A Randomized, Double-Blind, Active Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Liztox® versus Botox® in Post-Stroke Upper Limb Spasticity.

Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox® in comparison to onabotulinum toxin A (Botox®) for individuals with post-stroke upper limb spasticity. The primary outcome was the alteration in wrist flexor muscle tone from the initial assessment to the fourth week, evaluated using the modified Ashworth scale (MAS). Secondary outcomes included MAS score changes for the wrist at weeks 8 and 12 from baseline; MAS score changes for finger and elbow flexors; and changes in the Disability Assessment Scale (DAS), Subject's Global Assessment (SGA), the Investigator's Global Assessment (IGA), and Caregiver Burden Scale (CBS) at weeks 4, 8, and 12 from baseline. The MAS score for wrist flexor spasticity decreased by -1.14 ± 0.59 in the Liztox® group and -1.22 ± 0.59 in the Botox® group from baseline to week 4. The difference [97.5% confidence interval (CI)] between the test and control groups was 0.08 [-∞, 0.26], confirming the non-inferiority of the test group compared to the control group. Furthermore, there were consistent improvements in the IGA, SGA, and CBS scores across all assessment intervals, with no statistically significant variances detected between the two groups. No safety-related concerns were reported during the study. In conclusion, Liztox® injection proved to be a secure and efficacious intervention for managing upper extremity spasticity in post-stroke patients.

Prevalence and clinical predictors of dysphagia after heart transplantation.

INTRODUCTION: Dysphagia is a common complication after heart transplantation (HTPL), but few studies exist on dysphagia after HTPL, and the prevalence is unknown. The objective of our current study was to establish the prevalence and risk factors for dysphagia after HTPL and to classify its characteristics through Videofluoroscopic Swallowing Studies (VFSS). METHODS: The recipients of HTPL carried out at a single center from January 2011 to November 2019 were assessed retrospectively. Dysphagia was evaluated by a bedside swallowing exam and VFSS to evaluate for evidence of aspiration. The duration of ventilator and preoperative extracorporeal membrane oxygenation (ECMO) support, intensive care unit, hospital stay, the progress of oral feeding after surgery, the presence of a tracheostomy, and vocal cord palsy were analyzed. On the third and seventh days following surgery, we looked at the relationship between risk factors and oral feeding progress, respectively. Additionally, we contrasted these risk variables with the no penetration/aspiration (PA) group and the PA group on VFSS. RESULTS: Among the study cohort of 421 patients, 222 (52.7%) patients had access to oral feeding on the third day of surgery. The number of patients who underwent VFSS due to clinically suspected dysphagia was 96 (22.8%). Of these, 54 (56.2%) had aspiration or penetration (PA group), while 42 (43.8%) had no abnormal findings (No-PA group). In the multivariable regression model, preoperative ECMO support, vocal cord abnormalities, tracheostomy, and emergent need for HTPL were identified as independent risk variables for oral feeding progress on postoperative days (PODs) 3 and 7. Among these factors, preoperative ECMO support had the highest odds ratio (OR) at PODs 3 (OR: 4.73, CI: 1.997, 11.203, p < .001) and 7 (OR: 5.143, CI: 2.294, 11.53, p < .001). CONCLUSION: We identified the prevalence and potential risk factors for postoperative dysphagia in this retrospective analysis of 421 heart transplant recipients. The pathophysiology of postoperative dysphagia was multifactorial, and it was more common than the incidence after general cardiothoracic surgery.

An Unusual Case of Torticollis: Split Cord Malformation with Vertebral Fusion Anomaly: A Case Report and a Review of the Literature.

We describe the exceptional case of spinal cord malformation, associating neurenteric cyst, and cervical vertebral malformation, initially presenting as torticollis. A 4-month-old child presented with torticollis to the right since birth. A cervical spine X-ray revealed suspicious findings of fusion anomaly, and a cervical spine CT showed extensive segmentation-fusion anomaly with an anterior and posterior bony defect in the C1-6 vertebrae. A cervical spine MRI revealed extensive segmentation-fusion anomaly with an anterior bony defect, and the spinal cord split forward and backward at the C3 level, showing two hemicords. The anterior half of the hemicord and dural sac extended to the right inferior side, towards the upper blind end of esophageal duplication, and the posterior half joined the hemicord at the back and C6 level. After multidisciplinary collaboration, follow-up and conservative treatment were planned. At 12 months, he had developmental delay, and torticollis showed little improvement. No neurological abnormalities have been observed. The patient plans to undergo surgery for the cervical spine fusion anomaly. Cervical spine X-rays should always be performed when assessing a patient with torticollis to rule out cervical vertebral segmentation anomalies, despite the rarity of the condition.

Integrating Cardiac Rehabilitation with Neurorehabilitation in a Patient with Ischemic Stroke after Cardiac Surgery: a Case Report.

Stroke and cardiac disorders are difficult to approach separately. Stroke survivors commonly have cardiovascular comorbidities and vice versa. These patients often need both neurorehabilitation and cardiac rehabilitation; therefore, this is an important issue in the rehabilitation process. However, no consensus has been reached on the integration of cardiac rehabilitation and neurorehabilitation. We report the case of a 52-year-old male patient who had ischemic stroke after mitral valvuloplasty. The patient underwent 3 weeks of inpatient neurorehabilitation, and then transited to 6 weeks of outpatient cardiac rehabilitation and occupational therapy. After 9 weeks of well-integrated rehabilitation, the patient experienced neurologic recovery and improvement in his cardiopulmonary fitness. Like this case, successful integrated rehabilitation will contribute to enhancing patients' functional recovery.