Outcomes of the First 1300 Adult Heart Transplants in the United States After the Allocation Policy Change
2020; Lippincott Williams & Wilkins; Volume: 141; Issue: 20 Linguagem: Inglês
10.1161/circulationaha.119.045354
ISSN1524-4539
AutoresArman Kilic, Gavin Hickey, Michael A. Mathier, Robert L. Kormos, Ibrahim Sultan, Thomas G. Gleason, Mary Keebler,
Tópico(s)Renal Transplantation Outcomes and Treatments
ResumoHomeCirculationVol. 141, No. 20Outcomes of the First 1300 Adult Heart Transplants in the United States After the Allocation Policy Change Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBOutcomes of the First 1300 Adult Heart Transplants in the United States After the Allocation Policy Change Arman Kilic, MD, Gavin Hickey, MD, Michael A. Mathier, MD, Robert L. Kormos, MD, Ibrahim Sultan, MD, Thomas G. Gleason, MD and Mary E. Keebler, MD Arman KilicArman Kilic Arman Kilic, MD, Division of Cardiac Surgery, University of Pittsburgh Medical Center, 200 Lothrop St, Suite C-700, Pittsburgh, PA 15213. Email E-mail Address: [email protected] https://orcid.org/0000-0001-8112-8345 Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Gavin HickeyGavin Hickey Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Michael A. MathierMichael A. Mathier Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Robert L. KormosRobert L. Kormos Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Ibrahim SultanIbrahim Sultan Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Thomas G. GleasonThomas G. Gleason Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author and Mary E. KeeblerMary E. Keebler Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author Originally published18 May 2020https://doi.org/10.1161/CIRCULATIONAHA.119.045354Circulation. 2020;141:1662–1664Heart allocation policy was changed on October 18, 2018, to address several concerns with the previous system.1 We reviewed adult heart transplants performed in the United States between January 1, 2018, and March 31, 2019, and stratified patients based on date of waitlist registration and transplantation, with follow-up data through June 6, 2019. Changes in baseline characteristics, as well as waitlist and posttransplant outcomes, were compared. The institutional review board approved this study at the University of Pittsburgh Medical Center.The primary end point was overall survival after transplantation. Secondary end points included waitlist outcomes: waitlist mortality or clinical deterioration, rate of transplantation, and removal from the waitlist because of recovery. Student t test and χ2 tests were used. Time-to-event analyses were performed using the Kaplan-Meier method. Multivariable Cox regression analysis was used for risk adjustment. Waitlist outcomes were analyzed by using competing risks regression and the Fine and Gray method.A total of 3258 adult patients were waitlisted before the policy change and 1759 were waitlisted after the policy change. A total of 2371 and 1311 adult heart transplants were performed before and after the policy change, respectively. After the policy change, recipients were younger (54.3±12.7 versus 52.9±13.2 years; P=0.002) and more had nonischemic dilated cardiomyopathy (50.9% versus 52.0%) and congenital heart disease (3.4% versus 5.3%; P=0.03). Higher risk characteristics, including serum bilirubin (0.91±1.45 versus 1.17±2.44; P<0.001), mechanical ventilation (0.7% versus 2.4%; P<0.001), pretransplant intensive care unit (28.7% versus 47.0%; P<0.001), and bridging with the percutaneous Impella device (0.2% versus 0.6%; P=0.02), intra-aortic balloon pump (IABP; 7.1% versus 22.4%; P<0.001), surgically implanted temporary left ventricular assist devices (LVADs; 1.5% versus 3.9%; P<0.001), or extracorporeal membrane oxygenation (1.1% versus 4.9%; P<0.001) were greater after the policy change. Fewer recipients had durable LVADs after the change (44.8% versus 36.0%; P<0.001). More donors were hepatitis C positive (7.9% versus 11.1%; P=0.001) and had higher creatinine (1.51±1.52 versus 1.65±1.76; P=0.01) in the latter era. There were longer donor-to-recipient hospital distances (156.7±189.4 versus 264.6±241.9 miles; P<0.001) and cold ischemic times (3.02±1.01 versus 3.38±1.02 hours; P<0.001) after the policy change. Under the new policy, the distribution of statuses at transplantation was as follows: 8.6% status 1, 42.8% status 2, 26.2% status 3, 18.3% status 4, 0.3% status 5, and 3.7% status 6.Waitlist outcomes were improved after the policy change, with higher rates of transplantation (P<0.001) and lower rates of waitlist mortality or clinical deterioration (P=0.01; Figure, A and B). Rates of waitlist removal for recovery were low in both groups but lower after the policy change (P=0.01). Posttransplant survival was worse after the policy change, with 6-month survivals of 93.7% versus 86.5% (P<0.001). Similar findings persisted when limiting the analysis to first-time, primary isolated heart transplants (6-month survival: 93.9% versus 88.2%; P 3-fold, suggesting that many programs are favoring the use of IABP when hemodynamically indicated rather than increasing intravenous inotropes or durable LVAD implantation. These changes reflect the priority statuses that are applied under the new system, whereby patients with IABP are prioritized as status 2, and only in the setting of device malfunction, mechanical right ventricular support, or significant ventricular arrhythmias are patients with durable LVADs able to get priority status 1 or 2 listing.The current analysis demonstrates a shift favoring the improvement of waitlist outcomes with a decline in posttransplant survival. This appears to be a reflection of performing transplants in sicker patients with broader sharing of organs and longer ischemic times. The 6-month survival rates we demonstrate after the new policy change are lower than previously reported rates from registry analyses. It is important to note, however, that individual transplant centers are evaluated based on observed-to-expected ratios and not absolute outcomes. The models used for expected risk incorporate many of the risk factors identified as increasing in frequency after the policy change.5 In this manner, the observed-to-expected ratios of outcomes may be maintained despite a decrease in the absolute survival rates after the allocation change. There is also the potential that individual transplant centers may adjust their risk tolerance based on outcomes. This is an early analysis with associated limitations in follow-up after the policy change, and a reevaluation of these outcomes will therefore be essential.AcknowledgmentsThe data reported here have been supplied by the United Network for Organ Sharing as the contractor for the Organ Procurement and Transplantation Network. The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official policy of or interpretation by the Organ Procurement and Transplantation Network or the US government.DisclosuresDr Kilic is on the Medical Advisory Board, Medtronic, Inc. Dr Kormos is a current employee at Abbott, Inc, although this work was done during his time at the University of Pittsburgh. Dr Gleason is on the Medical Advisory Board, Abbott, Inc. Dr Keebler is a consultant at Abbott, Inc, and on the Medical Advisory Board, Medtronic, Inc. There are no conflicts of interest as they pertain directly to this article.FootnotesData sharing: The authors declare that all supporting data are available within the article.https://www.ahajournals.org/journal/circArman Kilic, MD, Division of Cardiac Surgery, University of Pittsburgh Medical Center, 200 Lothrop St, Suite C-700, Pittsburgh, PA 15213. Email [email protected]eduReferences1. Meyer DM, Rogers JG, Edwards LB, Callahan ER, Webber SA, Johnson MR, Vega JD, Zucker MJ, Cleveland JCThe future direction of the adult heart allocation system in the United States.Am J Transplant. 2015; 15:44–54. doi: 10.1111/ajt.13030CrossrefMedlineGoogle Scholar2. Castleberry AW, Patel CB, DeVore AD, Southerland KW, Rogers JG, Milano CA. Mortality differences after heart transplantation in patients bridged with balloon pumps vs left ventricular assist devices.J Heart Lung Transplant. 2013; 32:S23–S24.CrossrefMedlineGoogle Scholar3. Kilic A, Allen JG, Weiss ES. Validation of the United States-derived Index for Mortality Prediction After Cardiac Transplantation (IMPACT) using international registry data.J Heart Lung Transplant. 2013; 32:492–498. doi: 10.1016/j.healun.2013.02.001CrossrefMedlineGoogle Scholar4. Fukuhara S, Takeda K, Kurlansky PA, Naka Y, Takayama H. Extracorporeal membrane oxygenation as a direct bridge to heart transplantation in adults.J Thorac Cardiovasc Surg. 2018; 155:1607–1618.e6. doi: 10.1016/j.jtcvs.2017.10.152CrossrefMedlineGoogle Scholar5. SRTR risk adjustment model documentation: posttransplant outcomes. SRTR Scientific Registry of Transplant Recipients.https://www.srtr.org/reports-tools/posttransplant-outcomes/. Accessed October 18, 2019.Google Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Blitzer D and Copeland H (2022) The right time for ischemic time?, Journal of Cardiac Surgery, 10.1111/jocs.16557, 37:7, (2051-2052), Online publication date: 1-Jul-2022. Nordan T, Critsinelis A, Mahrokhian S, Kapur N, Vest A, DeNofrio D, Chen F, Couper G and Kawabori M (2022) Microaxial Left Ventricular Assist Device Versus Intraaortic Balloon Pump as a Bridge to Transplant, The Annals of Thoracic Surgery, 10.1016/j.athoracsur.2021.07.048, 114:1, (160-166), Online publication date: 1-Jul-2022. Lazenby K, Narang N, Pelzer K, Ran G and Parker W (2022) An updated estimate of posttransplant survival after implementation of the new donor heart allocation policy, American Journal of Transplantation, 10.1111/ajt.16931, 22:6, (1683-1690), Online publication date: 1-Jun-2022. Baran D, Jaiswal A, Hennig F and Potapov E (2022) Temporary mechanical circulatory support: Devices, outcomes, and future directions, The Journal of Heart and Lung Transplantation, 10.1016/j.healun.2022.03.018, 41:6, (678-691), Online publication date: 1-Jun-2022. Heidenreich P, Bozkurt B, Aguilar D, Allen L, Byun J, Colvin M, Deswal A, Drazner M, Dunlay S, Evers L, Fang J, Fedson S, Fonarow G, Hayek S, Hernandez A, Khazanie P, Kittleson M, Lee C, Link M, Milano C, Nnacheta L, Sandhu A, Stevenson L, Vardeny O, Vest A and Yancy C (2022) 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines, Circulation, 145:18, (e895-e1032), Online publication date: 3-May-2022. Wolfson A, DePasquale E, Starnes V, Cunningham M, Baker C, Lee R, Bowdish M, Fong M, Rahman J, Pandya K, Lewinger J, Kawaguchi E and Vaidya A (2021) Effect of UNOS policy change and exception status request on outcomes in patients bridged to heart transplant with an intra‐aortic balloon pump, Artificial Organs, 10.1111/aor.14109, 46:5, (838-849), Online publication date: 1-May-2022. Heidenreich P, Bozkurt B, Aguilar D, Allen L, Byun J, Colvin M, Deswal A, Drazner M, Dunlay S, Evers L, Fang J, Fedson S, Fonarow G, Hayek S, Hernandez A, Khazanie P, Kittleson M, Lee C, Link M, Milano C, Nnacheta L, Sandhu A, Stevenson L, Vardeny O, Vest A and Yancy C (2022) 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure, Journal of the American College of Cardiology, 10.1016/j.jacc.2021.12.012, 79:17, (e263-e421), Online publication date: 1-May-2022. Hess N, Witer L, Katz M, Pope N, Tedford R, Houston B and Kilic A (2021) HVAD versus heartmate III bridge to heart transplantation: Waitlist and posttransplant outcomes, Clinical Transplantation, 10.1111/ctr.14546, 36:3, Online publication date: 1-Mar-2022. DeFilippis E, Khush K, Farr M, Fiedler A, Kilic A and Givertz M (2022) Evolving Characteristics of Heart Transplantation Donors and Recipients, Journal of the American College of Cardiology, 10.1016/j.jacc.2021.11.064, 79:11, (1108-1123), Online publication date: 1-Mar-2022. Ashraf S, Hess N, Seese L, Kavarana M, Tedford R, Rajab T and Kilic A (2022) Impact of the 2018 change in US allocation policy on adults with congenital heart disease, The Journal of Heart and Lung Transplantation, 10.1016/j.healun.2021.11.006, 41:3, (373-381), Online publication date: 1-Mar-2022. Kwon J, Huckaby L, Sloan B, Pope N, Witer L, Tedford R, Houston B, Hashmi Z, Katz M and Kilic A (2022) Prolonged Ischemia Times for Heart Transplantation: Impact of the 2018 Allocation Change, The Annals of Thoracic Surgery, 10.1016/j.athoracsur.2022.02.029, Online publication date: 1-Mar-2022. Fuller R, Taimur S and Baneman E (2022) Mechanical Circulatory Support Infections in Heart Transplant Candidates, Current Infectious Disease Reports, 10.1007/s11908-022-00772-7, 24:1, (1-7), Online publication date: 1-Jan-2022. Huckaby L, Seese L, Handzel R, Wang Y, Hickey G and Kilic A (2021) Center-level Utilization of Hepatitis C Virus–positive Donors for Orthotopic Heart Transplantation, Transplantation, 10.1097/TP.0000000000003674, 105:12, (2639-2645), Online publication date: 1-Dec-2021. Elde S, He H, Lingala B, Baiocchi M, Wang H, Hiesinger W, MacArthur J, Shudo Y and Woo Y (2021) Analysis of the revised heart allocation policy and the influence of increased mechanical circulatory support on survival, The Journal of Thoracic and Cardiovascular Surgery, 10.1016/j.jtcvs.2021.11.076, Online publication date: 1-Dec-2021. Hess N, Seese L, Sultan I, Wang Y, Hickey G and Kilic A (2021) Geographic disparities in heart transplantation persist under the new allocation policy, Clinical Transplantation, 10.1111/ctr.14459, 35:11, Online publication date: 1-Nov-2021. Hoffman J, Larson E, Rahaman Z, Absi T, Levack M, Balsara K, McMaster W, Brinkley M, Menachem J, Punnoose L, Sacks S, Wigger M, Zalawadiya S, Stevenson L, Schlendorf K, Lindenfeld J and Shah A (2021) Impact of increased donor distances following adult heart allocation system changes: A single center review of 1‐year outcomes, Journal of Cardiac Surgery, 10.1111/jocs.15795, 36:10, (3619-3628), Online publication date: 1-Oct-2021. Salvalaggio P (2021) Geographic disparities in transplantation, Current Opinion in Organ Transplantation, 10.1097/MOT.0000000000000914, 26:5, (547-553), Online publication date: 1-Oct-2021. Huckaby L, Hickey G, Sultan I and Kilic A (2021) Improvements in Functional Status Among Survivors of Orthotopic Heart Transplantation Following High-risk Bridging Modalities, Transplantation, 10.1097/TP.0000000000003602, 105:9, (2097-2103), Online publication date: 1-Sep-2021. Hasankhani F and Khademi A (2021) Is it Time to Include Post‐Transplant Survival in Heart Transplantation Allocation Rules?, Production and Operations Management, 10.1111/poms.13399, 30:8, (2653-2671), Online publication date: 1-Aug-2021. Kim S, Tran Z, Xia Y, Hadaya J, Williamson C, Gandjian M, Choi C and Benharash P (2021) The 2018 adult heart allocation policy change benefits low‐volume transplant centers, Clinical Transplantation, 10.1111/ctr.14389, 35:8, Online publication date: 1-Aug-2021. Shad R, Fong R, Quach N, Bowles C, Kasinpila P, Li M, Callon K, Castro M, Guha A, Suarez E, Lee S, Jovinge S, Boeve T, Shudo Y, Langlotz C, Teuteberg J and Hiesinger W (2021) Long-term survival in patients with post-LVAD right ventricular failure: multi-state modelling with competing outcomes of heart transplant, The Journal of Heart and Lung Transplantation, 10.1016/j.healun.2021.05.002, 40:8, (778-785), Online publication date: 1-Aug-2021. Buchan T, Moayedi Y, Truby L, Guyatt G, Posada J, Ross H, Khush K, Alba A and Foroutan F (2021) Incidence and impact of primary graft dysfunction in adult heart transplant recipients: A systematic review and meta-analysis, The Journal of Heart and Lung Transplantation, 10.1016/j.healun.2021.03.015, 40:7, (642-651), Online publication date: 1-Jul-2021. Altshuler P, Helmers M and Atluri P (2021) Organ allocation and procurement in cardiac transplantation, Current Opinion in Organ Transplantation, 10.1097/MOT.0000000000000872, 26:3, (282-289), Online publication date: 1-Jun-2021. Nordan T, Critsinelis A, Mahrokhian S, Kapur N, Thayer K, Chen F, Couper G and Kawabori M (2021) Bridging With Extracorporeal Membrane Oxygenation Under the New Heart Allocation System: A United Network for Organ Sharing Database Analysis, Circulation: Heart Failure, 14:5, Online publication date: 1-May-2021. Rao V (2021) Commentary: The ethics of donor allocation, The Journal of Thoracic and Cardiovascular Surgery, 10.1016/j.jtcvs.2020.09.088, 161:5, (1849-1851), Online publication date: 1-May-2021. Huckaby L, Hickey G, Sultan I and Kilic A (2021) Trends in the utilization of marginal donors for orthotopic heart transplantation, Journal of Cardiac Surgery, 10.1111/jocs.15359, 36:4, (1270-1276), Online publication date: 1-Apr-2021. Afflu D, Diaz‐Castrillon C, Seese L, Hess N and Kilic A (2021) Changes in multiorgan heart transplants following the 2018 allocation policy change, Journal of Cardiac Surgery, 10.1111/jocs.15356, 36:4, (1249-1257), Online publication date: 1-Apr-2021. Li N, Jiang W, Wang W, Xiong R, Wu X and Geng Q (2021) Ferroptosis and its emerging roles in cardiovascular diseases, Pharmacological Research, 10.1016/j.phrs.2021.105466, 166, (105466), Online publication date: 1-Apr-2021. Diaz-Castrillon C, Huckaby L, Hickey G, Sultan I and Kilic A (2021) Induction Immunosuppression and Renal Outcomes in Adult Heart Transplantation, Journal of Surgical Research, 10.1016/j.jss.2020.11.021, 259, (14-23), Online publication date: 1-Mar-2021. Huckaby L, Seese L, Hickey G, Sultan I and Kilic A (2020) A mortality risk score for heart transplants after contemporary ventricular assist device bridging, Journal of Cardiac Surgery, 10.1111/jocs.15188, 36:2, (449-456), Online publication date: 1-Feb-2021. Kilic A, Mathier M, Hickey G, Sultan I, Morell V, Mulukutla S and Keebler M (2021) Evolving Trends in Adult Heart Transplant With the 2018 Heart Allocation Policy Change, JAMA Cardiology, 10.1001/jamacardio.2020.4909, 6:2, (159), Online publication date: 1-Feb-2021. Hess N, Hickey G, Sultan I and Kilic A (2020) Extracorporeal membrane oxygenation bridge to heart transplant: Trends following the allocation change, Journal of Cardiac Surgery, 10.1111/jocs.15118, 36:1, (40-47), Online publication date: 1-Jan-2021. Baran D (2020)(2021) Better Is the Enemy of Good: Ever-changing Heart Transplant Allocation, Transplantation Direct, 10.1097/TXD.0000000000001089, 7:1, (e645) García-Pinilla J, García-Cosío Carmena M, Farrero-Torres M, Recio-Mayoral A and González-Costello J (2021) Selección de lo mejor del año 2020 en insuficiencia cardiaca, REC: CardioClinics, 10.1016/j.rccl.2020.11.009, 56, (66-71), Online publication date: 1-Jan-2021. Lyle M and Vega J (2020) The New US Heart Allocation Scheme: Impact on Waitlist and Post-Transplant Survival, Current Transplantation Reports, 10.1007/s40472-020-00301-2, 7:4, (340-345), Online publication date: 1-Dec-2020. Seliem A and Hall S (2020) The New Era of Cardiogenic Shock: Progress in Mechanical Circulatory Support, Current Heart Failure Reports, 10.1007/s11897-020-00490-y, 17:6, (325-332), Online publication date: 1-Dec-2020. Varshney A, Hirji S and Givertz M (2020) Outcomes in the 2018 UNOS donor heart allocation system: A perspective on disparate analyses, The Journal of Heart and Lung Transplantation, 10.1016/j.healun.2020.08.012, 39:11, (1191-1194), Online publication date: 1-Nov-2020. Cogswell R (2020) Will Status 2 Become the New 1A?, Circulation: Heart Failure, 13:8, Online publication date: 1-Aug-2020. May 19, 2020Vol 141, Issue 20 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.045354PMID: 32421414 Originally publishedMay 18, 2020 Keywordsheart failureresource allocationheart transplantationtreatment outcomesPDF download Advertisement SubjectsCardiovascular SurgeryTransplantation
Referência(s)