RESUMO
BACKGROUND: Frail elderly patients are exposed to suffering strokes if they do not receive timely anticoagulation to prevent stroke associated to atrial fibrillation (AF). Evaluation in the cardiological ambulatory can be cumbersome as it often requires repeated visits. AIM: To develop and implement CardioShare, a shared-care model where primary care leads patient management, using a compact Holter monitor device with asynchronous remote support from cardiologists. METHODS: CardioShare was developed in a feasibility phase, tested in a pragmatic cluster randomization trial (primary care clinics as clusters), and its implementation potential was evaluated with an escalation test. Mixed methods were used to evaluate the impact of this complex intervention, comprising quantitative observations, semi-structured interviews, and workshops. RESULTS: Between February 2020 and December 2021, 314 patients (30% frail) were included, of whom 75% had AF diagnosed/not found within 13 days; 80% in both groups avoided referral to cardiologists. Patients felt safe and primary care clinicians satisfied. In an escalation test, 58 primary-care doctors evaluated 93 patients over three months, with remote support from four hospitals in the Capital Region of Denmark. CONCLUSIONS: CardioShare was successfully implemented for AF evaluation in primary care.
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.