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

Catheter Cardiovasc Interv. 2023 Mar;101(4):756-763. doi: 10.1002/ccd.30582. Epub 2023 Feb 7.


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/m2 ). In survivors, there was a significant improvement in CI (1.0, IQR (0.5-2.25 L/min/m2 ) 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.

Keywords: CS; TandemHeart; TandemLife; cardiogenic shock.

Publication types

  • Observational Study
  • Multicenter Study

MeSH terms

  • Heart-Assist Devices* / adverse effects
  • Humans
  • Prospective Studies
  • Registries
  • Shock, Cardiogenic* / therapy
  • Treatment Outcome

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