Assessment of fitness for open repair in patients with infrarenal abdominal aortic aneurysms.

OBJECTIVE: Endovascular aortic repair (EVAR) was originally designed as a treatment modality for patients with abdominal aortic aneurysms (AAAs) deemed unfit for open repair. However, the definition of "unfit for open repair" is largely subjective and heterogenous. The purpose of this study was to compare patients deemed unfit for open repair who underwent EVAR to a matched cohort who underwent open repair for infrarenal AAAs. METHODS: The Vascular Quality Initiative of the Society for Vascular Surgery was queried for patients who underwent EVAR and open infrarenal AAA repair from 2003 to 2022. Patients that underwent EVAR were included if they were deemed unfit for open repair by the operating surgeon. EVAR patients deemed unfit because of a hostile abdomen were excluded. Patients in both the open and EVAR datasets were excluded if their repair was deemed non-elective or if they had prior aortic surgery. EVAR patients were matched to a cohort of open patients. The primary outcome for this study was 1-year mortality. Secondary outcomes included 30-day mortality, major adverse cardiac events, pulmonary complications, non-home discharge, reinterventions, and 5-year survival. RESULTS: A total of 5310 EVAR patients were identified who were deemed unfit for open repair. Of those, 3028 EVAR patients (57.0%) were able to be matched 1:1 to a cohort of open patients. Open patients had higher rates of major adverse cardiac events (20.2% vs 4.4%; P < .001), pulmonary complications (12.8% vs 1.6%; P < .001), non-home discharges (28.5% vs 7.9%; P < .001), and 30-day mortality (4.5% vs 1.4%; P < .001). There were no differences in early survival, but open repair had better middle and late survival compared with EVAR over the course of 5 years. A total of 74 EVAR patients (2.4%) had reinterventions during the study period. EVAR patients that required interventions had higher 1-year (40.5% vs 7.3%; P < .001) and 5-year mortality (43.2% vs 14.1%; P < .001) compared with those that did not require reinterventions. EVAR patients who had reinterventions had higher 1-year (40.5% vs 6.3%; P < .001) and 5-year (43.2% vs 20.3%; P = .006) mortality compared with their matched open cohort. CONCLUSIONS: Patients undergoing EVAR for AAAs who are deemed unfit for open repair have better perioperative morbidity and mortality compared with open repair. However, patients who had an open repair had better middle and late survival over the course of 5 years. The categorization of unfitness for open surgery may be inaccurate and re-evaluation of this terminology/concept should be undertaken.

Image-based assessment of aortoiliac aneurysm anatomical characteristics in patients from the global iliac branch study.

OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.

Association of Premature Menopause With Risk of Abdominal Aortic Aneurysm in the Women's Health Initiative.

OBJECTIVE: To determine if premature menopause and early menarche are associated with increased risk of AAA, and to explore potential effect modification by smoking history. SUMMARY OF BACKGROUND DATA: Despite worse outcomes for women with AAA, no studies have prospectively examined sex-specific risk factors, such as premature menopause and early menarche, with risk of AAA in a large, ethnically diverse cohort of women. METHODS: This was a post-hoc analysis of Women's Health Initiative participants who were beneficiaries of Medicare Parts A&B fee-for-service. AAA cases and interventions were identified from claims data. Follow-up period included Medicare coverage until death, end of follow-up or end of coverage inclusive of 2017. RESULTS: Of 101,119 participants included in the analysis, the mean age was 63 years and median follow-up was 11.3 years. Just under 10,000 (9.4%) women experienced premature menopause and 22,240 (22%) experienced early men-arche. Women with premature menopause were more likely to be overweight, Black, have >20 pack years of smoking, history of cardiovascular disease, hypertension, and early menarche. During 1,091,840 person-years of follow-up, 1125 women were diagnosed with AAA, 134 had premature menopause (11.9%), 93 underwent surgical intervention and 45 (48%) required intervention for ruptured AAA. Premature menopause was associated with increased risk of AAA [hazard ratio 1.37 (1.14, 1.66)], but the association was no longer significant after multivariable adjustment for demographics and cardiovascular disease risk factors. Amongst women with ≥20 pack year smoking history (n = 19,286), 2148 (11.1%) had premature menopause, which was associated with greater risk of AAA in all models [hazard ratio 1.63 (1.24, 2.23)]. Early menarche was not associated with increased risk of AAA. CONCLUSIONS: This study finds that premature menopause may be an important risk factor for AAA in women with significant smoking history. There was no significant association between premature menopause and risk of AAA amongst women who have never smoked. These results suggest an opportunity to develop strategies for better screening, risk reduction and stratification, and outcome improvement in the comprehensive vascular care of women.

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.

Lipoprotein(a) levels and risk of abdominal aortic aneurysm in the Women's Health Initiative.

OBJECTIVE: Few studies have prospectively examined the associations of lipoprotein(a) [Lp(a)] levels with the risk of abdominal aortic aneurysm (AAA), especially in women. Accounting for commonly recognized risk factors, we investigated the baseline Lp(a) levels and the risk of AAA among postmenopausal women participating in the ongoing national Women's Health Initiative. METHODS: Women's Health Initiative participants with baseline Lp(a) levels available who were beneficiaries of Medicare parts A and B fee-for-service at study enrollment or who had aged into Medicare at any point were included. Participants with missing covariate data or known AAA at baseline were excluded. Thoracic aneurysms were excluded owing to the different pathophysiology. The AAA cases and interventions were identified using the International Classification of Diseases, 9th and 10th revision, codes and Current Procedural Terminology codes from claims data. Hazard ratios were computed using Cox proportional hazard models according to the quintiles of Lp(a). RESULTS: The mean age of the 6615 participants included in the analysis was 65.3 years. Of the 6615 participants, 66.6% were non-Hispanic white, 18.9% were black, 7% were Hispanic and 4.7% were Asian/Pacific Islander. Compared with the participants in the lowest Lp(a) quintile, those in higher quintiles were more likely to be overweight, black, and former or current smokers, to have hypertension, hyperlipidemia, and a history of cardiovascular disease, and to use menopausal hormone therapy and statins. During 65,476 person-years of follow-up, with a median of 10.4 years, 415 women had been diagnosed with an AAA and 36 had required intervention. More than one half had required intervention for a ruptured AAA. We failed to find a statistically significant association between Lp(a) levels and incident AAA. Additional sensitivity analyses stratified by race, with exclusion of statin users and alternative categorizations of Lp(a) using log-transformed levels, tertiles, and a cutoff of >50 mg/dL, were conducted, which did not reveal any significant associations. CONCLUSIONS: We found no statistically significant association between Lp(a) levels and the risk of AAA in a large and well-phenotyped sample of postmenopausal women. Women with high Lp(a) levels were more likely to be overweight, black, and former or current smokers, and to have hypertension, hyperlipidemia, and a history of cardiovascular disease, or to use hormone therapy and statins compared with those with lower Lp(a) levels. These findings differ from previous prospective, case-control, and meta-analysis studies that had supported a significant relationship between higher Lp(a) levels and an increased risk of AAA. Differences in the association could have resulted from study limitations or sex differences.

Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the clinical impact of iliac artery aneurysms (IAAs) in a population of patients with juxtarenal and thoracoabdominal aortic aneurysms being treated with fenestrated or branched aortic endografts. METHODS: Data from 364 patients with IAA (33%) were extracted from the 1118 patients treated for juxtarenal or thoracoabdominal aortic aneurysms with a fenestrated or branched aortic endograft in a physician-sponsored investigational device exemption trial (2001-2016). IAAs were defined as ≥21 mm in diameter, as measured by an imaging core laboratory. Outcomes were assessed by univariate and multivariable analysis. RESULTS: IAAs were unilateral in 219 (60%) and bilateral in 145 (40%) of the 364 patients. Treatment was iliac leg endoprosthesis without coverage of the hypogastric artery (seal distal to the IAA in the common iliac artery), placement of a hypogastric branched endograft in 105 (21%), and hypogastric artery coverage with extension into the external iliac artery in 103 (20%); 67 (13%) were untreated. Procedure duration was longer for those with IAA (5.3 ± 1.79 hours vs 4.6 ± 1.74 hours; P < .001), although hospital stay was not. There was no difference in aneurysm-related mortality and all-cause mortality for patients with unilateral and bilateral IAAs compared with those without an IAA. Treatment of patients with a hypogastric branched endograft had similar all-cause mortality compared with treatment of patients without a hypogastric branched endograft but also with an IAA. Reintervention rates were significantly higher in those with bilateral IAAs compared with no IAA (hazard ratio, 1.886; P < .001). Spinal cord ischemia trended higher in patients with bilateral IAA. CONCLUSIONS: IAA management at the time of fenestrated or branched endovascular aneurysm repair increases procedure time without increasing hospitalization. The reintervention rate and spinal cord ischemia rate are higher in patients with bilateral IAA compared with those with no IAA.

Regional variation in use and outcomes of combined carotid endarterectomy and coronary artery bypass.

OBJECTIVE: In treating concomitant carotid and coronary disease, some recommend staged carotid endarterectomy (CEA) and coronary artery bypass grafting, whereas others favor the combined approach (CCAB). Pressure to reduce surgical variation and to improve quality is real, yet little is known about how geographic practice differences affect outcomes. Using the Vascular Quality Initiative (VQI), this study evaluated regional variation in use and outcomes of CCAB. METHODS: All CCAB procedures in the VQI from 2003 to 2017 were reviewed and stratified into four regions, as defined by the United States Census Bureau. Primary outcomes included perioperative stroke, death, myocardial infarction (MI), and these as composite (SDM). A χ2 analysis was performed. RESULTS: There were 1495 CCAB procedures identified, representing 1.8% of the VQI CEAs. Regions included the following: Midwest (MW), 32%; Northeast (NE), 39%; South (S), 25%; and West (W), 4%. Most were male (70%) and white (92%). There was significant regional variation in proportional volume of CCABs to all CEAs (0.7% [W] to 2.5% [MW]; P < .001). Regional variation in patch use (78% [W] to 93% [MW]; P < .001), shunting (29% [W] to 71% [MW]; P < .001), and electroencephalography monitoring (13% [W] to 52% [NE]; P < .001) was also significant. Overall perioperative stroke was 3.6%; death, 3.0%; and SDM, 6.8%. No regional difference was seen in outcomes of mortality (1.5% [MW] to 4.2% [NE]; P = .05), stroke (2.8% [NE] to 4.4% [MW]; P = .52), and MI (0.6% [MW] to 1.8% [W]; P = .62). When the Bonferroni correction was used, there remained no difference in stroke, MI, or SDM across regions, but mortality became significant. Using the Society for Vascular Surgery guidelines for consideration of CCAB, the minority of patients fell within the symptomatic carotid stenosis (SYMP, 15%; n = 218) or severe (≥70%) asymptomatic bilateral carotid disease (BIL, 18%; n = 267) categories. The most common indication was asymptomatic unilateral severe carotid stenosis (UNI, 37%; n = 552). There were no differences in regional outcomes stratified by indication (SYMP, BIL, UNI). Overall, when SYMP and BIL were compared with UNI, UNI had lower rates of stroke (2.4% vs 4.9%; P = .03) but similar MI (0.7% vs 1.2%; P = .40) and mortality (2.2% vs 2.5%; P = .75). CONCLUSIONS: Significant variation exists across VQI centers in the use of CCAB. Despite differences in volume and practices, regional perioperative outcomes are similar. UNI is the most commonly used indication and has lower stroke rates relative to SYMP and BIL. CCAB is performed well across the United States, but most patients fall outside of Society for Vascular Surgery guidelines.

Diffusion of new technology in health care: the case of aorto-iliac occlusive disease.

BACKGROUND: The objective of the current study was to characterize temporal trends in the treatment of aorto-iliac occlusive disease (AIOD) and the impact of the introduction of less invasive therapy on overall intervention rates. METHODS: Patients with diagnostic codes for AIOD, and procedure codes for aortofemoral bypass (AFB) or iliac artery angioplasty and stenting were selected from the Nationwide Inpatient Sample for 1996 to 2000. Utilization rates of both intervention types were determined. Outcome variables including in-hospital mortality and duration of stay were assessed. RESULTS: The rate of iliac artery angioplasty and stenting increased 850%, from 0.4 to 3.4 cases per 100,000 adults (P <.001). The rate of AFB declined 15.5%, from 5.8 to 4.9 cases per 100,000 adults (P <.005). Older age, white race, and higher-income patients were more likely to undergo angioplasty and stenting. AFB had a higher mortality rate, longer duration of stay, and higher hospital charges compared to angioplasty and stenting. CONCLUSIONS: Iliac artery angioplasty and stenting has rapidly gained a large market share in the treatment of AIOD. Acceptable clinical outcomes have likely lowered the threshold for treatment and contributed to the rapid diffusion of this technology for the treatment of AIOD.