Impella 5.5 use in women: A multicenter study

Background We sought to compare the outcomes of Impella 5.5 use between sexes, assessing differential rates of complications. Methods All adult patients who underwent Impella 5.5 implantation at the University of Pennsylvania and Columbia University between June 2020 and May 2024 were retrospectively reviewed. Demographics, baseline status, complications, and outcomes were compared between sexes. Pertinent laboratory values were examined with a linear mixed model, and a parsimonious multivariable logistic regression was developed to assess factors predictive of in-hospital mortality. Results Of 254 patients, 41 (16%) were female and 213 (84%) were male. Prior to implant, females had lower hemoglobin levels (9.6 vs 11.2g/dL, p<0.05), but cardiac risk factors did not differ (all p>0.05). The smaller size of females did not preclude device implantation (Height: 1.7 vs 1.8m; Weight: 74.8 vs 88.0kg, all p<0.05), and only 1 out of 41 (2.4%) females required direct aortic placement due to prohibitive anatomy. Pre-implant mechanical circulatory support, duration of support, and post-implant rates of stroke, infection, and bleeding were similar (all p>0.05). In addition, laboratory markers of device biocompatibility did not differ between sexes, nor did rates of successful bridging to durable therapies (all p>0.05). Finally, in-hospital and one year mortality were similar between groups (all p>0.05), and female sex was not identified as a risk factor for in-hospital mortality (OR 0.91, p>0.05). Conclusions Females do not experience increased complications from the Impella 5.5, and device biocompatibility does not differ by sex. Our data supports greater consideration of device use in females.