Infrapopliteal Peripheral Vascular Interventions for Claudication are Performed Frequently in the USA and Are Associated with Poor Long Term Outcomes.

OBJECTIVE: Infrapopliteal peripheral vascular interventions (PVIs) for claudication are still performed in the USA. This study aimed to evaluate whether infrapopliteal PVI is associated with worse long term outcomes than isolated femoropopliteal PVI for treatment of claudication. METHODS: A retrospective analysis of fee for service claims in a national administrative database was conducted using 100% of the Medicare fee for service claims between 2017 and 2019 to capture all Medicare beneficiaries who underwent an index infra-inguinal PVI for claudication. Hierarchical Cox proportional hazards models were performed to assess the association of infrapopliteal PVI with conversion to chronic limb threatening ischaemia (CLTI), repeat PVI, and major amputation. RESULTS: In total, 36 147 patients (41.1% female; 89.7% age ≥ 65 years; 79.0% non-Hispanic White ethnicity) underwent an index PVI for claudication, of whom 32.6% (n = 11 790) received an infrapopliteal PVI. Of these, 61.4% (n = 7 245) received a concomitant femoropopliteal PVI and 38.6% (n = 4 545) received an isolated infrapopliteal PVI. The median follow up time was 3.5 years (interquartile range 2.7, 4.3). Patients receiving infrapopliteal PVI had a higher three year cumulative incidence of conversion to CLTI (26.0%; 95% confidence interval [CI] 24.9 - 27.2% vs. 19.9%; 95% CI 19.1 - 20.7%), repeat PVI (56.0%; 95% CI 54.8 - 57.3% vs. 45.7%; 95% CI 44.9 - 46.6%), and major amputation (2.2%; 95% CI 1.8 - 2.6% vs. 1.3%; 95% CI 1.1 - 1.5%) compared with patients receiving isolated femoropopliteal PVI. After adjusting for patient and physician level characteristics, the risk of conversion to CLTI (adjusted hazard ratio [aHR] 1.31, 95% CI 1.23 - 1.39), repeat PVI (aHR 1.12, 95% CI 1.05 - 1.20), and major amputation (aHR 1.72, 95% CI 1.42 - 2.07) remained significantly higher for patients receiving infrapopliteal PVI. An increasing number of infrapopliteal vessels treated during the index intervention was associated with increasingly poor outcomes (p < .001 for trend). CONCLUSION: Infrapopliteal PVI for claudication is associated with worse long term outcomes relative to isolated femoropopliteal PVI.

Infrapopliteal Endovascular Interventions for Claudication Are Associated with Poor Long-Term Outcomes in Medicare-Matched Registry Patients.

BACKGROUND: There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication. OBJECTIVES: We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication. METHODS: We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models. RESULTS: Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease. CONCLUSIONS: Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients.

Association of Frailty with Postoperative Survival and Outcomes Following Hemodialysis Vascular Access Creation.

BACKGROUND: The literature suggests that for patients to experience the purported advantages of an arteriovenous fistula (AVF) over arteriovenous graft (AVG), a minimum survival of 18 months is required. With the vascular access guideline shift away from "Fistula First" toward shared decision making, patient survival after vascular access creation is a major factor to consider in optimal access selection. The objective of this study is to examine outcomes of vascular access in patients with short survival and factors associated with short survival, including frailty. METHODS: We performed a retrospective review of 200 access procedures performed between August 2018 and November 2020 at a single institution. Maturation was defined as the date when the surgeon deemed the access ready to be used for dialysis. A modified Risk Analysis Index (RAI) score was used to calculate frailty. RESULTS: Within 3 years after access creation, 55 (27.5%) patients were recorded as dead (mortality within 3 years of access creation [3YMORT]). In the 3YMORT group, 5 did not follow-up with the surgeon prior to death and 22/34 (65%) of AVF versus 15/16 (94%) of AVGs were deemed mature prior to death (P = 0.03). Of the accesses that matured, the median days to maturation for AVF was 69 (interquartile range [IQR] 53, 87) versus 28 (IQR 18, 32) for AVG (P < 0.001). Patients in the 3YMORT group were older (70.6 vs. 63.4, P = 0.004) and had a lower body mass index (24.8 vs. 27.4, P = 0.03). Patients in the 3YMORT group had higher prevalence of dysrhythmia (35% vs. 15%, P = 0.002), chronic obstructive pulmonary disorder (20% vs. 10%, P = 0.048) and dialysis dependence at the time of access creation (91% vs. 75%, P = 0.01). There was no significant difference in sex, white race, Hispanic ethnicity, coronary artery disease, congestive heart failure, previous coronary artery bypass graft or percutaneous coronary intervention, diabetes, hypertension, and peripheral arterial disease between the 2 groups. The 3YMORT group had a significantly higher prevalence of frailty (78% vs. 49%, P = 0.0002). Patients categorized as frail by the RAI had a significantly higher risk of 3YMORT (odds ratio [OR] 3.74, 95% confidence interval [CI] 1.82-7.66) compared to nonfrail patients. Patients categorized as very frail by the RAI had an even higher risk of 3YMORT (OR 4.20, 95% CI 1.95-9.05), compared to nonfrail patients. CONCLUSIONS: Patients with short life expectancy after vascular access creation may have high rates of AVF nonmaturation and longer time to maturation. Factors associated with high risk of mortality within 3 years of vascular access creation correlate well with factors included in the RAI frailty score. Patients who are frail or very frail may be appropriate candidates for AVG creation over AVF considering their high risk for short life expectancy.

Patient Care Technician Staffing and Outcomes Among US Patients Receiving In-Center Hemodialysis.

Importance: Dialysis patient care technicians (PCTs) play a critical role in US in-center hemodialysis (HD) care, but little is known about the association of PCT staffing with patient outcomes at US HD facilities. Objective: To estimate the associations of in-center HD patient outcomes with facility-level PCT staffing. Design, Setting, and Participants: This was a retrospective cohort study, with data analysis performed from March 2023 to January 2024. Data on US patients with end-stage kidney disease and their treatment facilities were obtained from the US Renal Data System. Participants included patients (aged 18-100 years) initiating in-center HD between January 1, 2016, and December 31, 2018, who continued receiving in-center HD for 90 days or more and had data on PCT staffing at their initial treating HD facility. Exposure: Facility-level patient-to-PCT ratios (number of HD patients divided by the number of PCTs reported by the treating facility in the prior year), categorized into quartiles (highest quartile denotes the highest PCT burden). Main Outcomes and Measures: Patient-level outcomes included 1-year patient mortality, hospitalization, and transplantation. Associations of outcomes with quartile of patient-to-PCT ratio were estimated using incidence rate ratios (IRRs) from mixed-effects Poisson regression, with adjustment for patient demographics and clinical and facility factors. Results: A total of 236 126 patients (mean [SD] age, 63.1 [14.4] years; 135 952 [57.6%] male; 65 945 [27.9%] Black; 37 777 [16.0%] Hispanic; 153 637 [65.1%] White; 16 544 [7.0%] other race; 146 107 [61.9%] with diabetes) were included. After full adjustment, the highest vs lowest quartile of facility-level patient-to-PCT ratio was associated with a 7% higher rate of patient mortality (IRR, 1.07; 95% CI, 1.02-1.12), a 5% higher rate of hospitalization (IRR, 1.05; 95% CI, 1.02-1.08), an 8% lower rate of waitlisting (IRR, 0.92; 95% CI, 0.85-0.98), and a 20% lower rate of transplant (IRR, 0.80; 95% CI, 0.71-0.91). The highest vs lowest quartile of patient-to-PCT ratio was also associated with an 8% higher rate of sepsis-related hospitalization (IRR, 1.08; 95% CI, 1.03-1.14) and a 15% higher rate of vascular access-related hospitalization (IRR, 1.15; 95% CI, 1.03-1.28). Conclusions and Relevance: These findings suggest that initiation of treatment in facilities with the highest patient-to-PCT ratios may be associated with worse early mortality, hospitalization, and transplantation outcomes. These results support further investigation of the impact of US PCT staffing on patient safety and quality of US in-center HD care.

Factors associated with ablation-related thrombus extension following microfoam versus radiofrequency saphenous vein closure.

OBJECTIVE: Polidocanol endovenous microfoam ablation (MFA) is approved by the US Food and Drug Administration for great saphenous vein (GSV) closure, yet there are few published data on the subsequent risk of ablation-related thrombus extension (ARTE). Recent societal practice guidelines recommend against routine postprocedure duplex ultrasound (DU) examination after thermal ablation of the GSV in asymptomatic patients. At present, limited data do not allow this recommendation to extend to MFA. Our aim is to identify characteristics and outcomes associated with ARTE following MFA vs radiofrequency ablation (RFA). METHODS: A retrospective review of a prospectively maintained database was conducted of patients who underwent MFA and RFA closure of incompetent above-knee GSVs. Patients treated for isolated tributary vein treatment or did not have a postprocedure DU examination within 48 to 72 hours were not included. Patients were classified into two groups: ARTE and no ARTE. Demographic data, Clinical, Etiologic, Anatomic and Pathophysiologic class, Venous Clinical Severity Score, operative details, postprocedure (48-72 hours) DU findings, and adverse events were analyzed. Variables that were significant on univariate analysis were evaluated using multivariate logistic regression with the primary outcome being development of ARTE. RESULTS: Between June 2018 and February 2023, 800 limbs were treated with either MFA (n = 224) or RFA (n = 576). Ninety-six GSVs treated with MFA met the study criteria. One hundred fifty successive GSVs treated with RFA during the same period were included as a comparison group. There was no statistically significant difference in baseline demographics between the two groups. Six patients (2.4%) demonstrated ARTE on postoperative DU examination at 48 to 72 hours (MFA, n = 5 [5.2%]; RFA, n = 1 [0.7%]; P = .02). Saphenous vein ablation with MFA (P = .045) and a vein diameter of >10 mm (P = .017) were associated with ARTE on both univariable and multivariable analysis. All patients who developed ARTE were treated with oral anticoagulants (mean, 15.6 days). Body mass index, Clinical, Etiologic, Anatomic and Pathophysiologic class, Venous Clinical Severity Score, microfoam volume, operative time, and prior deep venous thrombosis were not predictive of ARTE. CONCLUSIONS: ARTE after above-knee GSV closure occurred more frequently after MFA. Our results suggest that a saphenous vein diameter of >10 mm may be associated with ARTE. Despite this finding, all patients with ARTE were treated with short-term anticoagulation with no related complications. Until larger studies with high-risk subgroups have been studied after MFA, DU examination should be performed routinely after this procedure and patients with ARTE anticoagulated until the thrombus retracts caudal to the saphenofemoral junction or is no longer present on DU examination. Current societal guidelines recommending against routine post-thermal ablation DU examination should not be applied to similar patients after saphenous nonthermal MFA ablation.

Peritoneal Dialysis Catheter Complications after Insertion by Surgeons, Radiologists, or Nephrologists.

SIGNIFICANCE STATEMENT: The Advancing American Kidney Health Initiative aims to increase rates of utilization of peritoneal dialysis (PD) in the United States. One of the first steps to PD is successful catheter placement, which can be performed by surgeons, interventional radiologists, or nephrologists. We examined the association between operator subspecialty and risk of needing a follow-up procedure in the first 90 days after initial PD catheter implantation. Overall, we found that 15.5% of catheters required revision, removal, or a second catheter placement within 90 days. The odds of requiring a follow-up procedure was 36% higher for interventional radiologists and 86% higher for interventional nephrologists compared with general surgeons. Further research is needed to understand how to optimize the function of catheters across different operator types. BACKGROUND: The US government has implemented incentives to increase the use of PD. Successful placement of PD catheters is an important step to increasing PD utilization rates. Our objective was to compare initial outcomes after PD catheter placement by different types of operators. METHODS: We included PD-naïve patients insured by Medicare who had a PD catheter inserted between 2010 and 2019. We examined the association between specialty of the operator (general surgeon, vascular surgeon, interventional radiologist, or interventional nephrologist) and odds of needing a follow-up procedure, which we defined as catheter removal, replacement, or revision within 90 days of the initial procedure. Mixed logistic regression models clustered by operator were used to examine the association between operator type and outcomes. RESULTS: We included 46,973 patients treated by 5205 operators (71.1% general surgeons, 17.2% vascular surgeons, 9.7% interventional radiologists, 2.0% interventional nephrologists). 15.5% of patients required a follow-up procedure within 90 days of the initial insertion, of whom 2.9% had a second PD catheter implanted, 6.6% underwent PD catheter removal, and 5.9% had a PD catheter revision within 90 days of the initial insertion. In models adjusted for patient and operator characteristics, the odds of requiring a follow-up procedure within 90 days were highest for interventional nephrologists (HR, 1.86; 95% confidence interval [CI], 1.56 to 2.22) and interventional radiologists (odds ratio, 1.36; 95% CI, 1.17 to 1.58) followed by vascular surgeons (odds ratio, 1.06; 95% CI, 0.97 to 1.14) compared with general surgeons. CONCLUSIONS: The probability of needing a follow-up procedure after initial PD catheter placement varied by operator specialty and was higher for interventionalists and lowest for general surgeons.

Increased body mass index and vein diameter are associated with incomplete target vein closure following microfoam ablation of incompetent saphenous veins.

OBJECTIVE: Patient characteristics and risk factors for incomplete or non-closure following thermal saphenous vein ablation have been reported. However, similar findings have not been clearly described following commercially manufactured polidocanol microfoam ablation (MFA). The objective of our study is to identify predictive factors and outcomes associated with non-closure following MFA of symptomatic, refluxing saphenous veins. METHODS: A retrospective review of a prospectively maintained patient database was performed from procedures in our Ambulatory Procedure Unit. All consecutive patients who underwent MFA with commercially manufactured 1% polidocanol microfoam for symptomatic superficial vein reflux between June 2018 and September 2022 were identified. Patients treated for tributary veins only, without truncal vein ablation, were excluded. Patients were then stratified into groups: complete closure (Group I) and non-closure (Group II). Preoperative demographics, procedural details, and postoperative outcomes were analyzed. Preoperative variables that were significant on univariate analysis (prior deep venous thrombosis [DVT], body mass index [BMI] ≥30 kg/m2, and vein diameter) were entered into a multivariate logistic regression model with the primary outcome being vein non-closure. RESULTS: Between June 2018 and September 2022, a total of 224 limbs underwent MFA in our ambulatory venous center. Of these, 127 limbs in 103 patients met study inclusion criteria. Truncal veins treated included the above-knee great saphenous vein (Group I: n = 89, 77% vs Group II: n = 7, 58%; P = .14), below-knee great saphenous vein (Group I: n = 7, 6% vs Group II: n = 0; P = .38), anterior accessory saphenous vein (Group I: n = 17, 15% vs Group II: n = 4, 33%; P = .12, and small saphenous vein (Group I: n = 4, 4% vs Group II: n = 1, 8%; P = .41). Complete closure (Group I) occurred in 115 limbs, and 12 limbs did not close (Group II) based on postoperative duplex ultrasound screening. The mean BMI in Group II (36.1 ± 6.4 kg/m2) was significantly greater than Group I (28.6 ± 6.1 kg/m2) (P < .001). Vein diameter of ≥10.2 mm was independently associated with truncal vein non-closure with an odds ratio of 4.8. The overall mean foam volume was 6.2 ± 2.7 ml and not different between the two cohorts (Group I: 6.2 ± 2.6 ml vs Group II: 6.3 + 3.5 ml; P = .89). Post MFA improvement in symptoms was higher in Group I (96.9%) compared with Group II (66.7%) (P = .001). The mean postoperative Venous Clinical Severity Score was also lower in Group I (8.0 ± 3.0) compared with Group II (9.9 ± 4.2) (P = .048). The overall incidences of ablation-related thrombus extension and DVT were 4.7% (n = 6) and 1.6% (n = 2), and all occurred in Group I. All were asymptomatic and resolved with anticoagulation. CONCLUSIONS: Microfoam ablation of symptomatic, refluxing truncal veins results in excellent overall closure rates and symptomatic relief. BMI ≥30 kg/m2 and increased vein diameter are associated with an increased risk of saphenous vein non-closure following MFA. Non-closure is associated with less symptomatic improvement and a lower post-procedure reduction in Venous Clinical Severity Score. Despite the incidence of ablation-related thrombus extension and DVT in this study being higher than reported rates following thermal ablation, MFA is safe for patients with early postoperative duplex ultrasound surveillance and selective short-term anticoagulation.

Short-term mortality and revisions to promote maturation after arteriovenous fistula creation.

OBJECTIVE: Arteriovenous fistula (AVF) for hemodialysis access is traditionally considered superior to grafts due to infection resistance and purported improved patency. However, challenges to AVF maturation and limited patient survival may reduce AVF benefits. The objective of this study is to identify factors associated with risk of AVF requiring revision before maturation and/or mortality within 2 years of creation. METHODS: We performed a retrospective review of 250 AVFs created between May 2017 and November 2020 at a single institution. Maturation was defined as the date the surgeon deemed the AVF ready for use or the patient successfully used the AVF for dialysis. The Risk Analysis Index was used to calculate frailty. The primary outcome was a composite of endovascular/surgical revision to promote maturation and/or mortality within 2 years of AVF creation (REVDEAD). The primary outcome was categorized as met if the patient required a revision to promote maturation or if the patient experienced mortality within 2 years of AVF creation, or if both occurred. REVDEAD was compared with those who did not meet the primary outcome and will be referred to as NOREVDEAD. RESULTS: Survival at 2 years after AVF creation was 82%, and 54 (22%) patients underwent AVF revision. Of those, 31 (59%) patients progressed to AVF maturation. Of the 250 AVFs, 91 (36%) met the primary outcome of REVDEAD and 159 (64%) did not (NOREVDEAD). There was no difference between the REVDEAD and NOREVDEAD groups in age (P = .18), sex (P = .75), White race (P = .97), Hispanic ethnicity (P = .62), obesity (P = .76), coronary artery disease (P = .07), congestive heart failure (P = .29), diabetes mellitus (P = .78), chronic obstructive pulmonary disease (P = .10), dialysis status (P = .63), hypertension (P = .32), peripheral arterial disease (P = .34), or dysrhythmia (P = .13). There was no difference between the groups in the forearm vs the upper arm location of AVF (P = .42) or the vein diameter (P = .58). Forearm access, as opposed to upper arm AVF creation, was associated with higher rate of revision before maturation (P = .05). More patients in REVDEAD were frail or very frail (60% vs 48%, P = .05). Of the AVFs that matured, maturation required longer time in REVDEAD at 110.0 ± 9.1 days vs 78.8 ± 5.6 days (mean ± standard deviation) (P = .003). Adjusted for the vein diameter and the forearm vs the upper arm, frailty increased the odds of REVDEAD by 1.9 (95% confidence interval: 1.1, 3.3). CONCLUSIONS: Frail patients who underwent AVF were significantly more likely to die within 2 years of AVF creation with no significant association between frailty and the need for revisions to promote maturation. Forearm AVFs were more likely to require revisions; in patients who are frail, with a high likelihood of 2-year mortality, graft may be more appropriate than AVF. If AVF is being considered in a frail patient, upper arm AVFs should be prioritized over forearm AVFs.

Improved long-term functional outcomes and mortality of patients with vascular-related amputations utilizing the lower extremity amputation pathway.

BACKGROUND: Enhanced recovery after surgery pathways lead to improve perioperative outcomes for patients with vascular-related amputations; however, long-term data and functional outcomes are lacking. This study evaluated patients treated by the lower extremity amputation pathway (LEAP) and identified predictors of ambulation. METHODS: A retrospective review of LEAP patients who underwent major amputation from 2016 to 2022 for Wound, Ischemia, and foot Infection stage V disease was performed. LEAP patients were matched 1:1 with retrospective controls (NOLEAP) by hospital, need for guillotine amputation, and final amputation type (above knee vs below knee). The primary end point was the Medicare Functional Classification Level (K level) (functional classification of patients with amputations) at the last follow-up. RESULTS: We included 126 patients with vascular-related amputations (63 LEAP and 63 NOLEAP). Seventy-one percent of the patients were male and 49% were Hispanic with a mean state Area Deprivation Index of 9/10. There were no differences in baseline demographics or comorbidities. All patients had a K level of >0 (ambulatory) before amputation and an average Modified Frailty Index of 4. The median follow-up was 270 days (interquartile range, 84-1234 days) in the NOLEAP group and 369 days (interquartile range, 145-481 days) in the LEAP group. Compared with NOLEAP patients, LEAP patients were more likely to receive a prosthesis (86% vs 44%;P > .001). LEAP patients were more likely to have a K level of >0 (60% vs 25%; P = .003). On multivariable logistic regression, participation in LEAP increased the odds of a K level of >0 at follow-up by 5.8-fold (odds ratio, 5.8; 95% confidence interval, 2.5-13.6). Patients with a K level of >0 had significantly higher survival at 4 years (93% vs 59%; P = .001). In a Cox proportional hazards model, adjusted for demographics, comorbidities and amputation level, a K level of >0 at follow-up was associated with an 88% decrease in the risk of mortality compared with a K level of 0. CONCLUSIONS: LEAP leads to improved ambulation with a prosthesis in a socioeconomically disadvantaged and frail patient population. Patients with a K level of >0 (ambulatory) have significantly improved mortality.

Sex disparities in hemodialysis access outcomes: A systematic review.

The goal of this systematic review was to collate and summarize the current literature on hemodialysis access outcomes in females, identify differences between females and men, and provide a foundation for future research. A systematic review of the English-language literature was conducted by searching PubMed and Google Scholar for the following terms: "sex," "hemodialysis access," "arteriovenous fistula," "arteriovenous graft," and "dialysis catheter." Reference lists from the resulting articles were also evaluated to ensure that any and all relevant primary sources were identified. Studies were then screened by two independent reviewers for inclusion. Of 967 total studies, 53 ultimately met inclusion criteria. Females have lower maturation rates; have decreased rates of primary, primary-assisted, and secondary patency; require more procedures per capita to achieve maturation and to maintain fistula patency; are more likely to receive dialysis via an arteriovenous graft or central venous catheter; and require a longer time and potentially more assistive invasive interventions to achieve a mature fistula. Our findings emphasize the urgent need for further research to evaluate and address the causes of these disparities. Discussion with patients undergoing hemodialysis should include these findings to improve patient education, expectations, satisfaction, and outcomes.

Enhanced recovery after surgery (ERAS) for vascular surgery: an evidence map and scoping review.

BACKGROUND: Enhanced recovery after surgery (ERAS) interventions aim to improve patient outcomes. Vascular surgery patients have unique requirements and it is unclear which ERAS interventions are supported by an evidence base. METHODS: We conducted a scoping review to identify ERAS randomized controlled trials (RCTs) published in the biomedical or nursing literature. We assessed interventions for applicability to vascular surgery and differentiated interventions given at preadmission, preoperative, intraoperative, and postoperative surgery stages. We documented the research in an evidence map. RESULTS: We identified 76 relevant RCTs. Interventions were mostly administered in preoperative (23 RCTs; 30%) or intraoperative surgery stages (35 RCTs; 46%). The majority of studies reported mortality outcomes (44 RCTs; 58%), but hospital (27 RCTs; 35%) and intensive care unit (9 RCTs; 12%) length of stay outcomes were less consistently described. CONCLUSION: The ERAS evidence base is growing but contains gaps. Research on preadmission interventions and more consistent reporting of key outcomes is needed.

Options for Dialysis and Vascular Access Creation.

End-stage kidney disease (ESKD) affects nearly 800,000 patients in the United States. The choice of peritoneal dialysis (PD) versus hemodialysis (HD) should be patient centric. An ESKD Life-Plan is crucial with the goal of creating the right access, for the right patient, at the right time, for the right reason. Complex access should be considered when straightforward access options have been exhausted. Evolving techniques such as percutaneous access for HD and PD should be further investigated. Shared decision-making and palliative care is an essential part of the care of patients with CKD and ESKD..

Barriers to Implementing the Kidney Disease Outcomes Quality Initiative End-Stage Kidney Disease Life Plan Guideline.

OBJECTIVE: The updated 2019 National Kidney Foundation Kidney Disease Outcomes Quality Initiative vascular access guidelines recommend patient-centered, multi-disciplinary construction and regular update of an individualized end-stage kidney disease (ESKD) Life-Plan (LP) for each patient, a dramatic shift from previous recommendations and policy. The objective of this study was to examine barriers and facilitators to implementing the LP among key stakeholders. METHODS: Semi-structured individual interviews were analyzed using inductive and deductive coding. Codes were mapped to relevant domains in the Consolidated Framework for Implementation Research (CFIR). RESULTS: We interviewed 34 participants: 11 patients with end-stage kidney disease, 2 care partners, and 21 clinicians who care for patients with end-stage kidney disease. In both the clinician and the patient/care partner categories, saturation (where no new themes were identified) was reached at 8 participants. We identified significant barriers and facilitators to implementation of the ESKD LP across three CFIR domains: Innovation, Outer setting, and Inner setting. Regarding the Innovation domain, patients and care partners valued the concept of shared decision-making with their care team (CFIR construct: innovation design). However, both clinicians and patients had significant concerns about the complexity of decision-making around kidney substitutes and the ability of patients to digest the overwhelming amount of information needed to effectively participate in creating the LP (innovation complexity). Clinicians expressed concerns regarding the lack of existing evidence base which limits their ability to effectively counsel patients (innovation evidence base) and the implementation costs (innovation cost). Within the Outer Setting, both clinicians and patients were concerned about performance measurement pressure under the existing "Fistula First" policies and had concerns about reimbursement (financing). In the Inner Setting, clinicians and patients stressed the lack of available resources and access to knowledge and information. CONCLUSION: Given the complexity of decision-making around kidney substitutes and vascular access, our findings point to the need for implementation strategies, infrastructure development, and policy change to facilitate ESKD LP development.

Community-wide feasibility of the Lower Extremity Amputation Protocol amongst vascular amputees.

BACKGROUND: The Lower Extremity Amputation Protocol (LEAP) is a multidisciplinary enhanced recovery after surgery pathway for vascular amputees. The objective of this study was to examine feasibility and outcomes of community-wide implementation of LEAP. METHODS: LEAP was implemented at three safety net hospitals for patients with peripheral artery disease or diabetes requiring major lower extremity amputation. Patients who underwent LEAP (LEAP) were matched 1:1 with retrospective controls (NOLEAP) on hospital location, need for initial guillotine amputation, and final amputation type (above- vs below-knee). Primary endpoint was postoperative hospital length of stay (PO-LOS). RESULTS: A total of 126 amputees (63 LEAP and 63 NOLEAP) were included with no difference between baseline demographics and co-morbidities between the groups. After matching, both groups had the same prevalence of amputation level (76% below-knee vs 24% above-knee). LEAP patients had shorter duration of postamputation bed rest (P = .003) and were more likely to receive limb protectors (100% vs 40%; P ≤ .001), prosthetic counseling (100% vs 14%; P ≤ .001), perioperative nerve blocks (75% vs 25%; P ≤ .001), and postoperative gabapentin (79% vs 50%; P ≤ .001). Compared with NOLEAP, LEAP patients were more likely to be discharged to an acute rehabilitation facility (70% vs 44%; P = .009) and less likely to be discharged to a skilled nursing facility (14% vs 35%; P = .009). The median PO-LOS for the overall cohort was 4 days. LEAP patients had a shorter median PO-LOS (3 [interquartile range, 2-5] vs 5 [interquartile range, 4-9] days; P < .001). On multivariable logistic regression, LEAP decreased the odds of a PO-LOS of ≥4 days by 77% (odds ratio, 0.23; 95% confidence interval, 0.09-0.63). Overall, LEAP patients were significantly less likely to have phantom limb pain (5% vs 21%; P = .02) and were more likely to receive a prosthesis (81% vs 40%; P ≤ .001). In a multivariable Cox proportional hazards model, LEAP was associated with an 84% reduction in time to receipt of prosthesis (hazard ratio, 0.16; 95% confidence interval, 0.085-0.303; P < .001). CONCLUSIONS: Community wide implementation of LEAP significantly improved outcomes for vascular amputees demonstrating that utilization of core ERAS principles in vascular patients leads to decreased PO-LOS and improved pain control. LEAP also affords this socioeconomically disadvantaged population a greater opportunity to receive a prosthesis and return to the community as a functional ambulator.

Lack of patient-centered evaluation of outcomes in intermittent claudication literature.

BACKGROUND: Peripheral arterial disease, characterized as arterial atherosclerotic disease, can lead to insufficient flow in the lower extremities and ischemia, with the most common clinical manifestation being intermittent claudication (IC). In 2022, the Society for Vascular Surgery (SVS) developed appropriate use criteria for the management of IC that used this systematic review as a source of evidence. The objective of this study is to synthesize the findings of the systematic review and identify evidence gaps. METHODS: A comprehensive search of literature databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was conducted from January 1, 2000, to November 30, 2022. Noncomparative and comparative observational studies and randomized controlled trials were included. Included studies evaluated exercise therapy, endovascular or open revascularization for the treatment of IC. Outcomes of interest (freedom from major adverse limb event, health-related quality of life, and walking distance) were compared in various subgroups (age, sex, diabetes, smoking status, anatomical location of disease, and optimal medical therapy). RESULTS: Twenty-six studies reported the outcomes of interest for the evidence map. The general conclusions of the studies that reported freedom from major adverse limb events were that reintervention rates for endovascular therapy at ≥2 years were >20%, major amputation rates were often not reported, and, after endovascular therapy, the 1-month mortality was low (<2%). Quality of life and walking distance data were sparse, limited to only endovascular intervention, and insufficient to make any strong conclusions. CONCLUSIONS: IC in patients with peripheral arterial disease poses a significant socioeconomic and health care burden. Major, consequential gaps exist in the IC literature with respect to the assessment of patient reported outcome measures, standardized measures of walking distance and the comparative effectiveness of initial exercise therapy vs invasive intervention. The evidence gaps identified by the Society for Vascular Surgery appropriate use criteria on IC systematic review serve as a guide for future research efforts to optimize care for this patient population.

Comparison of outcomes following polidocanol microfoam and radiofrequency ablation of incompetent thigh great and accessory saphenous veins.

BACKGROUND: Microfoam ablation (MFA) and radiofrequency ablation (RFA) are both approved by the Food and Drug Administration for treatment of proximal saphenous truncal veins. The objective of our study was to compare early postoperative outcomes between MFA and RFA following treatment of incompetent thigh saphenous veins. METHODS: A retrospective review of a prospectively maintained database was conducted of patients who underwent treatment of incompetent great saphenous veins (GSVs) or anterior accessory saphenous veins (AASVs) in the thigh. All the patients underwent duplex ultrasound of the treated leg at 48 to 72 hours postoperatively. Patients were excluded from analysis if concomitant stab phlebectomy was performed. Demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, venous clinical severity score (VCSS), and adverse events were recorded. RESULTS: Between June 2018 and September 2022, 784 consecutive limbs (RFA, n = 560; MFA, n = 224) underwent venous closure for symptomatic reflux. A total of 200 consecutive thigh GSVs and ASVs treated within the study period using either MFA (n = 100) or RFA (n = 100) were identified. The patients were predominantly women (69%) with a mean age of 64 years. The preoperative CEAP classification was similar between the MFA and RFA groups. The mean preoperative VCSS was 9.4 ± 2.6 for the RFA patients and 9.9 ± 3.3 for the MFA patients. Among the RFA patients, the GSV was treated in 98% and the AASV in 2% compared with the GSV in 83% and the AASV in 17% in the MFA group (P < .001). The mean operative time was 42.4 ± 15.4 minutes in the RFA group and 33.8 ±16.9 minutes in the MFA group (P < .001). The median follow-up was 64 days for the study cohort. The mean postoperative VCSS declined to 7.3 ± 2.1 in the RFA group and 7.8 ± 2.9 in the MFA group. Complete closure occurred in 100% of the limbs after RFA and 90% after MFA (P = .005). Eight veins were partially closed and two remained patent following MFA. The incidence of superficial phlebitis was 6% and 15% (P = .06) after RFA and MFA, respectively. Overall, symptomatic relief was 90% following RFA and 89.5% following MFA. The complete ulcer healing rate for the entire cohort was 77.8%. Deep venous proximal thrombus extension (RFA, 1%; vs MFA, 4%; P = .37) and remote deep vein thrombosis (RFA, 0%; vs MFA, 2%; P = .5) showed a trend toward being higher following MFA but the difference did not reach statistical significance. All were asymptomatic and resolved with short-term anticoagulation therapy. CONCLUSIONS: MFA and RFA are both safe and effective for treating incompetent thigh saphenous veins, with excellent symptomatic relief and a low incidence of postprocedure adverse thrombotic events. RFA resulted in improved complete closure rates following initial treatment compared with MFA. The operative times were shorter with MFA. Both modalities can be used for patients with active venous ulcers with good healing rates. Longer term studies are required to characterize the durability of MFA closure for above knee truncal veins.

Outcomes of Median Arcuate Ligament Release: A Single Institution Retrospective Review.

BACKGROUND: Median arcuate ligament syndrome (MALS) is an uncommon diagnosis that is often associated with variable clinical presentation and inconsistent response to treatment. Due to the nature of MALS, the optimal treatment modality and predictors of outcomes remain unclear. METHODS: A retrospective review was performed of all median arcuate ligament release (MALR) procedures at a single academic institution between 2000 and 2020. Variables examined included patient demographics, symptom characteristics, operative technique (open, robotic, laparoscopic), patient symptoms before release, symptom relief within 1 year, and recurrence of symptoms between release and last clinical follow-up. RESULTS: During the study period, 47 patients (75% female, mean age 42.1 years) underwent MALR with 19 (36%) robotic, 18 (34%) open, 14 (26%) laparoscopic, and 2 (4%) laparoscopic converted to open procedures. Abdominal pain, weight loss, and nausea and vomiting were the most common symptoms. Postoperatively, 19 (40%) had complete symptom relief within 1 year, 18 (38%) had partial relief, and 10 (21%) had no symptom improvement. 6 were excluded due to loss of follow-up. Laparoscopic and open procedures had the highest rate of complete symptom relief by year 1 with 7 (58%) and 8 (50%) respectively. Twenty-one (57%) patients had recurrence with the greatest rate of recurrence seen among laparoscopic (80%), compared to robotic (57%) and open (38%). Patients reporting a weight loss of 20 pounds or more before surgery were more likely to have partial or complete symptom relief after 1 year compared to those reporting less than 20-pound weight loss (92% vs. 64%). Furthermore, 84% of patients younger than 60 years old reported partial or complete symptom relief compared to only 56% of those older than 60. CONCLUSIONS: MALS continues to be a rare disorder with widely variable surgical outcomes, requiring further study. While our patients presented with several gastrointestinal symptoms, the most common was postprandial pain. Our center employed laparoscopic, open, and robotic operative techniques with varying success rates, in terms of symptom relief and recurrence. Consistent with current literature, our study found greater surgical success among patients younger than 60 years regardless of operative technique. This suggests the need for better predictors to determine which patients are the most likely to have complete or prolonged remission of symptoms following MALR.

Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial.

BACKGROUND: Treatment of end-stage kidney disease (ESKD) with hemodialysis requires surgical creation of an arteriovenous (AV) vascular access-fistula (AVF) or graft (AVG)-to avoid (or limit) the use of a central venous catheter (CVC). AVFs have long been considered the first-line vascular access option, with AVGs as second best. Recent studies have suggested that, in older adults, AVGs may be a better strategy than AVFs. Lacking evidence from well-powered randomized clinical trials, integration of these results into clinical decision making is challenging. The main objective of the AV Access Study is to compare, between the two types of AV access, clinical outcomes that are important to patients, physicians, and policy makers. METHODS: This is a prospective, multicenter, randomized controlled trial in adults ≥ 60 years old receiving chronic hemodialysis via a CVC. Eligible participants must have co-existing cardiovascular disease, peripheral arterial disease, and/or diabetes mellitus; and vascular anatomy suitable for placement of either type of AV access. Participants are randomized, in a 1:1 ratio, to a strategy of AVG or AVF creation. An estimated 262 participants will be recruited across 7 healthcare systems, with average follow-up of 2 years. Questionnaires will be administered at baseline and semi-annually. The primary outcome is the rate of CVC-free days per 100 patient-days. The primary safety outcome is the cumulative incidence of vascular access (CVC or AV access)-related severe infections-defined as access infections that lead to hospitalization or death. Secondary outcomes include access-related healthcare costs and patients' experiences with vascular access care between the two treatment groups. DISCUSSION: In the absence of studies using robust and unbiased research methodology to address vascular access care for hemodialysis patients, clinical decisions are limited to inferences from observational studies. The goal of the AV Access Study is to generate evidence to optimize vascular access care, based on objective, age-specific criteria, while incorporating goals of care and patient preference for vascular access type in clinical decision-making. TRIAL REGISTRATION: This study is being conducted in accordance with the tenets of the Helsinki Declaration, and has been approved by the central institutional review board (IRB) of Wake Forest University Health Sciences (approval number: 00069593) and local IRB of each participating clinical center; and was registered on Nov 27, 2020, at ClinicalTrials.gov (NCT04646226).