Background The optimal revascularisation strategy for patients undergoing percutaneous coronary intervention (PCI) after transcatheter aortic valve implantation (TAVI) remains undefined. In particular, the prognostic impact of complete revascularisation (CR) versus incomplete revascularisation (ICR) in this setting is unknown. Aims To evaluate the long-term clinical outcomes of CR versus ICR in patients undergoing PCI after TAVI. Methods We analysed 447 patients from the multicentre, international Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL) registry who underwent PCI after TAVI between 2008 and 2023. Patients were classified as CR or ICR according to the presence of residual significant stenosis following PCI. The primary endpoint was the 4-year incidence of major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction or stroke. The Kaplan-Meier method was used to estimate cumulative event rates, and a weighted Cox regression model employing an entropy balance approach was used to adjust for possible confounders. Results ICR was achieved in 132 patients (29.5%) and CR in 315 patients (70.5%). The mean follow-up after PCI was 1065±904 days (1213±938 in the ICR group; 1002±883 in the CR group). The crude 4-year incidence of MACE was 35.0% with ICR and 34.7% with CR (HR 0.93, 95% CI 0.62 to 1.39, p=0.710). Adjusted analysis confirmed no significant difference (32.5% vs 34.1%; HR 1.01, 95% CI 0.62 to 1.64, p=0.971). Conclusion In this registry, CR after TAVI was common but not associated with improved outcomes compared with ICR. These results support a selective rather than systematic pursuit of CR in elderly, high-risk post-TAVI patients.

Aims:The number of patients undergoing percutaneous coronary interventions (PCI) after transcatheter aortic valve replacement (TAVR) is expected to increase, but their prognosis remains poorly understood. Methods and results:Consecutive PCI patients with prior TAVR were compared to patients without prior TAVR between 2008 and 2023. The Kaplan-Meier method was used to estimate the 1-year incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death or myocardial infarction. An entropy balance approach was implemented to adjust for imbalances in patient and procedural characteristics. Adjusted hazard ratios (HRs) were estimated using weighted Cox regression models. Comparing 420 PCI patients with prior TAVR (mean age 80.8 years, 37.1% women) to 1197 without (mean age 70.4 years, 24.6% women), 1-year MACE was higher in the prior TAVR group (8.7 vs. 3.7%; unadjusted HR 2.35, 95% CI 1.49-3.69; P < 0.001). After adjustment for clinical and procedural characteristics, prior TAVR remained associated with an increased risk of MACE (adjusted HR 2.36, 95% CI 1.08-5.16; P = 0.032). This was primarily driven by higher cardiovascular death (adjusted HR 3.12, 95% CI 1.10-8.79, P = 0.032), while the association with myocardial infarction was attenuated post-adjustment and no longer statistically significant. Conclusion:Patients undergoing PCI after TAVR experience a higher incidence of MACE compared to those undergoing PCI without prior TAVR, underscoring the importance of accurate patient selection before performing PCI in patients with chronic coronary syndrome and history of TAVR.

Background: One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have a concomitant indication for oral anticoagulation (OAC). Previous studies suggested that periprocedural continuation of OAC could reduce transient hyper-coagulation after TAVI. Objective: To evaluate the effects of continuation versus interruption of OAC on periprocedural hemostasis function. Methods: Patients were randomized 1:1 to OAC continuation vs interruption. Plasma samples were taken at 6 time points, and hemostasis function was assessed by measuring thrombin and plasmin generation, as well as biomarkers of coagulation, fibrinolysis, platelet activation, and endothelial function. Results: A total of 167 patients were included: 82 were assigned to OAC continuation and 85 to OAC interruption. Pre-TAVI, a significantly lower endogenous thrombin potential (ETP) was observed in the continuation group compared with the interruption group. In both groups, ETP was reduced immediately post-TAVI, and its restoration was significantly lower in the continuation group. In contrast, levels of prothrombin fragment 1 + 2 were similar between the groups. A significantly lower endogenous plasmin potential was observed in the continuation group from pre-TAVI to 8 hours post-TAVI. In both groups, fibrin degradation products increased immediately post-TAVI, while this increase was significantly lower in the continuation group. Markers of endothelial and platelet activation were unaffected by the randomized strategy. Conclusion: Continuation of OAC during TAVI modestly reduced the acute activation of coagulation and fibrinolysis compared with the interruption of OAC. This did not translate into any apparent differences in thromboembolic risk in the main trial. However, continuation of OAC resulted in a marked suppression of ETP and an increased risk of bleeding.

BACKGROUND One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. METHODS We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. RESULTS A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). CONCLUSIONS In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days.

ABSTRACT Background Conduction disturbances are common after transcatheter aortic valve implantation (TAVI) and frequently require permanent pacemaker implantation (PPI). Data regarding its impact on mortality and morbidity are conflicting. This study aims to assess the impact of PPI before or within 30 days after TAVI on mortality and health‐related Quality of Life (QoL) during the first year after TAVI. Methods In this POPular TAVI substudy, 978 patients were included and categorized into three groups: Neither PPI before or within 30 days after TAVI (no PPI, n = 779), PPI before TAVI (PPI pre‐TAVI, n = 102), PPI within 30 days after TAVI (PPI post‐TAVI, n = 97). All‐cause death and cardiac death were evaluated at 1 year. QoL was assessed using the SF‐12 and EQ‐5D‐5L questionnaires at baseline and 3, 6, and 12 months. Results At 1‐year, all‐cause death was seen in 6.9% (PPI pre‐TAVI, p = 0.53) and 10.3% (PPI post‐TAVI, p = 0.66) of the patients compared to 8.7% of the patients (no PPI). Cardiac death was observed in 4.9% (PPI pre‐TAVI, p = 0.58) and 6.2% (PPI post‐TAVI, p = 0.94) of the patients compared to 6.2% of patients (no PPI). Regarding QoL, the PPI pre‐TAVI group showed lower PCS‐12 over time compared to the no PPI group ( p = 0.04), while MCS‐12, EQ‐5D Index and EQ‐5D VAS scores were equal. No significant differences in QoL were seen between the PPI post‐TAVI group and the no PPI group. Conclusion PPI before or within 30 days after TAVI was not associated with increased mortality within 1 year. PPI pre‐TAVI was associated with lower physical QoL.

BACKGROUND:Coronary access after transcatheter aortic valve replacement (TAVR) remains challenging, particularly with tall-framed valves (TFVs), raising concerns about long-term percutaneous coronary intervention (PCI). OBJECTIVES:The aim of this study was to evaluate the impact of bioprosthetic aortic valve type on long-term clinical outcomes in patients undergoing PCI following TAVR. METHODS:Data were derived from the multicenter REVIVAL-PCI registry, which included patients from 21 European centers who underwent PCI after TAVR between 2008 and 2023. Patients were classified according to valve frame height: TFVs or short-framed valves (SFVs). The primary endpoint was the 4-year incidence of major adverse cardiovascular events, defined as the composite of cardiovascular death, myocardial infarction, or stroke. Cumulative event rates were estimated using Kaplan-Meier method, and weighted Cox regression models using an entropy balance approach were used to adjust for imbalances in clinical and procedural confounders. RESULTS:The analysis included 441 patients, with 230 having undergone TAVR with SFVs (30.9% women) and 211 with TFVs (44.1% women). The median follow-up after PCI was 908 days (Q1-Q3: 322-1,728 days). The 4-year incidence of major adverse cardiovascular events was comparable between the SFV and TFV groups (38.1% [95% CI: 24.6%-43.9%] vs 31.9% [95% CI: 24.8%-41.0%]; HR: 1.04; 95% CI: 0.71-1.52; P = 0.846). Similar findings were observed after adjustment for potential confounders. CONCLUSIONS:In current practice, long-term outcomes after PCI in TAVR patients do not appear to be significantly different between those receiving SFVs and TFVs. Future investigations with newer generation valves and refined implantation techniques are needed to clarify these associations and optimize management strategies.

BACKGROUND:Bleeding and stroke are frequent complications after transcatheter aortic valve implantation (TAVI). The mortality risk associated with these events has been reported before, but data regarding their impact on health-related quality of life (QoL) is limited. AIM:To evaluate the impact of bleeding and stroke occurring within 30 days after TAVI, on mortality and QoL during the first year after TAVI. METHODS:POPular TAVI was a randomized clinical trial that evaluated the addition of clopidogrel to aspirin or oral anticoagulation in patients undergoing TAVI. Besides clinical outcomes, QoL was assessed using the Short Form-12 and EuroQoL Five Dimensions questionnaires before, and at 3, 6, and 12 months after TAVI. RESULTS:Major or life-threatening bleeding occurred in 81 patients (8.3%) and was associated with an increased risk of death (hazard ratio [HR] 1.95 [95% confidence interval (CI) 1.00-3.79]); minor bleeding occurred in 104 patients (10.6%) and was not associated with mortality (HR 0.75 [95% CI 0.30-1.89]). Stroke occurred in 35 patients (3.6%) and was associated with an increased risk of death (HR 2.90 [95% CI 1.23-6.83]). Mean mental component summary (MCS-12) scores over time were lower in patients with major or life-threatening bleeding (p = 0.01), and similar in patients with minor bleeding, compared to patients without bleeding; mean physical component summary (PCS-12) scores, EQ-5D index, and visual analog scale (VAS) were similar between those patients. Mean MCS-12 scores were lower in patients with stroke (p = 0.01), mean PCS-12, EQ-5D index, and VAS were similar compared to patients without stroke. CONCLUSION:Major or life-threatening bleeding and stroke were associated with an increased risk of death and decreased mental QoL in the first year after TAVI.

BACKGROUND Stroke and bleeding are complications after transcatheter aortic valve replacement (TAVR). A higher incidence of bleeding and stroke has been reported in women, but the role of antithrombotic management pre-and post-TAVR has not been studied.OBJECTIVES The study sought to compare bleeding and ischemic complications after TAVR between women and men stratified by antiplatelet and oral anticoagulant (OAC) regimen.METHODS The POPular TAVI (Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation) trial was a randomized clinical trial to test the hypothesis that monotherapy with aspirin or OAC after TAVR is safer than the addition of clopidogrel. The primary endpoints of interest of this post hoc subanalysis were: 1) all bleeding; and 2) a composite of ischemic events consisting of stroke and myocardial infarction. Secondary endpoints were: 1) nonprocedural bleeding; 2) major or life-threatening bleeding; 3) minor bleeding; 4) stroke; 5) myocardial infarction; and 6) all-cause death.RESULTS A total of 978 patients (466 [47.6%] women) were included in this study. All bleeding and the composite of myocardial infarction and stroke rates were similar between sexes (all bleeding: 106 [22.8%] women vs 121 [23.6%] men; P = 0.815; ischemic events: 26 [5.6%] vs 36 [7.0%]; P = 0.429). However, major or life-threatening bleeding occurred more often in women (58 [12.5%]) vs men (38 [7.4%]) (P = 0.011), most of which were access site bleedings. The use of aspirin pre-and post-TAVR increased major or life-threatening bleeding in women but not in men.CONCLUSIONS After TAVR, overall bleeding and ischemic outcomes were similar between women and men. However, women had more major or life-threatening bleedings, especially those receiving aspirin pre-and post-TAVR. (J Am Coll Cardiol Intv 2023;16:1095-1102) & COPY; 2023 by the American College of Cardiology Foundation.

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

OBJECTIVES The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI. (J Am Coll Cardiol Intv 2023;16:2004-2017) (c) 2023 by the American College of Cardiology Foundation.

Background: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. Methods: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. Results: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1–4, 4.1% [2.8–6.3%], 3.7% [2.6–5.3%], 3.3% [2.4–4.9%], 2.9% [2.2–4.3%]; P <0.001) and more moderate or heavy valve calcification (Q1–4, 80%, 80%, 82%, 88%; P =0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1–4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P =0.023) and early safety (Q1–4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P <0.001), with fewer permanent pacemaker implantations (Q1–4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P =0.023) and residual mild or greater paravalvular leaks (Q1–4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P <0.001). Conclusions: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Abstract Background Myocardial injury is frequently observed in patients undergoing transcatheter aortic valve implantation (TAVI) and has been linked to worse prognosis [1,2]. Yet, knowledge concerning the underlying mechanisms and preventive strategies is scarce. Purpose To identify clinical determinants and the effect of periprocedural antithrombotic strategies on markers of myocardial injury after TAVI. Methods The POPular TAVI trial was a prospective, open label, multicentre randomized controlled trial, investigating the addition of clopidogrel to aspirin (cohort A) or oral anticoagulation (OAC) (cohort B) in patients undergoing TAVI [3] Patients randomised to clopidogrel received a 300mg loading dose before TAVI, followed by a 75mg maintenance dose once daily. In patients using OAC, this was continued during TAVI with an international normalized ratio aimed at 2.0. All OAC patients used a vitamin-K antagonist. Blood samples were taken at baseline, 6, 24, 48, and 72 hours following TAVI to determine myocardial injury using Creatine Kinase-MB (CK-MB) and high-sensitive cardiac troponin T (hs-cTnT) according to the VARC-2 criteria. Also, baseline and procedural variables were collected in detail. A linear mixed effects model was used for pair-wise analysis of the changes in enzyme levels at different time points between groups. Regression analysis was performed using the logistic regression model. Statistical analyses were performed using R (version 3.4.1). Results In total, 131 patients undergoing transfemoral TAVI were included at two study sites, of whom 63 (48%) received clopidogrel and 68 (52%) did not. Almost half of the patients (45%) were on OAC. The rise in CK-MB (mean peak 23.4±13.3 U/l) and hs-cTnT (mean peak of 0.23±0.33 ug/) was maximal at 6 and 24 hours, respectively. The CK-MB and hs-cTnT levels did not differ between the clopidogrel and no clopidogrel group at any time point (figure 1). Myocardial injury occurred in 18 (30.1%) patients receiving OAC versus 39 (54.2%) patients not receiving OAC (p=0.007). The course of hs-cTnT reached higher levels in patients with chronic kidney disease (p<0.001) and in patients with a preserved left ventricular ejection fraction (LVEF) (p=0.008). Also, the use of a controlled mechanical expanding prosthesis was associated with a higher rise of hs-cTnT (p=0.007). (Figure 2) In multivariable analysis, predictors of a maximal increase in hs-cTnT were a preserved LVEF (OR 1.15, 95% CI 1.02–1.30) and chronic kidney disease (OR 1.13, 95% CI 1.01–1.28). Other procedural factors, like balloon dilation and rapid ventricular pacing, were not associated with myocardial injury. Conclusions The addition of clopidogrel to aspirin or OAC during TAVI was not associated with a reduction in myocardial injury. Instead, OAC therapy, as compared to aspirin, was associated with a reduction in rise and fall of hs-cTnT. Also, patients with a preserved LVEF or chronic kidney disease observed higher levels of hs-cTnT. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): ZonMWSt. Antonius Research Fund

Abstract Objectives To assess the diagnostic performance of CT-FFR for the diagnosis of CAD in the work-up for TAVI. Background Work-up for transcatheter aortic valve implantation (TAVI) currently utilizes computed tomography (CT) to evaluate annulus diameter and peripheral vascular access, plus invasive coronary angiography (ICA) to assess significant coronary artery disease (CAD). ICA might partially be redundant with the use of Coronary CT Angiography (CCTA). Prior studies found improvement of the diagnostic accuracy of CCTA by use of CT derived fractional flow reserve (CT-FFR). Methods Consecutive patients with severe symptomatic aortic valve stenosis who underwent TAVI work-up between 2015–2019 were included in this cross-sectional study. All patients underwent CCTA and ICA within 3 months and diagnostic performance of both CCTA and CT-FFR were assessed using ICA as reference. Results Seventy-six of the 338 patients included in the analysis had ≥1 significant coronary stenosis at ICA. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy per-patient were 76.9%, 64.5%, 34.0%, 92.1% and 66.9% for CCTA and 84.6%, 88.3%, 63.2%, 96.0% and 87.6% for CT-FFR. The area under the receiver-operating characteristic-curve significantly differ between CCTA and CT-FFR (0.84 versus 0.90 p=0.02). A CT-FFR guided approach could avoid ICA in 57.1% versus 43.6% using CCTA. Conclusions CT-FFR significantly improves the diagnostic accuracy of CCTA without additional testing and increases the proportion of patients in whom ICA could have been safely avoided It has the potential to be integrated in the current clinical work-up for TAVI for diagnosing stable CAD requiring treatment. Funding Acknowledgement Type of funding sources: None.

BACKGROUND The work-up for transcatheter aortic valve replacement (TAVR) currently uses computed tomography to evaluate the annulus diameter and peripheral vascular access plus invasive coronary angiography (ICA) to assess significant coronary artery disease (CAD). ICA might partially be redundant with the use of coronary computed tomography angiography (CCTA). Prior studies found an improvement of the diagnostic accuracy of CCTA with the use of computed tomography-derived fractional flow reserve (CT-FFR). OBJECTIVES The aim of this study was to assess the diagnostic performance of CT-FFR for the diagnosis of CAD in the work-up for TAVR. METHODS Consecutive patients with severe symptomatic aortic valve stenosis who underwent TAVR work-up between 2015 and 2019 were included in this retrospective cross-sectional study. All patients underwent CCTA and ICA within 3 months, and the diagnostic performance of both CCTA and CT-FFR was assessed using ICA as the reference. RESULTS Seventy-six of the 338 patients included in the analysis had >= 1 significant coronary stenosis on ICA. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy per patient were 76.9%, 64.5%, 34.0%, 92.1%, and 66.9% for CCTA and 84.6%, 88.3%, 63.2%, 96.0%, and 87.6% for CT-FFR. The area under the receiver-operating characteristic curve was significantly different between CCTA and CT-FFR (0.84 vs 0.90, P = 0.02). A CT-FFR-guided approach could avoid ICA in 57.1% versus 43.6% of patients using CCTA. CONCLUSIONS CT-FFR significantly improves the diagnostic accuracy of CCTA without additional testing and increases the proportion of patients in whom ICA could have been safely avoided. It has the potential to be integrated in the current clinical work-up for TAVR for diagnosing stable CAD requiring treatment. (C) 2022 by the American College of Cardiology Foundation.

Background In patients undergoing transcatheter aortic valve implantation without an indication for oral anticoagulation, it is unclear whether single or dual antiplatelet therapy (DAPT) is necessary to minimize both the bleeding and thromboembolic risk. In this patient‐level meta‐analysis, we further investigate the effect of aspirin alone compared with DAPT for preventing both thromboembolic and bleeding events after transcatheter aortic valve implantation. Methods and Results We conducted a systematic review of all available randomized controlled trials comparing aspirin with DAPT. In total, 1086 patients were included across 4 eligible trials. The primary outcomes were the composite of all‐cause mortality, major or life‐threatening bleeding, stroke or myocardial infarction (first composite outcome), and the same composite excluding bleeding (second composite outcome), both tested at 30 days and 3 months. The first composite outcome occurred significantly less in the aspirin‐alone group at 30 days (10.3% versus 14.7%, odds ratio [OR], 0.67; 95% CI, 0.46–0.97, P=0.034) and 3 months (11.0% versus 16.5%, hazard ratio [HR], 0.66; 95% CI, 0.47–0.94, P=0.02), compared with the DAPT group. The second composite outcome occurred in 5.5% and 6.6% at 30 days (OR, 0.83; 95% CI, 0.50–1.38, P=0.47) and in 6.9% and 8.5% at 3 months in the aspirin‐alone group compared with the DAPT group (HR, 0.82; 95% CI, 0.52–1.29, P=0.39), respectively. Conclusions In patients without an indication for oral anticoagulation undergoing transcatheter aortic valve implantation, aspirin alone significantly reduced the composite of thromboembolic and bleeding events, and does not increase the composite of thromboembolic events after transcatheter aortic valve implantation, compared with DAPT.

Objectives We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. Background Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). Methods This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. Results In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (<= 35%) increased mortality in all approaches. Conclusions The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

Background Outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) might be improved through better transcatheter heart valve (THV) sizing and positioning. Patient-specific computer simulation may be used to identify an optimal THV size and implant depth that minimizes paravalvular regurgitation. We sought to examine whether the usage of optimal THV sizing and positioning would be associated with improved clinical outcomes. Methods A multi-center retrospective study was performed on patients who had undergone TAVR in BAV. Finite element models of the aortic root were created and then finite element analysis was performed using different THV sizes and implant depths. Computational fluid dynamics was undertaken. Patients were classified as having optimal THV sizing and positioning if the predicted paravalvular regurgitation of the computer simulation corresponding to the implanted THV size and implant depth was within 5 mL/sec of the best possible computer simulation, and non-optimal if not. Clinical outcomes were compared between the two patient groups. Results A total of 50 patients were included in the study. Paravalvular regurgitation severity was higher in patients where non-optimal THV sizing and positioning was used (P < 0.001). At 2 years, the Kaplan-Meier estimate of the rate of death from any cause was higher in the group where non-optimal THV sizing and positioning was used (34.5% vs. 9.1%; hazard ratio, 6.23; 95% confidence interval, 1.04 to 37.44; P = 0.02 by log-rank test). Conclusion Computer simulation suggests that the usage of optimal THV sizing and positioning might improve clinical outcomes of TAVR in BAV.