Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Amusia for pitch caused by right middle cerebral artery infarct.

A 61-year-old right-handed man with hypertension and dyslipidemia noted that he was singing along to classic rock songs on his car radio, but his voice was off pitch. Six days later, a magnetic resonance imaging scan of his brain revealed a cerebral infarct of the right temporal parietal cortex and insula. Case reports of the precise anatomic correlates of disordered pitch musical processing have been few and fragmentary. The anatomic involvement of our case coincides with the areas of involvement in 3 previously reported cases. Increased awareness of amusia as a rare clinical presentation of stroke should lead to earlier stroke intervention.

Dedicated isotropic 3-D T1 SPACE sequence imaging for radiosurgery planning improves brain metastases detection and reduces the risk of intracranial relapse.

BACKGROUND: Stereotactic radiosurgery (SRS) is increasingly used for brain metastases (BM) patients, but distant intracranial failure (DIF) remains the principal disadvantage of this focal therapeutic approach. The objective of this study was to determine if dedicated SRS imaging would improve lesion detection and reduce DIF. METHODS: Between 02/2020 and 01/2021, SRS patients at a tertiary care institution underwent dedicated treatment planning MRIs of the brain including MPRAGE and SPACE post-contrast sequences. DIF was calculated using the Kaplan-Meier method; comparisons were made to a historical consecutive cohort treated using MPRAGE alone (02/2019-01/2020). RESULTS: 134 patients underwent 171 SRS courses for 821 BM imaged with both MPRAGE and SPACE (primary cohort). MPRAGE sequence evaluation alone detected 679 lesions. With neuroradiologists evaluating SPACE and MPRAGE, an additional 108 lesions were identified (p < 0.001). Upon multidisciplinary review, 34 additional lesions were identified. Compared to the historical cohort (103 patients, 135 SRS courses, 479 BM), the primary cohort had improved median time to DIF (13.5 vs. 5.1 months, p = 0.004). The benefit was even more pronounced for patients treated for their first SRS course (18.4 vs. 6.3 months, p = 0.001). SRS using MPRAGE and SPACE was associated with a 60% reduction in risk of DIF compared to the historical cohort (HR: 0.40; 95% CI: 0.28-0.57, p < 0.001). CONCLUSIONS: Among BM patients treated with SRS, a treatment planning SPACE sequence in addition to MPRAGE substantially improved lesion detection and was associated with a statistically significant and clinically meaningful prolongation in time to DIF, especially for patients undergoing their first SRS course.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial).

Cerebral embolization during transcatheter aortic valve implantation (TAVI) can lead to a spectrum of clinically relevant manifestations, ranging from overt stroke to mild neurologic or cognitive deficits and subclinical cerebral infarcts. This study sought to determine the frequency of neurologic injury, cerebral ischemic lesions, and cognitive dysfunction in subjects undergoing contemporary commercial TAVI in the United States. Neuro-TAVR is the first prospective, multicenter study to use serial systematic neurologic and cognitive assessments and diffusion-weighted magnetic resonance imaging (at 4 ± 2 days after procedure) to investigate the incidence and severity of neurologic injury after contemporary unprotected TAVI in the United States. A total of 44 consecutive patients underwent TAVI at 5 US sites. Diffusion-weighted magnetic resonance imaging lesions were detected in 94%, with a mean of 10.4 ± 15.3 lesions per subject and a median total lesion volume of 295 mm3 (interquartile range 71.6 to 799.6 mm3). New neurologic impairment (worsening in National Institutes of Health Stroke Scale score from baseline with new cerebral lesions) occurred in 22.6% (7 of 31) of subjects at discharge and 14.8% (4 of 27) at 30 days. In addition, cognitive decrements from baseline were identified by the Montreal Cognitive Assessment in 33% (12 of 36) of subjects at discharge and 41% (13 of 32) at 30 days. In conclusion, this contemporary cohort of US patients confirms that TAVI results in cerebral infarction in most patients and that 1 in 5 patients have measurable neurologic impairment and 1 in 3 patients have decrease in cognitive measures by Montreal Cognitive Assessment score after TAVI, reinforcing the need for methods to mitigate the risk of brain injury during TAVI.

Severe venous congestive encephalopathy secondary to a dialysis arteriovenous graft.

The clinical presentation and imaging of venous congestive encephalopathy (VCE) can mimic several neurological conditions, making the diagnosis challenging. We report a patient with end stage renal disease on dialysis who presented with a right occipital infarction. The patient developed progressive encephalopathy and increased intracranial pressure. Extensive imaging, electroencephalography and serum analysis did not explain the cause of his infarction and progressive neurological deterioration. Finally, cerebral angiography and venography demonstrated severe generalized VCE due to arterial shunting from a right upper extremity arteriovenous graft (AVG) and an occluded right innominate venous trunk. The right arm shunt resulted in severe cerebral venous hypertension due to ipsilateral occlusion of the innominate venous trunk. After the AVG was repaired, the cerebral venous hypertension resolved and the patient returned to baseline.

Zonal frequency analysis of infarct extent. Part II: anterior and posterior cerebral artery infarctions.

The object of the study was to test the hypotheses that analysis of the anatomic zones affected by single anterior (A), posterior (P), and middle (M) cerebral artery (CA) infarcts, and by dual- and triple-vessel infarcts, will disclose (i) sites most frequently involved by each infarct type (peak sites), (ii) sites most frequently injured by multiple different infarct types (vulnerable zones), and (iii) anatomically overlapping sites in which the relative infarct frequency becomes equal for two or more different infarct types and/or in which infarct frequency shifts greatly between single and multivessel infarcts (potential border zones). Precise definitions of each vascular territory were adopted. CT and MRI studies from 20 ACA, 20 PCA, three dual ACA-PCA, and four triple ACA-PCA-MCA infarcts were mapped onto a standard template (Part I). Relative infarct frequencies in each zone were analyzed within and across infarct types to identify the centers and peripheries of each infarct type, the zones most frequently affected by multiple different infarct types, the zones where relative infarct frequency was equal for different infarcts, and the zones where infarct frequency shifted markedly from single- to multiple-vessel infarcts. Zonal frequency analysis provided quantitative data on the relative infarct frequency in each anatomic zone for each infarct type. It displayed zones of peak infarct frequency for each infarct, zones more vulnerable to diverse types of infarct, peripheral "overlap" zones of equal infarct frequency, and zones where infarct frequency shifted markedly between single- and multiple-vessel infarcts. It is concluded that the hypotheses are correct.