Journal of Vascular Surgery最新文献

Background: Disparity in the allocation of medical services and resources based on race is present within the health care industry today, including the prescription of postoperative analgesics. The purpose of this study was to evaluate the presence of race-based disparity in the prescription of postdischarge opioids after lower extremity bypass (LEB) surgery for chronic limb-threatening ischemia (CLTI).

Methods: Retrospective analysis was conducted on adult CLTI patients who underwent LEB from 2000 to 2023 in the TrinetX database. Patients were stratified into two groups based on race: White (group I) and black or African American (AA) (group II). Primary outcomes were defined as oral opioid prescriptions at 7 days and 30 days after discharge, and mortality at 1 year postoperatively. Secondary outcomes included length of stay and 30-day postoperative outcomes, including myocardial infarction, pulmonary embolism, cerebral vascular accident, deep vein thrombosis, acute kidney injury, major amputation, minor amputation, major adverse cardiac events, and major adverse limb events. Stratified analysis was conducted based on disease stage (rest pain vs lower extremity ulcer vs gangrene). Univariate analysis was performed via two-sample t test and χ² test. Logistic regression was performed to estimate the association of Black or AA (vs White) race while controlling for pertinent preoperative potential confounders.

Results: There were 3345 patients who met the inclusion criteria. Group I included 2661 White patients and group II included 684 Black or AA patients. Group II patients were more likely to be younger, female, present with gangrene, and have a history of hypertension, diabetes, chronic kidney disease, or diabetic neuropathy. At both 7 and 30 days after discharge, the Black or AA cohort had significantly lower rates of opioid prescriptions (33.2% vs 42.5% and 35.8% vs 47.2%, respectively) (all P < .05). Stratification by indication showed that opioid prescription disparity persisted despite black or AA patients presenting at worse stages of disease both at 7 and 30 days after discharge (7 days: rest pain 43.4% vs 33.7% [P = .013], ulcer 41.4% vs 31.7% [P = .027], gangrene, 42.7% vs 33.6% [P = .006] and 30 days: rest pain 47.8% vs 37.1% [P = .007], ulcer 45.4% vs 33.5% [P = .007], gangrene, 48.2% vs 36.1% [P < .001]). Adjusted analysis confirmed that Black or AA race was associated with lower rates of 7- (adjusted odds ratio, 0.607; P = .001) and 30-day (adjusted odds ratio, 0.56; P = .001) postdischarge opioid prescriptions.

Conclusions: Black or AA patients were less likely to receive postdischarge opioid prescriptions compared with their White counterparts at 7 and 30 days after LEB for CLTI.

Objective: To report technical success and evaluate clinical outcomes of fenestrated and branched endovascular aortic repair (F/B-EVAR) incorporating a contralateral inverted limb.

Methods: Patients who underwent F/B-EVAR with a custom-made bifurcated device containing an inverted limb between January 2010 and September 2023 were retrospectively analyzed. Time-to-event data were analyzed using the Kaplan-Meier method.

Results: A total of 32 patients (26 men; mean age 77±6.2 years) were included in the analysis. Technical success was achieved in 28 patients (87.5%). Two technical failures resulted from misplaced contralateral limbs in patients with previous endovascular aortic repair (EVAR), necessitating one open conversion due to a type 3b endoleak, and one femoro-femoral crossover bypass after occlusion of a misplaced contralateral limb. Additionally, two technical failures were attributed to a type 3c endoleak and a type 1c endoleak, originating from a fenestrated device at the level of the left and right renal artery, respectively. One patient (3.1%) died <30 days post-operatively due to a subdural hemorrhage. Estimated patient survival after 1 and 2 years was 92.7%±5.1%, and 74.3%±10.1%, respectively. No aneurysm-related deaths were observed. During the median follow-up of 13 months, one (3.1%) inverted limb occluded, in addition to the occlusion resulting from a misplaced contralateral limb, and was treated with a femoro-femoral crossover bypass. One target vessel (right renal artery) occluded (0.9%), resulting in a permanent, significantly reduced renal function. Freedom from overall reintervention after 1 and 2 years was 73.5%±8.0% and 68.3%±9.0%, respectively. An additional four patients (12.5%) presented with a type 3c endoleak during follow-up scans, three of which originated from fenestrations at the level of the renal stents. There were no junctional problems between the inverted limb device and the main endograft, and no significant correlation was found between the one-sealing-stent inverted limb device design and the onset of type 3 endoleak (log-rank P=.064).

Conclusions: F/B-EVAR incorporating an inverted limb can be a viable endovascular option to manage complex aneurysms with a short renal artery to bifurcation distance. However, using the inverted limb presents a notable technical challenge and could be associated with a higher need for reintervention. Carefully confirming correct cannulation of the inverted limb is warranted.

Objective: The aim of this prospective monocentric cohort study was to analyze the risk of otolaryngologist-assessed cranial nerve injuries (CNIs) following carotid endarterectomy (CEA) in our academic center during a 15-year period, and to identify possible risk factors for CNI development.

Methods: From January 2007 to December 2022, 3749 consecutive CEAs were performed and their data prospectively recorded in a dedicated database. CNIs were assessed and defined according to a standardized protocol. Instrumental ear, nose, and throat (ENT) evaluations were conducted within 30 days before intervention and before discharge. Preoperative neurological assessments were carried out in all patients with symptomatic carotid stenosis, whereas postoperative neurological evaluations were performed in all patients. Patients with newly onset CNIs underwent follow-up assessments at 30 days and, if necessary, at 6, 12, and 24 months. Perioperative results, including mortality, major central neurological events, and postoperative CNIs, were analyzed. Regression or persistence of lesions during follow-up visits was assessed, and multivariate analysis (binary logistic regression) was conducted to evaluate clinical, anatomical, and surgical technique factors influencing the occurrence of CNIs.

Results: CEAs were performed more frequently in male patients (2453 interventions; 65.5%) than in females (1296 interventions; 34.5%). The interventions were performed in asymptomatic patients in 3078 cases (82%). In 66 cases, the interventions followed a previous ipsilateral CEA. At preoperative ENT evaluation, no cases of ipsilateral pre-existent CNI were recorded. The 30-day stroke and death rate was 1%. In 113 patients (3%), a postoperative neck bleeding requiring surgical revision and drainage was noted. Pre-discharge ENT evaluations identified 259 motor CNIs, accounting for 6.9% of the entire study group. Eighteen patients had lesions in more than one cranial nerve. ENT and neurological evaluations at 30 days showed the complete resolution of 161 lesions, whereas in 98 cases (2.6%), the CNI persisted. At 1 year, the rate of persistent CNI was 0.4% (10 patients), whereas at 2 years, it was 0.25% (6 cases), in all but one asymptomatic. At multivariate analysis, urgent intervention in unstable patients, secondary intervention, a clamping time >40 minutes, a hematoma requiring revision, and a postoperative stroke were independent predictors of CNIs.

Conclusions: Data from this prospective monocentric cohort study showed that the occurrence of CNI following CEA was low, even when an independent multi-specialist evaluation was performed. The percentage of persistent lesions at 2 years was negligible and, in most cases, asymptomatic.

Objective: Although diabetes has been shown to be negatively associated with development of abdominal aortic aneurysm (AAA), patients with diabetes may still develop aneurysms. In this study, we examined risk factors for the development of AAA in patients with diabetes.

Methods: Adults >50 years of age with diabetes who underwent health screening between 2009 and 2012 were followed for incident AAA until December 31, 2019. Cox proportional hazard regression models were used to calculate multivariate hazard ratios (HRs) and 95% confidence intervals (CIs) for risk factors associated with AAA.

Results: Among 1,913,066 participants (55.3% men), 6996 AAA cases were identified during a mean follow-up of 7.7 years. Increased AAA risk was observed for age ≥65 years (HR, 2.69; 95% CI, 2.55-2.83), men (HR, 1.81; 95% CI, 1.69-1.94), smoking (former smoker ≥20 pack-years [PY]; HR, 1.75; 95% CI, 1.61-1.89; current smoker <20 PY; HR, 1.76; 95% CI, 1.59-1.94; current smoker ≥20 PY; HR, 2.40; 95% CI, 2.23-2.59), abdominal obesity (HR, 1.30; 95% CI, 1.23-1.38), and comorbidities, including hypertension (HR, 1.63; 95% CI, 1.53-1.73), dyslipidemia (HR, 1.35; 95% CI, 1.29-1.42), chronic kidney disease (HR, 1.52; 95% CI, 1.44-1.61), and cardiovascular disease (HR, 1.71; 95% CI, 1.58-1.86). Heavy (HR, 0.67; 95% CI, 0.61-0.74) and mild alcohol consumption (HR, 0.78; 95% CI, 0.74-0.83), overweight (HR, 0.87; 95% CI, 0.81-0.93) and obesity (HR, 0.81; 95% CI, 0.75-0.87), longer diabetes duration (≥5 years: HR, 0.74; 95% CI, 0.70-0.78), and using three or more oral hypoglycemic agents (OHA) (HR, 0.84; 95% CI, 0.79-0.90) were associated with decreased AAA risk, whereas insulin use was associated with a marginally increased risk (HR, 1.09; 95% CI, 1.00-1.18). Among the OHAs, metformin (HR, 0.95; 95% CI, 0.90-1.00), thiazolidinediones (HR, 0.87; 95% CI, 0.79-0.97), and sulfonylureas (HR, 0.88; 95% CI, 0.83-0.93) were associated with a decreased risk of AAA.

Conclusions: Although diabetes is associated with decreased AAA risk, those with comorbid cardiometabolic diseases, abdominal obesity, and a smoking history should be aware of an increased AAA risk. Further studies are warranted to verify the potential use of OHAs for decreasing AAA risk.

Objective: The technical demands associated with pedal bypass (PB) surgery place it at risk of underutilization and may be limiting its widespread adoption as a valuable revascularization modality. This study aims to evaluate trends in PB performance, assess its outcomes, and compare its results between high- and low-volume centers.

Methods: All patients receiving a PB between 2003 and 2023 were identified in the Vascular Quality Initiative (VQI) infrainguinal bypass (IIB) module. The ratio of PB to total IIB performed was calculated for each year and trended over the study period. Centers performing PB were categorized according to their annual PB volume into tertiles of low-volume centers (LVC, <2 PB/year), medium-volume centers (MVC, 2-4 PB/year), and high-volume centers (HVC, >4 PB/year) for comparison. Patient characteristics and outcomes were compared using the χ² or Fisher exact test as appropriate for categorical variables and the analysis of variance test or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between center volume and the primary outcomes of primary patency, primary-assisted patency, secondary patency, reintervention, amputation, and major adverse limb events (MALE), defined as the composite outcome of amputation and/or reintervention.

Results: A total of 3466 patients received a PB during the study period. The ratio of PB to IIB dropped from 14% to 4% between 2003 and 2023. Primary, primary-assisted, and secondary patency rates were 65%, 76%, and 80%, respectively, and limb salvage rate was 83% at 1 year. Nineteen percent of centers performing IIBs in the VQI did not perform any PBs during the study period. Of the 246 centers performing PBs, 78% were LVC, 15% were MVC, and only 7% were HVC. On Cox regression analysis, HVCs were associated with a lower risk of primary patency loss (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.95; P = .010), reintervention (HR, 0.75; 95% CI, 0.60-0.95; P = .016), amputation (HR, 0.77; 95% CI, 0.61-0.98; P = .034), and MALE (HR, 0.78; 95% CI, 0.66-0.93; P = .005) compared with LVCs. No difference in secondary patency between high- and low-volume centers was observed (P = .680).

Conclusions: The utilization of PB operations experienced a four-fold decrease over the past 20 years, despite favorable patency and limb salvage outcomes. Centers with a higher operative volume in PB achieve better outcomes than LVCs, and accordingly, patients with extensive tibioperoneal disease may benefit from evaluation at centers with documented expertise in PB before resorting to an alternative revascularization modality or a major limb amputation.

Objective: Tailoring resources of peripheral vascular interventions (PVIs) to those who stand to gain the most would allow for more equitable and value-based care. One way of evaluating the benefit of PVIs in patients with symptomatic peripheral artery disease is evaluating their health status and identifying predictors of health status response 12 months after the intervention.

Methods: Patients who underwent femoropopliteal PVI between March 2005 and August 2008 from the Zilver PTX randomized trial and single-arm study were combined into a single cohort for secondary data analysis. The preprocedural and 12-month health status was assessed by the EuroQol-5D-3 L (EQ-5D). First, we evaluated the 12-month EQ-5D Index (per 1-unit increase), adjusted for treatment condition and patient characteristics using a linear regression. Second, using the minimally clinically important difference threshold for the EQ-5D Index, we identified 12-month nonresponders (worsened or no change) vs responders (improved) and conducted an adjusted logistic regression model.

Results: A total of 513 patients were included (mean age: 67.8 ± 9.2 years; 25.1% female), with 17.8% U.S. and 82.2% non-U.S. global enrollment sites. The minimally clinically important difference for the EQ-5D was 0.058. For 12-month health status after PVI, a total of 57.9% improved, 31.4% experienced no change, and 10.7% worsened, relative to their preprocedural health status. Patients who were more likely to be nonresponders were more likely to have a history of carotid artery disease or were located at a U.S. enrolling center.

Conclusions: The majority of patients reported improved or stable health status after femoral-popliteal PVI. Approximately 4 in 10 patients were nonresponders, with the highest risk for nonresponse including individuals with existing carotid disease or those undergoing PVIs in the U.S. vs non-U.S.

Settings:

Background: During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take ≤12 weeks. During this awaiting period, aortic-related mortality is increased. To overcome this limitation, off-the-shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Our aim was to evaluate systematically all the published studies of off-the-shelf endografts for the treatment of pararenal and TAAAs.

Methods: We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel instability, major adverse events, and reintervention rates. We estimated pooled proportions and 95% confidence intervals (CIs).

Results: A total of 1605 study titles were identified by the initial search strategy, of which 13 (8 t-Branch, 3 E-nside, 1 We-Flow, and 1 TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer multibranched group [OMG]; 6.1% inner multibranched group [IMG]) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95% CI, 83.8%-96.4%) and 96.9% (95% CI, 92.5%-98.8%) for the outer and inner multibranched endografts, respectively. The pooled 30-day mortality was 10.4 % (95% CI, 6.6%-16.1%,) and 4.2% (95% CI, 2.0%-8.6%) for the OMG and IMG, respectively. The pooled 30-day and late target visceral vessel instability for the OMG was 3.5% (95% CI, 2.0%-6.1%) and 6.2% (95% CI, 4.7%-8.0%) and for the IMG 10.4% (95% CI, 4.5%-22.5%) and 1.6% (95% CI, 0.7%-3.3%) respectively.

Conclusions: This pooled analysis indicated good technical success and mortality rates for both devices despite the high rate of urgent procedures. Pararenal and TAAAs can be treated safely using the included devices. However, further studies are required to draw additional conclusions for the IMG owing to the small sample size.

Objective: Spinal cord ischemia (SCI) is a devastating complication that is associated with thoracoabdominal aortic repair, with higher risk associated with increased aortic coverage length, making patients undergoing branched/fenestrated endovascular repair (B/FEVAR) particularly vulnerable. A bundled SCI prevention protocol was previously reported to reduce SCI rates when compared to a historic cohort in a single-center study. Therefore, this analysis aims to further validate and update outcomes associated with the protocol given the routine implementation of this strategy at two institutions (University of Florida and the University of Alabama at Birmingham) since inception.

Methods: Components of the SCI prevention protocol include selective cerebrospinal fluid drainage, specified blood pressure parameters, transfusion goals, and selective pharmacologic adjuncts (naloxone, steroids). This protocol was routinely implemented in May 2015. Patients undergoing B/FEVAR from May 2015 to December 2022 constituted the post-protocol cohort (n = 402) and were compared with the pre-protocol cohort (n = 160; January 2010-April 2015). The primary outcome was SCI incidence, and subgroup analysis was conducted among patients deemed to be high-risk (Crawford extent I-III thoracoabdominal aneurysm dissection-related disease, prior aortic repair, coverage proximal to zone 5). Survival analysis was performed using Kaplan-Meier methodology.

Results: The pre- and post-protocol cohorts were demographically similar, although more post-protocol patients were American Society of Anesthesiology class IV (86.1% vs 55.0%; P < .001). Thoracoabdominal aneurysm was the most common indication in both groups. Cerebrospinal fluid drain placement was more common in the post-protocol group, particularly among high-risk patients. SCI occurred in 15.9% of pre-protocol patients vs 3.0% of post-protocol patients (P < .001). In high-risk patients, the pre- and post-protocol cohort SCI incidence was 23.2% vs 5.0%, respectively (P < .001). Thirty-day mortality was decreased in the post-protocol cohort (6.3% vs 2.2%; P = .02). Although the post-protocol group had a trend toward improved 1-year survival, this was not statistically significant (84.4% vs 88.3%; log-rank P = .35). Among patients with SCI, 1-year mortality was 28% and 33.3% in the pre- and post-protocol groups, respectively (P = .46).

Conclusions: Implementation of a bundled SCI prevention protocol significantly reduces SCI rates in patients undergoing B/FEVAR, which has now been validated at two institutions, with the most significant reductions occurring among high-risk patients. Although the overall 1-year mortality difference was not significantly different between the cohorts, the high mortality rates among patients with SCI highlights the importance of preventative measures.

Objective: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.).

Methods: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥10 mm and proximal neck angulation of ≤60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes.

Results: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (≥10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention.

Conclusions: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Objectives: The optimal bridging stent for fenestrations during complex endovascular aortic aneurysm repair (EVAR) has not been defined. At our institution, the Viabahn VBX is frequently used given its availability and mechanical and heparin-bonding characteristics. This study aimed to assess the performance of the Viabahn VBX vs the iCast balloon-expandable covered stents as bridging stents for fenestrations during complex EVAR.

Methods: A retrospective study of consecutive patients undergoing complex EVAR between 2015 and 2021 was performed. Celiac arteries (CAs), superior mesenteric arteries (SMAs), left renal arteries, and right renal arteries stented with fenestrations were grouped according to the type of bridging stent, VBX vs iCast. Target vessels (TV) stented with a branch or scallop were excluded. The primary end points included primary patency and freedom from TV instability.

Results: A total of 292 patients undergoing complex EVAR were treated using VBX or iCast with a mean follow-up of 190 days (interquartile range, 36-384 days) for the VBX cohort and 804 days (interquartile range, 384-1507 days) for the iCast cohort. A total of 677 TVs were stented, including 134 CAs (20%), 175 SMAs (26%), 182 left RAs (27%), 186 right RAs (27%), and 12 additional vessels (2%). Proximal reinforcement was more frequent with VBX than with iCast stent (23% vs 2.4%; P < .0001). There was no difference in primary patency rates at 2 years between VBX and iCast stent for CA (100% vs 96.4%; P = .32), SMA (97.8% vs 100%; P = .14), and the RAs (96.7% vs 99.4%; P = .11). There was no difference between VBX and iCast in the cumulative incidence of type Ic and type IIIc endoleaks (3.2% vs 5.6%; P = .69) or freedom from TV instability at 2 years.

Conclusions: Viabahn VBX stents are a safe and effective option as bridging stents in fenestrations during complex EVAR with comparable midterm outcomes to iCast stents. However, proximal stent reinforcement may be required with VBX stent to ensure adequate sealing at the fenestrations. Longer follow-ups and larger series are required to assess long-term outcomes and durability.