Ting, Henry H.

Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Objectives: Patient involvement in the choice of whether to undergo emergency department observation unit (EDOU) admission and cardiac stress testing or follow-up with a physician could increase knowledge, increase satisfaction, and safely decrease resource use. We test this hypothesis in a randomized trial. Methods: We developed and tested Chest Pain Choice, a decision aid that communicates the pre-test probability of an acute coronary syndrome (ACS) within 45 days and makes management options (EDOU admission and stress testing or 24-72 hr follow-up with a physician) explicit to the patient. Patients with a primary complaint of chest pain and no known coronary artery disease who were being considered for EDOU admission were eligible. Patient-clinician pairs were randomized to intervention (decision aid plus risk estimate) or usual care (no decision aid, no risk estimate). We used patient surveys and 30-day phone follow-up to assess the primary outcome (patient knowledge regarding their short-term risk for ACS), patient satisfaction, safety (delayed or missed ACS defined as acute myocardial infarction, ventricular arrhythmia, cardiogenic shock, or cardiac/unknown death), and resource use. Analysis was by intention to treat. Results: The 205 patients had the following characteristics: mean age (SD) 54.7 (11.8), 59% female, 36% history of HTN and 10% history of diabetes. Compared with usual care patients (n=104), patients receiving the decision aid (n=101) less frequently decided to be admitted to the EDOU for cardiac stress testing (58% vs 77%, absolute difference = 19%, 95% CI 6, 31), had a lower rate of stress testing (74% vs 90%, absolute difference = 16%, 95% CI 6, 26), greater knowledge of their exact pre-test probability of ACS (25% vs 1%, absolute difference = 24%, 95% CI 15, 33) and reported greater satisfaction with the decision-making process (strongly agree: 61% vs 40%, absolute difference = 21%, 95% CI 7, 33). There were no cases of delayed or missed ACS in either arm. Conclusion: Use of a decision aid in ED chest pain patients increased knowledge, increased satisfaction, and safely decreased resource use. In an era of health care reform, shared decision-making is a promising approach that may both increase patient engagement and decrease resource use.Funding(This research has received full or partial funding support from the American Heart Association, National Center)

Importance: Up to 10% of patients with acute myocardial infarction (AMI) have right bundle branch block (RBBB), and RBBB has been associated with a higher risk of mortality. We performed a systematic review and meta-analysis to determine the prognostic significance of RBBB for patients with AMI. Acute coronary syndrome (ACS) Data Sources: We have systematically searched Ovid, Scopus and Web of Science through January 2014. Study Selection: Reviewers working independently and in duplicate screened all eligible abstracts, selecting studies that described all-cause mortality or cardiovascular death in patients with RBBB and suspected ACS. We excluded studies that reported unadjusted outcomes. Knowledge synthesis: We pooled risk ratio with hazard ratio in studies reporting those outcomes. When reported, odds ratio was converted into risk ratio using reported event rate in each study’s unexposed -read: non RBBB- group. Main Outcomes: All-cause mortality and cardiovascular mortality (death). Results: Eighteen studies were found that reported eligible data. All were observational studies, involving over 89,000 patients. In short-term follow up (up to 30 days), RBBB on presentation was associated with higher all-cause mortality rate, compared to patients without RBBB (RR 2.23, 95% CI 1.76-2.82). There was a trend for higher mortality at long-term follow up (range: 6 months-16 years) that did not reach statistical significance (RR 1.45, 95% CI 0.93-2.25). Figure-1 demonstrates the forest plot. Risk of bias was assessed with the Newcastle-Ottawa scale and majority of included studied were deemed moderate to high quality. Conclusion and Relevance: RBBB is associated with a more than 2-fold higher risk of all-cause mortality in patients with AMI at 30 days follow up. Patients with AMI and RBBB represent a high risk group for adverse outcomes. A sentence on the differential findings for new vs. old RBBB and association with outcomes could follow here.

Importance: Right bundle branch block (RBBB) is observed in approximately 5-14% of patients with heart failure (HF). Multiple observational studies have reported the association of RBBB with clinical outcomes in patients with HF. We performed a systematic review and meta-analysis to determine the prognostic significance of RBBB for patients with HF. Data Sources: We have systematically searched MEDLINE, EMBASE, Cochrane CENTRAL, Web of Science and Scopus through January 2014. Study Selection: Reviewers working independently and in duplicate screened all eligible abstracts that described all cause or cardiovascular mortality in patients with RBBB and HF. We excluded studies that reported unadjusted outcome, i.e.: unadjusted event rates. Knowledge synthesis: We pooled reported risk ratio and hazard ratio. Main Outcomes: All-cause mortality and cardiovascular mortality (death). Results: We found 12 relevant observational studies enrolling over 38,000 patients. Risk of bias was assessed using the Newcastle-Ottawa Scale. Included studies had at least a moderate quality. Seven of those evaluated prognosis of patients with RBBB and heart failure. After a mean follow up period of 2.5 years (range: 1-5 years), RBBB was associated with a statistically significant increased risk of all-cause mortality compared to patients with heart failure but no BBB, RR 1.27, 95% CI (1.08-1.50), Figure 1. The other 5 studies evaluated CHF patients receiving cardiac resynchronization therapy (CRT), comparing outcomes of patients with RBBB to those with LBBB. After a mean f/u period of 3 years, patients with RBBB were once again found to have an increased risk of all-cause mortality, RR 1.45, 95% CI 1.12-1.89. Conclusion and Relevance: RBBB in patients with HF is associated with higher all-cause mortality in comparison to patients without inter-ventricular conduction defects, as well as LBBB patients in patients undergoing CRT setting.

Background: Shared decision-making with decision aids (DA) improves patient knowledge and reduces decisional conflict. The extent to which they do so across sociodemographic subgroups remains unknown. Methods: An encounter-level meta-analysis of five DA randomized trials examined the impact of sociodemographic variables on knowledge transfer and decisional conflict using a generalized linear model stratified by study and adjusted by treatment arm. Results: We analyzed 595 patient-clinician encounters. Significantly higher knowledge transfer with DA occurred in nearly all patient subgroups when compared to usual care (UC). Patients with more formal education tended to have greater knowledge transfer with UC; this was diminished with DA. There was a trend towards improved decisional conflict in all subgroups with the use of DA; overall decisional conflict was low. (see Table) Conclusion: The use of DA compared to UC significantly increases knowledge transfer across diverse subgroups and there is a tendency towards reduced decisional conflict. Differences at baseline, such as knowledge transfer across educational strata, may be mitigated with use of DA. In conclusion, DA are found to be effective across patient subgroups and may represent a novel strategy to lessen disparities.

Background: While concerns about the safety and procedural success of radial, as opposed to femoral, access for PCI have largely been abated, the association of radial access with patients’ health status recovery has not been explored. To address this gap in knowledge, we compared the symptoms, physical function and quality of life 1 year after PCI in patients treated with radial, as compared with femoral, access. Methods: This is a 10-center study of PCI, in whom 48 of 139 (35%) interventionalists used both radial and femoral approaches between 2009-2010. A total 2628 patients without prior CABG were interviewed and followed for one year. The previously validated Seattle Angina Questionnaire (SAQ) was used to assess disease-specific health status and the EQ-5D was used to quantify generic quality of life. Clinical characteristics and health status outcomes were compared between 296 radial and 2332 femoral PCI procedures. Results: Radial access was used in 11.2% of patients. No demographic (age, gender, race) or clinical factors (e.g. BMI, smoking, diabetes, hypertension, renal disease or prior cardiac history) were associated with radial use, except for an increased use among those with PAD (10.5% radial vs. 6.8% femoral, p=0.022) but reduced use among those with prior PCI (38.3% vs. 32.1%, p=0.037). There was no difference in health status outcomes based on SAQ angina frequency and quality of life, or the EQ-5D at baseline, 6 months or one year (table). Conclusion: In this multi-center observational registry, there was no association of radial access with long-term health status outcomes. These data suggest that there are no offsetting concerns about patients’ long-term health status benefits to counterbalance the peri-procedural safety benefits of a radial approach.

Background: Whether patients with STEMI with longer times from symptom onset to hospital presentation are less likely to be treated with any reperfusion therapy or treated with less urgency resulting in longer door-to-balloon and door-to-needle times is not known. The relationship between delay in hospital presentation and the quality of reperfusion therapy for patients with STEMI has not been examined Methods: We constructed 3 cohorts of STEMI patients to analyze use of any reperfusion (n=440,398), door-to-balloon time (n=67,207), and door-to-drug time (n=183,441) as a function of delay in hospital presentation. We constructed multivariable generalized linear models for each outcome to estimate the associations between delay in hospital presentation adjusted for all patient and hospital characteristics. Results: In adjusted analysis, longer times from symptom onset to hospital presentation was associated with lower use of any reperfusion therapy (p<0.0001 for trend). For early presenters with times of ≤1 hour, >1 to 2 hours, and >2 to 3 hours, 77%, 77%, and 73% of patients received any reperfusion therapy, respectively, and late presenters with times >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours were treated with any reperfusion therapy in 53%, 50%, and 46%, respectively. Delay in hospital presentation was associated with longer drug-to-balloon and door-to-drug times (p<0.0001 for trend). For time intervals of ≤ 1 hour, >1 to 2 hours, >2 to 3 hours, >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours, patients with STEMI were treated with door-to-balloon times of 99, 101, 106, 123, 125, and 123 minutes respectively. For delay time intervals of ≤ 1 hour, >1 to 2 hours, >2 to 3 hours, >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours, patients were treated with door-to-drug times of 32, 34, 36, 46, 44, and 46 minutes, respectively. Conclusions: Longer time from symptom onset to hospital presentation has important implications for subsequent treatment and was associated with lower use of any reperfusion therapy and longer door-to-balloon and door-to-drug times. Longer delay in hospital presentation is associated with worse system performance for reperfusion therapy quality and represents an opportunity to improve quality of care for STEMI patients.

Delayed contact with the medical system may lead to worse patient outcomes in acute myocardial infarction (AMI), particularly ST-elevation myocardial infarction (STEMI). We examined the effect of previously unstudied aspects of patients’ characteristics on delays to presentation, including health status, depressive symptoms, and socioeconomic status. Within the Translational Research Investigating Underlying disparities in acute Myocardial infarction Patients’ Health status (TRIUMPH) study, we examined predictors of delays to hospital presentation in 1,476 patients with AMI from 26 sites using multivariable hierarchical ordinal models. Time from symptom onset to hospital presentation was categorized as ≤2 hours, >2 to 6 hours, and >6 hours. Time to hospital presentation was ≤2 hours in 540 (36.6%) patients, between 2– 6 hours in 354 (24.0%) patients, and >6 hours in 582 (39.4%) patients. Factors associated with longer delays to presentation included frequent angina (compared to no angina: daily angina, Odds Ratio [OR] of 3.48 [95% CI: 1.53–7.88]; weekly angina, 2.46 [1.64 –3.67]; and monthly angina, 1.26 [0.96 –1.64]; p for trend<.001), presentation during weekday work hours (8am to 5pm) (compared to weekend: weekday, 1.40 [1.06, 1.85]; weeknight, 1.15 [0.85,1.54]; p for trend = 0.05), cost barriers (1.39 [1.05 to 1.85]; p=0.02), and no healthcare insurance (1.56 [1.15–2.12]; p=0.005). In contrast, patients with STEMI (0.55 [0.43– 0.70]; p<.001), prior coronary revascularization (0.67 [0.48 – 0.92]; p=0.01) and prior AMI (0.68 [0.48 – 0.97]; p=0.03) were more likely to present earlier. No relationship was found for depression, educational level, social support, or marital status. More frequent angina, cost barriers, no healthcare insurance, and time of day are associated with longer delays to hospital presentation, while those with prior AMIs and coronary revascularization were more likely to present earlier. Efforts to reduce delays should address patient issues related to health status (like angina), cost burden, and healthcare access.

Background : The significant bidirectional changes in cardiovascular(CV) risk factor prevalence make the net trend in incident CV risk unknown. We assessed the trends in the net 10-year risk for incident CV disease using the Framingham risk model and data from the National Health and Nutrition Examination Surveys(NHANES). Methods : We used data from NHANES II (1976–1980), NHANES III (1988–1994), and NHANES 1999–2004, including major CV risk factors, all collected in a standardized manner. People with a history of CV disease, pregnant women, people with missing data and those outside the Framingham age range were excluded. The Framingham risk function estimated the 10-year risk for CV disease. The slope of change or rate of change per year between NHANES II/III, and between NHANES III/1999–2004 were determined. The slope difference was calculated and compared to zero. Results : The mean age-adjusted 10-year CV risk decreased from 10 to 7.9% between NHANES II and III, with a significant slope (p<0.001). However, the mean age-adjusted risk decreased to a lesser extent between NHANES III and NHANES 1999–2004 from 7.9 to 7.4% (p<0.001). The slopes were different (p<0.001). In women, CV risk did not change between NHANES III and 1999–2004, 7.9 to 7.5%, (p=0.40). Predicted 10-year risk by age group (Figure ) shows that the decrease in CV risk was lower in the second period compared to the first one in all age groups, except in the elderly. Conclusion : The estimated net risk for CV disease in the US population decreased from 1976–1980 to 1988–1994 but minimally changed from 1988–1994 to 1999–2004, particularly in women. The increased prevalence of obesity may have offset the gain in CV risk reduction. Predicted 10-year Framingham Risk by Age Group