Angioaccess for hemodialysis in kidney transplantation

Cardiovascular complications represent the main cause of morbidity and mortality in patients with chronic renal disease, so the objective of this article is to demonstrate the influence of the patency of the arteriovenous fistula on echocardiographic variables measured in the left heart. For this, a multivariate study, longitudinal, prospective and controlled study of independent groups after an intervention that included 39 patients who had their angioaccess closed (study group) and 42 who were not exposed to surgery (control group). Both groups exhibited functional kidney transplantation. The main results emerge when comparing the prevalence between the study group and the control group, the average age; 45.6 and 44.1 years, the male sex, 24 (60%) and 23 (53.5%) and the white skin color; 33 (82.5%) and 32 (74.4%). The most frequent etiology of the original nephropathy was hypertensive vascular nephropathy; 12 (30%) vs 14 (32.6%). Among the clinical manifestations, remission of palpitations and dyspnea on exertion were evidenced in the study group. With regard to blood pressure, for the systolic it ranged from 123 ±13.4 to 120.5 ±9.2 vs. 125.6 ±8.4 to 128 ±8.3 mmHg (p= 0.000), while the diastolic varied from; 76.8 ±7.5 to 76.3 ±6.2 vs. 78.6 ±4.9 to 82.4 ±3.9 mmHg (p= 0.000). The hematocrit had equivalent values; 0.43 ±0.06 and 0.45 ±0.06 vs 0.42 ±0.05 and 0.42 ±0.06 l/l (p= 0.035) and the serum creatinine showed decrease in the operated patients from; 106.8 ±26.2 to 99.8 ±23.9 μMol/l vs 114 ±27.8 to 120.3 ±31 μMol/l (p= 0.002). The echocardiographic variables measured comparatively according to the location of the angioaccesses at the left elbow level; diameter of the left ventricle: 3.12 ±4.08 vs 1.48 ±3.46 mms (p=0.001), ejection fraction of the left ventricle: 2.99 ±5.47 vs -1.98 ±6.23 % (p=0.018) and the telediasolic volume: -23 ±33.41 vs 10.86 ±36.87 ml (p=0.006). The contralateral elbow revealed; for the left ventricular ejection fraction: 3.32 ±3.42 vs -2.18 ±4.78 % (p=0.037) and for cardiac output: -1.29 ±0.88 vs -0.26 ±0.86 l/min (0.020). The conclusions show that the our study has shown that closing the angioaccess to patients with functioning renal transplants with respect to those not operated, contributes to the regression of morphological and hemodynamic alterations observed by transthoracic echocardiography in the left heart at the different locations of the vascular accesses.

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New Hybrid Method for Left Ventricular Ejection Fraction Assessment from Radionuclide Ventriculography Images

Current Medical Imaging Formerly Current Medical Imaging Reviews ◽

10.2174/1573405616666201118122509 ◽

2020 ◽

Vol 16 ◽

Author(s):

Halima Dziri ◽

Mohamed Ali Cherni ◽

Dorra Ben Sellem

Keyword(s):

Left Ventricular Ejection Fraction ◽

Left Ventricle ◽

Ejection Fraction ◽

Positive Predictive Value ◽

Roc Curve ◽

Radionuclide Ventriculography ◽

Left Ventricular ◽

The Other ◽

Left Ventricular Ejection ◽

Ventricular Ejection Fraction

Background: In this paper, we propose a new efficient method of radionuclide ventriculography image segmentation to estimate the left ventricular ejection fraction. This parameter is an important prognostic factor for diagnosing abnormal cardiac function. Methods: The proposed method combines the Chan-Vese and the mathematical morphology algorithms. It was applied to diastolic and systolic images obtained from the Nuclear Medicine Department of Salah AZAIEZ Institute.In order to validate our proposed method, we compare the obtained results to those of two methods of the literature. The first one is based on mathematical morphology, while the second one uses the basic Chan-Vese algorithm. To evaluate the quality of segmentation, we compute accuracy, positive predictive value and area under the ROC curve. We also compare the left ventricle ejection fraction estimated by our method to that of the reference given by the software of the gamma-camera and validated by the expert, using Pearson’s correlation coefficient, ANOVA test and linear regression. Results and conclusion: Static results show that the proposed method is very efficient in the detection of the left ventricle. The accuracy was 98.60%, higher than that of the other two methods (95.52% and 98.50%). Likewise, the positive predictive value was the highest (86.40% vs. 83.63% 71.82%). The area under the ROC curve was also the most important (0.998% vs. 0.926% 0.919%). On the other hand, Pearson's correlation coefficient was the highest (99% vs. 98% 37%). The correlation was significantly positive (p<0.001).

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COVID-19-associated myocarditis: single center experience of pathogenetic treatment

Ukrainian Journal of Cardiology ◽

10.31928/1608-635x-2021.3.919 ◽

2021 ◽

Vol 28 (3) ◽

pp. 9-19

Author(s):

V. M. Kovalenko ◽

E. G. Nesukay ◽

N. S. Titova ◽

S. V. Cherniuk ◽

R. M. Kirichenko ◽

...

Keyword(s):

Left Ventricular Ejection Fraction ◽

Left Ventricle ◽

Ejection Fraction ◽

Proinflammatory Cytokines ◽

Left Ventricular ◽

Ventricular Ejection ◽

Glucocorticoid Therapy ◽

Volume Index ◽

Left Ventricular Ejection ◽

Ventricular Ejection Fraction

The aim – to evaluate the effectiveness of glucocorticoid therapy in patients with myocarditis with reduced left ventricular ejection fraction that developed after COVID-19 infection.Materials and methods. The results of glucocorticoid therapy in 32 patients aged (35.2±2.3) years with acute myocarditis after COVID-19 infection and left ventricular ejection fraction < 40 % are presented. All patients were prescribed a 3-month course of methylprednisolone at a daily dose of 0.25 mg/kg, followed by a gradual dose reduction of 1 mg per week until complete withdrawal 6 months after the start of treatment.Results and discussion. The analysis of the results of the examinations was performed in the 1st month from the onset of myocarditis to the appointment of glucocorticoids and after 6 months of observation. Six months later, the end-diastolic volume index decreased by 18.5 %, the left ventricular ejection fraction increased by 23.8 %, and the longitudinal global systolic straine increased by 39.8 %. On cardiac MRI, the number of left ventricular segments affected by inflammatory changes decreased from 6.22±0.77 to 2.89±0.45 segments, and the number of segments with fibrotic changes did not change significantly. After 6 months of treatment, there was a significant decrease in the concentrations of proinflammatory cytokines and cardiospecific antibodies.Conclusions. The use of a 6-month course of glucocorticoid therapy in patients with myocarditis that developed after COVID-19 infection improved the contractility of the left ventricle against the background of a significant reduction in inflammatory lesions of the left ventricle and reduced concentrations of proinflammatory cytokines and cardiospecific antibodies.

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Abstract 14114: Sodium-glucose Cotransporter-2 Inhibitors Benefit Cardiac Diastolic Function

Circulation ◽

10.1161/circ.142.suppl_3.14114 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Anantha Madgula ◽

Kai Chen

Keyword(s):

Ejection Fraction ◽

Diastolic Function ◽

Multivariate Regression ◽

Statistical Significance ◽

Left Ventricular ◽

Volume Index ◽

Control Group ◽

Study Group ◽

Sodium Glucose Cotransporter ◽

Organ Systems

Introduction: Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors are drugs with profound interest because of their beneficial effect on multiple organ systems, including the cardiovascular and renal systems. Their interplay with these systems could prove beneficial in managing complex conditions like heart failure with preserved ejection fraction. We sought to compare cardiac diastolic function in patients on SGLT-2 inhibitors with those on metformin. Methods: Data were collected retrospectively after approval from our institutional review board. The study group included patients on SGLT-2 inhibitors (n=75), and the control group had patients on metformin (n=82), primarily for diabetes mellitus. Patients with ejection fraction less than 50% were excluded from the study. Data collected included age, systolic blood pressure (SBP), left ventricular (LV) ejection fraction, LV and left atrial dimensions, and diastolic parameters. Mean values, along with standard deviation, were calculated. Multivariate regression analysis for diastolic function was performed while adjusting for confounders, including age, body mass index, and SBP. Results: Study group showed better diastolic function as evidenced by significantly higher e’ medial (6.8 v/s 6.16 cm/s; p = 0.03) and e’ lateral (9.8 v/s 7.9 cm/s; p=0.008) when compared to the control group. E/e’, a marker of pulmonary capillary wedge pressure, was lower in the study group (12.87 v/s 14.36; p=0.08); however, it did not reach statistical significance. LA volume index was significantly lower in the study group, suggestive of favorable hemodynamic status (26.5 v/s 29.6 mL/m 2 ; p=0.03). SBP was significantly lower in the study group (127 v/s 135 mm Hg; p=0.01). Multivariate regression model demonstrated SBP as a significant confounder that contributed to e’ (average) difference between the two groups. Conclusions: SGLT-2 inhibitors favored better diastolic measurements when compared with metformin alone. The mechanism may be attributed to its BP-lowering effect. A larger prospective study is required to determine the role of SGLT-2 inhibitors.

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P971 The echocardiographic phenotype in patients with cardiac amyloidosis and heart failure with preserved ejection fraction

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez319.603 ◽

2020 ◽

Vol 21 (Supplement_1) ◽

Author(s):

M D M Perez Gil ◽

V Mora Llabata ◽

A Saad ◽

A Sorribes Alonso ◽

V Faga ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Cardiac Amyloidosis ◽

Nyha Class ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Control Group ◽

Ventricular Ejection Fraction ◽

Apical Rotation ◽

Dynamic Torsion

Abstract BACKGROUND New echocardiographic phenotypes of heart failure (HF) are focused on myocardial systolic involvement of the left ventricle (LV), either endocardial and/or transmural. PURPOSE. To study the pattern of myocardial involvement in patients (p) with HF with preserved left ventricular ejection fraction (pLVEF) and cardiac amyloidosis (CA). METHODS. Comparative study of 16 p with CA and HF with pLVEF, considering as cut point LVEF > 50%, in NYHA class ≥ II / IV, and a control group of 16 healthy people. Longitudinal Strain (LS) and Circumferential Strain (CS) were calculated using 2D speckle-tracking echocardiography, along with Mitral Annulus Plane Systolic Excursion (MAPSE) and Base-Apex distance (B-A). Also, the following indexes were calculated: Twist (apical rotation + basal rotation, º); Classic Torsion (TorC): (twist/B-A, º/cm); Torsion Index (Tor.I): (twist/MAPSE, º/cm) and Deformation Index (Def.I): (twist/LS, º). We suggest the introduction of these dynamic torsion indexes as Tor.I and Def.I that include twist per unit of longitudinal systolic shortening of the LV instead of using TorC which is the normalisation of twist to the end-diastolic longitudinal diameter of the LV. RESULTS There were no differences of age between the groups (68.2 ± 11.5 vs 63.7 ± 2.8 years, p = 0.14). Global values of LS and CS were lower in p with CA indicating endocardial and transmural deterioration during systole, while TorC and Twist of the LV remained conserved in p with CA. However, there is an increase of dynamic torsion parameters such as Tor.I and Def.I that show an increased Twist per unit of longitudinal shortening of the LV in the CA group (Table). CONCLUSIONS In p with CA and HF with pLVEF, the impairment of LS and CS indicates endocardial and transmural systolic dysfunction. In these conditions, LVEF would be preserved at the expense of a greater dynamic torsion of the LV. Table LS (%) CS (%) Twist (º) TorC (º/cm) Tor.I (º/cm) Def.I (º/%) CA pLVEF (n = 16) -11.7 ± 4.2 17.2 ± 4.8 19.8 ± 8.3 2.5 ± 1.1 27.7 ± 13.5 -1.8 ± 0.9 Control Group (n = 15) -20.6 ± 2.5 22.7 ± 4.9 21.7 ± 6.1 2.7 ± 0.8 16.4 ± 4.7 -1.0 ± 0.3 p < 0.001 < 0.01 0.46 0.46 < 0.01 < 0.01 Dynamic Torsion Indexes and Classic Torion Parameters in pLVEF CA patients vs Control group.

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559 An analysis of myocardial efficiency in patients with severe asymptomatic mitral regurgitation

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez319.289 ◽

2020 ◽

Vol 21 (Supplement_1) ◽

Author(s):

R Cetin Guvenc ◽

E Arugaslan ◽

T S Guvenc ◽

F Ozpamuk Karadeniz ◽

H Kasikcioglu ◽

...

Keyword(s):

Left Ventricular Ejection Fraction ◽

Left Ventricle ◽

Mitral Regurgitation ◽

Ejection Fraction ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Severe Mitral Regurgitation ◽

External Work ◽

Ventricular Ejection Fraction ◽

Myocardial Efficiency

Abstract Funding Acknowledgements None declared. Background and Aims It is difficult to determine left ventricular systolic performance in patients with severe mitral regurgitation (MR) since left ventricular ejection fraction (EF) could be preserved until the end stages of the disease. Myocardial efficiency describes the amount of external work (EW) done by the left ventricle per unit of oxygen consumed (mVO2). In the present study, we aimed to investigate MEf in patients with asymptomatic severe MR using a novel echocardiographic method. Methods: A total of 27 patients with severe asymptomatic MR and 26 healthy volunteers were included in this cross-sectional study. EW was measured using stroke volume and blood pressure, while mVO2 was estimated using double product and LV mass. Results: There were no differences between the groups with regards to EF (66%±5% vs. 69%±7%), while MEf was significantly reduced in patients with severe MR (25%±11% vs. 44%±12%, p < 0.001) (Table 1). This difference was maintained even after adjustment for age, gender and body surface area (adjusted :0.44, 95%CI: 0.39–0.49 for controls and adjusted :0.24, 95%CI: 0.19–0.29 for patients with severe MR). Further analysis showed that this reduction was due to an increase in total mVO2 in the severe MR group (Figure 1). Conclusions: Myocardial efficiency was significantly lower in patients with asymptomatic severe MR and preserved EF. Table 1 Parameter Control Group (n = 26) Severe Mitral Regurgitation (n = 27) P Value Age (y) 36.5 ± 8.9 41.3 ± 14.2 0.23 Gender (%Male) 9 (35%) 10 (37%) 1.0 BSA (m2) 1.82 ± 0.20 1.76 ± 0.18 0.64 LV End-Diastolic Volume (ml) 83.13 ± 18.88 121.91 ± 37.63 <0.001 LV End-Systolic Volume (ml) 28.07 ± 9.57 45.30 ± 17.42 <0.001 Left Ventricular Ejection Fraction (%) 0.69 ± 0.07 0.66 ± 0.05 0.29 Systolic Mitral Velocity (cm/s) 7.88 ± 1.14 8.07 ± 1.81 0.66 Stroke Work (j) 1.14 ± 0.21 1.15 ± 0.36 0.91 Minute External Work (j) 65.96 ± 14.71 70.17 ± 23.15 0.85 mVO2 (ml.min-1.100g-1) 6.79 ± 1.93 9.48 ± 4.71 0.02 Total mVO2 (j) 166.58 ± 77.14 346.46 ± 202.71 <0.001 Myocardial Efficiency (%) 44 ± 12 25 ± 11 <0.001 Table 1. Demographic, anthropometric, echocardiographic and mechanoenergetic data for study groups. BSA, body surface area; LV, left ventricle; mVO2, myocardial oxygen consumption. Abstract 559 Figure 1

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Influence of polypharmacy on patients with heart failure with preserved ejection fraction: a retrospective analysis on adverse outcomes in the TOPCAT trial

British Journal of General Practice ◽

10.3399/bjgp21x714245 ◽

2020 ◽

Vol 71 (702) ◽

pp. e62-e70

Author(s):

Yuzhong Wu ◽

Wengen Zhu ◽

Xin He ◽

Ruicong Xue ◽

Weihao Liang ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Retrospective Analysis ◽

Heart Function ◽

Left Ventricular ◽

Adverse Outcomes ◽

Left Ventricular Ejection ◽

Controlled Study ◽

Preserved Ejection Fraction ◽

Ventricular Ejection Fraction

BackgroundPolypharmacy is common in heart failure (HF), whereas its effect on adverse outcomes in patients with HF with preserved ejection fraction (HFpEF) is unclear.AimTo evaluate the prevalence, prognostic impacts, and predictors of polypharmacy in HFpEF patients.Design and settingA retrospective analysis performed on patients in the Americas region (including the US, Canada, Argentina, and Brazil) with symptomatic HF and a left ventricular ejection fraction ≥45% in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial, an international, randomised, double-blind, placebo-controlled study conducted during 2006–2013 in six countries.MethodPatients were categorised into four groups: controls (<5 medications), polypharmacy (5–9 medications), hyperpolypharmacy, (10–14 medications), and super hyperpolypharmacy (≥15 medications). The outcomes and predictors in all groups were assessed.ResultsOf 1761 participants, the median age was 72 years; 37.5% were polypharmacy, 35.9% were hyperpolypharmacy, and 19.6% were super hyperpolypharmacy, leaving 7.0% having a low medication burden. In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation. Furthermore, several comorbidities (dyslipidemia, thyroid diseases, diabetes mellitus, and chronic obstructive pulmonary disease), a history of angina pectoris, diastolic blood pressure <80 mmHg, and worse heart function (the New York Heart Association functional classification level III and IV) at baseline were independently associated with a high medication burden among patients with HFpEF.ConclusionA high prevalence of high medication burden at baseline was reported in patients with HFpEF. The high medication burden might increase the risk of hospital readmission, but not the mortality.

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Intramyocardial Angiogenic Cell Precursors in Nonischemic Dilated Cardiomyopathy

Asian Cardiovascular and Thoracic Annals ◽

10.1177/0218492309338105 ◽

2009 ◽

Vol 17 (4) ◽

pp. 382-388 ◽

Cited By ~ 7

Author(s):

Kitipan V Arom ◽

Permyos Ruengsakulrach ◽

Michael Belkin ◽

Montip Tiensuwan

Keyword(s):

Left Ventricular Ejection Fraction ◽

Ejection Fraction ◽

Dilated Cardiomyopathy ◽

Left Ventricular ◽

Ventricular Ejection ◽

Left Ventricular Ejection ◽

Cell Group ◽

Control Group ◽

Ventricular Ejection Fraction ◽

Nonischemic Dilated Cardiomyopathy

To determine the efficacy of intramyocardial injection of angiogenic cell precursors in nonischemic dilated cardiomyopathy, 35 patients with nonischemic dilated cardiomyopathy underwent injections of angiogenic cell precursors into the left ventricle (cell group). Seventeen patients with nonischemic dilated cardiomyopathy were matched from the heart failure database to form a control group that was treated medically. Angiogenic cell precursors were obtained from autologous blood, cultured in vitro, and injected into all free-wall areas of the left ventricle in the cell group. After these injections, New York Heart Association functional class improved significantly by 1.1 ± 0.7 classes at 284.7 ± 136.2 days, and left ventricular ejection fraction improved in 71.4% of patients (25/35); the mean increase in left ventricular ejection fraction was 4.4% ± 10.6% at 192.7 ± 135.1 days. Improved quality of life was demonstrated by better physical function, role-physical, general health, and vitality domains in a short-form health survey at the 3-month follow-up. In the control group, there were no significant improvements in left ventricular ejection fraction or New York Heart Association class which increased by 0.6 ± 0.8 classes. It was concluded that intramyocardial angiogenic cell precursor injection is probably effective in the treatment of nonischemic dilated cardiomyopathy. Disclosures and Freedom of Investigation Professor Michael Belkin is an advisory board member, a minor shareholder, and receives a consulting fee from TheraVitae Co. Ltd. However, the authors had full control of the study, methods used, outcome measurements, data analysis, and production of the written report.

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Early Left Ventricular Systolic and Diastolic Dysfunction in Patients with Newly Diagnosed Obstructive Sleep Apnoea and Normal Left Ventricular Ejection Fraction

The Scientific World JOURNAL ◽

10.1155/2014/898746 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Lisulov Popovic Danica ◽

Mirjana Krotin ◽

Marija Zdravkovic ◽

Ivan Soldatovic ◽

Darko Zdravkovic ◽

...

Keyword(s):

Mitral Valve ◽

Left Ventricle ◽

Ejection Fraction ◽

Tissue Doppler ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Lv Function ◽

Newly Diagnosed ◽

Mitral Flow ◽

Obstructive Sleep

The aim of the study was to evaluate whether obstructive sleep apnea (OSA) contributes directly to left ventricular (LV) diastolic and regional systolic dysfunction in newly diagnosed OSA with normal left ventricle ejection fraction.Methods. 125 consecutive patients were prospectively enrolled in the study. Control group consisted of 78 asymptomatic age-matched healthy subjects who did not have any cardiovascular and respiratory diseases. All patients had undergone overnight polysomnography and standard transthoracic and tissue Doppler imaging echocardiogram.Results. TheE/Aratio and the peakEwave at mitral flow were significantly lower and the peakAwave at mitral flow was significantly higher in OSA patients compared with control subjects. Left ventricle isovolumetric relaxation time (IVRT) and mitral valve flow propagation (MVFP) were significantly longer in OSA patients than in controls. Tissue Doppler derivedS′amplitude of lateral part at mitral valve (S′Lm) andE′wave amplitudes both at the lateral (E′Lm) and septal parts of the mitral valve (E′Sm) were significantly lower in OSA patients compared to controls.Conclusion. Newly diagnosed OSA patients with normal global LV function have significantly impaired diastolic function and regional longitudinal systolic function. OSA is independently associated with these changes in LV function.

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Hybrid telerehabilitation in patients with hypertrophic cardiomyopathy without left ventricular outflow tract obstruction and preserved left ventricular ejection fraction-the randomised clinical trial

European Heart Journal - Digital Health ◽

10.1093/ehjdh/ztab104.3106 ◽

2021 ◽

Vol 2 (4) ◽

Author(s):

K Sadowski ◽

R Piotrowicz ◽

M Klopotowski ◽

J Wolszakiewicz ◽

A Lech ◽

...

Keyword(s):

Hypertrophic Cardiomyopathy ◽

Left Ventricle ◽

Ejection Fraction ◽

Group Analysis ◽

Left Ventricular ◽

Outflow Tract ◽

Left Ventricular Ejection ◽

Nordic Walking ◽

Home Based ◽

Lv Ejection Fraction

Abstract Background Hypertrophic cardiomyopathy (HCM) is the most common hereditary heart disease, and its diagnosis is often associated with limited physical activity. Little is known about cardiac rehabilitation programs for patients with HCM. Therefore the novel hybrid cardiac telerehabilitation (HCTR) model consisting of hospital-based rehabilitation and home-based telemonitored rehabilitation might be an option to improve physical capacity in patients with HCM. Purpose To evaluate the safety, effectiveness and adherence to HCTR in patients with HCM without the left ventricle (LV) outflow tract obstruction and preserved LV ejection fraction. Methods The study group comprised 60 patients with HCM (51.1±13.3 years; NYHA II-III; LV ejection fraction 66.1±6.9%). Patients were randomised (1:1) to either HCTR program (hospital-based rehabilitation [1 month] based on cycloergometer training and home-based telemonitored rehabilitation [2 months] based on Nordic walking, five times a week, at 40–70% of maximal estimated heart rate) - training group (TG), or to a control group (CG). All patients had implantable cardioverter-defibrillator. In order to perform home-based telemonitored rehabilitation, a special device was used which enabled patients to: (1) do Nordic walking training according to a preprogrammed plan, (2) record and send electrocardiograms (ECGs) via mobile phone network to the monitoring centre. The moments of automatic ECGs registration were pre-set and coordinated with exercise training. The effectiveness of HCTR was assessed by changes - delta (Δ) in duration (t) of the workload, peak oxygen consumption (pVO2) in cardiopulmonary exercise test, 6-minute walking test distance (6-MWT) as a result of comparing t (s), pVO2 (ml/kg/min), 6-MWT (m) from the beginning and the end of the program. Results Safety of HCTR. Neither death nor other serious adverse events occurred during HCTR. We did not observe any ICDs intervention during the HCTR. Effectiveness of HCTR: Within-group analysis: t, pVO2, 6-MWT increased significantly in TG: t 657±183 vs 766±181 (p<0.001), pVO2 19.2±5.0 vs 20.6±4.9 (p=0.007), 6-MWT 445±88 vs 551±77 (p<0.001). In the untrained CG, the unfavourable results were observed: 695±198 vs 717±187 (p=0.114), pVO2 21.2±5.1 vs 21.1±5.6 (p=0.723), 6-MWT 512±83 vs 536±84 (p=0.061). Between-group analysis: The differences between TG and CG were statistically significant: in Δt (p<0.001); ΔpVO2 (p=0.012); Δ6-MWT (p<0.001). Adherence to HCTR: In TG 28 patients (93%) completed the HCTR program. Two patients did no undergo HCTR because of personal issues. Conclusion Hybrid cardiac telerehabilitation in patients with HCM without the left ventricle (LV) outflow tract obstruction and preserved LV ejection fraction is safe and effective. The adherence to HCTR is high. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Statutory work in The Cardinal Stefan Wyszyński National Institute of Cardiology in Warsaw, Poland

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Rationale and design of the PRevention of cArdiac Dysfunction during Adjuvant breast cancer therapy (PRADA II) trial: a randomized, placebo-controlled, multicenter trial

Cardio-Oncology ◽

10.1186/s40959-021-00115-w ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

A Mecinaj ◽

G Gulati ◽

SL Heck ◽

E Holte ◽

MW Fagerland ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Therapy ◽

Ejection Fraction ◽

Early Breast Cancer ◽

Cardiac Dysfunction ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Controlled Study ◽

Breast Cancer Therapy ◽

Adjuvant Breast Cancer

Abstract Background Recent advances in the treatment algorithms of early breast cancer have markedly improved overall survival. However, anthracycline- and trastuzumab-associated cardiotoxicity may lead to dose-reduction or halt in potentially life-saving adjuvant cancer therapy. Early initiated neurohormonal blockade may prevent or attenuate the cardiotoxicity-induced reduction in cardiac function, but prior studies have been inconclusive. The angiotensin receptor-neprilysin inhibitor sacubitril/valsartan has been shown to be superior to traditional treatment in heart failure with reduced ejection fraction, but its cardioprotective effects in the cardio-oncology setting remains to be tested. Objective To assess if sacubitril/valsartan given concomitantly with early breast cancer treatment regimens including anthracyclines, with or without trastuzumab, may prevent cardiac dysfunction. Methods PRADA II is a randomized, placebo-controlled, double blind, multi-center, investigator-initiated clinical trial. Breast cancer patients from four university hospitals in Norway, scheduled to receive (neo-)adjuvant chemotherapy with epirubicin independently of additional trastuzumab/pertuzumab treatment, will be randomized 1:1 to sacubitril/valsartan or placebo. The target dose is 97/103 mg b.i.d. The patients will be examined with cardiovascular magnetic resonance (CMR), echocardiography, circulating cardiovascular biomarkers and functional testing at baseline, at end of anthracycline treatment and following 18 months after enrolment. The primary outcome measure of the PRADA II trial is the change in left ventricular ejection fraction (LVEF) by CMR from baseline to 18 months. Secondary outcomes include change in LV function by global longitudinal strain by CMR and echocardiography and change in circulating cardiac troponin concentrations. Results The study is ongoing. Results will be published when the study is completed. Conclusion PRADA II is the first randomized, placebo-controlled study of sacubitril/valsartan in a cardioprotective setting during (neo-)adjuvant breast cancer therapy. It may provide new insight in prevention of cardiotoxicity in patients receiving adjuvant or neo-adjuvant therapy containing anthracyclines. Furthermore, it may enable identification of patients at higher risk of developing cardiotoxicity and identification of those most likely to respond to cardioprotective therapy. Trial registration The trial is registered in the ClinicalTrials.gov registry (identifier NCT03760588). Registered 30 November 2018.

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