Background: Bleeding risk is a concern in patients with atrial fibrillation (AF) on oral anticoagulants (OACs). The DOAC score, a novel bleeding risk score, was developed for patients on direct OACs (DOACs), but its applicability to all anticoagulated patients remains unclear. The aim of this study was to validate the DOAC score in patients with AF who received any OACs.

Methods and Results: We analyzed data for 6,505 patients with nonvalvular AF receiving OACs from 2 Japanese multicenter registries (RAFFINE, SAKURA-AF; mean age 72±9 years; 28.1% female). Major bleeding occurred in 76 patients within 1 year. The DOAC score was compared to the HAS-BLED score in discrimination ability. The DOAC score showed higher area under the curve (AUC), although the difference was not statistically significant (AUC 0.653 vs. 0.601, P=0.23). The DOAC score also showed a trend towards improved net reclassification over the HAS-BLED score (net reclassification improvement (NRI): 25.4%, P=0.073). In patients without a prior history of major bleeding, the DOAC score offered a significant improvement in the NRI (30.9%, P=0.030).

Conclusions: The DOAC score demonstrated moderate performance for predicting major bleeding in anticoagulated patients with AF. Although it did not significantly outperform the HAS-BLED score in this study, its applicability to both DOAC and warfarin users may offer a practical, unified approach.

Background: Atrial fibrillation-induced cardiomyopathy (AF-CM) is a secondary cardiomyopathy characterized by recovery of left ventricular (LV) dysfunction after restoration of sinus rhythm from atrial fibrillation (AF); however, the pathological evidence of AF-CM remains limited.

Methods and Results: We retrospectively analyzed AF-CM patients who underwent both endomyocardial biopsy (EMB) from the right ventricle and catheter ablation (CA) for AF at Kyushu University Hospital between 2014 and 2023. We investigated the relationships between histological features and the recovery process of LV function in AF-CM after CA for AF. Recovery of LV ejection fraction (EF) was defined as an improvement ≥15%. EMB specimens were evaluated for myocardial fibrosis, cytoplasmic vacuolization, and nuclear expression of phosphorylated histone H2A variant X (γ-H2A.X) and poly(ADP-ribose) (PAR). Among 23 patients, the median time from CA to LVEF recovery was 145 days [90–220], and 83% achieved an LVEF ≥50%. Greater myocardial fibrosis, cytoplasmic vacuolization, and higher nuclear expression of γ-H2A.X and PAR were associated with delayed LVEF recovery (r=0.43, 0.42, 0.49, and 0.47, respectively). AF-CM severity scores derived from these histological features demonstrated associations with LVEF recovery time (R²=0.33 for the “structural damage score” and R²=0.29 for the “DNA damage score”).

Conclusions: In AF-CM patients undergoing CA, severe myocardial degeneration and DNA damage were associated with delayed recovery of LV systolic function.

Background: The incidence and predictors of new-onset heart failure (HF) after catheter ablation for atrial fibrillation (AF) remain unclear, particularly in patients with preserved left ventricular ejection fraction (EF ≥50%) and no prior HF.

Methods and Results: We retrospectively analyzed 480 consecutive patients with EF ≥50% and no prior HF who underwent initial AF ablation. Recurrent atrial tachyarrhythmias (ATs) and new-onset HF were assessed during follow up. Landmark analyses at 3 and 12 months after the first procedure were performed to evaluate predictors of new-onset HF and the association between recurrence of early ATs and subsequent HF. Additionally, recurrence of ATs after the final ablation was examined as a time-dependent covariate using a Cox proportional hazards model. During a median follow up of 70 months (interquartile range 60–84 months), 18 (3.75%) patients developed new-onset HF. Age >75 years was the only consistent independent predictor in both landmark analyses. Early recurrence of ATs within 3 or 12 months was not associated with HF development. However, recurrence of ATs after the final procedure was independently associated with new-onset HF in a time-dependent analysis (hazard ratio 4.028; 95% confidence interval 1.564–10.378; P=0.004).

Conclusions: In patients with preserved EF and no prior HF, new-onset HF after AF ablation was uncommon but clinically relevant. Durable rhythm control may be important to reduce HF risk.

Background: Systemic air embolism remains a critical risk during left atrial procedures, particularly during the frequent exchanges required in pulsed field ablation (PFA). In this study we evaluated the air intrusion patterns using the VARIPULSE^TMPFA system with a relatively small sheath lumen, and assessed a custom-made “Adapter Sink” designed to eliminate air entry.

Methods and Results: Using an ex vivo water-tank model, we monitored the insertion of the VARIPULSE^TMcatheter through an 8.5Fr CARTO VIZIGO® Bi-Directional Guiding Sheath. Three protocols were compared: (1) standard insertion without suction, (2) insertion with active manual suction, and (3) insertion using the custom Adapter Sink (submerged entry). Air volume was quantified across 10 trials per group. Baseline insertion (no suction) consistently introduced visible small air bubbles, although manual suction by an assistant reduced the bubbles’ volume and frequency significantly. In contrast, the Adapter Sink group had zero air intrusion by operator alone without assistance, providing a complete physical barrier against atmospheric air.

Conclusions: Even with smaller profile sheaths such as the 8.5Fr VIZIGO®, a continuous saline drip may be insufficient. The Adapter Sink effectively minimized air intrusion and optimized manpower by requiring only a single operator, unlike manual suction, which relies on an assistant. However, further in vivo or clinical studies are warranted to validate the feasibility of our setup under physiological conditions.

Background: Peak oxygen uptake (V̇O₂) is a critical prognostic indicator in heart failure (HF) and is influenced by skeletal muscle oxygen utilization. Muscle oxygen saturation (SmO₂), assessed using near-infrared spectroscopy, reflects peripheral oxygenation capacity. Although higher leg muscle strength has been linked to greater peak V̇O₂, its relationship with muscle oxygenation dynamics remains unclear.

Methods and Results: Twenty-six men (age 64±11 years) with HF were categorized into high (n=13) and low (n=13) strength groups based on median knee extension strength normalized to body weight (BW). Cardiopulmonary exercise testing (CPX) was performed while monitoring SmO₂and total hemoglobin (THb) at the right vastus lateralis. Relative changes from rest to each exercise stage were calculated. A multivariable linear mixed-effects model evaluated the association between SmO₂changes and knee extension strength, adjusting for age, log-transformed B-type natriuretic peptide (log-BNP), leg muscle mass, THb changes, and adipose tissue thickness (ATT). Log-BNP was lower in the high-strength group (P=0.001). SmO₂reductions from rest to 40–100% peak V̇O₂were greater in the high-strength group. Knee extension strength (β=0.9±0.4; P=0.016) and THb change (β=−5.6±1.5; P=0.001) predicted SmO₂changes.

Conclusions: Higher leg muscle strength is associated with favorable muscle oxygenation dynamics during incremental exercise in HF, independent of blood volume dynamics.

Background: Physical performance during hospitalization is a central target of inpatient cardiac rehabilitation and is associated with the prognosis in patients with heart failure (HF). However, the prognostic significance of longitudinal changes in physical performance during acute hospitalization remains uncertain. We aimed to examine the association between in-hospital changes in the Short Physical Performance Battery (SPPB; ∆SPPB) and post-discharge outcomes among older, frail patients hospitalized for acutely decompensated HF (ADHF).

Methods and Results: This study included 504 older, frail patients with ADHF and baseline SPPB scores ≤9 (mean age 81.1±9.6 years; 49% male). SPPB was reassessed at discharge, and patients with ∆SPPB ≥3 and <3 were classified into the Improvement and Minimal Change groups, respectively. Kaplan–Meier and Cox regression analyses evaluated the association between ∆SPPB ≥3 and HF readmission and all-cause mortality. During a median follow up of 1.8 years (range 1.0–3.0 years), 294 (58.3%) patients had HF readmission and 161 (31.9%) died. The Improvement group had significantly lower HF readmission rates (P<0.05), whereas all-cause mortality showed a non-significant downward trend.

Conclusions: Improvement in physical performance during hospitalization was associated with a lower risk of HF readmission among older, frail patients with ADHF. These findings suggest that longitudinal functional recovery during acute care provides clinically relevant prognostic information.

Background: We evaluated the association between rectus femoris muscle thickness adjusted by body mass index (RFT/BMI) and oxygen uptake at anaerobic threshold (AT-V̇O₂) in patients with heart failure (HF) to assess whether RFT/BMI was associated with AT-V̇O₂, a key indicator of exercise tolerance and a known prognostic factor in HF.

Methods and Results: In this retrospective cross-sectional study, 103 patients with HF who underwent ultrasound-derived RFT measurement and cardiopulmonary exercise testing (CPX) were included. RFT/BMI was examined using multivariable linear regression and restricted cubic spline analysis. Receiver operating characteristic curve analysis identified optimal RFT/BMI cutoffs, and propensity score-adjusted modified Poisson regression assessed associations with subthreshold AT-V̇O₂. RFT/BMI was independently associated with AT-V̇O₂(β=0.62, 95% confidence interval (CI): 0.45 to 0.79, P<0.001), with a significant nonlinear relationship. Cutoffs of 0.55 and 0.69 discriminated AT-V̇O₂≥10.5 and ≥14.0 mL/min/kg, with AUCs of 0.89 and 0.75, respectively. In the modified Poisson regression, RFT/BMI ≥0.55 and ≥0.69 was associated with lower risk of AT-V̇O₂<10.5 mL/min/kg (aRR=0.22, 95% CI: 0.09 to 0.53, P=0.001) and <14.0 mL/min/kg (aRR=0.45, 95% CI: 0.28 to 0.73, P=0.001).

Conclusions: Ultrasound-derived RFT/BMI was associated with AT-V̇O₂in patients with HF, and thus may provide supportive information on exercise tolerance when CPX is not feasible.

Background: Transcatheter edge-to-edge repair (TEER) has increasingly been used for elderly patients with degenerative mitral regurgitation (DMR), while minimally invasive surgical approaches such as robotic mitral valve repair (RMVr) may offer durable repair with reduced invasiveness. We evaluated the safety and durability of RMVr in octogenarians with DMR and assessed its role in contemporary treatment strategies by comparison with younger patients as a reference cohort.

Methods and Results: We retrospectively analyzed 412 patients who underwent RMVr for DMR from 2018 to 2025. Patients were divided into an elderly group (E; age ≥80 years; n=42) and a younger group (Y; age <80 years; n=370). Octogenarians had higher operative risk with more atrial fibrillation, heart failure, pulmonary hypertension, and renal dysfunction. Cardiopulmonary bypass and cross-clamp times, repair complexity, and concomitant procedures were comparable. In the E group, hospital mortality and stroke were both 2.4%; there were no conversions to sternotomy, re-explorations for bleeding, or new renal replacement therapy. At discharge, mitral regurgitation was none or trivial in most patients in both groups. At 5 years, overall survival was lower in the E group (80.3% vs. 97.3%), but freedom from cerebrovascular events, reoperation, and moderate or greater mitral regurgitation was similar.

Conclusions: RMVr is a feasible and durable surgical option in selected octogenarians considering patient-specific risk, anatomical suitability, and institutional expertise.

Background: We aimed to elucidate the characteristics and prognosis of patients admitted to a medical intensive care unit (ICU) by helicopter emergency medical service (HEMS).

Methods and Results: Among 11,140 patients transported via the institute’s HEMS from January 2012 to December 2021, 459 were admitted to the medical ICU and included as the HEMS group. The 3,810 patients who were transported by other means to the medical ICU comprised the non-HEMS group. Multivariable logistic regression analysis revealed that cardiovascular etiologies other than acute heart failure (AHF), as well as younger age and the requirement of mechanical support (endotracheal intubation and intra-aortic balloon pumping), were associated with HEMS transport. Kaplan–Meier curve analysis revealed that 365-day survival was significantly better in the HEMS group than in the non-HEMS group. A multivariable Cox regression model identified HEMS transport as an independent predictor of a favorable 365-day all-cause survival (hazard ratio: 1.326, 95% confidence interval: 1.024–1.718, P=0.033) relative to other means of transport.

Conclusions: Cardiovascular diseases other than AHF were the main reasons for helicopter transportation to the medical ICU. The HEMS group were younger and more likely to require circulatory/respiratory assist devices than the non-HEMS group. The HEMS was significantly associated with better 365-day survival; therefore, appropriate transportation means need to be selected to improve the prognosis of non-surgical patients.

Background: Systemic amyloidosis has long been considered a rare disease, yet its nationwide epidemiology in Japan remains incompletely characterized, particularly with respect to geographical variation.

Methods and Results: We analyzed publicly available data from Japan’s national intractable disease registry (Designated Disease 28: systemic amyloidosis), which includes systemic AL/AH amyloidosis, wild-type and variant transthyretin amyloidosis, and other hereditary systemic forms, from 2015 to 2024. Annual prefecture-level counts of certified patients were extracted. Population-adjusted rates were calculated as the number of patients per 10,000 population using the 2020 national census as a fixed denominator. The total number of registered patients increased from 2,304 in 2015 to 8,168 in 2024, representing a 3.5-fold rise. The nationwide population-adjusted rate increased from 0.18 to 0.65 per 10,000 population. Marked geographical disparities were observed, with a pronounced west–east gradient and consistently higher rates in western Japan. In 2024, Oita Prefecture had the highest rate (2.2 per 10,000 population), followed by Kumamoto, Kochi, Nagano, Ehime, and Fukuoka.

Conclusions: Registered systemic amyloidosis cases in Japan increased substantially over the past decade, particularly after the approval of tafamidis for transthyretin amyloid cardiomyopathy in 2019. The persistent geographical disparities may reflect differences in diagnostic practice and certification processes rather than true variation in disease prevalence, suggesting that systemic amyloidosis may remain incompletely recognized nationwide.

Background: Low-density lipoprotein cholesterol (LDL-C) is an established therapeutic target for atherosclerotic cardiovascular diseases (ASCVD), particularly in high-risk individuals. In 2022, the Japan Atherosclerosis Society Guidelines (JAS-GL) for Prevention of Atherosclerotic Cardiovascular Diseases introduced more stringent LDL-C targets to reduce ASCVD. We evaluated the non-achievement rates of the LDL-C goals across risk groups using a nationwide real-world dataset, which included a broad range of ASCVD patients.

Methods and Results: This retrospective, cross-sectional study included 200,607 adults (aged ≥18 years) with dyslipidemia. Patients were stratified according to the JAS-GL 2022 into a high-risk primary prevention population (Groups I, II, and familial hypercholesterolemia [FH]: no history of coronary artery disease [CAD] or stroke, classified by comorbidities such as diabetes), and a secondary prevention population (Groups III and IV: history of CAD or stroke, with Group IV having additional conditions such as diabetes). The primary endpoint was the proportion of patients who did not achieve their target LDL-C goals. Non-achievement rates were 28.2% (Group I), 46.7% (Group II), 64.3% (Group FH), 30.0% (Group III), and 65.6% (Group IV). Importantly, these rates remained high and showed little change before and after the revision of the guidelines across all studied risk groups.

Conclusions: Non-achievement of LDL-C targets remained high despite updated recommendations. These findings highlight a need for more effective implementation strategies and sustained efforts to improve lipid management.

Background: Atrial fibrillation (AF) is a major cause of cardioembolic stroke and often remains undiagnosed because of its asymptomatic or paroxysmal nature. Although opportunistic AF screening has been advocated, sustainable community-based screening models that link the results to medical evaluations are limited. We implemented a pharmacy-based AF screening initiative (Catch AF project) led by a regional Stroke and Cardiovascular Disease Support Center with community pharmacists and physicians to assess its feasibility and follow-up outcomes.

Methods and Results: The Catch AF project was conducted at 34 community pharmacies in Nagasaki, Japan. A single-lead electrocardiogram (ECG) device with automated analysis was installed to offer opportunistic screening for pharmacy visitors. Of the 5,371 ECG recordings, 123 (2.29%) indicated possible AF. Pharmacists recommended medical consultation for 60 individuals (49% of the detected cases). Questionnaire surveys demonstrated that stakeholders generally perceived the initiative as acceptable and feasible. In contrast, only a small number of physicians reported encounters with referred patients, indicating a marked gap between AF detection through pharmacy-based screening and subsequent medical evaluation.

Conclusions: A center-led pharmacy-based AF screening initiative is feasible and well accepted in a real-world setting. However, a substantial gap between screening detection and clinical follow up highlights the need for improved referral pathways and coordination between pharmacies and medical institutions to enhance the effectiveness of community-based screening programs.

Background: Atrioventricular (AV) synchronous pacing with a transcatheter pacing system (TC-PM) is an alternative to transvenous pacemakers (TV-PM) in patients with AV block. In this study we assessed the potential cost-effectiveness of TC-PM in Japan and methodological implications for future global cost-effectiveness analyses.

Methods and Results: A decision-analytic Markov model captured strategy-specific complication rates, device replacements, and health-related quality of life. Parameter inputs were derived from systematic literature search, clinical studies, and claims data. The discounted lifetime incremental cost-effectiveness ratio (ICER, in JPY per quality-adjusted life-year (QALY) gained) was evaluated against a 5 million JPY per QALY willingness-to-pay threshold. Extensive scenario and sensitivity analyses were conducted. TC-PM was associated with lower complication rates (3.8% vs. 9.8% at 36 months, hazard ratio 0.39; P<0.001) and a lifetime cost increase of JPY632,849 (JPY2,268,945 vs. JPY1,636,096). TC-PM concurrently added 0.24 (3.33 vs. 3.09) QALYs, rendering TC-PM cost-effective in the base case (ICER JPY2,640,519 per QALY gained), but not all scenarios. Long-term quality-of-life assumptions, as also evidenced by a recent Japanese government study, are an important driver of cost-effectiveness.

Conclusions: AV-synchronous pacing with a TC-PM is associated with lower complication rates and some improvement in projected quality-adjusted survival that can render it a cost-effective intervention in the Japanese healthcare system as long as some of the observed short-term quality-of-life benefit is maintained.

Background: This study aimed to: (1) assess changes in peripheral skeletal muscle oxygenation during exercise after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS); and (2) identify characteristics of patients who exhibited improved exercise tolerance.

Methods and Results: In this single-center prospective study, 20 patients with severe symptomatic AS underwent evaluation before and 1 week after TAVI. Exercise tolerance was assessed using the incremental shuttle walk test (ISWT), and the incremental shuttle walk distance (ISWD) was recorded. Calf muscle oxygenation during the ISWT was continuously measured using near-infrared spectroscopy (NIRS). ISWD increased significantly after TAVI (P<0.01). During the ISWT, the change in oxygenated hemoglobin (∆O₂Hb) was greater after TAVI than before TAVI. Compared with non-responders, responders demonstrated lower ∆O₂Hb and greater increases in deoxygenated hemoglobin (∆HHb) from rest to peak exercise before TAVI (all P<0.05).

Conclusions: Peripheral skeletal muscle oxygenation during exercise improved early after TAVI. Moreover, a pre-TAVI pattern characterized by reduced oxygen delivery (lower ∆O₂Hb) and enhanced oxygen extraction/utilization (higher ∆HHb) during exercise was associated with greater improvement in exercise tolerance after TAVI.

Background: Atrial functional mitral regurgitation (AFMR) frequently affects older patients, but the high-risk patient subgroups requiring careful follow-up and targeted therapy remain unclear. AFMR causes venous congestion and reduced forward cardiac output, which may accelerate chronic kidney disease (CKD) and anemia. Cardiorenal anemia syndrome (CRAS) is a known prognostic factor in heart failure (HF), and AFMR-specific hemodynamic disturbances may amplify its consequences. The aim of this study was to evaluate the impact of CRAS on cardiovascular outcomes in AFMR.

Methods and Results: The multicenter, retrospective, observational REVEAL-AFMR registry enrolled patients with moderate-to-severe AFMR in 2019. Patients were stratified into CRAS and non-CRAS groups based on the simultaneous presence of HF, CKD, and anemia. The primary outcome was a composite of all-cause death and HF hospitalization. Among the 957 patients analyzed, 243 had CRAS. Over a median follow-up period of 1,043 days, 279 composite events occurred. Kaplan–Meier analysis demonstrated a higher incidence of composite outcomes in the CRAS group across all AFMR severities. Multivariable Cox regression analysis identified CRAS, older age, lower body mass index, and lower systolic blood pressure as independent predictors of cardiovascular events.

Conclusions: CRAS is common in AFMR and may be independently associated with an increased risk of future cardiovascular events. Assessment of CRAS may be helpful for risk stratification and management in this population.

Background: Coronary obstruction (CO) is a catastrophic complication of transcatheter aortic valve implantation (TAVI). Chimney stenting (CS) is one of the direct preventive measures for CO; however, data on its clinical course and characteristics are limited. We evaluated mid- to long-term outcomes of prophylactic CS during TAVI using supra-annular self-expanding bioprostheses.

Methods and Results: Among 315 consecutive TAVI procedures with supra-annular self-expanding valves between November 2015 and April 2022, 14 patients at high risk for CO underwent prophylactic CS. The clinical outcomes of the CS group were investigated using a non-CS group (n=301) as a comparison reference. High-risk anatomy was identified by preprocedural computed tomography assessing the sinotubular junction, sinus of Valsalva, coronary height, and annular calcification. CS was performed when balloon aortic valvuloplasty with simultaneous aortography demonstrated absent coronary opacification or impending obstruction. Patients in the CS group were predominantly female with a smaller body size, smaller aortic root dimensions, and low left coronary height (9.6 vs. 12.5 mm; P<0.001). Dual antiplatelet therapy was administered in 93% of CS patients for a mean duration of 7.4 months. During a mean follow up of 4.3 years, mortality was similar to that of non-CS patients (log-rank P=0.756).

Conclusions: The clinical outcomes of prophylactic chimney stenting were comparable with the conventional TAVI cohort; therefore, it may be considered a therapeutic option for patients at high risk of CO during supra-annular self-expanding TAVI.

Background: Evidence for structured post-discharge programs to improve long-term physical function and activities of daily living (ADL) after transcatheter mitral valve edge-to-edge repair is limited.

Methods and Results: In a single-center cohort, patients receiving outpatient guidance at 3 and 6 months (n=34) were compared with those receiving none (n=11). At 1 year, the guidance group had higher SPPB (12 vs. 8, P=0.034), higher Barthel Index (100 vs. 95, P=0.008), and shorter 5-STS time (8.1 vs. 14.5 s, P=0.002).

Conclusions: Guidance was associated with better 1-year function/ADL, but findings are hypothesis-generating.

Background: The clinical impact of tricuspid regurgitation (TR) on the long-term prognosis of heart failure with preserved ejection fraction (HFpEF) remains unclear.

Methods and Results: We analyzed the data of 4,456 patients with HFpEF from the Japanese Registry of Acute Decompensated Heart Failure (JROADHF) and identified 83 patients hospitalized primarily for TR. They had a higher mortality rate than those without TR. The 1- and 4-year mortality rates in the TR group were comparable with those for patients hospitalized primarily for aortic stenosis.

Conclusions: Hospitalization for TR is associated with a poor prognosis in patients with HFpEF.

Background: Inclisiran is a siRNA therapy that provides sustained reduction in low-density lipoprotein cholesterol (LDL-C) with twice-yearly dosing, but real-world data after switching from PCSK9 monoclonal antibodies remain limited.

Methods and Results: We retrospectively analyzed 32 patients with coronary artery disease who transitioned from evolocumab to inclisiran. Median LDL-C was 27.0 mg/dL at baseline and remained stable at 3, 6, and 9 months (29.0, 30.5, and 29.5 mg/dL). Eight patients (25%) exceeded the LDL-C target (<70 mg/dL) at least once, more frequently among those with heterozygous familial hypercholesterolemia. Discontinuation occurred in 12.5%.

Conclusions: Switching to inclisiran generally maintained LDL-C levels, although patients with familial hypercholesterolemia may require closer monitoring.

Background: Transcatheter closure of a patent foramen ovale (PFO) during pregnancy is generally not recommended, because of concerns regarding fetal safety, procedural radiation exposure, and a lack of robust evidence. Postpartum intervention therefore is usually preferred. Pregnancy itself is a hypercoagulable state, and a subset of pregnant patients with PFO may face an unacceptably high risk of recurrent embolic events after pregnancy recognition, despite optimized medical therapy. How such exceptional situations should be evaluated remains insufficiently defined.

Methods and Results: This Statement/Opinion (SO) synthesizes current recommendations from the 2025 European Society of Cardiology guidelines on cardiovascular disease in pregnancy and the relevant literature, to propose a structured framework for decision-making regarding antepartum PFO closure. We focus on (1) rigorous maternal risk stratification, (2) multidisciplinary evaluation by a pregnancy heart team, and (3) procedural strategies to minimize fetal risk, including adherence to the “as low as reasonably achievable” (ALARA) principle. A representative clinical case illustrates application of this framework.

Conclusions: Antepartum transcatheter PFO closure should not be considered a routine therapeutic option during pregnancy. However, it should also not be considered an absolute contraindication when the anticipated maternal risk of recurrent embolic events clearly outweighs the fetal procedural risk under carefully controlled conditions. This SO provides a conceptual framework to guide clinical judgment in rare, highly selected cases, without advocating indications.