Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.

BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.

BACKGROUND: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD). METHODS: ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups. RESULTS: After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups. CONCLUSIONS: Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD.

Same day discharge versus overnight observation following chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: Same day discharge (SDD) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We evaluated the clinical, angiographic, and procedural characteristics of patients discharged the same day versus those kept for overnight observation in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of the 7181 patients who underwent CTO PCI, 943 (13%) had SDD. The SDD rate increased from 3% in 2015 to 21% in 2022. Patients with SDD were less likely to have a history of heart failure (21% vs. 26%, p = 0.005), chronic lung disease (10% vs. 15%, p = 0.001), or anemia (12% vs. 19%, p < 0.001). Technical success (87% vs. 88%, p = 0.289) was similar, but in-hospital major adverse cardiovascular events (0.0% vs. 0.4%, p = 0.041) were lower in SDD. In multivariable logistic regression analysis, prior myocardial infarction odds ratio (OR): 0.71 (95% confidence interval [CI]: 0.59-0.87, p = 0.001), chronic lung disease OR: 0.64 (95% CI: 0.47-0.88, p = 0.006), and increasing procedure time OR: 0.93 (95% CI: 0.91-0.95, p < 0.001, per 10-min increase) were associated with overnight observation, while radial-only access OR: 2.45 (95% CI: 2.03-2.96, p < 0.001) had the strongest association with SDD. In the SDD, 2 (0.4%) of 514 patients were readmitted, due to retroperitoneal bleeding (n = 1) and ischemic stroke (n = 1). CONCLUSION: The overall frequency of SDD after CTO PCI was 13% and has been increasing over time. SDD is feasible in select patients following CTO PCI, and radial-only access had the strongest association with SDD.

Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study.

BACKGROUND: We aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial. METHODS: In a subanalysis of the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, we compared aspirin doses (81 vs 325 mg) among participants with PAD and study participation metrics in patients with and without PAD. The primary outcome composite was all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke. RESULTS: Among 14,662 participants enrolled in ADAPTABLE with PAD status available, 3493 (23.8%) had PAD. Participants with PAD were more likely to experience the primary composite (13.76% vs 5.31%, p < 0.001), all-cause mortality (7.55% vs 3.01%, p < 0.001), myocardial infarction (5.71% vs 2.09%, p < 0.001), stroke (2.45% vs 0.86%, p < 0.001), and major bleeding (1.19% vs 0.44%, p < 0.001). A higher aspirin dose did not reduce the primary outcome in patients with PAD (13.68% vs 13.84% in 81 mg and 325 mg groups; OR 1.05, 95% CI 0.88-1.25). Participants with PAD were less likely to enroll via email (33.0% vs 41.9%, p < 0.0001), less likely to choose internet follow-up (79.2% vs 89.5%, p < 0.0001), and were more likely to change their aspirin doses (39.7% vs 30.7%, p < 0.0001). CONCLUSIONS: ADAPTABLE participants with PAD did not benefit from a higher dose of aspirin and participated in the study differently from those without PAD. These results reinforce the need for additional PAD-specific research and suggest that different trial strategies may be needed for optimal engagement of patients with PAD. (ClinicalTrials.gov Identifier: NCT02697916).

Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry.

BACKGROUND: Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited. METHODS: We performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights. RESULTS: Our analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses. CONCLUSIONS: In this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.

Racial and Ethnic Differences in Presentation and Outcomes for Patients Hospitalized With COVID-19: Findings From the American Heart Association's COVID-19 Cardiovascular Disease Registry.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has exposed longstanding racial and ethnic inequities in health risks and outcomes in the United States. We aimed to identify racial and ethnic differences in presentation and outcomes for patients hospitalized with COVID-19. METHODS: The American Heart Association COVID-19 Cardiovascular Disease Registry is a retrospective observational registry capturing consecutive patients hospitalized with COVID-19. We present data on the first 7868 patients by race/ethnicity treated at 88 hospitals across the United States between January 17, 2020, and July 22, 2020. The primary outcome was in-hospital mortality. Secondary outcomes included major adverse cardiovascular events (death, myocardial infarction, stroke, heart failure) and COVID-19 cardiorespiratory ordinal severity score (worst to best: death, cardiac arrest, mechanical ventilation with mechanical circulatory support, mechanical ventilation with vasopressors/inotrope support, mechanical ventilation without hemodynamic support, and hospitalization alone. Multivariable logistic regression analyses were performed to assess the relationship between race/ethnicity and each outcome adjusting for differences in sociodemographic, clinical, and presentation features, and accounting for clustering by hospital. RESULTS: Among 7868 patients hospitalized with COVID-19, 33.0% were Hispanic, 25.5% were non-Hispanic Black, 6.3% were Asian, and 35.2% were non-Hispanic White. Hispanic and Black patients were younger than non-Hispanic White and Asian patients and were more likely to be uninsured. Black patients had the highest prevalence of obesity, hypertension, and diabetes. Black patients also had the highest rates of mechanical ventilation (23.2%) and renal replacement therapy (6.6%) but the lowest rates of remdesivir use (6.1%). Overall mortality was 18.4% with 53% of all deaths occurring in Black and Hispanic patients. The adjusted odds ratios for mortality were 0.93 (95% CI, 0.76-1.14) for Black patients, 0.90 (95% CI, 0.73-1.11) for Hispanic patients, and 1.31 (95% CI, 0.96-1.80) for Asian patients compared with non-Hispanic White patients. The median odds ratio across hospitals was 1.99 (95% CI, 1.74-2.48). Results were similar for major adverse cardiovascular events. Asian patients had the highest COVID-19 cardiorespiratory severity at presentation (adjusted odds ratio, 1.48 [95% CI, 1.16-1.90]). CONCLUSIONS: Although in-hospital mortality and major adverse cardiovascular events did not differ by race/ethnicity after adjustment, Black and Hispanic patients bore a greater burden of mortality and morbidity because of their disproportionate representation among COVID-19 hospitalizations.

The impact of a population-based prevention program on cardiovascular events: Findings from the heart of new Ulm project.

BACKGROUND: Cardiovascular disease (CVD) and its associated risk factors are the principal drivers of mortality and healthcare costs in the United States with rural residents experiencing higher CVD death rates than their urban counterparts. METHODS: The purpose of this study was to examine incidence of major CVD events over 9 years of implementation of the Heart of New Ulm (HONU) Project, a rural population-based CVD prevention initiative. HONU interventions were delivered at individual, organizational, and community levels addressing clinical risk factors, lifestyle behaviors and environmental changes. The sample included 4,056 residents of New Ulm matched with 4,056 residents from a different community served by the same health system. The primary outcome was a composite of major CVD events (myocardial infarction, ischemic stroke, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and CVD-related death). Secondary outcomes were the individual CVD events and procedures. RESULTS: The proportion of residents in New Ulm with a major CVD event (7.79%) was not significantly different than the comparison community (8.43%, P = .290). However, the total number of events did differ by community with fewer events in New Ulm than the comparison community (447 vs 530, P = .005), with 48 fewer strokes (84 vs 132, P = .001) and 42 fewer PCI procedures (147 vs 189, P = 0.019) in New Ulm. Incidence of ischemic stroke was lower in the New Ulm community (1.85 vs 2.61, P = .020) than in the comparison community. Other specific CVD events did not have significantly different incidence or frequencies between the 2 communities. CONCLUSION: In HONU, the proportion of residents experiencing a CVD event was not significantly lower than a match comparison community. However, there was a significant reduction in the total number of CVD events in New Ulm, driven primarily by lower stroke, PCI, and CABG events in the intervention community.

Use of oral anticoagulants in patients with valvular atrial fibrillation: findings from the NCDR PINNACLE Registry.

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Transcatheter aortic valve replacement in patients with severe comorbidities: A retrospective cohort study.

OBJECTIVE: To investigate the long-term outcomes of patients with severe comorbidities (sCM) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: The benefit of TAVR may be limited among patients with sCM due to a lack of mortality- or quality-of-life-benefit. METHODS: All TAVR patients in the Allina Health System between January 1, 2011 and August 7, 2018 were included (n = 890, 82 ± 8 years, 55% men). sCM included: severe lung disease, severe liver disease, end-stage renal disease, severe, severe dementia, severe dilated cardiomyopathy, and frailty. Outcomes between patients with (n = 215, 24%) and without (n = 675, 76%) sCM were compared. RESULTS: At baseline, patients with sCM had worse symptoms, higher STS-PROM and a lower Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to those without. During a median follow-up of 15 months (IQR, 7-29 months), there were 208 (23%) deaths. Patients with sCM had a lower 3-year survival free from all-cause mortality (40% vs. 79%, p < .001), and lower 3-year survival free from the composite endpoint of all-cause mortality, re-hospitalization for heart failure, myocardial infarction or stroke (31% vs. 64%, p < .001) compared to those without sCM. The estimated monthly increase in KCCQ scores following TAVR was 1.5, 95%CI (1.3, 1.7), p < .001 irrespective of sCM grouping. From Cox regression analysis, severe comorbidities, with the exception of liver disease, were associated with an increased risk of all-cause mortality and any additional comorbidity was associated with a multiplicative increase in risk of mortality of 2.8 (95%CI 2.3, 3.6), p < .001. CONCLUSIONS: TAVR patients with sCM have poor 3-year outcomes but may experience improvements in their quality of life.

Temporal changes in patient characteristics and outcomes in ST-segment elevation myocardial infarction 2003-2018.

BACKGROUND: We sought to describe changes in demographic variables, process of care measures, and outcomes of patients treated in a regional ST-segment elevation myocardial infarction (STEMI) program over the last 15 years. METHODS: We describe demographic variables, process of care measures, and outcomes of patients treated in the program in various 5-year time periods: 2003-2007 (n = 1,821), 2008-2012 (n = 1,968), and 2013-2018 (n = 2,223). The primary outcome measures were in-hospital and 30-day mortality. RESULTS: Among 6,012 STEMI patients treated from 2003 to 2018 we observed a significant increase in mean age at presentation (62 ± 14 to 64 ± 13 years) and diabetes (14-22%, p < .01). The proportion of patients with cardiogenic shock (CS) and cardiac arrest (CA) pre-PCI increased significantly from 9.5% to 11.1% and 8.5% to 12.7% (p < .05), respectively. The median door-to-balloon (D2B) times decreased from 98 to 93 min and total ischemic time decreased from 202 to 185 min (all p < .05). Despite increased patient complexity, the proportion of nontransfer and transfer patients achieving D2B times consistent with guideline recommendations remained unchanged (for nontransfer patients 79-82%, p = .45 and for transfer patients 65-64%, p = .34). Among all STEMI patients, in-hospital mortality increased during the study period from 4.9 to 6.9% (p = .007) but remained stable (<2%) when CA and CS patients were excluded. CONCLUSIONS: Over the last 15 years, short-term STEMI mortality has increased despite improvements in care delivery metrics. Patients with CA and/or CS now represent 10% of STEMI patients and are responsible for 80% of deaths. Therefore, efforts to improve STEMI mortality, and metrics for assessing STEMI programs, should focus on these patients.

Natural history observations in moderate aortic stenosis.

BACKGROUND: The natural history of patients with moderate aortic stenosis (AS) is poorly understood. We aimed to determine the long-term outcomes of patients with moderate AS. METHODS: We examined patients with moderate AS defined by echocardiography in our healthcare system, and performed survival analyses for occurrence of death, heart failure (HF) hospitalization, and progression of AS, with accounting for symptoms, left ventricular dysfunction, and comorbidities. RESULTS: We examined 729 patients with moderate AS (median age, 76 years; 59.9 % men) with a median follow-up of 5.0 years (interquartile range: 2.0 to 8.1 years). The 5-year overall survival was 52.3 % (95 % confidence interval [CI]: 48.6 % to 56.0 %) and survival free of death or HF hospitalization was 43.2 % (95 % CI: 39.5 % to 46.9 %). Worse New York Heart Association (NYHA) functional class was associated with poor long-term survival, with mortality rates ranging from 7.9 % (95 % CI: 6.6-9.2 %) to 25.2 % (95 % CI: 20.2-30.3 %) per year. Among patients with minimal or no symptoms, no futility markers, and preserved left ventricular function, 5-year overall survival was 71.9 % (95 % CI: 66.4-77.4 %) and survival free of death or HF hospitalization was 61.4 % (95 % CI: 55.5-67.3 %). Risk factors associated with adverse events were age, NYHA class, low ejection fraction and high aortic valve velocity (all p < 0.05). CONCLUSIONS: Patients with moderate AS are at significant risk of death. Our findings highlight the need for more study into appropriate therapeutic interventions to improve the prognosis of these patients.

Clinician engagement in the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial.

BACKGROUND: ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) is a pragmatic clinical trial examining high-dose versus low-dose aspirin among patients with cardiovascular disease. ADAPTABLE is leveraging novel approaches for clinical trial conduct to expedite study completion and reduce costs. One pivotal aspect of the trial conduct is maximizing clinician engagement. METHODS/RESULTS: Clinician engagement can be diminished by barriers including time limitations, insufficient research infrastructure, lack of research training, inadequate compensation for research activities, and clinician beliefs. We used several key approaches to boost clinician engagement such as empowering clinician champions, including a variety of clinicians, nurses and advanced practice providers, periodic newsletters and coordinated team celebrations, and deploying novel technological solutions. Specifically, some centers generated electronic health records-based best practice advisories and research dashboards. Future large pragmatic trials will benefit from standardization of the various clinician engagement strategies especially studies leveraging electronic health records-based approaches like research dashboards. Financial or academic "credit" for clinician engagement in clinical research may boost participation rates in clinical studies. CONCLUSION: Maximizing clinician engagement is important for the success of clinical trials; the strategies employed in the ADAPTABLE trial may serve as a template for future pragmatic studies.

Current landscape of hybrid revascularization: A report from the NCDR CathPCI Registry.

BACKGROUND: Hybrid revascularization, combining percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), may be used differently across hospitals. How outcomes compare with multivessel PCI is unknown. METHODS: We studied hybrid revascularization use in patients in the National Cardiovascular Data Registry from 2009 to 2017 who underwent PCI for multivessel coronary artery disease (CAD) at 711 hospitals, excluding patients with prior CABG, acute ST-elevation myocardial infarction, emergency/salvage CABG, or PCI without stent placement. In-hospital mortality associated with hybrid revascularization versus multivessel PCI was compared using a multivariable logistic model. RESULTS: Among 775,000 patients with multivessel CAD, 1,126 (0.2%) underwent hybrid revascularization and 256,865 (33%) were treated with multivessel PCI. Although 358 (50.4%) hospitals performed hybrid revascularizations, most (97.3%) performed <1 per year. Most patients (68.7%) treated with hybrid revascularization underwent CABG after PCI; only 79.4% of these patients were discharged on P2Y12 inhibitors. Patients who underwent hybrid revascularization were younger and more likely to have significant left main or proximal left anterior descending disease. Unadjusted in-hospital mortality rates were higher among patients treated with hybrid revascularization than multivessel PCI (1.5% vs 0.9%, P = .02), a difference that was not significant after multivariable adjustment (odds ratio = 1.54, 95% CI = 0.92-2.59). CONCLUSIONS: Hybrid revascularization remains an infrequently used treatment modality for multivessel CAD. Risk-adjusted in-hospital mortality was no different between hybrid revascularization and multivessel PCI; however, patients who underwent hybrid revascularization were less likely to be discharged on P2Y12 inhibitor therapy despite stent implantation.

Outcomes after pacemaker implantation in patients with new-onset left bundle-branch block after transcatheter aortic valve replacement.

New-onset left bundle branch block (N-LBBB) after transcatheter aortic valve replacement (TAVR) is a challenging clinical dilemma. In our single-center study, 60 out of 172 patients who underwent permanent pacemaker implantation (PPM) after TAVR had N-LBBB (34.9%). At a median follow-up duration of 357 days (IQR, 178; 560 days), two patients (3.5%) were completely pacemaker-dependent, and four others (7%) were partially dependent. Twelve patients (24%) recovered conduction in their left bundle at a median follow-up duration of 5 weeks (IQR, 4; 14 weeks). Due to the lack of clinical predictors of pacemaker dependency, active surveillance is warranted and may be an alternative to permanent pacemaker implantation.

Incidence, predictors, management and outcomes of coronary perforations.

OBJECTIVES: We examined the contemporary incidence, types, predictors, angiographic characteristics, management and outcomes of coronary perforation. BACKGROUND: Coronary perforation is a rare, but important, complication of percutaneous coronary intervention (PCI). There is lack of data on perforations stratified as large and distal vessel perforations. METHODS: Retrospective, observational cohort study of all patients who underwent PCI at a high volume, tertiary hospital between the years 2009 and 2016. Angiograms of all coronary perforation cases were reviewed to determine the mechanism, type, and management of perforation. Risk-adjusted periprocedural complication rates were compared between patients with and without coronary perforation. One-year mortality outcomes of patients with large vessel vs. distal vessel perforation were also examined. RESULTS: Coronary perforation occurred in 68 of 13,339 PCIs (0.51%) performed during the study period: 51 (75%) were large vessel perforations and 17 (25%) distal vessel perforations. Most (67%) large vessel perforations were due to balloon/stent inflation, whereas most (94%) distal vessel perforations were due to guidewire exit. Patients with coronary perforations had significantly higher risk for periprocedural complications (adjusted odds ratio 7.57; 95% CI: 4.22-13.50; P < 0.001). Only one patient with large vessel perforation required emergency cardiac surgery, yet in-hospital mortality was high with both large vessel (7.8%) and distal vessel (11.8%) perforations. CONCLUSIONS: Coronary perforation is an infrequent, but potentially severe PCI complication. Most coronary perforations are large vessel perforations. Although coronary perforations rarely lead to emergency cardiac surgery, both distal vessel and large vessel perforations are associated with high in-hospital mortality, highlighting the importance of prevention.

Determining post-test risk in a national sample of stress nuclear myocardial perfusion imaging reports: Implications for natural language processing tools.

BACKGROUND: Reporting standards promote clarity and consistency of stress myocardial perfusion imaging (MPI) reports, but do not require an assessment of post-test risk. Natural Language Processing (NLP) tools could potentially help estimate this risk, yet it is unknown whether reports contain adequate descriptive data to use NLP. METHODS: Among VA patients who underwent stress MPI and coronary angiography between January 1, 2009 and December 31, 2011, 99 stress test reports were randomly selected for analysis. Two reviewers independently categorized each report for the presence of critical data elements essential to describing post-test ischemic risk. RESULTS: Few stress MPI reports provided a formal assessment of post-test risk within the impression section (3%) or the entire document (4%). In most cases, risk was determinable by combining critical data elements (74% impression, 98% whole). If ischemic risk was not determinable (25% impression, 2% whole), inadequate description of systolic function (9% impression, 1% whole) and inadequate description of ischemia (5% impression, 1% whole) were most commonly implicated. CONCLUSIONS: Post-test ischemic risk was determinable but rarely reported in this sample of stress MPI reports. This supports the potential use of NLP to help clarify risk. Further study of NLP in this context is needed.

Retrospective cohort study of hospital variation in airway management during in-hospital cardiac arrest and the association with patient survival: insights from Get With The Guidelines-Resuscitation.

IMPORTANCE: The optimal approach to airway management during in-hospital cardiac arrest is unknown. OBJECTIVE: To describe hospital-level variation in endotracheal intubation during cardiopulmonary resuscitation (CPR) for in-hospital cardiac arrest and the association between hospital use of endotracheal intubation and arrest survival. DESIGN, SETTING, PARTICIPANTS: Retrospective cohort study of adult patients suffering in-hospital cardiac arrest at Get With The Guidelines-Resuscitation participating hospitals between January, 2000, and December, 2016. Hospitals were categorized into quartiles based on the proportion of in-hospital cardiac arrest patients managed with endotracheal intubation during CPR. Risk-adjusted mixed models with random intercepts were created to assess the association between hospital quartile of in-hospital arrests managed with endotracheal intubation during CPR and survival to hospital discharge. EXPOSURE: Hospital rate of endotracheal intubation during CPR for in-hospital arrest MAIN OUTCOMES AND MEASURES: Survival to hospital discharge RESULTS: Among 155,252 patients suffering in-hospital cardiac arrest at 656 hospitals, 69.7% of patients received endotracheal intubation during CPR and overall survival to discharge was 24.8%. At the hospital level, the median rate of endotracheal intubation use was 71.2% (interquartile range, 63.6 to 78.1%; range, 26.6 to 100%). We found a strong inverse association between hospital rate of endotracheal intubation and survival to discharge (risk-adjusted odds ratio comparing highest intubation quartile vs. lowest intubation quartile, 0.81; 95% confidence interval (CI), 0.74 to 0.90; p value < .001). This association was modified by the presence of respiratory failure prior to arrest (p for interaction < .001), and stratified analyses demonstrated lower patient survival at hospitals with higher rates of endotracheal intubation was limited to patients without respiratory failure prior to cardiac arrest. CONCLUSION: In a national sample of patients suffering IHCA, the use of endotracheal intubation during CPR varied across hospitals. We found a strong inverse association between hospital use of endotracheal intubation during CPR and survival to discharge, but this association was confined to patients without respiratory failure prior to arrest. Identifying the optimal approach to airway management for in-hospital cardiac arrest may have a significant impact on patient survival.

The Association of Duration of participation in get with the guidelines-resuscitation with quality of Care for in-Hospital Cardiac Arrest.

BACKGROUND: Large variations exist in the care processes and outcomes for patients who experience in-hospital cardiac arrest (IHCA). We examined if Get With The Guidelines-Resuscitation (GWTG-R) participation duration was associated with improved care processes. METHODS AND RESULTS: We calculated an overall process composite performance score for IHCA patients using five guideline-recommended process measures, calculating composite adherence among patients, and grouped at hospitals based on GWTG-R participation duration. Trend tests using logistic regression with generalized estimating equations examined the impact of participation duration on quality. Using multivariable regression models adjusting for patient factors, hospital factors, secular trends, and GWTG-R participation duration, we assessed the association between participation duration and process composite performance. We examined 149,551 patients from 447 hospitals (2000-2012). Over the study period we saw decreases in: median age of cardiac arrest (71 to 67 years), the proportion of whites (69.2% to 66.6%), and pulseless ventricular tachycardia/ventricular fibrillation frequency (32.3% to 17.3%). Hospitals were increasingly more likely to be in urban locations and have higher nurse-to-bed ratios. Guideline performance adherence improved with participation duration for several individual process measures and overall process composite performance: process composite score (P-value trend P < .001), confirmation of endotracheal tube (P < .001 trend), monitored/witnessed event (P < .001 trend), time to first chest compressions ≤1 minute (P < .001 trend), and time to vasopressor use ≤5 minutes (P-value trend = 0.0004). There was a decrease in adherence as duration of participation increased for time to defibrillation ≤2 minutes (P-value trend = 0.005). After adjusting for several factors including calendar time, GWTG-R participation duration was independently associated with improved process composite performance (OR 1.05 per year, 95% CI 1.03-1.07). CONCLUSIONS: GWTG-R participation duration was associated with a significant improvement in IHCA quality of care, yet significant opportunities remain to find ways to maximize quality of care in this high-risk patient group.

Sleep deprivation in interventional cardiology: Implications for patient care and physician-health.

The burden and impact of sleep deprivation on both patient care and on the health of interventional cardiologists is not well understood. Due to the nature of emergent procedures occurring in the cardiac catheterization laboratory, interventionalists are prone to suffer from acute and/or chronic sleep deprivation. Sleep deprivation has been associated with numerous adverse effects, such as impaired performance, cognitive deficits, reduced psychomotor vigilance, and workplace errors and injuries, among many others. Although sleep deprivation has been linked to more errors in trainees, there is paucity of data addressing outcomes in interventional cardiology. The purpose of this overview is to explore the possible impact of sleep deprivation on interventional cardiology in relation to patient care and physician health, and examine potential approaches to this issue.