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1.
Clin Transplant ; : e14266, 2021 Feb 22.
Artigo em Inglês | MEDLINE | ID: mdl-33615562

RESUMO

BACKGROUND: Adults with congenital heart disease (CHD) awaiting heart transplant (HT) have higher mortality and waitlist removal due to clinical deterioration than those without CHD. The selective use of non-lung donors (NLD) to recover donor pulmonary vasculature to assist in graft implantation may be a contributing factor, and is supported by consensus statements despite the recent use of pericardium or graft material as an alternative in pulmonary vascular reconstruction. The impact of selecting NLD for CHD recipients on wait time and mortality has not been evaluated. METHODS/RESULTS: In the United Network for Organ Sharing (UNOS) Registry, 1271 HT recipients age ≥18 with CHD were identified between 1987-2016, 68% of which had NLDs. Prior to HT, NLD recipients were significantly less likely to be listed UNOS Status 1A, require mechanical ventilation, or intra-aortic balloon pump support. There was no difference in mean waitlist time (254 vs. 278 days, p=0.31), 1-year mortality (82% vs. 80%, p=0.81; adjusted odds ratio 1.32, 95% confidence interval [CI] 0.96-1.83, p=0.08), or overall mortality (adjusted hazard ratio 1.08, 95% CI 0.86-1.36, p=0.48) between recipients from NLD and concomitant lung donors. CONCLUSIONS: Adult CHD patients who are less critically ill or listed at a lower status are more likely to receive HT from NLD. There is no overall mortality benefit associated with this practice. While specific cases may necessitate waiting for NLD, programs need to re-evaluate whether this should remain a more widespread practice among CHD patients.

2.
Circ Heart Fail ; 14(2): e007759, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33530705

RESUMO

BACKGROUND: A growing population of patients with end-stage heart failure (HF) with reduced ejection fraction has limited treatment options to improve their quality and quantity of life. Although positive inotropes have failed to show survival benefit, these agents may enhance patient-reported health status, that is, symptoms, functional status, and health-related quality of life. We sought to review the available clinical trial data on positive inotrope use in patients with end-stage HF and to summarize evidence supporting the use of these agents to improve health status of patients with end-stage HF. METHODS: A literature review of randomized controlled trials examining the use of positive inotropy in HF with reduced ejection fraction was conducted. We searched MEDLINE, SCOPUS, and Web of Science between January 1980 to December 2018 for randomized controlled trials that used as their main outcome measures the effects of inotrope therapy on (1) morbidity/mortality, (2) symptoms, (3) functional status, or (4) health-related quality of life. Inotropes of interest included adrenergic agents, phosphodiesterase inhibitors, calcium sensitizers, myosin activators, and SERCA2a (sarcoplasmic reticulum Ca2+-ATPase) modulators. RESULTS: Twenty-two out of 26 inotrope randomized controlled trials measured the effect of inotropes on at least one patient-reported health status domain. Among the 22 studies with patient-related health status outcomes, 11 (50%) gauged symptom response, 15 (68%) reported functional capacity changes, and 12 (54%) reported health-related quality of life measures. Fourteen (64%) of these trials noted positive outcomes in at least one health status domain measured; 11 (79%) of these positive studies used agents that worked through phosphodiesterase inhibition. CONCLUSIONS: There has been a lack of standardization surrounding measurement of patient-centered outcomes in studies of inotropes for end-stage HF with reduced ejection fraction. The degree to which positive inotropes can improve patient-reported health status and the adverse risk they pose remains unknown.

3.
Am Heart J ; 2021 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-33596412

RESUMO

The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy was being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This paper describes the revised trial and the scientific rationale for the specific changes in the protocol.

4.
JAMA Cardiol ; 2021 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-33533873

RESUMO

Importance: Transcatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT) reduced heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM) in symptomatic patients with HF and secondary mitral regurgitation (SMR) compared with GDMT alone in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial but not in a similar trial, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR), possibly because the degree of SMR relative to the left ventricular end-diastolic volume index (LVEDVi) was substantially lower. Objective: To explore contributions of the degree of SMR using the effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr in the COAPT trial. Design, Setting, and Participants: This post hoc secondary analysis of the COAPT randomized clinical trial performed December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n = 56) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n = 492) using the end point of ACM or HFH at 24 months, components of the primary end point, and quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD). The same end points were evaluated in 6 subgroups of COAPT by combinations of EROA and LVEDVi and of RV relative to LVEDVi. Interventions: Interventions were TMVr plus GDMT vs GDMT alone. Results: A total of 548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included. In group 1, no significant difference was found in the composite rate of ACM or HFH between TMVr plus GDMT vs GDMT alone at 24 months (27.8% vs 33.1%, P = .83) compared with a significant difference at 24 months (31.5% vs 50.2%, P < .001) in group 2. However, patients randomized to receive TMVr vs those treated with GDMT alone had significantly greater improvement in QOL at 12 months (mean [SD] Kansas City Cardiomyopathy Questionnaire summary scores: group 1: 18.36 [5.38] vs 0.43 [4.00] points; P = .01; group 2: 16.54 [1.57] vs 5.78 [1.82] points; P < .001). Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months (mean [SD] paired improvement: 39.0 [28.6] vs -48.0 [18.6] m; P = .02). Group 2 TMVr-randomized patients vs those treated with GDMT alone tended to have greater improvement in 6MWD at 12 months, but the difference did not reach statistical significance (mean [SD] paired improvement: 35.0 [7.7] vs 16.0 [9.1] m; P = .11). Conclusions and Relevance: A small subgroup of COAPT-resembling patients enrolled in MITRA-FR did not achieve improvement in ACM or HFH at 24 months but had a significant benefit on patient-centered outcomes (eg, QOL and 6MWD). Further subgroup analyses with 24-month follow-up suggest that the benefit of TMVr is not fully supported by the proportionate-disproportionate hypothesis. Trial Registration: ClinicalTrials.gov Identifier: NCT01626079.

5.
Eur J Heart Fail ; 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-33590579

RESUMO

Left Ventricular ejection time (LVET) is defined as the time interval from aortic valve opening to aortic valve closure, and is the phase of systole during which the left ventricle ejects blood into the aorta. LVET has been used for several decades to assess left ventricular function and contractility. However, there is a recent interest in LVET as a measure of therapeutic action for novel drugs in patients with heart failure with reduced ejection fraction (HFrEF), since LVET is shortened in these patients. This review provides an overview of the available information on LVET including methods of measuring LVET, mechanistic understanding of LVET, association of LVET with outcomes, mechanisms behind shortened LVET in HFrEF and the potential implications of drugs that affect and normalize LVET.

6.
J Card Fail ; 27(2): 159-167, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33388467

RESUMO

BACKGROUND: Peripartum cardiomyopathy (PPCM) causes significant morbidity and mortality in childbearing women. Delays in diagnosis lead to worse outcomes; however, no validated risk prediction model exists. We sought to validate a previously described model and identify novel risk factors for PPCM presenting at the time of delivery. METHODS AND RESULTS: Administrative hospital records from 5,277,932 patients from 8 states were screened for PPCM, identified by International Classification of Disease-9 Clinical Modification codes (674.5x) at the time of delivery. Demographics, comorbidities, procedures, and outcomes were quantified. Performance of a previously published regression model alone and with the addition of novel PPCM-associated characteristics was assessed using receiver operating characteristic area under the curve (AUC) analysis. Novel risk factors were identified using multivariate logistic regression and the likelihood ratio test. In total, 1186 women with PPCM were studied, including 535 of 4,003,912 delivering mothers (0.013%) in the derivation set compared with 651 of 5,277,932 (0.012%) in the validation set. The previously published risk prediction model performed well in both the derivation (area under the curve 0.822) and validation datasets (area under the curve 0.802). Novel PPCM-associated characteristics in the combined cohort included diabetes mellitus (odds ratio [OR] of PPCM 1.93, 95% confidence interval [CI] 1.23-3.02, P = .004), mood disorders (OR 1.74, 95% CI 1.22-2.47, P = .002), obesity (OR 1.92, 95% CI 1.45-2.55, P < .001), and Medicaid insurance (OR 1.54, 95% CI 1.22-1.96, P < .001). CONCLUSIONS: This is the first validated risk prediction model to identify women at increased risk for PPCM at the time of delivery. Diabetes mellitus, obesity, mood disorders, and lower socioeconomic status are risk factors associated with PPCM. This model may be useful for identifying women at risk and preventing delays in diagnosis.

8.
Eur Heart J ; 42(6): 700-710, 2021 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-33351892

RESUMO

AIMS: The EMPERIAL (Effect of EMPagliflozin on ExeRcise ability and HF symptoms In patients with chronic heArt faiLure) trials evaluated the effects of empagliflozin on exercise ability and patient-reported outcomes in heart failure (HF) with reduced and preserved ejection fraction (EF), with and without type 2 diabetes (T2D), reporting, for the first time, the effects of sodium-glucose co-transporter-2 inhibition in HF with preserved EF (HFpEF). METHODS AND RESULTS: HF patients with reduced EF (HFrEF) (≤40%, N = 312, EMPERIAL-Reduced) or preserved EF (>40%, N = 315, EMPERIAL-Preserved), with and without T2D, were randomized to empagliflozin 10 mg or placebo for 12 weeks. The primary endpoint was 6-minute walk test distance (6MWTD) change to Week 12. Key secondary endpoints included Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnoea score. 6MWTD median (95% confidence interval) differences, empagliflozin vs. placebo, at Week 12 were -4.0 m (-16.0, 6.0; P = 0.42) and 4.0 m (-5.0, 13.0; P = 0.37) in EMPERIAL-Reduced and EMPERIAL-Preserved, respectively. As the primary endpoint was non-significant, all secondary endpoints were considered exploratory. Changes in KCCQ-TSS and CHQ-SAS dyspnoea score were non-significant. Improvements with empagliflozin in exploratory pre-specified analyses of KCCQ-TSS responder rates, congestion score, and diuretic use in EMPERIAL-Reduced are hypothesis generating. Empagliflozin adverse events were consistent with those previously reported. CONCLUSION: The primary outcome for both trials was neutral. Empagliflozin was well tolerated in HF patients, with and without T2D, with a safety profile consistent with that previously reported in T2D. Hypothesis-generating improvements in exploratory analyses of secondary endpoints with empagliflozin in HFrEF were observed.

9.
JACC Heart Fail ; 9(1): 1-12, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33309582

RESUMO

The treatment of heart failure with reduced ejection fraction (HFrEF) has changed considerably over time, particularly with the sequential development of therapies aimed at antagonism of maladaptive biologic pathways, including inhibition of the sympathetic nervous system and the renin-angiotensin aldosterone system. The sequential nature of earlier HFrEF trials allowed the integration of new therapies tested against the background therapy of the time. More recently, multiple heart failure therapies are being evaluated simultaneously, and the number of therapeutic choices for treating HFrEF has grown considerably. In addition, implementation science has lagged behind discovery science in heart failure. Furthermore, given there are currently >200 ongoing clinical trials in heart failure, further complexities are anticipated. In an effort to provide a decision-making framework in the current era of expanding therapeutic options in HFrEF, the Heart Failure Collaboratory convened a multi-stakeholder group, including patients, clinicians, clinical investigators, the U.S. Food and Drug Administration, industry, and payers who met at the U.S. Food and Drug Administration campus on March 6, 2020. This paper summarizes the discussions and expert consensus recommendations.

10.
J Card Fail ; 2021 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-33358956

RESUMO

BACKGROUND: This study describes the authors' experience with a limited balloon atrial septostomy technique, using a median balloon size of 15 mm, as a left ventricular (LV) unloading strategy in venoarterial extracorporeal membrane oxygenation (VA-ECMO). There has been increasing use of VA-ECMO in cardiogenic shock. Although LV unloading strategies have been suggested to improve outcomes, it is unclear which strategy is optimal. METHODS AND RESULTS: We performed a retrospective study of patients who underwent a limited balloon atrial septostomy for LV unloading in peripheral VA-ECMO at a single center. The goal of this study was to define the procedural outcomes and clinical characteristics of these patients. Of the 12 patients identified, none had complications related to the procedure. There was a significant decrease in the mean left atrial pressure and the majority of patients had radiologic improvement in pulmonary vascular congestion. Of the 12 patients, 58.3% survived to discharge. CONCLUSIONS: Limited BAS is an elegant and safe method for unloading the LV in peripheral VA-ECMO.

11.
JACC Cardiovasc Interv ; 13(23): 2795-2803, 2020 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-33303119

RESUMO

OBJECTIVES: The aim of this study was to examine the relationship between chronic obstructive pulmonary disease (COPD) and outcomes after transcatheter mitral valve repair (TMVr) for severe secondary mitral regurgitation. BACKGROUND: TMVr with the MitraClip improves clinical and health-status outcomes in patients with heart failure and severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits are modified by COPD is unknown. METHODS: COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone. Patients on corticosteroids or continuous oxygen were excluded. Multivariable models were used to examine the associations of COPD with mortality, heart failure hospitalization (HFH), and health status and to test whether COPD modified the benefit of TMVr compared with GDMT. RESULTS: Among 614 patients, 143 (23.2%) had COPD. Among patients treated with TMVr, unadjusted analyses demonstrated increased 2-year mortality in those with COPD (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this association was attenuated after risk adjustment (adjusted HR: 1.48; 95% CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for patients with COPD, 2-year all-cause mortality was similar after TMVr versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65; pint = 0.04), findings that reflect offsetting effects on cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to 0.63]; pint = 0.89) and improved both generic and disease-specific health status to a similar extent compared with GDMT alone in patients with and without COPD (pint >0.30 for all scales). CONCLUSIONS: In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus GDMT compared with patients without COPD. However, the benefits of TMVr on both HFH and health status were similar regardless of COPD. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).

12.
J Am Coll Cardiol ; 76(20): 2368-2378, 2020 11 17.
Artigo em Inglês | MEDLINE | ID: mdl-33183511

RESUMO

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.


Assuntos
Ensaios Clínicos como Assunto , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Determinação de Ponto Final , Humanos , Fatores Socioeconômicos , Estatística como Assunto
13.
JACC Heart Fail ; 8(12): 961-972, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33199251

RESUMO

The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation.

14.
Circ Heart Fail ; 13(11): e007293, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33176460

RESUMO

BACKGROUND: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT. METHODS: Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use. RESULTS: Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P=0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted Pinteraction=0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted Pinteraction=0.14) and HF hospitalization (adjusted Pinteraction=0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity. CONCLUSIONS: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

15.
JAMA Cardiol ; 2020 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-33206126

RESUMO

Importance: Up to 20% of patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization. Compared with rates in hospitalized patients, readmission and mortality are worse for ED patients. Objective: To assess the impact of a self-care intervention on 90-day outcomes in patients with AHF who are discharged from the ED. Design, Setting, and Participants: Get With the Guidelines in Emergency Department Patients With Heart Failure was an unblinded, parallel-group, multicenter randomized trial. Patients were randomized 1:1 to usual care vs a tailored self-care intervention. Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included. The trial was conducted from October 28, 2015, to September 5, 2019. Interventions: Home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching for 3 months. Main Outcomes and Measures: The primary outcome was a global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS) at 90 days. Key secondary outcomes included the global rank outcome at 30 days and changes in the KCCQ-12 SS score at 30 and 90 days. Intention-to-treat analysis was performed for the primary, secondary, and safety outcomes. Per-protocol analysis was conducted including patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm. Results: Owing to slow enrollment, 479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm. The median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50%. There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28). At day 30, patients in the intervention arm had significantly better global rank (HR, 0.80; 95% CI, 0.64-0.99; P = .04) and a 5.5-point higher KCCQ-12 SS (95% CI, 1.3-9.7; P = .01), while at day 90, the KCCQ-12 SS was 2.7 points higher (95% CI, -1.9 to 7.2; P = .25). Conclusions and Relevance: The self-care intervention did not improve the primary global rank outcome at 90 days in this trial. However, benefit was observed in the global rank and KCCQ-12 SS at 30 days, suggesting that an early benefit of a tailored self-care program initiated at an ED visit for AHF was not sustained through 90 days. Trial Registration: ClinicalTrials.gov Identifier: NCT02519283.

16.
ASAIO J ; 66(10): 1087-1094, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33136594

RESUMO

The number of patients with left ventricular assist devices (LVAD) has increased over the years and it is important to identify the etiologies for hospital admission, as well as the costs, length of stay and in-hospital complications in this patient group. Using the National Readmission Database from 2010 to 2015, we identified patients with a history of LVAD placement using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code V43.21. We aimed to identify the etiologies for hospital admission, patient characteristics, and in-hospital outcomes. We identified a total of 15,996 patients with an LVAD, the mean age was 58 years and 76% were males. The most common cause of hospital readmission after LVAD was heart failure (HF, 13%), followed by gastrointestinal (GI) bleed (11.8%), device complication (11.5%), and ventricular tachycardia/fibrillation (4.2%). The median length of stay was 6 days (3-11 days) and the median hospital costs was $12,723 USD. The in-hospital mortality was 3.9%, blood transfusion was required in 26.8% of patients, 20.5% had acute kidney injury, 2.8% required hemodialysis, and 6.2% of patients underwent heart transplantation. Interestingly, the most common cause of readmission was the same as the diagnosis for the preceding admission. One in every four LVAD patients experiences a readmission within 30 days of a prior admission, most commonly due to HF and GI bleeding. Interventions to reduce HF readmissions, such as speed optimization, may be one means of improving LVAD outcomes and resource utilization.

17.
Am Heart J ; 232: 116-124, 2020 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-33144086

RESUMO

BACKGROUND: Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure. OBJECTIVE: The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24 hours of hospitalization in patients with AHF compared to usual care. METHODS: DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 mL/min/1.73m2 are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10 mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40 mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality. CONCLUSIONS: The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.

18.
J Am Coll Cardiol ; 76(22): 2595-2606, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33243380

RESUMO

BACKGROUND: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR). OBJECTIVES: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg). RESULTS: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (pinteraction = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009). CONCLUSIONS: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.

19.
Eur J Heart Fail ; 2020 Oct 05.
Artigo em Inglês | MEDLINE | ID: mdl-33017862

RESUMO

The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation.

20.
JACC Cardiovasc Interv ; 13(20): 2317-2328, 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33092705

RESUMO

OBJECTIVES: The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification. BACKGROUND: Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses. RESULTS: Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; pinteraction = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status. CONCLUSIONS: The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).

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