Comparative Costs to Medicare and Medicare Beneficiaries of Alternative AF Stroke Risk Reduction Strategies.

Background: As healthcare costs are increasingly being shifted from payers to patients, it is important to understand the economic consequences of therapeutic strategies to both payers and patients. Objective: To determine the relative costs to Medicare and Medicare beneficiaries (patients) of warfarin, non-vitamin K oral anticoagulants (NOACs), and left atrial appendage closure (LAAC) for stroke risk reduction in nonvalvular atrial fibrillation. Methods: An economic model was developed to assess costs at 5 and 10 years. For warfarin and NOACs, inputs were derived from published meta-analyses; for LAAC with the Watchman device, inputs were derived from pooled 5-year PROTECT AF and PREVAIL trial results. The model captured therapy costs vs clinical event costs, including procedural complications and follow-up clinical outcomes. Costs were based on 2023 Medicare reimbursement and copayment rates. Results: At 10 years, overall LAAC costs ($48,337) were lower than those of NOACs ($81,198) and warfarin ($52,359). Overall LAAC costs were lower than those of NOACs by year 5 and warfarin by year 9. At 5 years, patient LAAC costs were lowest at $4,764, compared to $7,146 and $6,453 for NOACs and warfarin, respectively. LAAC patient costs were lower than those of NOACs by year 3 and warfarin by year 4. Clinical events comprised 96% of overall warfarin costs vs 48% for LAAC and 40% for NOACs. Conclusion: LAAC yielded the lowest overall and patient costs. Warfarin costs were largely driven by clinical events, which may represent an unplanned financial burden for patients. These considerations should be incorporated into shared decision-making discussions about stroke prophylaxis strategies.

Cost-effectiveness of left atrial appendage closure with Watchman for non-valvular atrial fibrillation patients in Japan.

AIMS: Left atrial appendage closure (LAAC) has been demonstrated to be cost-saving relative to oral anticoagulants for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) in the United States and Europe. This study assessed the cost-effectiveness of LAAC with the Watchman device relative to warfarin and direct oral anticoagulants (DOACs) for stroke risk reduction in NVAF from a Japanese public healthcare payer perspective. METHODS: A Markov model was developed with 70-year-old patients using a lifetime time horizon. LAAC clinical inputs were from pooled, 5-year PROTECT AF and PREVAIL trials; warfarin and DOAC inputs were from published meta-analyses. Baseline stroke and bleeding risks were from the SALUTE trial on LAAC. Cost inputs were from the Japanese Medical Data Vision database. Probabilistic and one-way sensitivity analyses were performed. RESULTS: Over the lifetime time horizon, LAAC was less costly than warfarin (savings of JPY 1,878,335, equivalent to US $17,600) and DOACs (savings of JPY 1,198,096, equivalent to US $11,226). LAAC also provided 1.500 more incremental quality-adjusted life years (QALYs) than warfarin and 0.996 more than DOACs. In probabilistic sensitivity analysis, LAAC was cost-effective relative to warfarin and DOACs in 99.98% and 99.73% of simulations, respectively. LAAC dominated (had higher cumulative QALYs and was less costly than) warfarin and DOACs in 89.94% and 83.35% of simulations, respectively. CONCLUSIONS: Over a lifetime time horizon, LAAC is cost-saving relative to warfarin and DOACs for stroke risk reduction in NVAF patients in Japan and is associated with improved quality-of-life.

This study examined the cost-effectiveness of left atrial appendage closure (LAAC) compared to oral anticoagulants for stroke risk reduction among individuals with a specific type of irregular heart rhythm called non-valvular atrial fibrillation (NVAF). This study evaluated the cost-effectiveness of LAAC using the Watchman device in comparison to warfarin and direct oral anticoagulants (DOACs) from the perspective of Japan's public healthcare system. To investigate this, a computer-based model was developed involving 70-year-old patients over their lifetime. Data from notable studies such as the PROTECT AF and PREVAIL trials (covering 5 years) for LAAC and published meta-analyses for warfarin and DOACs were incorporated into the model. Baseline stroke and bleeding risks were derived from the SALUTE trial on LAAC. Cost inputs were based on data from the Japanese Medical Data Vision database. Additionally, we performed thorough cost-effectiveness analyses, including probabilistic and one-way sensitivity assessments. Our findings revealed that, over a lifetime, LAAC was more cost-effective than both warfarin and DOACs. Further, LAAC contributed an additional 1.500 quality-adjusted life years (QALYs) compared to warfarin and 0.996 QALYs compared to DOACs. In the long-term, adopting LAAC as an alternative to warfarin and DOACs is a cost-effective strategy for reducing stroke risk in NVAF patients in Japan. Moreover, it is associated with enhanced quality-of-life. These findings hold significant implications for informing decision-making in healthcare policies and clinical practices for NVAF patients.

Peridevice Leak After Left Atrial Appendage Occlusion: Incidence, Mechanisms, Clinical Impact, and Management.

Left atrial appendage occlusion is an increasingly adopted stroke prevention strategy in patients with atrial fibrillation. However, peridevice leaks after the procedure are not infrequent and have recently been shown to confer a higher risk for subsequent ischemic events. In this paper, the authors review the available research on the frequency, mechanisms, clinical significance, and management of peridevice leak after percutaneous left atrial appendage occlusion.

Management and Outcomes of Acute Myocardial Infarction-Cardiogenic Shock in Uninsured Compared With Privately Insured Individuals.

BACKGROUND: There are limited data on uninsured patients presenting with acute myocardial infarction-cardiogenic shock (AMI-CS). This study sought to compare the management and outcomes of AMI-CS between uninsured and privately insured individuals. METHODS: Using the National Inpatient Sample (2000-2016), a retrospective cohort of adult (≥18 years) uninsured admissions (primary payer-self-pay or no charge) were compared with privately insured individuals. Interhospital transfers were excluded. Outcomes of interest included in-hospital mortality, temporal trends in admissions, use of cardiac procedures, do-not-resuscitate status, palliative care referrals, and resource utilization. RESULTS: Of 402 182 AMI-CS admissions, 21 966 (5.4%) and 93 814 (23.3%) were uninsured and privately insured. Compared with private insured individuals, uninsured admissions were younger, male, from a lower socioeconomic status, had lower comorbidity, higher rates of acute organ failure, ST-segment elevation AMI-CS (77.3% versus 76.4%), and concomitant cardiac arrest (33.8% versus 31.9%; all P<0.001). Compared with 2000, in 2016, there were more uninsured (adjusted odds ratio, 1.15 [95% CI, 1.13-1.17]; P<0.001) and less privately insured admissions (adjusted odds ratio, 0.85 [95% CI, 0.83-0.87]; P<0.001). Uninsured individuals received less frequent coronary angiography (79.5% versus 81.0%), percutaneous coronary intervention (60.8% versus 62.2%), mechanical circulatory support (54% versus 55.5%), and had higher palliative care (3.8% versus 3.2%) and do-not-resuscitate status use (4.4% versus 3.2%; all P<0.001). Uninsured admissions had higher in-hospital mortality (adjusted odds ratio, 1.62 [95% CI, 1.55-1.68]; P<0.001) and resource utilization. CONCLUSIONS: Uninsured individuals have higher in-hospital mortality and lower use of guideline-directed therapies in AMI-CS compared with privately insured individuals.

Optimizing Web-Based Viewer of 4D CT Scans for Clinical Assessment of Injured Wrists.

Wrist injuries pose a unique challenge for patients and providers. Due to the complexity of the wrist, it is difficult to determine if a wrist injury is primarily a bone fracture or soft tissue damage. The scapholunate interosseous ligament (SLIL) is an important ligament in the function of the wrist, and it is also one of the most common soft tissue injuries in the wrist. Wrist arthroscopy is the gold standard for assessing injuries of the scapholunate joint; however, it is an invasive procedure. Recent advances in dynamic imaging with 4D Computed Tomography scans allow for the assessment of SLIL injuries non-invasively. Unfortunately, 4DCT scan data can be difficult to disseminate to clinical practitioners due to the large amount of data generated and the complexity in visualizing the data. A web-based application has been developed to interactively assess 4DCT scans of patients with suspected SLIL injury. Due to the magnitude of data and the diversity of hardware platforms used to visualize the data, the images are preprocessed with a rendering engine and presented in a pseudo-3D visualization paradigm where the user can interactively explore the 3D data without transmitting the entire dataset to the local computer. The technology has been used to assess 27 patients.

A Web-Based Software Platform for Efficient and Quantitative CT Image Quality Assessment and Protocol Optimization.

Channelized Hotelling observer (CHO), which has been shown to be well correlated with human observer performance in many clinical CT tasks, has a great potential to become the method of choice for objective image quality assessment. However, the use of CHO in clinical CT is still quite limited, mainly due to its complexity in measurement and calculation in practice, and the lack of access to an efficient and validated software tool for most clinical users. In this work, a web-based software platform for CT image quality assessment and protocol optimization (CTPro) was introduced. A validated CHO tool, along with other common image quality assessment tools, was made readily accessible through this web platform for clinical users and researchers without the need of installing additional software. An example of its application to evaluation of convolutional-neural-network (CNN)-based denoising was demonstrated.

Temporal Trends, Clinical Characteristics, and Outcomes of Emergent Coronary Artery Bypass Grafting for Acute Myocardial Infarction in the United States.

Background There are limited contemporary data on the use of emergent coronary artery bypass grafting (CABG) in acute myocardial infarction. Methods and Results Adult (aged >18 years) acute myocardial infarction admissions were identified using the National (Nationwide) Inpatient Sample (2000-2017) and classified by tertiles of admission year. Outcomes of interest included temporal trends of CABG use; age-, sex-, and race-stratified trends in CABG use; in-hospital mortality; hospitalization costs; and hospital length of stay. Of the 11 622 528 acute myocardial infarction admissions, emergent CABG was performed in 1 071 156 (9.2%). CABG utilization decreased overall (10.5% [2000] to 8.7% [2017]; adjusted odds ratio [OR], 0.98 [95% CI, 0.98-0.98]; P<0.001), in ST-segment-elevation myocardial infarction (10.2% [2000] to 5.2% [2017]; adjusted OR, 0.95 [95% CI, 0.95-0.95]; P<0.001) and non-ST-segment-elevation myocardial infarction (10.8% [2000] to 10.0% [2017]; adjusted OR, 0.99 [95% CI, 0.99-0.99]; P<0.001), with consistent age, sex, and race trends. In 2012 to 2017, compared with 2000 to 2005, admissions receiving emergent CABG were more likely to have non-ST-segment-elevation myocardial infarction (80.5% versus 56.1%), higher rates of noncardiac multiorgan failure (26.1% versus 8.4%), cardiogenic shock (11.5% versus 6.4%), and use of mechanical circulatory support (19.8% versus 18.7%). In-hospital mortality in CABG admissions decreased from 5.3% (2000) to 3.6% (2017) (adjusted OR, 0.89; 95% CI, 0.88-0.89 [P<0.001]) in the overall cohort, with similar temporal trends in patients with ST-segment-elevation myocardial infarction and non-ST-segment-elevation myocardial infarction. An increase in lengths of hospital stay and hospitalization costs was seen over time. Conclusions Utilization of CABG has decreased substantially in acute myocardial infarction admissions, especially in patients with ST-segment-elevation myocardial infarction. Despite an increase in acuity and multiorgan failure, in-hospital mortality consistently decreased in this population.

Racial, ethnic and socioeconomic disparities in patients undergoing left atrial appendage closure.

OBJECTIVE: This manuscript aims to explore the impact of race/ethnicity and socioeconomic status on in-hospital complication rates after left atrial appendage closure (LAAC). METHODS: The US National Inpatient Sample was used to identify hospitalisations for LAAC between 1 October 2015 to 31 December 2018. These patients were stratified by race/ethnicity and quartiles of median neighbourhood income. The primary outcome was the occurrence of in-hospital major adverse events, defined as a composite of postprocedural bleeding, cardiac and vascular complications, acute kidney injury and ischaemic stroke. RESULTS: Of 6478 unweighted hospitalisations for LAAC, 58% were male and patients of black, Hispanic and 'other' race/ethnicity each comprised approximately 5% of the cohort. Adjusted by the older Americans population, the estimated number of LAAC procedures was 69.2/100 000 for white individuals, as compared with 29.5/100 000 for blacks, 47.2/100 000 for Hispanics and 40.7/100 000 for individuals of 'other' race/ethnicity. Black patients were ~5 years younger but had a higher comorbidity burden. The primary outcome occurred in 5% of patients and differed significantly between racial/ethnic groups (p<0.001) but not across neighbourhood income quartiles (p=0.88). After multilevel modelling, the overall rate of in-hospital major adverse events was higher in black patients as compared with whites (OR: 1.60, 95% CI 1.22 to 2.10, p<0.001); however, the incidence of acute kidney injury was higher in Hispanics (OR: 2.19, 95% CI 1.52 to 3.17, p<0.001). No significant differences were found in adjusted overall in-hospital complication rates between income quartiles. CONCLUSION: In this study assessing racial/ethnic disparities in patients undergoing LAAC, minorities are under-represented, specifically patients of black race/ethnicity. Compared with whites, black patients had higher comorbidity burden and higher rates of in-hospital complications. Lower socioeconomic status was not associated with complication rates.

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States. METHODS: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables. RESULTS: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05­1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93­1.47]). CONCLUSIONS: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.

Noninvasive Hemodynamic Assessment of Shock Severity and Mortality Risk Prediction in the Cardiac Intensive Care Unit.

OBJECTIVES: This study sought to define the 2-dimensional and Doppler echocardiographic hemodynamics associated with each Society for Cardiovascular Angiography and Interventions (SCAI) stage, and to determine their association with mortality. BACKGROUND: The SCAI shock stages classification stratifies mortality risk in cardiac intensive care unit (CICU) patients, but the echocardiographic and hemodynamic parameters that define these SCAI shock stages are unknown. METHODS: Unique CICU patients admitted from 2007 to 2015 who had a transthoracic echocardiogram within 1 day of CICU admission were included. Echocardiographic variables were evaluated as a function of SCAI shock stage. Multivariable logistic regression determined the association between echocardiographic parameters with adjusted hospital mortality. RESULTS: We included 5,453 patients with a median age of 69.3 years (interquartile range: 58.2 to 79.0 years) (37% women), and a median left ventricular ejection fraction (LVEF) of 50% (interquartile range: 35% to 61%). Higher SCAI shock stages were associated with lower LVEF and worse systemic hemodynamics. Hospital mortality was higher in patients with LVEF <40%, cardiac index <1.8 l/min/m2, stroke volume index <35 ml/m2, cardiac power output <0.6 W, or medial early mitral valve inflow velocity to early diastolic annular velocity (E/e') ratio >15 (particularly in SCAI shock Stages A to C). After multivariable adjustment, only stroke volume index <35 ml/m2 (adjusted odds ratio: 2.0; 95% confidence interval: 1.4 to 3.0; p < 0.001) and E/e' ratio >15 (adjusted odds ratio: 1.52; 95% confidence interval: 1.04 to 2.23; p = 0.03) remained associated with higher hospital mortality. CONCLUSIONS: Noninvasive 2-dimensional and Doppler echocardiographic parameters correlate with the SCAI shock stages and improve risk stratification for hospital mortality in CICU patients. Low stroke volume index and high E/e' ratio demonstrated the strongest association with hospital mortality.

Sex and Gender Disparities in the Management and Outcomes of Acute Myocardial Infarction-Cardiogenic Shock in Older Adults.

OBJECTIVE: To evaluate outcomes by sex in older adults with cardiogenic shock complicating acute myocardial infarction (AMI-CS). MATERIALS AND METHODS: A retrospective cohort of older (≥75 years) AMI-CS admissions during January 1, 2000, to December 31, 2014, was identified using the National Inpatient Sample. Interhospital transfers were excluded. Use of angiography, percutaneous coronary intervention (PCI), mechanical circulatory support (MCS), and noncardiac interventions was identified. The primary outcome was in-hospital mortality stratified by sex, and secondary outcomes included temporal trends of prevalence, in-hospital mortality, use of cardiac and noncardiac interventions, hospitalization costs, and length of stay. RESULTS: In this 15-year period, there were 134,501 AMI-CS admissions 75 years or older, of whom 51.5% (n=69,220) were women. Women were on average older, were more often Hispanic or nonwhite race, and had lower comorbidity, acute organ failure, and concomitant cardiac arrest. Compared with older men (n=65,281), older women (n=69,220) had lower use of coronary angiography (55.4% [n=35,905] vs 49.2% [n=33,918]), PCI (36.3% [n=23,501] vs 34.4% [n=23,535]), MCS (34.3% [n=22,391] vs 27.2% [n=18,689]), mechanical ventilation, and hemodialysis (all P<.001). Female sex was an independent predictor of higher in-hospital mortality (adjusted odds ratio, 1.05; 95% CI, 1.02-1.08; P<.001) and more frequent discharges to a skilled nursing facility. In subgroup analyses of ethnicity, presence of cardiac arrest, and those receiving PCI and MCS, female sex remained an independent predictor of increased mortality. CONCLUSION: Female sex is an independent predictor of worse in-hospital outcomes in older adults with AMI-CS in the United States.

The outpatient management of hypertension at two Sierra Leonean health centres: A mixed-method investigation of follow-up compliance and patient-reported barriers to care.

BACKGROUND: Sub-Saharan Africa faces an increasing burden of non-communicable diseases. In particular, hypertension and its therapeutic control present a challenge and opportunity for health practitioners and health systems within the region. AIM: This study sought to assess an initiative conducted by two health clinics to begin treatment of hypertension amongst their patient populations by reviewing medication possession rates and documenting patient-reported barriers to care in the provision of chronic hypertension management. SETTING: Two private, outpatient health clinics in Sierra Leone recently beginning hypertension management initiatives. METHODS: A retrospective chart review identified 487 records of patients with diagnosed hypertension and assessed for medication adherence through calculation of medication possession ratios from pharmacy refill data. Surveys were conducted on a convenience sample of 68 patients of the hypertension treatment programme to discern patient-reported barriers of care. RESULTS: Medication possession rates were found to be less than 40% in 82% (399/487) of patients, between 40% and 79% in 12% (60/487) of patients and 80% or greater in 6% (28/487) of patients. In surveys of individuals being treated by the programme, patients were most likely to cite transportation (81%, 55/68), financial burden (69%, 47/68) and schedule conflicts with work or other prior commitments (25%, 17/68) as barriers to care. CONCLUSIONS: In this newly instituted outpatient hypertensive management initiative, 82% of patients had medication possession ratios under 40%, which is likely to impact the clinical effectiveness of the initiative. The most frequent patient-reported barriers to care in surveys included transportation, financial burden and schedule conflicts.

Intravascular ultrasound, optical coherence tomography, and fractional flow reserve use in acute myocardial infarction.

BACKGROUND: There are limited data on the use of intravascular ultrasound (IVUS), optical coherence tomography (OCT), and fractional flow reserve (FFR) during acute myocardial infarction (AMI). OBJECTIVES: To assess the temporal trends of IVUS, OCT, and FFR use in AMI. METHODS: A retrospective cohort study from the National Inpatient Sample (2004-2014) was designed to include AMI admissions that received coronary angiography. Administrative codes were used to identify percutaneous coronary intervention (PCI), IVUS, OCT, and FFR. Outcomes included temporal trends, inhospital mortality and resource utilization stratified by IVUS, OCT, or FFR use. RESULTS: In 4,419,973 AMI admissions, IVUS, OCT, and FFR were used in 2.6%, 0.1%, and 0.6%, respectively. There was a 22-fold, 118-fold, and 33-fold adjusted increase in IVUS, OCT, and FFR use, respectively, in 2014 compared to the first year of use. Non-ST-elevation AMI presentation, male sex, private insurance coverage, admission to a large urban hospital, and absence of cardiac arrest and cardiogenic shock were associated with higher IVUS, OCT, or FFR use. PCI was performed in 83.2% of the IVUS, OCT, or FFR cohort compared to 64.2% of the control group (p < .001). The cohort with IVUS/OCT/FFR use had lower inhospital mortality (adjusted odds ratio 0.53 [95% confidence interval 0.50-0.56]), more frequent discharges to home (83.7% vs. 76.8%), shorter hospital stays (4.3 ± 4.4 vs. 5.0 ± 5.5 days) and higher hospitalization costs ($90,683 ± 74,093 vs. $74,671 ± 75,841). CONCLUSIONS: In AMI, the use of IVUS, OCT, and FFR has increased during 2004-2014. Significant patient and hospital-level disparities exist in the use of these technologies.

Cost-Effectiveness of Left Atrial Appendage Closure for Stroke Reduction in Atrial Fibrillation: Analysis of Pooled, 5-Year, Long-Term Data.

Background Recent publications reached conflicting conclusions about the cost-effectiveness of left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, Marlborough, MA) for stroke risk reduction in nonvalvular atrial fibrillation (AF). This analysis sought to assess the cost-effectiveness of LAAC relative to both warfarin and nonwarfarin oral anticoagulants (NOACs) using pooled, long-term data from the randomized PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin) trials. Methods and Results A Markov model was constructed from a US payer perspective with a lifetime (20-year) horizon. LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF and PREVAIL trial 5-year data. Warfarin and NOAC inputs were derived from published meta-analyses. The model was populated with a cohort of 10 000 patients, aged 70 years, at moderate stroke and bleeding risk. Sensitivity analyses were performed. LAAC was cost-effective relative to warfarin by year 7 ($48 674/quality-adjusted life-year) and dominant (more effective and less costly) by year 10. LAAC became cost-effective and dominant compared with NOACs by year 5. Over a lifetime, LAAC provided 0.60 more quality-adjusted life-years than warfarin and 0.29 more than NOACs. In sensitivity analyses, LAAC was cost-effective relative to warfarin and NOACs in 98% and 95% of simulations, respectively. Conclusions Using pooled, 5-year PROTECT AF and PREVAIL trial data, LAAC proved to be not only cost-effective, but cost saving relative to warfarin and NOACs. LAAC with the Watchman device is an economically viable stroke risk reduction strategy for patients with AF seeking an alternative to lifelong anticoagulation.

Racial Disparities in the Utilization and Outcomes of TAVR: TVT Registry Report.

OBJECTIVES: This study sought to evaluate racial disparities in the performance and outcomes of transcatheter aortic valve replacement (TAVR). BACKGROUND: Racial disparities in cardiovascular diseases are well described. Whether the racial disparities observed in surgical aortic valve replacement also exist with TAVR remains unknown. METHODS: Patients undergoing TAVR between November 2011 and June 2016 were identified in the American College of Cardiology/Society of Thoracic Surgeons/Transcatheter Valve Therapy Registry. We described the racial distribution, and the risk-adjusted in-hospital morbidity, and mortality stratified by race. We evaluated 1-year outcomes in a subset of patients via linkage to Medicare (Centers for Medicare and Medicaid Services) claims. RESULTS: Among the 70,221 included patients, 91.3% were white, 3.8% were black, 3.4% were Hispanic, and 1.5% were of Asian/Native American/Pacific Islander race. This represented significant underrepresentation of nonwhite patients compared with their proportion of the population. After risk-adjustment, there was no difference in the rates of in-hospital mortality, myocardial infarction, stroke, major bleeding, vascular complications, or new pacemaker requirements among the 4 racial groups. Among 29,351 patients with Centers for Medicare and Medicaid Services linkage, 1-year adjusted mortality rates were similar in blacks and Hispanics compared with whites, but lower among patients of Asian/Native American/Pacific Islander race (adjusted hazard ratio: 0.71; 95% confidence interval: 0.55 to 0.92; p = 0.028). Black and Hispanic patients had more heart failure hospitalizations compared with whites (adjusted hazard ratio: 1.39; 95% confidence interval: 1.16 to 1.67; p < 0.001; and adjusted hazard ratio: 1.37; 95% confidence interval: 1.13 to 1.66; p = 0.004, respectively). These differences persisted after additional risk-adjustment for socioeconomic status. CONCLUSIONS: Racial minorities are underrepresented among patients undergoing TAVR in the United States, but their adjusted 30-day and 1-year clinical outcomes are comparable with those of white race.

Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry.

BACKGROUND: Patients with severe aortic stenosis (AS) have repeat hospitalizations for multiple conditions. OBJECTIVES: The purpose of this study was to assess the effect of transcatheter aortic valve replacement (TAVR) on hospitalizations in severe AS. METHODS: Using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry with linkage to Medicare claims, the authors examined rates of all-cause, cardiovascular, and noncardiovascular hospitalizations and hospital days, as well as inpatient costs in the year pre-TAVR and post-TAVR. Multivariable modeling was used to determine rate ratios of post-TAVR versus pre-TAVR hospitalizations and costs. RESULTS: Among 15,324 patients at 328 sites with Medicare linkage undergoing TAVR, the median age was 84 years, the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.0, and 61.1% patients underwent TAVR via transfemoral access. Post-TAVR, heart failure hospitalization rates and hospitalized days were reduced compared with pre-TAVR (rate ratio: 0.87 and 0.95 respectively; p < 0.01 for all). However, all-cause, noncardiovascular, and bleeding hospitalization rates and hospitalized days were increased (p < 0.01 for all). Post-TAVR hospitalizations were reduced the most among those with left ventricular ejection fraction <30%. Mean post-TAVR costs were reduced among all TAVR patients and among 1-year survivors (rate ratio: 0.95, p < 0.01; and 0.90; p < 0.01, respectively). CONCLUSIONS: Patients had lower costs and fewer heart failure hospitalizations but more all-cause, noncardiovascular, and bleeding hospitalizations post-TAVR. Reduction in hospitalizations varied by specific patient subgroups, and thus, payors and providers seeking to reduce resource use may consider strategies designed to improve processes of care among patients with increased resource utilization post-TAVR as compared with pre-TAVR.