Yasunori Ueda

BACKGROUND: Coronary bifurcation lesions remain one of the most challenging lesions. In particular, satisfactory clinical outcomes have not yet been achieved for side branches. The use of drug-coated balloons (DCBs) has demonstrated acceptable clinical outcomes in native coronary arteries. This study aimed to evaluate the efficacy and safety of additional DCB inflation in the side branches of bifurcation lesions. METHODS: The OCVC-BIF study (Comparison of Drug-Coated Versus Conventional Balloons for the Side Branch of Bifurcation Lesions) was conducted as a multicenter, randomized, open-label trial. Patients with bifurcation lesions scheduled for drug-eluting stent (DES) implantation in the main vessel followed by kissing balloon inflation were enrolled in the study. The patients were randomized to receive either additional dilatation of the side branch using a DCB after DES implantation with kissing balloon inflation (DCB group) or only DES implantation with kissing balloon inflation using conventional balloons (non-DCB group). The primary end point was restenosis of the side branch, assessed using scheduled coronary angiography at 9 months or symptom-driven coronary angiography during the 1-year follow-up. Restenosis was defined as ≥50% stenosis of the side branch, determined using 3-dimensional bifurcation quantitative coronary angiography. The key secondary end points included major adverse cardiac events at 12 months, which were defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis. RESULTS: In total, 299 patients were randomized into the DCB (151 patients) and non-DCB (148 patients) groups between October 2019 and September 2024. Serial 3-dimensional bifurcation quantitative coronary angiography evaluation was performed in 262 (87.6%) patients. The restenosis rate was lower in the DCB group than that in the non-DCB group (8.1% versus 18.3%, P =0.012). However, the incidence of major adverse cardiac events at 12 months was similar between them (10.1% versus 12.4%, P =0.58). CONCLUSIONS: Additional DCB inflation in the side branch after main-vessel DES implantation with kissing balloon inflation decreases restenosis in the side branch in the treatment of bifurcation lesions. REGISTRATION: URL: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs052200077 ; Unique identifier: jRCTs052200077.

Introduction: Unlike most pulsed‐field ablation (PFA) systems, Affera (Medtronic) delivers unipolar energy between a lattice‐tip catheter and a cutaneous return patch, potentially generating a broader electric field. We hypothesized that this may attenuate voltage beyond ablated regions and tested this using spatially matched pre‐ and post‐ablation maps. Methods and Results: We retrospectively studied five consecutive patients undergoing primary atrial fibrillation ablation with the Affera system. Pre‐ and immediate post‐ablation voltage maps were generated using CARTO 3 and OCTARAY (Biosense Webster) with identical settings during right atrial pacing. Because Affera lacks point‐level 3D coordinates for spatial matching, coordinates (x, y, z) and bipolar voltages were extracted from CARTO 3. Pre‐ and post‐ablation points—outside energy delivery sites, excluding the annulus and left atrial appendage—were spatially matched using a 2 mm mutual nearest‐neighbor criterion. This yielded 3772 pairs. Bipolar voltages were averaged by case. Mean bipolar voltage decreased in all cases from 1.01 ± 0.61 to 0.56 ± 0.29 mV, representing a 40.2% reduction (95% CI, 24.6%–55.8%; p = 0.044). In a distance‐stratified analysis, residual bipolar voltage (post/pre × 100) was lowest just beyond the ablated zone and increased progressively with distance from the nearest application tag center (16.5% at 10–15 mm to 57.8% at 25–30 mm; all p < 0.001), becoming numerically comparable to baseline beyond approximately 30 mm. Conclusions: Affera‐based unipolar ablation produced acute bipolar voltage attenuation that extended into non‐ablated myocardium adjacent to the lesion set but diminished with distance and was largely confined within approximately 30 mm of the application sites.

Background: Female sex has been associated with poor prognosis in hypertrophic cardiomyopathy (HCM), but the factors contributing to this disparity remain insufficiently defined. We aimed to clarify sex differences in clinical characteristics and factors associated with cardiovascular death in Japan. Methods: This multicenter, retrospective observational study of HCM was conducted between January 1, 2006, and December 31, 2018 (REVEAL‐HCM study [Multicenter Registry to Evaluate Risk Factors for Disease Progression, Sudden Cardiac Death and Adverse Clinical Outcomes in Japanese Patients With Hypertrophic Cardiomyopathy]; UMIN000046932). Patients aged ≥16 years with HCM were enrolled. Baseline characteristics and clinical outcomes including cardiovascular death were assessed. Univariable and multivariable Cox proportional hazards models were used to identify factors associated with cardiovascular death. Results: Of 3247 patients (median age, 67 years; 43% women), women were older and more symptomatic at presentation (52% New York Heart Association class II–IV versus 35% in men). Cardiovascular death was more common in women (hazard ratio [HR], 1.37 [95% CI, 1.02–1.82]; P =0.03). In multivariable analysis, older age (per 1‐year increase; HR, 1.04 [95% CI, 1.02–1.06]), advanced New York Heart Association class (HR, 1.99 [95% CI, 1.40–2.82]), history of atrial fibrillation (HR, 1.55 [95% CI, 1.10–2.18]), greater maximal wall thickness indexed to body surface area (per 1‐mm/m ² increase; HR, 1.12 [95% CI, 1.06–1.20]), and apical HCM (HR, 0.53 [95% CI, 0.32–0.88]) were independently associated with cardiovascular death, attenuating the HR for female sex. Conclusions: Sex differences in clinical characteristics and outcomes were observed. The excess cardiovascular death in women with HCM was largely explained by older age, more advanced symptoms, greater indexed wall thickness, and sex‐specific differences in both the prevalence and prognostic impact of apical HCM.

Background: The potential value of low‐voltage area (LVA) ablation for persistent atrial fibrillation (AF) has been suggested. However, its efficacy determinants remain unclear. We investigated the impact of diabetes on the outcomes of LVA ablation in patients with persistent AF. Methods: This post hoc subanalysis of the multicenter randomized controlled trial SUPPRESS‐AF (Efficacy and Safety of Low‐Voltage‐Guided Ablation for Recurrence Prevention Compared With Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation) included patients with persistent AF undergoing initial ablation. Following pulmonary vein isolation (PVI), patients with LVAs were randomized to PVI+LVA‐ablation or PVI alone. We compared recurrence‐free survival between patients with and without diabetes. The primary end point was freedom from AF/atrial tachycardia recurrence. Results: Of 1347 patients with persistent AF, 343 (25.5%) had left atrial LVAs. The nondiabetic group comprised 264 patients (136 and 128 in the PVI‐alone and PVI+LVA‐ablation arms, respectively), and the diabetic group comprised 77 patients (35 and 42 in each arm, respectively). No significant difference was observed in LVA extent between the groups. Overall recurrence rates were also similar (44% versus 42%; P =0.658). In the nondiabetic group, the PVI+LVA‐ablation arm showed significantly lower recurrence rates compared with the PVI‐alone arm (35% versus 49%; P =0.018). Conversely, patients with diabetes exhibited higher recurrence rates in the PVI+LVA‐ablation arm compared with those in the PVI‐alone arm (48% versus 40%; P =0.290). A significant interaction was observed between diabetes status and LVA ablation efficacy ( P for interaction=0.041). Conclusions: In this exploratory post hoc analysis, LVA ablation may benefit patients without diabetes, whereas no clear benefit, and a possible signal of futility, was observed in patients with diabetes.

Background: Guide extension catheters are specially designed for percutaneous coronary intervention (PCI) to enhance backup support of the guide catheter by providing coaxial alignment, thereby allowing deep intubation of the catheter. We have developed an innovative auxiliary support technique utilizing a dual guide extension catheter system, designed to enhance safety and facilitate deep coronary artery access. Case summary: A male in his sixties who presented with chest pain was diagnosed with non-ST elevation myocardial infarction. Percutaneous coronary intervention failed to achieve complete revascularization due to the presence of extensive chronic total occlusion (CTO) in the right coronary artery (RCA). A staged percutaneous intervention was performed to treat the tortuous CTO lesion. Dual guide extension catheters (DGEC), consisting of a 6 Fr Guideplus™ in the 8 Fr GuideZilla II™, were introduced. The Guideplus™ was deeply inserted into the distal RCA through the GuideZilla II™ support. This system provided a stable catheter platform, enabling successful negotiation of the guidewire and delivery of the catheter across the extensive, markedly tortuous segment of CTO of the RCA. Thereafter, the RCA was completely recanalized through stenting and balloon angioplasty following antegrade guidewire penetration. Subsequently, enhanced backup force of the DGEC was demonstrated through in vitro force gauge testing, suggesting that this novel technique might be promising for interventions for CTO in vessels with severe tortuosity. Discussion: The DGEC system facilitates substantial guide catheter backup support in the context of PCI for severely tortuous total occlusive disease.

Background: Drug‐coated balloons (DCBs) for femoropopliteal (FP) lesions have demonstrated superiority over standard percutaneous transluminal angioplasty (PTA) in maintaining vessel patency. However, data on whether the good durability of DCBs translates into improved wound outcome in chronic limb‐threatening ischemia (CLTI) patients are limited. Aims: The aim of this study was to compare the effectiveness of FP‐DCBs with that of standard PTA in achieving superior wound healing outcomes in CLTI patients. Methods: This was a sub‐analysis of the multicenter, retrospective, observational SAPLING (SAtellite database of Patients with chronic Limb‐threateniNG Ischemia) registry. CLTI patients with tissue loss who underwent endovascular therapy for FP lesions with either DCBs or PTA were analyzed using propensity score matching. Patients were classified into the DCB group or the PTA group. The primary outcome measure was 2‐year wound healing. Results: A total of 701 limbs were included in this study. After propensity score matching, the 2‐year cumulative incidence of wound healing was not significantly different between the DCB and PTA group (76.7% vs. 67.5%; hazard ratio: 1.129; 95% confidence interval: 0.861−1.480, p = 0.382). Interaction analysis demonstrated that DCB use was associated with a higher wound healing rate in patients with Wound grade 2 or 3 ( p for interaction = 0.002) and foot Infection grade 2 or 3 ( p for interaction = 0.03) in the Wound, Ischemia, and foot Infection classification. Conclusions: DCB use for FP lesions was not significantly associated with superior wound healing in patients with CLTI. However, DCB may offer benefits for patients with higher wound and foot infection grades.

Background: Although extracorporeal cardiopulmonary resuscitation (ECPR) is expected to improve outcomes in patients with cardiac arrest (CA), its impact on prognosis in acute myocardial infarction (MI) patients complicated by CA remains unclear. This study aimed to investigate the short- and long-term effects of ECPR on prognosis in these patients.Methods and Results: This single-center, retrospective study analyzed consecutive MI patients. Patients were classified into 3 groups: CA requiring ECPR (ECPR group); CA achieving return of spontaneous circulation without ECPR (CCPR group); and without CA (non-CA group). The primary endpoint was 30-day mortality, while long-term all-cause mortality, cardiovascular death, and major adverse cardiovascular events were evaluated among discharged patients. Of the 625 patients analyzed, 57 were in the ECPR group, 104 in the CCPR group, and 464 in the non-CA group. Multivariable analysis revealed that the ECPR group had a significantly higher prevalence of 30-day mortality than the CCPR group (adjusted hazard ratio [HR] 3.99; 95% confidence interval [CI] 2.23–7.13) and the non-CA group (HR 43.48; 95% CI 19.70–95.92). However, there were no significant differences in long-term outcomes among the 3 groups.Conclusions: The 30-day mortality was worse in the ECPR group than in the CCPR or non-CA groups. In contrast, the long-term prognosis was comparable among discharged patients, regardless of the presence of CA or the need for ECPR.