Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial.

INTRODUCTION: The COVID-19 pandemic has presented challenges to managing vascular risk factors with in-person follow-up of patients with asymptomatic carotid stenosis enrolled in the CREST2 trial. CREST2 is comparing intensive medical management alone versus intensive medical management plus revascularization with endarterectomy or stenting. We performed a study to evaluate the feasibility of a home-based program for testing blood pressure (BP) and low-density lipoprotein (LDL) in CREST2. METHODS: This study involved 45 patients at 10 sites in the CREST2 trial. The initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL > 90 mg/dl, or both. If a patient at the site declined participation, another was substituted. All patients who agreed to participate were sent a BP monitoring device and a commercially available at-home lipid test kit that uses a self-performed finger-stick blood sample that was resulted to the patient. Training on the use of the equipment and obtaining the risk factor results was done by the study coordinator by telephone. RESULTS: Ten of the 130 currently active CREST2 sites participated, 8 in the LDL portion and 5 in the BP portion (3 sites did both). Twenty-six BP devices and 23 lipid tests were sent to patients. Of the 26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3. Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4. CONCLUSION: This study established the feasibility of at-home monitoring of BP and LDL in a clinical trial and identified implementation challenges prior to widespread use in the trial. (ClinicalTrials.gov number NCT02089217).

Factors influencing credentialing of interventionists in the CREST-2 trial.

BACKGROUND: The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a pair of randomized trials assessing the relative efficacy of carotid revascularization in the setting of intensive medical management (IMM) in patients with asymptomatic high-grade atherosclerotic stenosis. One of the trials assesses IMM with or without carotid artery stenting (CAS). Given the low risk of stroke in nonrevascularized patients receiving IMM, it is essential that there be low periprocedural risk of stroke for CAS if it is to show incremental benefit. Thus, credentialing of interventionists to ensure excellence is vital. This analysis describes the protocol-driven approach to credentialing of CAS interventionists for CREST-2 and its outcomes. METHODS: To be eligible to perform stenting in CREST-2, interventionists needed to be credentialed on the basis of a detailed Interventional Management Committee (IMC) review of data from their last 25 consecutive cases during the past 24 months along with self-reported lifetime experience case numbers. When necessary, additional prospective cases performed in a companion registry were requested after webinar training. Here we review the IMC experience from the first formal meeting on March 21, 2014 through October 14, 2017. RESULTS: The IMC had 102 meetings, and 8311 cases submitted by 334 interventionists were evaluated. Most were either cardiologists or vascular surgeons, although no single specialty made up the majority of applicants. The median total experience was 130 cases (interquartile range [IQR], 75-266; range, 25-2500). Only 9% (30/334) of interventionists were approved at initial review; approval increased to 46% (153/334) after submission of new cases with added training and re-review. The median self-reported lifetime case experience for those approved was 211.5 (IQR, 100-350), and the median number of cases submitted for review was 30 (IQR, 27-35). The number of CAS procedures performed per month (case rate) was the only factor associated with approval during the initial cycle of review (P < .00001). CONCLUSIONS: Identification of interventionists who were deemed sufficiently skilled for CREST-2 has required substantial oversight and a controlled system to judge current skill level that controls for specialty-based practice variability, procedural experience, and periprocedural outcomes. High-volume interventionists, particularly those with more recent experience, were more likely to be approved to participate in CREST-2. Primary approval was not affected by operator specialty.

Validation of frontal near-infrared spectroscopy as noninvasive bedside monitoring for regional cerebral blood flow in brain-injured patients.

OBJECT: Near-infrared spectroscopy (NIRS) offers noninvasive bedside measurement of direct regional cerebral arteriovenous (mixed) brain oxygenation. To validate the accuracy of this monitoring technique, the authors analyzed the statistical correlation of NIRS and CT perfusion with respect to regional cerebral blood flow (CBF) measurements. METHODS: The authors retrospectively reviewed all cases in which NIRS measurements were obtained at a single, academic neurointensive care unit from February 2008 to June 2011 in which CT perfusion was performed at the same time as NIRS data was collected. Regions of interest were obtained 2.5 cm below the NIRS bifrontal scalp probe on CT perfusion with an average volume between 2 and 4 ml, with mean CBF values used for purposes of analysis. Linear regression analysis was performed for NIRS and CBF values. RESULTS: The study included 8 patients (2 men, 6 women), 6 of whom suffered subarachnoid hemorrhage, 1 ischemic stroke, and 1 intracerebral hemorrhage and brain edema. Mean CBF measured by CT perfusion was 61 ml/100 g/min for the left side and 60 ml/100 g/min for the right side, while mean NIRS values were 75 on the right and 74 on the left. Linear regression analysis demonstrated a statistically significant probability value (p<0.0001) comparing NIRS frontal oximetry and CT perfusion-obtained CBF values. CONCLUSIONS: The authors demonstrated a linear correlation for frontal NIRS cerebral oxygenation measurements compared with regional CBF on CT perfusion imaging. Thus, frontal NIRS cerebral oxygenation measurement may serve as a useful, noninvasive, bedside intensive care unit monitoring tool to assess brain oxygenation in a direct manner.

Intraventricular nicardipine for aneurysmal subarachnoid hemorrhage related vasospasm: assessment of 90 days outcome.

BACKGROUND: Delayed cerebral arterial vasospasm is one of the leading causes of death and disability after aneurysmal subarachnoid hemorrhage (aSAH). We evaluated the safety of intraventricular nicardipine (IVN) for vasospasm (VSP) in aSAH patients, and outcomes compared with a control population. METHODS: A retrospective case-control study was conducted for aSAH patients treated with IVN at Mayo Clinic, Jacksonville, FL, from March 2009 to January 2011. Controls were matched by age, gender, and Fisher grade. Safety was evaluated by the incidence of intracranial bleeding and infection. Outcome was measured by Glasgow Outcome Scale at 30 and 90 days. IVN effects on VSP were evaluated by transcranial Doppler (TCD). RESULTS: Thirteen aSAH patients and one arteriovenous malformation (AVM)-related SAH patient received IVN for VSP and were matched with 14 aSAH patients without IVN therapy for a total of 28 cases. Median dose was 4 mg (range 3-7), and median number of doses was seven (range 1-17). Mean flow velocity decreased after IVN (120.2 and 101.6 cm/s-82.0 and 72.8 cm/s, right and left middle cerebral arteries, respectively). No significant difference was seen in clinical outcomes between controls and cases at 30 days (P = 0.443) and 90 days (P = 0.153). There were no incidences of bleeding or infection with 111 nicardipine injections. CONCLUSIONS: IVN appears relatively safe and effective in treating VSP by TCD, but there was no difference in clinical outcomes between nicardipine and control patients at 30 and 90 days. In the future, larger studies are needed to evaluate the clinical outcome with IVN.

Behavioral symptoms in long-term survivors of ischemic stroke.

The range of behavioral changes occurring after stroke has not yet been fully characterized. To evaluate behavioral symptoms after stroke and clinical characteristics that may influence the number and frequency of such symptoms, we compared 53 survivors of mild ischemic stroke with 30 stroke-free controls. Stroke survivor and control participants completed self-ratings of behavioral symptoms and were administered measures of cognitive status (ie, Beck Depression Inventory II, Mini-Mental State Examination, and Controlled Oral Word Association Test). Informants of stroke survivors and controls completed ratings of behavioral symptoms and functional status (ie, Neuropsychiatric Inventory Questionnaire, Informant Questionnaire on Cognitive Decline in the Elderly, and Functional Activities Questionnaire). More behavioral symptoms were observed in stroke survivors than in controls (mean [standard deviation] total number of symptoms on the Neuropsychiatric Inventory Questionnaire, 2.1 [2.0] vs 1.1 [1.5]; P = .02). Informants of stroke survivors were more likely to recognize behavioral symptoms than were stroke survivors themselves. Higher initial stroke severity was associated with more behavioral symptoms. With more behavioral symptoms, there was more functional impairment. Our findings suggest that behavioral symptoms can have unique and troublesome effects on stroke patients. Future research is needed to understand how the identification of behavioral symptoms after stroke can improve care in stroke survivors.

Joint Commission primary stroke center certification does not affect proband enrollment: the siblings with ischemic stroke study.

BACKGROUND: The Joint Commission (JC) certifies primary stroke centers in the United States. Whether certification promotes enrollment of study subjects into stroke research studies is not known. We examined whether enrollment performance of centers was related to JC certification status. METHODS: The 51 US Siblings with Ischemic Stroke Study (SWISS) centers were characterized by JC certification status, year of certification, year initiated into SWISS, center location, and whether the center had a vascular/stroke neurology fellowship program accredited by the Accreditation Council for Graduate Medical Education. Performance measures included days elapsed from initiation to first enrollment, total enrollments within 12 months after initiation, and annual rate of enrollment thereafter. RESULTS: In all, 36 of 51 SWISS sites (71%) were JC certified. A total of 32 (63%) were initiated into the study from 2000 through 2002, and 19 (37%) were initiated from 2005 through May 2008. Comparison of certified and noncertified sites showed no significant difference in the time to first enrollment (median, 77.5 v 115 days; P = .90), total enrollees in the first year (median, 3 v 2 probands; P = .69), or annual enrollment rate (median, 1.9 v 1.8 probands; P = .72). The rate of enrollment or time to first enrollment was not different between 2000-to-2002 and 2005-to-2008 sites. Early-initiated centers tended to have better year-1 enrollment than later-initiated centers (3 v 2 probands; P = .056). CONCLUSIONS: JC certification did not have a significant effect on SWISS center enrollment. The JC should encourage the research mission among certified stroke centers.