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An abstract of the article "Left main disease and postprocedural TIMI 3, but not TIMI 2, coronary blood flow predict survival in patients with cardiogenic shock complicating acute myocardial infarction," by A. Garcia-Alvarez and colleagues is presented.

Recurrent tricuspid regurgitation (TR) following transcatheter edge-to-edge repair (TEER) has not been thoroughly investigated. We aimed to examine the predictive factors and mid-term outcomes of recurrent TR following successful TEER. Procedural success was defined as the reduction of TR grade to ≤2+, assessed at discharge. Recurrence of TR was defined as TR grade 3+ or worse at one year after initially successful TEER. The primary endpoint of this study was the composite of all-cause mortality and heart failure (HF) hospitalization at 2 years-follow up. Among 163 T-TEER patients with a reduction in TR to ≤2+, 37 patients developed recurrent TR within the first 12 months (76% females, mean age 75.5 ± 8.3 years). Fractional area change (odds ratio, 1.05; P=0.013), residual TR2+ (odds ratio, 5.08; P=0.002) and primary TR etiology (odds ratio, 3.45, P=0.043) were independent predictors of recurrent TR. Over a median follow-up of 18.4 months, the primary endpoint occurred in 11 (13.5%) and 17 (20.7%) of patients in the non-recurrent and recurrent TR groups, respectively, with a hazard ratio of 2.39 (1.09-5.26, P=0.030). In the survival analysis, there was a strong tendency toward higher rates of freedom from the primary endpoint in non-recurrent TR patients (84.5% vs. 73.2%; P=0.066), mainly driven by lower rates of HF hospitalization (79.8% vs. 65.2%; log-rank P=0.048) compared to patients with recurrent TR. In conclusion, recurrent TR was associated with worse outcomes. Right ventricular fractional area change, residual TR and primary TR were independent predictors for recurrent TR., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Julio Echarte reports a relationship with FIC-CSC that includes: funding grants. Xavier Freixa reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Xavier Freixa reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Vanessa Monivas reports a relationship with Abbott Vascular Inc that includes: speaking and lecture fees. Dabit Arzamendi reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Dabit Arzamendi reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Luis Nombela reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Fernando Carrasco reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Ignacio Cruz reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Ignacio Cruz reports a relationship with Boston Scientific Corporation that includes: consulting or advisory. Ignacio Cruz reports a relationship with Lifetech that includes: consulting or advisory. Laura Sanchis reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Laura Sanchis reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Chi Hion Li reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Chi Hion Li reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Isaac Pascual reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Manuel Barreiro reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Manuel Barreiro reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Mannuel Barreiro reports a relationship with Jenscare Scientific Co Ltd that includes: consulting or advisory. Manuel Barreiro reports a relationship with Venustech Group Inc that includes: consulting or advisory. Rodrigo Estevez reports a relationship with Abbott Laboratories that includes: consulting or advisory. Rodrigo Estevez reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Rodrigo Estevez reports a relationship with Venus Medtech that includes: consulting or advisory. Rodrigo Estevez reports a relationship with Jenscare Scientific Co Ltd that includes: consulting or advisory. Rodrigo Estevez reports a relationship with Boston Scientific Corporation that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025. Published by Elsevier Inc.)

Introduction and Objectives: This study aimed to assess the effectiveness and clinical outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with cardiac implantable electronic devices (CIEDs)., Methods: This subanalysis of the Transcatheter Tricuspid Valve Repair in Spain (TRI-SPA) registry included patients with at least severe tricuspid regurgitation (TR) who were treated with T-TEER between June 2020 and May 2023 in Spain. Patients with CIEDs and no or mild tricuspid lead-leaflet interaction were compared with those without CIEDs. The primary composite endpoint was all-cause mortality, heart failure-related hospitalization, and tricuspid valve reintervention at 12 months., Results: Among 310 patients (mean age 75.5 ± 9.1 years, 70% female) with significant TR treated with T-TEER, 35 (11%) had CIEDs. Device implantation success was high in both groups (97.1% in the CIED group vs 96.4% in the non-CIED group, P = .81), with a similar rate of ≤ 2+ residual TR (84.9% in the CIED group vs 91.0% in the non-CIED group, P = .26). Patients with CIEDs experienced comparable rates of the primary composite endpoint to the non-CIED group (23.8% vs 19.1%, respectively, HR, 1.40; 95%CI, 0.60-3.31; P = .44), sustained successful TR reduction (≤ 2+ in 55.0% vs 73.8%, P = .07), and functional improvement (NYHA class I/II 81.8% vs 79.9%, P = .79)., Conclusions: In a real-world setting, T-TEER seems to be an effective therapeutic option for selected patients with more than moderate TR and CIEDs with no or mild lead-leaflet interaction, offering comparable cardiovascular outcomes and clinical improvement to those without leads. However, the presence of CIEDs may represent an independent risk factor for TR recurrence., (Copyright © 2025. Published by Elsevier España, S.L.U.)

Background: Significant tricuspid regurgitation (TR) is associated with increased morbidity and mortality. The development of transcatheter valve repair therapies has opened a wide range of opportunities for treatment of patients with high surgical risk. Real-world data might improve patient selection and outcome. The authors sought to investigate acute and short-term cardiovascular outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with dedicated devices in a real-world setting., Methods and Results: This is a retrospective, single-arm, multicenter registry conducted at 15 sites in Spain. The primary end point was a composite of all-cause death, rehospitalization for heart failure, and tricuspid valve re-intervention. Patients included (n=283) were older (76±9 years, 70% female), and showed significant comorbidities. Massive or torrential TR was present in 55% of subjects, with secondary cause being the main mechanism of regurgitation in ≈80% of individuals. Intraprocedural success was achieved in 79% of patients. At 1-year follow-up, significant improvements in TR grade (≥3+, 100% to 25%, P <0.001) and New York Heart Association functional class (I/II, 33%-86%, P <0.001) were observed. Lead-induced cause and single leaflet device attachment emerged as independent predictors of at least severe predischarge residual TR. In-hospital mortality occurred in 4 (1.4%) patients, whereas the Kaplan-Meier estimated 1-year primary end point occurrence rate was 21%. Intraprocedural success (hazard ratio, 0.353 [95% CI, 0.156-0.798]; P =0.012), was found to be an independent predictor of primary end point., Conclusions: In a real-world contemporary setting, tricuspid transcatheter edge-to-edge repair with dedicated devices emerged as effective therapeutic option for patients with severe TR.

Aims: To evaluate the association between transcatheter edge-to-edge repair (TEER) and outcomes in patients with significant mitral regurgitation (MR) following acute myocardial infarction (MI), focusing on the aetiology of acute post-MI MR in high-risk surgical patients., Methods and Results: The International Registry of MitraClip in Acute Mitral Regurgitation following Acute Myocardial Infarction (IREMMI) includes 187 patients with severe MR post-MI managed with TEER. Of these, 176 were included in the analysis, 23 (13%) patients had acute papillary muscle rupture (PMR) and 153 (87%) acute secondary MR. The mean age was 70 ± 10 years and 41% were female. PMR patients had fewer cardiovascular risk factors: hypertension (52% vs. 73%, p = 0.04), diabetes (26% vs. 48%, p < 0.01) but a higher left ventricular ejection fraction (45±  15% vs.35±  10%, p < 0.01) compared secondary MR patients. PMR patients were more likely to present in cardiogenic shock (91% vs. 51%, p = 0.001), require mechanical circulatory support (74% vs. 34%, p = 0.01), and had a higher EuroSCORE II (23±  13% vs. 13±  11%, p = 0.011). The median time from MI to TEER was shorter in PMR (6 days) versus secondary MR (20 days) (p < 0.01). Procedural success was similar (87% vs. 92%, p = 0.49) with comparable MR grade reduction. However, PMR patients had significantly higher in-hospital mortality rates (adjusted odds ratio [OR] 3.05, 95% confidence interval [CI] 1.15-8.12, p = 0.02), 30-day mortality rates (unadjusted OR 3.99, 95% CI 1.42-11.26, p = 0.01) and a higher rate of conversion to surgical mitral valve replacement (22% vs. 3%, p < 0.01) (unadjusted OR 8.17, 95% CI 2.15-30.96, p < 0.001). Aetiology of MR, cardiogenic shock, and procedure timing significantly impacted in-hospital mortality. After adjusting for EuroSCORE II and cardiogenic shock, MR aetiology remained the strongest predictor (adjusted OR 6.71; 95% CI 2.06-21.86, p < 0.01)., Conclusion: Transcatheter edge-to-edge repair may be considered a salvage or bridge procedure in decompensated post-MI MR patients of both aetiologies; however, patients with PMR have a higher risk of mortality and conversion to surgery., (© 2025 European Society of Cardiology.)

Introduction and Objectives: In patients undergoing percutaneous coronary intervention (PCI) in the workup pre-transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup., Methods: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated., Results: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiac death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.31; 95%CI, 1.01-1.71; P=.042)., Conclusions: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: There is a large variability in the management of conduction disturbances (CDs) after transcatheter aortic valve replacement (TAVR)., Objective: This study aimed to validate a prespecified algorithm for managing CDs in patients undergoing TAVR., Methods: This was a prospective multicenter study including consecutive patients without prior pacemaker undergoing TAVR. Patients were stratified in different groups according to the presence of prior right bundle branch block (RBBB) and the occurrence of CDs during the procedure: no prior RBBB and no CDs (group NCD), prior RBBB and no CDs (group RBBB-NCD), and occurrence of CDs (group CD). A management algorithm was prespecified for each group. Permanent pacemaker (PPM) and mortality (overall, sudden cardiac death) at 30 days were the primary end points., Results: A total of 2110 TAVR recipients were included. Patients were distributed in NCD (32.0%), RBBB-NCD (5.1%), and CD (62.9%) groups. A total of 329 patients (15.6%) received a PPM at 30 days, with a PPM rate of 5.5%, 15.9%, and 20.7% in the NCD, RBBB-NCD, and CD groups, respectively (P < .001). The PPM rate was 17.4% and 57.2% in patients with procedural new-onset left bundle branch block and high-degree atrioventricular block/complete heart block, respectively. There were no differences in 30-day all-cause mortality and sudden cardiac death between groups (NCD group, 1.2% and 0.2%; RBBB-NCD group, 0% and 0%; CD group, 0.7% and 0.1%; P = .45 and P = .99 for all-cause mortality and sudden cardiac death, respectively)., Conclusion: A prespecified strategy for the management of CDs in contemporary TAVR recipients was feasible and safe, with no increased mortality and an extremely low rate of sudden cardiac death in patients with CDs. However, PPM rates remained high, and continued efforts for preventing the occurrence of CDs are warranted., Competing Interests: Disclosures Dr Rodés-Cabau has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic. Dr Nombela-Franco is proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr Regueiro is proctor for Meril and Abbott and consultant for Edwards Lifesciences. Dr Nazif is consultant for Medtronic, Boston Scientific, Teleflex, and EnCompass. Dr Ribeiro is proctor for Boston Scientific, Edwards Lifesciences, and Medtronic, and has received research grants from Medtronic. The other authors have no conflicts of interest to report with respect to the content of this article., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Procedural success following tricuspid transcatheter edge-to-edge repair (TEER) has been defined variably over time; however, the consequences of achieving a tricuspid regurgitation (TR) grade of 0/1+ are still unclear., Objectives: This study aimed to assess the predictors and prognostic impact of achieving TR 0/1+ after TEER and its role in clinical events., Methods: This multicenter registry included patients undergoing tricuspid TEER in 15 Spanish centers from June 2020 and May 2023. Patients were categorized into the following groups based on the TR grade after procedure: optimal (0/1+), acceptable (2+), and not acceptable (≥3+). The primary endpoint was the 1-year composite of all-cause death, heart failure hospitalization, and tricuspid reintervention. Secondary endpoints included each component of the primary endpoint assessed separately, NYHA functional class, and TR grade at follow-up., Results: Among 280 enrolled patients, 120 (42.9%) had residual TR 0/1+, 111 (39.6%) had residual TR 2+, and 49 (17.5%) had residual TR ≥3+. Patients with TR 0/1+ experienced lower rates of the primary endpoint (13% vs 20% vs 31%; log-rank P = 0.036). Residual TR ≥3+ was an independent predictor of primary endpoint (HR: 2.277; P = 0.044). Higher rates of NYHA functional class I or II and sustained TR reduction were seen in the TR 0/1+ group (P < 0.001 for both). A small coaptation gap and absence of septal leaflet tethering were independent predictors of achieving TR 0/1+., Conclusions: An optimal procedural result after TEER might be associated with improved outcomes. TR coaptation gap and leaflet restriction may aid in assessing suitability for TEER., Competing Interests: Funding Support and Author Disclosures Dr Echarte-Morales was supported by FIC-CSC through an educational grant. Dr Manuel Barreiro-Perez is proctor for Abbott Vascular, Edwards Lifesciences and Venus Medtech. Dr Rodrigo Estevez-Loureiro is a consultant and proctor for Abbott Vascular, Edwards Lifesciences, Boston Scientific and Venus Medtech. Dr Dabit Arzamendi is a consultant and proctor for Abbott Vascular and Edwards Lifesciences. Dr Xavier Freixa is a consultant and proctor for Abbott Vascular and Edwards Lifesciences. Dr Luis Nombela-Franco is a consultant and proctor for Abbott Vascular. Dr Ignacio Cruz-González is proctor for Abbott Vascular. Dr Fernando Carrasco-Chinchilla is proctor for Abbott Vascular. Dr Laura Sanchis is proctor for Abbott Vascular. Dr Ignacio J. Amat-Santos is consultant and proctor for P&F. Dr Ángel Sanchez-Recalde is proctor for P&F. Dr Chi Hion Li is proctor for Abbott Vascular and Edwards Lifesciences. Dr Isaac Pascual is proctor for Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: The optimal antithrombotic therapy (AT) after left atrial appendage closure (LAAC) is debated. We assessed the impact of intensive vs nonintensive AT on the incidence of device-related thrombus (DRT) based on whether the device implantation was classified as optimal or suboptimal., Methods: This study included patients who underwent successful LAAC in 9 centers. Patients were classified according to the quality of device implantation: optimal (proximal implant without ≥3mm peridevice leak) or suboptimal (distal implant and/or ≥3mm peridevice leak). Postimplant AT was classified as either intensive (dual antiplatelet therapy, anticoagulants, or a combination of both) or nonintensive (no AT or a single antiplatelet therapy). The primary endpoint was the incidence of DRT between the 6th and 12th weeks postprocedure., Results: A total of 1225 patients underwent LAAC, with 757 (61.8%) achieving optimal device implantation and 468 (38.2%) classified as suboptimal. After a median follow-up of 20 months, the incidence of DRT in the optimal implant group was 2.6% with intensive AT and 3.7% with nonintensive AT (P=.38). In the suboptimal implant group, the incidence of DRT increased to 11.2% with intensive AT and 15.5% with nonintensive AT (P=.19). On multivariate analysis, suboptimal implantation (HR, 4.51; 95%CI, 2.70-7.54, P<.001) but not intensive AT (HR, 0,66; 95%CI, 0.40-1.07, P=.09) emerged as an independent predictor of DRT., Conclusions: The incidence of DRT after LAAC was higher in patients with suboptimal device implantation. In patients with optimal implantation, the incidence of DRT was low and similar between nonintensive and intensive AT strategies. Large, randomized trials are warranted to confirm these results., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear., Objectives: This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort., Methods: The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality., Results: The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality., Conclusions: PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics., Competing Interests: Funding Support and Author Disclosures This work was supported by the Deutsche Forschungsgemeinschaft (397484323) to Drs Guthoff, Matti Adam and Stephan Baldus, and Mauri; PA 2409/5-2 to Drs Thurow and Pauly; the Dean’s Office, Faculty of Medicine, University of Cologne (clinician scientist position) to Dr Guthoff; and the Center for Molecular Medicine Cologne (Baldus B-02) to Dr Stephan Baldus. Dr Abdel-Wahab’s institution has received speaker honoraria and/or consultancy fees from Abbott, Boston Scientific, and Medtronic. Dr Kim has received proctor and personal fees from Abbott, Boston Scientific, Meril Life Sciences, and Shockwave Med; is a member of the advisory boards for Abbott, Boston Scientific, and HID Imaging; and Dr Kim’s institution has received fees from Boston Scientific. Dr Nombela-Franco has served as proctor for Abbott and Edwards Lifesciences. Dr Matjaz Bunc served as proctor for TAVR procedures with Edwards Lifesciences, Medtronic, Meril, and Abbott. Matjaz Bunc is a member of the advisory boards for Medtronic and Edwards Lifesciences. Dr Veulemans has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Tanja Rudolph has received lecture fees from Abbott, SIS Medical and Translumina. Dr Zeus has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: This article presents the 2023 activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC)., Methods: All interventional cardiology laboratories in Spain were invited to participate in an online survey. Data analysis was carried out by an external company and subsequently reviewed and presented by the members of the ACI-SEC board., Results: A total of 119 hospitals participated. The number of diagnostic studies decreased by 1.8%, while the number of percutaneous coronary interventions (PCI) showed a slight increase. There was a reduction in the number of stents used and an increase in the use of drug-coated balloons. The use of intracoronary diagnostic techniques remained stable. For the first time, data on PCI guided by intracoronary imaging was reported, showing a 10% usage rate in Spain. Techniques for plaque modification continued to grow. Primary PCI increased, becoming the predominant treatment for myocardial infarction (97%). Noncoronary structural procedures continued their upward trend. Notably, the number of left atrial appendage closures, patent foramen ovale closures, and tricuspid valve interventions grew in 2023. There was also a significant increase in interventions for acute pulmonary embolism., Conclusions: The 2023 Spanish cardiac catheterization and coronary intervention registry indicates a stabilization in coronary interventions, together with an increase in complexity. There was consistent growth in procedures for both valvular and nonvalvular structural heart diseases., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objectives : Mitral regurgitation (MR) is the second most common valve disease in Europe, and differences between men and women have been described in relation to aetiology or management, which might impact the decision for intervention and patients' clinical and economic outcomes. Thus, the objective was to analyse the burden of MR in Spain by aetiology and sex, and the management of all patients suffering from MR being admitted to hospital between 2016-2021. Methods : An analysis was carried out with the Ministry of Health's database, including all patients in public and subsidised hospitals and defining two groups, general MR and those patients undergoing Transcatheter Edge-to-Edge repair (TEER), using a descriptive analysis of patients' characteristics, use of resources, and outcomes; standardised rates were calculated and observed outcomes were described. Results : Hospital admissions increased from 2016 ( n = 32,806) to 2021 (total n = 61,036). In general, the women were older and presented more complications. The majority of patients suffered from degenerative MR (DMR) ( n = 183,005, 59.55%), and 61.56% were women, contrary to functional MR (FMR) ( n = 124,278), which consisted of 62.15% males. In total, 1,689 TEERs were performed, 23.33% of them in urgent admissions, and mostly in men (65.66%). All groups showed higher rates of intervention for males. Regarding costs, women presented lower mean costs in the general MR groups but those undergoing TEER presented, in all cases, costs higher than men. Conclusions : MR entails a significant burden for patients and the Spanish healthcare system, increasing over the period of study. Differences in aetiologies by sex have been found in patients' characteristics as well as outcomes. Further studies are needed to optimise patients' management and their outcomes in relation to sex and aetiology.

Importance: Optimal antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is not well established as no randomized evaluation has been performed to date., Objective: To compare the efficacy and safety of low-dose direct oral anticoagulation (low-dose DOAC) vs dual antiplatelet therapy (DAPT) for 3 months after LAAO., Design, Setting, and Participants: The ADALA (Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion) study was an investigator-initiated, multicenter, prospective, open-label, randomized clinical trial enrolling participants from June 12, 2019, to August 28, 2022 from 3 European sites. Patients who underwent successful LAAO were randomly assigned 1:1 to low-dose DOAC vs DAPT for 3 months after LAAO. The study was prematurely terminated when only 60% of the estimated sample size had been included due to lower recruitment rate than anticipated due to the COVID-19 pandemic., Interventions: The low-dose DOAC group received apixaban, 2.5 mg every 12 hours, and the DAPT group received aspirin, 100 mg per day, plus clopidogrel, 75 mg per day, for the first 3 months after LAAO., Main Outcomes and Measures: The primary end point was a composite of safety (major bleeding) and efficacy (thromboembolic events including stroke, systemic embolism, and device-related thrombosis [DRT]) within the first 3 months after successful LAAO. Secondary end points included individual components of the primary outcome and all-bleeding events., Results: A total of 90 patients (mean [SD] age, 76.6 [8.1] years; 60 male [66.7%]; mean [SD] CHADS-VASc score, 4.0 [1.5]) were included in the analysis (44 and 46 patients in the low-dose DOAC and DAPT groups, respectively). A total of 53 patients (58.8%) presented with previous major bleeding events (60 gastrointestinal [66.7%] and 16 intracranial [17.8%]). At 3 months, low-dose DOAC was associated with a reduction of the primary end point compared with DAPT (2 [4.5%] vs 10 [21.7%]; hazard ratio, 0.19; 95% CI, 0.04-0.88; P = .02). Patients in the low-dose DOAC group exhibited a lower rate of DRT (0% vs 6 [8.7%]; P = .04) and tended to have a lower incidence of major bleeding events (2 [4.6%] vs 6 [13.0%]; P = .17), with no differences in thromboembolic events such as stroke and systemic embolism between groups (none in the overall population)., Conclusions and Relevance: This was a small, randomized clinical trial comparing different antithrombotic strategies after LAAO. Results show that use of low-dose DOAC for 3 months after LAAO was associated with a better balance between efficacy and safety compared with DAPT. However, the results of the study should be interpreted with caution due to the limited sample size and will need to be confirmed in future larger randomized trials., Trial Registration: ClinicalTrials.gov Identifier: NCT05632445.

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT., Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT., Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score., Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group)., Main Outcomes and Measures: The primary outcome was time to first ischemic stroke., Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy., Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.