Publications by authors named "Luke Marone"

62 Publications

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

J Vasc Surg 2021 Nov 30. Epub 2021 Nov 30.

Division of Vascular and Endovascular Surgery, Department of Cardiovascular and Thoracic Surgery, West Virginia University School of Medicine, Morgantown, WVa.

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.
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http://dx.doi.org/10.1016/j.jvs.2021.11.058DOI Listing
November 2021

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

Angiology 2021 Nov 8:33197211052125. Epub 2021 Nov 8.

Heart and Vascular Institute, 5631West Virginia University Medicine, Morgantown, WV, USA.

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 ( = 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.
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http://dx.doi.org/10.1177/00033197211052125DOI Listing
November 2021

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

J Vasc Access 2021 Sep 21:11297298211045495. Epub 2021 Sep 21.

Division of Cardiovascular and Thoracic Anesthesiology, Department of Anesthesiology, West Virginia University, Morgantown, WV, USA.

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  < 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  < 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  < 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  < 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  < 0.0001; MAC 0.76, 0.13, and 0.43, respectively; all  < 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.
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http://dx.doi.org/10.1177/11297298211045495DOI Listing
September 2021

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

Prev Med Rep 2021 Sep 23;23:101505. Epub 2021 Jul 23.

West Virginia University School of Medicine, Department of Cardiovascular and Thoracic Surgery, Division of Vascular and Endovascular Surgery, United States.

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.
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http://dx.doi.org/10.1016/j.pmedr.2021.101505DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339221PMC
September 2021

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

Semin Thorac Cardiovasc Surg 2021 Summer;33(2):397-406. Epub 2020 Sep 23.

Division of Thoracic Surgery, Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia.

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.
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http://dx.doi.org/10.1053/j.semtcvs.2020.09.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985037PMC
July 2021

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

Diagnostics (Basel) 2020 Jul 24;10(8). Epub 2020 Jul 24.

Heart and Vascular Institute, West Virginia University, Morgantown, WV 26506, USA.

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.
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http://dx.doi.org/10.3390/diagnostics10080515DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7459735PMC
July 2020

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

J Vasc Surg 2020 09 19;72(3):1011-1017. Epub 2020 Jan 19.

Division of Vascular and Endovascular Surgery, West Virginia University School of Medicine, Morgantown, WV.

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.
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http://dx.doi.org/10.1016/j.jvs.2019.10.090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404623PMC
September 2020

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.

J Vasc Surg 2020 05 31;71(5):1708-1717.e5. Epub 2019 Oct 31.

Department of Epidemiology, West Virginia University School of Public Health, Morgantown, WV.

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.
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http://dx.doi.org/10.1016/j.jvs.2019.06.215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186153PMC
May 2020

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

Eur J Vasc Endovasc Surg 2019 Jun 23;57(6):809-815. Epub 2019 Feb 23.

Dartmouth-Hitchcock Medical Centre, Lebanon, NH, USA.

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.
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http://dx.doi.org/10.1016/j.ejvs.2019.01.018DOI Listing
June 2019

Long-Term Results of Endovascular Femoropopliteal Interventions.

Int J Angiol 2018 Sep 6;27(3):151-157. Epub 2018 Apr 6.

Department of Vascular Surgery, West Virginia Medical Center, Morgantown, Pennsylvania.

 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.  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.  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 (  = 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 (  = 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,  < 0.001, HR 3.33, 1.70-6.52,  < 0.001), respectively.  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.
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http://dx.doi.org/10.1055/s-0038-1629923DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6103768PMC
September 2018

Cardiopulmonary Exercise Testing Limitation in Peripheral Arterial Disease.

Ann Vasc Surg 2018 Oct 17;52:108-115. Epub 2018 May 17.

Heart and Vascular Institute, West Virginia University Medicine, Morgantown, WV.

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 VO max in patients with lesions depending on location of lesion. In all vessel groups, the existence of PAD was associated with a significantly reduced VO 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.
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http://dx.doi.org/10.1016/j.avsg.2018.03.014DOI Listing
October 2018

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

J Vasc Surg Cases Innov Tech 2018 Mar 13;4(1):24-26. Epub 2018 Feb 13.

Division of Vascular Surgery, West Virginia University, Morgantown, WVa.

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.
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http://dx.doi.org/10.1016/j.jvscit.2017.11.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5849779PMC
March 2018

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

Vasc Endovascular Surg 2016 Aug;50(6):405-10

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

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.
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http://dx.doi.org/10.1177/1538574416666228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7193277PMC
August 2016

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

Vascular 2017 Apr 9;25(2):130-136. Epub 2016 Jul 9.

1 Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.

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.
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http://dx.doi.org/10.1177/1708538116654638DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7193278PMC
April 2017

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

J Vasc Surg 2016 Sep 14;64(3):678-683.e1. Epub 2016 May 14.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

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.
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http://dx.doi.org/10.1016/j.jvs.2016.03.415DOI Listing
September 2016

Endovascular management of symptomatic gastrointestinal complications associated with retrievable inferior vena cava filters.

J Vasc Surg Venous Lymphat Disord 2015 Jul 8;3(3):276-82. Epub 2015 May 8.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: With the increase in retrievable inferior vena cava (IVC) filter use, a higher than expected reported rate of pericaval tine penetration is observed. Symptomatic gastrointestinal (GI) complications associated with retrievable IVC filters have been documented; however, their management remains controversial. We describe a series of GI complications of retrievable IVC filters, detailing the spectrum of presenting symptoms and multiple treatment options, including the safety of endovascular retrieval.

Methods: A retrospective chart review was performed to describe the presentation, diagnosis, and treatment of patients with symptomatic GI complications associated with retrievable IVC filters from 2008 to 2014.

Results: Nine patients had symptomatic GI complications associated with a retrievable IVC filter (two G2 Recovery [Bard Peripheral Vascular, Tempe, Ariz], seven Celect [Cook Medical, Bloomington, Ind]; six women; age range, 17-81 years). All patients had small bowel perforation on computed tomography scan, four confirmed by esophagogastroduodenoscopy. Concomitant aortic and vertebral penetration occurred in seven and five patients, respectively. Patients presented with various abdominal complaints; one patient presented in acute sepsis. Two patients underwent laparotomy without complications. The remaining seven patients had attempted endovascular retrieval, six of which were successful. One patient's IVC filter was unable to be retrieved, and he was managed medically. Of the six patients who had successful endovascular retrieval, all had resolution of their symptoms with no complications, except for transient sepsis in a single patient who was not receiving periprocedural antibiotics. A follow-up computed tomography scan was performed 48 to 72 hours after endovascular retrieval and ruled out duodenal leak in all patients. Long-term follow-up demonstrated continued resolution of GI symptoms without further episodes of deep venous thrombosis or pulmonary embolism.

Conclusions: GI complications of retrievable IVC filters are manifested with a wide spectrum of symptoms and frequent concomitant aortic and vertebral penetration. Endovascular retrieval can be safely used as a first-line therapy even in the setting of small bowel and aortic penetration.
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http://dx.doi.org/10.1016/j.jvsv.2015.03.008DOI Listing
July 2015

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

J Vasc Surg 2016 May 2;63(5):1156-62. Epub 2016 Mar 2.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

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.
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http://dx.doi.org/10.1016/j.jvs.2015.12.042DOI Listing
May 2016

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

Ann Vasc Surg 2016 Jan 10;30:82-92. Epub 2015 Nov 10.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.

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.
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http://dx.doi.org/10.1016/j.avsg.2015.10.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4698794PMC
January 2016

Contemporary outcomes of open and endovascular popliteal artery aneurysm repair.

J Vasc Surg 2016 Jan 21;63(1):70-6. Epub 2015 Oct 21.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

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.
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http://dx.doi.org/10.1016/j.jvs.2015.08.056DOI Listing
January 2016

Long-term clinical outcomes and cardiovascular events after carotid endarterectomy.

Ann Vasc Surg 2015 Aug 22;29(6):1265-71. Epub 2015 May 22.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.

Background: Long-term atherosclerotic adverse events are anticipated in patients undergoing carotid endarterectomy (CEA); however, their incidence and risk predictors remain unknown.

Methods: A consecutive cohort of CEAs between 1/1/2000-12/31/2007 was analyzed. End points were any stroke, coronary event (myocardial infarction, coronary bypass, or stenting), vascular interventions for critical limb ischemia, aortic aneurysm or carotid disease, and death. Survival analysis and Cox regression models were used to identify clinical predictors.

Results: A total of 1,136 CEAs (bilateral, 89; mean age, 71.2 ± 9.2 years; 56.5% male; 36.3% symptomatic, and 3.9% combined with coronary bypass) were performed during the study period with a mean clinical follow-up of 60 months (0-155 months). The postoperative combined stroke and/or death rate was 2.7% and 1.9% for asymptomatic and 4.1% for symptomatic patients. Five and 10-year risks of the end points were 7.2% and 16.1% for stroke, 18.4% and 31.5% for coronary interventions, 20.6% and 28.5% for major vascular interventions, and 25.8% and 50.1% for death. Statins conferred a significant protective effect for stroke (hazard ratio [HR], 0.53; P = 0.016) and death (HR, 0.66; P < 0.0001). Baseline vascular disease predicted future vascular interventions: aortic aneurysm (HR, 1.90; P = 0.003), peripheral arterial disease (HR, 2.03; P < 0.0001), and contralateral internal carotid artery (ICA) stenosis ≥50% (HR, 4.61; P < 0.0001). Renal insufficiency predicted worse outcomes for all other end points (HR, 2.21; P = 0.023 for stroke; HR, 1.62; P = 0.008 for coronary events; HR, 2.38; P < 0.0001 for death).

Conclusions: Patients undergoing CEA continue to derive long-term low stroke rate benefit but still sustain major coronary events and require vascular interventions, indicating a need for more intensive medical treatment and rigorous follow-up.
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http://dx.doi.org/10.1016/j.avsg.2015.03.031DOI Listing
August 2015

Contemporary outcomes of intact and ruptured visceral artery aneurysms.

J Vasc Surg 2015 Jun 7;61(6):1442-7. Epub 2015 Mar 7.

University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: The treatment outcomes of ruptured visceral artery aneurysms (rVAAs) have been sparsely characterized, with no clear comparison between different treatment modalities. The purpose of this paper was to review the perioperative and long-term outcomes of open and endovascular interventions for intact visceral artery aneurysms (iVAAs) and rVAAs.

Methods: This was a retrospective review of all treated VAAs at one institution from 2003 to 2013. Patient demographics, aneurysm characteristics, management, and subsequent outcomes (technical success, mortality, reintervention) and complications were recorded.

Results: The study identified 261 patients; 181 patients were repaired (77 ruptured, 104 intact). Pseudoaneurysms were more common in rVAAs (81.8% vs 35.3% for iVAAs; P < .001). The rVAAs were smaller than the iVAAs (20.7 mm vs 27.5 mm; P = .018), and their most common presentation was abdominal pain; 29.7% were hemodynamically unstable. Endovascular intervention was the initial treatment modality for 67.4% (75.3% for rVAAs, 61.5% for iVAAs). The perioperative complication rate was higher for rVAAs (13.7% vs 1% for iVAAs; P = .003), as was mortality at 30 days (13% vs 0% for iVAAs; P = .001), 1 year (32.5% for rVAAs vs 4.1% for iVAAs; P < .001), and 3 years (36.4% for rVAAs vs 8.3% for iVAAs; P < .001). Lower 30-day mortality was noted with endovascular repair for rVAAs (7.4% vs 28.6% open; P = .025). Predictors of mortality for rVAAs included age (odds ratio, 1.04; P = .002), whereas endovascular repair was protective (odds ratio, 0.43; P = .037). Mean follow-up was 26.2 months, and Kaplan-Meier estimates of survival were higher for iVAAs at 3 years (88% vs 62% for rVAAs; P = .045). The 30-day reintervention rate was higher for rVAAs (7.7% vs 19.5% for iVAAs; P = .019) but was similar between open and endovascular repair (8.2% vs 15%; P = NS).

Conclusions: rVAAs have significant mortality. Open and endovascular interventions are equally durable for elective repair of VAAs, but endovascular interventions for rVAAs result in lower morbidity and mortality. Aggressive treatment of pseudoaneurysms is electively recommended at diagnosis regardless of size.
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http://dx.doi.org/10.1016/j.jvs.2015.01.005DOI Listing
June 2015

Revascularization of asymptomatic carotid stenosis is not appropriate in patients on dialysis.

J Vasc Surg 2015 Mar;61(3):670-4

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Outcomes of carotid endarterectomy (CEA) or carotid angioplasty and stenting (CAS) for asymptomatic disease in patients on dialysis are not well characterized, with questionable stroke prevention and survival. This study reports outcomes of carotid revascularization in asymptomatic dialysis patients in the United States.

Methods: Using United States Renal Data System (USRDS) databases, we identified all dialysis patients who underwent CEA or CAS for asymptomatic disease from 2005 to 2008. CEA and CAS were identified by Current Procedural Terminology (American Medical Association, Chicago, Ill) codes, and symptom status and comorbidities by International Classification of Diseases-9th Revision, Clinical Modification codes. Primary outcomes were stroke, cardiac complications, and death at 30 days and at 1 and 3 years. Predictors of death were identified using multivariate regression models.

Results: Of 738,561 dialysis patients, 2131 asymptomatic patients underwent carotid revascularization (1805 CEA, 326 CAS). The mortality rate was 4.7% at 30 days (4.6% CEA, 4.9% CAS; P = .807). Kaplan-Meier estimates of survival were 75.1% at 1 year (75.9% CEA, 70.7% CAS) and 43.4% at 3 years (43.7% CEA, 41.6% CAS). The stroke rate was 6.5% at 30 days (6.4% CEA, 6.9% CAS; P = .774) and 13.6% at 1 year (13.3% CEA, 15.0% CAS; P = .490). Cardiac complications occurred in 22.0% of patients (3.3% myocardial infarction) at 30 days (22.2% CEA, 20.6% CAS; P = .525). The combined stroke or death rate was 10.2% at 30 days (10.1% CEA, 10.9% CAS; P = .490) and 33.5% at 1 year (32.2% CEA, 39.6% CAS; P = .025). Age >70 years at the time of surgery and increased time on dialysis were predictive of death, whereas a history of renal transplant was a protective factor.

Conclusions: Patients on dialysis have high perioperative and long-term stroke or death rates after CEA or CAS for asymptomatic stenosis, with a median survival that is less than recommended by current guidelines. As a result, carotid intervention in these patients appears to be inappropriate.
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http://dx.doi.org/10.1016/j.jvs.2014.10.002DOI Listing
March 2015

Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia.

J Vasc Surg 2015 Jan 28;61(1):147-54. Epub 2014 Jul 28.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Thrombolysis and open surgical revascularization are current options for the treatment of acute limb ischemia (ALI). Despite the several randomized controlled trials comparing the two options, no single treatment can yet be recommended as a universal initial management of ALI. The purpose of this study was to evaluate contemporary endovascular and surgical revascularization for ALI.

Methods: Consecutive patients with ALI treated with endovascular revascularization (ER) or open revascularization (OR) between 2005 and 2011 were identified and reviewed. Procedural success and outcomes were compared between the two groups. Limb salvage and survival were assessed by time-to-event methods, including Kaplan-Meier estimation and competing-risks regression models.

Results: A total of 154 limbs were treated in 147 patients in the ER group, compared with 326 limbs in 296 patients in the OR group. The mean follow-up was 14 ± 18.5 months. The majority of patients presented with Rutherford II ischemia (83% for OR, 90% for ER). In Rutherford II patients, technical success was achieved in 90.7% of the OR group vs 79.9% of the ER group (P = .002), with amputation rates of 10.0% vs 7.2% (P = .35) at 30 days and 16.3% vs 13.0% (P = .37) at 1 year, respectively. In Rutherford II patients with failed bypass graft, technical success rate was 95.0% (OR) vs 75.0% (ER) (P = .001), whereas the amputation rate was 6.3% vs 15.38% (P = .13) at 30 days and 24.1% vs 23.1% (P = .90) at 1 year, respectively. The overall 30-day mortality rate was 13.2% (OR) and 5.4% (ER) (P = .012). Overall amputation rates were 13.5% (OR) vs 6.5% (ER) at 30 days (P = .023) and 19.6% (OR) vs 13.0% (ER) at 1 year (P = .074). The primary patency rate was 57% (OR) and 51% (ER) at 1 year (P = .74). Predictors of limb loss by life-table analysis included coronary artery disease (hazard ratio [HR], 2.0; P = .007) and Rutherford category III (HR, 19.0; P < .001). Predictors of death by life-table analysis included age (HR, 1.03; P < .001), end-stage renal disease (HR, 7.28; P < .001), cancer (HR, 1.65; P = .005), and chronic obstructive pulmonary disease (HR, 1.61; P = .005).

Conclusions: In patients presenting with class II ALI, ER or surgical OR resulted in comparable limb salvage rates. Although technical success is higher with OR for patients presenting with failed bypass grafts, the amputation rates are comparable. Overall mortality rates are significantly higher at 30 days and 1 year in the OR group.
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http://dx.doi.org/10.1016/j.jvs.2014.06.109DOI Listing
January 2015

Inferior vena cava filter placement during thrombolysis for acute iliofemoral deep venous thrombosis.

J Vasc Surg Venous Lymphat Disord 2014 Jul 20;2(3):274-81. Epub 2014 Mar 20.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: The objectives of this study were to evaluate the need for inferior vena cava (IVC) filters and to identify anatomic and patient-specific risk factors associated with embolization in patients undergoing thrombolysis for acute iliofemoral deep venous thrombosis (DVT).

Methods: Consecutive patients who underwent catheter-directed thrombolysis or pharmacomechanical thrombolysis (PMT) for iliofemoral DVT from May 2007 to March 2012 were identified from a prospectively maintained database. Patients were categorized in two groups, depending on the status of IVC filtration during the lysis procedures: patients with an IVC filter protection (group A) and patients without an IVC filter protection (group B). The primary outcome was perioperative clinically significant pulmonary embolism (PE) or intraprocedural IVC filter clot capture.

Results: Eighty patients (mean age, 50 ± 16 years; 39 women) with symptoms averaging 12 ± 10 days were treated. A perioperative IVC filter was placed in 32 patients, and nine patients had an indwelling patent filter (group A, n = 41). Twenty patients received no filter, and 19 patients had an indwelling thrombosed filter (group B, n = 39). There were no clinically significant PE in either group. In group A, nine patients (22%) had documented embolic clot within the filter nest. The clot volume was deemed clinically significant in only two patients (5%). Factors related to embolization included female gender (odds ratio [OR], 5.833; 95% confidence interval [CI], 1.038-32.797; P = .032) and preoperative clinical PE (OR, 5.6; 95% CI, 1.043-30.081; P = .054). A trend for increased embolization was seen with a higher average number of DVT risk factors (1.44 vs 1; P = .065) and when PMT was used as a single treatment (OR, 4.32; 95% CI, 0.851-21.929; P = .087).

Conclusions: IVC filters during thrombolysis should be used selectively in patients with preoperative clinical PE, in women and potentially in patients with multiple risk factors for DVT, or when stand-alone PMT is planned.
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http://dx.doi.org/10.1016/j.jvsv.2013.12.006DOI Listing
July 2014

Anatomic and functional outcomes of pharmacomechanical and catheter-directed thrombolysis of iliofemoral deep venous thrombosis.

J Vasc Surg Venous Lymphat Disord 2014 Jul 22;2(3):246-52. Epub 2014 Mar 22.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Pharmacomechanical thrombolysis (PMT) and catheter-directed thrombolysis (CDT) are commonly used for the treatment of iliofemoral deep venous thrombosis (DVT). The purpose of this study was to examine the short- and long-term venous patency and venous valvular function as well as clinical outcomes of patients treated for iliofemoral DVT by PMT and CDT.

Methods: A retrospective review of all patients with symptomatic DVT treated between 2006 and 2011 with PMT or CDT was performed. All patients were treated by local tissue plasminogen activator delivered with PMT or CDT. Patients were divided into two groups on the basis of initial treatment modality: patients treated by PMT alone (group 1), and those who underwent PMT and CDT or CDT alone (group 2). Group comorbidities, initial presenting symptoms, and Clinical, Etiologic, Anatomic, and Pathologic (CEAP) classification scores were compared. Postprocedural duplex ultrasound was used to assess valve function and treated vein patency rates. At all visits, Villalta and CEAP scores were recorded and compared. Group demographic and procedural results were analyzed by Fisher exact test for dichotomous variables and Kruskal-Wallis equality-of-populations rank test for the ordinal and continuous data. Kaplan-Meier survival estimates were used to assess preserved valve function as well as primary and secondary patency rates.

Results: There were 79 patients with 102 limbs treated for extensive iliofemoral DVT (median age, 51.5 years; range, 16.6-83.8 years). There were 18 patients in group 1 and 61 patients in group 2 (PMT + CDT [n = 54] or CDT alone [n = 7]). There were no differences in demographics or comorbidities between groups aside from malignant disease, which was more common in group 1 (35.3% vs 11.5%; P = .03). A total of 102 limbs were analyzed, 24 in group 1 and 78 in group 2. Patients in group 1 had a shorter symptom duration compared with group 2 (7 days vs 16 days; P = .011). The median number of procedures in group 1 was lower than in group 2 (P < .001). At last clinical follow-up, there was no significant difference between the Villalta and CEAP scores or the rate of clinical improvement in symptoms between groups. By Kaplan-Meier analysis, there was no difference in primary patency, secondary patency, and treated valve function at 48 months.

Conclusions: This study suggests that PMT as a stand-alone therapy is as effective as CDT with or without PMT in preserving valve function and preventing postthrombotic syndrome. Long-term physiologic and functional outcomes are comparable between the modalities, with preserved venous valve function in the majority of patients.
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http://dx.doi.org/10.1016/j.jvsv.2014.02.003DOI Listing
July 2014

Limited survival in dialysis patients undergoing intact abdominal aortic aneurysm repair.

J Vasc Surg 2014 Oct 20;60(4):908-13.e1. Epub 2014 May 20.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Elective abdominal aortic aneurysm (AAA) repair in suitable candidates is a standard modality. The outcomes of AAA repair in patients with end-stage renal disease on dialysis are not well characterized, and there is questionable survival advantage in such patients with limited life expectancy. We sought to describe outcomes after AAA repair in U.S. dialysis patients.

Methods: The United States Renal Data System was used to collect data on intact asymptomatic AAA repair procedures in dialysis patients in the United States between 2005 and 2008. Endovascular AAA repair (EVAR) and open aortic repair (OAR) were identified by Current Procedural Terminology codes. Primary outcomes were perioperative (30-day) mortality and long-term survival. Predictors of mortality were identified by multivariate regression models.

Results: A total of 1557 patients were identified who had undergone elective AAA repair: 261 OAR and 1296 EVAR. The 30-day mortality was 11.3% (EVAR, 10.3%; OAR, 16.1%; P = .010), with increased age associated with increased mortality (odds ratio, 1.04; 95% confidence interval [CI], 1.02-1.07; P = .001). Kaplan-Meier survival estimates were 66.5% at 1 year (EVAR, 66.2%; OAR, 68%) and 37.4% at 3 years (EVAR, 36.8%; OAR, 40%; P = .33). Median survival was 25.3 months after EVAR and 27.4 months after OAR. Women had a higher mortality rate at 1 year (38.7%) compared with men (32.0%) (P = .015). There was no significant mortality difference at 1 year in comparing type of procedure in both men (EVAR, 31.6%; OAR, 34%; P = .55) and women (EVAR, 39.3%; OAR, 36%; P = .60). A Cox proportional hazards model demonstrated that male gender (hazard ratio [HR], 0.75; 95% CI, 0.62-0.92; P = .005), increased time on dialysis (HR for each year on dialysis, 0.79; 95% CI, 0.75-0.83; P < .001), kidney transplantation history (HR, 0.62; 95% CI, 0.43-0.88; P = .008), and diagnosis of hypertension (HR, 0.60; 95% CI, 0.48-0.75; P < .001) were protective against mortality. Increased age (HR, 1.02; 95% CI, 1.01-1.03; P < .001) and diabetes diagnosis (HR, 1.39; 95% CI, 1.13-1.71; P = .002) predicted increased mortality.

Conclusions: AAA patients on dialysis have high perioperative and 1-year mortality rates after EVAR or OAR, particularly diabetics, women, and the elderly. This raises questions about the indications for intact AAA repair in dialysis patients, in whom the size threshold may need to be raised. Dialysis patients may be best served by deferring repair of AAA until AAAs reach large size or become symptomatic, especially if OAR is required, given the higher perioperative mortality compared with EVAR.
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http://dx.doi.org/10.1016/j.jvs.2014.04.050DOI Listing
October 2014

Endovascular strategies for treatment of embolizing thoracoabdominal aortic lesions.

J Vasc Surg 2014 May 14;59(5):1256-64. Epub 2014 Jan 14.

University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Aortic sources of peripheral and visceral embolization remain challenging to treat. The safety of stent graft coverage continues to be debated. This study reports the outcomes of stent coverage of these complex lesions.

Methods: Hospital records were retrospectively reviewed for patients undergoing aortic stenting between 2006 and 2013 for visceral and peripheral embolic disease. Renal function, method of coverage, and mortality after stent grafting were reviewed.

Results: Twenty-five cases of embolizing aortic lesions treated with an endovascular approach were identified. The mean age was 65 ± 13 years (range, 45-87 years), and 64% were female. Sixteen (64%) patients presented with peripheral embolic events, six with concomitant renal embolization. Five patients presented with abdominal or flank pain, and two were discovered incidentally. Three patients had undergone an endovascular procedure for other indications within the preceding 6 months of presentation. Nineteen patients had existing chronic kidney disease (stage II or higher), but only three had stage IV disease. Of the eight patients tested, four had a diagnosed hypercoagulable state. Eight of the patients had lesions identified in multiple aortic segments, and aortic aneurysm disease was present in 24%. Coverage of both abdominal and thoracic sources occurred in eight patients, whereas 17 had only one segment covered. Minimal intraluminal catheter and wire manipulation was paired with the use of intravascular ultrasound in an effort to reduce embolization and contrast use. Intravascular ultrasound was used in the majority of cases and transesophageal echo in 28% of patients. Two patients with stage IV kidney disease became dialysis-dependent within 3 months of the procedure. No other patients had an increase in their postoperative or predischarge serum creatinine levels. No embolic events were precipitated during the procedure, nor were there any recurrent embolic events detected on follow-up. The 1-year mortality rate was 25%.

Conclusions: Endovascular coverage of atheroembolic sources in the aorta is feasible and is safe and effective in properly selected patients. It does not appear to worsen renal function when performed with the use of specific technical strategies.
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http://dx.doi.org/10.1016/j.jvs.2013.11.068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4027056PMC
May 2014

Endoscopic versus open saphenous vein graft harvest for lower extremity bypass in critical limb ischemia.

J Vasc Surg 2014 Jan;59(1):136-44

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Endoscopic vein harvest (EVH) has been demonstrated to improve early morbidity when compared with conventional open vein harvest (OVH) technique for infrainguinal bypass surgery. However, recent literature suggests conflicting results regarding mid- and long-term patency with EVH. The purpose of this study is to compare graft patency between harvest techniques specifically in patients with critical limb ischemia.

Methods: This retrospective study compared two groups of patients (EVH = 39 and OVH = 49) undergoing lower extremity revascularization from January 2009 to December 2011. Outcome measures included patency rates, postoperative complications, and wound infection. Graft patency was assessed using Kaplan-Meier curves.

Results: Both groups were matched for demographics and indications for bypass (critical limb ischemia). Median follow-up was 22 months. There was a significant reduction in the incidence of wound infection at the vein harvest site in the EVH group (OVH = 20%; EVH = 0%; P < .001), nevertheless, the difference was not significant when only the anastomotic sites were included (OVH = 12.2%; EVH = 15.4%; P = .43). The hospital length of stay was comparable between the two groups (EVH = 8.73 ± 9.69; OVH = 6.35 ± 3.28; P = .26) with no significant difference in the recovery time. Primary graft patency rate was 43.2% in the EVH group and 69.4% in the OVH group (P = .007) at 3 years. The most common reason for loss of primary patency was graft occlusion (61.5%) in the OVH group and vein graft stenosis (54.5%) in the EVH group. The average number of vascular reinterventions per bypass graft was significantly lower in the OVH group compared with the EVH group (OVH = 0.37; EVH = 1.28; P < .001).

Conclusions: Our findings demonstrate inferior primary patency when using the technique of EVH. Additionally, we identified a significantly higher rate of reintervention in the EVH cohort as well as a higher rate of vein graft body stenosis. However, EVH was associated with a decreased rate of wound complications with similar limb salvage and secondary patency rates when compared to OVH. EVH should therefore be selectively utilized in patients at high risk for wound complications.
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http://dx.doi.org/10.1016/j.jvs.2013.06.072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082991PMC
January 2014

Contemporary outcomes of endovascular interventions for acute limb ischemia.

J Vasc Surg 2014 Apr 17;59(4):988-95. Epub 2013 Dec 17.

Department of Surgery, Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Thrombolysis as a treatment for acute limb ischemia (ALI) has become a first-line therapy based on studies published over 2 decades ago. The purpose of this study was to assess outcomes of patients treated for ALI using contemporary thrombolytic agents and endovascular techniques.

Methods: Consecutive patients with ALI of the lower extremities treated between 2005 and 2011 were identified, and their records were retrospectively reviewed. All patients were treated with tissue plasminogen activator delivered via catheter-directed thrombolysis (CDT) and/or pharmacomechanical thrombolysis (PMT), with other adjunctive endovascular or surgical interventions. Procedural success, thrombolysis duration, and 30-day and long-term outcomes were obtained for the whole series and were also compared between the CDT and PMT groups. Limb salvage and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models.

Results: A total of 154 limbs were treated in 147 patients presenting with ALI (Rutherford class I, 9.7%; class IIa, 70.1%; class IIb, 20.1%). The mean follow-up was 15.20 months (range, 0.56-56.84 months). Indications for intervention included embolization (14.3%), thrombosed bypass (36.4%), thrombosed stent (26.6%), native artery thrombosis (24.0%), and thrombosed popliteal aneurysm (3.2%). Technical success was achieved in 83.8% of cases, with a 30-day mortality rate of 5.2%. Procedural complications included systemic bleeding (5.2%), access site hematoma (4.5%), acute renal failure (1.9%), and distal embolization (9.7%). The mean runoff score decreased from 13.42 preintervention to 7.43 postintervention. Adjuvant revascularization procedures were required in 89.0% of patients and were endovascular (68.8%), hybrid (9.1%), or open (11.0%). Only 3.2% of patients required a fasciotomy. The overall rate of major amputation was 15.0% (18.1% for CDT only, 11.3% for PMT; P = NS). Predictors of limb loss by Cox proportional hazards models included end-stage renal disease (hazard ratio [HR], 8.563; P < .001) and poor pedal outflow, with an incremental protective effect for improved pedal outflow (HR, 0.205; P < .001 for one pedal outflow vessel; HR, 0.074; P < .001 for ≥ two pedal outflow vessels). Gender, smoking, diabetes, Rutherford score, runoff score, thrombosed popliteal aneurysm, and PMT were not significant predictors of limb loss. The use of PMT was a significant predictor of technical success (odds ratio, 2.67; P = .046).

Conclusions: Endovascular therapy with thrombolysis using tissue plasminogen activator remains an effective treatment option for patients presenting with mild or moderate lower extremity ALI, with equal benefit derived with CDT or PMT. Patients with end-stage renal disease or poor pedal outflow have an increased risk of limb loss and may benefit from alternative revascularization strategies.
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http://dx.doi.org/10.1016/j.jvs.2013.10.054DOI Listing
April 2014
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