Left atrial appendage closure guided by fusion of 3D computational modelling on real-time fluoroscopy: A multicenter experience.

BACKGROUND: Patient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported. OBJECTIVES: To assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective. METHODS: We included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization. RESULTS: A total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device SINGLE-deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired. CONCLUSIONS: Fusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.

Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. Methods: Multicenter study including 10,449 patients undergoing TAVR. Based on consensus, twenty-one clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to VARC-HBR definition. The primary endpoint was the rate of BARC type 3 or 5 bleeding at 1 year, defined as the composite of peri-procedural (within 30 days) or late (after 30 days) bleeding. Results: Patients with at least one VARC-HBR criterion (n=9,267, 88.7%) had a higher risk of BARC 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under ROC curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very high-risk groups (HR: 1.33, 95% CI: 1.04-1.70; and HR: 1.97, 95% CI: 1.53-2.53, respectively). Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in TAVR. The results of the present study would support the predictive validity of the newly definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.

[Same-day discharge for left main artery PCI: how to process?] / L'angioplastie du Tronc commun gauche en ambulatoire : Comment s'y prendre ?

The steady development of same-day discharge (SDD) PCIs in recent years means that, by 2024, we will be able to tackle increasingly complex lesions, including those of the left main artery. This strategy is supported by the literature, but requires an appropriate patient selection (based on medical and social criteria) and precise assessment of the anatomical complexity of the lesion and the foreseeable risks of the PCI. Strict adherence to pre-established service protocols for patient preparation and follow-up, as well as the establishment of clinical and paraclinical criteria for discharge to a conventional hospital unit, are essential to the success of an SDD PCI program.

Outcomes of patients with active cancer after transcatheter aortic valve replacement: an updated meta-analysis.

BACKGROUND: Patients with active cancer and aortic stenosis may be under-referred for valve interventions due to concerns over a prohibitive risk. However, whether active cancer impacts outcomes after transcatheter aortic valve replacement (TAVR) remains unknown. METHODS: We searched PubMed, Embase, and Cochrane Library in December 2023 for studies comparing the post-TAVR outcomes of patients with versus without active cancer. We pooled odds ratios (OR) and adjusted hazard ratios (aHR) with 95% confidence intervals (CI) applying a random-effects model. Statistical analyses were performed in R version 4.3.2. RESULTS: We included nine observational studies analyzing 133,906 patients, of whom 9,792 (7.3%) had active cancer. Compared with patients without cancer, patients with active cancer had higher short- (OR 1.33; 95% CI 1.15-1.55; p < 0.001) and long-term mortality (OR 2.29; 95% CI 1.80-2.91; p < 0.001) rates, not driven by cardiovascular mortality (OR 1.30; 95% CI 0.70-2.40; p = 0.40), and higher major bleeding rates (OR 1.66; 95% CI 1.15-2.42; p = 0.008). The higher mortality rate was sustained in an adjusted analysis (aHR 1.77; 95% CI 1.34-2.35; p < 0.001). There was no significant difference in cardiac, renal, and cerebral complications at a follow-up ranging from 180 days to 10 years. CONCLUSION: Patients with active cancer undergoing TAVR had higher non-cardiovascular mortality and bleeding rates, with comparable incidences of other complications. This highlights the need for a shared decision and appropriate patient selection considering cancer type, staging, bleeding risk, and optimal timing for intervention.

Left Atrial Appendage Closure Compared With Oral Anticoagulants for Patients With Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long-term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation. METHODS AND RESULTS: Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta-analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62-1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71-1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61-1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58-1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all-cause death  compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53-0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85-0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%). CONCLUSIONS: As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.

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

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

Position Statement on Cardiac Computed Tomography Following Left Atrial Appendage Occlusion.

Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists.

Aortic Valve-in-Valve Procedures: Challenges and Future Directions.

Aortic valve-in-valve (ViV) procedures are increasingly performed for the treatment of surgical bioprosthetic valve failure in patients at intermediate to high surgical risk. Although ViV procedures offer indisputable benefits in terms of procedural time, in-hospital length of stay, and avoidance of surgical complications, they also present unique challenges. Growing awareness of the technical difficulties and potential threats associated with ViV procedures mandates careful preprocedural planning. This review article offers an overview of the current state-of-the-art ViV procedures, with focus on patient and device selection, procedural planning, potential complications, and long-term outcomes. Finally, it discusses current research efforts and future directions aimed at improving ViV procedural success and patient outcomes.

Artificial intelligence-based fully automated stress left ventricular ejection fraction as a prognostic marker in patients undergoing stress cardiovascular magnetic resonance.

AIMS: This study aimed to determine in patients undergoing stress cardiovascular magnetic resonance (CMR) whether fully automated stress artificial intelligence (AI)-based left ventricular ejection fraction (LVEFAI) can provide incremental prognostic value to predict death above traditional prognosticators. METHODS AND RESULTS: Between 2016 and 2018, we conducted a longitudinal study that included all consecutive patients referred for vasodilator stress CMR. LVEFAI was assessed using AI algorithm combines multiple deep learning networks for LV segmentation. The primary outcome was all-cause death assessed using the French National Registry of Death. Cox regression was used to evaluate the association of stress LVEFAI with death after adjustment for traditional risk factors and CMR findings. In 9712 patients (66 ± 15 years, 67% men), there was an excellent correlation between stress LVEFAI and LVEF measured by expert (LVEFexpert) (r = 0.94, P < 0.001). Stress LVEFAI was associated with death [median (interquartile range) follow-up 4.5 (3.7-5.2) years] before and after adjustment for risk factors [adjusted hazard ratio, 0.84 (95% confidence interval, 0.82-0.87) per 5% increment, P < 0.001]. Stress LVEFAI had similar significant association with death occurrence compared with LVEFexpert. After adjustment, stress LVEFAI value showed the greatest improvement in model discrimination and reclassification over and above traditional risk factors and stress CMR findings (C-statistic improvement: 0.11; net reclassification improvement = 0.250; integrative discrimination index = 0.049, all P < 0.001; likelihood-ratio test P < 0.001), with an incremental prognostic value over LVEFAI determined at rest. CONCLUSION: AI-based fully automated LVEF measured at stress is independently associated with the occurrence of death in patients undergoing stress CMR, with an additional prognostic value above traditional risk factors, inducible ischaemia and late gadolinium enhancement.

Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.

BACKGROUND: For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS-BCS) with 30 days of dual antiplatelet treatment (DAPT). The LEADERS FREE III (LF III) trial investigated clinical outcomes after PCI with the next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients. AIMS: To report the final 3-year results of the LF III trial and compare them to LF II. METHODS: LF III was a prospective, multicentre, open-label single-arm study to evaluate the safety and efficacy of the CoCr-BCS stent. The primary safety endpoint was the composite of cardiac death (CD), myocardial infarction(MI) or definite/probable stent thrombosis (ST). The primary efficacy endpoint was clinically driven target lesion revascularisation (cd-TLR). We performed a propensity-matched comparison to the 3-year outcomes of LF II. RESULTS: After 3 years, CD/MI/ST had occurred in 57 patients (15%, 95% CI 11.8% to 19%) and cd-TLR in 23 (6.2%, 95% CI 4.1% to 9.2%) patients. In a propensity-matched comparison of patients treated with the CoCr-BCS versus the SS-BCS, there were similar rates of CD (6.6% vs 7.8%, p=0.50), MI (7.1% vs 8.3%, p=0.47) and definite/probable ST (1.1% vs 2%, HR 0.56, 95% CI 0.16 to 1.93, p=0.35). The rates of cd-TLR were 5.3% with CoCr-BCS versus 9.8% with SS-BCS (HR 0.54, 95% CI 0.31 to 0.96, p=0.03). CONCLUSION: LF III confirms the long-term safety and efficacy of the CoCr-BCS in HBR patients treated with 1 month of DAPT. TRIAL REGISTRATION NUMBER: NCT02843633, NCT03118895.

Balloon-Expandable Valve for the Treatment of Self-Expanding Valve Failure: The Need for a Tailored Approach.

An 82-year-old patient experienced symptomatic intra-prosthetic aortic regurgitation 5 years after self-expandable transcatheter heart valve (THV) implantation. Redo-transcatheter aortic valve replacement was initially considered at high risk of coronary obstruction. Using a systematic computed tomography-based approach planning a low implantation with a SAPIEN 3 Ultra THV, we effectively mitigated risks.

Characterization and Management of Stable Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.

Case report: three ways to mitigate the risk of embolization during left atrial appendage closure in a patient with a massive and proximal left atrial appendage thrombus.

Background: Left atrial appendage (LAA) thrombus is a contraindication for LAA closure (LAAC). However, in selected cases, oral anticoagulants are strictly contraindicated because of a history of life-threatening bleeding, and LAAC remains the only possible therapy to avoid systemic and especially cerebral embolization. Case summary: We report a case of LAAC despite a massive proximal thrombus in a patient who had an absolute contraindication to anticoagulant therapy, with thorough pre-planning using CT scan, device modelling and thrombus trapping techniques to reduce the risk of systemic embolic events and perform LAAC safely. Discussion: Although LAAC remains at high risk in this setting, the use of cautious techniques and tools, from pre-procedure planning to systemic embolization prevention systems associated to a precise transoesopheageal echocardiography guiding throughout the procedure, allows it to be performed as safely as possible when no other option is available.

Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.

The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..

Transcatheter Aortic Valve Replacement for Sutureless Bioprosthetic Valve Tilting Resulting in Severe Paravalvular Leak.

Severe paravalvular leak (PVL) may be complicated by heart failure and haemolysis. PVL management is challenging, especially when the gap is large. We describe a case of PVL due to tilting of a sutureless biological prosthesis successfully treated by transcatheter aortic valve replacement (TAV-in-SAV).

Feasibility, safety and diagnostic yield of interventional cardiac magnetic resonance for routine right heart catheterization in adults.

BACKGROUND: Real-time cardiac magnetic resonance generates spatially and temporally resolved images of cardiac anatomy and function, without the need for contrast agent or X-ray exposure. Cardiac magnetic resonance-guided right heart catheterization (CMR-RHC) combines the benefits of cardiac magnetic resonance and invasive cardiac catheterization. The clinical adoption of CMR-RHC represents the first step towards the development of cardiac magnetic resonance-guided therapeutic procedures. AIM: To describe the feasibility, safety and diagnostic yield of CMR-RHC in consecutive all-comer patients with clinical indications for right heart catheterization. METHODS: From December 2018 to May 2021, 35 consecutive patients with prespecified indications for right heart catheterization were scheduled for CMR-RHC via the femoral route under local anaesthesia in a 1.5T cardiac magnetic resonance suite equipped for interventional cardiac magnetic resonance. The duration of various procedural components and safety data were recorded. Success rate (defined by the ability to record all prespecified haemodynamic measurements and imaging metrics), adverse events and patient/physician perprocedural comfort were assessed. RESULTS: One patient withdrew his consent before the study, and scanner troubleshooting occurred in one case. Among the 33 remaining patients, prespecified cardiac magnetic resonance imaging metrics were obtained in all patients, whereas full CMR-RHC measurements were obtained in 30 patients (91%). A dedicated cardiac magnetic resonance-compatible wire was used in 25/33 procedures. CMR-RHC was completed in 29±16minutes, and the total duration of the procedure, including conventional cardiac magnetic resonance imaging, was 62±20minutes. There were no adverse events and no femoral haematomas. Procedural comfort was deemed good by the patients and operators for all procedures. CMR-RHC significantly impacted diagnosis or patient management in 28/33 patients (85%). CONCLUSIONS: CMR-RHC seems to be a feasible and safe procedure that can be used in routine daily practice in consecutive adults with an impactful clinical yield.

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

BACKGROUND: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. OBJECTIVES: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. METHODS: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. RESULTS: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). CONCLUSIONS: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry.

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

Left atrial appendage closure in very elderly patients in the French National Registry.

OBJECTIVE: Left atrial appendage closure (LAAC) is recommended to decrease the stroke risk in patients with atrial fibrillation and contraindications to anticoagulation. However, age-stratified data are scarce. The aim of this study was to provide information on the safety and efficacy of LAAC, with emphasis on the oldest patients. METHODS: A nationwide, prospective, multicentre, observational registry was established by 53 French cardiology centres in 2018-2021. The composite primary endpoint included ischaemic stroke, systemic embolism, and unexplained or cardiovascular death. Separate analyses were done in the groups <80 years and ≥80 years. RESULTS: Among the 1053 patients included, median age was 79.7 (73.6-84.3) years; 512 patients (48.6%) were aged ≥80 years. Procedure-related serious adverse events were non-significantly more common in octogenarians (7.0% vs 4.4% in patients aged <80 years, respectively; p=0.07). Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events during the study was similar in both groups (3.0 vs 3.1/100 patient-years; p=0.85). By contrast, all-cause mortality was significantly higher in octogenarians (15.3 vs 10.1/100 patient-years, p<0.015), due to a higher rate of non-cardiovascular deaths (8.2 vs 4.9/100 patient-years, p=0.034). The rate of the primary endpoint was 8.1/100 patient-years overall with no statistically significant difference between age groups (9.4 and 7.0/100 patient-years; p=0.19). CONCLUSION: Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events after LAAC in this age group was similar to that in patients aged <80 years. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03434015).

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.