Greater Patient Travel Distance is Associated with Perioperative and One-Year Cost Increases After Complex Aortic Surgery.

BACKGROUND: With increasing regionalization of complex aortic surgery within fewer US centers, patients may face increased travel burden when accessing aortic surgery. Longer travel distances have been associated with inferior outcomes after major surgery; however, the impacts of distance on reinterventions and costs have not been described. This study aims to assess the association between patient travel distance and longer-term outcomes including costs and reinterventions after complex aortic surgery. METHODS: A retrospective review was conducted of all patients in the Vascular Implant Surveillance and Interventional Outcomes Network database undergoing complex endovascular aortic repair including internal iliac or visceral vessel involvement, complex thoracic endovascular aortic repair including Zone 0-2 proximal extent or branched devices, and complex open abdominal aortic aneurysm repair including suprarenal or higher clamp sites. Travel distance was stratified by Rural-Urban Commuting Area population-density category. Multinomial logistic regression models, negative-binomial models, and zero-inflated Poisson models were used to assess the association between travel distance and index procedural and comprehensive first-year costs, long-term imaging, and long-term reinterventions, respectively. RESULTS: Between 2011 and 2018, 8,782 patients underwent complex aortic surgery in the Vascular Implant Surveillance and Interventional Outcomes Network database, including 4,822 complex endovascular aortic repairs, 2,672 complex thoracic endovascular aortic repairs, and 1,288 complex open abdominal aortic aneurysm repairs. Median travel distance was 22.8 miles (interquartile range 8.6-54.8 miles, range 0-2,688.9 miles). Median age was 75 years for all distance quintiles. Patients traveling farther were more likely to be female (26.8% in quintile 5 [Q5] vs. 19.9% in Q1, P < 0.001) and to have had a prior aortic surgery (20.8% for Q5 vs. 5.9% for Q1, P < 0.001). Patients traveling farther had higher index procedural costs, with adjusted odds ratio (OR) 2.34 (95% confidence interval [CI] 1.86-2.94, P < 0.0001) of being in the highest cost tertile versus lowest for patients in Q5 vs. Q1. For patients with ≥ 1-year follow-up, those traveling farther had higher imaging costs, with adjusted Q5 OR 1.55 (95% CI 1.22-1.95, P = 0.0002), and comprehensive first-year costs, with adjusted Q5 OR 2.06 (95% CI 1.57-2.70, P < 0.0001). In contrast, patients traveling farther had similar numbers of reinterventions and imaging studies postoperatively. CONCLUSIONS: Patients traveling farther for complex aortic surgery have higher procedural costs, postoperative imaging costs, and comprehensive first-year costs. These patients should be targeted for increased care coordination for improved outcomes and healthcare system burden.

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.

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.

Sex-related outcomes after open type IV thoracoabdominal aortic aneurysm repair.

OBJECTIVE: Although outcomes after infrarenal abdominal aortic aneurysm surgery are worse in women, sex-specific differences in outcomes after open type IV thoracoabdominal aortic aneurysm (TAAA) surgery are undefined. The goal of this study was to define sex-based disparities in short- and long-term outcomes after open type IV TAAA surgery. METHODS: All open type IV TAAA repairs performed during 27 years were evaluated using a single institutional database. Charts were retrospectively evaluated for major adverse events (in-hospital death, other major in-hospital complication) and long-term complications (graft- and aortic-related events and death). Univariate analyses were performed using the Fisher's exact test for categorical variables and Wilcoxon rank-sum testing for continuous variables. Logistic multivariable regression was used for the in-hospital end points death and major complication, and survival analyses were performed with Cox proportional hazards modeling and Kaplan-Meier techniques. RESULTS: During the 27-year study period, 234 patients had an open type IV TAAA repair; 85 were female and 149 were male. There were 26 (17.5%) men and 16 (18.8%) women who suffered a major in-hospital complication/death. There were eight (3.4%) in-hospital deaths, all occurring in men. Unadjusted survival at 5 years was 67.9% for women and 58.4% for men. Multivariable analyses revealed no sex-based difference in combined major in-hospital events and death (female: odds ratio [OR], 1.8; confidence interval [CI], 0.83-4.0; P = .13) or any complication (OR, 1.0; CI, 0.55-1.8; P = .99). However, women were less likely than men to be discharged to home (OR, 0.28; CI, 0.13-0.60; P = .001) and had decreased survival compared with men after discharge (hazard ratio, 2.1; CI, 1.2-3.5; P = .008). CONCLUSIONS: No sex-based differences were found for the in-hospital outcomes of death or major complication after open type IV TAAA repair. However, women are less likely than men to be discharged home. Among those who survive the index operation, female sex portends decreased survival following discharge after repair.

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.

Educational resources for vascular laboratory education in vascular surgery residencies and fellowships: Survey of Vascular Surgery Program Directors.

OBJECTIVE: The Registered Physician in Vascular Interpretation (RPVI) credential is a prerequisite for certification by the Vascular Surgery Board of the American Board of Surgery. Of concern, as more current trainees and recent program graduates take the Physician Vascular Interpretation (PVI) examination, vascular surgery trainee pass rates have decreased. Residents and fellows have a lower PVI examination pass rates than practicing vascular surgeons. The purpose of this study was to assess current vascular laboratory (VL) training for vascular surgery residents and fellows and to identify gaps that residency and fellowship programs might address. METHODS: Program directors (PDs) of Accreditation Council for Graduate Medical Education-accredited vascular surgery programs (107 fellowships, 53 integrated residency programs) were surveyed using a web-based tool. Responses were submitted anonymously. Data collected included information about the program, the PD, accreditation status of the VL, and the curriculum used to meet the PVI prerequisites. Concurrent data (June 2017) on the credentials of all PDs were obtained from the Alliance for Physician Certification and Advancement (APCA). RESULTS: Sixty-one of 117 PDs participated in the survey (52% response rate). Of these, 44 individuals (72% of responders) reported they held the RPVI and/or Registered Vascular Technologist credential. Records from APCA indicated that 51 of 117 PDs of accredited vascular surgery residencies and fellowships (44%) had an RPVI/Registered Vascular Technologist credential. Ninety-four percent reported that their VL was accredited. Practical VL experience for trainees was reported to be 20 hours or less by 62% of respondents. The use of a structured curriculum for practical experience was reported by only 15 programs. Programs with fellowships established for more than 10 years were more likely to have a structured program for didactic instruction (P = .03). Only 23 programs reported a dedicated VL rotation. Didactic instruction provided was 20 hours or less for 75% of the cohort. CONCLUSIONS: In the absence of a standardized VL curriculum, there is variation in the VL instruction provided to trainees. Fellowship programs with longer histories have more structured instruction, but time allocated to VL education is substantially less than the 30 hours of didactic and 40 hours of practical experience recommended by the APCA. Programs and learners may benefit from the development of VL training guidelines and curriculum resources.

Use of extracorporeal bypass is associated with improved outcomes in open thoracic and thoracoabdominal aortic aneurysm repair.

OBJECTIVE: There is no consensus on the use or benefit of extracorporeal circulation (EC) during aneurysm repair of the descending thoracic aorta (DTA) or thoracoabdominal aorta (TAA). We evaluated the role of EC during DTA or TAA aneurysm repair using U.S. Medicare data. METHODS: Medicare (2004-2007) patients undergoing open repair of nonruptured DTA or TAA aneurysm were identified by International Classification of Diseases, Ninth Revision code. Specific exclusions included ascending aortic or arch repairs, concomitant cardiac procedures, and procedures employing deep hypothermic circulatory arrest. The impact of EC (code 3961) on early and late outcomes was analyzed using univariate analysis and multivariable regression. Survival was assessed using Kaplan-Meier analysis and Cox proportional hazards regression models. RESULTS: There were 4230 patients who had repair of intact DTA or TAA aneurysms, 2433 (57%) of which employed EC. Differences in baseline clinical features of EC and non-EC patients showed that patients undergoing aortic reconstruction with EC were older (73 ± 1 years vs 72 ± 1 years; P = .002), were more likely to be female (53% vs 47%; P < .001), and had more hypertension (56% vs 53%; P = .02); they had less chronic obstructive pulmonary disease (28% vs 34%; P < .0001), peripheral vascular disease (5.7% vs 11.3%; P < .001), and chronic kidney disease (7.7% vs 5.5%; P = .003). The 30-day mortality (9.7% for EC vs 12.2%; P = .02) and any major complication (49% for EC vs 58%; P < .001) were significantly reduced with EC use. EC use was associated with a shorter length of stay (13.5 ± 13 days vs 17.2 ± 18 days; P < .01) and lower total hospital charges ($151,000 ± 140,000 vs $180,000 ± 190,000; P < .01) compared with non-EC patients. EC patients were more likely to be discharged home instead of to an extended care facility (67% vs 56%; P < .01). Multivariable regression modeling to adjust for baseline clinical differences showed EC to independently reduce the risk of operative mortality (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.65-0.97; P = .02), any complication (OR, 0.67; 95% CI, 0.59-0.76; P < .01), pulmonary complications (OR, 0.68; 95% CI, 0.59-0.79; P < .01), and acute renal failure (OR, 0.52; 95% CI, 0.44-0.61; P < .01). Long-term survival was higher (log-rank, P < .01) in EC patients at 1 year (81% ± 0.8% vs 73% ± 1%) and 5 years (67% ± 1% vs 52% ± 1%). Risk-adjusted Cox proportional hazards regression also showed that EC was independently associated with improved long-term survival (hazard ratio, 0.69; 95% CI, 0.63-0.74; P < .01). CONCLUSIONS: Although important clinical variables such as DTA or TAA aneurysm extent and spinal cord ischemic complications cannot be assessed with the Medicare database, EC use during open DTA and TAA aneurysm repair is associated with improved late survival and a significant reduction in operative mortality, morbidity, and procedural costs. These data indicate that EC should be a more widely applied adjunct in open DTA or TAA aneurysm repair.

Risk and outcome profile of carotid endarterectomy with proximal intervention is concerning in multi-institutional assessment.

OBJECTIVE: Approaching tandem bifurcation and brachiocephalic disease using carotid endarterectomy (CEA) with ipsilateral proximal endovascular intervention (IPE) has been promulgated as safe and durable. There have been recent concerns about neurologic risk with this technique. The goal of this study was to define stroke and perioperative risk with this uncommon procedure across multiple centers. METHODS: Between August 2002 and July 2016, patients who underwent CEA + IPE were identified by operative records at three institutions. Primary end points were perioperative stroke and death, restenosis, freedom from neurologic event, and need for reintervention. Factors related to these end points were analyzed. RESULTS: There were 62 patients who underwent CEA + IPE. The average age was 69 ± 9 years. Most were female 34 (55%); 56 (90%) were taking a statin and at least one antiplatelet agent. Bilateral internal carotid stenosis (>50%) was present in 32 (52%); 26 (42%) patients were symptomatic and 12 (19%) had undergone prior ipsilateral CEA. Bifurcation operations included longitudinal CEA/patch (38 [61%]), eversion CEA (20 [32%]), bypass graft (3 [5%]), and CEA/primary repair (1 [2%]). CEA was performed first in 53 (85%). All IPEs included stenting, with a single stent used in 58 (94%). Balloon-expandable stents were placed in the majority of patients (51 [82%]). Proximal arteries treated included the innominate (20 [32%]), left common carotid (32 [52%]), right common carotid (8 [13%]) and both innominate and right common carotid (2 [3%]). IPE was protected by carotid cross-clamp in 48 (77%). Shunting occurred in 14 (23%). There were four (6.5%) perioperative ipsilateral strokes and two hyperperfusion events. There were three (4.8%) operative deaths, one from stroke and two cardiovascular. Combined stroke and death rate was 11.3% and was not different between centers. Mean clinical follow-up was 6 ± 4 years. Mean imaging follow-up was 3 ± 4 years. Restenosis ≥50% at either intervention occurred in 20 (34%). Reintervention was performed for five proximal and three bifurcation failures (14%). Symptomatic status, redo operation, carotid clamp protection, multiple stents, and procedural order were not associated with operative stroke. Carotid clamp protection was associated with less restenosis (P = .003). Redo operation (P = .04) and hyperlipidemia (P = .05) were associated with reintervention. The 5-year actuarial survival was 81%, whereas freedom from stroke and reintervention were 94% and 81%, respectively. CONCLUSIONS: Perioperative stroke and death with CEA + IPE are substantial and consistent across centers. It is strikingly different from isolated CEA or CEA added to open brachiocephalic reconstruction. Restenosis is frequent, and reintervention at either the proximal stent or bifurcation is common. This technical strategy should be used cautiously and selectively reserved for those who are symptomatic with hemodynamically relevant tandem lesions and unfit for open revascularization.

Select early type IA endoleaks after endovascular aneurysm repair will resolve without secondary intervention.

OBJECTIVE: Although it is traditionally considered ominous, the natural history of early proximal attachment site endoleaks (IA) after endovascular aneurysm repair (EVAR) is not well known. Our aim was to identify risk factors for persistent type IA endoleaks and to determine their effect on long-term outcomes after EVAR. METHODS: All patients who underwent infrarenal EVAR at a single institution between 1998 and 2015 were identified. Preoperative axial imaging and intraoperative arteriograms were reviewed, and those patients with a type IA endoleak were further studied. Aneurysm features were characterized by two reviewers and were studied for predictors of persistent endoleaks at the conclusion of the case. Patient records and the Social Security Death Index were used to record 1-year and overall survival. RESULTS: We identified 1484 EVARs, 122 (8%) of which were complicated by a type IA endoleak on arteriography after graft deployment, with a median follow-up of 4 years. The majority of patients underwent additional ballooning of the proximal site (52 [43%]) or placement of an aortic cuff (47 [39%]); 30 patients (25%) received a Palmaz stent, and four patients were treated with coils or anchors. At case end, only 43 (35%) of the type IA endoleaks remained; at 1 month, only 16 endoleaks persisted (13%), and only six persisted at 1 year (6%). In multivariable analysis, the only independent predictor of persistence of type IA endoleak at the conclusion of the case was the presence of extensive neck calcifications (odds ratio [OR], 9.9; 95% confidence interval [CI], 1.4-67.9; P = .02). Thirteen patients (11%) underwent reintervention for type IA endoleaks, with a time frame ranging from 3 days postoperatively to 11 years. There were three patients (2.4%) who experienced aneurysm rupture. Postoperative type IA endoleak was associated with lower survival at 1 year (79% vs 91%; relative risk, 2.5; 95% CI, 1.1-5.4; P = .02), but it did not affect long-term survival (log-rank, P = .45). Both an increase in aneurysm sac size and failure of the endoleak to resolve by case end were independent predictors of a need for reintervention (growth: OR, 8.3; 95% CI, 2.2-31.6; P < .01; persistent endoleak: OR, 7.6; 95% CI, 1.8-31.5; P < .01). A persistent type IA endoleak was not independently associated with an increase in sac size on surveillance imaging (P = .28). CONCLUSIONS: Aneurysm rupture secondary to persistent type IA endoleak is rare, and most will resolve within 1 year. Extensive neck calcification is the only independent predictor of persistent type IA endoleak, and an increase in sac size warrants reintervention. These data suggest that select early persistent type IA endoleaks can be safely observed.

Chronic Kidney Disease Class Predicts Mortality After Abdominal Aortic Aneurysm Repair in Propensity-matched Cohorts From the Medicare Population.

INTRODUCTION: Chronic kidney disease (CKD) predicts mortality after abdominal aortic aneurysm (AAA) repair. Few studies are adequately powered to stratify outcomes by CKD severity. This study assesses the effect of CKD severity on survival after AAA repair. METHODS: Patients who underwent AAA repair from 2006 to 2007 were retrospectively identified in the Medicare database and stratified by CKD class as follows: normal (CKD class 1 and 2), moderate (CKD class 3), and severe (CKD class 4 and 5). Propensity matching (30:1) by clinical factors and procedure type was performed to derive well-matched comparative cohorts. Primary outcomes were 30-day and long-term mortality; secondary outcomes included hospital length of stay and cost. RESULTS: A total of 47,715 patients were included (96.7% normal, 1.88% moderate, and 1.65% severe). Propensity matching was corrected for differences between cohorts. Thirty-day mortality was higher in moderate (5.7% vs normal 2.5%; P < 0.01) and severe (9.9% vs normal 1.8%; P < 0.01) groups. Hospital length of stay increased with CKD severity (4.4 ±â€Š3.7 days normal vs 6.5 ±â€Š4.2 days moderate CKD; P < 0.01/4.7 ±â€Š3.8 days normal vs 9.1 ±â€Š4.5 days severe CKD; P < 0.01) as did cost ($23 ±â€Š14K normal vs $25 ±â€Š16K moderate; P < 0.01 /$22 ±â€Š11K normal vs $29 ±â€Š22K severe; P < 0.01). Three-year survival favored the normal cohort (80% vs 64% moderate; log rank P < 0.01 /82% normal vs 44% severe; log rank P < 0.01). CONCLUSIONS: CKD severity is an important predictor of perioperative mortality and long-term survival after AAA repair in propensity-matched cohorts. The 5-fold increase in 30-day mortality and 44% in 3-year survival suggest that elective AAA repair is contraindicated in most severe CKD patients.

A risk prediction model for determining appropriateness of CEA in patients with asymptomatic carotid artery stenosis.

OBJECTIVE: The benefit of carotid endarterectomy (CEA) over medical therapy in patients with asymptomatic carotid artery stenosis is predicated upon a life expectancy of at least 5 years after the procedure. The goal of this study was to create a scoring system for prediction of 5-year survival after CEA that can be used to triage patients with ACAS. METHODS: All patients who underwent CEA for severe asymptomatic carotid stenosis from 1989 to 2005 were identified. Long-term survival was determined by a review of hospital records and the social security death index. Because all patients had at least 5-year follow-up, a logistic regression of predictors of survival at 5 years was performed and the odds ratios associated with particular significant comorbidities were used to create a scoring system to predict survival. The scoring system was then validated within the cohort using the Hosmer-Lemeshow Test and a derivation/validation receiver operating characteristic (ROC) curve. RESULTS: There were 2004 CEA performed in 1791 patients. The average follow-up was 130 ± 49 months. The clinical profile of the cohort data included 84% hypertension, 56% coronary artery disease (CAD), 24% diabetes, and 71% on statins. The 30-day stroke rate was 1.1% and the death rate was 0.7%. The actual 5-year survival was 73%. Logistic regression yielded the following predictors of mortality: age (by decade) (odds ratio [OR] = 1.8, P < 0.0001), CAD (OR = 1.5, P = 0.0007), chronic obstructive pulmonary disease (OR = 2.5; P < 0.0001), diabetes (OR = 1.7, P < 0.0001), neck radiation (OR = 2.6, P = 0.005), no statin (OR = 2.1, P < 0.0001), and creatinine more than 1.5 (OR = 2.6, P < 0.0001). These variables were then assigned a hierarchal point scoring system in accordance with the OR value. The 5-year survival based on the scoring system was as follows: 0 to 5 points = 92.5%, 6 to 8 points = 83.6%, 9 to 11 points = 63.7%, 12 to 14 points = 46.5%, and more than 15 points = 33.8%. The Hosmer-Lemeshow test validated the scoring system (P = 0.26) and there was no difference in the ROC curves (C statistic = 0.74 vs 0.73). CONCLUSIONS: This validated scoring system can be a useful tool for determining which patients are likely to benefit most from CEA based on the probability of long-term survival. Given that the 5-year survival of patients in the medical arm of the asymptomatic CEA trials was 60% to 70%, it is reasonable to conclude that patients who score 0 to 8 points are excellent candidates for CEA whereas most patients with ≥12 points should be managed with medical therapy alone.

Impact of hospital volume and type on outcomes of open and endovascular repair of descending thoracic aneurysms in the United States Medicare population.

OBJECTIVE: Favorable outcomes of thoracic endovascular aortic repair (TEVAR) compared with open repair for descending thoracic aortic aneurysms (DTAs) have led to increasing TEVAR use. We evaluated the effect of case volume and hospital teaching status on clinical outcomes of intact DTA repair. METHODS: The Medicare Provider Analysis and Review (MEDPAR) data set (2004 to 2007) was queried to identify open repair or TEVAR for DTA. Hospitals were stratified by DTA volume into high volume (HV; ≥ 8 cases/y) or low volume (LV; <8 cases/y) and teaching or nonteaching. The effect of hospital variables on the primary study end point of 30-day mortality and secondary end points of 30-day complications and long-term survival after open repair and TEVAR DTA repair were studied using univariate testing, multivariable regression modeling, Kaplan-Meier survival analysis, and Cox proportional hazards regression modeling. RESULTS: We identified 763 hospitals performing 3554 open repairs and 3517 TEVARs. Overall DTA repair increased (P < .01) from 1375 in 2004 to 1987 in 2007. The proportion of hospitals performing open repair significantly decreased from 95% in 2004 to 57% in 2007 (P < .01), whereas those performing TEVAR increased (P < .01) from 24% to 76%. Overall repair type shifted from open (74% in 2004, the year before initial commercial availability of TEVAR) to TEVAR (39% open in 2007; P < .01). The fraction of open repairs at LV hospitals decreased from 56% in 2004 to 44% in 2007 (P < .01), whereas TEVAR increased from 24% in 2004 to 51% in 2007 (P < .01). Overall mortality during the study interval for open repair was 15% at LV hospitals vs 11% at HV hospitals (P < .01), whereas TEVAR mortality was similar, at 3.9% in LV vs 5.5% in HV hospitals (P = .43). LV was independently associated with increased mortality after open repair (odds ratio, 1.4; 95% confidence interval, 1.1-1.8; P < .01) but not after TEVAR. There was no independent effect of hospital teaching status on mortality or complications after open repair or TEVAR repair. CONCLUSIONS: The total number of DTA repairs has significantly increased. Operative mortality for TEVAR is independent of hospital volume and type, whereas mortality after open surgery is lower at HV hospitals, suggesting that TEVAR can be safely performed across a spectrum of hospitals, whereas open surgery should be performed only at HV hospitals.

Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent.

OBJECTIVE: Several trials have reported early superior patency of stenting over isolated angioplasty (plain old balloon angioplasty [POBA]) for infra-inguinal occlusive disease, yet long-term data are sparse. The purpose of this study was to contrast long-term clinical outcomes and costs of angioplasty alone vs angioplasty with selective stenting in the treatment of femoropopliteal occlusive disease. METHODS: Patients undergoing primary endovascular treatments of the native femoropopliteal arteries from 2002 to 2009 were divided into two groups, POBA alone or stenting based on final treatment received at their index procedure. Study end points included actuarial 5-year primary patency (using strict criteria of any hemodynamic deterioration or return of symptoms), 5-year limb salvage, and 5-year survival and hospital costs. RESULTS: Eight hundred twenty-four primary procedures were performed during the study interval; 517 (63%) were POBA and 307 (37%) were stenting. The mean follow-up duration was 33 months (range, 0-98 months). The indication for intervention in the stenting group was claudication in 71% of the patients, whereas the remaining 29% had critical limb ischemia (CLI). In the POBA cohort, the indication for treatment was claudication in 59% of the patients and CLI in the remaining 41%. A higher percentage of POBA lesions were TransAtlantic Inter-Society Consensus (TASC) II A & B when compared to stenting (91% POBA vs 73% stenting; P < .001). There was no difference in overall 5-year primary patency (POBA 36% ± 3%; stenting 41% ± 4%; P = .31), nor was there a difference in patients with claudication (POBA 42% ± 4%; stenting 45% ± 4%; P = .8). In patients with CLI, the 4-year primary patency was 27% ± 5% (POBA) vs 36% ± 8% (stenting), P = .22; the 4-year limb salvage was 80% ± 4% (POBA) vs 90% ± 5% (stenting), P = .18. There was no difference in survival between the two groups (claudication: 83% ± 3% POBA vs 84% ± 4% stenting at 5 years (P = .65), CLI: 44% ± 4% POBA vs 49% ± 6% stenting at 4 years (P = .40). Subgroup analysis by lesion anatomy showed similar primary patency between POBA and stenting for TASC II A & B lesions, while the primary patency was significantly higher at 5 years after stenting of TASC II C & D lesions (34% ± 6% vs 12% ± 9%; P < .05). Stenting increased the procedural cost by 57% when compared to POBA (P < .001) regardless of treatment indication. In addition, stenting added 45% (P < .001) to the overall hospital cost of patients treated for claudication. CONCLUSION: Stenting resulted in equivalent long-term outcomes compared to POBA when stratified by indications. However, stenting yielded statistically better primary patency in patients with TASC II C & D lesions. The lack of improved clinical outcomes and significantly higher cost of stenting supports a posture of selective use of stents (especially in TASC II A & B) in the endovascular treatment of femoropopliteal occlusive disease.

Management of diseases of the descending thoracic aorta in the endovascular era: a Medicare population study.

OBJECTIVE: Prospective trials have shown improved perioperative outcomes with endovascular repair of thoracic aortic (TEVAR) pathologies compared with conventional surgery (OPEN). There are no long-term population data detailing the impact of TEVAR on practice patterns and results of treatment of descending thoracic aortic pathology (DTA), which are the goal of this study. METHODS: All procedures performed on the DTA captured in the Medicare database from 2004 to 2007 were identified by ICD-9 codes and stratified into OPEN and TEVAR cohorts. Outcomes included perioperative mortality (χ(2)) and 5-year actuarial survival. RESULTS: There were 11,166 patients identified (4838 [43%] TEVAR vs. 6328 [57%] OPEN) with 7247 (65%) nonruptured, degenerative thoracic aortic aneurysms (TAA), 2701 (24%) descending aortic dissections, 1033 (9%) thoracic aortic ruptures, and 185 (2%) traumatic aortic tears. The distribution of cases changed significantly during the study period (P < 0.0001) with an increase in TEVAR, decrease in OPEN, and increase in total cases over time (). The perioperative mortality was lower in the TEVAR group for the entire population (360 [7.4%] TEVAR vs. 1175 [18.5%] OPEN, P < 0.0001), and for the individual pathologies: TAA (182/3529 [5%] TEVAR vs. 451/3718 [12%] OPEN, P < 0.001), dissections (76/833 [9%] TEVAR vs. 399/1868 [21%] OPEN, P < 0.001) and ruptures (87/368 [24%] TEVAR vs. 298/665 [45%] OPEN, P < 0.0001). The Kaplan-Meier curve significantly favored TEVAR for the entire cohort because of the early mortality of the OPEN cohort but the curves converged by 5 years. The 5-year survival by indication was: entire population (53.4% TEVAR vs. 53.3% OPEN, P < 0.0001), TAA (55.8% TEVAR vs. 59.7% OPEN, P = 0.84), dissection (58.2% TEVAR vs. 50.6% OPEN, P < 0.0001), ruptures (23.3% TEVAR vs. 25.3% OPEN, P = 0.001), and trauma (62.9% TEVAR vs. 50.9% OPEN, P = 0.12). CONCLUSION: There has been a significant increase in the use of TEVAR for management of diseases of the DTA. TEVAR offers a significant perioperative survival advantage when compared with OPEN regardless of the indication for repair. However, in the Medicare population, the 5-year survival is similar between the 2 cohorts.

Preoperative functional status predicts perioperative outcomes after infrainguinal bypass surgery.

OBJECTIVE: Infrainguinal surgical bypass (BPG) is a durable method for lower extremity revascularization, but is accompanied by significant 30-day morbidity and mortality (MM). The goal of this study is to relate preoperative functional status, a defined metric in the National Surgical Quality Improvement Program (NSQIP) database, to perioperative MM. METHODS: Between January 1, 2005 and December 31, 2007, all patients who underwent BPG from the NSQIP private sector database were reviewed. The primary end-point was 30-day MM. Patients were stratified by preoperative functional status: independent (IND) vs dependent (DEP). Associated patient demographic/clinical data were analyzed using univariate and multivariate methods. Composite odds ratios were constructed with clusters of high-risk comorbidities. RESULTS: There were 5639 BPG patients (4600 [81.6%] IND and 1039 [18.4%]) DEP. DEP patients were significantly older (71.6 +/- 11.8 vs 66.8 +/- 11.8 years; P < .0001), had more chronic obstructive pulmonary disease (COPD) (16.7% vs 11.4%; P < .0001), diabetes (54.2% vs 40.7%; P < .0001), dialysis dependence (16.4% vs 5.6%; P < .0001), and critical limb ischemia (64.6% vs 44.0%; P < .0001). DEP patients had a higher incidence of death (6.1% vs 1.5%; P < .0001) and major complications (30.3% vs 14.2%; P < .0001). DEP was an independent predictor of major complications (odds ratio [OR]: 2.0; 95% confidence interval [CI]: [1.7-2.4]; P < .0001) major systemic complications (2.5 [1.9-3.2]; P < .0001), major operative site complications (1.6 [1.4-1.9]; P < .0001) and death (2.3[1.6-3.4]; P < .0001). The combination of DEP with emergency surgery, Cr > 1.8, or rest pain increased the odds of major complications by five, seven, or 11-fold, respectively. The combination of DEP with hemodialysis, emergency surgery, or age > or = 80 years increased the odds of death by 13, 38, or 87-fold, respectively. CONCLUSION: Preoperative DEP is significantly correlated with all adverse 30-day outcomes in BPG patients. Furthermore, when combined in high-risk composites with specific preoperative clinical variables, DEP is associated with prohibitive MM, thereby identifying patient cohorts that may be unsuitable for BPG.