A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Anesthetic choice for arteriovenous access creation: A National Anesthesia Clinical Outcomes Registry analysis.

BACKGROUND: We sought to evaluate differences in primary anesthetic type used in arteriovenous access creation with the hypothesis that administration of regional anesthesia and monitored anesthesia care (MAC) with local anesthesia as the primary anesthetic has increased over time. METHODS: National Anesthesia Clinical Outcomes Registry data were retrospectively evaluated. Covariates were selected a priori within multivariate models to determine predictors of anesthetic type in adults who underwent elective arteriovenous access creation between 2010 and 2018. RESULTS: A total of 144,392 patients met criteria; 90,741 (62.8%) received general anesthesia. The use of regional anesthesia and MAC decreased over time (8.0%-6.8%, 36.8%-27.8%, respectively; both p < 0.0001). Patients who underwent regional anesthesia were more likely to have ASA physical status >III and to reside in rural areas (52.3% and 12.9%, respectively; both p < 0.0001). Patients who underwent MAC were more likely to be older, male, receive care outside the South, and reside in urban areas (median age 65, 56.8%, 68.1%, and 70.8%, respectively; all p < 0.0001). Multivariate analysis revealed that being male, having an ASA physical status >III, and each 5-year increase in age resulted in increased odds of receiving alternatives to general anesthesia (regional anesthesia adjusted odds ratios (AORs) 1.06, 1.12, and 1.26, MAC AORs 1.09, 1.2, and 1.1, respectively; all p < 0.0001). Treatment in the Midwest, South, or West was associated with decreased odds of receiving alternatives to general anesthesia compared to the Northeast (regional anesthesia AORs 0.28, 0.38, and 0.03, all p < 0.0001; MAC 0.76, 0.13, and 0.43, respectively; all p < 0.05). CONCLUSIONS: Use of regional anesthesia and MAC with local anesthesia for arteriovenous access creation has decreased over time with general anesthesia remaining the primary anesthetic type. Anesthetic choice, however, varies with patient characteristics and geography.

Outcomes of carotid artery stenting in patients with radiation arteritis compared with those with atherosclerotic disease.

OBJECTIVE: Head and neck malignancies are often treated with radiotherapy (RT). Nearly 80% of patients who have undergone RT will develop carotid radiation arteritis to some degree and 29% will develop stenosis >50%. Surgery in a radiated neck has higher rates of complications, and carotid artery stenting (CAS) has become the primary therapy. The outcomes for CAS in patients with radiation arteritis have not been rigorously evaluated. The objective of the present study was to evaluate the differences in perioperative outcomes, restenosis rates, the need for reintervention, and freedom from mortality between RT patients and patients with atherosclerotic disease who had undergone CAS. METHODS: The national Vascular Quality Initiative CAS dataset from 2016 to 2019 comprised the sample for analyses (n = 7343). The primary independent variable was previous head and/or neck RT. The primary endpoint was the interval to mortality. The secondary endpoints were the cumulative incidence of restenosis (>50% and >70% by duplex ultrasound) and reintervention. We also examined the following secondary perioperative endpoints: myocardial infarction, in-hospital mortality (death before discharge), neurologic events, ipsilateral stroke, and contralateral stroke. Kaplan-Meier and multivariable Cox proportional hazard models were used to assess for mortality, and cumulative incidence function estimates were used for the nonfatal endpoints. RESULTS: Of the 7218 patients, 1199 (17%) had undergone prior RT. We found a significant difference in the 3-year estimates of mortality for those with and without prior RT (9.4% and 7.5%, respectively; P = .03). Furthermore, on adjusted analysis, we observed a 58% increase in the risk of mortality for those with prior RT (adjusted hazard ratio, 1.58; 95% confidence interval, 1.13-2.21). We did not observe any differences in the risk of perioperative complications (myocardial infarction, in-hospital mortality, ipsilateral or contralateral stroke), restenosis (>50% or >70%), or reintervention for the prior RT group compared with those without RT. CONCLUSIONS: The CAS patients with RT had significantly greater mortality at all time points compared with those without RT, even after adjusting for other covariates. No significant difference was found in the incidence of perioperative complications, reintervention, or restenosis between the two groups. The present study is unique because of the large sample size and length of follow-up. The results suggest that for this high-risk group, CAS provides the same patency as it does for atherosclerotic carotid stenosis and avoids potentially morbid cranial nerve injury and wound healing complications.

Correlating Toe-Brachial Indices and Angiographically Confirmed Peripheral Artery Disease: A Retrospective Review.

In advanced peripheral arterial disease (PAD), medial arterial calcification is known to inflate the ankle-brachial index. An alternative method of evaluating symptomatic patients is toe-brachial indexes (TBI), where a ratio less than .7 indicates PAD and less than .4 indicates a severe form. The objective of this retrospective analysis was to investigate the association between TBIs less than .7 and angiographically verified PAD. Patients were required to have either a leg angiogram 13 months prior to or 12 months after a 6-minute walk test. Of the 174 included patients, the mean overall TBI was .450. The mean TBI by location was highest at iliac and infra-geniculate with .544 and lowest at supra-geniculate with .372. Infra-geniculate lesions were also the most frequent (n = 46). A TBI less than .4 was found in 47.7% of patients. TBIs greater than .7 were present in 36 patients; however, only 16 had significant angiographic stenosis. In conclusion, the majority of patients with angiographic PAD had a TBI less than .7, especially less than .4. Contrary to suspicion, infra-geniculate lesions were the most common and had the highest TBI.

Opportunities for diabetes and peripheral artery disease-related lower limb amputation prevention in an Appalachian state: A longitudinal analysis.

Lower extremity amputation due to peripheral artery disease (PAD) and diabetes (DM) is a life-altering event that identifies disparities in access to healthcare and management of disease. West Virginia (WV), a highly rural state, is an ideal location to study these disparities. The WVU longitudinal health system database was used to identify 1) risk factors for amputation, 2) how disease management affects the risk of amputation, and 3) whether the event of amputation is associated with a change in HbA1c and LDL levels. Adults (≥18 years) with diagnoses of DM and/or PAD between 2011 and 2016 were analyzed. Multivariable logistic regression analyses were performed on patients with lab information for both HbA1c and LDL while adjusting for patient factors to examine associations with amputations. In patients who underwent amputation, we compared laboratory values before and after using Wilcoxon signed rank tests. 50,276 patients were evaluated, 369 (7.3/1000) underwent amputation. On multivariable analyses, Male sex and Self-pay insurance had higher odds for amputation. Compared to patients with DM alone, PAD patients had 12.3 times higher odds of amputation, while patients with DM and PAD had 51.8 times higher odds of amputation compared to DM alone. We found significant associations between odds of amputation and HbA1c (OR 1.31,CI = 1.15-1.48), but not LDL. Following amputation, we identified significant decreases in lab values for HbA1c and LDL. These findings highlight the importance of medical optimization and patient education and suggest that an amputation event may provide an important opportunity for changes in disease management and patient behavior.

Vascular Complications Increase Hospital Charges and Mortality in Adult Patients on Extracorporeal Membrane Oxygenation in the United States.

Patients on extracorporeal membrane oxygenation (ECMO) who suffer vascular complications frequently accrue additional procedures and costs. We sought to evaluate the effect of ECMO-related vascular complications on hospital charges and in-hospital mortality. Adult discharges involving ECMO from 2004 to 2013 in the National Inpatient Sample were examined. There were 12,636 patients in the cohort. Vascular complications, focusing on arterial complications were identified using ICD-9-CM diagnosis and procedure codes. A multivariable survey linear regression model using median hospital charges was used to model the effect of vascular complications on charges. We used multivariable survey logistic regression to evaluate the effect of vascular complications on in-hospital mortality. Of the 12,636 patients examined, 6467 (51.2%) had ECMO-related vascular complications. Median charges in patients with vascular complications were $ 477,363 (interquartile range: 258,660-875,823) and were $ 282,298 (interquartile range: 130,030-578,027) without vascular complications. On multivariable analysis, patients with vascular complications had 24% higher median charges than patients without vascular complications (Ratio: 1.24; 95% confidence interval [CI]: 1.16-1.33; P < 0.0001) and 34% higher odds of experiencing in-hospital mortality than patients without vascular complications (adjusted odds ratio: 1.34; 95% CI:1.08-1.66; P = 0.009). Vascular complications occur in over half of ECMO patients and are associated with an increased risk of high hospital charges and in-hospital mortality. These findings support the need for identification and modification of risk factors for ECMO-related vascular complications. Furthermore, the standardization of protocols using evidence-based measures to mitigate vascular complications may improve overall ECMO outcomes.

Machine Learning Confirms Nonlinear Relationship between Severity of Peripheral Arterial Disease, Functional Limitation and Symptom Severity.

BACKGROUND: Peripheral arterial disease (PAD) involves arterial blockages in the body, except those serving the heart and brain. We explore the relationship of functional limitation and PAD symptoms obtained from a quality-of-life questionnaire about the severity of the disease. We used a supervised artificial intelligence-based method of data analyses known as machine learning (ML) to demonstrate a nonlinear relationship between symptoms and functional limitation amongst patients with and without PAD. OBJECTIVES: This paper will demonstrate the use of machine learning to explore the relationship between functional limitation and symptom severity to PAD severity. METHODS: We performed supervised machine learning and graphical analysis, analyzing 703 patients from an administrative database with data comprising the toe-brachial index (TBI), baseline demographics and symptom score(s) derived from a modified vascular quality-of-life questionnaire, calf circumference in centimeters and a six-minute walk (distance in meters). RESULTS: Graphical analysis upon categorizing patients into critical limb ischemia (CLI), severe PAD, moderate PAD and no PAD demonstrated a decrease in walking distance as symptoms worsened and the relationship appeared nonlinear. A supervised ML ensemble (random forest, neural network, generalized linear model) found symptom score, calf circumference (cm), age in years, and six-minute walk (distance in meters) to be important variables to predict PAD. Graphical analysis of a six-minute walk distance against each of the other variables categorized by PAD status showed nonlinear relationships. For low symptom scores, a six-minute walk test (6MWT) demonstrated high specificity for PAD. CONCLUSIONS: PAD patients with the greatest functional limitation may sometimes be asymptomatic. Patients without PAD show no relationship between functional limitation and symptoms. Machine learning allows exploration of nonlinear relationships. A simple linear model alone would have overlooked or considered such a nonlinear relationship unimportant.

The effect of rurality on the risk of primary amputation is amplified by race.

OBJECTIVE: Primary amputation (ie, without attempted revascularization) is a devastating complication of peripheral artery disease. Racial disparities in primary amputation have been described; however, rural disparities have not been well investigated. The purpose of this study was to examine the impact of rurality on risk of primary amputation and to explore the effect of race on this relationship. METHODS: The national Vascular Quality Initiative amputation data set was used for analyses (N = 6795). The outcome of interest was primary amputation. Independent variables were race/ethnicity (non-Latinx whites vs nonwhites) and rural residence. Multivariable logistic regression examined impact of rurality and race/ethnicity on primary amputation after adjustment for relevant covariates and included an interaction for race/ethnicity by rural status. RESULTS: Primary amputation occurred in 49% of patients overall (n = 3332), in 47% of rural vs 49% of urban patients (P = .322), and in 46% of whites vs 53% of nonwhites (P < .001). On multivariable analysis, nonwhites had a 21% higher odds of undergoing primary amputation overall (adjusted odds ratio [AOR], 1.21; 95% confidence interval [CI], 1.05-1.39). On subgroup analysis, rural nonwhites had two times higher odds of undergoing primary amputation than rural whites (AOR, 2.06; 95% CI, 1.53-2.78) and a 52% higher odds of undergoing primary amputation than urban nonwhites (AOR, 1.52; 95% CI, 1.19-1.94). In the urban setting, nonwhites had a 21% higher odds of undergoing primary amputation than urban whites (AOR, 1.21; 95% CI, 1.05-1.39). CONCLUSIONS: In these analyses, rurality was associated with greater odds for primary amputation in nonwhite patients but not in white patients. The effect of race on primary amputation was significant in both urban and rural settings; however, the effect was significantly stronger in rural settings. These findings suggest that race/ethnicity has a compounding effect on rural health disparities and that strategies to improve health of rural communities need to consider the particular needs of nonwhite residents to reduce disparities.

Geographic variation in amputation rates among patients with diabetes and/or peripheral arterial disease in the rural state of West Virginia identifies areas for improved care.

OBJECTIVE: Amputation is a devastating but preventable complication of diabetes and peripheral arterial disease (PAD). Multiple studies have focused on disparities in amputation rates based on race and socioeconomic status, but few focus on amputation trends in rural populations. The objective of this study was to identify the prevalence of major and minor amputation among patients admitted with diabetes and/or PAD in a rural, Appalachian state, and to identify geographic areas with higher than expected major and minor amputations using advanced spatial analysis while controlling for comorbidities and rurality. METHODS: Patient hospital admissions of West Virginia residents with diagnoses of diabetes and/or PAD and with or without an amputation procedure were identified from the West Virginia Health Care Authority State Inpatient Database from 2011 to 2016 using relevant International Classification of Diseases, 9th edition and 10the edition codes. Bayesian spatial hierarchical modeling was conducted to identify areas of high risk, while controlling for important confounders for amputation. RESULTS: Overall, there were 5557 amputations among 459,452 hospital admissions with diabetes and/or PAD from 2011 to 2016. The majority of the amputations were minor (61.7%; n = 3430), with a prevalence of 7.5 per 1000 and 40.4% (n = 2248) were major, with a prevalence of 4.9 per 1000. Geographic analysis found significant variation in risk for both major and minor amputation across the state, even after adjusting for the prevalence of risk factors. Analyses indicated an increased risk of amputation in the central and northeastern regions of West Virginia at the county level, although zip code-level patterns of amputation varied, with high-risk areas identified primarily in the northeastern and south central regions of the state. CONCLUSIONS: There is significant geographic variation in risk of amputation across West Virginia, even after adjusting for disease-related risk factors, suggesting priority areas for further investigation. The level of granularity obtained using advanced spatial analyses rather than traditional methods demonstrate the value of this approach, particularly when risk estimates are used to inform policy or public health intervention.

A Novel Quality of Life Instrument for Patients with an Abdominal Aortic Aneurysm.

OBJECTIVE: The surveillance and treatment of abdominal aortic aneurysms (AAAs) may impact patient quality of life (QOL). A novel AAA specific QOL instrument was developed and validated to quantify the impact of AAA surveillance on QOL. METHODS: The study was performed in two phases: development (2011-2013) and validation (2013-2014) of a survey instrument. Content was informed by focus groups at three centres (22 patients) and two multidisciplinary physician focus groups (6 vascular surgeons, 7 primary care providers). Cognitive interviews (17 patients) ensured questions were understood as intended. The final survey was mailed to AAA patients at six US institutions. Patients were scored on two AAA specific domains of QOL: emotional impact (EIS) and behavioural change (BCS), range 0-100 with higher scores indicating worse quality of life. Test retest reliability and internal consistency were assessed. Discriminant validity was determined by comparing scores between patients under surveillance vs. those who had undergone AAA repair. Scores were externally validated by correlation with the Short Form (SF)-12. RESULTS: A total of 1,008 (73%) of 1,373 patients returned surveys: 351 (35%) were under surveillance, 657 (65%) had undergone repair (endovascular, 414; open, 179; unsure, 64). Median EIS was 11 (range 0-95; IQR 7-26). Median BCS was 13 (range 0-100; IQR 9-47). To test reliability, 337 patients repeated the survey after four weeks with no significant differences between scores over time. EIS and BCS demonstrated good internal consistency (Cronbach's Alpha 0.85 and 0.75 respectively). There was strong correlation between scores (r = 0.53) and both related moderately to SF-12 scores (r = 0.45 and r = 0.39, respectively). Patients under AAA surveillance had worse EIS than repair patients (22 vs. 13; p < .001). Patients with a higher perceived rupture risk had a worse EIS (45 vs. 12; p < .001) and BCS (30 vs. 13; p < .001). CONCLUSIONS: An AAA specific QOL instrument was successfully created and validated. The range of impact on QOL by AAA surveillance is broad. For most patients the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe.

Long-Term Results of Endovascular Femoropopliteal Interventions.

Background and Objective Short-term results of endovascular intervention for femoropopliteal lesions have been extensively reported; however, there exists a paucity of long-term objective data related to outcomes of these interventions. We sought to characterize these long-term results including patency, limb salvage, and mortality. Methods From May 2003 to July 2009, all patients who underwent technically successful endovascular balloon angioplasty and/or stenting for Trans-Atlantic Inter-Societal Consensus (TASC) II B, C, and D lesions were identified in a retrospective fashion. Patient demographics, clinical characteristics, arterial noninvasive data, and angiographic anatomic data were evaluated. Results A total of 236 limbs in 186 patients (mean age 74, range 37-94) were treated. Lesion distributions by TASC II classification B, C, and D were 121 (51.3%), 37 (15.7%), and 78 (33%), respectively. Critical limb ischemia (CLI) was the indication for intervention in 42.4% of patients. Five-year primary and primary-assisted patency rates stratified by TASC II classification were B: 55.1%, 91.9%; C: 37.4%, 74.6%; D: 35.5%, 67%, respectively ( p = 0.23). Secondary patency based on TASC II classification was B: 92.9%, C: 83%, and D: 75.9%, respectively. Univariate analysis identified age > 75, CLI, and cerebrovascular disease as predictors for loss of patency. Reinterventions to maintain patency were required in 26.5% of TASC II B, 43.2% of TASC II C, and 25.6% of TASCII D lesions ( p = NS) and mean time to reintervention ranged from 22 to 29 months with no significant difference related to TASC II classification. A total of eight limbs (3.38%) were converted to open revascularization with two (0.85%) having a change in their initial preoperatively identified bypass target site. Three limbs (1.27%) required a major amputation during follow-up. Survival at 5 years was 44.3%; CLI and smoking were identified as risk factors for death (hazard ratio [HR] 2.6, 1.75-3.84, p < 0.001, HR 3.33, 1.70-6.52, p < 0.001), respectively. Conclusion Long-term patency of endovascular interventions for complicated femoropopliteal lesions is acceptable across TASC II classification and is associated with excellent limb salvage. Mortality in this patient cohort is significant with CLI and smoking being identified as predictors of death.

Cardiopulmonary Exercise Testing Limitation in Peripheral Arterial Disease.

BACKGROUND: Peripheral artery disease (PAD) is associated with a markedly increased risk of cardiovascular mortality and remains underrecognized and undertreated. New screening approaches are needed to prevent disability in patients with PAD. METHODS: We performed a retrospective analysis of clinically stable cardiovascular patients who were referred for cardiopulmonary exercise testing (CPET) due to a variety of cardiovascular complaints. Angiograms were assessed for patients who prematurely terminated CPET. Estimated functional capacity in metabolic equivalents was also obtained from monitored bicycle exercise at the visit. RESULTS: According to our analysis, 351 patients were unable to complete the CPET test due to some limiting factor. Of these patients, a total of 216 had available angiographic assessment conducted, of whom 42.6% were males, 57.4% were females, and the mean age was 67 years. A total of 135 patients with a similar gender distribution and a mean age of 53 years did not undergo angiography for various reasons including feasibility. Most patients who underwent assessment were found to have lesions. Across all patients, 284 arterial lesions were identified: 55 were iliac, 67 were femoral, and 162 were below the knee. PAD was diagnosed in 165 of these lesions. There was a significant difference observed in the VO2 max in patients with lesions depending on location of lesion. In all vessel groups, the existence of PAD was associated with a significantly reduced VO2 max during CPET testing. CONCLUSIONS: The data obtained in this study provides a preliminary understanding of the underlying effects of PAD and provides a basis for further utilization of CPET termination as a potential screening signal for further PAD investigation in appropriate patients.

Transaortic gunshot wound through perivisceral segment successfully managed by placement of thoracic stent graft.

We describe a 36-year-old woman who presented to our facility after sustaining a gunshot wound to the epigastric region. The gunshot resulted in injury to the left lobe of the liver and the twelfth thoracic vertebral body as well as in a through-and-through injury to the abdominal aorta at the level of the celiac axis. The vascular injury was managed successfully by placement of a thoracic stent graft with coverage of the celiac axis. This case demonstrates the feasibility of managing this uncommon injury with endovascular techniques.

Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.

Objective The hemodynamic benefits of catheter-directed thrombolysis for acute pulmonary embolism have not been clearly defined beyond the periprocedural period. The objective of this study is to report midterm outcomes of catheter-directed thrombolysis for treatment of acute pulmonary embolism. Methods Records of all patients undergoing catheter-directed thrombolysis for high- or intermediate-risk pulmonary embolism were retrospectively reviewed. Endpoints were clinical success, procedure-related complications, mortality, and longitudinal echocardiographic parameter improvement. Results A total of 69 patients underwent catheter-directed thrombolysis (mean age 59 ± 15 y, 56% male). Eleven had high-risk and 58 intermediate-risk pulmonary embolism. Baseline characteristics did not differ by pulmonary embolism subtype. Fifty-two percent of patients underwent ultrasound-assisted thrombolysis, 39% standard catheter-directed thrombolysis, and 9% other interventional therapy; 89.9% had bilateral treatment. Average treatment time was 17.7 ± 11.3 h with average t-Pa dose of 28.5 ± 19.6 mg. The rate of clinical success was 88%. There were two major (3%) and six minor (9%) periprocedural bleeding complications with no strokes. All echocardiographic parameters demonstrated significant improvement at one-year follow-up. Pulmonary embolism-related in-hospital mortality was 3.3%, and estimated survival was 81.2% at one year. Conclusions Catheter-directed thrombolysis is safe and effective for treatment of acute pulmonary embolism, with sustained hemodynamic improvement at one year. Further prospective large-scale studies are needed to determine comparative effectiveness of interventions for acute pulmonary embolism.

Comparative Outcomes of Ultrasound-Assisted Thrombolysis and Standard Catheter-Directed Thrombolysis in the Treatment of Acute Pulmonary Embolism.

OBJECTIVES: The objective of this study was to compare the outcomes of patients undergoing ultrasound-accelerated thrombolysis (USAT) and standard catheter-directed thrombolysis (CDT) for the treatment of acute pulmonary embolism (PE). METHODS: The records of all patients in our institution having undergone CDT or USAT for massive or submassive PE from 2009 to 2014 were retrospectively reviewed. Standard statistical methods were used to compare characteristics and to assess for longitudinal change in outcomes. RESULTS: Sixty-three patients, 27 CDT and 36 USAT, were treated for massive (12.7%) or submassive (87.3%) PE. Of which, 96.8% were treated for bilateral PE. Baseline patient characteristics did not differ between the 2 treatment groups. There was no difference in total dose of lytic administered (CDT: 23.2 ± 13.7 mg; USAT: 27.5 ± 12.9 mg; P = .2). Two patients in the CDT and 1 in the USAT groups required conversion to surgical thrombectomy (CDT: 7.4%; USAT: 2.8%; P = .6). Rates of major and minor bleeding complications (CDT: 11.0%; USAT: 13.9%; P = .8) did not differ significantly between the CDT and USAT groups. Estimated survival at 90 days was 92% for CDT and 93% for USAT and 82% at 1 year for both groups (P = .8). All echocardiographic parameters improved significantly from baseline to 1-year follow-up, but quantitative improvement did not differ between groups. CONCLUSION: This study suggests no statistical differences in clinical and hemodynamic outcomes or procedural complication rates between USAT and standard CDT for the treatment of acute PE. Prospective studies are needed to further evaluate comparative and cost-effectiveness of different interventions for acute massive and submassive PE.

Primary closure after carotid endarterectomy is not inferior to other closure techniques.

OBJECTIVE: Primary closure after carotid endarterectomy (CEA) has been much maligned as an inferior technique with worse outcomes than in patch closure. Our purpose was to compare perioperative and long-term results of different CEA closure techniques in a large institutional experience. METHODS: A consecutive cohort of CEAs between January 1, 2000, and December 31, 2010, was retrospectively analyzed. Closure technique was used to divide patients into three groups: primary longitudinal arteriotomy closure (PRC), patch closure (PAC), and eversion closure (EVC). End points were perioperative events, long-term strokes, and restenosis ≥70%. Multivariate regression models were used to assess the effect of baseline predictors. RESULTS: There were 1737 CEA cases (bilateral, 143; mean age, 71.4 ± 9.3 years; 56.2% men; 35.3% symptomatic) performed during the study period with a mean clinical follow-up of 49.8 ± 36.4 months (range, 0-155 months). More men had primary closure, but other demographic and baseline symptoms were similar between groups. Half the patients had PAC, with the rest evenly distributed between PRC and EVC. The rate of nerve injury was 2.7%, the rate of reintervention for hematoma was 1.5%, and the length of hospital stay was 2.4 ± 3.0 days, with no significant differences among groups. The combined stroke and death rate was 2.5% overall and 3.9% and 1.7% in the symptomatic and asymptomatic cohort, respectively. Stroke and death rates were similar between groups: PRC, 11 (2.7%); PAC, 19 (2.2%); EVC, 13 (2.9%). Multivariate analysis showed baseline symptomatic disease (odds ratio, 2.4; P = .007) and heart failure (odds ratio, 3.1; P = .003) as predictors of perioperative stroke and death, but not the type of closure. Cox regression analysis demonstrated, among other risk factors, no statin use (hazard ratio, 2.1; P = .008) as a predictor of ipsilateral stroke and severe (glomerular filtration rate <30 mL/min/1.73 m(2)) renal insufficiency (hazard ratio, 2.6; P = .032) as the only predictor of restenosis ≥70%. Type of closure did not have any predictive value. CONCLUSIONS: In our study, baseline risk factors and statin use, but not the type of closure, affect perioperative and long-term outcomes after CEA.

A national survey of disease-specific knowledge in patients with an abdominal aortic aneurysm.

OBJECTIVE: Patient education is a fundamental responsibility of medical providers caring for patients with abdominal aortic aneurysms (AAA). We sought to evaluate and quantify AAA-specific knowledge in patients under AAA surveillance and in patients who have undergone AAA repair. METHODS: In 2013, 1373 patients from 6 U.S. institutions were mailed an AAA-specific quality of life and knowledge survey. Of these patients, 1008 (73%) returned completed surveys for analysis. The knowledge domain of the survey consisted of nine questions. An AAA knowledge score was calculated for each patient based on the proportion of questions answered correctly. The score was then compared according to sex, race, and education level. Surveillance and repaired patients were also compared. RESULTS: Among 1008 survey respondents, 351 were under AAA surveillance and 657 had AAA repair (endovascular repair, 414; open, 179; unknown, 64). The majority of patients (85%) reported that their "doctor's office" was their most important source of AAA information. The "Internet" and "other written materials" were each reported as the most important source of information 5% of the time with "other patients" reported 2% of the time. The mean AAA knowledge score was 47% (range 0%-100%; standard deviation, 23%) with a broad variation in percentage correct between questions. Thirty-two percent of respondents did not know that larger AAA size increases rupture risk, and 64% did not know that AAA runs in families. Only 15% of patients answered six or more of the nine questions correctly, and 23% of patients answered two or fewer questions correctly. AAA knowledge was significantly greater in men compared with women, whites compared with nonwhites, high school graduates compared with nongraduates, and surveillance compared with repaired patients. CONCLUSIONS: In a national survey of AAA-specific knowledge, patients demonstrated poor understanding of their condition. This may contribute to anxiety and uninformed decision making. The need for increased focus on education by vascular providers is a substantial unmet need.

Risk Factors for Long-Term Mortality and Amputation after Open and Endovascular Treatment of Acute Limb Ischemia.

BACKGROUND: Acute limb ischemia (ALI) is a highly morbid and fatal vascular emergency with little known about contemporary, long-term patient outcomes. The goal was to determine predictors of long-term mortality and amputation after open and endovascular treatment of ALI. METHODS: A retrospective review of ALI patients at a single institution from 2005 to 2011 was performed to determine the impact of revascularization technique on 5-year mortality and amputation. For each main outcome 2 multivariable models were developed; the first adjusted for preoperative clinical presentation and procedure type, the second also adjusted for postoperative adverse events (AEs). RESULTS: A total of 445 limbs in 411 patients were treated for ALI. Interventions included surgical thrombectomy (48%), emergent bypass (18%), and endovascular revascularization (34%). Mean age was 68 ± 15 years, 54% were male, and 23% had cancer. Most patients presented with Rutherford classification IIa (54%) or IIb (39%). The etiology of ALI included embolism (27%), in situ thrombosis (28%), thrombosed bypass grafts (32%), and thrombosed stents (13%). Patients treated with open procedures had significantly more advanced ischemia and higher rates of postoperative respiratory failure, whereas patients undergoing endovascular interventions had higher rates of technical failure. Rates of postprocedural bleeding and cardiac events were similar between both treatments. Excluding Rutherford class III patients (n = 12), overall 5-year mortality was 54% (stratified by treatment, 65% for thrombectomy, 63% for bypass, and 36% for endovascular, P < 0.001); 5-year amputation was 28% (stratified by treatment, 18% for thrombectomy, 27% for bypass, and 17% for endovascular, P = 0.042). Adjusting for comorbidities, patient presentation, AEs, and treatment method, the risk of mortality increased with age (hazard ratio [HR] = 1.04, P < 0.001), female gender (HR = 1.50, P = 0.031), cancer (HR = 2.19, P < 0.001), fasciotomy (HR = 1.69, P = 0.204) in situ thrombosis or embolic etiology (HR = 1.73, P = 0.007), cardiac AEs (HR = 2.25, P < 0.001), respiratory failure (HR = 2.72, P < 0.001), renal failure (HR = 4.70, P < 0.001), and hemorrhagic events (HR = 2.25, P = 0.003). Risk of amputation increased with advanced ischemia (Rutherford IIb compared with IIa, HR = 2.57, P < 0.001), thrombosed bypass etiology (HR = 3.53, P = 0.002), open revascularization (OR; HR = 1.95, P = 0.022), and technical failure of primary intervention (HR = 6.01, P < 0.001). CONCLUSIONS: After the treatment of ALI, long-term mortality and amputation rates were greater in patients treated with open techniques; OR patients presented with a higher number of comorbidities and advanced ischemia, while also experiencing a higher rate of major postoperative complications. Overall, mortality rates remained high and were most strongly associated with baseline comorbidities, acuity of presentation, and perioperative AEs, particularly respiratory failure. Comparatively, amputation risk was most highly associated with advanced ischemia, thrombosed bypass, and failure of the initial revascularization procedure.

Contemporary outcomes of open and endovascular popliteal artery aneurysm repair.

OBJECTIVE: The purpose of this study was to evaluate contemporary practice and outcomes of open repair (OR) or endovascular repair (ER) for popliteal artery aneurysms (PAAs). METHODS: Consecutive patients with PAA treated at one institution from January 2006 to March 2014 were reviewed under an Institutional Review Board-approved protocol. Demographics, indications, anatomic characteristics, and outcomes were collected. Standard statistical methods were used. RESULTS: A total of 186 PAAs were repaired in 156 patients (110 ORs, 76 ERs) with a mean age of 71 ± 11 years, and most were male (96%). Mean follow-up was 34.9 ± 28.6 months for OR and 28.3 ± 25.8 months for ER (P = .12). Comorbidities were similar between groups. OR was used in more patients with PAA thrombosis (41.8% vs 5.3%; P < .001), acute ischemia (24.5% vs 9.2%; P = .010), and ischemic rest pain (34.5% vs 6.6%; P < .001). Mean tibial (Society for Vascular Surgery) runoff score was 5.0 for OR vs 3.3 for ER (P = .006). OR was associated with increased 30-day complications (22% vs 2.6%; P < .001) and mean postoperative stay (5.8 vs 1.6 days; P < .001). There was no difference in 30-day mortality (OR, 1.8%; ER, 0%; P = .56) or major amputation rate (OR, 3.7%; ER, 1.3%; P = .65). Primary, primary assisted, and secondary patency rates were similar at 3 years (OR, 79.5%, 83.7%, and 85%; ER, 73.2%, 76.3%, and 83%; P = NS). Among 130 patients presenting electively without acute ischemia or thrombosed PAA (63 ORs and 67 ERs), OR had better 3-year primary patency (88.3% vs 69.8%; P = .030) and primary assisted patency (90.2% vs 73.5%; P = .051) but similar secondary patency (90.2% vs 82%; P = .260). ER thrombosis was noted in 8 of 24 patients treated in 2006-2008 (33%; mean time to failure, 49 months) but in only 4 of 51 patients treated in 2009-2013 (7.8%; mean time to failure, 30 months), suggesting a steep learning curve. CONCLUSIONS: ER is a safe and durable option for PAA, with lower complication rates and a shorter length of stay. OR has superior primary patency in patients treated electively but no difference in midterm secondary patency and amputations.