Extended Thoracic Endovascular Aortic Repair is Optimal Therapy in Acute Complicated Type B Dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) represents optimal therapy for complicated acute type B aortic dissection (aTBAD). Persistent knowledge gaps remain, including optimal length of aortic coverage, impact on distal aortic remodeling, and fate of the dissected abdominal aorta. METHODS: Review of the Emory Aortic Database identified 92 patients who underwent TEVAR for complicated aTBAD from 2012-2018. Standard TEVAR covered aortic zones 3 and 4 (from the left subclavian to the mid-descending thoracic aorta). Extended TEVAR fully covered aortic zones 3 though 5 (from the left subclavian to the celiac artery). Long-term imaging, clinical follow-up, overall and aortic-specific mortality were reviewed. RESULTS: Extended TEVAR (n=52) required a greater length of coverage vs. Standard TEVAR (n=40) (240±32mm vs. 183±23mm, p<0.01). In-hospital mortality occurred in 5.4% (7.7% vs. 2.5%, p=0.27) due to mesenteric malperfusion (n=3) or rupture (n=2). Overall incidence of postoperative stroke, transient paraparesis, paraplegia, and dialysis were 5.4% (3.9% vs. 7.5%, p=0.38), 3.2% (5.8% vs. 0%, p=0.18), 0%, and 0% respectively, equivalent between groups. Follow-up was 96.6% complete to a mean of 6.1 years (interquartile range 3.5-8.6 years). There were significantly higher rates of complete thrombosis/obliteration of the entire thoracic false lumen after Extended TEVAR (82.2% vs. 51.5% p=0.04). Distal aortic reinterventions were less frequent after Extended TEVAR (5.8% vs 20%, p=0.04). Late aorta-specific survival was 98.1% after Extended TEVAR vs. 92.3% for Standard TEVAR (p=0.32). CONCLUSION: Extended TEVAR for complicated aTBAD is safe, results in a high rate of total thoracic false lumen thrombosis/obliteration, and reduces distal reinterventions. Longer-term follow-up will be needed to demonstrate a survival benefit compared to limited aortic coverage.

Prosthetic Fitting and Mortality after Major Lower Extremity Amputation.

INTRODUCTION: Studies suggest that ambulation after major lower extremity amputation (LEA) is low and mortality after LEA is high. Successful prosthetic fitting after LEA has a significant quality of life benefit, however, it is unclear if there are benefits in post-LEA mortality. Our objective was to examine a contemporary cohort of patients who underwent LEA and determine if there is an association between fitting for a prosthetic and mortality. METHODS: We reviewed all patients who underwent LEA between 2015 and 2022 at two academic healthcare systems in a large metropolitan city. The exposure of interest was prosthetic fitting after LEA. The primary outcomes were mortality within 1- and 3-years of follow-up. Ambulation after LEA was defined as being ambulatory with or without an assistive device. Patients with prior LEA were excluded. Extended Cox models with time-dependent exposure were used to evaluate the association between prosthetic fitting and mortality at 1- and 3-years of follow up. RESULTS: Among 702 patients who underwent LEA, the mean (SD) age was 64.3 (12.6) years and 329 (46.6%) were fitted for prosthetic. The study population was mostly male (n=488, 69.5%), predominantly Non-Hispanic Black (n=410, 58.4%), and nearly one-fifth were non-ambulatory prior to LEA (n=139, 19.8%). Of note, 14.3% of all subjects who were non-ambulatory at some point after LEA, and 28.5% of patients not ambulatory preoperatively were eventually ambulatory after LEA. The rate of death among those fitted for a prosthetic was 12.0/100 person-years at 1 year and 5.8/100 person-years at 3 years of follow up and among those not fitted for a prosthetic, the rate of death was 55.7/100 person-years and 50.7/100 person-years at 1- and 3-years of follow up, respectively. After adjusting for several sociodemographic data points, comorbidities, pre- or post-COVID pandemic timeframe, and procedural factors, prosthetic fitting is associated with decreased likelihood of mortality within 1 year of follow-up (adjusted hazard ratio [aHR] 0.24; 95% CI, 0.14 - 0.40) as well as within 3 years (aHR 0.40; 95% CI, 0.29 - 0.55). CONCLUSIONS: Prosthetic fitting is associated with improved survival and preoperative functional status does not always predict postoperative functional status. Characterizing patient, surgical, and rehabilitation factors associated with receipt of prosthetic after LEA may improve long-term survival in these patients. Process measures employed by the VA, such as prosthetic department evaluation of all amputees, may represent a 'best practice'.

Factors associated with 90-day reintervention following lower extremity revascularization.

OBJECTIVE: Peripheral artery disease (PAD) represents a high-volume, high-cost burden on the health care system. The Centers for Medicare and Medicaid Services has developed the Bundled Payments for Care Improvement-Advanced program, in which a single payment is provided for all services administered in a postsurgical 90-day episode of care. Factors associated with 30- and 90-day reinterventions after PAD interventions would represent useful data for both payors and stake holders. METHODS: We conducted a national cohort study of adults 65 years and older in the Vascular Quality Initiative and Centers for Medicare and Medicaid Services-linked dataset who underwent an open, endovascular, or hybrid revascularization procedure for PAD between January 1, 2010, and December 31, 2018. Procedures for acute limb ischemia and aneurysms were excluded. The primary outcome was 90-day reintervention. Reintervention at 30 days was a secondary outcome. Covariates of interest included demographics, comorbidities, and patient- and facility-level characteristics. Multivariable Cox regression was used to determine the association between patient- and facility-level characteristics and the risk of 30- and 90-day reinterventions. RESULTS: Among 42,429 patients (71.3% endovascular, 23.3% open, and 5.4% hybrid), median age was 74 years (interquartile range, 69-80 years), 57.9% were male, and 84.3% were White. Chronic limb-threatening ischemia was the operative indication in 40.4% of the procedures. Overall, 42.8% were completed in the outpatient setting (40.3% outpatient, 2.5% office-based lab). Over 70% of procedures for chronic limb-threatening ischemia were completed as inpatient, whereas 60% of the claudication interventions were done as outpatient. The 90-day reintervention rate was 14.5%, and the 30-day reintervention rate was 5.5%. Compared with inpatient procedures, PAD interventions completed in the outpatient or office-based lab setting had significantly higher 90- and 30-day reintervention rates (reference, inpatient; outpatient 90-day reintervention: hazard ratio [HR], 1.41; 95% confidence interval [CI] 1.25-1.60; outpatient 30-day reintervention: HR, 1.90; 95% CI, 1.62-2.24; office-based lab 90-day reintervention: HR, 2.09; 95% CI, 1.82-2.41; office-based lab 30-day reintervention: HR, 3.54; 95% CI, 3.17-3.94). Open and hybrid approaches demonstrated lower risk of reintervention compared with endovascular procedures at 30 and 90 days and, compared with aortoiliac disease, all other anatomic segments of disease were associated with higher 90-day reintervention, but no difference was noted at 30 days. CONCLUSIONS: Although outpatient PAD interventions may be convenient for patients and providers, the outpatient setting is associated with a significant risk of subsequent reintervention. Additional work is needed to understand how to improve the longevity of outpatient PAD interventions.

Acute Type B Intramural Hematoma: Novel Insights in the Endovascular Era.

BACKGROUND: The pathophysiology and behavior of acute type B intramural hematoma (TBIMH) is poorly understood. The purpose of this study is to characterize the pathophysiology, fate, and outcomes of TBIMH in the endovascular era. METHODS: A retrospective analysis of a US Aortic Database identified 70 patients with TBIMH from 2008 to 2022. Patients were divided into groups and analyzed based upon subsequent management: early thoracic endovascular aortic repair (TEVAR; Group 1) or hospital discharge on optimal medical therapy (OMT) (Group 2). RESULTS: Of 70 total patients, 43% (30/70) underwent TEVAR (Group 1) and 57% (40/70) were discharged on OMT (Group 2). There were no significant differences in age, demographics, or comorbidities between groups. Indications for TEVAR in Group 1 were as follows: 1) Penetrating atheroscletoic ulcer (PAU) or ulcer-like projection (n = 26); 2) Descending thoracic aortic aneurysm (n = 3); or 3) Progression to type B aortic dissection (TBAD) (n = 2). Operative mortality was zero. No patient suffered a stroke or spinal cord ischemia. During the follow-up period, 50% (20/40) of Group 2 patients required delayed surgical intervention, including TEVAR in 14 patients and open repair in 6 patients. Indications for surgical intervention were as follows: 1) Development of a PAU / ulcer-like projection (n = 13); 2) Progression to TBAD (n = 3), or 3) Concomitant aneurysmal disease (n = 4). Twenty patients did not require surgical intervention. Of the initial cohort, 71% of patients required surgery, 9% progressed to TBAD, and 19% had regression or stability of TBIMH with OMT alone. CONCLUSIONS: The most common etiology of TBIMH is an intimal defect. Progression to TBAD and intramural hematoma regression without an intimal defect occurs in a small percentage of patients. An aggressive strategy with endovascular therapy and close surveillance for TBIMH results in excellent short-term and long-term outcomes.

Association between readmission care fragmentation and outcomes after interventions for peripheral arterial disease.

OBJECTIVE: Lower extremity revascularization (LER) for peripheral artery disease is complicated by the frequent need for readmission. However, it is unclear if readmission to a nonindex LER facility (ie, a facility different from the one where the LER was performed) compared with the index LER facility is associated with worse outcomes. METHODS: This was a national cohort study of older adults who underwent open, endovascular, or hybrid LER for peripheral artery disease (January 1, 2010, to December 31, 2018) in the Vascular Quality Initiative who were readmitted within 90 days of their vascular procedure. This dataset was linked to Medicare claims and the American Hospital Association Annual Survey. The primary outcome was 90-day mortality and the secondary outcome was major amputation at 90 days after LER. The primary exposure was the location of the first readmission after LER (categorized as occurring at the index LER facility vs a nonindex LER facility). Generalized estimating equations logistic regression models were used to assess the association between readmission location and 90-day mortality and amputation. RESULTS: Among 42,429 patients who underwent LER, 33.0% were readmitted within 90 days. Of those who were readmitted, 27.3% were readmitted to a nonindex LER facility, and 42.2% of all readmissions were associated with procedure-related complications. Compared with patients readmitted to the index LER facility, those readmitted to a nonindex facility had a lower proportion of procedure-related reasons for readmission (21.5% vs 50.1%; P < .001). Most of the patients readmitted to a nonindex LER facility lived further than 31 miles from the index LER facility (39.2% vs 19.6%; P < .001) and were readmitted to a facility with a total bed size of <250 (60.1% vs 11.9%; P < .001). Readmission to a nonindex LER facility was not associated with 90-day mortality or 90-day amputation. However, readmission for a procedure-related complication was associated with major amputation (90-day amputation: adjusted odds ratio, 3.33; 95% confidence interval, 2.89-3.82). CONCLUSIONS: Readmission after LER for a procedure-related complication is associated with subsequent amputation. This finding suggests that quality improvement efforts should focus on understanding various types of procedure-related failure after LER and its role in limb salvage.

Physician-Modified Endograft-Facilitated Transcatheter Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract.

BACKGROUND: Transcatheter pulmonary valve replacement (TPVR) in patients with a congenital or acquired abnormality resulting in enlarged right ventricular outflow tract (RVOT) is challenging and may preclude treatment with dedicated devices. We describe a technique using a physician-modified endograft to facilitate TPVR. METHODS: Six patients underwent physician-modified endograft-facilitated TPVR for severe symptomatic pulmonary insufficiency with enlarged RVOT. The fenestration was created in a commercially available endograft before implantation, which was then deployed from the dominant branch pulmonary artery into the RVOT, with the fenestration aligned with the ostium of the nondominant pulmonary artery. A covered stent was placed through the fenestration into the nondominant branch pulmonary artery, and a transcatheter heart valve was deployed within the endograft at the level of the original pulmonary valve. RESULTS: Four patients had tetralogy of Fallot, 1 had pulmonary atresia, and 1 had rheumatic valve disease. The RVOT/main pulmonary artery was severely enlarged (diameter, 44.2 [43.5-50.6] mm). All patients had reduced right ventricular (RV) function and dilated RVs (RV end-diastolic volume, 314 [235-316] mL). Successful endograft, covered stent, and transcatheter heart valve deployment were achieved in all cases without stent/valve embolization, vascular complications, or bleeding complications. At 30 days, 1 patient had mild pulmonary insufficiency, while others had none. The RV size measured by echocardiography was significantly reduced after TPVR (RV area, 34.4 [baseline] versus 29.0 [pre-discharge] versus 25.3 [30 days] cm2; P=0.03). During median follow-up of 221.5 (range, 29-652) days, there were no deaths or need for pulmonary valve reintervention. One patient developed severe tricuspid regurgitation due to entrapment of the anterior tricuspid leaflet by the endograft. The patient underwent successful tricuspid replacement and resection of the offending endograft with preservation of the pulmonary valve prosthesis. CONCLUSIONS: Simple fenestration of an off-the-shelf endograft and associated covered stent placement through the fenestration allows TPVR for patients with dysfunctional native or patch-repaired pulmonary valves and RVOT enlargement.

Early Results of Thoracic Endovascular Aortic Repair for the Management of Acute Uncomplicated Type B Aortic Dissection.

Historically, optimal medical therapy (OMT) has been the primary therapy for acute uncomplicated type B aortic dissection (auTBAD). However, recent data suggest that OMT provides poor long-term results, and aortic remodeling induced by thoracic endovascular aortic repair (TEVAR) may improve survival. This study compares adverse events and survival among auTBAD patients receiving either TEVAR or OMT. A retrospective analysis identified 146 consecutive auTBAD patients presenting to a single institution between 1/2012 and 10/2020. Patients were divided into 2 groups based upon whether they received TEVAR (n = 50) or OMT (n = 96) at index hospitalization. Major morbidity and survival were compared between groups. 67.1% of patients presented with a Debakey IIIB dissection with maximum thoracic aortic diameter of 4.3 ± 1.0 cm. Over follow-up, 35% of OMT patients failed medical therapy and underwent intervention (n = 23 TEVAR, n = 11 open). An additional 13 died for an all-cause failure rate of 49%. The composite incidence of renal failure, stroke, spinal cord ischemia, and retrograde type A dissections was similar between groups (TEVAR:6.0% vs OMT:4.2%). In-hospital mortality was 0%. Kaplan-Meier analysis demonstrated a trend towards improved survival among the TEVAR group at 1 and 3 years but no difference in overall survival (HR:0.30, 95% CI:0.08-1.08, P = 0.066). Five-year survival was 91% with TEVAR and 82% with OMT. Complete false lumen thrombosis was achieved in 72.1% with TEVAR and 20.0% with OMT (P < 0.001). In experienced centers, there is equivalent early mortality in the treatment of auTBAD with TEVAR compared to OMT. TEVAR provides superior aortic remodeling to OMT in auTBAD, which may translate into improved long-term survival.

Female gender is associated with increased late luminal narrowing within the stent graft after thoracic endovascular aortic repair.

BACKGROUND: Luminal narrowing, suspected secondary to thrombus, occurs within stent grafts at an unclear incidence after thoracic endovascular aortic repair (TEVAR). The significance of this phenomenon has not been determined, nor have the risk factors for development of intragraft luminal narrowing. Small graft diameter is hypothesized to be a risk factor for the development of ingraft stenosis. METHODS: A retrospective analysis was performed of a multicenter healthcare system including all patients who underwent TEVAR between July 2011 and July 2019 with at least 1 year of subsequently available surveillance contrast-enhanced computed tomography imaging. Standard demographic, preoperative, intraoperative, and postoperative variables were collected. Measurements were obtained via direct off-line images from computed tomography scans. Patent intragraft diameters were compared with baseline and interval change values were normalized to time to follow-up. The primary outcome measure was annual rate of intragraft luminal narrowing. RESULTS: There were 208 patients who met the inclusion criteria (94 women, 114 men) with a median follow-up of 822 days. The mean annual rate of percent intragraft diameter reduction was 10.5 ± 7.7% for women and 7.6 ± 5.6% for men (P = .0026). Multivariate analysis demonstrated female gender (P = .0283), preoperative diagnosis of hypertension (P = .0449), and need for coverage of the left subclavian artery (P = .0328) were all significant predictors of intragraft luminal narrowing. Small aortic diameters were not found to be associated independently with ingraft luminal narrowing nor was the concomitant use of antiplatelet or anticoagulation medications. Significant amounts of ingraft luminal narrowing, defined as a greater than 20% intragraft diameter decrease, were associated with an increased need for any reintervention, including for malperfusion, endoleak, and symptomatic aneurysm (P = .0249). Kaplan-Meier estimates demonstrated a significant gender-associated difference in high rates of intragraft luminal narrowing (P = .00189). CONCLUSIONS: In this analysis, female gender is shown to be a significant nonmodifiable risk factor for intragraft luminal narrowing after TEVAR. The development of this phenomenon is not benign; as such, these findings were associated with an increased need for reintervention. This finding may be attributable to differences in aortic compliance or gender-associated differences in coagulation pathways and merits further investigation. Surveillance after thoracic stent grafting must account for patient-specific variations in complication risk.

COVID-19-associated venous thromboembolism portends worse survival.

Patients with coronavirus disease 2019 (COVID-19) seem to be at high risk for venous thromboembolism (VTE) development, but there is a paucity of data exploring both the natural history of COVID-19-associated VTE and the risk for poor outcomes after VTE development. This investigation aims to explore the relationship between COVID-19-associated VTE development and mortality. A prospectively maintained registry of patients older than 18 years admitted for COVID-19-related illnesses within an academic health care network between March and September 2020 was reviewed. Codes from the tenth revision of the International Classification of Diseases for VTE were collected. The charts of those patients with a code for VTE were manually reviewed to confirm VTE diagnosis. There were 2,552 patients admitted with COVID-19-related illnesses. One hundred and twenty-six patients (4.9%) developed a VTE. A disproportionate percentage of patients of Black race developed a VTE (70.9% VTE v 57.8% non-VTE; P = .012). A higher proportion of patients with VTE expired during their index hospitalization (22.8% VTE v 8.4% non-VTE; P < .001). On multivariable logistic regression analysis, VTE was independently associated with mortality (odds ratio = 3.17; 95% confidence interval, 1.9-5.2; P < .001). Hispanic/Latinx ethnicity was associated with decreased mortality (odds ratio = 0.45; 95% confidence interval, 0.21-1.00; P = .049). Hospitalized patients of Black race with COVID-19 were more prone to VTE development, and patients with COVID-19 who developed in-hospital VTE had roughly nearly threefold higher odds of mortality. Further emphasis should be placed on optimizing COVID-19 anticoagulation protocols to reduce mortality in this high-risk cohort.

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

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

Left renal vein nutcracker syndrome and concurrent IVC duplication: Surgical treatment.

Multiple vascular anomalies may be encountered in patients with nutcracker syndrome; further compounding the surgical complexity in managing this condition. A 28-year-old male presented with persistent flank pain and hematuria. Imaging revealed narrowing of the left renal vein at the aortomesenteric junction, and a dilated vein consistent with the left gonadal vein. On surgical exploration, a duplicated IVC was found. The patient underwent a right caval-to-left caval bypass using a cryopreserved femoral vein homograft. The surgery was well tolerated and completely resolved the patient's symptoms.

Stent Graft Oversizing is Associated with an Increased Risk of Long-Term Left Ventricular Wall Thickening in Young Patients Following Thoracic Endovascular Aortic Repair.

BACKGROUND: Left ventricular (LV) wall thickening occurs in patients following thoracic endovascular aortic repair (TEVAR). Clinical consequences of cardiovascular (CV) remodeling may be more significant younger patients with longer anticipated life spans. Risk factors for CV remodeling following TEVAR are unknown but may be related to graft size. METHODS: A retrospective analysis was performed of a multicenter healthcare system including patients aged ≤60 who underwent TEVAR between 2011 and 2019 with at least 1 year follow-up computed tomography angiography imaging available. Standard perioperative variables, native aortic diameter, and stent graft specifications were collected. Graft oversizing was calculated by dividing proximal graft diameter by proximal aortic diameter on preoperative imaging. Posterior LV wall thickness was measured at baseline and interval increases were normalized to time-to-follow-up. Primary outcome was annual rate of posterior LV wall thickening. RESULTS: One hundred one patients met inclusion criteria with a mean (SD) follow-up time of 1270 (693) days. Overall mean (SD) rate of LV wall thickness change was 0.534 (0.750) mm per year. Mean (SD) absolute LV wall thickness at most recent follow-up was 10.97 (2.85) mm for men, 9.69 (2.03) mm for women. Multivariate analysis demonstrated that higher rates of LV wall thickening were associated with narrower graft diameters (P = 0.0311). Greater absolute LV wall thickness at follow-up was associated with narrower grafts (P= 0.0155) and greater graft oversizing (P= 0.0376). Logistic regression demonstrated individuals who met criteria for LV hypertrophy were more likely to have narrower stent-grafts (P= 0.00798) and greater graft oversizing (P= 0.0315). CONCLUSIONS: LV wall thickening occurred to a greater degree in individuals with narrower stent-grafts and higher rates of graft oversizing. This has significant implications for long-term cardiovascular health in younger patients may undergo TEVAR for atypical indications. Particular attention should be paid to long-term effects of stent-graft oversizing when selecting grafts in such populations.

Influence of baseline kidney dysfunction on perioperative renal outcomes after endovascular aneurysm repair with suprarenal fixation.

BACKGROUND: Conflicting evidence exists regarding the comparative effects of endovascular aneurysm repair (EVAR) with and without suprarenal fixation. We compare outcomes in patients treated by EVAR with baseline normal kidney function and moderate and severe chronic kidney disease. METHODS: Patients with normal kidney function (glomerular filtration rate [GFR] ≥60 mL/min/1.73 m2) or moderate (GFR = 30-59 mL/min/1.73 m2) or severe (GFR <30 mL/min/1.73 m2) kidney disease who underwent EVAR (N = 5534) were identified from the American College of Surgeons National Surgical Quality Improvement Program targeted database (2011-2015). Groups were determined by the presence (Cook Zenith [Cook Medical, Bloomington, Ind] or Medtronic Endurant [Medtronic, Minneapolis, Minn]) or absence (Gore Excluder [W. L. Gore & Associates, Flagstaff, Ariz]) of a suprarenal fixation system. Postoperative renal complications, defined as rise in creatinine concentration of >2 mg/dL without dialysis or new dialysis requirements, were analyzed within the first 30 days with results stratified by degree of kidney disease. RESULTS: A total of 5534 patients underwent EVAR, with 3225 (58.3%) receiving a device using a suprarenal fixation system. Suprarenal fixation systems were less commonly used for symptomatic patients (11.0% vs 13.7%; P = .002) and patients with ruptured abdominal aortic aneurysm (4.5% vs 6.3%; P = .01). There was no difference in baseline kidney function between groups. EVAR with suprarenal fixation was associated with more renal complications (1.40% vs 0.65%; P = .008). In subgroup analysis, patients with moderate kidney dysfunction (n = 1780) had more renal complications (2.2% vs 0.8%; P = .02) with suprarenal fixation systems. No differences were seen in patients with normal kidney function (0.4% vs 0.2%; P = .32; n = 3597) or severe kidney dysfunction (14.3% vs 10.2%; P = .45; n = 157). This difference was driven mostly by postoperative elevation of creatinine concentration (0.6% vs 0.2%; P = .03) without requirements for new dialysis (0.8% vs 0.4%; P = .08). After adjustments with multivariate logistic regression models, EVAR with suprarenal fixation was associated with more renal complications (odds ratio, 2.65; 95% confidence interval, 1.32-5.34). CONCLUSIONS: In our study, EVAR with suprarenal fixation devices was associated with more perioperative renal complications in patients with moderate kidney dysfunction. Long-term evaluation of these patients undergoing EVAR should be considered.

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.

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.

Vacuum-assisted extraction of ilio-caval and right heart masses: A 5-year single center experience.

PURPOSE: Despite paucity of data, there exists growing popularity of catheter-based extraction methods for intravascular thrombi and vegetations. We describe a large single center experience with vacuum-assisted extraction techniques (VAET) for right-sided intravascular and cardiac masses. METHODS: We retrospectively reviewed the perioperative course of patients undergoing VAET between 2014 and 2019. Primary outcomes were survival and freedom from recurrent bacteremia. Procedural success was a composite definition of survival, majority of mass extraction, absence of recurrent bacteremia, and valve function not requiring further intervention during index hospitalization. RESULTS: Of the entire cohort (n = 58), 48% and 52% underwent VAET for vegetations and sterile thrombi, respectively. Of those with positive cultures, the most common organism isolated was Staphylococcus aureus (48%). Preoperative active bacteremia was present in 36% (21/58) and of these patients, 76% (16/21) had neither recurrent nor persistent bacteremia post-op. The majority of masses (67%, 38/58) were debulked with an average reduction in size of 42%. Conversion to open surgery occurred in 3.5% (2/58). Intraoperative and 30-day survival were 98% (57/58) and 90% (28/31), respectively. Overall success was 86% (50/58). The prevalence of moderate/severe tricuspid regurgitation was 37% pre-op and 61% post-op. Average length of intensive care unit and overall hospital stay was 5.6 and 16 days, respectively. CONCLUSIONS: In this single center experience, VAET was conducted safely with a high degree of success and freedom from short-term recurrent bacteremia. This minimally invasive procedure is an attractive alternative to traditional open techniques for removal of right-sided intravascular and cardiac masses.

Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.

BACKGROUND: Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. METHODS: We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 µg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. CONCLUSION: GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.

The Safety and Efficacy of Extended TEVAR in Acute Type B Aortic Dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) with endograft coverage from the left subclavian artery to the celiac artery has been hypothesized to increase spinal cord ischemia. This study analyzes the impact of extended coverage on adverse outcomes and aortic remodeling in patients with complicated acute type B aortic dissection (aTBAD). METHODS: From January 2012 to October 2018, 91 patients underwent TEVAR for aTBAD. Median follow-up was 3.1 (interquartile range, 1.2-4.9) years and was complete in 94% of patients. The extent of aortic endograft coverage was categorized as standard (n = 39) or extended (n = 52). Contrast-enhanced imaging scans were analyzed to determine length of coverage, maximum aortic diameters, and false lumen (FL) status. RESULTS: The mean age was 52.6 ± 13.9 years, and 66% were men. The most common indications for intervention were malperfusion (42%) and refractory pain (34%). Thirteen (14%) patients required a lumbar drain (preoperative: n = 3; postoperative: n = 10). Mean duration between scans was 2.0 ± 1.9 years. Length of aortic coverage was significantly longer in the extended group (241.7 ± 29.2 mm vs 180.8 ± 22.3 mm in the standard group; P < .001). In-hospital and overall mortality were 6% and 11%, respectively. There were no cases of paraplegia, and the incidence of spinal cord ischemia was 3%. After TEVAR, there was a higher incidence of FL obliteration or thrombosis at the distal descending thoracic aorta in the extended group (53% vs 16% in the standard group; P = .004). CONCLUSIONS: Extended TEVAR carries a low risk of spinal cord ischemia and improves FL remodeling of the descending thoracic aorta in patients with aTBAD. This strategy may decrease the need for reinterventions on the thoracic aorta in the chronic phase of TBAD.