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2,213 results on '"Mehra, Mandeep R"'

3. Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT)

Author

Gosev, Igor, Pham, Duc Thinh, Um, John Y., Anyanwu, Anelechi C., Itoh, Akinobu, Kotkar, Kunal, Takeda, Koji, Naka, Yoshifumi, Peltz, Matthias, Silvestry, Scott C., Couper, Gregory, Leacche, Marzia, Rao, Vivek, Sun, Benjamin, Tedford, Ryan J., Mokadam, Nahush, McNutt, Robert, Crandall, Daniel, Mehra, Mandeep R., and Salerno, Christopher T.

Published
2024
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6. Inflammation and remodeling pathways and risk of cardiovascular events in patients with ischemic heart failure and reduced ejection fraction

Author

Girerd, Nicolas, Cleland, John, Anker, Stefan D, Byra, William, Lam, Carolyn SP, Lapolice, David, Mehra, Mandeep R, van Veldhuisen, Dirk J, Bresso, Emmanuel, Lamiral, Zohra, Greenberg, Barry, and Zannad, Faiez

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Heart Disease, Heart Disease - Coronary Heart Disease, Atrial Remodeling, Biomarkers, Case-Control Studies, Coronary Artery Disease, Death, Sudden, Cardiac, Growth Differentiation Factor 15, Heart Failure, Humans, Inflammation, Myocardial Infarction, Natriuretic Peptide, Brain, Peptide Fragments, Proteomics, Stroke, Stroke Volume, Ventricular Dysfunction, Left
Abstract

Patients with heart failure (HF) and coronary artery disease (CAD) have a high risk for cardiovascular (CV) events including HF hospitalization, stroke, myocardial infarction (MI) and sudden cardiac death (SCD). The present study evaluated associations of proteomic biomarkers with CV outcome in patients with CAD and HF with reduced ejection fraction (HFrEF), shortly after a worsening HF episode. We performed a case-control study within the COMMANDER HF international, double-blind, randomized placebo-controlled trial investigating the effects of the factor-Xa inhibitor rivaroxaban. Patients with the following first clinical events: HF hospitalization, SCD and the composite of MI or stroke were matched with corresponding controls for age, sex and study drug. Plasma concentrations of 276 proteins with known associations with CV and cardiometabolic mechanisms were analyzed. Results were corrected for multiple testing using false discovery rate (FDR). In 485 cases and 455 controls, 49 proteins were significantly associated with clinical events of which seven had an adjusted FDR  0.20). When adding the biomarkers significantly associated with the above outcome to a clinical model (including NT-proBNP), the C-index increase was 0.057 (0.033-0.082), p

Published
2022

7. A multicenter evaluation of the HeartMate 3 risk score

Author

Grewal, Jagpreet, Tripathi, Neeta, Bortner, Ben, Gregoski, Mathew J., Cook, Daniel, Britt, Annie, Hajj, Jennifer, Rofael, Michael, Sheidu, Mariyam, Montovano, Margaret J., Mehta, Mili, Hajduczok, Alexander G., Rajapreyar, Indranee N., Brailovsky, Yevgeniy, Genuardi, Michael V., Kanwar, Manreet K., Atluri, Pavan, Lander, Matthew, Shah, Palak, Hsu, Steven, Kilic, Arman, Houston, Brian A., Mehra, Mandeep R., Sheikh, Farooq H., and Tedford, Ryan J.

Published
2024
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8. A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device

Author

Wert, Leonhard, Stewart, Garrick C., Mehra, Mandeep R., Milwidsky, Assi, Jorde, Ulrich P., Goldstein, Daniel J., Selzman, Craig H., Stehlik, Josef, Alshamdin, Faisal D., Khaliel, Feras H., Gustafsson, Finn, Boschi, Silvia, Loforte, Antonio, Ajello, Silvia, Scandroglio, Anna M., Tučanová, Zuzana, Netuka, Ivan, Schlöglhofer, Thomas, Zimpfer, Daniel, Zijderhand, Casper F., Caliskan, Kadir, Dogan, Günes, Schmitto, Jan D., Maier, Sven, Schibilsky, David, Jawad, Khalil, Saeed, Diyar, Faerber, Gloria, Morshuis, Michiel, Hanuna, Maja, Müller, Christoph S., Mulzer, Johanna, Kempfert, Jörg, Falk, Volkmar, and Potapov, Evgenij V.

Published
2024
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11. Concurrent valvular procedures during left ventricular assist device implantation and outcomes: A comprehensive analysis of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 trial portfolio

Author

John, Ranjit, Kanwar, Manreet K., Cleveland, Joseph C., Jr., Uriel, Nir, Naka, Yoshifumi, Salerno, Christopher, Horstmanshof, Douglas, Hall, Shelley A., Cowger, Jennifer A., Heatley, Gerald, Somo, Sami I., and Mehra, Mandeep R.

Published
2023
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14. Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.

Author

Rizk, John G, Forthal, Donald N, Kalantar-Zadeh, Kamyar, Mehra, Mandeep R, Lavie, Carl J, Rizk, Youssef, Pfeiffer, JoAnn P, and Lewin, John C

Subjects
Humans, Antiviral Agents, Drug Approval, United States, Compassionate Use Trials, COVID-19, SARS-CoV-2, COVID-19 Vaccines, COVID-19 Drug Treatment, Infectious Diseases, Prevention, Emerging Infectious Diseases, Vaccine Related, Good Health and Well Being, Biochemistry and Cell Biology, Pharmacology and Pharmaceutical Sciences, Medicinal & Biomolecular Chemistry
Abstract

The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been the major focus, uncertainties around new vaccine safety and effectiveness have spawned interest in other pharmacological options. Experimental drugs can also be approved under the FDA Emergency Use Authorization (EUA) program, designed to combat infectious disease and other threats. Here, we review the US experience in 2020 with pharmacological EA and EUA approvals during the pandemic. We also provide a description of, and clinical rationale for, each of the EA- or EUA-approved drugs (e.g. remdesivir, convalescent plasma, propofol 2%, hydroxychloroquine, ruxolitinib, bamlanivimab, baricitinib, casirivimab plus imdevimab) during the pandemic and concluding reflections on the EA program and its potential future uses.

Published
2021

15. Pharmaco-Immunomodulatory Therapy in COVID-19.

Author

Rizk, John G, Kalantar-Zadeh, Kamyar, Mehra, Mandeep R, Lavie, Carl J, Rizk, Youssef, and Forthal, Donald N

Subjects
Humans, Pneumonia, Viral, Coronavirus Infections, Immunologic Factors, Treatment Outcome, Immunomodulation, Pandemics, Betacoronavirus, COVID-19, SARS-CoV-2, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, Lung, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Inflammatory and immune system, Good Health and Well Being, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy
Abstract

The severe acute respiratory syndrome coronavirus 2 associated coronavirus disease 2019 (COVID-19) illness is a syndrome of viral replication in concert with a host inflammatory response. The cytokine storm and viral evasion of cellular immune responses may play an equally important role in the pathogenesis, clinical manifestation, and outcomes of COVID-19. Systemic proinflammatory cytokines and biomarkers are elevated as the disease progresses towards its advanced stages, and correlate with worse chances of survival. Immune modulators have the potential to inhibit cytokines and treat the cytokine storm. A literature search using PubMed, Google Scholar, and ClinicalTrials.gov was conducted through 8 July 2020 using the search terms 'coronavirus', 'immunology', 'cytokine storm', 'immunomodulators', 'pharmacology', 'severe acute respiratory syndrome 2', 'SARS-CoV-2', and 'COVID-19'. Specific immune modulators include anti-cytokines such as interleukin (IL)-1 and IL-6 receptor antagonists (e.g. anakinra, tocilizumab, sarilumab, siltuximab), Janus kinase (JAK) inhibitors (e.g. baricitinib, ruxolitinib), anti-tumor necrosis factor-α (e.g. adalimumab, infliximab), granulocyte-macrophage colony-stimulating factors (e.g. gimsilumab, lenzilumab, namilumab), and convalescent plasma, with promising to negative trials and other data. Non-specific immune modulators include human immunoglobulin, corticosteroids such as dexamethasone, interferons, statins, angiotensin pathway modulators, macrolides (e.g. azithromycin, clarithromycin), hydroxychloroquine and chloroquine, colchicine, and prostaglandin D2 modulators such as ramatroban. Dexamethasone 6 mg once daily (either by mouth or by intravenous injection) for 10 days may result in a reduction in mortality in COVID-19 patients by one-third for patients on ventilators, and by one-fifth for those receiving oxygen. Research efforts should focus not only on the most relevant immunomodulatory strategies but also on the optimal timing of such interventions to maximize therapeutic outcomes. In this review, we discuss the potential role and safety of these agents in the management of severe COVID-19, and their impact on survival and clinical symptoms.

Published
2020

16. Authors' Reply to Vrachatis et al. "Pharmaco-Immunomodulatory Therapy I COVID-19".

Author

Rizk, John G, Kalantar-Zadeh, Kamyar, Mehra, Mandeep R, Lavie, Carl J, Rizk, Youssef, and Forthal, Donald N

Subjects
Humans, Pneumonia, Viral, Coronavirus Infections, Immunomodulation, Pandemics, Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy
Published
2020

18. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial

Author

Mehra, Mandeep R, Vaduganathan, Muthiah, Fu, Min, Ferreira, João Pedro, Anker, Stefan D, Cleland, John GF, Lam, Carolyn SP, van Veldhuisen, Dirk J, Byra, William M, Spiro, Theodore E, Deng, Hsiaowei, Zannad, Faiez, and Greenberg, Barry

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Research, Brain Disorders, Neurosciences, Stroke, Clinical Trials and Supportive Activities, Heart Disease, Cardiovascular, Heart Disease - Coronary Heart Disease, Patient Safety, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Brain Ischemia, Case-Control Studies, Coronary Artery Disease, Double-Blind Method, Drug Therapy, Combination, Factor Xa Inhibitors, Female, Heart Failure, Hemorrhage, Humans, Incidence, Ischemic Attack, Transient, Male, Middle Aged, Myocardial Infarction, Placebos, Platelet Aggregation Inhibitors, Rivaroxaban, Stroke Volume, Heart failure, Oral anticoagulation, Thrombotic, Transient ischaemic attack, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

AimsStroke is often a devastating event among patients with heart failure with reduced ejection (HFrEF). In COMMANDER HF, rivaroxaban 2.5 mg b.i.d. did not reduce the composite of first occurrence of death, stroke, or myocardial infarction compared with placebo in patients with HFrEF, coronary artery disease (CAD), and sinus rhythm. We now examine the incidence, timing, type, severity, and predictors of stroke or a transient ischaemic attack (TIA), and seek to establish the net clinical benefit of treatment with low-dose rivaroxaban.Methods and resultsIn this double-blind, randomized trial, 5022 patients who had HFrEF(≤40%), elevated natriuretic peptides, CAD, and who were in sinus rhythm were treated with rivaroxaban 2.5 mg b.i.d. or placebo in addition to antiplatelet therapy, after an episode of worsening HF. The primary neurological outcome for this post hoc analysis was time to first event of any stroke or TIA. Over a median follow-up of 20.5 (25th-75th percentiles 20.0-20.9) months, 150 all-cause stroke (127) or TIA (23) events occurred (ischaemic stroke in 82% and haemorrhagic stroke in 11% of stroke events). Overall, 47.5% of first-time strokes were either disabling (16.5%) or fatal (31%). Prior stroke, low body mass index, geographic region, and the CHA2DS2-VASc score were predictors of stroke/TIA. Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49-0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event. The principal safety endpoint of fatal bleeding or bleeding into a critical space, occurred at a similar rate on rivaroxaban and placebo (0.44 events vs. 0.55 events per 100 patient-years).ConclusionsPatients with HFrEF and CAD are at risk for stroke or TIA in the period following an episode of worsening heart failure in the absence of atrial fibrillation. Most strokes are of ischaemic origin and nearly half are either disabling or fatal. Rivaroxaban at a dose of 2.5 mg b.i.d. reduced rates of stroke or TIA compared with placebo in this population.Trial registrationCOMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure); ClinicalTrials.gov NCT01877915.

Published
2019

26. Right heart failure with left ventricular assist devices: Preoperative, perioperative and postoperative management strategies. A clinical consensus statement of the Heart Failure Association (HFA) of the ESC.

Author

Adamopoulos, Stamatis, Bonios, Michael, Ben Gal, Tuvia, Gustafsson, Finn, Abdelhamid, Magdy, Adamo, Marianna, Bayes‐Genis, Antonio, Böhm, Michael, Chioncel, Ovidiu, Cohen‐Solal, Alain, Damman, Kevin, Di Nora, Concetta, Hashmani, Shahrukh, Hill, Loreena, Jaarsma, Tiny, Jankowska, Ewa, Lopatin, Yury, Masetti, Marco, Mehra, Mandeep R., and Milicic, Davor

Subjects
ARTIFICIAL blood circulation, POSTOPERATIVE care, HEART failure, POSTOPERATIVE period, CARDIAC catheterization, HEART assist devices
Abstract

Right heart failure (RHF) following implantation of a left ventricular assist device (LVAD) is a common and potentially serious condition with a wide spectrum of clinical presentations with an unfavourable effect on patient outcomes. Clinical scores that predict the occurrence of right ventricular (RV) failure have included multiple clinical, biochemical, imaging and haemodynamic parameters. However, unless the right ventricle is overtly dysfunctional with end‐organ involvement, prediction of RHF post‐LVAD implantation is, in most cases, difficult and inaccurate. For these reasons optimization of RV function in every patient is a reasonable practice aiming at preparing the right ventricle for a new and challenging haemodynamic environment after LVAD implantation. To this end, the institution of diuretics, inotropes and even temporary mechanical circulatory support may improve RV function, thereby preparing it for a better adaptation post‐LVAD implantation. Furthermore, meticulous management of patients during the perioperative and immediate postoperative period should facilitate identification of RV failure refractory to medication. When RHF occurs late during chronic LVAD support, this is associated with worse long‐term outcomes. Careful monitoring of RV function and characterization of the origination deficit should therefore continue throughout the patient's entire follow‐up. Despite the useful information provided by the echocardiogram with respect to RV function, right heart catheterization frequently offers additional support for the assessment and optimization of RV function in LVAD‐supported patients. In any patient candidate for LVAD therapy, evaluation and treatment of RV function and failure should be assessed in a multidimensional and multidisciplinary manner. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial

Author

Lindenfeld, JoAnn, Zile, Michael R, Desai, Akshay S, Bhatt, Kunjan, Ducharme, Anique, Horstmanshof, Douglas, Krim, Selim R, Maisel, Alan, Mehra, Mandeep R, Paul, Sara, Sears, Samuel F, Sauer, Andrew J, Smart, Frank, Zughaib, Marcel, Castaneda, Paige, Kelly, Jean, Johnson, Nessa, Sood, Poornima, Ginn, Greg, Henderson, John, Adamson, Philip B, and Costanzo, Maria Rosa

Published
2021
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33. Heart Failure Association, Heart Failure Society of America, and Japanese Heart Failure Society Position Statement on Endomyocardial Biopsy

Author

Seferović, Petar M., Tsutsui, Hiroyuki, Mcnamara, Dennis M., Ristić, Arsen D., Basso, Cristina, Bozkurt, Biykem, Cooper, Leslie T., Filippatos, Gerasimos, Ide, Tomomi, Inomata, Takayuki, Klingel, Karin, Linhart, Aleš, lyon, Alexander R., Mehra, Mandeep R., Polovina, Marija, Milinković, Ivan, Nakamura, Kazufumi, Anker, Stefan D., Veljić, Ivana, Ohtani, Tomohito, Okumura, Takahiro, Thum, Thomas, Tschöpe, Carsten, Rosano, Giuseppe, Coats, Andrew J.S., and Starling, Randall C.

Published
2021
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35. Dynamic Risk Estimation of Adverse Events in Ambulatory LVAD Patients

Author

Shah, Palak, Sayer, Gabriel, Sinha, Shashank S., Kanwar, Manreet K., Cowger, Jennifer A., Pagani, Francis D., Nayak, Aditi, Mehra, Mandeep R., Cleveland, Joseph C., Psotka, Mitchell A., Singh, Ramesh, Desai, Shashank S., Lu, Qianhui, Hu, Yajing, Connolly, Allison, Kormos, Robert L., and Uriel, Nir

Abstract

Hemocompatibility-related adverse events affect patients after left ventricular assist device (LVAD) implantation but are hard to predict.

Published
2024
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36. Impact of Geographic Region on the COMMANDER-HF Trial

Author

Ferreira, João Pedro, Cleland, John G.F., Lam, Carolyn S.P., van Veldhuisen, Dirk J., Byra, William M., La Police, David A., Anker, Stefan D., Mehra, Mandeep R., Leroy, Céline, Eschwege, Valerie, Toussaint-Hacquard, Marie, Rossignol, Patrick, Greenberg, Barry, and Zannad, Faiez

Published
2021
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48. Utilization of hepatitis C virus–infected organ donors in cardiothoracic transplantation: An ISHLT expert consensus statement

Author

Aslam, Saima, Mehra, Mandeep R., Blumberg, Emily, Grossi, Paolo, Holm, Are M., Schlendorf, Kelly H., Woolley, Ann E., Silveira, Fernanda P., Teuteberg, Jeffrey, Crespo, Maria, Lyster, Haifa, Lourenco, Laura, Machado, Sara, Shullo, Michael, Hartwig, Matthew, Peraskeva, Miranda, Wolfe, Cameron, Khush, Kiran, Ison, Michael, Hall, Shelley, Mooney, Joshua, Ivulich, Steve, Cypel, Marcelo, Pretorius, Victor, Uber, Patricia, Kransdorf, Evan, Cochrane, Adam, Glanville, Alan, and Gray, Jennifer

Published
2020
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