Object Chronic subdural hematoma (CSDH) is perceived to be a “benign,” easily treated condition in the elderly, but reported follow-up periods are brief, usually limited to acute hospitalization. Methods The authors conducted a retrospective review of data obtained in a prospectively identified consecutive series of adult patients admitted to their institution between September 2000 and February 2008 and in whom there was a CT diagnosis of CSDH. Survival data were compared to life-table data. Results Of the 209 cases analyzed, 63% were men and the mean age was 80.6 years (range 65–96 years). Primary surgical interventions performed were bur holes in 21 patients, twist-drill closed-system drainage in 44, and craniotomies in 72. An additional 72 patients were simply observed. Reoperations were recorded in 5 patients—4 who had previously undergone twist-drill drainage and 1 who had previously undergone a bur hole procedure (p = 0.41, chi-square analysis). Thirty-five patients (16.7%) died in hospital, 130 were discharged to rehabilitation or a skilled care facility, and 44 returned home. The follow-up period extended to a maximum of 8.3 years (median 1.45 years). Six-month and 1-year mortality rates were 26.3% and 32%, respectively. In the multivariate analysis (step-wise logistic regression), the sole factor that predicted in-hospital death was neurological status on admission (OR 2.1, p = 0.02, for each step). Following discharge, the median survival in the remaining cohort was 4.4 years. In the Cox proportional hazards model, only age (hazard ratio [HR] 1.06/year, p = 0.02) and discharge to home (HR 0.24, p = 0.01) were related to survival, whereas the type of intervention, whether surgery was performed, size of subdural hematoma, amount of shift, bilateral subdural hematomas, and anticoagulant agent use did not affect the long- or short-term mortality rate. Comparison of postdischarge survival and anticipated actuarial survival demonstrated a markedly increased mortality rate in the CSDH group (median survival 4.4 vs 6 years, respectively; HR 1.94, p = 0.0002, log-rank test). This excess mortality rate was also observed at 6 months postdischarge with evidence of normalization only at 1 year. Conclusions In this first report of the long-term outcome of elderly patients with CSDH the authors observed persistent excess mortality up to 1 year beyond diagnosis. This belies the notion that CSDH is a benign disease and indicates it is a marker of other underlying chronic diseases similar to hip fracture.
OBJECTIVE Long-term outcomes of single-level lumbar arthroplasty are understood to be very good, with the most recent Investigational Device Exemption (IDE) trial showing a < 5% reoperation rate at the close of the 7-year study. This post hoc analysis was conducted to determine whether specific patients from the activL IDE data set had better outcomes than the mean good outcome of the IDE trial, as well as to identify contributing factors that could be optimized in real-world use. METHODS Univariable and multivariable logistic regression models were developed using the randomized patient set (n = 283) from the activL trial and used to identify predictive factors and to derive risk equations. The models were internally validated using the randomized patient set and externally validated using the nonrandomized patient set (n = 52) from the activL trial. Predictive power was assessed using area under the receiver operating characteristic curve analysis. RESULTS Two factors were significantly associated with achievement of better than the mean outcomes at 7 years. Randomization to receive the activL device was positively associated with better than the mean visual analog scale (VAS)–back pain and Oswestry Disability Index (ODI) scores, whereas preoperative narcotics use was negatively associated with better than the mean ODI score. Preoperative narcotics use was also negatively associated with return to unrestricted full-time work. Other preoperative factors associated with positive outcomes included unrestricted full-time work, working manual labor after index back injury, and decreasing disc height. Older age, greater VAS–leg pain score, greater ODI score, female sex, and working manual labor before back injury were identified as preoperative factors associated with negative outcomes. Preoperative BMI, VAS–back pain score, back pain duration ≥ 1 year, SF-36 physical component summary score, and recreational activity had no effect on outcomes. CONCLUSIONS Lumbar total disc replacement for symptomatic single-level lumbar degenerative disc disease is a well-established option for improving long-term patient outcomes. Discontinuing narcotics use may further improve patient outcomes, as this analysis identified associations between no preoperative narcotics use and better ODI score relative to the mean score of the activL trial at 7 years and increased likelihood of return to work within 7 years. Other preoperative factors that may further improve outcomes included unrestricted full-time work, working manual labor despite back injury, sedentary work status before back injury, and randomization to receive the activL device. Tailoring patient care before total disc replacement may further improve patient outcomes.
Background: This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes.Methods: This was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed !6 months of nonsurgical management. Patients (N ¼ 283) were randomized to receive activL (n ¼ 218) or ProDisc-L (n ¼ 65). At 7 years, data were available from 206 patients (activL, 160; 46). Logistic regression models were fit to predict 7-year outcomes for patients lost to follow-up after 2 years.Results: At 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint (P ¼ .0369). Both groups showed significant reductions in back/leg pain severity and improvements in disability index and quality-of-life relative to baseline (P , .0001). In both groups, opioid use was significantly reduced at 7 years (0%) relative to baseline (P , .01), and the overall reoperation rates were low (4.6%). activL patients showed a significantly better range of motion (ROM) for flexion-extension rotation than ProDisc-L patients (P ¼ .0334). A significantly higher proportion of activL patients did not report serious adverse events (activL, 62%; ProDisc-L, 43%; P ¼ .011). Predictive modeling indicated that .70% of patients (depending on outcome) lost to follow-up after 2 years would show clinically significant improvement at 7 years if improvements were achieved at 2 years.Conclusions: The benefits of activL and ProDisc-L are maintained after 7 years, with significant improvements from baseline observed in pain, function, and opioid use. activL is more effective at preserving ROM than ProDisc-L and has a more favorable safety profile. Improvements in other primary and secondary outcomes were similar between both disc designs.Level of Evidence: 1.
Study Design. A modified Delphi method was used to establish consensus. Subject matter experts were invited to participate as the expert panel. Best practice statements were distributed to the panel. Panel members were asked to mark “agree” or “disagree” after a series of statements during several rounds until either consensus could be obtained or the practice method was deemed unable to achieve consensus. Objective. Lumbar total disc replacement (TDR) is acknowledged as an alternative to spinal fusion in appropriately selected patients. There is a lack of unanimity on the appropriate postoperative patient protocols and rehabilitation expectations for the procedure. The long-term viability of Lumbar TDR, further adoption in the community setting and specific patient outcomes are contingent on the existence of appropriate postoperative recovery programs. Summary of Background Data. Currently there are no established methods for postoperative care following lumbar TDR. Establishing a postoperative clinical pathway algorithm may improve patient outcomes with respect to lumbar TDR. Method. A lumbar TDR expert panel of 22 spine surgeons employed a modified Delphi method to drive consensus on postoperative care following single-level Lumbar TDR. The panel first reviewed literature and guidelines relevant to postoperative care following lumbar TDR. Panel members considered 21 survey questions intended to determine “standard-practice” postoperative care recommendations for patients who have undergone lumbar TDR for the initial recovery phase (0–4 wk) and rehabilitation (4–20 wk). Each panel member participated in a round of anonymous voting followed by a group discussion. Consensus was defined as 80% agreement or higher among the respondents. Results. Consensus was achieved in 11 of the 21 survey questions. There was a high degree of consensus around the key goals for both the initial recovery and rehabilitation phases, ceased use of narcotics for pain management by 4 weeks postoperative, unrestricted walking immediately following surgery, timelines for physical therapy (within 2–4 wk) and return to work based on level of activity (as early as 1 wk postoperative). Lack of agreement included the use of back bracing and timing of postoperative visits. Generally, panel members felt that patient expectations regarding return to function were different following lumbar TDR versus fusion and warrant further study. Conclusion. Surgeon and patient alignment around postoperative expectations may significantly affect the long-term results of lumbar TDR. This surgeon consensus study found agreement for immediate postoperative ambulation, rapid reduction in opioids within the first month, and early return to work. When expectations are appropriately set with patients preoperatively, both provider and patient have shared goals in the return-to-function process. Level of Evidence: 5
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