Cowger, Jennifer A

Goldstein, Daniel

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Henry Ford Health Henry Ford Health Scholarly Commons Cardiology Articles Cardiology/Cardiovascular Research 7-10-2021 An opportunity to begin again Jennifer A. Cowger Henry Ford Health, jcowger1@hfhs.org Daniel Goldstein Henry Ford Health Follow this and additional works at: https://scholarlycommons.henryford.com/cardiology_articles Recommended Citation Cowger JA, and Goldstein DJ. An opportunity to begin again. J Heart Lung Transplant 2021. This Article is brought to you for free and open access by the Cardiology/Cardiovascular Research at Henry Ford Health Scholarly Commons. It has been accepted for inclusion in Cardiology Articles by an authorized administrator of Henry Ford Health Scholarly Commons. EDITORIALAn opportunity to begin againJennifer A. Cowger, MD, MS, and Daniel J. Goldstein, MDFrom the Cardiovasclar Medicine, Section of Advanced Heart Failure and Cardiac Transplant, Henry Ford Health System,Detroit, Michigan.On June 3, 2021, Medtronic Inc. (Minneapolis, MN)announced that it was terminating the manufacturing anddistribution of the HVAD system, simultaneously instruct-ing medical centers to cease further HVAD implants. 1 Thenews was followed by a tidal wave of emotions within theinternational mechanical circulatory support (MCS) com-munity, reminiscent of the feelings engendered by theretirement of the HeartMate XVE (Thoratec, Pleasanton,CA) in 2011 and the rapidly fading use of the HeartMate II(Abbott, Inc., Abbott Park, IL) in the past 5 years. As wereflect on the contributions of the HVAD system to MCSinnovation, we also need to cogitate about the present andfuture of the advanced heart failure field, including what isneeded to foster the continued evolution of durable MCSand how to ensure our profession becomes more pertinentto referring cardiologist and payors.The HVAD in PerspectiveThe HVAD was groundbreaking, miniaturized continuousflow technology. In contrast to the axial flow HeartMate II,which had blood inflow and outflow paths oriented parallelto the axis of rotation, the HVAD pump relied on centrifu-gal flow technology that propelled blood tangentially viaspinning discs suspended by hydrodynamic levitation. 2The centrifugal engineering of the HVAD imparted greaterflow sensitivity in relation to preload and afterload(described via the device head-pressure curve) which trans-lated within the human human vasculature as pulsations ofblood flow.2 While the impact on pulse pressure was highlyvariable between patients, the attempt of the HVAD systemto mimic physiologic pulsatility as a means of improvinghemocompatibility was met with zeal within the MCS com-munity. With over 18,000 implants worldwide, the HVADsystem prolonged survival and quality of life for manypatients with advanced refractory heart failure.1,3-5 Notably,the miniaturized technology opened the gateway of durableMCS to heart failure patients with small body surface areas,including women and children, for whom paracorporealtemporary support was previously their only option.6 Addi-tionally, the small size of the HVAD was welcomed bymany surgeons as it facilitated the implant procedure andallowed for the development of sternal-sparing, minimallyinvasive implant techniques.7 Moreover, for patients withbiventricular failure, the HVAD offered the innovative pos-sibility of dischargeable, durable biventricular assist devicesupport via off-label use.8 The experience gleaned from theHVAD encouraged industry to focus on areas for improve-ments in device engineering to reduce adverse events andto improve patient lifestyle through more compact periph-erals. Though achieved at a high empirical cost, the accruedHVAD clinical trial data highlighted the importance ofblood pressure control for optimization of device flow andto mitigate neurologic events.9,10The decision by Medtronic to retire the HVAD wasattributed to the “. . . growing body of observational clinicalcomparisons indicating a higher frequency of neurologicaladverse events, including stroke and mortality with theHVAD TM System as compared to other circulatory supportdevices available to patients. 1” Such evidence includedcomparative outcomes analyses of patients enrolled intoIntermacs, demonstrating 87% vs 80% 1-year survivals inpropensity matched patients supported with third generationHeartMate 3 (Abbott, Inc) centrifugal flow technology vs.HVAD, respectively, 11-13 as well as comparative data fromHeartMate 3 patients enrolled into the MOMENTUM 3clinical trial14. Additionally, Medtronic acknowledged con-cerns over failure of HVAD pumps to restart after controllerexchange or other instances of power loss and pump stop-page.1 However, when one examines MCS trends in thefield prior to this decision, the yearly frequency of durableMCS implants had already plateaued or had started todecline in many countries, including the United States(U.S.)15, and the bulk of the market had started to shifttoward third generation technology.15 In the field of MCSwhere technologic evolution is mandatory for therapeuticReprint requests: Jennifer A. Cowger,MD, MS, Cardiovascular Medi-cine, Henry Ford Health System, 2799 West Grand Blvd K14, Detroit, MI48202. Telephone: 313 916 2966. Fax: 313 916 8799.E-mail address: jennifercowger@gmail.com1053-2498/$ - see front matter  2021 International Society for Heart and Lung Transplantation. All rights reserved.https://doi.org/10.1016/j.healun.2021.07.003ARTICLE IN PRESShttp://www.jhltonline.orgDownloaded for Anonymous User (n/a) at Henry Ford Hospital / Henry Ford Health System (CS North America) from ClinicalKey.com by Elsevier on August 23, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.extension into more patients with advancing heart failure,the HVAD system should not be remembered as an inciden-tal technological failure but rather, as a sound and substanti-ative option that underscored the purported benefits ofcontinuous over pulsatile flow, packaged into a small,widely applicable and easy-to-implant pump.The present and future of the field of advancedheart failureThe sure-footedness of our field, especially within the U.S.,is being challenged in several ways. An unprecedented pan-demic turned off the spigot of our economy and affectedlives and livelihoods in way unimaginable prior to 2020.The COVID-19 pandemic exposed deep-rooted health careinequities and deficiencies in the preparedness of our globalhealth care systems, indubitably impacting the ability ofadvanced heart failure patients to seek care and our capacityto provide it. During 2020 and 2021, our field’s mission toadvance heart failure management felt trivial comparedwith the battle to save humanity from COVID-19. As such,MCS volumes fell and global heart failure outcomes tran-siently suffered.15-17Antecedent to this, an attempt to reduce heart transplantwaitlist mortality and geographic disparities led the UnitedNetwork of Organ Sharing (UNOS) to amend organ alloca-tion in the U.S. This policy change in late 201818 had amonumental - yet unsurprising - impact on advanced heartfailure in the U.S. with reverberations felt globally due tothe large market share that the U.S. has on MCS. The newUNOS policy favored the direct-to-transplant route overbridging with durable MCS, thereby effectively changingthe phenotype and intent of durable MCS patients in the U.S.18 Within our own community, some practitioners beganto lose enthusiasm for durable MCS, 19 favoring directtransplantation despite the laudable 84% 2-year survival onthird generation technology (mirroring the 82% survivalsattained with cardiac transplantation)20 and the dramaticreduction in the burden of hemocompatibility-relatedadverse events.14 These negative sentiments and trends inMCS utilization should trigger considerable concern. Fail-ure of advanced heart failure practitioners to embrace whatthe field has achieved with modern MCS support couldresult in future patient disenfranchisement and impede ourability to recruit promising young faculty into the profes-sion. Importantly, while transplantation carries a meaning-ful impact for the fortunate few recipients, it remainsepidemiologically trivial, even as efforts to expand thedonor pool with use of Hepatitis C 21 and DCD hearts 22 arebeing embraced. If governments, payors, and investorsinterpret the MCS market as stagnant, failing, or antiquated,the desire to expand MCS support or support new technolo-gies and innovation will wane.Outside of the heart failure community, widespreadacceptance of durable MCS as a management strategy foradvanced heart failure is lacking and patient care is increas-ingly siloed. To most cardiologists and cardiac surgeons,our offerings remain foreign or unfamiliar, and their generalknowledge of contemporary survival and quality of lifewith durable MCS and transplant remains woefully insuffi-cient. Yet, implementation of temporary circulatory supportfor cardiogenic shock management has soared despite highupfront care costs and even higher short- and longer-termmortalities23. In this patient population with so much togain from durable MCS and transplant, the utilization ofadvanced heart failure therapies in cardiogenic shockremains perplexingly low. Similarly, the extension of per-cutaneous mitral valve interventions for management offunctional mitral regurgitations in patients with lower ejec-tion fraction is rapidly growing, yet one year mortalityremains high.24 With advanced heart failure care becomingincreasingly attractive to other specialists (structural heart,electrophysiology), more and more care siloes have devel-oped, increasing the potential for delayed or insufficientreferrals despite years of data supporting the benefit of ourtherapies. Our specialty is at risk of becoming increasinglyniche or overlooked.Added to the above commingling forces is the unfore-seen dissolution of the long existing durable MCS duopolyenacted by the retirement of the HVAD. This newfoundmonopoly has introduced a sense of disquiet among heartfailure practitioners. These feelings are compounded by thereality that, because HVAD was the intended platform forMedtronic’s device evolution, new technologies in thedurable MCS pipeline from other manufacturers will likelynot be available for approved clinical use for years. Compe-tition in industry is important to make products better, tomake products different, and to improve market awareness,efficiency, pricing and customer satisfaction. More thanever, the field of MCS needs competition.A time for unity within the advanced heartfailure communityAt a time when the field of MCS is being challenged by alack of imminent new technologies, a durable MCS marketdominated by a single device, falling implant volumes, andcompetition from other cardiac specialists, it is time for theinternational field of advanced heart failure to unify itsefforts and to celebrate the astounding victories achieved ina mere 2 decades of scientific endeavor. The challengesabove cannot be met with pessimism or laissez faire indif-ference. While fortunate to have a third-generation technol-ogy with excellent early survival, we must continue ourquest to devise technologies that can successfully competewith transplantation for long-term survival. Similar to pace-makers and cardiac resynchronization therapy, we needdurable MCS devices to be “forgettable” to the patient, lessonerous for practitioners to manage, with lower readmissionand adverse event burdens.Admittedly, our efforts to educate and emphasize thepertinence of our treatment options to the general cardiol-ogy community have lacked broad and coordinated messag-ing. Along these lines, we propose that the immediate aimsfor the Advanced Heart Failure field should include: (1) anexpansion of advanced heart failure specialists and durableARTICLE IN PRESS2 The Journal of Heart and Lung Transplantation, Vol 00, No 00, Month 2021Downloaded for Anonymous User (n/a) at Henry Ford Hospital / Henry Ford Health System (CS North America) from ClinicalKey.com by Elsevier on August 23, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.MCS support within the general community; (2) a revisionof society guideline documents to better reflect the benefitsof MCS and transplant for many patients with end-stageheart failure (e.g., advanced heart failure evaluation forMCS and transplantation should be a Class I recommenda-tion for patients with recalcitrant cardiogenic shock or ino-trope dependence). This will require increased visibility ofkey opinion leaders at the more inclusive cardiology spe-cialty academic meetings; (3) the addition of an advancedheart failure specialist evaluation for high-risk heart failurepatients to payor or governmental quality metrics; and (4)the incorporation of a heart failure specialist within theinterdisciplinary structural heart, critical care, and cardio-genic shock teams so optimal therapy can be provided forthe patient with systolic heart failure.Thus, as we celebrate the history of HVAD system, thesuccess of third generation MCS technology, and the prom-ise of extended cardiac donation, we need to join forces topromote our field with an aim to change the global impres-sion that advanced heart failure care is a niche market. Weneed to tear down care silos within and between institutionsso we can increase our offerings to those with refractoryheart failure. Finally, our technology needs to continue toevolve to remain pertinent and less intimidating to patientsand providers. Henry Ford, a man who revolutionized theautomotive field, said “failure is simply the opportunity tobegin again, and this time more intelligently.” Our field,replete with brilliant minds, skilled surgeons, and life-sav-ing medical technology, will reinvent itself again with thesole aim to allow our advanced heart failure patients theopportunity to truly live and breathe again. We cannot losesight of these opportunities. Carpe diem.DisclosuresJennifer Cowger MD, MS- Advisory Board member andspeaker for Abbott (HeartMate 3 and Tendyne); AdvisoryBoard, speaker and National Co-pI for Medtronic (HVAD);Steering committee member for Procyrion (Aortix device)and Cordella (Endotronix device). Speaker for Zoll Medical(Zoll Lifevest). Henry Ford receives clinical trial fundsfrom Abbott, Medtronic, Procyrion, and Cordella.Danielle Goldstein, MD- Consultant (paid) and nationalCo-PI (unpaid) for Abbott and Abiomed technologies.References1. Urgent Medical Device Communication Notification Letter MedtronicHVADTM System 2021. https://www.medtronic.com/us-en/e/hvad-sys-tem-transition.html. Accessed June 5, 2021.2. Tang PC, Pagani FD. Continuous-flow device engineering and pumptechnology. Cardiol Clin 2018;36:451-63.3. Aaronson KD, Slaughter MS, Miller LW, et al. Use of an intrapericar-dial, continuous-flow, centrifugal pump in patients awaiting hearttransplantation. Circulation 2012;125:3191-200.4. Milano C, Pagani FD, Slaughter MS, et al. Clinical outcomes afterimplantation of a centrifugal flow left ventricular assist device andconcurrent cardiac valve procedures. Circulation 2014;130(11 Suppl1):S3-11.5. Rogers JG, Pagani FD, Tatooles AJ, et al. Intrapericardial left ventric-ular assist device for advanced heart failure. N Engl J Med 2017;376:451-60.6. Auerbach SR, Simpson KE. Action learning network I. HVAD usageand outcomes in the current pediatric ventricular assist device field: anadvanced cardiac therapies improving outcomes network (ACTION)analysis. ASAIO J 2021;67(6):675-80.7. Wieselthaler GM, Klein L, Cheung AW, et al. Two-Year follow up ofthe LATERAL clinical trial: a focus on adverse events. Circ HeartFail 2021;14:e006912.8. Shehab S, Macdonald PS, Keogh AM, et al. Long-term biventricularHeartWare ventricular assist device support−case series of right atrialand right ventricular implantation outcomes. J Heart Lung Transplant2016;35:466-73.9. Milano CA, Rogers JG, Tatooles AJ, et al. HVAD: the ENDURANCEsupplemental trial. JACC Heart Fail 2018;6:792-802.10. Teuteberg JJ, Slaughter MS, Rogers JG, et al. The HVAD left ventric-ular assist device: risk factors for neurological events and risk mitiga-tion strategies. JACC Heart Fail 2015;3:818-28.11. Teuteberg JJ, Stewart GC, Jessup M, et al. Implant strategies changeover time and impact outcomes: insights from the INTERMACS(Interagency Registry for Mechanically Assisted Circulatory Support).JACC Heart Fail 2013;1:369-78.12. Pagani FD, Mehra MR, Cowger JA, et al. Clinical outcomes andhealthcare expenditures in the real world with left ventricular assistdevices - the CLEAR-LVAD study. J Heart Lung Transplant 2021;40:323-33.13. Pagani FD, Cantor R, Cowger J, et al. Concordance of treatment effect:an analysis of the society of thoracic surgeons intermacs database. AnnThorac Surg 2021. https://doi.org/10.1016/j.athoracsur.2021.05.017. Inpress.14. Mehra MR, Uriel N, Naka Y, et al. A fully magnetically levitated leftventricular assist device - final report. N Engl J Med 2019;380:1618-27.15. Molina EJ, Shah P, Kiernan MS, et al. The Society of Thoracic Sur-geons Intermacs 2020 annual report. Ann Thorac Surg 2021;111:778-92.16. Shoaib A, Van Spall HGC, Wu J, et al. Substantial decline in hospitaladmissions for heart failure accompanied by increased communitymortality during COVID-19 pandemic. Eur Heart J Qual Care ClinOutcomes 2021;7:378-87.17. Bollmann A, Hohenstein S, K€onig S, Meier-Hellmann A, Kuhlen R,Hindricks G. In-hospital mortality in heart failure in Germany duringthe Covid-19 pandemic. ESC heart failure 2020;7:4416-9.18. https://optn.transplant.hrsa.gov/learn/professional-education/adult-heart-allocation/. 2018. Accessed June 29, 2021.19. Mullan CW, Sen S, Ahmad T. Left ventricular assist devices versusheart transplantation for end stage heart failure is a misleading equiva-lency. JACC Heart Fail 2021;9:290-2.20. Teuteberg JJ, Cleveland JC Jr., Cowger J, et al. The Society of Tho-racic Surgeons Intermacs 2019 annual report: the changing landscapeof devices and indications. Ann Thorac Surg 2020;109:649-60.21. Aslam S, Grossi P, Schlendorf KH, et al. Utilization of hepatitis Cvirus-infected organ donors in cardiothoracic transplantation: AnISHLT expert consensus statement. J Heart Lung Transplant 2020;39:418-32.22. Messer S, Cernic S, Page A, et al. A 5-year single-center early experi-ence of heart transplantation from donation after circulatory-deter-mined death donors. J Heart Lung Transplant 2020;39:1463-75.23. Shah M, Patnaik S, Patel B, et al. Trends in mechanical circulatorysupport use and hospital mortality among patients with acute myocar-dial infarction and non-infarction related cardiogenic shock in theUnited States. Clin Res Cardiol 2018;107:287-303.24. Alperi A, Granada JF, Bernier M, Dagenais F, Rodes-Cabau J. Currentstatus and future prospects of transcatheter mitral valve replacement:JACC state-of-the-art review. J Am Coll Cardiol 2021;77:3058-78.ARTICLE IN PRESSCowger and Goldstein An opportunity to begin again 3Downloaded for Anonymous User (n/a) at Henry Ford Hospital / Henry Ford Health System (CS North America) from ClinicalKey.com by Elsevier on August 23, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.

An opportunity to begin again

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An opportunity to begin again

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