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Purpose: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KCCQ-23 that are important to assess in men and/or women with heart failure (HF). Methods: Patients ≥ 22 years of age with clinician-diagnosed HF and left ventricular ejection fraction ≤ 40% were recruited from two academic medical centers to participate in semi-structured concept elicitation and cognitive debriefing interviews. Enrollment was stratified by patient-identified gender (half women/half men). All interviews were conducted over the phone/web and audio recorded. Interviews were transcribed and descriptive qualitative content analysis was used to summarize findings overall and by gender. Results: Twenty-five adults (56% women) diagnosed with HF participated. The average age was 67 years (range: 25–88). Women attributed a wider variety of symptoms to HF than men. Some participants had difficulty differentiating whether their experiences were due to HF, side effects of their medications, or age. We found very little evidence that participants interpreted KCCQ-23 items differently based on gender. Conclusions: Overall, our findings indicate that interpretation of the KCCQ-23 items were similar in men and women. However, some modifications to items may improve clarity of interpretation for a wide range of patients. [ABSTRACT FROM AUTHOR]

Importance: Contrast-associated acute kidney injury (AKI) is a common complication of coronary angiography and percutaneous coronary intervention (PCI) that has been associated with high costs and adverse long-term outcomes.Objective: To determine whether a multifaceted intervention is effective for the prevention of AKI after coronary angiography or PCI.Design, Setting, and Participants: A stepped-wedge, cluster randomized clinical trial was conducted in Alberta, Canada, that included all invasive cardiologists at 3 cardiac catheterization laboratories who were randomized to various start dates for the intervention between January 2018 and September 2019. Eligible patients were aged 18 years or older who underwent nonemergency coronary angiography, PCI, or both; who were not undergoing dialysis; and who had a predicted AKI risk of greater than 5%. Thirty-four physicians performed 7820 procedures among 7106 patients who met the inclusion criteria. Participant follow-up ended in November 2020.Interventions: During the intervention period, cardiologists received educational outreach, computerized clinical decision support on contrast volume and hemodynamic-guided intravenous fluid targets, and audit and feedback. During the control (preintervention) period, cardiologists provided usual care and did not receive the intervention.Main Outcomes and Measures: The primary outcome was AKI. There were 12 secondary outcomes, including contrast volume, intravenous fluid administration, and major adverse cardiovascular and kidney events. The analyses were conducted using time-adjusted models.Results: Of the 34 participating cardiologists who were divided into 8 clusters by practice group and center, the intervention group included 31 who performed 4327 procedures among 4032 patients (mean age, 70.3 [SD, 10.7] years; 1384 were women [32.0%]) and the control group included 34 who performed 3493 procedures among 3251 patients (mean age, 70.2 [SD, 10.8] years; 1151 were women [33.0%]). The incidence of AKI was 7.2% (310 events after 4327 procedures) during the intervention period and 8.6% (299 events after 3493 procedures) during the control period (between-group difference, -2.3% [95% CI, -0.6% to -4.1%]; odds ratio [OR], 0.72 [95% CI, 0.56 to 0.93]; P = .01). Of 12 prespecified secondary outcomes, 8 showed no significant difference. The proportion of procedures in which excessive contrast volumes were used was reduced to 38.1% during the intervention period from 51.7% during the control period (between-group difference, -12.0% [95% CI, -14.4% to -9.4%]; OR, 0.77 [95% CI, 0.65 to 0.90]; P = .002). The proportion of procedures in eligible patients in whom insufficient intravenous fluid was given was reduced to 60.8% during the intervention period from 75.1% during the control period (between-group difference, -15.8% [95% CI, -19.7% to -12.0%]; OR, 0.68 [95% CI, 0.53 to 0.87]; P = .002). There were no significant between-group differences in major adverse cardiovascular events or major adverse kidney events.Conclusions and Relevance: Among cardiologists randomized to an intervention including clinical decision support with audit and feedback, patients undergoing coronary procedures during the intervention period were less likely to develop AKI compared with those treated during the control period, with a time-adjusted absolute risk reduction of 2.3%. Whether this intervention would show efficacy outside this study setting requires further investigation.Trial Registration: ClinicalTrials.gov Identifier: NCT03453996. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) are elicited directly from patients so they can describe their overall health status, including their symptoms, function, and quality of life. While commonly used as end points in clinical trials, PROs can play an important role in routine clinical care, population health management, and as a means for quantifying the quality of patient care. In this review, we propose that PROs be used to improve patient-centered care in the treatment of cardiovascular diseases given their importance to patients and society and their ability to improve doctorprovider communication. Furthermore, given the current variability in patients' health status across different clinics and the fact that PROs can be improved by titrating therapy, we contend that PROs have a key opportunity to serve as measures of healthcare quality. [ABSTRACT FROM AUTHOR]

Background: In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status.Methods: We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy.Results: Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4).Conclusions: Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.). [ABSTRACT FROM AUTHOR]

Objective: The Appropriate Use Criteria (AUC) has been used to identify individuals who are likely to benefit from percutaneous coronary intervention (PCI) for stable ischaemic heart disease. However, whether physicians reliably grade PCI appropriateness and whether AUC categories stratify symptomatic improvement in real-world practice are unclear.Methods: Patient-reported outcomes measures (PROMs) for angina (Seattle Angina Questionnaire (SAQ-7)), dyspnoea (Rose Dyspnea Scale (RDS)) and depression (Patient Health Questionnaire-2 (PHQ-2)) were collected on patients undergoing elective coronary angiography at an academic medical centre. Retrospectively, two physicians independently determined PCI appropriateness by the AUC criteria.Results: Inter-rater agreement on appropriateness was moderate (κ=0.48, 95% CI 0.32 to 0.63). Of PCI procedures evaluated, 57 (47.1%) were appropriate (A-PCI), 62 (51.2%) were maybe appropriate (MA-PCI) and 2 (1.6%) were rarely appropriate. At baseline, A-PCI compared with MA-PCI patients had worse RDS scores (2.0 vs 1.2, p=0.01). At 30 days, the change in SAQ-7 summary score was similar between groups (A-PCI vs MA-PCI, +27.1 vs +20.7, p=0.11). The mean change in RDS score was greater in A-PCI than MA-PCI (-1.0 vs -0.5, p for group by time interaction=0.03). PHQ-2 scores were similar and did not improve at 30 days.Conclusion: In patients undergoing PCI with PROMs collected before and 30 days after PCI, similar improvements in angina were observed regardless of appropriateness. Inter-rater agreement on PCI appropriateness was only moderate. Use of PROMs may improve reliability of physician assessments of PCI appropriateness. [ABSTRACT FROM AUTHOR]

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: –7.0 [–10.7, –3.4]; p < 0.001 and EQ5D: –9.2 [–12.74, –5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: –8.4 [–13.0, –3.8]; p < 0.001 and EQ5D: –9.7 [–13.2, –6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080 [ABSTRACT FROM AUTHOR]

Background: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes.Methods: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness.Discussion: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients.Trial Registration: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ]. [ABSTRACT FROM AUTHOR]

Background: Prior studies have reported higher in-hospital survival with prompt defibrillation and epinephrine treatment in patients with in-hospital cardiac arrest (IHCA). Whether this survival benefit persists after discharge is unknown.Methods: We linked data from a national IHCA registry with Medicare files and identified 36 961 patients ≥65 years of age with an IHCA at 517 hospitals between 2000 and 2011. Patients with IHCA caused by pulseless ventricular tachycardia or ventricular fibrillation were stratified by prompt (≤2 minutes) versus delayed (>2 minutes) defibrillation, whereas patients with IHCA caused by asystole or pulseless electric activity were stratified by prompt (≤5 minutes) versus delayed (>5 minutes) epinephrine treatment. The association between prompt treatment and long-term survival for each rhythm type was assessed with multivariable hierarchical modified Poisson regression models.Results: Of 8119 patients with an IHCA caused by ventricular tachycardia or ventricular fibrillation, the rate of 1-year survival was higher in those treated with prompt defibrillation than with delayed defibrillation (25.7% [1466 of 5714] versus 15.5% [373 of 2405]; adjusted relative risk [RR], 1.49; 95% confidence interval [CI] 1.32-1.69; P<0.0001). This survival advantage persisted at 3 years (19.1% versus 11.0%; adjusted RR, 1.45; 95% CI, 1.23-1.69; P<0.0001) and at 5 years (14.7% versus 7.9%; adjusted RR, 1.50; 95% CI, 1.22-1.83; P<0.0001). Of 28 842 patients with an IHCA caused by asystole/pulseless electric activity, the rate of 1-year survival with prompt epinephrine treatment was higher than with delayed treatment (5.4% [1341 of 24 885] versus 4.3% [168 of 3957]; adjusted RR, 1.20; 95% CI, 1.02-1.41; P=0.02), but this survival benefit was no longer present at 3 years (3.5% versus 2.9%; adjusted RR, 1.17; 95% CI, 0.95-1.45; P=0.15) and at 5 years (2.3% versus 1.9%; adjusted RR, 1.18; 95% CI, 0.88-1.58; P=0.27).Conclusions: Prompt defibrillation for IHCA caused by ventricular tachycardia or ventricular fibrillation was associated with higher rates of long-term survival throughout 5 years of follow-up, whereas prompt epinephrine treatment for asystole/pulseless electric activity was associated with greater survival at 1 year but not at 3 or 5 years. By quantifying the greater survival associated with timely defibrillation and epinephrine administration, these findings provide important insights into the durability of survival benefits for 2 process-of-care measures in current resuscitation guidelines. [ABSTRACT FROM AUTHOR]

Background: Dyspnea is a common angina equivalent that adversely affects quality of life, but its prevalence in patients with chronic total occlusions (CTOs) and predictors of its improvement after CTO percutaneous coronary intervention (PCI) are unknown. We examined the prevalence of dyspnea and predictors of its improvement among patients selected for CTO PCI.Methods and Results: In the OPEN CTO registry (Outcomes, Patient health status, and Efficiency iN Chronic Total Occlusion) of 12 US experienced centers, 987 patients undergoing CTO PCI (procedure success 82%) were assessed for dyspnea with the Rose Dyspnea Scale at baseline and 1 month after CTO PCI. Rose Dyspnea Scale scores range from 0 to 4 with higher scores indicating more dyspnea with common activities. A total of 800 (81%) reported some dyspnea at baseline with a mean (±SD) Rose Dyspnea Scale of 2.8±1.2. Dyspnea improvement was defined as a ≥1 point decrease in Rose Dyspnea Scale from baseline to 1 month. Predictors of dyspnea improvement were examined with a modified Poisson regression model. Patients with dyspnea were more likely to be female, obese, smokers, and to have more comorbidities and angina. Among patients with baseline dyspnea, 70% reported less dyspnea at 1 month after CTO PCI. Successful CTO PCI was associated with more frequent dyspnea improvement than failure, even after adjustment for other clinical variables. Anemia, depression, and lung disease were associated with less dyspnea improvement after PCI.Conclusions: Dyspnea is a common symptom among patients undergoing CTO PCI and improves significantly with successful PCI. Patients with other potentially noncardiac causes of dyspnea reported less dyspnea improvement after CTO PCI. [ABSTRACT FROM AUTHOR]

Background: Previous studies suggest that among patients with stable coronary artery disease, patients with diabetes mellitus (DM) have less angina and more silent ischemia when compared with those without DM. However, the burden of angina in diabetic versus nondiabetic patients after elective percutaneous coronary intervention (PCI) has not been recently examined.Methods and Results: In a 10-site US PCI registry, we assessed angina before and at 1, 6, and 12 months after elective PCI with the Seattle Angina Questionnaire angina frequency score (range, 0-100, higher=better). We also examined the rates of antianginal medication prescriptions at discharge. A multivariable, repeated-measures Poisson model was used to examine the independent association of DM with angina over the year after treatment. Among 1080 elective PCI patients (mean age, 65 years; 74.7% men), 34.0% had DM. At baseline and at each follow-up, patients with DM had similar angina prevalence and severity as those without DM. Patients with DM were more commonly prescribed calcium channel blockers and long-acting nitrates at discharge (DM versus not: 27.9% versus 20.9% [P=0.01] and 32.8% versus 25.5% [P=0.01], respectively), whereas β-blockers and ranolazine were prescribed at similar rates. In the multivariable, repeated-measures model, the risk of angina was similar over the year after PCI in patients with versus without DM (relative risk, 1.04; range, 0.80-1.36).Conclusions: Patients with stable coronary artery disease and DM exhibit a burden of angina that is at least as high as those without DM despite more antianginal prescriptions at discharge. These findings contradict the conventional teachings that patients with DM experience less angina because of silent ischemia. [ABSTRACT FROM AUTHOR]

Importance: Dual antiplatelet therapy after percutaneous coronary intervention (PCI) reduces ischemia but increases bleeding.Objective: To develop a clinical decision tool to identify patients expected to derive benefit vs harm from continuing thienopyridine beyond 1 year after PCI.Design, Setting, and Participants: Among 11,648 randomized DAPT Study patients from 11 countries (August 2009-May 2014), a prediction rule was derived stratifying patients into groups to distinguish ischemic and bleeding risk 12 to 30 months after PCI. Validation was internal via bootstrap resampling and external among 8136 patients from 36 countries randomized in the PROTECT trial (June 2007-July 2014).Exposures: Twelve months of open-label thienopyridine plus aspirin, then randomized to 18 months of continued thienopyridine plus aspirin vs placebo plus aspirin.Main Outcomes and Measures: Ischemia (myocardial infarction or stent thrombosis) and bleeding (moderate or severe) 12 to 30 months after PCI.Results: Among DAPT Study patients (derivation cohort; mean age, 61.3 years; women, 25.1%), ischemia occurred in 348 patients (3.0%) and bleeding in 215 (1.8%). Derivation cohort models predicting ischemia and bleeding had c statistics of 0.70 and 0.68, respectively. The prediction rule assigned 1 point each for myocardial infarction at presentation, prior myocardial infarction or PCI, diabetes, stent diameter less than 3 mm, smoking, and paclitaxel-eluting stent; 2 points each for history of congestive heart failure/low ejection fraction and vein graft intervention; -1 point for age 65 to younger than 75 years; and -2 points for age 75 years or older. Among the high score group (score ≥2, n = 5917), continued thienopyridine vs placebo was associated with reduced ischemic events (2.7% vs 5.7%; risk difference [RD], -3.0% [95% CI, -4.1% to -2.0%], P < .001) compared with the low score group (score <2, n = 5731; 1.7% vs 2.3%; RD, -0.7% [95% CI, -1.4% to 0.09%], P = .07; interaction P < .001). Conversely, continued thienopyridine was associated with smaller increases in bleeding among the high score group (1.8% vs 1.4%; RD, 0.4% [95% CI, -0.3% to 1.0%], P = .26) compared with the low score group (3.0% vs 1.4%; RD, 1.5% [95% CI, 0.8% to 2.3%], P < .001; interaction P = .02). Among PROTECT patients (validation cohort; mean age, 62 years; women, 23.7%), ischemia occurred in 79 patients (1.0%) and bleeding in 37 (0.5%), with a c statistic of 0.64 for ischemia and 0.64 for bleeding. In this cohort, the high-score patients (n = 2848) had increased ischemic events compared with the low-score patients and no significant difference in bleeding.Conclusion and Relevance: Among patients not sustaining major bleeding or ischemic events 1 year after PCI, a prediction rule assessing late ischemic and bleeding risks to inform dual antiplatelet therapy duration showed modest accuracy in derivation and validation cohorts. This rule requires further prospective evaluation to assess potential effects on patient care, as well as validation in other cohorts.Trial Registration: clinicaltrials.gov Identifier: NCT00977938. [ABSTRACT FROM AUTHOR]

Importance: Appropriate Use Criteria for Coronary Revascularization were developed to critically evaluate and improve patient selection for percutaneous coronary intervention (PCI). National trends in the appropriateness of PCI have not been examined.Objective: To examine trends in PCI utilization, patient selection, and procedural appropriateness following the introduction of Appropriate Use Criteria.Design, Setting, and Participants: Multicenter, longitudinal, cross-sectional analysis of patients undergoing PCI between July 1, 2009, and December 31, 2014, at hospitals continuously participating in the National Cardiovascular Data Registry CathPCI registry over the study period.Main Outcomes and Measures: Proportion of nonacute PCIs classified as inappropriate at the patient and hospital level using the 2012 Appropriate Use Criteria for Coronary Revascularization.Results: A total of 2.7 million PCI procedures from 766 hospitals were included. Annual PCI volume of acute indications was consistent over the study period (377,540 in 2010; 374,543 in 2014), but the volume of nonacute PCIs decreased from 89,704 in 2010 to 59,375 in 2014. Among patients undergoing nonacute PCI, there were significant increases in angina severity (Canadian Cardiovascular Society grade III/IV angina, 15.8% in 2010 and 38.4% in 2014), use of antianginal medications prior to PCI (at least 2 antianginal medications, 22.3% in 2010 and 35.1% in 2014), and high-risk findings on noninvasive testing (22.2% in 2010 and 33.2% in 2014) (P < .001 for all), but only modest increases in multivessel coronary artery disease (43.7% in 2010 and 47.5% in 2014, P < .001). The proportion of nonacute PCIs classified as inappropriate decreased from 26.2% (95% CI, 25.8%-26.6%) to 13.3% (95% CI, 13.1%-13.6%), and the absolute number of inappropriate PCIs decreased from 21,781 to 7921. Hospital-level variation in the proportion of PCIs classified as inappropriate persisted over the study period (median, 12.6% [interquartile range, 5.9%-22.9%] in 2014).Conclusions and Relevance: Since the publication of the Appropriate Use Criteria for Coronary Revascularization in 2009, there have been significant reductions in the volume of nonacute PCI. The proportion of nonacute PCIs classified as inappropriate has declined, although hospital-level variation in inappropriate PCI persists. [ABSTRACT FROM AUTHOR]

Background: Early readmission after percutaneous coronary intervention is an important quality metric, but prediction models from registry data have only moderate discrimination. We aimed to improve ability to predict 30-day readmission after percutaneous coronary intervention from a previously validated registry-based model.Methods and Results: We matched readmitted to non-readmitted patients in a 1:2 ratio by risk of readmission, and extracted unstructured and unconventional structured data from the electronic medical record, including need for medical interpretation, albumin level, medical nonadherence, previous number of emergency department visits, atrial fibrillation/flutter, syncope/presyncope, end-stage liver disease, malignancy, and anxiety. We assessed differences in rates of these conditions between cases/controls, and estimated their independent association with 30-day readmission using logistic regression conditional on matched groups. Among 9288 percutaneous coronary interventions, we matched 888 readmitted with 1776 non-readmitted patients. In univariate analysis, cases and controls were significantly different with respect to interpreter (7.9% for cases and 5.3% for controls; P=0.009), emergency department visits (1.12 for cases and 0.77 for controls; P<0.001), homelessness (3.2% for cases and 1.6% for controls; P=0.007), anticoagulation (33.9% for cases and 22.1% for controls; P<0.001), atrial fibrillation/flutter (32.7% for cases and 28.9% for controls; P=0.045), presyncope/syncope (27.8% for cases and 21.3% for controls; P<0.001), and anxiety (69.4% for cases and 62.4% for controls; P<0.001). Anticoagulation, emergency department visits, and anxiety were independently associated with readmission.Conclusions: Patient characteristics derived from review of the electronic health record can be used to refine risk prediction for hospital readmission after percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

Background: China is experiencing increasing burden of acute myocardial infarction (AMI) in the face of limited medical resources. Hospital length of stay (LOS) is an important indicator of resource utilization. Methods: We used data from the Retrospective AMI Study within the China Patient-centered Evaluative Assessment of Cardiac Events, a nationally representative sample of patients hospitalized for AMI during 2001, 2006, and 2011. Hospital-level variation in risk-standardized LOS (RS-LOS) for AMI, accounting for differences in case mix and year, was examined with two-level generalized linear mixed models. A generalized estimating equation model was used to evaluate hospital characteristics associated with LOS. Absolute differences in RS-LOS and 95% confidence intervals were reported. Results: The weighted median and mean LOS were 13 and 14.6 days, respectively, in 2001 (n = 1,901), 11 and 12.6 days in 2006 (n = 3,553), and 11 and 11.9 days in 2011 (n = 7,252). There was substantial hospital level variation in RS-LOS across the 160 hospitals, ranging from 9.2 to 18.1 days. Hospitals in the Central regions had on average 1.6 days (p = 0.02) shorter RS-LOS than those in the Eastern regions. All other hospital characteristics relating to capacity for AMI treatment were not associated with LOS. Conclusions: Despite a marked decline over the past decade, the mean LOS for AMI in China in 2011 remained long compared with international standards. Inter-hospital variation is substantial even after adjusting for case mix. Further improvement of AMI care in Chinese hospitals is critical tofurther shorten LOS and reduce unnecessary hospital variation. [ABSTRACT FROM AUTHOR]

Background: Angina and depression are common in ischemic heart disease (IHD), but their association remains understudied. Purpose: This study was conducted in order to evaluate the association of 1 year change in depression with change in patient-reported outcomes of stable angina. Methods: Five hundred sixty-nine stable angina patients completed the Seattle Angina Questionnaire and Patient Health Questionnaire (PHQ) at baseline and 1 year. Participants were divided into four groups: not depressed, new onset of depression at 1 year, remitted at 1 year, and persistently depressed. Associations between depression and angina symptoms were evaluated using regression models. Results: Compared to those not depressed, newly depressed participants reported more angina ( β = −11.7, p < 0.001) and physical limitations ( β = −11.8, p < 0.001) and lower treatment satisfaction ( β = −15.03, p < 0.001) and quality of life ( β = −15.4, p < 0.001). Persistently depressed participants reported physical limitations ( β = −7.4, p < 0.05), lower treatment satisfaction ( β = −10.1, p < 0.001), and poorer quality of life ( β = −10.03, p < 0.001). Conclusions: Changes in depression scores and angina outcomes were significantly associated. [ABSTRACT FROM AUTHOR]

Background: Clinical trials and national performance measures increasingly mandate reporting patients' perspectives of their health status: their symptoms, function, and quality of life. Although the Seattle Angina Questionnaire (SAQ) is a validated disease-specific health status instrument for coronary artery disease (CAD) with high test-retest reliability, predictive power, and responsiveness, its use in routine clinical practice has been limited, in part, by its length (19 items).Methods and Results: Using data from 10 408 patients with CAD from 5 multicenter registries, we derived and validated a shortened version of the SAQ (SAQ-7) among patients presenting with stable CAD, undergoing percutaneous coronary intervention, and after acute myocardial infarction. We examined the psychometric properties of the SAQ-7 as compared with the full SAQ. Seven items from the Physical Limitation, Angina Frequency, and Quality of Life domains were identified for the SAQ-7, with high levels of concordance (0.88-1.00) with each original SAQ domain. The SAQ-7 demonstrated good construct validity (compared with Canadian Cardiovascular Society class for angina), with a correlation of 0.62 and 0.38 for patients with stable CAD and undergoing percutaneous coronary intervention, respectively. It was highly reproducible in patients with stable CAD (intraclass correlation, ≥0.78) and exhibited excellent responsiveness in patients after percutaneous coronary intervention (≥18 points in each SAQ domain). Finally, the SAQ-7 was predictive of 1-year mortality and readmission.Conclusions: To increase the feasibility of measuring patient-reported outcomes in patients with CAD, we developed and validated a shortened 7-item SAQ instrument for use in clinical trials and routine care. [ABSTRACT FROM AUTHOR]

Background: In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown.Methods and Results: We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]).Conclusion: Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657. [ABSTRACT FROM AUTHOR]

The article presents a study on the addition of frailty, comorbidity and quality of life in the risk assessment models for elderly patients undergoing percutaneous coronary interventions (PCI). The inclusion will improve the classification of patients according to their requirements for care, treatment and supervision. Better prognosis and better medical decision-making is expected and will lead to in-depth risk prediction of long term mortality and optimal treatments for patients.

The article discusses the relevance of percutaneous coronary intervention (PCI), which is performed in about 600,000 cases in the U.S. per year and costs a total of 12 billion U.S. dollars. In a study conducted by the authors to understand the need for the procedure, they use data from the National Cardiovascular Data Registry between July 1, 2009 and September 30, 2010 with an aim of finding the proportion of appropriate, uncertain or inappropriate PCI. They conclude that most PCIs done in the U.S. were appropriate with only 12% being tagged as inappropriate.

The article highlights the unfavorable future quality of life assessment for patients with heart failure. Data from the Kansas City Cardiomyopathy Questionnaire was used by the authors to identify the factors associated with 6-month mortality and additional data was derived from the Efficacy of Vasopressin Antagonism in HF Outcome Study with Tolvaptan (EVEREST). The authors say patients who were found to be at high risk for unfavorable QoL should be educated about his options before discharge.

The article discusses a research study on the cost-effectiveness of percutaneous coronary intervention (PCI) as a function of angina severity in patients with stable angina. The researchers assessed angina severity using the Seattle Angina Questionnaire (SAQ). They determined that incremental cost of PCI to provide meaningful clinical benefit was lower for patients with severe angina than those with mild or no angina.

The article compares three distinct healthcare systems (HCS) in North America, namely Department of Veterans Affairs HCS (VA HCS), US non-VA HCS and Canadian system, and determines treatment difference in cardiovascular outcomes by HCS. It mentions that the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has similar baseline demographics within each HCS. The article concludes that the addition of percutaneous coronary intervention to optimal medical therapy did not improve five-year survival among the 3 HCS.

The article offers information on a study which determined the link between lack of health insurance and financial concerns about accessing care among those with health insurance, and the time from symptom onset to hospital presentation during acute myocardial infarction (AMI). Data analyzed by researchers were from a registry of AMI patients enrolled between April 11, 2005 and December 31, 2008 at 24 U.S. hospitals. Medical records were utilized to determine insurance information, while information on financial concerns was taken from structured interviews. A detailed discussion on the research findings is presented.

Background: The field of outcomes research seeks to define optimal treatment in practice and to promote the rapid full adoption of efficacious therapies into routine clinical care. The American Heart Association (AHA) formed the AHA Pharmaceutical Roundtable (PRT) Outcomes Research Centers Network to accelerate attainment of these goals. Participating centers were intended to carry out state-of-the-art outcomes research in cardiovascular disease and stroke, to train the next generation of investigators, and to support the formation of a collaborative research network.Program: After a competitive application process, 4 AHA PRT Outcomes Research Centers were selected: Duke Clinical Research Institute; Saint Luke's Mid America Heart Institute; Stanford University-Kaiser Permanente of Northern California; and University of California, Los Angeles. Each center proposed between 1 and 3 projects organized around a single theme in cardiovascular disease or stroke. Additionally, each center will select and train up to 6 postdoctoral fellows over the next 4 years, and will participate in cross-collaborative activities among the centers.Conclusions: The AHA PRT Outcomes Research Centers Network is designed to further strengthen the field of cardiovascular disease and stroke outcomes research by fostering innovative research, supporting high quality training, and encouraging center-to-center collaborations. [ABSTRACT FROM AUTHOR]

The article presents a prospective cohort study which determined the rates of mortality and hospital codes before and after the introduction of long-term rapid response teams in hospitals. The authors explain that rapid response teams have been shown to decrease cardiopulmonary arrest code rates. Adult inpatients admitted between January 1, 2004 and August 31, 2007 were used for the study. 24,193 patient admissions were evaluated prior to the implementation of a rapid response team. 24,978 were evaluated after the intervention. Researchers found that implementation of the rapid response team was not associated with reductions in mortality or hospital-wide code rates.

Background: Because of the expense of drug-eluting stents (DES) and associated adjuvant therapy, nonclinical, socioeconomic factors may be associated with DES use in clinical practice. Methods: Data on 112,588 patients from the National Cardiovascular Data CathPCI Registry (NCDR) between 2004 and 2005 with “on-label” indications for DES were analyzed. Insurance status was categorized as No Insurance, Governmental, and Private Insurance. Hierarchical multivariable logistic regression analyses were used to evaluate the association between insurance status and DES use, after adjusting for patient and procedural characteristics. Results: Drug-eluting stent use was >96% during the study period, with utilization significantly associated with insurance status. Compared with patients with Private Insurance, patients with No Insurance (odds ratio 0.44, 95% confidence interval 0.37-0.53) and Government Insurance (odds ratio 0.73, 95% confidence interval 0.67-0.80) were significantly less likely to receive a DES than a bare metal stent. Repeat analysis of patients <65 years of age demonstrated virtually identical results. Conclusions: Despite the high penetration of DES, significant associations between insurance status and DES utilization were identified. This indicates that disparities in health care based on socioeconomic factors extend to DES utilization and highlights the need to address such disparities as novel therapies emerge. [Copyright &y& Elsevier]

The article reports on the association of early outpatient follow-up after acute myocardial infarction (AMI) and its relationship with the use of evidence-based therapies. Patients hospitalized with AMI were evaluated. Multivariable analyses evaluated the association between early outpatient follow-up and medication for 6 months. Moreover, a secondary analyses was used to compare medication use. Results suggest the association of early outpatient follow-up and collaborative follow-up after AMI with higher rates of use of evidence-based therapies.

Percutaneous coronary intervention (PCI) remains a major therapeutic option for the treatment of chronic coronary artery disease. In the COURAGE trial, 2287 patients with chronic coronary disease were randomized between PCI with medical management and medical management alone. Embedded within the COURAGE trial is a detailed economic analysis being conducted in three health care systems: the US Veterans Administration (VA), Canada, and the US non-VA. Resource use and costs are being collected for each system and overall. Survival is assessed internally in the trial with mean follow-up of 4.5 years. Long-term mean survival will be estimated by projecting survival beyond the trial period by extrapolating the in-trial hazard rates. Utility is being assessed at baseline and at 1, 3, and 6 months and annually thereafter, using a computer-administered standard gamble. Quality-adjusted life years are calculated by multiplying survival by utility. The incremental cost-effectiveness ratio of PCI will be defined as the additional cost of PCI divided by the gain in life years and quality-adjusted life years. The 95% confidence regions of efficacy and costs will be determined by bootstrap over a range of acceptability thresholds, which will then be displayed in the cost-effectiveness plane and as a cost-effectiveness acceptability curve. A multilevel regression model will assess cost-effectiveness from a net benefit perspective. These approaches should provide the most detailed assessment available of the cost-effectiveness of PCI for coronary artery disease. [Copyright &y& Elsevier]

This study examined how health services research connects with practice and policy, first by investigating whether successful research projects continued in their test settings and engendered replication and then by examining whether a coherent body of research helped shape public policy. Chronic heart failure (CHF) was studied because randomized, controlled trials of posthospital CHF disease management have repeatedly demonstrated patient benefits and reduced costs, yet this practice has not become standard in the United States. Literature review produced 30 randomized, controlled trials of multidisciplinary outpatient CHF management, generally yielding improved patient outcomes. An e-mail survey of first authors (97% response rate) showed that practices proven to be effective in U.S. studies generally did not continue or expand (13 of 15 studies), mostly attributed to financial constraints (11 of 13), whereas similar projects in other countries often became permanent (7 of 13). U.S. respondents generally rated current quality of clinical care as good, whereas those elsewhere mostly rated it as excellent. Recent Medicare reforms implemented a model of CHF management substantially different from those studied in health services research. The Congressional hearings leading to these Medicare reforms, and the statute itself, mostly evidence the model used by commercial disease-management firms. Policy-makers, health service researchers, and funding agencies could develop more-effective methods for translating proven models of healthcare delivery into routine practice. Reforms that might improve the effectiveness of the linkages between research, policy, and practice are suggested. [ABSTRACT FROM AUTHOR]

Objective. Weight assessment is a critical aid in patient care. It is particularly important in monitoring progression of pregnancies, heart failure status, and when adjusting medications. Although weight is generally determined using a scale, few studies have evaluated the precision of non-household scales. The objective of this study was to assess scale precision across a variety of settings. Methods. An evaluation of scales from randomly selected primary care clinics (n=30), diabetology/endocrinology clinics (n=7), weight loss facilities (n=25), and fitness centers (n=30) was performed. Assessments were completed on a total of 223 scales: 94 from primary care clinics, 32 from diabetology/endocrinology clinics, 39 from weight loss centers, and 58 from fitness centers. Scales were assessed for condition, location in facility, resting surface, commercial designation, and calibration history. Scale precision was validated using 100 lb. (45.5 kg), 150 lb. (68.3 kg), 200 lb. (90.9 kg), and 250 lb. (113.6 kg) certified weights. Results. Overall, scales demonstrated decreased precision with increased weight. At higher weights, more than 15% of scales were off by more than 6 lbs. (2.3 kg), approximately 1 Body Mass Index (BMI) unit. While facility type was not significant, condition, location in facility, resting surface, commercial designation, and calibration history were significant. Conclusions. This study demonstrates that many scales used to measure body weight are imprecise and that scales in health care settings are no more precise than those in other facilities. Clinical decisions based on scales that are imprecise have the potential to cause iatrogenic complications in patient care. [ABSTRACT FROM AUTHOR]

Abstract: The ability to quantify the quality of cardiovascular care critically depends on the translation of recommendations for high-quality care into the measurement of that care. As payers and regulatory agencies increasingly seek to quantify healthcare quality, the implications of the measurement process on practicing physicians are likely to grow. This statement describes the methodology by which the American College of Cardiology and the American Heart Association approach creating performance measures and devising techniques for quantifying those aspects of care that directly reflect the quality of cardiovascular care. Methods for defining target populations, identifying dimensions of care, synthesizing the literature, and operationalizing the process of selecting measures are proposed. It is hoped that new sets of measures will be created through the implementation of this approach, and consequently, through the use of such measurement sets in the context of quality improvement efforts, the quality of cardiovascular care will improve. [Copyright &y& Elsevier]

Objectives: The objective of this study was to identify the factors associated with the development of depressive symptoms in outpatients with heart failure (HF). Background: Depression is common in patients with HF and has been linked to adverse outcomes. Methods: This was a multicenter prospective cohort study of outpatients with HF and ejection fraction <0.40. Patients were evaluated at baseline and one year with a Medical Outcomes Study-Depression questionnaire, a Kansas City Cardiomyopathy Questionnaire (KCCQ), and a full clinical evaluation including patients'' social and economic status. Results: Of 245 patients without depressive symptoms at baseline, 52 (21.2%) developed depressive symptoms one year later. In multivariable analysis, living alone, alcohol abuse, perception of medical care as being a substantial economic burden, and health status as measured by the KCCQ were independent predictors of developing depressive symptoms. For patients without these factors, 7.9% developed depression by one year. When one factor was present, the one-year incidence was 15.5%, when two were present the incidence was 36.2%, and when three were present the incidence was 69.2%. There was a graded relationship between poorer health status and increased risk of developing depression (p < 0.001 for trend). No traditional clinical factors or measures of disease severity were significantly associated with the development of depression. Conclusions: Social factors and health status are predictive of the development of depression in outpatients with HF. Clinicians should be aware of which patients are at risk for the development of depression so that these patients may be targeted for screening and potentially for psychosocial intervention. [Copyright &y& Elsevier]

Background: Previous investigations suggest an important role of social support in the outcomes of patients treated for ischemic heart disease. The ENRICHD Social Support Instrument (ESSI) is a 7-item self-report survey that assesses social support. Validity and reliability of the ESSI, however, has not been formally tested in patients undergoing percutaneous coronary intervention (PCI). Methods: The ESSI, along with the Short Form-36 (SF-36), was sequentially administered to a cohort of 271 patients undergoing PCI. The test-retest reliability was examined with an intra-class correlation coefficient by comparing scores among 174 patients who completed both instruments 5 and 6 months after their procedure. Internal reliability was assessed using Cronbach's alpha at the time of patients' baseline procedure. The concurrent validity of the ESSI was assessed by comparing scores between depressed (MHI-5 score < 44) vs. non-depressed patients. The correlation between the ESSI and the SF-36 Social Functioning sub-scale, an accepted measure of social functioning, was also examined. Results: Test-retest reliability showed no significant differences in mean scores among ESSI questionnaires administered 1 month apart (27.8+/-1.4 vs 27.8+/-1.5, p = 0.98). The intra-class correlation coefficient was 0.94 and Cronbach's alpha was 0.88. Mean ESSI scores were significantly lower among depressed vs. non-depressed patients (24.6+/-1.7 vs 27+/-1.4, p < 0.018) and a positive albeit modest correlation with social functioning was seen (r = 0.19, p = 0.002). Conclusion: The ESSI appears to be a valid and reliable measure of social support in patients undergoing treatment for coronary artery disease. It may prove to be a valuable method of controlling for patient variability in outcomes studies where the outcomes are related to patients' social support. [ABSTRACT FROM AUTHOR]

Background: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns.Objectives: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan.Methods: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017.Results: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001).Conclusions: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States. [ABSTRACT FROM AUTHOR]

The author discusses recommendation made by the Society of Thoracic Surgeons (STS) that transfusion is reasonable in postoperative patients with hemoglobin level of less than 7g per deciliter. Topics discussed include clinical trials of alternative transfusion thresholds conducted to establish benefits of transfusion in postoperative patients with anemia and the steps for improving the quality of cardiac surgery such as creating transparent interpretations and developing protocols.

Background: Clinical and anatomical characteristics are often considered key factors in deciding between percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with complex coronary artery disease (CAD) such as left-main CAD or 3-vessel disease. However, little is known about the interaction between self-reported preprocedural physical/mental health and clinical outcomes after revascularization.Methods: This subgroup analysis of the SYNTAXES trial (SYNTAX Extended Survival), which is the extended follow-up of the randomized SYNTAX trial (Synergy Between PCI With Taxus and Cardiac Surgery) comparing PCI with CABG in patients with left-main CAD or 3-vessel disease, stratified patients by terciles of Physical (PCS) or Mental Component Summary (MCS) scores derived from the preprocedural 36-Item Short Form Health Survey, with higher PCS and MCS scores representing better physical and mental health, respectively. The primary end point was all-cause death at 10 years.Results: A total of 1656 patients with preprocedural 36-Item Short Form Health Survey data were included in the present study. Both higher PCS and MCS were independently associated with lower 10-year mortality (10-point increase in PCS adjusted hazard ratio, 0.84 [95% CI, 0.73-0.97]; P=0.021; in MCS adjusted hazard ratio, 0.85 [95% CI, 0.76-0.95]; P=0.005). A significant survival benefit with CABG over PCI was observed in the highest PCS (>45.5) and MCS (>52.3) terciles with significant treatment-by-subgroup interactions (PCS Pinteraction=0.033, MCS Pinteraction=0.015). In patients with both high PCS (>45.5) and MCS (>52.3), 10-year mortality was significantly higher with PCI compared with CABG (30.5% versus 12.2%; hazard ratio, 2.87 [95% CI, 1.55-5.30]; P=0.001), whereas among those with low PCS (≤45.5) or low MCS (≤52.3), there were no significant differences in 10-year mortality between PCI and CABG, resulting in a significant treatment-by-subgroup interaction (Pinteraction=0.002).Conclusions: Among patients with left-main CAD or 3-vessel disease, patient-reported preprocedural physical and mental health status was strongly associated with long-term mortality and modified the relative treatment effects of PCI versus CABG. Patients with the best physical and mental health had better 10-year survival with CABG compared with PCI. Assessment of self-reported physical and mental health is important when selecting the optimal revascularization strategy.Registration: URL: https://www.Clinicaltrials: gov; SYNTAXES Unique identifier: NCT03417050. URL: https://www.Clinicaltrials: gov; SYNTAX Unique identifier: NCT00114972. [ABSTRACT FROM AUTHOR]

Background: Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD.Methods: We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated.Results: Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality.Conclusions: OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population. [ABSTRACT FROM AUTHOR]

Background: Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction.Objectives: This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials.Methods: This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed.Results: Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (Pinteraction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: -0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: -0.53). The FREEDOM score showed some heterogeneity of treatment benefit.Conclusions: The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972) (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease [BEST]; NCT00997828) (Future Revascularization Evaluation in Patients with Diabetes Mellitus [FREEDOM]; NCT00086450). [ABSTRACT FROM AUTHOR]

: ObjectivesThe purpose of this study was to create an automated surveillance tool for reporting the incidence, prevalence and processes of care for patients with heart failure.: BackgroundPrevious epidemiologic studies suggest that the increasing prevalence of heart failure is a consequence of improved survival coupled with minimal changes in disease prevention. Developing new, efficient methods of assessing the incidence and prevalence of heart failure could allow continued surveillance of these rates during an era of rapidly changing treatments and health care delivery patterns.: MethodsUsing administrative data sets, we created a definition of heart failure using diagnosis codes. After adjustment for patients leaving our health system or death, we derived the incidence, prevalence and mortality of the population with heart failure from 1989 to 1999.: ResultsA total of 29,686 patients of all ages, 52.6% women and 47.4% men, met the definition of heart failure. Mean ages were 71.1 ± 14.5 for women and 67.7 ± 14.4 for men, p < 0.0001. Race proportions were 50.5% white, 44.6% African American and 4.9% other race. Incidence rates were higher in men and African Americans across all age groups. There was an annual increase in prevalence of 1/1,000 for women and 0.9/1,000 for men, p = 0.001 for both trends.: ConclusionsThrough the feasible and valid use of automated data, we have confirmed a chronic disease epidemic of heart failure manifested primarily by an increase in prevalence over the past decade. Our surveillance system mirrors the results of epidemiologic studies and may be a valid method for monitoring the impact of prevention and treatment programs. [Copyright &y& Elsevier]

Background: Standardization of risk is critical in benchmarking and quality improvement efforts for percutaneous coronary interventions (PCIs). In 2018, the CathPCI Registry was updated to include additional variables to better classify higher-risk patients.Objectives: This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables.Methods: Data from 706,263 PCIs performed between July 2018 and June 2019 at 1,608 sites were used to develop and validate a new full and pre-catheterization model to predict in-hospital mortality, and a simplified bedside risk score. The sample was randomly split into a development cohort (70%, n = 495,005) and a validation cohort (30%, n = 211,258). The authors created 1,000 bootstrapped samples of the development cohort and used stepwise selection logistic regression on each sample. The final model included variables that were selected in at least 70% of the bootstrapped samples and those identified a priori due to clinical relevance.Results: In-hospital mortality following PCI varied based on clinical presentation. Procedural urgency, cardiovascular instability, and level of consciousness after cardiac arrest were most predictive of in-hospital mortality. The full model performed well, with excellent discrimination (C-index: 0.943) in the validation cohort and good calibration across different clinical and procedural risk cohorts. The median hospital risk-standardized mortality rate was 1.9% and ranged from 1.1% to 3.3% (interquartile range: 1.7% to 2.1%).Conclusions: The risk of mortality following PCI can be predicted in contemporary practice by incorporating variables that reflect clinical acuity. This model, which includes data previously not captured, is a valid instrument for risk stratification and for quality improvement efforts. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials are considered the gold standard for testing the efficacy of novel therapeutic interventions, and typically report the average treatment effect as a summary result. As the result of treatment can vary between patients, basing treatment decisions for individual patients on the overall average treatment effect could be suboptimal. We aimed to develop an individualised decision making tool to select an optimal revascularisation strategy in patients with complex coronary artery disease.Methods: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries between March, 2005, and April, 2007. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to either the percutaneous coronary intervention (PCI) group or coronary artery bypass grafting (CABG) group. The SYNTAXES study ascertained 10-year all-cause deaths. We used Cox regression to develop a clinical prognostic index for predicting death over a 10-year period, which was combined, in a second stage, with assigned treatment (PCI or CABG) and two prespecified effect-modifiers, which were selected on the basis of previous evidence: disease type (three-vessel disease or left main coronary artery disease) and anatomical SYNTAX score. We used similar techniques to develop a model to predict the 5-year risk of major adverse cardiovascular events (defined as a composite of all-cause death, non-fatal stroke, or non-fatal myocardial infarction) in patients receiving PCI or CABG. We then assessed the ability of these models to predict the risk of death or a major adverse cardiovascular event, and their differences (ie, the estimated benefit of CABG versus PCI by calculating the absolute risk difference between the two strategies) by cross-validation with the SYNTAX trial (n=1800 participants) and external validation in the pooled population (n=3380 participants) of the FREEDOM, BEST, and PRECOMBAT trials. The concordance (C)-index was used to measure discriminative ability, and calibration plots were used to assess the degree of agreement between predictions and observations.Findings: At cross-validation, the newly developed SYNTAX score II, termed SYNTAX score II 2020, showed a helpful discriminative ability in both treatment groups for predicting 10-year all-cause deaths (C-index=0·73 [95% CI 0·69-0·76] for PCI and 0·73 [0·69-0·76] for CABG) and 5-year major adverse cardiovascular events (C-index=0·65 [0·61-0·69] for PCI and C-index=0·71 [0·67-0·75] for CABG). At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events. The estimated treatment benefit of CABG over PCI varied substantially among patients in the trial population, and the benefit predictions were well calibrated.Interpretation: The SYNTAX score II 2020 for predicting 10-year deaths and 5-year major adverse cardiovascular events can help to identify individuals who will benefit from either CABG or PCI, thereby supporting heart teams, patients, and their families to select optimal revascularisation strategies.Funding: The German Heart Research Foundation and the Patient-Centered Outcomes Research Institute. [ABSTRACT FROM AUTHOR]

Background: Some studies report that women are less likely to present with chest pain for acute myocardial infarction (AMI). Information on symptom presentation, perception of symptoms, and care-seeking behaviors is limited for young patients with AMI.Methods: We interviewed 2009 women and 976 men aged 18 to 55 years hospitalized for AMI at 103 US hospitals participating in the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Structured patient interviews during the index AMI hospitalization were used to collect information on symptom presentation, perception of symptoms, and care-seeking behaviors. We compared patient characteristics and presentation information by sex. Multivariable hierarchical logistic regression was used to evaluate the association between sex and symptom presentation.Results: The majority of women (87.0%) and men (89.5%) presented with chest pain (defined as pain, pressure, tightness, or discomfort). Women were more likely to present with ≥3 associated symptoms than men (eg, epigastric symptoms, palpitations, and pain or discomfort in the jaw, neck, arms, or between the shoulder blades; 61.9% for women versus 54.8% for men, P<0.001). In adjusted analyses, women with an ST-segment-elevation AMI were more likely than men to present without chest pain (odds ratio, 1.51; 95% confidence interval, 1.03-2.22). In comparison with men, women were more likely to perceive symptoms as stress/anxiety (20.9% versus 11.8%, P<0.001) but less likely to attribute symptoms to muscle pain (15.4% versus 21.2%, P=0.029). Approximately 29.5% of women and 22.1% of men sought medical care for similar symptoms before their hospitalization (P<0.001); however, 53% of women reported that their provider did not think these symptoms were heart-related in comparison with 37% of men (P<0.001).Conclusions: The presentation of AMI symptoms was similar for young women and men, with chest pain as the predominant symptom for both sexes. Women presented with a greater number of additional non-chest pain symptoms regardless of the presence of chest pain, and both women and their healthcare providers were less likely to attribute their prodromal symptoms to heart disease in comparison with men. [ABSTRACT FROM AUTHOR]

Background: Implementation of medical emergency teams has been identified as a potential strategy to reduce hospital deaths, because these teams respond to patients with acute physiological decline in an effort to prevent in-hospital cardiac arrest. However, prior studies of the association between medical emergency teams and hospital mortality have been limited and typically have not accounted for preimplementation mortality trends.Methods: Within the Pediatric Health Information System for freestanding pediatric hospitals, annual risk-adjusted mortality rates were calculated for sites between 2000 and 2015. A random slopes interrupted time series analysis then examined whether implementation of a medical emergency team was associated with lower-than-expected mortality rates based on preimplementation trends.Results: Across 38 pediatric hospitals, mean annual hospital admission volume was 15 854 (range, 6684-33 024), and there were a total of 1 659 059 hospitalizations preimplementation and 4 392 392 hospitalizations postimplementation. Before medical emergency team implementation, hospital mortality decreased by 6.0% annually (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.92-0.96) across all hospitals. After medical emergency team implementation, hospital mortality continued to decrease by 6% annually (OR, 0.94; 95% CI, 0.93-0.95), with no deepening of the mortality slope (ie, not lower OR) in comparison with the preimplementation trend, for the overall cohort (P=0.98) or when analyzed separately within each of the 38 study hospitals. Five years after medical emergency team implementation across study sites, there was no difference between predicted (hospital mean of 6.18 deaths per 1000 admissions based on preimplementation trends) and actual mortality rates (hospital mean of 6.48 deaths per 1000 admissions; P=0.57).Conclusions: Implementation of medical emergency teams in a large sample of pediatric hospitals in the United States was not associated with a reduction in hospital mortality beyond existing preimplementation trends. [ABSTRACT FROM AUTHOR]

Background: Drug-eluting stents (DES) reduce restenosis but require prolonged antiplatelet therapy, when compared with bare metal stents. Ideally, the patient should be involved in this risk:benefit assessment prior to selecting DES, to maximize the benefits and cost-effectiveness of care, and to improve medication adherence. However, accurate estimation of restenosis risk may require angiographic factors identified at cardiac catheterization.Methods: In a large PCI registry, we used logistic regression to identify clinical and angiographic predictors of clinically-driven target lesion revascularization (TLR) over the first year after stent placement. Discrimination c-statistic and integrated discrimination improvement (IDI) were used to calculate the incremental utility of angiographic variables when added to clinical predictors.Results: Of 8501 PCI patients, TLR occurred in 4.5%. After adjusting for DES use, clinical TLR predictors were younger age, female sex, diabetes, prior PCI, and prior bypass surgery (model c-statistic 0.630). Angiographic predictors were vein graft PCI, in-stent restenosis lesion, longer stent length, and smaller stent diameter (c-statistic 0.650). After adding angiographic factors to the clinical model, c-statistic improved to 0.680 and the average separation in TLR risk among patients with and without TLR improved by 1% (IDI=0.010, 95% CI 0.009-0.014), primarily driven by those experiencing TLR (from 5.9% to 6.9% absolute risk).Conclusions: Among unselected PCI patients, the incidence of clinically-indicated TLR is <5% at 1-year, and standard clinical variables only moderately discriminate who will and will not experience TLR. Angiographic variables significantly improve TLR risk assessment, suggesting that stent selection may be best performed after coronary anatomy has been delineated.Short Summary (for Annotated Table Of Contents): Although several recent studies have challenged traditional expectations regarding the duration of dual antiplatelet therapy, current guidelines recommend at least 6 to 12months of treatment after implantation of a drug eluting stent, with a shorter course for bare metal stents. Stent selection ideally should involve input from the patient receiving these stents, but multiple studies have suggested that angiographic factors - obtained after the patient has received sedation during the diagnostic catheterization - are important predictors of repeat revascularization. In this analysis from a large registry of patients receiving coronary stents, angiographic characteristics were found to significantly improve risk assessment for target lesion revascularization, when added to clinical variables alone. [ABSTRACT FROM AUTHOR]

Background: Stratifying patient risk for acute kidney injury (AKI) prior to percutaneous coronary intervention (PCI) can enable clinicians to tailor their approach to minimize AKI. The National Cardiovascular Data Registry (NCDR) CathPCI Registry recently developed 2 prediction models: for AKI and AKI requiring dialysis (AKI-D).Objectives: This study sought to externally validate the NCDR AKI and AKI-D models in a Japanese population. Determining the generalizability of the U.S. model could support quality improvement efforts in Japan.Methods: The NCDR prediction models were applied to 11,041 consecutive patients in the Japanese multicenter PCI registry. AKI was defined as an absolute increase ≥ 0.3 mg/dl or a relative increase of 50% in serum creatinine, in accordance with the definition of AKI Network criteria; AKI-D was defined as initiation of dialysis after PCI. Discrimination and calibration of the NCDR models were tested in the Japanese cohort. If the model was perfectly calibrated, the slope and intercept would equal 1.0 and 0.0, respectively.Results: In the Japanese PCI cohort, AKI and AKI-D occurred in 10.5% and 1.5% of patients, respectively. The NCDR AKI prediction model showed good discrimination (c-statistic = 0.76) and calibration (slope = 0.93 and intercept = -0.10) in both acute and nonacute PCI. The AKI-D prediction model had good discrimination (c-statistic = 0.92), but while the calibration slope was good (1.04), the intercept was significantly underestimated (0.96). However, this was corrected with recalibration (slope = 1.04 and intercept = -0.087).Conclusions: In a Japanese population, the NCDR AKI models validly predict post-procedural AKI and, with recalibration, AKI-D. Prospective use of these models to inform clinical decision making should be tested as a means of reducing AKI after PCI in Japan. (Japan Cardiovascular Database, Percutaneous Coronary Intervention Registry; UMIN R000004736). [ABSTRACT FROM AUTHOR]

The impact of baseline exercise capacity on clinical outcomes in patients with stable ischemic heart disease randomized to an initial strategy of optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI) in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has not been studied. A post hoc analysis was performed in 1,052 patients of COURAGE (PCI + OMT: n = 527, OMT: n = 525) who underwent exercise treadmill testing at baseline. Patients were categorized into 2 exercise capacity groups based on metabolic equivalents (METs) achieved during baseline exercise treadmill testing (<7 METs: n = 464, ≥7 METs: n = 588) and were followed for a median of 4.6 years. The primary composite end point of death or myocardial infarction was similar in the PCI + OMT group and the OMT group for patients with exercise capacity <7 METs (19.1% vs 16.1%, p = 0.31) and ≥7 METs (13.3% vs 10.3%, p = 0.27). After adjusting for baseline covariates, the hazard ratio (99% confidence interval) for the primary end point for the PCI + OMT group versus the OMT group was 1.42 (0.90 to 2.23, p = 0.05) and for the exercise capacity subgroups of ≥7 METs and <7 METs was 0.75 (0.46 to 1.22, p = 0.13). There was no statistically significant interaction between the original treatment arm allocation (PCI + OMT vs OMT) and baseline exercise capacity. In conclusion, there was no difference in the long-term clinical outcomes in patients with exercise capacity <7 METs compared with ≥7 METs, irrespective of whether they were assigned to initial PCI. Patients with exercise capacity <7 METs did not derive a proportionately greater clinical benefit from PCI + OMT compared with those patients who received OMT alone. [ABSTRACT FROM AUTHOR]

Background: Percutaneous coronary intervention (PCI) relieves angina in patients with stable ischemic heart disease, but clinical trials have not shown that it improves survival. Between June 1999 and January 2004, we randomly assigned 2287 patients with stable ischemic heart disease to an initial management strategy of optimal medical therapy alone (medical-therapy group) or optimal medical therapy plus PCI (PCI group) and did not find a significant difference in the rate of survival during a median follow-up of 4.6 years. We now report the rate of survival among the patients who were followed for up to 15 years.Methods: We obtained permission from the patients at the Department of Veterans Affairs (VA) sites and some non-VA sites in the United States to use their Social Security numbers to track their survival after the original trial period ended. We searched the VA national Corporate Data Warehouse and the National Death Index for survival information and the dates of death from any cause. We calculated survival according to the Kaplan-Meier method and used a Cox proportional-hazards model to adjust for significant between-group differences in baseline characteristics.Results: Extended survival information was available for 1211 patients (53% of the original population). The median duration of follow-up for all patients was 6.2 years (range, 0 to 15); the median duration of follow-up for patients at the sites that permitted survival tracking was 11.9 years (range, 0 to 15). A total of 561 deaths (180 during the follow-up period in the original trial and 381 during the extended follow-up period) occurred: 284 deaths (25%) in the PCI group and 277 (24%) in the medical-therapy group (adjusted hazard ratio, 1.03; 95% confidence interval, 0.83 to 1.21; P=0.76).Conclusions: During an extended-follow-up of up to 15 years, we did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease. (Funded by the VA Cooperative Studies Program and others; COURAGE ClinicalTrials.gov number, NCT00007657.). [ABSTRACT FROM AUTHOR]

OBJECTIVE: To derive risk models for percutaneous coronary intervention (PCI) outcomes from clinical and laboratory variables available before the procedure so they can be used for preprocedure risk stratification. PATIENTS AND METHODS: Using the Mayo Clinic registry, we analyzed 9035 PCls on 7640 unique patients from January 1, 2000, through April 30, 2005. We included only the first PCI per patient (n=7457). Logistic regression was used to model the calculated risk score and major procedural complications. Separate risk models were made for mortality and major adverse cardiovascular events (MACE) derived solely from baseline and laboratory characteristics. Final risk scores for procedural death, defined as any death during the index hospitalization, and MACE contained the same 7 variables (age, myocardial infarction ≤24 hours, preprocedural shock, serum creatinine level, left ventricular ejection fraction, congestive heart failure, and peripheral artery disease). RESULTS: Models had adequate goodness of fit, and areas under the receiver operating characteristic curve were 0.74 and 0.89 for MACE and procedural death, respectively, indicating excellent overall discrimination. The model was robust across many subgroups, including those undergoing elective PCI, those having diabetes mellitus, and elderly patients. Bootstrap analysis indicated that the model was not overfit to the available data set. CONCLUSIONS: Before coronary angiography is performed, a risk-scoring system based on 7 variables can be used conveniently to predict cardiovascular complications after PCI. This model may be useful for providing patients with individualized, evidence-based estimates of procedural risk as part of the informed consent process. [ABSTRACT FROM AUTHOR]