Journal of Vascular Surgery最新文献

Objective: Screening for abdominal aortic aneurysm defined as an infrarenal aortic diameter ≥30 mm reduces mortality, but managing patients with diameters of 25-29 mm is debated. Incorporating body surface area into diagnostic criteria may improve identification of those at risk of developing treatment-requiring aneurysms in this group. In a previous study, we defined a relative abdominal aortic aneurysm as an infrarenal aortic diameter ≥150% larger than expected, with the normal diameter calculated using body surface area as a scaling factor. This study aimed to determine if this criterion could identify those at risk of aneurysmal development among patients with aortic diameter of 25-29 mm at screening.

Methods: A cohort study was conducted on men with abdominal aortic diameters of 25-29 mm at AAA screening in Malmö, Sweden, with a median follow-up of 9.9 years. Growth rates were compared between the relative aneurysm group and the non-relative aneurysm group using a linear mixed-effects model to account for both fixed and random effects. Time and hazard ratio to reach 40 mm, a marker of significant aneurysmal progression, were assessed using a log-rank test and a Cox proportional hazards model, both adjusted for smoking status and diabetes.

Results: In a cohort of 270 men, three developed abdominal aortic aneurysms ≥55 mm. Baseline growth rate was 0.1 mm/year (95% CI: 0.0-0.3). Growth rates were increased by 0.4 mm/year (95% CI: 0.0-0.7) in the relative aneurysm group, and by 0.4 mm/year (95% CI: 0.2-0.7) in smokers. Median time to reach IAD ≥40 mm was 11.5 years for relative aneurysms, and was not reached for those without, with a significant difference shown by a log-rank test stratified for smoking (p=.009). Hazards ratio to reach IAD ≥40 mm for relative aneurysms was 2.77 (95% CI: 1.34-5.74, p=.006) compared to those without.

Conclusion: In men with diameters of 25-29 mm at screening for abdominal aortic aneurysms, the use of an individualised diagnostic criterion, based on height and weight, could identify those with increased aneurysm growth and a significantly shorter time to reach 40 mm compared to baseline. The relative aortic diameter, beyond the absolute diameter, appeared important for aneurysmal development. However, the differences were likely too small to warrant changes in clinical practice, highlighting the need for further research to establish clinical relevance.

Background: Endovascular thoracoabdominal aortic aneurysm (eTAAA) repair remains one of the more technically challenging aspect of vascular surgery, with significant risk of mortality, spinal cord ischemia (SCI), and end organ damage. Although fenestrated devices are available for juxtarenal aneurysms, there are no commercially available eTAAA devices on the US market currently. We therefore studied how the volume of juxtarenal repairs would translate to outcomes of these more complicated aneurysms.

Methods: We studied all eTAAA repairs (Crawford type 1-3) in the Vascular Quality Initiative from 2014-2021 and categorized surgeons into quartiles based on their average annual eTAAA volume and endovascular juxtarenal volume. Our primary outcome was thoracoabdominal life altering events (TALE-composite of perioperative death, stroke, permanent SCI and dialysis). We employed mixed effects logistic regression clustering by center and surgeon.

Results: We identified 5335 repairs from 607 surgeons, with annual average eTAAA volumes of 2,629 from 400 surgeons. Quartile 1 involved <2 repairs and quartile 4 involved >12 repairs per year. Repairs at higher quartiles were for larger aneurysms, more commonly employed staged repairs, utilized spinal drains, and more frequently utilized physician modified endografts, whereas low volume surgeons most commonly employed parallel grafting. Higher volume surgeons had overall shorter procedural times, fluoroscopy time, and less total contrast. Technical success similarly increased as procedure volume increased. In adjusted analyses, rates of perioperative death, TALE, stroke, acute kidney injury and major adverse cardiac events were all lower in the highest volume quartile compared to the lowest. However, after accounting for eTAAA volume, surgeon volume of endovascular juxtarenal repairs was not associated with any postoperative outcome, and there was no significant interaction between juxtarenal and eTAAA volume. Medium term mortality was lowest in patients treated in the top two quartiles of volume (HR 0.77 [0.61-0.97], P = .024.

Conclusion: Surgeon eTAAA experience shows a strong volume-outcome effect on outcomes in the immediate post operative period and in permanent patient-centered outcomes. However, experience in less extensive aneurysms did not directly translate to thoracoabdominal aneurysms. Further study is needed to evaluate the role that commercial graft availability and repair type contributes to these findings.

Objective: To characterize trends and outcomes with fenestrated and branched endovascular aortic repair (F/B-EVAR) performed at centers participating in the United States Aortic Research Consortium.

Methods: F/B-EVARs performed in 10 prospective, non-randomized, physician-sponsored investigative device exemption studies from 2015-2023 were retrospectively studied. Outcomes included 30-day major adverse event (MAE) and 1-year secondary reintervention. Outcome determinants were modeled with mixed-effects multivariable regression. Adjusted observed-minus-expected cumulative sum analysis was used to evaluate outcomes achieved over time.

Results: In the study period, 2,377 patients underwent F/B-EVAR. Median[IQR] follow-up was 2.3 years [0.7-3.5]. The proportion of thoracoabdominal aneurysms (p = 0.01) and aortic dissections (p = 0.001) increased over the study period while technical failure rates (p = 0.6) and length of hospital stay (p = 0.1) remained stable. Fusion imaging (p = 0.0005), low-profile devices (p < 0.0001), and completely transfemoral repair (p = 0.0005) were increasingly adopted over time. There were decreases in fluoroscopy time, procedure time, radiation dosage, and blood loss throughout the study (all p < 0.0001). Adjusted 30-day survival was 99.6% [99.3-99.8] and MAE occurred in 240 (10%). MAE determinants included age (OR[95%CI]: 1.3 per 10-years [1.1-1.6]; p = 0.005), eGFR (0.9 per 10-mL/min/1.73m2 [0.82-0.95]; p = 0.001), thoracoabdominal aneurysm (1.8 [1.3-2.6]; p = 0.002), operative time (1.04 per 10-minutes [1.03-1.06]; p < 0.0001), and technical failure (3.0 [1.7-5.1]; p = 0.0001). The cumulative rate of 30-day MAE remained stable, reflecting expected outcomes rates. The 1-year reintervention rate was 18% (n=435). Secondary intervention determinates included patient-specific device usage (0.4 [0.28-0.65]; p = 0.045) technical failure (3.1 [1.9-5.3]; p < 0.0001), total target vessels (1.3 per vessel [1.05-1.6]; p = 0.002), and prior aortic dissection (1.9 [1.3-2.6]; p = 0.0005). The cumulative rate of 1-year reintervention remained stable during the study period.

Conclusions: Data from multiple U.S. centers demonstrate that F/B-EVAR can be performed safely and with acceptable outcomes. Despite increasing repair extent and complexity, the rates of technical failure, adverse events, and reintervention remained stable, likely driven, in part, by evolutions in minimally-invasive technique.

Objectives: Aortobifemoral bypass (ABFB) is the gold-standard procedure for aortoiliac occlusive disease (AIOD). Axillobifemoral bypass (AxBFB) has been alternatively used for revascularization in patients who are deemed high risk for ABFB. However, in the endovascular era, covered endovascular reconstruction of aortic bifurcation (CEARB) is being used frequently in high- and standard-risk patients with AIOD. We aimed to compare the midterm outcomes of ABFB, AxBFB, and CERAB in the Vascular Quality Initiative (VQI)-Medicare-Linked database.

Methods: All patients with AIOD who underwent aortoiliac reconstruction by ABFB, AxBFB or CERAB during 2013-2019 in VQI-Medicare-Linked database were included. The primary outcome was amputation-free survival (AFS). The secondary outcomes were overall survival (OS), limb salvage (LS), and freedom from reintervention (FFR). Outcomes were assessed at one- and three-years. Kaplan-Meier estimates and Cox regression were used for the analyses.

Results: Three cohorts of patients undergoing ABFB (N=1,906, 60.4%), AxBFB (N=1,077, 34.1%) and CERAB (N=173, 5.5%) were studied. The patients in AxBFB and CERAB cohorts were older than the ABFB cohort and were more likely to have comorbidities compared to their ABFB counterparts. Three-year AFS was 79.4%, 54.6%, 71.1% in ABFB, AxBFB and CERAB cohorts, respectively (P<.001). After adjusting for potential confounders, AxBFB was associated with higher hazards of major amputation/death compared to ABFB at three-year (adjusted Hazard Ratio[aHR]=1.89, 95% Confidence Interval [CI], 1.61-2.23; P<.001) but CERAB was not (aHR=1.27, 95% CI, 0.84-1.91; P=0.251). AxBFB was also associated with higher hazards of major amputation compared to ABFB at three-year (aHR=1.74, 95% CI, 1.05-2.90; P=0.032) but CERAB was not (aHR=2.14, 95% CI, 0.73-6.31; P=0.166). On the other hand, CERAB was associated with increased hazards of three-year reintervention (aHR=1.75, 95% CI, 1.16-2.64; P=0.007) compared to ABFB. CERAB was also associated with lower hazards of major amputation/death at one-year compared to AxBFB (aHR=0.62, 95% CI, 0.38-0.99; P=0.048) but not at three-year.

Conclusions: We found that CERAB is comparable to ABFB in terms of OS, LS and AFS, albeit with substantial increase in reintervention rate at three years. AxBFB had worse OS, LS and AFS compared to ABFB. CERAB was associated with higher AFS compared to AxBFB at one-year. This national contemporary study supports the use of CERAB as a safe and durable alternative to ABFB and AxBFB. However, further prospective studies are necessary to confirm our findings.

Objectives: Hispanic patients have higher prevalence of peripheral artery disease (PAD) risk factors, undergo revascularization at lower rates, and have higher rates of major amputation. This study compares outcomes after open surgical revascularization within the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) Trial between Hispanic and Non-Hispanic White patients.

Methods: In a secondary analysis of the BEST-CLI trial, open surgical cohorts were combined (Cohort 1: suitable single segment greater saphenous vein (SSGSV), N=484; Cohort 2: lack of suitable SSGSV, N=150) and examined, by ethnicity, for the following 1-year outcomes: 1) above ankle amputation; 2) major reintervention; 3) major adverse limb event (MALE, composite of major amputation and major reintervention); and 4) survival. Cox regression models were constructed to determine the association between Hispanic ethnicity and selected endpoints after surgical bypass for patients enrolled in the BEST-CLI trial.

Results: Of the 634 patients who underwent open surgical bypass, 528 (83.3%) were Non-Hispanic White (White) and 106 (16.7%) were Hispanic. Compared to White patients, Hispanic patients were younger (64.6±8.6 vs 68.5±9.6, p<0.001), had a higher proportion of diabetes (91.5% vs 66.3%, p<0.001), end-stage renal disease (ESRD) (15.1% vs 6.8%, p=0.005), and were more often never smokers (44.3% vs 16.2%, p<0.001). Preoperative ankle brachial index was higher among Hispanic patients (0.7±0.4 vs 0.5±0.3, p<0.001). After controlling for age, sex, diabetes, ESRD, smoking history, infrapopliteal disease, WIfI Stage, and previous lower extremity revascularization, Hispanic ethnicity was not significantly associated with major amputation (aHR 0.67; 95% CI 0.30-1.48), major reintervention (aHR 0.81; 95% CI 0.35-1.87), MALE (aHR 0.64; 95% CI 0.34-1.21), or survival (aHR 0.69; 95% CI 0.42-1.13) one year after surgical bypass.

Conclusions: Disparities in limb-related outcomes were not observed for Hispanic patients undergoing open revascularization in the BEST-CLI Trial. Future PAD clinical trials should capture metrics of access to care, and timeliness of care for assessing risk of disparate outcomes among PAD populations thought to be at higher risk based on epidemiologic, and retrospective studies.

Objectives: The growing prevalence of diabetes and concomitant PAD(DM/PAD) has led to an increase in patients at-risk for adverse limb events in current practice. Despite a widespread perception that minor amputation may result in both limb salvage and preserved functionality, the natural history of minor amputations remains unknown. Thus, we sought to quantify the rates of subsequent major amputation and survival among DM/PAD patients with any prior minor amputation.

Methods: We performed a retrospective cohort study using US Medicare claims from 2007-2019. We included patients with DM/PAD based on ICD-9 and ICD-10 diagnosis codes. We excluded patients lacking continuous fee-for-service coverage or with incomplete demographic data. The primary exposure was prior minor(below-ankle) amputation. The primary outcome was major(above-ankle) amputation. Statistical analyses were performed using the Kaplan-Meier method and Cox proportional hazards modeling.

Results: We identified 12,257,174 patients(age 73±11 years,48% male,76% White) with DM/PAD. Of these patients, 2.2%(N=274,225) underwent prior minor amputation. Patients with prior minor amputation were more likely to be male(63% versus 47%,p<0.0001), Black non-Hispanic(17% versus 13%,p<0.0001), and rural(25% versus 21%,p<0.0001) than those without prior minor amputation. The five-year Kaplan-Meier cumulative incidence of major amputation was 27%(N=58,613) of patients with prior minor amputation, compared to 1.4%(N=129,872) of patients without prior minor amputation. After risk-adjustment, patients with prior minor amputations were 6.1-fold more likely to require a subsequent major amputation(HR 6.11[6.04-6.18]) compared to those without prior minor amputations.

Conclusions: This contemporary claims-based analysis demonstrates that approximately 25% of Medicare beneficiaries with DM/PAD and prior minor amputation will necessitate a major amputation within five years. Prior minor amputation carries a risk of major amputation comparable to de novo tissue loss, and is a stronger predictor than any demographic or socioeconomic exposure. These results help to inform both clinical decision-making and anticipated real-world outcomes among those at greatest risk for limb loss.

Objective: For patients initially presenting with unilateral chronic limb-threatening ischemia (CLTI), the progression and natural history of the contralateral limb (CL) remain underexplored, and current guidelines provide insufficient guidance for monitoring progression and managing contralateral disease. This study aims to evaluate the prevalence, risk factors, and outcomes associated with the development of contralateral CLTI (CL-CLTI) in patients initially diagnosed with unilateral CLTI.

Methods: Single-center, retrospective cohort study including patients with unilateral CLTI. Data on comorbidities, Wound, Ischemia, and Foot Infection (WIfI) grades/clinical stages, and outcomes were collected. Statistical analyses included univariate and Cox regression, as well as Kaplan-Meier (KM) survival estimates where appropriate.

Results: Over a 9-year period, 439 patients with unilateral CLTI were included in the analysis (63.1% male; median age 69, IQR 62-77). CL-CLTI developed in 36.4% of patients at a median of 24 months (IQR 10, 55). Univariate analysis revealed significant associations between CL-CLTI and Black race (p=0.037), diabetes (p<0.001), neuropathy (p<0.001), retinopathy (p=0.002), chronic kidney disease (p<0.001), end-stage renal disease (ESRD) (p<0.001), history of coronary artery bypass grafting (p=0.01), and lower baseline contralateral leg toe-brachial index (TBI) (p<0.001). Multivariable Cox regression identified low baseline contralateral TBI (HR 0.18; 95% CI 0.07-0.43, p<0.001) and ESRD (HR 1.95; 95% CI 1.26-2.99, p=0.003) as independent risk factors for CL-CLTI development. Patients with CL-CLTI exhibited more severe tissue loss in the index leg, higher wound scores (WIfI-W2), and more advanced disease stages (WIfI-Stage 4, 52.9% vs. 37.9%, p=0.003) compared to unilateral patients. During follow-up CL-CLTI patients experienced significantly higher rates of major amputations in both the index leg (43.3% vs. 12.0%, p<0.001) and the contralateral leg (22.0%). KM analysis showed significantly reduced amputation-free survival (AFS) in patients with CL-CLTI (70.9 months, 95% CI 58.9-82.8) compared to those with unilateral disease (85.3 months, 95% CI 76.8-93.9, p<0.001). Mortality rates were similar between groups (unilateral: 16.0%, contralateral: 20.7%, p=.21).

Conclusions: Within a median of 24 months of initial presentation, over one-third of CLTI patients develop CL-CLTI, which is associated with worse outcomes. Patients with end-stage renal disease and low initial contralateral TBI are at particularly high risk for contralateral disease progression. These findings help to define appropriate monitoring intervals for CL-CLTI patients and identify those at highest risk of disease progression.

Objective: To report clinical outcomes and quality-of-life (QOL) changes among 5-year survivors of fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal (CAAA) and thoracoabdominal aortic aneurysms (TAAA).

Summary background data: There is limited long-term data on FB-EVAR.

Methods: All consecutive patients enrolled in a prospective, non-randomized study of FB-EVAR for CAAAs and TAAAs between 2013-2019 was analyzed (ClinicalTrials.gov NCT01937949 and NCT02089607). Patients who completed 5-year clinical and imaging follow-up were classified as 5-year survivors. Primary endpoint was the cumulative incidence of aortic repair failure (ARF), defined as a composite of aortic-related mortality (ARM), aortic rupture (ARR), conversion to open repair, and type I or III endoleak. Secondary endpoints included physical (PCS) and mental component (MCS) QOL scores.

Results: Among 342 patients, 159 (70% male; median age 74-years (IQR 69-79-years) 5-year survivors were analyzed. Median follow-up was 63-months (IQR 59-82). Cumulative incidence of ARF at 5 years was 5.0% (95% CI 2.4-9.2). Cumulative incidences of ARR was 1.3% (95% CI 0.0-3.1) and type IIIB endoleaks was 2.4% (95% CI 0.0-5.2) at 5-years. There were no conversions to open repair or type IA endoleaks. PCS decline post-procedure improved but remained below baseline at 5-years. There was no change in MCS. The 8-year survival rate among patients who survived the first 5-years was 58.9% (95% CI 47.4-73.3%).

Conclusion: The 5-year risk of FB-EVAR failure is 5% among survivors, with a low risk of aortic rupture or device integrity issues. Early decline in physical QOL scores improves but does not return to baseline values.

Introduction: Despite an increase in prevalence of obesity over the last decades, few studies examine the influence of body mass index (BMI) on the outcome of thoracic outlet decompression (TOD) for neurogenic thoracic outlet syndrome (NTOS). However, it is important to understand the safety and efficacy of this procedure in patients with elevated BMI. This study aimed to determine the influence of BMI on surgical and functional outcomes following transaxillary thoracic outlet decompression (TA-TOD) in patients with NTOS.

Methods: We performed a retrospective review of a prospectively collected database with patients who underwent TA-TOD for NTOS from July 2016 to January 2023. Patients were categorized into three groups according to their BMI, normal weight (< 25.0 kg/m²), overweight (25.0 - 30.0 kg/m²), and obesity (> 30.0 kg/m²). Primary outcomes were peri- and postoperative complications, such as a hematoma, scapula alata, Horner syndrome, and wound infections. Secondary outcomes were length of stay (LOS), drain placement duration, pleural catheter placement duration, and functional outcome. Functional outcome was evaluated by using the Derkash classification, Disability of the Arm Shoulder, and Hand questionnaire (DASH), and Cervical Brachial Symptom questionnaire (CBSQ) scores up to 24 months of follow-up.

Results: The surgical results of 346 NTOS patients were analyzed. Of these patients 191 (55.2 %) were classified as normal weight, 98 (28.3 %) as overweight, and 57 (16.5 %) as obese. No significant difference in complication rates between BMI groups was found (p = 0.672). All groups had significant postoperative improvements in DASH and CBSQ scores (p < .001). There were no significant differences in functional outcomes between the three BMI groups.

Conclusions: The transaxillary approach for surgical treatment of NTOS can be used safely and effectively in patients of all BMI groups.