Clinical and Preclinical Evidence on a Novel Percutaneous Pulsatile Ventricular Assist Device (PulseCath): A Scoping Review.

Background: In recent decades, temporary mechanical circulatory support (tMCS) devices have garnered increasing interest for the treatment of cardiogenic shock. PulseCath-a pulsatile ventricular assist device-may address a critical unmet need within the tMCS array, offering an intermediate level of support between that of intra-aortic balloon pump (IABP) and more invasive tMCS devices (e.g., Impella and ECMO).

Methods: We conducted a systematic search of PubMed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, and Google Scholar databases to retrieve available clinical and preclinical in vivo data regarding the implantation of PulseCath.

Results: Five preclinical in vivo studies (38 animal models) and 16 clinical studies (386 patients) were identified and retrieved. When implanted in humans, PulseCath was mostly employed with a "pre-emptive" strategy, particularly in the context of high-risk percutaneous coronary interventions. However, cases reporting its "bail-out" deployment in instances of hemodynamic instability were also identified.

Conclusions: While the underreporting of adverse events and of PulseCath use as a bailout strategy across literature constrains a definitive evaluation of the device, preliminary findings suggest an apparent ease of use. Therefore, further research is warranted to better delineate which specific patient population would most likely benefit from the implantation of such a device. As such, the integration of underlying pathophysiological data, individualized risk assessment, and more robust clinical studies may potentially expand its use.