In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Effects of coronavirus disease 2019 on the Society for Vascular Surgery Vascular Quality Initiative arterial procedure registry.

In the present report, we have described the abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures in response to the coronavirus disease 2019 (COVID-19) pandemic. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020 to discern the effects of the COVID-19 pandemic. Approximately three fourths of physicians (74%) had adopted a restrictive operating policy for urgent and emergent cases only. However, one half had considered "time sensitive" elective cases as urgent. Data manager case entry was affected by both low case volumes and low staffing resulting from reassignment or furlough. A sevenfold reduction in arterial Vascular Quality Initiative case volume entry was noted in the first quarter of 2020 compared with the same period in 2019. The downstream consequences of delaying vascular procedures for carotid artery stenosis, aortic aneurysm repair, vascular access, and chronic limb ischemia remain undetermined. Further ramifications of the COVID-19 pandemic shutdown will likely be amplified if resumption of elective vascular care is delayed beyond a short window of time.

Long-term outcomes after pediatric peripheral revascularization secondary to trauma at an urban level I center.

OBJECTIVE: The purpose of this investigation was to determine our limb-related contemporary pediatric revascularization perioperative and follow-up outcomes after major blunt and penetrating trauma. METHODS: A retrospective review was performed of a prospectively maintained pediatric trauma database spanning January 2010 to December 2017 to capture all level I trauma activations that resulted in a peripheral arterial revascularization procedure. All preoperative, intraoperative, and postoperative continuous variables are reported as a mean ± standard deviation; categorical variables are reported as a percentage of the population of interest. RESULTS: During the study period, 1399 level I trauma activations occurred at a large-volume, urban children's hospital. The vascular surgery service was consulted in 2.6% (n = 36) of these cases for suspected vascular injury based on imaging or physical examination. Our study population included only patients who received an arterial revascularization, which was performed in 23 of the 36 consultations (1.6% of total traumas; median age, 11 years). These injuries were localized to the upper extremity in 60.9% (n = 14), lower extremity in 30.4% (n = 7), and neck in 8.7% (n = 2). The mean Injury Severity Score in the revascularized cohort was 14.0 (±7.6). Bone fractures were associated with 39.1% of the vascular injuries (90% of blunt injuries). Restoration of in-line flow was achieved by an endovascular solution in one patient and open surgery in the remainder, consisting of arterial bypass in 59.1% and direct repair in 40.9%. Within 30 days of the operation, we observed no deaths, no infections of the arterial reconstruction, and no major amputations. One patient required perioperative reintervention by the vascular team secondary to the development of a superficial seroma without evidence of graft involvement. Mean follow-up in our cohort was 43.3 (±35.4) months. During this phase, no additional deaths, amputations, chronic wounds, or limb length discrepancies were observed. All vascular repairs were patent, and all but one patient reported normal function of the affected limb at the latest clinic visit. CONCLUSIONS: Traumatic peripheral vascular injury is rare in the pediatric population but is often observed secondary to a penetrating force or after long bone fracture. However, contemporary perioperative and long-term outcomes after surgical revascularization are excellent as demonstrated in this institutional case series.

Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.

OBJECTIVE: This investigation describes the perioperative and early follow-up results associated with transcarotid artery revascularization (TCAR) in patients not participating in the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure II (ROADSTER-2) registry using the ENROUTE neuroprotection system (ENPS; Silk Road Medical, Sunnyvale, Calif). METHODS: A retrospective review was performed capturing all TCAR/ENPS procedures in patients deemed to be at high risk for complications after traditional carotid endarterectomy. All patients enrolled in the ROADSTER-2 registry were excluded, leaving only those treated outside trial regulations for analysis. Preoperative demographics, intraoperative variables, and perioperative and follow-up outcomes were abstracted and reported herein. RESULTS: From December 2015 to January 2018, there were 75 carotid arteries treated at our institution. All interventions were performed on carotid arteries that were symptomatic with ≥50% stenosis (46.7%) or asymptomatic with ≥80% stenosis (53.3%) by duplex ultrasound and computed tomography angiography. Technical success in our series was 97.3% (73/75), with treatment failures attributed to one case of common carotid artery dissection and another secondary to stent maldeployment in the external carotid artery. Perioperative (30-day) ipsilateral stroke rate was 2.7% (n = 2), myocardial infarction incidence was 0%, and mortality rate was 2.7% (n = 2). We did not observe any cranial nerve injuries. After a mean follow-up of 8.0 ± 6.7 months, no carotid stents required reintervention. However, we noted one instance of minor (<50%) in-stent stenosis and one asymptomatic stent thrombosis. One additional ipsilateral stroke was observed on follow-up, probably from a cardiac source. CONCLUSIONS: We report that dynamic reverse-flow TCAR using the ENPS continues to be safe, feasible, and efficacious with minimal risks of postoperative stroke, myocardial infarction, and mortality outside of ROADSTER-2 regulations.

Fenestrated endovascular aneurysm repair-induced acute kidney injury does not result in chronic renal dysfunction.

OBJECTIVE: Acute kidney injury (AKI) is a common physiologic complication after fenestrated endovascular aneurysm repair (FEVAR). This investigation was initiated to determine the unknown impact of post-FEVAR AKI on long-term renal function after index hospital discharge. METHODS: A retrospective review was performed of an institutional FEVAR database capturing preoperative, intraoperative, and postoperative variables related to the implantation of consecutive Zenith Fenestrated endografts (ZFEN; Cook Medical, Bloomington, Ind) between October 2012 and April 2018. AKI in this study was bimodally defined as qualification by either Risk, Injury, Failure, Loss of kidney function, and End-stage (RIFLE) criteria or a postoperative serum creatinine (sCr) concentration increase of 0.5 mg/dL from baseline. Glomerular filtration rate (GFR) was calculated using the validated Modification of Diet in Renal Disease (MDRD) study equation. RESULTS: During the study period, 120 FEVARs were performed at our institution. Twenty-four (20%) patients exhibited postoperative AKI by our established definitions. Two in-hospital deaths occurred in the AKI cohort compared with none in the remaining FEVARs (P = .04). Four (16.7%) AKI patients required perioperative (<30-day) renal replacement therapy, three of whom were successfully weaned before discharge. FEVARs uncomplicated by AKI exhibited no differences in sCr concentration from baseline to 1-month, 6-month, 1-year, and 2-year follow-up (mean, 1.8 ± 1.4 years). In contrast, patients exhibiting AKI experienced an sCr concentration increase of 57.1% (P = .01) at 1 month after the procedure. This elevation decreased to 14.3% (P = .35) at 6 months after the procedure and was maintained at baseline values at 1- and 2-year office visits (follow-up, 1.3 ± 1.5 years). A similar pattern of gradual recovery during follow-up was also observed with respect to calculated GFR. CONCLUSIONS: AKI is common after FEVAR but rarely results in permanent renal dysfunction as both sCr concentration and GFR return to baseline by 6 months after the procedure.

Procedural Complexity of TransCarotid Artery Revascularization Is Not Increased in Irradiated and Reoperative Necks.

BACKGROUND: TransCarotid Revascularization (TCAR) with dynamic flow reversal using the ENROUTE Neuroprotection System (ENPS) is a Food and Drug Administration-approved alternative carotid revascularization modality. The purpose of this investigation was to determine whether TCAR in a hostile (fibrotic) surgical field increases procedural complexity and postoperative complications. METHODS: Perioperative variables for all institutional TCARs performed between December 2015 and April 2019 were prospectively captured. Procedures performed as part of the ongoing ROADSTER-2 registry were excluded. Univariate analysis, consisting of Student's T and Fisher's exact testing, comparing virgin and hostile neck TCAR, was performed at an alpha of 0.05. RESULTS: During the study period, 149 total procedures (n = 30, hostile ipsilateral necks) qualified for inclusion. Both hostile and virgin neck groups were comparable with respect to preoperative comorbidities and medication profiles. The ipsilateral hostile neck cohort consisted of ten patients who underwent previous ipsilateral neck radiation and 23 who were status after neck dissection (3 had both). Intraoperatively, there were no differences with respect to estimated blood loss (47.2 vs. 44.8 mL, P = 0.81), operative time (69.5 vs. 74.5 min, P = 0.38), reverse flow time (12.4 vs. 10.4 min, P = 0.34), radiation exposure (217.7 vs. 226.2 mGy, P = 0.88), fluoroscopy time (5.4 vs. 5.0 min, P = 0.65), contrast usage (23.5 vs. 25.0 mL, P = 0.55), and ability to achieve technical success (96.7% vs. 100%, P = 0.58) between virgin and hostile necks, respectively. Perioperative (30-day) ipsilateral stroke and death rate was 2.5% vs. 0% (P = 1.0) and 2.5% vs. 0% (P = 1.0), respectively, between virgin and hostile necks. We observed one postoperative cranial nerve injury in any of our TCAR patients (hostile neck, P = 0.20). Finally, a total of 3 hematomas (requiring washout) occurred in our (2 in virgin necks and one in a hostile neck) surgical cohort (P = 0.49). CONCLUSIONS: Based on this limited, small series, TCAR in hostile surgical fields is not associated with an increase in case complexity and maintains a similar perioperative risk to virgin field procedures.

Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction.

BACKGROUND: Junctional separation and resulting type IIIa endoleak is a well-known problem after EVAR (endovascular aneurysm repair). This complication results in sac pressurization, enlargement, and eventual rupture. In this manuscript, we review the incidence of this late finding in our experience with the Cook Zenith fenestrated endoprosthesis (ZFEN, Bloomington, IN). METHODS: A retrospective review was performed of a prospectively maintained institutional ZFEN fenestrated EVAR database capturing all ZFENs implanted at a large-volume, academic hospital system. Patients who experienced junctional separation between the fenestrated main body and distal bifurcated graft (with or without type IIIa endoleak) at any time after initial endoprosthesis implantation were subject to further evaluation of imaging and medical records to abstract clinical courses. RESULTS: In 110 ZFENs implanted from October 2012 to December 2017 followed for a mean of 1.5 years, we observed a 4.5% and 2.7% incidence of clinically significant junctional separation and type IIIa endoleak, respectively. Junctional separation was directly related to concurrent type Ib endoleak in all 5 patients. Three patients presented with sac enlargement. One patient did not demonstrate any evidence of clinically significant endoleak and had a decreasing sac size during follow-up imaging. The mean time to diagnosis of modular separation in these patients was 40 months. Junctional separation was captured in surveillance in 2 patients and reintervened upon before manifestation of endoleak. However, the remaining 3 patients completed modular separation resulting in rupture and emergent intervention in 2 and an aortic-related mortality in the other. CONCLUSIONS: Junctional separation between the fenestrated main and distal bifurcated body with the potential for type IIIa endoleak is an established complication associated with the ZFEN platform. Therefore, we advocate for maximizing aortic overlap during the index procedure followed by aggressive surveillance and treatment of stent overlap loss captured on imaging.

Institutional experience with the Zenith Fenestrated aortic stent graft.

OBJECTIVE: The Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, Ind) aortic stent graft system was approved for commercial use by the Food and Drug Administration in April 2012. We report our single-center experience of 100 consecutive patients treated with the ZFEN platform from October 2012 to March 2017. METHODS: A retrospective review of our prospectively maintained fenestrated endovascular aneurysm repair (FEVAR) database at a tertiary care academic institution located in the Midwest United States was performed for descriptive analysis. All continuous variables are reported as a mean ± standard deviation and compared using two-sided Student t-tests. Categorical variables were compared using two-sided Fisher exact tests. RESULTS: All but one of the procedures were elective in nature. Overall intraoperative characteristics included a mean blood loss (estimated blood loss) of 388 ± 385 mL, fluoroscopy time of 63 ± 30 minutes, radiation dose of 437 ± 272 rad, contrast material volume of 99 ± 36 mL, and operative time of 236 ± 87 minutes. Average number of visceral arteries stented was 2.1 ± 0.5. Technical success was achieved in 98% of the patients. Statistically significant (P < .05) improvement in estimated blood loss (2.1-fold) was observed in the second half of our series. Interestingly, no improvements were made in terms of fluoroscopy time, radiation exposure, contrast material use, or operative time. However, procedural difficulty increased in the last half by number of visceral arteries stented as a surrogate (1.9 vs 2.2; P < .05). Mean length of stay was 3.6 ± 4.3 days. Perioperative mortality at 30 days was 2%. Perioperative morbidity included a 5% incidence of any bowel ischemia, 1% of spinal cord ischemia, 3% of renal failure requiring hemodialysis, 1% of stroke, and 4% of myocardial infarction. Average follow-up was 1.7 ± 1.4 years. Reintervention during the follow-up phase was 20%. Of the 209 visceral arteries stented, we noted 6 instances of stent thrombosis, 6 of kinking or stenosis, and 1 of stent fracture in follow-up. Endoleak, most commonly type II, was present or could not be excluded in 15% of all FEVARs at last available computed tomography angiography. CONCLUSIONS: In our experience, FEVAR with the ZFEN system continues to be safe and effective. There is a significant rate of reintervention observed, and close monitoring is fundamental to maintaining good clinical results.

Results of nonoperative management of acute limb ischemia in infants.

OBJECTIVE: Acute limb ischemia (ALI) in infants poses a challenge to the clinician secondary to poor operative outcomes, limb loss risk, and lifelong morbidity. This retrospective study reviewed a 10-year institutional experience with the nonoperative management of ALI in infants. METHODS: Infants (aged ≤12 months) diagnosed with ALI by duplex ultrasound and treated with initial nonoperative management at a tertiary care children's hospital were identified through vascular laboratory arterial duplex ultrasound records and International Classification of Diseases and Current Procedural Terminology codes associated with ALI. Demographics of the patients, injury characteristics, treatment administered, and outcomes were abstracted by chart review and presented using descriptive statistics. RESULTS: During the study period, a total of 25 (28% female) infant patients were diagnosed with ALI. The average age for this cohort was 3.5 ± 3.2 months (standard deviation). Most cases were secondary to iatrogenic injury (88%) from arterial cannulation. Injury sites were more concentrated to the lower extremities (84%) compared with the upper. Absence of Doppler signals was noted in 64% of infants, whereas limb cyanosis was observed in 60% at the time of presentation. Infants were initially treated with anticoagulation (80%) when possible. Two patients failed to respond to nonoperative management and required thrombolysis secondary to progression of thrombus burden while anticoagulated. There were no major (above-ankle) amputations at 30 days. Three deaths occurred within 30 days; all were unrelated to limb ischemia. In the 30-day survivors, overall duration of follow-up was 53.5 ± 38.5 months. One infant required above-knee amputation 6 weeks after diagnosis, resulting in an overall limb salvage rate of 96% on follow-up. Long-term morbidity included two patients with a chronic wound of the affected limb and one patient with limb length discrepancy. No subjects reported claudication at the latest follow-up appointment. In addition, all patients were independently ambulatory except for one adolescent girl who was using a walker with leg braces. CONCLUSIONS: In contrast to the adult population, ALI in infants can be managed with anticoagulation alone with good results. Long-term follow-up continues to demonstrate excellent functional results and minimal disability.

Use of the Zenith Fenestrated platform to rescue failing endovascular and open aortic reconstructions is safe and technically feasible.

OBJECTIVE: Proximal neck dilation is a serious long-term complication directly causing the failure of endovascular aneurysm repair (EVAR) and open surgical repair (OSR) of abdominal aortic aneurysms. However, the implantation of a fenestrated device presents the opportunity for proximal extension of the aortic reconstruction into a healthy segment while maintaining patency of the visceral vessels. The objective of this investigation was to report perioperative and follow-up outcomes using the Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, Ind) aortic stent system in salvaging previous aortic repairs undergoing type IA endoleak or aneurysmal degeneration of the proximal neck. METHODS: We performed a retrospective review of a prospectively maintained institutional database capturing all fenestrated EVAR (FEVAR) cases with the ZFEN platform. Fenestrated cases were classified as primary FEVAR or reoperative FEVAR (rFEVAR) after previous EVAR or OSR. Cohort comparisons were performed using Fisher exact tests and Student t-tests for categorical and continuous variables, respectively. RESULTS: Between October 2012 and March 2017, a total of 103 patients diagnosed with abdominal aortic aneurysm with an inadequate proximal seal zone for traditional EVAR were treated with ZFEN. In 12 patients, FEVAR was performed as a reoperation after previous EVAR (n = 6) or OSR (n = 6). The indications for rFEVAR were proximal neck dilation (>55 mm) after OSR (n = 6), type IA endoleak after EVAR (n = 5), and proximal neck dilation after EVAR without endoleak (n = 1). No difference in ability to achieve technical success was observed between primary FEVAR and rFEVAR (97.8% vs 100%; P = 1.00). In addition, there were no differences in estimated blood loss (363 vs 500 mL; P = .25) and intraoperative use of contrast material (97.3 vs 104.0 mL; P = .55). However, a significant increase in fluoroscopy time (61.1 vs 79.8 minutes; P = .04), radiation exposure (415.9 vs 606.3 rad; P = .02), and operative time (228.4 vs 287.6 minutes; P = .03) in the rFEVAR cohort was observed. In the 30-day perioperative period, there were no significant differences with regard to mortality (2.2% vs 0%; P = 1.0), major adverse cardiovascular events (5.5% vs 0%, P = 1.0), and stent-related adverse events (2.2% vs 0%; P = 1.0). There were no differences in rates of perioperative (5.5% vs 0%; P = 1.0) or follow-up reintervention after a mean follow-up duration of 20.8 months (18.6% vs 25.0%; P = .70). CONCLUSIONS: FEVAR with the ZFEN platform of failed and failing aortic reconstructions due to disease progression is safe and feasible without increased morbidity and mortality in select patients. These preliminary results support the inclusion of ZFEN as a treatment option for aortic reintervention.

Perioperative Outcomes are Adversely Affected by Poor Pretransfer Adherence to Acute Limb Ischemia Practice Guidelines.

BACKGROUND: The accepted treatment for acute limb ischemia (ALI) is immediate systemic anticoagulation and timely reperfusion to restore blood flow. In this study, we describe the retrospective assessment of pretransfer management decisions by referring hospitals to an academic tertiary care facility and its impact on perioperative adverse events. METHODS: A retrospective analysis of ALI patients transferred to us via our Level I Vascular Emergency Program from 2010 to 2013 was performed. Patient demographics, comorbidities, Rutherford ischemia classification, time to anticoagulation, and time to reperfusion were tabulated and analyzed for correlation to incidence of major adverse limb events (MALEs), mortality, and bypass patency in the perioperative period (30-day postoperative). All intervals were calculated from the onset of symptoms and categorized into 3 subcohorts (<6 hr, 6-48 hr, and >48 hr). RESULTS: Eighty-seven patients with an average age of 64.0 (±16.2) years presented to outlying hospitals and were transferred to us with lower extremity ALI. The mean delay from symptom onset to initial referring physician evaluation was 18.3 hr. At that time of evaluation, 53.8% had Rutherford class IIA ischemia and 36.3% had class IIB ischemia. Seventy-six patients (87.4%) were started on heparin previous to transfer. However, only 44 patients (57.9%) reached therapeutic levels as measured by activated partial thromboplastin time before definitive revascularization. A delay of anticoagulation initiation >48 hr from symptom onset was associated with increased 30-day reintervention rates compared with the <6 hr group (66.7% vs. 23.5%; P < 0.05). However, time to reperfusion had no statistically significant impact on MALE, 30-day mortality, or 30-day interventional patency in our small cohorts. Additionally, patients with a previous revascularization had a higher 30-day reintervention rate (46.5%; P < 0.05). CONCLUSIONS: The practice of timely therapeutic anticoagulation of patients referred for ALI from community facilities occurs less frequently than expected and is associated with an increased perioperative reintervention rate.

Cryopreserved Homografts in Infected Infrainguinal Fields Are Associated with Frequent Reinterventions and Poor Amputation-Free Survival.

BACKGROUND: Single-length saphenous vein continues to be the conduit of choice in infected-field critical limb ischemia. However, half of these individuals have inadequate vein secondary to previous use or chronic venous disease. We reviewed our outcomes of infected-field infrainguinal bypasses performed with cryopreserved homografts (CHs), a widely accepted alternative to autogenous vein in this setting. METHODS: This is a retrospective, institutional descriptive analysis of infected-field infrainguinal revascularizations between 2012 and 2015. RESULTS: Twenty-four operations were performed in the same number of patients for limb ischemia with signs of active infection. The mean age of the cohort examined was 62.5 ± 14.4 (standard deviation) years. Mean Society of Vascular Surgery risk score was 3.9 with a baseline Rutherford's chronic ischemia score of 4.3 at presentation. Emergent procedures constituted 29% of cases, and the remainder cases were urgent procedures. The CH bypass captured was a reoperative procedure in all but one of the patients. Culture positivity was present in 75% of cases with Staphylococcus aureus (29%), the most commonly isolated organism. Thirty-day mortality and major adverse cardiovascular events were both 4%. Amputation-free survival (AFS) was 75% at 30 days. Similarly, 30-day reintervention was 38% with debridement (43%) and bleeding (29%), the most common indications. Average duration of follow-up was 27.9 ± 20.4 months (range: 0.5-60.4). Mean length of stay was 14.8 days. Reinfection requiring an additional procedure or antibiotic regimen separate from the index antibiotic course was 13%. Primary patency and AFS at 1 year was 50% and 58%, respectively. Primary patency and AFS at 2 years was 38% and 52%, respectively. Limb salvage at 1 and 2 years was 70% and 65%, respectively. Fifteen patients (63%) required reintervention during the follow-up period with 40% of those subjects undergoing multiple procedures. CONCLUSIONS: CHs remain a marginal salvage conduit in the setting of infection and no autogenous choices. Therefore, clinicians should individualize usage of this high-cost product in highly selected patients only.

Variation in hospital costs and reimbursement for endovascular aneurysm repair: A Vascular Quality Initiative pilot project.

OBJECTIVE: Comparing costs between centers is difficult because of the heterogeneity of vascular procedures contained in broad diagnosis-related group (DRG) billing categories. The purpose of this pilot project was to develop a mechanism to merge Vascular Quality Initiative (VQI) clinical data with hospital billing data to allow more accurate cost and reimbursement comparison for endovascular aneurysm repair (EVAR) procedures across centers. METHODS: Eighteen VQI centers volunteered to submit UB04 billing data for 782 primary, elective infrarenal EVAR procedures performed by 108 surgeons in 2014. Procedures were categorized as standard or complex (with femoral-femoral bypass or additional arterial treatment) and without or with complications (arterial injury or embolectomy; bowel or leg ischemia; wound infection; reoperation; or cardiac, pulmonary, or renal complications), yielding four clinical groups for comparison. MedAssets, Inc, using cost to charge ratios, calculated total hospital costs and cost categories. Cost variation analyzed across centers was compared with DRG 237 (with major complication or comorbidity) and 238 (without major complication or comorbidity) coding. A multivariable model to predict DRG 237 coding was developed using VQI clinical data. RESULTS: Of the 782 EVAR procedures, 56% were standard and 15% had complications, with wide variation between centers. Mean total costs ranged from $31,100 for standard EVAR without complications to $47,400 for complex EVAR with complications and varied twofold to threefold among centers. Implant costs for standard EVAR without complications varied from $8100 to $28,200 across centers. Average Medicare reimbursement was less than total cost except for standard EVAR without complications. Only 9% of all procedures with complications in the VQI were reported in the higher reimbursed DRG 237 category (center range, 0%-21%). There was significant variation in hospitals' coding of DRG 237 compared with their expected rates. VQI clinical data accurately predict current DRG coding (C statistic, 0.87). CONCLUSIONS: VQI data allow a more precise EVAR cost comparison by identifying comparable clinical groups compared with DRG-based calculations. Total costs exceeded Medicare reimbursement, especially for patients with complications, although this varied by center. Implant costs also varied more than expected between centers for comparable cases. Incorporation of VQI data elements documenting EVAR case complexity into billing data may allow centers to better align respective DRG reimbursement to total costs.

Cryopreserved venous allograft is an acceptable conduit in patients with current or prior angioaccess graft infection.

OBJECTIVE: The durability of cryopreserved allograft has been previously demonstrated in the setting of infection. The objective of this study was to examine the safety, efficacy, patency, and cost per day of graft patency associated with using cryopreserved allograft (vein and artery) for hemodialysis access in patients with no autogenous tissue for native fistula creation and with arteriovenous graft infection or in patients at high risk for infection. METHODS: Patients implanted with cryopreserved allograft for hemodialysis access between January 2004 and January 2014 were reviewed using a standardized, multi-institutional database that evaluated demographic, comorbidity, procedural, and outcomes data. RESULTS: There were 457 patients who underwent placement of cryopreserved vein (femoral: n = 337, saphenous: n = 11) or artery (femoral: n = 109) for hemodialysis access at 20 hospitals. Primary indications for allograft use included high risk of infection in 191 patients (42%), history of infected prosthetic graft in 169 (37%), and current infection in 97 (21%). Grafts were placed more frequently in the arm (78%) than in the groin, with no difference in allograft conduit used. Mean time from placement to first hemodialysis use was 46 days (median, 34 days). Duration of functional graft use was 40 ± 7 months for cryopreserved vein and 21 ± 8 months for cryopreserved artery (P < .05), and mean number of procedures required to maintain patency at follow-up of 58 ± 21 months was 1.6 for artery and 0.9 for vein (P < .05). Local access complications occurred in 32% of patients and included late thrombosis (14%), graft stenosis (9%), late infection (9%), arteriovenous access malfunction (7%), early thrombosis (3%), and early infection (3%). Early and late infections both occurred more frequently in the groin (P = .030, P = .017, respectively), and late thrombosis occurred more frequently with cryopreserved artery (P < .001). Of the 82 patients (18%) in whom the cryopreserved allograft was placed in the same location as the excised infected prosthetic graft, 13 had infection of the allograft during the study period (early: n = 4; late: n = 9), with no significant difference in infection rate (P = .312) compared with the remainder of the study population. The 1-, 3-, and 5-year primary patency was 58%, 35%, and 17% for cryopreserved femoral vein and 49%, 17%, and 8% for artery, respectively (P < .001). Secondary patency at 1, 3, and 5 years was 90%, 78%, and 58% for cryopreserved femoral vein and 75%, 53%, and 42% for artery, respectively (P < .001). Mean allograft fee per day of graft patency was $4.78 for cryopreserved vein and $6.97 for artery (P < .05), excluding interventional costs to maintain patency. CONCLUSIONS: Cryopreserved allograft provides an excellent conduit for angioaccess when autogenous tissue is not available in patients with current or past conduit infection. Cryopreserved vein was associated with higher patency and a lower cost per day of graft patency. Cryopreserved allograft allows for immediate reconstruction through areas of infection, reduces the need for staged procedures, and allows early use for dialysis.

Failure mode analysis of the Endologix endograft.

OBJECTIVE: Type III (T-III) endoleaks following endovascular aneurysm repair (EVAR) remain a major concern. Our center experienced a recent concentration of T-III endoleaks requiring elective and emergency treatment and prompted our review of all EVAR implants over a 40-month period from April 2011 until August 2014. This report represents a single center experience with T-III endoleak management with analysis of factors leading to the T-III-related failure of EVAR. METHODS: A retrospective review of all the operative reports, medical records, and computed tomography scans were reviewed from practice surveillance. Using Society for Vascular Surgery aneurysm reporting standards, we analyzed the morphology of the aneurysms before and after EVAR implant using computed tomography. Index procedure and frequency of reinterventions required to maintain aneurysm freedom from rupture were compared across all devices using SAS v 9.4 (SAS Institute, Inc, Cary, NC). Major adverse events (MAEs) requiring secondary interventions for aneurysm treatment beyond primary implant were analyzed for methods of failure. Aneurysm morphology of patients requiring EVAR was compared across all endograft devices used for repair. For purposes of MAE analysis, patients receiving Endologix (ELX) endograft were combined into group 1; Gore, Cook, and Medtronic endograft patients were placed into group 2. RESULTS: Overall, technical success and discharge survival were achieved in 97.3% and 98% of patients regardless of device usage. There was no significant device related difference identified between patient survival or freedom from intervention. MAEs involving aneurysm treatment were over seven-fold more frequent with ELX (group 1) vs non-ELX (group 2) endografts (P < .01). Group 1 patients with aneurysm diameters larger than 65 mm were associated with a highly significant value for development of a T-III endoleak (odds ratio, 11.16; 95% confidence interval, 2.17, 57.27; P = .0038). CONCLUSIONS: While EVAR technical success and survival were similar across all devices, ELX devices exhibited an unusually high incidence of T-III endoleaks when implanted in abdominal aortic aneurysms with a diameter of more than 65 mm. Frequent reinterventions were required for Endologix devices for prevention of aneurysm rupture due to T-III endoleaks.

Impact of COVID-19 on the Society for Vascular Surgery Vascular Quality Initiative Venous Procedure Registries (varicose vein and inferior vena cava filter).

In response to the pandemic, an abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures occurred. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020. Approximately three-fourths (74%) of physicians adopted restrictive operating policies for urgent and emergent cases only, whereas one-half proceeded with "time sensitive" elective cases as urgent. Data manager case entry was negatively affected by both low case volumes and staffing due to reassignment or furlough. Venous registry volumes were reduced fivefold in the first quarter of 2020 compared with a similar period in 2019. The consequences of delaying vascular procedures for ambulatory venous practice remain unknown with increased morbidity likely. Challenges to determine venous thromboembolism mortality impact exist given difficulty in verifying "in home and extended care facility" deaths. Further ramifications of a pandemic shutdown will likely be amplified if postponement of elective vascular care extends beyond a short window of time. It will be important to monitor disease progression and case severity as a result of policy shifts adopted locally in response to pandemic surges.

The impact of COVID-19 pandemic on vascular registries and clinical trials.

Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.