Utilization of TandemHeart in cardiogenic shock: Insights from the THEME registry

Abstract Background TandemHeart has been demonstrated to improve hemodynamic and metabolic complications in cardiogenic shock (CS). Contemporary outcomes have not been reported. Objectives To evaluate the outcomes of the TandemHeart (LivaNova) in contemporary real‐world use. Methods We analyzed baseline characteristics, hemodynamic changes, and outcomes of all patients treated with TandemHeart who were enrolled in the THEME registry, a multicenter, prospective, observational study. Results Between May 2015 and June 2019, 50 patients underwent implantation of the TandemHeart device. 22% of patients had TandemHeart implanted within 12 h, 32% within 24 h, and 52% within 48 h of CS diagnosis. Cardiac index (CI) was significantly improved 24 h after implantation (median change 1.0, interquartile range (IQR) (0.5−1.4 L/min/m 2 ). In survivors, there was a significant improvement in CI (1.0, IQR (0.5−2.25 L/min/m 2 ) and lactate clearance −2.3 (−5.0 to −0.7 mmol/L). The 30‐day and 180‐day survival were 74% (95% confidence interval: 60%−85%) and 66% (95% confidence interval: 51%−79%), respectively. Survival was similarly high in those in whom TandemHeart has been used as a bridge to surgery (85% 180‐day survival). Conclusion In a contemporary cohort of patients presenting in CS, the use of TandemHeart is associated with a 74% 30‐day survival and a 66% 180‐day survival.