Long-term outcomes of phenoclusters in severe tricuspid regurgitation.

AIMS: Severe tricuspid regurgitation (TR) exhibits high 1-year morbidity and mortality, yet long-term cardiovascular risk overall and by subgroups remains unknown. This study characterizes 5-year outcomes and identifies distinct clinical risk profiles of severe TR. METHODS AND RESULTS: Patients were included from a large US tertiary referral center with new severe TR by echocardiography based on four-category American Society of Echocardiography grading scale between 2007 and 2018. Patients were categorized by TR etiology (with lead present, primary, and secondary) and by supervised recursive partitioning (survival trees) for outcomes of death and the composite of death or heart failure hospitalization. The Kaplan-Meier estimates and Cox regression models were used to evaluate any association by (i) TR etiology and (ii) groups identified by survival trees and outcomes over 5 years. Among 2379 consecutive patients with new severe TR, median age was 70 years, 61% were female, and 40% were black. Event rates (95% confidence interval) were 30.9 (29.0-32.8) events/100 patient-years for death and 49.0 (45.9-52.2) events/100 patient-years for the composite endpoint, with no significant difference by TR etiology. After applying supervised survival tree modeling, two separate groups of four phenoclusters with distinct clinical prognoses were separately identified for death and the composite endpoint. Variables discriminating both outcomes were age, albumin, blood urea nitrogen, right ventricular function, and systolic blood pressure (all P < 0.05). CONCLUSION: Patients with newly identified severe TR have high 5-year risk for death and death or heart failure hospitalization. Partitioning patients using supervised survival tree models, but not TR etiology, discriminated clinical risk. These data aid in identifying relevant subgroups in clinical trials of TR and clinical risk/benefit analysis for TR therapies.

Heart failure medical therapy prior to mitral transcatheter edge-to-edge repair: the STS/ACC Transcatheter Valve Therapy Registry.

BACKGROUND AND AIMS: Guideline-directed medical therapy (GDMT) is recommended before mitral valve transcatheter edge-to-edge repair (MTEER) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Whether MTEER is being performed on the background of optimal GDMT in clinical practice is unknown. METHODS: Patients with left ventricular ejection fraction (LVEF) < 50% who underwent MTEER for FMR from 23 July 2019 to 31 March 2022 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were identified. Pre-procedure GDMT utilization was assessed. Cox proportional hazards models were constructed to evaluate associations between pre-MTEER therapy (no/single, double, or triple therapy) and risk of 1-year mortality or HF hospitalization (HFH). RESULTS: Among 4199 patients across 449 sites, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, mineralocorticoid receptor antagonists, and angiotensin receptor-neprilysin inhibitors were used in 85.1%, 44.4%, 28.6%, and 19.9% before MTEER, respectively. Triple therapy was prescribed for 19.2%, double therapy for 38.2%, single therapy for 36.0%, and 6.5% were on no GDMT. Significant centre-level variation in the proportion of patients on pre-intervention triple therapy was observed (0%-61%; adjusted median odds ratio 1.48 [95% confidence interval (CI) 1.25-3.88]; P < .001). In patients eligible for 1-year follow-up (n = 2014; 341 sites), the composite rate of 1-year mortality or HFH was lowest in patients prescribed triple therapy (23.0%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P < .01 comparing across groups). Associations persisted after accounting for relevant clinical characteristics, with lower risk in patients prescribed triple therapy [adjusted hazard ratio (aHR) 0.73, 95% CI .55-.97] and double therapy (aHR 0.69, 95% CI .56-.86) before MTEER compared with no/single therapy. CONCLUSIONS: Under one-fifth of patients with LVEF <50% who underwent MTEER for FMR in this US nationwide registry were prescribed comprehensive GDMT, with substantial variation across sites. Compared with no/single therapy, triple and double therapy before MTEER were independently associated with reduced risk of mortality or HFH 1 year after intervention.

Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints.

Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options.

Clinical and cost implications of deferred testing in low-risk patients with stable chest pain: a simulation using the PROMISE trial.

Current guidelines recommend a deferred testing approach in low-risk patients presenting with stable chest pain. After simulating a deferred testing approach using the PROMISE Minimal Risk Score to identify 915 minimal risk participants with cost data from the PROMISE trial, a deferred testing strategy was associated with an adjusted cost savings of -$748.74 (95% CI: -1646.97, 158.06) per participant and 74.6% of samples had better clinical outcomes and lower mean cost. This supports the current guideline recommended deferred testing approach in low-risk patients with stable chest pain.

Left Atrial Appendage Occlusion Versus Oral Anticoagulation in Atrial Fibrillation : A Decision Analysis.

BACKGROUND: Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation. OBJECTIVE: To determine the optimal strategy for stroke prevention conditional on a patient's individual risks for ischemic stroke and bleeding. DESIGN: Decision analysis with a Markov model. DATA SOURCES: Evidence from the published literature informed model inputs. TARGET POPULATION: Women and men with nonvalvular AF and without prior stroke. TIME HORIZON: Lifetime. PERSPECTIVE: Clinical. INTERVENTION: LAAO versus warfarin or direct oral anticoagulants (DOACs). OUTCOME MEASURES: The primary end point was clinical benefit measured in quality-adjusted life-years. RESULTS OF BASE-CASE ANALYSIS: The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHA2DS2-VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHA2DS2-VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs. RESULTS OF SENSITIVITY ANALYSIS: Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data. LIMITATION: Clinical effectiveness data were drawn primarily from studies on the Watchman device. CONCLUSION: Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO. PRIMARY FUNDING SOURCE: None.

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation.

Importance: There are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting. Objective: To evaluate the outcomes of transcatheter mitral valve repair for degenerative MR. Design, Setting, and Participants: Cohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022. Exposure: Transcatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott). Main Outcomes and Measures: The primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or >5 to <10 mm Hg). Results: A total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P < .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P < .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P < .001). Conclusions and Relevance: In this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.

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.

Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. METHODS: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. RESULTS: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. CONCLUSIONS: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.

BACKGROUND: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions. METHODS: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital. RESULTS: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40). CONCLUSIONS: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).

Tricuspid valve disease prevalence and the impact of tricuspid valve surgery on cardiovascular events and hospital resource use in medicare beneficiaries.

BACKGROUND: Tricuspid valve disease (TVD) is presumed common, however, little is known about its prevalence or the impact of tricuspid valve surgery (TVS) on healthcare resource use. METHODS: To describe the prevalence of TVD and assess the impact of TVS on resource utilization, Medicare Fee-For-Service beneficiaries from 2011 -2019 were assessed for the prevalence of non-rheumatic TVD. Hospital costs and rates of all-cause, cardiovascular (CV), and heart failure (HF) hospitalizations were compared in the 3 months pre TVS to acute (0-3 months) and chronic (3 -12 months) post TVS periods. RESULTS: Among 80.3 million beneficiaries from 2011 - 2019 Q1, over 700,000 (0.9%) had non-rheumatic TVD with 1.4% undergoing TVS. Thirty-day and 1 year mortality after TVS was 5.5% to15.5%. Compared with pre-surgery, CV and HF hospitalizations decreased from 0.12 to 0.08 per patient-month (P <.001), and 0.06 to 0.04 (P <.001) acutely. All-cause hospitalizations increased from 0.18 per patient-month to 0.23 per patient-month acutely post-surgery (P <.001), before decreasing to 0.09 per patient-month chronically (P <.001). Hospital costs increased from $2,174 per patient-month to $4,171 per patient-month acutely (P < .001), before falling to $1,441 per patient-month (P < .001) chronically. Lower costs for HF and CV hospitalization in both acute (P = .028 and P < .001, respectively) and chronic (P < .001 for both) periods were observed. CONCLUSIONS: TVS is associated with reduced CV and HF hospitalizations and associated hospital costs. Future work should determine whether transcatheter tricuspid valve repair offers similar or additional benefits.

Clinical trajectory of patients with a worsening heart failure event and reduced ventricular ejection fraction.

BACKGROUND: Recent data suggest that patients with heart failure with reduced ejection fraction (HFrEF) and worsening heart failure (WHF) have potential for greater benefit from newer HF therapies. We investigated characteristics and outcomes of patients with HFrEF and WHF by severity of left ventricular dysfunction. METHODS: We identified patients with chronic symptomatic HFrEF (left ventricular ejection fraction [LVEF] ≤35%) and evidence of WHF (emergency department visit or hospitalization for acute HF within 12 months of index echocardiogram) treated at Duke University between 1/2009 and 12/2018. Patients were stratified by LVEF≤25% or 26% to35%. Cox models were used to estimate cause-specific hazard ratios and 5-year event incidence of death and hospitalization across the range of LVEF. RESULTS: Of 2823 patients with HFrEF and WHF, 1620 (57.4%) had an LVEF≤25% and 1203 (42.6%) had an LVEF 26% to35%. Compared to patients with LVEF 26% to35%, those with LVEF≤25% were younger and more commonly men with a lower cardiovascular comorbidity burden. Patients with LVEF≤25% were less commonly on beta blockers (85.9% vs 90.5%) but more commonly treated with mineralocorticoid receptor antagonists (49.3% vs 41.1%) and implantable defibrillators (41.3% vs 28.2%). Patients with LVEF≤25% had significantly higher hazards for death (HR 1.24 [95% CI 1.11 - 1.38]), all-cause hospitalization (HR 1.21 [95% CI 1.10 - 1.33]), and HF hospitalization (HR 1.25 [95% CI 1.1 - 1.38]) through 5-years. CONCLUSIONS: More than half of patients with chronic HFrEF and WHF have severe LV dysfunction. Important differences in comorbidities, HF therapies, and outcomes exist between those with LVEF≤25% and those with LVEF 26% to35%.

Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry.

BACKGROUND: Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight. METHODS: We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated. RESULTS: A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation. CONCLUSIONS: An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity.

The prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization: Rationale and design of the PRECISE trial.

BACKGROUND: Clinicians vary widely in their preferred diagnostic approach to patients with non-acute chest pain. Such variation exposes patients to potentially avoidable risks, as well as inefficient care with increased costs and unresolved patient concerns. METHODS: The Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE) trial (NCT03702244) compares an investigational "precision" diagnostic strategy to a usual care diagnostic strategy in participants with stable chest pain and suspected coronary artery disease (CAD). RESULTS: PRECISE randomized 2103 participants with stable chest pain and a clinical recommendation for testing for suspected CAD at 68 outpatient international sites. The investigational precision evaluation strategy started with a pre-test risk assessment using the PROMISE Minimal Risk Tool. Those at lowest risk were assigned to deferred testing (no immediate testing), and the remainder received coronary computed tomographic angiography (cCTA) with selective fractional flow reserve (FFRCT) for any stenosis meeting a threshold of ≥30% and <90%. For participants randomized to usual care, the clinical care team selected the initial noninvasive or invasive test (diagnostic angiography) according to customary practice. The use of cCTA as the initial diagnostic strategy was proscribed by protocol for the usual care strategy. The primary endpoint is time to a composite of major adverse cardiac events (MACE: all-cause death or non-fatal myocardial infarction) or invasive cardiac catheterization without obstructive CAD at 1 year. Secondary endpoints include health care costs and quality of life. CONCLUSIONS: PRECISE will determine whether a precision approach comprising a strategically deployed combination of risk-based deferred testing and cCTA with selective FFRCT improves the clinical outcomes and efficiency of the diagnostic evaluation of stable chest pain over usual care.

Underutilization of Guideline-based Abdominal Aortic Aneurysm Screening in an Academic Health System.

OBJECTIVES: The US Preventive Services Task Force (USPSTF) recommends a 1 time screening for AAA with ultrasonography in men aged 65-75 who have ever smoked. Our objectives were to identify the AAA screening rates in a large academic health system and assess factors associated with receipt of screening. METHODS: Data were extracted from electronic health records from the Duke University Health System and the US Census Bureau. Index screening eligibility date was defined as the 65th birthdate for male patients with a history of smoking. Patients with an index screening eligibility date between January 1, 2016 and December 31, 2018 were included in the study population and followed through December 31, 2019. Screened patients were identified by procedure codes for ultrasonography, CT or MRI. RESULTS: Among 6,682 eligible patients who turned 65 years old between January 1, 2016 and December 31, 2018 with at least 1 year of follow-up, only 463 (6.9%) received AAA screening during the study period. The odds of receiving AAA screening within 1 year of index eligibility were 27% lower for Black patients compared to whites [OR = 0.73, 95% CI (0.58,0.93)]. Patients who visited a PCP or were diagnosed with hypertension had 75% and 41% greater odds of receiving screening, respectively [OR 1.75, 95% CI (1.36,2.25)] and [OR 1.41 95% CI (1.11,1.80)] compared with patients who did not. Among 4,580 men with 2 years of follow-up, AAA screening rate increased to 13.0%. Patients who visited a PCP had 64% greater odds of receiving screening within 2 years of index eligibility compared to those who did not [OR = 1.64, 95% CI (1.30,2.06)]. CONCLUSIONS: Screening for AAA per USPSTF guidelines is underutilized with evidence of a racial disparity. Although PCP visit is the most consistent predictor of screening, provider screening rates are low.

Sex disparities in patients with symptomatic severe aortic stenosis.

BACKGROUND: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients. METHODS: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and 1-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable. RESULTS: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, P<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, P<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at 1 year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69). CONCLUSIONS: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment.

African American-Caucasian American differences in aortic valve replacement in patients with severe aortic stenosis.

BACKGROUND: Among patients with severe aortic stenosis (AS), there are limited data on aortic valve replacement (AVR), reasons for nonreceipt and mortality by race. METHODS: Utilizing the Duke Echocardiography Laboratory Database, we analyzed data from 110,711 patients who underwent echocardiography at Duke University Medical Center between 1999 and 2013. We identified 1,111 patients with severe AS who met ≥1 of 3 criteria for AVR: ejection fraction ≤50%, diagnosis of heart failure, or need for coronary artery bypass surgery. Logistic regression models were used to assess the association between race, AVR and 1-year mortality. χ2 testing was used to assess potential racial differences in reasons for AVR nonreceipt. RESULTS: Among the 1,111 patients (143 AA and 968 CA) eligible for AVR, AA were more often women, had more diabetes, renal insufficiency, aortic regurgitation and left ventricular hypertrophy. CA were more often smokers, had more ischemic heart disease, hyperlipidemia and higher median income levels. There were no racial differences in surgical risk utilizing logistic euroSCORES. Relative to CA, AA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) yet similar 1-year mortality (aHR 0.81, 95% CI 0.57-1.17, P = .262). There were no significant differences in reasons for AVR nonreceipt. CONCLUSIONS: We identified 143 African Americans (AA) and 968 Caucasian Americans(CA) with severe AS who met prespecified criteria for AVR.. AA relative to CA were more often women, had more diabetes, renal insufficiency, and left ventricular hypertrophy, however had less tobacco use, ischemic heart disease, hyperlipidemia and lower median income levels. Among patients with severe AS, AA relative to CA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) without significant differences in reasons for AVR nonreceipt and similar 1-year mortality.

Cardiovascular risk and outcomes in symptomatic patients with suspected coronary artery disease and non coronary vascular disease: A report from the PROMISE trial.

BACKGROUND: Non-coronary vascular disease (NCVD) is associated with adverse cardiovascular events. Little is known about physician risk assessment, prevalence of coronary artery disease (CAD), cardiac catheterization, and the performance of the atherosclerotic cardiovascular disease (ASCVD) risk score in patients with NCVD. METHODS: Retrospective analysis of outpatients with angina and no known CAD from the PROMISE trial. NCVD included carotid artery stenosis ≥50%, or history of stroke or peripheral artery disease. Multivariable models of physician estimates of the probability of obstructive CAD, prevalence of non-obstructive and obstructive CAD, referral to cardiac catheterization, and all-cause death/myocardial infarction/unstable angina were performed. RESULTS: Among 10,001 patients in the PROMISE trial, 379 (3.8%) patients had NCVD. Only 8.5% of participants with NCVD were categorized as high-risk for obstructive CAD by physicians, though 15.5% (25/161) had obstructive CAD in those randomized to coronary computed tomography (CTA). NCVD was independently associated with non-obstructive (aOR = 1.58; 95% CI 1.18-2.61; P = .006) but not obstructive CAD by CTA. Adjusted referral to cardiac catheterization was similar with and without NCVD (aOR 1.04; 95% CI 0.88-1.94, P = .19). NCVD was associated with an increased risk of all-cause death/MI/UA (aOR 2.03; 95% CI 1.37-3.01, P < .001). There was no interaction between NCVD status and ASCVD risk score. CONCLUSIONS: Among patients with NCVD and angina, NCVD had increased adjusted risks of CAD and adverse outcomes which were not well described by ASCVD risk score and were underrecognized by physicians. Increased awareness and better risk stratification tools for patients with NCVD may be necessary to recognize the associated CV risk and optimize diagnostic testing and therapies.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk.

Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Outcomes of transcatheter aortic valve replacement for patients with severe aortic stenosis and concomitant aortic insufficiency: Insights from the TVT Registry.

AIMS: Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group. METHODS AND RESULTS: Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001). CONCLUSIONS: Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit. SHORT ABSTRACT: In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001).

Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial.

BACKGROUND: Rates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events. METHODS: EUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. RESULTS: TIMI major bleeding occurred in 2.3% of participants overall (0.94 event/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and ß-blocker use. Patients with TIMI major bleeding postrandomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40-5.84; P < .0001) compared with those without major bleeding; the association was strongest within 30 days after a bleeding event. CONCLUSIONS: In patients with symptomatic PAD, 0.94 major bleeding event/100 patient-years was observed and associated with older age, residing in North America, disease severity, and ß-blocker use. Patients who had a major bleeding event were significantly more likely to experience MACE, especially within the first 30 days, when compared with patients who did not have major bleeding.