Publications by authors named "Michael Conte"

250 Publications

Risk Factors for Venous Thromboembolism after Vascular Surgery and Implications for Chemoprophylaxis Strategies.

J Vasc Surg Venous Lymphat Disord 2021 Oct 9. Epub 2021 Oct 9.

Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco. San Francisco, CA, USA.

Objective: Venous thromboembolism (VTE) is an important cause of postoperative morbidity and mortality, but the reported incidence after major vascular surgery ranges from as low as 1% to upwards of 10%. Further, little is known about optimal chemoprophylaxis regimens or rates of post-discharge VTE in this population. This study aimed to better characterize in-hospital and post-discharge VTE after major vascular surgery, the role of chemoprophylaxis timing, and the association of VTE with mortality.

Methods: A single center retrospective study of 1,449 major vascular operations (2013-2020) was performed, and included 189 EVARs (13%), 169 TEVARs (12%), 318 open aortic operations (22%), 640 lower extremity bypasses (44%), and 133 femoral endarterectomies (9%). Baseline characteristics, anticoagulant/antiplatelet medications, and outcomes were abstracted from an electronic data warehouse with medical chart auditing. Post-operative VTE (pulmonary embolism [PE] and deep vein thrombosis [DVT]) within 90-days of surgery was classified based on location, symptoms, and treatment. Cut point analysis using Youden's index identified the most VTE discriminating timing of chemoprophylaxis (including therapeutic/prophylactic anticoagulant and antiplatelet medications) and Caprini score. Multivariable logistic regression tested the association of VTE with chemoprophylaxis timing, Caprini score, and additional risk factors. Cox proportional hazard modeling measured the association between VTE and mortality.

Results: Overall VTE incidence was 3.4% (65% DVTs, 25% PEs, 10% both) and 37% were post-discharge. The rate of symptomatic VTE was 2.4%, which was lowest for EVAR (0.0%) and highest for open aortic operations (4.1%, p=0.02). Individuals who developed VTE had longer length of stay, higher rates of end-stage renal disease, prior VTE, and higher Caprini scores (8 vs 5 points) (all p<0.01). Individuals who developed VTE were also more likely to receive >2 units of blood postoperatively, have an unplanned return to the operating room, have delayed chemoprophylaxis/anticoagulation/antiplatelet initiation >4 days postoperatively, and had increased 90-day mortality (all p<0.01). Caprini score >7 (29% of patients) was associated with post-discharge VTE (2.6% vs 0.7%, p=0.01), and chemoprophylaxis/anticoagulation/antiplatelet timing >4 days was associated with increased adjusted odds of VTE (odds ratio 2.4 [1.1-4.9]). Although no fatal VTEs were identified, VTE was an independent predictor of 90-day mortality (adjusted hazard ratio 2.7 [1.3-5.9]).

Conclusions: These data highlight that patients undergoing major vascular surgery are particularly prone to VTE with frequent hypercoagulable comorbidities and earlier initiation of chemoprophylaxis is associated with reduced risk of development of VTE. Furthermore, post-discharge VTE rates may reach thresholds warranting post-discharge chemoprophylaxis, particularly for patients with Caprini scores >7.
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http://dx.doi.org/10.1016/j.jvsv.2021.10.001DOI Listing
October 2021

Pedal arterial calcification score is associated with the risk of major amputation in chronic limb-threatening ischemia.

J Vasc Surg 2021 Sep 3. Epub 2021 Sep 3.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, San Francisco, Calif. Electronic address:

Objective: The medial arterial calcification (MAC) score is a simple metric that describes the burden of inframalleolar calcification using a plain foot radiograph. We hypothesized that a higher MAC score would be independently associated with the risk of major amputation in patients with chronic limb-threatening ischemia (CLTI).

Methods: We performed a single-institution, retrospective study of 250 patients who had undergone infrainguinal revascularization for CLTI from January 2011 to July 2019 and had foot radiographs available for MAC score calculation. A single blinded reviewer assigned MAC scores of 0 to 5 using two-view minimum plain foot radiographs, with 1 point each for calcification of >2 cm in the dorsalis pedis, plantar, and metatarsal arteries and >1 cm in the hallux and non-hallux digital arteries.

Results: The MAC score was 0 in 36%, 1 in 5.2%, 2 in 8.4%, 3 in 14%, 4 in 14%, and 5 in 21%. The MAC score was trichotomized to facilitate analysis and clinical utility (mild, MAC score 0-1; moderate, MAC score 2-4; and severe, MAC score 5). The variables independently associated with a higher MAC score were male sex, diabetes, end-stage renal disease, and the global limb anatomic staging system pedal score. The MAC score was not associated with the Society for Vascular Surgery WIfI (wound, ischemia, foot infection) grade or overall WIfI stage (P = .58). The median follow-up was 759 days (interquartile range, 264-1541 days). A higher MAC score was significantly associated with the risk of major amputation (P < .0001). In a Cox proportional hazards multiple regression model for major amputation that included the trichotomized MAC score, diabetes, end-stage renal disease, and WIfI stage (1-3 vs 4). The MAC score (MAC score 5: hazard ratio [HR], 4.9; 95% confidence interval [CI], 1.9-13.1; P = .001; MAC score 2-4: HR, 3.4; 95% CI, 1.3-8.8; P = .01) and WIfI stage (WIfI stage 4: HR, 2.1; 95% CI, 1.1-3.9; P = .03) were significantly associated with the risk of major amputation. In the subsets of patients with the most advanced WIfI stage of 3 to 4 (191 of 250; 76%) and patients with diabetes (185 of 250; 74%), the MAC score further stratified the risk of major amputation on univariate and multivariate analyses.

Conclusions: The MAC score is a simple, practical tool and a strong independent predictor of major amputation in patients with CLTI. It provides novel clinical data that are currently unmeasured using any validated CLTI staging system. The MAC score is a promising standardized measure of inframalleolar disease burden that can be used in conjunction with the WIfI staging system to help improve outcomes stratification and determine the optimal treatment strategies for patients with CLTI.
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http://dx.doi.org/10.1016/j.jvs.2021.07.235DOI Listing
September 2021

The Global Limb Anatomic Staging System (GLASS) for CLTI: Improving Inter-Observer Agreement.

J Clin Med 2021 Aug 4;10(16). Epub 2021 Aug 4.

Department of Vascular Surgery, UCSF Medical Center, San Francisco, CA 94143, USA.

Objective: The 2020 Global Vascular Guidelines aim at improving decision making in Chronic Limb-Threatening Ischemia (CLTI) by providing a framework for evidence-based revascularization. Herein, the Global Limb Anatomic Staging System (GLASS) serves to estimate the chance of success and patency of arterial pathway revascularization based on the extent and distribution of the atherosclerotic lesions. We report the preliminary feasibility results and observer variability of the GLASS. GLASS is a part of the new global guideline and posed as a promising additional tool for EBR strategies to predict the success of lower extremity arterial revascularization. This study reports on the consistency of GLASS scoring to maximize inter-observer agreement and facilitate its application.

Methods: GLASS separately scores the femoropopliteal (FP) and infrapopliteal (IP) segment based on stenosis severity, lesion length and the extent of calcification within the target artery pathway (TAP). In our stepwise approach, we used two angiographic datasets. Each following step was based on the lessons learned from the previous step. The primary outcome was inter-observer agreement measured as Cohen's Kappa, scored by two (step 1 + 2) and four (step 3) blinded and experienced observers, respectively. Steps 1 ( = 139) and 2 ( = 50) were executed within a dataset of a Dutch interventional RCT in CLTI. Step 3 ( = 100) was performed in randomly selected all-comer CLTI patients from two vascular centers in the United States.

Results: In step 1, kappa values were 0.346 (FP) and 0.180 (IP). In step 2, applied in the same dataset, the use of other experienced observers and a provided TAP, resulted in similar low kappa values 0.406 (FP) and 0.089 (IP). Subsequently, in step 3, the formation of an altered stepwise approach using component scoring, such as separate scoring of calcification and adding a ruler to the images resulted in kappa values increasing to 0.796 (FP) and 0.730 (IP).

Conclusion: This retrospective GLASS validation study revealed low inter-observer agreement for unconditioned scoring. A stepwise component scoring provides acceptable agreement and a solid base for further prospective validation studies to investigate how GLASS relates to treatment outcomes.
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http://dx.doi.org/10.3390/jcm10163454DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8396876PMC
August 2021

Feasibility of Photo-Optical Transcutaneous Oxygen Tension Measurement During Revascularization of the Lower Extremity.

Ann Vasc Surg 2021 Aug 23. Epub 2021 Aug 23.

Department of Vascular and Endovascular Surgery, Jeroen Bosch Ziekenhuis, Netherlands. Electronic address:

Objectives: A novel approach in the evaluation of peripheral arterial disease is the photo-optical oxygen tension measurement (pTCpO2). This modality is suggested to be more practical in use in comparison to standard electro-chemical oxygen tension measurement. Hence, pTCpO2 might be of added value to evaluate revascularization of the lower extremities peri-procedural. We conducted a preliminary feasibility study to analyze the potential of pTCpO2 during revascularization.

Methods: Ten patients scheduled for revascularization of the lower extremities were enrolled. pTCpO2 values of the affected lower extremity were measured pre-operatively, during revascularization and after revascularization. Results were compared to the pre- and postoperative ankle-brachial index (ABI) and to perioperative angiography. Primary endpoint was the feasibility of perioperative pTCpO2 measurement. Secondary endpoints were concordance between pTCpO2, ABI, angiography and clinical outcome.

Results: Two out of twelve measurements were unsuccessful. Eight out of ten patients experienced significant clinical improvement and pTCpO2 increase. Two patients that did not experience clinical improvement corresponded with no changes in intraoperative angiography and without increase in ABI or pTCpO2. A significant and strong correlation was found between prior and after revascularization ABI and pTCpO2 measurements (r = 0.82 P = 0.04).

Conclusions: Photo-optical transcutaneous oxygen tension measurement may serve as an intraoperative tool to evaluate the success of revascularization. pTCpO2 could be an alternative for the ABI to determine the success of lower extremity revascularization.
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http://dx.doi.org/10.1016/j.avsg.2021.05.058DOI Listing
August 2021

A critical appraisal of registry-based objective performance goals in peripheral arterial disease.

J Vasc Surg 2021 09;74(3):1008-1012

Department of Surgery, Division of Vascular and Endovascular Surgery, San Francisco Medical School, University of California, San Francisco, Calif.

The multidisciplinary Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group, under the auspices of the Registry Assessment of Peripheral Interventional Devices (RAPID) partnership, recently published objective performance goals for peripheral vascular interventions in the femoropopliteal arteries. Retrospective outcomes from the Vascular Quality Initiative provided the sole study data source. Strengths and weaknesses of this landmark effort are examined. Critical concerns include the substantial risks of ascertainment bias, flawed end point selection, sparse and variable capture of midterm follow-up data, and lack of expected discrimination between treatment modalities. The current Vascular Quality Initiative registry data thus appear insufficiently robust for the generation of objective performance goals and practice benchmarks; suggestions for redesign are provided. The impact of the statutory framework of the US Food and Drug Administration on device approval pathways and the maturation of an evidence-based approach to peripheral vascular intervention is explored.
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http://dx.doi.org/10.1016/j.jvs.2021.04.028DOI Listing
September 2021

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

Circulation 2021 Oct 12;144(14):1104-1116. Epub 2021 Aug 12.

CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER.

Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee.

Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; =0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (=0.95) and postprocedural bleeding requiring intervention (=0.93) was not significantly increased.

Conclusions: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.054835DOI Listing
October 2021

Precision Medicine Enables More TNM-Like Staging in Patients With Chronic Limb Threatening Ischemia.

Front Cardiovasc Med 2021 16;8:709904. Epub 2021 Jul 16.

Department of Public Health Sciences, Clemson University, Clemson, SC, United States.

In cancer, there are survival-based staging systems and tailored, stage-based treatments. There is little personalized treatment in vascular disease. The 2019 Global Vascular Guidelines on the Management of CLTI proposed successful treatment hinges upon Patient risk, Limb severity, and ANatomic complexity (PLAN). We sought to confirm a three axis approach and define how increasing severity affects mortality, not just limb loss. Patients revascularized for incident CLTI at our institution from 2013 to 2017 were included. Outcomes were mortality, limb loss, the composite endpoint of amputation-free survival. Using Bayesian machine learning, specifically supervised topic modeling, clusters of patient features associated with mortality were formed after controlling for revascularization type. Patients were assigned to the cluster they belonged to with highest probability; clusters were characterized by analyzing the characteristics of patients within them. Patient outcomes were used to order the clusters into stages with increasing mortality. We defined three distinct clusters as the basis for patient- and limb-centered stages. Across stages, rates of 1-year mortality were 7.6, 13.8, 18.9% and rates of amputation-free survival were 84.8, 79.3, and 63.2%. Stage one had patients with rest pain and previous revascularization who were less likely to have wounds, diabetes, and renal disease. Stage two had doubled mortality, likely related to diabetes prevalence. Stage three is characterized by high rates of complicated comorbidities, particularly end stage renal disease, and significantly higher rate of limb loss (22.6 vs. 8% in stages one and two). Using precision medicine, we have demonstrated clustering of CLTI patients that can be used toward a robust staging system. We provide empiric evidence for PLAN and detail about how changes in each variable affect survival and amputation-free survival.
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http://dx.doi.org/10.3389/fcvm.2021.709904DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8322654PMC
July 2021

A Limb is a Peninsula- and No Clinician is an Island: Introducing the American Limb Preservation Society (ALPS).

Foot Ankle Surg (N Y) 2021 29;1(1). Epub 2021 Mar 29.

Department of Surgery, Keck School of Medicine of University of Southern California, 1510 San Pablo St, Health Sciences Campus, Los Angeles, CA 90033.

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http://dx.doi.org/10.1016/j.fastrc.2021.100005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8312703PMC
March 2021

Invasive treatment of claudication: Time for better measures and better controls.

Authors:
Michael S Conte

J Vasc Surg 2021 08;74(2):505

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, San Francisco, Calif.

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http://dx.doi.org/10.1016/j.jvs.2020.12.073DOI Listing
August 2021

Advances in Revascularization for Peripheral Artery Disease: Revascularization in PAD.

Circ Res 2021 Jun 10;128(12):1885-1912. Epub 2021 Jun 10.

Division of Vascular and Endovascular Surgery, University of California, San Francisco (P.A.S., M.S.C.).

Effective revascularization of the patient with peripheral artery disease is about more than the procedure. The approach to the patient with symptom-limiting intermittent claudication or limb-threatening ischemia begins with understanding the population at risk and variation in clinical presentation. The urgency of revascularization varies significantly by presentation; from patients with intermittent claudication who should undergo structured exercise rehabilitation before revascularization (if needed) to those with acute limb ischemia, a medical emergency, who require revascularization within hours. Recent years have seen the rapid development of new tools including wires, catheters, drug-eluting technology, specialized balloons, and biomimetic stents. Open surgical bypass remains an important option for those with advanced disease. The strategy and techniques employed vary by clinical presentation, lesion location, and lesion severity. There is limited level 1 evidence to guide practice, but factors that determine technical success and anatomic durability are largely understood and incorporated into decision-making. Following revascularization, medical therapy to reduce adverse limb outcomes and a surveillance plan should be put in place. There are many hurdles to overcome to improve the efficacy of lower extremity revascularization, such as restenosis, calcification, microvascular disease, silent embolization, and tools for perfusion assessment. This review highlights the current state of revascularization in peripheral artery disease with an eye toward technologies at the cusp, which may significantly impact current practice.
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http://dx.doi.org/10.1161/CIRCRESAHA.121.318261DOI Listing
June 2021

Understanding value and patient complexity among common inpatient vascular surgery procedures.

J Vasc Surg 2021 Oct 19;74(4):1343-1353.e2. Epub 2021 Apr 19.

Department of Surgery, University of California, San Francisco, San Francisco, Calif. Electronic address:

Objective: Vascular surgery patients are highly complex, second only to patients undergoing cardiac procedures. However, unlike cardiac surgery, work relative value units (wRVU) for vascular surgery were undervalued based on an overall patient complexity score. This study assesses the correlation of patient complexity with wRVUs for the most commonly performed inpatient vascular surgery procedures.

Methods: The 2014 to 2017 National Surgical Quality Improvement Program Participant Use Data Files were queried for inpatient cases performed by vascular surgeons. A previously developed patient complexity score using perioperative domains was calculated based on patient age, American Society of Anesthesiologists class of ≥4, major comorbidities, emergent status, concurrent procedures, additional procedures, hospital length of stay, nonhome discharge, and 30-day major complications, readmissions, and mortality. Procedures were assigned points based on their relative rank and then an overall score was created by summing the total points. An observed to expected ratio (O/E) was calculated using open ruptured abdominal aortic aneurysm repair (rOAAA) as the referent and then applied to an adjusted median wRVU per operative minute.

Results: Among 164,370 cases, patient complexity was greatest for rOAAA (complexity score = 128) and the least for carotid endarterectomy (CEA) (complexity score = 29). Patients undergoing rOAAA repair had the greatest proportion of American Society of Anesthesiologists class of ≥IV (84.8%; 95% confidence interval [CI], 82.6%-86.8%), highest mortality (35.5%; 95% CI, 32.8%-38.3%), and major complication rate (87.1%; 95% CI, 85.1%-89.0%). Patients undergoing CEA had the lowest mortality (0.7%; 95% CI, 0.7%-0.8%), major complication rate (8.2%; 95% 95% CI, 8.0%-8.5%), and shortest length of stay (2.7 days; 95% CI, 2.7-2.7). The median wRVU ranged from 10.0 to 42.1 and only weakly correlated with overall complexity (Spearman's ρ = 0.11; P < .01). The median wRVU per operative minute was greatest for thoracic endovascular aortic repair (0.25) and lowest for both axillary-femoral artery bypass (0.12) and open femoral endarterectomy, thromboembolectomy, or reconstruction (0.12). After adjusting for patient complexity, CEA (O/E = 3.8) and transcarotid artery revascularization (O/E = 2.8) had greater than expected O/E. In contrast, lower extremity bypass (O/E = 0.77), lower extremity embolectomy (O/E = 0.79), and open abdominal aortic repair (O/E = 0.80) had a lower than expected O/E.

Conclusions: Patient complexity varies substantially across vascular procedures and is not captured effectively by wRVUs. Increased operative time for open procedures is not adequately accounted for by wRVUs, which may unfairly penalize surgeons who perform complex open operations.
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http://dx.doi.org/10.1016/j.jvs.2021.03.036DOI Listing
October 2021

Closure device use for common femoral artery antegrade access is higher risk than retrograde access.

Ann Vasc Surg 2021 Oct 7;76:49-58. Epub 2021 Apr 7.

Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA, USA. Electronic address:

Objective: Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA).

Methods: This was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias.

Results: Overall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P<0.05). Patients with AA were more likely to be on dialysis (12.8% vs 10.1%) and have ultrasound-guided access (76.4% vs 66.2%; P<0.05 for all). Compared to RA, patients with AA were more likely to develop any access site hematoma (2.5% vs 1.8%; P<0.01) and a hematoma requiring intervention (0.7% vs 0.5%; P=0.03), but had no difference in access site stenosis or occlusion (0.3% vs 0.2%; P=0.21). On multivariable analyses, AA had increased odds of developing any access site hematoma (OR=1.46; 95% CI=1.22-1.76) and a hematoma requiring intervention (OR=1.48; 95% CI=1.10-1.98). Sensitivity analyses after coarsened exact matching confirmed these findings.

Conclusion: In this nationally representative sample, the use of CDs for femoral access was associated with an overall low rate of access site complications. However, there was an increased odds of access site hematomas with AA. Patient selection for AA remains important and ultrasound guided access should be the standard of care for this approach.
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http://dx.doi.org/10.1016/j.avsg.2021.03.009DOI Listing
October 2021

Contemporary Experience with Paravisceral Aortic Aneurysm (PVAAA) Repair in a Tertiary Center.

Ann Vasc Surg 2021 Aug 2;75:368-379. Epub 2021 Apr 2.

Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, California.

Objectives: To describe contemporary outcomes from a single center capable of both complex open and endovascular aortic repair for paravisceral aortic aneurysms (PVAAA).

Methods: Data on all patients receiving open or endovascular (endo) treatment for aortic aneurysms with proximal extent at or above the renal arteries and distal to the inferior pulmonary ligament (IPL) were reviewed. Coarsened exact matching (CEM) on age, aneurysm type, gender, coronary artery disease (CAD), previous aortic surgery and symptomatic status created balanced cohorts for outcomes comparisons.

Results: Between October, 2006 and February, 2018, 194 patients were treated for juxtarenal (40%), pararenal (21%), paravisceral (6%) and Type 4 thoracoabdominal (34%) aortic aneurysms with open (81, 42%) or endo (113, 58%) at a single tertiary center. Endo repairs included renal coverage with a bifurcated graft (2%), unilateral (13%) or bilateral (4%) renal snorkels, Z-fen (15%), multi-branched graft (IDE protocol; 62%) and unique complex configurations (4%). On multivariable analysis, patients selected for open surgery were more likely to be symptomatic, whereas older patients, female patients and those with Type 4 TAAA extent were more often selected for endovascular treatment. Matching based on the significant independent covariates reduced the open and endovascular groups by one-third. Survival at 30 days was 97% for endo and 94% for open repair, 98% for both subgroups when excluding symptomatic cases, and was not different between the matched groups (98% vs 89%; P=0.23). Hospital and ICU stays were longer in open patients (8 vs. 10 days, 2 vs. 4, both P≤0.001). Post-op CVA, MI, lower extremity ischemia, surgical site infections and reoperation were not different between matched groups (all p>0.05), while pulmonary and intestinal complications, as well as grade 1/2 renal dysfunction by RIFLE criteria, were more common after open repair (all P<0.05). Spinal cord ischemia was significantly more frequent in the unmatched Endo group (11% vs. 1%, P=0.02), but this difference was not significant after matching. Composite major aortic complications was no different between treatment groups (unmatched P=0.91, matched P=0.87). Endo treatment resulted in patients more frequently discharged to home (84% vs. 66%, P=0.02). Reintervention after 30 days occurred more frequently in the endo group (P=0.002). Estimated survivals at 1 and 5 years for endo and open are 96% vs. 81% and 69% vs. 81% respectively (Log-rank P=0.57).

Conclusions: Contemporary repair of PVAAA demonstrates safe outcomes with durable survival benefit when patients are well-selected for open or complex endovascular repair. We believe these data have implications for off-label device use in the treatment of PVAAA, and that open repair remains an essential option for younger, good risk patients in experienced centers.
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http://dx.doi.org/10.1016/j.avsg.2021.01.109DOI Listing
August 2021

The Significance of the Global Vascular Guidelines for Podiatrists: Answers to Key Questions in the Diagnosis and Management of the Threatened Limb.

J Am Podiatr Med Assoc 2021 Mar 17. Epub 2021 Mar 17.

The publication of the Global Vascular Guidelines in 2019 provide evidence-based, best practice recommendations on the diagnosis and treatment of chronic limb-threatening ischemia (CLTI). Certainly, the multidisciplinary team, and more specifically one with collaborating podiatrists and vascular specialists, has been shown to be highly effective at improving the outcomes of limbs at risk for amputation. This article uses the Guidelines to answer key questions for podiatrists who are caring for the patient with CLTI.
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http://dx.doi.org/10.7547/20-217DOI Listing
March 2021

The Global Limb Anatomic Staging System is associated with outcomes of infrainguinal revascularization in chronic limb threatening ischemia.

J Vasc Surg 2021 06 4;73(6):2009-2020.e4. Epub 2021 Feb 4.

Division of Vascular Surgery, Department of Surgery, University of California, San Francisco, San Francisco, Calif. Electronic address:

Objective: The Global Limb Anatomic Staging System (GLASS) has been proposed to facilitate clinical decision-making regarding revascularization for chronic limb threatening ischemia (CLTI). The purpose of the present study was to define its relationship to the treatment outcomes in CLTI.

Methods: Consecutive patients who had undergone peripheral angiography for rest pain or tissue loss from January 2017 to July 2019 at a tertiary referral center with a dedicated limb preservation program were reviewed. Subjects with significant aortoiliac disease, previous infrainguinal stenting or functioning bypass grafts, or GLASS stage 0 were excluded. The GLASS score was assigned from the preintervention angiography findings, and the treating surgeon determined the primary infrapopliteal target artery pathway for the limb at risk. The demographic data, procedural details, and clinical outcomes were analyzed.

Results: The study cohort included 167 patients and 194 limbs, of which 175 of 194 limbs (90%) had presented with tissue loss and 149 of 182 limbs (83%) with WIfI (Wound, Ischemia and foot Infection) stage 3 or 4. The GLASS stage was GLASS 1 in 14%, GLASS 2 in 18%, and GLASS 3 in 68%. GLASS 3 anatomy was present in 85% of 52 limbs treated by bypass and 55% of 108 limbs treated by endovascular intervention (EVI; P < .001). Revascularization was not performed in 34 limbs, most of which were GLASS 3 (85%). Immediate technical failure for EVI (ie, failure to establish target artery pathway) occurred exclusively in the setting of GLASS 3 anatomy (n = 13; 22%). After a median follow-up of 10 months, limb-based patency after EVI was significantly lower in GLASS 3 than in GLASS 1 or 2 limbs (42% vs 59%; P = .018). GLASS 3 was associated with reduced major adverse limb events-free survival in both the EVI group (P = .002) and the overall revascularized cohort (P = .001). GLASS 3 was also associated with significantly reduced overall survival, amputation-free survival, and reintervention-free survival. In a Cox proportional hazards model, GLASS 3 (hazard ratio, 2.35; 95% confidence interval, 1.30-4.24; P = .005) and WIfI wound grade 3 (hazard ratio, 2.64; 95% confidence interval, 1.26-5.53; P = .010) were independent predictors of reduced major adverse limb events-free survival after revascularization.

Conclusions: GLASS stage 3 was strongly associated with major adverse clinical outcomes after revascularization in patients with CLTI.
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http://dx.doi.org/10.1016/j.jvs.2020.12.094DOI Listing
June 2021

Depression Predicts Non-Home Discharge After Abdominal Aortic Aneurysm Repair.

Ann Vasc Surg 2021 Jul 24;74:131-140. Epub 2021 Jan 24.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, San Francisco, CA. Electronic address:

Background: Mental health's impact on vascular surgical patients has long been overlooked. While outside the expertise of most surgeons, understanding the role that depression plays in the postoperative course could provide additional insight into opportunities to improve surgical outcomes and healthcare value. Additionally, non-home discharge (NHD) to a rehabilitation or skilled nursing facility after surgery is associated with impaired quality of life and higher postdischarge complications, readmissions, and mortality. We hypothesized that depression would be associated with an increased risk for NHD following abdominal aortic aneurysm (AAA) repair.

Methods: Nonruptured AAA repair cases were identified from the National Inpatient Sample (NIS) using ICD-9 codes between 2005 and 2014. Depression, comorbidities, postoperative complications, and discharge destination were evaluated using statistical tests as appropriate to the data. A hierarchical multivariable logistic regression controlling for hospital level variation was used to examine the independent association between depression, and the primary outcome of NHD controlling for median income and confounders meeting P < 0.05 on univariate analysis.

Results: There were 99,934 total cases analyzed, of which 4,755 (4.8%) were diagnosed with depression and 10,618 (11.9%) required NHD. Patients with depression were younger, more likely to be women, white, have diabetes, chronic obstructive pulmonary disease, hypertension, tobacco use, and more likely to experience a postoperative complication. On adjusted multivariable analysis, patients with depression were more likely to require NHD (odds ratio [OR] 1.87, 95% confidence interval [CI]: 1.68-2.08, c-statistic = 0.82). On stratified analysis by operative approach, depression had a larger effect estimate in endovascular repair (OR 2.19; 95% CI: 1.90-2.52) versus open repair (OR 1.60; 95% CI: 1.38-1.87).

Conclusions: In a nationally representative sample, patients with depression were more likely to require NHD after AAA repair. This study highlights the importance that depression plays in postoperative outcomes after AAA repair. Furthermore, addressing mental health preoperatively has the potential to improve outcomes in patients undergoing AAA repair.
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http://dx.doi.org/10.1016/j.avsg.2020.12.019DOI Listing
July 2021

Patients with depression are less likely to go home after critical limb revascularization.

J Vasc Surg 2021 07 28;74(1):178-186.e2. Epub 2020 Dec 28.

Department of Surgery, University of California, San Francisco, San Francisco, Calif. Electronic address:

Background: Although often overlooked during the preoperative evaluation, recent evidence has suggested that depression in patients with peripheral artery disease is associated with increased postoperative complications, including decreased primary and secondary patency after revascularization and an increased risk of major amputation and mortality. Postoperative nonhome discharge (NHD) is an important outcome for patients and has also been associated with other adverse outcomes; however, the effect that depression has on NHD after vascular surgery has remained unexplored. We hypothesized that depression would be associated with an increased risk of NHD after revascularization for chronic limb threatening ischemia (CLTI).

Methods: Endovascular, open, and hybrid (combined open and endovascular) cases of revascularization for CLTI were identified from the 2012 to 2014 National (Nationwide) Inpatient Sample. CLTI, diagnoses of depression, and medical comorbidities were defined using the corresponding International Classification of Diseases, Ninth Revision, Clinical Modification codes. A hierarchical multivariable binary logistic regression controlling for hospital level variation and for confounders meeting P <.01 on bivariate analysis was used to examine the association between depression and NHD. A sensitivity analysis after coarsened exact matching for baseline characteristics that differed between the two groups was performed to reduce any imbalance.

Results: A total of 64,817 cases were identified, of which 5472 (8.4%) included a diagnosis of depression and 16,524 (25.5%) NHD. The patients with depression were younger and more likely to be women and white, have multiple comorbidities and a nonelective admission, and experience a postoperative complication (P <.05). On unadjusted analyses, patients with depression had an 8% absolute increased risk of requiring NHD (32.1% vs 24.9%; P <.001). On multivariable analysis, patients with depression had an increased odds for NHD (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.40-1.61; c-statistic, 0.81) compared with those without depression. After stratification by operative approach, depression had a larger effect estimate in endovascular revascularization (OR, 1.57; 95% CI, 1.42-1.74) compared with open (OR, 1.45; 95% CI, 1.30-1.62). A test for interaction between depression and gender identified that men with depression had greater odds of NHD compared with women with depression (OR, 1.68; 95% CI, 1.51-1.88; vs OR, 1.37; 95% CI, 1.25-1.51; interaction P <.01). A sensitivity analysis after coarsened exact matching confirmed these findings.

Conclusions: To the best of our knowledge, the present study is the first to identify an association between depression and NHD after revascularization for CLTI. These results provide further evidence of the negative effects that comorbid depression has on patients undergoing revascularization for CLTI. Future studies should examine whether treating depression can improve the outcomes in this patient population.
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http://dx.doi.org/10.1016/j.jvs.2020.12.079DOI Listing
July 2021

Endovascular interventions for claudication do not meet minimum standards for the Society for Vascular Surgery efficacy guidelines.

J Vasc Surg 2021 05 27;73(5):1693-1700.e3. Epub 2020 Nov 27.

Division of Vascular Surgery, University of California, Los Angeles, Los Angeles, Calif.

Objective: Because the treatment of intermittent claudication (IC) is elective, good short- and long-term outcomes are imperative. The objective of the present study was to examine the outcomes of endovascular management of IC reported in the Vascular Quality Initiative and compare them with the Society for Vascular Surgery guidelines for IC treatment to determine whether real-world results are within the guidelines.

Methods: Patients undergoing peripheral vascular intervention for IC from 2004 to 2017 with complete data and >9 month follow-up were included. The primary outcome measures were IC recurrence and repeat procedures performed ≤2 years after the initial treatment.

Results: A total of 16,152 patients met the inclusion criteria, with a mean age of 66 years. Of the 16,152 patients, 61% were men, 45% were current smokers, and 28% had been discharged without antiplatelet or statin medication. Adjusted analyses revealed that treatment of more than two arteries was associated with a shorter time to IC recurrence (hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.09-1.31) and a shorter time to repeat procedures (HR, 1.25; 95% CI, 1.09-1.45). The use of atherectomy was also associated with a shorter time to IC recurrence (HR, 1.29; 95% CI, 1.08-1.33) and a shorter time to repeat procedures (HR, 1.31; 95% CI, 1.13-1.52). Discharge with antiplatelet and statin medications was associated with a longer time to IC recurrence (HR, 0.84; 95% CI, 0.78-0.91) and a longer time to repeat procedures (HR, 0.77; 95% CI, 0.69-0.87). Life-table analysis at 2 years revealed that only 32% of patients were free from IC recurrence, although 76% had not undergone repeat procedures. Stratified by anatomic treatment level, 37% of isolated aortoiliac interventions, 22% of aortoiliac and femoropopliteal interventions, 30% of isolated femoropopliteal interventions, and 20% of femoropopliteal and tibial interventions had remained free from IC recurrence at 2 years.

Conclusions: Most patients treated with an endovascular approach to IC did not meet the Society for Vascular Surgery guidelines for long-term freedom from recurrent symptoms of >50% at 2 years. Many lacked preprocedure optimization of medical management. The use of atherectomy and treatment of more than two arteries were associated with poor outcomes after peripheral vascular intervention for IC, because only 32% of these patients were free from recurrent symptoms at 2 years. Even when risk factor modification is optimized before the procedure, vascular specialists should be aware of the association between atherectomy and multivessel interventions with poorer long-term outcomes and counsel patients appropriately before intervention.
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http://dx.doi.org/10.1016/j.jvs.2020.10.067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189641PMC
May 2021

Reply.

J Vasc Surg 2020 11;72(5):1831-1832

Department of Biomedical and Preclinical Sciences, University of Liège, Liège, Belgium.

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http://dx.doi.org/10.1016/j.jvs.2020.04.497DOI Listing
November 2020

A novel preoperative risk score for nonhome discharge after elective thoracic endovascular aortic repair.

J Vasc Surg 2021 05 14;73(5):1549-1556. Epub 2020 Oct 14.

Division of Vascular and Endovascular Surgery, University of California, San Francisco, Calif. Electronic address:

Background: Nonhome discharge (NHD) to a rehabilitation or skilled nursing facility after vascular surgery is poorly described despite its large impact on patients. Understanding postsurgical NHD risk is essential to providing adequate preoperative counseling and shared decision making, particularly for elective surgeries. We aimed to identify independent predictors of NHD after elective thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysms (TAA) and to create a clinically useful preoperative risk score.

Methods: Elective TEVAR cases for descending TAA were queried from the Society for Vascular Surgery Vascular Quality Initiative from 2014 to 2018. A risk score was created by splitting the dataset into two-thirds for model development and one-third for validation. A parsimonious stepwise hierarchical multivariable logistic regression controlling for hospital level variation was performed in the development dataset, and the beta-coefficients were used to assign points for a risk score. This score was then cross-validated and model performance assessed.

Results: Overall, 1469 patients were included and 213 (14.5%) required NHD. At baseline, patients who required NHD were more likely to be ≥80 years old (35.2% vs 19.4%), female (58.7% vs 40.6%), functionally dependent (42.3% vs 24.0%), and anemic (46.5% vs 27.8%), and to have chronic obstructive pulmonary disease (41.3% vs 33.4%), congestive heart failure (18.8% vs 11.1%), and American Society of Anesthesiologists class ≥4 (51.6% vs 39.8%; all P < .05). Multivariable analysis in the development group identified independent predictors of NHD that were used to create an 18-point risk score. Patients were stratified into three groups based upon their risk score: low risk (0-7 points; n = 563) with an NHD rate of 4.3%, moderate risk (8-11 points; n = 701) with an NHD rate of 17.0%, and high risk (≥12 points; n = 205) with an NHD rate of 34.2%. The risk score had good predictive ability with a c-statistic of 0.75 for model development and a c-statistic of 0.72 in the validation dataset.

Conclusions: This novel risk score can predict NHD after TEVAR for TAA using characteristics that can be identified preoperatively. The use of this score may allow for improved risk assessment, preoperative counseling, and shared decision making.
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http://dx.doi.org/10.1016/j.jvs.2020.10.005DOI Listing
May 2021

Consensus-based perioperative protocols during the COVID-19 pandemic.

J Neurosurg Spine 2020 Oct 2:1-9. Epub 2020 Oct 2.

Departments of1Neurological Surgery.

Objective: During the COVID-19 pandemic, quaternary-care facilities continue to provide care for patients in need of urgent and emergent invasive procedures. Perioperative protocols are needed to streamline care for these patients notwithstanding capacity and resource constraints.

Methods: A multidisciplinary panel was assembled at the University of California, San Francisco, with 26 leaders across 10 academic departments, including 7 department chairpersons, the chief medical officer, the chief operating officer, infection control officers, nursing leaders, and resident house staff champions. An epidemiologist, an ethicist, and a statistician were also consulted. A modified two-round, blinded Delphi method based on 18 agree/disagree statements was used to build consensus. Significant disagreement for each statement was tested using a one-sided exact binomial test against an expected outcome of 95% consensus using a significance threshold of p < 0.05. Final triage protocols were developed with unblinded group-level discussion.

Results: Overall, 15 of 18 statements achieved consensus in the first round of the Delphi method; the 3 statements with significant disagreement (p < 0.01) were modified and iteratively resubmitted to the expert panel to achieve consensus. Consensus-based protocols were developed using unblinded multidisciplinary panel discussions. The final algorithms 1) quantified outbreak level, 2) triaged patients based on acuity, 3) provided a checklist for urgent/emergent invasive procedures, and 4) created a novel scoring system for the allocation of personal protective equipment. In particular, the authors modified the American College of Surgeons three-tiered triage system to incorporate more urgent cases, as are often encountered in neurosurgery and spine surgery.

Conclusions: Urgent and emergent invasive procedures need to be performed during the COVID-19 pandemic. The consensus-based protocols in this study may assist healthcare providers to optimize perioperative care during the pandemic.
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http://dx.doi.org/10.3171/2020.6.SPINE20777DOI Listing
October 2020

Impact of the coronavirus disease 2019 pandemic on an academic vascular practice and a multidisciplinary limb preservation program.

J Vasc Surg 2020 12 12;72(6):1850-1855. Epub 2020 Sep 12.

Division of Vascular and Endovascular Surgery, University of California, San Francisco, Calif. Electronic address:

With the aggressive resource conservation necessary to face the coronavirus disease 2019 pandemic, vascular surgeons have faced unique challenges in managing the health of their high-risk patients. An early analysis of patient outcomes after pandemic-related practice changes suggested that patients with chronic limb threatening ischemia have been presenting with more severe foot infections and are more likely to require major limb amputation compared with 6 months previously. As our society and health care system adapt to the new changes required in the post-coronavirus disease 2019 era, it is critical that we pay special attention to the most vulnerable subsets of patients with vascular disease, particularly those with chronic limb threatening ischemia and limited access to care.
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http://dx.doi.org/10.1016/j.jvs.2020.08.132DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7486620PMC
December 2020

Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial.

J Am Heart Assoc 2020 10 13;9(19):e016573. Epub 2020 Sep 13.

Division of Cardiology Duke University Medical Center Durham NC.

Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5-Dimensions [EQ-5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization procedures during trial follow-up and the association between 12-month health status change scores and subsequent end points during follow-up. There were 13 217 (95%) patients with EQ-5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ-5D tertile (0 to <0.69) were more likely to be female with severe claudication compared with the highest tertile (0.79-1.0; <0.01). Patients in the lowest VAS (0-60) and peripheral artery questionnaire (0-49) tertiles had lower ankle-brachial indices compared with the highest tertiles (80-100 and 76-108, respectively; <0.01). There was a significant association between baseline EQ-5D, VAS, and peripheral artery questionnaire scores and adjusted major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization (<0.05). Improved EQ-5D and VAS scores over 12 months were associated with reduced risk of subsequent major adverse cardiovascular events or lower-extremity revascularization (all <0.01). Conclusions Although health status instruments are rarely used in clinical practice, these measures are associated with outcomes, including major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization. Further research is needed to determine the relationship between changes in these instruments, revascularization, and outcomes.
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http://dx.doi.org/10.1161/JAHA.120.016573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792388PMC
October 2020

Editor's Choice - Relationship Between Global Limb Anatomic Staging System (GLASS) and Clinical Outcomes Following Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial.

Eur J Vasc Endovasc Surg 2020 Nov 7;60(5):687-695. Epub 2020 Aug 7.

Department of Vascular Surgery, University of Birmingham, UK.

Objective: The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied.

Methods: Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004).

Results: There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p = .049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01-1.85; p = .042), LS (HR 1.96; 95 % CI 1.12-3.43; p = .018), and FF-MALE (HR 1.49; 95% CI 1.04-1.87; p = .028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p < .001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts.

Conclusion: In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials.
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http://dx.doi.org/10.1016/j.ejvs.2020.06.042DOI Listing
November 2020

Effect of Diabetes on Tubular Density and Push-out Bond Strength of Mineral Trioxide Aggregate to Dentin.

J Endod 2020 Nov 29;46(11):1584-1591. Epub 2020 Jul 29.

Biomaterial and Prosthodontics Laboratory, Department of Restorative Dentistry, Rutgers School of Dental Medicine, Newark, New Jersey.

Introduction: This study compared the tubular density and push-out bond strength of mineral trioxide aggregate (MTA) to dentin in diabetic and nondiabetic patients.

Methods: Ten extracted single-rooted human teeth from diabetic and nondiabetic patients (n = 5 in each group) were decoronated, prepared up to a #5 Gates-Glidden drill, and sectioned horizontally at the midroot area to prepare 3 dentin slices, each measuring 2 mm in thickness (1 slice for the push-out test and 2 slices for the tubular density test). MTA was prepared and packed into the root canal space followed by incubation for 3 days. The push-out bond strength values were determined using a universal testing machine. Specimens were viewed under a stereomicroscope and a scanning electron microscope to determine the failure types at the cement-dentin interface. Ten slice specimens in each group were evaluated under SEM at 3 different sites to determine the tubular density. Comparisons were performed using the Mann-Whitney U test (P < .05).

Results: Diabetic patients exhibited significantly lower push-out bond strength of MTA to root canal dentin (P < .05). The pattern of failure at the MTA-dentin interface was different between the 2 groups. The tubular density was significantly higher in diabetic patients (P < .05).

Conclusions: The dentin in diabetic patients exhibited different physicochemical properties. The failure patterns and modes in diabetic patients might be explained by the changes in the push-out bond strength, the calcification mechanism of the dentin-pulp complex, a higher dentinal tubule density, and less peritubular dentin. These differences could explain the higher failure rate of root canal treatment in these patients.
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http://dx.doi.org/10.1016/j.joen.2020.07.025DOI Listing
November 2020

Specialized pro-resolving lipid mediators in cardiovascular disease, diagnosis, and therapy.

Adv Drug Deliv Rev 2020 19;159:170-179. Epub 2020 Jul 19.

Division of Vascular and Endovascular Surgery, Cardiovascular Research Institute, University of California, San Francisco, USA. Electronic address:

Persistent inflammation is the key aggravator in many cardiovascular diseases, including atherosclerosis, aneurysm, injury/reperfusion, thrombosis, and neointimal hyperplasia following surgical or percutaneous interventions. Resolution is an active process orchestrated by specialized pro-resolving lipid mediators (SPMs) which tamp down acute inflammatory signals, promote healing and facilitate a return to homeostasis. SPMs are endogenously derived from poly-unsaturated fatty acids, and their biologic activity is mediated via specific G-protein coupled receptor binding. The potency of SPM in regulating the inflammatory response has encouraged investigation into their therapeutic and diagnostic use in cardiovascular pathologies. Herein we describe the translational groundwork which has established the synthesis and interactions of SPM in cardiovascular and hematologic cells, the therapeutic effects of SPM in animal models of cardiovascular disease, and some early technologies that harness and attempt to optimize SPM delivery and "resolution pharmacology". Further studies are required to precisely determine the mechanisms of resolution in the cardiovascular system and to determine the clinical settings in which SPM can be utilized to optimize patient outcomes.
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http://dx.doi.org/10.1016/j.addr.2020.07.011DOI Listing
August 2021

Treatment With a Marine Oil Supplement Alters Lipid Mediators and Leukocyte Phenotype in Healthy Patients and Those With Peripheral Artery Disease.

J Am Heart Assoc 2020 08 22;9(15):e016113. Epub 2020 Jul 22.

Division of Vascular and Endovascular Surgery Cardiovascular Research Institute University of California, San Francisco San Francisco CA.

Background Peripheral artery disease (PAD) is an advanced form of atherosclerosis characterized by chronic inflammation. Resolution of inflammation is a highly coordinated process driven by specialized pro-resolving lipid mediators endogenously derived from omega-3 fatty acids. We investigated the impact of a short-course, oral, enriched marine oil supplement on leukocyte phenotype and biochemical mediators in patients with symptomatic PAD and healthy volunteers. Methods and Results This was a prospective, open-label study of 5-day oral administration of an enriched marine oil supplement, assessing 3 escalating doses in 10 healthy volunteers and 10 patients with PAD. Over the course of the study, there was a significant increase in the plasma level of several lipid mediator families, total specialized pro-resolving lipid mediators, and specialized pro-resolving lipid mediator:prostaglandin ratio. Supplementation was associated with an increase in phagocytic activity of peripheral blood monocytes and neutrophils. Circulating monocyte phenotyping demonstrated reduced expression of multiple proinflammatory markers (cluster of differentiation 18, 163, 54, and 36, and chemokine receptor 2). Similarly, transcriptional profiling of monocyte-derived macrophages displayed polarization toward a reparative phenotype postsupplementation. The most notable cellular and biochemical changes over the study occurred in patients with PAD. There were strong correlations between integrated biochemical measures of lipid mediators (specialized pro-resolving lipid mediators:prostaglandin ratio) and phenotypic changes in circulating leukocytes in both healthy individuals and patients with PAD. Conclusions These data suggest that short-term enriched marine oil supplementation dramatically remodels downstream lipid mediator pathways and induces a less inflammatory and more pro-resolution phenotype in circulating leukocytes and monocyte-derived macrophages. Further studies are required to determine the potential clinical relevance of these findings in patients with PAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02719665.
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http://dx.doi.org/10.1161/JAHA.120.016113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792251PMC
August 2020
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