Cardiology

Ferreira, J.P., Claggett, B.L., Liu, J., Desai, A.S., Pfeffer, M.A., Anand, I.S., Van Veldhuisen, D.J., Kober, L., Cleland, J.G.F., Rouleau, J.L., Packer, M., Zile, M.R., Shi, V.C., Lefkowitz, M.P., Shah, S.J., Vardeny, O., Zannad, F., Solomon, S.D. and McMurray, J.J.V. (2021). “Serum potassium and outcomes in heart failure with preserved ejection fraction: a post-hoc analysis of the PARAGON-HF trial.” Eur J Heart Fail Feb 20. [Epub ahead of print].

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AIMS: The relationship between serum potassium concentration and outcomes in patients with heart failure and preserved ejection fraction (HFpEF) is not well-established. The aim of this study was to explore the association between serum potassium and clinical outcomes in the PARAGON-HF trial in which 4822 patients with HFpEF were randomised to treatment with sacubitril/valsartan or valsartan. METHODS AND RESULTS: The relationship between serum potassium concentrations and the primary study composite outcome of total (first and recurrent) heart failure hospitalisations and cardiovascular death was analysed. Hypo-, normo-, and hyperkalaemia were defined as serum potassium <4 mmol/L, 4-5 mmol/L and >5 mmol/L, respectively. Both screening and time-updated potassium (categorical and continuous spline-transformed) were studied. Patient mean age was 73 years and 52% were women. Patients with higher baseline potassium more often had an ischaemic aetiology and diabetes and mineralocorticoid receptor antagonist treatment. Compared with normokalaemia, both time-updated (but not screening) hypo- and hyperkalaemia were associated with a higher risk of the primary outcome [adjusted hazard ratio (HR) for hypokalaemia 1.55, 95% confidence interval (CI) 1.30-1.85; P < 0.001, and for hyperkalaemia HR 1.21, 95% CI 1.02-1.44; P = 0.025]. Hypokalaemia had a stronger association with a higher risk of all-cause, cardiovascular and non-cardiovascular death than hyperkalaemia. The association of hypokalaemia with increased risk of all-cause and cardiovascular death was most marked in participants with impaired kidney function (interaction P < 0.05). Serum potassium did not significantly differ between sacubitril/valsartan and valsartan throughout the follow-up. CONCLUSIONS: Both hypo- and hyperkalaemia were associated with heart failure hospitalisation but only hypokalaemia was associated with mortality, especially in the context of renal impairment. Hypokalaemia was as strongly associated with death from non-cardiovascular causes as with cardiovascular death. Collectively, these findings suggest that potassium disturbances are a more of a marker of HFpEF severity rather than a direct cause of death.

Rahimi, G., Tecson, K.M., Elsaid, O. and McCullough, P.A. (2021). “Role of Ischemic Heart Disease in Major Adverse Renal and Cardiac Events Among Individuals With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).” Am J Cardiol 142: 91-96.

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Despite improvements in the prognosis of patients with heart failure with reduced ejection fraction (HFrEF), established therapy for heart failure patients with preserved ejection fraction (HFpEF) is lacking. Additionally, ischemic heart disease adversely impacts the clinical course of HFrEF patients; however, its role in HFpEF is not fully understood. We conducted a post hoc analysis of propensity score matched patients from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial to compare HFpEF patients with versus without myocardial ischemia in terms of major adverse renal and/or cardiac events (MARCE). Of 3,445 participants, the prevalence of ischemia was 59%. For this analysis, we included 1,747 ischemic patients and 1,207 propensity matched nonischemic patients. Ischemia was associated with a 20% increased risk (HR = 1.20, 95% confidence interval [CI] = 1.042 to 1.382, p value = 0.0112) of major adverse renal and/or cardiac events (MARCE) in adjusted analyses. Other important predictors of MARCE were diabetes (hazard ratio [HR] = 1.60, 95% CI = 1.38 to 1.87, p <0.0001), dyslipidemia (HR = 1.30, 95% CI = 1.10 to 1.52, p = 0.001) and smoking (HR = 1.33, 95% CI = 1.04 to 1.69, p = 0.0197). Revascularization was not significantly associated with MARCE in the subgroup of ischemic HFpEF patients. Future work is warranted to develop tailored interventions for patients with both HFpEF and ischemic heart disease to mitigate the risk of MARCE .

Aldujeli, A., Hamadeh, A., Tecson, K.M., Krivickas, Z., Maciulevicius, L., Stiklioraitis, S., Sukys, M., Briedis, K., Aldujeili, M., Briede, K., Braukyliene, R., Pranculis, A., Unikas, R., Zaliaduonyte, D. and McCullough, P.A. (2021). “Six-Month Outcomes for COVID-19 Negative Patients with Acute Myocardial Infarction Before Versus During the COVID-19 Pandemic.” Am J Cardiol Feb 23;S0002-9149(21)00161-2. [Epub ahead of print].

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The Coronavirus disease 2019 (COVID-19) pandemic has changed the way patients seek medical attention and how medical services are provided. We sought to compare characteristics, clinical course, and outcomes of patients presenting with acute myocardial infarction (AMI) during the pandemic compared with before it. This is a multicenter, retrospective cohort study of consecutive COVID-19 negative patients with AMI in Lithuania from March 11, 2020 to April 20, 2020 compared with patients admitted with the same diagnosis during the same period in 2019. All patients underwent angiography. Six-month follow-up was obtained for all patients. A total of 269 patients were included in this study, 107 (40.8%) of whom presented during the pandemic. Median pain-to-door times were significantly longer (858 [quartile 1=360, quartile 3 = 2,600] vs 385.5 [200, 745] minutes, p <0.0001) and post-revascularization ejection fractions were significantly lower (35 [30, 45] vs 45 [40, 50], p <0.0001) for patients presenting during vs. prior to the pandemic. While the in-hospital mortality rate did not differ, we observed a higher rate of six-month major adverse cardiovascular events for patients who presented during versus prior to the pandemic (30.8% vs 13.6%, p = 0.0006). In conclusion, 34% fewer patients with AMI presented to the hospital during the COVID-19 pandemic, and those who did waited longer to present and experienced more 6-month major adverse cardiovascular events compared with patients admitted before the pandemic.

Jain, S.S., Cohen, D.J., Zhang, Z., Uriel, N., Sayer, G., Lindenfeld, J., Abraham, W.T., Mack, M.J., Stone, G.W. and Arnold, S.V. (2021). “Defining a Clinically Important Change in 6-Minute Walk Distance in Patients With Heart Failure and Mitral Valve Disease.” Circ Heart Fail Mar 5;CIRCHEARTFAILURE120007564. [Epub ahead of print].

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Patients with heart failure (HF) and secondary mitral regurgitation (SMR) have substantial impairment in patient-reported health status and functional status, both of which may improve rapidly after edge-to-edge transcatheter mitral valve repair (TMVr). As such, health status (assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]) and functional status (assessed with 6-minute walk distance [6MWD]) are increasingly incorporated as key end points in ongoing trials of novel HF therapies. It is therefore important to understand the magnitude of clinically relevant changes in these metrics. [No abstract; excerpt from article].

Thourani, V.H., George, I., Rucinskas, K., Kalinauskas, G., Janusauskas, V., Zakarkaite, D., Ailawadi, G., Smith, R. and Mack, M.J. (2021). “First in human experience with an epicardial beating heart device for secondary mitral regurgitation.” J Thorac Cardiovasc Surg 161(3): 949-958.e944.

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OBJECTIVE: We describe a novel, off-pump, epicardial implant that is intended to reshape both the mitral valve annulus and the left ventricle (LV) in those with secondary mitral regurgitation (MR). METHODS: Five patients underwent an epicardial implant with the Mitral Touch device (Mitre Medical Corp, Morgan Hill, Calif), during concomitant off-pump coronary artery bypass for secondary MR. The median age was 71.2 years; 4 patients had severe MR and 1 moderate. Patients were followed for 1 year with transthoracic echocardiography and computed tomography. Safety, cardiac remodeling, and MR were assessed by an independent core laboratory. RESULTS: One patient died within 30 days from nondevice-related organ failure and the remaining 4 survived through 1-year follow-up. Implant technical success was 100% and took an average of 52 minutes. Paired computed tomography showed mean left ventricular end-systolic volume remodeling at 1 and 12 months of -35% and -31%, respectively. They averaged left atrial end-systolic volume remodeling of -12% and -15% at 1 and 12 months. Right ventricular end-systolic volume changes of -19% and -8% and right atrial end-systolic volume remodeling of -5% and 1%, at the 1- and 12-month time points were noted. Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, respectively. There were no device-related complications reported to 1 year. CONCLUSIONS: The Epicardial Mitral Touch System for Mitral Regurgitation (ENRAPT-MR) study demonstrates a first-in-man, off-pump, epicardial repair of secondary MR. Procedural safety and geometric correction of the mitral valve apparatus and LV was achieved. Further studies in the United States are underway.