BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.
The neuroanatomical structures that approximate the bony pedicles of the lumbar spine allow little room for technical error or compromise of the bone during pedicle screw insertion. Currently available neurophysiological monitoring techniques detect compromised bone and nerve root injury after it occurs. The purpose of this prospective study is to evaluate the reliability and efficacy of a unique neurophysiological monitoring technique. This technique provides immediate evaluation of pedicle cortical bone integrity in patients undergoing lumbar fusion with instrumentation by using electrified surgical instruments throughout the pedicle screw fusion procedure. Spontaneous electromyographic (EMG) activity was also monitored. Intraoperative evoked EMG stimulation was performed using a pedicle probe and feeler as monopolar stimulators during the insertion of 164 pedicle bone screws in 32 patients. The EMG response to subthreshold stimulation intensities indicated cortical bone compromise. Immediate and conclusive feedback via evoked EMG activity using stimulating pedicle probes in appropriate muscle groups was successful in identifying pedicle cortical bone compromise in four patients. One false-negative evoked EMG study was noted but was identified via spontaneous EMG activity. Intraoperative EMG monitoring alerted the surgeon that redirection of the pedicle probe or screw was necessary to avoid nerve root irritation or injury and served as an early warning system. Evoked EMG stimulation proved to be reliable and efficacious, especially when used in combination with spontaneous EMG. This technique may provide an added safeguard during implant placement procedures at centers where intraoperative neurophysiological monitoring is routinely performed.
Frameless stereotaxy provided the surgeon with intraoperative information regarding the extent of bone and soft tissue resection. It provided a multidimensional view of anatomic relationships in the operative field, which significantly increased surgical accuracy and safety.
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