Publications by authors named "Lindenfeld J"

BAY 2413555 is a novel selective and reversible positive allosteric modulator of the type 2 muscarinic acetylcholine (M2) receptor, aimed at enhancing parasympathetic signaling and restoring cardiac autonomic balance for the treatment of heart failure (HF). This study tested the safety, tolerability and pharmacokinetics of this novel therapeutic option. REMOTE-HF was a multicenter, double-blind, randomized, placebo-controlled, phase Ib dose-titration study with two active arms.

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Background: Predicted heart mass ratio (PHMr) has become the standard donor-recipient size matching method in heart transplantation. While utilization of small PHMr hearts is associated with increased one-year mortality, the underlying mechanisms and time horizon of mortality remain uncertain.

Methods: A single institution analysis of isolated heart transplant recipients (01/2019-7/2022) was performed (N=334).

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Aims: The interstitial space is the major compartment in which the excess fluid is located, forming peripheral congestion in acute decompensated heart failure (ADHF). The lymphatic system is responsible for the constant drainage of the compartment. In ADHF, the inefficiency of this system causes extravascular fluid accumulation, underscoring the crucial role of lymphatic system failure in ADHF's pathophysiology.

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Introduction: Each year the number of combined heart-liver transplants (HLT) increases, with two distinct patient populations proceeding down this pathway. The first are patients with congenital heart disease (CHD), most commonly single ventricle patients palliated with Fontan. The second group are those with long standing congestive hepatopathy, amyloidosis, hemochromatosis, or alcohol induced myopathies and liver disease.

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Aims: In the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial, the soluble guanylate cyclase stimulator vericiguat reduced the risk of hospitalization for heart failure (HHF) or cardiovascular death in patients with heart failure (HF) and reduced ejection fraction (HFrEF) with recent worsening HF. The effect of vericiguat in patients with HFrEF without recent worsening HF remains unknown. The VICTOR (Vericiguat Global Study in Participants with Chronic Heart Failure) trial was designed to assess the efficacy and safety of vericiguat in patients with ejection fraction ≤40% without recent worsening HF on a background of current foundational HFrEF therapy.

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  • Home-time is the time patients spend alive and at home after being treated for heart failure, and it hasn't been studied much before. * -
  • The study looked at 66,019 older patients who had heart failure from 2019 to 2021 and found that many didn’t get to spend all their time at home; only 22% spent a full year at home after leaving the hospital. * -
  • A lot of older patients, especially Black patients, had less time at home, and many faced high rates of returning to the hospital or dying within a year after their discharge.*
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  • Study investigates the use of patiromer, a potassium binder, to improve the effectiveness of RAAS inhibitors in patients with heart failure and hyperkalemia.
  • In a trial with over 1,000 patients, those with hyperkalemia were able to optimize their medication while on patiromer, showing a slight reduction in serum potassium levels compared to placebo.
  • Results suggest patiromer helps patients with current hyperkalemia maintain optimal doses of medication more effectively than those with a history of hyperkalemia, enhancing treatment outcomes for heart failure management.
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Background: Psychosocial evaluations to assess candidacy for advanced heart failure therapies are not standardized across institutions, potentially contributing to disparities in approval for advanced therapies. Remediation rates of psychosocial stressors among patients with advanced HF and reconsideration for advanced therapies have not been well-described.

Methods And Results: We performed a retrospective, single-center study of 647 adults evaluated for heart transplant and ventricular assist device implantation between 2014 and 2020, of whom 89 (14%) were denied for psychosocial stressors, including caregiver, substance use, housing, financial, or mental health concerns.

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  • An interatrial shunt is being studied as a potential treatment for heart failure, aimed at lowering left atrial pressure and improving symptoms and outcomes for patients.
  • In a clinical trial involving 508 patients, participants were randomly assigned to receive either the shunt or a placebo, with their progress tracked over a maximum of two years.
  • Results showed that while the shunt had no major safety issues, it did not significantly improve overall effectiveness compared to the placebo, although it appeared to reduce adverse cardiovascular events in patients with reduced left ventricular ejection fraction.
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Background: The implications of pulmonary vein (PV) flow patterns in patients with heart failure (HF) and mitral regurgitation (MR) are uncertain. We examined PV flow patterns in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial (NCT01626079), in which patients with HF and moderate-to-severe or severe functional MR were randomized to transcatheter edge-to-edge repair (TEER) with the MitraClip device plus guideline-directed medical therapy (GDMT) vs. GDMT alone.

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Background: Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known.

Objectives: The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies.

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Background: Few study authors examined factors influencing health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) implantation.

Objective: The purpose of this study was to determine whether 5 novel self-report measures and other variables were significantly associated with overall HRQOL at 3 months after LVAD surgery.

Methods: Patients were recruited between October 26, 2016, and February 29, 2020, from 12 US sites.

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  • Pathologic left ventricular remodeling and valvular heart disease can worsen heart failure symptoms and reduce the effectiveness of standard treatments.
  • Surgical options like ventricular restoration and valve repair are effective, but transcatheter (minimally invasive) interventions are emerging as viable alternatives for patients who still suffer symptoms despite optimal medical therapy.
  • This statement will explore current and experimental percutaneous approaches to treat heart failure related to left ventricular cardiomyopathies and valve issues.
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Background: Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR.

Methods: Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days.

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  • Risk scores like MitraScore and COAPT help identify patients with mitral regurgitation (MR) who are at risk of adverse events but may still benefit from transcatheter edge-to-edge repair (TEER).
  • The study validated MitraScore in the COAPT trial with 614 patients and the COAPT risk score in the MIVNUT registry with 1007 patients, both focusing on predicting all-cause mortality over approximately 2 years.
  • Results indicated that both scores had fair to good predictive accuracy for mortality, with higher effectiveness seen in TEER patients, confirming the benefits of combining TEER with guideline-directed medical therapy (GDMT) across different risk levels.
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  • Diuresis is crucial for treating patients with acute decompensated heart failure (ADHF) to relieve fluid buildup, but there's no one-size-fits-all diuretic strategy that has proven to be the best.
  • Current research highlights the connection between urine sodium levels and patient outcomes, suggesting that monitoring urine chemistry could help tailor diuretic treatments.
  • The review aims to consolidate existing studies on diuretic management, identify what we still don't know, and outline ongoing clinical trials that explore urine sodium-guided diuresis in ADHF management.
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Background: Utilization of temporary mechanical circulatory support, including veno-arterial extra-corporeal membrane oxygenation as a bridge to heart transplantation (HT) has increased significantly under the revised United Network for Organ Sharing (UNOS) donor heart allocation system. The revised heart allocation system aimed to lower waitlist times and mortality for the most critically ill patients requiring biventricular, nondischargeable, mechanical circulatory support. While previous reports have shown improved 1-year post-HT survival in the current era, 3-year survival and factors associated with mortality among bridge-to-transplant (BTT) extra-corporeal membrane oxygenation (ECMO) patients are not well described.

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The "International Society for Heart and Lung Transplantation Guidelines for the Evaluation and Care of Cardiac Transplant Candidates-2024" updates and replaces the "Listing Criteria for Heart Transplantation: International Society for Heart and Lung Transplantation Guidelines for the Care of Cardiac Transplant Candidates-2006" and the "2016 International Society for Heart Lung Transplantation Listing Criteria for Heart Transplantation: A 10-year Update." The document aims to provide tools to help integrate the numerous variables involved in evaluating patients for transplantation, emphasizing updating the collaborative treatment while waiting for a transplant. There have been significant practice-changing developments in the care of heart transplant recipients since the publication of the International Society for Heart and Lung Transplantation (ISHLT) guidelines in 2006 and the 10-year update in 2016.

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  • About 40% of heart failure patients eligible for cardiac resynchronization therapy (CRT) do not respond or cannot be treated, highlighting the need for alternative options.
  • The SOLVE-CRT study evaluated the safety and effectiveness of a new leadless left ventricular pacing system for high-risk patients or those who had unsuccessful CRT using conventional methods.
  • The study involved 183 participants, primarily older males, and was stopped early due to positive results showing improvements in safety and a decrease in heart chamber size.
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  • In the last ten years, there have been many new heart failure drugs approved by the FDA, showing great progress in treatment.
  • The FDA has provided guidelines to help with the development of these drugs, but there are still challenges that need to be solved.
  • The Heart Failure Collaboratory wants to promote teamwork among scientists, doctors, patients, and regulatory groups to improve drug development and help people with heart failure better.
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  • * Many patients with serious symptoms of TR are included in clinical trials for new transcatheter devices, indicating they may be at an advanced stage of HFpEF.
  • * The review explores how treating HFpEF could influence TR's underlying issues and how changes after transcatheter TR treatment might improve symptoms and outcomes for HFpEF patients.
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Background: Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States.

Methods: Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity.

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