Tuesday, June 13, 2017

Udo Hoffmann, Maros Ferencik, James E. Udelson

Optimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing. In the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain and intermediate pretest probability for obstructive coronary artery disease (CAD) were randomly assigned to functional testing (exercise electrocardiography, nuclear stress, or stress echocardiography) or coronary computed tomography angiography (CTA). Site-based diagnostic test reports were classified as normal or mildly, moderately, or severely abnormal. The primary end point was death, myocardial infarction, or unstable angina hospitalizations over a median follow-up of 26.1 months.

Tuesday, May 16, 2017

Chokshi A, Udelson JE

Coronary artery calcification (CAC) by gated CT imaging has historically been used as a screening tool for the detection of atherosclerotic coronary artery disease (CAD). Advances in computed tomography (CT) technology have allowed for increased detection of CAC when performing routine non-gated chest CT for pulmonary pathology and lung cancer screening. The reporting of incidental CAC on these studies is neither common nor standardized. To date, only those patients enrolled in the American College of Radiology (ACR) lung cancer screening registry are required to have documentation of CAC, only if moderate or severe. A finding of incidental CAC will likely fall into the hands of the referring internist who is left with scarce data to guide subsequent management. Referral might then be made to a cardiologist who would be in a similar conundrum.

Monday, April 10, 2017

Butler J, Hamo CE, Udelson JE, O'Connor C, Sabbah HN, Metra M, Shah SJ, Kitzman DW, Teerlink JR

A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue on the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17, 2016, represented by clinicians, researchers, industry members, and regulators. 

Tuesday, March 14, 2017

Konstam MA, Hill JA, Kovacs RJ, Harrington RA, Arrighi JA, Khera A; Academic Cardiology Section Leadership Council of the ACC.

​Academic medical centers (AMCs) are presently facing enormous challenges arising from a prospective decline in government funding for research and education, shifting payment models emphasizing efficiency and value, and increasing competition. We propose a series of changes, including internal restructuring, system-wide partnership, and novel approaches to support research and education, that are designed to better position AMCs to compete and face their growing challenges in a manner that preserves their essential missions.

Thursday, September 01, 2016

Butler J, Hernandez AF, Anstrom K, Kalogeropoulos A, Redfield MM, Konstam MA

Mineralocorticoid receptor antagonist (MRA) therapy has not been studied well in acute HF (AHF) despite being commonly used in this setting. The ATHENA-HF (Aldosterone Targeted Neurohormonal Combined with Natriuresis Therapy in Heart Failure) trial is a randomized, double-blind, placebo-controlled study of the safety and efficacy of 100 mg/day spironolactone versus placebo (or continued low-dose spironolactone use in participants who are already receiving spironolactone at baseline) in 360 patients hospitalized for AHF. 

Wednesday, February 01, 2017

Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam

An expert panel of representatives from academia, industry and government Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. Sponsors and regulatory agencies discussed these challenges and proposed best practices and operating principles for the effective functioning of contemporary data monitoring committees.

Wednesday, March 01, 2017

Marvin A. Konstam, MD, Michael Kiernan, MD, MS, Arthur Chandler, MD, Ravi Dhingra, MD, MPH

Despite rapid and persistent weight loss with tolvaptan compared with placebo, in patients with AHF who were selected for greater potential benefit from vasopressin receptor inhibition, tolvaptan was not associated with greater early improvement in dyspnea. Apparent subsequent differences in dyspnea warrant further exploration of the temporal relationship between diuresis and dyspnea relief and a possible clinical role for tolvaptan. (To view HFSA poster, click here)

Wednesday, February 22, 2017

Marvin A. Konstam, MD, François M. Abboud, MD

The long-standing emphasis on ejection fraction (EF) is misguided. EF is erroneously assumed to be a measure of myocardial contractility. Of greater concern is the widespread classification of patients with heart failure (HF) based on whether EF is preserved (HFpEF) or reduced (HFrEF). In fact, EF does not provide any specific information on causation or underlying mechanisms. We believe that a revision or abandonment of this nomenclature is warranted, and categorization of patients with HF should more strongly emphasize underlying pathophysiology.

Sunday, September 04, 2011

Patel AR, Alsheikh-Ali AA, Mukherjee J, Evangelista A, Quraini D, Ordway LJ, Kuvin JT, Denofrio D, Pandian NG.

This study examined the utility of 3-dimensional right atrial volume index (3D-RAVi), combined with 2-dimensional echocardiographic (2DE) parameters, for the identification of elevated right atrial pressure (RAP) in patients with heart failure.​ Accurate noninvasive determination of RAP is clinically important for the management of patients with heart failure. Although 2DE methods have been used to noninvasively estimate RAP, the accuracy of these parameters has limitations when estimating RAP in an individual patient. Three-dimensional echocardiography (3DE) provides tomographic imaging of right atrial volume that may be helpful in refining the noninvasive assessment of hemodynamics in patients with heart failure.​ 2DE and 3DE studies were examined in 40 initial patients who were admitted for acutely decompensated heart failure. Simultaneous pulmonary artery catheter monitoring was performed. The relationship between echocardiographic parameters and RAP was examined in this derivation group. The findings from the derivation group were then prospectively tested in a validation group of 40 additional patients.

Tuesday, November 01, 2016

Javed Butler, MD, MPH, MBA; Carine E. Hamo, MD; James E. Udelson, MD

Parameters that adequately capture meaningful improvements in HFpEF patients will need to be incorporated within a regulatory pathway for drug approval. To initiate a dialogue about the compelling need for and the challenges in developing such alternative endpoints for patients with HFpEF, the US Food and Drug Administration on November 12, 2015, facilitated a meeting represented by clinicians, academia, industry, and regulatory agencies. 

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