Citations

Background: Race-ethnic disparities in stroke care can contribute to inequality in stroke outcomes. We sought to determine the disparities in stroke performance metrics by race-ethnicity in a voluntary stroke registry of Florida and Puerto Rico Get With The Guidelines-Stroke (GWTG-S) data. Methods: Sixty-three sites who had enrolled in the FL-PR Stroke Registry (54 FL; 9 PR) recorded 38,684 ischemic stroke cases from 2010 to 2013. Generalized linear regression models were used to evaluate race-ethnic differences in 7 pre-defined acute stroke performance measures and defect-free care (IV tPA treatment, in-hospital antithrombotic therapy, DVT prophylaxis, antithrombotic therapy at discharge, anticoagulation therapy, statin medication at discharge, and smoking cessation counseling), adjusting for age and region (FL vs. PR). Results: Of acute ischemic stroke cases, 63% were non-Hispanic White (NHW), 18% NH-Black (NHB), and 17% Hispanic. The mean age was 71±14 years. NHW were older (73±14), followed by Hispanics (70±14), and NHB (63±14); p<0.0001. Defect-free care was better among NHB (78%) and NHW (76%) than in Hispanics (68%), p<0.0001. Defect-free care improved over time and the race-ethnic disparity decreased (2010: NHW 61%, NHB 64%, Hispanic 46%, p<0.0001; 2013: 91%, 91%, 86%, p=0.47 respectively). NHW were most likely to receive IV tPA treatment (arrived by 2 hours and treated by 3 hours; 88%) and early antithrombotic treatment (96%). Hispanics were least likely to receive DVT prophylaxis (76%), anticoagulation (92%), statins (89%), and smoking cessation counseling (93%). Conclusions: Race-ethnic disparities in acute stroke care are evident yet decreasing, coinciding with improvements in quality of care over time in Florida and Puerto Rico hospitals participating in GWTG-S. Special stroke quality improvement programs to target areas where performance is less than expected and minimize race-ethnic disparities are necessary to improve stroke care for all Americans.

Background: Higher prevalence of stroke in women and sex-specific disparities in stroke care are reported. We sought to determine sex-specific differences in stroke performance metrics in a large quality improvement registry of Florida and Puerto Rico based on Get With The Guidelines-Stroke (GWTG-S). Methods: 38,684 (49% women) acute ischemic stroke patients were included from 63 sites (54 FL; 9 PR) from 2010 to 2013. Logistic regression was used to evaluate sex-specific differences in defect-free care (IV tPA therapy, in-hospital antithrombotic therapy, DVT prophylaxis, antithrombotic therapy at discharge, anticoagulation therapy, statin medication at discharge, smoking cessation counseling) adjusting for age and race-ethnicity. Results: As compared to men, women were older (73±15 vs. 69±14 years; p<0.0001), less likely Hispanic (17% vs. 18%; p=0.0001), with lower age- and race-ethnic-adjusted rates of hypertension (34% vs. 37%; p=0.0009) and smoking (13% vs. 21%; p<0.0001), but higher rates of atrial fibrillation (18% vs. 16%; p=0.02). Overall, 9% of patients received thrombolysis. Women were less likely to receive thrombolysis (OR 0.92, 95% CI 0.86-0.99) and less likely to have door-to-needle time <1 hour (OR 0.84, 95% CI 0.73-0.97). Overall, defect-free care was 75% in women and 76% in men (lower early antithrombotic therapy [OR 0.86, 95% CI 0.77-0.96], less antithrombotic at discharge [OR 0.87, 95% CI 0.77-0.99], less statin therapy at discharge [OR 0.81, 95% CI 0.74-0.88] and less smoking cessation counseling [OR 0.74, 95% CI 0.56-0.98]). Defect- free care improved over the study period; it was significantly lower in women vs. men in 2010 (58.2% vs. 60.7%, p=0.005), but similar in 2013 (90.2% vs 90.0%; p=0.64). Conclusions: Women eligible to receive IV tPA for acute ischemic stroke were less likely to be treated and received less defect-free care compared to men, but these measures improved over time. These findings suggest that the adoption of GWTG-S quality improvement program helps reduce sex disparities in quality of care for acute ischemic stroke patients.

Background: Racial and ethnic disparities in stroke care are known to contribute to inequality in stroke outcomes. The goal of the FL-PR CReSD Study is to assess and evaluate Get With The Guidelines-Stroke (GWTG-S) quality improvement data collected among Florida and Puerto Rico hospitals to evaluate for race-ethnic, sex, and regional disparities in stroke performance metrics. We sought to analyze the temporal trends in stroke performance metrics among the 9 hospitals located in Puerto Rico from 2010 to 2013. Methods: Age-adjusted temporal trends were evaluated in the following GWTG-S pre-defined performance measures (IV tPA treatment within 3 hours among eligible patients arriving in 2 hours, in-hospital antithrombotic therapy, DVT prophylaxis, antithrombotic therapy at discharge, anticoagulation therapy, statin medication at discharge, and smoking cessation counseling) and defect-free care (compliance with all 7 performance measures). Results: The mean age of 3,094 registered stroke cases was 69.5 ± 14.0 years, 50% were men, and 2,184 (71%) were diagnosed as ischemic strokes. Defect-free care occurred in 60% of ischemic stroke patients. Lower performance metrics were found for IV tPA treatment (78%), DVT prophylaxis (64%), and statin medication at discharge (83%). An additional IV tPA measure of treatment by 4.5 hours when arriving by 3.5 hours was observed in 65% of patients. The performance metrics that significantly improved over time from 2010 to 2013 included: IV tPA treatment within 3 hours (64% to 87%, p=0.04), DVT prophylaxis (33% to 87%, p<0.0001), statin medication at discharge (78% to 87%, p=0.01), and defect-free care (37% to 79%, p<0.0001). Conclusions: In only four years, Puerto Rico hospitals participating in GWTG-S showed significant improvement across all pre-defined acute stroke performance measures. Wider implementation of quality improvement programs like GWTG-S among the 3.7 million inhabitants of Puerto Rico could further improve acute stroke care.

Introduction: The long term effectiveness of preventive intracranial treatment of unruptured aneurysms for hemorrhage and aneurysm-related morbidity and mortality has been hypothesized. No randomized trial has been done. Propensity adjusted comparison within The International Study of Unruptured Intracranial Aneurysms was undertaken to compare long-term effectiveness. Hypothesis: The purpose of this analysis was to compare the long-term outcome in the treatment cohorts (surgery and endovascular) with those of the untreated subgroup. Methods: Patients were subdivided into the initial treatment and untreated cohorts based upon observation or treatment practices in 61 centers from 1991-1998. 1691 patients were in the observational cohort, 471 were in the endovascular cohort and 1917 patients were in the surgical cohort. The cohorts were followed for a median follow-up of 9.2 years. Outcomes were determined prospectively and with central review. The data were grouped together and analyzed to determine treatment decisions. Comparison of outcomes was done using covariate adjustment and using propensity analysis where equivalent probability groups were constructed. Similar main predictors of treatment and outcome were observed. Analysis of hemorrhage, mortality and short-term and long-term morbidity and mortality were assessed. Risk-benefit ratios were also calculated. Results: Significant differences in baseline variables between treatment and observed patients were aneurysm size, symptoms, age, prior SAH or not group, geographical region, family history, hypertension and myocardial infarction history. The results show comparability of groups using the patient propensity-based score subset. Using the propensity score method, the results showed a benefit in prevention of hemorrhage by surgery and endovascular treatment versus observation (p<.01). No difference was found between endovascular versus surgery. However when procedure-related outcomes are included, no significant difference at 1 year, 5 years or 10 years in the combined aneurysm or procedure related endpoint was evident between cohorts. Conclusions: Propensity score matching to achieve comparability resulted in balanced groups. Comparison of long-term results showed that intervention demonstrated a benefit in reducing hemorrhage risk. However, peri-procedural risk negates any short-term benefit for 10 years.

Introduction: Mortality in patients with unruptured intracranial aneurysm (UIA) is significantly higher than the general population. However a minority of the deaths are due to subarachnoid hemorrhage. Hypothesis: There are differential characteristics of patients that might predict specific causes of death that would be informative in counseling patients about aneurysm risk. Methods: 4059 patients with UIA who were enrolled prospectively between 1991 and 1998 were followed by 61 medical centers in North America, Canada, and Europe. Patients have at least one UIA, which may or may not be symptomatic. Patients were Rankin grade 1 or 2 at enrollment. Patients were followed annually from enrollment to 2007. For patients who died a death certificate search was done and information was requested from local physicians and other contacts. A National Death Index search in 2008 determined cases who died and cause of death. Foreign centers also did a national search where possible. Patients who died before 30 days post treatment or lost to follow up before 30 days post enrollment were excluded. Results: Twenty-five percent of patients died during follow-up. The life expectancy was significantly less than age-, sex-, and country-matched expected estimates. Among the total of 4004 patients with UIA who survived 30 days after enrollment, 2331 were treated and 1673 were not. There were 965 deaths after 30 days after treatment, of which 320 died from vascular disease (252 died from non-SAH vascular disease), 114 died from respiratory tract disease, 255 died from cancer, and the rest died of other or unknown reasons. Predictors of SAH death were aneurysm size, site, age and convulsive disorders at enrollment. Factors related to vascular death were UIA treatment, age, gender, race, hypertension, Rankin at discharge and diminishing influence of aneurysm characteristics over time. Respiratory deaths were related to treatment, race, smoking, age, initial Rankin and presentation with convulsive disorder. Cancer deaths were related to gender, race, smoking and age. Conclusions: In patients with UIA, an assessment of risk for death underscores the importance of age, race and gender and several modifiable risk factors. Patient management should include not only aneurysm rupture prevention but also modification of smoking and hypertension.

Background: Concerns for side-effects makes the identification of treatment targets of hypertension in the very elderly challenging. We sought to utilize natural language processing (NLP) to evaluate the prevalence of prespecified side-effects in a cohort of very elderly (≥80 years) patients. Methods and Results: We conducted a two-year, cross-sectional study involving 5169 very elderly patients with and without hypertension seen by primary or specialist providers. Hypertension patients had to have a prior hypertension ICD-9 code in the electronic medical records problem list and ≥2 office visits in 2008 and 2009. We used NLP to analyze extracted free text reports from last clinic visits between 2008 and 2009. Of the 10 prespecified side-effects, hypotension, fatigue, and dizziness were the commonest three conditions and hypotension was significantly higher in the HTN patients. Of the 2835 patients with no prior hypertension history and 2334 hypertension patients identified, the prevalence of each prespecified item in both groups were: acute renal failure (0.3% v 0.6%, p=0.13); syncope (2.8% v 2.2%, p = 0.17), dizziness (3.1% v 4.0%, p=0.09), history of fall (1.0% v 0.9%, p=0.65), fatigue (5.4% v 4.5%, p=0.19), femoral neck fracture (0.18% v 0.04%, p=0.16), palpitations (1.2% v 1.5%, p=0.35), hypotension (4.1% v 6.6%, p<0.001), hyperkalemia (1.1% v 1.7%, p=0.04), hypokalemia (0.4% v 0.9%, p=0.01). At least one presumed side-effect was present in 17.5% of all 5169 patients. Among hypertension patients, there was no significant difference in the prevalence of the side-effects among patients with BP above (578) or below 140/90 (1756) except for acute renal failure (1.21% vs 0.40%, p = 0.03). Conclusion: Analysis of free-text outpatient notes using NLP showed that hypotension and potassium abnormalities were significantly more prevalent in very elderly patients with hypertension compared to similarly aged patients with no hypertension history.

Background: Interruption of OAC is often required for invasive procedures, yet the frequency, management, and outcomes of temporary interruptions (TIs) in community practice are unknown. Methods: We assessed the frequency and reasons for TI in outpatients with AF enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF). Patient characteristics and use of bridging anticoagulants were analyzed. Endpoints included periprocedural adverse events (bleeding, thrombotic, or other) and cause-specific hospitalization within 30 days after TI. Results: Overall 7,372 patients were treated with OAC at baseline; 30% (n=2200) required at least 1 TI during median follow-up of 1 year. Patients requiring TI were similar in age (mean age 74 for both) and CHADS2 scores (mean 2.4 for both) to those not requiring TI. Among 3104 interruptions, the most commonly-identified reasons were for non-cardiac surgery (n=827, 27%), followed by endoscopic procedures (n=551, 18%) and cardiac catheterization (n=308, 10%). Bridging anticoagulants were used in 23% (n=709) of interruptions, including low-molecular weight heparin (n=512) or unfractionated heparin (n=109). Rates of bridging were highest during cardiac surgery (44%), cardiac catheterization (32%), and catheter ablation (33%). Patients with a prior stroke or TIA were significantly more likely to receive bridging (35% vs. 25%, p=0.0003), however there was no difference between patients with CHADS2 score >=2 vs. 0-1 (27% vs. 25%, p=NS). Adverse events during interruption were more common in bridged patients (5.1% vs. 2.9%, p=0.02), including bleeding events (3.6% vs. 1.8%, p=0.02); thrombotic events were uncommon (0.7 [n=4] vs. 0.5% [n=10], p=NS). After interruption, adverse events occurred early in follow-up (Figure), and bridged patients were more likely to experience any adverse event (13% vs. 6.3%, p<0.0001), cardiovascular hospitalization (4.3% vs. 2.3%, p=0.02), and bleeding hospitalization (2.2% vs. 0.7%, p=0.002) within 30 days. Conclusions: Temporary interruptions are common in patients receiving OAC for AF, however, bridging anticoagulation is used in a minority. Bleeding events following TI occurred significantly more often in patients receiving bridging anticoagulation.

Introduction: Quality of life changes can occur following procedural interventions and subarachnoid hemorrhage in unruptured intracranial aneurysms (UIA). The International Study of Unruptured Intracranial Aneurysms conducted quality of life assessment using the Mini-Mental State Exam, Rankin Score, and Barthel Index at baseline and the Telephone Interview Cognitive Status Exam (TICS), Rankin Score, and Barthel Index at follow-up. Hypothesis: The purpose of this analysis was to compare the 1 year and 5 year outcome in the treatment cohorts (surgery and endovascular) with those of the untreated subgroup. Methods: Patients were subdivided into the initial treated and untreated cohorts based upon observation or treatment practices in 61 centers from 1991-1998. 1691 patients were in the observational cohort and 2388 in the treated cohort. The cohorts were followed annually with measures of neurological status, Rankin Scale, Barthel Index and cognition (TICS). Outcomes were determined prospectively. Comparison of outcomes was done using continuous and categorical data. Covariate adjustment was done using general linear models. Stratified analysis was done by Rankin Score at the time of follow-up. Results: The percent of patients with a Barthel Index score of less than 60 at 1 year in the cohort was 9.4% (treated patients, 9.7%; untreated patients, 9.2%). The percent of patients at year 1 with a score of greater than 90 was 87.6%, 87.4% for treated patients and 87.8% for untreated patients. The percent of patients with a Barthel Index score of less than 60 at 5 years in the cohort was 41.4% (treated patients, 41.4%; untreated patients, 41.4%). The percent of patients at year 5 with a score of greater than 90 was 56.3%, 56.1% for treated patients and 56.5% for untreated patients. TICS and Barthel Index scores were significantly associated with each other for patients with Rankin Scores 0-2 (P<0.0001). This was seen at both year 1 and year 5 follow-up, but not for patients with Rankin Score 3-5. At both 1 year and 5 year follow-up, after controlling for Rankin Score, the distribution of Barthel Index scores of untreated patients and treated patients did not significantly differ. At both the 1 year follow-up, baseline Rankin Score, TICS and follow-up Rankin Score were significant predictors of Barthel Score (P<0.0001). At 5 years, only the follow-up Rankin Score was associated with Barthel Score (P<0.0001). Conclusions: Barthel Index Score decreased over time, but does not differ with treatment. The Rankin Score was the main predictor at follow-up of Barthel Index Score distribution.

Introduction: Transcatheter mitral valve replacement (TMVR) using aortic transcatheter heart valves (THV) is developing as an alternative to surgery for patients with severely degenerated mitral valve (MV) bioprostheses. Retrospective self-reported registries have collected outcomes on these TMVR procedures in the STS/ACC Transcatheter Valve Therapy Registry and in the Valve-in-Valve International Database. Most reported TMVR procedures for failed surgical bioprostheses have been performed using a transapical access approach. A prospective comprehensive evaluation of mitral Valve-in-Valve (VIV) outcomes, including transseptal access has not previously been conducted. Objectives: To evaluate in-hospital and 30-day clinical outcomes of transseptal mitral VIV with SAPIEN 3 THV in patients with very high surgical risk. Methods: Prospective enrollment of very high surgical risk patients with symptomatic severely degenerated MV surgical bioprostheses in 30 patients at 15 sites in the U.S. Candidates were assessed by a case review committee prior to approval. Baseline qualifying echocardiograms and cardiac CT studies were analyzed by independent core labs. Echocardiograms, cardiac CT studies and neurology evaluations were also performed after mitral VIV procedures. Clinical events were adjudicated by a clinical events committee and safety was monitored by a data safety monitoring board. Results: 26 patients have been enrolled between July 2016 and June 2017. Mean age was 83 years, 62% female, mean STS score was 10% and 62% were in New York Heart Association class III or IV. Transseptal access was used in all procedures. Technical success was achieved in all patients and there was no in-hospital mortality. There was no 30-day cardiovascular mortality and 4% (1 patient) 30-day all-cause mortality (1 patient died of asphyxia on day 29 after choking on pills at home), which was lower than the 30-day mortality in the TVT registry (9%). Detailed procedural, in-hospital and 30-day outcomes will be presented on the complete cohort of 30 patients. Conclusions: In patients without surgical alternatives, transseptal mitral ViV procedures in failed surgical bioprostheses are associated with high technical and procedural success and low 30-day mortality.

Introduction: Transcatheter mitral valve replacement (TMVR) using aortic transcatheter heart valves (THV) is developing as an alternative to surgery for patients with severe mitral valve disease due to degenerated mitral bioprostheses or failed surgical rings who are poor surgical candidates. Outcomes of off-label procedures in the United States are being collected in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry. A comprehensive analysis of mitral Valve-in-Valve (VIV) versus Valve-in-Ring (VIR) outcomes has not previously been performed. Objectives: To evaluate in-hospital and 30-day clinical outcomes of mitral VIV and VIR procedures in the United States. Methods: Retrospective analysis of data from the STS/ACC TVT Registry on patients who underwent mitral VIV or VIR procedures. Results: 587 patients underwent TMVR VIV (n=494) or VIR (n=93) procedures between January 2013 and December 2016 at 144 hospitals. Median age was 76 (VIV) and 73 (VIR) years, (p=0.024), 60.9% (VIV) and 44.1% (VIR) were female (p=0.003), median left ventricular ejection fraction was 55% in VIV and 50% in VIR (p <0.001), and median STS score was 10.5% (VIV) and 9.2% (VIR), p=0.131. Transseptal access was utilized in 35% VIV and 46.2% VIR procedures, p=0.081. Procedural success was achieved in 74.4% of VIV and 57.8%VIR (p=0.239). Left ventricular outflow tract (LVOT) obstruction was more common in VIR (5.4%) vs VIV (0.06%), p=0.003. Post-procedure median mean mitral valve gradient was 4mmHg in both groups. 95.7% of VIV and 86% of VIR patients had post-procedure mitral regurgitation ≤1(+), p<0.001. In-hospital mortality was 6.9% for VIV and 9.7% for VIR (p=0.343). 30-day mortality was 9% for VIV and 12% for VIR (p=0.387). At 30-day follow up, 85.6% of VIV and 77.7% of VIR patients were in New York Heart Association class I or II (p=0.398). Conclusions: TMVR VIV and VIR using aortic transcatheter heart valves in high surgical risk patients are associated with similar in-hospital and 30-day mortality and symptom benefit. LVOT obstruction post-TMVR and residual mitral regurgitation ≥2 (+) were more frequent in VIR procedures. The long-term effect of these procedures is not known and requires further evaluation.