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Thoracic Endovascular Aortic Repair for Symptomatic Penetrating Aortic Ulcers and Intramural Hematomas is Associated with Poor Outcomes

Rokosh, Rae S; Rockman, Caron B; Patel, Virendra I; Milner, Ross; Osborne, Nicholas H; Cayne, Neal S; Jacobowitz, Glenn R; Garg, Karan
INTRODUCTION/BACKGROUND:The natural history of penetrating aortic ulcers (PAU) and intramural hematomas (IMH) of the aorta is not well described. While repair is warranted for rupture, unremitting chest pain or growth, there is no established threshold for treating incidental findings. Thoracic endovascular aortic repair (TEVAR) offers an attractive approach in treating these pathologies, however, peri-procedural and post-operative outcomes are not well defined. METHODS:Patients 18 or older identified in the VQI database who underwent TEVAR for PAU and/or IMH between 1/2011-2/2020 were included. We identified 1042 patients, of whom 809 had available follow-up data. Patient demographics and comorbidities were analyzed to identify risk factors for major adverse events (MAE), as well as postoperative and late mortality. RESULTS:The cohort was 54.8% female and 69.9% former smokers with a mean age of 71.1 years. Comorbidities were prevalent with 57.8% classified ASA IV; 89.8% had hypertension, 28.3% chronic obstructive pulmonary disease (COPD), 17.9% coronary artery disease, and 12.2% congestive heart failure (CHF). Patients were predominately symptomatic (74%) and 44.5% underwent non-elective repair. MAE incidence was 17%. Independent predictors of MAE were history of CAD, non-Caucasian race, emergent procedural indication, ruptured presentation, and deployment of two or more endografts. In-hospital mortality was 4.3%. Seventy-three percent of index hospitalization mortalities were treatment-related. Of 809 patients with follow-up (mean 25.1 months±19 months), all-cause mortality was 10.6%. Predictors of late mortality in follow-up included age greater than 70 years, ruptured presentation, and history of COPD and ESRD. Subset analysis comparing symptomatic (74%) vs. asymptomatic (26%) patients demonstrated the former were frequently female (58.2% vs. 45.3%, p<.001) with a higher incidence of MAE (20.6% vs. 6.9%, p<.001), notably higher in-hospital reintervention rates (5.9% vs. 1.5%, p=.002) and mortality (5.6% vs. 0.7%, log-rank p=.015), and prolonged length of stay (6.9 vs. 3.7 days, p<.0001) despite similar procedural risks. In follow-up, late mortality was higher in the symptomatic cohort (12.2% vs. 6.5%, log-rank p=.025), with all treatment-related mortalities limited to the symptomatic group. CONCLUSIONS:We demonstrate significantly higher morbidity and mortality in symptomatic patients undergoing repair compared to asymptomatic patients, despite similar baseline characteristics. Asymptomatic patients treated with TEVAR had no treatment-related mortality in follow-up, with overall prognosis largely dependent on pre-existing comorbidities. These findings, in conjunction with growing evidence highlighting the risk of disease progression and attendant morbidity associated with these aortic entities, suggest a need for natural history studies and definitive guidelines on the elective repair of IMH and PAU.
PMID: 33340703
ISSN: 1097-6809
CID: 4725982

An algorithm combining VVSYmQ® and VCSS scores may help to predict disease severity in C2 patients

Sadek, Mikel; Pergamo, Matthew; Almeida, Jose I; Jacobowitz, Glenn R; Kabnick, Lowell S
OBJECTIVES/OBJECTIVE:The purpose was to assess whether combining patient reported scores (VVSymQ®) and physician reported scores (VCSS) stratifies disease severity in C2 patients. METHODS:Consecutive patients were pooled from the VANISH-1 and VANISH-2 cohorts. VCSS and VVSymQ® were calculated for each patient. The relationship between scoring systems was evaluated using Pearson's correlation and frequency distribution analysis. RESULTS:Two-hundred and ten C2 limbs were included. Scoring systems demonstrated: VVSymQ®: mean = 8.72; VCSS: mean = 6.32; correlation (r = 0.22, p = 0.05). Frequency distribution analysis demonstrated 61.4% of patients had low VVSymQ® and low VCSS; 31.3% had elevated VVSymQ® and increased VCSS; 7.3% were inconsistent with C2 disease. Strict concordance analysis revealed 40.5% had VVSymQ® (< 9)/VCSS (0-6), 18.6% had VVSymQ® (≥ 9)/VCSS (7-9), and 2.9% had VVSymQ® (≥9)/VCSS (≥10). CONCLUSIONS:For combined elevated VVSymQ® and VCSS, moderate/severe disease is corroborated, and intervention may be indicated. For combined lower scores, the disease severity is mild and conservative therapy is more appropriate.
PMID: 34121506
ISSN: 1758-1125
CID: 4907182

High incidence of patients lost to follow-up after venous thromboembolism diagnosis - Identifying an unmet need for targeted transition of care

Rokosh, Rae S; Grazi, Jack H; Ruohoniemi, David; Yuriditsky, Eugene; Horowitz, James; Sista, Akhilesh K; Jacobowitz, Glenn R; Rockman, Caron; Maldonado, Thomas S
OBJECTIVES/OBJECTIVE:Venous thromboembolism, including deep venous thrombosis and pulmonary embolism, is a major source of morbidity, mortality, and healthcare utilization. Given the prevalence of venous thromboembolism and its associated mortality, our study sought to identify factors associated with loss to follow-up in venous thromboembolism patients. METHODS:-value of <0.05 set for significance. RESULTS: = 0.03) as opposed to home. CONCLUSIONS:Our study demonstrates that over one-third of patients diagnosed with venous thromboembolism at our institution are lost to venous thromboembolism-specific follow-up, particularly those discharged to a facility. Our work suggests that significant improvement could be achieved by establishing a pathway for the targeted transition of care to a venous thromboembolism-specific follow-up clinic.
PMID: 34080914
ISSN: 1708-539x
CID: 4891752

Contemporary Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in Patients Deemed Unfit for Open Surgical Repair

Chang, Heepeel; Rockman, Caron B; Jacobowitz, Glenn R; Ramkhelawon, Bhama; Cayne, Neal S; Veith, Frank J; Patel, Virenda I; Garg, Karan
OBJECTIVE:Endovascular abdominal aortic aneurysm repair (EVAR) is preferred to open surgical repair (OSR) for the treatment of abdominal aortic aneurysm (AAA) in high-risk patients. We sought to compare perioperative and long-term outcomes for EVAR in patients designated as unfit for OSR using a large national dataset. METHODS:The Vascular Quality Initiative database collected from 2013 to 2019 was queried for patients undergoing elective EVARs for AAA > 5cm. The patients were stratified into two cohorts based on the suitability for OSR (FIT vs. UNFIT). Primary outcomes included perioperative (in-hospital) major adverse events, perioperative mortality, and mortality at 1 and 5 years. Patient demographics and postoperative outcomes were analyzed to identify predictors of perioperative and long-term mortality. RESULTS:Of 16,183 EVARs, 1,782 patients were deemed unfit for OSR. The UNFIT cohort was more likely to be older and female, with higher proportions of HTN, CAD, CHF, COPD, and larger aneurysm diameter. Postoperatively, the UNFIT cohort was more likely to have cardiopulmonary complications (6.5% vs. 3%; P<.001), with higher perioperative mortality (1.7% vs. 0.6%; P<.001) and 1 and 5-year mortality (13% and 29% UNFIT vs. 5% and 14% FIT; P<.001). Subgroup analysis within the UNFIT cohort revealed those deemed unfit due to hostile abdomen had significantly lower 1 and 5-year mortality (6% and 20%) compared to those unfit due to cardiopulmonary compromise and frailty (14% and 30%; P=.451). Reintervention-free survival at 1 and 5-years was significantly higher in the FIT cohort (93% and 82%) as compared to the UNFIT cohort (85% and 68%; P<.001). Designation as unfit for OSR was an independent predictor of both perioperative (OR 1.59; 95% CI, 1.03-2.46; P=.038) and long-term mortality (HR 1.92; 95% CI, 1.69-2.17; P<.001). Advanced age (OR 2.91; 95% CI, 1.28-6.66; P=.011) was the strongest determinant of perioperative mortality while ESRD (HR 2.51; 95% CI, 1.78-3.55; P<.001) was the strongest predictor of long-term mortality. Statin (HR 0.77; 95% CI, 0.69-0.87; P<.001) and ACE inhibitor (HR 0.83; 95% CI, 0.75-0.93; P<.001) were protective of long-term mortality. CONCLUSION/CONCLUSIONS:Despite low perioperative mortality, long-term mortality of those designated by the operating surgeons as unfit for OSR was rather high in patients undergoing elective EVARs, likely due to the competing risk of death from their medical frailty. Unfit designation due to hostile abdomen did not confer any additional risks after EVAR. Judicious estimation of the patient's life expectancy is essential when considering treatment options in this subset of patients deemed unfit for OSR.
PMID: 33035595
ISSN: 1097-6809
CID: 4627322

Deep Venous Thrombosis in Hospitalized Patients with Coronavirus Disease 2019

Chang, Heepeel; Rockman, Caron B; Jacobowitz, Glenn R; Speranza, Giancarlo; Johnson, William S; Horowitz, James M; Garg, Karan; Maldonado, Thomas S; Sadek, Mikel; Barfield, Michael E
OBJECTIVES/OBJECTIVE:The pandemic of Coronavirus disease 2019 (COVID-19) has caused devastating morbidity and mortality worldwide. In particular, thromboembolic complications have emerged as a key threat in COVID-19. We assessed our experience with deep venous thrombosis (DVT) in patients with COVID-19. METHODS:We performed a retrospective analysis of all patients with COVID-19 undergoing upper or lower extremity venous duplex ultrasonography at an academic health system in New York City between March 3 2020 and April 12 2020 with follow-up through May 12 2020. A cohort of hospitalized patients without COVID-19 (non-COVID-19) undergoing venous duplex ultrasonography from December 1 2019 to December 31 2019 was used for comparison. The primary outcome was DVT. Secondary outcomes included pulmonary embolism (PE), in-hospital mortality, admission to intensive care unit, and antithrombotic therapy. Multivariable logistic regression was performed to identify risk factors for DVT and mortality. RESULTS:Of 443 patients (188 COVID-19 and 255 non-COVID-19) undergoing venous duplex ultrasonography, patients with COVID-19 had higher incidence of DVT (31% vs. 19%; P=0.005), compared to the non-COVID-19 cohort. The incidence of PE was not statistically different between the COVID-19 and non-COVID-19 cohorts (8% vs. 4%; P=.105). The DVTs in the COVID-19 group were more distal (63% vs. 29%; P<.001) and bilateral (15% vs. 4%; P<.001). The result of duplex ultrasonography had a significant impact on the antithrombotic plan; 42 (72%) patients with COVID-19 in the DVT group had their therapies escalated while 49 (38%) and 3 (2%) patients had their therapies escalated and de-escalated in the non-DVT group, respectively (P<.001). Within the COVID-19 cohort, the D-dimer was significantly higher in the DVT group at the time of admission (2,746 ng/mL vs 1,481 ng/mL; P=.004) and at the time of the duplex exam (6,068 ng/mL vs. 3,049 ng/mL; P<0.01). At multivariable analysis, male sex (odd ratio (OR) 2.27; 95% confidence interval (CI), 1.06-4.87; P=.035), ICU admission (OR 3.42; 95% CI, 1.02-11.44; P=.046) and extracorporeal membrane oxygenation (OR 5.5; 95% CI, 1.01-30.13; P=.049) were independently associated with DVT. CONCLUSION/CONCLUSIONS:Given the high incidence of venous thromboembolic events in this population, we support the decision to empirically initiate therapeutic anticoagulation in patients with low bleeding risk and severe COVID-19 infection, with duplex ultrasonography reserved for patients with high clinical suspicion of VTE in which anticoagulation may pose a life-threatening consequence. Further study is warranted in patients with COVID-19 to elucidate the etiology of vascular thromboembolic events and guide prophylactic and therapeutic interventions in these patients.
PMID: 33039545
ISSN: 2213-3348
CID: 4632272

Management of inferior vena cava thrombosis with the FlowTriever and ClotTriever systems

Shah, Noor G; Wible, Brandt C; Paulisin, Joseph A; Zaki, Mina; Lamparello, Patrick; Sista, Akhilesh; Sadek, Mikel; Jacobowitz, Glenn R; Maldonado, Thomas S
OBJECTIVE:Although inferior vena cava (IVC) thrombosis is infrequently encountered, it carries a significant risk of post-thrombotic syndrome and pulmonary embolus. Recent studies show no difference in the incidence of post-thrombotic syndrome in patients with iliofemoral deep venous thrombosis (DVT) treated with pharmacothrombolysis vs anticoagulation alone; however, there is an associated increased risk of bleeding. The treatment of IVC thrombosis is less well-studied and the hemodynamic changes may be more significant with pharmacothrombolysis, although the bleeding risk remains. The ClotTriever and FlowTriever systems remove thrombus from veins without the use of thrombolytics. Our study evaluates outcomes of patients undergoing mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and FlowTriever devices. METHODS:A retrospective chart review was performed to identify consecutive patients who underwent mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and/or FlowTriever systems from November 2018 to January 2020 at four data-sharing institutions. The decision of which device(s) to use was at the discretion of the surgeon. Patient demographics, symptomatology, and imaging characteristics were captured at presentation and follow-up. RESULTS:A total of 15 patients met the inclusion criteria; 10 were male, and the average age was 59 years. The majority of patients were symptomatic at presentation (n = 14), had a prior history of DVT (n = 13), and had a preexisting IVC filter (n = 8). Eleven patients presented with acute onset (<1 week) of symptoms, whereas three patients had subacute (1-4 weeks) symptoms. Most patients had an associated iliofemoral DVT (n = 13) and were treated with both ClotTriever and FlowTriever (n = 8); others were treated with either ClotTriever or FlowTriever alone (n = 5 and n = 2, respectively). Technical success was achieved in all but two patients, one who had a nonocclusive thrombus densely adherent to a preexisting IVC filter and another who had a chronic rubbery clot in the IVC that could not be cleared. No patient required concomitant lytic therapy or a postoperative stay in the intensive care unit. Furthermore, there were no postoperative bleeding events, myocardial infarctions, pulmonary emboli, renal impairments, or deaths. The median length of stay was 3 days (range, 1-37 days). Patients underwent postoperative follow-up (n = 7) as well as extended follow-up (>6 months; n = 8). All patients who achieved technical success were asymptomatic without evidence of reocclusion of the IVC on follow-up imaging. CONCLUSIONS:In our multicenter series of 15 patients, The ClotTriever and FlowTriever showed promise in the treatment of IVC thrombosis without the use of fibrinolytic drugs, with no bleeding events and no requirement for intensive care unit stay.
PMID: 33045392
ISSN: 2213-3348
CID: 4663452

Assessment of Quality of Life Changes in Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home

Maldonado, Thomas S; Rokosh, Rae S; Padberg, Frank; Rotella, Vittorio; Miller, Hyman; Nassiri, Naiem; Jacobowitz, Glenn; Berland, Todd; Sadek, Mikel; Barfield, Michael E
OBJECTIVE:Lymphedema is associated with significant morbidity and healthcare resource usage. Conventional therapy efficacy is limited with poor surgical salvage options. Preliminary studies demonstrated advanced pneumatic compression devices (APCD) improve clinical outcomes, however limited evidence regarding their role in healthcare cost mitigation or health-related quality of life (QOL) is available. METHODS:) between February 2016 and March 2019. Patients were assessed at baseline, 12, 24, and 52 weeks from enrollment by limb circumference, QOL assessments (Short Form-36 [SF-36] and Lymphedema Quality of Life [LYMQOL]), device compliance, cellulitic episodes and lymphedema-related health care use since the previous visit. Primary endpoints of interest were QOL at baseline compared to 12 weeks as well as unscheduled lymphedema-related clinic visits and hospital admissions at 52 weeks. Secondary endpoints included change in limb girth and QOL at 52 weeks compared to baseline. RESULTS:178 patients with LE lymphedema were prospectively enrolled; this interim report represents the first 74 subjects to complete 52 weeks of APCD treatment. The cohort was predominately male (94.6%), elderly (mean 67 years), obese (median BMI 32), and most commonly enrolled for treatment of phlebolymphedema (71.6%) with largely bilateral LE involvement (91.9%). There was no significant difference in QOL at 12 weeks. However, at 52 weeks, LYMQOL was significantly improved from baseline (6.3 vs. 7.4, p<0.0001) and SF-36 demonstrated significant improvement from baseline in the Physical Component (38.6 vs. 40.8; p=0.035) with an effect towards overall improvement as well in the Mental Component (49.9 vs. 51.3; p=0.549). Limb circumference was significantly reduced at 12 weeks from baseline (28.5cm vs. 27.7cm; p=0.0005) in the most affected LE, and this reduction remained stable for the study duration. APCD treatment was associated with a significant reduction in cellulitic incidence (24.3% vs. 8.1%, p=0.005), lymphedema-related clinic visits (2.2 vs. 0.7; p=0.02), urgent care visits (1.2 vs. 0.3; p=0.004), and hospital admissions (0.5 vs. 0.1; p=0.047) per patient. CONCLUSIONS:The FLX APCD results in initial significant limb girth reduction as early as 12 weeks and a steady sustained improvement in health-related QOL up to one year. The latter is likely reflective of a decrease in cellulitis episodes and fewer associated lymphedema-related clinic, urgent care visits and hospital admissions.
PMID: 33137494
ISSN: 2213-3348
CID: 4664032

Histological Assessment of Lower Extremity Deep Vein Thrombi from Patients Undergoing Percutaneous Mechanical Thrombectomy

Yuriditsky, Eugene; Narula, Navneet; Jacobowitz, Glenn R; Moreira, Andre L; Maldonado, Thomas S; Horowitz, James M; Sadek, Mikel; Barfield, Michael E; Rockman, Caron B; Garg, Karan
BACKGROUND:Histological analyses of deep vein thrombi (DVT) are based on autopsy samples and animal models. No prior study has reported on thrombus composition following percutaneous mechanical extraction. As elements of chronicity and organization render thrombus resistant to anticoagulation and thrombolysis, a better understanding of clot evolution may inform therapies. METHODS:We performed histologic evaluation of DVTs from consecutive patients undergoing mechanical thrombectomy for extensive iliofemoral DVTs using the Clottriever/ Flowtriever device (Inari Medical, Irvine, CA). Thrombi were scored in a semi-quantitative manner based on the degree of fibrosis (collagen deposition on trichrome stain), and organization (endothelial growth with capillaries and fibroblastic penetration). RESULTS:Twenty-three specimens were available for analysis with 20 presenting with acute DVT (≤14 days from symptom onset). Eleven of 23 patients (48%) had >5% fibrosis (collagen deposition) and 14/23 patients (61%) had >5% organization (endothelial growth, capillaries, fibroblasts). Four patients with acute DVT had ≥25% organized thrombus and 2 had ≥ 25% collagen deposition. Among the 20 patients with acute DVT, 40% had >5% fibrosis and 55% had > 5% organization. Acuity of DVT did not correlate with the fibrosis or organizing scores. CONCLUSIONS:A large proportion of patients with acute DVT have histologic elements of chronicity and fibrosis. A better understanding of the relationship between such elements and response to anticoagulants and fibrinolytics may inform our approach to therapeutics.
PMID: 33836286
ISSN: 2213-3348
CID: 4839682

Interplay of Diabetes Mellitus and End-Stage Renal Disease in Open Revascularization for Chronic Limb Threatening Ischemia

Chang, Heepeel; Rockman, Caron B; Jacobowitz, Glenn R; Cayne, Neal S; Veith, Frank J; Han, Daniel K; Patel, Virenda I; Kumpfbeck, Andrew; Garg, Karan
OBJECTIVES/OBJECTIVE:Chronic limb threatening ischemia (CLTI) in patients with end-stage renal disease (ESRD) confers a significant survival disadvantage and is associated with a high major amputation rate. Moreover, diabetes mellitus (DM) is an independent risk factor for developing CLTI. However, the interplay between end stage renal disease (ESRD) and DM on outcomes after peripheral revascularization for CLTI is not well established. Our goal was to assess the effect of DM on outcomes after an infrainguinal bypass for CLTI in patients with ESRD. METHODS:Using the Vascular Quality Initiative dataset from January 2003 to March 2020, records for all primary infrainguinal bypasses for CLTI in patients with ESRD were included for analysis. One-year and perioperative outcomes of all-cause mortality, reintervention, amputation-free survival (AFS) and major adverse limb event (MALE) were compared for patients with DM versus those without DM. RESULTS:Of a total of 1,058 patients (66% male) with ESRD, 726 (69%) patients had DM, and 332 patients did not have DM. The DM group was younger (median age, 65 years vs. 68 years; P=.002), with higher proportions of obesity (body-mass index>30kg/m2; 34% vs. 19%; P<.001) and current smokers (26% vs. 19%; P=.013). The DM group presented more frequently with tissue loss (76% vs. 66%; P<.001). A distal bypass anastomosis to tibial vessels was more frequently performed in the DM group compared to the non-DM group (57% vs. 45%; P<.001). DM was independently associated with higher perioperative MALE (OR 1.34; 95% CI, 1.06-1.68; P=.013), without increased risks of loss of primary patency and composite outcomes of amputation or death. On the mean follow-up of 11.4 ± 5.5 months, DM patients had a significantly higher rate of one-year MALEs (43% vs. 32%; P=.001). However, the one-year primary patency and AFS, did not differ significantly. After adjusting for confounders, the risk-adjusted hazards for MALE (HR 1.34; 95% CI, 1.06-1.68; P=.013) were significantly increased in patients with DM. However, DM was not associated with increased risk of AFS (HR 1.16; 95% CI, 0.91-1.47; P=.238), or loss of primary patency (HR 1.04; 95% CI, 0.79-1.37; P=.767). CONCLUSION/CONCLUSIONS:DM and ESRD each independently predict early and late major adverse limb events after an infrainguinal bypass in patients presenting with CLTI. However, in the presence of ESRD, DM may increase perioperative adverse events, but does not influence primary patency and AFS at one-year. The risk profile associated with ESRD appears to supersede that of DM, with no additive effect.
PMID: 33227468
ISSN: 1615-5947
CID: 4680342

Antegrade Superficial Femoral Artery Access for Lower Extremity Arterial Disease is Safe and Effective in the Outpatient Setting

Pezold, Michael; Blumberg, Sheila; Sadek, Mikel; Maldonado, Thomas; Cayne, Neal; Jacobowitz, Glenn; James, Herbert; Berland, Todd
INTRODUCTION/BACKGROUND:Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation and contrast required with contralateral common femoral access (CFA). Yet, this technique remains underutilized in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and effectiveness of antegrade SFA access in the outpatient setting. METHODS:A retrospective review of lower extremity peripheral arterial interventions in our office-based endovascular suite was conducted from 2013 to 2018. Interventions necessitating CFA access such as iliac, common femoral or deep femoral artery revascularization were excluded (n = 206). In addition, interventions potentially requiring large sheaths not amenable to SFA access (e.g. popliteal aneurysm) were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. RESULTS:We identified 718 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in 448 patients (62.4%) with the remaining 270 patients having retrograde CFA access. Antegrade SFA access was achieved primarily with a 4 French sheath, while a majority of retrograde CFA interventions utilized a 6 French sheath for access (87.7% vs. 69.5%, p <0.001). Significantly less fluoroscopy (9.5 min vs 16.4 min, p <0.001) and contrast (25.4 mL vs. 38.5 mL, p <0.001) were used during SFA access compared with retrograde access. Technical success was achieved in 93.2% with antegrade SFA versus 94.8% retrograde CFA access (p 0.42). The overall rate of complications was low for both cohorts (2.7% vs. 3.7%, p 0.78) and there were no statistical differences in access-site complications (1.1% vs. 1.5%, p 0.94), hematoma (0.7% vs. 1.1%, p 0.84) and pseudoaneurysm (0.4% vs. 0%, p 0.98) between techniques. CONCLUSIONS:Percutaneous antegrade SFA access can be performed safely in the outpatient setting, and remains an effective alternative to retrograde CFA access with significantly less utilization of fluoroscopy and contrast.
PMID: 33271278
ISSN: 1615-5947
CID: 4694362