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1.
Artigo em Inglês | MEDLINE | ID: mdl-38984656

RESUMO

More than mild paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI) is associated with a twofold increase in all-cause mortality, heart failure hospitalizations, and the need for reintervention. Successfully addressing PVL in TAVIs is more challenging than in surgical valves. The arterial-arterial (A-A) rail technique emerges as a valuable strategy for post-TAVI PVL closure, enhancing success rates by enabling the effective use of lower-profile vascular plug devices. When standard approach is ineffective, generating an A-A loop for post-TAVI PVL closure is probably the most recommended strategy to ensure procedural success.

2.
Cardiology ; : 1-8, 2024 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-38986462

RESUMO

INTRODUCTION: Patients undergoing left atrial appendage occlusion (LAAO) are at increased risk for bleeding or thromboembolic events. Concurrently, biomarkers are of growing importance in risk stratification for atrial fibrillation patients. We aimed to evaluate the association of hematological markers and clinical characteristics with the occurrence of thromboembolic and bleeding events following LAAO. METHODS: Seven implanting centers retrospectively gathered data on hematological markers (i.e., platelet count [PC], mean platelet volume [MPV], and fibrinogen) prior to LAAO. Prespecified thromboembolic and major bleeding outcomes were collected and the association with pre-procedural hematological markers and clinical characteristics was evaluated using Cox regression analysis. RESULTS: In total, 1,315 patients were included (74 ± 9 years, 36% female, CHA2DS2-VASc 4.3 ± 1.5, HAS-BLED 3.3 ± 1.1). Over a total follow-up duration of 2,682 patient years, 77 thromboembolic events and 107 major bleeding events occurred after LAAO. Baseline PC was the only biomarker showing a signal for a relation to thromboembolic events (HR 1.18, 95% CI: 1.00-1.39) per 50*109 increment, p = 0.056). Thrombotic event rates, including device-related thrombus, increased within higher PC quartiles. Thromboembolism was associated with age (HR 1.05, 95% CI: 1.00-1.10, per year increase) and prior thromboembolism (HR 2.08, 95% CI: 1.07-4.03), but with none of the biomarkers in multivariate analysis. No association of any of the hematological markers with major bleeding was observed. Major bleeding following LAAO was associated with prior major bleeding (HR 5.27, 95% CI: 2.71-10.22), renal disease (HR 1.93, 95% CI: 1.17-3.18), and discharge on dual antiplatelet therapy (DAPT) (HR 1.71, 95% CI: 1.05-2.77). CONCLUSION: Most thrombotic events occurred in the highest PC quartile, but no association of any of the hematological markers with thromboembolism or major bleeding was observed in our analysis. In multivariate analysis, older age and prior thromboembolism were associated with thromboembolism. Prior major bleeding, renal disease and discharge on DAPT were multivariate predictors of major bleeding after LAAO.

3.
Rev Cardiovasc Med ; 24(7): 201, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39077013

RESUMO

Non-ST segment elevation myocardial infarction (NSTEMI) is the most frequent type of acute coronary syndrome in the elderly. Antithrombotic therapy is the cornerstone of pharmacological therapy in the setting of an acute ischemic event, a clinical scenario in which thrombotic and bleeding risks ought to be considered, particularly in older patients. In this article, specific aspects of antithrombotic therapy in elderly patients with NSTEMI are reviewed, including pharmacokinetic and pharmacodynamic characteristics and different clinical situations. The role of frailty and other common geriatric conditions, that are associated with worse prognosis in elderly patients with cardiovascular disease, is also addressed.

4.
Catheter Cardiovasc Interv ; 100(5): 801-809, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36153649

RESUMO

PURPOSE: The present article aims to compare a novel sizing chart based on both maximum and minimum diameters (novel MATRIX) with the current sizing recommendation instructions for use (IFU) based on the maximum diameter. BACKGROUND: Current IFU with the Amulet device are still based on the maximum left atrial appendage (LAA) diameter, which might lead to inappropriate oversizing, especially in elliptic appendages. METHODS: This was a retrospective analysis of patients undergoing LAA occlusion in two high-volume centers. Two hundred patients were included (100 patients with baseline cardiac computed tomography angiography [CCTA] and 100 with baseline 2D and 3D-transesophageal echocardiography [TEE]). The degree of concordance between the predicted device size recommendation and the actual device selection was the primary outcome. RESULTS: The novel MATRIX showed a higher level of concordance between the predicted and implanted device size, regardless of imaging modalities. CCTA showed the strongest, and 2D-TEE the weakest concordance between the predicted and implanted device for both MATRIX and IFU charts. The percentage of patients in whom the disagreement among the predicted and implanted device represented >1 size was higher when using the IFU chart. In elliptical LAA anatomies, the differences favoring the use of MATRIX compared to the IFU in terms of predicted/implanted agreement were higher. Finally, no significant differences in clinical or imaging endpoints were observed between the two different sizing charts. CONCLUSIONS: Incorporating both the LAA maximum and minimum diameters, as opposed to just maximum diameter, appears to improve sizing accuracy. The proposed MATRIX sizing chart offered a higher level of concordance between predicted and implanted device compared to the current IFU.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Humanos , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/terapia , Estudos Retrospectivos , Cateterismo Cardíaco/efeitos adversos , Resultado do Tratamento , Ecocardiografia Transesofagiana
5.
Catheter Cardiovasc Interv ; 97(3): 376-383, 2021 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-32096926

RESUMO

BACKGROUND: Chronic total occlusion (CTO) is common in patients with diabetes mellitus. Data on the long-term outcomes after treatment of CTOs in this high-risk population are scarce. AIM: To compare the long-term clinical outcomes of CTO revascularization either by coronary artery bypass graft (CABG) or successful percutaneous coronary intervention (PCI) versus optimal medical treatment (MT) alone in patients with diabetes. METHODS AND RESULTS: A total of 538 consecutive patients with diabetes and at least one CTO were identified from 2010 to 2014 in our center. In the present analysis, patients were stratified according to the CTO treatment strategy that was selected. MT was selected in 61% of patients whereas revascularization in the remaining 39%. Patients undergoing revascularization were younger, had higher left ventricular ejection fraction (LVEF), lower ACEF score, and more positive myocardial ischemia detection results compared to the MT group (p < .001).Patients referred for CABG had higher rates of left main disease compared to the PCI and MT groups (32% vs. 3% and 11%, respectively; p < .001). Complete revascularization was more often achieved in the CABG group, compared to the PCI group (62% vs. 32% p < .001). Multivariable analysis showed that revascularization with CABG was associated with lower rates of all-cause and cardiac mortality rates compared to MT, [hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.25-0.70, p < .001 and HR 0.40, 95% CI 0.20-81, p = .011, respectively]. Successful CTO-PCI showed a trend towards benefit in all-cause mortality (HR 0.58, 95% CI 0.33-1.04, p = .06). CONCLUSION: In our registry, CTO revascularization in diabetic patients, especially with CABG, was associated with lower long-term mortality rates as compared to MT alone.


Assuntos
Oclusão Coronária , Diabetes Mellitus , Intervenção Coronária Percutânea , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/cirurgia , Diabetes Mellitus/diagnóstico , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Fatores de Risco , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
6.
Artif Organs ; 44(5): 513-521, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31715006

RESUMO

The evidence about the effectiveness and safety of oral anticoagulation in patients on hemodialysis is conflicting and scarce. Percutaneous left atrial appendage occlusion (LAAO) has demonstrated to be a valid alternative therapeutic option for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). The aim of this study is to present the outcomes of percutaneous LAAO in patients with end-stage renal disease (ESRD) on hemodialysis and NVAF in our center. We conducted a retrospective review of clinical records, demographics, LAAO procedure, complications, and outcomes of patients with NVAF and ESRD on hemodialysis who underwent a percutaneous LAAO in our center between January 2017 and January 2019. In the period of the study, eight patients with ESRD on hemodialysis underwent a percutaneous LAAO in our center. The overall mean age was 67.5 years (range 56-81; SD ± 7.2). All patients had permanent NVAF. The total mean dialysis duration was 8.49 years (range 0.83-14.8; SD ± 6.2). The mean CHA2DS2-VASc and HAS-BLED scores were high (4.75 [SD ± 1.16] and 4.62 [SD ± 0.91], respectively). All patients had history of a major hemorrhagic event (BARC Score ≥3). Most patients (n = 6) showed left ventricular hypertrophy, and the average LVEF was 54% (SD ± 6.5). All devices were implanted successfully. Postprocedural antithrombotic regimen prescribed was based on antiplatelet therapy. No deaths, cardioembolic events, or major bleeding (according to the BARC scale) were reported during a mean follow-up of 14.24 months (SD ± 9.44). Percutaneous LAAO could be of particular interest in patients with NVAF and CKD in hemodialysis. Further studies will be necessary to confirm this hypothesis.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Procedimentos Endovasculares , Falência Renal Crônica/complicações , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia
8.
Catheter Cardiovasc Interv ; 94(4): 527-535, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-30828975

RESUMO

BACKGROUND: Chronic total occlusions (CTOs) are present in more than one third of older patients with myocardial ischemia, but controversy remains about the best therapeutic approach. AIMS: To compare long-term survival after CTO revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) versus medical treatment (MT) alone in patients aged 75 and older. METHODS AND RESULTS: A total of 1,252 consecutive patients with at least one CTO were identified from 2010 to 2014 in our center. Patients were stratified by age (<75 years vs. ≥75 years) in the present analysis. All-cause and cardiac mortality were assessed at a median follow-up of 3.5 years. In the older subgroup (26%), patients were more likely to be treated with MT alone (71% vs. 43% of younger patients; p < 0.001). Patients undergoing revascularization were younger and had higher left ventricular ejection fraction (LVEF) and lower age, creatinine, ejection fraction (ACEF) score (age/LVEF +1 if creatinine >2.0 mg/dL), compared to the MT group (p < 0.05). As compared to MT, revascularization predicted lower rates of cardiac mortality and all-cause mortality in older patients, both in the subgroups treated with CABG (hazard ratio [HR] 0.35, 95% confidence interval [CI] 0.17-0.71; HR 0.39, 95%CI 0.18-0.81) and PCI (HR 0.57, 95%CI 0.33-0.98; HR 0.59, 95%CI 0.28-1.2). No differences in mortality were observed according to type of revascularization procedure. CONCLUSIONS: Among patients aged at least 75 years with a CTO, revascularization (PCI or CABG) rather than MT alone may portend a better outcome in terms of all-cause and cardiac mortality.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Ponte de Artéria Coronária , Oclusão Coronária/terapia , Intervenção Coronária Percutânea , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/mortalidade , Oclusão Coronária/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular/efeitos dos fármacos
10.
Clin Transplant ; 32(10): e13401, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30176069

RESUMO

BACKGROUND: Renal replacement therapy (RRT) after heart transplant (HT) is associated with worse prognosis. We aimed to identify predictors of RRT and the impact of this complication on long-term survival. METHODS: Cohort study of HT patients. Univariate and multivariate competing-risk regression was performed to identify independent predictors of RRT. The cumulative incidence function was plotted for RRT. The Kaplan-Meier method was used to compare long-term survival. RESULTS: We included 103 patients. At multivariate analysis, only the emergency status of HT (short-term mechanical circulatory support as a bridge to transplant), chronic kidney disease, and low oxygen delivery were independent predictors of RRT (subhazard ratio [SHR] 4.11, 95% CI 1.84-9.14; SHR 3.17, 95% CI 1.29-7.77; SHR 2.86, 95% CI 1.14-7.19, respectively). Elective HT patients that required RRT showed a significantly reduced survival comparable to patients with emergency HT and RRT (75% ± 13% vs. 67% ± 16%). The absence of RRT implied an excellent survival in patients with an emergency status of HT and elective HT (100% vs. 93% ± 4%). CONCLUSION: The emergency status of HT, chronic kidney disease, and low oxygen delivery were independent predictors of RRT. The occurrence of RRT increases the risk of death in elective HT as much as in patients with an emergency status.


Assuntos
Injúria Renal Aguda/mortalidade , Rejeição de Enxerto/mortalidade , Transplante de Coração/mortalidade , Complicações Pós-Operatórias , Terapia de Substituição Renal/mortalidade , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/etiologia , Idoso , Feminino , Seguimentos , Rejeição de Enxerto/diagnóstico , Rejeição de Enxerto/etiologia , Sobrevivência de Enxerto , Transplante de Coração/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida
11.
J Clin Med ; 13(7)2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38610656

RESUMO

The growing geriatric population presenting with coronary artery disease poses a primary challenge for healthcare services. This is a highly heterogeneous population, often underrepresented in studies and clinical trials, with distinctive characteristics that render them particularly vulnerable to standard management/approaches. In this review, we aim to summarize the available evidence on the treatment of acute coronary syndrome in the elderly. Additionally, we contextualize frailty, comorbidity, sarcopenia, and cognitive impairment, common in these patients, within the realm of coronary artery disease, proposing strategies for each case that may assist in therapeutic approaches.

12.
Clin Res Cardiol ; 113(10): 1485-1500, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38112741

RESUMO

BACKGROUND: Chronic kidney disease (CKD) is a risk factor for embolic stroke, and many nonvalvular atrial fibrillation (NVAF) patients have concomitant CKD. Anticoagulation therapy can be challenging in CKD due to increased bleeding risk, and left atrial appendage occlusion (LAAO) may be a promising alternative. OBJECTIVE: This systematic review aimed to consolidate current evidence on the safety and effectiveness of transcatheter LAAO in patients with CKD and end-stage renal disease (ESRD). METHODS: Medline, Cochrane, and Embase databases were searched from inception to September 2, 2022. We conducted a meta-analysis if an outcome was evaluated in at least two similar studies. RESULTS: We included 15 studies with 77,780 total patients. Of the 15 studies, 11 had a cohort design (five prospective and six retrospective), and four were case series. Patients with CKD were older and had a higher prevalence of comorbidities than non-CKD patients. The two groups did not differ in procedural failure rate, vascular complications, or pericardial tamponade. CKD patients exhibited higher odds of in-hospital acute kidney injury (AKI) and bleeding, longer-term bleeding, and mortality than those without CKD. The risk of in-hospital and longer-term cardioembolic events was similar between CKD and non-CKD populations (odds ratio = 1.01 [95% CI 0.70-1.15] and 1.05 [95% CI 0.55-2.00], respectively). Patients with ESRD had higher odds of in-hospital mortality and cardioembolic events than non-ESRD patients, with no differences in risk of pericardial tamponade. CONCLUSIONS: Based on observational studies, LAAO may be an effective option to prevent cardioembolic events in CKD. However, CKD patients may have higher odds of AKI and in-hospital and long-term bleeding and mortality. The adverse clinical outcomes observed in CKD patients may be attributed to this population's high burden of comorbidities, especially among those with ERSD, rather than the LAAO procedure itself. To ensure maximum clinical benefit, careful patient selection, management, and surveillance involving multidisciplinary teams are essential for CKD patients undergoing LAAO.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Insuficiência Renal Crônica , Humanos , Apêndice Atrial/cirurgia , Insuficiência Renal Crônica/complicações , Fibrilação Atrial/complicações , Cateterismo Cardíaco/métodos , Fatores de Risco
13.
JACC Cardiovasc Interv ; 17(15): 1795-1807, 2024 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-39142756

RESUMO

BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for neurologic events after transcatheter aortic valve replacement (TAVR) lacks clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of neurologic events following TAVR as defined by VARC-3 criteria. METHODS: This was a multicenter study including 2,924 patients with severe aortic stenosis undergoing TAVR. Based on Neurologic Academic Research Consortium (NeuroARC) classification, neurologic events were classified as NeuroARC type 1 (stroke), NeuroARC type 2 (covert central nervous system injury), and NeuroARC type 3 (transient ischemic attack and delirium). Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. RESULTS: After a median follow-up of 13 (7-37) months, neurologic events occurred in 471 patients (16.1%), NeuroARC type 1, 2, and 3 in 37.4%, 4.7%, and 58.0% of cases, respectively, and the majority (58.6%) were periprocedural. Advanced age, chronic kidney disease, atrial fibrillation, major vascular complications, and in-hospital bleeding determined an increased risk of periprocedural events (P < 0.03 for all). Neurologic events occurring during the periprocedural time frame were independently associated with a substantial increase in mortality at 1 year after the intervention (HR: 1.91; 95% CI: 1.23-2.97; P = 0.004). However, although NeuroARC type 1 was associated with an increased mortality risk (IRR: 3.38; 95% CI: 2.30-5.56; P < 0.001 and IRR: 21.7; 95% CI: 9.63-49.1; P < 0.001 for ischemic and hemorrhagic stroke, respectively), the occurrence of NeuroARC type 3 events had no impact on mortality. CONCLUSIONS: Neurologic events after TAVR were associated with poorer short- and long-term survival. This correlation was related to the type of NeuroARC event defined by the VARC-3 criteria. Given the negative impact on clinical outcomes, every attempt should be made to reduce the risk of neurologic complications after TAVR.


Assuntos
Estenose da Valva Aórtica , Ataque Isquêmico Transitório , Índice de Gravidade de Doença , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Fatores de Risco , Feminino , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Incidência , Idoso , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso de 80 Anos ou mais , Fatores de Tempo , Medição de Risco , Ataque Isquêmico Transitório/etiologia , Ataque Isquêmico Transitório/mortalidade , Ataque Isquêmico Transitório/epidemiologia , Resultado do Tratamento , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/epidemiologia , Delírio/epidemiologia , Delírio/etiologia , Delírio/diagnóstico , Delírio/mortalidade , Bases de Dados Factuais , Valva Aórtica/cirurgia , Valva Aórtica/fisiopatologia , Valva Aórtica/diagnóstico por imagem
14.
Biomedicines ; 12(8)2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39200201

RESUMO

Cardiovascular disease constitutes the leading cause of morbimortality worldwide. Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is a common cardiovascular condition, closely related to the ageing population and significantly affecting survival and quality of life. The management of NSTE-ACS requires specific diagnosis and therapeutic strategies, thus highlighting the importance of a personalized approach, including tailored antithrombotic therapies and regimens, combined with timely invasive management. Moreover, specific and frequent populations in clinical practice, such as the elderly and those with chronic kidney disease, pose unique challenges in the management of NSTE-ACS due to their increased risk of ischemic and hemorrhagic complications. In this scenario, comprehensive management strategies and multidisciplinary care are of great importance. Cardiac rehabilitation and optimal management of cardiovascular risk factors are essential elements of secondary prevention since they significantly improve prognosis. This review highlights the need for a personalized approach in the management of NSTE-ACS, especially in vulnerable populations, and emphasizes the importance of precise antithrombotic management together with tailored revascularization strategies, as well as the role of cardiac rehabilitation in NSTE-ACS patients.

15.
J Clin Med ; 13(2)2024 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-38256497

RESUMO

Cardiovascular (CV) diseases remain a global health challenge, with ischemic heart disease (IHD) being the primary cause of both morbidity and mortality. Despite optimal pharmacological therapy, older patients with IHD exhibit an increased susceptibility to recurrent ischemic events, significantly impacting their prognosis. Inflammation is intricately linked with the aging process and plays a pivotal role in the evolution of atherosclerosis. Emerging anti-inflammatory therapies have shown promise in reducing ischemic events among high-risk populations. This review aims to explore the potential of targeted anti-inflammatory interventions in improving clinical outcomes and the quality of life for older patients with IHD.

16.
Artigo em Inglês | MEDLINE | ID: mdl-38936601

RESUMO

BACKGROUND: Transcarotid transcatheter aortic valve replacement (TC-TAVR) has emerged as an alternative access route for transcatheter aortic valve replacement (TAVR). However, scarce data exist on long-term outcomes following TC-TAVR. This study aimed to evaluate clinical outcomes at 5 years after TC-TAVR. METHODS: A total of 110 consecutive patients who underwent TC-TAVR were included. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. The primary endpoint was the incidence of a composite outcome of all-cause mortality, stroke, and repeat hospitalization at 5-year follow-up. Echocardiography results, New York Heart Association (NYHA) class, and quality of life (QoL) as assessed with the EuroQol visual analog scale (EQ-VAS) were examined over the 5-year follow-up. RESULTS: The median patient age was 77 years (interquartile range [IQR], 72-82.2 years), 42.3% were women, and the median Society of Thoracic Surgeons (STS) risk score was 5.02% (IQR, 3.4%-7.5%). The incidence of the composite primary endpoint was 54.5%. Death from any cause occurred in 45.6% of patients (11.9 per 100 patient-years); stroke in 8.2% (1.9 per 100 patient-years); disabling stroke in 2.7% (0.7 per 100 patient-years); and rehospitalization in 27.2%. The improvements in valve hemodynamics, NYHA class, and EQ-VAS following the procedure persisted at 5-year follow-up (P < .001). The incidence of bioprosthetic valve failure was 0.9%. CONCLUSIONS: About half of the moderate-to high-risk patients undergoing TC-TAVR survived with no major cardiovascular events at the 5-year follow-up. The yearly incidence of stroke events was low, and early improvements in valve hemodynamics, functional status, and QoL persisted at 5 years. These results suggest the long-term safety and efficacy of TC-TAVR and would support this approach as an alternative to surgery in non-transfemoral candidates.

17.
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.

18.
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
19.
Cardiovasc Revasc Med ; 60: 18-26, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37793964

RESUMO

AIM: To determine long-term survival of patients after cardiac arrest undergoing emergent coronary angiography and therapeutic hypothermia. METHODS: We analysed data from patients treated within the regional STEMI Network from January 2015 to December 2020. The primary endpoint was all-cause mortality at median follow-up. Secondary endpoints were periprocedural complications (arrhythmias, pulmonary edema, cardiogenic shock, mechanical complication, stent thrombosis, reinfarction, bleeding) and 6-month all-cause death. A landmark analysis was performed, studying two time periods; 0-6 months and beyond 6 months. RESULTS: From a total of 24,125 patients in the regional STEMI network, 494 patients who suffered from cardiac arrest were included and divided into two groups: treated with (n = 119) and without therapeutic hypothermia (n = 375). At median follow-up (16.0 [0.2-33.3] months), there was no difference in the adjusted mortality rate between groups (51.3 % with hypothermia vs 48.0 % without hypothermia; HRadj1.08 95%CI [0.77-1.53]; p = 0.659). There was a higher frequency of bleeding in the hypothermia group (6.7 % vs 1.1 %; ORadj 7.99 95%CI [2.05-31.2]; p = 0.002), without difference for the rest of periprocedural complications. At 6-month follow-up, adjusted all-cause mortality rate was similar between groups (46.2 % with hypothermia vs 44.5 % without hypothermia; HRadj1.02 95%CI [0.71-1.47]; p = 0.900). Also, no differences were observed in the adjusted mortality rate between 6 months and median follow-up (9.4 % with hypothermia vs 6.3 % without hypothermia; HRadj2.02 95%CI [0.69-5.92]; p = 0.200). CONCLUSIONS: In a large cohort of patients with cardiac arrest within a regional STEMI network, those treated with therapeutic hypothermia did not improve long-term survival compared to those without hypothermia.


Assuntos
Parada Cardíaca , Hipotermia , Parada Cardíaca Extra-Hospitalar , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Angiografia Coronária , Resultado do Tratamento , Parada Cardíaca/diagnóstico , Parada Cardíaca/terapia
20.
J Clin Med ; 13(15)2024 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-39124675

RESUMO

Background: Patients with cardiogenic shock (CS) and mitral regurgitation (MI) have a prohibitive risk that contraindicates surgical treatment. Although the feasibility of transcatheter edge-to-edge therapy (TEER) has been demonstrated in this setting, the benefit of the combined use of TEER with mechanical circulatory support devices (MCS) has not been studied. The aim of this study was to evaluate the clinical outcomes of TEER in patients with MCS. Methods: The MITRA-ASSIST study is a retrospective multicentre Spanish registry that included patients with MR and CS who underwent TEER in combination with MCS. The primary endpoint was death from any cause at 12 months. The secondary endpoint was a composite of death from any cause or hospitalisation for heart failure at 12 months. Results: A total of twenty-four patients in nine high-volume Spanish centres (66.2 (51-82) years, 70.8% female, EuroSCORE II 20.4 ± 17.8) were included. Acute ST-elevation myocardial infarction was the main CS aetiology (56%), and the most implanted MCS was the intra-aortic balloon pump (82.6%), followed by ECMO (8.7%), IMPELLACP® (4.3%), or a combination of both (4.3%). Procedural success was 95.8%, with 87.5% in-hospital survival. At 12-month follow-up, 25.0% of patients died, and 33.3% had a composite event of death from any cause or hospitalisation for heart failure. Conclusions: TEER in patients with concomitant CS and MR who require MCS appears to be a promising therapeutic alternative with a high device procedural success rate and acceptable mortality and heart failure readmission rates at follow-up.

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