enrollment have been excluded from previous large clinical studies, 4,5 so in many cases, the complete U.S. Food and Drug Administration (FDA)-approved postprocedural treatment protocols studied in pivotal trials of WATCHMAN are rarely adhered to and are adjusted for individual patients. 6 Findings from a large cohort study and metaanalysis on the safety and efficacy of postprocedural antithrombotic therapy at discharge are available, but few reports of long-term outcomes have been published. 7,8 The safety and efficacy of various antithrombotic regimens have been reported in small trials in other Western countries but these may result in an overdose in smaller-stature Japanese patients especially. 9 LAAC may become more widely used in Japan, and there is, therefore, a need for appropriate antithrombotic therapy for the Japanese population. 10 The aim of the present study was to discuss the safety and efficacy of reduced-dose postoperative antithrombotic therapy, especially in patients with HBR. Cardioembolic stroke is the most common adverse event in patients with atrial fibrillation (AF). Oral anticoagulants (OAC) are the gold standard for preventing stroke and systemic embolism, but some patients have contraindications to OAC therapy due to a high bleeding risk (HBR). In September 2019, the WATCHMAN TM left atrial appendage closure (LAAC) device (Boston Scientific, St. Paul, MN, USA) was commercially introduced in Japan as an alternative to anticoagulation therapy. In Japan, LAAC is approved for patients with nonvalvular AF (NVAF), long-term OAC use, and HBR (HAS-BLED score ≥3, a history of Bleeding Academic Research Consortium [BARC] type 3 bleeding, requiring dual antiplatelet therapy [DAPT] for ≥1 year, multiple episodes of falls requiring interventions, or a history of cerebral amyloid angiopathy). 1-3 However, anticoagulation therapy is required after the procedure to prevent device-related thrombosis (DRT), and the use of antithrombotic drugs after WATCHMAN implantation in patients with HBR is controversial. Patients with previous stroke/transient ischemic attack within 90 days of
Funding Acknowledgements Type of funding sources: None. Background Right ventricular fractional area change (RVFAC) as right ventricular function is recently referred as an independent predictor of sudden cardiac death (SCD). Light ventricular function is related with SCD and adopted as a criteria of ICD implantation for primary prophylaxis. The purpose of this study was to evaluate the association of RVFAC and appropriate ICD therapy. Methods Consecutive patients who underwent initial ICD implantation for any diseases except for hypertrophic cardiomyopathy and Brugada syndrome and long QT syndrome were retrospectively enrolled from 2012 to 2018. Transthoracic echocardiographic parameters before ICD implantation were evaluated to investigate the association with appropriate ICD therapy. We analyzed RV function of patients undergoing echocardiography one year after implantation. RVFAC was measured by one physician and one echocardiologist. Results In total, 172 patients (60.3±13.6 years, 131 males) including 63 ischemic cardiomyopathy were enrolled. Ninety patients received an ICD as a secondary prophylaxis. Mean LVEF and RVFAC were 38.3±14.3% and 35.8±8.82%, respectively. There was no correlation between RVFAC and LVEF (correlation coefficient =0.274). Regarding appropriate ICD therapy events, the best cut-off value of RVFAC was 34.8%. The odds ratio of low RVFAC was 2.731 (95%CI: 1.456-5.121, P<0.001, Fig.1). Secondary prophylactic cohort with low RVFAC significantly showed highest incidence of appropriate ICD therapy. In multivariate analysis, only low RVFAC was an independent predictor of appropriate ICD therapy (hazard ratio 3.53, 95%CI:1.78- 6.99, P<0.001). Among patients with RV dysfunction, RVFAC was normalized in 39% patients during follow up. This recovered group showed significantly lower incidence of appropriate ICD therapy than non-recovered group (P=0.037). In multivariate analysis, recovered RVFAC was related to decrease of appropriate ICD therapy rather than recovered LVEF. In patents without LV dysfunction, recovered RVFAC was significantly associated with lower incidence of ICD therapy (P=0.023, Fig.2) Conclusion RVFAC and RV function improvement may be important to stratify the prognosis of ICD patients.
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