Intravascular Microaxial LVAD Associated With Higher Risk of In-Hospital Mortality, Bleeding, NCDR Study Shows

In AMI patients complicated by cardiogenic shock (AMI-CS) undergoing PCI, use of an intravascular microaxial left ventricular assist device (LVAD) may be associated with higher rates of in-hospital adverse events compared with an intra-aortic balloon pump (IABP), according to a study published Feb. 10 in the Journal of the American Medical Association. Preliminary results were previously presented as a Late-Breaking Clinical Trial during AHA 2019 in Philadelphia, PA.

Sanket Dhruva, MD, MHS, FACC, et al., looked at data from ACC's CathPCI Registry and Chest Pain – MI Registry to assess mechanical circulatory support (MCS) device utilization from October 2015 to December 2017 among patients with AMI-CS undergoing PCI. Among the total of 28,304 AMI-CS patients, the mean age was 65 years, 33% were female, 81.3% had STEMI, and 43.3% had cardiac arrest. In addition, 8,471 (29.9%) received an IABP only, 1,768 (6.2%) received an intravascular microaxial LVAD only, 1,838 (6.5%) received other mechanical circulatory support or a combination of devices, and 16,227 (57.3%) received only medical therapy.

Results showed a significantly higher risk of in-hospital mortality with the intravascular microaxial LVAD vs. IABP (45% vs. 34.1%). In addition, the risk of in-hospital major bleeding was higher with the intravascular microaxial LVAD (31.3%) vs. IABP (16%). The differences were statistically significant "regardless of timing of device placement."

According to the researchers, the intravascular microaxial LVAD device was associated with a higher risk of in-hospital mortality and major bleeding. They note that the findings "highlight the need for additional data to guide optimal management" for AMI-CS patients and the role of MCS devices. "Further research may be needed to understand optimal device choice," they conclude.

In an accompanying editorial comment, Holger Thiele, MD, et al., write that the study provides "evidence to support a more restrictive use of these devices, and as based on current guidelines, only in selected patients with refractory cardiogenic shock."

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Implantable Devices, SCD/Ventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: Shock, Cardiogenic, Heart-Assist Devices, Hospital Mortality, Percutaneous Coronary Intervention, Intra-Aortic Balloon Pumping, Registries, National Cardiovascular Data Registries, CathPCI Registry, Chest Pain MI Registry, Heart Arrest, Chest Pain, Hemorrhage

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