BACKGROUND:Wire-based fractional flow reserve (wbFFR) is the gold standard for physiologic assessment of coronary artery disease (CAD). Recently, angiogram-based FFRangio have shown good diagnostic performance against wbFFR. Limited outcome data is available for FFRangio. The present study aimed to investigate the clinical outcomes of FFRangio-guided treatment for CAD in real-world practice. METHODS:In an international multicentre registry, CAD patients assessed using FFRangio underwent angiography/revascularisation at 7 centres. The primary endpoint was 1-year cumulative incidence of cardiovascular death/myocardial infarction (MI)/unplanned revascularisation (UR). RESULTS:Our cohort included 2129 lesions from 1579 patients. In 1951 lesions (91.6%) and 1435 patients (90.9%), treatment was concordant with FFRangio results. Mean age was 70.3 years and 30.6% were female. Mean FFRangio was 0.86 (0.66 and 0.95 in the revascularised and deferred lesions, respectively). After a median follow up of 365 (Q1-Q3: 326-365) days, the primary endpoint for the revascularisation and deferral groups was 6.8% and 1.6% (cardiovascular death 0% and 0.4%, MI 1.0% and 0.1%, UR 6.8% and 1.2%). Risk for the primary endpoint was 3.6% and 8.7% in the concordant and discordant groups, respectively (adjusted HR 0.38 [95%CI: 0.19-0.88], p = 0.006), driven by lower incidence of event in the concordant revascularisation vs. discordant deferral groups (6.8 vs. 12.3%, HR 0.43 [95%CI: 0.19-0.95], p = 0.038). CONCLUSIONS:In real-world setting, FFRangio-guided treatment yields excellent one-year outcomes for both revascularisation and deferred lesion, which are comparable with current data for wbFFR-guided treatment. FFRangio-concordant revascularisation was associated with better prognosis than FFRangio-discordant deferral for patients with FFRangio ≤ 0.8. TRIAL REGISTRATION:NCT05648396.

Despite significant advances in transcatheter tricuspid valve repair and replacement (TTVR), a substantial proportion of patients with severe tricuspid regurgitation (TR) remain ineligible for currently available therapies due to anatomical constraints, advanced disease, or prohibitive procedural risk. Heterotopic valve implantation strategies, in which prosthetic valves are positioned outside the native tricuspid annulus, have emerged as alternative approaches for this challenging population. The UNICA system represents a novel single-stent, double valve heterotopic platform designed for patients with symptomatic severe TR who are unsuitable for surgical or transcatheter annular interventions. Early clinical experience suggests high technical success, short procedural times, favorable short-term safety, and meaningful improvements in functional status and quality of life. Mechanistically, the system offers potential advantages over existing TTVR devices by bypassing complex annular anatomy and simplifying procedural execution. Nevertheless, further prospective data is required to define long-term durability, optimal patient selection, and comparative effectiveness.

BACKGROUND:Guide extension catheters (GECs) have become an essential adjunctive tool in complex percutaneous coronary interventions (PCIs). GECs provide additional catheter support and stability, enhancing device deliverability. AIMS:Our study aims to evaluate the technical and prognostic significance of the use of GECs in complex PCI. METHODS:Our study included 23,299 PCI cases performed in a large tertiary center between 2010 and 2023. We assessed rates of procedural success with GEC. The primary clinical endpoint was all cause-mortality. Other clinical endpoints included major adverse cardiac events (MACE) during follow-up. Cox regression, multivariate analysis, and propensity score matching were used to compare GEC and non-GEC PCI cases. RESULTS:Of the 23,299 PCI cases in our study, 532 patients (2%) were treated utilizing GECs. The median age was 66 [IQR 58-75], and 88% were males. Successful PCI was performed in 96.2% of the total cohort, with similar rates in the GEC and non-GEC group (94.9% vs. 96.2%, p = 0.144). GEC was used more often in calcified, bifurcation, and unprotected left main lesions. Patients requiring the use of GEC had higher long-term mortality rates (HR 1.86, 95% CI 1.54-2.23, p < 0.001) and MACE events (HR 1.26, 95% CI 1.07-1.47, p = 0.004). Multivariate adjustments, sensitivity analysis of complex-PCI cases, and a propensity score-matched model showed similar results. A landmark analysis showed no significant difference in 30-day mortality but divergence of the survival curves after 30 days with increased mortality among the GEC cohort. CONCLUSIONS:Our study showed that patients who required GEC during PCI were successfully treated in the vast majority of cases, with similar short-term results. However, the use of GEC is associated with a worse long-term prognosis, reflecting a surrogate for sicker patients and procedural complexity, thus requiring careful follow-up.

Purpose:Patients with a bicuspid aortic valve (BAV) often have an associated aortopathy and increased risk of aortic dissection. This study aimed to assess if the chronic use of renin-angiotensin-aldosterone system inhibitors (RAASi) or beta blockers (BB) may be associated with reducing the progression of aortic dilation in adult BAV patients. Methods:A retrospective cohort study was performed including adult patients with BAV with serial echocardiography over ≥5 years. The cohort was subdivided according to chronic use of RAASi or BB. The primary outcome was a composite of progression of absolute ascending aortic diameter ≥4.5 cm or surgery for ascending aortic replacement. Results:Included were 262 patients with mean age of 54.3 ± 19.5 years and 75.1 % male. The average follow-up time was 10.8 ± 0.8 years. The cumulative incidence of the primary endpoint was 14.6 % at 10-year follow up and 33.3 % at 15-year follow up. While those with RAASi (n = 39) had the primary endpoint numerically less that those without RAASi chronic therapy (12.8 % vs 24.8 %, p = 0.147), on multivariate analysis there was no significant decreased risk for the primary outcome. (HR = 0.89, 95 % CI [0.34-2.86], p = 0.97). Similarly, there was no significant decreased risk of the primary outcome amongst those with chronic beta blocker use following multivariate analysis (HR = 0.96, 95 % CI [0.37-2.51], p = 0.95). Conclusions:Our findings suggest that the chronic use of RAASi or BB was not associated with a blunted progression of BAV aortopathy in the adult population. These results highlight the need for larger, randomised studies to validate these observations and further explore potential preventative strategies in this population.

BACKGROUND:Assessing intermediate coronary lesions with an intracoronary pressure wire improves clinical outcomes in patients undergoing cardiac catheterization and percutaneous coronary intervention (PCI). However, clinical use of pressure-wire-based physiological assessment remains low. Measurement of fractional flow reserve (FFR) derived from coronary angiographic images alone correlates well with pressure-wire-based FFR measurements and may simplify procedures, but its effect on clinical outcomes is unknown. METHODS:In this international noninferiority trial, we randomly assigned patients undergoing coronary angiography who were found to have at least one intermediate coronary stenosis to physiological assessment with measurements derived from angiographic images (FFRangio) or with pressure-wire-based measurements. The primary end point was a composite of death, myocardial infarction, or unplanned, clinically indicated coronary revascularization at 1 year. The noninferiority margin was 3.5 percentage points. RESULTS:A total of 1930 patients were randomly assigned to physiological assessment with FFRangio (FFRangio group; 965 patients) or a pressure-wire-based approach (pressure-wire group; 965 patients). The mean age of the patients was 68.4 years, and 25.0% of the patients were women. At 1 year, a primary end-point event had occurred in 64 patients (Kaplan-Meier estimate, 6.9%) in the FFRangio group and 65 patients (Kaplan-Meier estimate, 7.1%) in the pressure-wire group (hazard ratio, 0.98; 95% confidence interval, 0.70 to 1.39; difference, -0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.1 percentage points; P<0.001 for noninferiority). There were no apparent differences between the groups with respect to the incidence of bleeding, acute kidney injury, or procedure-related adverse events. CONCLUSIONS:Among patients with intermediate coronary-artery lesions undergoing physiological assessment in the cardiac catheterization laboratory, an angiography-guided strategy involving FFRangio was noninferior to a pressure-wire-guided strategy with respect to a composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 year. (Funded by CathWorks; ALL-RISE ClinicalTrials.gov number, NCT05893498.).

Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) lower LDL cholesterol and may influence cancer through immunomodulatory pathways. However, their effect on human cancer incidence remains unknown. We conducted a retrospective, propensity score-matched study (Clalit Health Services, Israel, 2010-2023) comparing PCSK9 mAbs to ezetimibe. Adults prescribed PCSK9 mAbs for 6 months or more were matched 1:3 to ezetimibe-treated patients without prior cancer, applying a 1-year latency. The cohort included 9,876 patients (2,469 PCSK9 mAb; 7,407 ezetimibe; mean age 65). During a median 4.6-year follow-up, cancer occurred in 12% of PCSK9 mAb users and 11% of ezetimibe users (HR 1.09 [95% CI, 0.95-1.25]). In sex-stratified analysis, men on PCSK9 mAbs had a higher cancer incidence (12.5% vs. 10.3%, P = 0.03); no difference was observed in women. All-cause mortality was significantly lower in the PCSK9 mAb group (3% vs. 5%; HR 0.65 [95% CI, 0.54-0.80]). Post-cancer-diagnosis mortality did not differ. In this large cohort, PCSK9 mAb therapy appeared safe regarding overall cancer risk and was associated with a significant reduction in all-cause mortality; the slightly higher cancer incidence in men may likely be attributed to a higher prevalence of baseline risk factors.

Background: The prevalence of severe aortic stenosis (AS) is increasing, in accordance with a longer life expectancy. Aortic valve calcification is a multifactorial pathological process involving a complex interplay between different types of regenerative cellular and genetic factors. Among these cells, endothelial progenitor cells (EPCs) and their osteoblastic phenotype subpopulation (EPC-OCNs) have been implicated in vascular remodeling and disease progression. Objectives: To assess longitudinal changes in EPC and EPC-OCN levels in patients with severe symptomatic AS undergoing transcatheter aortic valve implantation (TAVI). Methods: In this prospective observational study, 65 patients with severe AS undergoing TAVI were enrolled. Circulating EPC and EPC-OCN levels were quantified by flow cytometry before the procedure, at 4 ± 1 days, and at 90 ± 29 days after TAVI. EPCs were defined by expression of CD133, CD34, and VEGFR-2. Results: Circulating EPC levels remained unchanged throughout the follow-up. In contrast, circulating EPC-OCNs increased significantly over time. Specifically, CD133+/VEGFR-2+/OCN+ cells rose from 2.50% to 6.25%, CD34+/VEGFR-2+/OCN+ from 2.04% to 4.05%, and VEGFR-2+/OCN+ from 1.46% to 3.01% (all p < 0.01). This suggests an osteogenic response to TAVI, while classical endothelial repair mechanisms were not systemically activated. Conclusions: EPC-OCNs increased significantly following TAVI, possibly reflecting ongoing tissue remodeling or calcification processes. In contrast, the stability of classical EPCs levels suggests limited systemic endothelial regeneration. These observations underscore the potential role of EPC-OCNs as markers or modulators of pre- and post-TAVI vascular remodeling.

BACKGROUND:Angiography-derived fractional flow reserve (Angio-FFR) is an emerging tool for guiding percutaneous coronary intervention (PCI). Its uptake and outcomes compared with pressure wire (PW)-based assessment in the United States are unknown. METHODS:We conducted a cohort study using US Medicare beneficiary data from January 1, 2019 to December 31, 2024. Propensity score matching (1:3) of Angio-FFR to PW was performed in patients who underwent PCI during the same procedure, and separately among those who did not undergo PCI during the same procedure. The primary outcome was the cumulative incidence of major adverse cardiovascular events through 2 years, including all-cause death, myocardial infarction, and repeat revascularization. Secondary outcomes included individual major adverse cardiovascular event components, 30-day acute kidney injury, and 30-day major bleeding. Falsification end points (hospitalization for pneumonia and hip fracture) were used to assess unmeasured confounding. RESULTS:Of 466 535 angiograms that included intraprocedural physiological assessment, 1.00% (N=4672) used Angio-FFR. Annual use increased from 0.47% in 2019 to 3.85% in 2024. Among patients with PCI, 1591 Angio-FFR and 4773 PW-matched patients with PCI had similar major adverse cardiovascular event rates through 2 years (24.8% versus 23.5%; hazard ratio, 1.01 [95% CI, 0.85-1.20]). Secondary outcomes and falsification end points were not significantly different. In non-PCI patients, 2532 Angio-FFR and 7596 PW-matched patients also had similar major adverse cardiovascular events through 2 years (24.1% versus 23.9%; hazard ratio, 0.97 [95% CI, 0.84-1.11]). CONCLUSIONS:Angio-FFR usage in the United States is modest but increasing. Angio-FFR guidance during angiography versus PW was associated with comparable outcomes through 2 years.

Background Acute kidney injury (AKI) is a serious complication of percutaneous coronary intervention (PCI) associated with increased mortality and health care costs. Traditional risk scores often rely on intraprocedural variables, limiting their utility for preprocedural prophylaxis. Objectives We aimed to develop and validate a machine learning model to predict post-PCI AKI using strictly preprocedural electronic health record data. Methods This retrospective cohort study analyzed routine electronic health record data from a tertiary medical center (2004-2022). The primary outcome was AKI, defined according to Kidney Disease: Improving Global Outcomes criteria (absolute serum creatinine increase ≥0.3 mg/dL or relative increase ≥50% within 48 hours). A gradient-boosted decision tree ensemble (CatBoost) was trained on preprocedural demographic, clinical, and laboratory variables. Performance was evaluated on a held-out test set (20%) using the area under the receiver operating characteristic curve and precision-recall curve. Results The final cohort included 23,728 PCI procedures from 17,943 patients, with an AKI prevalence of 7.0%. On the held-out test set, the model achieved an area under the receiver operating characteristic curve of 0.85 (95% CI: 0.82-0.87) and a precision-recall curve of 0.38 (95% CI: 0.32-0.43). Calibration was excellent (integrated calibration index = 0.017). At the screening threshold (probability 0.041), sensitivity was 0.83 (95% CI: 0.80-0.87). At the rule-in threshold (probability 0.199), specificity was 0.92 (95% CI: 0.91-0.93). Key predictors included baseline creatinine, hemoglobin, uric acid, and white blood cell count. Conclusions In this single-center study, we developed a machine learning model using preprocedural variables that predicts post-PCI AKI. Although external validation is required, this model could support individualized risk stratification and preventive strategies.

BACKGROUND:Degenerative calcification is the primary mechanism underlying severe aortic stenosis; however, some patients with hemodynamically severe aortic stenosis have low aortic valve calcium scores (AVCS), suggesting heterogeneous disease processes. This study aimed to evaluate the clinical characteristics and outcomes across the spectrum of AVCS. METHODS:We performed a retrospective analysis of the AMTRAC (Aortic+Mitral Transcatheter Valve) registry, including 3766 patients with severe aortic stenosis who underwent transcatheter aortic valve implantation across 16 centers mainly in Europe (2013-2024). Patients were stratified into three groups of low, high, or very high based on their AVCS. The primary end point was 3-year mortality. Secondary end points included periprocedural outcomes (Valve Academic Research Consortium-3) and posttranscatheter aortic valve implantation hemodynamics. RESULTS:Patients with low AVCS more frequently presented with low-gradient aortic stenosis and advanced New York Heart Association classes. At 3 years, mortality displayed a bimodal pattern in association with AVCS spectrum: 30.5% in the low, 26.5% in the high, and 31.3% in the very-high AVCS group (P<0.05). Paravalvular leak greater than moderate increased with AVCS severity (0.5%, 0.9%, 1.9%, for low, high, and very-high AVCS, respectively; P<0.01). The risk for stroke and permanent pacemaker implantation were also higher in the very-high AVCS group compared with the low/high AVCS groups (stroke: 4.1%, 1.4%, 2.4%; permanent pacemaker: 21.2%, 14.7%, 14.2%; for very-high, low, high, respectively; P<0.05 for both). CONCLUSIONS:Low AVCS defines a unique phenotype marked by predominant fibrosis, advanced symptoms, and increased mortality despite fewer procedural complications. In contrast, very-high AVCS is linked to higher procedural risk, more bicuspid valves, and increased mortality. These insights challenge calcification-based criteria and support incorporating fibrosis assessment into treatment strategies.

BACKGROUND:Patients with atrial fibrillation (AF) and chronic kidney disease (CKD) face an increased risk of both thromboembolic and bleeding events, making anticoagulation management challenging. OBJECTIVE:This study aimed to compare the efficacy and safety of direct oral anticoagulants (DOACs), warfarin, and no oral anticoagulation (OAC) in patients with AF and CKD. METHODS:Using data of 18,980 AF patients with CKD from Clalit database, we compared OAC vs no OAC and DOACs vs warfarin. Primary endpoints were composite-safety (intracranial hemorrhage, gastrointestinal bleeding) and efficacy (ischemic stroke, myocardial infarction, embolism, all-cause mortality). RESULTS:OAC therapy was associated with a lower risk of the primary composite efficacy outcome compared with no OAC (hazard ratio [HR]: 0.57, 95% confidence interval [CI]: 0.52-0.62), driven by reduced all-cause mortality (HR: 0.32, 95% CI: 0.29-0.36), with no significant differences in thromboembolic events or bleeding outcomes. In the comparison of DOACs vs warfarin, warfarin was associated with higher rates of composite bleeding (HR: 0.67, 95% CI: 0.5-0.89) and intracranial hemorrhage (HR: 0.51, 95% CI: 0.32-0.8). DOACs were associated with a lower risk of the primary composite efficacy outcome (HR: 0.84, 95% CI: 0.74-0.95), with no significant differences in ischemic stroke. Among appropriately anticoagulated patients, safety differences between DOACs and warfarin were no longer significant (composite bleeding HR: 0.87, 95% CI: 0.52-1.47); however, DOACs remained associated with fewer primary efficacy events (HR: 0.75, 95% CI: 0.60-0.94). CONCLUSION:In patients with AF and CKD, OAC therapy improved efficacy outcomes without increasing bleeding risk. DOACs were more effective and safer than warfarin, supporting their use as the preferred anticoagulant in this high-risk population. Appropriate dosing and therapeutic monitoring are essential to maximize benefits and minimize bleeding complications.

Background The use of angiogram‐based fractional flow reserve technologies in routine clinical practice is increasing steadily. Available data suggest that it is associated with comparable clinical outcomes compared with wire‐based fractional flow reserve (FFR), but evidence is still limited, especially in patients with acute coronary syndromes (ACSs). The aim of this study was to examine the real‐world clinical outcomes of an angiogram based fractional flow reserve technology (FFRangio; CathWorks, Kfar‐Saba, Israel) to guide treatment for coronary artery disease in patients presenting with acute versus chronic coronary syndromes (CCSs). Methods This is a retrospective, observational study. Our cohort included consecutive patients undergoing coronary angiography in 7 centers (Japan, 6; Israel, 1), whose treatment was guided by FFRangio between January 2021 and December 2023. The primary end point was 2‐year cumulative incidence of major adverse cardiac events, stratified by presentation (ACS/CCS) and treatment strategy (revascularization/deferral). Results Overall, 2245 patients (ACS, 756; CCS, 1489) were included. Patients with ACS were younger and more likely to be diabetic. At 2 years, ACS presentation resulted in higher risk of major adverse cardiac events (9.8% versus 5.6%; HR, 1.80; P<0.001). Stratified by presentation and treatment, deferred patients had similar risk of major adverse cardiac events (ACS, 5.4%; CCS, 4.7%; HR, 1.08; P=0.672) for treated patients, ACS presentation associated with increased risk for major adverse cardiac events (11.7% versus 7.3%; HR, 1.64; P<0.001). Conclusions In a real‐world setting, FFRangio‐guided treatment yields 2‐year outcomes comparable with current data for wire‐based fractional flow reserve for both patients with ACS and patients with CCS. ACS presentation is associated with increased risk for major adverse cardiac events in patients undergoing FFRangio‐guided revascularization but not deferral. These results demonstrate the clinical utility of FFRangio‐guided treatment across the spectrum of coronary artery disease presentation excluding ST‐segment–elevation myocardial infarction. Registration URL: https://clinicaltrials.gov/study/NCT05648396?term=FFRangio%20&viewType=Card&rank=3; Unique Identifier: NCT05648396.

BACKGROUND:The use of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is expanding to patients across the entire spectrum of surgical risk. We performed a meta-analysis and compared TAVI with surgical aortic valve replacement (SAVR) in trials that enrolled lower-risk patients. METHODS:We conducted a meta-analysis of randomized controlled trials and compared safety and efficacy outcomes between TAVI and SAVR among lower-risk patients (mean and/or median Society of Thoracic Surgeons [STS] score < 4). Point-estimate meta-analysis and reconstructed individual patient data survival analysis were conducted. Primary outcomes included all-cause mortality, stroke, and a composite of all-cause mortality or disabling stroke (PROSPERO, CRD42024541837). RESULTS:The analysis included 6 randomized controlled trials, totaling 2668 TAVI and 2573 SAVR patients, with a mean follow-up time of 3.02 years. TAVI was associated with lower risk of all-cause mortality (risk ratio, 0.68; 95% confidence interval, 0.52-0.88) and a composite of all-cause mortality or disabling stroke (risk ratio, 0.69; 95% confidence interval, 0.55-0.86) without a significant difference in stroke up to 2 years. Longer-term point-estimate analysis showed no difference. In reconstructed individual patient data, TAVI was associated with a lower risk of all-cause mortality, driven by an early advantage. Restricted mean survival time differences for primary outcomes were < 2.5 months and ≤ 1 month for all-cause mortality. TAVI was associated with a lower risk of bleeding, kidney injury, and atrial fibrillation, but a higher risk of pacemaker implantation and moderate to severe aortic regurgitation. CONCLUSIONS:In patients at lower surgical risk, TAVI was associated with improved short-term mortality. More data from long-term studies are needed.

BACKGROUND:Percutaneous left atrial appendage occlusion (LAAO) is a non-pharmacological strategy to prevent stroke and systemic emboli in patients with non-valvular atrial fibrillation (AF). However, data regarding its safety and efficacy profile compared to different oral anti-coagulant regimens remain limited. METHODS:A network meta-analysis compared LAAO, warfarin, and NOACs (standard dose [SD] and low-dose [LD]). Outcomes included all-cause mortality, stroke or systemic embolism, and bleeding risk. Bayesian models with surface under the cumulative ranking curve (SUCRA) and reconstructed individual patient data (IPD) were utilized. RESULTS:Twelve studies, including eight randomized controlled trials, were analyzed (13,049 patients with LD NOAC, 29,513 with SD NOAC, 29,611 with warfarin, and 2811 with LAAO). Warfarin was inferior for all-cause mortality compared to LAAO (OR 1.44 [95% CrI; 1.07-1.89]), LD NOAC (OR 1.13 [95% CrI; 1.01-1.26]), and SD NOAC (OR 1.11 [95% CrI; 1.02-1.20]). SUCRA analysis ranked SD NOAC as the most effective for stroke or systemic emboli prevention, LD NOAC as the most effective in preventing major bleeding and LAAO in preventing hemorrhagic stroke. CONCLUSIONS:SD NOACs were the most effective for preventing stroke or systemic embolism, while LD NOACs were the safest in terms of major bleeding. LAAO was comparable to NOACs and superior to warfarin in both safety and efficacy. Further studies are needed to clarify LAAO's role in the management of atrial fibrillation.

Bicuspid aortic valve (BAV) anatomy is highly heterogeneous with distinct anatomical variations that might differently influence the risk of conduction abnormalities (CA) in patients undergoing transcatheter aortic valve implantation (TAVI) We aimed to evaluate the impact of different BAV anatomy, specifically Sievers type 0 versus type I, on the incidence of CA in patients undergoing TAVI. All consecutive patients with symptomatic severe bicuspid aortic stenosis (AS), who underwent computed tomography (CT) before TAVI between January 2015 and May 2024 were included. Patients were categorized based on Sievers BAV morphology into type 0 and non-type 0 (type 1A, IB, and IC). The primary outcome was the development of post-procedural CA defined as new left bundle branch block (LBBB), high-grade atrioventricular block (AVB), or permanent pacemaker implantation (PPI) within 30 days after TAVI. A total of 248 patients were CT-confirmed for BAV during the study period; 115 (46%) patients with a mean age of 75±8 years and a Society of Thoracic Surgeons score of 1.9±1.2%, underwent TAVI with contemporary devices. Type 0 morphology was identified in 17/115 patients (15%), and non-type 0 in 98/115 patients (85%). LBBB was observed in 10/115 (9%) and PPI was implanted in 19/115 (16%). Self-expanding valves were implanted in 8/17 (47%) patients with type 0 morphology compared to 37/98 (38%) with non-type 0 morphology (P = 0.46). CAs occurred in 1/17 (6%) with type 0 BAV compared to 28/98 (28%) patients with Type 1 BAV (P = 0.047). In a multivariate regression analysis adjusting for baseline right bundle branch block, implanted valve size, balloon-expandable devices, and membranous septum length, Type 0 BAV morphology emerged as an independent protective predictor for CA (OR: 0.118; 95% CI: 0.014–0.990; P = 0.049) In bicuspid aortic stenosis, conduction abnormalities are influenced by valve morphology. Compared to Sievers type 1, type 0 BAV morphology was less frequently associated with conduction abnormalities in patients undergoing TAVI.

AIMS:Patients with aortic stenosis (AS) and severe left ventricular (LV) dysfunction, have poor outcomes following transcatheter aortic valve implantation (TAVI). There is limited data regarding the role of dobutamine stress echocardiography (DSE) in patients' selection for TAVI. Our aim was to examine the prognostic value of contractile reserve (CR) and its association with ejection fraction (EF) recovery. METHODS AND RESULTS:A multicenter registry of consecutive patients with EF ≤ 30 % undergoing TAVI at 17 European centers. Patients were grouped according to those with/without CR, and further stratified by EF recovery post TAVI. The primary endpoint was 3-year mortality. Our cohort included 296 patients who performed DSE, of whom 158 were CR+. After a median follow-up of 2.4 (IQR 2-3) years, 3-year mortality was 43.7 %-vs.34.0 % in the CR- and CR+ groups, respectively (Adjusted HR 1.98,95 % CI[1.21-3.29],p = 0.009). There was no interaction between CR+ and low-flow low-gradient AS. In the entire cohort, EF recovery occurred in 141 (47.6 %) patients, who experienced lower 3-year mortality (29.6 % vs.45.1 % for those without EF recovery; HR 1.68,95 % CI[1.24-2.97],p < 0.01). Following multivariate adjustment, CR+ was an independent predictor of EF recovery (OR 6.06 95 % CI[3.48-10.53],p < 0.001). Stratified by CR status and EF recovery, 3-year mortality was similar in the different EF recovery groups. CONCLUSION:CR on DSE is associated with reduced mortality, mediated through its impact on EF recovery. Our results highlight the potential of DSE and CR status in the triage of patients with severe AS and LV dysfunction, and support its routine use in the pre-TAVI assessment.

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS). Comparative data on the efficacy and safety of newer transcatheter heart valve (THV) devices is still evolving. We aim to compare clinical and hemodynamic outcomes of the Symetis ACURATE Neo-2® versus the Medtronic Evolut Pro/Pro+® and the Edwards Sapien-3® THVs, from a large cohort of patients undergoing TAVR. In this all-comer, single center trial, patients with severe symptomatic AS undergoing TAVR and treated with either ACURATE Neo-2 (N = 240), Evolut Pro/Pro+ (N = 324) or Sapien-3 (N = 485) THVs were included. Baseline clinical, demographic and follow-up data were collected. Patients (N = 1049) (female 48.6%) mean age 80.1 ± 7.7 years. ACURATE Neo-2 patients were predominantly female (81%) in comparison to Evolut Pro/Pro+ (59%) and Sapien-3 (26%). Need for post-TAVR permanent pacemaker implantation (PPI) was lower in the ACURATE Neo-2 group in comparison to the Evolut Pro/Pro+ and similar to the Sapien-3 group. Rates of ≥ moderate paravalvular leak (PVL) were similar between ACURATE Neo-2 and Evolut Pro/Pro+, but higher in comparison to Sapien-3. In sight of our center's clinical approach to choosing various THV's according to patient characteristics, The ACURATE Neo-2 constitutes a reliable and suitable tool for the treatment of patients with severe symptomatic AS undergoing TAVR. Even in the wake of the ACURATE Neo-2's withdrawal, our study offers valuable contributions to ongoing discourse in the field of TAVR, emphasizing the necessity for continuous research and innovation to improve patient care and device efficacy.