Prosthetic outcomes after amputation and the impact of mobility level on survival.

OBJECTIVE: Lower extremity amputation continues to be necessary in a significant number of patients with peripheral vascular disease. The 5-year survival following lower limb loss is markedly reduced. Many of these patients are never fitted with a prosthesis, and there is a dearth of knowledge regarding the barriers to prosthetic attainment. The goal of this study was to identify the risk factors for not receiving a prosthesis and the effect of mobility level on survival following major amputation. METHODS: This was a retrospective analysis of all patients that underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to December 31, 2019. Abstracted data included: age, sex, race, body mass index, comorbidities, American Society of Anesthesiologists score, statin use, level of amputation, stump revision, fitting for prosthesis, type of prosthesis, and the United States' Medicare Functional Classification Level, also called K level. Survival was determined using a combination of sources, including the Social Security Death Master File, searches of multiple genealogic registries, and general internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis attainment. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: A total of 464 patients were included in this study. The mean age was 65 years, and mean body mass index was 27 kg/m2. The majority of patients were male (68%), White (56%), diabetic (62%), and hypertensive (76%), and underwent below-the-knee amputation (69%). Prosthetic attainment occurred in 185 (40%). On multivariable analysis, age >81 years and current tobacco use were associated with no prosthetic fitting. Overall 5-year survival was 41.9% (95% confidence interval [CI], 37.6%-46.6%) (below-the-knee amputation, 47.7% [95% CI, 42.5%-53.5%]; above-the-knee amputation, 28.7% [95% CI, 22.1%-37.2%]). On multivariable analysis, age >60 years, congestive heart failure, above-the-knee amputation, and no prosthetic attainment were associated with decreased survival. Increasing K level was incrementally associated with improved survival. CONCLUSIONS: This study has identified several patient factors associated with prosthetic attainment, as well as multiple factors predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. The Medicare Functional Classification Level K level predicts survival. More research is needed to determine the barriers to prosthetic attainment and if improving a patients K level will improve survival.

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

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

Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair.

BACKGROUND: Left subclavian artery (LSA) revascularization has been recommended for patients undergoing elective thoracic endovascular aortic repair (TEVAR) with a proximal zone 2 landing requiring coverage of the LSA. The clinical standard of care remains surgical LSA revascularization. However, recently, the feasibility of using branched endografts has been demonstrated. We compared the perioperative and mid-term outcomes of these approaches. METHODS: We performed a retrospective review of consecutive patients who underwent TEVAR with a proximal zone 2 landing at a single center from 2014 to 2020. The patients were divided into cohorts for comparison: those who underwent surgical revascularization (SR-TEVAR group) and those who underwent thoracic branched endografting with an investigational device (TBE group). Those patients who did not undergo LSA revascularization were excluded. Perioperative outcomes, including procedural success, death, stroke, limb ischemia, and length of stay, were compared. Kaplan-Meier survival curves were compared using the log-rank test. The cumulative incidence of device-related endoleak (types I and III) and device-related reintervention, accounting for death as a competing hazard, were compared using the Fine-Gray test. RESULTS: A total of 55 patients were included: 31 (56%) in the SR-TEVAR group and 24 (44%) in the TBE group. The preoperative demographics and comorbidities were similar between the two groups. Procedural success was 100% in both cohorts, with no periprocedural strokes or left upper extremity ischemic events. One operative or 30-day death (TBE, 4.2%; vs SR-TEVAR, 3.2%; P = .99) occurred in each cohort. The total operative time (TBE, 203 ± 79 minutes; vs SR-TEVAR, 250 ± 79 minutes; P = .03) and total length of stay (TBE, 5.2 ± 3.6 days; vs SR-TEVAR, 9.9 ± 7.2 minutes; P = .004) were both significantly shorter in the TBE group. No difference was found in mid-term survival (log-rank test, P = .50) nor the cumulative incidence of device-related endoleak (Fine-Gray test, P = .51) or reintervention (Fine-Gray test, P = .72). No occlusions of the TBE graft or surgical bypass or transpositions had occurred after a mean follow-up of 28 ± 16 and 34 ± 24 months, respectively. CONCLUSIONS: TBE can be performed with procedural success rate and safety profile comparable to those of TEVAR with surgical revascularization, with a decreased total length of stay, for patients requiring proximal zone 2 coverage. The mid-term outcomes for each approach were also similar. Prospective, randomized comparisons of these techniques are warranted.

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases. METHODS: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.

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.

Systematic Review of the Influence of Anatomy and Aneurysm Type on Treatment Choice and Outcomes in Extracranial Carotid Artery Aneurysms.

BACKGROUND: Extracranial carotid artery aneurysms (ECAA) are rare. Open surgery has traditionally been the treatment of choice, and endovascular management has recently been increasingly described. However, operative guidelines have not been defined. METHODS: A systematic review following PRISMA guidelines was performed to identify articles related to the symptoms, treatments, and outcomes of ECAAs. Included studies were further evaluated to identify distribution of treatment strategy based on anatomical location by Attigah classification (Type I-V) and aneurysmal type (true versus pseudoaneurysm). RESULTS: Twenty-eight retrospective reviews were included. A total of 906 patients (63% male) with 959 ECAAS were identified. The most common presenting symptoms included neck mass (45%) and neurological deficits (26%), while 218 (23%) were asymptomatic. True aneurysms accounted for 52% and pseudoaneurysms for 45% of cases. Of the 959 ECAAs, 750 were treated with open surgery, 85 with an endovascular procedure, and 124 conservatively. Perioperative complications of open surgery included cranial nerve injuries (CNI) in 9% (68), strokes in 4% (27), and death in 2% (18) of cases. There were no CNI, perioperative stroke, or perioperative mortality associated with 85 endovascular procedures; however, there was 1 case of restenosis (1%). Of the 124 patients treated conservatively, 3% (4) died as a result of the aneurysm. Twenty-two of 28 studies (688 ECAAs) reported anatomical location according to Attigah classification. The distribution of ECAAs were Type I (296/688; 43%), Type II (19/688; 3%), Type III (195/688; 28%), Type IV (76/688: 11%), and Type V (102/688; 15%). Eleven of 28 studies (241 ECAAs) reported treatment choice according to Attigah classification and revealed that the majority of Type I (82%), Type II (81%), Type III (91%), and Type IV (100%) ECAAs were treated via open surgery, while Type V ECAAs were evenly treated by open surgery and endovascular surgery. Twenty-three of 28 studies (780 ECAAs) reported treatment choice stratified by aneurysmal type. Of 417 true ECAAs, 88% were treated open surgically, 4% were treated endovascularly, and 8% were treated conservatively. Of 357 pseudoaneurysms, 67% were treated open surgically, 14% were treated endovascularly, and 19% were treated conservatively. CONCLUSIONS: Most reported patients with ECAAs are symptomatic. Type I and III account for more than two-thirds of ECAAs, while true aneurysms account for roughly half. The vast majority of ECAAs have been treated surgically with results comparable to reoperative carotid endarterectomy. In selected patients, endovascular treatment has been very successful with no reported morbidity or mortality.

A prospective randomized feasibility trial comparing angiography and angiography with intravascular ultrasound for treatment of hemodialysis access failures.

OBJECTIVE: Hemodialysis accesses suffer from limited primary patency requiring frequent interventions, revisions, or even abandonment. Prolongation of access life and usability with minimization of these adverse events is paramount. Endovascular methods are established first-line interventions for failing arteriovenous access and treatment of venous outflow stenoses. The Primary goal of this feasibility study was to evaluate intravascular ultrasound (IVUS) during interventional treatments on outcomes in those undergoing angiography for failing hemodialysis access. Secondary goals were to determine differences between IVUS and angiography on vessel and lesion characteristics and impact on treatment. METHODS: In this prospective, randomized controlled trial, patients scheduled for angiography to evaluate and treat a failing hemodialysis access were randomized to use of angiography (DSA) alone or angiography plus IVUS (DSA + IVUS). Patients were treated by a standardized protocol and seen in follow-up at 2 weeks, and every 3 months for 2 years or until a study endpoint was reached. Measurement of vessel diameters, % stenosis, lesion length, and study endpoints (AV access thrombosis, re-intervention, or surgical revision) were recorded. RESULTS: A total of 55 subjects were enrolled, 27 in the DSA cohort and 28 in the DSA + IVUS cohort. There were 41 treated lesions in each group. Freedom from the composite endpoint of AV access thrombosis or re-intervention was 46.3% in the DSA cohort and 61.0% in the DSA + IVUS cohort (p = 0.27). Diameter measurements matched between the two imaging modalities only 9 times out of 41 total comparison measures. In pre-treatment lesions with >80% stenosis, IVUS had a greater tendency than DSA to underestimate the severity of stenosis, whereas in pre-treatment lesions with 50-80% stenosis, DSA was more likely than IVUS to underestimate the severity of stenosis. Post-treatment % stenosis had mean difference of -7.5% between DSA versus DSA + IVUS cohorts. In five lesions with <30% stenosis measured by angiogram, IVUS led to treatment escalation. CONCLUSION: In the interventional treatment of failing angioaccess, IVUS and angiography differ in the vast majority of cases in measurement of vessel diameter. A significant number of patients were found to have suboptimal therapeutic response by IVUS only, which led to an escalation in treatment, and in over one-third of cases, the IVUS results led to a change in treatment plan. The improved patency rates in the IVUS group was not statistically significant in this small population but should be further investigated in a larger trial.

Sex, age, and other barriers for prosthetic referral following amputation and the impact on survival.

BACKGROUND: Despite advances in peripheral vascular disease treatment, lower extremity amputation continues to be necessary in a significant number of patients. Up to 80% of amputees are not referred for prosthetic fitting. The factors contributing to referral decisions have not been adequately investigated, nor has the impact of prosthetic referral on survival. We characterized differences between patients who were successfully referred to our in-house prosthetists and those who were not, and identified factors associated with prosthetic referral and predictive of survival. METHODS: This was a retrospective analysis of all patients who underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to June 30, 2017. Data regarding age, sex, race, body mass index (BMI), diabetes, hypertension, hyperlipidemia, end-stage renal disease, prior coronary artery bypass graft surgery, congestive heart failure, tobacco use, American Society of Anesthesiologists (ASA) score, previous arterial procedure, chronic obstructive pulmonary disease, statin use, postoperative ambulatory status, level of amputation, stump revision, and referral for prosthesis were collected. Survival was determined from a combination of sources, including the Social Security Death Master Index, multiple genealogic registries, and internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis referral. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: There were 293 patients included in this study. Mean age was 66 years, and mean BMI 27 kg/m2. The majority of patients were male (69%), white (53%), with diabetes (65.4%) and hypertension (77.5%), and underwent below-the-knee amputation (BKA) (73%). Prosthetic referral occurred in 123 (42.0%). Overall 5-year survival was 61.7% (95% confidence interval [CI], 55.9%-68.1%) (BKA 64.7% [95% CI, 57.9%-72.3%]; above-the-knee amputation 53.8% [95% CI, 43.4%-66.6%]). On multivariate analysis, age >70 years, female sex, diabetes, ASA score 4 or 5, and current tobacco use were associated with no referral for prosthetic fitting. Patients with BMI 25 to 30, a previous arterial procedure, BKA, and history of stump revision were more likely to be referred. Factors associated with decreased survival were increasing age, higher ASA class, black race, and BMI; prosthetic referral was seen to be protective. CONCLUSIONS: We identified multiple patient factors associated with prosthetic referral, as well as several characteristics predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. Further research is needed to determine whether the factors identified as associated with nonreferral are markers for patient characteristics that make them clinically unsuitable for prosthetic fitting or if they are symptoms of unconscious bias or of the patient's access to care.

The value of the modern vascular surgeon to the health care system: A report from the Society for Vascular Surgery Valuation Work Group.

Vascular surgeons provide an important service to the health care system. They are capable of treating a wide range of disease processes that affect both the venous and arterial systems. Their presence broadens the complexity and diversity of services that a health care system can offer both in the outpatient setting and in the inpatient setting. Because of their ability to control hemorrhage, they are critical to a safe operating room environment. The vascular surgery service line has a positive impact on hospital margin through both the direct vascular profit and loss and the indirect result of assisting other surgical and medical services in providing care. The financial benefits of a vascular service line will hold true for a wide range of alternative payment models, such as bundled payments or capitation. To fully leverage a modern vascular surgeon's skill set, significant investment is required from the health care system that is, however, associated with substantial return on the investment.

Telemedicine platforms and their use in the coronavirus disease-19 era to deliver comprehensive vascular care.

Implementation of telemedicine for patient encounters optimizes personal safety and allows for continuity of patient care. Embracing telehealth reduces the use of personal protective equipment and other resources consumed during in-person visits. The use of telehealth has increased to historic levels in response to the coronavirus disease 2019 (COVID-19) pandemic. Telehealth may be a key modality to fight against COVID-19, allowing us to take care of patients, conserve personal protective equipment, and protect health care workers all while minimizing the risk of viral spread. We must not neglect vascular health issues while the coronavirus pandemic continues to flood many hospitals and keep people confined to their homes. Patients are not immune to diseases and illnesses such as stroke, critical limb ischemia, and deep vein thrombosis while being confined to their homes and afraid to visit hospitals. Emerging from the COVID-19 crisis, incorporating telemedicine into routine medical care is transformative. By leveraging digital technology, the authors discuss their experience with the implementation, workflow, coding, and reimbursement issues of telehealth during the COVID-19 era.

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

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

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.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

OBJECTIVE: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF. METHODS: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed. RESULTS: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality. CONCLUSIONS: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population.

Rare Etiology of Ischemic Steal Syndrome in the Left Peroneal Artery.

Ischemic steal syndrome (ISS) secondary to an arteriovenous fistula (AVF) in the lower extremity (LE) is a rare occurrence. Herein, we report a case of symptomatic ISS in an adult male due to an iatrogenic AVF in the left LE, which was surgically repaired by placing an arterial stent across the acquired AVF of the peroneal artery to the peroneal vein.

Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the GREAT Registry.

BACKGROUND: Arterial access and device delivery in endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have evolved from open femoral or iliac artery exposure to selective percutaneous arterial access. Although regional application of percutaneous access for these 2 procedures varies widely, the use of this technique continues to increase. Currently, differences in the use of percutaneous access between EVAR and TEVAR have not been well explored. The Gore Global Registry for Endovascular Aortic Treatment (GREAT) registry collected relevant data for evaluation of these issues and the comparative results between open and percutaneous approaches in regard to complication rates and length of stay (LOS). METHODS: This study was performed via a retrospective review of patients from the GREAT registry (Clinicaltrials.gov no. NCT01658787). The primary variable of this study was access site complications including postoperative hematoma, vessel dissection, and pseudoaneurysm. Patients were categorized by abdominal (EVAR) and thoracic (TEVAR) aortic procedures using percutaneous-only, cutdown-only, and combined vascular access techniques for a total of 6 groups. Standard statistical methodology was used to perform single-variable and multivariable analysis of a variety of covariates including LOS, geographical location of procedure, procedural success rate, and access sheath size. RESULTS: Of 4,781 patients from the GREAT registry, 3,837 (80.3%) underwent EVAR and 944 (19.7%) underwent TEVAR with percutaneous-only access techniques being used in 2,017 (42.2%) and cutdown-only in 2,446 (51.2%). There was variable application of percutaneous access by geographic region with Australia and New Zealand using this technique more frequently and Brazil using percutaneous access the least. No significant difference in the rate of access site complications was detected between the 6 groups of patients in the study; however, significantly lower rates of access site complications were associated with percutaneous-only compared with both cutdown-only and combined techniques (P = 0.03). In addition, associated with significantly higher rates of access site complications was longer LOS (P < 0.01). Average LOS was 5.2 days and was higher in the TEVAR group (10.1 days) than that in EVAR (4.0 days, P < 0.05). Increased sheath size does not appear to increase the risk of access site complication. CONCLUSIONS: There was no significant difference found in the complication rate between percutaneous and cutdown access techniques. This analysis demonstrates that percutaneous-only access is safe, has low complication rates, and has lower LOS compared with open access or combined access techniques.

Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results.

BACKGROUND: The utilisation rate of endovascular aortic aneurysm repair has increased continuously over the past 2 decades. Endovascular aortic aneurysm repair is still performed frequently in patients with an unfavourable proximal seal zone, despite the associated late complications. PURPOSE: We aimed to evaluate the mid-term durability of the GORE® EXCLUDER® AAA Endoprosthesis, featuring the C3 delivery system, in patients with a proximal neck anatomy outside the instructions for use (IFU). METHODS: A retrospective sub-analysis of the Global Registry for Endovascular Aortic Treatment including patients treated for abdominal aortic aneurysms with the GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) was performed. A "challenging neck" was defined as those treated outside the IFU with an aortic neck length <15 mm and/or aortic neck angle >60°. Cox proportional analyses were used to test for time-to-event differences between those treated within and outside the IFU while accounting for covariates, specifically proximal neck length and neck angle. The main outcomes assessed were 5-year all-cause mortality, 5-year endoleak development (type I or III), and 5-year device-related reinterventions. FINDINGS: Of the 3,324 patients included in the analysis, 411 (12.4%) had a challenging neck and 2,913 (87.6%) did not. The patients in the challenging neck group were significantly older (74.9 years vs. 73.2 years, p≤0.0001) and had a significantly larger aortic aneurysm diameter at the time of the intervention than those treated within the IFU (61.2 mm vs. 56.4 mm, P< 0.0001), shorter proximal neck length (18 mm vs. 30 mm, P< 0.0001) and larger infrarenal neck angle (60.8° vs. 25.8°, P< 0.0001). In the multivariate analysis, brachial access site and challenging neck were not independent risk factors; increased age was associated with a shorter time to mortality (hazard ratio 1.051, 95% confidence interval 1.039-1.062, P< 0.0001), as was the use of tobacco (hazard ratio 1.329, 95% confidence interval 1.124-1.571, P= 0.0009). The 5-year all-cause mortality (36.2% vs. 27.5%, P= 0.002) and aorta-related mortality (3.8% vs. 1.1%, P= 0.002) were significantly higher in the challenging neck group. The risk of death within 5 years also increased significantly at 1.1% per millimetre increase in the abdominal aortic aneurysm diameter (P= 0.0005). Furthermore, the rates of type Ia endoleak development (7% vs. 1.2%, P< 0.001) and requirement for reintervention (13.3% vs. 9.7%, P< 0.001) were higher in those treated outside the IFU (challenging neck group). CONCLUSIONS: Treatment with the Excluder AAA Endograft outside the IFU was associated with higher 5-year mortality values, increased type Ia endoleak development rates, and a greater need for reintervention compared with treatment within the IFU. This reiterates that fenestrated and open treatments should be strongly considered in cases with aortic neck anatomies outside the IFU. Infrarenal endovascular intervention outside the IFU should only be used when there is no alternative, with meticulous procedural planning and intervention to promote satisfactory outcomes.

Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.

National incidence, mortality outcomes, and predictors of spinal cord ischemia after thoracic endovascular aortic repair.

OBJECTIVE: Spinal cord ischemia (SCI) is a dreaded complication of thoracic endovascular aortic repair (TEVAR). There are limited national data describing the incidence and influence of in-hospital SCI recovery on survival. Moreover, no robust preoperative SCI risk assessment models currently exist. The purpose of this analysis was to analyze the Vascular Quality Initiative to determine the national incidence, survival association, and preoperative predictors of SCI after TEVAR. METHODS: All Vascular Quality Initiative TEVAR procedures (June 2014-June 2019) were reviewed. The primary end point was development of in-hospital SCI, defined as any new neurologic deficit or paralysis not attributable to intracranial disease. Secondary end points were disease-specific SCI rates and long-term out-of-hospital survival. Functional outcomes (transient vs permanent SCI) were independently determined by treating physicians. Kaplan-Meier analysis and Cox proportional hazards methodology were used to assess the association of SCI with survival. A logistic regression model of candidate preoperative SCI predictors was created, and bootstrapped backward elimination (retaining predictors with ≥50% selection frequency) was used for model reduction. Model fit and performance statistics were validated by adjustment for Efron's optimism. RESULTS: The overall rate of SCI was 3.7% (n = 422/11,473; transient, 1.6% [n = 179]; permanent, 2.1% [n = 243]). Patients who developed any SCI had significantly lower Kaplan-Meier survival estimate compared with those without SCI (1-year survival: SCI, 65%; no SCI, 87%; P < .0001), and patients with permanent SCI had notably worse survival than patients with transient SCI (1-year survival: permanent SCI, 54%; transient SCI, 80%; P < .0001). Disease-specific incidence of any SCI was as follows: aneurysm, 3.4%; dissection, 5.3%; aneurysm from dissection, 4.1%; trauma, 1.1%; penetrating ulceration, 2.4%; intramural hematoma, 5.7%; penetrating ulceration and intramural hematoma, 4.3%; and aortic thrombus, 4.8%. Several factors were selected on multivariable analysis as the most robust preoperative predictors of any SCI, including distal landing zone 5 to zone 10, nonelective case, creatinine concentration >1.38 mg/dL, smoking history, American Society of Anesthesiologists class, adjunctive procedure, nonwhite race, and preoperative hypertension (area under the curve = 0.72; Nagelkerke R2 = 0.06). CONCLUSIONS: SCI is a devastating complication after TEVAR that is associated with worse overall survival, particularly when no functional recovery occurs by hospital discharge. Disease-specific, real-world benchmarks for SCI rates are provided that may inform quality initiatives focused on reducing this complication. Importantly, this analysis is the first description of a preoperative prediction model derived from national data for determining SCI risk after TEVAR. These predictors should be used to identify high-risk patients to balance the risk of SCI and its associated increased short-term mortality with the risk of the underlying disease. Furthermore, all available adjunctive measures should be implemented in these high-risk patients to reduce risk of SCI.

Sex-Related Outcomes After Endovascular Aneurysm Repair Within the Global Registry for Endovascular Aortic Treatment.

BACKGROUND: Abdominal aortic aneurysms (AAAs) are more common in men. However, women have been shown to have more short- and long-term adverse outcomes after endovascular aneurysm repair. This disparity is thought to be multifactorial, including anatomical differences, hormonal differences, older age of presentation, and a greater degree of preoperative comorbidities. METHODS: A retrospective analysis that included data for 3,758 patients from the Global Registry for Endovascular Aortic Treatment (GREAT) was conducted. Patients were recruited into GREAT between August 2010 and October 2016 and received the Gore Excluder stent graft for infrarenal AAAs repair. Cox multivariate regression analyses were performed to analyze any reintervention and device-related intervention rates. RESULTS: Of the 3,758 patients, 3,220 were male (mean age 73 years) and 538 were female (mean age 75 years). Women had higher prevalence rates of chronic obstructive pulmonary disease (P < 0.0001) and renal insufficiency (P = 0.03), whereas men had higher rates of cardiovascular comorbidities. The AAAs in women were smaller in diameter with shorter and more angulated necks. Women did not experience a significantly higher rate of endoleaks but did exhibit higher reintervention rates, including reintervention for device-related issues. In terms of mortality, aorta-related mortality was most prevalent within the first 30 days after procedure in both sexes. CONCLUSIONS: Women were treated at an older age and had a more hostile aneurysmal anatomy. Although the mortality rates were lower in women, they had significantly higher rates of reintervention, and thus higher morbidity rates after endovascular aneurysm repair.

Sex as an independent risk factor for long-term survival after endovascular aneurysm repair.

BACKGROUND: Several vascular surgical procedures, including repair of abdominal aortic aneurysms (AAAs), show poorer outcomes for women than for men. We evaluated the impact of sex-based demographic differences on survival after endovascular aneurysm repair (EVAR). METHODS: We reviewed EVARs performed at our institution between 2003 and 2009 and assessed aortic neck variables (length, diameter, angulation, and calcification), iliac artery variables (length, tortuosity, angulation, and calcification), and AAA diameter. Cox proportional hazards models were used to examine the association between sex and 5-year mortality while adjusting for patients' demographics, comorbidities, anatomic variables, and AAA parameters. The final model adjusted for sex, age, body mass index, hypertension, iliac artery length, and aortic neck length. RESULTS: Of 336 patients, 278 were male (mean age, 73 years) and 58 were female (mean age, 77 years; P = .0005). Men had more coronary artery bypass grafts (79 vs 8; P = .02) and percutaneous coronary interventions (52 vs 4; P = .03) than women did. Significant differences between the sexes was seen for aortic neck angle, diameter, and length and for iliac artery diameter and length. Men (44%) were more likely than women (22%; P = .0002) to have EVAR performed within the device guidelines. Five-year survival was 73% in men and 49% in women. Multivariable analysis showed that female sex, increase in age, low body mass index (<25 kg/m2), and aortic neck length were significantly associated with risk of 5-year mortality. CONCLUSIONS: Women presented at an older age and with a more hostile anatomy. They had reduced survival compared with men after EVAR. After controlling for comorbidities and aortic neck and iliac artery anatomy, sex remained an independent predictor for survival.