Effectiveness of Intra-operative Contrast-Enhanced Ultrasound Assessment to Optimize Type II Endoleak Embolization.

PURPOSE: To analyze the effectiveness of type II endoleaks (T2E) embolization using intra-operative contrast-enhanced ultrasound (CEUS). METHODS: Consecutive patients treated for T2E underwent a standardized protocol with trans-arterial or trans-lumbar access, large volume embolization, onlay fusion, and intra-operative CEUS. Technical success was defined by exclusion of endoleak by CEUS. RESULTS: Twenty-six patients (mean age 81 ± 11 years old; 89% male) were treated. The mean aneurysm sac enlargement was 11 ± 8 mm from T2E diagnosis. Embolization was performed using Onyx® 18 in all patients with adjunctive coils in 13 patients (50%). After the first embolization, CEUS documented residual T2E in 13 patients (50%). Ten patients (38%) had additional embolization, which successfully eradicated the T2E in seven of them. Technical success was 50% after the first embolization attempt and 77% after additional attempts guided by CEUS (P = 0.080). There was no mortality. Median imaging follow-up was 22 months. Among the 20 patients with no residual T2E on completion CEUS, 16 (80%) had sac stabilization and none required additional interventions for T2E. Of the six patients with residual T2Es on CEUS, three had sac stabilization (50%) and one required additional reintervention for T2E. There was one late aortic rupture at 56 months. CONCLUSION: One in two patients treated by T2E embolization had residual endoleak on intra-operative CEUS after a first embolization attempt, decreasing to one in four patients after multiple attempts. A negative completion CEUS following embolization was associated with higher rates of sac stabilization and no need for additional T2E embolization.

Prospective Assessment of a Protocol Using Neuromonitoring, Early Limb Reperfusion, and Selective Temporary Aneurysm Sac Perfusion to Prevent Spinal Cord Injury During Fenestrated-branched Endovascular Aortic Repair.

OBJECTIVE: The aim of this study was to analyze the outcomes of a standardized protocol using routine CSFD, neuromonitoring, LL reperfusion, and selective TASP to prevent SCI during F-BEVAR. BACKGROUND: SCI is to be the most devastating complication for the patient, family, and surgeon, with impact on patient's quality of life and long-term prognosis. An optimal standardized protocol may be used to improve outcomes. METHODS: Patients enrolled in a prospective, nonrandomized single-center study between 2013 and 2018. A SCI prevention protocol was used for TAAAS or complex abdominal aneurysms with ≥5-cm supraceliac coverage including CSFD, neuromonitoring, LL reperfusion, and selective TASP. Endpoints included mortality and rates of SCI. RESULTS: SCI prevention protocol was used in 170 of 232 patients (73%) treated by F-BEVAR. Ninety-one patients (55%) had changes in neuromonitoring, which improved with maneuvers in all except for 9 patients (10%) who had TASP. There was one 30-day or in-hospital mortality (0.4%). Ten patients (4%) developed SCIs including in 1% (1/79) of patients with normal neuromonitoring and 10% (9/91) of those who had decline in neuromonitoring ( P = 0.02). Permanent paraplegia occurred in 2 patients (1%). Factors associated with SCI included total operating time (odds ratio 1.5, 95% confidence interval 1.1-2.2, P = 0.02) and persistent changes in neuromonitoring requiring TASP (odds ratio 15.7, 95% confidence interval 2.9-86.2, P = 0.001). CONCLUSION: This prospective nonrandomized study using a standardized strategy to prevent SCI was associated with low incidence of the SCI during F-BEVAR. Permanent paraplegia occurred in 1%.

Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium.

OBJECTIVE: Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. METHODS: The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). RESULTS: Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46). CONCLUSIONS: Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated.

Women have similar mortality but higher morbidity than men after elective endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Sex disparities regarding outcomes for women after open and endovascular abdominal aortic aneurysm repair have been well-documented. The purpose of this study was to review whether these disparities were also present at our institution for elective endovascular aneurysm repair (EVAR) and whether specific factors predispose female patients to negative outcomes. METHODS: All elective EVARs were identified from our three sites (Florida, Minnesota, and Arizona) from 2000 to 2018. The primary outcome was in-hospital mortality and three-year mortality. Secondary outcomes included complications requiring return to the operating room, length of hospitalization (LOH), intensive care unit (ICU) days, and location of discharge after hospitalization. Multivariable logistic regression models were used to assess for the risk of complications. RESULTS: There were 1986 EVARs; 1754 (88.3%) were performed in male and 232 (11.7%) in female patients. Female patients were older (79 years [interquartile range (IQR), 72-83 years] vs 76 years [IQR, 70-81 years]; P < .001), had a lower body mass index (median, 26.1 kg/m2 [IQR, 22.1-31.0 kg/m2] vs 28.3 kg/m2 [IQR, 25.3-31.6 kg/m2]; P < .001 and hematocrit (median, 37.6% [IQR, 33.4%-40.6%] vs 39.4% [IQR, 35.6%-42.6%]; P < .001) and had higher glomerular filtration rate (median, 84.4 mL/min per 1.73m2 [IQR, 62.3-103 mL/min/1.73 m2] vs 51.1 mL/min/1.73 m2 [IQR, 41.8-60.8 mL/min/1.73 m2]; P < .001. Female patients were also more likely to be active smokers (15.3% vs 13.1%; P < .001) and have chronic obstructive pulmonary disease (24.7% vs 15.3%; P = .001). They were less likely to have coronary artery disease (31.6% vs 45.6%; P < .001). Aneurysms in women were slightly smaller in size (median, 54 mm [IQR, 50.0-58.0 mm] vs 55 mm [IQR, 51.0-60.0 mm]; P = .004). In-hospital mortality and mortality at the 3-year follow-up was not significant between female and male patients (0.86% vs 0.17%; P = .11 and 38.4% vs 36.2%; P = .57). However, female patients returned to the operating room with a greater frequency than male patients (3.9% vs 1.4%; P = .011). LOH (mean, 3.4 ± 3.8 days vs 2.5 ± 2.4 days; P < .001) and ICU days (mean, 0.3 ± 2.0 days vs 0.1 ± 0.5 days; P < .001) were longer for female patients. After hospitalization, female patients were discharged to rehabilitation facilities in greater proportion (12.7% vs 3.1%; P < .001) than their male counterparts. On multivariable analysis, female sex was associated with a return to the operating room (odds ratio, 6.4; 95% confidence interval [CI], 1.4-3.5; P = .02), longer LOH (Coef 4.0; 95% CI, 1.0-2.5; P = .00007), more ICU days (Coef 2.8; 95% CI, 1.1-3.0; P = .005), and a greater likelihood of posthospitalization rehabilitation facility placement (odds ratio, 5.8; 95% CI, 1.5-2.4; P = .0001). CONCLUSIONS: Our three-site, single-institution data support sex disparities to the detriment of female patients regarding return to the operating room after EVAR, LOH, ICU days, and discharge to rehabilitation facility. However, we found no differences for in-hospital or 3-year mortality.

Incidence and natural history of isolated abdominal aortic dissection: A population-based assessment from 1995 to 2015.

BACKGROUND: Isolated abdominal dissection (IAD) is an uncommon clinical problem that is less well-understood than thoracic aortic dissection (AD). We performed a population-based assessment of the incidence, natural history, and treatment outcomes of IAD to better characterize this disease. METHODS: We used the Rochester Epidemiology Project to identify all Olmsted County, MN residents with a diagnosis of AD, intramural hematoma or penetrating ulcer (1995-2015). Diagnostic imaging of all patients was reviewed to confirm the diagnosis of IAD for inclusion. Presentation, treatment, and outcomes were reviewed. Survival of IAD patients was compared to age- and sex-matched population controls 3:1. RESULTS: Of 133 residents with aortic syndrome (AD, intramural hematoma, or penetrating ulcer), 23 were initially diagnosed with IAD. Nine were reclassified as having a penetrating aortic ulcer and were excluded, leaving 14 patients for review (10 male [71%]; mean age, 71 years). Three patients (21%) were symptomatic (abdominal pain, back pain, hypertension) and none had malperfusion or rupture. Prior aortic dilatation was present in eight patients (57%) and Marfan syndrome in one (7%). Two patients (14%) had iatrogenic IAD. Initial management was medical in 13 and endovascular aneurysm repair in one (symptomatic subacute, infrarenal dissection with small aneurysm). The median clinical and imaging follow-up was 6.7 years (range, 0-17 years). An abdominal aortic aneurysm occurred in eight (six at the time of IAD diagnosis, one at 2.9 years, and one at 5.2 years after diagnosis). The average growth in the entire cohort was 0.9 ± 0.4 cm, which translated to an average growth rate of 0.09 cm/year. Subsequent intervention was performed in two patients; for severe aortic stenosis with claudication in one (infrarenal aortic stenting) and increasing aortic size in one (open repair). One patient required reintervention (thrombolysis and stenting for endovascular aneurysm repair limb thrombosis). Survival for IAD at 1, 3, and 5 years was 93%, 85%, and 76%, respectively, compared with population controls at 98%, 85%, and 71%, respectively (long rank P = .38). Mortality was due to cardiovascular causes in three patients (21%) and no deaths were aortic related. Major adverse cardiac events occurred in five patients (36%) owing to heart failure. CONCLUSIONS: IAD is rare. The initial management for asymptomatic patients is medical. The aortic growth rate is slow, with no aortic-related mortality and a low rate of aortic intervention. The overall mortality is similar to population controls. Heart failure and cardiac-related death are prevalent, suggesting that close cardiovascular care is needed in this patient population.

Female Sex is a Marker for Higher Morbidity and Mortality after Elective Endovascular Aortic Aneurysm Repair: A National Surgical Quality Improvement Program Analysis.

BACKGROUND: The adverse gender disparities for women after open abdominal aortic aneurysm (AAA) repair have been well documented. The purpose of this study is to review whether these disparities extend to elective endovascular aneurysm repair (EVAR). METHODS: Nonruptured, elective AAA was identified from the American College of Surgeons' National Quality Improvement Program (NSQIP) Targeted Participant Use File for EVAR from 2012 to 2017. The primary outcome was mortality. Secondary outcomes included lower extremity ischemia requiring intervention (LEIRI) and prolonged operative time (>120 min). Multivariable logistic regression models were used to assess the risk of mortality, LEIRI, and prolonged operative time among women compared with men. RESULTS: There were 14,019 EVAR procedures captured. A total of 3,367 were included for analysis after limiting to nonruptured, elective cases for diagnosis of AAA with a Current Procedural Terminology procedure code for EVAR. Of those, 2,764 (82.1%) were performed in men and 603 (17.9%) in women. Female patients were older (median [interquartile range (IQR)] 77 years [70-82] versus 74 years [68-80], P < 0.001), more likely to smoke (35.5% versus 29.6%, P = 0.005), and less likely to have diabetes (12.4% versus 17.8%, P = 0.001). Women had slightly smaller AAA size (median [IQR] 5.4 cm [5.0-5.9] versus 5.5 cm [5.1-6.0], P < 0.001) and were more likely to have prior abdominal operations (35.3% versus 23.1%, P < 0.001). The operative time was longer among women (median 114 min. [85-150] versus 105 min. [82-140], P < 0.001). Postoperatively, mortality was higher in female patients (1.8% versus 0.9%, P = 0.036), LEIRI occurred in higher proportion among female patients (2.7% versus 1.2%, P = 0.009), and their hospital stay was also longer (median 2 days [1-3] versus 1 day [1-2] days, P < 0.001). On multivariable logistic regression analysis, hematocrit level <30 vol% versus ≥30 vol% (odds ratio (OR) 5.5, 95% confidence interval (CI) 2.1-14.5, P < 0.001) was associated with increased mortality. Although not statistically significant, there was also evidence that the odds of mortality were also greater among women (OR 2.0, 95% CI 0.98-4.2, P = 0.06). LEIRI was more likely among women (OR 2.1, 95% CI 1.2-3.9, P = 0.015) and patients with a smoking history (OR 1.8, 95% CI 1.0-3.2, P = 0.044). Finally, odds of prolonged operative time were higher among women (OR 1.4, 95% CI 1.2-1.7, P < 0.001) and patients with chronic obstructive pulmonary disease (OR 1.2, 95% CI 1.0-1.5, P = 0.033) or partial/total dependent functional status (OR 2.2, 95% CI 1.3-3.7, P = 0.003). CONCLUSIONS: Although EVAR has improved overall surgical AAA outcomes, the NSQIP data in elective EVAR demonstrate continued sex disparities in morbidity and mortality after AAA surgical repair to the detriment of female patients.

Population-Based Assessment of Aortic-Related Outcomes in Aortic Dissection, Intramural Hematoma, and Penetrating Aortic Ulcer.

BACKGROUND: The aim of the study was to analyze aortic-related outcomes after diagnosis of aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU) from a population-based approach. METHODS: Retrospective review of an incident cohort of AD, IMH, and PAU patients in Olmsted County, Minnesota from 1995 to 2015. Primary end point was aortic death. Secondary end points were subsequent aortic events (aortic intervention, new dissection, or rupture not present at presentation) and first-time diagnosis of an aortic aneurysm. Outcomes were compared with randomly selected population referents matched for age and sex in a 3:1 ratio using Cox proportional hazards regression adjusting for comorbidities. RESULTS: Among 133 patients (77 AD, 21 IMH, and 35 PAU), 57% were males, and mean age was 71.8 years (standard deviation, 14). Median follow-up was 10 years. Of 73 deaths among AD/IMH/PAU patients, 23 (32%) were aortic-related. Estimated freedom from aortic death was 84%, 80%, and 77% at 5, 10, and 15 years. There were no aortic deaths among population referents (adjusted hazard ratio [HR] for aortic death in AD/IMH/PAU, 184.7; 95% confidence interval [95% CI], 10.3-3,299.2; P < 0.001). Fifty (38%) AD/IMH/PAU patients had a subsequent aortic event (aortic intervention, new dissection, or rupture), whereas there were 8 (2%) aortic events among population referents (all elective aneurysm repairs; adjusted HR for any aortic event and aortic intervention in AD/IMH/PAU patients, 33.3; 95% CI, 15.3-72.0; P < 0.001 and 31.5; 95% CI, 14.5-68.4; P < 0.001, respectively). After excluding aortic events/interventions ≤14 days of diagnosis, AD/IMH/PAU patients remained at increased risk of any aortic event (adjusted HR, 10.8; 95% CI, 3.9-29.8; P < 0.001) and aortic intervention (adjusted HR, 9.6; 95% CI, 3.4-26.8; P < 0.001). Among those subjects with available follow-up imaging, the risk of first-time diagnosis of aortic aneurysm was significantly increased for AD/IMH/PAU patients when compared with population referents (adjusted HR, 10.9; 95% CI, 5.4-21.7; P < 0.001 and 8.3; 95% CI, 4.1-16.7; P < 0.001 for thoracic and abdominal aneurysms, respectively) and remained increased when excluding aneurysms that formed within 14 days of AD/IMH/PAU (adjusted HR, 6.2; 95% CI, 1.8-21.1; P = 0.004 and 2.8; 95% CI, 1.0-7.6; P = 0.040 for thoracic and abdominal aneurysms, respectively). CONCLUSIONS: AD/IMH/PAU patients have a substantial risk of aortic death, any aortic event, aortic intervention, and first-time diagnosis of aortic aneurysm that persists even when the acute phase (≤14 days after diagnosis) is uncomplicated. Advances in postdiagnosis treatment are necessary to improve the prognosis in these patients.

A scoping review of the rationale and evidence for cost-effectiveness analysis of fenestrated-branched endovascular repair for intact complex aortic aneurysms.

BACKGROUND: Cost-effectiveness analysis of new interventions is increasingly required by policymakers. For intact complex aortic aneurysms (CAAs), fenestrated-branched endovascular aneurysm repair (F/B-EVAR) offers a minimally invasive alternative option for patients who are physically ineligible for open surgical repair (OSR). Thus, F/B-EVAR is increasingly used, but whether it represents a cost-effective treatment option remains unknown. METHODS: A scoping review of the literature was conducted from the PubMed, Ovid Embase, and Scopus databases. They were searched to identify relevant English-language articles published from inception to December 31, 2019. All costs in the identified literature were transformed to U.S. dollar values by the following exchange rate: 1 GBP = 1.3 USD; 1 EUR = 1.1 USD. RESULTS: At this literature search, no randomized clinical trials assessing cost-effectiveness of F/B-EVAR vs OSR for intact CAAs were found. Also, no health economic evaluation studies were found regarding use of F/B-EVAR in patients unfit for OSR. A Markov model analysis based on seven observational center- or registry-based studies published from 2006 to 2014 found that the incremental cost-effectiveness ratio for F/B-EVAR vs OSR was $96,954/quality-adjusted life-year. In the multicenter French Medical and Economical Evaluation of Fenestrated and Branched Stent-grafts to Treat Complex Aortic Aneurysms (WINDOW) registry (2010-2012), F/B-EVAR had a higher cost than OSR for a similar clinical outcome and was therefore economically dominated. At 2 years, costs were higher with F/B-EVAR for juxtarenal/pararenal aneurysms and infradiaphragmatic thoracoabdominal aneurysms but similar for supradiaphragmatic thoracoabdominal aneurysms. The higher costs were related to a $24,278 cost difference of the initial admission (95% of the difference at 2 years) due to stent graft costs. Both these studies, however, included a highly varying center experience with complex endovascular aortic repair, and their retrospective design is subject to selection bias for chosen treatment, which could affect the studied outcome. In contrast, in a more recent U.S. database analysis (879 thoracoabdominal aortic aneurysm repairs, 45% OSRs), the unadjusted total hospitalization cost of OSR was significantly higher compared with F/B-EVAR (median, $44,355 vs $36,612; P = .004). In-hospital mortality as well as major complications were two to three times higher after OSR, indicating that endovascular repair might be the economically dominant strategy. CONCLUSIONS: The literature regarding cost-effectiveness analysis of F/B-EVAR for intact CAAs is scarce and ambiguous. Based on the limited nonrandomized available evidence, stent grafts are the main driver for F/B-EVAR expenses, whereas cost-effectiveness in relation to OSR may vary by health care setting and selection of patients.

Prospective nonrandomized study to evaluate cone beam computed tomography for technical assessment of standard and complex endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the utility of cone beam computed tomography (CBCT) for technical assessment of standard and complex endovascular aneurysm repair (EVAR). METHODS: Data of consecutive patients who underwent standard or complex EVAR in 2016 and 2017 at our institution were entered into a prospective database and analyzed retrospectively. There were 154 patients (126 male; mean age, 74 ± 8 years) enrolled in a prospective study between 2016 and 2017. A total of 170 aortic procedures were investigated, including 85 fenestrated-branched EVARs (F-BEVARs), 42 abdominal and thoracic EVARs, 32 EVARs with iliac branch devices, and 11 aorta-related interventions. Technical assessment was done using CBCT with and without contrast enhancement, digital subtraction angiography (DSA), and computed tomography angiography (CTA). Patients with stage 3B or stage 4 chronic kidney disease had CBCT without contrast enhancement. Radiation exposure (mean dose-area product), effective dose (ED), and amount of iodine contrast agent were analyzed. End points were presence of any endoleak, positive findings warranting possible intervention (stent kink or compression, type I or type III endoleak, dissection, thrombus), and need for secondary intervention. RESULTS: Radiation exposure and amount of iodine contrast agent were significantly higher (P < .05) for F-BEVAR compared with other aortic procedures (174±101 Gy∙cm2 vs 1135±113 Gy∙cm2 and 144±60 mL vs 122±49 mL). ED averaged 74±36 mSv for the aortic procedure, 18 ± 18 mSv for fluoroscopy, 7 ± 7 mSv for DSA acquisition, 15±7 mSv for CBCT, and 34±17 mSv for CTA imaging (P < .001). Endoleak detection was significantly higher (P < .001) with CBCT (53%) compared with DSA (14%) and CTA (46%). CBCT identified 52 positive findings in 43 patients (28%), higher for F-BEVAR compared with other aortic procedures (35% vs 16%; P = .01). Positive findings included stent compression or kink in 29 patients (17%), type I or type III endoleak in 16 patients (10%), and arterial dissection or thrombus in 7 patients (5%). Of these, 28 patients (18%) had positive findings that prompted an intraoperative (17%) or delayed intervention (1%). Another 15 patients (10%) with minor positive findings were observed with no clinical consequence. DSA alone would not have detected positive findings in 34 of 43 patients (79%), including 21 patients (49%) who needed secondary interventions. CTA diagnosed two (1%) additional endoleaks requiring intervention (one type IC, one type IIIC) that were not diagnosed by CBCT. Replacing DSA and CTA by CBCT would have resulted in 53% ± 13% reduction in amount of iodine contrast agent and 55% ± 12% reduction in ED (P < .05). CONCLUSIONS: CBCT reliably detected positive findings prompting immediate revisions in nearly one of five patients, with the highest rates among F-BEVAR patients. Detection of any endoleak was higher with CBCT compared with DSA or CTA, but most endoleaks were observed. DSA alone failed to detect positive findings warranting revisions.

Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts.

OBJECTIVE: The objective of this study was to investigate changes in health-related quality of life (QOL) in patients treated for pararenal aortic aneurysms (PAAs) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated-branched endovascular aneurysm repair (F-BEVAR). METHODS: A total of 159 consecutive patients (70% male; mean age, 75 ± 7 years) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (2013-2016). All patients were observed for at least 12 months (mean follow-up time, 27 ± 12 months). Patients' health-related QOL was assessed using the 36-Item Short Form Health Survey questionnaire at baseline (N = 159), 6 to 8 weeks (n = 136), 6 months (n = 129), and 12 months (n = 123). Physical component scores (PCSs) and mental component scores (MCSs) were compared with historical results of patients enrolled in the endovascular aneurysm repair (EVAR) 1 trial who were treated by standard EVAR for simple infrarenal abdominal aortic aneurysms. RESULTS: There were 57 patients with PAAs and 102 patients with TAAAs (50 extent IV and 52 extent I-III TAAAs). There were no 30-day deaths, in-hospital deaths, conversions to open surgery, or aorta-related deaths. Survival was 96% at 1 year and 87% at 2 years. Major adverse events occurred in 18% of patients, and 1-year reintervention rate was 14%. There were no statistically significant differences between the groups in 30-day outcomes. Patients treated for TAAAs had lower baseline scores compared with those treated for PAAs (P < .05). PCS declined significantly 6 to 8 weeks after F-BEVAR in both groups and returned to baseline values at 12 months in the PAA group but not in the TAAA group. Patients with TAAAs had significantly lower PCSs at 12 months compared with those with PAAs (P < .001). There was no decline in mean MCS. Major adverse events were associated with decline in PCS assessed at 6 to 8 weeks (P = .021) but not in the subsequent evaluations. Reinterventions had no effect on PCS or MCS. Overall, patients treated by F-BEVAR had similar changes in QOL measures as those who underwent standard EVAR in the EVAR 1 trial, except for lower PCS in TAAA patients at 12 months. CONCLUSIONS: Patients treated for TAAAs had lower scores at baseline in their physical aspect of health-related QOL. F-BEVAR was associated with significant decline in PCSs in both groups, which improved after 2 months and returned to baseline values at 12 months in patients with PAAs but not in those with TAAAs. Patients treated for PAAs had similar changes in QOL compared with those treated for infrarenal aortic aneurysms with standard EVAR.

Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the impact of advanced imaging applications and cone beam computed tomography (CBCT) on radiation exposure of the patient and operator and detection of technical problems during fenestrated-branched endovascular aortic repair (F-BEVAR) for treatment of pararenal aneurysms and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 386 consecutives patients (289 male; mean age, 75 ± 8 years) treated by F-BEVAR for 196 pararenal aneurysms and 190 TAAAs (mean, 3.4 ± 0.9 targeted vessels/patient) between 2007 and 2017. Radiation exposure (cumulative air kerma) was analyzed in three fixed imaging systems used between 2007 and 2011 (system 1), 2012 and 2016 (system 2), and 2016 and 2017 (system 3). Onlay fusion and CBCT were available with systems 2 and 3, whereas digital zoom with fusion overlay was used with system 3. Operator effective dose was measured per month using a radiation dosimeter badge. Computed tomography angiography and CBCT were analyzed for findings requiring immediate revision or secondary interventions. End points were patient radiation exposure; operator effective dose; procedure technical success; and 30-day rates of mortality, major adverse events, and secondary interventions. RESULTS: F-BEVAR was performed using system 1 in 98 patients, system 2 in 198 patients, and system 3 in 90 patients. Use of onlay fusion/CBCT was 0% with system 1, 42% with system 2, and 98% with system 3. Procedures performed with onlay fusion/CBCT had significantly (P < .05) higher technical success (99.4% vs 98.8%) and lower contrast material volume (155 ± 58 mL vs 172 ± 80 mL), fluoroscopy time (83 ± 34 minutes vs 94 ± 49 minutes), and cumulative air kerma (2561 ± 1920 mGy vs 3767 ± 2307 mGy). Despite higher case volume and increasing complexity during the experience, operator effective dose decreased to 9 ± 4 × 10-2 mSv/case with system 3 compared with 26 ± 3 × 10-2 mSv/case with system 1 and 20 ± 2 × 10-2 mSv/case with system 2 (P = .001). Among 219 patients who had no CBCT, 18 (8%) had computed tomography angiography findings that prompted secondary interventions before dismissal. Conversely, among 167 patients who had CBCT, 14 patients (8%) had intraoperative CBCT findings requiring immediate revision, with no additional secondary interventions. Patients treated with onlay fusion/CBCT had significantly (P < .05) lower mortality (4% vs 1%), major adverse events (43% vs 19%), and secondary interventions (10% vs 4%) at 30 days. CONCLUSIONS: Radiation exposure and operator effective dose significantly decreased with evolution of F-BEVAR experience and use of advanced imaging applications such as onlay fusion and CBCT. CBCT allowed immediate assessment and identified intraoperative technical problems, leading to immediate revision and avoiding early secondary interventions.

Population-Based Assessment of the Incidence of Aortic Dissection, Intramural Hematoma, and Penetrating Ulcer, and Its Associated Mortality From 1995 to 2015.

Background Aortic syndromes (ASs), including aortic dissection, intramural hematoma, and penetrating aortic ulcer, carry significant acute and long-term morbidity and mortality. However, the contemporary incidence and outcomes of AS are unknown. Methods and Results We used the Rochester Epidemiology Project record linkage system to identify all Olmsted County, MN, residents with AS (1995-2015). Diagnostic imaging, medical records, and death certificates were reviewed to confirm the diagnosis and AS subtype. Age- and sex-adjusted incidence rates were estimated using annual county-level census data. Survival for patients with AS was compared with age- and sex-matched controls using Cox regression to adjust for comorbid conditions. We identified 133 patients with AS (77, aortic dissection; 21, intramural hematoma; and 35, penetrating aortic ulcer). Average age was 71.8 years (SD=14.1), and 57% were men. The age- and sex-adjusted incidence was 7.7 per 100 000 person-years, was higher for men than women (10.2 versus 5.7 per 100 000 person-years), and increased with age. Among subtypes, the incidence of aortic dissection was highest (4.4 per 100 000 person-years), whereas the incidence of penetrating aortic ulcer and intramural hematoma was lower (2.1 and 1.2 per 100 000 person-years). Overall, the incidence of AS was stable over time ( P trend=0.33), although the incidence of penetrating aortic ulcer seemed to increase from 0.6 to 2.6 per 100 000 person-years ( P=0.008) with variability over the study interval. Patients with AS had more than twice the mortality rate at 5, 10, and 20 years when compared with population-based controls (5-, 10-, and 20-year mortality 39%, 57%, and 91% versus 18%, 41%, and 66%; overall adjusted mortality hazards ratio=2.1; P<0.001). Survival was lower than expected up to 90 days after AS diagnosis and did not differ significantly by subtype or by 5-year strata of diagnosis. Conclusions Overall, the incidence of aortic dissection and intramural hematoma has remained stable since 1995, despite the decline noted for other cardiovascular disease. AS confers increased early and long-term mortality that has not changed. These data highlight the need to improve long-term care to impact the prognosis of this patient group.

Assessment of aortic wall thrombus predicts outcomes of endovascular repair of complex aortic aneurysms using fenestrated and branched endografts.

OBJECTIVE: The goal of this study was to investigate the correlation between atherothrombotic aortic wall thrombus (AWT) and clinical outcomes in patients treated by fenestrated-branched endovascular aortic repair (F-BEVAR) and present a new classification system for assessment of AWT burden. METHODS: The clinical data of 301 patients treated for pararenal and thoracoabdominal aortic aneurysms (TAAAs) by F-BEVAR was reviewed. The study excluded 89 patients with extent I to III TAAA because of extensive laminated thrombus within the aneurysm sac. Computed tomography angiograms were analyzed in all patients to determine the location, extent, and severity of atherothrombotic AWT. The aorta was divided into three segments: ascending and arch (A), thoracic (B) and renal-mesenteric (C). Volumetric measurements (cm3) of AWT were performed using TeraRecon software (TeraRecon Inc, Foster City, Calif). These volumes were used to create an AWT index by dividing the AWT volume from the total aortic volume. A classification system was proposed using objective assessment of the number of affected segments, thrombus type, thickness, area, and circumference. Clinical outcomes included 30-day mortality, neurologic and gastrointestinal complications, renal events (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease [RIFLE]), and solid organ infarction. RESULTS: The study included 212 patients, 169 men (80%) and 43 women (20%), with a mean age of 76 ± 7 years. A total of 700 renal-mesenteric arteries were incorporated (3.1 ± 1 vessels/patient). AWT was classified as mild in 98 patients (46%) and was considered moderate or severe in 114 (54%). There was one death (0.5%) at 30 days. Solid organ infarction was present in 50 patients (24%), and acute kidney injury occurred in 45 patients (21%) by RIFLE criteria. An association with higher AWT indices was found for time to resume enteral diet (P = .0004) and decline in renal function (P = .0003). Patients with acute kidney injury 2 by RIFLE criterion had significantly higher (P = .002) AWT index scores in segment B. Spinal cord injury occurred in three patients (1.4%) and stroke in four (1.9%), but were not associated with the AWT index. Severity of AWT using the new proposed classification system correlated with the AWT index in all three segments (P < .001). Any of the end points occurred in 35% of the patients with mild and in 53% of those with moderate or severe AWT (P = .016). CONCLUSIONS: AWT predicts solid organ infarction, renal function deterioration, and longer time to resume enteral diet after F-BEVAR of pararenal and type IV TAAAs. Evaluation of AWT should be part of preoperative planning and decision making for selection of the ideal method of treatment in these patients.

Outcomes of Women Treated for Popliteal Artery Aneurysms.

BACKGROUND: Popliteal artery aneurysms (PAAs) in women are rare and their outcomes compared with men with PAA are unknown. The purpose of this study was to compare the surgical outcomes of PAA of women with men. METHODS: All patients who underwent PAA repair at a single institution from 1985 to 2013 were reviewed. All women with degenerative PAA treated during that time frame were matched on year of repair to men. Presentation, mode of repair, and outcomes were reviewed. Survival and amputation-free survival were evaluated by life table analysis. RESULTS: During the study interval, 8 women with degenerative PAA underwent surgical treatment (1.6% of 485 total PAA repairs). The overall median follow-up was 5 years (range 1 month to 19 years), but the median follow-up was shorter for women than men (1.6 vs. 6 years, P = 0.04). At the time of repair, women were of similar age compared with men (73.5 vs. 71.7 years) and had similar aneurysm size (2.7 vs. 2.9 cm). Women had similar urgency (25 vs. 17.5% emergent) and symptomatic status (50% vs. 55% acute) even though 7 of the 8 women had a thrombosed PAA at the time of repair. Operative time, approach, graft type, and inflow and outflow sources were similar between genders. No women received endovascular repair (0% vs. 10%, P = 0.5). One patient of each gender underwent major amputation (one woman on post-operative day 158 and one man on post-operative day 3). Overall, women had lower survival and amputation-free survival at 2 years (51% vs. 100% and 20% vs. 94%, P < 0.01 for both, standard error 0.2). CONCLUSIONS: PAA requiring intervention in women is a rare clinical occurrence. Although our series is limited, women requiring PAA repair had higher long-term mortality compared with men with a similar pathology and treatment strategy.

The Cook Zenith AAA endovascular graft.

From its inception in 1993, the Cook Zenith endovascular abdominal aortic aneurysm (AAA) graft presented a more complex but very controlled deployment mechanism. It has undergone several modifications since its first implantation and now can accommodate aortic neck diameters up to 32 mm and iliac artery diameters up to 20 mm. In addition, it possesses an uncovered, barbed suprarenal stent to allow for transrenal fixation of the device and has been loaded into low-profile, flexible, hydrophilic sheaths, which facilitate device delivery. The major advantages of the Zenith endograft include suprarenal fixation, a flexible delivery system, and the ability to treat a broad range of aortic and iliac artery diameters. This review will discuss the evolution of the Cook Zenith abdominal aortic aneurysm endovascular graft and will focus on the history and development of the device, device description and characteristics, and a thorough literature review focusing on the US Pivotal Study 4-year results, device-specific outcomes, factors associated with poor results, transrenal fixation and renal function, endoleaks, migration, aneurysm sac shrinkage, secondary procedures, and device cost.