Journal of Vascular Surgery最新文献

Objective: Chronic limb-threatening ischemia (CLTI) patients with diabetes mellitus (DM) have increased risk for major amputation despite surgical revascularization. As demonstrated in BEST-CLI (Best Surgery versus Best Endovascular Therapy in Critical Limb Ischemia), autologous great saphenous vein (GSV) remains the standard for revascularization in CLTI. However, alternative conduits such as autologous arm vein (AAV) and nonautologous biologic (cryovein) were infrequently used in the trial. Using data from the Vascular Quality Initiative, this study examined the outcomes of patients with DM undergoing infrainguinal bypass with AAV and cryovein for CLTI.

Methods: The prospectively collected Vascular Quality Initiative 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 with the GSV group. The primary outcome was amputation-free survival; long-term freedom from index limb reintervention and freedom from major adverse limb events (MALEs) were analyzed as secondary outcomes.

Results: Of 17,701 patients with DM undergoing bypass, 87.0% (n = 15,393) received a GSV, 3.5% (n = 616) received an AAV, and 9.6% (n = 1692) received a cryovein. There was no difference in perioperative mortality and early thrombosis between the AAV and GSV groups. Patients in the cryovein cohort, however, demonstrated significantly higher rates of perioperative graft occlusion (3.8% vs 1.5%; P < .001) and major amputation (4.1% vs 1.9%; P < .001) compared with GSV patients, with no difference in mortality. Kaplan-Meier analyses demonstrate that amputation-free survival rates at 5 years were lower for patients receiving cryovein as compared with those receiving GSV (55.8% vs 70.4%; P < .001). Patients receiving AAV exhibited similar rates of amputation-free survival (69.0% vs 70.4%; P = .9) and freedom from MALEs (66.4% vs 68.4%; P = .5) compared with GSV patients at 5 years, whereas cryovein patients experienced significantly more MALEs (55.0% vs 68.4%; P < .001). After multivariate regression analysis, cryovein was independently associated with increased amputation or death (hazard ratio, 1.64; 95% confidence interval, 1.4-1.8) when compared with GSV, whereas AAV demonstrated no difference (hazard ratio, 0.91; 95% confidence interval, 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 seems to offer acceptable limb salvage in patients with no other options for conduit.

On November 3, 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 Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network 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 vs Surgical Therapy in Patients with Chronic Limb-Threatening Ischemia (CLTI) (BEST-CLI) trial compared surgical bypass and endovascular treatment in patients with CLTI. Although 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 events (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 < .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, whereas 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 the bottom and top quartiles. Top performing centers consistently achieved above-average outcomes in both bypass and endovascular treatment. Conversely, centers exceling 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: The aim of this study was 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 to 2024 was performed across seven institutions. Inclusion criteria followed AUC assumptions. All treated limbs were rated as appropriate (benefit outweighs risk [B>R]), indeterminate (IND) or inappropriate (R>B) per the original AUC by two 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, 433-2115 days). Treatment was classified as B>R/IND in 245 patients (66%) and R>B in 127 (34%). More patients in the R>B group identified as Black (12.7% vs 6.7%) and Hispanic (19.8% vs 9.2%) (P = .006). Fewer patients in the R>B group were on optimal medical therapy at the time of evaluation (58.3% vs 75.9%; P < .01). More patients in R>B had mild or moderate lifestyle limitations (93.7% vs 68.6%; P < .01) and fewer patients in R>B had exercise therapy prior to revascularization (22% vs 54%; P < .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 the 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 with 57% in the B>R/IND group (P < .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 = .07). Freedom from reintervention at 2 years following revascularization was significantly lower in the R>B group (64% vs 84%; P = .01). A total of 10 major amputations and 11 minor amputations occurred in 17 patients (4.6%) over the study period. Among patients who had mild/moderate lifestyle limitations and were classified as R>B, 15 (11.8%) underwent nine minor amputations and 10 major amputations. Among patients who had mild or moderate lifestyle limitations and were classified as B>R/IND, no patients underwent any type of amputation.

Conclusions: In this retrospective multi-institutional cohort, patients with IC who were treated inappropriately (R>B) per the Society for Vascular Surgery AUC experienced significantly worse outcomes compared with those who received appropriate/indeterminate (B>R/IND) treatment.

Background: Age remains an important factor in decision-making and operative outcomes in patients with chronic limb-threatening ischemia (CLTI). Prior studies have used arbitrary age categories. Our aim is to identify an evidence-based age cutoff to differentiate patient outcomes between open and endovascular therapy (ET) in Best Endovascular vs Best Surgical Therapy in Patients with CLTI.

Methods: The Best Endovascular vs Best Surgical Therapy in Patients with CLTI trial dataset was queried to include all patients who underwent open surgical bypass or ET. Patient age on the day of the index revascularization was identified as a continuous variable. Restricted cubic splines were generated to examine the moderating effect of age on the outcomes of procedure type in cohort 1 (bypass with single-segment saphenous vein [SSGSV] vs ET) and cohort 2 (bypass with an alternative conduit vs ET). Four separate spline models for each cohort were generated corresponding to our outcomes of interest: major amputation (above ankle), all-cause mortality, major adverse limb events (MALE defined as above-ankle amputation or major reintervention), and MALE/death.

Results: Our study included 1780 patients with a mean age of 67.2 ± 9.7 years (range, 27.9-94.1 years). In cohort 1, the MALE/death spline model showed a lower hazard for SSGSV compared with ET across all ages; however, the upper limit of the hazard ratio confidence interval approaches 1.0 at age 72. There was no age inflection point identified with regard to mortality. Amputation risk was lower with SSGSV compared with ET up to around the age of 57, beyond which there was no difference between the two treatment modalities. Furthermore, the risk of MALE was consistently lower with SSGSV for patients up to age 83. In contrast, in cohort 2, age was not found to be an effect modifier in revascularization outcomes or survival among patients undergoing bypass with an alternative conduit compared with ET.

Conclusions: In this study, we confirmed that bypass with SSGSV was associated with superior MALE-free survival compared with ET up to the age of 72, beyond which there was no significant difference in outcomes between the two strategies. MALE was significantly higher for ET for patients up to age 83. Patient age was not found to favor one revascularization method over the other if the bypass was performed using an alternative conduit. Further studies are needed to compare the effectiveness of revascularization strategies among older patients with CLTI.