Percutaneous left atrial appendage occlusion and risk of stroke, hospitalized bleeding and death in Medicare beneficiaries.

PURPOSE: Among patients with atrial fibrillation (AF), a nonpharmacologic option (e.g., percutaneous left atrial appendage occlusion [LAAO]) is needed for patients with oral anticoagulant (OAC) contraindications. Among beneficiaries in the Medicare fee-for-service coverage 20% sample databases (2015-18) who had AF and an elevated CHA2DS2-VASc score, we assessed the association between percutaneous LAAO versus OAC use and risk of stroke, hospitalized bleeding, and death. METHODS: Patients undergoing percutaneous LAAO were matched to up to five OAC users by sex, age, date of enrollment, index date, CHA2DS2-VASc score, and HAS-BLED score. Overall, 17 156 patients with AF (2905 with percutaneous LAAO) were matched (average ± SD 78 ± 6 years, 44% female). Cox proportional hazards model were used. RESULTS: Median follow-up was 10.3 months. After multivariable adjustments, no significant difference for risk of stroke or death was noted when patients with percutaneous LAAO were compared with OAC users (HRs [95% CIs]: 1.14 [0.86-1.52], 0.98 [0.86-1.10]). There was a 2.94-fold (95% CI: 2.50-3.45) increased risk for hospitalized bleeding for percutaneous LAAO compared with OAC use. Among patients 65 to <78 years old, those undergoing percutaneous LAAO had higher risk of stroke compared with OAC users. No association was present in those ≥78 years. CONCLUSION: In this analysis of real-world AF patients, percutaneous LAAO versus OAC use was associated with similar risk of death, nonsignificantly elevated risk of stroke, and an elevated risk of bleeding in the post-procedural period. Overall, these results support results of randomized trials that percutaneous LAAO may be an alternative to OAC use for patients with contraindications.

Post-Stroke Brain Health Monitoring and Optimization: A Narrative Review.

Significant advancements have been made in recent years in the acute treatment and secondary prevention of stroke. However, a large proportion of stroke survivors will go on to have enduring physical, cognitive, and psychological disabilities from suboptimal post-stroke brain health. Impaired brain health following stroke thus warrants increased attention from clinicians and researchers alike. In this narrative review based on an open timeframe search of the PubMed, Scopus, and Web of Science databases, we define post-stroke brain health and appraise the body of research focused on modifiable vascular, lifestyle, and psychosocial factors for optimizing post-stroke brain health. In addition, we make clinical recommendations for the monitoring and management of post-stroke brain health at major post-stroke transition points centered on four key intertwined domains: cognition, psychosocial health, physical functioning, and global vascular health. Finally, we discuss potential future work in the field of post-stroke brain health, including the use of remote monitoring and interventions, neuromodulation, multi-morbidity interventions, enriched environments, and the need to address inequities in post-stroke brain health. As post-stroke brain health is a relatively new, rapidly evolving, and broad clinical and research field, this narrative review aims to identify and summarize the evidence base to help clinicians and researchers tailor their own approach to integrating post-stroke brain health into their practices.

Mobile health technology for hypertension management with Hmong and Latino adults: mixed-methods community-based participatory research.

OBJECTIVE: To identify Hmong and Latino adults' perspectives about a mHealth-based care model for hypertension (HTN) management involving blood pressure (BP) self-monitoring, electronic transmission of BP readings, and responsive HTN medication adjustment by a provider team. DESIGN: We conducted a mixed-methods formative study with 25 Hmong and 25 Latino participants with HTN at an urban federally-qualified health center. We used a tool to assess HTN knowledge and conducted open-ended interviews to identify perspectives about mHealth-based care model. RESULTS: While most participants agreed that lowering high blood pressure decreased the risk of strokes, heart attacks, and kidney failure, there were gaps in medical knowledge. Three major themes emerged about the mHealth-based care model: (1) Using mHealth technology could be useful, especially if assistance was available to patients with technological challenges; (2) Knowing blood pressures could be helpful, especially to patients who agreed with doctors' medical diagnosis and prescribed treatment; (3) Transmitting blood pressures to the clinic and their responsive actions could feel empowering, and the sense of increased surveillance could feel entrapping. Some people may feel empowered since it could increase patient-provider communication without burden of clinic visits and could increase involvement in BP control for those who agree with the medical model of HTN. However, some people may feel entrapped as it could breach patient privacy, interfere with patients' lifestyle choices, and curtail patient autonomy. CONCLUSIONS: In general, Hmong and Latino adults responded positively to the empowering aspects of the mHealth-based care model, but expressed caution for those who had limited technological knowledge, who did not agree with the medical model and who may feel entrapped. In a shared decision-making approach with patients and possibly their family members, health care systems and clinicians should explore barriers and potential issues of empowerment and entrapment when offering a mHealth care model in practice.

Emergency Medical Services Utilization for Acute Stroke Care: Analysis of the Paul Coverdell National Acute Stroke Program, 2014-2019.

Objective: Emergency medical service (EMS) transportation after acute stroke is associated with shorter symptom-to-arrival times and more rapid medical attention when compared to patient transportation by private vehicle. Methods: We analyzed data from the Paul Coverdell National Acute Stroke Program from 2014 to 2019 among stroke (ischemic and hemorrhagic) and transient ischemic attack (TIA) patients to examine patterns in EMS utilization. Results: Of 500,829 stroke and TIA patients (mean age 70.9 years, 51.3% women) from 682 participating hospitals during the study period, 60% arrived by EMS. Patients aged 18-64 years vs. ≥65 years (AOR 0.67) were less likely to utilize EMS. Severe stroke patients (AOR 2.29, 95%CI, 2.15-2.44) and hemorrhagic stroke patients vs. ischemic stroke patients (AOR 1.47, 95% CI, 1.43-1.51) were more likely to utilize EMS. Medicare (AOR 1.35, 95% CI, 1.32-1.38) and Medicaid (AOR 1.41, 95% CI, 1.37-1.45) beneficiaries were more likely than privately insured patients to utilize EMS, but no difference was found between no insurance/self-pay patients and privately insured patients on EMS utilization. Overall, there was a decreasing trend in the utilization of EMS (59.6% to 59.3%, p = 0.037). The decreasing trend was identified among ischemic stroke (p < 0.0001) patients but not among TIA (p = 0.89) or hemorrhagic stroke (p = 0.44) patients. There was no observed trend in pre-notification among stroke patients' arrival by EMS across the study period (56.9% to 56.5%, p = 0.99). Conclusions: Strategies to help increase stroke awareness and utilization of EMS among those with symptoms of stroke should be considered in order to help improve stroke outcomes.

Effect of Insurance Status on Outcomes of Acute Ischemic Stroke Patients Receiving Intra-Arterial Treatment: Results from the Paul Coverdell National Acute Stroke Program.

BACKGROUND: Stroke continues to be a leading cause of death and disability in the United States. Rates of intra-arterial reperfusion treatments (IAT) for acute ischemic stroke (AIS) are increasing, and these treatments are associated with more favorable outcomes. We sought to examine the effect of insurance status on outcomes for AIS patients receiving IAT within a multistate stroke registry. METHODS: We used data from the Paul Coverdell National Acute Stroke Program (PCNASP) from 2014 to 2019 to quantify rates of IAT (with or without intravenous thrombolysis) after AIS. We modeled outcomes based on insurance status: private, Medicare, Medicaid, or no insurance. Outcomes were defined as rates of discharge to home, in-hospital death, symptomatic intracranial hemorrhage (sICH), or life-threatening hemorrhage during hospitalization. RESULTS: During the study period, there were 486,180 patients with a clinical diagnosis of AIS (mean age 70.6 years, 50.3% male) from 674 participating hospitals in PCNASP. Only 4.3% of patients received any IAT. As compared to private insurance, uninsured patients receiving any IAT were more likely to experience in-hospital death (AOR 1.36 [95% CI 1.07-1.73]). Medicare (AOR 0.78 [95% CI 0.71-0.85]) and Medicaid (AOR 0.85 [95% CI 0.75-0.96]) beneficiaries were less likely but uninsured patients were more likely (AOR 1.90 [95% CI 1.61-2.24]) to be discharged home. Insurance status was not found to be independently associated with rates of sICH. CONCLUSIONS: Insurance status was independently associated with in-hospital death and discharge to home among AIS patients undergoing IAT.

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

BACKGROUND: Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system-based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. OBJECTIVE: The mGlide randomized controlled trial is a National Institutes of Health-funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. METHODS: We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. RESULTS: To date, we have randomized 107 participants (54 intervention, 53 control). CONCLUSIONS: This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25424.

Triggering of cardiovascular disease by infection type: The Atherosclerosis Risk in Communities study (ARIC).

INTRODUCTION: Acute infections are known triggers of cardiovascular disease (CVD) but how this association varies across infection types is unknown. We hypothesized while acute infections increase CVD risk, the strength of this association varies across infection types. METHOD: Acute coronary heart disease (CHD) and ischemic stroke cases were identified in the Atherosclerosis Risk in Communities Study (ARIC). ICD-9 codes from Medicare claims were used to identify cellulitis, pneumonia, urinary tract infections (UTI), and bloodstream infections. A case-crossover design and conditional logistic regression were used to compare infection types among acute CHD and stroke cases 14, 30, 42, and 90 days before the event with two corresponding control periods (1 and 2 years prior). RESULTS: Of the 1312 acute CHD cases, 116 had a UTI, 102 had pneumonia, 43 had cellulitis, and 28 had a bloodstream infection 90 days before the CHD event. Pneumonia (OR = 25.53 (9.21,70.78)), UTI (OR = 3.32 (1.93, 5.71)), bloodstream infections (OR = 5.93 (2.07, 17.00)), and cellulitis (OR = 2.58 (1.09, 6.13)) were associated with higher acute CHD risk within 14 days of infection. Of the 727 ischemic stroke cases, 12 had cellulitis, 27 had pneumonia, 56 had a UTI, and 5 had a bloodstream infection within 90 days of the stroke. Pneumonia (OR = 5.59 (1.77, 17.67)) and UTI (OR = 3.16 (1.68, 5.94)) were associated with higher stroke risk within 14 days of infection. CONCLUSIONS: Patients with pneumonia, UTI, or bloodstream infection appear to be at a 2.5 to 25.5 fold elevated CVD risk following infection. Preventive therapies during this high-risk period should be considered.

Comparison of Medicare claims versus physician adjudication for identifying stroke outcomes in the Women's Health Initiative.

BACKGROUND AND PURPOSE: Many studies use medical record review for ascertaining outcomes. One large, longitudinal study, the Women's Health Initiative (WHI), ascertains strokes using participant self-report and subsequent physician review of medical records. This is resource-intensive. Herein, we assess whether Medicare data can reliably assess stroke events in the WHI. METHODS: Subjects were WHI participants with fee-for-service Medicare. Four stroke definitions were created for Medicare data using discharge diagnoses in hospitalization claims: definition 1, stroke codes in any position; definition 2, primary position stroke codes; and definitions 3 and 4, hemorrhagic and ischemic stroke codes, respectively. WHI data were randomly split into training (50%) and test sets. A concordance matrix was used to examine the agreement between WHI and Medicare stroke diagnosis. A WHI stroke and a Medicare stroke were considered a match if they occurred within ±7 days of each other. Refined analyses excluded Medicare events when medical records were unavailable for comparison. RESULTS: Training data consisted of 24 428 randomly selected participants. There were 577 WHI strokes and 557 Medicare strokes using definition 1. Of these, 478 were a match. With regard to algorithm performance, specificity was 99.7%, negative predictive value was 99.7%, sensitivity was 82.8%, positive predictive value was 85.8%, and κ=0.84. Performance was similar for test data. Whereas specificity and negative predictive value exceeded 99%, sensitivity ranged from 75% to 88% and positive predictive value ranged from 80% to 90% across stroke definitions. CONCLUSIONS: Medicare data seem useful for population-based stroke research; however, performance characteristics depend on the definition selected.

Incidence of stroke before and after dialysis initiation in older patients.

The incidence of stroke is substantially higher among hemodialysis patients than among patients with earlier stages of CKD, but to what extent the initiation of dialysis accelerates the risk for stroke is not well understood. In this cohort study, we analyzed data from incident hemodialysis and peritoneal dialysis patients in 2009 who were at least 67 years old and had Medicare as primary payer. We noted whether each of the 20,979 hemodialysis patients initiated dialysis as an outpatient (47%) or inpatient (53%). One year before initiation, the baseline stroke rate was 0.15%-0.20% of patients per month (ppm) for both outpatient and inpatient initiators. Among outpatient initiators, stroke rates began rising approximately 90 days before initiation, reached 0.5% ppm during the 30 days before initiation, and peaked at 0.7% ppm (8.4% per patient-year) during the 30 days after initiation. The pattern was similar among inpatient initiators, but the stroke rate peaked at 1.5% ppm (18% per patient-year). For both hemodialysis groups, stroke rates rapidly declined by 1-2 months after initiation, fluctuated, and stabilized at approximately twice the baseline rate by 1 year. Among the 620 peritoneal dialysis patients, stroke rates were slightly lower and variable, but approximately doubled after initiation. In conclusion, these data suggest that the process of initiating dialysis may cause strokes. Further studies should evaluate methods to mitigate the risk for stroke during this high-risk period.

Five-year rehospitalization outcomes in a cohort of patients with acute ischemic stroke: Medicare linkage study.

BACKGROUND AND PURPOSE: The purposes of this study were to track mortality and rehospitalizations over 5 years poststroke in a stroke cohort (SC) and compare long-term risks of complications to a matched nonstroke cohort (NSC). METHODS: A cohort design with a matched NSC comparison was used. The SC constituted a validated database of acute ischemic stroke patients, ≥65 years, hospitalized across 19 Minnesota hospitals in the year 2000. The NSC was constructed from the year 2000 General Medicare Population by matching SC members on age, race, and sex. Both cohorts were tracked across 5 years of Medicare claims data to identify dates and causes of rehospitalization and death dates. Kaplan-Meier survival curves estimated cumulative incidence rates. Cox models calculated adjusted hazard ratios. RESULTS: Event rates and adjusted hazard ratios were: mortality: 1 year SC=24%, NSC=4%; 5 years SC=49%, NSC=24% (hazard ratio, 4.4; 95% CI, 3.6 to 5.5). Overall rehospitalization rates were: 1 year SC=49%, NSC=20%; 5 years SC=83%; NSC=63% (hazard ratio, 2.6; 95% CI, 2.2 to 3.0). Cause-specific 5-year rehospitalization rates were significantly higher in SC versus NSC for recurrent ischemic stroke, heart failure, cardiac events, any vascular events, pneumonia, and hip fractures. The excess risk of mortality and rehospitalizations in the SC persisted beyond the initial aftermath of the acute stroke (i.e., beyond 30 days poststroke) and persisted even after 1 year poststroke. Average acute care Medicare charges in SC were more than doubled those in NSC. CONCLUSIONS: The high rates of acute care poststroke readmissions indicate a need for trials to prevent long-term complications in stroke survivors.

Impact of International Subarachnoid Aneurysm Trial results on treatment of ruptured intracranial aneurysms in the United States. Clinical article.

OBJECT: The utilization of endovascular treatment for ruptured intracranial aneurysms is expected to change since the publication of the International Subarachnoid Aneurysm Trial (ISAT) in 2002. The authors performed this analysis to determine the impact of ISAT results on treatment selection for ruptured intracranial aneurysms and associated in-hospital outcomes using nationally representative data. METHODS: We determined the national estimates of treatments used for ruptured intracranial aneurysms and associated in-hospital outcomes, length of stay, mortality, and cost incurred using the Nationwide Inpatient Survey (NIS) data. The NIS is the largest all-payer inpatient care database in the US and contains data from 986 hospitals approximating a 20% stratified sample of US hospitals. All the variables pertaining to hospitalization were compared between 2000-2002 and 2004-2006, and in-hospital outcomes were analyzed using multivariate analysis. RESULTS: In the 3-year periods prior to and after the ISAT, there were 70,637 and 77,352 admissions for ruptured intracranial aneurysms, respectively. There was a significant increase in endovascular treatment after publication of the ISAT (trend test, p < 0.0001) The in-hospital mortality for ruptured intracranial aneurysm admissions decreased from 27% to 24% (odds ratio [OR] 0.89, 95% CI 0.83-0.96, p = 0.003) after the publication of the ISAT. The cost of hospitalization after adjusting for procedures practices was not significantly higher after the publication of the ISAT ($21,437 vs $22,817, p < 0.89), but cost of hospitalization was higher in the post-ISAT period for patients undergoing endovascular procedure. CONCLUSIONS: The results of the ISAT have been associated with a prominent change in practice patterns related to the treatment of ruptured aneurysms. The cost of hospitalization has increased and the mortality has decreased, presumably due to a larger proportion of patients receiving any treatment and endovascular treatment.

Cost-effectiveness analysis of protected carotid artery stent placement versus endarterectomy in high-risk patients.

PURPOSE: To determine the cost-effectiveness of carotid angioplasty with stent placement (CAS) under emboli protection versus carotid endarterectomy (CEA) in patients with severe carotid stenosis considered to be at high surgical risk for CEA. METHODS: The probabilities of various outcomes were adopted from the SAPPHIRE trial results. The quality-adjusted life year (QALYs) associated with each treatment modality were estimated by using the frequencies of various quality-adjusted outcomes (QALY weights of ipsilateral stroke, myocardial infarction, and death). Total cost associated with each intervention was computed using the frequency of stroke, myocardial infarction, and death in each group. Costs are expressed in 2006 US$. Incremental cost-effectiveness ratios (ICERs) were estimated for a 1-year postprocedure period. RESULTS: The mean (range) estimated net costs at 1 year for patients treated with CAS and CEA were $12,782 ($12,205-$13,563) and $8,916 ($8,267-$9,766), respectively. Overall QALYs for the CAS and CEA groups were 0.753 and 0.701 [within a range of 0.0 (meaning death) to 0.815 (meaning no adverse events)]. The mean cost per QALY gained for CAS was $16,223 ($15,315-$17,474) and the mean cost per QALY gained for CEA was $12,745 ($11,372-$14,605). The estimated median ICER for CAS versus CEA treatment was $67,891 (-$129,372 to $379,661). CONCLUSION: The proven non-inferiority of CAS versus CEA in high-surgical-risk patients with severe carotid stenosis might provide a marginal benefit that is offset by the higher cost associated with this procedure.

Cost-effectiveness analysis of endovascular versus neurosurgical treatment for ruptured intracranial aneurysms in the United States.

OBJECT: The results of the International Subarachnoid Aneurysm Trial (ISAT) demonstrated lower rates of death and disability with endovascular treatment (coiling) than with open surgery (clipping) to secure the ruptured intracranial aneurysm. However, cost-effectiveness may not be favorable because of the greater need for follow-up cerebral angiograms and additional follow-up treatment with endovascular methods. In this study, the authors' goal was to compare the cost-effectiveness of endovascular and neurosurgical treatments in patients with ruptured intracranial aneurysms who were eligible to undergo either type of treatment. METHODS: Clinical data (age, sex, frequency of retreatment, and rebleeding) and quality of life values were obtained from the ISAT. Total cost included those associated with disability, hospitalization, retreatment, and rebleeding. Cost estimates were derived from the Premier Perspective Comparative Database, data from long-term care in stroke patients, and relevant literature. Incremental cost-effectiveness ratios (ICERs) were estimated during a 1-year period. Parametric bootstrapping was used to determine the uncertainty of the estimates. RESULTS: The median estimated costs of endovascular and neurosurgical treatments (in US dollars) were $45,493 (95th percentile range $44,693-$46,365) and $41,769 (95th percentile range $41,094-$42,518), respectively. The overall quality-adjusted life years (QALY) in the endovascular group was 0.69, and for the neurosurgical group it was 0.64. The cost per QALY in the endovascular group was $65,424 (95th percentile range $64,178-$66,772), and in the neurosurgical group it was $64,824 (95th percentile range $63,679-$66,086). The median estimated ICER at 1 year for endovascular treatment versus neurosurgical treatment was $72,872 (95th percentile range $50,344-$98,335) per QALY gained. Given that most postprocedure angiograms and additional treatments occurred in the 1st year and the 1-year disability status is unlikely to change in the future, ICER for endovascular treatment will progressively decrease over time. CONCLUSIONS: Using outcome and economic data obtained in the US at 1 year after the procedure, endovascular treatment is more costly but is associated with better outcomes than the neurosurgical alternative among patients with ruptured intracranial aneurysms who are eligible to undergo either procedure. With accrual of additional years with a better outcome status, the ICER for endovascular coiling would be expected to progressively decrease and eventually reverse.

Atrial fibrillation and stroke in the general medicare population: a 10-year perspective (1992 to 2002).

BACKGROUND AND PURPOSE: Clinical trials have illustrated warfarin's protective effect on stroke risk in patients with atrial fibrillation (AF). The current study investigated temporal trends in AF prevalence, warfarin use, and its relation to stroke risk in Medicare patients with AF from 1992 to 2002. METHODS: The Medicare 5% sample for 1992 to 2002 was used to create 1-year cohorts of patients with Medicare as primary payer throughout the year. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify AF, ischemic and hemorrhagic stroke, and comorbid conditions. A previously validated surrogate measure, prothrombin/international normalized ratio claims, was used to identify warfarin use. Cox proportional hazards regression was used to examine time to stroke with warfarin use as a time-dependent variable. RESULTS: Among Medicare patients aged > or = 65 years, AF prevalence increased from 3.2% in 1992 to 6.0% in 2002 with higher prevalence in older subsets of the study population. Among patients with AF, warfarin use increased significantly (P< or = 0.001) for each year examined, from 24.5% in 1992 to 56.3% in 2002. Stroke rates per 1000 patient-years declined from 46.7 in 1992 to 19.5 in 2002 for ischemic stroke but remained fairly steady for hemorrhagic stroke (range, 1.6 to 2.9). Time-to-event modeling confirmed a protective association of warfarin against ischemic stroke among Medicare patients with AF. CONCLUSIONS: This analysis represents an observational validation of stroke prevention in AF trials. The significant increase in warfarin use among patients with AF illustrates diffusion of trial evidence into clinical practice.