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Gastrointestinal bleeding following Heartmate 3 left ventricular assist device implantation: The Michigan Bleeding
Yoav Hammer1, Jiaheng Xie2, Guangyu Yang3
1Division of Cardiovascular Disease, Michigan Medicine - University of Michigan, Ann Arbor, Michigan.
Insights
Gastrointestinal bleeding (GIB) is common in left ventricular assist device (LVAD) recipients. A new risk score using 13 preimplantation factors can predict GIB likelihood and aid patient management.
Area of Science:
- Cardiology
- Medical Devices
- Gastroenterology
Background:
- Gastrointestinal bleeding (GIB) is a significant complication for patients with durable left ventricular assist devices (LVADs).
- GIB negatively impacts quality of life and leads to frequent hospitalizations in LVAD recipients.
- Predicting GIB risk before LVAD implantation is crucial for patient selection and management.
Purpose of the Study:
- To identify preimplantation predictors of post-LVAD GIB in HeartMate 3 (HM3) recipients.
- To develop a risk score for predicting GIB based on preimplantation factors.
- To assess the relationship between GIB events and mortality in LVAD patients.
Main Methods:
- Analysis of adult HM3 primary LVAD recipients from the STS Intermacs registry (January 2017-December 2020).
- Utilized multivariable modeling to investigate relationships between preimplantation characteristics and postimplant GIB.
- Developed a risk score using 13 independent preimplantation predictors of GIB.
Main Results:
- 15.7% of 6,425 HM3 LVAD recipients experienced GIB.
- Thirteen preimplantation factors independently predicted post-LVAD GIB.
- By 3 years, GIB occurred in 11% (low-risk), 26% (medium-risk), and 43% (high-risk) of patients.
- One GIB event increased the risk of recurrence (33.9% recurrence rate).
- Post-LVAD GIB was associated with mortality, but the number of GIB events was not directly linked to death.
Conclusions:
- The Michigan Bleeding Risk Model, using 13 preimplantation variables, effectively predicts post-LVAD GIB in HM3 recipients.
- This risk score aids in stratifying patients and has potential therapeutic and clinical implications.
- The model facilitates better patient selection and management strategies for LVAD implantation.
Background:
Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management.
Methods:
The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors.
Results:
Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death.
Conclusions:
The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.
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