From April 6 to 8, local time, the 73rd Annual Scientific Meeting of the American College of Cardiology (ACC.24) was held in Atlanta, USA. During the conference, two studies by Professor He Ben's team from the Chest Hospital of Shanghai Jiao Tong University School of Medicine were selected. One study investigated the safety and efficacy of the novel Lesifter left atrial appendage occluder in patients with atrial fibrillation at increased risk of stroke, and the other investigated the effect of prepercutaneous coronary intervention (PCI) platelet hyperresponsiveness (HPR) on post-PCI myocardial perfusion in patients with high-risk non-ST-elevation acute coronary syndrome (NSTE-ACS). In this article, the two studies are collated for the benefit of readers.
Left atrial appendage closure using the novel Lesifter device is effective in preventing stroke in patients with nonvalvular atrial fibrillation
Percutaneous left atrial appendage closure (LAAC) is a viable alternative to long-term oral anticoagulation in patients with nonvalvular atrial fibrillation and may reduce the risk of thromboembolism. This study aims to evaluate the safety and efficacy of the novel Lesifter left atrial appendage occluder in patients with atrial fibrillation who are at increased risk of stroke. The results of the study showed that LAAC with the novel Lesifter device was effective in preventing stroke in patients with nonvalvular atrial fibrillation, with a high surgical success rate and a low incidence of adverse events.
Research Methods:
The study is a prospective, non-randomized, multicenter registry study conducted in 6 hospitals in China. The primary endpoints were the incidence of ischemic stroke within 12 months after surgery and the closure of the left atrial appendage (residual leakage around the occluder<5 mm) assessed by transesophageal echocardiography (TEE) at 6 months after surgery. Pre-defined secondary endpoints included surgery-related complications within 7 days postoperatively or at hospital discharge, whichever occurs later, major clinical events within 12 months, and device-related complications assessed by TEE at 2 and 6 months follow-up.
Findings:
A total of 187 patients were included in the study, with a mean age of 67.7±7.5 years, a mean CHA₂DS₂-VASc score of 4.0±1.6, and a mean HAS-BLED score of 2.5±1.1. Among the 187 patients, 184 (98.4%) were successfully implanted.
Table 1 Baseline characteristics (left) and surgical characteristics (right) of the patient
Four major perioperative complications (2.1%) were identified, including two deaths (1.1%). During the 12-month follow-up period, the risk of ischemic stroke was 0.58% (95% CI: 0%~1.7%), which was lower than expected based on the CHA₂DS₂-VASc score of the patient cohort (6.29%/year), and the statistically non-inferiority was met (95% CI upper limit: 1.7% < preset maximum annual incidence rate of 7.3%).
According to the TEE results, the effective closure rate of the left atrial appendage was 100% (95% CI: 97.6%~100%) 6 months after surgery, and the preset effectiveness target (lower limit of 95% CI: 97.6% > the preset minimum closure rate was 89.5%). At the 2-month and 6-month TEE follow-up, 3 (1.9%) and 1 (0.7%) patients developed occluder-related thrombus, respectively. A total of 11 major clinical events (5.9%) occurred within 12 months after surgery.
Table 2 Outcomes of one-year follow-up
Fig.1 Risk of ischemic stroke
Conclusions of the study
LAAC with the novel Lesifter device is effective in preventing stroke in patients with nonvalvular atrial fibrillation, with a high surgical success rate and a low incidence of adverse events.
Preoperative platelet hyperresponsiveness to PCI in patients with high-risk NSTE-ACS may be an independent predictor of impaired postoperative myocardial perfusion
Current guidelines do not recommend routine pretreatment with P2Y12 receptor inhibitors in patients with high-risk NSTE-ACS prior to early invasive angiography. Inhibition of platelet function during PCI may be suboptimal, leading to an intracoronary thrombotic environment and possibly increasing the risk of atherosclerotic thrombosis. This study aimed to explore the effect of pre-PCI HPR on myocardial perfusion after PCI in patients with high-risk NSTE-ACS. The results suggest that pre-PCI HPR in patients with high-risk NSTE-ACS may be an independent predictor of impaired myocardial perfusion after PCI
Research Methods:
The study is a single-center, prospective, observational study that consecutively enrolled 137 guideline-defined patients with high-risk NSTE-ACS who were scheduled to receive invasive therapy from April 2021 to September 2023.
The MIMI myocardial perfusion grade (TMPG) and TIMI myocardial perfusion frame number (TMPFC) were used to evaluate the myocardial perfusion after PCI. Pre-PCI platelet reactivity is assessed by thromboelastography immediately prior to invasive angiography. HPR is defined as adenosine diphosphate (ADP)-induced platelet-fibrin clot strength >47 mm + ADP-induced platelet inhibition <50%.
Findings:
In this study, 30 patients (21.9%) developed HPR prior to PCI. ADP-induced platelet inhibition before PCI was significantly correlated with TMPFC after PCI (Pearson r=-0.3164, P<0.0001).
Fig.2 Correlation between ADP-induced platelet inhibition before PCI and TMPFC after PCI (left) and TMPFC after PCI in patients with or without HPR (right)
Compared with patients without HPR, patients with HPR had more severe TMPG impairment (TMPG 0~2) (60.0% vs 23.1%, P=0.0002), higher TMPFC (113.0±47.6 vs 78.7±29.5, P<0.0001), and more severe TMPFC impairment (TMPFC ≥90 frames) (61.3% vs 25.2%, P=0.0005).
Fig.3 Proportion of TMPG grade 0~2 after PCI in patients with or without HPR (left) and TMPFC ≥ 90 frames (right)
Multivariate logistic regression analysis showed that preoperative HPR was independently associated with impaired TMPG (OR=5.13; 95% CI: 2.03~12.98, P=0.001) and impaired TMPFC (OR=6.93; 95% CI: 2.53~19.00, P<0.001).
Table 3 Univariate and multivariate logistic regression analysis of impaired myocardial perfusion after PCI
Conclusions of the study
Pre-PCI HPR in high-risk NSTE-ACS patients may be an independent predictor of impaired myocardial perfusion after PCI. Further research is needed to explore strategies to optimize the perioperative antiplatelet therapy strategy of PCI in the acute phase of high-risk NSTE-ACS patients.
Source: ACC official website
Expert Profile
Professor Ben He
•Director of the Heart Center, Director of the Department of Cardiology, Chief Physician, Ph.D./Postdoctoral Supervisor, Second-level Professor, National Standing Committee Member of the Chinese Society of Cardiology, Deputy Head of the Structural Cardiology Group, Shanghai Chest Hospital. He is a leading talent in Shanghai, a young and middle-aged expert with outstanding contributions to the National Health Commission, and an expert with special subsidies from the State Council
•He has rich experience in the diagnosis and treatment of coronary heart disease, structural heart disease, heart failure, etc., especially good at the interventional treatment of various difficult coronary heart diseases, and has high attainments in percutaneous left atrial appendage closure surgery to prevent atrial fibrillation stroke, transcatheter aortic valve replacement and percutaneous mitral valve repair surgery. He has experienced more than 20,000 cardiac catheterization procedures. His research interests revolve around the prevention and treatment of the acute event chain of coronary heart disease, from fragile plaques to myocardial reperfusion injury, from basic to clinical. He has presided over a number of national key projects, and published more than 100 papers included in SCI as the first or corresponding author, with a total impact factor of more than 500 points and an H-index of 36. As the first completer, he has won many awards such as the first prize of Shanghai Medical Science and Technology Award, the first prize of Science and Technology Progress Award of the Ministry of Education
•He is currently an expert member of the American College of Cardiology (FACC), an expert member of the European College of Cardiology (FESC), an expert member of the American Society of Cardiography and Interventional Imaging (FSCAI), a member of the National Standing Committee of the Cardiovascular Branch of the Chinese Medical Association, the vice chairman of the Cardiovascular Evidence-based and Precision Medicine Professional Committee of the Chinese Research Hospital Association, the vice chairman of the Cardiovascular Professional Committee of the Cross-Strait Medical and Health Association, and the leader of the left atrial appendage occlusion group of the Chinese Heart Rhythm Association. He has been awarded the "Top Ten Doctors in Shanghai", "Top Ten Doctors in China", the Shanghai May Day Labor Medal, the President Award of Shanghai Jiao Tong University, and the Baosteel National Outstanding Teacher Award
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