Impact of Gore Cardioform ASD Occluder on atrial and ventricular electro-mechanics in a pediatric population

Transcatheter closure is the first-line treatment for ostium secundum atrial septal defect (ASD). The GORE Cardioform ASD Occluder (GCA) is potentially innovative compared with other self-centering devices. This study aimed to compare the mechanic changes in atrial and ventricular properties before and after GCA implantation. All consecutive patients aged <18 years who underwent isolated ASD closure with a single GCA device were enrolled from 2 centers. Echocardiography and electrocardiogram were performed the day before, 24 hours, and 6 months after ASD closure. Between January 2020 and February 2021, 70 pediatric patients with ASD were enrolled. The mean age was 7.9 ± 3.9 years, and the mean defect diameter was 17.1 ± 4.5 mm. Global longitudinal strain analysis showed no change in left ventricular longitudinal function (T0 −23.2 ± 2.8%, 24 hours −23.0 ± 2.8%, and 6 months −23.5 ± 2.7%). An early and transient reduction in longitudinal strain was detected in the basal septal segments (T0 −19.8 ± 3.3%, 24 hours −18.7 ± 3.6%, and 6 months −19.2 ± 3.4%), left atrium (T0 41.4 ± 15.3%, 29.2 ± 1.4%, and 39.0 ± 12.9%), and right ventricle (−27.6 ± 5.4%, −23.6 ± 5.0%, and −27.3 ± 4.6) 24 hours after closure, secondary to hemodynamic changes because of flow redirection after ASD closure. Six months after the procedure, only the left atrium showed a mild global longitudinal strain reduction because of the presence of the device within the septum. GCA device had no impact on global and regional ventricular function. Atrial mechanics were preserved, except for the segments covered by the device. This is the first device demonstrating no impact on the left and right ventricular mechanics, irrespective of the device size. Transcatheter closure is the first-line treatment for ostium secundum atrial septal defect (ASD). The GORE Cardioform ASD Occluder (GCA) is potentially innovative compared with other self-centering devices. This study aimed to compare the mechanic changes in atrial and ventricular properties before and after GCA implantation. All consecutive patients aged <18 years who underwent isolated ASD closure with a single GCA device were enrolled from 2 centers. Echocardiography and electrocardiogram were performed the day before, 24 hours, and 6 months after ASD closure. Between January 2020 and February 2021, 70 pediatric patients with ASD were enrolled. The mean age was 7.9 ± 3.9 years, and the mean defect diameter was 17.1 ± 4.5 mm. Global longitudinal strain analysis showed no change in left ventricular longitudinal function (T0 −23.2 ± 2.8%, 24 hours −23.0 ± 2.8%, and 6 months −23.5 ± 2.7%). An early and transient reduction in longitudinal strain was detected in the basal septal segments (T0 −19.8 ± 3.3%, 24 hours −18.7 ± 3.6%, and 6 months −19.2 ± 3.4%), left atrium (T0 41.4 ± 15.3%, 29.2 ± 1.4%, and 39.0 ± 12.9%), and right ventricle (−27.6 ± 5.4%, −23.6 ± 5.0%, and −27.3 ± 4.6) 24 hours after closure, secondary to hemodynamic changes because of flow redirection after ASD closure. Six months after the procedure, only the left atrium showed a mild global longitudinal strain reduction because of the presence of the device within the septum. GCA device had no impact on global and regional ventricular function. Atrial mechanics were preserved, except for the segments covered by the device. This is the first device demonstrating no impact on the left and right ventricular mechanics, irrespective of the device size. The first device for percutaneous closure of atrial septal defects (ASDs) was developed by King and Mills in 1972.1King TD Thompson SL Steiner C Mills NL Secundum atrial septal defect. Nonoperative closure during cardiac catheterization.JAMA. 1976; 235: 2506-2509Crossref PubMed Google Scholar During the following years, the evolution of percutaneous implant devices has fitted within a path of innovation in the field of structural/congenital cardiology. The percutaneous approach represents the first-line treatment for ASD according to current guidelines,2Baumgartner H De Backer J Babu-Narayan SV Budts W Chessa M Diller GP Lung B Kluin J Lang IM Meijboom F Moons P Mulder BJM Oechslin E Roos-Hesselink JW Schwerzmann M Sondergaard L Zeppenfeld K ESC Scientific Document Group2020 ESC Guidelines for the management of adult congenital heart disease.Eur Heart J. 2021; 42 (3): 563-645Crossref PubMed Scopus (808) Google Scholar as it shows higher benefits in terms of cost-effectiveness compared with the surgical one. Despite rare, erosion after Amplatzer septal occluder (ASO) (Abbott Amplatzer Septal Occluder) or ASO-like device implantation has been reported,3Amin Z Hijazi ZM Bass JL Cheatham JP Hellenbrand WE Kleinman CS Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk.Catheter Cardiovasc Interv. 2004; 63: 496-502Crossref PubMed Scopus (487) Google Scholar resulting in hemodynamic instability and need for surgical removal (incidence 0.1% to 0.3%).5Abd El Rahman MY Hui W Timme J Ewert P Berger F Dsebissowa F Hetzer R Lange PE Abdul-Khaliq H Analysis of atrial and ventricular performance by tissue Doppler imaging in patients with atrial septal defects before and after surgical and catheter closure.Echocardiography. 2005; 22: 579-585Crossref PubMed Scopus (47) Google Scholar Furthermore, several studies evaluated the impact of ASD devices on cardiac mechanics, showing a possible device negative impact on atrial function6Di Salvo G Drago M Pacileo G Rea A Carrozza M Santoro G Bigazzi MC Caso P Russo MG Carminati M Calabro’ R Atrial function after surgical and percutaneous closure of atrial septal defect: a strain rate imaging study.J Am Soc Echocardiogr. 2005; 18: 930-933Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar,7Di Salvo G Drago M Pacileo G Carrozza M Santoro G Bigazzi MC Caso P Russo MG Carminati M Calabró R Comparison of strain rate imaging for quantitative evaluation of regional left and right ventricular function after surgical versus percutaneous closure of atrial septal defect.Am J Cardiol. 2005; 96: 299-302Abstract Full Text Full Text PDF PubMed Scopus (45) Google Scholar and left ventricular (LV) basal-midwall segment deformation properties.8Castaldi B Santoro G Di Salvo G Gaio G Palladino MT D'Aiello F Iacono C Pacileo G Calabrò R Russo MG Impact of the Amplatzer atrial septal occluder device on left ventricular function in pediatric patients.Pediatr Cardiol. 2013; 34: 1645-1651Crossref PubMed Google Scholar Similar studies found a correlation between device size and the magnitude of the speckle tracking parameter changes.9Sommer RJ Love BA Paolillo JA Gray RG Goldstein BH Morgan GJ Gillespie MJ ASSURED InvestigatorsASSURED clinical study: new GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect.Catheter Cardiovasc Interv. 2020; 95: 1285-1295Crossref PubMed Scopus (27) Google Scholar ASO or ASO-like devices are currently the most common devices used in the cath lab because of the ease of use and availability in a wide size range (4 to 38 to 42 mm). Differently, GORE devices are made of a nitinol wire frame with a flower's petals shape, entirely covered with an expanded polytetrafluoroethylene membrane. Ideally, this design should reduce the risk of erosion secondary to the metal wires’ interaction with the surrounding structures. In contrast, the softness of this device seems to facilitate prosthesis wire frame fractures (WFFs). The latter are relatively frequent in gore septal occluder (GSO) devices, accounting for up to 35% of the devices screened when routinely explored by fluoroscopy.10Castaldi B Cabrelle G Padalino M Vida V Milanesi O Di Salvo G Percutaneous closure of patent foramen ovale and secundum atrial septal defects with the GORE࿽CARDIOFORM septal occluder: incidence andImplications of device wire frame fracture.Congenit Heart Dis. 2020; 15: 347-360Crossref Scopus (2) Google Scholar,11Kumar P Orford JL Tobis JM Two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder.Catheter Cardiovasc Interv. 2020; 96: 219-224Crossref PubMed Scopus (17) Google Scholar However, device removal is not recommended in the case of WFF because this event does not impact the device's function and stability, and the reports of complications are anecdotal.12GORE® CARDIOFORM ASD Occluder IFU. Gore. Available at: https://eifu.goremedical.com/. Accessed on December 6, 2023.Google Scholar The GORE Cardioform ASD Occluder device (GCA, WL Gore & Associates, Flagstaff, Arizona) was designed with a self-centering mechanism to exploit the advantages of the versatile structure of the GSO device and allow the closure of a wider range of ASD sizes. GCA device recently received the Food and Drug Association (May 2018) and Conformite Europeenne (October 2019) marks and has been launched on the European market in January 2020. This study aimed to evaluate atrial and ventricular electromechanic remodeling after ASD closure using a GCA device in a pediatric cohort. Available literature data about ASO or ASO-like devices or surgically closed ASD were used for comparison. This is a single-arm prospective nonrandomized multicenter study conducted at the Pediatric Cardiology Unit of the University of Padua (Italy) and at the Pediatric Cardiology and ACHD Unit of the Ospedale del Cuore “G. Pasquinucci” in Massa (Italy). Pediatric patients with isolated, hemodynamically significant ostium secundum ASD scheduled for percutaneous closure between January 2020 and February 2021 were enrolled. Patients with genetic syndromes and significant cardiac or extracardiac co-morbidities were excluded. Indication for ASD closure was given in the presence of right ventricle volume overload on 2-dimensional (2D)-transthoracic echocardiography (TTE) evaluation (right ventricular [RV] end-diastolic diameter Z score >2; QP/QS >1.5, confirmed by invasive hemodynamic study; or RV end-diastolic diameter to LV end-diastolic diameter ratio >0.7). ASDs were considered “complex” in case of one or more deficient rims (<5 mm) except for aortic rim, aneurysmal, or multifenestrated (MF) septum or in case of the ASD diameter/patient's body weight ratio (ASD/BW) >1.2. The study protocol complies with ethics guidelines according to the 1975 Declaration of Helsinki. The University of Padua Institutional Research Board approved this study (project code AOP2076). The study end points were: (1) immediate procedural outcome, including the implantation rate and safety (adverse cardiac or extracardiac events and device embolization or unplanned rescue surgical treatment), complete closure of ASD, and short to medium-term clinical safety (free from cardiac or extracardiac adverse events) at 24 hours and 6 months after the procedure; and (2) changes in electromechanic properties by electrocardiogram (ECG), TTE, and 2D-speckle tracking strain analysis (S) were evaluated at baseline (T0), 24 hours (T24h), and 6 months (T6m) after the procedure. At the admission to the Cardiology Unit (T0) a physical examination, routine blood tests, chest x-ray, ECG, TTE, and 2D-speckle tracking echocardiography (STE) were performed. Informed consent to the procedure was collected from the parents. The interventional procedure was performed under general anesthesia with fluoroscopic guidance and transesophageal echocardiography. Measurement of the ASD diameter was obtained by static or dynamic sizing based on the operator preference. The device size was chosen based on the manufacturer's indications.13Badano LP Kolias TJ Muraru D Abraham TP Aurigemma G Edvardsen T D'Hooge J Donal E Fraser AG Marwick T Mertens L Popescu BA Sengupta PP Lancellotti P Thomas JD Voigt JU Industry representatives, Reviewers: This document was reviewed by members of the 2016–2018 EACVI Scientific Documents Committee. Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: a consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging.Eur Heart J Cardiovasc Imaging. 2018; 19: 591-600Crossref PubMed Scopus (823) Google Scholar In the case of multiple ASDs, each of the significant defects was explored with a sizing balloon. Procedure and fluoroscopy times, radiation dose data (dose-area product), procedural complications, ECG early changes, adequate positioning of the device, and the presence of residual shunts were evaluated. ECG, TTE, and STE were repeated at T24h and T6m. In addition, a 24-hour ECG Holter monitoring was performed 1 and 6 months after the procedure. An adverse event was any complication that required previously unplanned cardiac or extracardiac treatment, unplanned hospitalization, or any medical problem involving long-term effects or requiring long-term treatment. Whenever possible, fluoroscopy was performed at 6 months to assess the presence of WFFs. A Vivid E9 echocardiograph (GE Vingmed Ultrasound AS, Horten, Norway) with a 5 or 6-MHz probe was used for echocardiographic data collection. Conventional function parameters were collected: LV and RV diameters (M-mode from parasternal short-axis view); atrial septal length from subcostal left oblique view and from apical chambers view, we reported the longest one; LV ejection fraction calculated according to the Simpson biplane method; RV systolic function parameters (tricuspid annulus peak systolic excursion and S’ systolic velocity peak from the tissue Doppler); LV diastolic function parameters (early diastole -E- velocity peak, atrial contraction -A- velocity peak and E/A ratio from the mitral valve inflow pattern; and E/E’ ratio, where E′ was the average between lateral E′ and medial E’ of the mitral annulus tissue Doppler spectrum). Residual atrial shunts were classified as negligible (color Doppler jet ≤1 mm), mild (color Doppler jet ≤2 mm), moderate (color Doppler jet 2 to 4 mm), and severe (color Doppler jet ≥4 mm). Atrial and ventricular longitudinal strain (L-S) analysis was performed on images saved in cine-loop format and analyzed offline using Echopac v12 software (GE, Echopac, Horten, Norway). The LV L-S was assessed from the apical 4-, 3- and 2-chamber views. The RV, right atrium (RA), and left atrium (LA) L-S were assessed from the apical 4-chamber view. For the RA and RV L-S analysis, the septal segments were excluded (FW-RV=free wall right ventricle).14Badano LP Muraru D Parati G Haugaa K Voigt JU How to do right ventricular strain.Eur Heart J Cardiovasc Imaging. 2020; 21: 825-827Crossref PubMed Scopus (42) Google Scholar,15Du ZD Hijazi ZM Kleinman CS Silverman NH Larntz K Amplatzer InvestigatorsComparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: Results of a multicenter nonrandomized trial.J Am Coll Cardiol. 2002; 39: 1836-1844Crossref PubMed Scopus (839) Google Scholar STE analysis was performed following current European Association of Cardiovascular Imaging recommendations.14Badano LP Muraru D Parati G Haugaa K Voigt JU How to do right ventricular strain.Eur Heart J Cardiovasc Imaging. 2020; 21: 825-827Crossref PubMed Scopus (42) Google Scholar A standard 12-lead ECG was recorded at a rate of 25 mm/s and a calibration of 1 mV/cm for all the patients at the baseline. ECG was digitally stored. Thus, we were able to change appropriately the speed scale for postprocessing. P wave, PR interval, QRS amplitude, QRS, and QTc dispersion were manually measured using ComPacs software by 2 experienced operators, blinded on the clinical features of the patients. Parameters were recorded in all the leads available. (1) P wave: defined as the interval between the onset (junction of the isoelectric line at the beginning of the P wave deflection) to the offset (junction between the end of the P wave and the isoelectric line) of the P wave, (2) P wave dispersion (P dis=P max−P min) was calculated using these values, (3) PR interval: defined as the interval between the beginning of the P wave and the beginning of the QRS complex, (4) QRS voltage: defined as the amplitude measured from the nadir of the QRS complex to its peak, (5) QRS duration: defined as the maximum QRS duration in any lead from the first to the last sharp vector crossing the isoelectric line, (6) QT interval: defined as the interval between the beginning of the QRS complex and the end of the T wave. QTc dispersion was defined as the difference between the maximum and minimum QTc intervals that could be measured in any of the 12 ECG leads but preferably in C2 or V5 lead. We calculated QTc using Bazzett's method. Heart rate was <100 beats/min in all the patients, so Friedericia correction was not necessary. Statistical analysis was performed using the Statistical Package for the Social Sciences version 27.0 (SPSS Software, IBM, Chicago, Illinois). Continuous data was summarized by mean ± SD. The normal distribution of the variables was verified using the Kolmogorov–Smirnov test. Categoric variables are presented as absolute numbers and percentages. In the case of not-normal distribution, data were expressed in interquartile ranges. Comparisons between groups were made using the Student's t test for unpaired data. Comparison between different follow-up phases was performed using Wilcoxon's Test. Correlation between continuous data was performed using Spearman's test. Correlation between categoric data was performed using Pearson's test. The comparison between ≥3 groups of variables was performed using a one-way analysis of variance and post hoc Bonferroni Test (normal distribution) or by Kruskall–Wallis test (not-normal distribution) when appropriate. The null hypothesis was rejected for p <0.05. Between January 2020 and February 2021, 70 consecutive pediatric patients underwent percutaneous closure of hemodynamically significant ASD using the GCA device. Demographic data are summarized in Table 1. The mean age was 8.4 ± 3.9 years. No significantly different characteristics were found in the subjects enrolled by the 2 centers. One patient had an aortic coarctation surgically corrected at birth without residual stenosis; a second patient showed a tiny ventricular septal defect with no significant QP/QS after percutaneous ASD closure. None of the patients had significant extracardiac co-morbidities or associated residual cardiac malformations or ventricular dysfunction.Table 1Demographic data, anatomical features, and hemodynamic data. In case of multiple atrial septal defects, the diameter of the main defect was reportedPatients n°70Female n° (%)46 (66)Age (years)7.9±3.9Height (cm)127.4±18.7Weight (kg)29.6±15.3BSA (m2)1.0±0.3ASD size^ (mm)17.1±4.5ASD/BW (mm/kg)0.7±0.3Septal length (mm)40.0±5.5Device/Atrial septal length (mm/mm)0.83±0.11QP/QS1.7±0.6Mean pulmonary artery pressure (PAP, mmHg)18.4±3.3Total procedure time (min)53.3 ±28.3Fluoroscopy time (min)10.1±6.6Dose-Area Product (Gy*cm2)12.1±10.2Complex ASD n° (%)38 (54)- ASD diameter to body weight ratio >1.212 (17)- Multi-fenestrated ASD and/or septal aneurysm21 (30)- Deficient aortic rim (<5,5 mm)9 (13)- Deficient posterior rim6 (9)- Deficient posterior-inferior rim7 (10)- Deficient superior caval rim1 (1)Implanted devices n° (%)- 27 mm14 (20)- 32 mm31 (44)- 37 mm15 (21)- 44 mm10 (14)Oversized devices n° (%)7 (10)Serious adverse events n° (%)6 (9)- device embolization1 (1)- clinically significant new arrhythmia4 (6)- pericardial effusion1 (1)ASD = atrial septal defect; BSA = body surface area; BW = body weight. Open table in a new tab ASD = atrial septal defect; BSA = body surface area; BW = body weight. ASD anatomical features, hemodynamic, and procedural data are listed in Table 1. The mean defect diameter was 17.1 ± 4.5 mm, and Qp/Qs was 1.7 ± 0.6. Thirty-eight patients (54.3%) had complex ASD because of a deficient rim except for aortic rim (deficient posterior rim n = 6, deficient posterior-inferior rim n = 7, and deficient superior cava rim n = 1; 12 patients in total), a MF atrial septum, fossa ovalis aneurysm (n = 21), and/or ASD/ BW >1.2 (n = 12). Nine patients had a deficient aortic rim. Nineteen patients (27%) had surgical indications for ASD closure because of a deficient posterior-inferior rim or ASD/BW>1.2. The device was successfully implanted in 69 of 70 cases (98.6%) and in 64 (91.4%) at the first attempt. In 7 cases (10%), the device was oversized to cover the entire septal aneurysm, had close MF defects, or achieved greater stability on the deficient rim(s). WFFs were investigated in 56% of patients at T6m; 38.5% had one or more wire frame fractures. None of them had fracture-related adverse events throughout the follow-up. A complete ASD closure was achieved in 60 of 70 cases (85.7%) at T24h. Residual shunts have always been negligible or intraprosthetic. No residual shunts or adverse cardiovascular events were reported in any of the patients at T6m. Six major adverse events were reported (8.6%). Early device embolization was seen in a 24 kg child with a 24 mm ASD once awake from sedation after implantation of a 44-mm device (single attempt) and required emergent cardiac surgery. Four cases of arrhythmia were reported: a case of variable atrioventricular block after closure of a 22 mm ASD with a 44-mm device, resolved spontaneously; a case of second-degree atrioventricular block occurred 24 hours after the implantation of a 37 mm GCA in a 22 mm ASD and regressed after steroid therapy; 2 cases of sustained supraventricular tachycardia responsive to antiarrhythmic therapy (β blocker), in a case of 18 mm ASD closed with a 37-mm device, and a 22 mm ASD closed with 44-mm device. Finally, a case of pericardial effusion treated with Ibuprofen was experienced by a 16 kg child with a 20 mm ASD closed with a 37 mm prosthesis. Minor early adverse events were also recorded in 3 patients (4%): a case of vascular access bleeding resolved with manual compression; a case of hypersensitivity reaction related to acetylsalicylic acid administration during the procedure; and a case of mild laryngeal edema secondary to intubation, treated with antihistaminic and steroid therapy. Standard echocardiographic data are listed in Table 2. A significant reduction in the right chamber sizes was observed 24 hours after the procedure (RV end-diastolic diameter and RA end-systolic volume, p <0.01). Similarly, a relative reduction in the RV longitudinal systolic function indexes was also observed (tricuspid annulus peak systolic excursion and RV s′, p <0.01 in both cases) despite their values remaining in the normal range.Table 2Standard echocardiographic dataT 0T 24 hT 6 monthsLVEDD (mm)34.5±6.836.0±5.7*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.39.9±5.3*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.LVESD (mm)21.5±3.821.6±3.9*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.25.0±4.5*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.BP-LVEDV (mL)47.1±20.148.7±19.7*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.56.9±21.7*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.BP- LVESV (mL)16.1±7.117.2±7.4*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.20.5±8.6*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.BP- LVEF (%)70±765±664±7RVEDD (mm)23.5±5.520.0±4.4*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.18.5±4.3*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.TAPSE23.6±3.921±4.3*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.21.6±4.5RV-S’14.4±2.012.6±2.2*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio; E/E’ Avg = mitral valve E wave to mean E’ TDI value ratio; LVEDD = left ventricular end diastolic diameter; LVESD = left ventricular end systolic diameter; RVEDD = right ventricular end diastolic diameter; RV-S’ = right ventricular S’ value; TAPSE = tricuspid annulus peak systolic excursion.13.3±2.4E/A1.7±0.41.9±0.6*p<0,05 compared to T0 (paired data T-Student test). BP-LVEDV = biplane left ventricular end diastolic volume; BP-LVEF = biplane left ventricular ejection fraction; BP-LVESV = biplane left ventricular end systolic volume; E/A = mitral valve E wave A wave ratio;