525 results on '"Doros G"'
Search Results
102. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience
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Cowan, A. J., primary, Skinner, M., additional, Seldin, D. C., additional, Berk, J. L., additional, Lichtenstein, D. R., additional, O'Hara, C. J., additional, Doros, G., additional, and Sanchorawala, V., additional
- Published
- 2012
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103. Erratum: Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome
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Fujii, A M, primary, Patel, S M, additional, Allen, R, additional, Doros, G, additional, Guo, C-Y, additional, and Testa, S, additional
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- 2011
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104. Clinical features and survival in senile systemic amyloidosis: comparison to familial transthyretin cardiomyopathy
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Connors, L. H., primary, Doros, G., additional, Sam, F., additional, Badiee, A., additional, Seldin, D. C., additional, and Skinner, M., additional
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- 2011
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105. High-dose melphalan and autologous stem cell transplantation for AL amyloidosis: recent trends in treatment-related mortality and 1-year survival at a single institution
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Seldin, D. C., primary, Andrea, N., additional, Berenbaum, I., additional, Berk, J. L., additional, Connors, L., additional, Dember, L. M., additional, Doros, G., additional, Fennessey, S., additional, Finn, K., additional, Girnius, S., additional, Lerner, A., additional, Libbey, C., additional, Meier-Ewert, H. K., additional, O'Connell, R., additional, O'Hara, C., additional, Quillen, K., additional, Ruberg, F. L., additional, Sam, F., additional, Segal, A., additional, Shelton, A., additional, Skinner, M., additional, Sloan, J. M., additional, Wiesman, J. F., additional, and Sanchorawala, V., additional
- Published
- 2011
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106. The changing face of AA amyloidosis: a single center experience
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Girnius, S., primary, Dember, L., additional, Doros, G., additional, and Skinner, M., additional
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- 2011
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107. Caregiving, Metabolic Syndrome Indicators, and 1-year Decline in Walking Speed: Results of Caregiver-SOF
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Fredman, L., primary, Doros, G., additional, Cauley, J. A., additional, Hillier, T. A., additional, and Hochberg, M. C., additional
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- 2010
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108. Penetrating Inferior Vena Cava Injuries are Associated with Thromboembolic Complications: A Review of the National Trauma Data Bank
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Joglar, F.L., primary, Shaw, P., additional, Eberhardt, R., additional, Hamburg, N., additional, Kalish, J., additional, Rybin, D., additional, Doros, G., additional, and Farber, A., additional
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- 2010
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109. Hepatic response after high-dose melphalan and stem cell transplantation in patients with AL amyloidosis associated liver disease
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Girnius, S., primary, Seldin, D. C., additional, Skinner, M., additional, Finn, K. T., additional, Quillen, K., additional, Doros, G., additional, and Sanchorawala, V., additional
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- 2009
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110. Caregiving Intensity and Change in Physical Functioning Over a 2-Year Period: Results of the Caregiver-Study of Osteoporotic Fractures
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Fredman, L., primary, Doros, G., additional, Ensrud, K. E., additional, Hochberg, M. C., additional, and Cauley, J. A., additional
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- 2009
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111. Ultrasonography in the diagnosis and follow-up of hematologic emergencies of patients with hemophilia
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Zoica, BS, primary, Petrescu, C, additional, Oprisoni, A, additional, Pop, L, additional, Gafencu, M, additional, Bataneant, M, additional, Doros, G, additional, Ciocarlie, O, additional, and Serban, M, additional
- Published
- 2008
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112. Total anomalous pulmonary venous connections
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Popoiu, A, primary, Doros, G, additional, Zoica, B, additional, and Matu, A, additional
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- 2008
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113. Ultrasonography in the diagnosis and follow-up of pediatric solid tumors
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Zoica, BS, primary, Doros, G, additional, Ciocarlie, O, additional, Oprisoni, A, additional, Arghirescu, S, additional, Boeriu, E, additional, Popoiu, A, additional, Costa, R, additional, and Serban, M, additional
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- 2008
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114. Echographic findings in a complex and rare vascular malformation: persistance of the primitive hepatic venous plexus, inferior vena cava interruption and Scimitar syndrome
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Doros, G, primary, Zoica, BS, additional, Iacob, I, additional, Popoiu, A, additional, Gafencu, M, additional, Marusteri, M, additional, Miclaus, G, additional, Ciocarlie, O, additional, and Oprisoni, A, additional
- Published
- 2008
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115. Role of echocardiography in detecting cardiovascular pathology associated with diaphragmatic relaxation
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Doros, G, primary, Popoiu, A, additional, Gafencu, M, additional, Zoica, B, additional, Ciocarlie, OC, additional, Marusteri, M, additional, and Miclaus, G, additional
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- 2008
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116. Clinical effects of erdosteine in the treatment of acute respiratory tract diseases in children
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Balli, F., primary, Bergamini, B., additional, Calistru, P., additional, Ciofu, E.P., additional, Domenici, R., additional, Doros, G., additional, Dragomir, D., additional, Gherghina, I., additional, Iordachescu, F., additional, Murgoci, G., additional, Orasanu, D., additional, Plesca, D., additional, Vaccaro, A., additional, and Assereto, R., additional
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- 2007
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117. Effectiveness of Antiretroviral Therapy among HIV-Infected Prisoners: Reincarceration and the Lack of Sustained Benefit after Release to the Community
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Springer, S. A., primary, Pesanti, E., additional, Hodges, J., additional, Macura, T., additional, Doros, G., additional, and Altice, F. L., additional
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- 2004
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118. Driving awareness: can discrepancies between self perception and actual performance identify drivers who would benefit from assessment and intervention?
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Marottoli, R., Peduzzi, P., and Doros, G.
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Health ,Seniors - Abstract
While debate regarding the identification of high risk drivers has centered on the merits of age, medical conditions, or functional impairments, of greatest concern are drivers who do not adequately adjust exposure to their capabilities and limitations. A discrepancy in awareness was defined as rating oneself better than other drivers before, and a 9 or 10 on a 10 point performance scale after, having completed a road test, while being rated by an evaluator as having major problems, committing 3 critical errors, or having crash in the previous year. Among 552 community volunteers, discrepant drivers were the same age (77.7 v. 76.9 years, P=.20), equally confident (82.6 v. 81.4, p=.53), and drove as frequently (77% v 80% drove daily, p=.80), but performed less well on tests of cognition (MMSE 27.3 v 27.9, p=.03; visual attention 59.5 v. 63.1, p=.096) and manual dexterity (34.0 v.30.8 sec, p=.03). Identifying factors contributing to discrepant self-assessment may allow for better identification of high-risk drivers and lead to interventions to better align capabilities, limitations, and exposure.
- Published
- 2002
119. The influence of black race on treatment and mortality for early-stage breast cancer.
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Berz JP, Johnston K, Backus B, Doros G, Rose AJ, Pierre S, Battaglia TA, Berz, Jonathan P B, Johnston, Katherine, Backus, Bertina, Doros, Gheorghe, Rose, Adam J, Pierre, Snaltze, and Battaglia, Tracy A
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- 2009
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120. Failure of high-risk minority patients to show up for outpatient psychiatric treatment.
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de Figueiredo JM, Boerstler H, and Doros G
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- 2009
121. Soft tissue, joint, and bone manifestations of AL amyloidosis: clinical presentation, molecular features, and survival.
- Author
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Prokaeva T, Spencer B, Kaut M, Ozonoff A, Doros G, Connors LH, Skinner M, and Seldin DC
- Abstract
OBJECTIVE: To characterize symptoms and signs of AL amyloidosis that may bring patients to the attention of rheumatologists, evaluate Ig V(L) gene usage in this subgroup of patients, and assess the impact of soft tissue and bone involvement and V(L) gene usage on survival. METHODS: Clinical features of soft tissue and bone involvement were assessed in 191 patients with AL amyloidosis. V(L) gene sequencing was carried out to determine light-chain family, rate of somatic mutation, and evidence of antigen selection. The association of soft tissue and bone involvement with V(L) gene usage was assessed by logistic regression analysis, and survival time was analyzed using log rank tests and Cox regression models. RESULTS: Soft tissue and bone involvement occurred in 42.9% of the patients, and 9.4% had dominant soft tissue and bone involvement. The most common manifestations were submandibular gland enlargement, macroglossia, and carpal tunnel syndrome. Dominant soft tissue and bone involvement was significantly associated with V(L)kappaI gene usage. Mutation rate and evidence of antigen selection in the V(L) genes were not found to be confounding factors, providing evidence against a contribution of autoimmunity in this type of AL amyloidosis. Survival time was initially longer in patients with dominant soft tissue and bone involvement than in patients with other dominant organ involvement; however, this difference diminished over time. CONCLUSION: Amyloid infiltration into soft tissue, joints, periarticular structures, and bones can bring patients with AL amyloidosis to the attention of rheumatologists. Recognition of the presenting symptoms is essential for accurate diagnosis and appropriate treatment, since the long-term outlook for untreated patients with dominant soft tissue and bone involvement is not better than that for patients with other dominant features of AL amyloidosis. [ABSTRACT FROM AUTHOR]
- Published
- 2007
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122. A randomized, open-label, crossover study comparing the effects of oral versus transdermal estrogen therapy on serum androgens, thyroid hormones, and adrenal hormones in naturally menopausal women.
- Author
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Shifren JL, Desindes S, McIlwain M, Doros G, and Mazer NA
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- 2007
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123. A0880 - Effectiveness of long-term testosterone therapy for up to 15 years on erectile function and sexual activity in men with functional hypogonadism.
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Haider, A., Haider, K.S., Doros, G., and Traish, A.
- Subjects
- *
SEXUAL intercourse , *HYPOGONADISM , *TESTOSTERONE - Published
- 2024
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124. OC-83 Unexpected life-threatening thromboembolism in children
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Serban, M, Doros, G, Popoiu, A, Ursu, E, Cernat, L, Savescu, D, Jinca, C, Boc, M, and Arghirescu, S
- Abstract
IntroductionThromboembolism, notwithstanding its increasing rate in the last decade, remains a rare disorder in children. Its development is a consequence of a long and varied list of congenital or acquired risk factors. Approximately 95% of children with such a pathology have one or more underlying risk factors, the majority of them having even more than one.ObjectiveWe would like to draw the attention on the exceptionally rare thromboembolic disorders lacking, at least at admission, risk factors for them.Patients and methodsFrom the relatively large list of patients admitted during a year in the clinic with thromboembolic disorder (14), we selected three patients, without personal or familial risk factors, illustrating severe life-threatening conditions, generated by an unexpectedly developed thromboembolism. An extensive workup (thrombophilia, surgery, insertion of arterial or venous catheters, surgery, immobilisation, malignancy, congenital heart disease, aso) was performed for explanation of the pathogenic background and for tackling an adapted, more efficacious therapy.Results and discussionIt is a heterogeneous group of three patients: a new-born with thrombosis of inferior cava vein extended in both renal veins, a school boy with peripheral pulmonary thromboembolism of multiple segmental and sub-segmental arteries, severe pulmonary hypertension and cardiac insufficiency NYHA IV and an adolescent with peripheral pulmonary thromboembolism with right pulmonary infarction, without pulmonary hypertension and cardiac insufficiency.ConclusionThromboembolism can encompass all paediatric ages, from new-borns, infants, to children and adolescents. Considering their potential severity and the relative high risk of recurrence rate an optimal diagnostic approach and therapeutical management are of life importance.
- Published
- 2017
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125. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome.
- Author
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Fujii, A M, Patel, S M, Allen, R, Doros, G, Guo, C-Y, and Testa, S
- Abstract
A correction to the article "Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome" in previous issue is presented.
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- 2012
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126. A0221 - Effects of long-term testosterone therapy on quality of life and lower urinary tract symptoms in men with functional hypogonadism.
- Author
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Haider, A., Haider, K.S., Doros, G., and Traish, A.
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- *
URINARY organs , *HYPOGONADISM , *TESTOSTERONE , *QUALITY of life , *SYMPTOMS - Published
- 2023
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127. THYROID DYSFUNCTION IN AN AIDS PATIENT.
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Gafencu, M., Bizerea, T. O., Stroescu, R. F., Costa, R., Marginean, O., and Doros, G.
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HIGHLY active antiretroviral therapy , *THYROID diseases , *AIDS patients , *IMMUNE reconstitution inflammatory syndrome , *AUTOIMMUNE thyroiditis - Abstract
Objective. Highly active antiretroviral therapy (HAART) is involved in the potential pathogenic mechanisms linking thyroid autoimmunity with immune restoration. The objective is to emphasize the emergence of autoimmune thyroid disease in a HIV patient long period after restoration of immune competence, unlinked to the immune reconstitution inflammatory syndrome (IRIS) occurring shortly after HAART initiation. We report a case of acute autoimmune thyroiditis with thyrotoxicosis in a patient with stage C3 HIV infection, who had been under HAART for more than 7 years. From the beginning there was a good immune response to the regimen, due to a good adherence and compliance (over 90%). Nine months after HAART initiation the viral load was undetectable (under 34 copies/µL) and the CD4 count reached 645 cells/mm3 (within normal range) after one year of treatment. Eight years after HAART initiation, based on clinical and laboratory findings, autoimmune thyroiditis was diagnosed. At this time immune competence with a normal CD4 count and a CD4/CD8 ratio over 1 was achieved. The chronic inflammation status of an HIV infection is the reason that autoimmunity appears outside the IRIS period. Treatment was initiated with antithyroid drugs. Thyroid function should be monitored periodically in HIV patients undergoing HAART. Future observations must be made for HIV related thyroid disorders using new classifications and studies with a larger number of patients. [ABSTRACT FROM AUTHOR]
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- 2017
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128. The impact of revascularization strategy on clinical failure, hemodynamic failure, and chronic limb-threatening ischemia symptoms in the BEST-CLI Trial.
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Menard MT, Farber A, Doros G, McGinigle KL, Chisci E, Clavijo LC, Kayssi A, Schneider PA, Hawkins BM, Dake MD, Hamza T, Strong MB, Rosenfield K, and Conte MS
- Subjects
- Humans, Male, Female, Aged, Time Factors, Risk Factors, Middle Aged, Limb Salvage, Chronic Limb-Threatening Ischemia surgery, Ischemia physiopathology, Ischemia surgery, Ischemia therapy, Ischemia diagnosis, Ankle Brachial Index, Chronic Disease, Vascular Grafting adverse effects, Proportional Hazards Models, Hemodynamics, Endovascular Procedures adverse effects, Recurrence, Peripheral Arterial Disease physiopathology, Peripheral Arterial Disease therapy, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease surgery, Treatment Failure, Amputation, Surgical, Vascular Patency
- Abstract
Objective: Sustained clinical and hemodynamic benefit after revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI after endovascular (ENDO) vs bypass (OPEN) revascularization in the Best-Endovascular-versus-best-Surgical-Therapy-in-patients-with-CLTI (BEST-CLI) trial., Methods: As planned secondary analyses of the BEST-CLI trial, we examined the rates of (1) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); (2) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to an initial increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); (3) time to resolution of presenting CLTI symptoms; and (4) incidence of recurrent CLTI. Time-to-event analyses were performed by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein [SSGSV], N = 1434; cohort 2: lacking suitable SSGSV, N = 396), and multivariate stratified Cox regression models were created., Results: In cohort 1, there was a significant difference in time to clinical failure (log-rank P < .001), hemodynamic failure (log-rank P < .001), and resolution of presenting symptoms (log-rank P = .009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank P = .006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with a significantly lower risk of clinical and hemodynamic failure in both cohorts and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1, including after adjustment for key baseline patient covariates (end-stage renal disease [ESRD], prior revascularization, smoking, diabetes, age >80 years, WIfI stage, tissue loss, and infrapopliteal disease). Factors independently associated with clinical failure included age >80 years in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2., Conclusions: Durable clinical and hemodynamic benefit after revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions, and limb loss. When compared with ENDO, initial treatment with OPEN surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms., Competing Interests: Disclosures M.T.M. is the advisor for Janssen. A.F. grants from Novo Nordisk Foundation; is a consultant for Sanifit, LeMaitre, and BioGenCell; and is on the advisor board of Dialysis-X and iThera Medical. L.C.C. is a consulting speaker for Cook Medical. P.A.S. is a consultant for Medtronic, Boston Scientific, Philips, Silk Road, Surmodics, Cagent, and Limflow. B.M.H. reports research grants (site PI for clinical trials, no compensation) from Boston Scientific and NIH/NHLBI. M.D.D. is a consultant for Cook Medical, W.L. Gore, and Boston Scientific. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; and owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi. K.R. or his institution (on his behalf) receives research grants from the following entities: NIH, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium. He serves as a member of the Board of Directors of the following organization: The National PERT Consortium. M.S.C. has a relationship with Abbott Vascular DSMB. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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129. Lymphatic Disorder Management in Pediatric Patients With Congenital Heart Disease in European Pediatric Cardiology Centers: Current Status, Disparities, and Future Considerations.
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Safi S, Hjortdal VE, Gewillig M, Miller O, Abumehdi MR, Cantinotti M, Grotenhuis H, Raimondi F, Garrido AO, Roest A, Sunnegårdh J, Saleats T, Brun H, Pärna H, Nolan O, Rotés AS, Deri A, De Wolf D, Herberg U, Liuba P, Möller T, Óskarsson G, Rebonato M, Helbing WA, Doros G, Muntean I, Ojala T, Lubaua I, Bhat M, Wacker J, Bonello B, Ramcharan T, Greil G, Sendzikaite S, Bonnet D, Marek J, Voges I, and McMahon CJ
- Subjects
- Humans, Europe epidemiology, Child, Lymphatic Diseases therapy, Lymphatic Diseases epidemiology, Lymphatic Diseases diagnosis, Health Care Surveys, Lymphography, Cardiac Care Facilities organization & administration, Child, Preschool, Fontan Procedure adverse effects, Practice Patterns, Physicians' trends, Heart Defects, Congenital therapy, Heart Defects, Congenital epidemiology, Healthcare Disparities trends
- Abstract
Background: Lymphatic disorders such as protein-losing enteropathy, plastic bronchitis, and chylothorax are important complications of the Fontan circulation and ultimately result in an increased risk of early death. Several European centers are now performing lymphatic procedures. The aim of this study is to map the extent of these lymphatic disorders and treatments provided across European pediatric cardiology centers., Methods and Results: A survey was circulated to 49 European pediatric cardiology centers consisting of 37 questions including a mix of binary, categorical, and continuous variables. Thirty-one centers (63%) participated in the study, performing a median of 250 (interquartile range, 178 - 313) cardiopulmonary bypass procedures per year. Chylothorax emerged as the most prevalent lymphatic disorder followed by protein-losing enteropathy and plastic bronchitis. The most common diagnostic investigation method was noncontrast magnetic resonance lymphangiography (52%). Eleven centers (35%) conducted lymphatic interventions with a median of 3 (interquartile range, 1 - 4) procedures per year and 12 (interquartile range, 5 - 15) interventions in total per center., Conclusions: This study confirms the rarity of and variation in treatment approaches for lymphatic disorders across Europe. With at least 11 centers offering lymphatic interventions, the adoption of these procedures is on the rise in Europe. To improve the quality of care and treatment outcomes for these complex patients, it is crucial to consider evidence-based lymphatic diagnostics, interventional lymphatic procedures, and the centralization of services in Europe.
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- 2024
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130. Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.
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Giles KA, Farber A, Menard MT, Conte MS, Nolan BW, Siracuse JJ, Strong MB, Doros G, Venermo M, Azene E, Rosenfield K, and Powell RJ
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- Humans, Male, Female, Aged, Time Factors, Risk Factors, Treatment Outcome, Middle Aged, Proportional Hazards Models, Kaplan-Meier Estimate, Vascular Grafting adverse effects, Vascular Grafting mortality, Vascular Grafting methods, Aged, 80 and over, Ischemia surgery, Ischemia mortality, Ischemia therapy, Ischemia diagnostic imaging, Chronic Disease, Vascular Patency, Progression-Free Survival, Critical Illness, Amputation, Surgical, Limb Salvage, Peripheral Arterial Disease mortality, Peripheral Arterial Disease surgery, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease therapy, Chronic Limb-Threatening Ischemia surgery, Chronic Limb-Threatening Ischemia mortality, Popliteal Artery surgery, Popliteal Artery diagnostic imaging, Saphenous Vein transplantation, Saphenous Vein surgery, Endovascular Procedures adverse effects, Endovascular Procedures mortality
- Abstract
Objective: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2., Methods: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models., Results: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12)., Conclusions: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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131. Editor's Choice - Reduction of Major Amputations after Surgery versus Endovascular Intervention: The BEST-CLI Randomised Trial.
- Author
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Venermo MA, Farber A, Schanzer A, Menard MT, Rosenfield K, Dosluoglu H, Goodney PP, Abou-Zamzam AM, Motaganahalli R, Doros G, and Creager MA
- Subjects
- Humans, Female, Male, Aged, Middle Aged, Treatment Outcome, Time Factors, Ischemia surgery, Limb Salvage, Saphenous Vein surgery, Peripheral Arterial Disease surgery, Chronic Limb-Threatening Ischemia surgery, Risk Factors, Aged, 80 and over, Vascular Grafting adverse effects, Vascular Grafting methods, Amputation, Surgical statistics & numerical data, Amputation, Surgical adverse effects, Endovascular Procedures adverse effects
- Abstract
Objective: BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated., Methods: A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2. Differences in time to first event and number of amputations were evaluated., Results: In cohort 1, there were 410 (45.6%) total amputation events in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during a mean follow up of 2.7 years. Approximately one in three patients underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical group and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (74/718) of patients in the surgical group and 14.9% (107/716) in the endovascular group (p = .008). In cohort 2, there were 199 amputation events in 132 patients (33.3%) during a mean follow up of 1.6 years: 95 (47.7%) in the surgical group vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (30/197) of patients in the surgical group and 14.1% (28/199) in the endovascular group (p = .74)., Conclusion: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations, mainly due to a decrease in major amputations subsequent to minor amputations., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
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132. COVID-19 and Its Potential Impact on Children Born to Mothers Infected During Pregnancy: A Comprehensive Review.
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Stolojanu C, Doros G, Bratu ML, Ciobanu I, Munteanu K, Iacob ER, Ghenciu LA, Stoicescu ER, and Dima M
- Abstract
Pregnancy is a vulnerable period of time during which pregnant people are prone to infections like COVID-19, which can increase risks for both the mother and fetus. These infections may lead to complications such as preterm birth, developmental delays, and congenital abnormalities. While COVID-19 poses additional risks like placental dysfunction and neonatal infections, studies on long-term effects remain limited. Ongoing research and monitoring are essential to understand and mitigate potential cognitive and developmental challenges in children born to mothers infected with COVID-19. This review aims to guide clinicians in managing these risks throughout childhood. Maternal COVID-19 infection during pregnancy can have significant implications for fetal development, even if the newborn is not infected at birth. The release of inflammatory cytokines may cross the placental barrier, potentially disrupting fetal brain development and increasing the risk of long-term cognitive and behavioral issues, such as ADHD or autism. Placental dysfunction, caused by inflammation or thrombosis, can lead to intrauterine growth restriction (IUGR), preterm birth, or hypoxia, affecting both neurological and respiratory health in newborns. Furthermore, a compromised fetal immune system can increase susceptibility to autoimmune conditions and infections. The early diagnosis and management of infections during pregnancy are crucial in mitigating risks to both the mother and fetus. Swift intervention can prevent complications like preterm birth and long-term developmental challenges, ensuring better health outcomes for both the mother and child. Long-term monitoring of children born to mothers infected with COVID-19 is necessary to understand the full extent of the virus's impact. This review evaluates the long-term systemic effects of maternal COVID-19 infection during pregnancy on fetuses, newborns, and children, focusing beyond vertical transmission. It highlights the broader impacts on fetal development, offering insights to help clinicians manage potential issues that may arise later in life., Competing Interests: The authors declare no conflicts of interest.
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- 2024
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133. Female patients have fewer limb amputations compared to male patients in the BEST-CLI trial.
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McGinigle KL, Doros G, Alabi O, Brooke BS, Vouyouka A, Hiramoto J, Charlton-Ouw K, Strong MB, Rosenfield K, Menard MT, Farber A, and Giles KA
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Objective: Female patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular vs best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort., Methods: In a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb-threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared with all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females., Results: Among 1830 patients, females were significantly underrepresented, comprising only 28% (n = 519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared with males: females were more likely to have rest pain alone (72% vs 60%; P < .0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%; P = .01). Females were less likely to have an adequate single-segment greater saphenous vein (SSGSV) available (82% vs 89%; P = .01). Controlled for baseline clinical factors, at 1 year, females had significantly lower rates of major limb amputation compared with males (hazard ratio [HR], 0.70; P = .023), which drove better amputation- and MALE-free survival rates. All-cause death at 1 year was not statistically different between sexes (11.8% vs 11.2%; P = .286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared with endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared with females undergoing open surgical bypass (24.8% vs 10.5%; P < .001)., Conclusions: Despite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all-female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at 1 year compared with male patients. These findings suggest that in treating female patients with CLTI considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex., Competing Interests: Disclosures K.M. reports consultant for Medtronic Inc, and Vascular Technologies Inc; and research funding from NovoNordisk Foundation. K.R. reports consultant or member of a scientific advisory board for the following entities: Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi; and K.R. or his institution (on his behalf) receive research grants from the following entities: National Institutes of Health, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium; and serves as a member of the Board of Directors of the following organization: The National PERT Consortium. M.M. reports research grant from NovoNordisk Foundation; and advisory board for Janssen. A.F. reports grants from the Novo Nordisk Foundation; consultant for Sanifit, LeMaitre, and BioGenCell; and advisory board for Dialysis-X and iThera Medical. K.C. reports consultant for W.L. Gore & Associates and Venostent; and research support from Inari Medical, Vesper Medical, BD, and Johnson & Johnson. K.G. reports advisory board for Boston Scientific., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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134. Evaluation of Computerized Tomography Utilization in Comparison to Digital Subtraction Angiography in Patients with Peripheral Arterial Disease.
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Cheng TW, Doros G, Jones DW, Vazirani A, and Malikova MA
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- Humans, Male, Middle Aged, Female, Aged, Constriction, Pathologic, Time Factors, Retrospective Studies, Adult, Angiography, Digital Subtraction, Peripheral Arterial Disease diagnostic imaging, Predictive Value of Tests, Computed Tomography Angiography, Lower Extremity blood supply, Vascular Calcification diagnostic imaging
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Background: Perform literature review to analyze current practices in imaging patient with peripheral arterial disease (PAD) and examine patterns in our practice in order to assess whether a lower extremity computed tomography angiography (CTA) in addition to digital subtraction angiography enhanced the assessment of vessel calcification, percentage of stenosis, and affected outcomes in patients with PAD., Methods: The study included patients who underwent lower extremity imaging and were followed up to 12 months. This population was divided into cases who had both an angiogram and CTA performed within 30 days (n = 20), and controls who underwent angiography only (n = 19). Baseline characteristics, imaging results, and clinical outcomes were analyzed., Results: Thirty-nine patients met study criteria (mean age was 58.4 years, 69.2% were males, and 33.3% had diabetes). Patients mostly presented with tissue loss/rest pain (10.3%), claudication (15.4%), acute limb (10.3%), and trauma (15.4%). We have not observed any statistically significant differences in various examined blood vessels when their features (e.g., vessel diameter, stenosis, calcifications) were assessed by CTA combined with angiography versus angiography alone. The exceptions were external iliac artery, superficial femoral artery and dorsalis pedis vessels. In external iliac artery percentage of stenosis was 1.11% as determined by computed tomography (CT) scan versus 30% by angiography (P = 0.009). For superficial femoral artery stenosis, the percentage determined by CT was 48.68% vs. 81.41% by angiography, and observed difference between 2 modalities was statistically significant (P = 0.025). For dorsalis pedis percentage of stenosis detected by CT scan was 60.63% vs. 22.73% by angiography, and the differences in findings by these modalities were statistically significant (P = 0.039). The most frequent perioperative complication was cardiac-related (35.5%). Nineteen patients were readmitted and 8 had reinterventions within 12 months., Conclusions: Both imaging modalities yielded similar results for assessing vessel calcification and percentage of stenosis regardless of anatomic vessel location. Overall, utilization of CTA in addition to angiography for large vessels above the knee (e.g., iliac artery, superficial femoral artery) and below the knee for dorsalis pedis provided more detailed information on the properties of these vessels. Therefore, during preoperative assessments, CTA may be helpful in addition to angiography for planning surgical and endovascular interventions for symptomatic PAD treatment in larger vessels., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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135. The impact of diabetes mellitus on the outcomes of revascularization for chronic limb-threatening ischemia in the BEST-CLI trial.
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Ochoa Chaar CI, Malas M, Doros G, Schermerhorn M, Conte MS, Alameddine D, Siracuse JJ, Yadavalli SD, Dake MD, Creager MA, Tan TW, Rosenfield K, Menard MT, Farber A, and Hamdan A
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Objective: Several observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial., Methods: Baseline characteristics were compared between patients with and without DM in the BEST-CLI trial. Cox regression was used to determine the association between DM and major outcomes of major adverse limb events (MALE), reintervention, above-ankle amputation, and all-cause death., Results: Among 1777 patients who underwent LER, 69.2% had DM. Compared with patients without DM, those with DM were significantly younger, less likely to be White, and more likely to be Hispanic. Patients with DM were more likely to have hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, and renal disease and be on optimal medical therapy (antiplatelets and statins), whereas patients without DM were significantly more likely to be smokers and have chronic obstructive pulmonary disease. Patients with DM were significantly more likely to present with late Wound Ischemia foot Infection (WIfI) stages (3-4) (73.7% vs 45.9%; P < .001) that were driven predominantly by differences in wound and infection grade. Conversely, patients without DM had significantly lower ankle pressures and toe pressures and were significantly more likely to have WIfI ischemia grade 3 compared with patients with DM (60% vs 52.5%; P = .016). At 3 years, patients with DM exhibited higher rates of above-ankle amputation and all-cause death compared with patients without DM. Kaplan-Meier analysis demonstrated significantly higher MALE or all-cause death compared with patients without DM (3-year estimate: 53.5% vs 46.4%; P < .001). After adjusting for potential confounders, regression analysis demonstrated that DM was independently associated with increased above-ankle amputation (1.75 [1.22-2.51]), all-cause death (1.63 [1.31-2.03]), and MALE or all-cause death (1.24 [1.04-1.47])., Conclusions: Patients with DM undergoing LER for chronic limb-threatening ischemia experienced a greater incidence of MALE or all-cause death compared with patients without DM. The impact of DM seems to be mediated by more severe wounds and infections at the time of presentation, and a higher prevalence of cardiac and renal disease., Competing Interests: Disclosures J.S. reports education grants provided by Becton, Dickinson and Company and W. L. Gore & Associates; funds were paid to Boston University. A.F. reports consultant to LeMaitre, Sanifit, and BiogenCell, and is on the advisory board of iThera and DilaysisX. C.I.O.C. reports consultant for Envveno. Patent: U.S.S.N. 10,524,891 B1 “Inferior vena cava filter retrieval device and method of retrieving same.”, (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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136. Prosthetic conduits have worse outcomes compared with great saphenous vein conduits in femoropopliteal and infrapopliteal bypass in patients with chronic limb-threatening ischemia.
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Farber A, Menard MT, Conte MS, Rosenfield K, Schermerhorn M, Schanzer A, Powell RJ, Chaar CIO, Hicks CW, Doros G, Strong MB, Leers SA, Motaganahalli R, Stangenberg L, and Siracuse JJ
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Objective: Single segment great saphenous vein (SSGSV) traditionally has been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some investigators have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable. We sought to evaluate long-term outcomes of infrainguinal bypass based on conduit type for treating chronic limb-threatening ischemia (CLTI)., Methods: Data from the Best Endovascular vs Best Surgical Therapy of Patients with CLTI multicenter, prospective, randomized controlled trial, comparing infrainguinal bypass with endovascular therapy in patients with CLTI, were evaluated. In this as-treated analysis, we compared outcomes of infrainguinal bypass using prosthetic, alternative autogenous vein (AAV), and cryopreserved vein (Cryo) with SSGSV bypass. Kaplan-Meier and multivariable analyses were performed to examine the associations of conduit type with major adverse limb events (MALE), reinterventions, above-ankle amputations, and all-cause death rates., Results: In total, 784 bypasses were analyzed (120 prosthetic, 33 AAV, 21 Cryo, AND 610 SSGSV). For prosthetic and SSGSV, the distribution was 357 femoropopliteal (93 prosthetic and 264 GSV) and 373 infrapopliteal (27 prosthetic and 346 GSV). The mean age for the overall cohort was 67.1 years; 27.4% were female, 29.9% were non-White, and 11.5% were of Hispanic ethnicity. Patients undergoing prosthetic bypass were older (69.2 years vs 66.7 years); more likely to have chronic obstructive pulmonary disease (22.5% vs 14.0%), prior coronary artery bypass grafting (88.9% vs 66.5%), and prior stroke (23.3% vs 14%); but less often were of Hispanic ethnicity (5.8% vs 12.6%) and had diabetes (59.2% vs 71.3%) (P < .05 for all). For femoropopliteal bypass, use of prosthetic conduit was associated with increased major reinterventions at 3 years overall (19.0% vs 11.5%; P = .06) and on risk-adjusted analysis (hazard ratio [HR], 2.13; 95% confidence interval [CI], 1.09-4.2; P = .028). No significant differences in MALE or death, above-ankle amputation, or death were observed. Outcomes were similar for bypasses to above-knee popliteal targets and below-knee popliteal targets. For infrapopliteal bypass, the use of a prosthetic conduit was associated with increased major reintervention (25.3% vs 10.3%; P = .005), death (68.6% vs 34.8%; P < .001), and MALE or death (90.0% vs 48.1%; P < .001) at 3 years. After risk adjustment, infrapopliteal bypass with prosthetic conduit was associated with higher major reintervention (HR, 4.14; 95% CI, 1.36-12.6; P = .012), above-ankle amputation (HR, 4.64; 95% CI, 1.59-13.5; P = .005), death (HR, 2.96; 95% CI, 1.4-6.2; P = .004), and MALE or death (HR, 3.59; 95% CI, 1.64-7.86; P = .001) compared with bypass with SSGSV. Overall, AAV had similar outcomes at 3 years as SSGSV; however, Cryo had significantly higher above-ankle amputation (50.0% vs 12.8%) (HR, 4.2; 95% CI, 1.68-10.5; P = .002), major reintervention (41.9% vs 10.7%) (HR, 3.12; 95% CI, 1.18-8.22; P = .02), and MALE/death (88.8% vs 37.8%) (HR, 2.96; 95% CI, 1.43-6.14; P = .004)., Conclusions: The use of a prosthetic conduit in infrainguinal bypass is associated with inferior outcomes compared with bypass using SSGSV, particularly for bypass to infrapopliteal targets. Cryo grafts were infrequent and also demonstrated inferior outcomes. SSGSV remains the preferred conduit of choice for infrainguinal bypass., Competing Interests: Disclosures J.S. reports educational grants from W. L. Gore & Associates and BD. M.M. is a member of the scientific advisory board for Janssen. M.C. is on the Abbott Vascular DSMB. K.R. is a member of the Scientific Advisory Board or Consultant for Abbott Vascular, Access Vascular, Boston Scientific-BTG, Volcano-Philips, Surmodics, Cruzar Systems, Magneto, Summa Therapeutics, and University of Maryland; an unpaid member of the Scientific Advisory Board of Thrombolex, Inc; received grants from NIH and Boston Scientific; has equity from Access Vascular, Accolade, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture, Vascular, Magneto, Micell, and Valcare; and is a board member of VIVA Physicians, a not-for-profit 501c3, and National PERT ConsortiumTM, a not for profit 501c3. A.F. is a grant recipient of the Novo Nordisk Foundation; a consultant for Sanifit, LeMaitre, and BioGenCell; and on the advisory board for Dialysis-X and iThera Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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137. Transatlantic analysis of patient profiles and mid-term survival after isolated coronary artery bypass grafting: a head-to-head comparison between the European DuraGraft Registry and the US STS Registry.
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Caliskan E, Misfeld M, Sandner S, Böning A, Aramendi J, Salzberg SP, Choi YH, Perrault LP, Tekin I, Cuerpo GP, Lopez-Menendez J, Weltert LP, Böhm J, Krane M, González-Santos JM, Tellez JC, Holubec T, Ferrari E, Doros G, and Emmert MY
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Introduction: Although cardiovascular surgery societies in Europe and the USA constantly strive for the exchange of knowledge and best practices in coronary artery bypass grafting (CABG), the available evidence on whether such efforts result in similar patient outcomes is limited. Therefore, in the present analysis, we sought to compare patient profiles and overall survival outcomes for up to 3 years between large European and US patient cohorts who underwent isolated CABG., Methods: Patients from the European DuraGraft Registry ( n = 2,522) who underwent isolated CABG at 45 sites in eight different European countries between 2016 and 2019 were compared to randomly selected patients from the US STS database who were operated during the same period ( n = 294,725). Free conduits (venous and arterial grafts) from the DuraGraft Registry patients were intraoperatively stored in DuraGraft, an endothelial damage inhibitor, before anastomosis, whereas grafts from the STS Registry patients in standard-of-care solutions (e.g., saline). Propensity score matching (PSM) models were used to account for differences in patient baseline and surgical characteristics, using a primary PSM with 35 variables (2,400 patients matched) and a secondary PSM with 25 variables (2,522 patients matched, sensitivity analysis). The overall survival for up to 3 years after CABG was assessed as the primary endpoint., Results: The comparison of patient profiles showed significant differences between the European and US cohorts. The European patients had more left main disease, underwent more off-pump CABG, and received more arterial grafts together with more complete arterial grafting procedures. In contrast, the US patients received more distal anastomoses with more saphenous vein grafts (SVGs) that were mainly harvested endoscopically. Such differences, however, were well balanced after PSM for the mortality comparison. Mortality comparison at 30 days, 12 months, and 24 months between the European and US patients was 2.38% vs. 1.96%, 4.32% vs. 4.79%, and 5.38% vs. 6.96%, respectively. At 36 months, the mortality was significantly lower in the European patients than that of their US counterparts (7.37% vs. 9.65%; p -value = 0.016). The estimated hazard ratio (HR) was 1.29 (95% CI 1.05-1.59)., Conclusion: This large-scale transatlantic comparative analysis shows that there are some significant differences in patient profiles between large cohorts of European and US patients. These differences were adjusted by using PSM for the mortality analysis. No significant difference in mortality was detected between groups through 2 years, but survival was significantly better in the European DuraGraft Registry patients at 3 years post-CABG., Competing Interests: EC, MM, JA, SS, Y-HC, and AB are members of the registry advisory committee (RAC). LP is a member of the RAC and is a consultant for Marizyme. ME is the principal investigator of the registry, the chair of the RAC, and a consultant for Marizyme. EF received research grants from Somalution, a Marizyme company. Other authors have nothing to disclose. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Caliskan, Misfeld, Sandner, Böning, Aramendi, Salzberg, Choi, Perrault, Tekin, Cuerpo, Lopez-Menendez, Weltert, Böhm, Krane, González-Santos, Tellez, Holubec, Ferrari, Doros and Emmert.)
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- 2024
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138. Characterization of cardiovascular serious adverse events after bypass or endovascular revascularization for limb-threatening ischemia in the BEST-CLI trial.
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Siracuse JJ, Menard MT, Rosenfield K, Conte MS, Powell R, Hamburg N, Doros G, Strong MB, and Farber A
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- Humans, Prospective Studies, Female, Male, Treatment Outcome, Aged, Time Factors, Risk Factors, Peripheral Arterial Disease surgery, Peripheral Arterial Disease diagnostic imaging, Middle Aged, Ischemia surgery, Ischemia etiology, Ischemia diagnosis, Chronic Limb-Threatening Ischemia surgery, Vascular Grafting adverse effects, Risk Assessment, Endovascular Procedures adverse effects, Endovascular Procedures mortality
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Objective: Cardiovascular complications after revascularization to treat chronic limb-threatening ischemia (CLTI) are a major concern that guides treatment. Our goal was to assess periprocedural cardiac and vascular serious adverse events (SAEs) in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial., Methods: BEST-CLI was a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Adverse events are defined as serious when they affect safety in the trial, require prolonged hospitalization, result in significant disability or incapacitation, are life-threatening, or result in death. Interventions were analyzed in a per protocol fashion., Results: In the BEST-CLI trial, 850 OPEN and 896 ENDO interventions were evaluated. Forty (4.7%) and 34 (3.8%) patients experienced at least one cardiac SAE after OPEN and ENDO intervention, respectively (P = .35). Overall, there were 53 cardiac SAEs (0.06 per patient) after OPEN and 40 (0.045 per patient) after ENDO interventions. Cardiac SAEs in the OPEN arm were classified as related to ischemia (50.9%), arrhythmias (17%), heart failure (15.1%), arrest (13.2%), and heart block (3.8%); in the ENDO arm, they were classified as ischemia (47.5%), heart failure (17.5%), arrhythmias (15%), arrest (15%), and heart block (5%). Approximately half of SAEs were classified as severe for both OPEN and ENDO. SAEs were definitely or probably related to the procedure in 30.2% and 25% in the OPEN and ENDO arms, respectively (P = .2). Vascular SAEs occurred in 58 (6.8%) and 86 (9.6%) of patients after OPEN and ENDO revascularization, respectively (P = .19). In total, there were 59 (0.07 per patient) and 87 (0.097 per patient) vascular SAEs after OPEN and ENDO procedures. Vascular SAEs in the OPEN arm were classified as distal ischemia/infection (44.1%), bleeding (16.9%), occlusive (15.3%), thromboembolic (15.3%), cerebrovascular (5.1%), and other (3.4%); in the ENDO arm, they were distal ischemia/infection (40.2%), occlusive (31%), bleeding (12.6%), thromboembolic (8%), cerebrovascular (1.1%), and other (4.6%). SAEs were classified as severe for OPEN in 45.8% and ENDO in 46%. SAEs were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P = .35), respectively., Conclusions: Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAEs. The majority were not related to the index intervention, but approximately half were severe., Competing Interests: Disclosures J.J.S. reports education grants from WL Gore and BD paid to Boston University. A.F. is a consultant for Sanifit. M.T.M. has served on the scientific advisory board for Janssen. M.S.C. is on the Data Safety Monitoring Board for Abbott Vascular. K.R. is a member of the scientific advisory board or a consultant for Abbott Vascular, Access Vascular, Boston Scientific-BTG, Volcano-Philips, Surmodics, Cruzar Systems, Magneto, Summa Therapeutics, and University of Maryland; is an unpaid member of the scientific advisory board of Thrombolex, Inc; received grants from the National Institutes of Health and Boston Scientific; has equity from Access Vascular, Accolade, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture Vascular, Magneto, Micell, and Valcare; and is a board member of VIVA Physicians, a not-for-profit 501c3, and National PERT Consortium, a not-for-profit 501c3. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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139. Systemic AL Amyloidosis in Patients Younger Than 40 Years of Age: Clinical Presentation and Outcomes.
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Verma K, Staron A, Zheng L, Cetin O, Doros G, and Sanchorawala V
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Competing Interests: Disclosure The authors have stated that they have no conflicts of interest.
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- 2024
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140. General Characteristics and Current State of Antibiotic Resistance in Pediatric Urinary Tract Infection-A Single Center Experience.
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Isac R, Doros G, Stolojanu CA, Steflea RM, Stroescu RF, Olariu IC, Micsescu-Olah AM, and Gafencu M
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Urinary tract infection (UTI) represents one of the most common bacterial infections in children, mainly caused by Gram-negative bacteria. Empirical antibiotic treatment is based on international and national guidelines for treating UTIs in children and is individualized with local antibiotic resistance patterns. The aim of this study is to bring a clear view of present-day particularities of UTIs in children., Methods: We analyzed 210 positive urine cultures identified in 141 pediatric patients admitted to the hospital over a 6-month period., Results: The majority of patients were females (57%) with a median age of 5 years (IQR 12), while male patients revealed a median age of 2 (IQR 7). Most patients originated from urban areas (53%). Only 18 patients (12.76%) were identified with underlying Congenital Anomalies of the Kidney and Urinary Tract (CAKUT). Escherichia Coli was the most frequent pathogen. Increased antibiotic resistance was found in commonly-used antibiotics Ampicillin and Trimethoprim/Sulfamethoxazole, and in the case of patients with CAKUT. Suitable antibiotics for treating a Gram-negative UTI are aminoglycosides, Meropenem, third-generation Cephalosporins, and Nitrofurantoin. Vancomycin upholds efficacy in treating a Gram-positive pediatric UTI., Conclusion: Periodical analysis needs to be performed in order to constantly update clinicians on uropathogenic antibiotic resistance and optimal empirical treatment options.
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- 2024
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141. Neurofilament light chain kinetics as a biomarker for polyneuropathy in V122I hereditary transthyretin amyloidosis.
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Lau KHV, Prokaeva T, Zheng L, Doros G, Kaku MC, Spencer B, Berk J, and Sanchorawala V
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- Humans, Male, Female, Middle Aged, Kinetics, Aged, Amyloid Neuropathies, Familial genetics, Amyloid Neuropathies, Familial diagnosis, Amyloid Neuropathies, Familial pathology, Biomarkers metabolism, Neurofilament Proteins genetics, Prealbumin genetics, Prealbumin metabolism, Polyneuropathies genetics, Polyneuropathies diagnosis
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- 2024
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142. Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial.
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Conte MS, Azene E, Doros G, Gasper WJ, Hamza T, Kashyap VS, Guzman R, Mena-Hurtado C, Menard MT, Rosenfield K, Rowe VL, Strong M, and Farber A
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- Humans, Male, Female, Aged, Treatment Outcome, Time Factors, Risk Factors, Middle Aged, Proportional Hazards Models, Peripheral Arterial Disease surgery, Peripheral Arterial Disease mortality, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease physiopathology, Chronic Limb-Threatening Ischemia surgery, Chronic Disease, Vascular Grafting adverse effects, Vascular Grafting mortality, Multivariate Analysis, Critical Illness, Intention to Treat Analysis, Kaplan-Meier Estimate, Saphenous Vein transplantation, Saphenous Vein surgery, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Amputation, Surgical, Ischemia surgery, Ischemia mortality, Ischemia physiopathology, Ischemia diagnosis, Limb Salvage, Reoperation
- Abstract
Objectives: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints., Methods: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models., Results: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial., Conclusions: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions., Competing Interests: Disclosures M.C. is on the DSMB for Abbott Vascular. M.M. is an advisor for Janssen. K.R. receives income as a consultant or member of a scientific advisory board for Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, BectonDickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi; serves as a member of the board of directors of the following organization: The National PERT ConsortiumTMA; and K.R. or his institution (on his behalf) receive research grants from the following entities: NIH, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium. A.F. received a grant from Novo Nordisk Foundation; is a consultant with Sanifit, LeMaitre, and BioGenCell; and is on the advisory board for Dialysis-X and iThera Medical. E.A. is a consultant with Philips and is participating in clinical trials with Inari Medical. C.M. is a consultant with Cook, Abbott, Penumra, and Optum Labs; and received a research grant from Shockwave and Philips., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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143. A Pilot Comparative Study between Creatinine- and Cystatin-C-Based Equations to Estimate GFR and Kidney Ultrasound Percentiles in Children with Congenital Anomalies of the Kidney and Urinary Tract.
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Steflea RM, Stroescu R, Gafencu M, Stoicescu ER, Isac R, Olariu IC, Micsescu-Olah AM, Susa SR, Murariu M, and Doros G
- Abstract
Congenital anomalies affecting the kidneys present significant challenges in pediatric nephrology, needing precise methods for assessing renal function and guiding therapeutic intervention. Bedside Schwartz formula with the cystatin-C-based Full Age Spectrum formula and Chronic Kidney Disease in Children (CKiD) U 25 formula used in estimating glomerular filtration rate (eGFR) and also to assess if the eGFR in association with kidney length percentiles can be a monitoring parameter for the progression of chronic kidney disease in children with congenital anomalies of the kidney and urinary tract (CAKUT). A total of 64 pediatric patients (median age at diagnostic was 12 months with an interquartile range of 2 to 60) were diagnosed with congenital anomalies in the kidney and urinary tract between June 2018 and May 2023 at "Louis Turcanu" Emergency Hospital for Children in Timisoara, Romania. Baseline characteristics, CAKUT types, associated pathologies, CKD staging, and eGFR using creatinine and cystatin C were analyzed. The mean age at the moment of examination was 116.50 months; (65, 180). Chronic kidney disease staging revealed a predominance of patients in CKD stages G1 and A1. Analysis of eGFR methods revealed a small mean difference between eGFR estimated by creatinine and cystatin C, with a moderate-strong positive correlation observed between the eGFR and ultrasound parameters. Using cystatin-C-based formulas for eGFR, in conjunction with ultrasound measurements, may offer reliable insights into renal function in pediatric patients with congenital anomalies affecting the kidney and urinary tract. However, the economic aspect must be taken into consideration because cystatin C determination is approximately eight times more expensive than that of creatinine. An interdisciplinary approach is crucial for managing patients with CAKUT.
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- 2024
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144. Organisation of paediatric echocardiography laboratories and governance of echocardiography services and training in Europe: current status, disparities and potential solutions. A survey from the Association for European Paediatric and Congenital Cardiology (AEPC) imaging working group - CORRIGENDUM.
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Cantinotti M, Voges I, Miller O, Raimondi F, Grotenhuis H, Bharucha T, Garrido AO, Valsangiacomo E, Roest A, Sunnegårdh J, Salaets T, Brun H, Khraiche D, Jossif A, Schokking M, Sabate-Rotes A, Meyer-Szary J, Deri A, Koopman L, Herberg U, du Marchie Sarvaas G, Leskinen M, Tchana B, Ten Harkel ADJ, Ödemis E, Morrison L, Steimetz M, Laser KT, Doros G, Bellshan-Revell H, Muntean I, Anagostopoulou A, Alpman MS, Hunter L, Ojala T, Bhat M, Olejnik P, Wacker J, Bonello B, Ramcharan T, Greil G, Marek J, DiSalvo G, and McMahon CJ
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- 2024
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145. Kidney Function Tests and Continuous eGFR Decrease at Six Months after SARS-CoV-2 Infection in Patients Clinically Diagnosed with Post-COVID Syndrome.
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Boruga M, Septimiu-Radu S, Nandarge PS, Elagez A, Doros G, Lazureanu VE, Stoicescu ER, Tanase E, Iacob R, Dumitrescu A, Bota AV, Cotoraci C, and Bratu ML
- Abstract
The long-term sequelae of SARS-CoV-2 infection are still under research, since extensive studies showed plenty of systemic effects of the viral infection, extending even after the acute phase of the infection. This study evaluated kidney function tests six months after SARS-CoV-2 infection in patients clinically diagnosed with Post-COVID Syndrome, hypothesizing persistent renal dysfunction evidenced by altered kidney function tests compared to baseline levels. Continuous eGFR decrease <30 at six months post-infection was considered the main study outcome. Conducted at the "Victor Babes" Hospital, this retrospective observational study involved adults with laboratory-confirmed SARS-CoV-2 infection and clinically-diagnosed Post-COVID Syndrome, excluding those with prior chronic kidney disease or significant renal impairment. Kidney function tests, including serum creatinine, blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), alongside markers of kidney damage such as proteinuria and hematuria, were analyzed. Among 206 participants, significant differences were observed between the control ( n = 114) and the Post-COVID group ( n = 92). The Post-COVID group exhibited higher serum creatinine (109.7 μmol/L vs. 84.5 μmol/L, p < 0.001), lower eGFR (65.3mL/min/1.73 m
2 vs. 91.2 mL/min/1.73 m2 , p < 0.001), and elevated BUN levels (23.7 mg/dL vs. 15.2 mg/dL, p < 0.001) compared to the control group. Regression analysis highlighted significant predictors of continuous eGFR decrease <30 at six months post-infection. The development of acute kidney injury (AKI) during the initial COVID-19 illness emerged as a strong predictor of reduced eGFR (β = 3.47, p < 0.001). Additional factors, including a creatinine increase (23 μmol/L above the normal range) and an elevated Albumin to Creatinine Ratio (ACR) (>11 mg/g above the normal range), were significantly associated with eGFR reduction. Patients with Post-COVID Syndrome demonstrate significant renal impairment six months post-SARS-CoV-2 infection. The study's findings stress the need for ongoing monitoring and intervention strategies for renal health in affected individuals, underscoring the persistent impact of COVID-19 on renal function., Competing Interests: The authors declare no conflict of interest.- Published
- 2024
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146. Investigator attitudes on equipoise and practice patterns in the BEST-CLI trial.
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Farber A, Siracuse JJ, Giles K, Jones DW, Laskowski IA, Powell RJ, Rosenfield K, Strong MB, White CJ, Doros G, and Menard MT
- Subjects
- Humans, Prospective Studies, Treatment Outcome, Veins surgery, Ischemia, Chronic Limb-Threatening Ischemia, Limb Salvage methods, Risk Factors, Retrospective Studies, Endovascular Procedures methods, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease surgery
- Abstract
Objectives: There has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb-threatening ischemia (CLTI). We aimed to assess treatment preferences of Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) investigators prior to and following the trial., Methods: An electronic 60-question survey was sent to 1180 BEST-CLI investigators in 2022, after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon (VS) surgical and ENDO preferences were compared with a 2010 survey administered to prospective investigators before trial funding., Results: For the 2022 survey, the response rate was 20.2% and was comprised of VSs (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for >20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between ENDO and OPEN procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and ENDO interventions (86%). A minority reported always or usually using the wound, ischemia, and foot infection (WIfI) criteria (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than one-half (52.9%) agreed that the statement "no bridges are burned with an ENDO-first approach" was false. Intervention choice was influenced by availability of the operating room or ENDO suite, personal schedule, and personal skill set in 30.1%, 18.0%, and 45.9% of respondents, respectively. Most respondents reported routinely using paclitaxel-coated balloons (88.1%) and stents (67.5%); however, 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing >10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing >10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI teams improved care; however, only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by VSs to the 2010 survey, there were no changes in preferred treatment based on Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification or conduit preference. In 2022, OPEN surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except a decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs 30.8%) (P < .05)., Conclusions: There is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced OPEN and ENDO techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial, there was overall similar equipoise among VSs., Competing Interests: Disclosures A.F. has received a grant from the Novo Nordisk Foundation; is a consultant for Sanifit, LeMaitre, and BioGenCell; and is on the advisory board of Dialysis-X and iThera Medical. M.M. is an advisor for Janssen. K.G. is an advisory board member for Boston Scientific. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular; Althea Medical; Angiodynamics; Auxetics; Becton-Dickinson; Boston Scientific; Contego; Crossliner; Innova Vascular; Inspire MD; Janssen/Johnson and Johnson; Magneto; Mayo Clinic; MedAlliance; Medtronic; Neptune Medical; Penumbra; Philips; Surmodics; Terumo; Thrombolex; Truvic; Vasorum; Vumedi. KR owns equity or stock options in the following entities: Access Vascular; Aerami; Althea Medical; Auxetics; Contego; Crossliner; Cruzar Systems; Endospan; Imperative Care/Truvic; Innova Vascular; InspireMD; JanaCare; Magneto; MedAlliance; Neptune Medical; Orchestra; Prosomnus; Shockwave; Skydance; Summa Therapeutics; Thrombolex; Vasorum; Vumedi. K.R. or his institution (on my behalf) receive research grants from the following entities: NIH; Abiomed; Boston Scientific; Novo Nordisk Foundation; Penumbra; Gettinge-Atrium. K.R. serves as a member of the Board of Directors of the following organization: The National PERT ConsortiumTM., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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147. A Retrospective Analysis of Systemic Bartonella henselae Infection in Children.
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Stroescu RF, Chisavu F, Steflea RM, Doros G, Bizerea-Moga TO, Vulcanescu DD, Marti TD, Boru C, Avram CR, and Gafencu M
- Abstract
Systemic Bartonella henselae infection, also known as cat-scratch disease (CSD), presents a diagnostic challenge due to the variability of clinical manifestations and the potential for serological cross-reactivity with other organisms. This study aimed to retrospectively analyze the epidemiological, clinical, laboratory, and imaging characteristics of pediatric patients diagnosed with systemic B. henselae infection, to improve understanding and facilitate timely diagnosis and treatment. We conducted a 10-year retrospective study at the "Louis Turcanu" Children's Emergency Hospital and private clinics in Timisoara, Romania, reviewing records for confirmed cases of B. henselae infection from January 2014 to January 2024. The study adhered to the Declaration of Helsinki and received approval from the Institutional Review Board. Diagnostic criteria included contact with animals, prolonged fever, hematological and/or hepatosplenic manifestations, and positive serological tests for B. henselae . Nineteen pediatric patients were identified with a median age of 8.1 years. The majority were exposed to felines (94.7%), reflecting the disease's epidemiological profile. Clinical findings highlighted fever (47.4%), lymphadenopathy (78.9%), and less frequently, abdominal pain and headache (both 10.5%). Laboratory analyses revealed a mean hemoglobin of 12.6 mg/dL, WBC count of 13.1 × 10
3 cells/microliter, and platelet count of 340.6 × 103 per microliter. Significant findings included elevation in ESR and CRP in 47.4% and 21.1% of patients, respectively, and high seropositivity rates for B. henselae IgM (63.2%) and IgG (94.7%). Imaging studies demonstrated widespread lymphadenopathy and occasional splenomegaly and hepatic microabscesses. All patients received antibiotic therapy, with azithromycin being the most commonly used (94.7%). Co-infections with Epstein-Barr Virus, Cytomegalovirus, and Toxoplasma gondii were documented, indicating the complex infectious status of the patients. Systemic B. henselae infection in children predominantly manifests with fever and lymphadenopathy, with a significant history of exposure to felines. Laboratory and imaging findings support the diagnosis, which is further complicated by potential co-infections. Effective antibiotic therapy, primarily with azithromycin, underscores the need for comprehensive diagnostic and treatment strategies. This study emphasizes the importance of considering systemic B. henselae infection in pediatric patients with prolonged fever and contact with cats, to ensure timely and appropriate treatment.- Published
- 2024
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148. Outcomes after surgical revascularization in diabetic patients.
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Misfeld M, Sandner S, Caliskan E, Böning A, Aramendi J, Salzberg SP, Choi YH, Perrault LP, Tekin I, Cuerpo GP, Lopez-Menendez J, Weltert LP, Adsuar-Gomez A, Thielmann M, Serraino GF, Doros G, Borger MA, and Emmert MY
- Abstract
Objectives: Patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) have been repeatedly demonstrated to have worse clinical outcomes compared to patients without DM. The objective of this study was to evaluate the impact of DM on 1-year clinical outcomes after isolated CABG., Methods: The European DuraGraft registry included 1130 patients (44.6%) with and 1402 (55.4%) patients without DM undergoing isolated CABG. Intra-operatively, all free venous and arterial grafts were treated with an endothelial damage inhibitor. Primary end point in this analysis was the incidence of a major adverse cardiac event (MACE), a composite of all-cause death, repeat revascularization or myocardial infarction at 1 year post-CABG. To balance between differences in baseline characteristics (n = 1072 patients in each group), propensity score matching was used. Multivariable Cox proportional hazards regression was performed to identify independent predictors of MACE., Results: Diabetic patients had a higher cardiovascular risk profile and EuroSCORE II with overall more comorbidities. Patients were comparable in regard to surgical techniques and completeness of revascularization. At 1 year, diabetics had a higher MACE rate {7.9% vs 5.5%, hazard ratio (HR) 1.43 [95% confidence interval (CI) 1.05-1.95], P = 0.02}, driven by increased rates of death [5.6% vs 3.5%, HR 1.61 (95% CI 1.10-2.36), P = 0.01] and myocardial infarction [2.8% vs 1.4%, HR 1.99 (95% CI 1.12-3.53) P = 0.02]. Following propensity matching, no statistically significant difference was found for MACE [7.1% vs 5.7%, HR 1.23 (95% CI 0.87-1.74) P = 0.23] or its components. Age, critical operative state, extracardiac arteriopathy, ejection fraction ≤50% and left main disease but not DM were identified as independent predictors for MACE., Conclusions: In this study, 1-year outcomes in diabetics undergoing isolated CABG were comparable to patients without DM., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)
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- 2024
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149. Adult congenital heart disease training in Europe: current status, disparities and potential solutions.
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McMahon CJ, Voges I, Jenkins P, Brida M, van der Bosch AE, Dellborg M, Heying R, Stein JI, Georgiev B, Mesihovic-Dinarevic S, Prokšelj K, Oskarsson G, Frogoudaki A, Karagöz T, Jossif A, Doros G, Nielsen D, Jalanko M, Sanchez Perez I, Alvares S, Estensen ME, Petropoulos A, Tagen R, Gumbienė L, Michel-Behnke I, Olejnik P, Clift PF, Sendzikaite S, Albert-Brotons DC, Rhodes M, Pitkänen O, Bassareo PP, Gatzoulis MA, Walsh K, Milanesi O, Ladouceur M, Chessa M, and Budts W
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- Humans, Adult, Quality of Health Care, Europe epidemiology, Heart Defects, Congenital diagnosis, Heart Defects, Congenital epidemiology, Heart Defects, Congenital therapy, Cardiology education, Cardiologists
- Abstract
Objectives: This study aimed to determine the status of training of adult congenital heart disease (ACHD) cardiologists in Europe., Methods: A questionnaire was sent to ACHD cardiologists from 34 European countries., Results: Representatives from 31 of 34 countries (91%) responded. ACHD cardiology was recognised by the respective ministry of Health in two countries (7%) as a subspecialty. Two countries (7%) have formally recognised ACHD training programmes, 15 (48%) have informal (neither accredited nor certified) training and 14 (45%) have very limited or no programme. Twenty-five countries (81%) described training ACHD doctors 'on the job'. The median number of ACHD centres per country was 4 (range 0-28), median number of ACHD surgical centres was 3 (0-26) and the median number of ACHD training centres was 2 (range 0-28). An established exit examination in ACHD was conducted in only one country (3%) and formal certification provided by two countries (7%). ACHD cardiologist number versus gross domestic product Pearson correlation coefficient=0.789 (p<0.001)., Conclusion: Formal or accredited training in ACHD is rare among European countries. Many countries have very limited or no training and resort to 'train people on the job'. Few countries provide either an exit examination or certification. Efforts to harmonise training and establish standards in exit examination and certification may improve training and consequently promote the alignment of high-quality patient care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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150. Safety and Efficacy of Propylene Glycol-Free Melphalan in Patients with AL Amyloidosis Undergoing Autologous Stem Cell Transplantation: Results of a Phase II Study.
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Sarosiek S, Lee MH, Doros G, Edwards CV, Quillen K, Brauneis D, Shelton AC, Sanchorawala V, and Sloan JM
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- Humans, Melphalan adverse effects, Transplantation, Autologous, Arrhythmias, Cardiac complications, Arrhythmias, Cardiac drug therapy, Immunoglobulin Light-chain Amyloidosis therapy, Immunoglobulin Light-chain Amyloidosis drug therapy, Hematopoietic Stem Cell Transplantation methods, Amyloidosis therapy, Kidney Diseases complications, Kidney Diseases drug therapy
- Abstract
Patients with systemic light chain (AL) amyloidosis undergoing treatment with high-dose melphalan and autologous stem cell transplantation (HDM/SCT) may develop renal and cardiac toxicities potentially exacerbated by the co-solvent propylene glycol in conventional melphalan formulations. We investigated the safety and efficacy of propylene glycol-free melphalan (PGF-Mel) during HDM/SCT in patients with AL amyloidosis (ClinicalTrials.gov identifier NCT02994784). The primary objective of this phase II, open-label study was evaluation for renal dysfunction, new cardiac arrhythmias, and postural hypotension related to autonomic dysfunction. Secondary objectives included time to neutrophil and platelet engraftment, treatment-related mortality (TRM), overall hematologic response, organ response, and number of peritransplantation hospitalizations. Twenty-eight patients with AL amyloidosis enrolled, of whom 27 underwent HDM/SCT. PGF-Mel at 140 to 200 mg/m
2 was administered i.v. in 2 equally divided doses. Patients were monitored for up to 30 days after the last administration of PGF-Mel to assess for treatment-related toxicity. Patients were followed for 12 months from the time of treatment with HDM/SCT for evaluation of hematologic and organ responses. Kaplan-Meier analysis was used to estimate progression-free survival. Two patients (7%) developed renal dysfunction, 5 (19%) experienced new cardiac arrhythmias, and 3 (11%) developed orthostatic hypotension. All patients achieved neutrophil and platelet engraftment, at a median of 10 days and 17 days post-HDM/SCT, respectively. TRM on day +100 was 0%. Peritransplantation hospitalization was required for 23 patients (85%). The most common nonhematologic adverse events were diarrhea (93%), fatigue (82%), and nausea (74%). At 6 months post-HDM/SCT, hematologic complete response or very good partial response occurred in 66% of the patients. At 12 months post-HDM/SCT, renal response occurred in 12 of 23 (52%) patients with renal involvement, and cardiac response occurred in 3 of 11 (27%) patients with evaluable cardiac involvement. Our data indicate that PGF-Mel is safe and efficacious as a high-dose conditioning regimen for autologous SCT in patients with AL amyloidosis., (Copyright © 2023 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)- Published
- 2023
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