The association between frailty and outcomes following ruptured abdominal aortic aneurysm repair.

OBJECTIVE: Endovascular aortic repair (EVAR) is a less invasive method than the more physiologically stressful open surgical repair (OSR) for patients with anatomically appropriate abdominal aortic aneurysms (AAAs). Early postoperative outcomes are associated with both patients; physiologic reserve and the physiologic stresses of the surgical intervention. Among frail patients with reduced physiologic reserve, the stress of an aortic rupture in combination with the stress of an operative repair are less well tolerated, raising the risk of complications and mortality. This study aims to evaluate the difference in association between frailty and outcomes among patients undergoing minimally invasive EVAR and the physiologically more stressful OSR for ruptured AAAs (rAAAs). METHODS: Our retrospective cohort study included adults undergoing rAAA repair in the Vascular Quality Initiative from 2010 to 2022. The validated Risk Analysis Index (RAI) (robust, ≤20; normal, 21-29; frail, 30-39; very frail, ≥40) quantified frailty. The association between the primary outcome of 1-year mortality and frailty status as well as repair type were compared using multivariable Cox models generating adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs). Interaction terms evaluated the association's moderation. RESULTS: We identified 5806 patients (age, 72 ± 9 years; 77% male; EVAR, 65%; robust, 6%; normal, 48%; frail, 36%; very, frail 10%) with a 53% observed 1-year mortality rate following rAAA repair. OSR (aHR, 1.43; 95% CI, 1.19-1.73) was associated with increased 1-year mortality when compared with EVAR. Increasing frailty status (frail aHR, 1.26; 95% CI, 1.00-1.59; very frail aHR, 1.64; 95% CI, 1.26-2.13) was associated with increased 1-year mortality, which was moderated by repair type (P-interaction < .05). OSR was associated with increased 1-year mortality in normal (aHR, 1.49; 95% CI, 1.20-1.87) and frail (aHR, 1.51; 95% CI, 1.20-1.89), but not among robust (aHR, 0.88; 95% CI, 0.59-1.32) and very frail (aHR, 1.29; 95% CI, 0.97-1.72) patients. CONCLUSIONS: Frailty and OSR were associated with increased adjusted risk of 1-year mortality following rAAA repair. Among normal and frail patients, OSR was associated with an increased adjusted risk of 1-year mortality when compared with EVAR. However, there was no difference between OSR and EVAR among robust patients who can well tolerate the stress of OSR and among very frail patients who are unable to withstand the surgical stress from rAAA regardless of repair type.

The Role of Integrated Air Transport System in Managing Patients with Abdominal Aortic Aneurysm Rupture.

OBJECTIVE: Ruptured abdominal aortic aneurysms (rAAAs) are highly morbid emergencies. Not all hospitals are equipped to repair them, and an air ambulance network may aid in regionalising specialty care to quaternary referral centres. The association between travel distance by air ambulance and rAAA mortality in patients transferred as an emergency for repair was examined. METHODS: A retrospective review of institutional data. Adults with rAAA (2002 - 2019) transferred from an outside hospital (OSH) to a single quaternary referral centre for repair via air ambulance were identified. Patients who arrived via ground transport or post-repair at an OSH for continued critical care were excluded. Patients were divided into near and far groups based on the 75th percentile of the straight line travel distance (> 72 miles) between hospitals. The primary outcome was 30 day mortality. Multivariable logistic regression was used to assess the association between distance and mortality after adjusting for age, sex, race, cardiovascular comorbidities, and repair type. RESULTS: A total of 290 patients with rAAA were transported a median distance of 40.4 miles (interquartile range 25.5, 72.7) with 215 (74.1%) near and 75 (25.9%) far patients. Both the near and far groups had similar ages, sex, and race. There was no difference in pre-operative loss of consciousness, intubation, or cardiac arrest between groups. Endovascular aneurysm repair utilisation and intra-operative aortic occlusion balloon use were also similar. Neither the observed (26.8% vs. 23.9%, p = .61) nor the adjusted odds ratio (0.70, 95% confidence interval 0.36 - 1.39, p = .32) 30 day mortality rate differed significantly between the near and far groups. CONCLUSION: Increasing distance travelled during transfer by air ambulance was not associated with worse outcomes in patients with rAAA. The findings support the regionalisation of rAAA repair to large quaternary centres via an integrated and robust air ambulance network.

Outcomes of octogenarians receiving aortic repair.

OBJECTIVE: Abdominal aortic aneurysm (AAA) repair is recommended for aneurysms greater than 5.5 cm in men and 5 cm in women. Because AAA is more common among the elderly, we sought to evaluate contemporary practices of elective AAA repair and 2-year postoperative outcomes in octogenarians. METHODS: We identified octogenarians undergoing elective AAA repair in the Vascular Quality Initiative from 2012 to 2019. We included patients undergoing endovascular (EVAR) and open (OAR) aortic repair. Demographics and comorbid conditions were compared between patient groups. Frailty was calculated using previously published methods. Patients with frailty scores above the 75th percentile of the operative cohort were considered high frailty. The primary outcome was 1- and 2-year mortality. Secondary outcomes included postoperative complications. Standard statistical methods were utilized. Cox proportional hazard models were used to identify factors that affect mortality. RESULTS: The frequency of AAA repair in octogenarians has remained stable. Of all aortic operations, 21.4% were performed on octogenarians; 9735 (23.3% of 41,712) EVAR and 755 (10.3% of 7325) OARs. Among octogenarian patients, 42.0% of EVARs were under size thresholds: 48.3% males ≤5.5 cm diameter and 21.5% females ≤5.0 cm diameter compared with 18.8% OARs: 23.4% males and 10.7% females. Additionally, 25.6% had high frailty scores. Among octogenarians, 1- and 2-year mortality was 9.3% ± 0.3% and 14.8% ± 0.4% for EVAR and 15.2% ± 1.3% and 18.9% ± 1.5% for OAR patients, respectively (P < .01). In-hospital mortality rate was higher after OAR (0.87% EVAR vs 7.55% OAR; P < .01) and differed with frailty (EVAR, low frailty 0.2% vs high frailty 1.7%; OAR, low frailty 2.3% vs high frailty 15.6%). For EVAR, patient factors associated with mortality included heart failure (hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.06-1.25; P = .001) and dialysis (HR, 1.71; 95% CI, 1.13-2.59; P = .012). For OAR, coronary artery disease (HR, 1.55; 95% CI, 0.98-2.44; P = .062) was associated with mortality. Statin use was protective of mortality for all patients (EVAR: HR, 0.68; 95% CI, 0.60-0.78; P < .01): OAR: HR, 0.58; 95% CI, 0.37-0.92; P = .020). Among octogenarians, high frailty was independently associated with 2-year mortality (EVAR: HR, 3.36; 95% CI, 2.62-4.31; P < .01 and OAR: HR, 2.35; 95% CI, 1.09-5.10; P = .030). CONCLUSIONS: Nationally, a large portion of elective AAA repair in octogenarians is performed below recommended size thresholds, one-quarter of whom are frail with poor long-term 2-year mortality rates. High 2-year mortality following AAA repair in this age group exceeds the published risk of rupture for 5- to 5.5-cm AAA, suggesting that increase in the size threshold of elective repair among octogenarians should be explored.

Socioeconomic factors predict successful supervised exercise therapy completion.

OBJECTIVE: Supervised exercise therapy (SET) for patients with intermittent claudication (IC) can lower the risk of progression to chronic limb-threatening ischemia and amputation, while preserving and restoring functional status. Despite supporting evidence, it remains underutilized, and among those who initiate programs, attrition rates are extremely high. We hypothesize that socioeconomic factors may represent significant barriers to SET completion. METHODS: Patients with IC referred to SET at a multi-hospital, single-institution health care system (2018-2022) from a prospectively maintained database were retrospectively analyzed. Our primary endpoint was SET program completion and graduation, defined as completion of 36 sessions. Our secondary endpoints were vascular intervention within 1 year of referral and change in ankle-brachial index (ABI). Baseline demographics were assessed using standard statistical methods. Predictors of SET graduation were analyzed using multivariable logistic regression generating adjusted odds ratios (aORs) with 95% confidence intervals (CIs). Change in ABI was analyzed using t-test between subgroups. Reasons for attrition were tabulated. Patient Health Questionnaire-9 (PHQ-9), metabolic equivalent level, Vascular QOL, Duke Activity Status, and ABI were analyzed using paired t-tests across the entire cohort. RESULTS: Fifty-two patients met inclusion criteria: mean age 67.85 ± 10.69 years, 19 females (36.54%), mean baseline ABI of 0.77 ± 0.16. The co-pays for 100% of patients were fully covered by primary and secondary insurance plans. Twenty-one patients (40.38%) completed SET. On multivariable analysis, residence in a ZIP code with median household income <$47,000 (aOR, 0.10; 95% CI, 0.01-0.76; P = .03) and higher body mass index (aOR, 0.81; 95% CI, 0.67-0.99; P = .04) were significant barriers to SET graduation. There were no differences in ABI change or vascular intervention within 1 year between graduates and non-graduates. Non-graduates reported transportation challenges (25.00%), lack of motivation (20.83%), and illness/functional limitation (20.83%) as primary reasons for SET attrition. Metabolic Equivalent Level (P ≤ .01) and Duke Activity Status scores (P = .04) were significantly greater after participating in a SET program. CONCLUSIONS: Although SET participation improves lower extremity and functionality outcomes, only 40% of referred patients completed therapy in our cohort. Our findings suggest that both socioeconomic and functional factors influence the odds of completing SET programs, indicating a need for holistic pre-referral assessment to facilitate enhanced program accessibility for these populations.

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.

The regulatory environment for artificial intelligence-enabled devices in the United States.

The regulatory environment in the United States has not kept pace with the rapidly developing market for artificial intelligence (AI)-enabled devices. The number of AI-enabled devices has increased year after year. All of these devices are registered or cleared by the US Food and Drug Administration through exempt or 510(k) premarket notification pathways, and the majority are related to the radiology or cardiovascular spaces. US Food and Drug Administration guidance has not yet addressed the unique challenges of AI-enabled devices, including development, comprehensibility, and continuously learning models. The liability aspects of AI-enabled devices deployed into use by clinicians in practice have yet to be addressed. Future guidance from government regulatory sources will be necessary as the field moves forward.

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.

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.

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.

Association between neighborhood deprivation and presenting with a ruptured abdominal aortic aneurysm before screening age.

OBJECTIVE: Recent data indicate social determinants of health (SDOH) have a great impact on prevention and treatment outcomes across a broad variety of disease states, especially cardiovascular diseases. The area deprivation index (ADI) is a validated measure of neighborhood level disadvantage capturing key social determinate factors. Abdominal aortic aneurysm rupture (rAAA) is highly morbid, but also preventable through evidence-based screening. However, the association between rAAA and SDOH is poorly characterized. Our objective is to study the association of SDOH with rAAA and screening age. METHODS: This retrospective study included patients who underwent operative repair of a rAAA at a multihospital healthcare system (2003-2019). Deprivation was measured by the ADI (scale 1-100), grouped into quintiles for simplicity, with higher quintiles indicating greater deprivation. Patients with the highest quintile ADI (89-100) were categorized as the most deprived. We investigated the association between neighborhood deprivation with the odds of (i) undergoing repair for rAAA before screening age 65 and (ii) undergoing endovascular aortic repair (EVAR) using logistic regression, sequentially modeling nonmodifiable then both nonmodifiable and modifiable confounding variables. RESULTS: There were 632 patients who met the inclusion criteria (aged 74.2 ± 9.4 years; 174 women [27.6%]; 564 White [89.2%]; ADI 66.8 ± 22.3). Those from the most deprived neighborhoods (n = 118) were younger (71.7 ± 10.0 years vs 74.8 ± 9.2 years; P = .002), more likely to be female (36% vs 26%; P = .031), more likely to be Black (5.9% vs 0.4%; P = .007), and fewer underwent EVAR (28% vs 39.5%; P = .020) compared with those from other neighborhoods. On sequential modeling, residing in the most deprived neighborhoods was associated with undergoing rAAA repair before age 65 after adjusting for nonmodifiable factors (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.39-2.95; P < .001), and nonmodifiable as well as modifiable factors (OR, 2.22; 95% CI, 1.56-3.16; P < .001). Those in the most deprived neighborhoods had a lower odds of undergoing EVAR compared with open repair after adjusting for nonmodifiable factors (OR, 0.64; 95% CI, 0.41-0.98; P = .042), and nonmodifiable as well as modifiable factors (OR, 0.61; 95% CI, 0.37-0.99; P = .047). CONCLUSIONS: Among patients who underwent rAAA, residing in the most deprived neighborhoods was associated with greater adjusted odds of presenting under age 65 and undergoing an open repair. These neighborhoods represent tangible geographic targets that may benefit from a younger screening age, enhanced education, and access to care. These findings stress the importance of developing strategies for early prevention and diagnosis of cardiovascular diseases among patients with disadvantageous SDOH.

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.

Any Postoperative Surveillance Improves Survival after Endovascular Repair of Ruptured Abdominal Aortic Aneurysms.

BACKGROUND: Endovascular aortic repair (EVAR) has advanced the care of patients with ruptured abdominal aortic aneurysms (rAAA) with improved early postoperative morbidity and mortality. However, this comes at the cost of a rigorous postoperative surveillance schedule to monitor for further aneurysmal degeneration. Adherence to surveillance recommendations is known to be poor in the elective setting, but has yet to be studied in the ruptured population. The aim of this study is to investigate predictors of incomplete surveillance after EVAR for rAAA (rEVAR) and examine how adherence impacts outcomes. METHODS: This was a retrospective case control study of patients undergoing rEVAR at a multiple hospital single healthcare center (2003-2020). Patients were excluded if they underwent open conversion during their index hospitalization or died within 60 days of surgery. Follow-up was broadly categorized as complete surveillance (60-day postoperative visit and annually thereafter) or incomplete surveillance, comprising both patients with less than recommended surveillance (minimal surveillance) and completely lost to follow-up (LTF). Any follow-up was defined as patients with complete or minimal surveillance. We investigated predictors of complete versus incomplete surveillance by multivariate logistic regression. Secondary outcomes included overall survival and cumulative incidence of reintervention controlling for the competing risk of mortality, generating hazard ratios (HR) and subdistribution hazard ratios (SHR). RESULTS: One-hundred and sixty patients (mean age 74 ± 10.1 years, 81.2% male) out of 673 total rAAA met study inclusion criteria. Complete surveillance was seen in 41.3% of our cohort, with the remainder with minimal surveillance (29.4%) or LTF (29.4%). Incomplete surveillance was associated with male sex (odds ratio [OR] 2.56; 95% CI 1.02-6.43), lack of a primary care provider (PCP; OR 0.20; 95% CI 0.04-0.99), and longer driving distance from home to treating hospital (OR 2.37; 95% CI 1.08-5.20). Survival was not different between complete and incomplete surveillance groups, however any follow-up conferred improved survival over LTF (HR 0.57; 95% CI 0.331-0.997; P = 0.049). Reintervention was associated with incomplete surveillance (SHR 0.29; 95% CI 0.11-0.75), and discharge to a facility (SHR 0.25; 95% CI 0.067-0.94). CONCLUSIONS: Incomplete surveillance was observed in over 50% of patients who underwent rEVAR and was associated with male sex, lack of PCP, and longer driving distance. Any follow-up conferred a survival benefit, yet incomplete surveillance was associated with a lower risk of reintervention. Targeted strategies to prevent LTF, and less stringent, personalized follow-up plans that may confer similar survival benefit with better patient adherence should be investigated.

The Correlation Between Case Total Work Relative Value Unit, Operative Stress, and Patient Frailty: Retrospective Cohort Study.

OBJECTIVE: Assess the relationships between case total work relative value units (wRVU), patient frailty, and the physiologic stress of surgical interventions. SUMMARY OF BACKGROUND DATA: Surgeon reimbursement is frequently apportioned by wRVU. These subjective, procedure-specific valuations generated by physician survey estimate the intensity and time for typical patient care services. We hypothesized wRVU would not adequately account for patient-specific factors, such as frailty, that modify the required physician work, regardless of procedural complexity. METHODS: Using National and Veterans Affairs Surgical Quality Improvement Programs (2015-2018), we evaluated the correlation between case total wRVU, patient frailty (risk analysis index) and physiologic surgical stress (operative stress score). RESULTS: Of 4,111,371 (86%) cases, the correlation between total wRVU and operative stress was moderate [ρs = 0.587 (95% confidence interval, 0.586-0.587)], but negligible with frailty ρ = 0.177 (95% confidence interval, 0.176-0.178)]. Very high operative stress procedures [n = 34,047 (1%)] generated a mean total wRVU of 55.1 (standard deviation, 12.9), comprising 7%, 2%, and 1% of thoracic, vascular, and general surgical cases, respectively. Very frail patients [n = 152,535 (4%)] accounted for 9% of thoracic, 9% of vascular, 4% of general, 5% of urologic, and 4% of neurologic surgical cases, generating 21.0 (standard deviation, 12.4) mean total wRVU. Some nonfrail patients undergoing low operative stress procedures [n = 60,128 (2%)] nonetheless generated the highest quintile wRVU; these comprised >15% of plastic, gynecologic, and urologic surgical cases. CONCLUSIONS: Surgeon reimbursement correlates with operative stress but not patient frailty. The total wRVU does not adequately reflect patient-specific factors that increase the physician workload required to render optimal care to complex patients.

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.

Complete Venous Ulceration Healing after Perforator Ablation Does Not Depend on Treatment Modality.

BACKGROUND: Venous leg ulceration (VLU) represents the most advanced form of chronic venous insufficiency (CVI). Persistent VLU that fails to respond to noninvasive treatment requires a minimally invasive endovascular treatment, which may include chemical (ultrasound-guided foam sclerotherapy [UGFS]) and thermal ablation (endovenous laser therapy [EVLT] or radiofrequency ablation [RFA]) targeting incompetent veins. Current guidelines suggest ablation of incompetent perforating veins (IPVs) juxtaposed to active or healed VLU; however, the ideal treatment modality is unknown. We hypothesize that similar to incompetent superficial vein treatment options therapies, VLU healing will be equivalent across minimally invasive IPV treatment options. METHODS: Using the Vascular Low Frequency Disease Consortium, adults with VLU across 11 medical centers were retrospectively reviewed (2013-2017). We included those who underwent IPV therapies. The primary outcome was complete ulcer healing over time compared with cumulative hazard curves, log-rank testing, and multivariable Cox proportional hazard regression. Secondary outcomes included number of subsequent procedures, which were compared using negative binomial regression. RESULTS: Of the 832 adults with VLU, 158 (19%) were exclusively treated conservatively, and 232 (28%) underwent index treatment for IPV and constitute the full and final cohort. The mean age was 60 ± 14 years, 57% were men, and the mean ulcer area was 3.0 cm2 (interquartile range, 1-6 cm2). Ninety-one (39%) were treated with EVLT, 127 (55%) RFA, and 14 (6%) UGFS. Patients treated with RFA were older (RFA 62 ± 14 years; EVLT 59 ± 14 years; UGFS 52 ± 9 years; P = 0.01), more likely to be men (RFA 68%, n = 86; EVLT 41%, n = 37; UGFS 64%, n = 9; P < 0.001), with a higher frequency of anticoagulation (RFA 36%, n = 46; EVLT 18%, n = 16; UGFS 14%, n = 2; P = 0.005). VLU did not significantly differ in size between groups (RFA 6.2 ± 8; EVLT 4.2 ± 5.4; UGFS 6.1 ± 8; P < 0.001). There were no differences in 1-year ulcer healing rates between groups (P = 0.18). The number of subsequent procedures did not differ by treatment modality (P = 0.47). CONCLUSIONS: This multi-institutional retrospective study does not demonstrate any association of IPV treatment modality with differing rates of VLU healing or number of subsequent procedures.

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.

Systematic review of plasma/packed red blood cell ratio on survival in ruptured abdominal aortic aneurysms.

BACKGROUND: The ideal perioperative fluid resuscitation for patients with ruptured abdominal aortic aneurysms (rAAAs) is unknown. It has been shown in trauma studies that a higher ratio of plasma and platelets to packed red blood cells confers a mortality benefit. Controversy remains whether this is true also in the rAAA population. The objective of the present study was to investigate the benefit of a greater ratio of plasma/packed red blood cells in patients with rAAAs. METHODS: A health sciences librarian searched four electronic databases, including PubMed, Embase, Cochrane, and ClinicalTrials.gov, using concepts for the terms "fluid resuscitation," "survival," and "ruptured abdominal aortic aneurysm." Two reviewers independently screened the studies that were identified through the search strategy and read in full any study that was potentially relevant. Studies were included if they had compared the mortality of patients with rAAAs who had received a greater ratio of plasma to other component therapy with that of patients who had received a lower ratio. The risk of bias was assessed using the ROBINS-I (risk of bias in nonrandomized studies of interventions) validated tool, and evidence quality was rated using the GRADE (grades of recommendation assessment, development, and evaluation) profile. No data synthesis or meta-analysis was planned or performed, given the anticipated paucity of research on this topic and the high degree of heterogeneity of available studies. RESULTS: Our search identified seven observational studies for inclusion in the present review. Of these seven studies, three found an associated decrease in mortality with a greater ratio of plasma to packed red blood cells. The remaining four found no significant differences. The overall risk of bias was serious, and the evidence quality was very low. CONCLUSIONS: Overall, the findings from the available studies would suggest that for patients who have undergone open surgery for a rAAA, mortality tends to be decreased when the amount of plasma transfused perioperatively is similar to the amount of packed red blood cells. However, the included studies reported very low-quality evidence based solely on highly heterogeneous observational studies, and further research is warranted.

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.