Shen B, Chy SK, et al. Transforaminal endoscopic system technique for discogenic low back pain: A prospective Cohort study. Int J Surg 2016; 35: 134-8.[http://dx.doi.org/10.1016/j.ijsu.2016.09.091] [PMID: 27693825][4]Yeung AT. Lessons learned from 27 years’ experience and focus operating on symptomatic conditions of the spine under local anesthesia: the role and future of endoscopic spine surgery as a “disruptive technique” for evidenced based medicine. J Spine 2018; 7: 413.[http://dx.doi.org/10.4172/2165-7939.1000413][5]Lewandrowski KU, Soriano-Sánchez JA, Xifeng Z, et al. Regional variations in acceptance, and utilization of minimally invasive spinal surgery techniques among spine surgeons: results of A global survey. J Spine Surg 2018; 6(Suppl 1): S260-74.[6]Lewandrowski KU, Soriano-Sánchez JA, Xifeng Z, et al. Surgeon motivation, and obstacles to the implementation of minimally invasive spinal surgery techniques: results of a global survey. J Spine Surg 2018; 6(Suppl 1): S249-59.[7]Lewandrowski KU, Soriano-Sánchez JA, Xifeng Z, et al. Surgeon training and clinical implementation of spinal endoscopy in routine practice: results of a global survey. J Spine Surg 2018; 6(Suppl 1): S237-48.[8]Lewandrowski KU. Kim-JS, Yeung AT. Is Asia truly a hotspot of contemporary minimally invasive and endoscopic spinal surgery? Results of a global survey. J Spine Surg 2018; 6(Suppl 1): S224-36.[9]Moulton H, Tosteson TD, Zhao W, et al. Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes. Spine 2018; 43(24): 1731-8.[http://dx.doi.org/10.1097/BRS.0000000000002723] [PMID: 29877995][10]Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 2006; 296(20): 2451-9.[http://dx.doi.org/10.1001/jama.296.20.2451] [PMID: 17119141][11]Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 2006; 296(20): 2441-50.[http://dx.doi.org/10.1001/jama.296.20.2441] [PMID: 17119140][12]Yeung AT, Roberts A, Shin P, Rivers E, Paterson A. Suggestions for a Practical and Progressive Approach to Endoscopic Spine Surgery Training and Privileges. J Spine 2018; 7: 414.[http://dx.doi.org/10.4172/2165-7939.1000414][13]Yeung AT. The Yeung Percutaneous Endoscopic Lumbar Decompressive Technique (YESSTM). J Spine 2018; 7: 408.[http://dx.doi.org/10.4172/2165-7939.1000408][14]Hignite J. Understanding the Impact of the CMS 2017 ASC Payment Rule on Spine Procedures. 2016. https://www.beckersspine.com/spine/item/34156-understanding-the-impact-of-the-cms-2017-asc-payment-rule-on-spine-procedures.html[15]AMA includes 1st endoscopic spine surgery code in 2017 codebook: 6 things to know. 2017. https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/33403-ama-includes-1st-endoscopic-spine-surgery-code-in-2017-codebook-6-things-to-know.html[16]Issues CMS. Final physician fee schedule: what spine surgeons should know. 2017. https://www.isass.org/awp/wp-content/uploads/2016/11/Final-2017-PFS-Rule-Summary.pdf[17]Wang B, Lü G, Patel AA, Ren P, Cheng I. An evaluation of the learning curve for a complex surgical technique: the full endoscopic interlaminar approach for lumbar disc herniations. Spine J 2011; 11(2): 122-30.[http://dx.doi.org/10.1016/j.spinee.2010.12.006] [PMID: 21296295][18]Hersht M, Massicotte EM, Bernstein M. Patient satisfaction with outpatient lumbar microsurgical discectomy: a qualitative study. Can J Surg 2007; 50(6): 445-9.[PMID: 18053372][19]Lewandrowski KU. Retrospective analysis of accuracy and positive predictive value of preoperative lumbar MRI grading after successful outcome following outpatient endoscopic decompression for lumbar foraminal and lateral recess stenosis. Clin Neurol Neurosurg 2019; 179: 74-80.[http://dx.doi.org/10.1016/j.clineuro.2019.02.019] [PMID: 30870712][20]Lewandrowski KU. Successful outcome after outpatient transforaminal decompression for lumbar foraminal and lateral recess stenosis: The positive predictive value of diagnostic epidural steroid injection. Clin Neurol Neurosurg 2018; 173: 38-45.[http://dx.doi.org/10.1016/j.clineuro.2018.07.015] [PMID: 30075346][21]Yeung AT, Yeung CA, Salari N, Field J, Navratil J. Lessons Learned Using Local Anesthesia for Minimally Invasive Endoscopic Spine Surgery. J Spine 2017; 6: 377.[http://dx.doi.org/10.4172/2165-7939.1000377][22]Yeung AT. In-vivo Endoscopic Visualization of Pain Generators in the Lumbar Spine. J Spine 2017; 6: 385.[http://dx.doi.org/10.4172/2165-7939.1000385][23]Yeung A, Yeung CA. Endoscopic identification and treating the pain generators in the lumbar spine that escape detection by traditional imaging studies. J Spine 2017; 6: 369.[24]Yeung AT. Transforaminal endoscopic decompression for painful degenerative conditions of the lumbar spine: a review of one surgeon’s experience with over 10,000 cases since 1991. J Spine Neurosurg 2017; 6: 2.[25]Lewandrowski KU. Surgical technique of endoscopic transforaminal decompression and fusion with a threaded expandable interbody fusion cage and a report of 24 cases. J Spine 2018; 7: 2.[http://dx.doi.org/10.4172/2165-7939.1000409][26]Yeung AT. Delivery of spine care under health care reform in the united states. J Spine 2017; 6: 372.[http://dx.doi.org/10.4172/2165-7939.1000372][27]Yeung AT. Intradiscal therapy and transforaminal endoscopic decompression: opportunities and challenges for the future. J Neurol Disord 2016; 4: 303.[http://dx.doi.org/10.4172/2329-6895.1000303][28]Yeung AT. Enhancement of KTP/532 laser disc decompression and arthroscopic microdiscectonmy with a vital dye. Proc SPIE 1880, Lasers in Orthopedic, /dental and /veterinary. Medicine (Baltimore) 1993.[http://dx.doi.org/10.111/12.148334]Evidence Based Medicine versus Personalized Treatment of Symptomatic Conditions of the Spine Under Local Anesthesia: the Role of Endoscopic versus Spinal Fusion Surgery as a “Disruptive” Technique
Anthony Yeung1,Kai-Uwe Lewandrowski2,3,4Abstract
Runaway cost for surgical spine care has led to increased scrutiny on its medical necessity. Consequently, the beaurocracy involved in determining coverage for these services has grown. The call for high-grade clinical evidence dominates the debate on whether endoscopic surgery has a place in treating painful conditions of the aging spine. The cost-effectiveness and durability of the endoscopic treatment benefit are questioned every time technology advances prompt an expansion of its clinical indications. The authors of this chapter introduce the concept of early-staged management of spine pain and make the case for personalized spine care focused on predominant pain generators rather than image-based necessity criteria for surgery often applied in population-based management strategies. The authors stipulate that future endoscopic spine care will likely bridge the gap between interventional pain management and open spine surgery. This emerging field of interventional endoscopic pain surgery aims to meet the unanswered patient demand for less burdensome treatments under local anesthesia and sedation. The very young and old patients often are ignored because their conditions are either not bad enough or too advanced for a successful outcome with traditional spine care. In this watershed area of spine care, the authors predict endoscopic spine surgery will thrive and carve out accepted surgical
indications in direct competition with pain management and traditional open spine fusion protocols.
INTRODUCTION
Clinical treatment guidelines are reflected in the health insurance industry's medical necessity and coverage rules. Many organizations and their “key opinion” leaders (KOLs) structure their medical and surgical treatments' narrative based on consensus finding and peer-reviewed articles. Health care, in general, is becoming more and more regulated and reliant on subsidies by the government or payers, making payments dependent on compliance with their treatments- and coverage guidelines and thereby increasing the bureaucracy in the delivery of healthcare on the backend to the individual patient. Bureaucratic hurdles have created more significant headwinds on the front end of the medical innovation cycle that effectively hamper the dissemination and publication of original and pioneering literature, which by definition starts with low-level V research and expert opinions. This low- level evidence is often unable to survive the rigorous review process of a medical publishing system geared towards publishing higher-level studies. Surgeon innovators often lack resources, institutional, and funding support to conduct prospective randomized single or multicenter trials. Even if able to orchestrate those trials, researchers in academic institutions are dependent on NIH or institutional support to get their clinical research published. Publication fees associated with many open-access Journals and the bureaucracy associated with traditional journals often requiring institutional review board (IRB) approval before submitting even low-level retrospective studies. This dynamic may pose additional unintended hurdles to disseminating novel and disruptive information, which is often created under the premise of reining in runaway healthcare cost.
In spine surgery, introducing new evidence in support of novel treatments can be particularly challenging since it is always compared to evidence relying on fusion as the ultimate solution. Combining these factors may hinder the entry of innovative clinical information into the mainstream peer-reviewed literature because spine surgeons, especially in a private practice setting, are too busy dealing with the increasing non-clinical and managerial workload while trying to pay clinical practice overhead. Academic surgeons may have institutional support, but the new challenges in endoscopic spine surgery can be daunting, whether in an academic or private setting. Endoscopic spine surgery is innovative but lacks traditional evidence-based criteria of conventional spine surgery for several reasons. First, the number of surgeons performing endoscopic spine surgery is still significantly less than surgeons performing traditional and other forms of translaminar minimally invasive spinal surgeries. The objectives of endoscopic spine surgery are different from other forms of spine surgery since it focuses on the patient's individual needs for their painful patho-anatomy of the spinal motion segment rather than treating pain syndromes from overt instability or severe spinal stenosis, which lends itself better for the study of outcomes and cost-effectiveness of lumbar spine surgery in a large population of patients. Third, by definition, endoscopic spine surgery is “disruptive” to the evidence-based medicine (EBM) study approach since there are many more study variables due to a large number of concurrent pain generators that are not considered for treatment with other forms of lumbar spine surgery. Taking all this into consideration, it comes as no surprise that true level I and II studies investigating the merits of endoscopic spine surgery are rare. In awake patients, randomization is not possible. Even level I and II studies are subject to different interpretations by academicians and payors. Most patients cannot receive meaningful treatment until their symptoms are out of control and all non-operative measures have failed. The many patients that cannot find help by institutionalized surgeons turn to alternative medicine and pain management to control their symptoms. Surgery is usually reserved for more severe conditions supported by traditionally accepted imaging studies.
TREATMENT NECESSITY RATIONALES
Radiologic imaging is alone often unable to explain the pain that does not meet medical necessity criteria for surgery. A lumbar MRI scan has been demonstrated not to correlate with the severity and low back pain duration [1]. In the treating physician’s and surgeon’s judgment, the disability may not be severe enough for consideration by traditional surgeons, especially when the risk and benefits of established spinal treatments and surgeries are factored in. Pain management treatments with narcotics, helpful or not, as well as a multitude of alternative medicine remedies, and durable medical equipment (DME) are often overutilized. For example, braces and home traction devices such as inversion tables are sold without prescription and are typically not covered by insurance. Some payors allow for chiropractic care. The concepts employed in endoscopy spine surgery are disruptive and will likely continue to be disruptive to our current established scientific validation system on large patient populations. If performed expertly and adequately, superior outcomes with endoscopic spine care can be provided in a more cost- effective and less burdensome manner both to the patient and the health care system as a whole.
INSURANCE AUTHORIZATION
Rigid adherence to established protocols may impact reimbursement for endoscopic spine surgery [2]. Payers and insurance companies deny reimbursement for experimental procedures or those which lack level I or II evidence and do not recognize expert opinion [3]. Insurance companies also employ many means to deny reimbursement and fail to honor contracts using arbitrary criteria of post-preauthorization denial of payment for services rendered to patients – many of whom benefited and were rendered pain-free because of the “out-of-the-box” approach with targeted endoscopic procedures. The rigid EBM approach to spine care could delay implementing more cost-effective, innovative technologies – all of which start with level V expert opinions. On the other hand, having high-grade clinical evidence is not a guarantee that a procedure is implemented. One such example is chymopapain. The supporting evidence is high-grade, but was largely ignored. It fell out of favor [4]
THE PERSONALIZED MEDICINE APPROACH
Symptomatic conditions of the spine can be endoscopically evaluated. At the same time, most patients may eventually be taken seriously, mainly if they continue to complain of debilitating pain or are realistic about the anticipated surgical results [5]. Contrary to traditional spine care, where the patient's disability is attempted to be treated in one intervention, the personalized approach to endoscopic spine care takes into account that multiple pain generators may exist with varying degrees of pain and disability. At times it can be confusing as surgeon and patient are trying to prioritize spine care to attend to the most painful condition. Other pain generators may exist and become clinically relevant at a later time in a different functional context. Personalized spine care revolves around these staged management concepts and is embraced by endoscopic visualization and therapy. It has been the first author's focus for 28 years [6].
THE SOCIETAL BURDEN
The cumulative effect of aging in the spine may lead to pain [7]. Validating pain generators early on can be accomplished with diagnostic injections. Ineffective and expensive spine care can be avoided by incorporating endoscopically visualized procedures earlier in the disease process rather than waiting until the underlying degenerative condition progresses to its end-stage, where aggressive and costly fusion surgeries are considered the only option [8, 9]. Directly visualizing and treating the pain generator is the key element of endoscopic spine surgery than any other form of spine surgery cannot replicate [10
