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/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.
Subject(s)
Heart-Assist Devices , Shock, Cardiogenic , Humans , Shock, Cardiogenic/therapy , Prospective Studies , Heart-Assist Devices/adverse effects , Treatment Outcome , RegistriesABSTRACT
We have utilized soft lithography techniques to create three-dimensional arrays of blood microchannels and gas pathways in poly(dimethylsiloxane) (PDMS) that approach the microvascular scale of the natural lung. The blood microchannels were lined with endothelial cells in an effort to provide a non-thrombogenic surface that might ultimately reduce the need for systemic anticoagulation. A novel design and fabrication method were developed to create prototype modules for gas permeance and cell culture testing. The gas permeance modules contained 6 layers, four gas and two blood, while the modules for cell culture testing contained two layers of blood channels. The gas permeance of the modules was examined and maximum values of 9.16 x 10(-6) and 3.55 x 10(-5) mL/s/cm(2)/cmHg, for O(2) and CO(2) respectively, were obtained. Finally, endothelial cells were seeded and dynamically cultured in prototype cell culture modules. Confluent and viable cell monolayers were achieved after 10 days of perfusion.