Cardiology

Posted March 15th 2016

Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Trial.

Milton Packer M.D.

Milton Packer, M.D.

Solomon, S. D., B. Claggett, A. S. Desai, M. Packer, M. Zile, K. Swedberg, J. L. Rouleau, V. C. Shi, R. C. Starling, O. Kozan, A. Dukat, M. P. Lefkowitz and J. J. McMurray (2016). “Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Trial.” Circ Heart Fail 9(3): e002744.

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BACKGROUND: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan (LCZ696) reduced cardiovascular morbidity and mortality compared with enalapril in patients with heart failure (HF) and reduced ejection fraction (EF) in the Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial. We evaluated the influence of EF on clinical outcomes and on the effectiveness of sacubitril/valsartan compared with enalapril. METHODS AND RESULTS: Eight thousand three hundred ninety-nine patients with New York Heart Association class II to IV HF with reduced EF [left ventricular EF (LVEF) less than of equal to 40%] were randomized to sacubitril/valsartan 97/103 mg twice daily versus enalapril 10 mg twice daily and followed for a median of 27 months. The primary study end point was cardiovascular death or HF hospitalization. LVEF was assessed at the sites and recorded on case report forms. We related LVEF to study outcomes and assessed the effectiveness of sacubitril/valsartan across the LVEF spectrum. The mean LVEF in PARADIGM-HF, reported by sites, was 29.5 (interquartile range, 25-34). The risk of all outcomes increased with decreasing LVEF. Each 5-point reduction in LVEF was associated with a 9% increased risk of cardiovascular death or HF hospitalization (hazard ratio, 1.09; 95% confidence interval, 1.05-1.13; P<0.001), a 9% increased risk for CV death (hazard ratio, 1.09; 95% confidence interval, 1.04-1.14), a 9% increased risk in HF hospitalization (hazard ratio, 1.09; 95% confidence interval, 1.04-1.14) and a 7% increased risk in all-cause mortality (hazard ratio, 1.07; 95% confidence interval, 1.03-1.12) in adjusted analyses. Sacubitril/valsartan was effective across the LVEF spectrum, with no evidence of heterogeneity, when modeled either in tertiles (P interaction=0.87) or continuously (P interaction=0.95). CONCLUSIONS: In patients with HF and reduced EF enrolled in PARADIGM-HF, LVEF was a significant and independent predictor of all outcomes. Sacubitril/valsartan was effective at reducing cardiovascular death and HF hospitalization throughout the LVEF spectrum. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255.


Posted February 19th 2016

Echocardiographic and Blood Pressure Characteristics of First-Year Collegiate American-Style Football Players.

John P. Erwin M.D.

John P. Erwin, M.D.

Crouse, S. F., S. White, J. P. Erwin, T. H. Meade, S. E. Martin, J. M. Oliver, D. P. Joubert, B. S. Lambert, J. P. Bramhall, K. Gill and D. Weir (2016). “Echocardiographic and Blood Pressure Characteristics of First-Year Collegiate American-Style Football Players.” Am J Cardiol 117(1): 131-134.

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Echocardiographic (echo) and blood pressure (BP) reference values may help identify athletes at cardiovascular risk, yet benchmarks are inadequate for collegiate American-style football (ASF) players. Our purpose was to describe echo characteristics and BP values in collegiate ASF athletes compared with normal. First-year players (n = 80, age = 18 +/- 1 years, height = 186 +/- 7 cm, weight = 100.1 +/- 22.0 kg, body mass index = 28.7 +/- 5.0), body surface area [BSA] = 2.24 +/- 0.25; percentage fat = 16.5 +/- 9.7%) were measured for systolic and diastolic BP, and underwent echo procedures by a certified sonographer. Data analyses included simple statistics, Pearson r, frequencies in normal ranges, and t test; alpha = 0.05. Selected echo measurements (and indexed by BSA) were: left ventricular (LV) internal diameter diastole = 5.3 +/- 0.5 cm (2.4 +/- 0.3); left atrial diameter = 3.9 +/- 0.5 cm (1.8 +/- 0.2): LV end-diastolic volume = 138 +/- 30 ml (62 +/- 11); septal wall thickness = 1.0 +/- 0.2 cm (0.5 +/- 0.1); LV posterior wall thickness = 1.0 +/- 0.1 cm (0.5 +/- 0.1), LV mass = 212 +/- 46 g (95 +/- 18); and relative wall thickness = 0.39 +/- 0.07. Correlations between BSA and echo variables were significant (r = 0.26 to 0.50). Indexing by BSA reduced percentages above reference ranges from 36% to 7%. Septal wall thickness index was significantly greater in black (0.5 +/- 0.1) than nonblack (0.4 +/- 0.1) athletes. Fifty-nine athletes were hypertensive or prehypertensive, and diastolic BP was significantly greater in black (76 +/- 10 mm Hg) compared with nonblack athletes (71 +/- 8 mm Hg). ASF athletes demonstrated LV wall thicknesses and cavity sizes consistent with sport-training hypertrophy but which were unremarkable when indexed by BSA. Ethnicity generally did not influence echo variables. No ASF players were identified with cardiac dysfunction or disease.


Posted February 19th 2016

The National Cardiovascular Data Registry Voluntary Public Reporting Program: An Interim Report From the NCDR Public Reporting Advisory Group.

Gregory J. Dehmer M.D.

Gregory J. Dehmer, M.D.

Dehmer, G. J., J. Jennings, R. A. Madden, D. J. Malenka, F. A. Masoudi, C. R. McKay, D. L. Ness, S. V. Rao, F. S. Resnic, M. E. Ring, J. S. Rumsfeld, M. E. Shelton, M. C. Simanowith, L. E. Slattery, W. S. Weintraub, A. Lovett and S. L. Normand (2016). “The National Cardiovascular Data Registry Voluntary Public Reporting Program: An Interim Report From the NCDR Public Reporting Advisory Group.” J Am Coll Cardiol 67(2): 205-215.

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Public reporting of health care data continues to proliferate as consumers and other stakeholders seek information on the quality and outcomes of care. Medicare’s Hospital Compare website, the U.S. News & World Report hospital rankings, and several state-level programs are well known. Many rely heavily on administrative data as a surrogate to reflect clinical reality. Clinical data are traditionally more difficult and costly to collect, but more accurately reflect patients’ clinical status, thus enhancing the validity of quality metrics. We describe the public reporting effort being launched by the American College of Cardiology and partnering professional organizations using clinical data from the National Cardiovascular Data Registry (NCDR) programs. This hospital-level voluntary effort will initially report process of care measures from the percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries of the NCDR. Over time, additional process, outcomes, and composite performance metrics will be reported.


Posted February 19th 2016

Comparison of Transesophageal and Transthoracic Echocardiographic Measurements of Mechanism and Severity of Mitral Regurgitation in Ischemic Cardiomyopathy (from the Surgical Treatment of Ischemic Heart Failure Trial).

Paul A. Grayburn M.D.

Paul A. Grayburn, M.D.

Grayburn, P. A., L. She, B. J. Roberts, K. S. Golba, K. Mokrzycki, J. Drozdz, A. Cherniavsky, R. Przybylski, K. Wrobel, F. M. Asch, T. A. Holly, H. Haddad, M. Yii, G. Maurer, I. Kron, H. Schaff, E. J. Velazquez and J. K. Oh (2015). “Comparison of Transesophageal and Transthoracic Echocardiographic Measurements of Mechanism and Severity of Mitral Regurgitation in Ischemic Cardiomyopathy (from the Surgical Treatment of Ischemic Heart Failure Trial).” Am J Cardiol 116(6): 913-918.

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Mitral regurgitation (MR) is common in ischemic heart disease and contributes to symptoms and mortality. This report compares the results of baseline transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE) imaging of the mechanism and severity of functional MR in patients with ischemic cardiomyopathy in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. Independent core laboratories measured both TTE and TEE images on 196 STICH participants. Common measurements to both models included MR grade, mitral valve tenting height and tenting area, and mitral annular diameter. For each parameter, correlations were assessed using Spearman rank correlation coefficients. A modest correlation was present between TEE and TTE for overall MR grade (n = 176, r = 0.52). For mechanism of MR, modest correlations were present for long-axis tenting height (n = 152, r = 0.35), tenting area (n = 128, r = 0.27), and long-axis mitral annulus diameter (n = 123, r = 0.41). For each measurement, there was significant scatter. Potential explanations for the scatter include different orientation of the imaging planes between TEE and TTE, a mean temporal delay of 6 days between TEE and TTE, and statistically significant differences in heart rate and blood pressure and weight between studies. In conclusion, TEE and TTE measurements of MR mechanism and severity correlate only modestly with enough scatter in the data that they are not interchangeable.