Early Outcomes After Heart Transplantation in Recipients Bridged With a HeartMate 3 Device

Alejandro Suarez-Pierre, Cecillia Lui, Xun Zhou, Todd C. Crawford, Charles D. Fraser, Katherine Giuliano, Steven Hsu, Robert Higgins, Kenton J Zehr, Glenn Whitman, Chun Woo Choi, Ahmet Kilic

Research output: Contribution to journalArticle

Abstract

Background: Left ventricular assist devices are increasingly used as bridge-to-transplantation in eligible patients. The HeartMate 3 (HM3; Abbott Laboratories, Abbot Park, IL) is the latest device to obtain US Food and Drug Administration approval as bridge-to-transplantation. This study examines early outcomes of transplant recipients after HM3 in comparison with recipients bridged with the HeartMate 2 (HM2; Abbott Laboratories) and HeartWare Ventricular Assist System (HVAD; Medtronic, Minneapolis, MN) devices. Methods: Using the Organ Procurement and Transplantation Network database, we identified all adult patients who were slated for bridge-to-transplantation with a continuous-flow left ventricular assist devices (HM2, HVAD, or HM3) between April 1, 2015 and January 31, 2018. The primary endpoint was all-cause mortality 6 months after transplantation. The independent influence of the bridging device on outcomes was determined using Cox proportional hazard models. Results: Patients (N = 1,978) were successfully bridged to transplantation with the HM2 (n = 881), HVAD (n = 920), or HM3 (n = 177) device. Six-month mortality rates were similar across these devices (HM2, 5.9%; HVAD, 7.7%; HM3, 4.7%; log-rank p = 0.30). On average HM2 patients were on a left ventricular assist device for 2 months longer (p < 0.01). The HVAD had the lowest rate of device exchange before transplant (p = 0.01). The HM3 had no events of pump thrombosis (p < 0.01). HVAD patients had the lowest rate of device malfunction before to transplant (p < 0.01). Panel reactive antibodies at the time of transplantation were lower for HM3 patients (p < 0.01); however rates of graft rejection at 6 months were not different (p = 0.25). Conclusions: The HM3 device provides excellent early outcomes as a bridge to transplantation and may be associated with a reduction in comorbidities. Longer follow-up is needed to better define differences between durable left ventricular assist devices.

Original languageEnglish (US)
JournalAnnals of Thoracic Surgery
DOIs
StatePublished - Jan 1 2019

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Heart Transplantation
Transplantation
Equipment and Supplies
Heart-Assist Devices
Transplants
Drug Approval
Tissue and Organ Procurement
Mortality
Graft Rejection
Organ Transplantation
Proportional Hazards Models
Comorbidity
Thrombosis
Databases
Food
Antibodies

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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Early Outcomes After Heart Transplantation in Recipients Bridged With a HeartMate 3 Device. / Suarez-Pierre, Alejandro; Lui, Cecillia; Zhou, Xun; Crawford, Todd C.; Fraser, Charles D.; Giuliano, Katherine; Hsu, Steven; Higgins, Robert; Zehr, Kenton J; Whitman, Glenn; Choi, Chun Woo; Kilic, Ahmet.

In: Annals of Thoracic Surgery, 01.01.2019.

Research output: Contribution to journalArticle

Suarez-Pierre, Alejandro ; Lui, Cecillia ; Zhou, Xun ; Crawford, Todd C. ; Fraser, Charles D. ; Giuliano, Katherine ; Hsu, Steven ; Higgins, Robert ; Zehr, Kenton J ; Whitman, Glenn ; Choi, Chun Woo ; Kilic, Ahmet. / Early Outcomes After Heart Transplantation in Recipients Bridged With a HeartMate 3 Device. In: Annals of Thoracic Surgery. 2019.
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abstract = "Background: Left ventricular assist devices are increasingly used as bridge-to-transplantation in eligible patients. The HeartMate 3 (HM3; Abbott Laboratories, Abbot Park, IL) is the latest device to obtain US Food and Drug Administration approval as bridge-to-transplantation. This study examines early outcomes of transplant recipients after HM3 in comparison with recipients bridged with the HeartMate 2 (HM2; Abbott Laboratories) and HeartWare Ventricular Assist System (HVAD; Medtronic, Minneapolis, MN) devices. Methods: Using the Organ Procurement and Transplantation Network database, we identified all adult patients who were slated for bridge-to-transplantation with a continuous-flow left ventricular assist devices (HM2, HVAD, or HM3) between April 1, 2015 and January 31, 2018. The primary endpoint was all-cause mortality 6 months after transplantation. The independent influence of the bridging device on outcomes was determined using Cox proportional hazard models. Results: Patients (N = 1,978) were successfully bridged to transplantation with the HM2 (n = 881), HVAD (n = 920), or HM3 (n = 177) device. Six-month mortality rates were similar across these devices (HM2, 5.9{\%}; HVAD, 7.7{\%}; HM3, 4.7{\%}; log-rank p = 0.30). On average HM2 patients were on a left ventricular assist device for 2 months longer (p < 0.01). The HVAD had the lowest rate of device exchange before transplant (p = 0.01). The HM3 had no events of pump thrombosis (p < 0.01). HVAD patients had the lowest rate of device malfunction before to transplant (p < 0.01). Panel reactive antibodies at the time of transplantation were lower for HM3 patients (p < 0.01); however rates of graft rejection at 6 months were not different (p = 0.25). Conclusions: The HM3 device provides excellent early outcomes as a bridge to transplantation and may be associated with a reduction in comorbidities. Longer follow-up is needed to better define differences between durable left ventricular assist devices.",
author = "Alejandro Suarez-Pierre and Cecillia Lui and Xun Zhou and Crawford, {Todd C.} and Fraser, {Charles D.} and Katherine Giuliano and Steven Hsu and Robert Higgins and Zehr, {Kenton J} and Glenn Whitman and Choi, {Chun Woo} and Ahmet Kilic",
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T1 - Early Outcomes After Heart Transplantation in Recipients Bridged With a HeartMate 3 Device

AU - Suarez-Pierre, Alejandro

AU - Lui, Cecillia

AU - Zhou, Xun

AU - Crawford, Todd C.

AU - Fraser, Charles D.

AU - Giuliano, Katherine

AU - Hsu, Steven

AU - Higgins, Robert

AU - Zehr, Kenton J

AU - Whitman, Glenn

AU - Choi, Chun Woo

AU - Kilic, Ahmet

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Left ventricular assist devices are increasingly used as bridge-to-transplantation in eligible patients. The HeartMate 3 (HM3; Abbott Laboratories, Abbot Park, IL) is the latest device to obtain US Food and Drug Administration approval as bridge-to-transplantation. This study examines early outcomes of transplant recipients after HM3 in comparison with recipients bridged with the HeartMate 2 (HM2; Abbott Laboratories) and HeartWare Ventricular Assist System (HVAD; Medtronic, Minneapolis, MN) devices. Methods: Using the Organ Procurement and Transplantation Network database, we identified all adult patients who were slated for bridge-to-transplantation with a continuous-flow left ventricular assist devices (HM2, HVAD, or HM3) between April 1, 2015 and January 31, 2018. The primary endpoint was all-cause mortality 6 months after transplantation. The independent influence of the bridging device on outcomes was determined using Cox proportional hazard models. Results: Patients (N = 1,978) were successfully bridged to transplantation with the HM2 (n = 881), HVAD (n = 920), or HM3 (n = 177) device. Six-month mortality rates were similar across these devices (HM2, 5.9%; HVAD, 7.7%; HM3, 4.7%; log-rank p = 0.30). On average HM2 patients were on a left ventricular assist device for 2 months longer (p < 0.01). The HVAD had the lowest rate of device exchange before transplant (p = 0.01). The HM3 had no events of pump thrombosis (p < 0.01). HVAD patients had the lowest rate of device malfunction before to transplant (p < 0.01). Panel reactive antibodies at the time of transplantation were lower for HM3 patients (p < 0.01); however rates of graft rejection at 6 months were not different (p = 0.25). Conclusions: The HM3 device provides excellent early outcomes as a bridge to transplantation and may be associated with a reduction in comorbidities. Longer follow-up is needed to better define differences between durable left ventricular assist devices.

AB - Background: Left ventricular assist devices are increasingly used as bridge-to-transplantation in eligible patients. The HeartMate 3 (HM3; Abbott Laboratories, Abbot Park, IL) is the latest device to obtain US Food and Drug Administration approval as bridge-to-transplantation. This study examines early outcomes of transplant recipients after HM3 in comparison with recipients bridged with the HeartMate 2 (HM2; Abbott Laboratories) and HeartWare Ventricular Assist System (HVAD; Medtronic, Minneapolis, MN) devices. Methods: Using the Organ Procurement and Transplantation Network database, we identified all adult patients who were slated for bridge-to-transplantation with a continuous-flow left ventricular assist devices (HM2, HVAD, or HM3) between April 1, 2015 and January 31, 2018. The primary endpoint was all-cause mortality 6 months after transplantation. The independent influence of the bridging device on outcomes was determined using Cox proportional hazard models. Results: Patients (N = 1,978) were successfully bridged to transplantation with the HM2 (n = 881), HVAD (n = 920), or HM3 (n = 177) device. Six-month mortality rates were similar across these devices (HM2, 5.9%; HVAD, 7.7%; HM3, 4.7%; log-rank p = 0.30). On average HM2 patients were on a left ventricular assist device for 2 months longer (p < 0.01). The HVAD had the lowest rate of device exchange before transplant (p = 0.01). The HM3 had no events of pump thrombosis (p < 0.01). HVAD patients had the lowest rate of device malfunction before to transplant (p < 0.01). Panel reactive antibodies at the time of transplantation were lower for HM3 patients (p < 0.01); however rates of graft rejection at 6 months were not different (p = 0.25). Conclusions: The HM3 device provides excellent early outcomes as a bridge to transplantation and may be associated with a reduction in comorbidities. Longer follow-up is needed to better define differences between durable left ventricular assist devices.

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