Hypertension during transfer is associated with poor outcomes in unstable patients with ruptured abdominal aortic aneurysm.

OBJECTIVE: Limited data exist for optimal blood pressure (BP) management during transfer of patients with ruptured abdominal aortic aneurysm (rAAA). This study evaluates the effects of hypertension and severe hypotension during interhospital transfers in a cohort of patients with rAAA in hemorrhagic shock. METHODS: We performed a retrospective, single-institution review of patients with rAAA transferred via air ambulance to a quaternary referral center for repair (2003-2019). Vitals were recorded every 5 minutes in transit. Hypertension was defined as a systolic BP of ≥140 mm Hg. The primary cohort included patients with rAAA with hemorrhagic shock (≥1 episode of a systolic BP of <90 mm Hg) during transfer. The primary analysis compared those who experienced any hypertensive episode to those who did not. A secondary analysis evaluated those with either hypertension or severe hypotension <70 mm Hg. The primary outcome was 30-day mortality. RESULTS: Detailed BP data were available for 271 patients, of which 125 (46.1%) had evidence of hemorrhagic shock. The mean age was 74.2 ± 9.1 years, 93 (74.4%) were male, and the median total transport time from helicopter dispatch to arrival at the treatment facility was 65 minutes (interquartile range, 46-79 minutes). Among the cohort with shock, 26.4% (n = 33) had at least one episode of hypertension. There were no significant differences in age, sex, comorbidities, AAA repair type, AAA anatomic location, fluid resuscitation volume, blood transfusion volume, or vasopressor administration between the hypertensive and nonhypertensive groups. Patients with hypertension more frequently received prehospital antihypertensives (15% vs 2%; P = .01) and pain medication (64% vs 24%; P < .001), and had longer transit times (36.3 minutes vs 26.0 minutes; P = .006). Episodes of hypertension were associated with significantly increased 30-day mortality on multivariable logistic regression (adjusted odds ratio [aOR], 4.71; 95% confidence interval [CI], 1.54-14.39; P = .007; 59.4% [n = 19] vs 40.2% [n = 37]; P = .01). Severe hypotension (46%; n = 57) was also associated with higher 30-day mortality (aOR, 2.82; 95% CI, 1.27-6.28; P = .01; 60% [n = 34] vs 32% [n = 22]; P = .01). Those with either hypertension or severe hypotension (54%; n = 66) also had an increased odds of mortality (aOR, 2.95; 95% CI, 1.08-8.11; P = .04; 58% [n = 38] vs 31% [n = 18]; P < .01). Level of hypertension, BP fluctuation, and timing of hypertension were not significantly associated with mortality. CONCLUSIONS: Hypertensive and severely hypotensive episodes during interhospital transfer were independently associated with increased 30-day mortality in patients with rAAA with shock. Hypertension should be avoided in these patients, but permissive hypotension approaches should also maintain systolic BPs above 70 mm Hg whenever possible.

Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

A Comparison of Surgical Techniques and Outcomes for Primary Infected Abdominal Aortic Aneurysms.

BACKGROUND: Primary infected abdominal aortic aneurysms (PIAAAs) are associated with high morbidity and mortality. Three repair approaches include open in-situ repair (OIR), extra-anatomic repair (EAR), and endovascular abdominal aortic aneurysm repair (EVAR). This study is one of the largest single-center case series comparing the outcomes of the different surgical approaches for PIAAA. METHODS: This is a retrospective cohort study of all patients treated surgically for PIAAA between 2000 and 2021. PIAAA diagnosis was defined as the presence of an abdominal aortic aneurysm with evidence of infection on clinical presentation, laboratory markers, radiology, or surgically. Patients with prior aortic surgery were excluded from this study. Basic demographics were compared across the 3 surgical groups using standard statistical methods. Our primary outcomes included mortality at 1 and 5 years. Kaplan-Meier curves were generated and compared using log-rank testing. Multivariate Cox proportional hazards models were created to assess determinants of mortality. RESULTS: A total of 43 patients were included in the full cohort. Patients undergoing EVAR more often had diabetes, end-stage renal disease, and coronary artery disease. EVAR was also more often done in patients with a saccular aneurysm rather than fusiform. (93% vs. 70% in EAR and 42% in OIR; P = 0.015). All-cause mortality rates at 1 year were not significantly different between the 3 groups. Survival at 5 years did show a significant benefit of OIR over EVAR and EAR: OIR had an 8% mortality rate with EAR having a 53% rate and EVAR having the highest (72%) mortality rate at 5 years (P = 0.03). Multivariable Cox regression analysis showed that EVAR (aHR 12.1, (95% CI 1.42 to 103.9), P = 0.02) and EAR (aHR 15.1, (95% CI 1.59 to 143.3), P = 0.0.02) had an increased 5-year mortality risk when compared to OIR. CONCLUSIONS: Repair of primary infected aortic aneurysm is associated with high complication and mortality rates regardless of the approach. In our studied sample, OIR offered an improved long-term survival without added benefits in terms of complication rates. In infected AAA, EVAR should be considered bridging stage between the urgent situation and eventual open repair.

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

Characterization of multiple organ failure after ruptured abdominal aortic aneurysm repair.

BACKGROUND: Multiple organ failure (MOF) is associated with poor outcomes and increased mortality in sepsis and trauma. There are limited data regarding MOF in patients after ruptured abdominal aortic aneurysm (rAAA) repair. We aimed to identify the contemporary prevalence and characteristics of patients with rAAA with MOF. METHODS: We retrospectively reviewed patients with rAAA who underwent repair (2010-2020) at our multihospital institution. Patients who died within the first 2 days after repair were excluded. MOF was quantified by modified (excluding hepatic system) Denver, Sequential Organ Failure Assessment (SOFA) score, and Multiple Organ Dysfunction Score (MODS) for postoperative days 3 to 5 to determine the prevalence of MOF. MOF was defined as a Denver score of >3, dysfunction in two or more organ systems by SOFA score, or a MODS score of >8. Kaplan-Meier curves and log-rank testing were used to evaluate differences in 30-day mortality between multiple organ failure and patients without MOF. Logistic regression was used to assess predictors of MOF. RESULTS: Of 370 patients with rAAA, 288 survived past two days (mean age, 73±10.1 years; 76.7% male; 44.1% open repair), and 143 had data for MOF calculation recorded. From postoperative days 3 to 5, 41 (14.24%) had MOF by Denver, 26 (9.03%) by SOFA, and 39 (13.54%) by MODS criteria. Among these scoring systems, pulmonary and neurological systems were impacted most commonly. Among patients with MOF, pulmonary derangement occurred in 65.9% (Denver), 57.7% (SOFA), and 56.4% (MODS). Similarly, neurological derangement occurred in 92.3% (SOFA) and 89.7% (MODS), but renal derangement occurred in 26.8% (Denver), 23.1% (SOFA), and 10.3% (MODS). MOF by all three scoring systems was associated with increased 30-day mortality (Denver: 11.3% vs 41.5% [P < .01]; DOFA: 12.6% vs 46.2% [P < .01]; MODS: 12.5% vs 35.9% [P < .01]), as was MOF by any criteria (10.8% vs 35.7 %; P < .01). Patients with MOF were more likely to have a higher body mass index (55.9±26.6 vs 49.0±15.0; P = .011) and to have had a preoperative stroke (17.9% vs 6.0%; P = .016). Patients with MOF were less likely to have undergone endovascular repair (30.4% vs 62.1%; P < .001). Endovascular repair was protective against MOF (any criteria) on multivariate analysis (odds ratio, 0.23; 95% confidence interval, 0.08-0.64; P = .019) after adjusting for age, gender, and presenting systolic blood pressure. CONCLUSIONS: MOF occurred in only 9% to 14% of patients after rAAA repair, but was associated with a three-fold increase in mortality. Endovascular repair was associated with a reduced MOF incidence.

COVID-associated acute limb ischemia during the Delta surge and the effect of vaccines.

OBJECTIVE: Hypercoagulability is common in severe acute respiratory syndrome coronavirus 2 and has been associated with arterial thrombosis leading to acute limb ischemia (ALI). Our objective was to determine the outcomes of concurrent coronavirus disease 2019 (COVID-19) infection and ALI, particularly during the Delta variant surge and the impact of vaccination status. METHODS: A retrospective review was performed of patients treated at a single health care system between March 2020 and December 2021 for ALI and recent (<14 days) COVID-19 infection or who developed ALI during hospitalization for the same disease. Patients were grouped by year as well as by pre and post Delta variant emergence in 2021 based on the World Health Organization timeline (January to May vs June to December). Baseline demographics, imaging, interventions, and outcomes were evaluated. A control cohort of all patients with ALI requiring surgical intervention for a 2-year period prior to the pandemic was used for comparison. Primary outcomes were in-hospital mortality and amputation-free survival. Kaplan-Meier survival and Cox proportional hazards analysis were performed. RESULTS: Forty acutely ischemic limbs were identified in 36 patients with COVID-19, the majority during the Delta surge (52.8%) and after the wide availability of vaccines. The rate of COVID-19-associated ALI, although low overall, nearly doubled during the Delta surge (0.37% vs 0.20%; P = .09). Intervention (open or endovascular revascularization vs primary amputation) was performed on 31 limbs in 28 individuals, with the remaining eight treated with systemic anti-coagulation. Postoperative mortality was 48%, and overall mortality was 50%. Major amputation following revascularization was significantly higher with COVID-19 ALI (25% vs 3%; P = .006) compared with the pre-pandemic group. Thirty-day amputation-free survival was significantly lower (log-rank P < .001). COVID-19 infection (adjusted hazard ratio, 6.2; P < .001) and age (hazard ratio, 1.1; P = .006) were associated with 30-day amputation in multivariate analysis. Severity of COVID-19 infection, defined as vasopressor usage, was not associated with post-revascularization amputation. There was a higher incidence of re-thrombosis in the latter half of 2021 with the Delta surge, as reintervention for recurrent ischemia of the same limb was more common than our previous experience (21% vs 0%; P = .55). COVID-19-associated limb ischemia occurred almost exclusively in non-vaccinated patients (92%). CONCLUSIONS: ALI observed with Delta appears more resistant to standard therapy. Unvaccinated status correlated highly with ALI occurrence in the setting of COVID-19 infection. Information of limb loss as a COVID-19 complication among non-vaccinated patients may help to increase compliance.

Characterization of immediate and early mortality after repair of ruptured abdominal aortic aneurysm.

BACKGROUND: We sought to compare immediate and early mortality among patients undergoing ruptured abdominal aortic aneurysm (RAAA) repair. Evaluation of RAAA has focused on 30-day postoperative mortality. Other emergency conditions such as trauma have demonstrated a multimodal mortality distribution within the 30-day window, expanding the pathophysiologic understanding and allowing for intervention investigations with practice changing and lifesaving results. However, the temporal distribution and risk factors of postoperative morbidity and mortality in RAAA have yet to be investigated. METHODS: We evaluated factors associated with RAAA postoperative mortality in immediate (<1 day) and early (1-30 days) postoperative periods in a landmarked retrospective cohort study using data from the Vascular Quality Initiative (2010-2020). RESULTS: We identified 5157 RAAA repairs (mean age, 72 ± 10 years; 77% male; 88% White; 61% endovascular). The mortality rate in the immediate period was 10.2% (528/5157) and the early mortality rate was 22.1% (918/4163). In multivariable regression analyses, signs of hemorrhagic shock (ie, hemoglobin <7 g/dL: adjusted odds ratio [aOR], 1.87 [95% confidence interval [CI], 1.14-3.06]; any preoperative systolic blood pressure <70 mm Hg: aOR, 1.40 [95% CI, 1.04-1.89]; and estimated blood loss >40%: aOR, 3.65 [95% CI, 2.29-5.83]) were associated with an increased risk of immediate mortality. Comorbid conditions (heart failure: aOR, 1.38 [95% CI, 1.00-1.92]; pulmonary disease: aOR, 1.29 [95% CI, 1.05-1.58]; elevated creatinine: aOR 1.26 [95% CI, 1.31-1.41]) were associated with increased risk of early mortality. CONCLUSIONS: Immediate deaths were associated predominantly with shock from massive hemorrhage, whereas early deaths were associated with comorbid conditions predisposing patients to multisystem organ failure despite successful repair. These temporal distinctions should guide future mechanistic and intervention evaluations to improve RAAA mortality.

Endovascular repair of abdominal and thoracoabdominal aneurysms using chimneys and periscopes is associated with poor outcomes.

OBJECTIVE: Chimneys and periscopes are often used to treat pararenal or thoracoabdominal aneurysms de novo or after failed open or endovascular repair. We sought to describe our institutional experience, given their limited success and questionable long-term outcomes. METHODS: We retrospectively reviewed the electronic records for patients treated with chimneys/periscopes from 1997 through 2020. Baseline characteristics, procedural details, periprocedural complications, reinterventions, and midterm outcomes were collected. RESULTS: Fifty-eight patients (86 vessels) were treated; the median follow-up was 32 months (range, 0.03-104 months). There were 36% (n = 21) juxta-renal, 2% (n = 1) para-visceral, and 21% (n = 12) thoracoabdominal aneurysms, and 41% (n = 24) had pararenal failure of prior endovascular aneurysm repair (n = 17) or open repair (n = 7). Stent configuration for the majority of the 86 vessels (n = 80; 93%) treated were chimney configuration (n = 6 periscopes; 7%). The most common stent graft utilized was Viabahn, and 8.1% (n = 7) were reinforced with a bare metal stent. Although the majority of the cases were elective, 36.2% (n = 21) of the cases were urgent/emergent. At the conclusion of the initial procedure, 16 of 58 patients had an endoleak (gutter, 50% [8/16]; type Ia, 25% [4/16]; and type II, 25% [4/16]). On follow-up, 14 of 58 patients developed one or more endoleaks, with the most common endoleaks being a gutter endoleak (35% [7/20]). Other endoleaks observed included 30% (6/20) type III, 15% (3/20) type Ia, 15% (3/20) type Ib, and 5% (1/20) type II. Eleven of 58 patients underwent interventions for one or more endoleak (gutter, 33% [5/15]; type Ib, 20% [3/15]; type II, 7% [1/15]; and type III, 40% [6/15]). Twelve of 58 patients returned to the operating room for one or more procedures during the index hospitalization (five laparotomies, three dialysis access, three acute limb ischemia, and four chimney/periscope interventions). Ten of 58 patients underwent angioplasty/stenting for chimney/periscope compression or occlusion during the follow-up period. Survival was 61.3% at 1 year by Kaplan-Meier analysis (75% for elective, 37% for urgent/emergent) (aneurysm-related death, 22%). Cox hazard modeling showed that aneurysm diameter (hazard ratio, 1.03; 95% confidence interval, 1.004-1.05; P = .02) and urgent/emergent interventions (hazard ratio, 3.6; 95% confidence interval, 1.33-9.74; P = .01) were predictors of mortality. CONCLUSIONS: Endovascular repair of aortic aneurysms with chimneys/periscopes is associated with poor outcomes, including limited technical success and aneurysm exclusion, as well as high morbidity and mortality, with a high rate of reinterventions both in the immediate postoperative period and on follow-up. They should be used only when other surgical or endovascular options are not possible.

Outcomes of operative and nonoperative management of blunt thoracic aortic injury.

OBJECTIVE: Although the current guidelines for the management of blunt traumatic aortic injury (BTAI) have recommended intervention for grade 2 injuries or higher, a national trend has occurred for aggressive endovascular treatment of low-grade BTAIs. Little is known about the natural history of grade 1 and 2 injuries treated nonoperatively. We hypothesized that most of these low-grade injuries would remain stable with nonoperative management. METHODS: We performed a review of BTAIs at a large referral level 1 trauma center from 2004 to 2020. The injuries were graded using a standard 1 to 4 scale. The outcomes of the nonoperative and thoracic endovascular aortic repair (TEVAR) management strategies were compared, including post-trauma morbidity, mortality, reinterventions, and lesion stability. RESULTS: A total of 176 patients with BTAIs and sufficient imaging studies and follow-up data available were identified during the study period, including 36 with grade 1, 24 with grade 2, 115 with grade 3, and 1 with a grade 4 injury. Of these 176 patients, 112 had undergone TEVAR and 64 had been treated nonoperatively. Most of the patients (90.2%) who had undergone TEVAR had had grade 3 injuries. Nonoperative management was performed for 97.2% of the grade 1 injuries and 62.5% of the grade 2 injuries. Endovascular reintervention after TEVAR was rare (2.7%). The rates of post-trauma morbidity within 30 days (stroke, 3.6% vs 3.1%; myocardial infarction/arrhythmia, 8.9% vs 1.6%; respiratory failure, 31.2% vs 28.1%; acute kidney injury, 9.8% vs 12.5%; urinary tract infection, 2.7% vs 4.8%; gastrointestinal bleeding, 3.6% vs 0.0%; pulmonary embolism, 10.9% vs 4.5%) and 1-year mortality after discharge (1.8% vs 3.1%) were comparable between the operative and nonoperative groups. The median follow-up was 1501 days (interquartile range [IQR], 475.6-2804 days) for the TEVAR group and 1170.5 days (IQR, 317-2173 days) for the nonoperative group. No lesion progression had occurred in the patients with low-grade (grade 1-2) injuries managed nonoperatively. Resolution of grade 1 and 2 injury had occurred in 20% of the patients at 30 days, which had improved to 44% at long-term follow-up. Fourteen patients with grade 3 injuries (12.2% of the grade 3 injuries in our series) were also observed and did not require future intervention. These patients had generally had smaller pseudoaneurysms with minimal periaortic hematoma. None of these 14 patients had experienced progression or rupture during follow-up (median, 454.5 days; IQR, 81-1199 days) using computed tomography. CONCLUSIONS: Nonoperative management of low-grade BTAIs did not result in long-term aortic complications or the need for reintervention. We found that grade 3 injuries with smaller pseudoaneurysms and minimal periaortic hematoma can be safely observed if the patients can be appropriately followed up. Thus, the indications for treatment of select grade 3 injuries merit further consideration.

Contemporary management of acute and chronic mesenteric ischemia: 10-year experience from a multihospital healthcare system.

OBJECTIVE: Endovascular and hybrid methods have been increasingly used to treat mesenteric ischemia. However, the long-term outcomes and risk of symptom recurrence remain unknown. The objective of the present study was to define the predictors of postoperative morbidity, mortality, and patency loss for acute mesenteric ischemia (AMI) and chronic mesenteric ischemia (CMI). METHODS: The inpatient and follow-up records for all patients who had undergone revascularization for AMI and CMI from 2010 to 2020 at a multicenter hospital system were reviewed. Patency and mortality were evaluated with Cox regression, visualized with Kaplan-Meier curves, and compared using log-rank testing. Patency was further evaluated using Fine-Gray regression with death as a competing risk. The postoperative major adverse events (MAE) and 30-day mortality were evaluated with logistic regression. RESULTS: A total of 407 patients were included, 148 with AMI and 259 with CMI. For the AMI group, the 30-day mortality was 31%. Open surgery was associated with lower rates of bowel resection (odds ratio [OR], 0.23; 95% confidence interval [CI], 0.13-0.61). The etiology of AMI also did not change the outcomes (OR, 1.30; 95% CI, 0.77-2.19). Adjusted analyses indicated that a history of diabetes (OR, 2.77; 95% CI, 1.37-5.61) and sepsis on presentation (OR, 2.32; 95% CI, 1.18-4.58) were independently associated with an increased risk of 30-day MAE. In the CMI group, open surgery and chronic kidney disease were associated with a higher incidence of MAE (OR, 3.03; 95% CI, 1.14-8.05; OR, 2.37; 95% CI, 1.31-4.31). In contrast, chronic kidney disease (OR, 3.02; 95% CI, 1.10-8.37) and inpatient status before revascularization (OR, 2.78; 95% CI, 1.01-7.61) were associated with increased 30-day mortality. For the CMI group, the endovascular cohort had experienced greater rates of symptom recurrence (29% vs 13%) with a faster onset (endovascular, 64 days; vs bypass, 338 days). CONCLUSIONS: AMI remains a morbid disease despite the evolving revascularization techniques. An open approach should remain the reference standard because it reduces the likelihood of bowel resection. For CMI, endovascular interventions have improved the postoperative morbidity but have also resulted in early symptom recurrence and reintervention. An endovascular-first approach should be the standard of care for CMI with close surveillance.

Midterm Outcomes of Endovascular Repair of Aortic Arch Aneurysms with the Gore Thoracic Branch Endoprosthesis.

OBJECTIVE: Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported. METHODS: This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported. RESULTS: The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement > 5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm. CONCLUSION: Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.

Improved outcomes of endovascular repair of thoracic aortic injuries at higher volume institutions.

BACKGROUND: The use of thoracic endovascular aortic repair (TEVAR) has significantly improved the ability to treat traumatic aortic injuries (tTEVAR). We sought to determine whether a greater center volume correlated with better outcomes. METHODS: Vascular Quality Initiative data of TEVAR (2011-2017) for trauma were used in the present analysis. Using the distribution of the annual case volume at the participating centers, the sample was stratified into three terciles. In-hospital mortality at high-volume centers (HVCs) and low-volume centers (LVCs) was compared after adjustment for risk factors established in our previous Vascular Quality Initiative-based risk model containing age, gender, renal impairment, left subclavian artery involvement, and select concomitant injuries. RESULTS: A total of 619 tTEVAR cases were studied across 74 centers. HVCs (n = 184 cases) had performed ≥4.9 cases annually and LVCs (n = 220 cases) had performed ≤2.4 cases annually. Both crude mortality (4.4% vs 8.6%; P = .22) and adjusted odds of mortality (odds ratio, 0.44; 95% confidence interval, 0.18-1.09; P = .08) showed a trend toward better outcomes for tTEVAR performed at HVCs than at LVCs. The addition of center volume to our previous multivariate model significantly improved its discriminative ability (C-statistic, 0.90 vs 0.88; P = .02). The overall TEVAR volume (for all indications) was not associated with increased odds of mortality for tTEVAR (odds ratio, 0.46; 95% confidence interval, 0.17-1.20; P = .11), nor did it improve the model's discriminative ability. CONCLUSIONS: Higher volume centers showed improved perioperative mortality after tTEVAR. The thoracic aortic trauma volume was more predictive than the overall TEVAR volume, suggesting that technical expertise is not the driving factor. Stable patients might benefit from transfer to a higher volume center before repair.

Poor runoff and distal coverage below the knee are associated with poor long-term outcomes following endovascular popliteal aneurysm repair.

OBJECTIVE: Reports of good short-term outcomes for endovascular repair of popliteal artery aneurysms have led to an increased use of the technique. However, data are lacking on long-term limb-related outcomes and factors associated with the failure of endovascular repair. METHODS: All patients who underwent endovascular popliteal aneurysm repair (EPAR) at a single institution from January 2006 to December 2018 were included in the study. Demographics, indications, anatomic and operative details, and outcomes were reviewed. Long-term patency, major adverse limb event-free survival (MALE-FS) and graft loss/occlusion were analyzed with multivariable cox regression analysis and Kaplan-Meier curves. RESULTS: We included 117 limbs from 101 patients with a mean follow-up of 55.6 months (range, 0.43-158 months). The average age was 73 ± 9.3 years. Thirty-two patients (29.1%) were symptomatic (claudication, rest pain, tissue loss, or rupture). The stent grafts crossed the knee joint in 91.4% of cases. In all, 36.8% of procedures used one stent graft, 41.0% used two stent grafts, and 22.2% of procedures used more than two stent grafts. The median arterial length covered was 100 mm, with an average length of stent overlap of 25 mm. Tapered configurations were used in 43.8% of cases. The majority of limbs (62.8%) had a three-vessel runoff, 20.2% had a two-vessel runoff, and 17% has a one-vessel runoff. The Kaplan-Meier estimates of graft occlusion at 1 and 3 years were 6.3% and 16.2%, respectively. The 1- and 3-year primary patency rates were 88.2% and 72.6%, and the 1- and 3-year major adverse limb event-free survival (MALE-FS) rates were 82% and 57.4%. The 1- and 3-year survival rates were 92.9% and 76.2%, respectively. On multivariable Cox regression, aneurysm size, one-vessel runoff, and coverage below the knee were associated with a lower 3-year MALE-FS. Coverage below the knee was also associated with a lower 3-year MALE-FS. Other anatomic or technical details were not associated with limb-related events or patency. CONCLUSIONS: This study is the largest single center analysis to describe the predictors of poor outcomes after EPAR. EPAR is a safe and effective way to treat popliteal artery aneurysms. Factors associated with poor MALE-FS after EPAR include single-vessel tibial runoff and coverage below the knee.

Five-year results of the INSPIRATION study for the INCRAFT low-profile endovascular aortic stent graft system.

OBJECTIVE: We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms. METHODS: This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture. RESULTS: One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years. CONCLUSIONS: This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy.

Risk factors for mortality after endovascular repair for blunt thoracic aortic injury.

OBJECTIVE: Despite high use of endovascular repair, blunt thoracic aortic injury (BTAI) leads to significant mortality. We sought to identify risk factors and create a predictive model for mortality after thoracic endovascular aortic repair (TEVAR) based on available preoperative clinical data. METHODS: We queried the Vascular Quality Initiative TEVAR dataset from April 2011 to November 2017 to identify patients with BTAI as the indication for repair. Patient characteristics, injury grade, timing of repair, and technical aspects including left subclavian artery (LSCA) involvement and coverage were evaluated. Logistic regression was used to identify univariable predictors of the primary outcome of in-hospital mortality. A multivariable model was constructed to predict in-hospital mortality after TEVAR for traumatic aortic injury. The model was tested as a prediction tool, internally validated using 10-fold cross-validation approach, externally validated using early and late split samples, and finally simplified into a scoring system. RESULTS: We identified 633 TEVAR cases performed for blunt trauma. The majority of patients were male (73.9%) with median age of 39 years (interquartile range, 27-56 years). Although 18.6% documented zone 2 or proximal involvement, 28.1% documented involvement or treatment of the LSCA. 8.9% of repairs were performed for a grade 1 injury, with an increase from 6.4% in 2014 to 16.7% in 2017 (P = .04). The overall in-hospital mortality rate was 7.3%. Independent predictors of mortality were age 60 year or greater (odds ratio [OR], 11.33; 95% confidence interval [CI], 5.30-24.23; P < .001), creatinine 1.2 or greater (OR, 5.28; 95% CI, 2.46-11.34; P < .001), male gender (OR, 4.26; 95% CI, 1.53-11.84; P = .005), Injury Severity Score of greater than 30 (OR, 3.86; 95% CI, 1.74-8.57; P = .001), and LSCA involvement (OR, 2.25; 95% CI, 1.11-4.53; P = .02). The model predicted in-hospital mortality with a C-statistic of 0.86 (95% CI, 0.80-0.92), and a simplified model based on a point system had a similar C-statistic of 0.86 (95% CI, 0.80-0.92; P = .44). CONCLUSIONS: TEVAR for BTAI is associated with a 7.3% in-hospital mortality in the Vascular Quality Initiative. Treatment of grade 1 injuries has increased significantly in recent years. Factors most strongly associated with mortality include age, male gender, renal impairment, LSCA involvement, and high ISS score. A simple point score model based on these variables robustly predicts in-hospital mortality and may assist in appropriate patient selection and risk stratification.

External validation of the Vascular Study Group of New England carotid endarterectomy risk predictive model using an independent U.S. national surgical database.

OBJECTIVE: Previously, we described a Vascular Study Group of New England (VSGNE) risk predictive model to predict composite adverse outcomes (postoperative death, stroke, myocardial infarction, or discharge to extended care facilities) after carotid endarterectomy (CEA). The goal of this study was to externally validate this model using an independent database. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) CEA-targeted database (2010-2014) was used to externally validate the risk predictor model of adverse outcomes after CEA previously created using the VSGNE carotid database. Emergent cases and those in which CEA was combined with another operation were excluded. Cases in which a discharge destination cannot be determined were also excluded. To assess the predictive power of our VSGNE prediction score within this sample, a receiver operating characteristic curve was constructed. Risk scores for each NSQIP patient were also computed using beta weights from the VSGNE CEA model. To further assess the construct validity of our VSGNE prediction score, the observed proportion of adverse outcomes was examined at each level of our prediction scale and within five roughly equally sized risk groups formed on the basis of our VSGNE prediction scores. RESULTS: In this database, 10,889 cases met our inclusion criteria and were used in this analysis. The overall rate of adverse outcomes in this cohort was 8.5%. External validation of the VSGNE model on this sample showed moderately good predictive ability (area under the curve = 0.745). Patients in progressively higher risk groups, based on their VSGNE model scores, exhibited progressively higher rates of observed adverse outcomes, as predicted. CONCLUSIONS: The VSGNE CEA risk predictive model was externally validated on an NSQIP CEA-targeted sample and showed a fairly accurate global predictive ability for adverse outcomes after CEA. Although this model has a good population concordance, the lack of cut point indicates that individual risk prediction requires more evaluation. Further studies should be geared toward identification of variables that make this risk predictive model more robust.

Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries.

OBJECTIVE: Drug-coated balloons (DCB) and drug-eluting stents (DES) have significantly altered treatment paradigms for femoropopliteal lesions. We aimed to describe changes in practice patterns as a result of the infusion of these technologies into the treatment of peripheral arterial disease. METHODS: We queried the Vascular Quality Initiative registry from 2010 to 2017 for all peripheral vascular interventions involving the superficial femoral artery and/or the popliteal artery. Cases were divided into a PRE and a POST era with a cutoff of September 2016, when specific device identity was first recorded in Vascular Quality Initiative. For each artery, a primary treatment was identified as either plain balloon angioplasty, atherectomy, DCB, bare-metal stent, or DES. The relative distribution of primary treatments between the PRE and POST eras was evaluated, as were lesion characteristics associated with DCB and DES use and regional variability in the adoption of these new technologies. RESULTS: Of 210,666 arteries in the dataset, 91,864 femoropopliteal arteries (across 74,842 procedures in 55,437 patients) were included. Each artery received 1.5 ± 0.6 treatments. Primary treatment use changed from 40% balloon angioplasty, 45% stenting, and 15% atherectomy in the PRE era to 22% plain balloon angioplasty, 26% bare-metal stent, 8% atherectomy, 37% DCB, and 8% DES in the POST era (P < .001). Forty-three percent of arteries received a drug-containing device as a primary or adjunctive therapy and 1.3% received both a DCB and DES in the POST era. DCB use as the primary treatment was highest in lesions with length 10.0 to 19.9 cm (42%), TransAtlantic InterSociety A, B, or C lesions (38%), and lesions with mild to no calcification (38%). DES use was highest in lesions with a length of 20 cm or more (12%), TransAtlantic InterSociety D lesions (13%), and lesions with moderate to severe calcification (9%). The range of use across 18 regions was 125 to 40% for DCB and 1% to 14% for DES. Regional variability was greater for DES (SD 4% vs mean 8%) than for DCB (SD 7% vs mean 29%). CONCLUSIONS: There has been a rapid dissemination of DCB and DES technology in the femoropopliteal vessels, with nearly one-half of arteries receiving a drug-containing therapy in modern practice. DCBs are most used in medium length, minimally calcified lesions and DESs are most used in longer, more heavily calcified lesions. There is significant regional variability in adoption, especially with DES.

Comparable Patency of Open and Hybrid Treatment of Venous Anastomotic Lesions in Thrombosed Haemodialysis Grafts.

OBJECTIVE: Arteriovenous graft (AVG) failures are typically associated with venous anastomotic (VA) stenosis. Current evidence regarding AVG thrombosis management compares surgical with purely endovascular techniques; few studies have investigated the "hybrid" intervention that combines surgical balloon thrombectomy and endovascular angioplasty and/or stenting to address VA obstruction. This study aimed to describe outcomes after hybrid intervention compared with open revision (patch venoplasty or jump bypass) of the VA in thrombosed AVGs. METHODS: Retrospective cohort study. Consecutive patients with a thrombosed AVG who underwent thrombectomy between January 2014 and July 2018 were divided into open and hybrid groups based on VA intervention; patients who underwent purely endovascular thrombectomy were excluded. Patient demographics, previous access history, central vein patency, AVG anatomy, type of intervention, and follow up data were recorded. Kaplan-Meier curves were used to analyse time from thrombectomy to first re-intervention (primary patency) and time to abandonment (secondary patency). Cox regression analysis was performed to evaluate predictors of failure. RESULTS: This study included 97 patients (54 females) with 39 forearm, 47 upper arm, and 11 lower extremity AVGs. There were 34 open revisions (25 patches, nine jump bypasses) and 63 hybrid interventions, which included balloon angioplasty ± adjunctive procedures (15 stents, five cutting balloons). Technique selection was based on physician preference. Primary patency for the open and hybrid groups was 27.8% and 34.2%, respectively, at six months and 17.5% and 12.9%, respectively, at 12 months (p = .71). Secondary patency was 45.1% and 38.5% for open and hybrid treatment, respectively, at 12 months (p = .87). An existing VA stent was predictive of graft abandonment (hazard ratio 4.4, 95% confidence interval 1.2-16.0; p = .024). Open vs. hybrid intervention was not predictive of failure or abandonment. CONCLUSION: Hybrid interventions for thrombosed AVGs are not associated with worse patency at six and 12 months compared with open revision.

Impact of Medicaid Expansion of the Affordable Care on the Outcomes of Lower Extremity Bypass for Patients With Peripheral Artery Disease in the Vascular Quality Initiative Database.

OBJECTIVE: The aim of this study was to evaluate changes in the utilization and outcomes of surgery after Medicaid Expansion (ME) for patients with peripheral artery disease (PAD). SUMMARY BACKGROUND DATA: Recent studies have demonstrated increased insurance coverage and improved care with the Affordable Care Act's (ACA) state expansion of Medicaid. METHODS: Infrainguinal bypass procedures performed due to occlusive pathology in the Vascular Quality Initiative database between 2010 and 2017 were included. Primary outcomes including postoperative mortality and major adverse limb events (MALE) at 1-year of follow-up were analyzed using interrupted time-series analysis (ITS). RESULTS: Out of 26,446 infrainguinal bypass procedures, 13,955 (52.8%) were included in this analysis. ME states witnessed an annual decrease in infrainguinal surgery for acute ischemia [annual change in post vs pre-ME period (95% confidence interval): -4.3% (-7.5% to -1.0%), P = 0.02] and an increase in revascularization for claudication [3.7% (1.7%-5.6%), P = 0.01]. Among nonacute cases, elective procedures increased in ME states [3.9% (0.1%-7.7%), P = 0.05] along with a significant annual decrease in in-hospital mortality [-0.4% (-0.8 to -0.02), P = 0.04) and MALE at 1 year of follow up [-9.0% (-20.3 to 2.3), P = 0.09]. These results were statistically significant after comparing them with the annual trend changes in states which did not adopt ME. CONCLUSIONS: The adoption of ME in 2014 was associated with significant increase in the use of infrainguinal bypass for nonsevere and elective cases, along with improved in-hospital mortality and MALE at 1 year. Longer follow-up is needed to evaluate the impact of ME on other aspects of care and longer term outcomes of PAD patients.

Occult type I or III endoleaks are a common cause of failure of type II endoleak treatment after endovascular aortic repair.

OBJECTIVE: Most type II endoleaks have a benign natural history, but 6% to 8% are associated with sac enlargement and respond poorly to treatment. Our aim was to evaluate whether these enlargements are associated with delayed or occult type I and III endoleaks. METHODS: Patients with interventions for endoleak after endovascular aortic repair from 2000 to 2016 were reviewed retrospectively. Patient demographics, comorbidities, endoleak type, secondary procedures, aortic sac growth (≥5 mm), and mortality were collected. Successful treatment was defined as endoleak resolution with no further aortic sac growth. Secondary procedures, ruptures, endograft explant, and death were captured. RESULTS: There were 130 patients diagnosed with a primary type II endoleak after endovascular aortic repair at a median of 1.3 months (interquartile range, 1.0-13.3 months). One hundred eighteen had their initial treatment for a primary type II. Twelve of the 130 were initially stable and observed, but were treated for a delayed type I or III endoleak. The 130 patients underwent 279 procedures for endoleaks (mean of 2.2 ± 1.3) over 6.9 ± 3.8 years of follow-up. Of the 118 patients treated for primary type II endoleaks, 26 (22.0%) later required interventions for delayed type I and III endoleaks. The mean time to intervention for a delayed type I or III endoleak was 5.4 ± 2.8 years. Overall, there were 16 type IA, 11 type IB, 2 type III, 7 combined type IA/IB, and 2 type IA/III delayed endoleaks. The odds of harboring a delayed type I or III endoleak was 22.0% before the first attempt at type II endoleak treatment, 35.1% before the second, 44.8% before the third, and 66.6% before the fourth attempts. Rapid aortic sac growth of ≥5 mm/y before initial endoleak treatment was associated with increased risk for delayed type I or III endoleak (47.8 vs 14.1%; P = .003). Patients with delayed type I or III endoleaks had a lower successful treatment rate (8.3% vs 52.3%; P = .001) than those with only type II endoleaks. Late rupture was increased with delayed type I or III endoleak (P = .002), whereas mortality (P = .96) and aortic-related mortality (P = .46) were similar. Graft explant (P = .06) trended toward an increase with a delayed type I or III endoleak, but was not statistically significant. CONCLUSIONS: Failed attempts treating type II endoleaks and/or a rapid aortic sac growth of 5 mm/y or greater should raise the suspicion of a delayed or occult type I or III endoleak. Occult endoleaks are associated with decreased chance of endoleak resolution.