The ongoing collaboration between Massachusetts Institute of Technology (MIT) and Abiomed aims to elucidate the bidirectional impact of Abiomed’s Impella transvalvular mechanical support pump on cardiac function, as well as the impact of end-organ function on the behaviour of Impella. Dr Edelman described a linear format of patient care prior to the collaboration, in which physicians provided mechanical support without any detailed feedback on performance. Impella is a combined sensor and pump, providing left ventricular (LV) mechanical unloading while simultaneously querying patient state. This bidirectional feedback enables titration of support to optimise care in cardiogenic shock patients, in contrast to the intermittent monitoring approach provided by the current standard of care.
Collaboration between MIT and Abiomed began in 2015 to further understand how the Impella device impacts cardiovascular physiology and how end-organ function impacts device performance in vivo. Dr Josephy spurred Abiomed engineers to include haemodynamic information on the device display after recognising similarities in appearance between an LV pressure tracing and Impella’s motor current signal. Abiomed and MIT then formulated a goal to enable Impella to provide both haemodynamic support and meaningful patient-specific physiological information to the team managing the patient. This academic-industry partnership set out to fill the information void that often exists between devices and patients.
Early studies by Dr Edelman identified LV end-diastolic pressure (LVEDP) as a key cardiac marker of the interaction between patient physiology and Impella device function. Research teams lead by Dr El Katerji and Dr Keller subsequently developed algorithms for Impella to calculate cardiac output and measures of vascular impedance. Cardiac output is determined by novel calculations not used on any device approved by the Food and Drug Administration (FDA). Abiomed is currently working with the FDA to establish the first regulatory submission of this sensor type. Patient-specific measures of cardiac output and LVEDP make the Impella attractive for clinical studies, and device commercialisation efforts are currently underway.
Identifying a common goal of improving patient outcomes is key to the success of this industry and academic collaboration. Starting the collaboration with a shared goal in mind was fundamental to building a strong, trusting relationship. Weekly meetings between Abiomed and MIT ensured open communication, keeping the group informed and efficient. The framework for all animal testing and clinical testing must be agreed upon by the group. Honest bidirectional feedback and criticism help to stress test concepts and produce the best ideas. The FDA is considered a third partner in this team, providing key insight on how to propel mechanical support devices into the clinic.
Impella’s unique position within the patient’s circulation, specifically within the heart, provides local, regional and systemic circulatory feedback. Future directions include the use of non-intuitive advanced metrics to assist support timing and elucidating mechanical support device-to-device interactions, such as Impella with extracorporeal membrane oxygenation.
Industry and academic collaboration are the hallmarks of great medical interventions, including antibiotics, genomics and medical devices. The amalgamation of academic ideas and industrial engineering enables innovation from bench to bedside.