A dedicated risk prediction model of 1-year mortality following endovascular aortic aneurysm repair involving the renal-mesenteric arteries.

OBJECTIVE: Treatment goals of prophylactic endovascular aortic repair of complex aneurysms involving the renal-mesenteric arteries (complex endovascular aortic repair [cEVAR]) include achieving both technical success and long-term survival benefit. Mortality within the first year after cEVAR likely indicates treatment failure owing to associated costs and procedural complexity. Notably, no validated clinical decision aid tools exist that reliably predict mortality after cEVAR. The purpose of this study was to derive and validate a preoperative prediction model of 1-year mortality after elective cEVAR. METHODS: All elective cEVARs including fenestrated, branched, and/or chimney procedures for aortic disease extent confined proximally to Ishimaru landing zones 6 to 9 in the Society for Vascular Surgery Vascular Quality Initiative were identified (January 2012 to August 2023). Patients (n = 4053) were randomly divided into training (n = 3039) and validation (n = 1014) datasets. A logistic regression model for 1-year mortality was created and internally validated by bootstrapping the AUC and calibration intercept and slope, and by using the model to predict 1-year mortality in the validation dataset. Independent predictors were assigned an integer score, based on model beta-coefficients, to generate a simplified scoring system to categorize patient risk. RESULTS: The overall crude 1-year mortality rate after elective cEVAR was 11.3% (n = 456/4053). Independent preoperative predictors of 1-year mortality included chronic obstructive pulmonary disease, chronic renal insufficiency (creatinine >1.8 mg/dL or dialysis dependence), hemoglobin <12 g/dL, decreasing body mass index, congestive heart failure, increasing age, American Society of Anesthesiologists class ≥IV, current tobacco use, history of peripheral vascular intervention, and increasing extent of aortic disease. The 1-year mortality rate varied from 4% among the 23% of patients classified as low risk to 23% for the 24% classified as high risk. Performance of the model in validation was comparable with performance in the training data. The internally validated scoring system classified patients roughly into quartiles of risk (low, low/medium, medium/high and high), with 52% of patients categorized as medium/high to high risk, which had corresponding 1-year mortality rates of 11% and 23%, respectively. Aneurysm diameter was below Society for Vascular Surgery recommended treatment thresholds (<5.0 cm in females, <5.5 cm in males) in 17% of patients (n = 679/3961), 41% of whom were categorized as medium/high or high risk. This subgroup had significantly increased in-hospital complication rates (18% vs 12%; P = .02) and 1-year mortality (13% vs 5%; P < .0001) compared with patients in the low- or low/medium-risk groups with guideline-compliant aneurysm diameters (≥5.0 cm in females, ≥5.5 cm in males). CONCLUSIONS: This validated preoperative prediction model for 1-year mortality after cEVAR incorporates physiological, functional, and anatomical variables. This novel and simplified scoring system can effectively discriminate mortality risk and, when applied prospectively, may facilitate improved preoperative decision-making, complex aneurysm care delivery, and resource allocation.

Current Medicare reimbursement for complex endovascular aortic repair is inadequate based on results from a multi-institutional cost analysis.

OBJECTIVE: Complex endovascular juxta-, para- and suprarenal abdominal aortic aneurysm repair (comEVAR) is frequently accomplished with commercially available fenestrated (FEVAR) devices or off-label use of aortoiliac devices with parallel branch stents (chEVAR). We sought to evaluate the implantable vascular device costs incurred with these procedures as compared with standard Medicare reimbursement to determine the financial viability of comEVAR in the modern era. METHODS: Five geographically distinct institutions with high-volume, complex aortic centers were included. Implantable aortoiliac and branch stent device cost data from 25 consecutive, recent, comEVAR in the treatment of juxta-, para-, and suprarenal aortic aneurysms at each center were analyzed. Cases of rupture, thoracic aneurysms, reinterventions, and physician-modified EVAR were excluded, as were ancillary costs from nonimplantable equipment. Data from all institutions were combined and stratified into an overall cost group and two, individual cost groups: FEVAR or chEVAR. These groups were compared, and each respective group was then compared with weighted Medicare reimbursement for Diagnosis-Related Group codes 268/269. Median device costs were obtained from an independent purchasing consortium of >3000 medical centers, yielding true median cost-to-institution data rather than speculative, administrative projections or estimates. RESULTS: A total of 125 cases were analyzed: 70 FEVAR and 53 chEVAR. Two cases of combined FEVAR/chEVAR were included in total cost analysis, but excluded from direct FEVAR vs chEVAR comparison. Median Medicare reimbursement was calculated as $35,755 per case. Combined average implantable device cost for all analyzed cases was $28,470 per case, or 80% of the median reimbursement ($28,470/$35,755). Average FEVAR device cost per case ($26,499) was significantly lower than average chEVAR cost per case ($32,122; P < .002). Device cost was 74% ($26,499/$35,755) of total reimbursement for FEVAR and 90% ($32,122/$35,755) for chEVAR. CONCLUSIONS: Results from this multi-institutional analysis show that implantable device cost alone represents the vast majority of weighted total Medicare reimbursement per case with comEVAR, and that chEVAR is significantly more costly than FEVAR. Inadequate Medicare reimbursement for these cases puts high-volume, high-complexity aortic centers at a distinct financial disadvantage. In the interest of optimizing patient care, these data suggest a reconsideration of previously established, outdated, Diagnosis-Related Group coding and Medicare reimbursement for comEVAR.

One-hundred Consecutive Physician-Modified Fenestrated Endovascular Aneurysm Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using the Terumo TREO Stent Graft.

BACKGROUND: Fenestrated endovascular aortic aneurysm repair (FEVAR) has been widely applied for the treatment of pararenal (PAA) and thoracoabdominal aortic aneurysms (TAAA). If custom-made devices or off-the-shelf devices are not available, physician-modified endografts (PMEGs) are an alternative device option. Several different endograft platforms have been used for PMEG; however, minimal data exists on utilizing the Terumo TREO abdominal stent graft system in this setting. The purpose of this study was to evaluate our single-center experience treating PAA and TAAA, with a physician-modified FEVAR, using the Terumo TREO platform. METHODS: A prospective database of consecutive patients with PAA and TAAA treated at a single center, with a FEVAR, utilizing a PMEG device between March 2021 and September 2023 was queried for those having a Terumo TREO device implanted. The demographics, operative details, and postoperative complications were analyzed. The rates of technical success, type I or III endoleak, branch vessel status, reintervention, and 2-year survival were also assessed. RESULTS: Of the 153 patients who underwent FEVAR with a PMEG device during the study period, 100 had repair using a Terumo TREO stent graft. The mean age of the cohort was 73.7 ± 7.0 years with the majority suffering from hypertension (n = 94, 94%), coronary artery disease (n = 51, 51%), and chronic obstructive pulmonary disease (n = 40, 40%). Thirty-four patients (34%) had a prior failed EVAR device in place. The mean aneurysm size was 66.0 ± 13.7 mm, with 58 (50%) patients classified as PAA and 30 (30%) patients as an extent IV TAAA. Six (6%) patients presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8 ± 0.6. The overall technical success was 99%, procedure time was 218 ± 116 min, contrast volume was 82 ± 21 mL, and cumulative air kerma was 3,054 ± 1,560 mGy. Postoperative complications were present in 20 patients (20%), and 2 patients (2%) died within 30 days. Rates of type I or III endoleak, branch vessel stenosis or occlusion, and reintervention were 2%, 1%, and 7%, respectively. The two-year overall survival was 87%. CONCLUSIONS: Treatment of PAA and the extent IV TAAA using a physician-modified fenestrated Terumo TREO endograft is safe and effective. This large, early experience using the Terumo TREO platform supports preferential use of this device in this setting due to the device design and low likelihood of type I or III endoleak.

Comparative outcomes of physician-modified fenestrated/branched endovascular aortic aneurysm repair in the setting of prior failed endovascular aneurysm repair.

OBJECTIVE: Endovascular treatment of aortic aneurysms involving renal-mesenteric arteries, especially in the setting of prior failed endovascular aneurysm repair (EVAR) typically requires fenestrated/branched endovascular aneurysm repair (F/BEVAR) with a custom-made device (CMD). CMDs are limited to select centers, and physician-modified endografts are an alternative treatment platform. Currently, there is no data on the outcomes of physician-modified F/BEVAR (PM-F/BEVAR) in the setting of failed prior EVAR. The purpose of this study was to evaluate the use of PM-F/BEVAR in patients with prior failed EVAR. METHODS: A prospective database of consecutive patients treated at a single center with PM-F/BEVAR between March 2021 and November 2022 was retrospectively reviewed. The cohort was stratified by presence of a failed EVAR (type Ia endoleak or aneurysm development proximal to a prior EVAR) prior to PM-F/BEVAR. Demographics, operative details, and postoperative complications were compared between the groups using univariate analysis. One-year survival and freedom from reintervention were compared using the Kaplan-Meier method. RESULTS: A total of 103 patients underwent PM-F/BEVAR during the study period; 27 (26%) were in the setting of prior EVAR. Patients with prior failed EVAR had similar age (75.2 ± 7.7 vs 71.5 ± 8.8 years; P = .058), male gender (n = 24 ; 89% vs n = 57 ; 75%; P = .130), and comorbid conditions except higher incidence of moderate-to-severe chronic obstructive pulmonary disease (n = 7 ; 26% vs n = 7 ; 9%; P = .047). Overall, aneurysm diameter was 65.5 ± 13.9 mm with aneurysms categorized as juxta-/pararenal in 43% and thoracoabdominal in 57%, with no differences between the groups. Twelve patients (14%) presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8. Four different aortic devices were modified with a greater proportion of Terumo TREO devices used in the failed EVAR group (P = .03). There was no difference in procedure time, radiation dose, or iodinated contrast use between groups. Overall technical success was 99%. Rates of 30-day mortality (n = 0 ; 0% vs n = 3 ; 4%; P = .565) and major adverse events (n = 6 ; 22% vs n = 16 ; 21%; P = 1.0) were similar between groups. For the overall cohort, rates of type 1 or 3 endoleak, branch vessel stenosis/occlusion, and reintervention were 2%, 1%, and 8%, respectively, with no difference between groups. One-year survival (failed EVAR 94% vs no EVAR 82%; P = .756) was similar between groups. CONCLUSIONS: PM-F/BEVAR is a safe and effective treatment for patients with aneurysms involving the renal-mesenteric arteries in the setting of prior failed EVAR where additional technical challenges may be present. Additional follow-up is warranted to demonstrate long-term efficacy, but early results are encouraging and similar to those using CMDs.

Contact Cooling of Random-Pattern Cutaneous Flaps: Does it Increase Necrosis?

BACKGROUND: Cooling after surgery reduces pain, swelling and ecchymosis. However, the fear of adverse effects of vasoconstriction caused by cooling may prevent its use when the skin is undermined extensively, for example, after rhytidectomy. The purpose of this study is to determine whether the contact cooling of random-pattern skin flaps increases the area of necrosis observed. METHODS: Twenty-eight random-pattern skin flaps (4 × 10 cm) were raised on four pigs. Flaps were divided into three groups: control, intermittently cooled and continuously cooled. Pads connected to a ThermaZone cooling device delivered local hypothermia in the range of 4-6 °C for 24 h postoperatively. ImageJ software was used to calculate the area of necrosis on each flap on postoperative day 7, confirmed with histological analysis. RESULTS: The average areas of necrosis observed were as follows: control (17.61 cm2; SD 5.23), intermittent cooling (15.65 cm2; SD 3.76) and continuous cooling (14.16 cm2; SD 3.91). An ANOVA revealed no statistically significant differences between the three interventions (p = 0.35). CONCLUSIONS: Postoperative continuous or intermittent cooling does not increase the area of necrosis in random-pattern flaps. In fact, a trend was observed, demonstrating decreasing area of necrosis with increased periods of hypothermia. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors. www.springer.com/00266 .