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Highlights. Non-invasive method for the assessment of the mobility and deformation of the wire element of the bioprosthesis in the cardiac cycle based on the developed mathematical algorithm is presented. Numerical analysis of the behavior of the wire element of the “TiAra” bioprosthesis is shown for the first time. The developed method can be used for other medical devices as well.Aim. To develop a method for non-invasive assessment of the mobility and deformation of the wire element of the aortic heart valve bioprosthesis in the cardiac cycle based on mathematical processing of visual medical data.Methods. Multidetector computed tomography data of patient P. (male, 66 years old), who received the “TiAra” aortic bioprosthesis (NeoCor CJSC, Kemerovo), were used for the study. Using the built-in tools in the Mimics Medical Image Processing Software (Materialize, Belgium), based on the radio density, 5 stages of movement of the wire element of the bioprosthesis were reconstructed in the form of 3D-models. The differences between the models, characterizing deformation in the cardiac cycle, were quantitatively assessed using a proprietary Matlab algorithm (The MathWorks, USA), calculating the distance between similar points. Moreover, obtained data on displacements was used in the numerical study of the stress-strain state of a 3D-model of the wire element by the finite element method in the Abaqus/CAE software (Dassault Systèmes SE, France).Results. The proposed method for assessing the mobility of the wire element made it possible to quantitatively evaluate the biomechanics of the “TiAra” stentless bioprosthesis based on multidetector computed tomography, a non-invasive clinical tool. The movements that the bioprosthesis undergoes during the cardiac cycle (the maximum value is 2.04 mm in the radial direction) are comparable to the movement of the aortic root of a healthy patient. The results of the numerical modeling of the stress state of the wire element did not indicate high amplitudes (peak value – 564 MPa) that would be capable of causing critical damage to the wire. It allows us to confirm the clinical safety of the bioprosthesis in real conditions like asymmetric and uneven loads. Moreover, deformations observed in the bioprosthesis are similar in the amplitude to the displacements of the aortic root described in the literature, which highlights the main feature of the bioprosthesis – ensuring the physiological biomechanics throughout the cardiac cycle.Conclusion. The presented method of qualitative computer assessment of the movement of the wire element of heart valve prosthesis using the “TiAra” bioprosthesis as an example demonstrates its validity as a tool for studying prosthesis functioning.
Highlights. Non-invasive method for the assessment of the mobility and deformation of the wire element of the bioprosthesis in the cardiac cycle based on the developed mathematical algorithm is presented. Numerical analysis of the behavior of the wire element of the “TiAra” bioprosthesis is shown for the first time. The developed method can be used for other medical devices as well.Aim. To develop a method for non-invasive assessment of the mobility and deformation of the wire element of the aortic heart valve bioprosthesis in the cardiac cycle based on mathematical processing of visual medical data.Methods. Multidetector computed tomography data of patient P. (male, 66 years old), who received the “TiAra” aortic bioprosthesis (NeoCor CJSC, Kemerovo), were used for the study. Using the built-in tools in the Mimics Medical Image Processing Software (Materialize, Belgium), based on the radio density, 5 stages of movement of the wire element of the bioprosthesis were reconstructed in the form of 3D-models. The differences between the models, characterizing deformation in the cardiac cycle, were quantitatively assessed using a proprietary Matlab algorithm (The MathWorks, USA), calculating the distance between similar points. Moreover, obtained data on displacements was used in the numerical study of the stress-strain state of a 3D-model of the wire element by the finite element method in the Abaqus/CAE software (Dassault Systèmes SE, France).Results. The proposed method for assessing the mobility of the wire element made it possible to quantitatively evaluate the biomechanics of the “TiAra” stentless bioprosthesis based on multidetector computed tomography, a non-invasive clinical tool. The movements that the bioprosthesis undergoes during the cardiac cycle (the maximum value is 2.04 mm in the radial direction) are comparable to the movement of the aortic root of a healthy patient. The results of the numerical modeling of the stress state of the wire element did not indicate high amplitudes (peak value – 564 MPa) that would be capable of causing critical damage to the wire. It allows us to confirm the clinical safety of the bioprosthesis in real conditions like asymmetric and uneven loads. Moreover, deformations observed in the bioprosthesis are similar in the amplitude to the displacements of the aortic root described in the literature, which highlights the main feature of the bioprosthesis – ensuring the physiological biomechanics throughout the cardiac cycle.Conclusion. The presented method of qualitative computer assessment of the movement of the wire element of heart valve prosthesis using the “TiAra” bioprosthesis as an example demonstrates its validity as a tool for studying prosthesis functioning.
Highlights. It is the first pseudorandomized comparative study of xenopericardial frame and half-frame bioprostheses treated with diepoxin in the aortic position use and its direct results.Aim. A comparative assessment using the Propensity Score Matching method of the in-hospital clinical and hemodynamic results of the semi-framed epoxy-treated xenopericardial prosthesis “T-ara” and the framed epoxy-treated xenopericardial prosthesis “UniLine” (“NeoKor”, Kemerovo, Russia) for isolated aortic valve replacement implantation.Methods. 33 recipients of the “UniLine” prosthesis were selected by Propensity Score Matching method in a ratio of 1:1 to 33 observations from the “T-ara” group according to the compliance criteria: gender, age, body surface area, end-diastolic volume of the left ventricle (LV) and the pre-operative presence/absence of the aortic regurgitation.Results. Hospital mortality in the “T-ara” and “UniLine” groups was 3.03 (n = 1) and 6.06% (n = 2), respectively, p = 0.920. Non-fatal complications in the “T-ara” and “UniLine” groups was 7 (21.2%) and 18 (54.6%), p = 0.163. The incidence of postoperative heart failure and arrhythmias was higher in “UniLine” recipients (p = 0.001). The average stay in the intensive care unit was longer in the “UniLine” group than in the “T-ara” group, p = 0.05. Postoperative end-systolic and end-diastolic dimensions and volumes (and the corresponding indexes) of the LV, as well as the myocardial mass and its index in both groups had no statistically significant changes in relation to preoperative data. The comparative assessment of left ventricular remodeling parameters depending on the prosthetic size revealed no significant differences. The average pressure gradient in the “T-ara» and “UniLine” group of size 21mm was 12.2±7.4 and 12.2±5.0 mm Hg. (p>0.050). The average pressure gradient in the group “T-ara” and “UniLine” size 23–25 mm was 10.2±4.1 and 9.9±0.3 mm Hg, p>0.050. The regression degree of LV myocardial mass index in the groups did not have significant differences.Conclusion. At the hospital stage, the semi-framed epoxy-treated biological prosthesis “T-ara” has a similar clinical and hemodynamic profile with the framed biological prosthesis “UniLine”. The frequency of postoperative heart failure and cardiac arrhythmias is statistically significantly higher in the “UniLine” group (framed bioprostheses).
Cardiac surgery research shows that isolated aortic valve (AV) procedures account for 9% of all cardiac surgeries, with a surgery mortality rate of 2.3% and the predominance of bioprosthese use. Despite the widespread use of these methods, there is a high rate of patient-prosthesis mismatch affecting long-term survival. In this context, new technologies are emerging, such as Tiara bioprostheses and Ozaki neocuspidization of AV, but their comparative analysis is currently lacking.Aim: to compare short-term outcomes of the Tiara bioprosthesis implantation and the Ozaki procedure.Methodology and Research Methods. Retrospective analysis of 387 patients who underwent Ozaki procedure or the Tiara bioprosthesis implantation was performed. Inclusion criteria are patient age 18 years or older, Ozaki procedure performed or the Tiara bioprosthesis implantation. Exclusion criteria are use of a mini-access, the presence of infective endocarditis and repeated cardiac surgery. Ultimately, 352 patients were selected. Given the statistically significant differences in clinical and demographic characteristics between the groups, a propensity score matching was used in a 1 : 1 ratio. As a result two balanced groups of 58 patients each were formed.Results. In the group, where the Tiara bioprosthesis was implanted, the average age was 69 ± 5 years. In the group, where the Ozaki procedure was performed, the average age was 68 ± 6 years (p = 0.3). There were 14 men and 44 women in the Tiara group and 21 men and 37 women in the Ozaki group (p = 0.1). The median diameter of the annulus in the Tiara group was 20 (20–22) mm, while in the Ozaki group it was 21 (20–22) mm (p = 0.2). Statistically significant differences were noted in the duration of the surgery, cardiopulmonary bypass and cross-clamp time, which were statistically less in the Tiara group compared to the Ozaki group: surgery duration – 160 (145–199) minutes versus 250 (220–295) minutes (p < 0.001 ), cardiopulmonary bypass time – 72 (60–97) minutes versus 112 (92–133) minutes (p < 0.001), cross-clamp time – 55 (46–70) minutes versus 81 (71–100) minutes (p < 0.001). There was no statistically significant difference between the groups in terms of postoperative complications and hospital mortality. In-hospital mortality was 0% versus 2 (3.4%) cases (p = 0.4). Resternotomy due to bleeding was performed in 1 patient (1.7%) in the Tiara group and in 4 patients (6.9%) in the Ozaki group (p = 0.3). Pacemaker implantation was required in 2 patients (3.4%) in the Tiara group, whereas such a need did not arise in the Ozaki group (p = 0.4). Stroke occurred in 4 patients (6.9%) in the Tiara group and in 1 patient (1.7%) in the Ozaki group (p = 0.3). Acute kidney injury was recorded only in 1 patient in the Ozaki group (1.7%) (p = 1). Both groups had similar rates of patient-prosthesis mismatch; moderate discrepancy was noted in only one patient (1.7%) in the Tiara group; no such cases were recorded in the Ozaki group. However, significant differences were found in peak and mean gradients on AV. In the Tiara group, the peak gradient was 32 ± 12 mmHg, and the average was 17 (11–20) mmHg. In comparison, in the Ozaki group the average values were significantly lower: peak gradient – 11 ± 5 mmHg, average – 5 (3–8) mmHg. (p < 0.001 for both comparisons).Conclusion. The study showed that the surgery duration, cardiopulmonary bypass, and myocardial ischemia period was statistically significantly shorter in the Tiara group compared with the Ozaki group. Despite this, transvalvular gradients on the AV were smaller in the Ozaki group.
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