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INTRODUCTION AND OBJECTIVES: Percutaneous left atrial appendage closure (LAAC) has emerged as a nonpharmacological alternative for thromboembolic event prevention in patients with nonvalvular atrial fibrillation. However, there are few data on readmissions after LACC. The aim of this study was to determine the rate of early (≤ 30 days) and late (31-365 days) readmission after LAAC, and to assess the predictors and clinical impact of rehospitalization. METHODS: This multicenter study included 1419 consecutive patients who underwent LAAC. The median follow-up was 33 [17-55] months, and follow-up was complete in all but 54 (3.8%) patients. The primary endpoint was readmissions for any cause. Logistic regression and Cox regression analysis were performed to determine the predictors of readmission and its clinical impact. RESULTS: A total of 257 (18.1%) patients were readmitted within the first year after LAAC (3.2% early, 14.9% late). The most common causes of readmission were bleeding (24.5%) and heart failure (20.6%). A previous gastrointestinal bleeding event was associated with a higher risk of early readmission (OR, 2.65; 95%CI, 1.23-5.71). The factors associated with a higher risk of late readmission were a lower body mass index (HR, 0.96-95%CI, 0.93-0.99), diabetes (HR, 1.38-95%CI, 1.02-1.86), chronic kidney disease (HR, 1.60; 95%CI, 1.21-2.13), and previous heart failure (HR, 1.69; 95%CI, 1.26-2.27). Both early (HR, 2.12-95%CI, 1.22-3.70) and late (HR, 1.75; 95%CI, 1.41-2.17) readmissions were associated with a higher risk of 2-year mortality. CONCLUSIONS: Readmissions within the first year after LAAC (primary endpoint) were common (18.1%), were mainly related to bleeding and heart failure events, and were associated with the patients' comorbidity burden. Readmission after LAAC confers a higher risk of mortality during the first 2 years after the procedure.
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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.
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BACKGROUND: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited. OBJECTIVES: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned. METHODS: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm). RESULTS: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size. CONCLUSIONS: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies.
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Cateterismo Cardíaco , Ensayos de Uso Compasivo , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Recuperación de la Función , Sistema de Registros , Insuficiencia de la Válvula Tricúspide , Válvula Tricúspide , Humanos , Femenino , Masculino , Estudios Retrospectivos , Anciano , Resultado del Tratamiento , Factores de Tiempo , Anciano de 80 o más Años , Válvula Tricúspide/cirugía , Válvula Tricúspide/fisiopatología , Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/mortalidad , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Factores de Riesgo , Mortalidad Hospitalaria , Complicaciones Posoperatorias/etiología , Venas YugularesRESUMEN
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.
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Apéndice Atrial , Fibrilación Atrial , Cateterismo Cardíaco , Consenso , Valor Predictivo de las Pruebas , Accidente Cerebrovascular , Tomografía Computarizada por Rayos X , Humanos , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/fisiopatología , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/terapia , Fibrilación Atrial/fisiopatología , Resultado del Tratamiento , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/normas , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Factores de Riesgo , Ecocardiografía TransesofágicaRESUMEN
BACKGROUND: Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk. AIMS: This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients. METHODS: This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy). RESULTS: A total of 1,135 patients were included. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049). CONCLUSIONS: In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.
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Apéndice Atrial , Fibrilación Atrial , Fibrinolíticos , Hemorragia , Inhibidores de Agregación Plaquetaria , Humanos , Apéndice Atrial/cirugía , Masculino , Femenino , Anciano , Estudios Retrospectivos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/efectos adversos , Anciano de 80 o más Años , Fibrinolíticos/uso terapéutico , Fibrinolíticos/efectos adversos , Hemorragia/inducido químicamente , Resultado del Tratamiento , Factores de Riesgo , Anticoagulantes/uso terapéutico , Anticoagulantes/efectos adversos , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Medición de Riesgo , Terapia Antiplaquetaria Doble/métodos , Persona de Mediana Edad , Cierre del Apéndice Auricular IzquierdoRESUMEN
BACKGROUND: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly. AIMS: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events. METHODS: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted. RESULTS: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF. CONCLUSIONS: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.
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Fibrilación Atrial , Cateterismo Cardíaco , Foramen Oval Permeable , Humanos , Foramen Oval Permeable/complicaciones , Foramen Oval Permeable/cirugía , Femenino , Masculino , Anciano , Persona de Mediana Edad , Factores de Riesgo , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Resultado del Tratamiento , Fibrilación Atrial/complicaciones , Fibrilación Atrial/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Embolia Paradójica/etiología , Embolia Paradójica/epidemiología , Embolia Paradójica/prevención & control , Dispositivo Oclusor Septal/efectos adversos , Anciano de 80 o más Años , Factores de Edad , IncidenciaRESUMEN
BACKGROUND: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. METHODS AND RESULTS: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC. CONCLUSION: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective.
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Apéndice Atrial , Fibrilación Atrial , Sistema de Registros , Trombosis , Humanos , Femenino , Masculino , Apéndice Atrial/cirugía , Anciano , Trombosis/etiología , Fibrilación Atrial/cirugía , Factores Sexuales , Anticoagulantes/uso terapéutico , Factores de Riesgo , Complicaciones Posoperatorias , Dispositivo Oclusor Septal , Resultado del Tratamiento , Ecocardiografía Transesofágica/métodos , Europa (Continente)/epidemiología , Cierre del Apéndice Auricular IzquierdoRESUMEN
BACKGROUND: Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES: This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS: This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS: A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS: Early nonprocedural bleeding after LAAO occurred in â¼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.
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Apéndice Atrial , Fibrilación Atrial , Cateterismo Cardíaco , Hemorragia , Inhibidores de Agregación Plaquetaria , Humanos , Apéndice Atrial/fisiopatología , Apéndice Atrial/diagnóstico por imagen , Masculino , Femenino , Anciano , Factores de Riesgo , Factores de Tiempo , Fibrilación Atrial/mortalidad , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/complicaciones , Resultado del Tratamiento , Medición de Riesgo , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Hemorragia/etiología , Incidencia , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Terapia Antiplaquetaria Doble/efectos adversos , Estados Unidos/epidemiología , Persona de Mediana Edad , Fibrinolíticos/efectos adversos , Fibrinolíticos/administración & dosificación , Estudios Retrospectivos , Europa (Continente) , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificaciónRESUMEN
BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.
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Apéndice Atrial , Fibrilación Atrial , Cateterismo Cardíaco , Remoción de Dispositivos , Sistema de Registros , Humanos , Masculino , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/fisiopatología , Femenino , Anciano , Estudios Retrospectivos , Resultado del Tratamiento , Factores de Tiempo , Anciano de 80 o más Años , Factores de Riesgo , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Fibrilación Atrial/terapia , Fibrilación Atrial/mortalidad , Remoción de Dispositivos/efectos adversos , Embolia/etiología , Embolia/mortalidad , Persona de Mediana Edad , Dispositivo Oclusor Septal , Cierre del Apéndice Auricular IzquierdoRESUMEN
A simple and reproducible technique to achieve commissural alignment during transcatheter aortic valve replacement with the Allegra valve is described. Slight rotation of the system before system insertion is necessary. Moreover, thanks to its permaflow system (Biosensors) and its radiopaque markings, small adjustments before valve deployment can be made to reassess correct alignment.
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INTRODUCTION AND OBJECTIVES: Advanced chronic kidney disease (A-CKD) combined with atrial fibrillation increases the risk of both thrombogenic and bleeding events. Left atrial appendage occlusion (LAAO) may be an alternative to oral anticoagulation to prevent thromboembolic events. We aimed to evaluate the outcomes of LAAO in patients with A-CKD. METHODS: Comparison at long-term follow-up of patients diagnosed with and without A-CKD (eGFR<30 mL/min/1.73 m2 ) who underwent LAAO between 2009 and May 2022. RESULTS: Five hundred seventy-three patients were included. Eighty-one (14%) were diagnosed with A-CKD. There were no differences in sex, age, and cardiovascular risk factors, except for diabetes which was more frequent in patients with A-CKD. The control group had higher rates of stroke, both ischemic and hemorrhagic. There were no differences in the CHA2 DS2 -VASc score, although A-CKD patients had a higher bleeding risk according to the HASBLED scale. Global procedural success was 99.1%. At follow-up, there were no differences in stroke rate: at 1-year (HR: 1.22, IC-95%: 0.14-10.42, p = 0.861); at 5-years (HR: 0.60, IC-95%: 0.08-4.58, p = 0.594). Although bleeding events were higher in the A-CKD group, no differences were found in major bleeding (defined BARC ≥ 3) at 1-year (HR: 1.34, IC-95%: 0.63-2.88, p = 0.464) or at 5-years follow-up (HR: 1.30, IC-95%: 0.69-2.48, p = 0.434). Mortality rate at 5 years was higher in the A-CKD patients (HR: 1.84, IC-95%: 1.18-2.87, p = 0.012). CONCLUSIONS: LAAO is an effective and safe treatment in A-CKD patients to prevent ischemic events and bleeding. This strategy could be an alternative to oral anticoagulation in this high-risk group of patients.
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Apéndice Atrial , Fibrilación Atrial , Insuficiencia Renal Crónica , Accidente Cerebrovascular , Humanos , Estudios de Seguimiento , Apéndice Atrial/diagnóstico por imagen , Resultado del Tratamiento , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Anticoagulantes/efectos adversosRESUMEN
BACKGROUND: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. OBJECTIVES: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. METHODS: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. RESULTS: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. CONCLUSIONS: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Cateterismo Cardíaco , Estudios de Seguimiento , Estudios Prospectivos , Calidad de Vida , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
BACKGROUND: Left atrial appendage occlusion (LAAO) is a safe and effective alternative to oral anticoagulation for thromboprophylaxis in patients with nonvalvular atrial fibrillation. Technological development in devices and imaging techniques, as well as accumulated experience, have increased procedural success rates and decreased complications. Same-day discharge protocols have been proposed in the field of structural heart disease, but this approach has not been studied in detail for the LAAO procedure. AIM: The aim of this study is to assess the safety and efficacy of an outpatient program for LAAO when compared to the conventional treatment approach. METHODS: We present a retrospective, non-randomized single-center study of 262 consecutive patients undergoing LAAO. Patients were divided into two groups, the first (n = 131) followed a conventional protocol (CP), and the second (n = 131) an outpatient protocol (OP). The primary composite endpoint comprised MACCE (death, stroke, and bleeding), cardiac tamponade, vascular complication, or attendance in the emergency department after hospital discharge at 30 days. RESULTS: The overall success rate was 99.6%, with a periprocedural complication rate of 2.29%. With regards to the CP versus OP group, there were no differences between incidences of the primary composite endpoint (6.1% PC vs. 3.0% PA, p = 0.24), or after an analysis, with propensity score matching. No differences were observed in the individual endpoints. There was a decrease in hospital length of stay in the same-day discharge group (p < 0.01). CONCLUSIONS: A same-day discharge LAAO program is safe, effective, and feasible when compared to the conventional strategy. Moreover, it reduces hospital length of stay, which might have clinical and economic benefits.
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Apéndice Atrial , Fibrilación Atrial , Procedimientos Quirúrgicos Cardíacos , Accidente Cerebrovascular , Humanos , Apéndice Atrial/diagnóstico por imagen , Resultado del Tratamiento , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Cateterismo Cardíaco/efectos adversosRESUMEN
INTRODUCTION AND OBJECTIVES: This article presents the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) for the year 2022. METHODS: All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company in collaboration with the members of the board of the ACI-SEC. RESULTS: A total of 111 centers participated. The number of diagnostic studies increased by 4.8% compared with 2021, while that of percutaneous coronary interventions (PCI) remained stable. PCIs on the left main coronary artery increased by 22%. The radial approach continued to be preferred for PCI (94.9%). There was an upsurge in the use of drug-eluting balloons, as well as in intracoronary imaging techniques, which were used in 14.7% of PCIs. The use of pressure wires also increased (6.3% vs 2021) as did plaque modification techniques. Primary PCI continued to grow and was the most frequent treatment (97%) in ST-segment elevation myocardial infarction. Most noncoronary procedures maintained their upward trend, particularly percutaneous aortic valve implantation, atrial appendage closure, mitral/tricuspid edge-to-edge therapy, renal denervation, and percutaneous treatment of pulmonary arterial disease. CONCLUSIONS: The Spanish cardiac catheterization and coronary intervention registry for 2022 reveals a rise in the complexity of coronary disease, along with a notable growth in procedures for valvular and nonvalvular structural heart disease.
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Cardiología , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Cateterismo Cardíaco , Sistema de RegistrosRESUMEN
BACKGROUND: Device-related thrombus (DRT) remains one of the main concerns after left atrial appendage occlusion (LAAO). Several risk factors have been proposed, but most cannot be modulated. A modifiable factor such as device implantation depth is a potential target to adjust the risk for DRT. OBJECTIVES: The aim of this study was to assess the impact of LAAO device implantation depth as a predisposing factor for DRT. METHODS: The study included patients who underwent successful LAAO at 9 centers in Europe and Canada. Patients were classified into 2 groups: proximal device implantation (covered pulmonary ridge [PR] in the lobe and disc cohort or <5 mm from the PR in the single-lobe cohort) and distal device implantation (uncovered PR in the disc and lobe cohort and ≥5 mm in the single-lobe cohort). RESULTS: A total of 1,317 patients were included. Among these, proximal and distal device implantation was achieved in 732 (55%) and 585 (45%) patients, respectively. No differences in procedural outcomes were observed between the groups. At follow-up, patients with proximal implantation had a lower incidence of DRT (2.3%) than those with distal implantation (12.2%) (P < 0.001). Deeper device implantation and a larger uncovered left atrial appendage area were associated with a higher incidence of DRT (P < 0.001), regardless of device type. In multivariable analysis, distal implant (HR: 5.92; 95% CI: 3.39-10.36) and no or single antiplatelet therapy (HR: 1.62; 95% CI: 0.99-2.62) emerged as independent predictors of DRT. CONCLUSIONS: LAAO device implantation depth is an independent risk factor for DRT. Deeper device implantation and larger uncovered left atrial appendage areas were associated with a higher incidence of DRT.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Trombosis , Humanos , Apéndice Atrial/diagnóstico por imagen , Resultado del Tratamiento , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/terapia , Trombosis/etiología , Factores de Riesgo , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND: Myocardial revascularization failure (MRF) and Secondary revascularization (SR) are contemporary interventional cardiology challenges. AIM: To investigate the characteristics, management, and prognosis of patients with myocardial revascularization failure (MRF) and need for secondary revascularization (SR) in contemporary practice. METHODS: The REVASEC study is a prospective registry (NCT03349385), which recruited patients with prior revascularization referred for coronary angiography at 19 centers. The primary endpoint is a patient-oriented composite (POCE) at 1 year, including death, myocardial infarction, or repeat revascularization. RESULTS: A total of 869 patients previously revascularized by percutaneous intervention (83%) or surgery (17%) were recruited. MRF was found in 83.7% (41.1% stent/graft failure, 32.1% progression of coronary disease, and 10.5% residual disease). SR was performed in 70.1%, preferably by percutaneous intervention (95%). The POCE rate at 1 year was 14% in the overall cohort, with 6.4% all-cause death. In the multivariate analysis, lower POCE rates were found in the groups without MRF (9.4%) and with disease progression (11%) compared with graft/stent failure (17%) and residual disease (18%), hazard ratio 0.67 (95% confidence interval: 0.45-0.99), p = 0.043. At 1 year, the SR group had less chronic persistent angina (19% vs. 34%, p < 0.001), but a higher rate of repeat revascularization (9% vs. 2.9%, p < 0.001). CONCLUSION: MRF was found in 84% of patients with prior revascularization referred for coronary angiography. Stent/graft failure and residual coronary disease were associated with a worse prognosis. SR provided better symptom control at the expense of a higher rate of new revascularization.