Journal of Vascular Surgery最新文献

Objective: Transcatheter arterialization of the deep veins (TADV) has been demonstrated to be safe and effective among no-option chronic limb-threatening ischemia (CLTI) patients, who lack suitable treatment alternatives. This study reports clinical and economic outcomes based on pooled data from PROMISE I and II trials of TADV for no-option compared to propensity-matched standard of care (SoC) patients from the concurrent CLariTI natural history registry.

Methods: PROMISE I and II were single-arm, multicenter, prospective studies evaluating the safety and efficacy of TADV in no-option CLTI patients, assessed by an independent committee. Both the PROMISE and CLariTI cohorts included patients with Rutherford disease class 5 or 6. Propensity score matching (PSM) was performed on 118 TADV patients and 132 SoC patients based on age, sex, diabetes status, and Rutherford classification. Patients on dialysis at baseline were excluded from analysis. One-year clinical outcomes including limb salvage, overall survival, and amputation-free survival (AFS), were analyzed using Cox regression and Kaplan-Meier methods. Cost-effectiveness of TADV vs. SoC was evaluated using a decision-analytic Markov model, projecting outcomes over a lifetime horizon. One-year clinical event rates previously discussed were relied upon in conjunction with contemporary U.S. cost data, including the incorporation of the new technology add-on payment (NTAP) granted for TADV. The resulting incremental cost-effectiveness ratio (ICER), reported in Dollars per quality-adjusted life year (QALY) gained, was evaluated against established willingness-to-pay thresholds. Extensive scenario and sensitivity analyses were performed.

Results: After matching, 228 patients (114 matched pairs) were analyzed. At one year, compared to matched SoC, patients treated with TADV demonstrated superior limb salvage rates (74.6% vs. 57.8%, p=0.003), survival rates (86.4% vs. 71.1%, p=0.013), and AFS rates (64.9% vs. 39.1%, p<0.001). Over lifetime and under the base case assumptions, TADV (vs. SoC) provided an additional 1.15 QALYs (2.32 vs. 1.17), with increased costs of $24,738 ($101,235 vs. $76,497), and a projected survival gain of 2.33 life years. The base case ICER was $21,600 per QALY gained. TADV demonstrated to be highly cost-effective across the range of sensitivity analyses explored, including scenarios considering application of the NTAP.

Conclusion: TADV with the LimFlow System resulted in significantly improved limb salvage, survival, and AFS at one year compared to the SoC. Based on projections using a previously validated health-economic model, these improvements were shown to translate to meaningful lifetime benefits that help to justify the upfront cost of TADV, rendering it a cost-effective intervention for no-option CLTI patients.

Objectives: This study aimed to evaluate the incidence, degree, and potential predictors of rotational deviation in custom-made triple-branch endografts (Cook Medical, Bloomington, IN, USA) deployed in the aortic arch, and to assess its impact on technical and clinical outcomes.

Methods: This single-center retrospective study included 75 patients who underwent total endovascular aortic arch repair using custom-made Cook triple-branch devices between October 2018 and April 2025. Endograft rotational deviation was assessed by comparing intended and actual branch positions using clock-face orientation with three-dimensional centerline reconstruction. Anatomic variables, including arch, aortic and iliac tortuosity, and device specifications were analyzed to identify potential predictors of rotation. Patients were stratified into three groups based on total rotation: <20°, 20-40°, and >40°.

Results: Most patients (74.7%) had minimal rotation (<20°), while 17.3% had moderate (20-40°) and 8% severe (>40°) rotation. No significant differences in arch anatomy, aortic diameter, or graft dimensions were associated with rotation. However, higher iliac tortuosity index (p = 0.041) and smaller BCT branch diameter (p < 0.001) were significantly correlated with severe rotation. Arch tortuosity index did not significantly (p=0.088) impact graft rotation. Technical success was 96%, unaffected by rotational deviation. Although early stroke incidence was higher in patients with severe rotation (33.3%), this did not reach statistical significance (7.1% vs 0% in mild and moderate rotation, p = 0.089). Midterm outcomes, including mortality and reintervention, were comparable across groups.

Conclusions: The delivery system of the triple-branch Cook CMD demonstrates excellent precision, with limited graft rotation in the majority of cases. While there was a trend towards arch tortuosity in device rotation, iliac tortuosity was significantly associated with rotational deviation. Preoperative assessment of such anatomical factors may enhance procedural planning and reduce intraoperative challenges.

Background: In 2024, numerous scholars introduced the concept of "woundosome" in an editorial, highlighting the necessity of prioritizing perfusion and microcirculation function within patient wound areas. Building upon this foundation, we systematically compared this concept with the previously established angiosome theory.

Methods: A comprehensive search was performed across the Cochrane Central Register of Controlled Trials, Embase, and PubMed. Twenty-five relevant studies met the inclusion criteria, including four investigations employing wound blush (WB). We implemented a Bayesian network meta-analysis to evaluate angiosome-related studies and reviewed the literature on WB. Within the framework of the network meta-analysis, therapeutic efficacy was compared among direct revascularization (DR), indirect revascularization (IR), and indirect revascularization with collateral vessels (IRc). Primary outcome measures encompassed wound healing rate (WHR), amputation-free survival (AFS), and limb salvage rate (LSR).

Results: The network meta-analysis revealed that the DR was significantly higher than IR in WHR outcomes at 3, 6, and 12 months, as well as in the overall analysis. Additionally, IRc demonstrated a significant advantage over IR in both the 12-month and overall analyses. The SUCRA values for WHR indicated that DR achieved the highest ranking at 3-, 6-, and 12-months post-surgery. IRc SUCRA values at 6 months, 12 months, and in the overall analysis were comparable to those of DR. In terms of AFS, DR showed significantly higher results than IR at 6 months, 12 months, and in the overall analysis. LSR analysis indicated that both DR and IRc were significantly superior to IR at 12 months and in the overall analysis. The SUCRA curves for AFS and LSR revealed that DR and IRc had similar SUCRA values and higher compared to IR. In the second part of the study, we reviewed research related to wound blush (WB). Our findings indicated that WHR, LSR, and AFS were significantly higher in the WB+ group compared to the WB- group. The benefit of LSR in WB+ patients persisted for over three years, while there was no significant difference in DR/IR between the two groups. Notably, the proportion of DR patients in the WB+ group was higher than in the WB- group, suggesting that DR may increase the likelihood of WB+.

Conclusions: For endovascular treatment of CLTI disease, DR and IRc exhibit comparable efficacy across all three endpoints and are both superior to IR. WB reflects a focus on wound microcirculation and appears to better inform intraoperative decision-making and predict favorable clinical outcomes.

Objective: To compare the midterm outcomes after fenestrated and branched endovascular repair in male and female patients and to assess factors associated with sex-related outcomes.

Methods: Data from 423 patients who underwent fenestrated and/or branched endovascular repair between 2016 and 2021 in two aortic centers for degenerative aneurysm or postdissection involving the thoracoabdominal aorta and pararenal aorta were retrospectively collected. The cohort was dichotomized according to sex, and sex-related outcomes after fenestrated and/or branched endovascular repair were assessed. Cases managed for type I to III thoracoabdominal aortic aneurysms were analyzed separately from type IV and pararenal aneurysms. The implanted devices were custom-made devices (COOK Medical) or off-the-shelf t-branch (COOK Medical).

Results: Among 423 patients included, 73 (17.3%) were female. Female patients had more extensive disease, with 50.7% treated for type II/III thoracoabdominal aneurysms compared with 23.1% in male patients; consequently, female patients were more frequently treated with branched grafts. The estimated freedom from aorta-related mortality at 12 and 36 months was 99.1% and 93.4% in females and 98.6% and 95.7% in males, respectively (log rank P = .401). In multivariate analysis, female sex remained not associated with aortic-related mortality (hazard ratio [HR]: 0.62, 95% confidence interval [CI]: 0.20-1.91; P = .41). Freedom from aortic-related intervention at 12 and 36 months was 95.7% and 66.3% in females and 92.9% and 72.6% in males, respectively (log rank P = .588). Sex was not significantly associated with target vessel instability after multivariate analysis (HR: 1.28, 95% CI: 0.63-2.57; P = .497). Major adverse events (MAEs) were more frequent among female patients (9.5% vs 2.6%; P = .004) with a higher rate of myocardial infarction, acute renal failure with dialysis, and spinal cord ischemia. In multivariate logistic regression, female sex remained independently associated with a higher risk of MAEs (odds ratio: 0.222, 95% CI: 0.066-0.752; P = .015). In adjusted analysis, no independent association between sex and either device- or procedure-related complications was observed. The extent of aneurysm was not significantly associated with MAEs (HR: 1.137, 95% CI: 0.359-3.598; P = .828).

Conclusions: Female sex was independently associated with a higher risk of MAEs, whereas aneurysm-related mortality and rates of aortic reintervention were comparable between males and females at a midterm follow-up after fenestrated and branched endovascular aortic repair.