Romano, José G.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

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.

Background: Information on the associations among arterial stiffness, carotid intima-media thickness (cIMT) and carotid plaques as biomarkers of atherosclerosis is limited. We aimed to assess whether aortic pulse wave velocity (PWV) - as a surrogate of arterial stiffness - is associated with increased cIMT and the presence of carotid plaques in a cohort of older adults of Amerindian ancestry. Methods: Atahualpa residents aged ≥60 years (n=320) underwent aortic PWV determinations, and carotid ultrasound for cIMT and plaque assessment. Multivariate models were fitted to assess the independent association between the aortic PWV, and cIMT and carotid plaques (as dependent variables), after adjusting for relevant confounders. Differences in risk factors across these biomarkers were investigated. Results: Mean values of aortic PWV were 10.3±1.8 m/s, and those of cIMT were 0.91±0.21 mm (24% had a cIMT >1 mm). Carotid plaques were observed in 118 (37%) subjects. In univariate analyses, risk factors associated with an increased aortic PWV included age, female gender, poor physical activity and high blood pressure. An increased cIMT was associated with age, male gender, poor diet, high blood pressure and severe edentulism. The presence of carotid plaques was associated with increasing age, poor physical activity and high blood pressure. A fully-adjusted generalized linear model showed a significant association between aortic PWV and cIMT (β: 0.028; 95% C.I.: 0.001 - 0.056; p =0.047). In contrast, a logistic regression model showed no association between aortic PWV and carotid plaques (OR: 1.14; 95% C.I.: 0.83 - 1.56; p =0.423), after adjusting for relevant confounders. Conclusions: This study shows an independent association between aortic PWV and cIMT but not with carotid plaques. These biomarkers may indicate distinct phenotypes for atherosclerosis.

Background: Poor collateral circulation and hypoperfusion may lead to recurrent stroke in intracranial atherosclerotic disease (ICAD). The role of perfusion in silent strokes and potentially insidious cognitive impairment in ICAD is unknown. We used evidence of impaired perfusion at angiography in SAMMPRIS to predict subsequent cognitive changes. Methods: Angiography at enrollment in the SAMMPRIS trial was independently evaluated, blind to clinical data and cognitive testing. Antegrade flow in the symptomatic arterial territory and corresponding collateral flow were scored. Impaired perfusion was defined by poor antegrade and poor collateral flow. Serial testing with the Montreal Cognitive Assessment (MoCA) was done in subjects without aphasia or neglect at baseline, 4 mo, 12 mo and closeout, or until subjects had a clinical stroke endpoint. Results: 207 subjects (median age 61, range 33-81 years; 37% women) had baseline MoCA scores with angiography data on territorial perfusion. Baseline MoCA scores (mean 24.2±4.1) were similar between categories of antegrade flow and collateral circulation. Impaired perfusion was noted in 33/207 (16%). Serial MoCA revealed that changes in cognition over time were different at 4 mo, 12 mo and closeout based on the presence of impaired perfusion at baseline (p<0.001). After more modest (mean MoCA change = 0.5 increase from baseline, p=0.80) early improved cognitive function at 4 mo, those with impaired perfusion had cognitive decline at 12 mo (mean MoCA change, p<0.01) unlike the continued improvement in other subjects. Cognitive changes in those with impaired perfusion were associated with a higher frequency of subsequent stroke in the territory. Conclusions: Impaired perfusion in the symptomatic arterial territory of ICAD predicts cognitive outcomes that may precede recurrent ischemia. Future studies may define the role of noninvasive perfusion imaging in ICAD to predict cognitive trajectories and recurrent stroke.

Objective Information on the associations among arterial stiffness, carotid intima-media thickness (cIMT) and carotid plaques as biomarkers of atherosclerosis is limited in diverse populations. We aimed to assess whether aortic pulse wave velocity (aPWV) – as a surrogate of arterial stiffness – is associated with increased cIMT and the presence of carotid plaques in a cohort of older adults of Amerindian ancestry. Methods Atahualpa residents aged ≥60 years ( n = 320) underwent aPWV determinations, and carotid ultrasounds for cIMT and plaque assessment. Multivariate models were fitted to assess the independent association between the aPWV, and cIMT and carotid plaques, after adjusting for relevant confounders. Differences in risk factors across these biomarkers were investigated. Results Mean values of aPWV were 10.3 ± 1.8 m/s, and those of cIMT were 0.91 ± 0.21 mm (24% had a cIMT >1 mm). Carotid plaques were observed in 118 (37%) subjects. In univariate analyses, risk factors associated with an increased aPWV included age, female gender, poor physical activity and high blood pressure. An increased cIMT was associated with age, male gender, a poor diet, high blood pressure and severe tooth loss. The presence of carotid plaques was associated with increasing age, poor physical activity and high blood pressure. Multivariate models showed a significant association between aPWV and cIMT (β: 0.028; 95% C.I.: 0.001–0.056; p = 0.047) but not between aPWV and carotid plaques (OR: 1.14; 95% C.I.: 0.83–1.56; p = 0.423). Conclusions This study shows an independent association between aPWV and cIMT but not with carotid plaques. These biomarkers may indicate distinct phenotypes for atherosclerosis.