Objective: Arteriovenous fistulae (AVF) are necessary for hemodialysis in patients with end-stage kidney disease (ESKD) but are frequently complicated by thrombosis, stenosis, and need for revision. Glucagon-like peptide-1 receptor agonist (GLP-1RA) are increasingly used in type 2 diabetic patients with kidney disease, with recent evidence of both cardiovascular and renoprotective effects, yet their influence on AVF outcomes is unknown. The aim of this study was to investigate the impact of GLP-1RA on AVF outcomes in patients with ESKD.
Methods: We conducted a multicenter, retrospective cohort study utilizing the TriNetX Research Network. This included 37,694 patients with ESKD who underwent open AVF creation from January 2017 to October 2022, with a minimum of one year follow-up. Patients started on new GLP-1RA therapy were matched 1:1 to non-GLP-1RA controls using propensity scores accounting for patient demographics, comorbidities, medication history, and diagnoses. Primary outcomes included the risk of fistula thrombosis, stenosis, infection, percutaneous angioplasty, and open revision over one year. Secondary outcomes included dialysis catheter intervention, major adverse cardiovascular events (MACE), and all-cause mortality. Cox proportional hazards regression and survival analyses were performed.
Results: After matching, 1,239 well-matched pairs were created. Patients started on GLP-1RA therapy were associated with a lower risk of fistula thrombosis (HR, 0.77; 95% CI, 0.60-0.97; log-rank p=0.03), stenosis (HR, 0.82; 95% CI, 0.71-0.95; log-rank p=0.01), infection (HR, 0.61; 95% CI, 0.41-0.90; log-rank p=0.01), dialysis catheter intervention (HR, 0.63; 95% CI, 0.53-0.76; log-rank p<0.01), and open revision (HR, 0.57; 95% CI, 0.47-0.69; log-rank p<0.01) at one year. No significant effects were observed for percutaneous angioplasty (HR, 0.88; 95% CI, 0.75-1.05; log-rank p=0.15), MACE (HR, 0.99; 95% CI, 0.88-1.11; log-rank p=0.86), or all-cause mortality (HR, 0.79; 95% CI, 0.59-1.05; log-rank p=0.10. The protective effects of GLP-1RA were more prominent among male patients and in those with HgbA1c ≥7%, BMI ≥35 kg/m2, or eGFR ≤30 mL/min/1.73 m2. These protective effects were also seen as early as twelve weeks after AVF creation and persisted through three years, at which point GLP-1RA use was associated with improved survival (HR, 0.81; 95% CI, 0.68-0.96; log-rank p=0.02).
Conclusions: In patients with ESKD undergoing AVF creation, new GLP-1RA therapy was associated with reduced access complications, fewer dialysis catheter intervention, and improved long-term survival. These findings suggest that GLP-1RA use may promote a favorable environment following access creation, allowing AVF to mature.
Objective: Fragmentation of care (FOC) is referred to as receipt of care across multiple unaffiliated health systems (HS). We evaluated whether FOC was associated with outcomes in patients with uncomplicated type B aortic dissection (uTBAD).
Methods: The Healthcare Cost and Utilization Project State Inpatient Databases, for California (2018-2021), New York/Maryland/Florida (2016-2020) were queried using International Classification of Disease-10th (ICD-10) edition to identify patients who underwent medical management for uTBAD. Patient's hospital affiliation and its linkage to a HS during follow up were verified using the American Hospital Association data (AHA). FOC was defined as receipt of care across multiple unaffiliated, AHA defined HS, care delivered among transitions within the same HS was not classified as FOC. Univariate analyses were conducted to compare outcomes between patients with and without FOC, employing Chi-square or Fisher's exact tests as appropriate. Multivariable logistic regression models were constructed to investigate associations between FOC and outcomes. Model validation was performed using Hosmer-Lemeshow test, and receiver operating characteristic curve analysis.
Results: Among 5,476 patients included in the analysis, FOC was observed in 3,046 (55.6%). Baseline characteristics between those with and without FOC differed significantly. During follow-up, while mortality rates were similar between groups, FOC group had significantly more computed tomography scans, higher rates of aortic interventions, and elevated complication rates. Furthermore, total costs were markedly higher with FOC. Multivariable analysis also showed that FOC was associated with increased aortic interventions [TEVAR: OR 1.47, 95%CI 1.26-1.74] and complication rates (renal failure [OR 1.3, 95% CI 1.17-1.50], paraplegia [OR 1.60, 95% CI 1.07-2.42], and stroke [OR 1.31, 95%CI 1.09-1.58]) during follow-up. Total costs were 31% higher in the FOC group (p<0.001).
Conclusions: FOC in uTBAD patients is associated with increased likelihood of intervention with higher post-procedural complications and elevated healthcare costs. Coordinated care within a single HS should be prioritized to improve outcomes and reduce healthcare cost.
Objective: Chronic Limb-Threatening Ischemia (CLTI) patients with diabetes mellitus (DM) have increased risk for major amputation despite surgical revascularization. As demonstrated in the BEST-CLI trial, autologous great saphenous vein (GSV) remains the standard for revascularization in CLTI. However, alternative conduits such as autologous arm vein (AAV) and non-autologous biologic (cryovein) were infrequently used in the trial. Using the Vascular Quality Initiative (VQI), this study examined the outcomes of patients with DM undergoing infrainguinal bypass with AAV and cryovein for CLTI.
Methods: The prospectively collected VQI database was retrospectively queried for all patients with DM undergoing infrainguinal bypass for CLTI between 2010 and 2023. Patients were stratified into three cohorts according to the type of graft they received. Baseline characteristics and outcomes for the AAV and cryovein cohorts were compared individually to the GSV group. The primary outcome was amputation-free survival, while long-term freedom from index limb reintervention and freedom from major adverse limb events (MALEs) were analyzed as secondary outcomes.
Results: Out of 17,701 patients with diabetes undergoing bypass, 87.0% (N=15,393) received GSV, 3.5% (N=616) received AAV, and 9.6% (N=1,692) received cryovein. There was no difference in perioperative mortality and early thrombosis between AAV and GSV groups. Patients in the cryovein cohort, however, demonstrated significantly higher rates of perioperative graft occlusion (3.8% vs 1.5%, P<0.001) and major amputation (4.1% vs 1.9%, P<0.001) compared to GSV patients, with no difference in mortality. KM analyses demonstrate that amputation-free survival rates at 5 years were decreased for patients receiving cryovein as compared to those receiving GSV (55.8% vs 70.4%; p<0.001). Patients receiving AAV exhibited similar rates of amputation-free survival (69.0% vs 70.4%; p=0.9) and freedom from MALEs (66.4% vs 68.4%, p=0.5) compared to GSV patients at 5 years, while cryovein patients experienced significantly more MALEs (55.0% vs 68.4%, p<0.001). Following multivariate regression analysis, cryovein was independently associated with increased amputation or death (HR=1.64, 95% CI: 1.4-1.8) when compared to GSV, while AAV demonstrated no difference (HR=0.91, 95% CI: 0.7-1.1).
Conclusions: AAV is an effective alternative conduit to GSV in patients with DM undergoing infrainguinal bypass for CLTI. Cryovein has inferior outcomes to GSV but seem to offer acceptable limb salvage in patients with no other options for conduit.
On November 3rd, 2021, the Circulatory System Devices Panel of the Medical Device Advisory Committee met to discuss the role of real-world evidence in measuring the safety and long-term effectiveness of endovascular stent grafts used to treat abdominal aortic aneurysms. The panel concluded that long-term surveillance after endovascular aortic aneurysm repair (EVAR) was necessary, and 10-year outcomes in real-world practice should be collected and reported to stakeholders. In collaboration with endograft manufacturers, a multidisciplinary group created the Long-Term EVAR Assessment and Follow-up (LEAF) surveillance program. This program leverages registry-based data sources and data from a national health care system, Medicare claims-based linkages, enhanced registry data entry and targeted clinical and imaging follow-up to better surveil long-term device performance after EVAR. In this practice management guideline, we discuss the role of the VQI-VISION and Kaiser Permanente in this process, the methodology of linking registry-level and Medicare claims data for long-term device surveillance, the development of LEAF and key points for the future and additional possible applications to cardiovascular procedures. This guideline can inform the processes behind developing long-term device monitoring protocols which can serve as a benchmark report for the iterative expansion for future surveillance programs.
Background: The Best Endovascular versus Surgical Therapy in Patients with Chronic Limb-Threatening Ischemia (CLTI) (BEST-CLI) trial compared surgical bypass and endovascular treatment in patients with CLTI. While center-level variation in vascular surgery outcomes is well-documented, its impact within BEST-CLI has not been explored. Moreover, traditional quality metrics often fail to adequately discriminate center-level performance. This study introduces cumulative, probability-based quality metrics-similar to those employed in professional sports (earned outcomes [EO] and wins above average [WAA])-to evaluate center-level performance in both surgical and endovascular treatment of CLTI. We hypothesized that high performance in both modalities conferred the best overall outcomes among centers.
Methods: Participating BEST-CLI centers were evaluated by composite Major Adverse Limb Event (MALE) or death, for all patients treated at a given site (bypass and endovascular, all BEST-CLI cohorts). WAA was calculated as a risk-adjusted, volume-sensitive measure derived from MALE/death using EO methods. Risk adjustment accounted for patient-level differences using a Cox proportional hazards model, excluding patients with incomplete data. Centers were ranked and divided into WAA quartiles from bottom (Q1) to top (Q4). Patient-level demographics and outcomes were compared across quartiles. Centers were further categorized based on WAA performance: above average (WAA>0) or below average (WAA<0) in bypass, endovascular therapy, or both.
Results: Analyses included 1440 patients (79% of randomized patients) across 146 centers. At 2-years, unadjusted MALE/Death rates varied significantly by quartile (Bottom-Q1: 58%, Q2: 43%, Q3: 33%, Top-Q4: 30%; P<0.001). Centers were evenly distributed based on WAA: both modalities above average (27%), bypass above average only (27%), endovascular above average only (21%), and both below average (25%). Among top centers (Q4), 84% achieved above average outcomes in both modalities, while 62% of bottom centers (Q1) were below average in both. Centers excelling in only one modality constituted 16% of top centers (3% bypass above average only, 14% endovascular above average only) and 38% of bottom centers (27% bypass above average only, 11% endovascular above average only).
Conclusions: MALE/death varied considerably among BEST-CLI centers, with a difference of approximately 30% seen at 2-years between bottom and top quartiles. Top-performing centers consistently achieved above-average outcomes in both bypass and endovascular treatment. Conversely, centers excelling in only one modality were less likely to be top performers. These findings suggest that optimal CLTI care demands proficiency in both bypass and endovascular treatment and highlights the need for quality metrics that better differentiate center-level performance.
Objective: To perform a multi-institutional retrospective validation of the Society for Vascular Surgery Appropriate Use Criteria (AUC) for management of intermittent claudication (IC).
Methods: A retrospective review of patients treated for IC from 2005-2024 was performed across 7 institutions. Inclusion criteria followed AUC assumptions. All treated limbs were rated as appropriate (benefit outweighs risk, B>R), indeterminate (IND) or inappropriate (risk outweighs benefit, R>B) per the original AUC by 2 authors, who resolved discrepancies through discussion. Analysis was performed on the patient level. If one limb was rated as R>B, the patient was rated as R>B. For the purposes of comparison, B>R and IND were grouped together (B>R/IND).
Results: A total of 372 patients were included. The median follow-up was 1190 days (interquartile range [IQR] 433-2115). Treatment was classified as B>R/IND in 245 patients (66%) and R>B in 127 (34%). More patients in R>B identified as Black (12.7% vs 6.7%) and Hispanic (19.8% vs 9.2%) (p=0.006). Fewer patients in R>B were on optimal medical therapy at the time of evaluation (58.3% vs 75.9%, p<0.01). More patients in R>B had mild or moderate lifestyle limitation (93.7% vs 68.6%, p<0.01) and fewer patients in R>B had exercise therapy prior to revascularization (22% vs 54%, p<0.01). The most affected segments were aortoiliac (30.9%) and femoropopliteal (49.7%). Revascularization was performed in 231 patients (104 B>R/IND and 127 R>B). Of patients who underwent revascularization, 149 underwent unilateral revascularization and 82 underwent bilateral revascularization. Interventions were most often performed in the femoropopliteal (48.1%) and aortoiliac (35.1%) segments. At 2 years from initial consultation with the vascular surgeon, 19% in the R>B group were free from revascularization compared to 57% in the B>R/IND group (p<0.01). Freedom from symptom recurrence at 2 years was lower in the R>B group but did not reach statistical significance (48.9% vs 60%, p=0.07). Freedom from reintervention at 2 years following revascularization was significantly lower in the R>B group (44% vs 72%, p=0.01). A total of 10 major amputations and 11 minor amputations occurred in 17 (4.6%) patients over the study period. Among patients who had mild/moderate lifestyle limitation and were classified as R>B, 15 (11.8%) underwent 9 minor amputations and 10 major amputations. Among patients who had mild or moderate lifestyle limitation and were classified as B>R/IND, no patients underwent any type of amputation.
Conclusion: In this retrospective multi-institutional cohort, patients with IC who were treated inappropriately (R>B) per SVS AUC experienced significantly worse outcomes compared to those who received appropriate/indeterminate (B>R/IND) treatment.
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