Elective left ventricular unloading with a microaxial flow pump did not reduce major adverse clinical outcomes at ≥12 months in patients with severe LV impairment undergoing complex PCI.
Does elective left ventricular unloading with a microaxial flow pump reduce major adverse clinical outcomes in patients with severely impaired left ventricular function undergoing complex PCI?
Elective left ventricular unloading with a microaxial flow pump does not improve clinical outcomes in patients with severe LV dysfunction undergoing complex PCI.
Absolute Event Rate: 0% vs 0%
BACKGROUND: Complex percutaneous coronary intervention (PCI) in patients with severely impaired left ventricular function carries a high risk of death and complications. Whether percutaneous left ventricular unloading improves outcomes remains unclear. METHODS: We randomly assigned 300 patients with severe left ventricular dysfunction and extensive coronary artery disease in a 1:1 ratio to a strategy of elective unloading with a microaxial flow pump or to standard care during planned complex PCI. The primary outcome was a hierarchical composite that included death from any cause, disabling stroke, spontaneous myocardial infarction, hospitalization for cardiovascular causes, or periprocedural myocardial injury at a minimum of 12 months, as analyzed according to a win ratio. RESULTS: A total of 148 patients were assigned to receive a microaxial flow pump and 152 to receive standard care. At a median of 22 months (interquartile range, 16 to 30), 36.6% of pairwise comparisons favored the microaxial flow pump, and 43.0% favored standard care (win ratio, 0.85; 95% confidence interval CI, 0.63 to 1.15; difference, -6.4 percentage points; P = 0.30). Death from any cause occurred in 47 patients in the microaxial-flow-pump group and 33 in the standard-care group (hazard ratio, 1.54; 95% CI, 0.99 to 2.41). There was no material between-group difference in the risk of bleeding or vascular complications. CONCLUSIONS: Among patients with severely impaired left ventricular function undergoing complex PCI, elective left ventricular unloading with a microaxial flow pump did not reduce the risk of major adverse clinical outcomes at a minimum of 12 months. (Funded by the U.K. National Institute for Health and Care Research; CHIP-BCIS3 ClinicalTrials.gov number, NCT05003817.).
“The results were 'surprising because the whole premise of LV unloading was that it protects the heart.' But we found that patients assigned to LV unloading had more damage to the [LV] than those assigned to standard care. Our findings strongly suggest that we shouldn't be using this device routinely without more evidence of benefit.”
Late-breaking at ACC.26 with simultaneous NEJM publication; >600 social media mentions in past 14 days, extensive coverage in ACC, TCTMD, SCAI feeds; sparked heated expert debate on X with >150 quote-tweets; high news amplification (15+ major outlets) and conference spotlight as a surprise negative result in high-risk PCI population.
Perera et al. (Sun,) reported a other. Elective left ventricular unloading with a microaxial flow pump did not reduce major adverse clinical outcomes at ≥12 months in patients with severe LV impairment undergoing complex PCI.