Xin Li

Objective: To evaluate the efficacy and safety of a novel single-use peripheral intravascular ultrasound (IVUS) system in a porcine model. Methods: Six healthy white pigs were randomized into 2 groups. The Efficacy Valuation Group (group A, self-controlled, n = 3) underwent imaging before and after stent implantation with both the test device (automated pullback) and a control IVUS system (manual pullback). The Safety Evaluation Group (group B, n = 3) was imaged with the test device only for safety and pathological evaluation. Endpoints included mean stent cross-sectional area (MSA), stent length, measurement agreement, image quality, device usability, vital signs, adverse events, and vascular safety. Results: For the primary endpoint, the 95% confidence intervals (CIs) for the relative difference in MSA between devices fell within the prespecified ±10% equivalence margin at both low-speed (2.010%-4.649%) and high-speed (0.844%-6.968%) pullback, as confirmed by two one-sided tests (TOST). A prespecified subgroup analysis by vessel type (arterial vs venous) confirmed consistent equivalence within each subgroup. The 95% limits of agreement for MSA were within ±1.5 mm ² for both speeds. Stent length measurements correlated excellently with digital subtraction angiography ( r = .997, P < .0001). Lumen measurements showed good inter-device agreement. Both systems achieved a 100% image-quality excellence rate. Operators rated the test device significantly higher for overall usability (4.8 ± 0.4 vs 4.5 ± 0.5, P < .05). All animals remained hemodynamically stable with no device-related adverse events, and pathological examination revealed no significant vascular injury. It should be noted that key study limitations include the comparison of automated versus manual pullback, potential data clustering from multiple measurements per animal, and the use of a healthy animal model that does not replicate human atherosclerotic disease. Conclusion: In a porcine model, the novel high-frequency automated-pullback IVUS system demonstrated imaging efficacy noninferior to a control device, with a favorable safety profile and no observed complications. These preclinical findings support its further clinical investigation for peripheral vascular interventions. Clinical Impact: This preclinical study demonstrates that a novel peripheral IVUS system, featuring a higher-frequency transducer (30 MHz) and automated pullback, achieves imaging efficacy and acute safety comparable to a control device in a porcine model. The higher-frequency design may improve resolution, and automated pullback enables standardized, operator-independent measurements. These features could enhance procedural planning for complex interventions. The system clearly visualized vessel microstructures, supporting more precise device selection with the potential to improve outcomes in precision vascular medicine. Future clinical studies are warranted to translate these advancements into clinical benefits for patients with atherosclerotic arterial or relevant venous diseases.

Background: Right-sided aortic arch with Kommerell diverticulum (RAA-KD) has complex three-dimensional anatomy. Methods: We retrospectively analyzed computed tomography angiography data from 65 adults with RAA-KD using centerline-based reconstruction. Patients were stratified by conventional maximal KD diameter (D_KDmax) into n = 38) and ≥55 mm (n = 27) groups. Age associations, adjusted group differences, and continuous associations with centerline-derived KD diameter at maximal cross-sectional area (D₁₀) were examined. Results: After sex adjustment and false-discovery-rate correction, all aortic diameters increased with age; the ascending aorta, arch, and descending thoracic aorta also elongated, whereas aortic isthmus (L₄) and KD (L₅) lengths were not age-associated. After age and sex adjustment and false-discovery-rate correction, diameters of the ascending aorta, aortic arch, and descending thoracic aorta (D₂–D₈), as well as KD-related diameters (D₉–D₁₂), remained larger in the ≥55 mm group; L4 was shorter and L5 longer. In continuous models, D₁₀ was positively associated with all non-KD diameters, most strongly with the adjacent proximal descending aorta (D₇), and independently associated with shorter L₄ (B = −0.548; 95% CI, −0.828 to −0.268) and longer L₅ (B = 0.639; 95% CI, 0.412–0.866; both p < 0.001). Conclusions: RAA-KD demonstrates generalized age-associated thoracic aortic enlargement and localized KD-associated remodeling. Comprehensive three-dimensional assessment may inform evaluation of the adjacent aorta and proximal sealing zone for thoracic endovascular aortic repair.

Aims: Heart failure (HF) is a major global public health challenge, with obesity being one of its key risk factors. Although several HF risk prediction models have been developed in the general population, few are specifically tailored to individuals with obesity. This underscores the urgent need for precise biomarkers to improve individual risk stratification and enable personalized prevention strategies. We aimed to develop and validate a plasma proteomics‐based protein risk score (PRS) to predict incident HF among individuals with obesity. Materials and Methods: We analysed 9831 participants with obesity (BMI ≥ 30 kg/m ² ) from the UK Biobank with baseline measurements of 2911 circulating proteins and up to 16 years of follow‐up. Multivariable Cox regression identified proteins associated with incident HF after comprehensive covariate adjustment. A PRS was constructed using LASSO regression and evaluated in a held‐out test set. Protein trajectories before HF onset were reconstructed using LOESS modelling. To enhance clinical feasibility, a minimal protein panel was identified using LightGBM with forward feature selection. Results: A total of 727 participants developed HF during follow‐up. Multivariable cox analyses identified 578 proteins significantly associated with HF. LASSO regression further selected 81 proteins to build the PRS, which showed a strong association with HF risk in both training (HR 3.57; 95% CI 3.19–4.00) and test cohorts (HR 2.45; 95% CI 2.20–2.74). Adding the PRS improved prediction beyond age and sex (Δ C = 0.091) and beyond the Pooled Cohort Equations to Prevent Heart Failure (PCP‐HF) model (Δ C = 0.052), with consistent gains in NRI and IDI. Proteomic deviations were detectable up to 16 years before diagnosis. A four‐protein panel (GDF15, NT‐proBNP, TNFRSF10B, CTHRC1) achieved robust discrimination (AUC 0.789), outperforming NT‐proBNP alone (AUC 0.695) and complementing the PCP‐HF model (combined AUC 0.803). Discussion: Large‐scale plasma proteomics substantially improves HF risk prediction in individuals with obesity and reveals long‐standing molecular alterations preceding clinical onset. A simplified four‐protein panel maintains robust predictive accuracy and provides a practical approach for the early detection and targeted prevention of obesity‐related HF.

Objective: To evaluate the feasibility and early outcomes of a curvature-guided strategy that guides dual-branch revascularization during Zone 1 Thoracic Endovascular Aortic Repair (TEVAR) based on whether the aortic pathology is predominantly located on the greater or lesser curvature of the arch. Methods: In this retrospective, descriptive study (February 2023–June 2024), 43 consecutive patients were included under a predefined anatomical protocol. Of these, 3 patients (7.0%) were lost to follow-up and were included in the analysis of baseline characteristics and perioperative outcomes. The remaining 40 patients constituted the per-protocol follow-up cohort. Pathologies predominantly on the aortic arch’s greater curvature (n = 21) were managed with a Castor single-branched stent-graft for the left subclavian artery (LSA) and a left common carotid artery (LCCA) chimney stent. Those on the lesser curvature (n = 22) received a physician-modified endograft (PMEG). The primary outcome was technical success; secondary outcomes included safety, branch patency, and reintervention. Results: The overall technical success rate was 97.7% (100% in the Castor-chimney cohort [21/21] vs. 95.5% in the PMEG cohort [21/22]). No perioperative stroke, spinal cord ischemia, or retrograde type A dissection occurred in either cohort. Two type II endoleaks were observed: one intraoperative in the Castor-chimney cohort and one during follow-up in the PMEG cohort. Among the 40 patients (20 per cohort) who completed a median follow-up of 22.5 months, freedom from aortic-related reintervention was 95% (38/40), with one reintervention occurring in each cohort. Branch patency was 100% (20/20) in the PMEG cohort, whereas it was 95% (one asymptomatic LSA occlusion) in the Castor-chimney cohort. Conclusions: The implementation of a curvature-guided protocol, which rationally matches endograft techniques to arch anatomy, suggests acceptable early safety and efficacy for complex Zone 1 TEVAR. This anatomy-driven framework offers a potential personalized approach to dual-branch revascularization and warrants prospective validation.

Objective: To compare perioperative outcomes between resuscitative endovascular balloon occlusion of the aorta (REBOA) and non-REBOA management in ruptured abdominal aortic aneurysm (rAAA) repair, and to perform an exploratory comparison of REBOA outcomes between open surgical repair (OSR) and endovascular aortic repair (EVAR). Methods: A retrospective analysis was conducted of 107 consecutive rAAA patients (2013-2022), stratified by surgical approach (OSR vs EVAR) and REBOA utilization. Propensity score matching (1:2) was performed based on preoperative shock, comorbidities, and aneurysm morphology, yielding 22 REBOA and 44 non-REBOA patients. Outcomes were compared statistically. Results: Resuscitative endovascular balloon occlusion of the aorta was utilized in 22 patients (10/45 [22.2%] OSR and 12/62 [19.4%] EVAR), with a 100% technical success rate. One Clavien-Dindo grade I access site hematoma occurred (4.5%). No instances of aortic injury, distal embolization, limb ischemia, or balloon failure were observed. After matching, 30-day mortality did not differ significantly (13.6% vs 22.7%, p=0.555). Resuscitative endovascular balloon occlusion of the aorta was associated with a significantly reduced rate of major adverse cardiovascular event (MACE) (4.5% vs 20.5%, p=0.043) and a higher intraoperative diastolic blood pressure (BP) (mean difference+6.7 mm Hg, p=0.031). Blood loss, intensive care unit stay length, and costs were comparable between groups. Long-term survival was similar (log-rank p=0.375). In an exploratory analysis, outcomes between REBOA-OSR (n=10) and REBOA-EVAR (n=12) subgroups showed no significant differences in mortality or MACE, although this analysis was underpowered. Conclusions: Resuscitative endovascular balloon occlusion of the aorta demonstrated high technical success and an excellent safety profile in rAAA repair. Its use was associated with improved intraoperative hemodynamic stability (higher diastolic BP) and a reduced rate of MACE, although it did not significantly impact mortality or survival. Larger, prospective trials are warranted to confirm the observed reduction in MACE. The comparative outcomes of REBOA in OSR versus EVAR settings remain inconclusive due to the limited sample size. Clinical Impact: This study demonstrates that resuscitative endovascular balloon occlusion of the aorta (REBOA) in ruptured abdominal aortic aneurysm (rAAA) repair is safe and feasible, and is associated with improved intraoperative hemodynamics and reduced major adverse cardiovascular events. For clinicians, these findings support its use for unstable rAAA patients, particularly those with refractory shock or challenging anatomy. Resuscitative endovascular balloon occlusion of the aorta may serve as both a resuscitative and a cardioprotective strategy by augmenting coronary perfusion. The innovation lies in validating its contemporary safety and proposing a mechanism for cardiac benefits, potentially changing risk-benefit assessments in emergency aortic surgery.

Objective: To evaluate the early-term outcomes of endovascular repair for zone 2 aortic arch pathologies using the Castor single-branched stent-graft, with adjunctive chimney technique employed when extending for proximal extension into zones 1 and 0. Methods: A s ingle-center retrospective study was conducted on 63 patients (mean age=57.0±13.4 years; 55 males, 87.3%) with zone 2 aortic pathologies treated between February 2023 and June 2024. Proximal landing zones determined treatment strategy: Standard zone 2 landing (n=37, Castor branch in left subclavian artery [LSA]); extended zone 1 landing (n=20, Castor branch in LSA+LCCA chimney); extended zone 0 landing (n=6, Castor branch in LCCA+innominate artery (IA) chimney+selective LSA revascularization based on vertebral artery dominance). Baseline characteristics, procedural data, and outcomes were analyzed to assess technical success, perioperative/follow-up complications, reinterventions, and branch patency. Outcomes were described separately for each landing zone cohort (zones 2, 1, and 0). Results: The overall technical success was 96.8% (61/63). No mortality, stroke, paraplegia, retrograde type A aortic dissection/ (RTAAD), endoleak, or upper limb ischemia occurred within the 30-day postoperative period. During a mean follow-up of 17.4±5.5 months, the overall endoleak rate was 1.6% (1/63), comprising a single zone 2 landing type II endoleak (LSA backflow) detected at the 3-month follow-up. No graft-related type I/III endoleaks occurred. Branch occlusion occurred in 1.6% of cases (1/63), involving the Castor LSA branch in a zone 1 landing case at 10 months. All chimney stent-grafts maintained patency. Reinterventions (3.2%, 2/63) comprised: one zone 2 landing type II endoleak, and one zone 1 landing complications (LSA occlusion). All-cause mortality was 1.6% (1/63, occurring at 11 months postoperatively in a zone 1 landing patient due to non-aortic-related causes). Conclusions: The Castor single-branched stent-graft enabled effective zone 2 reconstruction. Combined with chimney technique, it facilitated treatment extension into zone 1 and exploratory applications in zone 0. The results for each strategy demonstrate high technical success, a favorable safety profile, high branch/chimney patency rates, and low-complication rates. Clinical Impact: This study demonstrates that the Castor single-branched stent-graft is safe and effective in endovascular repair of zone 2 aortic arch pathologies. Combined with a chimney stent, its application can be successfully extended to zone 1 and exploratory zone 0 cases. This hybrid strategy provides a minimally invasive endovascular alternative for complex arch pathologies, particularly in patients at high surgical risk or ineligible for custom-made devices. This work contributes by providing the first detailed perioperative and follow-up data for this combined approach, including preliminary technical experience in highly selected zone 0 reconstructions, thereby enriching the evidence base for endovascular arch repair.

Objectives: To identify potential pathophysiological connections between intravascular ultrasound virtual histology (IVUS-VH) analyzed plaque characteristics and laboratory data while verifying possible connections with long-term clinical outcomes in real-world clinical practice. Materials and Methods: This retrospective study analyzed clinical data from 54 consecutive patients undergoing endovascular therapy (EVT) in our department between June 2019 and June 2023. The data set encompassed comprehensive parameters including IVUS-VH imaging findings, laboratory data, procedural details of interventional treatments, and post-operative clinical outcomes. Patients’ IVUS-VH data were analyzed in relation to laboratory data (D-dimer, C-reactive protein [CRP], triglycerides, total cholesterol, NRL, etc) and clinical outcomes (ABI change, survival rate, major amputation rate, primary patency, and re-intervention rate). Results: The average age of the 54 patients is 66.8±11.2 years old. Among them, 35 patients (64.8%) experienced rest pain, and 19 patients (35.2%) experienced claudication. All patients successfully underwent IVUS and IVUS-VH. General IVUS data for the most severe sections included: minimal area 4.4±2.2 mm ² , minimal diameter 2.0±0.5 mm, total lesion area 24.6±7.2 mm ² , and plaque burden 86.6±5.7%. The IVUS-VH data includes (1) the fibrotic plaque area, which is 13.3±5.3 mm ² ; (2) the Fibro-fatty area, which is 9.1±4.0 mm ² ; (3) the necrotic core area, which is 1.8±1.5 mm ² ; and (4) the dense calcium area, which is 0.5±0.5 mm ² . During the correlation analysis of IVUS-VH data, we find that a significant negative correlation between dense calcium and fibro-fatty plaque area (r=−0.380, p=0.005; q=0.028). In addition, the CRP levels were significantly positively correlated with dense calcium area (r=0.411, p=0.004; q=0.024) and negatively correlated with fibro-fatty plaque area (r=−0.324, p=0.026; q=0.048). Conclusions: In CLTI patients, dense calcium and fibro-fatty plaque areas are negatively correlated in IVUS-VH data. The CRP levels are positively correlated with dense calcium lesion area and negatively correlated with fibro-fatty plaque lesion area in CLTI patients. These findings are consistent with research in coronary arteries. This study did not find correlations between IVUS-VH data and other clinical outcomes; however, a larger data set and longer follow-up may provide new insights in the future. Clinical Impact: This study provides insights into plaque phenotyping in chronic limb-threatening ischemia (CLTI) by demonstrating correlations between C-reactive protein (CRP) levels and specific intravascular ultrasound-virtual histology (IVUS-VH) plaque components (dense calcium and fibro-fatty tissue). This suggests that CRP, a readily available biomarker, may reflect underlying plaque morphology in peripheral arteries, similar to coronary findings. Clinically, these results highlight the potential of integrating systemic inflammatory markers with advanced imaging for more comprehensive risk assessment. Although not yet predictive of long-term outcomes, this integrative approach represents a step toward personalized therapy in CLTI and encourages future research into interventions targeting specific plaque compositions.

Background: Stress hyperglycemia ratio (SHR) is closely related to adverse clinical outcomes. However, the link between general population all‐cause mortality (ACM) and cardiovascular mortality (CVM) remains undetermined. Thus, this research was designed to investigate the associations between SHR and ACM and CVM. Methods: The research data are sourced from NHANES. The correlations between SHR and death were examined via multivariate Cox proportional hazards models. These models were adjusted for clinical, socioeconomic, and demographic characteristics. Potential nonlinear relationships were estimated via restricted cubic spline (RCS) analysis. Predictive accuracy was measured by time‐dependent ROC curves, and mortality risk across SHR quartiles was examined by Kaplan–Meier survival curves. Age, sex, race, BMI, level of education, smoke, and poverty‐income ratio were used as subgroups to investigate potential moderators of the effect. Results: About 1847 people died from any cause and 589 from cardiovascular disease throughout the median follow‐up period of 97 months. SHR was negatively associated with ACM (HR: 0.77, 95% CI: 0.68–0.88) and CVM (HR: 0.73, 95% CI: 0.60–0.90) when SHR was below the threshold values (SHR < 0.81 in ACM and SHR< 0.84 in CVM), whereas it was positively associated with ACM (HR: 1.10, 95%CI: 1.05–1.15) and CVM (HR: 1.08, 95%CI: 1.00–1.16) when it was above the threshold values. The ROC curve revealed that the SHR may serve as a predictor of ACM and CVM. Conclusions: SHR exhibits a nonlinear, threshold‐dependent association with ACM and CVM, and it may serve as a predictor of ACM and CVM.