Evaluation of oversizing in association with conduction disorder after implantation of a rapid deployment valve.

Rapid deployment valve has expanded surgical indication for high-risk patients with aortic stenosis despite its accommodated risk for conduction disorder (CD). The purpose of this study was to evaluate the degree of oversizing in association with postoperative CD. During June 2019 to September 2021, 25 patients underwent aortic valve replacement with Edwards INTUITY. Device size selection was evaluated intraoperatively using provided sizers. Oversizing was evaluated retrospectively by measuring the difference of the dimension of the annulus and left ventricular outflow tract (LVOT) compared to the dimensions of the device used by preoperative-computed tomography. Although there was no incidence of pacemaker implantation, seven patients (28.0%) experienced CD after surgery. There was no difference in device area and annulus area (CD: - 37 ± 22.7 mm2 vs. no CD: - 56 ± 63.6 mm2, p = 0.47), and device circumference and annulus circumference (CD: - 4.4 ± 2.77 mm vs. no CD: - 6.9 ± 5.60 mm, p = 0.26) in patients with and without CD. However, there was a significant difference in area of the device skirt and sub-annular area at the LVOT (CD: 114 ± 28.4 mm2 vs. no CD: - 8 ± 80.0 mm2, p < 0.001), and circumference of device skirt and the LVOT (CD: 3.9 ± 2.08 mm vs. no CD: - 4.6 ± 5.24 mm, p < 0.001) between the two groups. Receiver operating characteristic curve analysis showed that an area difference of 77.7 mm2 and circumference difference of 0.91 mm at LVOT were associated with postoperative CD with specificities of 0.83, 0.78 and sensitivity of 1.0, 1.0, respectively. Preoperative measurement of the LVOT may be useful in evaluating the risk of postoperative CD in patients receiving rapid deployment valve.

Native Aortic Valve Disease Progression and Bioprosthetic Valve Degeneration in Patients With Transcatheter Aortic Valve Implantation.

BACKGROUND: Major uncertainties remain regarding disease activity within the retained native aortic valve, and regarding bioprosthetic valve durability, after transcatheter aortic valve implantation (TAVI). We aimed to assess native aortic valve disease activity and bioprosthetic valve durability in patients with TAVI in comparison with subjects with bioprosthetic surgical aortic valve replacement (SAVR). METHODS: In a multicenter cross-sectional observational cohort study, patients with TAVI or bioprosthetic SAVR underwent baseline echocardiography, computed tomography angiography, and 18F-sodium fluoride (18F-NaF) positron emission tomography. Participants (n=47) were imaged once with 18F-NaF positron emission tomography/computed tomography either at 1 month (n=9, 19%), 2 years (n=22, 47%), or 5 years (16, 34%) after valve implantation. Patients subsequently underwent serial echocardiography to assess for changes in valve hemodynamic performance (change in peak aortic velocity) and evidence of structural valve dysfunction. Comparisons were made with matched patients with bioprosthetic SAVR (n=51) who had undergone the same imaging protocol. RESULTS: In patients with TAVI, native aortic valves demonstrated 18F-NaF uptake around the outside of the bioprostheses that showed a modest correlation with the time from TAVI (r=0.36, P=0.023). 18F-NaF uptake in the bioprosthetic leaflets was comparable between the SAVR and TAVI groups (target-to-background ratio, 1.3 [1.2-1.7] versus 1.3 [1.2-1.5], respectively; P=0.27). The frequencies of imaging evidence of bioprosthetic valve degeneration at baseline were similar on echocardiography (6% versus 8%, respectively; P=0.78), computed tomography (15% versus 14%, respectively; P=0.87), and positron emission tomography (15% versus 29%, respectively; P=0.09). Baseline 18F-NaF uptake was associated with a subsequent change in peak aortic velocity for both TAVI (r=0.7, P<0.001) and SAVR (r=0.7, P<0.001). On multivariable analysis, 18F-NaF uptake was the only predictor of peak velocity progression (P<0.001). CONCLUSIONS: In patients with TAVI, native aortic valves demonstrate evidence of ongoing active disease. Across imaging modalities, TAVI degeneration is of similar magnitude to bioprosthetic SAVR, suggesting comparable midterm durability. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02304276.

Fourier transform infrared spectroscopy coupled with machine learning classification for identification of oxidative damage in freeze-dried heart valves.

Freeze-drying can be used to ensure off-the-shelf availability of decellularized heart valves for cardiovascular surgery. In this study, decellularized porcine aortic heart valves were analyzed by nitroblue tetrazolium (NBT) staining and Fourier transform infrared spectroscopy (FTIR) to identify oxidative damage during freeze-drying and subsequent storage as well as after treatment with H2O2 and FeCl3. NBT staining revealed that sucrose at a concentration of at least 40% (w/v) is needed to prevent oxidative damage during freeze-drying. Dried specimens that were stored at 4 °C depict little to no oxidative damage during storage for up to 2 months. FTIR analysis shows that fresh control, freeze-dried and stored heart valve specimens cannot be distinguished from one another, whereas H2O2- and FeCl3-treated samples could be distinguished in some tissue section. A feed forward artificial neural network model could accurately classify H2O2 and FeCl3 treated samples. However, fresh control, freeze-dried and stored samples could not be distinguished from one another, which implies that these groups are very similar in terms of their biomolecular fingerprints. Taken together, we conclude that sucrose can minimize oxidative damage caused by freeze-drying, and that subsequent dried storage has little effects on the overall biochemical composition of heart valve scaffolds.

Recent Progress Toward Clinical Translation of Tissue-Engineered Heart Valves.

Surgical replacement remains the primary option to treat the rapidly growing number of patients with severe valvular heart disease. Although current valve replacements-mechanical, bioprosthetic, and cryopreserved homograft valves-enhance survival and quality of life for many patients, the ideal prosthetic heart valve that is abundantly available, immunocompatible, and capable of growth, self-repair, and life-long performance has yet to be developed. These features are essential for pediatric patients with congenital defects, children and young adult patients with rheumatic fever, and active adult patients with valve disease. Heart valve tissue engineering promises to address these needs by providing living valve replacements that function similarly to their native counterparts. This is best evidenced by the long-term clinical success of decellularised pulmonary and aortic homografts, but the supply of homografts cannot meet the demand for replacement valves. A more abundant and consistent source of replacement valves may come from cellularised valves grown in vitro or acellular off-the-shelf biomaterial/tissue constructs that recellularise in situ, but neither tissue engineering approach has yet achieved long-term success in preclinical testing. Beyond the technical challenges, heart valve tissue engineering faces logistical, economic, and regulatory challenges. In this review, we summarise recent progress in heart valve tissue engineering, highlight important outcomes from preclinical and clinical testing, and discuss challenges and future directions toward clinical translation.

Current Indications for Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valves: Valve-in-Valve, Valve-in-Ring, and Valve-in-Mitral Annulus Calcification.

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.

In vitro evaluation of a new aortic valved conduit.

BACKGROUND: This study examined whether the presence of a sinus of Valsalva equivalent in the KONECT RESILIA aortic valved conduit (Edwards Lifesciences, Irvine, Calif) improves valve hemodynamics, kinematics, and performance. METHODS: A 28-mm KONECT RESILIA aortic valved conduit was used to create an in vitro flow test model, and the same aortic valved conduit model without a sinus section was used as a control. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated left-heart simulator at 3 cardiac output levels. In addition, leaflet kinematics of the valves were determined through en face high-speed imaging. RESULTS: The KONECT RESILIA aortic valved conduit model exhibited lower mean and peak transvalvular pressure gradients than the control model at all 3 cardiac outputs. In addition, its leaflets opened more fully than did those of the valved conduit without the sinuses, yielding greater effective and geometric orifice areas. It was found that the presence of the sinuses not only facilitated the development of larger and more stable vortices at the initial stages of the cardiac cycle but also helped to maintain these vortices during the late stages of the cardiac cycle, leading to smoother valve closure. CONCLUSIONS: The KONECT RESILIA aortic valved conduit reproduces the bulged section of the aortic root corresponding to the sinuses of Valsalva. With this Valsalva-type conduit, larger orifice areas were observed, improving valve hemodynamics that may enhance performance.

Essential Information on Surgical Heart Valve Characteristics for Optimal Valve Prosthesis Selection: Expert Consensus Document From the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: Expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Transcatheter aortic valve implantation versus surgical aortic valve replacement during the COVID-19 pandemic-Current practice and concerns.

COVID-19 has had a dramatic impact on the provision of healthcare. COVID-19 can manifest with cardiac and thrombotic presentations. Additionally, patients with cardiovascular comorbidities are at an increased risk of adverse outcomes related to COVID-19 infection. This in turn has led to a significant reduction in the provision of cardiac surgery with alternative management options utilized to address patients with significant disease. In terms of aortic valve disease, transcatheter aortic valve implantation (TAVI) provides advantages over surgical aortic valve replacement in with a lower burden on healthcare resources. COVID-19 also resulted in changes in management strategies and as such TAVI is now being considered in younger- and low-risk patients. However, long term data with regard to TAVI is still unknown, and the use in patient groups that have been excluded in the large pivotal studies that established TAVI as an alternative to surgery has raised specific concerns in the use of TAVI as the preferred treatment choice. With the long term ramification unknown, it is essential that decisions are made with caution.

The value of brain natriuretic peptide in the prosthetic valve thrombosis.

: We aimed to investigate how prosthetic valve thrombosis (PVT) affects brain natriuretic peptide (BNP) levels and how BNP changes following thrombolytic therapy. The study included 70 consecutive patients with left-sided mechanical PVT who received thrombolytic therapy. The patients were divided into two groups, namely obstructive thrombus (n = 42) and nonobstructive thrombus (NOT, n = 28). BNP levels of patients were assessed before and after thrombolytic therapy. BNP levels were higher in obstructive thrombus group than NOT group in whole study population, in patients with mitral PVT and in patients with aortic PVT [325.0 (189.5-496.0) vs. 84.0 (44.5-140.0), P < 0.001, 323.0 (193-449.0) vs. 59.0 (37.0-131.0), P < 0.001 and 321.0 (132.0-525.0) vs. 99.0 (60.5-173.0), P < 0.001]. BNP levels were positively correlated with transmitral and transaortic mean gradients, and negatively correlated with mitral valve area (r: 0.374, P = 0.013; r: 0.432, P = 0.035 and; r: -0.642, P < 0.001, respectively). BNP values above 165 pg/ml may predict the presence of obstructive thrombus with a sensitivity of 88.0%, and a specificity of 79.0% (AUC = 0.928, 95% confidence interval: 0.871-0.986, P < 0.001). Following thrombolytic therapy, BNP levels (pg/ml) significantly decreased from 325.0 (189.5-496.0) to 137.0 (101.7-224.5), P < 0.001, in all patients with obstructive thrombus, from 323.0 (193.0-449.0) to 129.0 (98.0-223.0), P < 0.001, in patients with only mitral obstructive thrombus and from 321.0 (132.0-525.0) to 181.0 (99.0-217.5), P < 0.001, in patients with only aortic obstructive thrombus. BNP levels are significantly higher in prosthetic valve patients with obstructive thrombus than in those with NOT and decrease in patients with obstructive thrombus after thrombolytic therapy. A cut off value of BNP of at least 165.0 pg/ml was found to discriminate obstructive thrombus from NOT.

The short-term and long-term outcomes of transcatheter or surgical aortic valve replacement in elderly patients: A protocol for a systematic review.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an essential alternate option for people suffering from aortic stenosis. However, the efficacy and safety of TAVR for elderly population (aged over 80 years) is still unclear. METHODS: We plan to perform a systematic review and meta-analysis of clinical controlled trials and propensity-match cohort studies to evaluate the short- and long-term outcomes in elderly aortic stenosis patients who undergo a transcatheter or surgical aortic valve replacement. We will search PubMed, EMBASE, and Cochrane Library using a comprehensive strategy. The related conference proceedings and reference lists of the included studies will also be checked to identify additional studies. Two reviewers will screen retrieved records, extract information, and assess the risk of bias independently. STATA software will be used to conduct data synthesis. There is no requirement of ethical approval and informed consent. RESULTS: This study will be submitted to a peer-reviewed journal for publication. CONCLUSION: This is the first systematic assessment of TAVR for elderly patients with aortic stenosis. We hope it will provide a relatively comprehensive reference for clinical practice and future relevant clinical trials. ETHICS AND DISSEMINATION: Ethics approval and patient consent are not required as this study is a systematic review and meta-analysis. PROSPERO REGISTRATION NUMBER: CRD42019140857. STUDY PROTOCOL REGISTRY: The protocol has been registered in PROSPERO, which is an International Prospective Register of Systematic Reviews. The registration number is CRD42019140857.

4D Flow MRI hemodynamic benchmarking of surgical bioprosthetic valves.

PURPOSE: We exploited 4-dimensional flow magnetic resonance imaging (4D Flow), combined with a standardized in vitro setting, to establish a comprehensive benchmark for the systematic hemodynamic comparison of surgical aortic bioprosthetic valves (BPVs). MATERIALS AND METHODS: 4D Flow analysis was performed on two small sizes of three commercialized pericardial BPVs (Trifecta™ GT, Carpentier-Edwards PERIMOUNT Magna and Crown PRT®). Each BPV was tested over a clinically pertinent range of continuous flow rates within an in vitro MRI-compatible system, equipped with pressure transducers. In-house 4D Flow post-processing of the post-valvular velocity field included the quantification of BPV effective orifice area (EOA), transvalvular pressure gradients (TPG), kinetic energy and viscous energy dissipation. RESULTS: The 4D Flow technique effectively captured the 3-dimensional flow pattern of each device. Trifecta exhibited the lowest range of velocity and kinetic energy, maximized EOA (p < 0.0001) and minimized TPGs (p ≤ 0.015) if compared with Magna and Crown, these reporting minor EOA difference s (p ≥ 0.042) and similar TPGs (p ≥ 0.25). 4D Flow TPGs estimations strongly correlated against ground-truth data from pressure transducers; viscous energy dissipation proved to be inversely proportional to the fluid jet penetration. CONCLUSION: The proposed 4D Flow analysis pinpointed consistent hemodynamic differences among BPVs, highlighting the not negligible effect of device size on the fluidynamic outcomes. The efficacy of non-invasive 4D Flow MRI protocol could shed light on how standardize the comparison among devices in relation to their actual hemodynamic performances and improve current criteria for their selection.

Treatment of failed aortic bioprostheses: An evaluation of conventional redo surgery and transfemoral transcatheter aortic valve-in-valve implantation.

BACKGROUND: The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR). METHODS AND RESULTS: Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days. Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of "early safety" endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p < 0.01), the rate of "clinical efficacy" endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p < 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR. CONCLUSION: VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.

The Russian Conduit - Combining Bentall and Ozaki Procedures for Concomitant Ascending Aorta Replacement and Aortic Valve Neocuspidization.

In aortic valve disease cases, prosthetic valves have been used for valve replacement, however, these prostheses have inherent problems, and their quality in some countries is lower comparing to new-generation models, causing shorter durability. Aortic valve neocuspidization (AVNeo) has emerged as an option, which can be applied to a wide spectrum of these diseases. Despite the promising results, this procedure is not widely spread among cardiac surgeons yet. We developed a surgical technique combining Bentall and Ozaki procedures to treat patients with concomitant ascending aorta replacement and AVNeo and we describe it in this paper.