Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.

BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement.

[Figure: see text].

Impact of the COVID-19 pandemic on interventional cardiology training in the United States.

OBJECTIVES: We sought to determine the effect of COVID-19 related reduction in elective cardiac procedures and acute coronary syndrome presentations on interventional cardiology (IC) training. BACKGROUND: The COVID-19 pandemic has significantly disrupted healthcare in the United States, including cardiovascular services. The impact of COVID-19 on IC fellow training in the United States has not been assessed. METHODS: The Society for Cardiovascular Angiography and Interventions (SCAI) surveyed IC fellows training in both accredited and advanced non-accredited programs, as well as their program directors (PD). RESULTS: Responses were received from 135 IC fellows and 152 PD. All respondents noted reductions in procedural volumes beginning in March 2020. At that time, only 43% of IC fellows had performed >250 PCI. If restrictions were lifted by May 15, 2020 78% of IC fellows believed they would perform >250 PCI, but fell to only 70% if restrictions persisted until the end of the academic year. 49% of IC fellows felt that their procedural competency was impaired by COVID-19, while 97% of PD believed that IC fellows would be procedurally competent at the end of their training. Most IC fellows (65%) noted increased stress at work and at home, and many felt that job searches and/or existing offers were adversely affected by the pandemic. CONCLUSION: The COVID-19 pandemic has substantially affected IC training in the United States, with many fellows at risk of not satisfying current program procedural requirements. These observations support a move to review current IC program requirements and develop mitigation strategies to supplement gaps in education related to reduced procedural volume.

Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.

BACKGROUND: The number of patients treated for aortic valve disease in the United States is increasing rapidly. Transcatheter aortic valve replacement (TAVR) is supplanting surgical aortic valve replacement (SAVR) and medical therapy (MT). The economic implications of these trends are unknown. Therefore, we undertook to determine the costs, inpatient days, and number of admissions associated with treating aortic valve disease with SAVR, TAVR, or MT. METHODS: Using the Nationwide Readmissions Database, we identified patients with aortic valve disease admitted 2012 to 2016 for SAVR, TAVR, and disease symptoms (congestive heart failure, unstable angina, non-ST-elevation myocardial infarction, syncope). Patients not undergoing SAVR or TAVR were classified as receiving MT. Beginning with the index admission, we estimated inpatient costs, days, and admissions over 6 months. RESULTS: Among 190 563 patients with aortic valve disease, the average aggregate 6-month inpatient costs were $59 743 for SAVR, $64 395 for TAVR, and $23 460 for MT. Mean index admission was longer for SAVR (10.0 days) than for TAVR (7.0 day) or MT (5.3 days), but the average number of unplanned readmission inpatient days was 2.0 for SAVR, 3.0 for TAVR, and 4.3 for MT; the average number of total admissions was 1.3 for SAVR, 1.5 for TAVR, and 1.7 for MT (P<0.01 for all). TAVR index admission costs decreased over time to become similar to SAVR costs by 2016. CONCLUSIONS: Aggregate costs were higher for TAVR than SAVR and were significantly more expensive than MT alone. However, TAVR costs decreased over time while SAVR and MT costs remained unchanged.

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.

ACC/AATS/AHA/ASE/ASNC/HRS/SCAI/SCCT/SCMR/STS 2019 Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and the Society of Thoracic Surgeons.

This document is the second of 2 companion appropriate use criteria (AUC) documents developed by the American College of Cardiology, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. The first document1 addresses the evaluation and use of multimodality imaging in the diagnosis and management of valvular heart disease, whereas this document addresses this topic with regard to structural (nonvalvular) heart disease. While dealing with different subjects, the 2 documents do share a common structure and feature some clinical overlap. The goal of the companion AUC documents is to provide a comprehensive resource for multimodality imaging in the context of structural and valvular heart disease, encompassing multiple imaging modalities. Using standardized methodology, the clinical scenarios (indications) were developed by a diverse writing group to represent patient presentations encountered in everyday practice and included common applications and anticipated uses. Where appropriate, the scenarios were developed on the basis of the most current American College of Cardiology/American Heart Association Clinical Practice Guidelines. A separate, independent rating panel scored the 102 clinical scenarios in this document on a scale of 1 to 9. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented. Midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is considered rarely appropriate for the clinical scenario. The primary objective of the AUC is to provide a framework for the assessment of these scenarios by practices that will improve and standardize physician decision making. AUC publications reflect an ongoing effort by the American College of Cardiology to critically and systematically create, review, and categorize clinical situations in which diagnostic tests and procedures are utilized by physicians caring for patients with cardiovascular diseases. The process is based on the current understanding of the technical capabilities of the imaging modalities examined.

Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts.

OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Outcomes of Treatment of Nonagenarians With Severe Aortic Stenosis.

BACKGROUND: Because nonagenarians with aortic stenosis (AS) often present as frail with more comorbid conditions, long-term outcomes and quality of life are important treatment considerations. The aim of this report is to describe survival and functional outcomes of nonagenarians undergoing treatment for AS by surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: This is a retrospective analysis of all patients aged 90 years or more undergoing treatment for AS between 2007 and 2013 at two centers. Outcomes were compared between SAVR and TAVR. Long-term survival was compared with an age- and sex-matched population from the Social Security Actuarial Life Table. RESULTS: In all, 110 patients underwent treatment for isolated AS (20 SAVR and 90 TAVR). Mean age was 91.85 ± 1.80 years, and 50.9% were female. The Society of Thoracic Surgeons mean predicted risk of mortality was 11.11% ± 5.74%. Operative mortality was 10.9% (10.0% SAVR; 11.1% TAVR); 2.7% of patients had a stroke. The TAVR patients were more likely to be discharged home (75.9% versus 55.6% for SAVR, p = 0.032). Mean follow-up was 1.8 ± 1.5 years, with a 1-year and 5-year survival of 78.7% and 45.3%, respectively, which approximated the US actuarial survival. There was a significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire at 1 year compared with baseline. CONCLUSIONS: Treatment of AS approximates natural life expectancy in select nonagenarians, with no significant difference in long-term survival between SAVR and TAVR. Importantly, patient quality of life improved at 1 year. With appropriate selection, nonagenarians with severe AS can benefit from treatment.

Sex differences in response to treatments for chronic coronary artery disease.

More women than men die of coronary artery disease (CAD) each year. In women, cardiovascular disease can present atypically and may be caused by small vessel disease rather than by major epicardial coronary luminal narrowing. Women with CAD tend to have more diffuse disease, endothelial dysfunction, and microvascular disease than men. In those studies that have looked at sex differences in treatment response, sex-specific physiologic, pharmacokinetic, and pharmacodynamic differences appear to be the cause. Women have smaller hearts, higher heart rates, shorter cardiac cycle lengths, and longer QT intervals than men. CAD medical treatments such as antiplatelet agents, anticoagulants, beta-blockers, and antithrombin agents may have different effects in women and men. Only 30% of percutaneous coronary interventions are performed in women. Women are less likely than men to undergo diagnostic angiography and are more likely to experience delays in treatment.