Each dot represents the monthly percentage of transplant candidates supported by VA-ECMO or LVAD at the time of initial transplant listing in the United States from January 1, 2014, to June 30, 2019. The change in percentage per month (ie, slope) is displayed for the first period, and the change in slope compared with the immediate prior period is displayed for the second and third periods.
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Hanff TC, Harhay MO, Kimmel SE, et al. Trends in Mechanical Support Use as a Bridge to Adult Heart Transplant Under New Allocation Rules. JAMA Cardiol. 2020;5(6):728–729. doi:10.1001/jamacardio.2020.0667
On October 18, 2018, new US adult heart transplant allocation rules were implemented by the Organ Procurement and Transplantation Network (OPTN). Updated rules were needed primarily to reduce significant overcrowding in the top-priority tier.1,2 A key modification divided the prior status 1A into 3 categories (status 1-3), reserving status 1 for the sickest few, and created status 4 corresponding to prior status 1B.3 In this division, patients supported by durable left ventricular assist devices (LVADs) were largely redistributed to lower tiers, reflecting improved waitlist survival with continuous-flow LVADs over the last decade.4 Patients with most LVAD complications or within the 30-day LVAD discretionary window, previously assigned status 1A, were made status 3. Remaining LVAD-supported patients became status 4 unless they have device malfunction (status 2) or life-threatening ventricular arrhythmias (status 1). Conversely, the smaller number of transplant candidates requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO), typically for biventricular failure, retain status 1 listing if stringent criteria are met justifying VA-ECMO. While the goal of these changes was to redistribute donor hearts to patients at higher risk of pretransplant mortality,2 the degree to which this has affected VA-ECMO or LVAD use as a bridge to transplantation is unknown.
We conducted a retrospective analysis of all adult patients in the OPTN registry listed for isolated heart transplant from January 1, 2014, to June 30, 2019, excluding retransplantation. We performed interrupted time series analysis to evaluate trends of VA-ECMO or dischargeable LVAD support at initial listing (defined via status justification forms with all data present) during each of 3 periods: (1) before the new allocation tiers were publicized in August 2016 (n = 8658),5 (2) after rule publication but prior to implementation (n = 7422), and (3) after implementation in October 2018 (n = 2599). The month of October 2018 overlapped both allocation systems and was treated as a transition period. Given that this is a publicly available, deidentified database, we obtained an institutional review board exemption from the University of Pennsylvania that also applied to patient consent. Linear mixed models were fit with center-level random slope and intercept along with first-order autoregressive errors to account for center effect and time-dependent autocorrelation. A 2-sided α of .05 was used.
The percentage of patients supported by LVAD at listing had been stable since 2014 under both preimplementation periods but began decreasing under the new allocation rules, from 35.1% in November 2018 to 24.5% in June 2019 (Figure). Before rule publication, LVAD listings were increasing only 0.11% per month (95% CI, −0.007% to 0.2%; P = .07), and this slope decreased by only 0.10% after rule publication (95% CI, −0.32% to 0.12%; P = .37). After rule implementation, the slope decreased significantly by 1.44% per month compared with after publication (95% CI, −2.2% to −0.64%; P < .001).
Conversely, the percentage of patients supported by VA-ECMO at listing had been decreasing slightly during both preimplementation periods but began increasing significantly after rule implementation, from 1.2% in November 2018 to 3.2% in June 2019. Before rule publication, VA-ECMO listings were decreasing 0.03% per month (95% CI, −0.06% to −0.009%; P = .008), and this slope was unchanged after rule publication (slope change, 0.04% per month; 95% CI, −0.01% to 0.09%; P = .17). After rule implementation, the slope increased significantly by 0.33% per month compared with after publication (95% CI, 0.10% to 0.56%; P = .005).
Compared with the prior allocation system, the percentage of patients supported by durable LVAD at listing has been significantly decreasing while VA-ECMO percentages have been significantly increasing. These results suggest some exchangeability between initial support platforms, aligning with allocation incentives in spite of stringent listing criteria. These changes could be detrimental to waitlist or posttransplant outcomes if lower-acuity patients are prioritized for transplantation or if VA-ECMO support in the pretransplant period is itself directly harmful compared with LVAD. This study has several limitations associated with the use of a large retrospective database. However, this database is the largest and most comprehensive database for heart transplants in the United States and as such represents all patients transplanted in the United States and the criteria used to justify their listing status.
Accepted for Publication: December 30, 2019.
Corresponding Author: Edo Y. Birati, MD, Perelman Center for Advanced Medicine, Hospital of the University of Pennsylvania, 3400 Civic Center Blvd, South Tower, 11th Floor, Philadelphia, PA 19104 (firstname.lastname@example.org).
Published Online: April 15, 2020. doi:10.1001/jamacardio.2020.0667
Author Contributions: Drs Hanff and Harhay had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Hanff and Harhay are co–first authors.
Concept and design: Hanff, Harhay, Molina, Birati.
Acquisition, analysis, or interpretation of data: Hanff, Harhay, Kimmel, Mazurek, Goldberg, Birati.
Drafting of the manuscript: Hanff, Harhay, Molina, Mazurek, Birati.
Critical revision of the manuscript for important intellectual content: Hanff, Harhay, Kimmel, Goldberg, Birati.
Statistical analysis: Hanff, Harhay, Kimmel.
Administrative, technical, or material support: Hanff, Molina, Goldberg, Birati.
Supervision: Goldberg, Birati.
Conflict of Interest Disclosures: Dr Hanff reported grants from National Institute of Health/National Heart, Lung, and Blood Institute outside the submitted work. Dr Mazurek reported personal fees and other support from United Therapeutics outside the submitted work. Dr Goldberg reported grants and personal fees from Respircardia and personal fees from Novartis, Abbott, and Medtronic outside the submitted work. Dr Birati reported other support from Impulse Dynamics Inc and Medtronic Inc outside the submitted work. No other disclosures were reported.
Funding/Support: Dr Hanff was supported by the National Institute of Health/National Heart, Lung, and Blood Institute T32 training grant HL-007891. Dr Harhay was supported by the National Institute of Health/National Heart, Lung, and Blood Institute grant K99 HL-141678.
Role of the Funder/Sponsor: The National Heart, Lung, and Blood Institute had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute . 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.
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