Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System

Daniel J. Goldstein, Keith D. Aaronson, Antone J. Tatooles, Scott C. Silvestry, Valluvan Jeevanandam, Robert Gordon, David R. Hathaway, Kevin B. Najarian, Mark S. Slaughter

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Objectives: This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP). Background: GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB. Methods: Bleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg. Results: Overall, 59 of 382 (15.4%) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1% of events occurred beyond 30 days. Freedom from GIB was 84.1% at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred. Conclusions: Recipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1% at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31% of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).

Original languageEnglish (US)
Pages (from-to)303-313
Number of pages11
JournalJACC: Heart Failure
Volume3
Issue number4
DOIs
StatePublished - Apr 1 2015

Fingerprint

Hemorrhage
Heart-Assist Devices
International Normalized Ratio
Heart Failure
Transplants
Arteriovenous Malformations
Warfarin
Aspirin
Small Intestine
Heparin
Therapeutics
Recurrence
Equipment and Supplies
Survival
Incidence

Keywords

  • ASA
  • AVM
  • CAP
  • CF-LVAD
  • Gastrointestinal bleeding
  • GIB
  • Heart failure
  • HVAD
  • INR
  • Left ventricular assist device
  • LVAD

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Goldstein, D. J., Aaronson, K. D., Tatooles, A. J., Silvestry, S. C., Jeevanandam, V., Gordon, R., ... Slaughter, M. S. (2015). Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System. JACC: Heart Failure, 3(4), 303-313. https://doi.org/10.1016/j.jchf.2014.11.008

Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System. / Goldstein, Daniel J.; Aaronson, Keith D.; Tatooles, Antone J.; Silvestry, Scott C.; Jeevanandam, Valluvan; Gordon, Robert; Hathaway, David R.; Najarian, Kevin B.; Slaughter, Mark S.

In: JACC: Heart Failure, Vol. 3, No. 4, 01.04.2015, p. 303-313.

Research output: Contribution to journalArticle

Goldstein, DJ, Aaronson, KD, Tatooles, AJ, Silvestry, SC, Jeevanandam, V, Gordon, R, Hathaway, DR, Najarian, KB & Slaughter, MS 2015, 'Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System', JACC: Heart Failure, vol. 3, no. 4, pp. 303-313. https://doi.org/10.1016/j.jchf.2014.11.008
Goldstein, Daniel J. ; Aaronson, Keith D. ; Tatooles, Antone J. ; Silvestry, Scott C. ; Jeevanandam, Valluvan ; Gordon, Robert ; Hathaway, David R. ; Najarian, Kevin B. ; Slaughter, Mark S. / Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System. In: JACC: Heart Failure. 2015 ; Vol. 3, No. 4. pp. 303-313.
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abstract = "Objectives: This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP). Background: GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB. Methods: Bleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg. Results: Overall, 59 of 382 (15.4{\%}) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1{\%} of events occurred beyond 30 days. Freedom from GIB was 84.1{\%} at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred. Conclusions: Recipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1{\%} at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31{\%} of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).",
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AU - Jeevanandam, Valluvan

AU - Gordon, Robert

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N2 - Objectives: This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP). Background: GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB. Methods: Bleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg. Results: Overall, 59 of 382 (15.4%) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1% of events occurred beyond 30 days. Freedom from GIB was 84.1% at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred. Conclusions: Recipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1% at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31% of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).

AB - Objectives: This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP). Background: GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB. Methods: Bleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg. Results: Overall, 59 of 382 (15.4%) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1% of events occurred beyond 30 days. Freedom from GIB was 84.1% at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred. Conclusions: Recipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1% at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31% of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).

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KW - Heart failure

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KW - INR

KW - Left ventricular assist device

KW - LVAD

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