Gaps in guideline-recommended anticoagulation in patients with atrial fibrillation and elevated thromboembolic risk within an integrated healthcare delivery system.

BACKGROUND: Atrial Fibrillation (AF) is the leading cause of stroke, which can be reduced by 70% with appropriate oral anticoagulation (OAC) therapy. Nationally, appropriate anticoagulation rates for patients with AF with elevated thromboembolic risk are as low as 50% even across the highest stroke risk cohorts. This study aims to evaluate the variability of appropriate anticoagulation rates among patients by sex, ethnicity, and socioeconomic status within the Kaiser Permanente Mid-Atlantic States (KPMAS). METHODS: This retrospective study investigated 9513 patients in KPMAS's AF registry with CHADS2 score ≥ 2 over a 6-month period in 2021. RESULTS: Appropriately anticoagulated patients had higher rates of diabetes, prior stroke, and congestive heart failure than patients who were not appropriately anticoagulated. There were no significant differences in anticoagulation rates between males and females (71.8% vs. 71.6%%, [OR] 1.01; 95% CI, 0.93-1.11; P = .76) nor by SES-SVI quartiles. There was a statistically significant difference between Black and White patients (70.8% vs. 73.1%, P = .03) and Asian and White patients (68.3% vs. 71.6%, P = .005). After adjusting for CHADS2, this difference persisted for Black and White participants with CHADS2 scores of ≤3 (62.6% vs. 70.6%, P < .001) and for Asian and White participants with CHADS2 scores > 5 (68.0% vs. 79.3%, P < .001). CONCLUSIONS: Black and Asian patients may have differing rates of appropriate anticoagulation when compared with White patients. Characterizing such disparities is the first step towards addressing treatment gaps in AF.

Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II).

BACKGROUND: A randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study. STUDY DESIGN AND OBJECTIVES: REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial pressures. Up to 608 HF patients age ≥ 40 years with LVEF ≥40%, PCWP ≥25 mm Hg during supine ergometer exercise, and PCWP ≥5 mm Hg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent) HF hospitalizations or healthcare facility visits for intravenous diuretics up to 24 months, analyzed when the last randomized patient completes 12 months of follow-up; and (3) change in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline to 12 months. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure. CONCLUSIONS: REDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40%.

Tricuspid Regurgitation: Disease State and Advances in Percutaneous Therapy.

Tricuspid regurgitation (TR) is a relatively common finding. There has been growing recognition of the morbidity and adverse prognosis of severe TR, which affects 1.6 million people in the US. However, symptomatic TR remains undertreated despite emerging therapeutic modalities. In this review, the pathophysiological and epidemiological features of TR are examined and the diagnosis, natural history, and clinical presentation are discussed. An overview of TR therapy is provided, including medical and surgical treatments, as well as novel percutaneous approaches. The currently available studies on percutaneous therapy demonstrate promise for transcatheter valve repair and replacement with favourable clinical outcomes and short-term durability. However, further study is needed.

Sequential transcatheter aortic and pulmonic valve replacement in bioprosthetic valve dysfunction: a case report.

Background: Transcatheter valve replacement is a less invasive alternative to surgical valve replacement and has become increasingly popular. It is often the preferred approach for patients with high surgical risk. In patients with multiple prior sternotomies and multi-valvular failure, sequential transcatheter valve replacements may be a viable option. Case summary: We present the case of a 61-year-old-man with two prior sternotomies who underwent sequential transcatheter replacements of the aortic and pulmonic valves for symptomatic aortic and pulmonary stenosis. He was deemed high risk for a repeat sternotomy. The decision to perform sequential transcatheter aortic valve replacement (TAVR) and transcatheter pulmonic valve replacement (TPVR) a month apart was made. Patient underwent valve-in-valve TAVR in a stentless bioprosthetic valve with 29-mm Edwards Sapien 3 followed by TPVR with 26-mm Edwards Sapien 3. He tolerated both procedures well and was asymptomatic at 1-month follow up. Discussion: To our knowledge, this is the first reported successful case of sequential TAVR and TPVR with right ventricular outflow tract stenting in a patient with both aortic and pulmonic bioprosthetic valve dysfunction. Our case demonstrates that transcatheter approach to multi-valvular replacements may be a viable option for high-risk surgical patients.

Factors that predict compliance in a virtual cardiac rehabilitation program.

BACKGROUND: Despite the well-established benefits of cardiac rehabilitation (CR) for patients with cardiovascular disease (CVD), participation in CR remain low. Virtual CR programs present a unique opportunity to promote utilization. To date, few virtual CR cohorts have been analyzed for compliance. This study aims to determine factors that predict compliance within a large virtual CR program in the United States. METHODS: We analyzed 1409 patients enrolled in the Kaiser Permanente Mid-Atlantic States Virtual CR program that consists of 12 CR sessions via telephone. Demographic characteristics, as well as body weight, blood pressure, HbA1c level, and smoking status were collected at admission. Patients were further classified by CVD diagnosis codes. Compliance was defined as at least 75% (9/12 sessions) attendance. Data was analyzed using simple and multiple regression models with significance defined as P < 0.05. RESULTS: Age was the single strongest predictor for virtual CR compliance (adjusted R2 = 0.58; P < 0.001), and non-compliant patients were younger. HbA1C level, CVD diagnosis codes, and smoking status each moderately predicted compliance (adjusted R2 = 0.48, 0.42, and 0.31, respectively; P < 0.001). Smoking and HbA1C level combined in a multiple regression model significantly improved prediction of compliance (adjusted R2 = 0.79, P < 0.01). Sex, baseline weight or hypertension were not significant predictors of CR compliance. CONCLUSIONS: Age, diabetes, CVD diagnoses, smoking status at admission are independent predictors of compliance in a large virtual CR program. Targeted intervention could be designed accordingly to improve CR compliance.

Temporal trends in the prevalence and severity of aortic stenosis within a contemporary and diverse community-based cohort.

BACKGROUND: Data on the epidemiology of aortic stenosis (AS) are primarily derived from single center experiences and administrative claims data that do not delineate by degree of disease severity. METHODS: An observational cohort study of adults with echocardiographic AS was conducted January 1st, 2013-December 31st, 2019 at an integrated health system. The presence/grade of AS was based on physician interpretation of echocardiograms. RESULTS: A total of 66,992 echocardiogram reports for 37,228 individuals were identified. The mean ± standard deviation (SD) age was 77.5 ± 10.5, 50.5% (N = 18,816) were women, and 67.2% (N = 25,016) were non-Hispanic whites. The age-standardized AS prevalence increased from 589 (95% Confidence Interval [CI] 580-598) to 754 (95% CI 744-764) cases per 100,000 during the study period. The age-standardized AS prevalences were similar in magnitude among non-Hispanic whites (820, 95% CI 806-834), non-Hispanic blacks (728, 95% CI 687-769), and Hispanics (789, 95% CI 759-819) and substantially lower for Asian/Pacific Islanders (511, 95% CI 489-533). Finally, the distribution of AS by degree of severity remained relatively unchanged over time. CONCLUSIONS AND RELEVANCE: The population prevalence of AS has grown considerably over a short timeframe although the distribution of AS severity has remained stable.

Cardiomyocyte death: insights from molecular and microstructural magnetic resonance imaging.

Cardiomyocytes can die via necrosis, apoptosis, and autophagy. Although the molecular signals and pathways underlying these processes have been well elucidated, the pathophysiology of cardiomyocyte death remains incompletely understood. This review describes the development and application of novel imaging techniques to detect and characterize cardiomyocyte death noninvasively in vivo. It focuses on molecular and microstructural magnetic resonance images (MRIs) and their respective abilities to image cellular events such as apoptosis, inflammation, and myofiber architecture. These in vivo imaging techniques have the potential to provide novel insights into the mechanisms of cardiomyocyte death and to help guide the development of novel cardioprotective therapies.

Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial.

BACKGROUND: The REDUAL PCI trial (Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting) demonstrated that, in patients with atrial fibrillation following percutaneous coronary intervention, bleeding risk was lower with dabigatran plus clopidogrel or ticagrelor (dual therapy) than warfarin plus clopidogrel or ticagrelor and aspirin (triple therapy). Dual therapy was noninferior for risk of thromboembolic events. Whether these results apply equally to patients at higher risk of ischemic events due to lesion complexity or clinical risk factors is unclear. METHODS: The primary end point was time to first major or clinically relevant nonmajor bleeding event. The composite efficacy end point was death, thromboembolic event, or unplanned revascularization. Our prespecified subgroup analysis categorized patients by presence of procedural complexity and/or clinical complexity factors at baseline. A modified dual antiplatelet therapy score categorized patients according to degree of clinical risk. RESULTS: Of 2725 patients, 43.1% had clinical complexity factors alone, 9.9% procedural factors alone, 10.0% both, and 37.0% neither. Risk of the primary bleeding end point was lower in both dabigatran dual therapy groups than warfarin triple therapy groups, regardless of procedural and/or clinical lesion complexity (interaction P values: 0.90 and 0.37, respectively). Importantly, a similar risk of the efficacy end point was observed between dabigatran dual and warfarin triple therapy, regardless of the presence of clinical or procedural complexity factors (interaction P values: 0.67 and 0.54, dabigatran 110 and 150 mg dual therapy, respectively). Similar benefit was seen for each dose of dabigatran dual therapy for bleeding events regardless of dual antiplatelet therapy score (interaction P values: 0.53 and 0.54, respectively), with similar risk of thromboembolic events (interaction P values: 0.20 and 0.08, respectively). CONCLUSIONS: In patients with atrial fibrillation undergoing percutaneous coronary intervention, dabigatran 110 and 150 mg dual therapy reduced bleeding risk compared with warfarin triple therapy, with a similar risk of thromboembolic outcomes, irrespective of procedural and/or clinical complexity and modified dual antiplatelet therapy score. Registration: URL: https://clinicaltrials.gov/; Unique identifier: NCT02164864.

Utility of 90-Day Mortality vs 30-Day Mortality as a Quality Metric for Transcatheter and Surgical Aortic Valve Replacement Outcomes.

Importance: Questions have recently arisen as to whether 30-day mortality is a reasonable metric for understanding institutional practice differences after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Objective: To examine the utility of 30-day vs 90-day mortality after TAVR and SAVR as a mortality quality metric. Design, Setting, and Participants: This nationally representative, multicenter, cohort study analyzed data from Medicare beneficiaries undergoing TAVR and SAVR procedures from January 1, 2012, to December 31, 2015. Concomitant coronary artery bypass grafting and other heart valve or other major open-heart procedures were excluded. Hospitals that performed fewer than 50 TAVR or 70 SAVR procedures per year were excluded to ensure reliable estimates and to reduce the risks of inflated results because of small institutional sample sizes. Data were analyzed from October 2018 to August 2019. Exposures: Hospitals were ranked into top- (10%), middle- (80%), and bottom-performing (10%) groups based on their 4-year mean 30-day mortality. Main Outcomes and Measures: Changes in hospital performance rankings at 90 days and 1 year and correlation of 30- and 90-day mortality with 1-year mortality were examined. Results: A total of 30 329 TAVR admissions at 184 hospitals and 26 021 SAVR admissions at 191 hospitals were evaluated. For TAVR, 40 hospitals (21.7%) changed performance rankings at 90 days: 13 (48.1%) in the top-performing group and 8 (29.6%) in the bottom-performing group. At 1 year, 56 hospitals (30.4%), which included 21 (77.8%) in the top-performing group and 12 (44.4%) in the bottom-performing group, changed rankings. Similar findings were observed for SAVR, with an overall 90-day conversion rate of 17.3% and a 1-year rate of 30.3%. These findings persisted after adjusting for the differences in patient risk profiles among the 3 groups. Capturing 90-day events was also more robustly informative regarding expected 1-year outcomes after both TAVR and SAVR, largely owing to the observed plateau in the instantaneous hazard observed beyond this point. Conclusions and Relevance: The findings suggest that evaluation of hospital performance based on 30-day mortality may underestimate outcomes and therefore substantially misrepresent institutional performance after TAVR and SAVR compared with 90-day mortality, even after risk adjustment. Although 30-day mortality has been validated, 90-day mortality may be a more reliable outcome metric for measuring hospital performance and capturing procedure-related mortality.

Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes.

OBJECTIVES: The aim of this study was to examine whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes. BACKGROUND: Recent studies have demonstrated a volume-outcome relationship for TAVR. METHODS: In total, 208,400 fee-for-service Medicare beneficiaries were analyzed for all aortic valve replacement procedures from 2012 to 2015. Claims for patients <65 years of age, concomitant coronary artery bypass grafting surgery, other heart valve procedures, or other major open heart procedures were excluded, as were secondary admissions for aortic valve replacement. Hospital SAVR volumes were stratified on the basis of mean annual SAVR procedures during the study period. The primary outcomes were 30-day and 1-year post-operative TAVR survival. Adjusted survival following TAVR was assessed using multivariate Cox regression. RESULTS: A total of 65,757 SAVR and 42,967 TAVR admissions were evaluated. Among TAVR procedures, 21.7% (n = 9,324) were performed at hospitals with <100 (group 1), 35.6% (n = 15,298) at centers with 100 to 199 (group 2), 22.9% (n = 9,828) at centers with 200 to 299 (group 3), and 19.8% (n = 8,517) at hospitals with ≥300 SAVR cases/year (group 4). Compared with group 4, 30-day TAVR mortality risk-adjusted odds ratios were 1.32 (95% confidence interval: 1.18 to 1.47) for group 1, 1.25 (95% confidence interval: 1.12 to 1.39) for group 2, and 1.08 (95% confidence interval: 0.82 to 1.25) for group 3. These adjusted survival differences in TAVR outcomes persisted at 1 year post-procedure. CONCLUSIONS: Total hospital SAVR volume appears to be correlated with TAVR outcomes, with higher 30-day and 1-year mortality observed at low-volume centers. These data support the importance of a viable surgical program within the heart team, and the use of minimum SAVR hospital thresholds may be considered as an additional metric for TAVR performance.

Comparison of Sex-Based Differences in Home or Nonhome Discharge Utilization of Rehabilitative Services and Outcomes Following Transcatheter Aortic Valve Implantation in the United States.

Sex-based differences in outcomes have been shown to affect caregiving in medical disciplines. Increased spending due to postacute care transfer policies has led hospitals to further scrutinize patient outcomes and disposition patterns after inpatient admissions. We examined sex-based differences in rehabilitative service utilization after transcatheter aortic valve implantation (TAVI). We queried all TAVI discharges in the National Inpatient Sample database from 2012 to 2014 (n = 40,900). Thirteen thousand eight hundred fifteen patients were discharged to home and 12,175 patients were discharged to rehabilitation facility; those not discharged routinely or to a rehabilitation facility were excluded. Patients with nonhome discharges were older (83.3 vs 79.0 years) and female (58.3% vs 37.7%) with a greater number of chronic conditions (9.91 vs 9.03) and number of Elixhauser co-morbidities (6.5 vs 5.8, all p < 0.05). Nonhome discharge patients also had a significantly longer length of stay (LOS) (11.3 days vs 5.3 days) and higher hospitalization costs ($66,246 vs $48,710, all p < 0.001) compared to home-discharged patients. Overall in-hospital mortality for female patients who underwent TAVI was higher compared to males (4.6% vs 3.6%, p < 0.05). On multivariable logistic regression, female sex was an independent predictor for disposition to rehabilitation facilities after TAVI (odds ratio 2.17; 95% confidence interval: 1.88 to 2.50; p < 0.001). Other independent predictors for females discharged to rehabilitation included the presence of rheumatoid arthritis and collagen vascular disease, body mass index greater than 30 kg/m2, depression, and sum of Elixhauser co-morbidities (all p < 0.001). In conclusion, nonhome discharge TAVI patients added LOS and hospital costs compared to home discharge TAVI patients, and female sex was one of the major predictors despite the lower co-morbidities.

Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women.

BACKGROUND: Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS: Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.

Protocol for exercise hemodynamic assessment: performing an invasive cardiopulmonary exercise test in clinical practice.

Invasive cardiopulmonary exercise testing (iCPET) combines full central hemodynamic assessment with continuous measurements of pulmonary gas exchange and ventilation to help in understanding the pathophysiology underpinning unexplained exertional intolerance. There is increasing evidence to support the use of iCPET as a key methodology for diagnosing heart failure with preserved ejection fraction and exercise-induced pulmonary hypertension as occult causes of exercise limitation, but there is little information available outlining the methodology to use this diagnostic test in clinical practice. To bridge this knowledge gap, the operational protocol for iCPET at our institution is discussed in detail. In turn, a standardized iCPET protocol may provide a common framework to describe the evolving understanding of mechanism(s) that limit exercise capacity and to facilitate research efforts to define novel treatments in these patients.