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Published on: August 16, 2021
Utilization of TandemHeart in cardiogenic shock: Insights from the THEME registry
Michael Megaly1, Chaun Gandolfo1, Samer Zakhour1
1Division of Cardiology, Henry Ford Health System, Detroit, Michigan, USA.
Insights
TandemHeart device implantation in cardiogenic shock patients showed a 74% 30-day survival rate. This study highlights the device
Area of Science:
- Cardiology
- Medical Devices
- Critical Care Medicine
Background:
- TandemHeart has previously shown efficacy in managing cardiogenic shock (CS) complications.
- Contemporary real-world outcomes for TandemHeart in CS patients require updated reporting.
Purpose of the Study:
- To evaluate the real-world effectiveness and outcomes of the TandemHeart device in contemporary patients with cardiogenic shock.
- To assess hemodynamic improvements and survival rates associated with TandemHeart use.
Main Methods:
- A prospective, observational study (THEME registry) analyzed 50 patients treated with TandemHeart.
- Data collected included baseline characteristics, hemodynamic changes, and patient outcomes.
- Implantation timing relative to CS diagnosis was recorded.
Main Results:
- Cardiac index significantly improved 24 hours post-implantation (median change 1.0 L/min/m²).
- Survivors demonstrated improved cardiac index and lactate clearance.
- 30-day and 180-day survival rates were 74% and 66%, respectively.
- Patients using TandemHeart as a bridge to surgery had an 85% 180-day survival rate.
Conclusions:
- TandemHeart use in a contemporary CS cohort is associated with significant survival benefits.
- The device demonstrates favorable outcomes, including high 30-day and 180-day survival rates.
- TandemHeart is a viable option for managing cardiogenic shock, including as a bridge to surgery.
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.
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