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Owoicho Adogwa, Isaac O. Karikari, Aladine A. Elsamadicy, Amanda R. Sergesketter, Diego Galan and Keith H. Bridwell

OBJECTIVE

Patient-reported outcomes (PROs) are often measured up to 2 years after surgery; however, prospective collection of longitudinal outcomes for 5 years postoperatively can be challenging due to lack of patient follow-up. The aim of this study was to determine whether PROs collected at 2-year follow-up accurately predict long-term PROs 5 years after complex spinal fusion (≥ 5 levels).

METHODS

This was an ambispective study of 118 adult patients (≥ 18 years old) undergoing ≥ 5-level spinal arthrodesis to the sacrum with iliac fixation from January 2002 to December 2011. Patient demographics and radiographic parameters as well as intraoperative variables were collected. PRO instruments (Scoliosis Research Society [SRS]-22r function, self-image, mental health, pain, and Oswestry Disability Index [ODI]) were completed before surgery then at 2 and 5 years after surgery. Primary outcome investigated in this study was the correlation between SRS-22r domains and ODI collected at 2- and 5-year follow-up.

RESULTS

Of the 118 patients, 111 patients had baseline PROs, 105 patients had 2-year follow-up data, and 91 patients had 5-year follow-up PRO data with 72% undergoing revision surgery. The average pre- and postoperative major coronal curve Cobb angles for the cohort were 32.1° ± 23.7° and 19.8° ± 19.3°, respectively. There was a strong correlation between 2- and 5-year ODI (r2 = 0.80, p < 0.001) and between 2- and 5-year SRS-22r domains, including function (r2 = 0.79, p < 0.001), self-image (r2 = 0.82, p < 0.001), mental health (r2 = 0.77, p < 0.001), and pain (r2 = 0.79, p < 0.001). Of the PROs, ODI showed the greatest absolute change from baseline to 2- and 5-year follow-up (2-year Δ 17.6 ± 15.9; 5-year Δ 16.5 ± 19.9) followed by SRS-22r self-image (2-year Δ 1.4 ± 0.96; 5-year Δ 1.3 ± 1.0), pain (2-year Δ 0.94 ± 0.97; 5-year Δ 0.80 ± 1.0), function (2-year Δ 0.60 ± 0.62; 5-year Δ 0.49 ± 0.79), and mental health (2-year Δ 0.49 ± 0.77; 5-year Δ 0.38 ± 0.84).

CONCLUSIONS

Patient-reported outcomes collected at 2-year follow-up may accurately predict long-term PROs (5-year follow-up).

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Owoicho Adogwa, Aladine A. Elsamadicy, Victoria D. Vuong, Jessica Moreno, Joseph Cheng, Isaac O. Karikari and Carlos A. Bagley

OBJECTIVE

Geriatric patients undergoing lumbar spine surgery have unique needs due to the physiological changes of aging. They are at risk for adverse outcomes such as delirium, infection, and iatrogenic complications, and these complications, in turn, contribute to the risk of functional decline, nursing home admission, and death. Whether preoperative and perioperative comanagement by a geriatrician reduces the incidence of in-hospital complications and length of in-hospital stay after elective lumbar spine surgery remains unknown.

METHODS

A unique model of comanagement for elderly patients undergoing lumbar fusion surgery was implemented at a major academic medical center. The Perioperative Optimization of Senior Health (POSH) program was launched with the aim of improving outcomes in elderly patients (> 65 years old) undergoing complex lumbar spine surgery. In this model, a geriatrician evaluates elderly patients preoperatively, in addition to performing routine preoperative anesthesia surgical screening, and comanages them daily throughout the course of their hospital stay to manage medical comorbid conditions and coordinate multidisciplinary rehabilitation along with the neurosurgical team. The first 100 cases were retrospectively reviewed after initiation of the POSH protocol and compared with the immediately preceding 25 cases to assess the incidence of perioperative complications and clinical outcomes.

RESULTS

One hundred twenty-five patients undergoing lumbar decompression and fusion were enrolled in this pilot program. Baseline characteristics were similar between both cohorts. The mean length of in-hospital stay was 30% shorter in the POSH cohort (6.13 vs 8.72 days; p = 0.06). The mean duration of time between surgery and patient mobilization was significantly shorter in the POSH cohort compared with the non-POSH cohort (1.57 days vs 2.77 days; p = 0.02), and the number of steps ambulated on day of discharge was 2-fold higher in the POSH cohort (p = 0.04). Compared with the non-POSH cohort, the majority of patients in the POSH cohort were discharged to home (24% vs 54%; p = 0.01).

CONCLUSIONS

Geriatric comanagement reduces the incidence of postoperative complications, shortens the duration of in-hospital stay, and contributes to improved perioperative functional status in elderly patients undergoing elective spinal surgery for the correction of adult degenerative scoliosis.

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Owoicho Adogwa, Aladine A. Elsamadicy, Amanda Sergesketter, Victoria D. Vuong, Ankit I. Mehta, Raul A. Vasquez, Joseph Cheng, Carlos A. Bagley and Isaac O. Karikari

OBJECTIVE

Wound infections following spinal surgery for deformity place a high toll on patients, providers, and the health care system. The prophylactic application of intraoperative vancomycin powder has been shown to lower the infection risk after thoracolumbar decompression and fusion for deformity correction. The purpose of this study was to assess the microbiological patterns of postoperative surgical site infections (SSIs) after prophylactic use of vancomycin powder in adult patients undergoing spinal deformity surgery.

METHODS

All cases involving adult patients who underwent spinal deformity reconstruction at Duke University Medical Center between 2011 and 2013 with a minimum of 3 months of clinical follow-up were retrospectively reviewed. In all cases included in the study, crystalline vancomycin powder was applied to the surgical bed for infection prophylaxis. Baseline characteristics, operative details, rates of wound infection, and microbiological data for each case were gathered by direct medical record review.

RESULTS

A total of 1200 consecutive spine operations were performed for deformity between 2011 and 2013. Review of the associated records demonstrated 34 cases of SSI, yielding an SSI rate of 2.83%. The patients’ mean age (± SD) was 62.08 ± 14.76 years. The patients’ mean body mass index was 30.86 ± 7.15 kg/m2, and 29.41% had a history of diabetes. The average dose of vancomycin powder was 1.41 ± 2.77 g (range 1–7 g). Subfascial drains were placed in 88% of patients. All SSIs occurred within 30 days of surgery, with deep wound infections accounting for 50%. In 74% of the SSIs cultures were positive, with about half the organisms being gram negative, such as Citrobacter freundii, Proteus mirabilis, Morganella morgani, and Pseudomonas aeruginosa. There were no adverse clinical outcomes related to the local application of vancomycin.

CONCLUSIONS

Our study suggests that in the setting of prophylactic vancomycin powder use, the preponderance of SSIs are caused by gram-negative organisms or are polymicrobial. Further randomized control trials of prophylactic adjunctive measures are warranted to help guide the choice of empirical antibiotic therapy while awaiting culture data.

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Aladine A. Elsamadicy, Owoicho Adogwa, Emily Lydon, Amanda Sergesketter, Rayan Kaakati, Ankit I. Mehta, Raul A. Vasquez, Joseph Cheng, Carlos A. Bagley and Isaac O. Karikari

OBJECTIVE

Depression is the most prevalent affective disorder in the US, and patients with spinal deformity are at increased risk. Postoperative delirium has been associated with inferior surgical outcomes, including morbidity and mortality. The relationship between depression and postoperative delirium in patients undergoing spine surgery is relatively unknown. The aim of this study was to determine if depression is an independent risk factor for the development of postoperative delirium in patients undergoing decompression and fusion for deformity.

METHODS

The medical records of 923 adult patients (age ≥ 18 years) undergoing elective spine surgery at a single major academic institution from 2005 through 2015 were reviewed. Of these patients, 255 (27.6%) patients had been diagnosed with depression by a board-certified psychiatrist and constituted the Depression group; the remaining 668 patients constituted the No-Depression group. Patient demographics, comorbidities, and intra- and postoperative complication rates were collected for each patient and compared between groups. The primary outcome investigated in this study was rate of postoperative delirium, according to DSM-V criteria, during initial hospital stay after surgery. The association between depression and postoperative delirium rate was assessed via multivariate logistic regression analysis.

RESULTS

Patient demographics and comorbidities other than depression were similar in the 2 groups. In the Depression group, 85.1% of the patients were taking an antidepressant prior to surgery. There were no significant between-group differences in intraoperative variables and rates of complications other than delirium. Postoperative complication rates were also similar between the cohorts, including rates of urinary tract infection, fever, deep and superficial surgical site infection, pulmonary embolism, deep vein thrombosis, urinary retention, and proportion of patients transferred to the intensive care unit. In total, 66 patients (7.15%) had an episode of postoperative delirium, with depressed patients experiencing approximately a 2-fold higher rate of delirium (10.59% vs 5.84%). In a multivariate logistic regression analysis, depression was an independent predictor of postoperative delirium after spine surgery in spinal deformity patients (p = 0.01).

CONCLUSIONS

The results of this study suggest that depression is an independent risk factor for postoperative delirium after elective spine surgery. Further studies are necessary to understand the effects of affective disorders on postoperative delirium, in hopes to better identify patients at risk.

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Mazda K. Turel, Mena G. Kerolus, Owoicho Adogwa and Vincent C. Traynelis

OBJECTIVE

The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published.

METHODS

The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed.

RESULTS

In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success.

CONCLUSIONS

This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

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Owoicho Adogwa, Aladine A. Elsamadicy, Jing L. Han, Joseph Cheng, Isaac Karikari and Carlos A. Bagley

OBJECTIVE

With the recent passage of the Patient Protection and Affordable Care Act, there has been a dramatic shift toward critical analyses of quality and longitudinal assessment of subjective and objective outcomes after lumbar spine surgery. Accordingly, the emergence and routine use of real-world institutional registries have been vital to the longitudinal assessment of quality. However, prospectively obtaining longitudinal outcomes for patients at 24 months after spine surgery remains a challenge. The aim of this study was to assess if 12-month measures of treatment effectiveness accurately predict long-term outcomes (24 months).

METHODS

A nationwide, multiinstitutional, prospective spine outcomes registry was used for this study. Enrollment criteria included available demographic, surgical, and clinical outcomes data. All patients had prospectively collected outcomes measures and a minimum 2-year follow-up. Patient-reported outcomes instruments (Oswestry Disability Index [ODI], SF-36, and visual analog scale [VAS]-back pain/leg pain) were completed before surgery and then at 3, 6, 12, and 24 months after surgery. The Health Transition Index of the SF-36 was used to determine the 1- and 2-year minimum clinically important difference (MCID), and logistic regression modeling was performed to determine if achieving MCID at 1 year adequately predicted improvement and achievement of MCID at 24 months.

RESULTS

The study group included 969 patients: 300 patients underwent anterior lumbar interbody fusion (ALIF), 606 patients underwent transforaminal lumbar interbody fusion (TLIF), and 63 patients underwent lateral interbody fusion (LLIF). There was a significant correlation between the 12- and 24-month ODI (r = 0.82; p < 0.0001), SF-36 Physical Component Summary score (r = 0.89; p < 0.0001), VAS-back pain (r = 0.90; p < 0.0001), and VAS-leg pain (r = 0.85; p < 0.0001). For the ALIF cohort, patients achieving MCID thresholds for ODI at 12 months were 13-fold (p < 0.0001) more likely to achieve MCID at 24 months. Similarly, for the TLIF and LLIF cohorts, patients achieving MCID thresholds for ODI at 12 months were 13-fold and 14-fold (p < 0.0001) more likely to achieve MCID at 24 months. Outcome measures obtained at 12 months postoperatively are highly predictive of 24-month outcomes, independent of the surgical procedure.

CONCLUSIONS

In a multiinstitutional prospective study, patient-centered measures of surgical effectiveness obtained at 12 months adequately predict long-term (24-month) outcomes after lumbar spine surgery. Patients achieving MCID at 1 year were more likely to report meaningful and durable improvement at 24 months, suggesting that the 12-month time point is sufficient to identify effective versus ineffective patient care.