Aortic Valve Prosthesis Research Articles

Thrombocytopenia after Implantation of the Perceval, Intuity, and Sapien Aortic Valve Prostheses.

An increased incidence of thrombocytopenia was reported after implantation of the LivaNova Perceval and the Edwards Sapien aortic valve bioprostheses. Aim of this study is to assess the perioperative platelet count and bleeding complications in three different types of aortic valve bioprostheses intended for high-risk patients, the sutureless LivaNova Perceval, the rapid deployment Edwards Intuity, and the transcatheter Edwards Sapien. We performed a retrospective analysis of the perioperative data of patients receiving the Perceval, Intuity, and Sapien aortic valve bioprosthesis. The platelet count was collected preoperatively, at nadir postoperatively, and at discharge. The bioprostheses were compared for between-group differences in platelet count and postoperative bleeding complications. Overall, 37 patients received the Perceval, 42 the Intuity, and 58 the Sapien bioprosthesis. There was no significant between-group difference in the preoperative platelet count [Perceval 203(178-246)G/l, Intuity 214(190-232)G/l, Sapien 201(178-275)G/l, p = 0.800]. There was a significant between-group difference in the postoperative platelet count, both at nadir value [Perceval 57(37-80)G/l, Intuity 91(73-109)G/l, Sapien 126(105-170)G/l, p < 0.0001] and at discharge [Perceval 150(83-257)G/l, Intuity 239(200-343)G/l, Sapien 232(179-284)G/l, p = 0.001]. There was no significant between-group difference regarding red blood cell transfusions (p = 0.242), platelet transfusions (p = 0.656), and rethoracotomy for bleeding (p = 0.847). We found a significant platelet count reduction in all three bioprostheses which was more marked in the Perceval group. The platelet count reduction was transient and fully recovered in the Intuity and Sapien groups, whereas the Perceval group showed only a partial platelet count recovery. However, bleeding complications were not different between the three bioprostheses.

Prognosis after aortic valve replacement in dialysis patients: results from the Swedish Renal Registry

Abstract Background The choice of aortic valve prosthesis in aortic stenosis patients is based on patient preference, preoperative age, life expectancy, need for anticoagulant therapy and valve durability. Major uncertainties remain regarding optimal prosthetic valve choice in dialysis patients. Objectives The aim of the study was to compare the clinical outcomes after aortic valve replacement with mechanical (MAV) or bioprosthetic valves (BAV) in dialysis patients. Methods We used the observational, prospective, multicenter cohort from the Swedish Renal Registry, which includes all dialysis patients in Sweden. The study included 294 dialysis patients with aortic stenosis who underwent aortic valve replacement with MAV or BAV (obtained from surgical procedure codes) between 2005 and 2018, either before (n=155) or after dialysis start (n=139). Comorbidities and net adverse clinical events (bleeding events, stroke and reoperation) were obtained from national registries and defined by International Classification of Diseases codes (ICD-10). The incidence rate (IR) of primary endpoint comprised of all-cause death, bleeding events, stroke and aortic valve reoperation, as well as only all-cause death rates between recipients of MAV or BAV were estimated with Kaplan – Meier curves. Results The median age was 72 years (interquartile range [IQR]: 63.9, 77.3), 77% were males and 60% received mechanical valves. During a median follow-up of 1.49 years (IQR: 0.66–2.83), the primary endpoint occurred in 202 patients. Compared to BAV-recipients, those who received MAV had comparable IR of the primary end-point (40.1/100 person-years; [95% Confidence Interval (CI): 33.7–47.7], vs 36.2/100 person-years; [95% CI: 28.9–45.4], P=0.322) (Figure 1). Mortality rate at 1-year of follow-up was 28.9% without difference between recipients of MAV or BAV (68.8% in MAV-group and 57.6% with BAV; mortality rate MAV 33.3/100 person-year; (95% CI: 27.9–39.8) vs BAV 27.3/100 person-year; (95% CI: 21.5–34.6), P=0. 183)), (Figure 2). Additional statistical analysis of the secondary endpoint based on the occurrence of aortic valve intervention before or after dialysis start, was consistent with the main results. Conclusion There is no difference in mortality and complication rates in dialysis patients who underwent aortic valve replacement with MAV or BAV. Funding Acknowledgement Type of funding sources: None.

First 12-month follow-up of bioresorbable synthetic heart valves implanted in the aortic position in sheep

Abstract Background Replacement of diseased heart valves with the currently available valve prostheses has serious drawbacks. The use of bioresorbable synthetic “in situ tissue engineered” heart valve prostheses has been proposed to overcome the limitations of traditional heart valve prostheses. Such bioresorbable synthetic heart valve prostheses have been successfully tested as pulmonary valve replacements in preclinical studies, but data on aortic valve replacement is lacking. Here, we present the first in-vivo study on the long-term functionality of bioresorbable synthetic heart valves in the high-pressure circulation. Methods Approval for the animal studies was obtained by the Amsterdam University Medical Centres Animal Care Ethics Committee (AVD1180020197705) and are in agreement with the current Dutch law on animal experiments (WOD). We surgically implanted bioresorbable synthetic aortic valve prostheses in 20 female Swifter sheep in orthotopic position. The scheduled follow-up times were 1, 3, 6, 9 and 12 months. Results Fifteen sheep (75%) recovered well from the surgical valve implantation procedure and were included in this analysis. No sheep died due to valve failure. All valves remained free from active infectious endocarditis, thrombotic complications, and pathological calcification. A total of 10 valves (67%) were intact, thin and pliable and remained free from leaflet thickening, retraction and degradation up to 12 months after implantation. In most valves (67%), the scaffold remained sparsely- or unpopulated by cells during 12 months follow up. In some valves (33%), colonization of the valve scaffold was observed, however this was most often associated with partial degradation of the leaflet and leaflet thickening. In general, the degradation of the scaffold fibres was limited throughout the follow-up period. Conclusion We are the first to evaluate in vivo bioresorbable synthetic heart valves in aortic position. While valves remained functional, the study also serves as a starting point to further optimize scaffold and neotissue development for heart valve replacement in the high-pressure environment. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): 1. Cardiovasculair Onderzoek Nederland (grant number CVON2012-01)2. Netherlands Organization for Scientific Research (024.003.013)

Autologous or bovine pericardium for aortic cusp replacement? Histomorphological and biomechanical properties as decision making tools

Abstract Background/Introduction Aortic valve cusp replacement using autologous pericardium is a promising technique. Expected advantages are reduced immune response, proper biomechanics and lower treatment expenses. During surgery decision for preferred pericardium segment is based on visual criteria. Autologous pericardium can be affected by patient's condition and age. Bovine pericardium, also the basic material for aortic valve prostheses, is easy available and carefully pre-examined. In this study, the homogeneity of tissue thickness, elastic modulus, vessel density and ECM components of GA-treated residual pericardia after surgery is compared with bovine pericardia equivalently treated. Purpose Aim of the study is the comparison of homogeneity of remaining autologous pericardium after surgical aortic valve replacement with bovine pericardia to evaluate and classify the individual applicability. Methods Up to 12 samples of human (n=7) or bovine (n=3) pericardia were analysed. Tissues were treated with 0.6% glutaraldehyde according to surgical protocol. Picrosiriusred- and HE-staining were performed (three edges per separated leaflet). Vessel or collagen content was determined with Zen Blue resp. Fiji software (colour deconvolution plugin, user threshold values). Sample thickness was measured via thickness gauge FD50 before uniaxial tensile testing. Hydroxyproline content was determined and related to dry weight. T-Test or ANOVA were used to test inter-species or intra-individual differences, respectively. Results Human pericardia contain with 64.66±3.85% less collagenous fibres compared to bovine pericardia (86.01±1.713%); their vessel density is with 29.46±3.73 mm–2 significantly higher than in bovine samples (12.34±1.636 mm–2). In addition, human pericardia are with 367.7±59.2 μm significantly thinner than bovine (524.4±96.8 μm). Tensile testing (human: 36.00±15.17 MPa; bovine: 41.30±7.767 MPa) also revealed significant differences. With 77.80±11.76 mg/g merely a trend was observed for a lower hydroxyproline content in human samples (bovine 93.16±5.130 mg/g). ANOVA analyses of human pericardia illustrate significant differences for all properties, thus thickness, elastic modulus and hydroxyproline and collagen content between the individual human pericardium samples. In contrast, bovine pericardia showed an intra-individual difference only for the parameter of tissue thickness. Conclusion Human and bovine pericardia differ in histological and biomechanical parameters. In contrast to bovine pericardia, individual human pericardia were significantly different in most parameters investigated, leading to the conclusion that autologous materials are critically more heterogeneous than xenogeneic tissues. Vessel density in human pericardium was twofold higher than in bovine pericardia and can result in a higher risk for calcification. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): TU Dresden

Computation of flow through TAVI device by means of physics informed neural networks

Abstract Cardiovascular diseases are among the most common diseases with high mortality, including aortic valve stenosis and insufficiency. Minimally invasive implantation of transcatheter aortic valve prosthesis (TAVI) has become the standard procedure for patients with increased risk for open surgery. It is commonly accepted that the long-term outcome of aortic valve replacement depends on hemodynamic performance. This motivates the analysis of the velocity field in the vicinity of the TAVI. Computational fluid dynamics (CFD) methods have been established in the past, but show limitations in terms of computational effort when rapid design optimization or patient-specific decision making in real time is required. In this study we show the usage of PINNs for predicting fluid flow through a TAVI device. We also show a method of enforcing boundary conditions for this specific problem. Due to the physics involved in the training process, this principle does in theory not require additional training data. To validate the method, we performed CFD simulations that solved the Navier-Stokes equations be means of finite volume methods. Besides the good estimation of the main flow components, discrepancies between CFD and PINN results are present. Nevertheless, the flow structures have certain similarities in the coarse spatial localization of the vortex patterns occurring in flow around the TAVI device.

Sutureless aortic valve replacement in high-risk patients with active infective endocarditis.

BackgroundSurgical aortic valve replacement remains the gold standard of treatment in patients with active infective endocarditis. Such procedures tend to carry a significantly higher operative risk when compared to the conventional aortic valve replacement for a non-infective aortic valve disease. Sutureless aortic valve replacement (SU-AVR) has been introduced into cardiac surgery to allow for a simpler implementation of minimally invasive procedures. Although SU-AVR in several extended indications has proven to be successful, the data on the implementation of SU-AVR in patients with infective aortic valve endocarditis remain scarce. The aim of the study was to examine the feasibility of SU-AVR in high-risk patients with active infective aortic valve endocarditis.MethodsBetween December 2019 and March 2022, a total of 151 consecutive patients underwent a SU-AVR for various indications at our institution. Of those, in 13 consecutive high-risk patients SU-AVR was indicated because of infective aortic valve endocarditis. In all cases Perceval S aortic valve prosthesis (Corcym, Saluggia, Italy) was used and the implantation has been performed with Snugger-method.ResultsThe mean age of the patients at operation was 74.05±11.6 years. Eight of the patients suffered from prosthesis endocarditis while the other five patients presented with the endocarditis of the native aortic valve. All patients suffered from multiple comorbidities, as reflected by a mean logistic EuroSCORE of 47.9%±23.1% and EuroSCORE II of 28.7%±22.0%. In 8 patients (61.5%) a concomitant procedure was necessary. Also 8 patients (61.5%) underwent a redo procedure. Bypass- and cross-clamp (CC) times were 89.8±33.6 and 59.1±27.8 minutes, respectively. We observed no paravalvular leakage and no cases of left-ventricular outflow tract obstruction. Postoperative mean gradients after SU-AVR implantation were 8.1±4.8 mmHg.ConclusionsSU-AVR in patients presenting with active infective endocarditis is a safe and feasible surgical alternative to the conventional operation. Clearly, this operative approach should be considered particularly for high-risk patients in whom successful operative outcomes are determined by a reduction in bypass and CC time. SU-AVR provides excellent hemodynamic performance with a low risk of paravalvular leakage and low transvalvular gradients, whilst simplifying the surgical procedure.

Fluid dynamics and blood damage in the dilated ascending aorta after mechanical prosthetic valve implantation: an in vitro study

The implantation of aortic valve prostheses is often associated with the dilation of the ascending aorta. It is well known that the modification of the fluid dynamics induced by both the prosthetic valve and aortic dilation may, in turn, promote further vessel remodelling. Besides, when the prosthesis is mechanical, a major concern is the blood cell damage and platelet activation which requires a lifelong anticoagulant therapy, which in turn is an additional significant factor of comorbidity. We analysed in vitro the combined effect of the presence of a bileaflet mechanical aortic valve and the dilation of the aortic root in patient specific laboratory models. Three model aortas with increasing degree of dilation, hosted in a mock loop reproducing the heart flow pulsatility, were investigated. The measurement of the time-resolved velocity field allowed the analysis of the general structure of the flow and shear strain-rate distribution. Additionally, the Blood Damage Indexes (BDIs) for both haemolysis and platelet activation were computed along synthetic particle trajectories. Results suggest that a feedback process can be triggered since the aortic dilation tends to decrease the shear stresses at the walls and favour blood stasis: two factors that are known to promote vessel remodelling. Secondly, the analysis of BDIs shows that aortic dilation significantly increases the damage index for haemolysis, whereas a similar effect is not shown when focusing on platelet activation.Graphical abstract

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes.

Although transcatheter aortic valve replacement (TAVR) therapy continues to grow, there have been concerns about the occurrence of hypoattenuating leaflet thickening (HALT), which may affect prosthesis function or durability. This study aimed to examine prosthesis frame factors and correlate their extent to the frequency of HALT and clinical outcomes. We prospectively examined 565 patients with cardiac computed tomography screening for HALT at 30 days after balloon-expandable SAPIEN3 and self-expanding EVOLUT TAVR. Deformation of the TAVR prostheses, asymmetric prosthesis leaflet expansion, prosthesis sinus volumes, and commissural alignment were analyzed on the postprocedural computed tomography. For descriptive purposes, an index of prosthesis deformation was calculated, with values >1.00 representing relative midsegment underexpansion. A time-to-event model was performed to evaluate the association of HALT with the clinical outcome. Overall, HALT was present in 21% of SAPIEN3 patients and in 16% of EVOLUT patients at 30 days after TAVR. The occurrence of HALT was directly associated with greater prosthesis frame deformation (P<0.001), worse asymmetry of the leaflets (P<0.001), and smaller TAVR neosinus volumes (P<0.001). These relations were present in both prosthetic types and in all of their size ranges (all P<0.05). In multivariable analyses that include clinical variables previously associated with HALT (eg, anticoagulant therapy), variables of TAVR prosthesis deformation remained predictive of HALT. Although HALT was not associated with changes in prosthetic hemodynamics, its presence was associated with the risk of mortality at 1 year, with respect to greater incidences of all-cause mortality (hazard ratio, 2.98 [95% CI, 1.57-5.63]; P=0.001), cardiac death (hazard ratio, 4.58 [95% CI, 1.81-11.6]; P=0.001), and a composite outcome of all-cause mortality and heart failure hospitalization (hazard ratio, 1.94 [95% CI, 1.14-3.30]; P=0.02) with adjustment for age, sex, and comorbidities. Nonuniform expansion of TAVR prostheses resulting in frame deformation, asymmetric leaflet, and smaller neosinus volume is related to occurrence of HALT in patients who undergo TAVR. These data may have implications for both prosthesis valve design and deployment techniques to improve clinical outcomes for these patients.

Completely detached mechanical aortic valve prosthesis stuck to the aortic arch in a patient with Behçet’s disease

BackgroundAlthough detachment of the implanted valve prosthesis was a well-known complication in patients with Behçet’s disease, complete detachment of an aortic bileaflet valve prosthesis has never been reported.Case presentationAn 18-year-old boy with Behçet’s disease (HLA-A26 positive) who had previously undergone aortic valve replacement with an 18-mm ATS-Advanced Performance (ATS-AP) valve (ATS Medical, Inc., Minneapolis, MN) at the age of 12 years, presented sudden-onset general fatigue and was emergently transferred to the regional hospital. Chest X-ray showed displacement of the implanted mechanical valve. An echocardiogram revealed mobile valve prosthesis and severe aortic regurgitation. Just before leaving for our hospital for surgical treatment, a completely detached valve prosthesis was floating in the ascending aorta. On arrival, the valve prosthesis was stuck to the transverse arch. Emergent removal of the previous mechanical valve from the aortic arch and redo aortic valve replacement with a 24-mm ATS-AP valve were performed under total circulatory arrest. Infectious endocarditis was denied by histopathological examination. The patient was back to the intensive care unit with extracorporeal membrane oxygenation support, which was successfully decannulated 5 days later.ConclusionsThis was the first report of a patient with Behçet’s disease who encountered a complete detachment of implanted aortic valve prosthesis. The patient could be rescued by emergent surgery.

The use of sutureless and rapid-deployment aortic valve prosthesis in patients with bicuspid aortic valve: A focused review.

The objective of this scoping review is to describe the postoperative outcomes and complications of patients with bicuspid aortic valve (BAV) treated with sutureless or rapid-deployment prosthesis. The use of sutureless and rapid-deployment prostheses is generally avoided in patients with BAVdue to anatomical concerns and the elevated risk of para-prosthetic leaks. Multiple studies have reported the use of these prostheses into patients with BAV with varying degrees of success. The focus of this review is to consolidate the current available evidence on this topic. A scoping review was conducted using a comprehensive search strategy in multiple databases (Medline, Embase, Cochrane Central Register of Controlled Clinical Trials) for relevant articles. All abstracts and full texts were screened by two independent reviewers according to predefined inclusion and exclusion criteria. Thirteen articles, including case reports and case series were ultimately included for analysis. Of 1052 total citations, 44 underwent full text review and 13 (4 case reports, 6 retrospective analyses, and 3 prospective analyses) were included in the scoping review. Across all 13 studies, a total of 314 patients with BAV were used for data analysis. In sutureless and rapid-deployment prostheses, the mean postoperative aortic valvular gradients were less than 15 mmHg in all studies with mean postoperative aortic valvular areas all greater than 1.3 cm.2 There were 186 total complications for an overall complication rate of 59%. Individual complications included new onset atrial fibrillation (n = 65), required pacemaker insertion (n = 24), intraprosthetic aortic regurgitation (n = 20), new onset atrioventricular block (n = 18), and new onset paravalvular leakage (n = 10). The use of sutureless and rapid deployment prostheses in patients with BAV showed comparable intraoperative and implantation success rates to patients without BAV. Postoperative complications from using these prostheses in patients with BAV included new onset atrial fibrillation, intraprosthetic aortic regurgitation, new onset atrioventricular block, and required pacemaker insertion. Various techniques have been described to minimize these complications in patients with BAV receiving sutureless or rapid deployment prostheses.

The role of sutureless or rapid-deployment aortic valve prosthesis in bicuspid aortic valve: Standard AVR, TAVR, or somewhere in between?

Journal of Cardiac SurgeryVolume 37, Issue 10 p. 3363-3364 COMMENTARY The role of sutureless or rapid-deployment aortic valve prosthesis in bicuspid aortic valve: Standard AVR, TAVR, or somewhere in between? Suguru Ohira MD, PhD, Corresponding Author Suguru Ohira MD, PhD Suguru.Ohira@wmchealth.org orcid.org/0000-0003-0247-865X Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York, USA Correspondence: Suguru Ohira, MD, PhD, Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, 100 Woods Rd, Macy Pavilion, Valhalla, NY 10595, USA. Email: Suguru.Ohira@wmchealth.orgSearch for more papers by this authorCorazon De La Pena MD, Corazon De La Pena MD Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York, USASearch for more papers by this author Suguru Ohira MD, PhD, Corresponding Author Suguru Ohira MD, PhD Suguru.Ohira@wmchealth.org orcid.org/0000-0003-0247-865X Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York, USA Correspondence: Suguru Ohira, MD, PhD, Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, 100 Woods Rd, Macy Pavilion, Valhalla, NY 10595, USA. Email: Suguru.Ohira@wmchealth.orgSearch for more papers by this authorCorazon De La Pena MD, Corazon De La Pena MD Department of Surgery, Division of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York, USASearch for more papers by this author First published: 28 July 2022 https://doi.org/10.1111/jocs.16802Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume37, Issue10October 2022Pages 3363-3364 RelatedInformation

Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.

With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses. Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described. Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%. Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted.

Single-center experience in sutureless aortic valve implantation using two aortic valve prostheses

Background and aim of the study: Sutureless aortic valves are used to reduce operation time. However, the stent implantation might cause postoperative ECG alterations and a higher risk of paravalvular leakage. In literature, some cases of thrombocytopenia are described after implantation. We investigated the Sorin Perceval S Sutureless Valve and the Edwards Intuity Sutureless Valve. Material and methods: Seventy-nine patients underwent aortic valve replacement using a sutureless valve in a single center between 2015 - 2018. Thirty-seven patients received Sorin Perceval S (Group A) and 42 Edwards Intuity (Group B). Simultaneous bypass surgery was performed in 23 patients in Group A and 22 patients in Group B. We compared the groups regarding postoperative TTE and paravalvular leakage, postoperative ECG alterations, need for pacemaker implantation, postoperative platelet count, and 30-day mortality Results: Only in Group B 2 patients had paravalvular leakage, and one was reoperated within the same hospital stay. In Group A, nine patients suffered from postoperative atrial fibrillation, and in Group B, 16 patients. Left bundle branch block (LBBB) was observed in 5 patients in Group A, and 13 patients in Group B. Two patients in Group A needed a definite pacemaker, and five patients in Group B. Tachy-Brady Syndrome and LBBB were observed more frequently in Group B as well as ECG alterations. One patient died within 30 days in Group A due to multiorgan failure. This patient was older and multimorbid compared to the average. Regarding platelet count, we saw a statistically significant decrease in both groups. There were no major bleeding complications or reoperations due to hemorrhage. Conclusion: Our data shows that sutureless aortic valve replacement is associated with new postoperative ECG alterations, which are self-limiting in most cases. Compared to the literature pacemaker implantation rate in Group B is higher.

The results of the application of a new technique of open implantation of self-opening transcatheter aortic valves in an experiment

Background. In recent years, transcatheter implantation of the aortic valve has become increasingly performed as an alternative to "open" prosthetics. The undoubted advantage of this technology is its minimally invasive nature, which in most cases provides a favorable clinical outcome of the intervention. The transcatheter method of aortic valve prosthetics does not require sternotomy and connection of an artificial circulation device, which significantly reduces the risk of postoperative mortality and complications. However, despite all the advantages of the existing models, they are not without drawbacks that force researchers to develop and test new transcatheter valves. The problem of experimental studies of new models of self-opening transcatheter aortic valves is mainly determined by the anatomical features of the aortic root of animals. In this regard, the development of a reliable method of implantation of valve prostheses in the experiment is an urgent problem of preclinical testing.Aim. Development of a protocol for open implantation of a transcatheter aortic valve in experiment and evaluation of long-term results.Methods. To develop an experimental model, pigs of the "Landras" breed, females weighing 129.83 ± 9 kg were used. Transcatheter aortic valve implantation was performed under conditions of artificial circulation and moderate hypothermia (33-34°C) through a transverse aortotomy under the control of vision. During the experiment, invasive monitoring of blood pressure, central venous pressure, heart rhythm, body temperature, blood gas composition, activated clotting time was performed. The correct positioning and hemodynamic parameters after implantation were evaluated using transesophageal echocardiography.Results. In a series of chronic experiments, 18 open implantations of self-opening transcatheter aortic valves were performed. Successful positioning was achieved in 100% of cases. The developed protocol of open implantation made it possible to achieve reliable fixation of the prosthesis in the orthotopic position, as well as to prevent the migration of the prosthesis, the development of mitral regurgitation, paraaortic fistulas and coronary circulation disorders.Conclusion. In the course of the study, a simple and effective method of open implantation of a transcatheter aortic heart valve prosthesis was developed in an experiment. Received 1 October 2021. Revised 1 November 2021. Accepted 12 November 2021. Funding: This work was carried out within the framework of the state task of Ministry of Health of Russian Federation No. 121032300337-5. Conflict of interest: Authors declare no conflict of interest. Contribution of the authorsConception and study design: M.O. Zhulkov, D.A. Sirota, K.V. Kozyr, D.S. SergeevichevData collection and analysis: M.O. ZhulkovDrafting the article: M.O. ZhulkovCritical revision of the article: D.A. Sirota, A.M. ChernyavskiyExperimental part: M.O. Zhulkov, H.A. Agaeva, A.K. Sabetov, I.S. Zykov, A.R. TarkovaFinal approval of the version to be published: M.O. Zhulkov, K.V. Kozyr, I.S. Zykov, A.R. Tarkova, H.A. Agaeva, A.K. Sabetov, D.A. Sirota, D.S. Sergeevichev, A.M. Chernyavski

Balloon expandable vs. self-expandable transcatheter aortic valve prosthesis short-term results of retrospective study

Transcutaneous aortic valve implantation has been established as an effective method for the treatment of highgrade aortic stenosis in non-operative, high-risk for conventional surgery patients. According to the developed implantation technologies, the prostheses are divided into balloon-expandable valve prostheses (balloon-expandable valves, BEV) and self-expanding valve prostheses (self-expanding prostheses SEV). The two types of devices have different models for implantation, stratum architecture, cusps characteristics, leading to different hemodynamics, frequency of use and performance of normal prosthesis function. The research aims to monitor the short-term results, up to 1 month after discharge, in terms of mortality, the manifestation of heart failure, (para) prosthetic regurgitation, implantation of a pacemaker, and vascular complications. Materials and methods: the article presents a retrospective follow-up of a total of 230 high-risk for conventional cardiac surgery patients with high-grade aortic stenosis treated in a cardiology clinic at UMHAT St. Ekaterina Sofia until 2020, divided into two groups depending on the implanted type of prosthesis. Conclusions: The results obtained based on our experience prove the safety of new prostheses. When choosing between BEV and SEV, the best clinical outcome requires a good knowledge of the strengths and weaknesses of using medical devices with a personalized approach consistent with the clinical and anatomical characteristics of the patient.

Comparative evaluation of the efficiency of aortic valve prosthesis through mini sternotomy and traditional sternotomy access

The paper compared the results of surgical treatment of patients with acquired aortic valve disease using classical sternotomy (54 patients) and mini-J sternotomy (35 patients). There has been a gradual increase in the use of minimally invasive approaches in comparison with traditional approaches for aortic valve replacement. The advantages of using ministernotomy access in terms of faster recovery in the postoperative period and improving the patient’s quality of life in the long term after surgery are shown. The use of mini-accesses for the treatment of patients with cardiovascular pathology is a promising and safe direction.

First Dedicated Minimally Invasive Right Atrial Retractor.

The importance of correcting tricuspid valve insufficiency in patients with left-sided valve disease is clear. In the United States, up to 30% of mitral valve operations are minimally invasive, while the data for isolated tricuspid valve is not known. A minimally invasive approach to the tricuspid valve provides faster recovery with lower transfusion rates and lower length of stay. There are no dedicated right atrial (RA) retractors for minimally invasive tricuspid valve (TV) operations. TV exposure is different from mitral given the proximity of the tricuspid anterior annulus to the cut edge of the atrium. An RA retractor should be shallow while preventing slippage of the RA roof and should be quick to deploy and remove. We created a dedicated minimally invasive RA retractor to expose the TV and RA structures (fossa ovalis and coronary sinus). The retractor is a fenestrated shallow and wide retractor with bilateral articulating "wings" to expose left and right of the atrium. This retractor is compatible with the left atrial system by USB Medical Limited (Hatboro, Pennsylvania) and has tilting capability. A three-dimensional (3D)-printed prototype was modified after evaluation by two experienced minimally invasive surgeons (MCS and RKV). Once modifications were finalized, the retractor was then deployed in surgery. The RA retractor was used in isolated TV repairs, RA myxoma resection, RA clot removal, removal of RA migrated stents, select mitral valve operations, and closure of atrial septal defects. The retractor proved effective, safe, and fast to deploy and remove and allowed for full visualization of the tricuspid valve, interatrial septum, ostia of both vena cavas, and coronary sinus. The retractor was useful in mitral valve operations with existing aortic valve prosthesis and in the small left atria. The minimally invasive RA retractor affords excellent, stable exposure of the right atrial structures with fast deployment and removal.

P107 MULTIMODALITY IMAGING IN ASCENDING AORTA PSEUDO–ANEURYSM COMPLICATED BY MOBILE TROMBUS SYMPTOMATIC FOR RECURRENT ISCHEMIC STROKE

Abstract A 80–year–old male patient was admitted to hospital with a clinical picture of Broca‘s aphasia. The patient had arterial hypertension, diabetes, chronic kidney disease and peripheral vasculopathy. In remote cardiological history he presents long standing persistent atrial fibrillation on OAC and he had a biological aortic valve prosthesis (Medtronic 23). Overall time in the therapeutic range (INR 2.0–2.5) was adequate considering the presence of atrial fibrillation. A CT scan was performed on suspicion of stroke, showing a recent ischemic lesion in the left middle temporal region complicated by same–site subarachnoid blood suffusion. During the hospital stay there was a recurrence of the aforementioned symptoms: at the CT check a new acute ischemic same–site lesion and a new ischaemic lesion at the left temporal site was highlighted. In the suspicion of a cardio–embolic origin of cerebro–vascular events, it was decided to carry out imaging for the study of the aorta and heart cavities to exclude embolic sources. Given the patient‘s comorbidities and the reported allergies (contrast medium with angioedema–like reaction at a previous CT) it was decided to perform transesophageal echocardiography (TEE) first. TEE documented the presence of a saccular aneurysm of probable pseudo–aneurysmatic nature, which extends from 20 mm from the valvular plane, characterized by pedunculated, mobile thrombotic apposition, adhered to the internal collar, projecting into the psueudo–aneurysmatic cavity (image 1). This finding was confirmed and better characterized with the help of the real time three–dimensional echocardiographic method (image 2). To confirm and better characterize the extension of the pseudo–aneurysm and plan any strategy, a CT scan with contrast medium was required. Performing contrast–enhanced CT, after careful preparation with premedication with antihistamine and cortisone, confirmed the finding of pseudo–aneurysm of the ascending aorta, but the pedunculated thrombotic apposition was less clearly evidenced compared with TEE (giving the superior temporal resolution of TEE) (image 3). The case was therefore assessed in Heart Team and the patient was scheduled for surgically exclusion of the pseudo–aneurysm. Conclusion In our case a multimodality imaging approach was used to diagnose and confirm the presence of ascending aorta pseudo–aneurysm complicated by pedunculated thrombotic apposition inside it, symptomatic for recurrent ischaemic stroke.

Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method.

Recent evidence has shown that transcatheter heart valve (THV) anchoring in bicuspid aortic valve (BAV) patients occurs at the level of the raphe, known as the LIRA (Level of Implantation at the RAphe) plane. Our previous work in a cohort of 20 patients has shown that the delineation of the perimeter and device sizing at this level is associated with optimal procedural outcome. The goals of this study were to confirm the feasibility of this method, evaluate 30-day outcomes of LIRA sizing in a larger cohort of patients, assess interobserver variation and reproducibility of this sizing methodology, and analyse the interaction of LIRA-sized prostheses with the surrounding anatomy. The LIRA sizing method was applied to consecutive patients presenting to our centre with raphe-type BAV disease between November 2018 and October 2021. Supra-annular self-expanding THVs were sized based on baseline CT scan perimeters at the LIRA plane and the virtual basal ring. In cases where there was discrepancy between the two measurements, the plane with the smallest perimeter was considered the reference for prosthesis sizing. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. A total of 50 patients (mean age 80 ± 6 years, 70% male) with raphe-type BAV disease underwent transcatheter aortic valve replacement (TAVR) using different THV prostheses. The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, no moderate-severe paravalvular leak, and low transprosthetic gradients (residual mean gradient 8.2 ± 3.4 mmHg). There were no strokes, no in-hospital or 30-day mortality, and an incidence of in-hospital pacemaker implantation of 10%. Furthermore, measurement of the LIRA plane perimeter was highly reproducible between observers (r = 0.980; P < 0.001) and predictive of the post-procedural prosthetic valve perimeter on CT scanning (r = 0.981; P < 0.001). We confirm the feasibility of supra-annular sizing using the LIRA method in a large cohort of patients with high procedural success and good clinical outcomes at 30 days. Application of the LIRA method optimizes THV prosthesis sizing in patients with raphe-type BAV disease.

The performance of the supra-annular Top-Hat aortic valves compared to the standard Carbomedics valves

Background: The CarboMedics Top-Hat aortic valve prosthesis was designed to be implanted in a supra-annular position. This study aimed to compare the hemodynamic performance of the Top-Hat aortic prostheses versus the standard CarboMedics aortic valve prostheses.&#x0D; Methods: The study included 98 patients who had aortic valve replacement and were divided into two groups. Group A included 60 patients who had standard aortic valve prostheses, and Group B included 38 patients who had the Top-Hat aortic prostheses. The study endpoints were hospital outcomes, the effective orifice area, and the pressure gradient during a one-year follow-up.&#x0D; Results: There was no significant difference in the baseline echocardiographic data and risk factors between the groups. The patients who had Top-Hat aortic prosthesis were younger, with a mean age of 47.5 (44-55) years, and those who had the standard prosthesis were 53.5 (48-56) years old (P= 0.02). The cardiopulmonary bypass time was significantly less in the Top-Hat prosthesis group with an average of 78 min (75- 81) compared to 88 min (84- 95) in the other group (P ˂0.001). The effective orifice surface area was significantly larger in the group with Top-Hat prosthesis; 0.9 mm/m2 (0.88- 0.92) compared to 0.84 mm/m 2 (0.79- 0.87) for the standard aortic valve prosthesis group (P ˂0.001). The pressure gradient over the aortic valve decreased significantly postoperatively (coefficient -1.98 (-2.21- -1.75); P˂0.001). Patients with Top-Hat valves had significantly lower gradient (coefficient: -4.22 (-6.61- -1.82); P= 0.001), while age had no effect on the pressure gradient (coefficient: 0.1 ( -0.07- 0.27); P= 0.25).&#x0D; Conclusion: The Top-Hat CarboMedics prostheses could be superior to the standard CarboMedics aortic valve prosthesis regarding the effective orifice area and pressure gradient over the valve.