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.

Background: Complex coronary artery disease frequently coexists with severe aortic stenosis. The prognostic impact of complete revascularization (CR) versus incomplete revascularization (IR) in patients undergoing complex and/or high-risk indicated percutaneous coronary intervention (CHIP) and transcatheter aortic valve implantation (TAVI) remains unclear. Methods: We analyzed 550 patients who underwent CHIP and transfemoral TAVI between 2013 and 2023 at 14 international centers. Patients were stratified by completeness of revascularization. The primary endpoint was a composite of all-cause death and unplanned cardiovascular (CV) hospitalization at 1 year. Results: CR was achieved in 299 patients (54.4%). Patients with IR more frequently had three-vessel disease, bifurcation lesions, left main disease, and need for mechanical support. Balloon-expandable valves were more frequently implanted in the CR cohort. Short-term outcomes were similar in the two groups. At 1 year, the incidence of the primary endpoint did not differ significantly between CR and IR groups (20.1 vs. 27.3%, hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.49-1.07). CV rehospitalizations were significantly reduced in the CR group (14.8 vs. 22.8%, HR 0.61, 95% CI 0.38-0.97) even after multivariable adjustment and excluding hospitalizations for repeat revascularization. Conclusions: In patients undergoing CHIP and TAVI, CR was associated with a reduction in CV hospitalizations. Further studies are needed to confirm this finding.

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 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.

Abstract Background Diabetes mellitus (DM) is associated with peripheral artery disease (PAD) and may increase the risk of vascular complications (VC) in patients with hostile femoral access undergoing TAVI. Aims To evaluate the association between DM, VC and clinical outcomes in this population. Methods and results The HOSTILE registry is an international study including consecutive patients undergoing TAVI with hostile femoral access, defined as severe bilateral iliofemoral PAD requiring percutaneous transluminal angioplasty or alternative access. Outcomes of patients with and without diabetes were compared and stratified by access strategy. Inverse probability of treatment weighting (IPTW) was used to adjust for baseline differences. The primary endpoint was VC of any vascular access. Secondary endpoints included major and minor VC and 30-day and one-year clinical outcomes. Among 1707 patients, 559 (32.7%) had diabetes. Diabetic patients had a higher burden of comorbidities and more severe PAD, represented by higher Hostile scores. Despite this, rates of VC were similar between diabetic and non-diabetic patients (IPTW-adjusted odds ratio 0.86, 95% confidence interval 0.68–1.08, P = .184), consistently across access strategies. 30-day and one-year all-cause mortality and ischemic outcomes did not differ between groups. DM was associated with a lower incidence of any bleeding at one year, driven by minor bleeding events. Conclusion In patients with hostile femoral anatomy undergoing TAVI, diabetes was associated with more severe PAD but not with an increased risk of VC, mortality, or ischemic events. These findings support the feasibility and safety of contemporary TAVI strategies in diabetic patients with complex peripheral anatomy.

OBJECTIVES:Several models have been evaluated for the prediction of transcatheter aortic valve replacement (TAVR)-related cerebrovascular accidents (CVA). The HOSTILE registry recently investigated TAVR outcomes in patients with severe peripheral artery disease (PAD), assessed using a multi-parameter score (HOSTILE score). Among patients treated with transfemoral access (TFA), higher HOSTILE score was associated with higher rates of CVA. We sought to assess the efficacy of different modalities of risk estimation for TAVR-related CVA prediction in a population with severe PAD. METHODS:The predictive ability of the risk assessment modalities was compared using the area under the receiving-operator characteristic (ROC) curve and Harrell's C-statistic. The pre-defined outcome was any CVA occurring within 30 days after TAVR. RESULTS:The study population consisted of 1707 patients, 518 (30.3%) treated via TFA and 1189 treated via transthoracic and trans-axillary routes. The CHA2DS2-VASc and the HOSTILE score showed fair performance only in the TFA cohort (AUC 0.68, 95% CI 0.53-0.83, and 0.68, 95% CI 0.55-0.81, respectively); values of CHA2DS2-VASc >5 and HOSTILE >6 exhibited the best discriminatory ability. The highest risk group (CHA2DS2-VASc >5 and HOSTILE >6) showed a five-fold higher incidence of CVA as compared to the other groups (incidence 6.7%; HR: 5.38, CI95%: 1.80-16.01; p = 0.003). CONCLUSIONS:In a population of patients with severe PAD treated with TAVR via TFA, the integration of a clinical score (CHA2DS2-VASc score) with a purely anatomical one (HOSTILE score) increased the discriminative ability towards 30-day CVA. Further analyses are needed in order to prospectively evaluate this strategy in different cohorts.

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:Lifetime treatment of aortic valve disease is a matter of increasing debate. Although the risks of a second aortic valve intervention are recognized, little attention has been given to the challenges of a third. OBJECTIVES:This study delves into the clinical characteristics, indications, and outcomes of patients undergoing 3 aortic valve interventions. METHODS:The THIRD (THree aortIc Reinterventions for valve Disease) registry is a retrospective multicenter, international study of patients who underwent a third procedure on the aortic valve, either surgically or transcatheter-based. Patients undergoing 2 aortic procedures during the same hospital admission were excluded. Baseline characteristics, timing, and mode of bioprosthetic failure, sequence of the procedures, and clinical outcomes were adjudicated according to the Valve Academic Research Consortium criteria. RESULTS:A total of 51 patients from 11 centers were enrolled in this study. Median follow-up time was 565 (314-1,560) days. Eighteen patients (35%) underwent surgical aortic valve replacement (SAVR), and 33 of 51 patients (65%) underwent transcatheter aortic valve replacement (TAVR) as the third intervention. Mean age was 69 ± 14 years, 20 of 51 patients (39%) were female. STS score was 5.0% (Q1-Q3: 3.3%-7.0%). In all TAVR cases, the indication for the first intervention was severe aortic stenosis, as was the indication in 31 of 45 (69%) of SAVR cases (33% bicuspid). The most prevalent procedure sequence was SAVR-SAVR-TAVR (19/51, 37%), followed by SAVR-SAVR-SAVR (10/51, 20%) and SAVR-TAVR-TAVR (10/51, 20%). TAVR-TAVR-TAVR was performed in 4 of 51 cases (8%). The primary indications for a third intervention included structural valve deterioration (SVD) (39/51, 76%), non-SVD (8/51, 16%), and endocarditis (2/51, 4%). Excluding patients with a mechanical prosthesis, predictors of SAVR as third intervention included a lower STS score (OR: 0.58; 95% CI: 0.34-0.98; P = 0.04) and the presence of moderate or severe prosthesis-patient mismatch (OR: 44.8; 95% CI: 2.41-122.00; P = 0.01). Thirty-day device success was 85% for TAVR and 94% for SAVR. CONCLUSIONS:In the THIRD registry, SVD emerged as the predominant indication for a third aortic valve procedure. The most frequent procedure sequence was SAVR-SAVR-TAVR, whereas TAVR-TAVR-TAVR was less common. Although the short-term outcomes in our selected cohort were favorable, further investigation is needed.

Background/Objectives: The optimal method to facilitate femoral access in patients with aortic stenosis and severe peripheral arterial disease (PAD) undergoing transcatheter aortic valve implantation (TAVI) remains unclear. This study compared the safety and efficacy of percutaneous transluminal angioplasty (PTA) versus Shockwave® intravascular lithotripsy (IVL) in patients with severe PAD undergoing TAVI via the trans-femoral route enrolled in the Hostile TAVI registry trial. Methods: Patients with severe PAD from 28 international centers were enrolled in the registry. This sub-study analyzed patients who underwent transfemoral TAVI facilitated by PTA (n = 352) or IVL (n = 166). Primary endpoints included rates of survival, major vascular complications, and major bleeding. Outcomes were also stratified according to the severity of PAD using the novel Hostile risk score. Results: Patients in the PTA group were older and had lower rates of prior stroke/TIA. All-cause mortality at 3 years was similar between PTA and IVL groups (34.9% vs. 38.6%; p = 0.27, respectively). However, IVL was associated with fewer major vascular complications (21.7% vs. 13.3%; p = 0.033, respectively), less major bleeding (14.0% vs. 7.0%; p = 0.024, respectively), and shorter hospital stays (7.06 ± 6.69 vs. 4.29 ± 4.78 days; p < 0.001; 95% CI: 1.63–3.91, respectively). Cox regression analysis showed that at low (≤8.5) Hostile Scores, PTA was associated with higher rates of major vascular complications and major bleeding than IVL. Conclusions: In patients with aortic stenosis and severe PAD undergoing TAVI via the transfemoral route, IVL is safer than PTA, with fewer vascular and bleeding complications but similar intermediate-term survival.

Objectives: Infective endocarditis (IE) after transcatheter aortic valve replacement (TAVR) is rare. We describe patients referred to a tertiary heart center endocarditis team, with post-TAVR IE complicated by infected ascending aorta false aneurysms. Methods: Among 60 patients with post-TAVR IE who were referred to our center between January 2016 and October 2024, 7 (11.7%) patients were complicated by false aneurysm and aortitis. In all cases, self-expanding transcatheter heart valves (THVs), primarily Symetis ACURATE neo, were used. Results: Infected false aneurysm formation mainly at the tip of the THV stabilization arches and aortitis were identified only on cardiac computerized tomography. Five patients underwent surgical explant of the TAVR valve with aortic valve replacement. Interposition graft replacement of the ascending aorta was performed in 4 cases whereas 1 patient underwent aorta patch repair. Mitral valve surgery and coronary artery bypass graph were performed as a concomitant procedure in 2 cases. Two patients were managed conservatively due to extreme surgical risk. One patient died perioperatively, and one patient died during follow-up. Conclusions: Unlike prosthetic valve endocarditis after surgical aortic valve replacement, TAVR-IE may involve the ascending aorta, leading to life-threatening false aneurysm formation at the tip of the THV stabilization arches, where the device was adherent to the aortic wall. This pathology often eludes detection by echocardiography, underscoring the essential role of cardiac computed tomography in diagnosis and surgical planning. Clinicians should maintain a high index of suspicion for this rare but unique life-threatening complication and consider early use of advanced imaging.

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.

Objectives. The authors compared the risk of cerebrovascular events (CVE) with self-expanding vales (SEV) vs balloon-expandable valves (BEV) in patients with or without peripheral artery disease (PAD), stratified by the access route and the complexity of PAD (Hostile score). Methods. The PAD-related risk of CVE between SEV vs BEV was investigated using data from the HOSTILE Registry, an observational study including 1707 patients with severe PAD undergoing transcatheter aortic valve replacement (TAVR) via different access routes. The relative risk of CVE with SEV vs BEV in patients without PAD was investigated in a meta-analysis of randomized controlled transfemoral access (TFA)-TAVR trials of patients with normal femoral arteries. The primary endpoint was the risk of 30-day CVE. Results. Among the 1021 patients undergoing TAVR through TFA or transaxillary access (TAxA), 674 (66.0%) received SEVs and 329 (32.2%) received BEVs. The 30-day propensity-adjusted risk of CVE was higher for SEV compared with BEV (adjusted hazard ratio [HR], 2.70; 95% CI, 1.16-6.23), with no significant interaction between the transcatheter heart valve and either the access route or the Hostile score. Similar results were apparent at 1 year (adjusted HR, 2.98; 95% CI, 1.30-6.83). In contrast, in a meta-analysis of 4 RCTs and 2131 patients with femoral arteries suitable for TAVR, there were no significant differences in the 30-day rates of CVE between SEV and BEV (odds ratio, 0.58; 95% CI, 0.24-1.40). Conclusions. Compared with BEVs, SEVs were associated with higher 30-day and 1-year rates of CVE in patients with PAD, a finding not apparent in patients with suitable femoral arteries enrolled in randomized controlled trials.

Background:Real-time 3-dimensional transesophageal echocardiography (3DTEE) data acquired during interventional procedures are displayed on 2-dimensional screens, limiting intuitive depth perception and spatial comprehension. The study objectives were to evaluate the feasibility of intraprocedural use of a holography display during structural cardiology procedures employing 3DTEE, and to assess the accuracy of offline linear measurements in 3DTEE datasets. Methods:A prospective single-center study was conducted using the HOLOSCOPE-i to guide catheter-based procedures using intraprocedural 3DTEE. Qualitative measures of recognition of anatomic structures, 3D spatial comprehension, and interaction with intracardiac anatomic structures and catheter position were evaluated using a Likert scale. Additionally, a retrospective analysis of offline 3DTEE datasets of mitral valve measurements were performed using the HOLOSCOPE-i vs QLAB. Intra- and interobserver variability was assessed, assuming an intraclass correlation coefficient > 0.75 indicates adequate reliability. Results:A total of 13 patients were enrolled. In all cases, anatomic structures were identified in real time, and spatial comprehension was enhanced (Likert scale). No nausea or headache was reported by the operators. Retrospective analysis of 41 mitral valve 3DTEE datasets was performed. Annular diameter measurements (anteroposterior [AP] and anterolateral-posteromedial [AL-PM]) demonstrated a Pearson correlation of 0.89 (HOLOSCOPE-i) and 0.91 (QLAB). Intraobserver ICC for AP, AL-PM was 0.97, 0.94 (HOLOSCOPE-i) and 0.95, 0.97 (QLAB); interobserver ICC for AP and AL-PM was 0.77 and 0.88 (HOLOSCOPE-i) and 0.96 and 0.98 (QLAB). Conclusions:Holographic display of intraprocedural real-time 3DTEE data is feasible and augments the experience of the operator. Linear measurements in the 3D holographic display are accurate, with good correlation to those using 2-dimensional multiplanar reconstruction 3DTEE software. Clinical Trial Registration:MOH_2021-09-13_010255.

BACKGROUND:Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis. METHODS:Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography-diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke. After propensity score matching in 10 data sets generated by multiple imputation, outcomes from transcatheter aortic valve replacement to 3-year follow-up were computed by multivariable binomial logistic mixed-effects models, multivariable linear mixed-effects models, or multivariable frailty models accounting for center-related influences and residual confounding effects (doubly robust adjustment). The results were replicated by inverse probability of treatment weighting and multivariable adjustment. RESULTS:A total of 1443 consecutive patients with bicuspid aortic valve stenosis undergoing BE-THV (n=860) or SE-THV (n=583) implantation were included. In-hospital and 30-day death or stroke did not significantly differ between BE-THV and SE-THV groups (5.1% versus 6.1%; hazard ratio after propensity score matching, 1.02 [95% CI, 0.51-2.02]). BE-THV implantation was associated with higher annulus rupture and mean transvalvular gradient compared with SE-THV implantation. In contrast, SE-THV implantation was associated with higher additional valve implantation and paravalvular regurgitation compared with BE-THV implantation. The results were consistent across the statistical methods used and between early- and new-generation THVs. At 30 days, pacemaker implantation was lower in the BE-THV group compared with the SE-THV group (11.9% versus 18.6%; hazard ratio after propensity score matching, 0.58 [95% CI, 0.36-0.93]). This result did not depend on the statistical method used. At 3 years, consistent with the 1- and 2-year analyses, death or stroke was not significantly different between the BE-THV and SE-THV groups (23.7% versus 26.2%; hazard ratio after propensity score matching, 0.99 [95% CI, 0.65-1.51]). Death or stroke across major clinical, anatomical, functional, and procedural conditions was consistent with the main analysis. After inverse probability of treatment weighting and multivariable adjustment, these conclusions remained unchanged. CONCLUSIONS:In patients undergoing transcatheter aortic valve replacement for bicuspid aortic valve stenosis, death or stroke does not significantly differ between those receiving a BE-THV and those receiving an SE-THV over a follow-up of 3 years. BE-THV is associated with higher transvalvular mean gradient and more frequent annulus rupture, whereas SE-THV is associated with more frequent moderate to severe aortic regurgitation, additional THV implantation, and permanent pacemaker implantation.

INTRODUCTION:Permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR) is associated with adverse outcomes. This study aimed to evaluate the long-term outcomes of PPM implantation post-TAVR in patients with high and low ventricular pacing (Vp) burden. METHODS:A single-center, retrospective cohort study of consecutive patients who underwent PPM implantation within 90 days post-TAVR from 2003 to 2022. Patients were divided into two groups based on Vp burden at 1 year: <20 % and ≥ 20 %. The primary outcome was a composite of first cardiovascular hospitalization or all-cause mortality, assessed from 1 to 5 years post-PPM after a 1-year pacing burden assessment. RESULTS:Of 1573 TAVR patients, 229 required a PPM, of whom 199 had complete Vp data at 1 year post-PPM implantation and were included: 84 (42 %) patients with Vp < 20 % and 115 (58 %) patients with Vp ≥ 20 %. Persistent complete atrioventricular block (CAVB) was the most common PPM indication in patients with Vp ≥ 20 % (66 % vs. 11 %, P < 0.001), while transient CAVB was more prevalent in those with Vp < 20 % (48.2 % vs. 11.8 %, P < 0.001). From 1 to 5 years after the post-PPM landmark, patients with Vp ≥ 20 % had higher rates of the composite outcome of cardiac-related first hospitalization or mortality (adjusted HR 3.4; 95 % CI 1.7-6.7; P < 0.001), driven by each of its independent components. They also had a higher incidence of new reduced left ventricular ejection fraction (LVEF<40 %) at 1 year (12 % vs. 1.6 %, P = 0.024). In multivariate analysis, persistent CAVB was the strongest predictor of Vp ≥ 20 % at 1 year (adjusted OR 14.2; 95 % CI 5.3-37.9; P < 0.001). CONCLUSION:1-year VP ≥20 % post-TAVR PPM implantation was associated with higher cardiac hospitalizations and mortality over 5 years of follow-up.

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.