Clinical Trial Perspective: Cost-effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients with Heart Failure and Secondary Mitral Regurgitation. Results From the COAPT Trial

Treatment of secondary (or functional) mitral regurgitation had traditionally been limited to optimal medical therapy because studies have failed to show a survival benefit with mitral valve surgery for this condition. However, recently the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial demonstrated a significant decrease in heart failure hospitalizations and mortality in patients with severe secondary mitral regurgitation treated with percutaneous edge-to-edge mitral valve repair (TMVr) using the MitraClip device compared with medical therapy. Based o the results of the COAPT trial, the Food and Drug Administration granted approval for MitraClip treatment of patients with severe secondary mitral regurgitation in March 2019. In an attempt to understand the economic impact of treating this patient population with TMVr using the MitraClip device, a formal cost-effectiveness analysis was performed alongside the COAPT trial. This review summarizes the methods and results of the economic substudy of the COAPT trial and discusses the value of the MitraClip device from the perspective of the US healthcare system in the treatment of patients with symptomatic heart failure and secondary mitral regurgitation

The Evolving Role of the Multidisciplinary Heart Team in Aortic Stenosis

Transcatheter aortic valve replacement has transformed the paradigm of care for patients with severe aortic stenosis (AS). With transcatheter aortic valve replacement now commercially approved for AS patients of all surgical risk, clinical decision-making regarding the initial mode of valve replacement (e.g. surgical versus transcatheter) and prosthesis type has become even more complex. The updated American College of Cardiology/American Heart Association and European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on valvular heart disease offer a strong foundation from which to address the nuances of the treatment of AS; however, there remain several clinical scenarios for which evidence and thus definitive societal recommendations are lacking. As such, the heart team continues to play an invaluable role in the management of the AS patient by combining available scientific evidence, expertise across disciplines, and the patient’s preferences to optimize individualized patient care and healthcare resource usage

Spoken Word Learning in Children With Developmental Language Disorder or Dyslexia

Purpose Word learning difficulties have been documented in multiple studies involving children with dyslexia and developmental language disorder (DLD; see also specific language impairment). However, no previous studies have directly contrasted word learning in these two frequently co-occurring disorders. We examined word learning in second-grade students with DLD-only and dyslexia-only as compared to each other, peers with both disorders (DLD + dyslexia), and peers with typical development. We hypothesized that children with dyslexia-only and DLD-only would show differences in word learning due to differences in their core language strengths and weaknesses. Method Children ( = 244) were taught eight novel pseudowords paired with unfamiliar objects. The teaching script included multiple exposures to the phonological form, the pictured object, a verbal semantic description of the object, and spaced retrieval practice opportunities. Word learning was assessed immediately after instruction with tasks requiring recall or recognition of the phonological and semantic information. Results Children with dyslexia-only performed significantly better on existing vocabulary measures than their peers with DLD-only. On experimental word learning measures, children in the dyslexia-only and DLD + dyslexia groups showed significantly poorer performance than typically developing children on all word learning tasks. Children with DLD-only differed significantly from the TD group on a single word learning task assessing verbal semantic recall. Conclusions Overall, results indicated that children with dyslexia display broad word learning difficulties extending beyond the phonological domain; however, this contrasted with their relatively strong performance on measures of existing vocabulary knowledge. More research is needed to understand relations between word learning abilities and overall vocabulary knowledge and how to close vocabulary gaps for children with both disorders. Supplemental Material https://doi.org/10.23641/asha.14832717

A cross-sectional study of determinants of indoor environmental exposures in households with and without chronic exposure to biomass fuel smoke

BACKGROUND: Burning biomass fuels indoors for cooking is associated with high concentrations of particulate matter (PM) and carbon monoxide (CO). More efficient biomass-burning stoves and chimneys for ventilation have been proposed as solutions to reduce indoor pollution. We sought to quantify indoor PM and CO exposures in urban and rural households and determine factors associated with higher exposures. A secondary objective was to identify chronic vs. acute changes in cardiopulmonary biomarkers associated with exposure to biomass smoke. METHODS: We conducted a census survey followed by a cross-sectional study of indoor environmental exposures and cardiopulmonary biomarkers in the main household cook in Puno, Peru. We measured 24-hour indoor PM and CO concentrations in 86 households. We also measured PM(2.5) and PM(10) concentrations gravimetrically for 24 hours in urban households and during cook times in rural households, and generated a calibration equation using PM(2.5) measurements. RESULTS: In a census of 4903 households, 93% vs. 16% of rural vs. urban households used an open-fire stove; 22% of rural households had a homemade chimney; and <3% of rural households participated in a national program encouraging installation of a chimney. Median 24-hour indoor PM(2.5) and CO concentrations were 130 vs. 22 μg/m(3) and 5.8 vs. 0.4 ppm (all p<0.001) in rural vs. urban households. Having a chimney did not significantly reduce median concentrations in 24-hour indoor PM(2.5) (119 vs. 137 μg/m(3); p=0.40) or CO (4.6 vs. 7.2 ppm; p=0.23) among rural households with and without chimneys. Having a chimney did not significantly reduce median cook-time PM(2.5) (360 vs. 298 μg/m(3), p=0.45) or cook-time CO concentrations (15.2 vs. 9.4 ppm, p=0.23). Having a thatched roof (p=0.007) and hours spent cooking (p=0.02) were associated with higher 24-hour average PM concentrations. Rural participants had higher median exhaled CO (10 vs. 6 ppm; p=0.01) and exhaled carboxyhemoglobin (1.6% vs. 1.0%; p=0.04) than urban participants. CONCLUSIONS: Indoor air concentrations associated with biomass smoke were six-fold greater in rural vs. urban households. Having a homemade chimney did not reduce environmental exposures significantly. Measures of exhaled CO provide useful cardiopulmonary biomarkers for chronic exposure to biomass smoke

Clinical Research on Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Disease: Principles, Challenges, and an Agenda for the Future.

Bicuspid aortic valve disease (BAVD) is present in up to half of all patients referred for surgical aortic valve replacement (SAVR) yet was an exclusion criterion for all randomized controlled trials (RCTs) comparing transcatheter aortic valve replacement (TAVR) to SAVR. Nonetheless, approximately 10% of patients currently treated with TAVR have BAVD and available observational data for performing TAVR in these patients are limited by selection bias. Many in the cardiovascular community have advocated for RCTs in this population, but none have been performed. The Heart Valve Collaboratory (HVC) is a multidisciplinary community of stakeholders with the aim of creating significant advances in valvular heart disease by stimulating clinical research, engaging in educational activities, and advancing regulatory science. In December 2020, the HVC hosted a Global Multidisciplinary workshop involving over 100 international experts in the field. Following this 2-day symposium, working groups with varied expertise were convened to discuss BAVD, including the need for and design of RCTs. This review, conducted under the auspices of the HVC, summarizes available data and knowledge gaps regarding procedural therapy for BAVD, outlining specific challenges for trials in this population. We also propose several potential studies that could be performed and discuss respective strengths and weaknesses of each approach. Finally, we present a roadmap for future directions in clinical research in TAVR for BAVD with an emphasis both on RCTs and also prospective registries focused on disease phenotyping to develop parameters and risk scores that could ultimately be applied to patients to inform clinical decision-making

CRT-700.05 Impella Utilization in High-Risk Percutaneous Coronary Intervention Mitigates the Risks of Procedural and Clinical Adverse Events Independent of Left Ventricular Ejection Fraction: The Protect III Study

Background: Left ventricular (LV) dysfunction is associated with an increased risk of adverse events in patients undergoing percutaneous coronary intervention (PCI). However, the impact of LV ejection fraction (LVEF) on the outcomes of Impella-supported high-risk PCI (HRPCI) is unknown. Methods: Patients enrolled in the prospective, multicenter, and observational PROTECT III study from March 2017 to March 2020 who underwent Impella-supported HRPCI at the operator’s discretion (non-cardiogenic shock). Patients were divided into three tertiles (T) based on baseline LVEF: T1 (the lowest), T2, and T3 (the highest). The primary outcome is the rate of 90-day major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeated revascularization as adjudicated by an independent CEC. Results: Of 1237 patients, 940 with available baseline LVEF were analyzed. T1 included 353 patients (mean LVEF 19.6±4.7), T2 included 274 patients (mean LVEF 32.2±3.5), and T3 included 313 patients (mean LVEF 52.6±9.2). Patients in the higher tertiles were older, more likely to be females, presented more with acute coronary syndrome, and had more frequent left main disease. Also, severely calcified lesions and atherectomy utilization were more frequent in the higher tertiles. The rates of 90-day MACCE were comparable across all tertiles. Furthermore, PCI-related complications and 1-year mortality were also comparable (Table). After multivariable adjustment, 90-day MACCE was not significantly different between the LVEF tertiles (p=0.32). Conclusion: In patients with HRPCI supported by Impella, the rates of in-hospital adverse events, PCI-related complications, 90-day MACCE, and 1-year mortality were comparable among the different LVEF tertiles

TCT-545 Angiographic Features, Lesion, and Procedural Characteristics in Patients With Chronic Kidney Disease Undergoing Protected High-Risk Percutaneous Coronary Intervention

Background: Patients with chronic kidney disease (CKD) are at risk for accelerated atherosclerosis. There is a paucity of data regarding coronary lesion characteristics and procedural details of CKD patients, especially those on dialysis, undergoing high-risk percutaneous coronary intervention (HRPCI) with left ventricular support. Methods: We analyzed patients from the PROTECT III study who underwent Impella-supported HRPCI, stratified into 3 groups according to kidney function status based on history: 1) normal kidney function; 2) CKD not on dialysis; and 3) CKD on dialysis. Baseline characteristics, angiographic features, and procedural details were assessed. Results: The study population included 3,702 treated lesions in 1,223 patients with a mean age of 71 ± 11 years; 73% (893) were male, 68% (834) had normal kidney function (serum creatinine = 1 mg/dL [IQR: 0.9-1.2]), 23% (278) had CKD not on dialysis (serum creatinine = 1.6 mg/dL [IQR: 1.3-1.9]), and 9% (111) were on dialysis. Patients on dialysis were significantly younger and had more comorbidities, as well as a greater incidence of acute myocardial infarction as an indication for HRPCI compared with the other 2 groups (45.0 [dialysis] vs 30.1 [CKD not on dialysis] vs 36.0 [normal kidney function]; P = 0.03). There was no difference between groups in prevalence of 3-vessel disease (P = 0.63). Patients on dialysis had greater prevalence of severely calcified lesions and higher use of rotational and orbital atherectomy with greater number of passes (Table 1). Despite this, no significant differences were observed in post-PCI Thrombolysis In Myocardial Infarction flow, incidence of no-reflow, or dissection/perforation. Conclusion: In contrast to patients with normal kidney function, patients with CKD with or without dialysis treated with Impella had more comorbidities, higher prevalence of severely calcified lesions, and greater use of atherectomy with more passes. Despite the complexity of PCI, no significant differences in complications were observed. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-99 Short- and Long-Term Outcomes of Patients With Chronic Kidney Disease Undergoing Protected High-Risk Percutaneous Coronary Intervention

Background: Patients with chronic kidney disease (CKD) and concomitant multivessel coronary artery disease (CAD) with or without left ventricular dysfunction often have high surgical risk and are declined for coronary artery bypass grafting. There is little data regarding clinical outcomes in these patients undergoing high-risk PCI (HRPCI) using Impella. Methods: We analyzed patients from the PROTECT III Study who underwent Impella-supported HRPCI and stratified them into 3 groups by kidney function status based on history: 1) normal kidney function, 2) CKD without dialysis, and 3) CKD with dialysis. We compared the composite incidence of major adverse cardiac and cerebrovascular events (MACCE) rate, defined as all-cause death, myocardial infarction (MI), stroke/transient ischemic attack (TIA), and repeat revascularization at 30 and 90 days. Results: We included 1,223 patients, aged 71 ± 11 years; 73% (893) were men, 68% (834) had normal kidney function (serum creatinine [Cr] 1.1 mg/dL, IQR 0.9-1.2), 23% (278) had CKD without dialysis (Cr 1.7 mg/dL, IQR 1.3-1.9), and 9% (111) were on dialysis. Patients on dialysis were younger with more comorbidities such as diabetes, heart failure, anemia, PVD and prior stroke. HRPCI status (urgent or elective), proportion of acute MI, and mean SYNTAX scores were similar. No significant differences in MACCE were shown between groups at 30 days or 90 days (Table). Patients with normal kidney function had comparable risks of 30-day and 90-day MACCE compared with CKD patients without dialysis with Cox proportional hazards analysis, and lower risk of 90-day MACCE compared to CKD patients with dialysis. Notably, CKD patients with or without dialysis also had similar 90-day MACCE risk (Table). Conclusion: Patients with CKD and dialysis undergoing HRPCI exhibit higher risk for 90-day MACCE compared to patients with normal kidney function. CKD patients without dialysis also had higher risk of MI at 90 days. Further research is needed. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

Clinical Research on Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Disease: Principles, Challenges, and an Agenda for the Future

Bicuspid aortic valve disease (BAVD) is present in up to half of all patients referred for surgical aortic valve replacement (SAVR) yet was an exclusion criterion for all randomized controlled trials (RCTs) comparing transcatheter aortic valve replacement (TAVR) to SAVR. Nonetheless, approximately 10% of patients currently treated with TAVR have BAVD and available observational data for performing TAVR in these patients are limited by selection bias. Many in the cardiovascular community have advocated for RCTs in this population, but none have been performed. The Heart Valve Collaboratory (HVC) is a multidisciplinary community of stakeholders with the aim of creating significant advances in valvular heart disease by stimulating clinical research, engaging in educational activities, and advancing regulatory science. In December 2020, the HVC hosted a Global Multidisciplinary workshop involving over 100 international experts in the field. Following this 2-day symposium, working groups with varied expertise were convened to discuss BAVD, including the need for and design of RCTs. This review, conducted under the auspices of the HVC, summarizes available data and knowledge gaps regarding procedural therapy for BAVD, outlining specific challenges for trials in this population. We also propose several potential studies that could be performed and discuss respective strengths and weaknesses of each approach. Finally, we present a roadmap for future directions in clinical research in TAVR for BAVD with an emphasis both on RCTs and also prospective registries focused on disease phenotyping to develop parameters and risk scores that could ultimately be applied to patients to inform clinical decision-making