The impact of a statewide payment reform on transcatheter aortic valve replacement (TAVR) utilization and readmissions.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an increasingly used but relatively expensive procedure with substantial associated readmission rates. It is unknown how cost-constrictive payment reform measures, such as Maryland's All Payer Model, impact TAVR utilization given its relative expense. This study investigated the impact of Maryland's All Payer Model on TAVR utilization and readmissions among Maryland Medicare beneficiaries. METHODS: This was a quasi-experimental investigation of Maryland Medicare patients undergoing TAVR between 2012 and 2018. New Jersey data were used for comparison. Longitudinal interrupted time series analyses were used to study TAVR utilization and difference-in-differences analyses were used to investigate post-TAVR readmissions. RESULTS: During the first year of payment reform (2014), TAVR utilization among Maryland Medicare beneficiaries dropped by 8% (95% confidence interval [CI]: -9.2% to -7.1%; p < 0.001), with no concomitant change in TAVR utilization in New Jersey (0.2%, 95% CI: 0%-1%, p = 0.09). Longitudinally, however, the All Payer Model did not impact TAVR utilization in Maryland compared to New Jersey. Difference-in-differences analyses demonstrated that implementation of the All Payer Model was not associated with significantly greater declines in 30-day post-TAVR readmissions in Maryland versus New Jersey (-2.1%; 95% CI: -5.2% to 0.9%; p =0.1). CONCLUSIONS: Maryland's All Payer Model resulted in an immediate decline in TAVR utilization, likely a result of hospitals adjusting to global budgeting. However, beyond this transition period, this cost-constrictive reform measure did not limit Maryland TAVR utilization. In addition, the All Payer Model did not reduce post-TAVR 30-day readmissions. These findings may help inform expansion of globally budgeted healthcare payment structures.

Myocardial Injury in Severe COVID-19 Compared With Non-COVID-19 Acute Respiratory Distress Syndrome.

BACKGROUND: Knowledge gaps remain in the epidemiology and clinical implications of myocardial injury in coronavirus disease 2019 (COVID-19). We aimed to determine the prevalence and outcomes of myocardial injury in severe COVID-19 compared with acute respiratory distress syndrome (ARDS) unrelated to COVID-19. METHODS: We included intubated patients with COVID-19 from 5 hospitals between March 15 and June 11, 2020, with troponin levels assessed. We compared them with patients from a cohort study of myocardial injury in ARDS and performed survival analysis with primary outcome of in-hospital death associated with myocardial injury. In addition, we performed linear regression to identify clinical factors associated with myocardial injury in COVID-19. RESULTS: Of 243 intubated patients with COVID-19, 51% had troponin levels above the upper limit of normal. Chronic kidney disease, lactate, ferritin, and fibrinogen were associated with myocardial injury. Mortality was 22.7% among patients with COVID-19 with troponin under the upper limit of normal and 61.5% for those with troponin levels >10 times the upper limit of normal (P<0.001). The association of myocardial injury with mortality was not statistically significant after adjusting for age, sex, and multisystem organ dysfunction. Compared with patients with ARDS without COVID-19, patients with COVID-19 were older and had higher creatinine levels and less favorable vital signs. After adjustment, COVID-19-related ARDS was associated with lower odds of myocardial injury compared with non-COVID-19-related ARDS (odds ratio, 0.55 [95% CI, 0.36-0.84]; P=0.005). CONCLUSIONS: Myocardial injury in severe COVID-19 is a function of baseline comorbidities, advanced age, and multisystem organ dysfunction, similar to traditional ARDS. The adverse prognosis of myocardial injury in COVID-19 relates largely to multisystem organ involvement and critical illness.

Radial versus femoral secondary access for transcatheter aortic valve replacement: A systematic review and meta-analysis.

OBJECTIVES: We aimed to evaluate the risk of procedural complications after TAVR using secondary radial access (RA) versus femoral access (FA) through a systematic review and meta-analysis of the published literature. BACKGROUND: Transcatheter aortic valve replacement (TAVR) entails both large-bore arterial access for device delivery and secondary arterial access for hemodynamic and imaging assessments. It is unknown whether RA versus FA for this secondary access reduces the risk of procedural complications. METHODS: We searched PubMed, Embase, the Cochrane Library, and Web of Science for observational studies comparing TAVR procedural complications in RA versus FA. Event rates were compared via weighted summary odds ratios using the Mantel-Haenszel method. RESULTS: Six manuscripts encompassing 6132 patients were included. Meta-analysis showed that RA reduced the risk of major vascular complications (OR 0.58, 95% CI 0.43-0.77, p < 0.001, I2 0%) and major/life-threatening bleeding (OR 0.46, 95% CI 0.36-0.59, p < 0.001, I2 0%) as compared to FA for secondary TAVR access. We also observed a reduction 30-day mortality (OR 0.55, 95% CI 0.38-0.79, p = 0.001, I2 0%), acute kidney injury (OR 0.45, 95% CI 0.34-0.60, p < 0.001, I2 0%), and stroke and transient ischemic attack (OR 0.43, 95% CI 0.27-0.67, p < 0.001, I2 0%). CONCLUSIONS: RA reduced the risk of major vascular and bleeding complications when compared to FA for secondary access in TAVR. RA is associated with reduced risk of other adverse outcomes including mortality, but these associations may be related to selection bias and confounding given the observational study designs.

Nonprimary PCI at hospitals without cardiac surgery on-site: Consistent outcomes for all?

BACKGROUND: The CPORT-E trial showed the noninferiority of nonprimary percutaneous coronary intervention (PCI) at hospitals without cardiac surgery on-site (SoS) compared with hospitals with SoS for 6-week mortality and 9-month major adverse cardiac events (MACE). However, target vessel revascularization (TVR) was increased at non-SoS hospitals. Therefore, we aimed to determine the consistency of the CPORT-E trial findings across the spectrum of enrolled patients. METHODS: Post hoc subgroup analyses of 6-week mortality and 9-month MACE, defined as the composite of death, Q-wave myocardial infarction, or TVR, were performed. Patients with and without 9-month TVR and rates of related outcomes were compared. RESULTS: There was no interaction between SoS status and clinically relevant subgroups for 6-week mortality or 9-month MACE (P for any interaction=.421 and .062, respectively). In addition to increased 9-month rates of TVR and diagnostic catheterization at hospitals without SoS, non-TVR was also increased (2.7% vs 1.9%, P=.002); there was no difference in myocardial infarction-driven TVR, non-TVR, or diagnostic catheterization. Predictors of 9-month TVR included intra-aortic balloon pump use, any index PCI complication, and 3-vessel PCI, whereas predictors of freedom from TVR included SoS, discharge on a P2Y12 inhibitor, and stent implantation. CONCLUSIONS: The noninferiority of nonprimary PCI at non-SoS hospitals was consistent across clinically relevant subgroups. Elective PCI at an SoS hospital conferred a TVR benefit which may be related to a lower rate of referral for diagnostic catheterization for reasons other than myocardial infarction.

Heparin versus bivalirudin for non-primary percutaneous coronary intervention: A post-Hoc analysis of the CPORT-E trial.

OBJECTIVES: To compare bivalirudin to heparin during non-primary percutaneous coronary intervention (PCI). BACKGROUND: The optimal anticoagulant to support PCI remains uncertain. METHODS: We performed a propensity score-based analysis comparing clinical outcomes of patients receiving heparin to those receiving bivalirudin during non-primary PCI. RESULTS: Of 18,867 patients in the Cardiovascular Patient Outcomes Research Team Non-Primary PCI (CPORT-E) trial, we selected 7,913 patients undergoing non-staged PCI of whom 57.3% received heparin and 42.7% received bivalirudin. In-hospital myocardial infarction occurred in 4.4% of patients receiving bivalirudin and 3.0% of patients receiving heparin (relative risk [RR] 1.5, 95% confidence interval [CI] 1.1-2.1, P = 0.022); this difference persisted at 6 weeks (5.0% vs. 3.6%, RR 1.4, 95% CI 1.0-1.8, P = 0.041). There was no difference in all-cause mortality either in-hospital (0.2% vs. 0.1% for heparin vs. bivalirudin, P = 0.887) or at 6 weeks (0.5% vs. 0.7%, P = 0.567). In-hospital bleeding requiring transfusion occurred in 0.9% of patients receiving bivalirudin and 1.9% of patients receiving heparin (RR 0.4, 95% CI 0.3-0.7, P <0.001), but there was no difference at 6 weeks (2.7% for heparin vs. 1.9% for bivalirudin, RR 0.7, 95% CI 0.5-1.0, P = 0.062). CONCLUSIONS: In patients undergoing non-primary PCI at hospitals without on-site cardiac surgery, bivalirudin was associated with a decreased risk of in-hospital bleeding requiring transfusion and an increased risk of in-hospital MI compared to heparin. © 2017 Wiley Periodicals, Inc.

Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland.

BACKGROUND: Mitral regurgitation (MR) is the most common valvular disease in the United States and increases the risk of death and hospitalization. The economic burden of MR in the United States is not known. METHODS AND RESULTS: We analyzed inpatient hospitalization data from the 1 221 173 Maryland residents who had any in-state admissions from October 1, 2015, to September 30, 2019. We assessed the total charges for patients without MR and for patients with MR who underwent medical management, transcatheter mitral valve repair or replacement, or surgical mitral valve repair or replacement. During the study period, 26 076 inpatients had a diagnosis of MR. Compared with patients without MR, these patients had more comorbidities and higher inpatient mortality. Patients with medically managed MR incurred average total charges of $23 575 per year; MR was associated with $10 559 more in charges per year and an incremental 3.1 more inpatient days per year as compared with patients without MR. Both surgical mitral valve repair or replacement and transcatheter mitral valve repair or replacement were associated with higher charges as compared with medical management during the year of intervention ($47 943 for surgical mitral valve repair or replacement and $63 108 for transcatheter mitral valve repair or replacement). Annual charges for both groups were significantly lower as compared with medical management in the second and third years postintervention. CONCLUSIONS: MR is associated with higher mortality and inpatient charges. Patients who undergo surgical or transcatheter intervention incur lower charges compared with medically managed MR patients in the years after the procedure.

Outcomes among patients undergoing transcatheter aortic valve replacement with very low baseline gradients.

Background: While there is evidence that patients with low-flow, low-gradient aortic stenosis (AS) benefit from transcatheter aortic valve replacement (TAVR), data are lacking regarding outcomes of patients with a very low gradient (VLG). Methods: In this retrospective, single-center study of patients with severe AS who underwent TAVR, three groups were defined using baseline mean aortic valve gradient: VLG (≤25 mmHg), low gradient (LG, 26-39 mmHg), and high gradient (HG, ≥40 mmHg). The primary outcome was the composite of Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 of <45, decrease in KCCQ-12 of ≥10 compared with baseline, or death at 1 year. Results: One-thousand six patients were included: 571 HG, 353 LG, and 82 VLG. The median age was 82.1 years [interquartile range (IQR) 76.3-86.9]; VLG patients had more baseline comorbidities compared with the other groups. The primary outcome was highest at 1 year in the VLG group (VLG, 46.7%; LG, 29.9%; HG, 23.1%; p = 0.002), with no difference between groups after adjustment for baseline characteristics. At baseline, <30% of VLG patients had an excellent or good (50-100) KCCQ-12, whereas more than 75% and 50% had an excellent or good KCCQ-12 at 30-day and 1-year follow-up, respectively. Conclusion: Although patients with VLG undergoing TAVR have a higher rate of poor outcomes at 1 year compared with patients with LG and HG severe AS, this difference is largely attributable to baseline comorbidities. Patients with severe AS undergoing TAVR have significant improvement in health status outcomes regardless of resting mean gradient.

Sex Differences in Health Status and Clinical Outcomes After Nonprimary Percutaneous Coronary Intervention.

BACKGROUND: Greater insight into sex-based differences in health status can lay the foundation for more equitable health care. This study compares differences in health status of women and men in the CPORT-E trial (Cardiovascular Patient Outcomes Research Team Non-Primary Percutaneous Coronary Intervention) undergoing nonprimary percutaneous coronary intervention. METHODS: We compared Seattle Angina Questionnaire scores at baseline, 6 weeks, and 9 months for 6851 women and 12 016 men undergoing nonprimary percutaneous coronary intervention. RESULTS: Proportions of angina-free patients increased from 26.2% and 29.8% at baseline to 71.6% and 78.7% at 6 weeks to 78.1% and 83.0% at 9 months in women and men, respectively (P<0.001 for all). After adjusting for clinical and procedural characteristics as well as baseline angina, freedom from angina in women was 34% less likely at 6 weeks (odds ratio, 0.66 [95% CI, 0.61-0.71]; P<0.001) and 32% less likely at 9 months (odds ratio, 0.68 [95% CI, 0.62-0.74]; P<0.001) compared with men. CONCLUSIONS: Although health status increased significantly after percutaneous coronary intervention in both women and men, women had poorer health status outcomes than men before and after percutaneous coronary intervention. Additional investigation into therapies that address the causes of poorer health status in women with coronary artery disease is needed. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00549796.

Association Between Omega-3 Fatty Acid Levels and Aortic Valve Calcium (from the Multi-Ethnic Study of Atherosclerosis).

Calcific aortic valve disease, a condition of chronic inflammation, is associated with increased cardiovascular events and all-cause mortality. Omega-3 fatty acids (O3FAs) reduce both acute and chronic inflammation, but their associations with aortic valve calcium (AVC) have not been studied. The Multi-Ethnic Study of Atherosclerosis is a prospective cohort study of 6,814 adults without clinical cardiovascular disease. Plasma fatty acid levels and cardiac computed tomography (CT) scans were performed at baseline, and CT scans were performed at subsequent clinical visits over a median 9-year period. We assessed whether plasma levels of O3FAs and their species correlate with the presence, severity, and progression of AVC measured by CT in Multi-Ethnic Study of Atherosclerosis. The mean age of the 6,510 included participants with baseline fatty acid levels, AVC, and covariate data was 62.1 ± 10.2 years, and 47.1% of the participants were male. Race distribution was 38.6% White, 27.2% Black, 22.1% Hispanic/Latino, and 12.1% Chinese. Among the 6,510 participants, 5,884 had a subsequent CT scan, and 3,304 had a third CT scan with AVC measurements. At baseline, 862 participants (13.2%) had prevalent AVC (Agatston score >0), and were more likely to be of older age, male, of the White race, have a lower education level, and have co-morbidities that are associated with a higher risk for AVC. Plasma tertiles of eicosapentaenoic acid, docosahexaenoic acid, and total O3FA were not associated with prevalent AVC at baseline, incident AVC, or change in AVC. In conclusion, plasma levels of O3FAs in subjects not routinely supplemented with O3FAs are not useful for predicting the presence or development of AVC. Whether high plasma O3FA levels, achievable by high-dose O3FA over-the-counter supplementation or pharmacotherapy, is associated with AVC requires further investigation.

Inequities in Aortic Stenosis and Aortic Valve Replacement Between Black/African-American, White, and Hispanic Residents of Maryland.

Background Racial and ethnic inequities exist in surgical aortic valve replacement for aortic stenosis (AS), and early studies have suggested similar inequities in transcatheter aortic valve replacement. Methods and Results We performed a retrospective analysis of the Maryland Health Services Cost Review Commission inpatient data set from 2016 to 2018. Black patients had half the incidence of any inpatient AS diagnosis compared with White patients (incidence rate ratio [IRR], 0.50; 95% CI, 0.48-0.52; P<0.001) and Hispanic patients had one fourth the incidence compared with White patients (IRR, 0.25; 95% CI, 0.22-0.29; P<0.001). Conversely, the incidence of any inpatient mitral regurgitation diagnosis did not differ between White and Black patients (IRR, 1.00; 95% CI, 0.97-1.03; P=0.97) but was significantly lower in Hispanic compared with White patients (IRR, 0.36; 95% CI, 0.33-0.40; P<0.001). After multivariable adjustment, Black race was associated with a lower incidence of surgical aortic valve replacement (IRR, 0.67; 95% CI, 0.55-0.82 P<0.001 relative to White race) and transcatheter aortic valve replacement (IRR, 0.77; 95% CI, 0.65-0.90; P=0.002) among those with any inpatient diagnosis of AS. Hispanic patients had a similar rate of surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients. Conclusions Hospitalization with any diagnosis of AS is less common in Black and Hispanic patients than in White patients. In hospitalized patients with AS, Black race is associated with a lower incidence of both surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients, whereas Hispanic patients have a similar incidence of both. The reasons for these inequities are likely multifactorial.

Bioethics and professionalism in popular television medical dramas.

Television medical dramas sometimes depict medical professionalism and bioethical issues, but their nature and extent are unclear. The authors systematically analysed the bioethical and professionalism content of one season each of Grey's Anatomy and House M.D., two of the most popular current television medical dramas. The results indicate that these programmes are rife with powerful portrayals of bioethical issues and egregious deviations from the norms of professionalism and contain exemplary depictions of professionalism to a much lesser degree.

In-Hospital Management and Outcomes of Patients With Acute Myocardial Infarction and Influenza.

Patients with influenza infection are at increased risk of acute myocardial infarction (AMI). There are limited data on the short-term prognosis and management of patients with AMI and concomitant influenza. We examined the National Inpatient Sample from 2010 to 2014 for adult patients with a diagnosis of AMI. Patients were stratified into those with or without concomitant influenza. In-hospital therapies and outcomes were compared between groups in unadjusted and adjusted analyses. Standardized differences of >10% and p values <0.05 were considered significant. Propensity matching was performed using a caliper radius of 0.01*sigma. Of 4,285,641 patients with a discharge diagnosis of AMI, 12,830 had concomitant influenza. Patients with influenza were older, had a higher burden of co-morbidities, and more often presented with non-ST elevation AMI (90% vs 74%) as compared with those without influenza. Coronary angiography (23% vs 54%) and revascularization (11% vs 41%) were less often pursued in AMI patients with influenza. Patients with AMI and influenza had elevated in-hospital mortality (14%) and multiorgan failure (33%). In a propensity-matched analysis of 23,415 patients, in-hospital mortality (odds ratio [OR] 1.26; p = 0.01), acute kidney injury (OR 1.36; p <0.01), multiorgan failure (OR 1.81; p <0.01), length-of-stay, and hospital costs were significantly higher in those with influenza. In conclusion, patients with AMI and concomitant influenza have an adverse in-hospital prognosis as compared with those without influenza.

Fibrotic Lung Disease at CT Predicts Adverse Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

PURPOSE: To evaluate the relationship between CT findings of diffuse lung disease and post-transcatheter aortic valve replacement (TAVR) outcomes. MATERIALS AND METHODS: Retrospective review of pre-TAVR CT scans obtained during 2012-2017 was conducted. Emphysema, reticulation, and honeycombing were separately scored using a five-point scale and applied to 10 images per examination. The fibrosis score was the sum of reticulation and honeycombing scores. Lung diseases were also assessed as dichotomous variables (zero vs nonzero scores). The two outcomes evaluated were death and the composite of death and readmission. RESULTS: The study included 373 patients with median age of 84 years (age range, 51-98 years; interquartile range, 79-88 years) and median follow-up of 333 days. Fibrosis and emphysema were present in 66 (17.7%) and 95 (25.5%) patients, respectively. Fibrosis as a dichotomous variable was independently associated with the composite of death and readmission (hazard ratio [HR], 1.54; P = .030). In those without known chronic lung disease (CLD) (HR, 3.09; P = .024) and those without airway obstruction, defined by a ratio of forced expiratory volume in 1 second to the forced vital capacity greater than or equal to 70% (HR, 1.67, P = .039), CT evidence of fibrosis was a powerful predictor of adverse events. Neither emphysema score nor emphysema as a dichotomous variable was an independent predictor of outcome. CONCLUSION: The presence of fibrosis on baseline CT scans was an independent predictor of adverse events after TAVR. In particular, fibrosis had improved predictive value in both patients without known CLD and patients without airway obstruction.Supplemental material is available for this article.© RSNA, 2020.

Medical and nursing students' television viewing habits: potential implications for bioethics.

Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students' beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in them. More than 80% of medical and nursing students watch television medical dramas. Students with more clinical experience tended to have impressions that were more negative than those of students without clinical experience. Furthermore, viewing of television medical dramas is a social event and many students discuss the bioethical issues they observe with friends and family. Television medical dramas may stimulate students to think about and discuss bioethical issues.

The Genetics of Aortopathies in Clinical Cardiology.

Aortopathies pose a significant healthcare burden due to excess early mortality, increasing incidence, and underdiagnosis. Understanding the underlying genetic causes, early diagnosis, timely surveillance, prophylactic repair, and family screening are keys to addressing these diseases. Next-generation sequencing continues to expand our understanding of the genetic causes of heritable aortopathies, rapidly clarifying their underlying molecular pathophysiology and suggesting new potential therapeutic targets. This review will summarize the pathogenetic mechanisms and management of heritable genetic aortopathies with attention to specific forms of both syndromic and nonsyndromic disorders, including Marfan syndrome, Loeys-Dietz syndrome, vascular Ehlers-Danlos syndrome, and familial thoracic aortic aneurysm and dissection.

Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry.

BACKGROUND: The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed. METHODS AND RESULTS: Within the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2% versus 42.6%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease. CONCLUSIONS: Within the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.