Cardiological Monitoring and Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery for Patients Affected by Breast Cancer: an Observational Prospective Cohort Study

This prospective cohort study aims to assess heart toxicity and safety using a 1-week radiation schedule regimen of 26 Gy in five daily fractions.

The primary endpoint was defined as detection of any subclinical impairment in myocardial function and deformation (decrease ≥10%) measured with standard and 3-dimensional (3D) echocardiography and left ventricular (LV) global longitudinal strain (GLS).

Cardiac assessment. Medical history, electrocardiogram (EKG), clinical examination with specific attention to signs of heart failure, New York Heart Association (NYHA) class and Canadian angina grading scale score were recorded during each visit. Transthoracic echocardiography was performed with a commercially available system (EPIQ, X5-1 transducer, Philips Healthcare, Andover, Massachusetts). All measurements were performed and reported accordingly to the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI) recommendations. Each measure was averaged over three cardiac cycles. Two-dimensional LVEF (2D-LVEF) was measured by Simpson rule, throughout apical 4- and 2-chamber views. LV mass was calculated from LV oriented M-mode tracings using the Devereux formula, ASE convention, and was indexed to body surface area (BSA). Diastolic function was evaluated by left atrial volume index, systolic pulmonary pressure, mitral inflow E/A pattern, E/A ratio, E velocity deceleration time, annular tissue Doppler e', and E/e' ratio. After optimizing image quality, maximizing frame rate, and minimizing foreshortening, which are all critical to reduce measurement variability, GLS measurements were made in the three standard apical views and averaged. LV 4-, 3-, and 2-chamber views were acquired during breath hold. From apical long-axis view to visualize aortic valve closure, using opening and closing clicks of the aortic valve the timing of aortic valve opening and closing on continuous wave (CW) Doppler imaging respect to EKG R wave was measured. Full-volume six-cycles gated acquisition breath hold images of left ventricle were acquired for Q-lab analysis to obtain end-diastolic volume, end systolic volume, indexed to BSA (EDVI and ESVI) and 3D-LVEF. Q-lab version in this study was 10.5. All echocardiography data was stored including the original Digital Imaging and Communications in Medicine (DICOM) images. All scans were read jointly by two experienced board certified echocardiographers who were blinded to all clinical characteristics. Systemic arterial pressure was measured simultaneously with echo measurements, by means of an arm-cuff sphygmomanometer.