Durotomy- and Irrigation-Related Serious Adverse Events During Spinal Endoscopy: Illustrative Case Series and International Surgeon Survey.

BACKGROUND: Durotomy during endoscopic spine surgery can cause a patient's neurological or cardiovascular status to deteriorate unexpectedly intra- or postoperatively. There is currently limited literature regarding appropriate fluid management strategies, irrigation-related risk factors, and clinical consequences of incidental durotomy during spinal endoscopy, and no validated irrigation protocol exists for endoscopic spine surgery. Thus, the present article sought to (1) describe 3 cases of durotomy, (2) investigate standard epidural pressure measurements, and (3) survey endoscopic spine surgeons on the incidence of adverse effects believed to result from durotomy. MATERIALS AND METHODS: The authors first reviewed clinical outcomes and analyzed complications in 3 patients with intraoperatively recognized incidental durotomy. Second, the authors conducted a small case series with intraoperative epidural pressure measurements during gravity-assisted irrigated video endoscopy of the lumbar spine. Measurements were conducted on 12 patients with a transducer assembly that was introduced through the endoscopic working channel of the RIWOSpine Panoview Plus and Vertebris endoscope to the decompression site in the spine. Third, the authors conducted a retrospective, multiple-choice survey of endoscopic spine surgeons to better understand the frequency and seriousness of problems they attributed to irrigation fluid escaping from the surgical decompression site into the spinal canal and neural axis. Descriptive and correlative statistical analyses were performed on the surgeons' responses. RESULTS: In the first part of this study, durotomy-related complications during irrigated spinal endoscopy were observed in 3 patients. Postoperative head computed tomographic (CT) images revealed massive blood in the intracranial subarachnoid space, the basal cisterns, the III and IV ventricle, and the lateral ventricles characteristic of an arterial fisher grade IV subarachnoid hemorrhage, and hydrocephalus without evidence of aneurysms or angiomas. Two additional patients developed intraoperative seizures, cardiac arrhythmia, and hypotension. The head CT image in 1 of these 2 patients had intracranial air entrapment.In the second part, epidural pressure measurements in 12 patients who underwent uneventful routine lumbar interlaminar decompression for L4-L5 and L5-S1 disc herniation showed an average epidural pressure of 24.5 mm Hg.In the third part, the online survey was accessed by 766 spine surgeons worldwide and had a response rate of 43.6%. Irrigation-related problems were reported by 38% of responding surgeons. Only 11.8% used irrigation pumps, with 90% running the pump above 40 mm Hg. Headaches (4.5%) and neck pain (4.9%) were observed by nearly a 10th (9.4%) of surgeons. Seizures in combination with headaches, neck and abdominal pain, soft tissue edema, and nerve root injury were reported by another 5 surgeons. One surgeon reported a delirious patient. Another 14 surgeons thought that they had patients with neurological deficits ranging from nerve root injury to cauda equina syndrome related to irrigation fluid. Autonomic dysreflexia associated with hypertension was attributed by 19 of the 244 responding surgeons to the noxious stimulus of escaped irrigation fluid that migrated from the decompression site in the spinal canal. Two of these 19 surgeons reported 1 case associated with a recognized incidental durotomy and another with postoperative paralysis. CONCLUSIONS: Patients should be educated preoperatively about the risk of irrigated spinal endoscopy. Although rare, intracranial blood, hydrocephalus, headaches, neck pain, seizures, and more severe complications, including life-threatening autonomic dysreflexia with hypertension, may arise if irrigation fluid enters the spinal canal or the dural sac and migrates from the endoscopic site along the neural axis rostrally. Experienced endoscopic spine surgeons suspect a correlation between durotomy and irrigation-related extra- and intradural pressure equalization that could be problematic if associated with high volumes of irrigation fluid LEVEL OF EVIDENCE: 3.

Differential Agnostic Effect Size Analysis of Lumbar Stenosis Surgeries.

STUDY DESIGN: A meta-analysis of 89 randomized prospective, prospective, and retrospective studies on spinal endoscopic surgery outcomes. OBJECTIVE: The study aimed to provide familiar Oswestry Disability Index (ODI), visual analog scale (VAS) back, and VAS leg effect size (ES) data following endoscopic decompression for sciatica-type back and leg pain due to lumbar herniated disc, foraminal, or lateral recess spinal stenosis. BACKGROUND: Higher-grade objective clinical outcome ES data are more suitable than lower-grade clinical evidence, including cross-sectional retrospective study outcomes or expert opinion to underpin the ongoing debate on whether or not to replace some of the traditional open and with other forms of minimally invasive spinal decompression surgeries such as the endoscopic technique. METHODS: A systematic search of PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials from 1 January 2000 to 31 December 2019 identified 89 eligible studies on lumbar endoscopic decompression surgery enrolling 23,290 patient samples using the ODI and VAS for back and leg pain used for the ES calculation. RESULTS: There was an overall mean overall reduction of ODI of 46.25 (SD 6.10), VAS back decrease of 3.29 (SD 0.65), and VAS leg reduction of 5.77 (SD 0.66), respectively. Reference tables of familiar ODI, VAS back, and VAS leg show no significant impact of study design, follow-up, or patients' age on ES observed with these outcome instruments. There was no correlation of ES with long-term follow-up (P = 0.091). Spinal endoscopy produced an overall ODI ES of 0.92 extrapolated from 81 studies totaling 12,710 patient samples. Provided study comparisons to tubular retractor microdiscectomy and open laminectomy showed an ODI ES of 0.9 (2895 patients pooled from 16 studies) and 0.93 (1188 patients pooled from 5 studies). The corresponding VAS leg ES were 0.92 (12,631 endoscopy patients pooled from 81 studies), 0.92 (2348 microdiscectomy patients pooled from 15 studies), and 0.89 (1188 open laminectomy patients pooled from 5 studies). CONCLUSION: Successful clinical outcomes can be achieved with various lumbar surgeries. ESs with endoscopic spinal surgery are on par with those found with open laminectomy and microsurgical decompression. CLINICAL RELEVANCE: This article is a meta-analysis on the benefit overlap between lumbar endoscopy, microsurgical decompression, laminectomy, and lumbar decompression fusion.

Rompiendo el efecto ''techo de cristal'' en la generación de evidencia clínica de alto nivel en ortopedia y traumatología / Breaking the "glass ceiling" effect in the generation of high-level clinical evidence in orthopedics and traumatology

Introduction: In clinical studies involving common orthopedic problems and traumatic injuries, randomization methods are difficult to orchestrate. The lack of high-level clinical evidence based on prospective, randomized, double-blind studies is often cited as a major reason for rejecting proposed therapeutic advances in orthopedic surgery. Materials and methods: This opinion document summarizes the limitations of clinical trials in surgical subspecialties. A consensus is presented about how the practicing orthopedic surgeon can produce high-quality clinical evidence and thus make changes to their clinical practice protocols. Results: This literature review revealed that level of evidence classifications vary among surgical subspecialties. Research in orthopedics and traumatology is primarily directed toward diagnosis, preferred treatment, and economic decision analysis, while other prognostic classifications are preferred in other areas, such as plastic surgery. In orthopedics, double-blind controlled studies are rare and often impractical or even unethical. Crossover between randomized surgical trials of study groups is more common. Other difficulties in surgical trials range from: lack of organizational and financial support, institutional approval or ethics committee and registration requirements for clinical trials, and to insufficient time outside of an already busy clinical program to dedicate to this laborious task. uncompensated task. Conclusion: Orthopedic surgery is a subspecialty based on experience and skill. Many innovations begin with enterprising surgeons reporting opinion reports or retrospective cohort studies, many of which are biased. Prospective observational cohort studies with consistent results may offer higher grade clinical evidence than poorly executed randomized trials.

Durability of Endoscopes Used During Routine Lumbar Endoscopy: An Analysis of Use Patterns, Common Failure Modes, Impact on Patient Care, and Contingency Plans.

BACKGROUND: Successful implementation of endoscopic spinal surgery programs hinges on reliable performance and case cost similar to traditional decompression surgeries of the lumbar spine. MATERIALS AND METHODS: To improve the statistical power of studying the durability of endoscopes with routine lumbar endoscopy, the authors performed a retrospective survey study among endoscopic spine surgeons by email and chat groups on social media networks WhatsApp and WeChat. Descriptive and correlative statistics were done on the surgeon's responses recorded in multiple-choice questions. Surgeons were asked about their clinical experience with spinal endoscopy, training background, the types of lumbar endoscopic decompression they perform by approach, their preferred decompression instruments, and their experience with endoscopic equipment failure. RESULTS: A total of 485 surgeons responded, of whom 85 submitted a valid survey recording, rendering a completion rate of 27.1%. These 85 respondents reported a case volume of 12,650 lumbar endoscopies within the past year and, to date, had performed a total of 120,150 spinal endoscopies over their collective career years. The majority of respondents performed endoscopic surgery for herniated disc (65.9%) vs spinal stenosis (34.1%) in a hospital setting, preferentially employing the transforaminal (76.5%), interlaminar (51.8%), and unilateral biportal endoscopic (UBE; 15.3%) approach technique. The most commonly used endoscopic spine systems were Wolf/Riwo Spine (38.8%), Joimax (36.5%), Storz (24.7%), unspecified Chinese brand (22.4%), Maxmore (15.3%), Spinendos (12.9%), Elliquence (10.6%), unspecified Korean brand (7.1%), and asap Endosystems GmbH (2.4%). The most frequent failure mode of the endoscope reported by survey respondents was a blurry image (71.8%), followed by the loss of focus (21.2%), the loss of illumination of the surgical site (18.8%), and the failure of the irrigation/suction system integrated into the endoscope (4.7%). Most respondents thought they had problems with the lens (67.1%), the fiberglass light conductor (23.5%), the prism (16.5%), or the rod system (4.7%). Motorized high-speed power burrs and hand reamers and trephines were the reported favorite decompression tools that were presumably associated with the endoscope's failure. The majority of respondents (49.5%) performed up to 50 endoscopies before the endoscope had to be either exchanged or repaired. Another 15.3% of respondents reported their endoscope lasted between 101 and 200 cases and only 12.9% reported more than 300 cases. Besides abuse during surgery (25.9%), bad handling by staff was the most common suspected reason (45.9%), followed by the wrong sterilization technique (21.2%). Some 23.5% of respondents noted that the endoscope failed during their surgery. In that case, 66.3% asked for a replacement endoscope, and 36.1% completed the surgery with the broken endoscope. However, 10.8% stopped and another 6% of respondents woke the patient up and rescheduled the surgery to complete the decompression at another time. CONCLUSIONS: Spinal endoscopes used during routine lumbar decompression surgeries for herniated disc and spinal stenosis have an estimated life cycle between 50 and 100 surgeries. Abusive use by surgeons, mishandling by staff, and deviation for prescribed cleaning and sterilization protocols may substantially shorten the life cycle. Contingency protocols should be in place to readily replace a broken spinal endoscope during surgery. More comprehensive implementation of endoscopic spine surgery techniques will hinge on technology advancements to make these hightech surgical instruments more resistant to the stress of daily use and abuse of expanded clinical indications' for surgery. The regulatory burden on endoscope makers is likely to increase, calling for increased reimbursement for facilities to cover the added expense for capital equipment purchase, disposables, and the endoscopic spine surgery program's maintenance. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: End user surgeon survey study.