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2. Characteristics and outcomes of patients with COVID-19 supported by extracorporeal membrane oxygenation: A retrospective multicenter study

Author

Alvarez, Chikezie, DeAnda, Abe, Jr., Gluck, Jason, Jermyn, Rita, Kuntzman, Matthew, McKellar, Stephen, Parides, Michael K., Saunders, Paul, Saeed, Omar, Tatooles, Antone J., Farooq, Muhammad, Schwartz, Gary, Pham, Duc T., Mustafa, Asif K., D'Alessandro, David, Abrol, Sunil, Jorde, Ulrich P., Gregoric, Igor D., Radovancevic, Rajko, Lima, Brian, Bryner, Benjamin S., Ravichandran, Ashwin, Salerno, Christopher T., Spencer, Philip, Friedmann, Patricia, Silvestry, Scott, and Goldstein, Daniel J.

Published
2022
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6. HVAD to HeartMate 3 Left Ventricular Assist Device Exchange: Best Practices Recommendations

Author

Salerno, Christopher T., primary, Hayward, Christopher, additional, Hall, Shelley, additional, Goldstein, Daniel, additional, Saeed, Diyar, additional, Schmitto, Jan, additional, Kaczorowski, David, additional, Molina, Ezequiel, additional, Zimpfer, Daniel, additional, Tsui, Steven, additional, Soltesz, Edward, additional, Pham, Duc Thin, additional, Mokadam, Nahush A., additional, Kilic, Arman, additional, Davis, Erin, additional, Feller, Erika, additional, Lorts, Angela, additional, Silvestry, Scott, additional, Slaughter, Mark S., additional, Potapov, Evgenij, additional, Atluri, Pavan, additional, Cowger, Jennifer, additional, Pagani, Francis D., additional, and Salerno, Christopher T., additional

Published
2022
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7. Outcomes in Smaller Body Size Adults After HeartMate 3 Left Ventricular Assist Device Implantation

Author

Molina, Ezequiel J., primary, Cowger, Jennifer, additional, Lee, Sangjin, additional, Horstmanshof, Douglas, additional, Cleveland, Joseph C., additional, Goldstein, Daniel J., additional, Mehra, Mandeep R., additional, Uriel, Nir, additional, Salerno, Christopher T., additional, Bourque, Kevin, additional, Chuang, Joyce, additional, and Naka, Yoshifumi, additional

Published
2022
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9. Characteristics and outcomes of patients with COVID-19 supported by extracorporeal membrane oxygenation: A retrospective multicenter study

Author

Saeed, Omar, primary, Tatooles, Antone J., additional, Farooq, Muhammad, additional, Schwartz, Gary, additional, Pham, Duc T., additional, Mustafa, Asif K., additional, D'Alessandro, David, additional, Abrol, Sunil, additional, Jorde, Ulrich P., additional, Gregoric, Igor D., additional, Radovancevic, Rajko, additional, Lima, Brian, additional, Bryner, Benjamin S., additional, Ravichandran, Ashwin, additional, Salerno, Christopher T., additional, Spencer, Philip, additional, Friedmann, Patricia, additional, Silvestry, Scott, additional, Goldstein, Daniel J., additional, Alvarez, Chikezie, additional, DeAnda, Abe, additional, Gluck, Jason, additional, Jermyn, Rita, additional, Kuntzman, Matthew, additional, McKellar, Stephen, additional, Parides, Michael K., additional, and Saunders, Paul, additional

Published
2022
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10. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

Author

Mehra, Mandeep R., Goldstein, Daniel J., Cleveland, Joseph C., Cowger, Jennifer A., Hall, Shelley, Salerno, Christopher T., Naka, Yoshifumi, Horstmanshof, Douglas, Chuang, Joyce, Wang, AiJia, and Uriel, Nir

Subjects
Heart Failure, Male, Stroke, Treatment Outcome, Humans, Female, Heart-Assist Devices, Kaplan-Meier Estimate, General Medicine, Middle Aged, Original Investigation, Follow-Up Studies
Abstract

ImportanceAlthough durable left ventricular assist device (LVAD) therapy has emerged as an important treatment option for patients with advanced heart failure refractory to pharmacological support, outcomes, including survival, beyond 2 years remain poorly characterized.ObjectiveTo report the composite end point of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Scale score >3) or reoperation to replace the pump 5 years after the implant in participants who received the fully magnetically levitated centrifugal-flow HeartMate 3 or axial-flow HeartMate II LVAD in the MOMENTUM 3 randomized trial and were still receiving LVAD therapy at the 2-year follow-up.Design, Setting, and ParticipantsThis observational study was a 5-year follow-up of the MOMENTUM 3 trial, conducted in 69 US centers, that demonstrated superiority of the centrifugal-flow LVAD to the axial-flow pump with respect to survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump at 2 years. A total of 295 patients were enrolled between June 2019 to April 2021 in the extended-phase study, with 5-year follow-up completed in September 2021.ExposuresOf 1020 patients in the investigational device exemption per-protocol population, 536 were still receiving LVAD support at 2 years, of whom 289 received the centrifugal-flow pump and 247 received the axial-flow pump.Main Outcomes and MeasuresThere were 10 end points evaluated at 5 years in the per-protocol population, including a composite of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump between the centrifugal-flow and axial-flow pump groups and overall survival between the 2 groups.ResultsA total of 477 patients (295 enrolled and 182 provided limited data) of 536 patients still receiving LVAD support at 2 years contributed to the extended-phase analysis (median age, 62 y; 86 [18%] women). The 5-year Kaplan-Meier estimate of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump in the centrifugal-flow vs axial-flow group was 54.0% vs 29.7% (hazard ratio, 0.55 [95% CI, 0.45-0.67]; P P = .003). Serious adverse events of stroke, bleeding, and pump thrombosis were less frequent in the centrifugal-flow pump group.Conclusions and RelevanceIn this observational follow-up study of patients from the MOMENTUM 3 randomized trial, per-protocol analyses found that receipt of a fully magnetically levitated centrifugal-flow LVAD vs axial-flow LVAD was associated with a better composite outcome and higher likelihood of overall survival at 5 years. These findings support the use of the fully magnetically levitated LVAD.Trial RegistrationClinicalTrials.gov Identifier: NCT02224755 and NCT03982979

Published
2022

11. HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations.

Author

Salerno, Christopher T, Hayward, Christopher, Hall, Shelley, Goldstein, Daniel, Saeed, Diyar, Schmitto, Jan, Kaczorowski, David, Molina, Ezequiel, Zimpfer, Daniel, Tsui, Steven, Soltesz, Edward, Pham, Duc Thin, Mokadam, Nahush A, Kilic, Arman, Davis, Erin, Feller, Erika, Lorts, Angela, Silvestry, Scott, Slaughter, Mark S, and Potapov, Evgenij

Subjects
*HEART assist devices, *BEST practices, *MEDICAL equipment, *MEDICAL communication, *MORTALITY
Abstract

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1–8) [ABSTRACT FROM AUTHOR]

Published
2022
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12. Shared Decision Making in Cardiac Transplantation during the COVID19 Pandemic: Patient Refusal of Transplantation

Author

Chaudhry, Sunit-Preet, Salerno, Christopher T., Ravichandran, Ashwin K., and Walsh, Mary Norine

Subjects
UNOS, United Network for Organ Sharing, LVAD, Left Ventricular Assist Device, cardiomypathy, cardiovascular system, GI, Gastrointestinal, COVID19, Coronavirus Disease 2019, cardiac transplant, SDM, Shared Decision Making, Article, chronic heart failure
Abstract

SDM with advanced heart failure patients is critical in making decisions regarding therapies such as LVAD and cardiac transplantation. We describe a case wherein the risks of COVID19 infection affected the decision of a patient around proceeding with cardiac transplantation.

Published
2020

15. The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications

Author

Teuteberg, Jeffrey J., primary, Cleveland, Joseph C., additional, Cowger, Jennifer, additional, Higgins, Robert S., additional, Goldstein, Daniel J., additional, Keebler, Mary, additional, Kirklin, James K., additional, Myers, Susan L., additional, Salerno, Christopher T., additional, Stehlik, Josef, additional, Fernandez, Felix, additional, Badhwar, Vinay, additional, Pagani, Francis D., additional, and Atluri, Pavan, additional

Published
2020
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17. HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations

Author

Atluri, Pavan, Cowger, Jennifer, Davis, Erin, Feller, Erika, Goldstein, Daniel, Hall, Shelley, Hayward, Christopher, Kaczorowski, David, Kilic, Arman, Lorts, Angela, Mokadam, Nahush A., Molina, Ezequiel, Pagani, Francis D., Pham, Duc Thin, Potapov, Evgenij, Saeed, Diyar, Salerno, Christopher T., Schmitto, Jan, Silvestry, Scott, Slaughter, Mark S., Soltesz, Edward, Tsui, Steven, and Zimpfer, Daniel

Published
2022
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19. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants.

Author

Mehra, Mandeep R., Cleveland, Joseph C., Uriel, Nir, Cowger, Jennifer A., Hall, Shelley, Horstmanshof, Douglas, Naka, Yoshifumi, Salerno, Christopher T., Chuang, Joyce, Williams, Christopher, Goldstein, Daniel J., Cleveland, Joseph C Jr, MOMENTUM 3 Investigators, and  on behalf of the MOMENTUM 3 Investigators

Subjects
HEART assist devices, INTRA-aortic balloon counterpulsation, OVERALL survival, HEART failure, SURVIVAL rate, HEART failure treatment, RESEARCH, STROKE, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, TREATMENT effectiveness, COMPARATIVE studies, LONGITUDINAL method
Abstract

Aim: The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated centrifugal-flow pump, over the HeartMate II axial-flow pump. We now evaluate HM3 LVAD outcomes in a single-arm prospective continuous access protocol (CAP) post-pivotal trial study.Methods and Results: We enrolled 2200 HM3 implanted patients (515 pivotal trial and 1685 CAP patients) and compared outcomes including survival free of disabling stroke or reoperation to replace or remove a malfunctioning device (primary composite endpoint), overall survival and major adverse events at 2 years. The 2-year primary endpoint [76.7% vs. 74.8%; adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.71-1.08, P = 0.21] and overall survival (81.2% vs. 79.0%) were similar among CAP and pivotal cohorts despite sicker patients (more intra-aortic balloon pump use and INTERMACS profile 1) in CAP who were more often intended for destination therapy. Survival was similar between the CAP and pivotal trial in transplant ineligible patients (79.1% vs. 76.7%; adjusted HR 0.89, 95% CI 0.68-1.16, P = 0.38). In a pooled analysis, the 2-year primary endpoint was similar between INTERMACS profiles 1-2 ('unstable' advanced heart failure), profile 3 ('stable' on inotropic therapy), and profiles 4-7 ('stable' ambulatory advanced heart failure) (75.7% vs. 77.6% vs. 72.9%, respectively). The net burden of adverse events was lower in CAP (adjusted rate ratio 0.93, 95% CI 0.88-0.98, P = 0.006), with consequent decrease in hospitalization.Conclusions: The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial. [ABSTRACT FROM AUTHOR]

Published
2021
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22. Outcomes of Patients Receiving Temporary Circulatory Support Before Durable Ventricular Assist Device

Author

Shah, Palak, primary, Pagani, Francis D., additional, Desai, Shashank S., additional, Rongione, Anthony J., additional, Maltais, Simon, additional, Haglund, Nicholas A., additional, Dunlay, Shannon M., additional, Aaronson, Keith D., additional, Stulak, John M., additional, Davis, Mary Beth, additional, Salerno, Christopher T., additional, and Cowger, Jennifer A., additional

Published
2017
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23. Human lung carcinomas express Fas ligand

Author

Niehans, Gloria A., Frizelle, Sandra P., Liston, Jacob C., Salerno, Christopher T., Knapp, Dennis J., Green, Douglas R., Kratzke, Robert A., and Brunner, Thomas

Subjects
ddc:570, chemical and pharmacologic phenomena
Abstract

To reach a clinically detectable size, neoplasms must be able to suppress or evade a host immune response. Activated T cells may enter apoptosis in the presence of Fas ligand (FasL) (1), and tissue expression of FasL has been shown to contribute to immune privilege in the eye and testis (2, 3). We have demonstrated that all human lung carcinoma cell lines tested (16 of 16) express a Mr 38,000 protein consistent with FasL by immunoblotting, whereas the majority of resected tumors (23 of 28) show positive staining for FasL by immunohistochemistry. DNA sequencing of reverse transcription-PCR products from lung cancer cells and resected lung tumors confirms the presence of human FasL mRNA in these neoplastic tissues. Furthermore, lung carcinoma cells are capable of killing a Fassensitive human T cell line (Jurkat) in coculture experiments; this killing was inhibited by a recombinant form of the soluble portion of the Fas receptor (FasFc). FasL expression by neoplastic cells represents a potential mechanism for peripheral deletion of tumor-reactive T-cell clones.

Published
1997

30. HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations.

Author

Salerno CT, Hayward C, Hall S, Goldstein D, Saeed D, Schmitto J, Kaczorowski D, Molina E, Zimpfer D, Tsui S, Soltesz E, Pham DT, Mokadam NA, Kilic A, Davis E, Feller E, Lorts A, Silvestry S, Slaughter MS, Potapov E, Atluri P, Cowger J, and Pagani FD

Subjects
Equipment Design, Heart Failure surgery, Humans, Retrospective Studies, Stroke epidemiology, Heart-Assist Devices adverse effects
Abstract

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices., (Copyright © 2022 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery and European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. and Oxford. All rights reserved. Published by Elsevier Inc. All rights reserved.)

Published
2022
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