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1.
JACC Cardiovasc Interv ; 17(15): 1747-1764, 2024 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-39142755

RESUMO

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.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Consenso , Valor Preditivo dos Testes , Acidente Vascular Cerebral , Tomografia Computadorizada por Raios X , Humanos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/terapia , Fibrilação Atrial/fisiopatologia , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/normas , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/etiologia , Fatores de Risco , Ecocardiografia Transesofagiana
2.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-39128822

RESUMO

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.

3.
JAMA Cardiol ; 2024 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-39110427

RESUMO

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.

4.
EuroIntervention ; 20(16): 1018-1028, 2024 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-39155755

RESUMO

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.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Fibrinolíticos , Hemorragia , Inibidores da Agregação Plaquetária , Humanos , Apêndice Atrial/cirurgia , Masculino , Feminino , Idoso , Estudos Retrospectivos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Idoso de 80 Anos ou mais , Fibrinolíticos/uso terapêutico , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Resultado do Tratamento , Fatores de Risco , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/etiologia , Medição de Risco , Terapia Antiplaquetária Dupla/métodos , Pessoa de Meia-Idade , Oclusão do Apêndice Atrial Esquerdo
5.
EuroIntervention ; 20(16): 1029-1038, 2024 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-39155753

RESUMO

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.


Assuntos
Fibrilação Atrial , Cateterismo Cardíaco , Forame Oval Patente , Humanos , Forame Oval Patente/complicações , Forame Oval Patente/cirurgia , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Fatores de Risco , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Resultado do Tratamento , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Embolia Paradoxal/etiologia , Embolia Paradoxal/epidemiologia , Embolia Paradoxal/prevenção & controle , Dispositivo para Oclusão Septal/efeitos adversos , Idoso de 80 Anos ou mais , Fatores Etários , Incidência
7.
JACC Cardiovasc Interv ; 17(15): 1765-1776, 2024 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-39023452

RESUMO

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 ∼7% 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.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Hemorragia , Inibidores da Agregação Plaquetária , Humanos , Apêndice Atrial/fisiopatologia , Apêndice Atrial/diagnóstico por imagem , Masculino , Feminino , Idoso , Fatores de Risco , Fatores de Tempo , Fibrilação Atrial/mortalidade , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/complicações , Resultado do Tratamento , Medição de Risco , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Hemorragia/etiologia , Incidência , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Terapia Antiplaquetária Dupla/efeitos adversos , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Fibrinolíticos/efeitos adversos , Fibrinolíticos/administração & dosagem , Estudos Retrospectivos , Europa (Continente) , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem
8.
Echocardiography ; 41(8): e15888, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39042643

RESUMO

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.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Sistema de Registros , Trombose , Humanos , Feminino , Masculino , Apêndice Atrial/cirurgia , Idoso , Trombose/etiologia , Fibrilação Atrial/cirurgia , Fatores Sexuais , Anticoagulantes/uso terapêutico , Fatores de Risco , Complicações Pós-Operatórias , Dispositivo para Oclusão Septal , Resultado do Tratamento , Ecocardiografia Transesofagiana/métodos , Europa (Continente)/epidemiologia , Oclusão do Apêndice Atrial Esquerdo
10.
Cardiovasc Revasc Med ; 64: 7-14, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38448258

RESUMO

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.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Remoção de Dispositivo , Sistema de Registros , Humanos , Masculino , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/fisiopatologia , Feminino , Idoso , Estudos Retrospectivos , Resultado do Tratamento , Fatores de Tempo , Idoso de 80 Anos ou mais , Fatores de Risco , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Fibrilação Atrial/terapia , Fibrilação Atrial/mortalidade , Remoção de Dispositivo/efeitos adversos , Embolia/etiologia , Embolia/mortalidade , Pessoa de Meia-Idade , Dispositivo para Oclusão Septal , Oclusão do Apêndice Atrial Esquerdo
11.
JACC Case Rep ; 29(4): 102190, 2024 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-38379652

RESUMO

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.

12.
Catheter Cardiovasc Interv ; 103(3): 499-510, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38168895

RESUMO

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.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Insuficiência Renal Crônica , Acidente Vascular Cerebral , Humanos , Seguimentos , Apêndice Atrial/diagnóstico por imagem , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Anticoagulantes/efeitos adversos
13.
JACC Cardiovasc Interv ; 17(1): 60-72, 2024 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-38069986

RESUMO

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).


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Cateterismo Cardíaco , Seguimentos , Estudos Prospectivos , Qualidade de Vida , Índice de Gravidade de Doença , Resultado do Tratamento , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia
15.
Rev. esp. cardiol. (Ed. impr.) ; 76(12): 1021-1031, Dic. 2023. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-228120

RESUMO

Introducción y objetivos: Se presenta el informe de actividad del año 2022 de la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC). Métodos: Se invitó a todos los laboratorios de hemodinámica a participar en el registro. La recogida de datos se realizó a través de un cuestionario telemático. Una empresa externa realizó el análisis de datos, revisados por la junta directiva de la ACI-SEC. Resultados: Participaron 111 centros. El número de estudios diagnósticos aumentó un 4,8% con respecto a 2021, y el número de intervenciones coronarias percutáneas (ICP) se mantuvo estable. Las ICP sobre tronco coronario izquierdo aumentaron un 22%. El abordaje radial sigue siendo preferencial para las ICP (94,9%) y se observa un incremento de uso del balón farmacoactivo. El uso de técnicas de imagen intracoronaria se ha incrementado y se utilizan en el 14,7% de las ICP. También aumenta el uso de guía de presión (el 6,3% con respecto a 2021) y técnicas de modificación de placa. Sigue creciendo la ICP primaria, el tratamiento más frecuente (97%) en el infarto agudo de miocardio con elevación del segmento ST. La mayoría de los procedimientos no coronarios mantienen su tendencia creciente; destacan los implantes percutáneos de válvula aórtica, el cierre de orejuela, la técnica borde-a-borde mitral/tricuspídea, la denervación renal y el tratamiento de la enfermedad de la arteria pulmonar. Conclusiones: El Registro español de hemodinámica y cardiología intervencionista de 2022 demuestra un incremento en la complejidad de la enfermedad coronaria y un crecimiento notable de los procedimientos en cardiopatía estructural valvular y no valvular.(AU)


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.(AU)


Assuntos
Humanos , Masculino , Feminino , Serviço Hospitalar de Cardiologia/estatística & dados numéricos , Hemodinâmica , Intervenção Coronária Percutânea/estatística & dados numéricos , Laboratórios , Espanha , Inquéritos e Questionários
16.
J Clin Med ; 12(21)2023 Oct 24.
Artigo em Inglês | MEDLINE | ID: mdl-37959194

RESUMO

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.

17.
Rev Esp Cardiol (Engl Ed) ; 76(12): 1021-1031, 2023 Dec.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-37863184

RESUMO

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.


Assuntos
Cardiologia , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Cateterismo Cardíaco , Sistema de Registros
19.
JACC Cardiovasc Interv ; 16(15): 1889-1898, 2023 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-37587597

RESUMO

BACKGROUND: Left atrial appendage occlusion (LAAO) procedures are widely guided by standard transesophageal echocardiography (TEE) probes, requiring general anesthesia in most patients. The use of miniaturized TEE probes allows for LAAO guidance under local anesthesia and offers an attractive imaging alternative to standard TEE probes. OBJECTIVES: The aim of this study was to assess the safety and efficacy of miniaturized TEE probes for procedural guidance of LAAO. METHODS: Multicenter retrospective observational study of LAAO procedures performed under miniaturized TEE guidance and conscious sedation. The primary efficacy endpoint was technical success. The secondary efficacy endpoint was procedural success (technical success without major periprocedural complications). The safety outcome was a composite of major periprocedural complications. RESULTS: A total of 546 consecutive LAAO procedures were performed in 5 European centers. Technical success was achieved in 534 (98.0%) patients. Sixteen major periprocedural complications occurred in 15 (2.9%) patients, yielding a procedural success rate of 97.0%. Conversion to general anesthesia was required in 4 (0.7%) patients. Short-term imaging follow-up was available in 422 patients with an incidence of major (>5 mm) TEE-detected residual leaks of 0.7%, complete LAA occlusion of 82.2% on cardiac computed tomography, and device-related thrombus of 5%. As compared with procedural 2-dimensional imaging for device sizing, preprocedural assessment by 3-dimensional imaging resulted in improved technical success (100% vs 95.0%; P < 0.001). CONCLUSIONS: LAAO under conscious sedation and miniaturized TEE guidance is safe and feasible with a high rate of technical success and a low rate of periprocedural complications.


Assuntos
Apêndice Atrial , Ecocardiografia Transesofagiana , Humanos , Sedação Consciente/efeitos adversos , Apêndice Atrial/diagnóstico por imagem , Resultado do Tratamento , Anestesia Geral
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