The influence of gender on outcomes following transcatheter aortic valve implantation.

Objectives: This study aimed to compare gender-related differences in short- and long-term outcomes after transcatheter aortic valve implantation. Methods: Patients who underwent transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) from September 2017 to December 2022 were enrolled. The primary endpoint was 5-year all-cause mortality. The secondary endpoints were 30-day mortality and the incidence of post-procedural complication. Patients were separated according to gender before statistical analysis. To compare patients with similar baseline characteristics, we performed a propensity matching. Results: A total of 704 patients [females, 361 (51.3%); males, 343 (48.7%)] were enrolled. Compared to women, men had a higher incidence of smoking (40.5% vs. 14.7%, p < 0.001), diabetes (32.9% vs. 25.1%, p < 0.025), peripheral artery disease (35.8% vs. 18.3%, p < 0.001), and previous cardiac surgery (13.7% vs. 7.2%, p = 0.006) and a lower ejection fraction [56.6 (9.3) vs. 59.8 (7.5), p = 0.046]. Female patients were frailer at the time of the procedure [poor mobility rate, 26% vs. 11.7%, p < 0.001; CCI (Charlson comorbidity index) 2.4 (0.67) vs. 2.32 (0.63), p = 0.04]. Despite these different risk profiles, no significant differences were reported in terms of post-procedural outcomes and long-term survival. Propensity score matching resulted in a good match of 204 patients in each group (57.9% of the entire study population). In the matched cohort, men had a significantly higher incidence of new pacemaker implantation compared to women [33 (16.2%) vs. 18 (8.8%)]. The Kaplan-Meier 5-year survival estimate was 82.4% for women and 72.1% for men, p = 0.038. Conclusions: Female gender could be considered as a predictor of better outcomes after TAVI.

The importance of MDCT in the evaluation of risk factors before the TAVI procedure and its complications after implantation.

Transcatheter aortic valve implantation (TAVI) is the alternative to surgical valve replacement, expanding its indications in the latest guidelines. Multimodal CT (MDCT) is essential in patient selection and detection of complications. Vascular complications are frequent, so it is important to analyse the anatomy of the vessels before the procedure. Regarding annular ruptures and ventricular perforations, the volume and distribution of calcium and the ventricular diameter play an important role. Finally, valve migration is a rare complication that can occur both during and after TAVI. Proper planning of the MDCT procedure reduces the risk of complications and gives the interventional cardiologist security both before and during the procedure.

The impact of transcatheter aortic valve implantation (TAVI) on mitral regurgitation - a single center study.

BACKGROUND: The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. METHODS: Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. RESULTS: Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. CONCLUSIONS: Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.

Bicuspid Aortic Valve dilemma: TAVI or SAVR? Insights from the NOTION-2 trial.

The Nordic Aortic Valve Intervention-2 (NOTION-2) trial is the first randomized controlled trial to compare transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in low-risk patients, specifically focusing on relatively younger patients and those with bicuspid valves. It randomized 370 patients (mean age 71 years) to assess outcomes at 1 year. Results indicated a higher composite primary endpoint rate for TAVI (10.2%) compared to SAVR (7.1%) in the overall cohort, with even more pronounced differences in patients with bicuspid valves (14.3% for TAVI vs. 3.9% for SAVR). The risk of death or disabling stroke at 1 year was also three times higher with TAVI.

[How to deal with elevated gradient following TAVR?] / Le gradient reste élevé après mon TAVI, que faire?

Over the past two decades, transcatheter aortic valve implantation (TAVI) has become a safe and effective therapeutic option for symptomatic and severe aortic stenosis, regardless of the surgical risk spectrum. With the expansion of TAVI indications to low-risk and younger patients, it is crucial to ensure satisfactory and durable hemodynamic outcomes to guarantee transcatheter heart valve (THV) longevity. However, secondary THV dysfunction may occur, often manifested by an increased transvalvular gradient. According to VARC-3 criteria, these dysfunctions can be attributed to four main mechanisms: 1) structural valve deterioration; 2) non-structural valve dysfunction; 3) thrombosis; 4) and endocarditis. Each mechanism leads to specific abnormalities, requiring a systematic diagnostic approach and appropriate treatment. This article illustrates, through two clinical cases, the diagnosis and management of secondary transvalvular gradient elevation after TAVI.

[Local versus locoregional anesthesia in transfemoral TAVI procedures]. / Anesthésie locale comparée à l'anesthésie locorégionale dans les procédures TAVI par voie transfémorale.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has become the treatment of choice for the most fragile patients with severe aortic stenosis. The transfemoral route is preferred as the simplest and safest. The aim of our study was to compare the efficacy, tolerance and safety of local vs. locoregional anesthesia in trans-femoral TAVI procedures. MATERIAL AND METHOD: This was a single-center retrospective study. Patients treated with femoral TAVI between February 25 and November 15, 2022 at the University Hospital of Reims were included, and two groups (local and locoregional anesthesia) were compared. RESULTS: TAVI success rate (92.9%), death rate (3.0%) and procedure duration (90.5 ± 13.5 minutes) did not differ between groups (p = 0.18, 0.15 and 0.55 respectively). For intra- and post-procedural treatments, the use of sedation, analgesics and benzodiazepines did not differ between groups. The cumulative dose of Remifentanil used per-procedure was lower in the local anesthesia group than in the locoregional anesthesia group (148.6 ± 71.9 mcg vs. 208.9 ± 110.0 mcg; p = 0.025). CONCLUSIONS: In this non-randomized retrospective study, local and locoregional anesthesia had comparable safety and efficacy in transfemoral TAVI procedures. In a constrained context and with a view to simplification, these results encourage transfemoral TAVIs to be performed under local anaesthesia, and to consider a "PCI-like" approach, without the presence of an anaesthetist, for selected patients without respiratory, musculoskeletal or agitation disorders, or vascular approach difficulties.

Strain assessment in patients with aortic regurgitation undergoing transcatheter aortic valve implantation: case series.

Background: Limited data exist on strain changes after transcatheter aortic valve implantation (TAVI) in patients with aortic regurgitation (AR). Case summary: Three patients with AR undergoing TAVI showed an initial reduction in global longitudinal strain (GLS), followed by sustained GLS improvement within the first year. Discussion: Findings align with those of surgically treated patients with AR. There is a possible superiority of GLS to left ventricular end-diastolic diameter ratio in assessing patients with severe volume overload.

Fluid-Solid Interaction Analysis for Developing In-Situ Strain and Flow Sensors for Prosthetic Valve Monitoring.

Transcatheter aortic valve implantation (TAVI) was initially developed for adult patients, but there is a growing interest to expand this procedure to younger individuals with longer life expectancies. However, the gradual degradation of biological valve leaflets in transcatheter heart valves (THV) presents significant challenges for this extension. This study aimed to establish a multiphysics computational framework to analyze structural and flow measurements of TAVI and evaluate the integration of optical fiber and photoplethysmography (PPG) sensors for monitoring valve function. A two-way fluid-solid interaction (FSI) analysis was performed on an idealized aortic vessel before and after the virtual deployment of the SAPIEN 3 Ultra (S3) THV. Subsequently, an analytical analysis was conducted to estimate the PPG signal using computational flow predictions and to analyze the effect of different pressure gradients and distances between PPG sensors. Circumferential strain estimates from the embedded optical fiber in the FSI model were highest in the sinus of Valsalva; however, the optimal fiber positioning was found to be distal to the sino-tubular junction to minimize bending effects. The findings also demonstrated that positioning PPG sensors both upstream and downstream of the bioprosthesis can be used to effectively assess the pressure gradient across the valve. We concluded that computational modeling allows sensor design to quantify vessel wall strain and pressure gradients across valve leaflets, with the ultimate goal of developing low-cost monitoring systems for detecting valve deterioration.

SURgical vs. PERcutaneous ACCESS in Transfemoral Transcatheter Aortic Valve Implantation (SU-PER-ACCESS Study).

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

[When the blood cells suffer after a TAVR]. / Quand les hématies souffrent en post TAVI.

We present here a case of documented paraprosthetic valvular leak following TAVI treated medically initially. This led to a poorly tolerated hemolytic anemia. We were able to correct this paraprosthetic valvular leak by a postdilation of the TAVI valve with a good result and uncomplicated follow-up.

Clot lysis time and thrombin generation in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Aortic valve stenosis (AS) is the most prevalent valvular heart disease and is associated with a significant increase in mortality. AS has been shown to be linked with numerous coagulation system abnormalities, including increased fibrin deposition on the stenotic aortic valves. Transcatheter aortic valve implantation (TAVI) is the primary treatment method for patients at high surgical risk. OBJECTIVES: The aim of the study was to assess the impact of treating severe AS with TAVI on thrombin generation and clot lysis time (CLT). METHODS: We studied 135 symptomatic AS patients recommended for TAVI by the local Heart Team. All measurements were performed before and 5-7 days after TAVI. Alongside clinical assessment and echocardiographic analysis, we assessed clot lysis time (CLT) and thrombin generation parameters, including lag time, peak thrombin generation, time to peak thrombin generation (ttPeak), and endogenous thrombin potential (ETP). RESULTS: 70 patients were included in the final analysis. After TAVI, there was a significant 9% reduction in CLT despite a 12% increase in fibrinogen concentration. We observed significant increase in lag time and ttPeak (20% and 12%, respectively), and 13% decrease in peak thrombin concentration compared to pre-procedural levels. Multivariable linear regression analysis demonstrated that baseline CLT and C-reactive protein (CRP) levels were independent predictors of significant reduction in mean aortic gradient, defined as TAVI procedure success. CONCLUSIONS: CLT and peak thrombin concentration decreased, while Lag time and ttPeak increased significantly after TAVI. Multivariable linear regression analysis demonstrated CLT and CRP levels as independent predictors of achieving a reduction in mean aortic gradient, defining TAVI procedure success.

Alternative access in transcatheter aortic valve replacement-an updated focused review.

Aortic Stenosis (AS) is a common condition with an estimated pooled prevalence of all AS in the elderly population at around 12.4%, with that of severe AS estimated to be around 3.4%. In the past, surgical aortic valve replacement was the primary treatment option for severe AS for decades. However, with the compelling evidence on the safety and efficacy of transcatheter aortic valve replacement (TAVR), it has become the gold standard treatment option for many patients with symptomatic severe AS. Transfemoral access has been the preferred method for transcatheter heart valve delivery. However, the prevalent use of TAVR on a diverse patient profile with different risk factors, such as peripheral artery disease, precluded the possibility of a transfemoral approach despite the improvement of valves and delivery systems technology. Therefore, alternative TAVR approaches have gained increasing utility in cases where transfemoral access is unfavorable. We review the journey, evolution, and techniques for different approaches of percutaneous TAVR, including transfemoral, transcarotid, transsubclavian/transaxillary, and transcaval approaches, in addition to the traditional "surgical" transaortic and transapical accesses. Consolidating these data highlights each approach's practicality and limitations, providing additional grounding for case-by-case utilization and future clinical research.

Human Aortic Stenotic Valve-Derived Extracellular Vesicles Induce Endothelial Dysfunction and Thrombogenicity Through AT1R/NADPH Oxidases/SGLT2 Pro-Oxidant Pathway.

Pathological tissues release a variety of factors, including extracellular vesicles (EVs) shed by activated or apoptotic cells. EVs trapped within the native pathological valves may act as key mediators of valve thrombosis. Human aortic stenosis EVs promote activation of valvular endothelial cells, leading to endothelial dysfunction, and proadhesive and procoagulant responses.

Nature of aortic annulus: Influence of annulus dynamic on the aortic valve hemodynamics.

Accurate imaging reports of the aortic valve indicate that the diameter of the aortic annulus changes regularly during a cardiac cycle. Most of these studies aim to demonstrate the proper method for estimating the aortic annulus diameter before performing TAVR surgery, revealing that the aortic annulus is dynamic and not constant throughout the cardiac cycle. This raises the question of how fixing the aortic annulus might affect valve function, which is a question that still needs to be addressed. Therefore, the present study seeks to address this question and elucidate the dynamic impact of the aortic annulus on aortic valve hemodynamics. Two computational models based on this hypothesis were created and solved, and then their results were compared. Both models are identical, except for the intrinsic dynamic nature of the aortic annulus. One model consists of the dynamic behavior, and the other simulates a fixed annulus, resembling the effect of a TAVR operation, SAVR, or any phenomenon that eliminates the dynamic nature of the annulus. Our research findings indicate that the dynamic nature of the annulus enhances blood flow (+2.7 %), increases mean velocity (+11.9) and kinetic energy density (+34 %), prolongs momentum retention during systole, stabilizes the flow jet at the end of systole, reduces the required pressure to keep the leaflets open (-40.9 % at 0.3s), and sustains ventricular pressure superiority (+9.4 %) over the aorta for a longer duration (+17.7 % of systole), a crucial factor in preventing backflow during aortic valve closure. Based on these results, more attention should be paid to the dynamic nature of the annulus.

Prediction model for leaflet thrombosis in patients undergoing transcatheter aortic valve implantation: the EFFORT study.

BACKGROUND: Leaflet thrombosis (LT) is a multifaceted and underexplored condition that can manifest following transcatheter aortic valve implantation (TAVI). The objective of this study was to formulate a prediction model based on laboratory assessments and clinical parameters, providing additional guidance and insight into this relatively unexplored aspect of post-TAVI complications. METHODS: The present study was an observational prospective hypothesis-generating study, including 101 patients who underwent TAVI and a screening for LT (the primary endpoint) by multidetector computed tomography (MDCT). All images were acquired on a third-generation dual-source CT system. Levels of von Willebrand factor (vWF) activity, hemoglobin (Hb), and lactate dehydrogenase (LDH) were measured among other parameters. A predictive score utilizing binary logistic regression, Kaplan-Meier time-to-event analysis, and receiver operating characteristics (ROC) analysis was established. RESULTS: LT (11 subclinical and 2 clinical) was detected in 13 of 101 patients (13%) after a median time to screening by MDCT of 105 days (IQR, 98-129 days). Elevated levels of vWF activity (> 188%) pre-TAVI, decreased Hb values (< 11.9 g/dL), as well as increased levels of LDH (> 312 U/L) post-TAVI and absence of oral anticoagulation (OAC) were found in patients with subsequent LT formation as compared to patients without LT. The established EFFORT score ranged from - 1 to 3 points, with an increased probability for LT development in patients with ≥ 2 points (85.7% of LT cases) vs < 2 points (14.3% of LT cases; p < 0.001). Achieving an EFFORT score of ≥ 2 points was found to be significantly associated with a 10.8 times higher likelihood of developing an LT (p = 0.001). The EFFORT score has an excellent c-statistic (area under the curve (AUC) = 0.89; 95% CI 0.74-1.00; p = 0.001) and a high negative predictive value (98%). CONCLUSION: An EFFORT score might be a helpful tool to predict LT development and could be used in risk assessment, if validated in confirmatory studies. Therefore, the score has the potential to guide the stratification of individuals for the planning of subsequent MDCT screenings.

Structural heart transcatheter interventions in orthotopic cardiac transplant and left ventricular assist devices recipients: A nationwide study.

BACKGROUND: The current incidence and outcomes of structural transcatheter procedures in heart transplant (HTx) recipients and left-ventricular assist devices (LVAD) carriers is unknown. AIMS: To provide insights on structural transcatheter procedures performed across HTx and LVAD patients in Spain. METHODS: Multicenter, ambispective, observational nationwide registry. RESULTS: Until May/2023, 36 percutaneous structural interventions were performed (78% for HTx and 22% for LVAD) widely varying among centers (0%-1.4% and 0%-25%, respectively). Percutaneous mitral transcatheter edge-to-edge (TEER) was the most common (n = 12, 33.3%), followed by trancatheter aortic valve replacement (n = 11, 30.5%), and tricuspid procedures (n = 9, 25%). Mitral TEER resulted in mild residual mitral regurgitation in all but one case, mean gradient was <5 mmHg in 75% of them at 1-year, with no mortality and 8.3% re-admission rate. Tricuspid TEER resulted in 100% none/mild residual regurgitation with a 1-year mortality and readmission rates of 22% and 28.5%, respectively. Finally, trancatheter aortic valve replacement procedures (n = 8 in LVADs due to aortic regurgitation and n = 3 in HTx), were successful in all cases with one prosthesis degeneration leading to severe aortic regurgitation at 1-year, 18.2% mortality rate and no re-admissions. Globally, major bleeding rates were 7.9% and 12.5%, thromboembolic events 3.7% and 12.5%, readmissions 37% and 25%, and mortality 22% and 25%, in HTx and LVADs respectively. No death was related to the implanted transcatheter device. CONCLUSIONS: Most centers with HTx/LVAD programs perform structural percutaneous procedures but with very inconsistent incidence. They were associated with good safety and efficacy, but larger studies are required to provide formal recommendations.

Antithrombotic Therapy Following Structural Heart Disease Interventions: Current Status and Future Directions.

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it's crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations.

Red blood cell transfusion and mortality after transcatheter aortic valve implantation via transapical approach: A propensity-matched comparison from the TRITAVI registry.

Objective: Bleeding is frequent during transcatheter aortic valve implantation (TAVI), especially when performed through a transapical approach (TA), and is associated with a worse prognosis. The present study aims to test the implication of red blood cell (RBC) transfusion and the optimal transfusion strategy in this context. Methods: Among 11,265 participants in the multicenter TRITAVI (Transfusion Requirements in Transcatheter Aortic Valve Implantation) registry, 548 patients (4.9%) who received TA-TAVI at 19 European centers were included. One-to-one propensity score matching was performed to reduce treatment selection bias and potential confounding among transfused versus non-transfused patients. The primary endpoint of the study was the 30-day occurrence of all-cause mortality. Results: 209 patients (38 %) received RBC transfusions. The primary endpoint occurred in 47 (8.6 %) patients. Propensity score matching identified 188 pairs of patients with and without RBC transfusion. In the propensity score-matched analysis, RBC transfusion was associated with increased 30-day mortality (HR 3.35, 95 % CI 1.51 - 7.39; p = 0.002). At multivariable cox regression analysis, RBC transfusion was an independent predictor of 30-day mortality (HR 3.07, 95 % CI 1.01-9.41, p = 0.048), as well as baseline ejection fraction (HR 0.96, 95 % CI 0.92-0.99, p = 0.043), and acute kidney injury (HR 3.95, 95 % CI 1.11-14.05, p = 0.034). Conclusions: RBC transfusion is an independent predictor of short-term mortality in patients undergoing TA-TAVI, regardless of major bleeding.Clinical trial registration: https://www.clinicaltrials.gov Unique identifier: NCT03740425.

Prediction of Major Adverse Cardiac Events After Transcatheter Aortic Valve Implantation: A Machine Learning Approach with GRACE Score.

Objectives: Predictive risk scores have a significant impact on patient selection and assessing the likelihood of complications following interventions in patients with severe aortic stenosis (AS). This study aims to explore the utility of machine learning (ML) techniques in predicting 30-day major adverse cardiac events (MACE) by analyzing parameters, including the Global Registry of Acute Coronary Events (GRACE) score. Methods: This retrospective, multi-center, observational study enrolled 453 consecutive patients diagnosed with severe AS who underwent transcatheter aortic valve implantation (TAVI) from April 2020 to January 2023. The primary outcome was defined as a composition of MACE comprising periprocedural myocardial infarction (MI), cerebrovascular events (CVE), and all-cause mortality during the 1-month follow-up period after the procedure. Conventional binomial logistic regression and ML models were utilized and compared for prediction purposes. Results: The study population had a mean age of 76.1, with 40.8% being male. The primary endpoint was observed in 7.5% of cases. Among the individual components of the primary endpoint, the rates of all-cause mortality, MI, and CVE were reported as 4.2%, 2.4%, and 1.9%, respectively. The ML-based Extreme Gradient Boosting (XGBoost) model with the GRACE score demonstrated superior discriminative performance in predicting the primary endpoint, compared to both the ML model without the GRACE score and the conventional regression model [Area Under the Curve (AUC)= 0.98 (0.91-0.99), AUC= 0,87 (0.80-0.98), AUC= 0.84 (0.79-0.96)]. Conclusion: ML techniques hold the potential to enhance outcomes in clinical practice, especially when utilized alongside established clinical tools such as the GRACE score.

[How to avoid and manage a vascular complication during TAVI procedure]. / Comment éviter et gérer une complication vasculaire pendant la procédure de TAVI.

Transcatheter aortic valve implantation (TAVI) has established as a gold standard in the treatment of elderly patients with severe aortic stenosis. Vascular access marks the first step in a TAVI procedure where the transfemoral access is preferred. Therefore, vascular complications are one of the main concerns of operators. With the increasing number of TAVIs performed, the focus is on the prevention and management of vascular complications. Illustrated by a clinical case, this article attempts to review the main vascular complications, their management and how to prevent them.