Feasibility study of the use of the TandemHeart® percutaneous ventricular assist device for treatment of cardiogenic shock

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Abstract
Background: The mortality of cardiogenic shock (CGS) remains high despite currently available pharmacological and mechanical treatment options. The standard of care in medically refractory situations has been the insertion of an intra‐aortic balloon pump. The purpose of this study was to investigate the feasibility, safety, and hemodynamic impact of the TandemHeart® percutaneous left ventricular assist device (pVAD) in CGS. Methods: Thirteen patients from five centers in the US with the diagnosis of CGS were enrolled in the study. Hemodynamic measurements, including cardiac index (CI), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP), and central venous pressure (CVP) were performed presupport, during support and after device removal. Patients were monitored for 6 months. Results: The pVAD was successfully implanted in all 13 patients, with duration of support averaging 60 ± 44 hr. During support, CI increased from 2.09 ± 0.64 at baseline to 2.53 ± 0.65 (P = 0.02), MAP increased from 70.6 ± 11.1 to 81.7 ± 14.6 (P = 0.01), PCWP decreased from 27.2 ± 12.2 to 16.5 ± 4.8 (P = 0.01), and CVP from 12.9 ± 3.7 to 12.6 ± 3.6 (P = NS). Ten patients survived to device explant, 6 of whom were bridged to another therapy. Seven patients survived to hospital discharge and were all alive at 6 months. The two most common adverse events were distal leg ischemia (n = 3) and bleeding from the cannulation site (n = 4). Conclusion: The TandemHeart® PTVA System may be a useful complementary treatment for patients with CGS, especially as a bridge to another treatment. Further study is needed to definitively establish safety and efficacy.