Objective assessment of physician work in infrainguinal arterial bypass surgery.

OBJECTIVE: The purpose of this study is obtain robust objective data from the Vascular Quality Initiative on physician work in infrainguinal artery bypass surgery. Operative time, patient comorbidities, anatomical complexity, consequences of adverse outcomes, and postoperative length of stay all factor into procedure relative value unit assignment and physician reimbursement. METHODS: Baseline demographics and comorbidities were identified among 74,920 infrainguinal bypass surgeries in Vascular Quality Initiative between 2003 and 2022. Investigation into areas of progressive complexity over time was conducted. Bypasses were divided into 10 cohorts based on inflow and target arteries and conduit type. Mean operative times, lengths of stay, major morbidity rates, and 90-day mortality rates were identified across the various bypasses. Comparison of relative value unit per minute service time during the acute inpatient hospital admission was performed between the most 4 common bypasses and 14 commonly performed highly invasive major surgeries across several subdisciplines. RESULTS: Patients undergoing infrainguinal arterial bypass have an advanced combination of medical complexities highlighted by diabetes mellitus in 40%, hypertension in 88%, body mass index >30 in 30%, coronary artery disease that has clinically manifested in 31%, renal insufficiency in 19%, chronic obstructive pulmonary disease in 27%, and prior lower extremity arterial intervention (endovascular and open combined) in >50%. The need for concomitant endarterectomy at the proximal anastomosis site of infrainguinal bypasses has increased over time (P < .001). The indication for bypass being limb-threatening ischemia as defined by ischemic rest pain, pedal tissue loss, or acute ischemia has also increased over time (P < .001), indicating more advanced extent of arterial occlusion in patients undergoing infrainguinal bypass. Finally, there has been a significant (P < .001) progression in the percentage of patients who have undergone a prior ipsilateral lower extremity endovascular intervention at the time of their bypass (increasing from 9.9% in 2003-2010 to 31.9% in the 2018-2022 eras). Among the 18 procedures investigated, the 4 most commonly performed infrainguinal bypasses were included in the analysis. These ranked 14th, 16th, 17th and 18th as the most poorly compensated per minute service time during the acute operative inpatient stay. CONCLUSIONS: Infrainguinal arterial bypass surgery has an objectively undervalued physician work relative value unit compared with other highly invasive major surgeries across several subdisciplines. There are elements of progressive complexity in infrainguinal bypass patients over the past 20 years among a patient cohort with a very high comorbidity rate, indicating escalating intensity for infrainguinal bypass.

Management of Arterio-Venous Fistula Side Branches During Maturation: Ligation or Coil Embolization.

OBJECTIVE: Failure of maturation of arteriovenous fistulae (AVF) remains an ongoing concern for dialysis access. One etiology is the presence of side branches that divert flow from the main AVF channel. This study aims to evaluate the outcomes of endovascular and open surgical interventions for AVF side branches in the setting of maturation failure. METHODS: A retrospective review of all patients within a 10-year period with primary radio cephalic and brachiocephalic AVF was undertaken, and 380 cases of maturation failure related to branch diversion were selected for the study. Fifty-four percent and 48% of the AVF in the ENDO and OPEN groups respectively have concomitant stenosis further along in the flow path that required intervention by balloon angioplasty at the same time as a side branch intervention. All patients underwent duplex imaging or a fistulogram before intervention. Indications were low flow (<600 mL/min) or failure to increase in size (<6 mm diameter) in all cases. Interventions were divided into endovascular (coil embolization; ENDO) and surgical (branch ligation; OPEN) interventions. Outcomes of maturation (successful progression to hemodialysis (HD)), re-intervention, and functional dialysis (continuous HD for three consecutive months) were examined. RESULTS: From January 2008 to December 2018, 187 patients (49^ of all cases with side branches; 65% female, age of 57 ± 18 years; mean ± SD) with poorly maturing radiocephalic (70%) and brachiocephalic AVF (30%) underwent intervention due to the presence of accessory venous branches only. Indications were failure to mature in 54% and low flow in 46%. The average time to intervention due to failure to mature was 5 ± 4 weeks (mean ± SD) after primary access placement. Eighty-one had coil embolization and 106 had open branch ligation. Technical success was 90% in ENDO and 100% in OPEN. Technical ENDO failures had a secondary open branch ligation but were considered failures for analysis. Repeat interventions by balloon-assisted maturation were required in 45% of all the cases with no difference between ENDO and OPEN. Recannulation of the ENDO branches occurred in 10% of the cases requiring repeat intervention. Sixty one percent of isolated endovascular (n = 49) and 64% of isolated open (n = 68) matured to successful cannulation (P = 0.84). Median functional dialysis durations remained equivalent between ENDO (2.6 years) and OPEN (2.8 years) groups (P = 0.12). CONCLUSION: There is an improved maturation rate following the ENDO group compared to OPEN interventions while both ENDO and OPEN modalities demonstrated similar long-term functionality.

The Society for Vascular Surgery Alternative Payment Model Task Force report on opportunities for value-based reimbursement in care for patients with peripheral artery disease.

The Society for Vascular Surgery Alternative Payment Model (APM) Taskforce document explores the drivers and implications for developing objective value-based reimbursement plans for the care of patients with peripheral arterial disease (PAD). The APM is a payment approach that highlights high-quality and cost-efficient care and is a financially incentivized pathway for participation in the Quality Payment Program, which aims to replace the traditional fee-for-service payment method. At present, the participation of vascular specialists in APMs is hampered owing to the absence of dedicated models. The increasing prevalence of PAD diagnosis, technological advances in therapeutic devices, and the increasing cost of care of the affected patients have financial consequences on care delivery models and population health. The document summarizes the existing measurement methods of cost, care processes, and outcomes using payor data, patient-reported outcomes, and registry participation. The document also evaluates the existing challenges in the evaluation of PAD care, including intervention overuse, treatment disparities, varied clinical presentations, and the effects of multiple comorbid conditions on the cost potentially attributable to the vascular interventionalist. Medicare reimbursement data analysis also confirmed the prolonged need for additional healthcare services after vascular interventions. The Society for Vascular Surgery proposes that a PAD APM should provide patients with comprehensive care using a longitudinal approach with integration of multiple key medical and surgical services. It should maintain appropriate access to diagnostic and therapeutic advancements and eliminate unnecessary interventions. It should also decrease the variability in care but must also consider the varying complexity of the presenting PAD conditions. Enhanced quality of care and physician innovation should be rewarded. In addition, provisions should be present within an APM for high-risk patients who carry the risk of exclusion from care because of the naturally associated high costs. Although the document demonstrates clear opportunities for quality improvement and cost savings in PAD care, continued PAD APM development requires the assessment of more granular data for accurate risk adjustment, in addition to largescale testing before public release. Collaboration between payors and physician specialty societies remains key.

Extent of heel ulceration influences the outcomes in patients with isolated infrapopliteal limb threatening critical ischemia.

BACKGROUND: The aim of the present study was to assess the effects of the extent of heel ulceration on the outcomes of limb threatening critical ischemia due to isolated infrapopliteal disease. METHODS: A retrospective review identified 989 patients with isolated infrapopliteal disease and heel ulceration treated from 2001 to 2018. The heel was defined as the back of the foot, extending from the Achilles tendon to around the plantar surface and covering the apex of the calcaneum bone. Heel ulceration was categorized into three groups by area: <5 cm2, 5 to 10 cm2, and >10 cm2. The interventions were endovascular, open bypass, major amputation, and wound care. An intention-to-treat analysis by patient group was performed. The 30-day outcomes and amputation-free survival (AFS; survival without a major amputation) were evaluated. RESULTS: Of the 989 patients, 384 (58% male; average age, 65 years; n = 768 vessels) had undergone isolated endovascular tibial intervention, 124 (45% male; average age, 59 years) had undergone popliteal tibial vein bypass for limb threatening critical ischemia, 219 (52% male; average age, 67 years) had undergone major amputation, and 242 (49% male; average age, 66 years) had received wound care. No difference was found in the 30-day major adverse cardiac events in the endovascular and open bypass groups, with significantly more events in the major amputation group (P = .03). The 30-day major adverse limb events and 30-day amputation rates were equivalent between the open bypass and endovascular groups. The 5-year AFS rate was superior in the open bypass group (37% ± 8%; mean ± standard error of the mean) compared with the endovascular group (27% ± 9%; P = .04). The wound care group had a 5-year AFS rate of 20% ± 9%, which was not significantly different from that of the endovascular group. Patients with heel ulcers of <5 cm2 had better AFS (47% ± 8%) than those with 5- to 10- cm2 heel ulceration (24% ± 9%). Heel ulcers >10 cm2 were associated with markedly worse 5-year AFS outcomes (0% ± 0%). The presence of end-stage renal disease, osteomyelitis, uncontrolled diabetes (hemoglobin A1c >10%), and/or frailty combined with a heel ulcer >10 cm2 were predictive of poor AFS. CONCLUSIONS: An increasing heel ulcer area combined with osteomyelitis and systemic comorbidities was associated with worsening 30-day outcomes and 5-year AFS, irrespective of the therapy chosen.

Vascular Surgeons Are Not Adequately Valued by Traditional Productivity Metrics.

BACKGROUND: Reimbursements for professional services performed by clinicians are under constant scrutiny. The value of a vascular surgeon's services as measured by work relative value units (wRVUs) and professional reimbursement has decreased for some of the most common procedures performed. Hospital reimbursements, however, often remain stable or increases. We sought to evaluate fistulagrams as a case study and hypothesized that while wRVUs and professional reimbursements decrease, hospital reimbursements for these services increased over the same time period. METHODS: Medicare 5% claims data were reviewed to identify all fistulagrams with or without angioplasty or stenting performed between 2015 and 2018 using current procedural terminology codes. Reimbursements were classified into 3 categories: medical center (reimbursements made to a hospital for a fistulagram performed as an outpatient procedure), professional (reimbursement for fistulagrams based on compensation for procedures: work RVUs, practice expense RVU, malpractice expense RVU), and office-based laboratory (OBL, reimbursement for fistulagrams performed in an OBL setting). Medicare's Physician Fee Schedule was used to calculate wRVU and professional reimbursement. Medicare's Hospital Outpatient Prospective Payment System-Ambulatory Payment Classification was used to calculate hospital outpatient reimbursement. RESULTS: From 2015 to 2018, we identified 1,326,993 fistulagrams. During this study period, vascular surgeons experienced a 25% increase in market share for diagnostic fistulagrams. Compared with 2015, total professional reimbursements from 2017 to 2018 for all fistulagram procedures decreased by 41% (-$10.3 million) while OBL reimbursement decreased 29% (-$42.5 million) and wRVU decreased 36%. During the same period, medical center reimbursement increased by 6.6% (+$14.1 million). CONCLUSIONS: Vascular surgeons' contribution to a hospital may not be accurately reflected through traditional RVU metrics alone. Vascular surgeons performed an increasing volume of fistulagram procedures while experiencing marked reductions in wRVU and reimbursement. Medical centers, on the other hand, experienced an overall increase in reimbursement during the same time period. This study highlights that professional reimbursements, taken in isolation and without consideration of medical center reimbursement, undervalues the services and contributions provided by vascular surgeons.

Outcomes of isolated inframalleolar interventions for chronic limb-threatening ischemia in diabetic patients.

BACKGROUND: Inframalleolar disease is present in many diabetic patients presenting with tissue loss. The aim of this study was to examine the patient-centered outcomes after isolated inframalleolar interventions. METHODS: A database of patients undergoing lower extremity endovascular interventions for tissue loss (critical limb-threatening ischemia, Wound, Ischemia, and foot Infection [WIfI] stage 1-3) and a de novo intervention on the index limb between 2007 and 2017 was retrospectively queried. Those patients with isolated inframalleolar interventions on the dorsalis pedis and medial and lateral tarsal arteries were identified. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (AFS; survival without major amputation), and freedom from major adverse limb events (above-ankle amputation of the index limb or major reintervention [new bypass graft, jump or interposition graft revision]) were evaluated. RESULTS: There were 109 patients (48% male; average age, 65 years; 153 vessels) who underwent isolated inframalleolar interventions for tissue loss. All patients had diabetes, and 53% had chronic renal insufficiency (47% of these were on hemodialysis). The majority of the patients had WIfI stage 3 disease. Technical success was 81%, with a median of one vessel treated per patient. Thirty-four percent of interventions were a direct revascularization of the intended angiosome in the foot. The 30-day major adverse cardiovascular event rate was 0%. The majority of patients underwent some form of planned forefoot surgery (single digit, multiple digits, ray or transmetatarsal amputation). Wound healing at 3 months in those not requiring amputation was 76%. Predictors for wound healing were improved pedal runoff score (<7), absence of infection, direct angiosome revascularization, and absence of end-stage renal disease. Those in whom the primary wounds or the initial amputation site failed to heal ultimately underwent below-knee amputations. The clinical efficacy was 25% ± 7% (mean ± standard error of the mean) at 5 years. The 5-year AFS rate was 33% ± 8%, and the 5-year freedom from major adverse limb events was 27% ± 9%. On Cox proportional multivariate analysis, predictors for AFS were absence of significant coronary disease, postprocedure pedal runoff score <7 (good runoff), WIfI stage <3, and absence of end-stage renal disease. CONCLUSIONS: Inframalleolar intervention can be successfully performed in high-risk limbs with acceptable short-term results. However, long-term AFS remains poor because of the underlying disease process.

Implications of early failure of isolated endovascular tibial interventions.

BACKGROUND: Endovascular tibial interventions for chronic limb-threatening ischemia are frequent, but the implications of early failure (≤30 days) of an isolated tibial intervention are still unclear. The aim of this study was to examine the patient-centered outcomes after early failure of isolated tibial artery intervention. METHODS: A database of patients undergoing lower extremity endovascular interventions between 2007 and 2017 was retrospectively queried. Patients with chronic limb-threatening ischemia (Rutherford classes 4, 5, and 6) were selected, and failures within 30 days were identified. Lack of technical success at the time of the procedure was an exclusion. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention [new bypass graft, jump or interposition graft revision]) were evaluated. RESULTS: There were 1779 patients (58% male; average age, 65 years; 2898 vessels) who underwent tibial intervention for chronic limb-threatening ischemia; 284 procedures (16%) were early failures. In the early failure group, 124 cases (44%) were considered immediate (<24 hours), and 160 cases (56%) failed within the first 30 days after intervention. The two modes of failure were hemodynamic failure (47%) and progression of chronic limb-threatening ischemia (53%). Bypass after early failure was successful in patients with adequate vein, target vessel of ≥3 mm, and good inframalleolar runoff. Progression of symptoms was associated with major amputation in patients with Rutherford class 5 and class 6 disease. Presentation with diabetes and end-stage renal disease were identified as independent clinical predictors for early failure. Lesion calcification, reference vessel diameter <3 mm, lesion length >300 mm, and poor inframalleolar runoff were identified as independent anatomic predictors for early failure and increased MALEs. Early failure was predictive of poor long-term clinical efficacy (11% ± 9% vs 39% ± 8% at 5 years, mean ± standard error of the mean, early vs no early failure; P = .01) and amputation-free survival (16% ± 9% vs 47% ± 9% at 5 years, mean ± standard error of the mean, early vs no early failure; P = .02). CONCLUSIONS: Both clinical and anatomic factors can predict early failure of endovascular therapy for isolated tibial disease. Early failure significantly increases 30-day major amputation and 30-day MALEs and is associated with poor long-term patient-centered outcomes.

Short-term contemporary outcomes for staged versus primary lower limb amputation in diabetic foot disease.

BACKGROUND: Major lower extremity amputations remain among the most common procedures performed by vascular surgeons in patients with diabetes and its associated peripheral vascular disease. After major amputation, this population commonly suffers from high readmission rates, increased wound complications, and conversion to more proximal major amputations. These events impact quality in terms of cost, resources, and subjective quality of life. The aim of this study is to compare outcomes between primary lower extremity above-ankle amputations (primary amputation [PA]) and staged ankle guillotine amputations followed by interval formalization to an above-ankle amputation (staged amputation [SA]) for nonsalvageable infected diabetic foot disease. METHODS: A retrospective review of all de novo major lower extremity amputations performed by the vascular surgery service at a single institution between January 2014 and March 2017 was performed. Inclusion criteria were diabetic patients with foot gangrene who underwent a major de novo above- or below-knee amputation. Amputations for trauma, acute limb ischemia, or malignancy were excluded. Per institutional practice, SA was performed for uncontrolled infection and/or infection with uncontrolled diabetes, and PA was performed in the absence of active infection and in stable diabetes. The primary outcome measure was 30-day freedom from conversion to a higher level amputation. Secondary outcome measures were 30-day stump complications, 30-day readmissions, 30-day major adverse cardiovascular events, and 30-day mortality. RESULTS: One hundred sixteen patients met the inclusion criteria. Sixty-eight percent were male, 18% were active smokers, 30% had end-stage renal disease, and 22% had congestive heart failure. Sixty-one patients underwent SA, and 55 patients underwent PA. The two cohorts were well-matched by demographics and comorbidities. Consistent with the institutional practice, 57% of SA patients met two or more systemic inflammatory response syndrome criteria at presentation compared with 24% of PA patients (P = .0003). There were no 30-day mortalities. There was no significant difference in major adverse cardiovascular events between the groups (2% vs 4%; SA vs PA, respectively; P = .6). The average length of stay did not significantly differ between SA and PA (mean of 14 ± 8 days vs 11 ± 11 days; P = .1). SA patients had a lower rate of 30-day readmission (7% vs 27%; P = .005) and 30-day unplanned conversion to higher level amputation (2% vs 13%; P = .026) compared with PA patients. CONCLUSIONS: In the setting of infected diabetic foot disease, a staged lower extremity amputation achieves quality outcomes superior to a one-stage amputation, despite the former cohort's greater illness acuity level. SA should be considered in all diabetic patients presenting with active foot infection.

Upper extremity arterial endovascular interventions for symptomatic vascular access-induced steal syndrome.

BACKGROUND: Critical hand ischemia owing to vascular access-induced steal syndrome (VASS) continues to be a significant problem. The aim of this study was to examine the outcomes of arterial endovascular interventions in the upper extremity of patients presenting with VASS. METHODS: A database of patients presenting with documented VASS between 2006 and 2016 was retrospectively queried. Patients who underwent isolated endovascular intervention in the upper extremity were analyzed. RESULTS: Ninety-eight patients (66% female; average age 65 years) presented with VASS: 28 presented with upper arm atherosclerotic disease above the arteriovenous (AV) anastomosis (above elbow) and the remaining 70 patients with below AV anastomotic atherosclerotic disease at the elbow (below elbow). Sixty-three percent of the entire patient cohort (N = 65) presented with rest pain and the remainder (n = 33 [34%]) with minor digital ulceration. Of those with upper arm disease above the AV anastomosis, one-third of patients had subclavian occlusive disease and two-thirds had brachial artery occlusive disease. Patients with subclavian disease underwent stent placement, and patients with brachial artery disease underwent balloon angioplasty. Technical success was 100% (n = 28). Ninety-one percent of these patients (n = 25) had symptomatic success at 30 days and the remainder (n = 3) required proximalization of the access. Of those with below AV anastomosis at the elbow disease, all had disease in the forearm vessels with 42% (n = 29) having either the ulnar or radial artery occlusion. Balloon angioplasty was performed in one vessel in 55% (n = 38) and in two vessels in 45% (n = 32) of patients. Technical success was 79% (n = 81 of 102 vessels) with 51% of the patients (n = 36) having symptomatic success at 30 days; of those who remained symptomatic, 80% (n = 27) required proximalization of the access and 20% (n = 7) required ligation. The major adverse cardiovascular event rate for the entire patient cohort was 4% (n = 4). The 30-day complications for the entire patient cohort included continued steal (38%; all resolved with secondary procedures), thrombosis (3%; all forearm vessels treated for occlusion), bleeding (0%), infection (0%), and mortality (1%). Primary clinical success defined as the relief of distal ischemic symptoms and the preservation of a functional access site for dialysis showed rates of 42 ± 9% (mean ± standard error of the mean) and 0 ± 0% at 5 years (above and below elbow groups, respectively). CONCLUSIONS: Upper extremity interventions for VASS owing to above elbow disease are associated with a high rate of success, whereas interventions for below elbow disease have a poor clinical success with more patients requiring secondary procedures and low long-term survival for the access site. Male patients presenting with rest pain, larger forearm vessels (approximately 3 mm), short occlusive lesions (<100 mm), two-vessel runoff, and an intact palmer arch are good candidates for below elbow interventions.

Outcomes of upper extremity interventions for chronic critical ischemia.

BACKGROUND: Critical hand ischemia owing to below-the-elbow atherosclerotic occlusive disease is relatively uncommon. The aim of this study was to examine the outcomes in patients presenting with critical ischemia owing to below-the-elbow arterial atherosclerotic disease who underwent nonoperative and operative management. METHODS: A database of patients undergoing operative and nonoperative management for symptomatic below-the-elbow atherosclerotic disease between 2006 and 2016 was retrospectively queried. Patients with critical ischemia (tissue loss and rest pain) were identified. Three management groups were identified: no revascularization (None), endovascular revascularization (Endo), and open revascularization by bypass (Bypass). Patients with acute embolism, active vasculitis, end-stage renal disease, ipsilateral dialysis access complications of steal, and ipsilateral trauma were excluded. RESULTS: One hundred eight patients (56% male; average age, 59 years) presented with symptomatic below-the-elbow disease: 93% presented with digital ulceration and the remainder with rest pain. Eighty-one percent had diabetes and 41% had chronic renal insufficiency (not on dialysis). All underwent catheter-based angiography. Fifty-three patients (49%) had no intervention and subsequently were committed to wound care; 26 of these required no further intervention, 10 had an interval palmar sympathectomy, and 17 underwent either a phalanx or digital amputation. Thirty-four patients (31%) underwent an endovascular intervention with a median of 1.5 vessels (ulnar, radial, or interosseous arteries) intervened on. Technical success was achieved in 29 patients (85%). Of the five technical failures, two went on to bypass, one had a focal endarterectomy and patch angioplasty, and one was treated conservatively. Ten patients in the Endo group required either a phalanx or digital amputation. Twenty-one patients (19%) underwent a saphenous vein bypass (reversed or nonreserved) to the radial in 12 and the ulnar in 11 limbs. In follow-up, 11 patients underwent open or endovascular intervention to maintain patency of the bypass. There were nine phalanx or digital amputations in the Bypass group. No below-the-elbow or above-the-elbow amputations were performed within 30 days. The wound healing rate without amputation was 78% (85 of 108). The predictors of wound healing were technical success of the revascularization, intact palmar arch and presence of digital run-off. The presence of an incomplete arch and poor digital run-off were associated with a phalanx or digital amputation. CONCLUSIONS: Upper extremity interventions for critical ischemia are associated with a high rate of success. Major amputations are rare and the many can be treated nonoperatively. In appropriately selected patients, both endovascular and open interventions have a high rate of success.

Outcomes of reintervention for recurrent symptomatic disease after tibial endovascular intervention.

OBJECTIVE: Tibial interventions for critical limb ischemia are now commonplace. Restenosis and occlusion remain barriers to durability after intervention. The aim of this study was to examine the patient-centered outcomes of open and endovascular reintervention for symptomatic recurrent disease after a primary isolated tibial endovascular intervention. METHODS: A database of patients undergoing isolated primary lower extremity tibial endovascular interventions between 2006 and 2016 was retrospectively queried. Patients with recurrent critical ischemia (Rutherford 4 and 5) were identified. Outcomes in this cohort were analyzed, and three groups were defined: endovascular reintervention (ie, a repeated tibial or pedal endovascular intervention), bypass (bypass to a tibial or pedal vessel), and primary amputation (ie, above- or below-knee amputation) on the ipsilateral leg. Patient-oriented outcomes of clinical efficacy (absence of recurrent signs or symptoms of critical ischemia, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (above-ankle amputation of the index limb or major reintervention, such as new bypass graft or jump or interposition graft revision) were evaluated after the reintervention. RESULTS: There were 1134 patients (56% male; average age, 59 years) who underwent primary tibial intervention for critical ischemia, and 54% presented with symptomatic restenosis and occlusion. Of the 513 patients with recurrent disease, 58% presented with rest pain and the remainder with ulceration. A repeated tibial endovascular intervention was performed in 64%, open bypass in 19%, and below-knee amputation in 17%. Bypass was employed in patients with a good target vessel, venous conduit, and good pedal runoff. Patient-centered outcomes were better in the bypass group compared with the reintervention group (amputation-free survival, 45% ± 9% vs 27% ± 9% [P < .01]; major adverse limb events, 50% ± 9% vs 31% ± 9% [P < .05]; clinical efficacy, 60% ± 7% vs 30% ± 9% [P < .01], mean ± standard error of the mean at 5 years). CONCLUSIONS: Tibial interventions for critical ischemia are associated with a high rate of reintervention. In patients with good target vessel, venous conduit, and good pedal runoff, bypass appears more durable than repeated tibial endovascular intervention.

Outcomes of tibial endovascular intervention in patients with poor pedal runoff.

OBJECTIVE: Tibial interventions for critical limb ischemia are now commonplace. The aim of this study was to examine the impact of pedal runoff on patient-centered outcomes after tibial endovascular intervention. METHODS: A database of patients undergoing lower extremity endovascular interventions at a single urban academic medical center between 2006 and 2016 was retrospectively queried. Patients with critical ischemia (Rutherford 5 and 6) were identified. Preintervention angiograms were reviewed in all cases to assess pedal runoff. Each dorsalis pedis, lateral plantar, and medial plantar artery was assigned a score according to the reporting standards of the Society for Vascular Surgery (0, no stenosis >20%; 1, 21%-49% stenosis; 2, 50%-99% stenosis; 2.5, half or less of the vessel length occluded; 3, more than half the vessel length occluded). A foot score (dorsalis pedis + medial plantar + lateral plantar + 1) was calculated for each foot (1-10). Two runoff score groups were identified: good vs poor, <7 and ≥7, respectively. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (above-ankle amputation of the index limb or major reintervention [new bypass graft, jump/interposition graft revision]) were evaluated. RESULTS: There were 1134 patients (56% male; average age, 59 years) who underwent tibial intervention for critical ischemia, with a mean of two vessels treated per patient and a mean pedal runoff score of 6 (47% had a runoff score ≥7). Overall major adverse cardiac events were equivalent at 30 days after the procedure in both groups. At 5 years, vessels with compromised runoff (score ≥7) had significantly lower ulcer healing (25% ± 3% vs 73% ± 4%, mean ± standard error of the mean [SEM]) and a lower 5-year limb salvage rate (45% ± 6% vs 69% ± 4%, mean ± SEM) compared with those with good runoff (score <7). Patients with poor pedal runoff (score ≥7) had significantly lower clinical efficacy (23% ± 8% vs 38% ± 4%, mean ± SEM), amputation-free survival (32% ± 6% vs 48% ± 5%, mean ± SEM), and freedom from major adverse limb events (23% ± 9% vs 41% ± 8%, mean ± SEM) at 5 years compared with patients with good runoff (score <7). CONCLUSIONS: Pedal runoff score can identify those patients who will not achieve ulcer healing and patient-centered outcomes after tibial intervention. Defining such subgroups will allow stratification of the patients and appropriate application of interventions.

Outcomes of Isolated Tibial Endovascular Intervention for Rest Pain in Patients on Dialysis.

BACKGROUND: Tibial interventions for critical limb ischemia are frequent in patients with end-stage renal disease (ESRD) presenting with critical ischemia. The aim of this study was to examine impact of ESRD on the patient-centered outcomes following tibial endovascular Intervention for rest pain. METHODS: A database of patients undergoing lower extremity endovascular interventions between 2006 and 2016 was retrospectively queried. Patients with rest pain (Rutherford 4) were identified. Patients with claudication (Rutherford 1 to 3) and tissue loss (Rutherford 5 and 6) were excluded. Patients were categorized by the presence or absence of ESRD. Patient-orientated outcomes of clinical efficacy (CE; absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (AFS; survival without major amputation), and freedom from major adverse limb events (MALEs; above ankle amputation of the index limb or major reintervention new bypass graft, jump/interposition graft revision) were evaluated. RESULTS: A total of 829 patients (56% male, average age 59 years; 658 nonhemodialysis [non-HD] and 171 HD) underwent isolated tibial intervention in one leg for rest pain. Technical success was 99% with a median of 2 vessels treated per patient. There was no difference in the distribution of Trans-Atlantic Inter-Society Consensus I lesions, but both the modified Society for Vascular Surgery (SVS) runoff score and the pedal runoff score were worse in the HD group. The 30-day major adverse cardiac events and 30-day MALEs were equivalent in both groups. CE was 38 ± 9% and 19 ± 8% at 5 years for the non-HD and HD groups, respectively (P < 0.01). Overall, AFS was 45 ± 8% and 18 ± 9% at 5 years for the non-HD and HD groups, respectively (P < 0.01). Freedom from MALE was 41 ± 9% and 21 ± 8% at 5 years for the non-HD and HD groups, respectively (P < 0.01). CONCLUSIONS: Patients with ESRD who present with rest pain have equivalent short-term outcomes to those not on dialysis but do not achieve long-term satisfactory CE and AFS after isolated tibial intervention for rest pain.

Endoscopic basilic vein transposition for hemodialysis access.

BACKGROUND: Hemodialysis access by autogenous arteriovenous fistulas (AVFs) is generally recommended due to lower mortality, morbidity, and cost vs graft and catheter use. Many dialysis patients lack the common superficial veins used for standard AVF options and require transposition of a deep vein for autogenous dialysis access through a long open incision (open/AVF-T). These operations may require prolonged time for healing, thus extending catheter-based dialysis. We report our experience with minimally invasive techniques for creating AVF-Ts using an endoscopic procedure (endo/AVF-T). METHODS: We reviewed our vascular access database of consecutive access operations to identify consecutive patients with endo/AVF-Ts. For comparison, we also reviewed the immediate preceding traditional open/AVF-T operations that we previously reported. We evaluated demographics, time to access use, and primary, assisted, and cumulative patency. RESULTS: We identified 100 consecutive endo/AVF-T operations attempted, and 98 were technically successful. The analysis excluded two conversions to successful open/AVF-T. The mean age of the 98 patients in the endo/AVF-T study group was 60 years (range, 22-94 years), 59 (60.2%) were women, 48 (49.0%) were diabetic, 20 (20.4%) were obese, and 52 (53.1%) had had previous access surgery. Mean time to initial use of the access for endo/AVF-Ts was 6 weeks for primary and 12 weeks for staged transpositions. Mean follow-up was 14 months (range, 1-30 months). The 12- and 24-month cumulative patencies were 95.5% and 88.6%. The 78 traditional open/AVF-T operations from our previous report were reviewed for comparison. The mean age was 62 years (range, 18-83 years), 57 (73.1%) were women, 44 (56.4%) were diabetic, 15 (19.2%) were obese, and 46 (59.0%) had previous access surgery. Mean time to initial use of the access for open/AVF-Ts was 8 weeks for primary and 16 weeks for staged operations. Mean follow-up was 18 months (range, 3-48 months). The 12- and 24-month cumulative patencies were 96.0 and 88.9%. No grafts were used in any patient during the study period. CONCLUSION: Time to access use was less with endoscopic AVF-T (P < .01) for both primary and staged operations. Primary, assisted, and cumulative patency rates were the same for open and technically successful endoscopic transpositions. Endoscopic AVF-Ts offer a viable alternative to open AVF-Ts.

Brachial vein transposition arteriovenous fistulas for hemodialysis access.

BACKGROUND: An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis, offering lower morbidity, mortality, and cost compared with grafts or catheters. Patients with a difficult access extremity have often lost all superficial veins, and even basilic veins may be obliterated. We have used brachial vein transposition AVFs (BVT-AVFs) in these challenging patients and review our experience in this report. METHODS: The study reviewed consecutive patients in whom BVT-AVFs were created from September 2006 to March 2009. Most BVT-AVFs were created in staged procedures, with the second-stage transposition operations completed 4 to 6 weeks after the first-stage AVF operation. A single-stage BVT-AVF was created when the brachial vein diameter was > or =6 mm. RESULTS: We identified 58 BVT-AVF procedures, comprising 41 women (71.0%), 28 diabetic patients (48.3%), and 29 (50.0%) had previous access surgery. The operation was completed in two stages in 45 operations (77.6%) and was a primary transposition in 13 patients. However, five of these were secondary AVFs with previous distal AV grafts or AVFs placed elsewhere; effectively, late staged procedures. Follow-up was a mean of 11 months (range, 2.0-31.7 months). Primary patency, primary-assisted patency, and cumulative (secondary) patency were 52.0%, 84.9%, and 92.4% at 12 months and 46.2%, 75.5%, and 92.4% at 24 months, respectively. Harvesting the brachial vein was tedious and more difficult than harvesting other superficial veins. No prosthetic grafts were used. CONCLUSION: BVT-AVFs provide a suitable option for autogenous access when the basilic vein is absent in patients with difficult access extremities. Most patients required intervention for access maturation or maintenance. Most BVT-AVFs were created with staged procedures. Cumulative (secondary) patency was 92.4% at 24 months.

Primary and staged transposition arteriovenous fistulas.

BACKGROUND: The use of catheters or prosthetic grafts for vascular access has significantly higher mortality and morbidity risks, in addition to higher costs, than arteriovenous fistulas (AVF). Many patients have a difficult access extremity due to complex medical illnesses, previous vascular access procedures, intravenous catheters, diabetes, vascular disease, female sex, age, and other complicating factors. Transposition AVFs (AVF-T) have been used for these individuals to avoid catheters and grafts. We report our experience with primary and staged basilic vein AVF-Ts and staged brachial vein AVF-Ts. METHODS: From our database of consecutive vascular access operations, we reviewed patients from May 2003 to September 2006 for all upper extremity AVF-Ts. A primary AVF-T was used when the basilic vein was continuous with a minimum diameter of 4 mm and of adequate length. When the basilic vein was 2.5 to 4 mm, the procedure was staged. The proximal radial artery was used for inflow, if possible. When the basilic vein was not suitable, a radial vein or brachial vein anastomosis was performed as the first stage of a planned brachial vein AVF-T. The second stage operations of staged AVF-Ts were generally done 4 to 6 weeks after the primary AVF construction. All patients were evaluated with preoperative ultrasound imaging by the operating surgeon. RESULTS: From a database of 412 consecutive vascular access patients, 78 upper extremity transposition procedures were identified. Of these, 57 patients (73.1%) were women, 44 (56.4%) were diabetic, and 46 (59.0%) had previous access surgery. Fifty-eight operations were staged procedures. The basilic vein was used in 68 AVF-T, the brachial vein in six, and cephalic vein in four. The anastomosis was based on the proximal radial artery in 60 patients. Mean follow-up was 18 months (range, 3-48 months). Primary patency, primary assisted patency, and cumulative patency were 45.7%, 93.5%, and 96.0% at 12 months and 27.6%, 86.5%, and 88.9% at 24 months, respectively. No prosthetic grafts were used in the study period. CONCLUSION: Both primary and staged AVF-T procedures were successfully used in patients with difficult access extremities. AVF-Ts were durable, although many required an interventional procedure for maturation or maintenance. Cumulative (secondary) patency was 96.0% at 12 months and 88.9% at 24 months. The absence of an adequate basilic vein does not preclude the use of a staged AVF-T because the brachial vein offers a suitable alternative.

The difficult hemodialysis access extremity: proximal radial arteriovenous fistulas and the role of angioscopy and valvulotomes.

BACKGROUND: Native arteriovenous (AV) fistulas (NAVF) offer significantly lower risks than grafts or catheters. Individuals with a difficult access extremity (DAE) are often viewed as unsuitable for NAVFs. The proximal radial artery (PRA) NAVF offers a safe and reliable opportunity for a direct fistula in most patients, and we find it an important surgical option in the DAE. METHODS: Consecutive vascular access operations were reviewed to find individuals with DAE. We defined the DAE patient group as those individuals where a wrist (Cimino) or upper arm brachiocephalic NAVF was not possible or was predicted to fail. RESULTS: Preoperative physical and ultrasound examinations identified 58 individuals with DAE. Mean age was 56 years (range 11 to 87), 34 were female, 29 were diabetic, and 27 had previous access surgery. NAVFs were constructed in all patients. No grafts were utilized. Forty-six patients had a PRA NAVF constructed. NAVF patency was 91%. Twenty-three patients required retrograde angioscopy or passage of a valvulotome to gain forearm access. Twenty-one of these 23 individuals maintained an open NAVF segment in the forearm. CONCLUSION: NAVFs were constructed in all patients. PRA NAVFs play an important role in extending hemodialysis by NAVF for this difficult patient group. Forearm access is often possible in these patients and may be successfully augmented by angioscopy or valvulotomes.