Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device

Simon Maltais*, Keit H.D. Aaronson, Jeffrey J. Teuteberg, Mark S. Slaughter, Samer S. Najjar, Valluvan Jeevanandam, Duc Thinh Pham, Edwin C. McGee, Katrin Leadley, Robert L. Kormos

*Corresponding author for this work

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridgeto-Transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management. ASAIO Journal 2017; 63:745-751.

Original languageEnglish (US)
Pages (from-to)745-751
Number of pages7
JournalASAIO Journal
Volume63
Issue number6
DOIs
StatePublished - Jan 1 2017

Fingerprint

Left ventricular assist devices
Transplants
Heart-Assist Devices
Survival
Clinical Protocols
Cardiac Arrhythmias
Heart Failure
Stroke
Quality of Life
Hemorrhage
Infection

Keywords

  • Adverse events
  • Left ventricular assist device
  • Patient management
  • Patient outcomes

ASJC Scopus subject areas

  • Biophysics
  • Bioengineering
  • Biomaterials
  • Biomedical Engineering

Cite this

Maltais, S., Aaronson, K. H. D., Teuteberg, J. J., Slaughter, M. S., Najjar, S. S., Jeevanandam, V., ... Kormos, R. L. (2017). Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device. ASAIO Journal, 63(6), 745-751. https://doi.org/10.1097/MAT.0000000000000585
Maltais, Simon ; Aaronson, Keit H.D. ; Teuteberg, Jeffrey J. ; Slaughter, Mark S. ; Najjar, Samer S. ; Jeevanandam, Valluvan ; Pham, Duc Thinh ; McGee, Edwin C. ; Leadley, Katrin ; Kormos, Robert L. / Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device. In: ASAIO Journal. 2017 ; Vol. 63, No. 6. pp. 745-751.
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Maltais, S, Aaronson, KHD, Teuteberg, JJ, Slaughter, MS, Najjar, SS, Jeevanandam, V, Pham, DT, McGee, EC, Leadley, K & Kormos, RL 2017, 'Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device', ASAIO Journal, vol. 63, no. 6, pp. 745-751. https://doi.org/10.1097/MAT.0000000000000585

Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device. / Maltais, Simon; Aaronson, Keit H.D.; Teuteberg, Jeffrey J.; Slaughter, Mark S.; Najjar, Samer S.; Jeevanandam, Valluvan; Pham, Duc Thinh; McGee, Edwin C.; Leadley, Katrin; Kormos, Robert L.

In: ASAIO Journal, Vol. 63, No. 6, 01.01.2017, p. 745-751.

Research output: Contribution to journalArticle

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T1 - Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device

AU - Maltais, Simon

AU - Aaronson, Keit H.D.

AU - Teuteberg, Jeffrey J.

AU - Slaughter, Mark S.

AU - Najjar, Samer S.

AU - Jeevanandam, Valluvan

AU - Pham, Duc Thinh

AU - McGee, Edwin C.

AU - Leadley, Katrin

AU - Kormos, Robert L.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridgeto-Transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management. ASAIO Journal 2017; 63:745-751.

AB - The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridgeto-Transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management. ASAIO Journal 2017; 63:745-751.

KW - Adverse events

KW - Left ventricular assist device

KW - Patient management

KW - Patient outcomes

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