Article
Cardiac & Cardiovascular Systems
Sneha S. Jain, Kevin J. Clerkin, Edmund Anstey, Qi Liu, Justin A. Fried, Jayant Raikhelkar, Jan M. Griffin, Dylan Marshall, Paolo Colombo, Melana Yuzefpolskaya, Veli Topkara, Yoshifumi Naka, Koji Takeda, Gabriel Sayer, Nir Uriel, Jay Leb
Summary: This study describes the prevalence, imaging findings, and clinical outcomes associated with outflow graft narrowing in patients with the HeartMate 3 left ventricular assist device (LVAD). The results showed that 33% of patients had outflow graft narrowing, which was significantly associated with a longer duration of LVAD support. There was no significant difference in LV unloading between patients with and without narrowing.
ANNALS OF THORACIC SURGERY
(2023)
Review
Cardiac & Cardiovascular Systems
Christopher T. Salerno, Christopher Hayward, Shelley Hall, Daniel Goldstein, Diyar Saeed, Jan Schmitto, David Kaczorowski, Ezequiel Molina, Daniel Zimpfer, Steven Tsui, Edward Soltesz, Duc Thin Pham, Nahush A. Mokadam, Arman Kilic, Erin Davis, Erika Feller, Angela Lorts, Scott Silvestry, Mark S. Slaughter, Evgenij Potapov, Pavan Atluri, Jennifer Cowger, Francis D. Pagani
Summary: The HeartWare HVAD System is being discontinued due to critical device malfunctions and higher risks, with patients being recommended to switch to the HeartMate 3 left ventricular assist system. This document discusses the differences between HVAD and HeartMate 3 in terms of medical management and technical aspects, providing evidence for best practices.
ANNALS OF THORACIC SURGERY
(2022)
Article
Cardiac & Cardiovascular Systems
Christopher T. Salerno, Christopher Hayward, Shelley Hall, Daniel Goldstein, Diyar Saeed, Jan Schmitto, David Kaczorowski, Ezequiel Molina, Daniel Zimpfer, Steven Tsui, Edward Soltesz, Duc Thin Pham, Nahush A. Mokadam, Arman Kilic, Erin Davis, Erika Feller, Angela Lorts, Scott Silvestry, Mark S. Slaughter, Evgenij Potapov, Pavan Atluri, Jennifer Cowger, Francis D. Pagani
Summary: The HeartWare HVAD System, a durable left ventricular assist device, has been discontinued due to device malfunction and higher risk compared to other devices. Patients previously implanted with HVAD will now need to use the HeartMate 3 system for pump exchange. This document aims to review the design differences and assess the technical aspects of transitioning from HVAD to HeartMate 3.
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
(2022)
Review
Cardiac & Cardiovascular Systems
Christopher T. Salerno, Christopher Hayward, Shelley Hall, Daniel Goldstein, Diyar Saeed, Jan Schmitto, David Kaczorowski, Ezequiel Molina, Daniel Zimpfer, Steven Tsui, Edward Soltesz, Duc Thin Pham, Nahush A. Mokadam, Arman Kilic, Erin Davis, Erika Feller, Angela Lorts, Scott Silvestry, Mark S. Slaughter, Evgenij Potapov, Pavan Atluri, Jennifer Cowger, Francis D. Pagani
Summary: This article provides an overview of the HeartWare HVAD System, highlighting its usage and identifying associated issues, such as potential delays or failure to restart and increased risks compared to other devices. As a result, Medtronic has decided to discontinue the sale and distribution of the HVAD System.
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY
(2022)
Article
Cardiac & Cardiovascular Systems
Kevin Bourque, Matthew J. Martin, Daniel I. Harjes, David L. Cassidy, Francis D. Pagani, Robert L. Kormos
Summary: The study found that using a remnant HVAD graft during pump exchange may require higher rotor speeds for the HeartMate 3, indicating the importance of complete conversion to the HeartMate 3 graft from an engineering perspective.
ANNALS OF THORACIC SURGERY
(2022)
Article
Engineering, Biomedical
Katherine R. Whitehouse, Divya Avula, Tanvir Kahlon, Devan Costelle, Christina Dunbar-Matos, Siddharth Pahwa, Jaimin R. Trivedi, Mark S. Slaughter
Summary: This study compared adverse events between patients with a HeartMate 3 LVAD receiving apixaban and warfarin. The results showed that apixaban group had lower rates of bleeding complications and there were no significant differences in thrombotic complications and death. Therefore, apixaban may be a safe alternative anticoagulant therapy for HM3 LVAD patients.
Article
Cardiac & Cardiovascular Systems
Ezequiel J. Molina, Jennifer Cowger, Sangjin Lee, Douglas Horstmanshof, Joseph C. Cleveland Jr, Daniel J. Goldstein, Mandeep R. Mehra, Nir Uriel, Christopher T. Salerno, Kevin Bourque, Joyce Chuang, Yoshifumi Naka
Summary: Outcomes after HM3 implantation are comparable between smaller and larger patients. Smaller patients have different characteristics than larger patients in terms of gender distribution, prevalence of diabetes and hypertension, indexed left ventricular end-diastolic dimension, and serum creatinine concentration. However, the adverse event rates and the achievement of the composite primary endpoint are similar between the two groups at 2 years.
ANNALS OF THORACIC SURGERY
(2022)
Article
Cardiac & Cardiovascular Systems
Kevin Watanakeeree, Sukardi Suba, Lynda A. Mackin, Fabio Badilini, Michele M. Pelter
Summary: In LVAD patients, audible arrhythmia alarms have low accuracy, and technical alarms are frequent, with the majority being false and artifact alerts. Future studies are needed to explore strategies to improve arrhythmia detection and reduce technical alarms.
Article
Engineering, Biomedical
Cornelis W. van der Heiden, Casper F. Zijderhand, Kevin M. Veen, Alina A. Constantinescu, Olivier C. Manintveld, Jasper J. Brugts, Jos A. Bekkers, Ozcan Birim, Ad J. J. C. Bogers, Kadir Caliskan
Summary: We investigated the incidence of mechanical device malfunction in LVADs and found that it occurred significantly less in HeartMate 3 patients compared to HeartMate II patients.
Article
Cardiac & Cardiovascular Systems
Dylan Marshall, Joseph Sanchez, Melana Yuzefpolskaya, Gabriel T. Sayer, Koji Takeda, Yoshifumi Naka, Paolo C. Colombo, Nir Uriel, Veli K. Topkara
Summary: This retrospective study analyzed the use of RT in patients with HM3 LVAD and found that RT can reduce bleeding without increasing the incidence of thrombosis. Switching patients from ST to RT therapy significantly decreased the rate of major bleeding events.
JOURNAL OF HEART AND LUNG TRANSPLANTATION
(2021)
Article
Medicine, General & Internal
Agnieszka Kuczaj, Bartosz Hudzik, Jacek Kaczmarski, Piotr Przybylowski
Summary: Left ventricular assist devices are a treatment option for end-stage heart failure patients. However, bleeding and thromboembolic events significantly impact the survival and quality of life of these patients. Little is known about prognostic factors determining these adverse events. Therefore, this study aims to investigate the hemostasis system and fibrin clot properties in LVAD patients to identify prognostic factors of adverse outcomes.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Health Care Sciences & Services
Gregor Widhalm, Theodor Abart, Moritz Noeske, Lisa Kumer, Katharina Ebenberger, Clemens Atteneder, Angelika Berger, Guenther Laufer, Dominik Wiedemann, Daniel Zimpfer, Heinrich Schima, Michael Wagner, Thomas Schloeglhofer
Summary: This study evaluated the user experience of non-HeartMate 3 (LVAD) heart transplant patients and laypersons using LVAD peripherals in simulated everyday and emergency scenarios. The results showed that battery exchanges and power supply changes were more complex and some participants encountered hazardous situations. The study provides suggestions for improving the design of LVAD wearables.
JOURNAL OF MEDICAL SYSTEMS
(2023)
Article
Engineering, Biomedical
Rashmi Jain, Marlena V. Habal, Kevin J. Clerkin, Farhana Latif, Susan W. Restaino, Emmanuel Zorn, Koji Takeda, Yoshifumi Naka, Melana Yuzefpolskaya, Maryjane A. Farr, Paolo C. Colombo, Gabriel T. Sayer, Nir Uriel, Veli K. Topkara
Summary: This study found that HM3 is associated with a lower risk of de novo HLA sensitization compared with HMII, which has important clinical implications for patients with left ventricular assist devices.
Review
Medicine, General & Internal
Yue Qu, Anton Y. Peleg, David McGiffin
Summary: Ventricular assist device (VAD)-specific infections, particularly driveline infections, are a concerning complication of VAD implantation due to biofilm formation and migration. Despite multiple preventative strategies, driveline infections still have a high prevalence and unsatisfactory treatment outcomes.
JOURNAL OF CLINICAL MEDICINE
(2021)
Article
Medicine, General & Internal
Philipp Opfermann, Alessia Felli, Christine Schloemmer, Martin Dworschak, Michele Bevilacqua, Mohamed Mouhieddine, Daniel Zimpfer, Andreas Zuckermann, Barbara Steinlechner
Summary: This study found that preoperative Multiplate(R) and ROTEM(R) measurements can serve as indicators for assessing the risk of postoperative bleeding in LVAD patients, providing guidance for perioperative clinical management.
FRONTIERS IN MEDICINE
(2022)
Article
Hematology
Bastien Poitier, Richard Chocron, Christophe Peronino, Aurelien Philippe, Yuri Pya, Nadia Rivet, Ulysse Richez, Mahabbat Bekbossynova, Nicolas Gendron, Marc Grimme, Marie Cecile Bories, Julie Brichet, Antoine Capel, Jeanne Rancic, Benoit Vedie, Jean Christian Roussel, Anne-Sophie Jannot, Piet Jansen, Alain Carpentier, Peter Ivak, Christian Latremouille, Ivan Netuka, David M. Smadja
Summary: This study evaluates the potential hemolysis and acquired von Willebrand syndrome (AVWS) after A-TAH implantation. The results demonstrate that A-TAH support does not cause hemolysis or modify the multimers profile of VWF. Fluid structure interaction models and computational fluid dynamics simulations show an increase in blood damage with increasing cardiac output.
ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY
(2022)
Editorial Material
Cardiac & Cardiovascular Systems
Mandeep R. Mehra
JOURNAL OF CARDIAC FAILURE
(2022)
Article
Cardiac & Cardiovascular Systems
Hoong Sern Lim, Steven Shaw, Alexander W. Carter, Sahan Jayawardana, Elias Mossialos, Mandeep R. Mehra
Summary: This study conducted an indirect comparison between HM3 LVAD and medical therapy (MT) to evaluate the clinical and cost-effectiveness in the context of the UK National Health Service (NHS). The results indicate that HM3 LVAD therapy may be cost-effective for patients with advanced heart failure who are ineligible for heart transplantation, especially for those dependent on inotropic support. However, for ambulatory patients who do not require inotropic therapy, the cost-effectiveness ratio exceeds the willingness to pay threshold.
JOURNAL OF HEART AND LUNG TRANSPLANTATION
(2022)
Article
Cardiac & Cardiovascular Systems
Michael R. Zile, Akshay S. Desai, Maria Rosa Costanzo, Anique Ducharme, Alan Maisel, Mandeep R. Mehra, Sara Paul, Samuel F. Sears, Frank Smart, Christopher Chien, Ashrith Guha, Jason L. Guichard, Shelley Hall, Orvar Jonsson, Nessa Johnson, Poornima Sood, John Henderson, Philip B. Adamson, JoAnn Lindenfeld
Summary: During the COVID-19 pandemic, there were significant changes in heart failure event rates. Compared to the pre-COVID-19 period, the control group showed a decrease in the primary event rate, while the treatment group maintained a low event rate. These changes were not due to changes in provider- or disease-dependent factors, but were influenced by patient-dependent factors.
EUROPEAN HEART JOURNAL
(2022)
Article
Cardiac & Cardiovascular Systems
David M. Smadja, Peter Ivak, Yuri Pya, Christian Latremouille, Finn Gustafsson, Jean Christian Roussel, Andre Vincentelli, Erwan Flecher, Piet Jansen, Ivan Netuka
JOURNAL OF HEART AND LUNG TRANSPLANTATION
(2022)
Editorial Material
Cardiac & Cardiovascular Systems
Carl J. Lavie, Adrian daSilva-deAbreu, Hector O. Ventura, Mandeep R. Mehra
JOURNAL OF THE AMERICAN HEART ASSOCIATION
(2022)
Article
Engineering, Biomedical
Christophe Peronino, Coralie L. Guerin, Peter Ivak, Lea Guyonnet, Richard Chocron, Gregoire Detriche, Christian Latremouille, Maxime Gruest, Aurelien Philippe, Antoine Capel, Yuri Pya, Anne-Celine Martin, Piet Jansen, Nicolas Gendron, Ivan Netuka, David M. Smadja
Summary: This study aimed to assess the inflammatory status in patients with biventricular failure implanted with A-TAH. By evaluating leukocyte counts, inflammatory cytokines, and immune cell subpopulations, the study found no inflammatory signals in peripheral blood over the 12-month period following A-TAH implantation.
Article
Biochemistry & Molecular Biology
Zdenek Matloch, Milos Mraz, Barbora Judita Kasperova, Helena Kratochvilova, Petr Svoboda, Iveta Pleyerova, Katerina Reznickova, Sarah Norman, Daniel Hlavacek, Jakub Mahrik, Peter Ivak, Zdenka Lacinova, Ivan Netuka, Martin Haluzik
Summary: In this study, changes in serum CTRP3 and its gene expression in patients with CAD and T2DM undergoing cardiac surgery were examined. The results showed that decreased EAT mRNA levels of CTRP3 may contribute to higher risk of atherosclerosis in patients with CAD and T2DM.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Editorial Material
Cardiac & Cardiovascular Systems
Jacinthe Boulet, Aditi Nayak, Mandeep R. Mehra
JOURNAL OF CARDIAC FAILURE
(2022)
Article
Cardiac & Cardiovascular Systems
Mandeep R. Mehra, Aditi Nayak, Alanna A. Morris, David E. Lanfear, Hassan Nemeh, Sapna Desai, Aditya Bansal, Cesar Guerrero-Miranda, Shelley Hall, Joseph C. Cleveland, Daniel J. Goldstein, Nir Uriel, Leway Chen, Stephen Bailey, Anelechi Anyanwu, Gerald Heatley, Joyce Chuang, Jerry D. Estep
Summary: A patient-specific risk score was developed and validated to predict 1- and 2-year survival after HM3 LVAD implantation. This has important implications for guiding treatment decisions.
JACC-HEART FAILURE
(2022)
Editorial Material
Cardiac & Cardiovascular Systems
Hector O. Ventura, Carl J. Lavie, Mandeep R. Mehra
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
(2023)
Letter
Cardiac & Cardiovascular Systems
John W. Ostrominski, Sara R. Machado, Elias Mossialos, Mandeep R. Mehra, Muthiah Vaduganathan
JACC-HEART FAILURE
(2023)
Article
Cardiac & Cardiovascular Systems
Akshay S. Desai, Alan Maisel, Mandeep R. Mehra, Michael R. Zile, Anique Ducharme, Sara Paul, Samuel F. Sears, Frank Smart, Kunjan Bhatt, Selim Krim, John Henderson, Nessa Johnson, Philip B. Adamson, Maria Rosa Costanzo, Joann Lindenfeld
Summary: This study assessed the efficacy and safety of hemodynamic-guided heart failure (HF) management in patients with elevated natriuretic peptides (NPs) but no recent HF hospitalization (HFH). The results showed consistent effects of hemodynamic monitoring in both patient groups, supporting the consideration of hemodynamic monitoring in the expanded group of chronic HF patients with elevated NPs.
JACC-HEART FAILURE
(2023)
Editorial Material
Cardiac & Cardiovascular Systems
Mandeep R. Mehra, Aditi Nayak, Akshay S. Desai
Summary: Contemporary durable LVAD therapy remains an important approach in the care paradigm for patients with advanced HF. We suggest a strategy to timely recognize disease progression, effectively communicate therapeutic benefits, and enhance life quality and expectancy through timely referral and treatment for these vulnerable patients.
JACC-HEART FAILURE
(2023)
Meeting Abstract
Cardiac & Cardiovascular Systems
Z. Tucanova, M. Pokorny, O. Szarszoi, P. Ivak, M. Hegarova, H. Riha, I. Netuka
JOURNAL OF HEART AND LUNG TRANSPLANTATION
(2021)