The natural history of isolated common femoral endarterectomy for chronic limb-threatening ischemia.

OBJECTIVE: Occlusive disease of the common femoral artery can generate profound lower extremity ischemia as the normal collateral pathways from the profunda to the superficial femoral artery cannot adequately develop. In patients with lifestyle-limiting claudication, isolated endarterectomy of the common femoral artery (CFE) is highly effective. As CFE does not provide direct, in-line flow to the plantar arch, it has been felt to provide inadequate revascularization to patients with chronic limb-threatening ischemia (CLTI). The purpose of this retrospective clinical study was to report and assess the natural history of selected patients with CLTI treated with isolated CFE (without concomitant infrainguinal revascularization). METHODS: Consecutive CFE performed in a large, urban hospital for CLTI between 2014-2021 were reviewed. Patient characteristics, limb, and anatomic stages using the Wound, Ischemia, foot Infection (WIfI) and Global Anatomic Staging Systems (GLASS) were tabulated. Limb-specific and survival-related endpoints were analyzed. RESULTS: 58 patients presenting with CLTI underwent isolated CFE (mean age 74±10 years; 62% male, 90% current or prior smoker). Comorbidities included diabetes (52%), coronary artery disease (55%), congestive heart failure (22%), and end-stage renal failure on hemodialysis (5%). Patients presented with either rest pain (36%) or tissue loss (64%); the latter group exhibited advanced limb threat (68% in WIfI stage 3 or 4). The majority of patients had associated severe infrainguinal disease (50% GLASS 3). After a median follow-up of 17 months (range 10-29 months), vascular reintervention was required in 7 patients (12%). One patient (2%) required major limb amputation after presentation in WIfI stage 4 (W3I3fI0). Indeed, WIfI stage 4 was a significant univariate predictor of the need for subsequent infrainguinal bypass (p=0.034). CONCLUSIONS: Isolated CFE as primary therapy in highly selected patients with CLTI was safe and effective. Index limb stage is predictive of the need for associated infrainguinal revascularization in this complex population.

Morbidity and mortality of common femoral endarterectomy.

OBJECTIVE: Common femoral endarterectomy (CFE) comprises the current standard-of-care for symptomatic common femoral artery occlusive disease. Although it provides effective inflow revascularization via a single incision, it remains an invasive procedure in an often-frail patient population. The purpose of this retrospective clinical study was to assess the morbidity and mortality of CFE in a contemporary cohort. METHODS: Consecutive CFEs performed at a large, urban hospital were reviewed. Six-month mortality, local complications (hematoma, lymphatic leak, pseudoaneurysm, wound infection, and/or dehiscence), and systemic complications were analyzed using univariate and multivariate analyses. RESULTS: A total of 129 isolated CFEs were performed over 7 years for claudication (36%), rest pain (16%), tissue loss (29%), or acute on chronic limb ischemia (21%). Mean age was 75 ± 9 years, and 68% of patients were male. Comorbidities were prevalent, including coronary artery disease (54%), diabetes (41%), chronic pulmonary disease (25%), and congestive heart failure (22%). The majority of CFEs were performed under general anesthesia (98%) with patch angioplasty using bovine pericardium (73% vs 27% Dacron). Twenty-two patients (17%) sustained local complications following the procedure; their occurrence was significantly associated with obesity (P = .002) but no technical or operative factors. Nineteen patients (15%) sustained serious systemic complications; their occurrence was significantly associated with chronic limb-threatening ischemia (P < .001), and a high American Society of Anesthesiologists (ASA) class (P = .002). By 6 months, 17 patients (13%) had died. Being on dialysis, presenting with chronic limb-threatening ischemia, and being in a high ASA class at the time of operation were all associated with 6-month mortality; a high ASA class at the time of operation was independently predictive of mortality (odds ratio, 3.08; 95% confidence interval, 1.03-9.24; P = .044). CONCLUSIONS: Although commonly performed, CFE is not a benign vascular procedure. Disease presentation, anesthetic risk, and expected longevity play an important role in clinical outcomes. Evolving endovascular approaches to the common femoral artery could serve to reduce morbidity and mortality in the future.

Slowly moving the needle away from Fistula First.

OBJECTIVE: In 2019, the management of end-stage kidney disease (ESKD) shifted away from "Fistula First" (FF) to "ESKD Life-Plan: Patient Life-Plan First then Access Needs." Indeed, some patients exhibit such excessive comorbidity that even relatively minor vascular surgery may be complicated. The purpose of this study was to retrospectively assess complications and mortality (and delineate operative futility) in patients undergoing arteriovenous fistula (AVF) creation in the FF era. METHODS: Consecutive AVFs created in a single institution before 2021 were retrospectively reviewed. Operative futility was defined as never-accessed fistula, no initiation of dialysis, failure of access maturation (despite secondary intervention), hemodialysis access-induced distal ischemia requiring ligation, early loss of secondary patency, and/or patient mortality within the first 6 postoperative months. RESULTS: A total of 401 AVFs were created including radial-cephalic (44%), brachial-cephalic (41%), and brachial-basilic (15%) constructions. Patients exhibited a mean age of 69 ± 15 years; 63% were male, and most (74%) were already being hemodialyzed at the time of fistula creation. Forty-five patients (11%) suffered a cardiac event, and five patients died (1%) within 90 days of their access surgery. Perioperative cardiac events were significantly more common after age 80 (19% vs 8%; P = .004); age >80 years was an independent predictor of major 90-day complications (odds ratio [OR], 1.88; 95% confidence interval [CI], 1.04-3.39; P = .036) and the sole independent predictor of major morbidity defined as cardiopulmonary complications, stroke, or death within the first year (OR, 2.01; 95% CI, 1.24-3.25; P = .004). Operative futility was encountered in 52% of the cohort (n = 208 patients): 40% (n = 160) of primary AVFs failed to mature despite assistance, 19% (n = 77) had lost secondary patency by 6 months, 13% of patients (n = 53) were never started on dialysis after access creation, 4% (n = 16) were dead by 6 months, 2% of AVFs (n = 10) matured but were never accessed, and 2% (n = 9) required ligation for hemodialysis access-induced distal ischemia. Not surprisingly, the sole independent protector against operative futility was that catheter-based dialysis had been established prior to AVF creation (OR, 0.36; 95% CI, 0.22-0.59; P < .01). CONCLUSIONS: Approximately 50% of primary AVF operations performed in the aggressive FF era were deemed futile. Octogenarians were particularly prone to futility and complications during this era. A paradigm shift, from FF to an "ESKD Life-Plan" will, hopefully, more thoughtfully match vascular access strategies to individual patient needs.

Drug-eluting, balloon-expandable, bioresorbable vascular scaffolds reduce neointimal thickness and stenosis in an animal model of percutaneous peripheral intervention.

Objective: Recanalization with balloon angioplasty and/or self-expanding stents (SES) has become the endovascular treatment of choice for symptomatic femoropopliteal occlusive disease. These strategies generate suboptimal clinical results, however, because they fail to expand the artery fully and ineffectively prevent recoil, neointimal hyperplasia, and restenosis. Balloon-expandable stents, given their greater radial force and rigid structure, represent a more effective treatment strategy, but only short lengths can be implanted safely in arteries that deform and bend with skeletal motion. The purpose of this preclinical experiment was to test the hypothesis that simultaneous implantation of a series of short, resorbable, balloon-expandable, paclitaxel-eluting scaffolds would prevent neointimal hyperplasia and stenosis compared with SES in an animal model of percutaneous femoropopliteal intervention. Methods: We extruded 6 × 60 mm Efemoral Vascular Scaffold Systems (EVSS) from copolymers of poly-L-lactic acid, coated with paclitaxel 3 µg/mm2, crimped onto a single delivery balloon, and implanted percutaneously into the iliofemoral arteries of eight Yucatan mini-swine. We implanted 7- to 8-mm × 60 mm SES into the contralateral experimental arteries. The animals were serially imaged with contrast angiography and optical coherence tomography after 30, 90, 180, 365, and 730 days. The primary end point of this study was neointimal morphometry over time. Secondary end points included acute deformation and angiographic and optical coherence tomography-derived measurements of chronic vascular response. Results: Over the 2-year study period, one SES was found to be completely occluded at 90 days; all EVSS were widely patent at all time points. Arteries treated with SES exhibited profound neointimal hyperplasia with in-stent stenosis. In contrast, arteries treated with EVSS exhibited only modest vascular responses and minimal stenosis. After 2 years, the mean neointimal thickness (0.45 ± 0.12 vs 1.31 ± 0.91 mm; P < .05) and area (8.41 ± 3.35 vs 21.86 ± 7.37 mm2; P < .05) were significantly decreased after EVSS implantation. By 2 years, all scaffolds in all EVSS-treated arteries had resorbed fully. Conclusions: In this preclinical animal model of peripheral endovascular intervention, the EVSS decreased neointimal hyperplasia and stenosis significantly compared with SES, then dissolved completely between the first and second years after implantation.

Intravascular treatment of long segments of experimental peripheral arteries with multiple, serial, balloon-expandable, resorbable scaffolds.

Symptomatic femoropopliteal occlusive disease has been increasingly treated using endovascular methods. However, restenosis, especially after implantation of permanent metallic stents, has remained common. To date, resorbable scaffolds have failed to achieve sufficient radial strength to enable the successful treatment of long, mobile, peripheral arteries. In the present nonsurvival, large animal experiment, a novel device consisting of multiple, short, serial, balloon-expandable, bioresorbable scaffolds was deployed in arteries subjected to supraphysiologic deformation. Compared with native vessels, the scaffolded arteries continued to bend (113° ± 19° vs 110° ± 20°; P = .10) and shorten (15% ± 15% vs 20% ± 14%; P = .16), unencumbered by the placement of the investigational device. The mean luminal diameter of the scaffolded arteries was preserved without kinks or occlusions in exaggerated flexion (4.7 ± 0.7 vs 4.7 ± 0.5 mm in extension vs flexion; P = .80). Arterial deformation was borne by shortening of the interscaffold spaces (2.2 ± 0.8 mm vs 1.9 ± 0.7 mm in extension vs flexion; P < .01) and the scaffolds themselves (10.7 ± 1.4 mm vs 9.9 ± 1.1 mm in extension vs flexion; P < .01). The results from the present study challenge the perceived limitations of balloon-expandable devices implanted in peripheral mobile arteries. We have presented a bioresorbable scaffold that combines sufficient radial strength to preserve the mean luminal diameter with movement and the flexibility to accommodate femoropopliteal deformation.

Predictors of Amputation-free Survival after Endovascular Intervention for Chronic Limb-Threatening Ischemia in the Modern era.

BACKGROUND: Chronic limb-threatening (CLTI) is associated with 25% limb loss and 25% mortality at 1-year. Its lethality increases to 45% in patients subjected to a major amputation. Percutaneous peripheral intervention (PPI) constitutes an attractive and less morbid treatment option for patients with CLTI. The purpose of this study was to assess amputation-free survival (AFS) in a contemporary cohort treated with endovascular recanalization and assess its predictors. METHODS: Patients with CLTI undergoing endovascular revascularization at a single regional hospital between 2015-2019 were reviewed. Baseline demographic characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, technical details, and clinical outcomes were tabulated. The primary endpoint was AFS; a P-value < 0.05 was used for univariate screening and inclusion in a multivariable model. RESULTS: A total of 137 limbs in 111 patients were studied. Comorbidities were prevalent and included diabetes (65%), congestive heart failure (21%), and dialysis dependence (18%). The majority of revascularized limbs presented with advanced wounds (66% WIfI stages 3-4; 47% Rutherford category 6). Presenting WIfI stages were similar across races (P = 0.26). Peripheral interventions most commonly targeted femoropopliteal disease (69%), although 26% were multilevel. Percutaneous atherectomy, stenting, and paclitaxel-coated or eluting devices were utilized in 68%, 28%, and 15% of cases, respectively. After a median follow-up of 16 months (interquartile range IQR = 4-29 months), significant independent predictors of reduced AFS included nonWhite race (HR = 2.96 [1.42-6.17]; P = 0.004) and WIfI stage 4 wounds (HR = 2.23 [1.10-4.52]; P = 0.026). At one year following successful revascularization, only 59% ± 1% of patients were alive with their limb intact. CONCLUSIONS: Despite considerable and consistent advances in urban health care delivery and the techniques of PPI, CLTI remains a morbid and deadly disease. Even in the endovascular era, nearly half of all patients presenting with CLTI will lose their limb and/or life within the first year. Unfortunately, late-stage presentation continues to be commonplace. Although endovascular intervention can reliably restore patency to affected arteries, this appears insufficient to restore most patients to health.

Transposition of left subclavian artery with reimplantation of isolated left vertebral artery before thoracic endovascular aneurysm repair for type B aortic dissection.

Understanding and recognizing anatomic anomalies of the aortic arch is important when planning extra-anatomic debranching before thoracic endovascular aortic repair. A rare anomaly is the left vertebral artery aberrantly arising from the aortic arch; found in ∼5% of adults. When present, the artery courses through the carotid sheath at a variable length before entering the third or fourth cervical transverse foramen. In the present report, we have described the case of a 49-year-old man with a symptomatic, enlarging type B aortic dissection with an aberrant left vertebral artery and the novel methods used to surgically correct his pathology.

Thoracobifemoral bypass for infrarenal aortic occlusion caused by retroperitoneal fibrosis.

Retroperitoneal fibrosis (RPF) is an uncommon fibrotic disorder that can cause pain, ureteral obstruction, deep venous thrombosis, hydrocele, and, rarely, aortic occlusion. Herein is described a 65-year-old man with aortic occlusion from idiopathic RPF who was treated with axillobifemoral bypass grafting, which failed in the intermediate term. On representation with critical claudication, he underwent thoracobifemoral bypass grafting via a lateral retroperitoneal tunnel created through a midline, infraumbilical counterincision. He was discharged home on postoperative day 5. This illustrates the successful use of thoracic aortic inflow to treat the aortoiliac occlusive complication of RPF.

Reliability of preoperative venous mapping ultrasonography in predicting for autogenous arteriovenous fistula maturation.

BACKGROUND: Autogenous arteriovenous fistula creation is the preferred route for vascular access for hemodialysis. Although preoperative venous mapping ultrasonography has been advocated as an operative planning adjunct and recently incorporated into the Society for Vascular Surgery clinical guidelines, controversy remains regarding its usefulness for predicting access success. The purpose of the present retrospective clinical study was to test the hypothesis that vein size measured on routine preoperative venous mapping is a poor predictor of primary fistula maturation. METHODS: Consecutive upper extremity autogenous arteriovenous fistulas created by three dedicated vascular surgeons were retrospectively reviewed. The demographic characteristics, preoperative venous mapping, functional maturation, and patency were analyzed. The clinically relevant variables were tested for predictive significance using a logistic regression model. RESULTS: A total of 199 upper extremity autogenous arteriovenous fistulas had been created during a 5-year period. Patients were aged 70 ± 16 years (range, 20-96 years), and 62% were men. Most had already been undergoing dialysis before fistula creation (83%), usually via a tunneled central venous catheter (62%). Radial-cephalic, brachial-cephalic, and brachial-basilic arteriovenous fistulas had been created in 82 patients (41%), 76 patients (38%), and 10 patients (5%), respectively. Fistula maturation, defined as a palpable thrill and/or successful cannulation of the fistula with the ability to deliver a flow rate of 400 mL/min, was achieved in 67% of the patients. A higher body mass index was associated with nonmaturation on both univariate and multivariate analyses (success, 28.6 ± 7.7 kg/m2; vs failed, 31.6 ± 9.4 kg/m2; P = .029; odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10; P < .01). On univariate analysis, the maximum target vein diameter assessed by preoperative venous mapping was slightly larger in the group achieving successful maturation (2.9 ± 1.1 mm vs 2.6 ± 0.9 mm; P = .014). However, neither the maximum target vein diameter nor a target vein size >3 mm was significantly predictive of maturation on multivariate analysis (maximum vein diameter: OR, 0.65; 95% CI, 0.35-1.22; P = .176; vein size >3 mm: OR, 0.91; 95% CI, 0.32-2.60; P = .857). After a median follow-up of 15 months (interquartile range, 26 months), the primary functional patency, primary-assisted patency, and secondary patency rates were 39.1% ± 0.6%, 94.5% ± 0.6%, and 97.9% ± 0.5%. No association of vein diameter with long-term patency was found. CONCLUSIONS: Despite the national fistula-first initiatives, most patients still undergo access via catheter at the initiation of hemodialysis. The use of routine preoperative venous mapping does not predict successful primary maturation. Also, no clinically useful predictor of fistula maturation was identified in the present study.

Treatment of Post-Evar Aortoduodenal Fistula Without Endograft Excision.

An 80 year-old gentleman presented with aortoduodenal fistula 2 months after uncomplicated endovascular aneurysm repair (EVAR). Upon laparotomy and fistula takedown, there was no active hemorrhage from the excluded aneurysm. It was theorized the fistula had originated from an occult type II endoleak which had since thrombosed. The duodenum was repaired primarily; the anterior defect in the aneurysm sac was packed and covered with omentum. The patient recovered uneventfully and remains well after 9 months. This is the first case, to our knowledge, of a post-EVAR aortoduodenal fistula successfully treated without endograft excision.

"Failure-to-Cross" in Patients Undergoing Percutaneous Peripheral Intervention: The Nonreimbursed Procedure.

BACKGROUND: Percutaneous peripheral intervention (PPI) is often the first mode of therapy for patients with symptomatic arterial occlusive disease. Technical success generally remains high although "failure-to-cross" still complicates 5-20% of cases. Extended efforts to cross long, occlusive lesions can utilize significant hospital and practitioner resources. The hospital is typically reimbursed for this effort as facility fees are charged by the hour and materials are charged per use. However, given the lack of a CPT® code for "failure-to-cross," practitioners are rarely appropriately compensated. The purpose of this study is to analyze the predictors, technical details, outcomes, and costs of "failure-to-cross" during PPI. METHODS: All PPI procedures over a 2-year period at a single institution were retrospectively reviewed. Clinical characteristics, results, costs, and reimbursements obtained from hospital cost accounting were compared among successful therapeutic interventions, crossing failures, and diagnostic angiograms without attempted intervention. RESULTS: A total of 146 consecutive PPIs were identified; the rate of "failure-to-cross" was 11.6% (17 patients). The majority of patients with "failure-to-cross" were male (82%) with single-vessel runoff (53%). Compared to successful interventions, the incidences of chronic limb-threatening ischemia (82% vs. 70%, P = 0.34) and infrapopliteal occlusive disease were similar (47% vs. 31%, P = 0.20). "Failure-to-cross" procedures were just as long as successful procedures; there were no significant differences in fluoroscopy time (27 ± 10 vs. 24 ± 14 min, P = 0.52), in-room time (106 ± 98 vs. 103 ± 44 min, P = 0.84), or contrast dye volume utilization (73 ± 37 vs. 96 ± 54 mL, P = 0.12). As expected, "failure-to-cross" procedures incurred far higher hospital charges and costs compared to noninterventional diagnostic angiograms (charges $13,311 ± 6,067 vs. $7,690 ± 1,942, P < 0.01; costs $5,289 ± 2,099 vs. $2,826 ± 1,198, P < 0.01). Despite the additional time and effort spent attempting to cross difficult lesions, the operators were reimbursed at the same low rate as a purely diagnostic procedure (average fee charge $7,360; average reimbursement $992). After 1 year, the 17 patients in whom lesions could not be crossed were treated with advanced interventional procedures with success (n = 2), surgical bypass grafting (n = 5), extremity amputation (n = 4), or no additional intervention in their salvaged limb (n = 6). CONCLUSIONS: Patients whose lesions cannot be crossed during PPI fare worse than patients undergoing successful interventions. Hospital costs and charges appropriately reflect the high technical difficulty and resource utilization of extended attempts at endovascular therapy. For practitioners, crossing lesions during PPI is truly a "pay-for-performance" procedure in that only successful procedures are reasonably reimbursed.

Minimally Invasive Repair of Left Subclavian Artery Aneurysm.

A 79 year-old gentleman with a history of trauma resulting in paraplegia was being evaluated for vascular access for hemodialysis. Cardiac catheterization revealed a large, asymptomatic left subclavian artery aneurysm. The patient was taken to the hybrid vascular intervention suite. A small incision was made in the left arm to gain access to the left brachial artery into which a sheath was inserted. The aneurysm was crossed with a wire through which two, overlapping covered stents were deployed completely excluding the aneurysm. The patient was discharged to home the following day. Endovascular exclusion has become the treatment of choice for aneurysms of the subclavian artery.

An Animal Model of Human Peripheral Arterial Bending and Deformation.

BACKGROUND: Designing peripheral arterial stents has proved challenging, as implanted devices will repetitively and unpredictably deform and fatigue during movement. Preclinical testing is often inadequate, given the lack of relevant animal models. The purpose of this study was to test the hypothesis that deformation of the human peripheral vasculature could be qualitatively and quantitatively modeled using an experimental animal. METHODS: Anteroposterior contrast angiography was performed in domestic Landrace-Yorkshire farm pigs. Images were obtained with the hind limbs naturally extended then repeated, (1) flexed approximately 90° at the hip and knee, (2) overflexed in a nonphysiological fashion. Quantitative vascular angiographic analysis was utilized to measure arterial diameter, length, and deformation. Percent axial arterial compression and bending were assessed. RESULTS: Eight iliofemoral arteries in four animals were imaged. Mean luminal diameters of the iliac and femoral segments in the neutral position were 5.4 ± 0.5 mm and 4.6 ± 0.5 mm. Hind limb physiologic flexion induced profound arterial compression, 17 ± 8% and 29 ± 6% and bending, 36°±10° and 76° ± 13° within the iliac and femoral segments, respectively. With extreme flexion, the femoral artery could be reliably bent >90°. The observed findings exceeded the deformation observed historically within the human superficial femoral (∼5% compression and 10° bending) and popliteal artery (∼10% compression and 70° bending). CONCLUSIONS: Significant nonradial deformation of the porcine iliofemoral arteries was observed during manual hind limb flexion and exceeded that typically observed in humans. This model constitutes a "worst case" scenario for testing deformation and fatigue of intravascular devices indicated for the human peripheral vasculature.

Crush Deformation of a Balloon-Expandable Stent Implanted in an Infrainguinal Bypass Graft.

A 59-year-old man with critical claudication underwent left femoro-anterior bypass grafting, which was uneventful. The graft was tunneled medially across the knee, then anterior to the tibia. His symptoms recurred 1 year later and he was found to have critical stenosis of the vein graft just proximal to the anterior tibial arterial anastomosis. This was treated with scaffolded balloon angioplasty and implantation of a coronary, zotarolimus-eluting balloon-expandable stent, which was also uneventful. However, his claudication again recurred 1 year later. Diagnostic angiography revealed crush, deformation and restenosis of the balloon-expandable stent requiring surgical revision of the bypass graft.

Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

OBJECTIVES: This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). BACKGROUND: Drug-eluting BVS has shown promise in coronary arteries. METHODS: The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. RESULTS: Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. CONCLUSIONS: The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).