RESUMO
BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score. METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90%). CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery. TRIAL REGISTRATION: NCT03724318.
Assuntos
Apêndice Atrial , Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Apêndice Atrial/cirurgia , Resultado do Tratamento , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
Contemporary surgical and transcatheter aortic valve interventions offer effective therapy for a broad range of patients with severe symptomatic aortic valve disease. Both approaches have seen significant advances in recent years. Guidelines have previously emphasized 'surgical risk' in the decision between surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), although this delineation becomes increasingly obsolete with more evidence on the effectiveness of TAVR in low surgical risk candidates. More importantly, decisions in tailoring aortic valve interventions should be patient-centered, accounting not only for operative risk, but also anatomy, lifetime management and specific co-morbidities. Aspects to be considered in a patient-tailored aortic valve intervention are discussed in this article.
RESUMO
The saphenous vein is a frequently used graft material in coronary artery bypass grafting. In this review, three harvesting techniques are presented, and their benefits and disadvantages are discussed. Endoscopic harvesting (EVH) has reduced harvest site complications. The method is safe in terms of mortality, myocardial infarction and revascu-larisation frequency compared with open vein harvesting. A recent meta-analysis recommends EVH as first of choice. The no-touch technique has shown a tendency towards increased graft patency, however, further studies are needed in comparing this technique with EVH.
Assuntos
Ponte de Artéria Coronária , Veia Safena , Endoscopia , Humanos , Veia Safena/transplante , Coleta de Tecidos e Órgãos , Grau de Desobstrução VascularRESUMO
BACKGROUND: Despite increasing survival, cardiovascular disease remains the primary cause of death worldwide with an estimated 7.4 million annual deaths. The main symptom of ischaemic heart disease is chest pain (angina pectoris) most often caused by blockage of a coronary artery. The aim of coronary artery bypass surgery is revascularisation achieved by surgically grafting harvested arteries or veins distal to the coronary lesion restoring blood flow to the heart muscle. Older evidence suggested a clear survival benefit of coronary artery bypass graft surgery, but more recent trials yield less clear evidence. We want to assess the benefits and harms of coronary artery bypass surgery combined with different medical therapies versus medical therapy alone in patients with ischaemic heart disease. METHODS: This protocol for a systematic review follows the recommendations of Cochrane and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all randomised clinical trials assessing coronary artery bypass surgery combined with different medical therapies versus medical therapy alone in patients with ischaemic heart disease. We plan to search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, Science Citation Index Expanded on Web of Science, and BIOSIS to identify relevant trials. Any eligible trial will be assessed as high risk or low risk of bias, and our conclusions will primarily be based on trials at low risk of bias. The analyses of the extracted data will be performed using Review Manager 5, STATA 16 and trial sequential analysis. For both our primary and secondary outcomes, we will create a 'Summary of Findings' table and use GRADE to assess the certainty of the evidence. DISCUSSION: Coronary artery bypass surgery is invasive and can cause death, which is why its use must be thoroughly studied to determine if it yields a large enough long-term benefit for the thousands of patients receiving it every year. SYSTEMATIC REVIEW REGISTRATION: PROSPERO ID 131924.