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.

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.

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.

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 race) 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.

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.

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.

Factors associated with successful median arcuate ligament release in an international, multi-institutional cohort.

OBJECTIVE: Prior research on median arcuate ligament syndrome has been limited to institutional case series, making the optimal approach to median arcuate ligament release (MALR) and resulting outcomes unclear. In the present study, we compared the outcomes of different approaches to MALR and determined the predictors of long-term treatment failure. METHODS: The Vascular Low Frequency Disease Consortium is an international, multi-institutional research consortium. Data on open, laparoscopic, and robotic MALR performed from 2000 to 2020 were gathered. The primary outcome was treatment failure, defined as no improvement in median arcuate ligament syndrome symptoms after MALR or symptom recurrence between MALR and the last clinical follow-up. RESULTS: For 516 patients treated at 24 institutions, open, laparoscopic, and robotic MALR had been performed in 227 (44.0%), 235 (45.5%), and 54 (10.5%) patients, respectively. Perioperative complications (ileus, cardiac, and wound complications; readmissions; unplanned procedures) occurred in 19.2% (open, 30.0%; laparoscopic, 8.9%; robotic, 18.5%; P < .001). The median follow-up was 1.59 years (interquartile range, 0.38-4.35 years). For the 488 patients with follow-up data available, 287 (58.8%) had had full relief, 119 (24.4%) had had partial relief, and 82 (16.8%) had derived no benefit from MALR. The 1- and 3-year freedom from treatment failure for the overall cohort was 63.8% (95% confidence interval [CI], 59.0%-68.3%) and 51.9% (95% CI, 46.1%-57.3%), respectively. The factors associated with an increased hazard of treatment failure on multivariable analysis included robotic MALR (hazard ratio [HR], 1.73; 95% CI, 1.16-2.59; P = .007), a history of gastroparesis (HR, 1.83; 95% CI, 1.09-3.09; P = .023), abdominal cancer (HR, 10.3; 95% CI, 3.06-34.6; P < .001), dysphagia and/or odynophagia (HR, 2.44; 95% CI, 1.27-4.69; P = .008), no relief from a celiac plexus block (HR, 2.18; 95% CI, 1.00-4.72; P = .049), and an increasing number of preoperative pain locations (HR, 1.12 per location; 95% CI, 1.00-1.25; P = .042). The factors associated with a lower hazard included increasing age (HR, 0.99 per increasing year; 95% CI, 0.98-1.0; P = .012) and an increasing number of preoperative diagnostic gastrointestinal studies (HR, 0.84 per study; 95% CI, 0.74-0.96; P = .012) Open and laparoscopic MALR resulted in similar long-term freedom from treatment failure. No radiographic parameters were associated with differences in treatment failure. CONCLUSIONS: No difference was found in long-term failure after open vs laparoscopic MALR; however, open release was associated with higher perioperative morbidity. These results support the use of a preoperative celiac plexus block to aid in patient selection. Operative candidates for MALR should be counseled regarding the factors associated with treatment failure and the relatively high overall rate of treatment failure.

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.

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).

Patient Frailty and Functional Use of Hemodialysis Vascular Access: A Retrospective Study of the US Renal Data System.

RATIONALE & OBJECTIVE: Despite the high prevalence of frailty among dialysis patients, it is unknown whether frailty is associated with dialysis vascular access failure. This study examined the association between frailty and functional use of vascular access. STUDY DESIGN: Retrospective observational study. SETTING & PARTICIPANTS: Patients who initiated hemodialysis through a tunneled catheter in the US Renal Data System database from 2012 through 2017 and underwent subsequent creation of an arteriovenous fistula or graft. PREDICTORS: The "claims-based frailty indicator" (CFI) was calculated using a validated claims-based disability status model anchored to a well-described frailty phenotype. OUTCOMES: Time to functional use for fistulas and grafts defined as the time from initiation of hemodialysis to treatments using the index vascular access with 2 needles. ANALYTICAL APPROACH: Fine and Gray competing risk models separately examining fistula and graft outcomes. Patient survival was modeled for the entire cohort using Cox proportional hazards regression. RESULTS: A total of 41,471 patients met inclusion criteria, including 33,212 who underwent fistula creation and 8,259 who underwent graft placement. Higher CFI quartiles were associated with a greater rate of mortality. Patients in the highest CFI quartile had more than 2 times the rate of mortality compared with patients in the lowest CFI quartile (hazard ratio [HR], 2.49 [95% CI, 2.41-2.58]). In multivariable analyses, the highest CFI quartile was significantly associated with longer time to functional use of fistulas (HR, 0.65 [95% CI, 0.62-0.69]) and grafts (HR, 0.88 [95% CI, 0.79-0.98]). LIMITATIONS: Generalizability may be limited by the requirement of 12 months of Medicare claims availability before initiation of dialysis. There were no data on patient anatomic characteristics or surgeon characteristics and limited patient-specific sociodemographic data. CONCLUSIONS: Higher degrees of frailty are associated with longer times to vascular access functional use. Frailty may be useful for informing clinical decision-making regarding choice of vascular access.

Association of preoperative vein mapping with hemodialysis access characteristics and outcomes in the Vascular Quality Initiative.

BACKGROUND: Preoperative vein mapping before arteriovenous fistula (AVF) or arteriovenous graft (AVG) placement has been debated as a possible method of improving hemodialysis access outcomes for patients. However, high-quality national studies that have addressed this relationship are lacking. Thus, we assessed the association of preoperative vein mapping with hemodialysis access configuration and outcomes. METHODS: In the present cohort study, we analyzed all patients who had undergone AVF or AVG placement with data captured in the Vascular Quality Initiative hemodialysis access dataset from August 2011 to September 2019. The patients were stratified by whether they had undergone preoperative vein mapping. The primary (configuration) outcomes were access type (AVF vs AVG) and location (upper arm vs forearm). The secondary (longitudinal) outcomes were the successful initiation of hemodialysis, maintenance of secondary patency, and the need for reintervention 1 year after the index operation. RESULTS: Overall, 85.6% of the 46,010 included patients had undergone preoperative vein mapping. Of the 46,010 patients, 76.1% and 23.9% had undergone AVF and AVG creation, respectively. AVF creation (77.6% vs 67.3%) and forearm location (54.6% vs 47.3%) were more frequent for the patients who had undergone preoperative vein mapping than for those who had not (P < .001). After adjusting for baseline differences between the groups, preoperative vein mapping was associated with increased odds of receiving an AVF vs AVG (adjusted odds ratio, 1.64; 95% confidence interval [CI], 1.55-1.75) and forearm vs upper arm access (adjusted odds ratio, 1.22; 95% CI, 1.16-1.30). The incidence of the loss of secondary patency was lower for patients with preoperative vein mapping (P < .001), and persisted after risk adjustment (adjusted hazard ratio, 0.81; 95% CI, 0.75-0.88). CONCLUSIONS: Preoperative vein mapping was associated with favorable hemodialysis access configurations and outcomes in real-world practice. These data suggest that the use of preoperative vein mapping could improve the likelihood of favorable outcomes for patients requiring hemodialysis access.

Society for Vascular Surgery appropriate use criteria for management of intermittent claudication.

The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Professionalism in (vascular) surgery: What does it mean?

A publication in the August 2020 issue of the Journal of Vascular Surgery, "Prevalence of unprofessional social media content among young vascular surgeons," brought the concept of professionalism in the vascular surgery community to the forefront. In response to the methodology used in the article, and the definitions of professionalism, a global backlash from health care providers and lay people ensued. The article has since been retracted; however, its publication highlighted the need to reexamine current definitions and philosophies surrounding professionalism in medicine and surgery that may be discriminatory and exclusive. The term professionalism has no standard definition as evidenced by varying definitions among different societies and organizations. The lack of a structured, universally accepted definition of professionalism in the medical and surgical communities has resulted in no standard by which to measure the actions of physicians and surgeons. The definition of professionalism need not be complex and should not vary among specialties and societies. In its most simplistic form, the core definition of "professionalism" embedded in the volumes of publications, guidelines, and charters that exist on the subject of professionalism in medicine is respect. We propose a tiered approach to define professionalism in medicine that builds on fundamental principles of respect and inclusivity, and includes actionable steps at three levels: (1) individual, (2) organizational, and (3) societal. Through this approach, any physician, regardless of specialty, practice type or location, can apply these concepts to ensure they consistently embody what it means to be "professional."

Endovascular interventions for claudication do not meet minimum standards for the Society for Vascular Surgery efficacy guidelines.

OBJECTIVE: Because the treatment of intermittent claudication (IC) is elective, good short- and long-term outcomes are imperative. The objective of the present study was to examine the outcomes of endovascular management of IC reported in the Vascular Quality Initiative and compare them with the Society for Vascular Surgery guidelines for IC treatment to determine whether real-world results are within the guidelines. METHODS: Patients undergoing peripheral vascular intervention for IC from 2004 to 2017 with complete data and >9 month follow-up were included. The primary outcome measures were IC recurrence and repeat procedures performed ≤2 years after the initial treatment. RESULTS: A total of 16,152 patients met the inclusion criteria, with a mean age of 66 years. Of the 16,152 patients, 61% were men, 45% were current smokers, and 28% had been discharged without antiplatelet or statin medication. Adjusted analyses revealed that treatment of more than two arteries was associated with a shorter time to IC recurrence (hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.09-1.31) and a shorter time to repeat procedures (HR, 1.25; 95% CI, 1.09-1.45). The use of atherectomy was also associated with a shorter time to IC recurrence (HR, 1.29; 95% CI, 1.08-1.33) and a shorter time to repeat procedures (HR, 1.31; 95% CI, 1.13-1.52). Discharge with antiplatelet and statin medications was associated with a longer time to IC recurrence (HR, 0.84; 95% CI, 0.78-0.91) and a longer time to repeat procedures (HR, 0.77; 95% CI, 0.69-0.87). Life-table analysis at 2 years revealed that only 32% of patients were free from IC recurrence, although 76% had not undergone repeat procedures. Stratified by anatomic treatment level, 37% of isolated aortoiliac interventions, 22% of aortoiliac and femoropopliteal interventions, 30% of isolated femoropopliteal interventions, and 20% of femoropopliteal and tibial interventions had remained free from IC recurrence at 2 years. CONCLUSIONS: Most patients treated with an endovascular approach to IC did not meet the Society for Vascular Surgery guidelines for long-term freedom from recurrent symptoms of >50% at 2 years. Many lacked preprocedure optimization of medical management. The use of atherectomy and treatment of more than two arteries were associated with poor outcomes after peripheral vascular intervention for IC, because only 32% of these patients were free from recurrent symptoms at 2 years. Even when risk factor modification is optimized before the procedure, vascular specialists should be aware of the association between atherectomy and multivessel interventions with poorer long-term outcomes and counsel patients appropriately before intervention.

The impact of the COVID-19 pandemic on vascular surgery practice in the United States.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to widespread postponement and cancelation of elective surgeries in the United States. We designed and administered a global survey to examine the impact of COVID-19 on vascular surgeons. We describe the impact of the pandemic on the practices of vascular surgeons in the United States. METHODS: The Pandemic Practice, Anxiety, Coping, and Support Survey for Vascular Surgeons is an anonymous cross-sectional survey sponsored by the Society for Vascular Surgery Wellness Task Force disseminated April 14 to 24, 2020. This analysis focuses on pattern changes in vascular surgery practices in the United States including the inpatient setting, ambulatory, and vascular laboratory setting. Specific questions regarding occupational exposure to COVID-19, adequacy of personal protective equipment, elective surgical practice, changes in call schedule, and redeployment to nonvascular surgery duties were also included in the survey. Regional variation was assessed. The survey data were collected using REDCap and analyzed using descriptive statistics. RESULTS: A total of 535 vascular surgeons responded to the survey from 45 states. Most of the respondents were male (73.1%), white (70.7%), practiced in urban settings (81.7%), and in teaching hospitals (66.8%). Almost one-half were in hospitals with more than 400 beds (46.4%). There was no regional variation in the presence of preoperative COVID-19 testing, COVID-19 OR protocols, adherence to national surgical standards, or the availability of personal protective equipment. The overwhelming majority of respondents (91.7%) noted elective surgery cancellation, with the Northeast and Southeast regions having the most case cancellations 94.2% and 95.8%, respectively. The Northeast region reported the highest percentage of operations or procedures on patients with COVID-19, which was either identified at the time of the surgery or later in the hospital course (82.7%). Ambulatory visits were performed via telehealth (81.3%), with 71.1% having restricted hours. More than one-half of office-based laboratories (OBLs) were closed, although there was regional variation with more than 80% in the Midwest being closed. Cases performed in OBLs focused on critical limb ischemia (42.9%) and dialysis access maintenance (39.9%). Call schedules modifications were common, although the number of call days remained the same (45.8%). CONCLUSIONS: Vascular surgeons in the United States report substantial impact on their practices during the COVID-19 pandemic, and regional variations are demonstrated, particularly in OBL use, intensive care bed availability, and COVID-19 exposure at work.

Defining the 90-day cost structure of lower extremity revascularization for alternative payment model assessment.

BACKGROUND: The U.S. healthcare system is undergoing a broad transformation from the traditional fee-for-service model to value-based payments. The changes introduced by the Medicare Quality Payment Program, including the establishment of Alternative Payment Models, ensure that the practice of vascular surgery is likely to face significant reimbursement changes as payments transition to favor these models. The Society for Vascular Surgery Alternative Payment Model taskforce was formed to explore the opportunities to develop a physician-focused payment model that will allow vascular surgeons to continue to deliver the complex care required for peripheral arterial disease (PAD). METHODS: A financial analysis was performed based on Medicare beneficiaries who had undergone qualifying index procedures during fiscal year 2016 through the third quarter of 2017. Index procedures were defined using a list of Healthcare Common Procedural Coding (HCPC) procedure codes that represent open and endovascular PAD interventions. Inpatient procedures were mapped to three diagnosis-related group (DRG) families consistent with PAD conditions: other vascular procedures (codes, 252-254), aortic and heart assist procedures (codes, 268, 269), and other major vascular procedures (codes, 270-272). Patients undergoing outpatient or office-based procedures were included if the claims data were inclusive of the HCPC procedure codes. Emergent procedures, patients with end-stage renal disease, and patients undergoing interventions within the 30 days preceding the index procedure were excluded. The analysis included usage of postacute care services (PACS) and 90-day postdischarge events (PDEs). PACS are defined as rehabilitation, skilled nursing facility, and home health services. PDEs included emergency department visits, observation stays, inpatient readmissions, and reinterventions. RESULTS: A total of 123,180 cases were included. Of these 123,180 cases, 82% had been performed in the outpatient setting. The Medicare expenditures for all periprocedural services provided at the index procedure (ie, professional, technical, and facility fees) were higher in the inpatient setting, with an average reimbursement per index case of $18,755, $34,600, and $25,245 for DRG codes 252 to 254, DRG codes 268 and 269, and DRG codes 270 to 272, respectively. Outpatient facility interventions had an average reimbursement of $11,458, and office-based index procedures had costs of $11,533. PACS were more commonly used after inpatient index procedures. In the inpatient setting, PACS usage and reimbursement were 58.6% ($5338), 57.2% ($4192), and 55.9% ($5275) for DRG codes 252 to 254, DRG codes 268 and 269, and DRG codes 270 to 272, respectively. Outpatient facility cases required PACS for 13.7% of cases (average cost, $1352), and office-based procedures required PACS in 15% of cases (average cost, $1467). The 90-day PDEs were frequent across all sites of service (range, 38.9%-50.2%) and carried significant costs. Readmission was associated with the highest average PDE expenditure (range, $13,950-$18.934). The average readmission Medicare reimbursement exceeded that of the index procedures performed in the outpatient setting. CONCLUSIONS: The cost of PAD interventions extends beyond the index procedure and includes relevant spending during the long postoperative period. Despite the analysis challenges related to the breadth of vascular procedures and the site of service variability, the data identified potential cost-saving opportunities in the management of costly PDEs. Because of the vulnerability of the PAD patient population, alternative payment modeling using a bundled value-based approach will require reallocation of resources to provide longitudinal patient care extending beyond the initial intervention.

Current status of patient-reported outcome measures in vascular surgery.

A previously published review focused on generic and disease-specific patient-reported outcome measures (PROMs) relevant to vascular surgery but limited to arterial conditions. The objective of this project was to identify all available PROMs relevant to diseases treated by vascular surgeons and to evaluate vascular surgeon perceptions, barriers to widespread implementation, and concerns regarding PROMs. We provide an overview of what a PROM is and how they are developed, and summarize currently available PROMs specific to vascular surgeons. We also report results from a survey of 78 Society for Vascular Surgery members serving on committees within the Policy and Advocacy Council addressing the barriers and facilitators to using PROMs in clinical practice. Finally, we report the qualitative results of two focus groups conducted to assess granular perceptions of PROMS and preparedness of vascular surgeons for widespread implementation of PROMs. These focus groups identified a lack of awareness of existing PROMs, knowledge of how PROMs are developed and validated, and clarity around how PROMs should be used by the clinician as main subthemes for barriers to PROM implementation in clinical practice.