Search Results (61)

Aortic stenosis is the most prevalent valvular disease globally. Transcatheter aortic valve replacement (TAVR) has become a well-established treatment for aortic stenosis, offering outcomes comparable to surgical aortic valve replacement (SAVR). Its use has expanded to include younger, lower-risk patients and those with more complex anatomies. Recent advancements in TAVR include the increased adoption of transfemoral access, prosthesis designs optimized for challenging anatomies, enhanced delivery systems with repositioning capabilities, and outer skirts to minimize paravalvular leaks. Despite these innovations, several challenges remain. This review highlights recent updates in transcatheter heart valve (THV) systems, leaflet modification devices, and the current limitations of TAVR. Full article

Background: The Tendyne™ transcatheter heart valve (THV) system is a promising option for high-risk patients with severe mitral regurgitation (MR) who are ineligible for surgery or transcatheter edge-to-edge repair (TEER). As most fatal complications occur within the first 90 days, this study aimed to identify anatomical predictors of in-hospital mortality after transcatheter mitral valve replacement (TMVR). Methods: In this subanalysis of the TENDER registry, data from 110 patients who underwent TMVR across 26 centers between January 2020 and June 2022 were evaluated. Preprocedural imaging parameters were analyzed, including transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and cardiac 4D computed tomography (CT). Results: We identified LVEDDi as a significant predictor of in-hospital mortality (p = 0.022), with lower values in non-survivors (26.42 ± 3.76 mm/m²) than in survivors (30.37 ± 5.58 mm/m²). Both indexed and absolute LVEDDi predicted in-hospital complications (p < 0.001 and p = 0.008). In multivariate analysis, LVEDDi (p = 0.048; OR = 0.856) and STS score (p = 0.038; OR = 1.114) remained independent predictors of in-hospital mortality. In an extended model, only LVEDDi persisted as a significant predictor (p = 0.007), highlighting its robustness. Conclusions: This analysis identified a small LVEDDi as a novel, clinically relevant risk factor in TMVR and showed its added value alongside conventional markers. Its easy calculation supports incorporating LVEDDi thresholds into screening to improve patient selection and outcomes. Full article

Background: This single-center retrospective observational study reviewed data from 2305 persons examined for coronary artery calcium (CAC) with non-contrast-enhanced cardiac CT. Other cardiac structures, including chamber volumes, were evaluated besides the CAC scoring. We proposed a novel body size indexing measure that may outperform common indices for quantifying total heart volume (THV). Methods: This index is the sum of height and the difference between height (unitless) and body surface area (unitless), [h+(h-BSA)], and if the (h-BSA) equals “zero”, it is a feature of the “standard human”. Results: We found that, in subjects with a low cardiovascular (CV) risk, the THV normalized for the novel index was simply a function of BW gain, being the highest in obese. If high-CV-risk features (hypertension, diabetes) were present, the measured THV was larger than expected for BW gain, exceeding values observed in low-CV-risk ones. Differences were found to be sex-independent in all BMI categories. Conclusions: Common BSA correction hides these differences and makes the prognostication of CV risk error-introducing. The indexation we proposed might help distinguish the effects of body weight gain from the ones resulting from the presence of certain cardiovascular diseases. Full article

Evapotranspiration (ET) is a critical component of the hydrological cycle. The eddy covariance data at 40 flux stations in different climatic regions in China were used to evaluate the accuracy of five reanalysis actual ET datasets (ERA5, ERA5-LAND, GLDAS-2.1, MERRA-2, TerraClimate) and four remote sensing estimation ET datasets (ETMonitor, GLEAM4.2a, PML_V2, SiTHv2), which are widely used by the hydrometeorological and climatological communities, in terms of the root mean square error, Pearson correlation coefficient, mean absolute deviation, and Taylor skill score. The results show that remote sensing products outperform reanalysis datasets. Among them, ETMonitor has the highest accuracy, followed by PML_V2 and SiTHv2. TerraClimate and MERRA-2 have the least agreement with the observations at flux sites across nearly all evaluation metrics. All products can capture the seasonality of ET in China, but underestimate ET in northwest China and overestimate ET in southern China throughout the year. We tried to merge three optimal data products (ETMonitor, PML_V2, and SiTHv2) using the triple collocation analysis method to improve the ET estimation, but the results showed that the improvement by the data fusion approach is marginal. The estimation of the multi-year average evapotranspiration during the period from 2001 to 2020 ranges from 397.8 mm/year (GLEAM4.2a) to 504.8 mm/year (ERA5-Land) in China. From 2001 to 2020, annual evapotranspiration in China generally increased, but with varying rates across different products. MERRA-2 showed the largest annual increase rate (3.71 mm/year), while SiTHv2 had the smallest (0.17 mm/year). There are no significant changes in the seasonality of ET by most ET products from 2001 to 2020, except for PML_V2 and SiTHv2, which indicate an increase in seasonality in terms of the evapotranspiration concentration index. This ET intercomparison addresses a key knowledge gap in terrestrial water flux quantification, aiding climate and hydrological research. Full article

Pulmonary disfunction is frequent in repaired congenital heart diseases. Both pulmonary regurgitation and pulmonary stenosis are possible complications over time. In the past, the surgical approach was the only feasible management but exposed the patient to a redo-surgery with its consequent risks. Nowadays, the development of novel devices and techniques has made possible a transcatheter pulmonary valve implantation. The Melody Transcatheter Pulmonary Valve (TPV) (Medtronic Inc., Minneapolis, MN, USA) and the Edwards Sapien XT and S3 Transcatheter Heart Valve (Edwards Lifesciences LLC, Irvine, CA, USA) are balloon-expandable valvular bioprostheses approved for pulmonary position. Venus P-Valve (Venus Medtech, Shanghai, China) and Harmony TPV (Medtronic Inc., Minneapolis, MN, USA) are self-expandable pulmonary valves. Alterra Adaptive Prestent (Edwards Lifesciences LLC, Irvine, CA, USA) is an hourglass self-expandable stent that reduces the size of large right ventricular outflow tracts, creating a suitable landing zone to implant an Edwards Sapien S3 THV 29 mm. Novel stents and percutaneous valves are being planned and experimented with to widen the field of transcatheter approach. The aim of this review is to describe both the current approaches, strategies, and techniques as well as the future perspective to deal with the patients with significant pulmonary stenosis and/or regurgitation. Full article

Bicuspid aortic valve (BAV) is the most common congenital heart disease, affecting 0.5–2% of the population and often leading to early aortic valve degeneration. While surgical aortic valve replacement (SAVR) remains the gold standard for treating severe bicuspid aortic stenosis (AS), transcatheter aortic valve implantation (TAVI) is emerging as a viable alternative in selected BAV anatomies. Initial experiences with first-generation transcatheter heart valves (THVs) showed the feasibility of this technique, but were associated with lower device success rates and higher complications, such as paravalvular leak (PVL) and pacemaker implantation. Advancements in second- and third- generation THVs, together with better pre-procedural imaging assessment and growing operator experience, have significantly enhanced TAVI outcomes in BAV patients, with results now comparable to those seen in tricuspid aortic valves (TAVs). Proper patient selection, pre-procedural sizing, and device implantation are key to improving TAVI success in BAV. Recent registry data on contemporary THV platforms demonstrate improved procedural success, hemodynamic performance, and the safety of TAVI in BAV. However, higher rates of PVL, pacemaker implantation, and strokes remain concerns. Ongoing advancements in THV design and procedural techniques will further enhance outcomes for this challenging population. Up to the present, there are no dedicated THVs for BAV, but the latest-generation THVs offer promising results. Full article

With recent guidelines expanding transcatheter aortic valve replacement (TAVR) to younger patients, indications for redo-TAVR will also likely increase. When compared with TAVR, redo-TAVR is a rare and novel procedure. Current clinical data derived from registries suggest excellent safety, with low rates of 30-day and 1-year mortality following redo-TAVR. Proper understanding of data from bench studies regarding optimal valve configurations, of patient anatomy and of the technical properties of transcatheter heart valves (THV) is essential for patient selection and procedural success. Lifetime management of redo-TAVR should start before the index procedure, as the choice of the index THV has a major impact on the feasibility of redo-TAVR. Procedural optimization by adequate valve sizing, commissural alignment and adequate implant depth of both index and redo-THV are critical determinants of optimal hemodynamics for maximized valve longevity, as well as lifelong coronary access. Full article

Aims: The aim of this paper is to report 30-day and 1-year outcome data regarding the first 200 patients who underwent the TAVR procedure using the Myval THV system at our single centre. Methods: From November 2019 to October 2022, 200 consecutive patients underwent TAVR procedure. Outcomes were analysed according to the VARC-2 definitions, and device performance was assessed via transthoracic echocardiography. Data collection was approved by the local Ethical Committee. Results: The mean age of the cohort was 75.3 ± 6.9 years, and 122 (61%) participants were male. The mean EuroSCORE II and STS was 5.4 ± 5.4 and 5.8 ± 3.8, respectively. The proportion of patients with a bicuspid aortic valve was 18%. The transfemoral access approach was the most common (surgical vs. percutaneous: 1% vs. 98%), and in two patients, surgical subclavian access was used. VARC-2 outcomes were as follows: 99% device success, 2% STROKE, 5% and 4.5% major and minor vascular complications, respectively, and a 29.5% rate of new permanent pacemaker implantation. At discharge, the incidence of aortic regurgitation grade II or above was 5.5% without relevant PVL (grade II or above 0.5%). In-hospital mortality was only 1%. At 1 year, the all-cause mortality rate was 8.5% (cardiac origin in three cases), and two patients had valve-related dysfunction requiring surgical aortic replacement. Conclusions: Our results showed excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events using the Myval transcatheter heart valve system. The limitations of our study comprise a single-centre design with retrospective data collection. Full article

Background: Prosthesis-patient mismatch (PPM) has been demonstrated to affect the outcome of both surgical (SAVR) and transcatheter aortic valve replacement (TAVR) patients. Supra-annular transcatheter valves (SAV) appear to offer a superior solution to intra-annular valves (IAV) in this regard. However, data on the comparison of the intra-annular self-expanding (SE) NAVITOR and the intra-annular balloon-expandable (BE) Sapien 3 Ultra in small annuli are limited. Methods: A total of 179 patients with severe native aortic valve stenosis were treated with either the SE NAVITOR (SEV; n = 104) or the BE Sapien 3 Ultra (BEV; n = 75) between March 2019 and June 2024. We compared the clinical and hemodynamic outcomes of the cohort according to the implanted prostheses. BMI-adjusted PPM was defined in accordance with the VARC-3 recommendations. Results: The device success at 30 days was superior in patients treated with the NAVITOR prosthesis (94.2% vs. 80.0%, p < 0.001), mainly driven by a higher rate of elevated gradients in the BEV group. The post-procedural mean gradient (8.0 mmHg vs. 13.0 mmHg, p < 0.001) as well as the rate of moderate to severe prosthesis patient mismatch (12.2% vs. 33.3%, p = 0.002) was higher in BEV recipients while the rate of more than moderate paravalvular leakage (PVL) or Valve in Valve (VinV) due to PVL (1.0% vs. 1.3%, p = 1.000) was similar between both groups. Pacemaker implantations were numerically more common after SEV (18.4% vs. 8.5%, p = 0.110). There was a trend towards higher thirty-day all-cause mortality among patients treated with SAV (3.8% vs. 1.3%, p = 0.401). Conclusion: The NAVITOR system may offer a more favorable hemodynamic profile compared to the Sapien 3 Ultra device in patients with small aortic annuli. Full article

Objectives: The aim of this study was to evaluate the influence of three-dimensional transcatheter heart valve (THV) position on mid-term pacing burdens and to examine the effect of stimulation rates on survival after transcatheter aortic valve implantation (TAVI). Methods: In patients receiving a new PPM before discharge after TAVI, we analyzed the final three-dimensional THV position in 107 patients (78 with Sapien S3 THV and 29 with Evolut R THV) using fusion imaging from pre- and post-TAVI computed tomography angiography. The PPM stimulation rates were examined pre-discharge and after 3 months. Patient survival was tracked over a period of 5 years. Results: A high pacing burden (stimulation rate of >20%) was observed in 69% of patients before discharge and in 67% after three months. One-third of the patients with an initial low pacing burden developed a high pacing burden after 3 months. The implantation depth did not differ between patients with or without a high pacing burden at discharge (p = 0.550) or after 3 months (p = 0.901). The three-dimensional THV position showed no influence on the pacing burden pre-discharge (p = 0.550) and after 3 months (0.901). There were no significant differences in survival, regardless of the pacing burden pre-discharge and after 3 months (log-rank p = 0.676). Conclusions: Three-dimensional THV position did not predict a high pacing burden after TAVI. Pacing burden was not associated with survival. One-third of patients experienced an increase to a high pacing burden within 3 months, suggesting potential long-term conduction system damage after TAVI. Full article

Calcific aortic stenosis (CAS) is currently recognized as the third most frequent cardiovascular disorder in persons aged above 60 years, after atherosclerotic disease and hypertension, and together with its precursor aortic sclerosis it has been found in more than 30% of elderly individuals. CAS is an active multifactorial process characterized by a progressive fibro-calcific remodeling and thickening of the AV leaflets caused by hemodynamic flow factors, genetic factors, lipoprotein deposition, oxidation, chronic inflammation, immunomodulators, and finally osteoblastic transformation of cardiac. Herein a comprehensive state-of-the-art paper is presented regarding the underlying pathophysiological mechanisms of CAS and the potential preventive strategies as an alternative to surgical and interventional treatment. Full article

The Myval is a balloon-expandable transcatheter heart valve (THV) developed by Meril Life Sciences Pvt. Ltd. (Vapi, Gujarat, India) that has an innovative operator-friendly design that aids in improving deliverability and features precise deployment. Various clinical studies demonstrate its effectiveness and safety, making it a promising choice in valvular interventions. Myval has been successfully utilized as a transcatheter aortic valve implantation (TAVI) device in cases with conduction disturbances, bicuspid aortic valve anatomy, non-calcified aortic regurgitation, dysfunctional stenosed right ventricular outflow tract (RVOT) conduits, pulmonary valve replacement, mitral valve replacement, and valve-in-valve and valve-in-ring implantation procedures. Myval’s diverse sizes are also of key importance in complex cases of large annuli and complex anatomy. Further long-term studies are needed to consolidate these results. Its introduction signifies a significant advancement in cardiology, aiming to enhance patient outcomes and quality of life. In the present review, we provide an update on new-generation Myval THV series and review the available clinical data published to date with an emphasis on diverse use in specific clinical scenarios. Full article

Background: Balloon aortic valvuloplasty (BAV) is currently used as pre-treatment for patients undergoing trans-catheter aortic valve replacement (TAVR) as well as a stand-alone option for subjects with significant contraindications to TAVR. Mammoth is a newly available non-compliant balloon catheter (BC) included in the balloon-expandable Myval THV system (Meril Life Sciences Pvt. Ltd., India). As limited data on the performance of this BC are available, we here report the results following its use for BAV as pre-dilatation during TAVR or as a stand-alone procedure. Methods: A retrospective, single-center cohort analysis was performed on patients with severe aortic valve stenosis (AS) treated with the Mammoth BC at IRCCS Ospedale Galeazzi Sant’Ambrogio, Milan, Italy. The primary endpoint was technical success defined as successful Mammoth BC advancement across the AS followed by its full and homogeneous inflation without major complications such as aortic root/left ventricular outflow tract injury and/or stroke. Results: A total of 121 patients were treated by BAV with Mammoth BC during the study period. Among these, 105 patients underwent BAV pre-dilatation before TAVR while 16 patients underwent a stand-alone BAV procedure. Mammoth BC was delivered and successfully inflated at the target site in all of the 121 cases without BC-related complications (100% technical success). However, in the BAV “stand-alone group”, three patients required two different balloon sizes while in nine patients multiple rounds (two to three) of balloon inflation were needed to significantly lower the transvalvular gradient. No cases of aortic root injury or massive aortic regurgitation due to Mammoth BC-related aortic leaflet injury were reported while one major stroke occurred late after TAVR. No intra-procedural deaths occurred nor bleeding (BARC 3-4) or major vascular complication. Conclusions: Mammoth BC use in patients with severe AS proved safe and effective, either before TAVR or as a stand-alone procedure, expanding the range of available tools for structural operators. Full article

Background: Precise implantation could play a crucial role in the technical success of transcatheter aortic valve replacement (TAVR) for some prostheses. The impact of an accidental implantation depth (ID) outside the recommended range has not been assessed for the ACURATE neo2 (NEO2). Methods: Data from 1839 patients with severe native aortic stenosis treated with the NEO2 prosthesis were evaluated. We compared the results of prostheses implanted in an ID both inside and outside the recommendations. The outcome assessment followed the Valve Academic Research Consortium-3 criteria. Results: Patients were retrospectively divided into high (<3 mm; n = 412), optimal (3–7 mm; n = 1236), and low (>7 mm; n = 169) implantations. Technical success (94.7% vs. 94.7% vs. 91.7%, p = 0.296) and device success were high (90.1% vs. 89.3% vs. 84.6%, p = 0.112) without differences between groups. Rates of relevant paravalvular regurgitation (PVL; >mild or VinV due to PVL) were comparable (1.2% vs. 1.8% vs. 1.2%, p = 0.759). Even when hemodynamics were superior in the high-implantation group, with greater iEOA (1.01 cm²/m² vs. 0.95 cm²/m² vs. 0.92 cm²/m², p < 0.001), spontaneous embolization or after post-dilatation was more common. Low implantation was associated with a higher rate of associated pacemaker implantation (PPI) (6.1% vs. 8.8% vs. 14.8%, p = 0.001). Conclusions: Implantation with the ACURATE neo2 showed excellent hemodynamic results, including low gradients and a small number of relevant PVL, in line with a high technical success rate that was irrespective of the ID. A favorable outcome can also be achieved in accidental low or high positions. Low implantation was associated with a higher rate of associated pacemaker implantation. Deliberately high implantation should be avoided due to the risk of embolization. Full article

(1) Background: This study aimed to analyse the hydrodynamic performance of two generations of self-expanding transcatheter heart valves (THV) as a valve-in-valve (ViV) in different surgical aortic valve (SAV) models under standardised conditions. The nitinol-based Evolut R valve is frequently used in ViV procedures. It is unclear whether its successor, the Evolut PRO, is superior in ViV procedures, particularly considering the previously implanted SAV model. (2) Methods: Evolut^TM R 26 mm and Evolut^TM PRO 26 mm prostheses were implanted in nine 21 mm labelled size SAV models (Hancock^® II, Mosaic^® Ultra^TM, Epic^TM Supra, Trifecta^TM GT, Perimount^®, Perimount^® Magna Ease, Avalus^TM, Intuity^TM, Freestyle^®) to analyse their hydrodynamic performance under defined circulatory conditions in a pulse duplicator. (3) Results: Both THVs presented with the lowest effective orifice area (EOA) and highest mean pressure gradient (MPG) inside Hancock^® II, whereas THVs in Intuity showed the highest EOA and lowest MPG. Evolut R and Evolut PRO showed significant hydrodynamic differences depending on the SAV. Both THVs performed similarly in porcine valves. Although the Evolut R performed better than Evolut PRO in stented bovine SAVs, the Evolut PRO was superior inside the Intuity. Further, the SAV model design markedly influenced the TAV’s geometric orifice area and pin-wheeling index. (4) Conclusions: These findings show that the Evolut R and Evolut PRO perform differently depending on the previously implanted SAV model. THV selection for treatment of a specific SAV model should consider these results. Full article