The Effect of Early Initiation of Rehabilitation After Lumbar Spinal Fusion: A Randomized Clinical Study

STUDY DESIGN.: A multicenter randomized clinical trial including 82 patients. OBJECTIVE.: To examine the effect of early initiation of rehabilitation after instrumented lumbar spinal fusion. SUMMARY OF BACKGROUND DATA.: Lumbar spinal fusion has been performed for more than 70 years. Yet, few studies have examined patients' subsequent rehabilitation. Group-based rehabilitation is both efficient and cost-effective in rehabilitation of lumbar spinal fusion patients. METHODS.: Patients with degenerative disc diseases undergoing instrumented lumbar spinal fusion were randomly assigned to initiate their rehabilitation 6 weeks (6-wk group) or 12 weeks after lumbar spinal fusion (12-wk group). Both groups received the same group-based rehabilitation. Primary outcome was the Oswestry Disability Index. Secondary outcome was the Dallas Pain Questionnaire, the Low Back Pain Rating Scale, and absence from work. Wilcoxon rank-sum test was used to compare the groups in terms of differences from baseline to 6 months and 1-year follow-up. Results are presented in median with 25th and 75th percentiles. RESULTS.: According to the Oswestry Disability Index, at 1-year follow-up, the 6-week-group had a median reduction of -6 (-19; 4) compared with -20 (-30;-7) in the 12-week group (P, 0.05). The Dallas Pain Questionnaire showed overall the same tendency, and within daily activities were significantly reduced in favor of the 12-week group (P, 0.05). For back pain, the 6-week group had a median reduction of -2.2 (-3.0; -0.7) similar with -3.3 (-4.7; -1.7) in the 12-week group (P, 0.05). The results at 6 months of follow-up were similar. No difference was found according to return to work 1 year postsurgery. CONCLUSION.: Early start of rehabilitation (6 wk vs. 12 wk) after lumbar spinal fusion resulted in inferior outcomes. The improvements in the 12-week group were 4 times better than that in the 6-week group, indicating that the start-up time of rehabilitation is an important contributing factor for the overall outcome.     

Monitoring the one year postoperative infection rate after primary total hip replacement

Purpose

Infection of a total hip replacement is potentially a devastating complication. Statistical process control methods have been generating interest as a means of improving the quality of healthcare, and we report our experience with the implementation of such a method to monitor the one year infection rate after primary total hip replacement.

Method

Infection was defined as the growth of the same organism in cultures of at least two aspirates or intra-operative specimens, or growth of one pathogen in a patient with local signs of infection such as erythema, abscess or draining sinus tract. The cumulative summation test (CUSUM test) was used to continuously monitor the one year postoperative infection rate. The target performance was 0.5% and the test was set to detect twice that rate.

Results

Over the three year study period, 2006 primary total hip replacements were performed. Infection developed within one year after surgery in eight (0.4%) hips. The CUSUM test generated no alarms during the study period, indicating that there was no evidence that the process was out of control.

Conclusion

The one year infection rate after primary total hip replacement was in control. The CUSUM test is a useful method to continuously ensure that performance is maintained at an adequate level.     

Phrenic nerve stimulation in CRT patients and benefits of electronic lead repositioning: the ERACE trial

Purpose

Despite novel left ventricular (LV) lead technologies, phrenic nerve stimulation (PNS) remains an adverse effect observed in many patients with cardiac resynchronization therapy (CRT). Beyond anatomic repositioning, modern CRT devices allow avoidance of PNS also by software-based adaption of the pacing configuration. The Electronic Repositioning With Acuity and Easytrak Leads study evaluated the incidence of PNS in a CRT population and examined how often LV lead relocation can be avoided by “electronic repositioning” (ER).

Methods

Patients who had an indication for implantation of a first CRT defibrillator with the option of ER were enrolled. Primary endpoint was the efficiency of ER determined by the frequency of PNS with the standard pacing configuration (LV tip to RV coil) avoidable by ER. PNS and pacing parameters were evaluated during implant, predischarge, and first routine follow-up (FU) using four different pacing configurations available by ER.

Results

In total, 292 patients were enrolled and provided with a transvenous LV lead (82.2 % male, 65.5?±?9.2 years old). The majority of the population was in NYHA III (84.2 %) with a LV ejection fraction of 25.3?±?6.8 % and mean QRS width of 155?±?27 ms, ischemic cardiomyopathy was present in 43.6 %. Median FU was 116 days. In the standard pacing configuration, PNS was inducible in 19.0/25.6/24.6 % at implant/predischarge/FU, respectively, resulting in 32.2 % of the patients presenting at least once with PNS. The safety margin for the standard pacing configuration between LV and PNS threshold was <1.0 V at 0.5 ms in 5.6/7.0/5.0 % of the patients, corresponding with a total rate of 11.6 % during the FU. In the finally chosen configuration, clinically relevant PNS occurred in 1.0/2.2/1.3 %. The four vector configurations allowed all but 6 of 292 (2 %) patients to be reprogrammed using ER without reoperation.

Conclusions

The incidence of inducible PNS in CRT patients is considerable. In this study, PNS could be avoided in the majority of the patients by means of electronic repositioning. Thus, the use of ER should be considered for CRT patients.     

Hypoglycemia-Associated Electroencephalogram and Electrocardiogram Changes Appear Simultaneously

Background

Tight glycemic control in type 1 diabetes mellitus (T1DM) may be accomplished only if severe hypoglycemia can be prevented. Biosensor alarms based on the body’s reactions to hypoglycemia have been suggested. In the present study, we analyzed three lead electrocardiogram (ECG) and single-channel electroencephalogram (EEG) in T1DM patients during hypoglycemia.

Methods

Electrocardiogram and EEG recordings during insulin-induced hypoglycemia in nine patients were used to assess the presence of ECG changes by heart rate, and estimates of QT interval (QTc) and time from top of T wave to end of T wave corrected for heartbeat interval and EEG changes by extraction of the power of the signal in the delta, theta, and alpha bands. These six features were assessed continuously to determine the time between changes and severe hypoglycemia.

Results

QT interval changes and EEG theta power changes were detected in six and eight out of nine subjects, respectively. Rate of false positive calculations was one out of nine subjects for QTc and none for EEG theta power. Detection time medians (i.e., time from significant changes to termination of experiments) was 13 and 8 min for the EEG theta power and QTc feature, respectively, with no significant difference (p = .25).

Conclusions

Severe hypoglycemia is preceded by changes in both ECG and EEG features in most cases. Electroencephalogram theta power may be superior with respect to timing, sensitivity, and specificity of severe hypoglycemia detection. A multiparameter algorithm that combines data from different biosensors might be considered.     

Transcatheter Aortic valve implantation in a patient with circulatory collapse,using the lucas® chest compression system

We describe a case of Transcatheter Aortic Valve Implantation (TAVI) using the LUCAS® Chest Compression System in an elderly high risk patient with severe aortic stenosis and heart failure. In this case, the patient developed severe aortic regurgitation following predilatation of the native aortic valve and automated cardiopulmonary resuscitation (A‐CPR) was initiated. The procedure was performed under ongoing A‐CPR for a total of 28 min. The patient was transferred to the intensive care unit and to a step down unit the following day. At follow‐up 30 days later, she showed no signs of neurologic or cardiac damage. This case report shows, that it is possible to perform the TAVI procedure under ongoing A‐CPR and that A‐CPR, judged by invasive blood pressures, was capable of maintaining a satisfactory perfusion pressure even with a damaged aortic valve. © 2013 Wiley Periodicals, Inc.