Device-Related Adverse Events and Clinical Outcomes in Patients With Cardiogenic Shock on Temporary Mechanical Circulatory Support

<h2>Abstract</h2><h3>Background</h3> Temporary mechanical circulatory support (tMCS) is associated with a high risk of device-related adverse events (DRAEs) in patients with cardiogenic shock (CS). We aimed to describe the prevalence of DRAEs in patients with CS on tMCS and investigate whether DRAEs are associated with worse outcomes. <h3>Methods</h3> We performed a retrospective review of patients at our center with CS on tMCS (intra-aortic balloon pump [IABP] or left-sided microaxial flow pump [mAFP]) between 8/2021 and 8/2023. Patients were stratified by presence/absence of a DRAE occurring while on tMCS or within 72 hours of tMCS removal. Baseline characteristics were described, multivariable logistic regression was performed to compare outcomes, and Cox proportional hazards models were used to compare survival between groups. <h3>Results</h3> Among 268 patients with tMCS (55.6% with IABP exposure, 62.3% with mAFP exposure, median 9 [5, 17] device days), 112 (41.8%) experienced 1 or more DRAEs and 156 (58.2%) did not. The most prevalent DRAEs were bleeding (19.8% prevalence) and bacteremia (11.9%). Patients with a DRAE had advanced CS (SCAI D/E in 72.3% vs 15.4%, p<0.01) and more device exposure (mean 1.5±0.8 vs 1.2±0.5 total devices; p<0.01). Those with a DRAE had a higher unadjusted (OR 3.42; 1.83-6.37) and adjusted odds (aOR 2.24; 1.08-4.65) of in-hospital mortality compared to those without a DRAE, as well as a higher 30-day, 180-day, and 1-year hazard of death. <h3>Conclusion</h3> DRAEs are common in patients with CS on tMCS and are associated with a significant increase in the risk of in-hospital and long-term mortality. <h3>Disclosures</h3> Dodson reports consulting for Johnson & Johnson MedTech; Tedford reports no disclosures relevant to this manuscript. He has served on a research advisory board for ​Abiomed. He reports general disclosures to include consulting relationships with and receiving honorarium/consulting fees from Abbott, Acorai, Adona, Aria CV Inc., Acceleron, Boston Scientific, CVRx, Endotronix, Edwards LifeSciences, Fauna Bio, Gradient, Imbria, Medtronic, Merck, Morphic Therapeutics, Pulmovant, Restore Medical, Tempus AI, and United Therapeutics. He serves on steering committees for Abbott, Edwards, Endotronix, Gradient, Merck and Tempus AI; Kilic reports no disclosures relevant to this manuscript. He reports general disclosures to include consulting relationships with and receiving honorarium/consulting fees from Abbott, 3ive, and LivaNova. He is a founder/owner of QImetrix; Houston reports general disclosures to include consulting relationships with Abbott, Edwards Lifesciences, Gradient, and Aria CV; Carnicelli reports research support from Acorai and Johnson & Johnson MedTech paid to institution, speaker honoraria and travel support from Johnson & Johnson MedTech, and consulting fees from Precision Cardiovascular; all other authors report no relevant disclosures.