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Item Acute effects of leg heat therapy on walking performance and cardiovascular and inflammatory responses to exercise in patients with peripheral artery disease(Wiley, 2021) Monroe, Jacob C.; Song, Qifan; Emery, Michael S.; Hirai, Daniel M.; Motaganahalli, Raghu L.; Roseguini, Bruno T.; Surgery, School of MedicineLower-extremity peripheral artery disease (PAD) is associated with increased risk of cardiovascular events and impaired exercise tolerance. We have previously reported that leg heat therapy (HT) applied using liquid-circulating trousers perfused with warm water increases leg blood flow and reduces blood pressure (BP) and the circulating levels of endothelin-1 (ET-1) in patients with symptomatic PAD. In this sham-controlled, randomized, crossover study, sixteen patients with symptomatic PAD (age 65 ± 5.7 years and ankle-brachial index: 0.69 ± 0.1) underwent a single 90-min session of HT or a sham treatment prior to a symptom-limited, graded cardiopulmonary exercise test on the treadmill. The primary outcome was the peak walking time (PWT) during the exercise test. Secondary outcomes included the claudication onset time (COT), resting and exercise BP, calf muscle oxygenation, pulmonary oxygen uptake (V̇O2 ), and plasma levels of ET-1, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Systolic, but not diastolic BP, was significantly lower (~7 mmHg, p < .05) during HT when compared to the sham treatment. There was also a trend for lower SBP throughout the exercise and the recovery period following HT (p = .057). While COT did not differ between treatments (p = .77), PWT tended to increase following HT (CON: 911 ± 69 s, HT: 954 ± 77 s, p = .059). Post-exercise plasma levels of ET-1 were also lower in the HT session (CON: 2.0 ± 0.1, HT: 1.7 ± 0.1, p = .02). Calf muscle oxygenation, V̇O2 , COT, IL-6, and TNF-α did not differ between treatments. A single session of leg HT lowers BP and post-exercise circulating levels of ET-1 and may enhance treadmill walking performance in symptomatic PAD patients.Item Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction(Elsevier, 2019) Wang, S. Keisin; Lemmon, Gary W.; Gupta, Alok K.; Dalsing, Michael C.; Sawchuk, Alan P.; Motaganahalli, Raghu L.; Murphy, Michael P.; Fajardo, Andres; Surgery, School of MedicineBackground Junctional separation and resulting type IIIa endoleak is a well-known problem after EVAR (endovascular aneurysm repair). This complication results in sac pressurization, enlargement, and eventual rupture. In this manuscript, we review the incidence of this late finding in our experience with the Cook Zenith fenestrated endoprosthesis (ZFEN, Bloomington, IN). Methods A retrospective review was performed of a prospectively maintained institutional ZFEN fenestrated EVAR database capturing all ZFENs implanted at a large-volume, academic hospital system. Patients who experienced junctional separation between the fenestrated main body and distal bifurcated graft (with or without type IIIa endoleak) at any time after initial endoprosthesis implantation were subject to further evaluation of imaging and medical records to abstract clinical courses. Results In 110 ZFENs implanted from October 2012 to December 2017 followed for a mean of 1.5 years, we observed a 4.5% and 2.7% incidence of clinically significant junctional separation and type IIIa endoleak, respectively. Junctional separation was directly related to concurrent type Ib endoleak in all 5 patients. Three patients presented with sac enlargement. One patient did not demonstrate any evidence of clinically significant endoleak and had a decreasing sac size during follow-up imaging. The mean time to diagnosis of modular separation in these patients was 40 months. Junctional separation was captured in surveillance in 2 patients and reintervened upon before manifestation of endoleak. However, the remaining 3 patients completed modular separation resulting in rupture and emergent intervention in 2 and an aortic-related mortality in the other. Conclusions Junctional separation between the fenestrated main and distal bifurcated body with the potential for type IIIa endoleak is an established complication associated with the ZFEN platform. Therefore, we advocate for maximizing aortic overlap during the index procedure followed by aggressive surveillance and treatment of stent overlap loss captured on imaging.Item Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting With Stroke or Death Among Patients With Carotid Artery Stenosis(American Medical Association, 2019-12-17) Schermerhorn, Marc L.; Liang, Patric; Eldrup-Jorgensen, Jens; Cronenwett, Jack L.; Nolan, Brian W.; Kashyap, Vikram S.; Wang, Grace J.; Motaganahalli, Raghu L.; Malas, Mahmoud B.; Surgery, School of MedicineImportance: Several trials have observed higher rates of perioperative stroke following transfemoral carotid artery stenting compared with carotid endarterectomy. Transcarotid artery revascularization with flow reversal was recently introduced for carotid stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral carotid artery stenting, are not well characterized. Objective: To compare outcomes associated with transcarotid artery revascularization and transfemoral carotid artery stenting. Design, setting, and participants: Exploratory propensity score-matched analysis of prospectively collected data from the Vascular Quality Initiative Transcarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transcarotid artery revascularization and transfemoral carotid artery stenting for carotid artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures: Transcarotid artery revascularization vs transfemoral carotid artery stenting. Main outcomes and measures: Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results: During the study period, 5251 patients underwent transcarotid artery revascularization and 6640 patients underwent transfemoral carotid artery stenting. After matching, 3286 pairs of patients who underwent transcarotid artery revascularization or transfemoral carotid artery stenting were identified (transcarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). Transcarotid artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, -1.52% [95% CI, -2.29% to -0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72]; P < .001), stroke (1.3% vs 2.4%; absolute difference, -1.10% [95% CI, -1.79% to -0.41%]; RR, 0.54 [95% CI, 0.38 to 0.79]; P = .001), and death (0.4% vs 1.0%; absolute difference, -0.55% [95% CI, -0.98% to -0.11%]; RR, 0.44 [95% CI, 0.23 to 0.82]; P = .008). There was no statistically significant difference in the risk of perioperative myocardial infarction between the 2 cohorts (0.2% for transcarotid vs 0.3% for the transfemoral approach; absolute difference, -0.09% [95% CI, -0.37% to 0.19%]; RR, 0.70 [95% CI, 0.27 to 1.84]; P = .47). At 1 year using Kaplan-Meier life-table estimation, the transcarotid approach was associated with a lower risk of ipsilateral stroke or death (5.1% vs 9.6%; hazard ratio, 0.52 [95% CI, 0.41 to 0.66]; P < .001). Transcarotid artery revascularization was associated with higher risk of access site complication resulting in interventional treatment (1.3% vs 0.8%; absolute difference, 0.52% [95% CI, -0.01% to 1.04%]; RR, 1.63 [95% CI, 1.02 to 2.61]; P = .04), whereas transfemoral carotid artery stenting was associated with more radiation (median fluoroscopy time, 5 minutes [interquartile range {IQR}, 3 to 7] vs 16 minutes [IQR, 11 to 23]; P < .001) and more contrast (median contrast used, 30 mL [IQR, 20 to 45] vs 80 mL [IQR, 55 to 122]; P < .001). Conclusions and relevance: Among patients undergoing treatment for carotid stenosis, transcarotid artery revascularization, compared with transfemoral carotid artery stenting, was significantly associated with a lower risk of stroke or death.Item Balloon dilation strategy does not affect outcomes for transcarotid artery revascularization in prospective trials(Elsevier, 2022) Thomas, Jones P.; Kumins, Norman H.; Schneider , Peter A.; Kwolek , Christopher J.; Malas , Mahmoud B.; Schermerhorn, Marc L.; Patel , Avkash J.; Motaganahalli, Raghu L.; Stoner , Michael C.; Cambria, Richard P.; Kashyap , Vikram S.; Surgery, School of MedicineObjectives: Strategies of balloon dilation during transfemoral carotid artery stenting include prestent dilation only (PRE), post-stent dilation only (POST), or both predilation and postdilation (PRE+POST). Concerns over higher neurological risk have been raised with POST and PRE+POST during transfemoral carotid artery stenting. Whether these concerns are applicable to transcarotid artery revascularization (TCAR), which uses proximal clamping and cerebral blood flow reversal during stent deployment and balloon angioplasty remains unknown. Our aim is to analyze outcomes of PRE, POST, or PRE+POST balloon dilation strategies during TCAR. Methods: We analyzed the prospectively collected data from the ROADSTER1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All trial patients had a high risk anatomic or clinical factors for carotid endarterectomy and were included, unless they did not undergo stent deployment or balloon dilation. For trial inclusion, asymptomatic patients had a carotid stenosis of more than 80%, and symptomatic patients had stenosis of more than 50%. Primary outcome measures were stroke, death, and myocardial infarction (MI) at 30 days. Data were statistically analyzed with χ2, analysis of variance, and multivariable analysis, as appropriate. Results: There were 851 patients (566 male) who underwent dilation by PRE (n = 216), POST (n = 249), or PRE+POST (n = 386). Patients had carotid stenosis of greater than 70% (n = 828, 97%), and 207 (24%) were symptomatic. Flow reversal times were longer in the PRE+POST group (PRE 10.2 minutes, POST 9.8 minutes, and PRE+POST 13.3 minutes; P < .001). The 30-day stroke rate for the whole cohort was 1.9%, mortality was 0.5%, and MI rate was 0.94%. Stroke rates for the PRE cohort (1.9%), POST cohort (2.0%), and PRE+POST cohort (1.8%; P = .98) were similar. Also, death rates at 30 days, and composite stroke, death, and MI rates were similar in the three cohorts. No significant differences in adverse outcomes were noted among the various dilation strategies for both symptomatic and asymptomatic patients. Conclusions: Based on these prospective trial data, there is no difference in neurological complications owing to balloon dilation strategy during TCAR. The balloon dilation technique best suited to the patient's specific lesion morphology should be used. Further studies are needed to evaluate the relationship of these dilation strategies to long-term outcomes, including stent patency, restenosis, and reintervention.Item Clinical and Laboratory characteristics of patients with COVID-19 Infection and Deep Venous Thrombosis(Elsevier, 2020-10-22) Motaganahalli, Raghu L.; Kapoor, Rajat; Timsina, Lava R.; Gutwein, Ashley R.; Ingram, Michael D.; Raman, Subha; Roberts, Scott D.; Rahman, Omar; Rollins, David; Dalsing, Michael C.; Surgery, School of MedicineObjective: Early reports suggest that patients with novel coronavirus disease-2019 (COVID-19) infection carry a significant risk of altered coagulation with an increased risk for venous thromboembolic events. This report investigates the relationship of significant COVID-19 infection and deep venous thrombosis (DVT) as reflected in the patient clinical and laboratory characteristics. Methods: We reviewed the demographics, clinical presentation, laboratory and radiologic evaluations, results of venous duplex imaging and mortality of COVID-19-positive patients (18-89 years) admitted to the Indiana University Academic Health Center. Using oxygen saturation, radiologic findings, and need for advanced respiratory therapies, patients were classified into mild, moderate, or severe categories of COVID-19 infection. A descriptive analysis was performed using univariate and bivariate Fisher's exact and Wilcoxon rank-sum tests to examine the distribution of patient characteristics and compare the DVT outcomes. A multivariable logistic regression model was used to estimate the adjusted odds ratio of experiencing DVT and a receiver operating curve analysis to identify the optimal cutoff for d-dimer to predict DVT in this COVID-19 cohort. Time to the diagnosis of DVT from admission was analyzed using log-rank test and Kaplan-Meier plots. Results: Our study included 71 unique COVID-19-positive patients (mean age, 61 years) categorized as having 3% mild, 14% moderate, and 83% severe infection and evaluated with 107 venous duplex studies. DVT was identified in 47.8% of patients (37% of examinations) at an average of 5.9 days after admission. Patients with DVT were predominantly male (67%; P = .032) with proximal venous involvement (29% upper and 39% in the lower extremities with 55% of the latter demonstrating bilateral involvement). Patients with DVT had a significantly higher mean d-dimer of 5447 ± 7032 ng/mL (P = .0101), and alkaline phosphatase of 110 IU/L (P = .0095) than those without DVT. On multivariable analysis, elevated d-dimer (P = .038) and alkaline phosphatase (P = .021) were associated with risk for DVT, whereas age, sex, elevated C-reactive protein, and ferritin levels were not. A receiver operating curve analysis suggests an optimal d-dimer value of 2450 ng/mL cutoff with 70% sensitivity, 59.5% specificity, and 61% positive predictive value, and 68.8% negative predictive value. Conclusions: This study suggests that males with severe COVID-19 infection requiring hospitalization are at highest risk for developing DVT. Elevated d-dimers and alkaline phosphatase along with our multivariable model can alert the clinician to the increased risk of DVT requiring early evaluation and aggressive treatmentItem Combined transbrachial and transfemoral strategy to deploy an iliac branch endoprosthesis in the setting of a pre-existing endovascular aortic aneurysm repair(Elsevier, 2019-06-29) Wang, S. Keisin; Miladore, Julia N.; Yee, Elliott J.; Liao, Jane L.; Donde, Nikunj N.; Motaganahalli, Raghu L.; Surgery, School of MedicineThis article describes brachial access to position a long sheath in the abdominal aorta in conjunction with a large caliber sheath via the femoral artery ipsilateral to the target site to deliver a 0.018 bodyfloss wire. This bodyfloss wire is inserted into the precannulation port of the iliac branch endoprosthesis (W. L. Gore and Associates, Flagstaff, Ariz), which is then advanced from the groin. Once the bifurcated device is deployed, hypogastric access and stenting is achieved from the upper extremity. This technique is an alternative to safely extend the distal seal while preserving the hypogastric artery and has the advantage of limited iliac bifurcation manipulation.Item Cryopreserved Homografts in Infected Infrainguinal Fields Are Associated with Frequent Reinterventions and Poor Amputation-Free Survival(Elsevier, 2018) Wang, S. Keisin; Gutwein, Ashley R.; Drucker, Natalie A.; Murphy, Michael P.; Fajardo, Andres; Dalsing, Michael C.; Motaganahalli, Raghu L.; Lemmon, Gary W.; Surgery, School of MedicineBackground Single-length saphenous vein continues to be the conduit of choice in infected-field critical limb ischemia. However, half of these individuals have inadequate vein secondary to previous use or chronic venous disease. We reviewed our outcomes of infected-field infrainguinal bypasses performed with cryopreserved homografts (CHs), a widely accepted alternative to autogenous vein in this setting. Methods This is a retrospective, institutional descriptive analysis of infected-field infrainguinal revascularizations between 2012 and 2015. Results Twenty-four operations were performed in the same number of patients for limb ischemia with signs of active infection. The mean age of the cohort examined was 62.5 ± 14.4 (standard deviation) years. Mean Society of Vascular Surgery risk score was 3.9 with a baseline Rutherford's chronic ischemia score of 4.3 at presentation. Emergent procedures constituted 29% of cases, and the remainder cases were urgent procedures. The CH bypass captured was a reoperative procedure in all but one of the patients. Culture positivity was present in 75% of cases with Staphylococcus aureus (29%), the most commonly isolated organism. Thirty-day mortality and major adverse cardiovascular events were both 4%. Amputation-free survival (AFS) was 75% at 30 days. Similarly, 30-day reintervention was 38% with debridement (43%) and bleeding (29%), the most common indications. Average duration of follow-up was 27.9 ± 20.4 months (range: 0.5–60.4). Mean length of stay was 14.8 days. Reinfection requiring an additional procedure or antibiotic regimen separate from the index antibiotic course was 13%. Primary patency and AFS at 1 year was 50% and 58%, respectively. Primary patency and AFS at 2 years was 38% and 52%, respectively. Limb salvage at 1 and 2 years was 70% and 65%, respectively. Fifteen patients (63%) required reintervention during the follow-up period with 40% of those subjects undergoing multiple procedures. Conclusions CHs remain a marginal salvage conduit in the setting of infection and no autogenous choices. Therefore, clinicians should individualize usage of this high-cost product in highly selected patients only.Item Description of human AAA by cytokine and immune cell aberrations compared to risk-factor matched controls(Elsevier, 2018-08) Wang, S. Keisin; Green, Linden A.; Gutwein, Ashley R.; Drucker, Natalie A.; Motaganahalli, Raghu L.; Gupta, Alok K.; Fajardo, Andres; Murphy, Michael P.; Surgery, School of MedicineBACKGROUND: The pathogenesis driving the formation of abdominal aortic aneurysms continues to be poorly understood. Therefore, we systemically define the cytokine and circulating immune cell environment observed in human abdominal aortic aneurysm compared with risk-factor matched controls. METHODS: From 2015 to 2017, a total of 274 patients donated blood to the Indiana University Center for Aortic Disease. Absolute concentrations of circulating cytokines were determined, using enzyme-linked immunosorbent assays while the expression of circulating immune cell phenotypes were assayed via flow cytometric analysis. RESULTS: Human abdominal aortic aneurysm is characterized by a significant depletion of the antigen-specific, CD4+ Tr1 regulatory lymphocyte that corresponds to an upregulation of the antigen-specific, inflammatory Th17 cell. We found no differences in the incidence of Treg, B10, and myeloid-derived suppressor regulatory cells. Similarly, no disparities were noted in the following inflammatory cytokines: IL-1β, C-reactive protein, tumor necrosis factor α, interferon γ, and IL-23. However, significant upregulation of the inflammatory cytokines osteopontin, IL-6, and IL-17 were noted. Additionally, no changes were observed in the regulatory cytokines IL-2, IL-4, IL-13, TNF-stimulated gene 6 protein, and prostaglandin E2, but we did observe a significant decrease in the essential regulatory cytokine IL-10. CONCLUSION: In this investigation, we systematically characterize the abdominal aortic aneurysm-immune environment and present preliminary evidence that faulty immune regulation may also contribute to aneurysm formation and growth.Item Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial(American Physiological Society, 2022) Monroe, Jacob C.; Pae, Byung Joon; Kargl, Christopher; Gavin, Timothy P.; Parker, Jason; Perkins, Susan M.; Han, Yan; Klein, Janet; Motaganahalli, Raghu L.; Roseguini, Bruno T.; Radiology and Imaging Sciences, School of MedicineFew noninvasive therapies currently exist to improve functional capacity in people with lower extremity peripheral artery disease (PAD). The goal of the present study was to test the hypothesis that unsupervised, home-based leg heat therapy (HT) using water-circulating trousers perfused with warm water would improve walking performance in patients with PAD. Patients with symptomatic PAD were randomized into either leg HT (n = 18) or a sham treatment (n = 16). Patients were provided with water-circulating trousers and a portable pump and were asked to apply the therapy daily (7 days/wk, 90 min/session) for 8 wk. The primary study outcome was the change from baseline in 6-min walk distance at 8-wk follow-up. Secondary outcomes included the claudication onset-time, peak walking time, peak pulmonary oxygen consumption and peak blood pressure during a graded treadmill test, resting blood pressure, the ankle-brachial index, postocclusive reactive hyperemia in the calf, cutaneous microvascular reactivity, and perceived quality of life. Of the 34 participants randomized, 29 completed the 8-wk follow-up. The change in 6-min walk distance at the 8-wk follow-up was significantly higher (P = 0.029) in the group exposed to HT than in the sham-treated group (Sham: median: -0.9; 25%, 75% percentiles: -5.8, 14.3; HT: median: 21.3; 25%, 75% percentiles: 10.1, 42.4, P = 0.029). There were no significant differences in secondary outcomes between the HT and sham group at 8-wk follow-up. The results of this pilot study indicate that unsupervised, home-based leg HT is safe, well-tolerated, and elicits a clinically meaningful improvement in walking tolerance in patients with symptomatic PAD. NEW & NOTEWORTHY: This is the first sham-controlled trial to examine the effects of home-based leg heat therapy (HT) on walking performance in patients with peripheral artery disease (PAD). We demonstrate that unsupervised HT using water-circulating trousers is safe, well-tolerated, and elicits meaningful changes in walking ability in patients with symptomatic PAD. This home-based treatment option is practical, painless, and may be a feasible adjunctive therapy to counteract the decline in lower extremity physical function in patients with PAD.Item Left colic artery aneurysm(Elsevier, 2020-10) Kota, Albert A.; Wang, Keisin; Leckie, Katherine; King, Justin; Maijub, John; Motaganahalli, Raghu L.; Medicine, School of MedicineAn aneurysm of the inferior mesenteric artery is a rarely described clinical presentation. We have presented the case of a ruptured aneurysm originating from a branch of the inferior mesenteric artery that might represent an aneurysm of the left colic artery or the arc of Riolan. Aneurysms of this anatomic location can develop secondary to mesenteric occlusive disease, alterations in mesenteric blood flow from previous operations, or connective tissue disease. In the present case, a patient with a ruptured inferior mesenteric artery branch aneurysm had presented with intra-abdominal hemorrhage, which was successfully treated with endovascular embolization.
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