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Dr. Salman Sharif
Publication Secretarry PSN

INTRODUCTION

Background
Osteoporosis and osteoporotic vertebral compression fractures are commonly encountered clinical problems. The definition of osteoporosis is diminished bone density measuring 2.5 standard deviations below the average bone density of healthy, 25-year-old, same-sex members of the population. In the United States, approximately 35% of women older than 65 years have osteoporosis. Vertebral compression fracture is the most common complication of osteoporosis. More than 700,000 new vertebral compression fractures occur every year in the United States alone, accounting for more than 100,000 hospital admissions and resulting in close to $1.5 billion in annual costs.

Most of patients experiencing an osteoporotic vertebral compression fracture remain asymptomatic or minimally symptomatic; however, a large number of these patients do experience significant pain, resulting in decreased quality of life and disability. Conventional medical treatment for these patients includes pain medication, activity limitation, physical therapy, and (possibly) bracing.1, 2 Vertebroplasty and kyphoplasty are 2 minimally invasive spinal procedures that have emerged as viable treatments for patients who do not respond to more conservative measures.3, 4, 5, 6 Surgery for this population of patients is not well tolerated and is typically performed only as a last resort in severe cases.

TREATMENT

Rehabilitation Program

Physical Therapy
The critical element in deciding a treatment regimen is pain and percentage of vertebral collapse. If a patient rates his/her pain as being greater than 4 out of 10 (when 10 equals worst pain imaginable and 0 equals no pain) or the vertebral bodies are collapsed more than 40%, then kyphoplasty or vertebroplasty is indicated as an initial intervention. Other patients may initially attempt more conservative care.

Patients with osteoporotic vertebral compression fractures are usually treated nonoperatively. Heat, massage, analgesic medications, and bed rest may provide symptomatic relief.

Bracing used to be common. However, the use of extension bracing has become controversial because of concerns regarding the placement of increased stress on the posterior elements of the spine.

Patients should be treated for their osteoporosis with anti-osteoporotic medications, including second-generation bisphosphonates, as well as (daily) with 1500 mg of elemental calcium and 400 IU of vitamin D.

A structured exercise program is essential and should be tailored to enhance axial muscle strength. Early mobilization should be employed to prevent secondary complications of immobility. Back strengthening exercises may improve kyphotic deformity.8 Back extension exercises should be used preferentially over abdominal flexion exercises.9, 10 Weight-bearing exercises are considered the mainstay of therapy to prevent extension of osteoporosis. Crunches and sit-ups should be excluded. Many consider pilates to be an excellent physical exercise regimen. If balance is impaired, Tai Chi Chuan is recommended.

Occupational Therapy
This is primarily used in an inpatient setting.

Recreational Therapy
This is primarily used in an inpatient setting. Along with occupational therapy, recreational therapy is an important component of a patient's transition from an inpatient setting to an outpatient setting.

Medical Issues/Complications

Analgesic medications are often poorly tolerated, especially in an elderly population. Complications from anti-inflammatory and narcotic medications include confusion, increased falling risk, and gastrointestinal symptoms. Bed rest and immobilization result in disuse, osteopenia, and an increased risk of a thrombo-embolic event. All vertebral compression fractures require a systematic examination to rule out an underlying systemic illness, such as malignancy, infection, or renal or liver disease.

Surgical Intervention

The 2 main minimally invasive surgical procedures are kyphoplasty and vertebroplasty 3, 4, 5, 6 More aggressive surgical intervention in an osteoporotic spine is fraught with difficulties. The patient's advanced age, comorbid diseases, and difficulty in securing fixation to weakened osteoporotic bone make surgical intervention an absolute last resort. However, surgical intervention may be required in patients with neurologic impairment, such as paresis, paralysis, saddle anesthesia, or bowel or bladder changes. Surgical intervention may also be required in a patient who is clinically unimproved despite adequate conservative care.

Surgery may be indicated in a patient with radiographic evidence of instability. This is exhibited by ligamentous disruption with potential pending canal compromise or when movement is exhibited on dynamic or motion radiographic examination. The advancement of kyphosis despite adequate conservative care may also be an indication for surgery.

Other Treatment

Two minimally invasive alternatives that are available for the treatment of osteoporotic vertebral compression fractures include vertebroplasty and kyphoplasty.3, 4, 5, 6

Vertebroplasty was first introduced in France in 1987 and involves the percutaneous injection of polymethylmethacrylate (PMMA) directly into the fractured vertebral body under fluoroscopic guidance.12 This procedure stabilizes the fracture. Substantial pain relief has been noted in the majority of patients treated with this procedure.13

Kyphoplasty is a newer percutaneous procedure that addresses the kyphotic deformity as well as the fracture pain. Kyphoplasty involves the percutaneous insertion of an inflatable bone tamp into the fractured vertebral body under fluoroscopic guidance. The bone tamp is then inflated, elevating the endplates and restoring the vertebral body toward its original height. Thick PMMA is then injected in a controlled manner under low pressure into the cavity of the body. The bone tamp is deflated and removed. Kyphoplasty has been shown to provide significant pain relief as well as substantial improvement in the height of the collapsed vertebral body and has been found to reduce the spinal kyphosis.

The indications for vertebroplasty include stabilization of painful osteoporotic vertebral fractures, painful vertebra due to metastases or multiple myeloma, Kümmell disease, and painful vertebral hemangioma.14 Indications for kyphoplasty include painful or progressive osteoporotic and osteolytic vertebral compression fractures. Neither procedure should be performed on more than 3 levels at a single time. Contraindications and precautions for vertebroplasty include sepsis, coagulopathy, posterior vertebral body wall deficiency or fracture, inadequate intra-operative visualization of the fracture, anatomic variant limiting vertebral body access, neurologic compromise related to the fracture, and localized spine infection.

Partial or complete relief of pain symptoms is experienced by 60-100% of patients within 72 hours following vertebroplasty. This improvement has been noted to persist for at least 4 years. Kyphoplasty is a newer procedure with shorter follow-up available. However, one study found that in 1439 patients with 2194 vertebral fractures, 90% of vertebral fractures had significant pain relief within 2 weeks of kyphoplasty. In addition to pain relief, kyphoplasty has been shown to produce a 70-97% reversal of kyphotic deformity in patients.

Complications from vertebroplasty include radiculopathy, rare cement leakage into the epidural space (necessitating surgical decompression), and frequent, asymptomatic leakage of PMMA into the perivertebral veins.3, 4, 5, 6 This leakage has prompted concern about potential embolization of PMMA to the lungs via the venous system. Kyphoplasty uses much lower pressure to inject the cement and has been shown to have a lower rate of intravenous and transcortical leakage of contrast. However, research indicates that kyphoplasty and vertebroplasty can increase the risk of adjacent vertebral body fracture. This risk remains under active investigation.15

When kyphoplasty has been performed within 1 month of fracture, easier endplate elevation and restoration of vertebral body height has been observed. Current care emphasizes conservative medical care for approximately 1-2 months. Earlier kyphoplasty or vertebroplasty may be more appropriate when analgesic medications are insufficient for pain relief or in patients with significant kyphosis. Patients with fractures at the thoracolumbar junction may also benefit from early kyphoplasty, because this fracture location is prone to produce more significant kyphosis. However, the potential risk of future adjacent body compression fracture should be taken into consideration.

When kyphoplasty has been performed within 1 month of fracture, easier endplate elevation and restoration of vertebral body height has been observed. Current care emphasizes conservative medical care for approximately 1-2 months. Earlier kyphoplasty or vertebroplasty may be more appropriate when analgesic medications are insufficient for pain relief or in patients with significant kyphosis. Patients with fractures at the thoracolumbar junction may also benefit from early kyphoplasty, because this fracture location is prone to produce more significant kyphosis. However, the potential risk of future adjacent body compression fracture should be taken into consideration.

MEDICATION
Oral medications have many roles in the treatment of patients with osteoporotic vertebral compression fractures. Pain relief is often the initial goal. Patients with osteoporosis need to be placed on anti-osteoporotic medications. As always, the benefits of the medications need to be weighed against the adverse effects. Anti-inflammatory medications may produce gastrointestinal adverse effects. Strong analgesic medications may cause confusion, disorientation, increased risk of falling, constipation, and respiratory depression.

Drug Category: Analgesic medications
Essential for providing initial pain relief.

http://jama.ama-assn.org/cgi/content/full/296/20/2441

Non-operative treatment of lumbar disc herniations is as effective as surgery:

AANS, CNS and their joint section on spine, welcomed the study and said that we have known for a while that non operative therapy is sometimes as effective as surgery. To be politically correct they even called it a "Major Scientific Study" …

Why would a worker compensation adjuster approve surgery for anyone with a herniated lumbar disc, if the statistics derived from a large multi center study indicates that surgery is no better than non-operative therapy in the long term?

There are several problems with this "study."

1.40% of the patients that were selected for the non-operative arm of the study chose to break the protocol because of the intensity of their pain. They did better with surgery!
2. substantial crossover occurred in both treatment groups, resulting in difference in surgery rate of only 14% at 6 weeks.
3.The fact that non-operative therapy, even if associated with improvement of symptoms, is often associated with lingering neuropathic symptoms that are due to partial nerve root injury requiring long term treatment, was ignored.
4. The economic, social and psychological aspects were not looked at...

We must look carefully at such studies in which the facts are twisted by playing with statistics and not clearly describing the deficiencies... Please spread the word.

17th European Stroke Conference. Presented May 14, 2008.

May 15, 2008 (Nice, France) — Treatment of intraventricular hemorrhage (IVH) with catheter-based clot lysis using low-dose tissue plasminogen activator (tPA) is safe and dramatically reduces death and disability in individuals with this usually lethal condition.

Here at the 17th European Stroke Conference, investigators presented the final results of the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR-IVF) trial, showing that administration of 1-mg tPA every 8 hours to a maximum of 4 days reduced expected mortality by approximately 70% and resulted in a dramatic improvement in functional outcomes.

"At 30 days, the mortality rate in study subjects was 15%. Typically, the expected 30-day mortality in such patients is about 80% to 85%," study investigator Daniel F. Hanley, MD, told Medscape Neurology & Neurosurgery.

However, he added, the "real news" is that fact that over 30, 90, and 180 days, more than 40% of patients recovered to the point that they were able to live independently, a result that Dr. Hanley described as "phenomenal."

"With this type of devastating disease, there is always the consideration that even if you can save lives, are patients paying a price in terms of their quality of life? In this study, 40% of our subjects recovered to the point of living independently, and 10% were completely normal with no deficits. The most recent patient I saw has now returned to work," he said.

Counterintuitive Treatment?

According to Dr. Hanley, while the idea of using thrombolysis to treat hemorrhagic stroke may seem "counterintuitive," he pointed out that over the past 15 years there has been a large number of published case series suggesting the use of tPA for IVH is feasible and likely safe.

However, dose effect and dose safety remained unclear as well as the treatment's potential impact on outcome. Dr. Hanley said the CLEAR-IVH trial is the first multicenter, international prospective assessment of this treatment.

Building on previous research showing that low-dose tPA did not increase bleeding risk and that the treatment is more effective if the catheter used to deliver the drug is placed closer to the clot, the researchers embarked on the current phase 2 study to determine the safest and most effective regimen.

Developed by Dr. Hanley and colleagues, the procedure clears trapped blood by bathing — and dissolving — the clot directly in tPA in a system that is closed for 1 hour to allow the drug to interact with the clot. The system is then opened up to facilitate drainage of lysed clot materials.

The study included 52 patients from 20 centers in the United States, Canada, the United Kingdom, and Germany. All subjects had a confirmed diagnosis of IVH via CT scan with third or fourth ventricle obstruction.

Six-Hour Stability Period Crucial

A second CT scan was performed 6 hours after catheter placement to ensure that there was no ongoing bleeding before administration of the drug.

"This six-hour stability period is necessary to make sure there is no bleeding. After dose, I believe this is the single most important component in determining the safe use of this drug in this [clinical] situation," said Dr. Hanley.

Subjects received 1 of 3 regimens — 0.3 mg of the drug every 12 hours, 1 mg of the drug every 12 hours, or 1 mg of the drug every 8 hours.

Patients were monitored with daily CT scans, and the investigators found that clots dissolved on average within 3 to 4 days. Study subjects who received the 1-mg dose every 8 hours experienced dissolution of their clots an average of 1 day earlier than their counterparts on the other 2 regimens.

The investigators found symptomatic bleeding occurred at a rate of about 6% — a rate that was the same as that found in the placebo group in the investigators' prior trial. "There was no enhanced bleeding as a result of the procedure," said Dr. Hanley. Other complications included a 2% rate of bacterial ventriculitis.

Worldwide Applicability

Because the procedure is relatively simple, uses currently available technology, and requires no special training, the CLEAR-IVH approach could easily be applied worldwide, said Dr. Hanley.

"It requires a CT scan, a neurosurgeon to place a catheter, and a proper understanding of how to use a lower-dose thrombolytic. There's no particular special training required, although there are nuances in the daily reading of the CT scans," he said.

Despite these encouraging findings, Dr. Hanley said it is not yet clear whether this should be employed as a standard treatment for IVH, which affects about 50,000 Americans every year.

To answer this question, the investigators are planning a definitive, multicenter, randomized phase 3 trial that will include 500 patients and is expected to launch at the end of 2008 or early 2009.

"Our group is fully committed to testing the novel ideal that IVH clot-size reduction with thrombolysis decreases mortality and increases good outcome," said Dr. Hanley.

The study was supported by Johns Hopkins University, the FDA Office of Orphan Products Development, and Genentech.

When analyzed, smoke from electrosurgical units, commonly known as Bovie smoke, is shown to be quite similar to that of other potentially pathogenic smoke, behaving as a carcinogen, a mutagen and an infectious vector. In addition, particulate matter in smoke is known to have health risks related to inducing inflammatory and allergic responses in susceptible people.

The fact that electrosurgical smoke is common and has been present in operating rooms for many years has led to a complacency regarding this smoke and its potential toxicity. A comparison of laser plume and electrosurgical smoke shows little difference in terms of the health risk, and in some respects the electrosurgical smoke poses a greater risk, particularly if these risks are quantified on a time-weighted basis that takes into account accumulation over long periods of exposure. For example, a study that directly compared electrosurgical smoke with laser plume and tobacco smoke showed that electrosurgical smoke is more toxic than laser plume or tobacco smoke (5). One gram of tissue was lasered with a carbon dioxide laser, and an identical gram of tissue was vaporized with electrosurgical current. A comparison of the emitted chemical byproducts to those present in average tobacco smoke demonstrated that the laser smoke generated from a gram of tissue was equivalent to smoking three unfiltered cigarettes, while the electrosurgical smoke was equivalent to smoking six unfiltered cigarettes.

This article details some of the known risks of exposure to Bovie smoke. As importantly, it presents best practices for avoiding Bovie smoke exposure to the greatest extent possible.

Electrosurgical units transmit a current from a dissecting or cutting surgical instrument to a dispersion electrode. The resistance to the flow of this current at the tissue interface generates heat, which causes coagulation of proteins that leads to hemostasis and vaporization of tissue by superheating intracellular water content. The result is disintegration of cell integrity and aerosolization of cellular debris. The destruction of biological tissue with heat results in the generation of smoke that is composed of volatile organic compounds, inorganic compounds, and both inert and biologically active particulate matter such as viruses. The smoke generated by an electrosurgical unit is comparable to that generated by a laser, and the mechanism is fundamentally the same (3). Aerosols of biological tissue and smoke due to heat generated by friction also are generated by high-speed air drills.

The mutagenicity of electrocautery smoke has been evaluated by collecting smoke produced during reduction mammoplasty (6). The smoke was collected at locations between two-and-a-half and three feet above the operative field, typical of the exposure experienced by the operating team. The smoke was collected in filters and extracted for analysis. The extracts were tested with strains of Salmonella typhimurium in a standardized Ames test, which is a well‑recognized technique for evaluating the mutagenicity of a substance. The results demonstrated that all of the smoke samples contained mutagens. The finding of mutagens is an important qualitative result because there is no established safe level of mutagens, and the likelihood of establishing safe levels is quite remote. Therefore, the implication is that the amount of smoke to which operating personnel are exposed should be as minimal as possible.

Volatile Organic Compounds

With regard to carcinogenicity, attention is typically focused on the volatile organic compounds and polycyclic aromatic compounds contained in the smoke. A health hazard evaluation report by the National Institute for Occupational Safety and Health, NIOSH, discussed the content of volatile organic compounds in surgical smoke (7). Volatile organic compounds are described as a class of molecules that have a sufficiently high vapor pressure to allow the compound to exist in a gaseous state at room temperature. Of the array of chemicals known to exist in biological tissue smoke, formaldehyde, acetaldehyde, and toluene were identified.

Formaldehyde concentrations were quite variable. They ranged as high as 0.021 parts per million, ppm, compared to a sample taken outside the operating room door of 0.005 to 0.007 ppm. Formaldehyde is known to be an irritant at exposures of 1.0 ppm or greater in the general population, but symptoms of irritation occur earlier in persons with preexisting conditions such as allergies or respiratory disease. In addition, NIOSH identifies formaldehyde as a potential human carcinogen, and the Occupational Safety and Health Administration, OSHA, has identified a 0.75 ppm eight-hour time‑weighted average as the upper limits of allowable worker exposure. The time-weighted average accounts for the elevation in the concentration of formaldehyde during exposure to surgical smoke over a period of time in a typical working day.

The report identified acetaldehyde concentrations that ranged from 0.001 ppm to 0.012 ppm, compared to a background of 0.002 ppm. Acetaldehyde is considered by the Environmental Protection Agency as a probable human carcinogen, and NIOSH recommends keeping exposure to acetaldehyde at the lowest feasible concentration. However, the OSHA guidelines for an eight-hour time-weighted exposure are much higher than those identified in this report at 200 ppm.

Toluene was identified in concentrations of 0.002 ppm to 0.015 ppm. Toluene is a known respiratory and eye irritant, and excessive inhalation exposure can lead to neurotoxicity. The symptoms of toluene exposure are not identified below 100 ppm in published studies.

The Particulars of Particulate Matter

Particulate matter is found in electrosurgical smoke, and the nonliving particulate matter is typically quantified as particles per cubic foot, ppcf. It has been noted that baseline measurements in an operating room are typically near 60,000 ppcf (4). With the use of electrosurgical tools that generate smoke, the typical rise in particulate matter plateaus at approximately one million ppcf in five minutes. It takes approximately 20 minutes following cessation of generation of electrocautery smoke for the operating room ventilation system to return particulate concentrations to baseline level. Comparison of laser plume and electrosurgical smoke using a spectrophotometer has demonstrated that both types of smoke have a very similar particle content and size distribution.

The smaller particulate matter is thought to be the most harmful in that it typically penetrates surgical masks and travels through the respiratory tree to the alveolar level. The particles typically are less than five microns in size, and more than 77 percent of particulate matter within surgical smoke is less than 1.1 µm in size. An experimental protocol using Sprague‑Dawley rats exposed to electrocautery exhaust demonstrated lung parenchyma changes, including alveolar congestion, blood vessel hypertrophy of varying degrees, focal emphysematous changes, and muscular hypertrophy of blood vessels (10). A previous study demonstrated similar changes with carbon dioxidelaser plume (2).

The particulate matter also includes living organisms, and both viable bacteria and viruses in electrosurgical smoke has been reported. Papillomavirus was identified in vapor from bovine warts treated with both laser-derived material and electrosurgical cautery (8). Of the two, more virus load was present in the laser-derived material. Despite this provocative finding, the size of these particles is such that they are easily filtered out by a surgical mask and that there appears to be a low likelihood of transmission of the papillomavirus through its presence in electrosurgical smoke. Surgical smoke has been identified to carry viable bacteria that have been cultured from surgical smoke, including Bacillus subtilis and Staphylococcus aureus. In addition, mycobacteria have been isolated from smoke, including Mycobacterium tuberculosis (9).

However, the presence of carcinogenic and mutagenic chemicals as well as inert and biologically active particulate matter represents a health hazard that varies with the susceptibility of the exposed individual. The presence of hypersensitivities, allergies, immunocompromised states, and/or a combination of surgical toxic exposures with other toxic environmental exposures such as smoking may change the risk profile on a case-by-case basis. Given the complexity of the variables involved, individual risk stratification cannot be established in a rigorous scientific fashion. The hazards of electrosurgical smoke are for the most part potential hazards without a large epidemiological database demonstrating their harmfulness to humans. In the presence of a scientifically verifiable hazard and the absence of definitive epidemiologic proof of health consequences, the most prudent course of action is to minimize exposure, which has virtually no downside risk.

Evacuators and Masks

There is almost uniform agreement among authors in this field that evacuation of the smoke near the source has the greatest likelihood of preventing exposure and any health consequences associated with it. The NIOSH recommendations suggest a smoke evacuator system that can pull approximately 50 cubic feet per minute with a capture velocity of 100 to 150 feet per minute at the inlet nozzle (1). Filters are necessary to capture the contents of the smoke and must be replaced regularly. Used filters are considered biohazardous wastes that require proper disposal. The regulations further suggest that a smoke evacuator nozzle be kept within two inches of the surgical site to maximize effective capturing of airborne contaminants. The use of routine suction designed for elimination of liquids from the surgical field is not adequate to evacuate electrosurgical smoke and eliminate the health hazards associated with it.

The other common practice is the use of a surgical mask. It is true that surgical masks cannot eliminate the very fine particles that are associated with respiratory inhalation, and even high-efficiency masks will become saturated at a certain point, thus allowing the air to flow around the mask rather than through it. Nonetheless, the masks are -efficient in eliminating larger particle sizes, including viruses.

References

1. AORN Recommended Practices Committee: Recommended practices for electrosurgery. AORN J 81(3):616–618, 621–626,629–632, 2005

2. Baggish MS, Elbakry M: The effects of laser smoke on the lungs of rats. Am J Obstet Gynecol 156:1260–65, 1987

3. Ball KA: Surgical smoke: is it safe to breathe? Today's Surg Nurse 18:16–21, 1996

4. Brandon HJ, Young VL: Characterization and removal of electrosurgical smoke. Surg Serv Manage 3(3):14–16, 1997

5. Dikes CN: Is it safe to allow smoke in our operating room? Today's Surg Nurse 21(2):15–21, 1999

6. Gatti JE, Bryant CJ, Noone RB, Murphy JB: The mutagenicity of electrocautery smoke. Plast Reconstr Surg 89(5):781–784, 1992

7. King B, McCullough J: Health hazard evaluation report 2001-0030-3020. NIOSH, 2006

8. Sawchuk WS, Weber PJ, Lowy DR, Dzubow LM: Infectious papillomavirus in the vapor of warts treated with carbon dioxide laser or electrocoagulation: detection and protection. J Am Acad Dermatol 21(1):41–49, 1989

9. Walker B: High efficiency filtration removes hazards from laser
surgery. Natnews 27(6):10–12

10. Wenig BL, Stenson KM, Wenig BM, Tracey D: Effects of plume produced by the Nd:YAG laser and electrocautery on the respiratory system. Lasers Surg Med 13(2):242–245, 1993

TAMPA, May 10, 2008 - For low-back pain patients and their doctors, the American Pain Society, said today it is expanding its evidence-based, clinical practice guideline on diagnosis and treatment of chronic low back pain to include recommendations on surgery and other interventional treatments. The expanded guideline was previewed today in a symposium at the APS Annual Scientific Meeting.

The second part of the APS guideline is based on a multidisciplinary panel¡¦s review and analysis of volumes of evidence related to diagnosis and treatment of low-back pain with a number of interventional procedures and surgeries, according to Roger Chou, MD, director of the American Pain Society¡¦s Clinical Practice Guideline Program and associate professor of internal medicine, Oregon Health & Science University.

"Prior to finalizing the guideline, APS conducts extensive peer review, and has sent the guideline to more than 20 experts in surgery, interventional pain medicine, primary care, and other disciplines for comments and feedback," Chou said.

Low-back pain is the fifth most common reason for doctor¡¦s office visits and one in four adults report having it last a least a day. Annually, low-back pain is estimated to account for more than $26 billion in direct health care costs in the U.S.

"The evidence is much better than even five or 10 years ago and both the primary care and interventional recommendations will help physicians be more confident when evaluating possible therapies for low back pain," said Chou. "As always, physicians and patients should discuss possible options proven by the evidence and choose the ones that make sense for their situation," he added.

During the symposium, Chou and two panel co-chairs, Richard Rosenquist, MD, assistant professor of anesthesiology, University of Iowa, and John Loeser, MD, professor, Department of Neurological Surgery, University of Washington, reported that for many interventional procedures the evidence from randomized controlled trials is mixed, sparse, not available or showed no benefits. Accordingly, the expanded, evidence-based APS guideline will report:

• The expert panel reaffirms its previous recommendation that all low-back pain patients stay active and talk honestly with their physicians about self care and other interventions. "In general, non-invasive therapies supported by evidence showing benefits should be tried before considering interventional therapies or surgery," said Chou.

Full-time employment of an intensivist in an ICU is associated with reduced mortality rates in adult patients following abdominal aortic aneurysm repair. There are few studies related to the influence of an intensivist on neurologic and neurosurgical patients, however. In a retrospective study, Varelas et al. evaluated the impact of a newly appointed neurointensivist on mortality rate, length of stay (LOS), and discharge disposition of all patients with head injury who had been admitted to a 10-bed tertiary care university hospital neurologic/neurosurgical ICU.
Using hospital and the university health system consortium (UHC) database, Varelas et al. analyzed data related to all neurologic/neurosurgical ICU trauma admissions during two consecutive 19-month periods, one before (n = 328) and one after (n = 264) the appointment of a neurointensivist. During the period after the new appointment, the in-hospital mortality rate (unadjusted mean) increased by 1.1%. This increase was lower, however, compared with the expected UHC-based increase of 8.1% during the same period (P < .0001). A decrease in the mortality rate in the neurologic/neurosurgical ICU (from 13.4% to 12.9%) and a mean increase in neurologic/neurosurgical ICU LOS (from 3.1 to 3.6 days) were found to be nonsignificant. During the period after the new appointment, the multivariate analyses showed a 51% decrease in the neurologic/neurosurgical ICU-associated mortality rate (P = .01), a 12% shorter hospital LOS (P = .026), and 57% greater odds of being discharged to a home or rehabilitation setting (P = .009).

The authors conclude that the appointment of a neurointensivist had a positive impact on patient outcomes. They suggest that additional studies are warranted to evaluate the long-term outcome of this model, the contribution of health care personnel, and hospital cost savings.

In an editorial, Suarez notes that despite some limitations (including a lack of information regarding the patient premorbid functional status, underlying severity of illness, long-term mortality rate, and quality-of-life assessment), the study by Varelas et al. further supports the role of specialized neurocritical care teams in patient outcomes. In a second editorial, Bleck emphasizes the equally crucial role of neurocritical unit nursing staffs. In ICUs, nurses manage most of the therapy and act as psychologists and spiritual advisors for patients and families. Bleck recommends that nurses should be fully familiar with components of neurologic measurements and protocols.

References
1. Varelas PN, Eastwood D, Yun HJ, et al: Impact of a neurointensivist on outcomes in patients with head trauma treated in a neurosciences intensive care unit. J Neurosurg 104(5):713-719, 2006.
2. Suarez JI: Neurocritical care. J Neurosurg 104(5):711-712; discussion 712, 2006.
3. Bleck TP: The impact of specialized neurocritical care. J Neurosurg 104(5):709-710; discussion 710, 2006.

STASCIS: Early Surgery in Spinal Cord Injury Improves Outcomes, Lowers Complications

April 29, 2008 (Chicago, Illinois) — Early decompressive surgery significantly improves outcomes and reduces complication rates in patients with spinal cord injury (SCI), a large multicenter study suggests.

Presented here at the American Association of Neurological Surgeons (AANS) 76th Annual Meeting, preliminary, 1-year results from the Surgical Treatment of Acute Spinal Cord Injury Study (STASCIS) showed 24% of patients who received decompressive surgery within 24 hours of their injury experienced a 2-grade or greater improvement on the American Spinal Injury Association (ASIA) scale, compared with 4% of those in the delayed-treatment group.

"A 2-grade improvement is a large change that is, without question, of clinical importance. It is still not a home run and far from a cure, but what it means is that 1 in 5 individuals is walking away from an injury they wouldn't normally walk away from," principal investigator Michael Fehlings, MD, PhD, head of the Krembil Neuroscience Centre at the University Health Network, in Toronto, Ontario, told Medscape Neurology & Neurosurgery.

Furthermore, he said, complication rates among individuals who received early intervention were about 20% lower than in those whose treatment was delayed.

According to Dr. Fehlings, the role and timing of decompression in SCI is controversial. In large part, he said, the debate centers on whether timing of surgery makes any difference to outcomes.

"Many people believe that it is better to stabilize patients first and that the timing of the intervention doesn't really matter. This prevailing attitude is based on the idea that all of the damage occurs during the initial trauma," he said.

However, he added, there is now strong evidence to suggest there is a biologic rationale for using decompressive surgery early on to mitigate progressive secondary injury.

"During the primary injury, the blood vessels in the spinal cord are mechanically disrupted, but then there are chemical reactions that occur that cause further damage. This secondary injury initiates a cascade of events that includes the release of calcium and sodium, which causes further damage and leads to cell death," said Dr. Fehlings.

Lower Complication Rate

To determine whether early surgical intervention would limit spinal cord damage and improve outcomes, the investigators recruited 170 consecutive patients from 10 centers in Canada and the United States who had subaxial cervical SCI and imaging evidence of spinal cord compression.

The investigators chose 24 hours as the cutoff point for early decompression based on pilot data indicating that it may be an optimal time point for the prevention of secondary injury.

According to Dr. Fehlings, whether patients were in the "early" or "delayed" group was determined by natural variations in the length of time it took them to reach the study center.

Patients were eligible for the study only if they were enrolled within 24 hours of injury and had to undergo surgery within 7 days of SCI. Outcomes were assessed at 6 months and 1 year postinjury.

In addition to an average 2-grade or greater improvement in ASIA scores, Dr. Fehlings said, the investigators found that complications, particularly those involving the cardiopulmonary system and urinary tract, were lower in the early surgery group — 37.1% vs 48.6%.

"Going into this study, I was prepared that we might not see a difference in outcomes. But I think that the fact that we are seeing reductions in complications and improved neurological outcomes is amazing," said Dr. Fehlings.

"Our initial estimates of a sample size required to show a difference was on the order of around 400 patients, and the fact that we saw any difference at all, particularly with 170 patients, was a bit of a surprise," he added.

A Medical Emergency

While further study is required to validate these findings, Dr. Fehlings said the results suggest that, like stroke, where timing of treatment is critical to outcome, SCI should be considered a medical emergency.

In fact, he said, based on the current literature and emerging data from STASCIS, the Spine Study Trauma Group, a consensus-based group of the world's 40 top spine surgeons, has recommended that patients with an acute SCI, without other life-threatening conditions, should have early decompression surgery within 24 hours of injury.

Furthermore, he noted, early intervention offers clinicians the opportunity to apply other, so-called regenerative treatments that may augment the effect of surgery and further improve recovery in SCI patients.

One such treatment may be Cethrin (Alseres Pharmaceuticals), a recombinant protein antagonist of a molecule known as Rho, which inhibits nerve cell regeneration and repair, which is showing "very promising results" in SCI patients.

A second study presented at the AANS meeting by Dr. Fehlings and colleagues shows that this so-called regenerative treatment is safe and well-tolerated and has potential neurological benefit.

"With the emergence of the era of regenerative medicine and the resulting treatments that are now finding their way into the clinic, we have an opportunity to optimize the milieu for recovery in spinal cord injury patients," he said.