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1. Repairing Bilateral Coronary-Pulmonary Artery Fistulas During Coronary Artery Bypass Grafting

Author

Alexander L. Chen, DO, Alessandro Vivacqua, MD, Jeffrey M. Altshuler, MD, Francis L. Shannon, MD, Rajesh C. Gulati, MD, Thomas A. Schwann, MD, and Bogdan A. Kindzelski, MD, MS

Subjects
Surgery, RD1-811, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Coronary-pulmonary artery fistulas (CPAFs) are rare entities that can cause significant left-to-right shunting and complicate routine coronary artery bypass grafting. There are no best practice guidelines and a scarcity of reports regarding concomitant treatment of CPAF with coronary artery disease. We present a case of bilateral CPAFs in a 60-year-old man with symptomatic coronary artery disease treated successfully with coronary artery bypass, epicardial ligation, and transpulmonary closure of CPAF with patch reconstruction. This case highlights the importance of optimal myocardial protection and complete closure of the fistula to prevent risk of coronary steal.

Published
2024
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2. Effect of therapeutic-dose heparin on severe acute kidney injury and death in noncritically ill patients hospitalized for COVID-19: a prespecified secondary analysis of the ACTIV4a and ATTACC randomized trial.

Author

Smilowitz, Nathaniel, Hade, Erinn, Kornblith, Lucy, Castellucci, Lana, Cushman, Mary, Farkouh, Michael, Gong, Michelle, Heath, Anna, Hunt, Beverly, Kim, Keri, Kindzelski, Andrei, Lawler, Patrick, Leaf, David, Goligher, Ewan, Leifer, Eric, McVerry, Bryan, Reynolds, Harmony, Zarychanski, Ryan, Hochman, Judith, Neal, Matthew, and Berger, Jeffrey

Subjects
COVID-19, acute kidney injury, anticoagulants, death, heparin, kidney diseases, mortality
Abstract

BACKGROUND: Acute kidney injury (AKI) in patients with COVID-19 is partly mediated by thromboinflammation. In noncritically ill patients with COVID-19, therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support. OBJECTIVES: We investigated whether therapeutic-dose heparin reduces the incidence of AKI or death in noncritically ill patients hospitalized for COVID-19. METHODS: We report a prespecified secondary analysis of the ACTIV4a and ATTACC open-label, multiplatform randomized trial of therapeutic-dose heparin vs usual-care pharmacologic thromboprophylaxis on the incidence of severe AKI (≥2-fold increase in serum creatinine or initiation of kidney replacement therapy (KDIGO stage 2 or 3) or all-cause mortality in noncritically ill patients hospitalized for COVID-19. Bayesian statistical models were adjusted for age, sex, D-dimer, enrollment period, country, site, and platform. RESULTS: Among 1922 enrolled, 23 were excluded due to pre-existing end stage kidney disease and 205 were missing baseline or follow-up creatinine measurements. Severe AKI or death occurred in 4.4% participants assigned to therapeutic-dose heparin and 5.5% assigned to thromboprophylaxis (adjusted relative risk [aRR]: 0.72; 95% credible interval (CrI): 0.47, 1.10); the posterior probability of superiority for therapeutic-dose heparin (relative risk < 1.0) was 93.6%. Therapeutic-dose heparin was associated with a 97.7% probability of superiority to reduce the composite of stage 3 AKI or death (3.1% vs 4.6%; aRR: 0.64; 95% CrI: 0.40, 0.99) compared to thromboprophylaxis. CONCLUSION: Therapeutic-dose heparin was associated with a high probability of superiority to reduce the incidence of in-hospital severe AKI or death in patients hospitalized for COVID-19.

Published
2023

3. Effect of the P-Selectin Inhibitor Crizanlizumab on Survival Free of Organ Support in Patients Hospitalized for COVID-19: A Randomized Controlled Trial.

Author

Solomon, Scott, Lowenstein, Charles, Bhatt, Ankeet, Peikert, Alexander, Vardeny, Orly, Kosiborod, Mikhail, Berger, Jeffrey, Reynolds, Harmony, Mavromichalis, Stephanie, Barytol, Anya, Althouse, Andrew, Luther, James, Leifer, Eric, Kindzelski, Andrei, Cushman, Mary, Gong, Michelle, Khatri, Pooja, Kim, Keri, Baumann Kreuziger, Lisa, Wahid, Lana, Kirwan, Bridget-Anne, Geraci, Mark, Neal, Matthew, Hochman, Judith, and Kornblith, Lucy

Subjects
COVID-19, P-selectin, crizanlizumab, Humans, COVID-19, SARS-CoV-2, P-Selectin, Endothelial Cells, Treatment Outcome
Abstract

BACKGROUND: COVID-19 has been associated with endothelial injury, resultant microvascular inflammation and thrombosis. Activated endothelial cells release and express P-selectin and von Willebrand factor, both of which are elevated in severe COVID-19 and may be implicated in the disease pathophysiology. We hypothesized that crizanlizumab, a humanized monoclonal antibody to P-selectin, would reduce morbidity and death in patients hospitalized for COVID-19. METHODS: An international, adaptive, randomized controlled platform trial, funded by the National Heart, Lung, and Blood Institute, randomly assigned 422 patients hospitalized with COVID-19 with moderate or severe illness to receive either a single infusion of the P-selectin inhibitor crizanlizumab (at a dose of 5 mg/kg) plus standard of care or standard of care alone in an open-label 1:1 ratio. The primary outcome was organ support-free days, evaluated on an ordinal scale consisting of the number of days alive free of organ support through the first 21 days after trial entry. RESULTS: The study was stopped for futility by the data safety monitoring committee. Among 421 randomized patients with known 21-day outcomes, 163 patients (77%) randomized to the crizanlizumab plus standard-of-care arm did not require any respiratory or cardiovascular organ support compared with 169 (80%) in the standard-of-care-alone arm. The adjusted odds ratio for the effect of crizanlizumab on organ support-free days was 0.70 (95% CI, 0.43-1.16), where an odds ratio >1 indicates treatment benefit, yielding a posterior probability of futility (odds ratio 1] = 0.879). CONCLUSIONS: Crizanlizumab, a P-selectin inhibitor, did not result in improvement in organ support-free days in patients hospitalized with COVID-19. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04505774.

Published
2023

4. Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial

Author

Avancini Caramori, PR, Esteves Hernandes, M, Babudieri, S, Contoli, M, Fernando, M, Gonzalez Juanatey, JR, Ibañez Estellez, F, Mateos, E, Tidswell, M, Akala, O, Pursley, M, Jathavedam, A, Markley, J, Gelman, M, Ajani, Z, Mackay, F, Kunisaki, K, Martin, K, Exline, M, Huggins, J, Nicholson, L, Lim, G, Aboudara, M, Sherwin, R, Torbati, S, Wilson, J, Latorre, JG, Busch, J, Albertson, T, Matthay, M, Gandotra, S, Joseph, B, Hudock, K, Iovine, N, Quigley, J, Hyzy, R, Kutcher, M, Huang, D, Pandey, A, Sheehan, J, Solankhi, N, Rodriguez, W, Shah, B, Khanna, A, Bochicchio, G, McCarthy, M, Pan, S, Balasubraman, P, Kosiborod, Mikhail N, Windsor, Sheryl L, Vardeny, Orly, Berger, Jeffrey S, Reynolds, Harmony R, Boumakis, Stavroula, Althouse, Andrew D, Solomon, Scott D, Bhatt, Ankeet S, Peikert, Alexander, Luther, James F, Leifer, Eric S, Kindzelski, Andrei L, Cushman, Mary, Ng Gong, Michelle, Kornblith, Lucy Z, Khatri, Pooja, Kim, Keri S, Baumann Kreuziger, Lisa, Javaheri, Ali, Carpio, Carlos, Wahid, Lana, Lopez-Sendon Moreno, Jose, Alonso, Alvaro, Ho, Minh Quang, Lopez-Sendon, Jose, Lopes, Renato D, Curtis, Jeffrey L, Kirwan, Bridget-Anne, Geraci, Mark W, Neal, Matthew D, and Hochman, Judith S

Published
2024
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6. Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial

Author

Bledsoe, Joseph, Woller, Scott C., Brooks, Maria, Sciurba, Frank C., Krishnan, Jerry A., Martin, Deborah, Hou, Peter, Lin, Janet Y., Kindzelski, Andrei, Handberg, Eileen, Kirwan, Bridget-Anne, Zaharris, Elaine, Castro, Lauren, Shapiro, Nancy L., Pepine, Carl J., Majercik, Sarah, Fu, Zhuxuan, Zhong, Yongqi, Venugopal, Vidya, Lai, Yu-Hsuan, Ridker, Paul M., and Connors, Jean M.

Published
2023
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8. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, Kutcher, Matthew E, Laffan, Michael A, Lamontagne, Francois, and Le Gal, Grégoire

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Comparative Effectiveness Research, Cardiovascular, Good Health and Well Being, Aged, Anticoagulants, COVID-19, Critical Illness, Female, Hemorrhage, Heparin, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Respiration, Artificial, Thrombosis, Treatment Failure, COVID-19 Drug Treatment, REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.MethodsIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.ResultsThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

9. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Krishnan, Vidya

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Hematology, Transplantation, Good Health and Well Being, Adult, Aged, Anticoagulants, COVID-19, Female, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Hospital Mortality, Humans, Male, Middle Aged, Survival Analysis, Thrombosis, COVID-19 Drug Treatment, ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

10. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.

Author

REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Kutcher, Matthew E

Subjects
REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Humans, Thrombosis, Critical Illness, Hemorrhage, Heparin, Anticoagulants, Treatment Failure, Respiration, Artificial, Hospital Mortality, Logistic Models, Odds Ratio, Aged, Middle Aged, Female, Male, COVID-19, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.MethodsIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.ResultsThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

11. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.

Author

ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, and King, Andrew J

Subjects
ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Humans, Thrombosis, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Anticoagulants, Hospital Mortality, Survival Analysis, Adult, Aged, Middle Aged, Female, Male, COVID-19, Hematology, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Cardiovascular, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

12. Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial

Author

Joseph Bledsoe, Scott C. Woller, Maria Brooks, Frank C. Sciurba, Jerry A. Krishnan, Deborah Martin, Peter Hou, Janet Y. Lin, Andrei Kindzelski, Eileen Handberg, Bridget-Anne Kirwan, Elaine Zaharris, Lauren Castro, Nancy L. Shapiro, Carl J. Pepine, Sarah Majercik, Zhuxuan Fu, Yongqi Zhong, Vidya Venugopal, Yu-Hsuan Lai, Paul M. Ridker, and Jean M. Connors

Subjects
SARS-CoV-2, COVID-19, Pulmonary embolism, PE, Venous thromboembolic disease, VTE, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary analysis of the ACTIV-4B Outpatient Thrombosis Prevention trial. Methods A secondary analysis of the ACTIV-4B trial that was conducted at 52 US sites between September 2020 and August 2021. Participants were enrolled through acute unscheduled episodic care (AUEC) enrollment location (emergency department, or urgent care clinic visit) compared to minimal contact (MC) enrollment (electronic contact from test center lists of positive patients).We report the primary composite outcome of cardiopulmonary hospitalizations, symptomatic venous thromboembolism, myocardial infarction, stroke, transient ischemic attack, systemic arterial thromboembolism, or death among stable outpatients stratified by enrollment setting, AUEC versus MC. A propensity score for AUEC enrollment was created, and Cox proportional hazards regression with inverse probability weighting (IPW) was used to compare the primary outcome by enrollment location. Results Among the 657 ACTIV-4B patients randomized, 533 (81.1%) with known enrollment setting data were included in this analysis, 227 from AUEC settings and 306 from MC settings. In a multivariate logistic regression model, time from COVID test, age, Black race, Hispanic ethnicity, and body mass index were associated with AUEC enrollment. Irrespective of trial treatment allocation, patients enrolled at an AUEC setting were 10-times more likely to suffer from the adjudicated primary outcome, 7.9% vs. 0.7%; p

Published
2023
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13. Modern practice and outcomes of reoperative cardiac surgery

Author

McCurry, Kenneth R., Smedira, Nicholas G., Unai, Shinya, Najm, Hani, Kawalet, Mariana, Ravichandren, Kirthi, Saleh, Osama Abou, Zaki, Anthony, Hodges, Kevin, Kindzelski, Bogdan A., Bakaeen, Faisal G., Tong, Michael Z., Roselli, Eric E., Soltesz, Edward G., Johnston, Douglas R., Wierup, Per, Pettersson, Gösta B., Houghtaling, Penny L., Blackstone, Eugene H., Gillinov, A. Marc, and Svensson, Lars G.

Published
2022
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17. Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial

Author

Kosiborod, Mikhail N, Windsor, Sheryl L, Vardeny, Orly, Berger, Jeffrey S, Reynolds, Harmony R, Boumakis, Stavroula, Althouse, Andrew D, Solomon, Scott D, Bhatt, Ankeet S, Peikert, Alexander, Luther, James F, Leifer, Eric S, Kindzelski, Andrei L, Cushman, Mary, Ng Gong, Michelle, Kornblith, Lucy Z, Khatri, Pooja, Kim, Keri S, Baumann Kreuziger, Lisa, Javaheri, Ali, Carpio, Carlos, Wahid, Lana, Lopez-Sendon Moreno, Jose, Alonso, Alvaro, Ho, Minh Quang, Lopez-Sendon, Jose, Lopes, Renato D, Curtis, Jeffrey L, Kirwan, Bridget-Anne, Geraci, Mark W, Neal, Matthew D, Hochman, Judith S, Avancini Caramori, PR, Esteves Hernandes, M, Babudieri, S, Contoli, M, Fernando, M, Gonzalez Juanatey, JR, Ibañez Estellez, F, Mateos, E, Tidswell, M, Akala, O, Pursley, M, Jathavedam, A, Markley, J, Gelman, M, Ajani, Z, Mackay, F, Kunisaki, K, Martin, K, Exline, M, Huggins, J, Nicholson, L, Lim, G, Aboudara, M, Sherwin, R, Torbati, S, Wilson, J, Latorre, JG, Busch, J, Albertson, T, Matthay, M, Gandotra, S, Joseph, B, Hudock, K, Iovine, N, Quigley, J, Hyzy, R, Kutcher, M, Huang, D, Pandey, A, Sheehan, J, Solankhi, N, Huang, D, Rodriguez, W, Shah, B, Khanna, A, Bochicchio, G, McCarthy, M, Pan, S, and Balasubraman, P

Abstract

Patients hospitalised for COVID-19 are at risk for multiorgan failure and death. Sodium–glucose co-transporter-2 (SGLT2) inhibitors provide cardiovascular and kidney protection in patients with cardiometabolic conditions and could provide organ protection during COVID-19. We aimed to investigate whether SGLT2 inhibitors can reduce the need for organ support in patients hospitalised for COVID-19.

Published
2024
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18. Abstract 14850: Effect of Therapeutic-Dose Heparin on Acute Kidney Injury in Non-Critically Ill Hospitalized Patients With Covid-19: The Activ4a and Attac Randomized Trial

Author

Smilowitz, Nathaniel, Hade, Erinn, Kornblith, Lucy, Castellucci, Lana, Cushman, Mary, Farkouh, Michael E, Hunt, Beverly, Kim, Keri, Kindzelski, Andrei, Lawler, Patrick R, Leifer, Eric, McVerry, Bryan J, Reynolds, Harmony, Hochman, Judith, Hochman, Judith S, Neal, Matthew D, and Berger, Jeffrey S

Published
2022
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19. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

Author

Sichlau, Michael, Vlahos, Athanasios, Smith, Steven, Thalheimer, Quinn, Singh, Nisha, Harting, Rekha, Gocke, John, Guth, Scott, Shah, Neel, Brady, Paul, Schatz, Marvin, Horrow, Mindy, Markazi, Peyman, Forouzan, Leli, Matalon, Terence A.S., Hertzog, David, Goday, Swapna, Kennedy, Margaret, Kaplan, Robert, Campbell, Thomas, Hartman, Jamie, Nahum, Elmer, Venkat, Arvind, Krishnamurthy, Venkataramu, Rectenwald, John, Henke, Peter, Eliason, Jonathan, Willatt, Jonathon, Escobar, Guillermo, Samuels, Shaun, Katzen, Barry, Benenati, James, Powell, Alex, Pena, Constantino, Wallach, Howard, Gandhi, Ripal, Schneider, Joseph, Kim, Stanley, Hashemi, Farrah, Boyle, Joseph, Patel, Nilesh, Verta, Michael, Leung, Daniel, Garcia, Marc, Blatt, Phillip, Khatri, Jamil, Epstein, Dave, Ryan, Randall, Sweeny, Tom, Stillabower, Michael, Kimbiris, George, Raman, Tuhina, Sierzenski, Paul, Getto, Lelia, Dignazio, Michael, Horvath, Mark, Gornik, Heather, Bartholomew, John, Shishehbor, Mehdi, Peacock, Frank, Joseph, Douglas, Kim, Soo Hyum, Mahlay, Natalia Fendrikova, Clair, Daniel, Lyden, Sean, Kapoor, Baljendra, McLennon, Gordon, Pierce, Gregory, Newman, James, Spain, James, Gill, Amanjiit, Hamilton, Aaron, Rizzo, Anthony, Park, Woosup, Dietzek, Alan, Galin, Ira, Plummer, Dahlia, Hsu, Richard, Broderick, Patrick, Keller, Andrew, Sayeed, Sameer, Slater, Dennis, Lustberg, Herb, Akus, Jan, Sidman, Robert, Dhami, Mandeep, Kohanski, Phillip, Bulgaru, Anca, Dulala, Renuka, Burch, James, Kapur, Dinesh, Yang, Jie, Ranson, Mark, Wladis, Alan, Varnagy, David, Mekhail, Tarek, Winter, Robert, Perez-Izquierdo, Manuel, Motew, Stephen, Royd-Kranis, Robin, Workman, Raymond, Kribbs, Scott, Hogsette, Gerald, Moore, Phillip, Thomason, Bradley, Means, William, Bonsall, Richard, Stewart, John, Golwya, Daniel, Azene, Ezana, Bottner, Wayne, Bishop, William, Clayton, Dave, Gundersen, Lincoln, Riherd, Jody, Shakhnovich, Irina, Ziegelbein, Kurt, Chang, Thomas, Sharma, Karun, Allison, Sandra, Banovac, Fil, Cohen, Emil, Furlong, Brendan, Kessler, Craig, McCullough, Mike, Spies, Jim, Lin, Judith, Kaatz, Scott, Getzen, Todd, Miller, Joseph, Schwartz, Scott, Kabbani, Loay, McVinnie, David, Rundback, John, Manno, Joseph, Schwab, Richard, Cole, Randolph, Herman, Kevin, Singh, David, Barkama, Ravit, Patel, Amish, Comerota, Anthony, Pigott, John, Seiwert, Andrew, Whalen, Ralph, Russell, Todd, Assi, Zakaria, Kazanjian, Sahira, Yobbagy, Jonathan, Kaminski, Brian, Kaufman, Allan, Begeman, Garett, DiSalle, Robert, Thakur, Subash, Kim, Paul, Jacquet, Marc, Dykes, Thomas, Gerding, Joseph, Baker, Christopher, Debiasto, Mark, Mittleider, Derek, Higgins, George, III, Amberson, Steven, Pezzuti, Roger, Gallagher, Thomas, Schainfeld, Robert, Wicky, Stephan, Kalva, Sanjeeva, Walker, Gregory, Salazar, Gloria, Pomerantz, Benjamin, Patel, Virenda, Kabrhel, Christopher, Iqbal, Shams, Gangull, Suvranu, Oklu, Rahmi, Brannan, Scott, Misra, Sanjay, Bjarnason, Haraldur, Ashrani, Aneel, Caccavale, Michael, Fleming, Chad, Friese, Jeremy, Heit, John, Kalra, Manju, Macedo, Thanila, McBane, Robert, McKusick, Michael, Stockland, Andrew, Woodrum, David, Wysokinski, Waldemar, Verma, Adarsh, Davis, Andrew, Chung, Jerry, Nicker, David, Anderson, Brian, Stein, Robert, Weiss, Michael, Patel, Parag, Rilling, William, Tutton, Sean, Hieb, Robert, Hohenwalter, Eric, Colella, M. Riccardo, Gosset, James, White, Sarah, Lewis, Brian, Brown, Kellie, Rossi, Peter, Seabrook, Gary, Guimaraes, Marcelo, Selby, J. Bayne, McGary, William, Hannegan, Christopher, Robison, Jacob, Brothers, Thomas, Elliott, Bruce, Garg, Nitin, Anderson, M. Bret, Uflacker, Renan, Schonholz, Claudio, Raney, Laurence, Greenberg, Charles, Kaufman, John, Keller, Frederick, Kolbeck, Kenneth, Landry, Gregory, Mitchell, Erica, Barton, Robert, DeLoughery, Thomas, Kalbfleisch, Norman, Minjarez, Renee, Lakin, Paul, Liem, Timothy, Moneta, Gregory, Farsad, Khashayar, Fleischman, Ross, French, Loren, Marques, Vasco, Al−Hassani, Yasir, Sawar, Asad, Taylor, Frank, Patel, Rajul, Malhotra, Rahul, Hashemi, Farah, Padnick, Marvin, Gurley, Melissa, Cucher, Fred, Sterrenberg, Ronald, Deepthi, G. Reshmaal, Cumaranatunge, Gomes, Bhatla, Sumit, Jacobs, Darick, Dolen, Eric, Gamboa, Pablo, Dean, L. Mark, Davis, Thomas, Lippert, John, Khanna, Sanjeev, Schirf, Brian, Silber, Jeffrey, Wood, Donald, McGraw, J. Kevin, LaPerna, Lucy, Willette, Paul, Murphy, Timothy, Cerezo, Joselyn, Dhangana, Rajoo, Ahn, Sun Ho, Dubel, Gregory, Haas, Richard, Jay, Bryan, Prince, Ethan, Soares, Gregory, Klinger, James, Lambiase, Robert, Jay, Gregory, Tubbs, Robert, Beland, Michael, Hampson, Chris, O'Hara, Ryan, Thompson, Chad, Frodsham, Aaron, Gardiner, Fenwick, Jaffan, Abdel, Keating, Lawrence, Zafar, Abdul, Alicic, Radica, Raabe, Rodney, Brower, Jayson, McClellan, David, Pellow, Thomas, Zylak, Christopher, Davis, Joseph, Reilly, M. Kathleen, Symington, Kenneth, Seibold, Camerson, Nachreiner, Ryan, Murray, Daniel, Murray, Stephen, Saha, Sandeep, Luna, Gregory, Hodgson, Kim, McLafferty, Robert, Hood, Douglas, Moore, Colleen, Griffen, David, Hurst, Darren, Lubbers, David, Kim, Daniel, Warren, Brent, Engel, Jeremy, Suresh, D.P., VanderWoude, Eric, Razdan, Rahul, Hutchins, Mark, Rounsborg, Terry, Midathada, Madhu, Moravec, Daniel, Tilford, Joni, Beckman, Joni, Razavi, Mahmood, Openshaw, Kurt, Flanigan, D. Preston, Loh, Christopher, Dorne, Howard, Chan, Michael, Thomas, Jamie, Psaila, Justin, Ringold, Michael, Fisher, Jay, Lipcomb, Any, Oskin, Timothy, Wible, Brandt, Coleman, Brendan, Elliott, David, Gaddis, Gary, Cochran, C. Doug, Natarajan, Kannan, Bick, Stewart, Cooke, Jeffrey, Hedderman, Ann, Greist, Anne, Miller, Lorrie, Martinez, Brandon, Flanders, Vincent, Underhill, Mark, Hofmann, Lawrence, Sze, Daniel, Kuo, William, Louie, John, Hwang, Gloria, Hovsepian, David, Kothary, Nishita, Berube, Caroline, Schreiber, Donald, Jeffrey, Brooke, Schor, Jonathan, Deitch, Jonathan, Singh, Kuldeep, Hahn, Barry, Ardolic, Brahim, Gupta, Shilip, Bashir, Riyaz, Rao, Angara Koneti, Garg, Manish, Patil, Pravin, Zack, Chad, Cohen, Gary, Schmieder, Frank, Lakhter, Valdimir, Sacks, David, Guay, Robert, Scott, Mark, Cunningham, Karekin, Sigal, Adam, Cescon, Terrence, Leasure, Nick, Dhurairaj, Thiruvenkatasamy, Muck, Patrick, Knochel, Kurt, Lohr, Joann, Barreau, Jose, Recht, Matthew, Bhaskaran, Jayapandia, Brahmamdam, Ranga, Draper, David, Mehta, Apurva, Maher, James, Sharafuddin, Melhem, Lentz, Steven, Nugent, Andrew, Sharp, William, Kresowik, Timothy, Nicholson, Rachel, Sun, Shiliang, Youness, Fadi, Pascarella, Luigi, Ray, Charles, Knuttinen, Martha-Gracia, Bui, James, Gaba, Ron, Dobiesz, Valerie, Shamim, Ejaz, Nimmagadda, Sangeetha, Peace, David, Zain, Aarti, Palumto, Alison, Haskal, Ziv, Hirshon, Jon Mark, Richard, Howard, Verceles, Avelino, Wong-You-Chong, Jade, Othee, Bertrand, Patel, Rahul, Iliescu, Bogdan, Williams, David, Gemmete, Joseph, Cwikiel, Wojciech, Cho, Kyung, Schields, James, Vellody, Ranjith, Novelli, Paula, Dasika, Narasimham, Wakefield, Thomas, Desmond, Jeffrey, Froehlich, James, Khaja, Minhajuddin, Hunter, David, Golzarian, Jafar, Cressman, Erik, Dotta, Yvonne, Schmiechen, Nate, Marek, John, Garcia, David, Tawil, Isaac, Langsfeld, Mark, Moll, Stephan, Mauro, Matthew, Stavas, Joseph, Burke, Charles, Dixon, Robert, Yu, Hyeon, Keagy, Blair, Kim, Kyuny, Kasthuri, Raj, Key, Nigel, Chaer, Rabih, Makaroun, Michael, Rhee, Robert, Cho, Jae−Sung, Baril, Donald, Marone, Luke, Hseih, Margaret, Feterik, Kristian, Smith, Roy, Jeyabalan, Geetha, Rogers, Jennifer, Vinik, Russel, Kinikini, Dan, Kraiss, Larry, Mueller, Michelle, Pendleton, Robert, Rondina, Matthew, Sarfati, Mark, Wanner, Nathan, Johnson, Stacy, Hopkins, Christy, Ihnat, Daniel, Angle, John, Matsumoto, Alan, Harthun, Nancy, Turba, Ulku, Saad, Wael, Uthlaut, Brian, Nannapaneni, Srikant, Ling, David, Sabri, Saher, Kern, John, Macik, B. Gail, Hoke, George, Park, Auh Wahn, Stone, James, Sneed, Benjamin, Syverud, Scott, Davidson, Kelly, Sharma, Aditya, Wilkins, Luke, Black, Carl, Asay, Mark, Hatch, Daniel, Smilanich, Robert, Patten, Craig, Brown, S. Douglas, Nielsen, Ryan, Alward, William, Collins, John, Nokes, Matthew, Geary, Randolph, Edwards, Matthew, Godshall, Christopher, Levy, Pavel, Winokur, Ronald, Sista, Akhilesh, Madoff, David, Lee, Kyungmouk, Pua, Bradley, DeSancho, Maria, Milizia, Raffaele, Gao, Jing, McLean, Gordon, Khalid, Sanualah, Vedantham, Suresh, Lewis, Larry, Saad, Nael, Thoelke, Mark, Pallow, Robert, Klein, Seth, Sicard, Gregorio, Cohen, David J., Comerota, Anthony J., Gornik, Heather L., Jaff, Michael R., Julian, Jim, Kahn, Susan R., Kearon, Clive, Kee, Stephen, Kindzelski, Andrei L., Lewis, Lawrence, Magnuson, Elizabeth, Razavi, Mahmood K., Murphy, Timothy P., Julian, Jim A., Gu, Chu-Shu, Magnuson, Elizabeth A., Goldhaber, Samuel Z., Schneider, Joseph R., Sista, Akhilesh K., McLafferty, Robert B., Kaufman, John A., Wible, Brandt C., and Blinder, Morey

Published
2020
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21. LB 01.5 Effect of the P-selectin Inhibitor Crizanlizumab on Survival Free of Organ Support in Patients Hospitalized for COVID-19: A Randomized Controlled Trial

Author

Lowenstein, C., primary, Solomon, S., additional, Bhatt, A., additional, Peikert, A., additional, Vardeny, O., additional, Kosiborod, M., additional, Berger, J., additional, Reynolds, H., additional, Althouse, A., additional, Leifer, E., additional, Kindzelski, A., additional, Cushman, M., additional, Gong, M., additional, Kornblith, L., additional, Kim, K., additional, Baumann Kreuziger, L., additional, Kirwan, B., additional, Geraci, M., additional, Neal, M., additional, and Hochman, J., additional

Published
2023
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22. TCT-59 Surgical Aortic Valve Deterioration: Time to Redo-SAVR in Trifecta Versus Non-Trifecta Valves

Author

Madanat, Luai, primary, Kheyrbek, Mazhed, additional, Chandra, Rohit, additional, Niroula, Shailesh, additional, Dixon, Simon, additional, Hanson, Ivan, additional, Bloomingdale, Richard, additional, Renard, Brian, additional, Cami, Elvis, additional, Altshuler, Jeffrey, additional, Vivacqua, Alessandro, additional, Kindzelski, Bogdan, additional, Fazzalari, Franco, additional, and Abbas, Amr, additional

Published
2023
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24. NIH workshop report on the trans-agency blood–brain interface workshop 2016: exploring key challenges and opportunities associated with the blood, brain and their interface

Author

Margaret J. Ochocinska, Berislav V. Zlokovic, Peter C. Searson, A. Tamara Crowder, Richard P. Kraig, Julia Y. Ljubimova, Todd G. Mainprize, William A. Banks, Ronald Q. Warren, Andrei Kindzelski, William Timmer, and Christina H. Liu

Subjects
Blood–brain barrier, Extracellular vesicles, Exosomes, Cancer, Neurodegeneration, Traumatic brain injury, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract A trans-agency workshop on the blood–brain interface (BBI), sponsored by the National Heart, Lung and Blood Institute, the National Cancer Institute and the Combat Casualty Care Research Program at the Department of Defense, was conducted in Bethesda MD on June 7–8, 2016. The workshop was structured into four sessions: (1) blood sciences; (2) exosome therapeutics; (3) next generation in vitro blood–brain barrier (BBB) models; and (4) BBB delivery and targeting. The first day of the workshop focused on the physiology of the blood and neuro-vascular unit, blood or biofluid-based molecular markers, extracellular vesicles associated with brain injury, and how these entities can be employed to better evaluate injury states and/or deliver therapeutics. The second day of the workshop focused on technical advances in in vitro models, BBB manipulations and nanoparticle-based drug carrier designs, with the goal of improving drug delivery to the central nervous system. The presentations and discussions underscored the role of the BBI in brain injury, as well as the role of the BBB as both a limiting factor and a potential conduit for drug delivery to the brain. At the conclusion of the meeting, the participants discussed challenges and opportunities confronting BBI translational researchers. In particular, the participants recommended using BBI translational research to stimulate advances in diagnostics, as well as targeted delivery approaches for detection and therapy of both brain injury and disease.

Published
2017
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25. Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial

Author

Magnuson, Elizabeth A., Chinnakondepalli, Khaja, Vilain, Katherine, Kearon, Clive, Julian, Jim A., Kahn, Susan R., Goldhaber, Samuel Z., Jaff, Michael R., Kindzelski, Andrei L., Herman, Kevin, Brady, Paul S., Sharma, Karun, Black, Carl M., Vedantham, Suresh, and Cohen, David J.

Published
2019
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26. TACTIC: Trans‐Agency Consortium for Trauma‐Induced Coagulopathy

Author

Mann, K.G., Freeman, K., Mann, Kenneth G., Esmon, Charles T., Wisnewski, Stephen, Tracy, Russell P., Kindzelski, Andrei L., Pusateri, Anthony, Banerjee, Anirban, Brass, Lawrence F., Brummel‐Ziedins, Kathleen E., Butenas, Saulius, Cohen, Mitchell J., Diamond, Scott L., Freeman, Kalev, Moore, Ernest E., Morrissey, James H., Nelson, Mark T., Park, Myung S., Ruf, Wolfram, Shupp, Jeffrey W., Sperry, Jason L., Spiess, Bruce D., Stalker, Timothy J., and Zuckerbraun, Brian S.

Published
2015
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28. Modern practice and outcomes of reoperative cardiac surgery

Author

Kindzelski, Bogdan A., primary, Bakaeen, Faisal G., additional, Tong, Michael Z., additional, Roselli, Eric E., additional, Soltesz, Edward G., additional, Johnston, Douglas R., additional, Wierup, Per, additional, Pettersson, Gösta B., additional, Houghtaling, Penny L., additional, Blackstone, Eugene H., additional, Gillinov, A. Marc, additional, Svensson, Lars G., additional, McCurry, Kenneth R., additional, Smedira, Nicholas G., additional, Unai, Shinya, additional, Najm, Hani, additional, Kawalet, Mariana, additional, Ravichandren, Kirthi, additional, Saleh, Osama Abou, additional, Zaki, Anthony, additional, and Hodges, Kevin, additional

Published
2022
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31. Heterogeneous treatment effects of therapeutic-dose heparin in patients hospitalized for COVID-19

Author

Goligher, EC, Lawler, PR, Jensen, TP, Talisa, V, Berry, LR, Lorenzi, E, McVerry, BJ, Chang, C-CH, Leifer, E, Bradbury, C, Berger, J, Hunt, BJ, Castellucci, LA, Kornblith, LZ, Gordon, AC, McArthur, C, Webb, S, Hochman, J, Neal, MD, Zarychanski, R, Berry, S, Angus, DC, Aday, A, Ahuja, T, Al-Beidh, F, Annane, D, Arabi, YM, Aryal, D, Baumann Kreuziger, L, Beane, A, Berger, JS, Berry, SM, Bhimani, Z, Bihari, S, Billett, HH, Bond, L, Bonten, M, Bradbury, CA, Brooks, MM, Brunkhorst, F, Buxton, M, Buzgau, A, Carrier, M, Castelucci, LA, Chekuri, S, Chen, J-T, Cheng, AC, Chkhikvadze, T, Coiffard, B, Contreras, A, Costantini, TW, Cushman, M, De Brouwer, S, Derde, LPG, Detry, MA, Duggal, A, Džavík, V, Effron, MB, Eng, HF, Escobedo, J, Estcourt, LJ, Everett, BM, Farkough, ME, Fergusson, DA, Fitzgerald, M, Fowler, RA, Froess, JD, Fu, Z, Galanaud, J-P, Galen, BT, Gandotra, S, Girard, TD, Godoy, LD, Gong, MN, Goodman, AL, Goossens, H, Green, C, Greenstein, YY, Gross, PL, Guerrero, RM, Hamburg, N, Haniffa, R, Hanna, G, Hanna, N, Hedge, SM, Hendrickson, CM, Higgins, AM, Hindenburg, AA, Hite, RD, Hochman, JS, Hope, AA, Horowitz, JM, Horvat, CM, Houston, BL, Huang, DT, Hudock, K, Husain, M, Hyzy, RC, Iyer, V, Jacobson, JR, Jayakumar, D, Kahn, SR, Keller, NM, Khan, A, Kim, Y, Kim, KS, Kindzelski, A, King, AJ, Kirwan, B-A, Knudson, MM, Kornblith, AE, Krishnan, V, Kumar, A, Kutcher, ME, Laffan, MA, Lamontagne, F, Le Gal, G, Leeper, CM, Leifer, ES, Lewis, RJ, Lim, G, Lima, FG, Linstrum, K, Litton, E, Lopez-Sendon, J, Lopez-Sendon Moreno, JL, Lother, SA, Madrona, SG, Malhotra, S, Marcos Martin, M, Marshall, JC, Marten, N, Martinez, AS, Martinez, M, Mateos Garcia, E, Matthay, MA, Mavromichalis, S, McArthur, CJ, McAuley, DF, McDonald, EG, McGlothlin, A, McGuinness, SP, McQuilten, ZK, Middeldorp, S, Montgomery, SK, Moore, SC, Mouncey, PR, Murthy, S, Nair, GB, Nair, R, Nichol, AD, Nicolau, JC, Nunez-Garcia, B, Pandey, A, Park, JJ, Park, PK, Parke, RL, Parker, JC, Parnia, S, Paul, JD, Pompilio, M, Prekker, M, Quigley, JG, Reynolds, HR, Rosenson, RS, Rost, NS, Rowan, K, Santos, MO, Santos, FO, Santos, M, Satterwhite, L, Saunders, CT, Schreiber, J, Schutgens, REG, Seymour, CW, Shankar Hari, M, Sheehan, JP, Siegal, DM, Silva Jr., DG, Singhal, AB, Slutsky, AS, Solvason, D, Stanworth, SJ, Tritschler, T, Turgeon, AF, Turner, AM, Van Bentum-Puijk, W, Van de Veerdonk, FL, Van Diepen, S, Vazquez Grande, G, Wahid, L, Wareham, V, Webb, SA, Wells, B, Widmer, RJ, Wilson, JG, Yuriditsky, E, Zampieri, F, and Zhong, Y

Abstract

Importance Randomized clinical trials (RCTs) of therapeutic-dose heparin in patients hospitalized with COVID-19 produced conflicting results, possibly due to heterogeneity of treatment effect (HTE) across individuals. Better understanding of HTE could facilitate individualized clinical decision-making. Objective To evaluate HTE of therapeutic-dose heparin for patients hospitalized for COVID-19 and to compare approaches to assessing HTE. Design, Setting, and Participants Exploratory analysis of a multiplatform adaptive RCT of therapeutic-dose heparin vs usual care pharmacologic thromboprophylaxis in 3320 patients hospitalized for COVID-19 enrolled in North America, South America, Europe, Asia, and Australia between April 2020 and January 2021. Heterogeneity of treatment effect was assessed 3 ways: using (1) conventional subgroup analyses of baseline characteristics, (2) a multivariable outcome prediction model (risk-based approach), and (3) a multivariable causal forest model (effect-based approach). Analyses primarily used bayesian statistics, consistent with the original trial. Exposures Participants were randomized to therapeutic-dose heparin or usual care pharmacologic thromboprophylaxis. Main Outcomes and Measures Organ support–free days, assigning a value of −1 to those who died in the hospital and the number of days free of cardiovascular or respiratory organ support up to day 21 for those who survived to hospital discharge; and hospital survival. Results Baseline demographic characteristics were similar between patients randomized to therapeutic-dose heparin or usual care (median age, 60 years; 38% female; 32% known non-White race; 45% Hispanic). In the overall multiplatform RCT population, therapeutic-dose heparin was not associated with an increase in organ support–free days (median value for the posterior distribution of the OR, 1.05; 95% credible interval, 0.91-1.22). In conventional subgroup analyses, the effect of therapeutic-dose heparin on organ support–free days differed between patients requiring organ support at baseline or not (median OR, 0.85 vs 1.30; posterior probability of difference in OR, 99.8%), between females and males (median OR, 0.87 vs 1.16; posterior probability of difference in OR, 96.4%), and between patients with lower body mass index (BMI 90% for all comparisons). In risk-based analysis, patients at lowest risk of poor outcome had the highest propensity for benefit from heparin (lowest risk decile: posterior probability of OR >1, 92%) while those at highest risk were most likely to be harmed (highest risk decile: posterior probability of OR

Published
2023

32. Evolution of Alternative-access Transcatheter Aortic Valve Replacement

Author

Samir R. Kapadia, Eugene H. Blackstone, James Yun, Kevin Hodges, Bogdan A. Kindzelski, Tamer Attia, Ashley M. Lowry, Zoran B. Popović, Shinya Unai, Stephanie Mick, Shirin Siddiqi, Lars G. Svensson, and Amar Krishnaswamy

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Transcatheter aortic, business.industry, medicine.medical_treatment, Preoperative risk, MEDLINE, Surgery, Text mining, Valve replacement, medicine, Cardiology and Cardiovascular Medicine, business, Transaxillary approach
Abstract

Background Transfemoral access is the most common approach for transcatheter aortic valve replacement (TAVR). However, a subset of patients require alternative access. This study describes the evolution and outcomes of alternative-access TAVR at Cleveland Clinic. Methods From January 2006 to January 2019, 2446 patients underwent TAVR, 414 (17%) through alternative access (247 transapical, 95 transaortic, 56 transaxillary, 2 transcarotid, 10 transiliac, 4 transcaval). Patients undergoing alternative-access TAVR had high preoperative risk. Propensity-matched comparisons were targeted at comparing transfemoral versus transaxillary approaches since 2012. Results Over time, the favored alternative-access approach shifted from transapical and transaortic to transaxillary. Pacemaker requirement was similar for alternative-access and transfemoral approaches. Compared with transfemoral access, major vascular injuries were higher in the alternative-access group (12 [2.9%] vs 27 [1.3%], P = .02), but minor vascular injuries were lower (13 [3.1%] vs 198 [9.8%], P Conclusions The transaxillary approach has emerged as our preferred alternative-access strategy for TAVR. It is associated with superior operative outcomes compared with transthoracic approaches, and results are comparable with those of the transfemoral approach.

Published
2021

34. Transmyocardial revascularization devices: technology update

Author

Kindzelski BA, Zhou Y, and Horvath KA

Subjects
Medical technology, R855-855.5
Abstract

Bogdan A Kindzelski, Yifu Zhou, Keith A Horvath Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA Abstract: Transmyocardial laser revascularization (TMR) emerged as treatment modality for patients with diffuse coronary artery disease not amendable to percutaneous or surgical revascularization. The procedure entails the creation of laser channels within ischemic myocardium in an effort to better perfuse these areas. Currently, two laser devices are approved by the US Food and Drug Administration for TMR – holmium:yttrium–aluminum–garnet and CO2. The two devices differ in regard to energy outputs, wavelengths, ability to synchronize with the heart cycle, and laser–tissue interactions. These differences have led to studies showing different efficacies between the two laser devices. Over 50,000 procedures have been performed worldwide using TMR. Improvements in angina stages, quality of life, and perfusion of the myocardium have been demonstrated with TMR. Although several mechanisms for these improvements have been suggested, evidence points to new blood vessel formation, or angiogenesis, within the treated myocardium, as the major contributory factor. TMR has been used as sole therapy and in combination with coronary artery bypass grafting. Clinical studies have demonstrated that TMR is both safe and effective in angina relief long term. The objective of this review is to present the two approved laser devices and evidence for the safety and efficacy of TMR, along with future directions with this technology. Keywords: laser, revascularization, angiogenesis, coronary artery disease

Published
2014

38. Recommended primary outcomes for clinical trials evaluating hemostatic blood products and agents in patients with bleeding: Proceedings of a National Heart Lung and Blood Institute and US Department of Defense Consensus Conference

Author

Joshua N. Goldstein, Andrew P. Cap, Alfonso Iorio, Nahed El Kassar, Roger J. Lewis, Andrei L. Kindzelski, Alan N. Barkun, Stephan A. Mayer, Philip C. Spinella, Jerrold H. Levy, Nigel S. Key, Dennis M. Jensen, Simon J. Stanworth, Marie E. Steiner, Terry Gernsheimer, Christopher S. Almond, John B. Holcomb, and Ernest E. Moore

Subjects
Severe bleeding, medicine.medical_specialty, Endpoint Determination, Blood Loss, Surgical, MEDLINE, Hemorrhage, Hemophilia A, Critical Care and Intensive Care Medicine, Article, Hemostatics, Humans, Medicine, In patient, Cardiac Surgical Procedures, Intensive care medicine, Randomized Controlled Trials as Topic, Hemostatic Agent, Adult patients, business.industry, Consensus conference, Clinical trial, Clinical Practice, Treatment Outcome, Wounds and Injuries, Surgery, Gastrointestinal Hemorrhage, business, Intracranial Hemorrhages
Abstract

High-quality evidence guiding optimal transfusion and other supportive therapies to reduce bleeding is needed to improve outcomes for patients with either severe bleeding or hemostatic disorders that are associated with poor outcomes. Alongside challenges in performing high-quality clinical trials in patient populations who are at risk of bleeding or who are actively bleeding, the interpretation of research evaluating hemostatic agents has been limited by inconsistency in the choice of primary trial outcomes. This lack of standardization of primary endpoints or outcomes decreases the ability of clinicians to assess the validity of endpoints and compare research results across studies, impairs meta-analytic efforts, and, ultimately, delays the translation of research results into clinical practice. To address this challenge, an international panel of experts was convened by the National Heart Lung and Blood Institute and the US Department of Defense on September 23 and 24, 2019, to develop expert opinion, consensus-based recommendations for primary clinical trial outcomes for pivotal trials in pediatric and adult patients with six categories in various clinical settings. This publication documents the conference proceedings from the workshop funded by the National Heart Lung and Blood Institute and the US Department of Defense that consolidated expert opinion regarding clinically meaningful outcomes across a wide range of disciplines to provide guidance for outcomes of future trials of hemostatic products and agents for patients with active bleeding.

Published
2021

39. Impact of Endovascular False Lumen Embolization on Thoracic Aortic Remodeling in Chronic Dissection

Author

Kyle G. Miletic, Faisal G. Bakaeen, Michael Z. Tong, Douglas R. Johnston, Kevin Hodges, Eric E. Roselli, Sean P. Lyden, Bogdan A. Kindzelski, Milind Y. Desai, and Jocelyn M. Beach

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Time Factors, medicine.medical_treatment, False lumen, Aorta, Thoracic, Dissection (medical), Vascular Remodeling, 030204 cardiovascular system & hematology, Aortography, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, medicine, Humans, Embolization, Reverse remodeling, Retrospective Studies, Aortic dissection, Aortic Aneurysm, Thoracic, business.industry, Endovascular Procedures, Middle Aged, medicine.disease, Embolization, Therapeutic, Thrombosis, Surgery, Aortic Dissection, Treatment Outcome, 030228 respiratory system, Chronic Disease, Female, Aortic diameter, Tomography, X-Ray Computed, Cardiology and Cardiovascular Medicine, business, Perfusion, Follow-Up Studies
Abstract

Retrograde false lumen (FL) perfusion after thoracic endovascular aortic repair (TEVAR) for chronic dissection is a mode of treatment failure. Thrombosis of the FL is associated with favorable reverse remodeling. Objectives are to describe FL embolization (FLE) strategy and assess aortic remodeling and survival.From January 2009 to December 2017, 51 patients with chronic dissection underwent FLE, most after previous TEVAR. Devices included a combination of iliac plug (29 patients), coils (19 patients), or nitinol plug (3 patients). Computed tomography was performed before discharge, at 3 months, and annually (median follow-up 2 years [range, 1 month to 7 years]).After FLE, mean maximum aortic diameter decreased (64.2 ± 12 mm to 61.0 ± 13 mm; P = .03), true lumen diameter increased (24.7 ± 10 mm to 33.7 ± 8 mm; P.001), and FL diameter decreased (36.7 ± 12 mm to 25.6 ± 15 mm, P.001). For reverse remodeling, FL thrombosis with ≥10% decrease in diameter and ≥10% increase in true lumen diameter was achieved in 20 (39.2%; 16 primarily, 4 secondarily). Nine patients progressed after the first FLE: persistent FL flow with increase in aortic diameter and underwent repeat FLE with complete thrombosis (n = 4) or open thoracoabdominal completion (n = 5). A total of 26 patients had indeterminate response (FL thrombosis without change in maximum diameter), and none have required reoperation. Six patients had complete obliteration of the entire FL. At last follow-up, 42 (82%) patients were alive. Three deaths were related to aortic pathology.FLE is an important endovascular adjunct to TEVAR promoting reverse aortic remodeling in select patients with chronic aortic dissection and persistent retrograde FL perfusion.

Published
2021

43. Evolution of Alternative-access Transcatheter Aortic Valve Replacement

Author

Kindzelski, Bogdan, primary, Mick, Stephanie L., additional, Krishnaswamy, Amar, additional, Kapadia, Samir R., additional, Attia, Tamer, additional, Hodges, Kevin, additional, Siddiqi, Shirin, additional, Lowry, Ashley M., additional, Blackstone, Eugene H., additional, Popovic, Zoran, additional, Svensson, Lars G., additional, Unai, Shinya, additional, and Yun, James J., additional

Published
2021
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44. Statin Therapy in Patients Undergoing Thoracic Aorta Replacement for Aortic Aneurysms

Author

Ashley M. Lowry, Kyle G. Miletic, Eric E. Roselli, Eugene H. Blackstone, Bogdan A. Kindzelski, David R. Van Wagoner, and Andrea Hanick

Subjects
medicine.medical_specialty, Statin, medicine.drug_class, thoracic aortic aneurysm surgery, medicine.medical_treatment, Thoracic aortic aneurysm, statins, medicine.artery, medicine, Thoracic aorta, Radiology, Nuclear Medicine and imaging, cardiovascular diseases, Original Research Article, Stroke, Dialysis, business.industry, Perioperative, medicine.disease, Comorbidity, Surgery, postoperative renal failure, Propensity score matching, cardiovascular system, Cardiology and Cardiovascular Medicine, business
Abstract

Background Patients undergoing surgery for thoracic aortic aneurysms receive statin therapy out of proportion to cardiovascular comorbidity. We sought to determine the prevalence of statin use among patients presenting for thoracic aortic aneurysm surgery and investigate its effect on outcomes. Methods From January 1, 2005 to January 1, 2011, 1,839 consecutive patients underwent aortic replacement for degenerative thoracic aortic aneurysm at Cleveland Clinic. Of these, 771 (42%) were on statins preoperatively. Statin users (vs. nonstatin users) were older (65 ± 11 vs. 56 ± 16 years) and had more hypertension (78 vs. 59%). Propensity matching based on 56 preoperative variables other than lipid levels was used to compare outcomes among 570 matched patient pairs (74% of possible pairs). Results Propensity-matched statin and nonstatin users were aged 64 ± 11 years, 394 (69%) versus 387 (68%) were male, and 437 (77%) versus 442 (78%) had ascending aortic aneurysms, respectively. Overall, 25% of patients were followed for more than 8.2 years and 10% for more than 10 years. Perioperative outcomes were similar, including hospital mortality (11 [1.9%] vs. 5 [0.88%]) and stroke (22 [3.9%] vs. 13 [2.3%]), but 16 statin users (2.8%) versus 5 nonstatin users (0.88%) required temporary dialysis after surgery (p = 0.02). At 6 years, 3.7% of statin users versus 5.1% of nonstatin users (p[log-rank] = 0.5) underwent further aortic surgery, and at 10 years, mortality was 25% in both groups (p > 0.5). Conclusion Patients presenting for thoracic aortic aneurysm surgery frequently receive unnecessary statins. Additionally, statin use was associated with more postoperative renal failure, but not less intermediate-term risk for aortic reintervention or all-cause mortality after surgery. Therefore, presence of a thoracic aortic aneurysm should not be considered an indication for statin therapy in the absence of well-established indications.

Published
2021

46. Serious Gastrointestinal Complications After Cardiac Surgery and Associated Mortality

Author

Elgharably, Haytham, primary, Gamaleldin, Maysoon, additional, Ayyat, Kamal S., additional, Zaki, Anthony, additional, Hodges, Kevin, additional, Kindzelski, Bogdan, additional, Sharma, Shashank, additional, Hassab, Tarek, additional, Yongue, Camille, additional, Serna, Solanus de la, additional, Perez, Juan, additional, Spencer, Capri, additional, Bakaeen, Faisal G., additional, Steele, Scott R., additional, Gillinov, A. Marc, additional, Svensson, Lars G., additional, and Pettersson, Gosta B., additional

Published
2021
Full Text
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47. Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial

Author

Noor Al-Hammadi, Jonathan Schor, Mahmood K. Razavi, Samuel Z. Goldhaber, Sanjay Misra, Heather L. Gornik, Michael R. Jaff, Amber Salter, Jim A. Julian, Darren Hurst, Ido Weinberg, Attract Trial Investigators, John F. Angle, Anthony J. Comerota, Robert M. Schainfeld, Gail Hadley, Andrei L. Kindzelski, Suresh Vedantham, and Clive Kearon

Subjects
medicine.medical_specialty, business.industry, Deep vein, Femoral vein, 030204 cardiovascular system & hematology, medicine.disease, Thrombosis, Article, 3. Good health, Surgery, 03 medical and health sciences, Venous thrombosis, 0302 clinical medicine, medicine.anatomical_structure, Deep vein thrombosis (DVT), Popliteal vein, medicine, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, Fibrinolytic agent, Post-thrombotic syndrome
Abstract

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335.

Published
2019

48. Adjunctive endovascular balloon fracture fenestration for chronic aortic dissection

Author

Kyle G. Miletic, Eugene H. Blackstone, Jeevanantham Rajeswaran, Bogdan A. Kindzelski, Eric E. Roselli, Melissa M. Levack, Douglas R. Johnston, Patrick R. Vargo, and Faisal G. Bakaeen

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Lumen (anatomy), Vascular Remodeling, 030204 cardiovascular system & hematology, Balloon, Aortography, Blood Vessel Prosthesis Implantation, 03 medical and health sciences, 0302 clinical medicine, Aneurysm, Intravascular ultrasound, medicine, Humans, Retrospective Studies, Aortic dissection, Aortic Aneurysm, Thoracic, medicine.diagnostic_test, business.industry, Endovascular Procedures, Stent, Thrombosis, medicine.disease, Blood Vessel Prosthesis, Surgery, Aortic Dissection, Treatment Outcome, 030228 respiratory system, Stents, Cardiology and Cardiovascular Medicine, business, Paraplegia
Abstract

Objective Positive remodeling after thoracic endovascular aortic repair (TEVAR) for chronic thoracic aortic dissection is variable due to incomplete distal seal and retrograde false lumen perfusion. We assessed the outcomes of adjunctive balloon fracture fenestration (BFF) during TEVAR in patients with chronic aortic dissection complicated by negative remodeling. Methods From June 2013 to January 2016, 49 patients with chronic aortic dissection complicated by aneurysm due to negative remodeling underwent TEVAR with BFF. Contrast-enhanced computed tomography was performed before discharge, at 3 to 6 months, and annually. Results Intraoperatively, endovascular stent graft expansion was achieved in all patients. There was 1 hospital death due to visceral malperfusion related to acute-on-chronic dissection noted before planned BFF. There were no occurrences of paraplegia, 3 patients had stroke, and 3 had acute renal failure. Survival at 1 year was 91%. Late reintervention for incomplete false lumen exclusion was required in 16 patients and freedom from reintervention was 75% at 1 year. Thirty-six patients (73.5%) had complete false lumen thrombosis through the treated segment. True lumen area increased following TEVAR with BFF and continued to incrementally expand with subsequent aortic remodeling at 1-year follow-up. Thirteen patients had positive remodeling, defined as thrombosis of false lumen, ≥10% decrease in aortic dimension, and ≥10% increase in true lumen diameter. Patients with positive remodeling had an average decrease of 11 mm in maximal aortic diameter at final follow-up. Conclusions BFF of chronic dissection membrane is a beneficial adjunct to TEVAR during short-term follow-up and may promote positive aortic remodeling and is worthy of further study.

Published
2022

49. Not All Alternatives Are Created Equal

Author

James Yun and Bogdan A. Kindzelski

Subjects
Pulmonary and Respiratory Medicine, Information retrieval, Text mining, business.industry, MEDLINE, Medicine, Surgery, Cardiology and Cardiovascular Medicine, business
Published
2021

50. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, E.C., Bradbury, C.A., McVerry, B.J., Lawler, P.R., Berger, J.S., Gong, M.N., Carrier, M., Reynolds, H.R., Kumar, A., Turgeon, A.F., Kornblith, L.Z., Kahn, S.R., Marshall, J.C., Kim, K.S., Houston, B.L., Derde, L.P.G., Cushman, M., Tritschler, T., Angus, D.C., Godoy, L.C., McQuilten, Z., Kirwan, B.A., Farkouh, M.E., Brooks, M.M., Lewis, R.J., Berry, L.R., Lorenzi, E., Gordon, A.C., Ahuja, T., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Contreras, A., Costantini, T.W., Brouwer, S., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Eng, H.F., Escobedo, J., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Froess, J.D., Fu, Z., Galanaud, J.P., Galen, B.T., Gandotra, S., Girard, T.D., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Haniffa, R., Hegde, S.M., Hendrickson, C.M., Higgins, A.M., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Huang, D.T., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A., King, A.J., Knudson, M.M., Kornblith, A.E., Kutcher, M.E., Laffan, M.A., Lamontagne, F., Gal, G. Le, Veerdonk, F.L. van de, Middeldorp, S., Schouten, J.A., Pickkers, P., Webb, S.A., Zarychanski, R., Goligher, E.C., Bradbury, C.A., McVerry, B.J., Lawler, P.R., Berger, J.S., Gong, M.N., Carrier, M., Reynolds, H.R., Kumar, A., Turgeon, A.F., Kornblith, L.Z., Kahn, S.R., Marshall, J.C., Kim, K.S., Houston, B.L., Derde, L.P.G., Cushman, M., Tritschler, T., Angus, D.C., Godoy, L.C., McQuilten, Z., Kirwan, B.A., Farkouh, M.E., Brooks, M.M., Lewis, R.J., Berry, L.R., Lorenzi, E., Gordon, A.C., Ahuja, T., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Contreras, A., Costantini, T.W., Brouwer, S., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Eng, H.F., Escobedo, J., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Froess, J.D., Fu, Z., Galanaud, J.P., Galen, B.T., Gandotra, S., Girard, T.D., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Haniffa, R., Hegde, S.M., Hendrickson, C.M., Higgins, A.M., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Huang, D.T., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A., King, A.J., Knudson, M.M., Kornblith, A.E., Kutcher, M.E., Laffan, M.A., Lamontagne, F., Gal, G. Le, Veerdonk, F.L. van de, Middeldorp, S., Schouten, J.A., Pickkers, P., Webb, S.A., and Zarychanski, R.

Abstract

Item does not contain fulltext, BACKGROUND: Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS: In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS: The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS: In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulati

Published
2021

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