Key result
Additional MCS linked to ~60% higher 30-day bleeding risk vs. pLVAD alone in ACS.
Why the study?
Bleeding is a clinically important complication during percutaneous left ventricular assist device support, yet its determinants remain unclear.
Does the use of additional mechanical circulatory support increase the risk of 30-day bleeding in patients undergoing percutaneous left ventricular assist device support?
Observational (n=5,608)
Yes
Does the use of additional mechanical circulatory support increase the risk of 30-day bleeding in patients undergoing percutaneous left ventricular assist device support?
In real-world pLVAD practice, early bleeding affects approximately 26% of patients, and the use of additional mechanical circulatory support is the dominant independent predictor of this risk.
Answers are grounded in this paper and cite their sources.
Additional MCS use was associated with higher bleeding risk in pLVAD recipients; leaves open optimal support strategies pending prospective trials.
BACKGROUND: Bleeding is a clinically important complication during percutaneous left ventricular assist devices (pLVAD) support, yet its determinants remain unclear. OBJECTIVES: The objective of the study was to identify predictors of bleeding after pLVAD implantation using a nationwide Japanese registry, J-PVAD (Japanese registry for Percutaneous Ventricular Assist Device). METHODS: A total of 5,608 patients with complete follow-up were analyzed and stratified into acute coronary syndrome (ACS) and non-ACS strata. The primary outcome measure was any bleeding within 30 days. Multivariable Cox proportional hazards model were used to identify predictors within each stratum, with competing-risk analyses using Fine-Gray models performed for sensitivity. Machine learning (ML) with Shapley Additive exPlanations analysis was conducted as a complementary approach. RESULTS: The cohort included 2,667 ACS and 2,941 non-ACS patients. The 30-day incidence of bleeding was similar between the ACS and Non-ACS strata (25.7% vs 26.2%; P = 0.951), with most events occurring within several days after implantation. Additional mechanical circulatory support (MCS) was the strongest factor associated with bleeding in both strata (ACS: adjusted HR: 1.60; non-ACS: adjusted HR 1.75; both P < 0.001). Competing-risk analyses accounting for early mortality yielded consistent results (ACS: subdistribution HR: 1.52; non-ACS: subdistribution HR: 1.74). ML analyses consistently identified additional MCS use as the dominant contributor to bleeding. Shapley Additive exPlanations-based clustering suggested 2 high-risk phenotypes characterized by procedural complexity including additional MCS use and inflammatory-hemodynamic instability. CONCLUSIONS: Bleeding after pLVAD support is common and occurs early, with comparable incidence across ACS and non-ACS strata. Additional MCS use is the dominant determinant of bleeding risk. ML-based phenotyping provides complementary insights into heterogeneous bleeding mechanisms.
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Sano et al. (2026) conducted an observational in Cardiogenic shock or acute heart failure requiring percutaneous left ventricular assist device (pLVAD) (n=5,608). Additional mechanical circulatory support (MCS) vs. pLVAD alone was evaluated on Any bleeding within 30 days (ACS stratum) (HR 1.60, 95% CI 1.24-2.06, p=<0.001). Additional mechanical circulatory support use was the strongest determinant of 30-day bleeding risk, significantly increasing bleeding incidence compared to pLVAD alone (HR 1.60 in the ACS stratum).
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