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.

Role of imaging in third aortic valve implantation: TAV-in-TAV-in-SAV.

Coronary obstruction remains a primary concern for redo transcatheter aortic valve implantation (TAVI) due to supra-annular leaflets. Hereby, we present two valve-in-valve-in-valve cases, initially incorporating a surgical valve implanted to clarify our concept that the surgical valve serves to safeguard against the coronary ostium obstruction.

Patients with paradoxical low-flow, low-gradient aortic stenosis gain the least benefit from TAVI among all hemodynamic subtypes.

BACKGROUND: Substantial controversy exists regarding the clinical benefit of patients with severe paradoxical low-flow, low-gradient aortic stenosis (PLF-LG AS) from TAVI. Therefore, we compared post-TAVI benefit by long-term mortality (all-cause, CV and SCD), clinical improvement of heart failure symptoms, and cardiac reverse remodelling in guideline-defined AS subtypes. METHODS: We prospectively included 250 consecutive TAVI patients. TTE, 6mwt, MLHFQ, NYHA status and NT-proBNP were recorded at baseline and 6 months. Long-term mortality and causes of death were assessed. RESULTS: 107 individuals suffered from normal EF, high gradient AS (NEF-HG AS), 36 from low EF, high gradient AS (LEF-HG), 52 from "classic" low-flow, low-gradient AS (LEF-LG AS), and 38 from paradoxical low-flow, low-gradient AS (PLF-LG AS). TAVI lead to a significant decrease in MLHFQ score and NT-proBNP levels in all subtypes except for PLF-LG. Regarding reverse remodelling, a significant increase in EF and decrease in LVEDV was present only in subtypes with reduced baseline EF, whereas a significant decrease in LVMI and LAVI could be observed in all subtypes except for PLF-LG. During a follow-up of 3-5 years, PLF-LG patients exhibited the poorest survival among all subtypes (HR 4.2, P = 0.0002 for CV mortality; HR 7.3, P = 0.004 for SCD, in comparison with NEF-HG). Importantly, PLF-LG was independently predictive for CV mortality (HR 2.9 [1.3-6.9], P = 0.009). CONCLUSIONS: PLF-LG patients exhibit the highest mortality (particularly CV and SCD), the poorest symptomatic benefit and the least reverse cardiac remodelling after TAVI among all subtypes. Thus, this cohort seems to gain the least benefit.

Syncope due to recurrent ventricular tachycardias after transcatheter aortic valve implantation with unexpected diagnosis in cardiac computed tomography: a case report.

Background: Delayed coronary obstruction (DCO) is a rare but potentially life-threatening complication after transcatheter aortic valve implantation (TAVI) mostly affecting the left main coronary artery (LMCA) and often caused by prosthesis endothelialization or thrombus formations. Herein, we report an unusual case of a delayed LMCA-obstruction caused by a calcium nodule, which was diagnosed 4 months after TAVI due to recurrent ventricular tachycardia (VT) episodes. Case summary: A 73-year-old patient was readmitted to an external hospital with syncope three months after TAVI. Fast VT could be induced in electrophysiological examination, why the patient received a two-chamber implantable cardioverter defibrillator (ICD). However, after 1 month the patient was readmitted to our department with another syncope. Implantable cardioverter defibrillator records revealed multiple fast VT episodes (200-220 b.p.m.). In addition, the patient reported new-onset exertional dyspnoea (New York Class Association Stage III) and elevated high-sensitive cardiac troponin of 115 ng/L. Due to the symptoms and laboratory markers indicating potential myocardial ischaemia, a cardiac computed tomography angiography (CCTA) was performed. Cardiac computed tomography angiography revealed obstruction of the LMCA likely caused by calcium shift during TAVI. After CCTA-guided percutaneous coronary intervention, patient's course remained uneventful. Discussion: The present case report highlights the role of CCTA as a powerful non-invasive diagnostic tool in complex settings after TAVI. Delayed coronary obstruction as a procedural complication can occur after TAVI and manifest with various symptoms, including new-onset or recurrent VTs, like in the present case. Cardiac computed tomography angiography provided accurate assessment of the implanted prosthesis and detection of DCO, thus guiding the subsequent PCI.

Short-term outcomes after surgical aortic valve replacement in elderly patients - results of a comparative cohort study.

BACKGROUND: With the introduction of transcatheter aortic valve implantation, the role of surgical aortic valve replacement (SAVR) in elderly patients has been called into question. We investigated the short-term outcomes of SAVR in the elderly population. METHODS: All patients aged ≥ 70 years who underwent isolated SAVR in our centre between 2008 and 2017 were included in the study. Survival at 30 days and 1 year were compared for patients aged 70-79 years (n = 809) versus patients aged ≥ 80 years (n = 322). Factors associated with poorer survival outcomes were identified using multivariable Cox regression analysis. RESULTS: Patients aged 70-79 years and patients aged ≥ 80 years had similar survival rates at 30 days (98.1% vs. 98.4%, p = 0.732) and 1 year (96.0% vs. 94.1%, p = 0.162) post-SAVR. This remained true after multivariable adjustment. Risk factors for 30 day all-cause mortality included insulin dependent diabetes (HR 6.17, 95% CI 1.32-28.92, p = 0.021) and increasing cardiopulmonary bypass time (HR 2.72, 95% CI 1.89-3.91, p < 0.0001). Significant risk factors for 1 year all-cause mortality were New York Heart Association (NYHA) class IV (HR 6.25, 95% CI 1.55-25.24, p = 0.010) and longer cardiopulmonary bypass time (HR 1.94, 95% CI 1.40-2.69, p < 0.0001). Similar results were obtained for cardiac-specific mortality. CONCLUSIONS: Short-term outcomes of SAVR are excellent in elderly patients and age alone is not a predictor of poorer outcomes. However, the increased risk of mortality in patients with insulin-dependent diabetes and those with severe functional impairment (NYHA class IV) should be carefully considered when selecting patients for SAVR in this elderly population.

Comparative Analysis of PCI Strategies in Aortic Stenosis Patients Undergoing TAVI: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been increasingly used in patients with severe aortic stenosis (AS). Since coronary artery disease (CAD) is common among these patients, it is crucial to choose the best method and timing of revascularization. This study aims to compare different timing strategies of percutaneous coronary intervention (PCI) in patients with severe AS undergoing TAVI to clarify whether PCI timing affects the patients' outcomes or not. METHODS: A frequentist network meta-analysis was conducted comparing three different revascularization strategies in patients with CAD undergoing TAVI. The 30-day all-cause mortality, in-hospital mortality, all-cause mortality at 1 year, 30-day rates of myocardial infarction (MI), stroke, and major bleeding, and the need for pacemaker implantation at 6 months were analyzed in this study. RESULTS: Our meta-analysis revealed that PCI during TAVI had higher 30-day mortality (RR = 2.46, 95% CI = 1.40-4.32) and in-hospital mortality (RR = 1.70, 95% CI = [1.08-2.69]) compared to no PCI. Post-TAVI PCI was associated with higher 1-year mortality compared to other strategies. While no significant differences in major bleeding or stroke were observed, PCI during TAVI versus no PCI (RR = 3.63, 95% CI = 1.27-10.43) showed a higher rate of 30-day MI. CONCLUSION: Our findings suggest that among patients with severe AS and CAD undergoing TAVI, PCI concomitantly with TAVI seems to be associated with worse 30-day outcomes compared with no PCI. PCI after TAVI demonstrated an increased risk of 1-year mortality compared to alternative strategies. Choosing a timing strategy should be individualized based on patient characteristics and procedural considerations.

The Predictive Value of Aortic Calcification on Computed Tomography for Major Cardiovascular Events.

As the prevalence of cardiovascular disease continues to increase, early identification of patients at high risk of major adverse cardiovascular events (MACE) using reliable diagnostic modalities is important. Transcatheter aortic valve implantation (TAVI) is a minimally invasive percutaneous procedure used to replace the aortic valve with a bioprosthetic one, often without the need for surgery. Extra coronary calcification in the ascending and/or descending thoracic aorta, aortic arch, and abdominal aorta has recently been identified as a method to quantify the extent of atherosclerotic cardiovascular disease. However, its definitive role in the prediction of MACE remains unclear. We performed a comprehensive review to summarize the current literature on the diagnostic and predictive value of thoracic and abdominal aortic calcification, as quantified in computed tomography, for the association, risk stratification, and prediction of MACE and after TAVI procedures. Despite increasing evidence, the predictive role of thoracic calcification still remains unproven, with a need for carefully tailored studies to confirm these findings.

Prognostic relevance of pre-procedural plasma volume status estimation in patients undergoing transcatheter aortic valve implantation: A meta-analysis.

BACKGROUND: To systematically evaluate the prognostic utility of estimated plasma volume status (ePVS) on the outcomes of patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: The exposure variable of interest was the ePVS, enumerating the percentage change of the actual plasma volume from the ideal plasma volume, and being calculated on the basis of weight and hematocrit using sex-specific constants. A random-effects meta-analysis was performed after a systematic literature search in PubMed, Scopus and Web Of Science. RESULTS: The systematic literature search yielded 5 eligible observational cohort studies encompassing a total of 7,121 patients undergoing TAVI. The meta-analysis suggested that "high ePVS" status was independently associated with increased risk for 1-year all-cause mortality (pooled adjusted hazard ratio: 1.63, 95 % confidence intervals: 1.36-1.95) compared to "low ePVS". Also, the pooled unadjusted odds for 1-year mortality, 30-day mortality, peri-procedural stroke, major bleeding, and acute kidney injury were significantly increased in the "high ePVS" group of patients. Conversely, the unadjusted risk of pacemaker implantation and major vascular complications did not differ significantly between the 2 groups. CONCLUSIONS: Plasma volume expansion appears to be linked with a worse peri-procedural and long-term prognostic course in TAVI. Its use in clinical practice could refine risk stratification and candidate selection practices.

Cardiac output in patients with small annuli undergoing transcatheter aortic valve implantation with self-expanding versus balloon expandable valve (COPS-TAVI).

BACKGROUND: There is limited data on cardiac output in patients with small aortic annuli undergoing trans-catheter aortic valve implantation (TAVI) according to the implanted platform of balloon-expandable (BEV) compared to self-expanding valves (SEV). METHODS: This is a retrospective analysis of consecutive patients with severe aortic stenosis and small annuli who underwent successful TAVI. Cardiac output was measured using echocardiography within 4 weeks following TAVI. Data were recorded and analysed by an experienced operator who was not aware of the type of the implanted valve. RESULTS: 138 patients were included in the analysis, of whom 57 % underwent TAVI with BEV. Clinical and echocardiographic characteristics were comparable between the two platforms, except for more frequent previous cardiac surgery and smaller indexed aortic valve in the BEV group. There was no relationship between computed tomography-derived aortic annulus area and cardiac output post TAVI. When compared to patients who underwent TAVI with BEV, those with SEV had larger cardiac output [mean difference - 0.50 l/min, 95 % CI (-0.99, -0.01)] and cardiac index [mean difference - 0.20 l/min/m2, 95 % CI (-0.47, 0.07)], although the latter did not reach statistical significance. Unlike patients with small body surface area, in those with large body surface area both cardiac output and cardiac index were statistically larger in patients who underwent SEV compared to BEV. CONCLUSION: Cardiac output, as measured by echocardiography, was larger in patients with small annuli who underwent TAVI procedure with SEV compared to BEV. Such difference was more evident in patients with large body surface area.

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.

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.

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.

Comparative Outcomes of Surgical and Transcatheter Aortic Valve Replacement: A Meta-analysis and Parametric Extrapolation of Clinical Trials.

INTRODUCTION: We aimed to pool randomized clinical trials (RCTs) comparing surgical aortic valve replacement (SAVR) with transcatheter aortic valve replacement (TAVR) and extrapolate pooled time-to-event data to compare long-term outcomes. METHODS: An electronic database search was performed for RCTs comparing SAVR with TAVR. The most current longest follow-up data for each RCT were included. Data were pooled using a random-effects model. Survival data were pooled for Kaplan-Meier analysis as well as parametric modeling with extrapolation. RESULTS: Seven RCTs comprising 7774 patients were included. Mean valve gradient at 5 y was comparable between SAVR [11 mmHg (3.7; 18.3)] and TAVR [8.1 mmHg (1.9; 14.3)] (P = 0.38). TAVR had a higher mean valve area at 30 d, 1 y, and 2 y [1.68 cm2 (1.22; 2.13) versus 1.8 cm2 (1.35; 2.25), P = 0.02]. SAVR had a higher freedom from any paravalvular leak at 30 d and 1 y [86% (81; 90) versus 39% (36; 41), P < 0.01]. All-cause death was lower in the SAVR group at 5 y [39% (29; 50) versus 43% (31; 57), P < 0.01]. Although no differences were seen between SAVR and TAVR in the pooled Kaplan-Meier analysis of all-cause mortality and composite of all-cause mortality or stroke, parametric modeling with extrapolation showed significant divergence for both outcomes. CONCLUSIONS: Pooled all-cause mortality as well as pooled composite of all-cause mortality or stroke indicated better survival with SAVR at 5 y. Long-term parametric extrapolation also indicated superior survival with SAVR.

[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.

Reverse left ventricular remodeling after aortic valve replacement for aortic stenosis: a systematic review and meta-analysis.

Reverse left ventricular (LV) remodeling after aortic valve replacement (AVR), in patients with aortic stenosis, is well-documented as an important prognostic factor. With this systematic review and meta-analysis, we aimed to characterize the response of the unloaded LV after AVR. We searched on MEDLINE/PubMed and Web of Science for studies reporting echocardiographic findings before and at least 1 month after AVR for the treatment of aortic stenosis. In total, 1,836 studies were identified and 1,098 were screened for inclusion. The main factors of interest were structural and dynamic measures of the LV and aortic valve. We performed a random-effects meta-analysis to compute standardized mean differences (SMD) between follow-up and baseline values for each outcome. Twenty-seven studies met the eligibility criteria, yielding 11,751 patients. AVR resulted in reduced mean aortic gradient (SMD: - 38.23 mmHg, 95% CI: - 39.88 to - 36.58 , I 2 = 92 % ), LV mass (SMD: - 37.24 g, 95% CI: - 49.31 to - 25.18 , I 2 = 96 % ), end-diastolic LV diameter (SMD: - 1.78 mm, 95% CI: - 2.80 to - 0.76 , I 2 = 96 % ), end-diastolic LV volume (SMD: - 1.6 ml, 95% CI: - 6.68 to 3.51, I 2 = 91 % ), increased effective aortic valve area (SMD: 1.10 cm2, 95% CI: 1.01 to 1.20, I 2 = 98 % ), and LV ejection fraction (SMD: 2.35%, 95% CI: 1.31 to 3.40%, I 2 = 94.1 % ). Our results characterize the extent to which reverse remodeling is expected to occur after AVR. Notably, in our study, reverse remodeling was documented as soon as 1 month after AVR.

Performance of federated learning-based models in the Dutch TAVI population was comparable to central strategies and outperformed local strategies.

Background: Federated learning (FL) is a technique for learning prediction models without sharing records between hospitals. Compared to centralized training approaches, the adoption of FL could negatively impact model performance. Aim: This study aimed to evaluate four types of multicenter model development strategies for predicting 30-day mortality for patients undergoing transcatheter aortic valve implantation (TAVI): (1) central, learning one model from a centralized dataset of all hospitals; (2) local, learning one model per hospital; (3) federated averaging (FedAvg), averaging of local model coefficients; and (4) ensemble, aggregating local model predictions. Methods: Data from all 16 Dutch TAVI hospitals from 2013 to 2021 in the Netherlands Heart Registration (NHR) were used. All approaches were internally validated. For the central and federated approaches, external geographic validation was also performed. Predictive performance in terms of discrimination [the area under the ROC curve (AUC-ROC, hereafter referred to as AUC)] and calibration (intercept and slope, and calibration graph) was measured. Results: The dataset comprised 16,661 TAVI records with a 30-day mortality rate of 3.4%. In internal validation the AUCs of central, local, FedAvg, and ensemble models were 0.68, 0.65, 0.67, and 0.67, respectively. The central and local models were miscalibrated by slope, while the FedAvg and ensemble models were miscalibrated by intercept. During external geographic validation, central, FedAvg, and ensemble all achieved a mean AUC of 0.68. Miscalibration was observed for the central, FedAvg, and ensemble models in 44%, 44%, and 38% of the hospitals, respectively. Conclusion: Compared to centralized training approaches, FL techniques such as FedAvg and ensemble demonstrated comparable AUC and calibration. The use of FL techniques should be considered a viable option for clinical prediction model development.

Next-Day Discharge After Transcatheter Aortic Valve Implantation With the ACURATE neo/neo2 Self-Expanding Aortic Bioprosthesis.

Previous studies have shown the safety of early discharge pathways in selected patients and using selected transcatheter heart valves. Hence, we sought to evaluate the safety of next-day discharge (NDD) in patients who underwent transfemoral transcatheter aortic valve implantation (TF-TAVI) with the ACURATE neo/neo2 (Boston Scientific, Marlborough, Massachusetts) self-expanding aortic bioprosthesis. Patients who underwent TF-TAVI between January 2018 and April 2023 were prospectively included. Patients were stratified into 3 groups according to discharge times within 24 hours (NDD), between 24 and 48 hours, and those discharged >48 hours after TAVI. The primary outcome was the first unplanned readmission at 30 days after TAVI. Log-rank test was used to assess the differences in the outcome of interest between the groups. A total of 368 all-comers were included in this study. According to discharge times, 204 patients followed NDD, 69 patients 24 to 48 hours discharge, and 95 patients >48 hours discharge after TAVI. The mean age was 84 ± 6.3 years and 61% were women, without differences between the groups. The mean Society of Thoracic Surgeons score was lower in those with NDD versus 24 to 48 hours and >48 hours (2.9 ± 1.0, 3.2 ± 1.2, and 3.4 ± 1.4, respectively, p = 0.014). There were no differences between the groups in terms of preprocedural right bundle branch block or pacemaker. The need for new permanent pacemaker implantation was the leading postprocedural complication; it occurred more frequently in the >48 hours group than the 24 to 48 hours, and <24 hours groups (24% vs 8.6% and 2.2%, p <0.001). There were 5 strokes (1.4%) and all of them occurred in the >48 hours group (p = 0.005). At 30 days after discharge, there were no deaths and no differences in all-cause readmissions (9.3% in <24 hours, 8.6% in 24 to 48 hours, and 19% in >48 hours, log-rank p = 0.087). The readmission rates for new permanent pacemaker implantation requirement were 3.3% (n = 6) in NDD, 0% in 24 to 48 hours, and 1.6% (n = 5) in the >48 hours groups (p = 0.27). In conclusion, in unselected patients who underwent TF-TAVI with the ACURATE neo/neo2 self-expanding bioprosthesis, the NDD pathway is feasible and appears to be safe, without an increased risk of death or all-cause rehospitalization through 30 days after hospital discharge.

A Comprehensive Evaluation of the NAVITOR Transcatheter Aortic Valve Replacement System.

Transcatheter aortic valve replacement (TAVR) has undergone significant advancements in the last two decades, expanding its indications and refining transcatheter heart valve (THV) and delivery system designs to improve procedural success and patient outcomes. This review focuses on the Navitor™ valve, a third-generation intra-annular Portico™ valve (Abbott Structural Heart, St Paul, MN, USA) designed to address TAVR complications, particularly paravalvular leak (PVL). We present an overview of the Navitor™ system, comparing it to the first-generation Portico™ THV in terms of THV design, key iterations and clinical outcomes. The Navitor™ THV introduces two key refinements-a protective outer sealing skirt and a more flexible delivery system. These enhancements have led to a significant reduction in 30 day PVL rates, from 6.3% with the first-generation Portico™ to 0% with the Navitor™ system. Additionally, the Navitor™ system exhibited lower rates of severe bleeding (27.3% versus 13.1%) and major vascular complications (5.8% versus 0.7%) compared with the first-generation Portico™. The Navitor™ valve represents a promising advancement in TAVR technology, with notable reductions in complications such as PVL, severe bleeding, and major vascular issues, compared with its predecessor. While further research is needed to assess long-term durability, these results underscore its potential benefits in enhancing patient outcomes and reducing complications. This review provides insights into the evolving landscape of TAVR technology and its quantifiable impact on patient care.