ABSTRACT Background Real‐world data after percutaneous coronary intervention (PCI) using drug‐coated balloons (DCBs) in acute coronary syndrome (ACS) are limited. Aims We compared 1‐year clinical outcomes after PCI with paclitaxel DCBs between the ACS and non‐ACS patients. Methods The ALLIANCE is a prospective, multicenter registry of PCI using paclitaxel DCBs. Primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization. Secondary endpoints included all‐cause mortality at 1 year. Adverse events were adjudicated by an independent committee. Propensity score matching was performed to adjust for baseline differences between the ACS and non‐ACS patients. Results From July 2023 to February 2024, 1794 patients with de novo lesions (ACS 513 [28.6%] and non‐ACS 1281 [71.4%]) were enrolled at 57 medical institutions in Japan. Mean age was 71 years, and 76% were male. Among ACS patients, 34.7% had ST‐segment elevation MI, 33.9% non–ST‐segment elevation MI, and 31.4% unstable angina. Intracoronary imaging was used in 88.5% of lesions. Bailout stenting after DCB angioplasty was required in only 1.1% of 1984 lesions. Technical success, defined as post‐procedural residual stenosis < 40% and absence of flow‐limiting coronary dissection, was significantly lower in patients with ACS than those with non‐ACS. At 1 year, TLF occurred in 7.0% of ACS and 3.8% of non‐ACS patients (adjusted HR 1.83; 95% CI 1.06–3.17, p = 0.03). All‐cause mortality was 6.4% and 3.3%, respectively (adjusted HR 2.06; 95% CI 1.13–3.75, p = 0.02). Conclusions One‐year TLF and all‐cause mortality were significantly higher in ACS than non‐ACS patients treated with paclitaxel DCBs in real‐world clinical settings. Registration: Japan Registry of Clinical Trials ( https://jrct.mhlw.go.jp ); unique identifier: jRCT1032230218.
ABSTRACT Background Frailty is highly prevalent among elderly patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI) and is associated with adverse clinical outcomes and impaired health‐related quality of life. However, different frailty assessment tools vary in their conceptual frameworks, assessment domains, and predictive performance, and their applicability in elderly PCI populations remains unclear. Aims To compare four commonly used frailty assessment tools, including the Frailty Phenotype (FP), FRAIL scale, Tilburg Frailty Indicator (TFI), and Frailty Index (FI), and to investigate their associations with quality of life in elderly patients with CHD undergoing PCI. Methods This cross‐sectional study included 244 elderly patients with CHD undergoing PCI at a tertiary hospital in Shanghai from August to December 2024. Frailty was assessed using the Frailty Phenotype (FP), FRAIL scale, Tilburg Frailty Indicator (TFI), and Frailty Index (FI), and quality of life using the 12‐Item Short Form Health Survey (SF‐12). Agreement was evaluated using the Kappa statistic. Associations with physical component summary (PCS) and mental component summary (MCS) scores were assessed using correlation and multivariable linear regression, while discriminatory performance was examined using receiver operating characteristic (ROC) and Bayesian discriminant analyses. Results Mean PCS and MCS scores were 40.08 ± 11.23 and 52.30 ± 7.82, respectively. Frailty prevalence was 40.6% by FP, 8.6% by FRAIL, 28.3% by TFI, and 22.1% by FI. Agreement was fair to moderate (Kappa = 0.242–0.496). Higher frailty scores were independently associated with lower PCS and MCS after adjustment for age, sex, education, smoking, and comorbidity burden. FP and FI showed comparable discrimination for PCS, whereas TFI had the highest AUC for MCS. Classification accuracy was highest for FP in PCS and TFI in MCS (both 79.51%). Conclusion Frailty was consistently associated with poorer quality of life. FP and FI performed similarly for physical health, whereas TFI showed the most favorable performance for mental health.
ABSTRACT Background Catheter‐directed therapies for acute pulmonary embolism (PE) are being adopted rapidly, yet real‐world safety data remain limited. Aims To characterize adverse events, device failure patterns, and mortality signals for three FDA‐cleared catheter‐directed PE platforms (EKOSONIC, INDIGO, and FlowTriever) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods Medical device reports (MDRs) were downloaded from each device's PE clearance (2008, 2015, and 2018, respectively) through March 2026 and filtered by text to retain PE‐specific reports. Reports were classified by manufacturer, event type (death, injury, malfunction), device problem, and patient problem, and trends were assessed by calendar year. Results Of 2528 reports, 389 were PE‐specific (INDIGO 228 [58.6%], EKOSONIC 149 [38.3%], FlowTriever 12 [3.1%]), spanning 2009 to January 2026. There were 76 deaths (19.5%), 133 injuries (34.2%), and 180 malfunctions (46.3%). Annual death reports rose from 2023 (15 in 2023, 13 in 2024, 8 in 2025, and 3 in January 2026). Among 47 INDIGO deaths, 28 (59.6%) involved Lightning/Flash large‐bore catheters, and 36 (76.6%) carried a perforation‐, hemoptysis‐, tamponade‐, or extravasation‐related patient problem code. Separator wire break/fracture was the leading INDIGO device failure. EKOSONIC reports showed thrombolytic‐related bleeding, including intracranial or cerebral hemorrhage in 12 reports (8.1%). Conclusions MAUDE reports reveal distinct device‐specific safety signals: pulmonary artery perforation with large‐bore INDIGO aspiration catheters, and intracranial hemorrhage with EKOSONIC. Death reports increased from 2023 as mechanical thrombectomy use expanded. Absent procedural denominators, rates and causality cannot be inferred; findings support operator awareness, careful patient selection, and continued post‐market surveillance.
ABSTRACT Systemic atrioventricular valve (SAVV) regurgitation contributes importantly to systemic right ventricular deterioration in adults with congenitally corrected transposition of the great arteries (ccTGA) and dextro‐transposition of the great arteries ( d ‐TGA) after atrial‐switch repair. Transcatheter edge‐to‐edge repair (TEER) has emerged as an option for selected patients at high or prohibitive surgical risk, and prior congenital series have established the feasibility of transseptal, transbaffle, and alternative access strategies. However, procedural execution remains highly anatomy‐dependent because systemic venous pathways, atrial baffles, ventricular topology, cardiac orientation, and access‐to‐valve geometry can substantially alter guide‐catheter support and device coaxiality. We report a single‐center Interventional Rounds experience of four consecutive high‐risk adults undergoing SAVV‐TEER across four distinct transposition anatomies: ccTGA with dextrocardia, d ‐TGA after Mustard atrial‐switch repair, Mustard anatomy with severe iliofemoral tortuosity, and ccTGA with interrupted inferior vena cava and azygos continuation. Transfemoral access was used in two patients, and right internal jugular access in two. Three procedures were performed with PASCAL ACE and one with MitraClip. Device implantation was successful in all four patients, with SAVV regurgitation reduced from severe (3+) to mild (1+). Final mean SAVV gradients were 1.5, 2.1, 1.9, and 1.8 mmHg, respectively, and no major acute procedural complications occurred. The principal technical message is that access selection should be guided not only by anatomic patency but by the anticipated mechanical trajectory of the delivery system. Right internal jugular access may be selected prospectively as the preferred primary route when inferior venous anatomy is absent or expected to provide unfavorable curvature, support, or device alignment. Dextrocardia and atrial‐switch baffle anatomy may additionally require specific steering and traversal adaptations. These observations represent focused procedural refinements within the evolving congenital TEER experience rather than evidence of comparative efficacy or safety.
ABSTRACT Background Angina with non‐obstructive coronary arteries (ANOCA) is an underrecognized cause of angina with non‐universal diagnostic techniques and patient management strategies. Among ANOCA testing, vasospasm provocation is not always performed mainly due to differences in institutional availability. Aims Using the FlowLab Study, we quantified vasospasm prevalence among patients with ANOCA at US centers and compared physician decision‐making, endotype distribution, and management between sites that did and did not include vasospasm testing in their workup. Methods The FlowLab Study was a prospective, multicenter, US‐based study of patients who were referred for coronary angiography and underwent ANOCA testing using the bolus thermodilution method. Presumed diagnosis before cardiac catheterization and final diagnosis after ANOCA testing were compared between participating sites with or without acetylcholine testing availability. Results A total of 253 procedures at 14 US sites were included in this study. There were 155 procedures among sites performing spasm provocation testing and 98 procedures among sites not performing spasm provocation testing. Prior to cardiac catheterization, sites with spasm provocation testing were less likely to suspect epicardial coronary artery disease as the cause of angina compared to sites without (27% vs. 59.2%, p < 0.0001). A diagnosis of CMD was made more frequently at sites performing spasm testing compared to sites not performing spasm testing (68% vs. 29.6%, p < 0.0001). Similarly, among 125 patients who underwent spasm provocation testing, diagnostic yield increased from 34.4% with bolus thermodilution alone to 84.8% after the addition of spasm provocation testing ( p < 0.001). In these patients, intensification involving calcium channel blockers was more frequent with epicardial (67%) and microvascular spasm (41%) than without spasm (24%, p = 0.001). Conclusions In contemporary US practice, adding spasm provocation testing to bolus thermodilution more than doubled diagnostic yield and was followed by medication changes directed toward the diagnosed endotype. Differences between sites with and without spasm testing also reflected variation in procedural practice.
