Clinical Research
Heart Failure
Major Bleeding During HeartMate II Support

https://doi.org/10.1016/j.jacc.2013.05.089Get rights and content
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Objectives

The aim of this study was to characterize a single-center experience of major bleeding complications during HeartMate II (HMII) (Thoratec Corp., Pleasanton, California) left ventricular assist device support, with focus on the subtypes and temporal patterns of post-operative bleeding.

Background

Bleeding complications are the most common post-operative adverse events after HMII implantation. The timing of bleeding events, relationship to coagulation status, and effect on post-operative survival are incompletely understood.

Methods

From October 2004 to June 2010, 139 HMII recipients at the Cleveland Clinic received 145 devices as a bridge to transplant or destination therapy for advanced heart failure. Major bleeding was defined using Interagency Registry for Mechanically Assisted Circulatory Support criteria, with an additional category created to maximize sensitivity for events. Pre-operative variables, coagulation status, and bleeding recurrence were assessed for correlation to primary events using modulated renewal within a multivariable analysis.

Results

The cumulative occurrence of major bleeding was 58% during 171 patient-years of follow-up. There were 1.14 major bleeds per patient-year, with 44% occurring as repeat bleeding events. A first bleed did not predict subsequent bleeding. The greatest risk of bleeding was noted within 2 weeks post-implantation. The international normalized ratio profile correlated poorly with the risk of bleeding. Bleeding early after surgery was associated with reduced survival while on HMII support.

Conclusions

The risk of bleeding peaks early after HMII implantation. Bleeding of thoracic and gastrointestinal sources dominates these events, although many patients undergo transfusions for anemia without an apparent source of hemolysis or bleeding.

Key Words

anticoagulation
bleeding
HeartMate II

Abbreviations and Acronyms

AUS
anemia of undetermined source
BTT
bridge to transplant
GI
gastrointestinal
HMII
HeartMate II
INR
international normalized ratio

Cited by (0)

Dr. Starling has accepted honoraria from Thoratec Corporation, although all funds have been directed to a research fund of the Cleveland Clinic. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.