Aarts, Emmeke

Asselbergs, Folkert W

Guenther, Sabina PW

Morshuis, Michiel

Numan, Lieke

Oerlemans, Marish IFJ

Oppelaar, Anne-Marie

Ramjankhan, Faiz Z

Riebandt, Julia

Schramm, Rene

van der Kaaij, Niels P

Van Laake, Linda W

Wiedemann, Dominik

Zimpfer, Daniel

English

UCL Discovery

Survival after HeartMate 3 left ventricular assist deviceimplantation: real-world data from EuropeSurvival of end-stage heart failure patients on left ventricularassist device (LVAD) support continuously increases.1 Nowa-days, the HeartMate 3 (HM3, Abbott, Chicago, IL, USA) LVADis most commonly implanted. Mehra et al. showed a 5 yearsurvival of 58.4% in HM3 patients included in theextended-phase analysis of the MOMENTUM 3 trial. Patientsincluded in this trial were treated in the United States.2 LVADpatient selection and donor heart availability differ betweenUnited States and Europe.3 In addition, outcomes in clinicaltrials may differ from those in common practice due to pa-tient selection criteria and intensity of follow-up.The aim of this study was to present the real world longterm survival data of HM3 patients implanted in three largecentres in Europe.A cohort study was performed that was approved by thelocal ethics committee of the University Medical CentreUtrecht (UMCU), the Netherlands (METC: 20-195). The needfor informed consent was waived. The study was conductedin accordance with Good Clinical Practice and the 2002Declarations of Helsinki. Patients primarily implanted withHM3 between December 2015 and December 2019 in threeEuropean participating centres were included for analysis.Participating centres were University Medical CentreUtrecht (UMCU, the Netherlands), Heart and Diabetes CentreNorth Rhine-Westphalia (HDZ NRW, Bad Oeynhausen,Germany) and the Medical University of Vienna (MedUni Vi-enna, Austria).4 Baseline characteristics and survival datawere retrieved from the electronic health record and localdatabases. Patients were followed-up until September 2022.The primary and secondary endpoints were survival and sur-vival free from stroke and pump replacement, respectively.Kaplan–Meier analysis was used to evaluate the endpoints,censoring for LVAD explantation, heart transplantation or on-going support at the end of the follow-up. Stroke (includingboth haemorrhagic and ischemic stroke) was defined usingthe definition of the Interagency Registry for MechanicallyAssisted Circulatory Support (INTERMACS).5 Baseline charac-teristics were presented as mean and standard deviation ormedian and interquartile range (IQR). All statistical analyseswere done using R software version 4.0.3.In total, 377 patients were included for analysis. Themedian time from primary implantation to the end of thefollow-up was 4.4 years (IQR 2.2 years). Patients had amedian age of 60 at implantation and 83.6% were male(Table 1). Baseline characteristics were complete forall patients except for diabetes, stroke in medical historyTable 1 Baseline demographics of all primary HeartMate 3 implantations in all three included centres compared to MOMENTUMcharacteristicsVariableTotal(n = 377)UMCU(n = 80)HDZ NRW(n = 194)MedUni Vienna(n = 103)MOMENTUM 3(n = 515)Age, median (IQR), years 60 (52–66) 56 (47–61) 60 (53–66) 64 (56–68) 62 (52–68)Sex (% male) 315 (83.6) 52 (65.0) 171 (88.1) 92 (89.3) 410 (79.6)BSA, mean (SD), m2 2.03 (0.21) 1.98 (0.23) 2.05 (0.20) 2.03 (0.20) 2.07 (0.27)BMI, median (IQR), kg/m2 25.7 (23.1–29.4) 24.7 (21.6–27.8) 25.7 (23.6–29.6) 27.2 (24.2–31.2) 28.4 (24.6–33.0)Ischemic CMP (%) 185 (49.1) 19 (23.8) 98 (50.5) 68 (66.0) 216 (41.9)Diabetes (%) 109 (30.0) 12 (15.0) 63 (35.0) 34 (33.0) 233 (45.2)Stroke (%) 32 (8.8) 3 (3.8) 21 (11.7) 8 (7.8) 50 (9.7)eGFR (mL/min/1.73 m2) 51 (36–70) 61 (43–83) 53 (36–78) 41 (32–53) 58 (43–75)INTERMACS (%)1–2 198 (52.5) 41 (51.2) 114 (58.8) 43 (41.7) 167 (32.5)3 98 (26.0) 21 (26.2) 56 (28.9) 21 (20.4) 272 (52.9)4–7 81 (21.5) 18 (22.5) 24 (12.4) 39 (37.9) 75 (14.6)IABP (%) 8 (2.1) 1 (1.2) 6 (3.1) 1 (1.0) 64 (12.4)BMI, body mass index; BSA, body surface area; CMP, cardiomyopathy; eGFR, estimated glomerular filtration rate; HDZ NRW, Heart andDiabetes Centre North Rhine-Westphalia; INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support; MedUni Vi-enna, Medical University of Vienna; UMCU, University Medical Centre Utrecht.LETTER TO THE EDITOR© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any me-dium, provided the original work is properly cited and is not used for commercial purposes.ESC HEART FAILUREESC Heart Failure 2023; 10: 2754–2756Published online 2 July 2023 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.14444(i.e. before LVAD) and eGFR, with 3.7%, 3.7% and 8.2% miss-ing data, respectively. One hundred forty-four patients (38%)died, 7 patients (2%) were explanted and 75 patients (20%)were transplanted during follow-up. Eight patientsunderwent replacement surgery after a median of 419 days(IQR: 892 days). Sixty-two patients suffered from a stroke af-ter a median of 159 days (IQR: 436 days). Figure 1 shows sur-vival of all HM3 patients, with a 5 year survival of 54%. Sur-vival free from stroke and pump replacement was 48% at5 years.HM3 is increasingly used in end-stage heart failure patientswith a 5 year survival of 54.0% in three large centres acrossEurope. To put this in perspective, patients included in theextended phase of the MOMENTUM 3 trial had a survival of58.4% at 5 years.6 Moreover, they showed a survival free ofdebilitating stroke or pump replacement of 54.0% at 5 years,which is in line with our results. Although we used a slightlystricter definition in our database(s) and included allhaemorrhagic stroke and ischemic stroke, whereas the ex-tended Momentum 3 study used ‘disabling stroke’. Neverthe-less the results are similar, compatible with the very low rateof disabling stroke seen in both studies. Patients in the MO-MENTUM cohort and our cohort differ in baseline character-istics, due to a different patient selection in the United Statesand Europe. Our cohort included patients with a lower BMIand lower prevalence of diabetes, a higher number of pa-tients with ischemic cardiomyopathy, and more kidney dys-function. In addition, patients more often were classified asINTERMACS 1 or 2 cLassification before implantation com-pared to patients included in the MOMENTUM 3 trial. LVADpatients awaiting a donor heart in the United States have ashorter median duration of LVAD support and a higher fre-quency of comorbid conditions when compared to patientsin Europe.3 Despite differences in patient selection and donorheart availability, long-term survival after HM3 implantationis comparable. In addition, the ELEVATE registry showed sim-ilarly beneficial outcomes in a cohort of 463 patients from 26centres in Europe and the Middle East, although the cohortwas slightly different in some baseline characteristics.7,8 Forexample, they included more male patients, less patientsclassified as INTERMACS 1 or 2 and patients were slightlyyounger when compared to our cohort, including 377 im-planted in three large volume centres.In conclusion, real-world data from patients on HM3 sup-port implanted in Europe confirm the promising findings ofthe MOMENTUM 3 trial, demonstrating the vital role of LVADtherapy in contemporary treatment of advanced heartfailure.Lieke NumanDepartment of Cardiology, University Medical CenterUtrecht, Utrecht University, Utrecht, The NetherlandsRene SchrammClinic for Thoracic- and Cardiovascular Surgery, Heart andDiabetes Center Northrhine Westfalia, Ruhr-UniversityBochum, Bad Oeynhausen, GermanyMarish I.F.J. OerlemansDepartment of Cardiology, University Medical CenterUtrecht, Utrecht University, Utrecht, The NetherlandsNiels P. van der KaaijDepartment of Cardiothoracic Surgery, University MedicalCentre Utrecht, University of Utrecht, Utrecht, TheNetherlandsEmmeke AartsDepartment of Methodology and Statistics, Utrecht Uni-versity, Utrecht, The NetherlandsFigure 1 (A) Long-term survival of patients on HeartMate 3 left ventricular assist device support. (B) Survival free from stroke and pump replacement.Letter to the Editor 2755ESC Heart Failure 2023; 10: 2754–2756DOI: 10.1002/ehf2.14444 20555822, 2023, 4, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/ehf2.14444 by University College London UCL Library Services, Wiley Online Library on [11/08/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons LicenseFaiz Z. RamjankhanDepartment of Cardiothoracic Surgery, University MedicalCentre Utrecht, University of Utrecht, Utrecht, TheNetherlandsAnne-Marie OppelaarDepartment of Cardiothoracic Surgery, University MedicalCentre Utrecht, University of Utrecht, Utrecht, TheNetherlandsMichiel MorshuisClinic for Thoracic- and Cardiovascular Surgery, Heart andDiabetes Center Northrhine Westfalia, Ruhr-UniversityBochum, Bad Oeynhausen, GermanySabina P.W. GuentherClinic for Thoracic- and Cardiovascular Surgery, Heart andDiabetes Center Northrhine Westfalia, Ruhr-UniversityBochum, Bad Oeynhausen, GermanyDaniel ZimpferDepartment of Cardiac Surgery, Medical University ofVienna, Vienna, AustriaJulia RiebandtDepartment of Cardiac Surgery, Medical University ofVienna, Vienna, AustriaDominik WiedemannDepartment of Cardiac Surgery, Medical University ofVienna, Vienna, AustriaFolkert W. AsselbergsDepartment of Cardiology, University Medical CenterUtrecht, Utrecht University, Utrecht, The NetherlandsFaculty of Population Health Sciences, Institute of Cardio-vascular Science, University College London, London, UKHealth Data Research UK and Institute of Health Informat-ics, University College London, London, UKDepartment of Cardiology, Amsterdam Cardiovascular Sci-ences, Amsterdam University Medical Centre, University ofAmsterdam, Amsterdam, The NetherlandsE-mail: f.asselbergs@ucl.ac.ukLinda W. Van LaakeDepartment of Cardiology, University Medical CenterUtrecht, Utrecht University, Utrecht, The NetherlandsReferences1. Shah P, Yuzefpolskaya M, Hickey GW,Breathett K, Wever-Pinzon O, Ton VK,Hiesinger W, Koehl D, Kirklin JK, CantorRS, Jacobs JP, Habib RH, Pagani FD,Goldstein DJ. Twelfth Interagency Regis-try for Mechanically Assisted CirculatorySupport Report: readmissions after leftventricular assist device. Ann Thorac Surg.2022; 113: 722–737.2. Mehra MR, Uriel N, Naka Y, Cleveland JCJr, Yuzefpolskaya M, Salerno CT, WalshMN, Milano CA, Patel CB, Hutchins SW,Ransom J, Ewald GA, Itoh A, Raval NY,Silvestry SC, Cogswell R, John R,Bhimaraj A, Bruckner BA, Lowes BD, UmJY, Jeevanandam V, Sayer G, Mangi AA,Molina EJ, Sheikh F, Aaronson K, PaganiFD, Cotts WG, Tatooles AJ, Babu A,Chomsky D, Katz JN, Tessmann PB, DeanD, Krishnamoorthy A, Chuang J, TopuriaI, Sood P, Goldstein DJ. A fully magneti-cally levitated left ventricular assist de-vice — final report. N Engl J Med. 2019;380: 1618–1627.3. 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ESC Heart Fail. 2023; 10:1656–1665.5. Kormos RL, Antonides CFJ, GoldsteinDJ, Cowger JA, Starling RC, Kirklin JK,Rame JE, Rosenthal D, Mooney ML,Caliskan K, Messe SR, Teuteberg JJ,Mohacsi P, Slaughter MS, Potapov EV,Rao V, Schima H, Stehlik J, Joseph S,Koenig SC, Pagani FD. Updated defini-tions of adverse events for trials andregistries of mechanical circulatory sup-port: a consensus statement of the me-chanical circulatory support academicresearch consortium. J Heart LungTransplant. 2020; 39: 735–750.6. Mehra MR, Goldstein DJ, Cleveland JC,Cowger JA, Hall S, Salerno CT, Naka Y,Horstmanshof D, Chuang J, Wang AJ,Uriel N. Five-year outcomes in patientswith fully magnetically levitated vsaxial-flow left ventricular assist devicesin the MOMENTUM 3 randomized trial.JAMA. 2022; 328: 1233–1242.7. Zimpfer D, Gustafsson F, Potapov E, PyaY, Schmitto J, Berchtold-Herz M,Morshuis M, Shaw SM, Saeed D, LaveeJ, Heatley G, Gazzola C, Garbade J.Two-year outcome after implantation ofa full magnetically levitated left ventric-ular assist device: results from the ELE-VATE registry. Eur Heart J. 2020; 41:3801–3809.8. Schmitto JD, Shaw S, Garbade J. Long-term results in real world patients treatedwith HeartMate 3 LVAD for advancedheart failure: data frm the ELEVATE reg-istry. Presented at: European Associationfor Cardio-Thoracic Surgery (EACTS) An-nual Meeting; 2022; Milan, Italy.2756 Letter to the EditorESC Heart Failure 2023; 10: 2754–2756DOI: 10.1002/ehf2.14444 20555822, 2023, 4, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/ehf2.14444 by University College London UCL Library Services, Wiley Online Library on [11/08/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

Survival after HeartMate 3 left ventricular assist device

implantation: real-world data from Europe

https://discovery.ucl.ac.uk/10175071/1/ESC%20Heart%20Failure%20-%202023%20-%20Numan.pdf

Survival after HeartMate 3 left ventricular assist device implantation: real-world data from Europe

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