Publications by authors named "Randall C Starling"

383 Publications

Early diuretic strategies and the association with In-hospital and Post-discharge outcomes in acute heart failure.

Am Heart J 2021 May 27;239:110-119. Epub 2021 May 27.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Duke University Medical Center, Durham, NC.

Background: Decongestion is a primary goal during hospitalizations for decompensated heart failure (HF). However, data surrounding the preferred route and strategy of diuretic administration are limited with varying results in prior studies.

Methods: This is a retrospective analysis using patients from ASCEND-HF with a stable diuretic strategy in the first 24 hours following randomization. Patients were divided into three groups: intravenous (IV) continuous, IV bolus and oral strategy. Baseline characteristics, in-hospital outcomes, 30-day composite cardiovascular mortality or HF rehospitalization and 180-day all-cause mortality were compared across groups. Inverse propensity weighted modeling was used for adjustment.

Results: Among 5,738 patients with a stable diuretic regimen in the first 24 hours (80% of overall ASCEND trial), 3,944 (68.7%) patients received IV intermittent bolus administration of diuretics, 799 (13.9%) patients received IV continuous therapy and 995 (17.3%) patients with oral administration. Patients in the IV continuous group had a higher baseline creatinine (IV continuous 1.4 [1.1-1.7]; intermittent bolus 1.2 [1.0-1.6]; oral 1.2 [1.0-1.4] mg/dL; P <0.001) and high NTproBNP (IV continuous 5,216 [2,599-11,603]; intermittent bolus 4,944 [2,339-9,970]; oral 3,344 [1,570-7,077] pg/mL; P <0.001). There was no difference between IV continuous and intermittent bolus group in weight change, total urine output and change in renal function till 10 days/discharge (adjusted P >0.05 for all). There was no difference in 30 day mortality and HF readmission (adjusted OR 1.08 [95%CI: 0.74, 1.57]; P = 0.701) and 180 days mortality (adjusted OR 1.04 [95%CI: 0.75, 1.43]; P = 0.832).

Conclusion: In a large cohort of patients with decompensated HF, there were no significant differences in diuretic-related in-hospital, or post-discharge outcomes between IV continuous and intermittent bolus administration. Tailoring appropriate diuretic strategy to different states of acute HF and congestion phenotypes needs to be further investigated.
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http://dx.doi.org/10.1016/j.ahj.2021.05.011DOI Listing
May 2021

HFA/HFSA/JHFS Position Statement on Endomyocardial Biopsy.

J Card Fail 2021 Apr 27. Epub 2021 Apr 27.

Cleveland Clinic, Cleveland OH, USA.

Endomyocardial biopsy (EMB) is an invasive procedure, globally most often used for the monitoring of heart transplant (HTx) rejection. In addition, EMB can have an important complementary role to the clinical assessment in establishing the diagnosis of diverse cardiac disorders, including myocarditis, cardiomyopathies, drug-related cardiotoxicity, amyloidosis, other infiltrative and storage disorders, and cardiac tumours. Improvements in EMB equipment and the development of new techniques for the analysis of EMB samples has significantly improved diagnostic precision of EMB. The present document is the result of the Trilateral Cooperation Project between the Heart Failure Association of the European Society of Cardiology, Heart Failure Society of America, and the Japanese Heart Failure Society. It represents an expert consensus aiming to provide a comprehensive, up-to-date perspective on EMB, with a focus on the following main issues: 1) an overview of the practical approach to EMB, 2) an update on indications for EMB, 3) a revised plan for HTx rejection surveillance, 4) the impact of multimodality imaging on EMB, and 5) the current clinical practice in the worldwide use of EMB.
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http://dx.doi.org/10.1016/j.cardfail.2021.04.010DOI Listing
April 2021

Heart Failure Association of the ESC, Heart Failure Society of America and Japanese Heart Failure Society Position statement on endomyocardial biopsy.

Eur J Heart Fail 2021 May 19. Epub 2021 May 19.

Cleveland Clinic, Cleveland, OH, USA.

Endomyocardial biopsy (EMB) is an invasive procedure, globally most often used for the monitoring of heart transplant (HTx) rejection. In addition, EMB can have an important complementary role to the clinical assessment in establishing the diagnosis of diverse cardiac disorders, including myocarditis, cardiomyopathies, drug-related cardiotoxicity, amyloidosis, other infiltrative and storage disorders, and cardiac tumours. Improvements in EMB equipment and the development of new techniques for the analysis of EMB samples have significantly improved diagnostic precision of EMB. The present document is the result of the Trilateral Cooperation Project between the Heart Failure Association of the European Society of Cardiology, the Heart Failure Society of America, and the Japanese Heart Failure Society. It represents an expert consensus aiming to provide a comprehensive, up-to-date perspective on EMB, with a focus on the following main issues: (i) an overview of the practical approach to EMB, (ii) an update on indications for EMB, (iii) a revised plan for HTx rejection surveillance, (iv) the impact of multimodality imaging on EMB, and (v) the current clinical practice in the worldwide use of EMB.
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http://dx.doi.org/10.1002/ejhf.2190DOI Listing
May 2021

Percutaneous Mitral Valve Annuloplasty in Patients With Secondary Mitral Regurgitation and Severe Left Ventricular Enlargement.

JACC Heart Fail 2021 Jun 12;9(6):453-462. Epub 2021 May 12.

Department of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi, USA.

Objectives: This study sought to determine the effect of percutaneous mitral valve annuloplasty with the Carillon device versus guideline-directed medical therapy (GDMT) alone in patients with secondary mitral regurgitation (MR) and severe left ventricular (LV) enlargement.

Background: The clinical impact of the Carillon device in patients with severe LV dilation is not well established.

Methods: This is a pooled analysis involving 3 prospective trials (TITAN [Transcatheter Implantation of Carillon Mitral Annuloplasty Device], TITAN II, and REDUCE FMR [CARILLON Mitral Contour System for Reducing Functional Mitral Regurgitation] trials) in which patients with functional MR and severe LV enlargement (LV end-diastolic diameter >65 mm) were treated with GDMT and the Carillon device versus GDMT alone. Key outcomes of this analysis were changes over 1 year of follow-up in mitral valve and LV echocardiographic parameters, functional outcome, quality of life, mortality, and heart failure hospitalization (HFH).

Results: A total of 95 patients (67 in the Carillon group, 28 in the GDMT group) with severe LV enlargement were included. In the Carillon group, all mitral valve and LV morphology parameters were significantly improved at 1 year. Regurgitant volume decreased by 12 ml (p < 0.001), MR grade decreased by 0.6 U (p < 0.001), LV end-diastolic volume decreased by 25 cm (p = 0.005), and LV end-systolic volume decreased by 21 cm (p = 0.01). Significant functional improvement differences were also noted between the Carillon group and the GDMT group including an improvement of Kansas City Cardiomyopathy Questionnaire score (15 ± 4 vs. 6 ± 6; p = 0.03). The incidence of HFH was 29.9% versus 50.0% and the cumulative rate of HFH was 0.43 versus 0.75 (p < 0.001).

Conclusions: In patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared with patients receiving GDMT only. Preoperative LV dimension should not be a limiting factor when evaluating patient eligibility or anticipated response to therapy with the Carillon device.
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http://dx.doi.org/10.1016/j.jchf.2021.03.002DOI Listing
June 2021

Impact of an electronic medical record-based appointment order on outpatient cardiology follow-up after hospital discharge.

NPJ Digit Med 2021 May 6;4(1):77. Epub 2021 May 6.

Heart, Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, OH, USA.

Outpatient follow-up after hospital discharge improves continuity of care and reduces readmissions, but rates of follow-up remain low. It is not known whether electronic medical record (EMR)-based tools improve follow-up. The aim of this study was to determine if an EMR-based order to secure cardiology follow-up appointments at hospital discharge would improve follow-up rates and hospital readmission rates. A pre-post interventional study was conducted and evaluated 39,209 cardiovascular medicine discharges within an academic center between 2012 and 2017. Follow-up rates and readmission rates were compared during 2 years prior to EMR-order implementation (pre-order era 2012-2013, n = 12,852) and 4 years after implementation (EMR-order era 2014-2017, n = 26,357). The primary endpoint was 90-day cardiovascular follow-up rates within our health system. In the overall cohort, the mean age of patients was 69.3 years [SD 14.7] and 60.7% (n = 23,827) were male. In the pre-order era, 90-day follow-up was 56.7 ± 0.4% (7286 of 12,852) and increased to 67.9 ± 0.3% (17,888 of 26,357, P < 0.001) in the EMR-order era. The use of the EMR follow-up order was independently associated with increased outpatient follow-up within 90 days after adjusting for patient demographics and payor status (OR 3.28, 95% CI 3.10-3.47, P < 0.001). The 30-day readmission rate in the pre-order era was 12.8% (1642 of 12,852) compared with 13.7% (3601 of 26,357, P = 0.016) in the EMR-order era. An EMR-based appointment order for follow-up appointment scheduling was associated with increased cardiovascular medicine follow-up, but was not associated with an observed reduction in 30-day readmission rates.
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http://dx.doi.org/10.1038/s41746-021-00443-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8102598PMC
May 2021

Left atrial assist device for heart failure with preserved ejection fraction: initial results with torque control mode in diastolic heart failure model.

Heart Fail Rev 2021 May 1. Epub 2021 May 1.

Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.

A novel pump, the left atrial assist device (LAAD), is a device specifically for the treatment of heart failure with preserved ejection fraction (HFpEF). The LAAD is a mixed-flow pump that is implanted in the mitral position and delivers blood from the left atrium to the left ventricle. During the development process, we aimed to explore whether device activation in torque control (TC) mode would improve the function of the LAAD. The TC mode causes adjustment of the pump speed automatically during each cardiac cycle in order to maintain a specified torque. In this study, we tested four different TC settings (TC modes 0.9, 1.0, 1.25, and 1.5) using an in vitro mock circulatory loop. Mild, moderate, and severe diastolic heart failure (DHF) conditions, as well as normal heart condition, were simulated with the four TC modes. Also, we evaluated the LAAD in vivo with three calves. The LAAD was implanted at the mitral position with four TC settings (TC modes 0.9, 1.0, 1.1, 1.2). With LAAD support, the in vitro cardiac output and aortic pressure recovered to normal heart levels at TC 1.25 and 1.5 even under severe DHF conditions with little pump regurgitation. The TC mode tested in vivo with three calves, and it also showed favorable result without elevating the left ventricular end-diastolic pressure. These initial in vitro and in vivo results suggest that the TC mode could be potentially effective, and the LAAD could be a treatment option for HFpEF patients.
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http://dx.doi.org/10.1007/s10741-021-10117-6DOI Listing
May 2021

Kinetics of generic tacrolimus in heart transplantation: A cautionary note.

J Heart Lung Transplant 2021 Apr 17. Epub 2021 Apr 17.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

Tacrolimus is a core component of immunosuppressive regimens. This study compared active pharmaceutical ingredient (API) and dissolution kinetics of branded tacrolimus and formulations from three generic manufacturers (Mylan, Dr. Reddy's, Intas) including samples from patients who suffered acute cardiac allograft rejection. Generic samples showed similar API content compared to branded samples with no major impurities. Capsules that underwent uniformity testing had consistent capsule-to-capsule API. Dissolution testing showed similar profiles between branded tacrolimus and Mylan, but notable differences with Dr. Reddy's and Intas. The approximate maximal inhibitory concentration (IC) was highest in branded tacrolimus (29 minutes), followed by Mylan (26 minutes), Dr. Reddy's (19 minutes), and Intas (14 minutes) (Student-Newman-Keuls Multiple Comparisons Test; overall ANOVA: p = 0.0199, F = 6.469). This study suggests that the bioavailability of certain generic tacrolimus formulations peak significantly earlier than branded tacrolimus. Further study is needed to determine whether these differences are clinically relevant.
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http://dx.doi.org/10.1016/j.healun.2021.03.009DOI Listing
April 2021

A Comprehensive Review of Risk Factor, Mechanism, and Management of Left Ventricular Assist Device-Associated Stroke.

Semin Neurol 2021 Apr 13. Epub 2021 Apr 13.

Neurological Institute, Cleveland Clinic, Cleveland, Ohio.

The use of left ventricular assist devices (LVADs) has been increasing in the last decade, along with the number of patients with advanced heart failure refractory to medical therapy. Ischemic stroke and intracranial hemorrhage remain the leading causes of morbidity and mortality in LVAD patients. Despite the common occurrence and the significant outcome impact, underlying mechanisms and management strategies of stroke in LVAD patients are controversial. In this article, we review our current knowledge on pathophysiology and risk factors of LVAD-associated stroke, outline the diagnostic approach, and discuss treatment strategies.
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http://dx.doi.org/10.1055/s-0041-1726328DOI Listing
April 2021

Obesity, inflammation, and heart failure: links and misconceptions.

Heart Fail Rev 2021 Apr 7. Epub 2021 Apr 7.

Second Department of Cardiology, National and Kapodistrian University of Athens, Attikon University Hospital, Haidari, Athens, Greece.

Obesity has been linked with heart failure (HF) with preserved left ventricular (LV) ejection fraction (HFpEF). This link has been attributed to obesity-induced metabolic and inflammatory disturbances leading to HFpEF. However, HF is a syndrome in which disease evolvement is associated with a dynamic unraveling of functional and structural changes leading to unique disease trajectories, creating a spectrum of phenotypes with overlapping distinct characteristics extending beyond the LV ejection fraction (LVEF). In this regard, despite quantitative differences between the two extremes (HFpEF and HF with reduced LVEF, HFrEF), there is important overlap between the phenotypes along the entire spectrum. In this paper, we describe the systemic pro-inflammatory state that is present throughout the HF spectrum and emphasize that obesity intertwines with HF beyond the LVEF construct.
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http://dx.doi.org/10.1007/s10741-021-10103-yDOI Listing
April 2021

Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure.

J Card Fail 2021 Mar 1. Epub 2021 Mar 1.

In this document, we propose a universal definition of heart failure (HF) as the following: HF is a clinical syndrome with symptoms and or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and or objective evidence of pulmonary or systemic congestion. We propose revised stages of HF as follows. At-risk for HF (Stage A), for patients at risk for HF but without current or prior symptoms or signs of HF and without structural or biomarkers evidence of heart disease. Pre-HF (stage B), for patients without current or prior symptoms or signs of HF, but evidence of structural heart disease or abnormal cardiac function, or elevated natriuretic peptide levels. HF (Stage C), for patients with current or prior symptoms and/or signs of HF caused by a structural and/or functional cardiac abnormality. Advanced HF (Stage D), for patients with severe symptoms and/or signs of HF at rest, recurrent hospitalizations despite guideline-directed management and therapy (GDMT), refractory or intolerant to GDMT, requiring advanced therapies such as consideration for transplant, mechanical circulatory support, or palliative care. Finally, we propose a new and revised classification of HF according to left ventricular ejection fraction (LVEF). The classification includes HF with reduced EF (HFrEF): HF with an LVEF of ≤40%; HF with mildly reduced EF (HFmrEF): HF with an LVEF of 41% to 49%; HF with preserved EF (HFpEF): HF with an LVEF of ≥50%; and HF with improved EF (HFimpEF): HF with a baseline LVEF of ≤40%, a ≥10-point increase from baseline LVEF, and a second measurement of LVEF of >40%.
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http://dx.doi.org/10.1016/j.cardfail.2021.01.022DOI Listing
March 2021

Dynamic Assessment of Pulmonary Artery Pulsatility Index Provides Incremental Risk Assessment for Early Right Ventricular Failure After Left Ventricular Assist Device.

J Card Fail 2021 Feb 25. Epub 2021 Feb 25.

Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; Department of Cardiology, Mater Misericordiae University Hospital, Dublin, Ireland.

Background: The pulmonary artery pulsatility index (PAPi) has been studied to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation, but only as a single time point before LVAD implantation. Multiple clinical factors and therapies impact RV function in pre-LVAD patients. Thus, we hypothesized that serial PAPi measurements during cardiac intensive care unit (CICU) optimization before LVAD implantation would provide incremental risk stratification for early RVF after LVAD implantation.

Methods And Results: Consecutive patients who underwent sequential pulmonary artery catherization with cardiac intensive care optimization before durable LVAD implantation were included. Serial hemodynamics were reviewed retrospectively across the optimization period. The optimal PAPi was defined by the initial PAPi + the PAPi at optimized hemodynamics. RVF was defined as need for a right ventricular assist device or prolonged inotrope use (>14 days postoperatively). Patients with early RVF had significantly lower mean optimal PAPi (3.5 vs 7.5, P < .001) compared with those who did not develop RVF. After adjusting for established risk factors of early RVF after LVAD implantation, the optimal PAPi was independently and incrementally associated with early RVF after LVAD implantation (odds ratio 0.64, 95% confidence interval 0.532-0.765, P < .0001).

Conclusions: Optimal PAPi achieved during medical optimization before LVAD implantation provides independent and incremental risk stratification for early RVF, likely identifying dynamic RV reserve.
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http://dx.doi.org/10.1016/j.cardfail.2021.02.012DOI Listing
February 2021

Universal definition and classification of heart failure: a report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure: Endorsed by the Canadian Heart Failure Society, Heart Failure Association of India, Cardiac Society of Australia and New Zealand, and Chinese Heart Failure Association.

Eur J Heart Fail 2021 Mar 3;23(3):352-380. Epub 2021 Mar 3.

In this document, we propose a universal definition of heart failure (HF) as a clinical syndrome with symptoms and/or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. We also propose revised stages of HF as: At risk for HF (Stage A), Pre-HF (Stage B), Symptomatic HF (Stage C) and Advanced HF (Stage D). Finally, we propose a new and revised classification of HF according to left ventricular ejection fraction (LVEF). This includes HF with reduced ejection fraction (HFrEF): symptomatic HF with LVEF ≤40%; HF with mildly reduced ejection fraction (HFmrEF): symptomatic HF with LVEF 41-49%; HF with preserved ejection fraction (HFpEF): symptomatic HF with LVEF ≥50%; and HF with improved ejection fraction (HFimpEF): symptomatic HF with a baseline LVEF ≤40%, a ≥10 point increase from baseline LVEF, and a second measurement of LVEF > 40%.
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http://dx.doi.org/10.1002/ejhf.2115DOI Listing
March 2021

Interleukin-6 and Outcomes in Acute Heart Failure: An ASCEND-HF Substudy.

J Card Fail 2021 Jun 23;27(6):670-676. Epub 2021 Jan 23.

Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: The inflammatory cytokine IL-6 has been previously implicated in the pathophysiology of acute decompensated heart failure (HF). Prior observations in acute HF patients have suggested that IL-6 may be associated with outcomes and modulated by nesiritide. We aimed to evaluate the associations between serial IL-6 measurements, mortality and rehospitalization in acute HF.

Methods And Results: We analyzed the associations between IL-6 in acute HF, readmission, and mortality (30 and 180 days) using a cohort of 883 hospitalized patients from the ASCEND-HF trial (nesiritide vs placebo). Plasma IL-6 was measured at randomization (baseline), 48-72 hours, and 30 days. The median IL-6 was highest at baseline (14.1 pg/mL) and decreased at subsequent time points (7.6 pg/mL at 30 days). In a univariable Cox regression analysis, the baseline IL-6 was associated with 30- and 180-day mortality (hazard ratio per log 1.74, 95% confidence interval 1.09-2.78, P = .021; hazard ratio 3.23, confidence interval 1.18-8.86, P = .022, respectively). However, there was no association after multivariable adjustment. IL-6 at 48-72 hours was found to be independently associated with 30-day mortality (hazard ratio 8.2, confidence interval 1.2-57.5, P= .03), but not 180-day mortality in multivariable analysis that included the ASCEND-HF risk model and amino terminal pro-B-type natriuretic peptide as covariates. In comparison with placebo, nesiritide therapy was not associated with differences in serial IL-6 levels.

Conclusions: Although elevated IL-6 levels were associated with higher all-cause mortality in acute HF, no independent association with this outcome was identified at baseline or 30-day measurements. In contrast with prior reports, we did not observe any impact of nesiritide over placebo on serial IL-6 levels.
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http://dx.doi.org/10.1016/j.cardfail.2021.01.006DOI Listing
June 2021

The Counter Regulatory Axis of the Lung Renin-Angiotensin System in Severe COVID-19: Pathophysiology and Clinical Implications.

Heart Lung Circ 2021 Jun 9;30(6):786-794. Epub 2020 Dec 9.

Department of Medicine/Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.

The severe acute respiratory syndrome coronavirus (SARS-CoV)-2, which is responsible for coronavirus disease 2019 (COVID-19), uses angiotensin (ANG)-converting enzyme 2 (ACE2) as the entrance receptor. Although most COVID-19 cases are mild, some are severe or critical, predominantly due to acute lung injury. It has been widely accepted that a counter regulatory renin-angiotensin system (RAS) axis including the ACE2/ANG [1-7]/Mas protects the lungs from acute lung injury. However, recent evidence suggests that the generation of protective ANG [1-7] in the lungs is predominantly mediated by proinflammatory prolyl oligopeptidase (POP), which has been repeatedly demonstrated to be involved in lung pathology. This review contends that acute lung injury in severe COVID-19 is characterised by a) ACE2 downregulation and malfunction (inflammatory signalling) due to viral occupation, and b) dysregulation of the protective RAS axis, predominantly due to increased activity of proinflammatory POP. It follows that a reasonable treatment strategy in COVID-19-related acute lung injury would be delivering functional recombinant (r) ACE2 forms to trap the virus. Additionally, or alternatively to rACE2 delivery, the potential benefits resulting from lowering POP activity should also be explored. These treatment strategies deserve further investigation.
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http://dx.doi.org/10.1016/j.hlc.2020.11.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7831862PMC
June 2021

Device-based treatment options for heart failure with preserved ejection fraction.

Heart Fail Rev 2021 Jul 12;26(4):749-762. Epub 2021 Jan 12.

Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.

Heart failure with preserved ejection fraction (HFpEF) is a syndrome with an unfavorable prognosis, and the number of the patients continues to grow. Because there is no effective therapy established as a standard, including pharmacological treatments, a movement to develop and evaluate device-based therapies is an important emerging area in the treatment of HFpEF patients. Many devices have set their target to reduce the left atrial pressure or pulmonary capillary wedge pressure because they are strongly related to the symptoms and prognosis of HFpEF, but the methodology to achieve it varies based on the devices. In this review, we summarize and categorize these devices into the following: (1) interatrial shunt devices, (2) left ventricle expander, (3) electrical therapy, (4) left ventricular assist devices, and (5) mechanical circulatory support devices under development. Here, we describe the features and specifications of device-based therapies currently under development and those at more advanced stages of preclinical testing. Advantages and limitations of these technologies, with insights on their safety and feasibility for HFpEF patients, are described.
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http://dx.doi.org/10.1007/s10741-020-10067-5DOI Listing
July 2021

Acute Hemodynamic Effects of Sacubitril-Valsartan In Heart Failure Patients Receiving Intravenous Vasodilator and Inotropic Therapy.

J Card Fail 2021 Mar 16;27(3):368-372. Epub 2021 Jan 16.

Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart and Vascular Institute, George M. and Linda H. Kaufman Center for Heart Failure and Recovery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Prior study has demonstrated that transitioning patients in acutely decompensated heart failure with a low cardiac output directly from intravenous (i.v.) vasoactive (ie, vasodilators or inotropes) drugs to sacubitril-valsartan (S/V) can be done safely with tolerance to the 1-month follow-up. Here, we further characterize the hemodynamic impact of S/V after patients have been optimized on vasoactive therapy.

Methods And Results: In a single-center, retrospective analysis, 25 patients with cardiac index of less than 2.2 L/min/m were admitted to the cardiac intensive care unit and newly initiated on angiotensin receptor-neprilysin inhibitor therapy with the guidance of invasive hemodynamic monitoring. Hemodynamic data were gathered and compared upon cardiac intensive care unit admission, after optimization with i.v. vasoactive therapy, and after S/V initiation and weaning off i.v.

Therapy: All patients who tolerated S/V (n = 20) were weaned off vasoactive medications before transfer out of cardiac intensive care unit. Patients maintained their significant improvement in cardiac index and reduction in SVR/PVR on transition from i.v. inotropic and vasodilator therapy to oral S/V. There was an increase in pulmonary artery pulsatility index with S/V therapy compared with the i.v. vasoactive phase of care.

Conclusions: Patients in the cardiac intensive care unit can be successfully bridged from vasoactive i.v. therapy to oral S/V with sustained improvement in cardiac index garnered from vasoactive agents. We also observed improvement in the pulmonary artery pulsatility index and maintenance of left and right ventricular unloading with S/V. These encouraging findings merit further prospective study.
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http://dx.doi.org/10.1016/j.cardfail.2020.12.013DOI Listing
March 2021

Left atrial assist device function at various heart rates using a mock circulation loop.

Int J Artif Organs 2020 Dec 1:391398820977508. Epub 2020 Dec 1.

Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.

We are developing a new left atrial assist device (LAAD) for patients who have heart failure with preserved ejection fraction (HFpEF). This study aimed to assess the hemodynamic effects of the LAAD under both normal heart conditions and various diastolic heart failure (DHF) conditions using a mock circulatory loop. A continuous-flow pump that simulates LAAD, was placed between the left atrial (LA) reservoir and a pneumatic ventricle that simulated a native left ventricle on a pulsatile mock loop. Normal heart (NH) and mild, moderate, and severe DHF conditions were simulated by adjusting the diastolic drive pressures of the pneumatic ventricle. With the LAAD running at 3200 rpm, data were collected at 60, 80, and 120 bpm of the pneumatic ventricle. Cardiac output (CO), mean aortic pressure (AoP), and mean LA pressure (LAP) were compared to evaluate the LAAD performance. With LAAD support, the CO and AoP rose to a sufficient level at all heart rates and DHF conditions (CO; 3.4-3.8 L/min, AoP; 90-105 mm Hg). Each difference in the CO and the AoP among various heart rates was minuscule compared with non-pump support. The LAP decreased from 21-23 to 17-19 mm Hg in all DHF conditions (difference not significant). Furthermore, hemodynamic parameters improved for all DHF conditions, independent of heart rate. The LAAD can provide adequate flow to maintain the circulation status at various heart rates in an in vitro mock circulatory loop.
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http://dx.doi.org/10.1177/0391398820977508DOI Listing
December 2020

Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]): Medium-Term and Primary End Point Results.

Circulation 2020 Nov 26;142(21):2016-2028. Epub 2020 Oct 26.

Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (K.B.M., J.E.R.).

Background: Left ventricular assist device (LVAD) unloading and hemodynamic support in patients with advanced chronic heart failure can result in significant improvement in cardiac function allowing LVAD removal; however, the rate of this is generally considered to be low. This prospective multicenter nonrandomized study (RESTAGE-HF [Remission from Stage D Heart Failure]) investigated whether a protocol of optimized LVAD mechanical unloading, combined with standardized specific pharmacological therapy to induce reverse remodeling and regular testing of underlying myocardial function, could produce a higher incidence of LVAD explantation.

Methods: Forty patients with chronic advanced heart failure from nonischemic cardiomyopathy receiving the Heartmate II LVAD were enrolled from 6 centers. LVAD speed was optimized with an aggressive pharmacological regimen, and regular echocardiograms were performed at reduced LVAD speed (6000 rpm, no net flow) to test underlying myocardial function. The primary end point was the proportion of patients with sufficient improvement of myocardial function to reach criteria for explantation within 18 months with sustained remission from heart failure (freedom from transplant/ventricular assist device/death) at 12 months.

Results: Before LVAD, age was 35.1±10.8 years, 67.5% were men, heart failure mean duration was 20.8±20.6 months, 95% required inotropic and 20% temporary mechanical support, left ventricular ejection fraction was 14.5±5.3%, end-diastolic diameter was 7.33±0.89 cm, end-systolic diameter was 6.74±0.88 cm, pulmonary artery saturations were 46.7±9.2%, and pulmonary capillary wedge pressure was 26.2±7.6 mm Hg. Four enrolled patients did not undergo the protocol because of medical complications unrelated to the study procedures. Overall, 40% of all enrolled (16/40) patients achieved the primary end point, <0.0001, with 50% (18/36) of patients receiving the protocol being explanted within 18 months (pre-explant left ventricular ejection fraction, 57±8%; end-diastolic diameter, 4.81±0.58 cm; end-systolic diameter, 3.53±0.51 cm; pulmonary capillary wedge pressure, 8.1±3.1 mm Hg; pulmonary artery saturations 63.6±6.8% at 6000 rpm). Overall, 19 patients were explanted (19/36, 52.3% of those receiving the protocol). The 15 ongoing explanted patients are now 2.26±0.97 years after explant. After explantation survival free from LVAD or transplantation was 90% at 1-year and 77% at 2 and 3 years.

Conclusions: In this multicenter prospective study, this strategy of LVAD support combined with a standardized pharmacological and cardiac function monitoring protocol resulted in a high rate of LVAD explantation and was feasible and reproducible with explants occurring in all 6 participating sites. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01774656.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.046415DOI Listing
November 2020

Myocarditis and inflammatory cardiomyopathy: current evidence and future directions.

Nat Rev Cardiol 2021 03 12;18(3):169-193. Epub 2020 Oct 12.

Berlin Institute of Health Center for Regenerative Therapies (BCRT), Charité - University Medicine Berlin, Campus Virchow Clinic, Berlin, Germany.

Inflammatory cardiomyopathy, characterized by inflammatory cell infiltration into the myocardium and a high risk of deteriorating cardiac function, has a heterogeneous aetiology. Inflammatory cardiomyopathy is predominantly mediated by viral infection, but can also be induced by bacterial, protozoal or fungal infections as well as a wide variety of toxic substances and drugs and systemic immune-mediated diseases. Despite extensive research, inflammatory cardiomyopathy complicated by left ventricular dysfunction, heart failure or arrhythmia is associated with a poor prognosis. At present, the reason why some patients recover without residual myocardial injury whereas others develop dilated cardiomyopathy is unclear. The relative roles of the pathogen, host genomics and environmental factors in disease progression and healing are still under discussion, including which viruses are active inducers and which are only bystanders. As a consequence, treatment strategies are not well established. In this Review, we summarize and evaluate the available evidence on the pathogenesis, diagnosis and treatment of myocarditis and inflammatory cardiomyopathy, with a special focus on virus-induced and virus-associated myocarditis. Furthermore, we identify knowledge gaps, appraise the available experimental models and propose future directions for the field. The current knowledge and open questions regarding the cardiovascular effects associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are also discussed. This Review is the result of scientific cooperation of members of the Heart Failure Association of the ESC, the Heart Failure Society of America and the Japanese Heart Failure Society.
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http://dx.doi.org/10.1038/s41569-020-00435-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548534PMC
March 2021

Plasma Volume Status and Its Association With In-Hospital and Postdischarge Outcomes in Decompensated Heart Failure.

J Card Fail 2021 Mar 7;27(3):297-308. Epub 2020 Oct 7.

Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina. Electronic address:

Background: Prior analyses suggest an association between formula-based plasma volume (PV) estimates and outcomes in heart failure (HF). We assessed the association between estimated PV status by the Duarte-ePV and Kaplan Hakim (KH-ePVS) formulas, and in-hospital and postdischarge clinical outcomes, in the ASCEND-HF trial.

Methods And Results: The KH-ePVS and Duarte-ePV were calculated on admission. We assessed associations with in-hospital worsening HF, 30-day composite cardiovascular mortality or HF rehospitalization and 180-day all-cause mortality. There were 6373 (89.2%), and 6354 (89.0%) patients who had necessary characteristics to calculate KH-ePVS and Duarte-ePV, respectively. There was no association between PV by either formula with in-hospital worsening HF. KH-ePVS showed a weak correlation with N-terminal prohormone BNP, and with measures of decongestion such as body weight change and urine output (r < 0.3 for all). Duarte-ePV was trending toward an association with worse 30-day (adjusted odds ratio 1.07, 95% confidence interval [CI] 1.00-1.15, P = .058), but not 180-day outcomes (adjusted hazard ratio 1.03, 95% CI 0.97-1.09, P = .289). A continuous KH-ePVS of >0 (per 10-unit increase) was associated with improved 30-day outcomes (adjusted odds ratio 0.75, 95% CI 0.62-0.91, P = .004). The continuous KH-ePVS was not associated with 180-day outcomes (adjusted hazard ratio 1.05, 95% CI 0.98-1.12, P = .139).

Conclusions: Baseline PV estimates had a weak association with in-hospital measures of decongestion. The Duarte-ePV trended toward an association with early clinical outcomes in decompensated HF, and may improve risk stratification in HF.
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http://dx.doi.org/10.1016/j.cardfail.2020.09.478DOI Listing
March 2021

The Effects of Preserving Mitral Valve Function on a Left Atrial Assist Device: An In Vitro Mock Circulation Loop Study.

ASAIO J 2021 05;67(5):567-572

From the Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.

We are developing a left atrial assist device (LAAD) to pump blood from the left atrium to the left ventricle for patients who have heart failure with preserved ejection fraction (HFpEF). This study aimed to assess the hemodynamics with the LAAD implanted at two different levels: the mitral valve (MV) level, after removing the MV; and the supravalvular level, preserving MV function conditions using an in vitro mock circulatory loop. Normal heart and mild, moderate, and severe diastolic heart failure conditions were simulated, and the LAAD was set at three different speeds. Without the LAAD support, cardiac output (CO) decreased from 3.7 to 1.1 L/min, aortic pressure (AoP) decreased from 100 to 33 mm Hg, and left atrial pressure (LAP) increased from 16 to 23 mm Hg as the diastolic function became impaired. With high pump support after removing the MV, CO and AoP readings were comparable with those for preserved MV function (CO reached 3.9-4.1 L/min, AoP reached more than 110 mm Hg, and LAP dropped to 16-17 mm Hg under both conditions at high pump speeds). In the mock circulatory loop, our LAAD appeared to have sufficient ability to maintain the hemodynamic status at both positions.
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http://dx.doi.org/10.1097/MAT.0000000000001257DOI Listing
May 2021

Renin-angiotensin-system inhibition in the context of corona virus disease-19: experimental evidence, observational studies, and clinical implications.

Heart Fail Rev 2021 03 1;26(2):381-389. Epub 2020 Sep 1.

Department of Medicine/Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.

Coronavirus disease 2019 (COVID-19) is due to severe acute respiratory syndrome coronavirus (SARS-CoV)-2 which binds and enters the host cells through the angiotensin-converting enzyme (ACE)2. While the potential for benefit with the use of renin-angiotensin-aldosterone system inhibitors (RAASi) and the risks from stopping them is more evident, potential harm by RAΑSi may also be caused by the increase in the activity of the ACE2 receptor, the inefficient counter regulatory axis in the lungs in which the proinflammatory prolyloligopeptidase (POP) is the main enzyme responsible for the conversion of deleterious angiotensin (ANG) II to protective ANG [1-7] and the proinflammatory properties of ACE2(+) cells infected with SARS-CoV-2. Acknowledging the proven RAΑSi benefit in patients with several diseases such as hypertension, heart failure, coronary disease, and diabetic kidney disease in the non-COVID-19 era, it is a reasonable strategy in this period of uncertainty to use these agents judiciously with careful consideration and to avoid the use of RAASi in select patients whenever possible, until definitive evidence becomes available.
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http://dx.doi.org/10.1007/s10741-020-10022-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462660PMC
March 2021

Outcomes of Percutaneous Coronary Intervention in Cardiac Transplant Patients: A Binational Analysis Derived From the United Kingdom and United States.

J Invasive Cardiol 2020 Sep;32(9):321-329

Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, United Kingdom.

Aims: To compare and contrast the indications, clinical and procedural characteristics, and periprocedural outcomes of patients with cardiac transplant undergoing percutaneous coronary intervention (PCI) in the United States and United Kingdom.

Methods And Results: The British Cardiovascular Intervention Society Registry (BCIS) (2007-2014) and the United States National Inpatient Sample (NIS) (2004-2014) data were utilized for this analysis. There were 466 PCIs (0.09%) and 1122 PCIs (0.02%) performed in cardiac transplant patients in the BCIS and NIS registries, respectively. The cardiac transplant PCI cohort was younger and mostly men, with an increased prevalence of chronic kidney disease, left main PCI, and multivessel disease, and with lower use of newer antiplatelets agents, antithrombotics, and radial artery access vs the non-cardiac transplant PCI cohort. In the BCIS registry, the cardiac transplant PCI cohort had similar in-hospital mortality (odds ratio [OR], 1.05; P=.91), 30-day mortality (OR, 1.38; P=.31), vascular complications (OR, 0.69; P=.46), and major adverse cardiovascular event (OR, 1.41; P=.26) vs the non-cardiac transplant PCI cohort. However, the cardiac transplant group had higher 1-year mortality (OR, 2.30; P<.001). The NIS data analysis revealed similar rates of in-hospital mortality (OR, 2.40; P=.14), cardiac complications (OR, 0.26; P=.17), major bleeding (OR, 0.36; P=.16), vascular complications (OR, 0.46; P=.45), and stroke (OR, 0.50; P=.40) in the cardiac transplant PCI cohort vs the non-cardiac transplant PCI cohort.

Conclusions: PCI in cardiac transplant recipients was associated with similar short-term mortality and vascular complications compared with PCI in the general populace. However, a higher 1-year morality was observed in the BCIS cohort.
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September 2020

Ischemic Stroke and Intracranial Hemorrhages During Impella Cardiac Support.

ASAIO J 2020 08;66(8):e105-e109

From the Cerebrovascular Center, Department of Neurology, Neurological Institute, Cleveland Clinic, Cleveland, Ohio.

Impella is a percutaneously placed, ventricular assist device for short-term cardiac support. We aimed to study acute neurologic complications during short-term cardiac support with Impella. We reviewed prospectively collected data of 79 consecutive persons implanted with Impella at a single tertiary center. Acute neurologic events (ANE) were defined as ischemic strokes or intracranial hemorrhages. Among those with ANE, specific causes of ischemic and hemorrhagic events were collected and discussed. Of 79 persons with Impella with median 8 days of support (range 1-33 days), six (7.5%) developed ANE at a median of 5 days from implant (range 1-8 days). There were three ischemic strokes, two intracerebral hemorrhages, and one subdural hematoma. Hemorrhagic events were attributed to anticoagulant use and thrombocytopenia at the time of the events. Two ischemic strokes were attributed to inadequate anticoagulation with one case of pump thrombosis diagnosed at the time of ischemic stroke. Only two of the six patients survived the acute cardiogenic shock period to achieve heart transplantation. In-hospital ischemic strokes and intracranial hemorrhages are not uncommon during short-term cardiac support period with Impella. Antithrombotic intensity, duration of device support time, and thrombocytopenia might contribute to the incidence of these events.
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http://dx.doi.org/10.1097/MAT.0000000000001132DOI Listing
August 2020

Heart failure and COVID-19.

Heart Fail Rev 2021 01;26(1):1-10

Department of Cardiovascular Medicine, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, OH, USA.

Heart failure is a common disease state that can be encountered at different stages in the course of a COVID-19 patient presentation. New or existing heart failure in the setting of COVID-19 can present a set of unique challenges that can complicate presentation, management, and prognosis. A careful understanding of the hemodynamic and diagnostic implications is essential for appropriate triage and management of these patients. Abnormal cardiac biomarkers are common in COVID-19 and can stem from a variety of mechanisms that involve the viral entry itself through the ACE2 receptors, direct cardiac injury, increased thrombotic activity, stress cardiomyopathy, and among others. The cytokine storm observed in this pandemic can be a culprit in many of the observed mechanisms and presentations. A correct understanding of the two-way interaction between heart failure medications and the infection as well as the proposed COVID-19 medications and heart failure can result in optimal management. Guideline-directed medical therapy for heart failure should not be interrupted for theoretical concerns but rather based on tolerance and clinical presentation. Initiating specific cardiac or heart failure medications to prevent the infection or mitigate the disease is also not an evidence-based practice at this time. Heart failure patients on advanced therapies including those with heart transplantation will particularly benefit from involving the advanced heart failure team members in the overall management if they contract the virus.
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http://dx.doi.org/10.1007/s10741-020-10008-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383122PMC
January 2021

Postimplant Phosphodiesterase Type 5 Inhibitors Use Is Associated With Lower Rates of Thrombotic Events After Left Ventricular Assist Device Implantation.

J Am Heart Assoc 2020 07 10;9(14):e015897. Epub 2020 Jul 10.

Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.

Background Left ventricular assist device (LVAD) thrombosis is clinically devastating and impacts the cost effectiveness of LVAD therapy for advanced heart failure. Anticoagulation and antiplatelet therapies represent the standard of care to mitigate LVAD thrombosis. Phosphodiesterase type 5 inhibitors (PDE-5is) exhibit hemodynamic, antiplatelet, and antithrombotic effects. Using a national registry, we examined the relationship of PDE-5i use on thrombotic events in patients with continuous-flow LVADs. Methods and Results We obtained data from 13 772 patients with continuous flow LVADs participating in a national registry. Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis. The primary end point was a composite of LVAD thrombosis and ischemic stroke. Patients were analyzed according to any use of PDE-5i after LVAD implantation (PDE-5i group) versus no use after LVAD implantation (no PDE-5i group). The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91; <0.001) at 48 months. The components of the primary end point (LVAD thrombosis: HR, 0.82; 95% CI, 0.74-0.90; <0.001; and ischemic stroke: HR, 0.85; 95% CI, 0.75-0.97; =0.019), as well as the secondary end point all-cause mortality (HR, 0.86; 95% CI, 0.79-0.93; <0.001) were lower in the PDE-5i group versus the no PDE-5i at 48 months post LVAD. The favorable results observed with postimplant PDE-5i use were consistent with both axial and centrifugal flow devices. Conclusions The postimplant use of PDE-5i was associated with fewer thrombotic events and improved survival in LVAD patients. A randomized clinical trial is warranted to confirm these findings.
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http://dx.doi.org/10.1161/JAHA.119.015897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660717PMC
July 2020

Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.

JACC Heart Fail 2020 10 10;8(10):789-799. Epub 2020 Jun 10.

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).
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http://dx.doi.org/10.1016/j.jchf.2020.05.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7286640PMC
October 2020

Sacubitril/valsartan in patients post-left ventricular assist device implant: a single-centre case series.

Eur J Heart Fail 2020 08 20;22(8):1490-1492. Epub 2020 Jun 20.

Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

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http://dx.doi.org/10.1002/ejhf.1873DOI Listing
August 2020