iCVCT 6. Shock and STEMI Trials - Hemodynamic Support in Shock
Monday, December 7th: 1:30 – 3:30 pm
Cardiogenic shock (CS) remains the leading cause of early mortality following acute myocardial infarction (AMI), and its incidence is increasing. This condition can develop rapidly, with makes it particularly challenging to treat effectively. Intra-aortic balloon pump (IABP) has been widely used short-term mechanical circulatory support device to stabilize hemodynamics. However, it has not been shown to decrease in mortality, and it is generally no longer routinely recommended. Extracorporeal membrane oxygenation (ECMO) and the percutaneous ventricular assist devices (pVAD) such as Impella and TandemHeart) are more invasive devices that provide a greater level of hemodynamic support. But, how do you chose which patients should receive which device? What is the optimal design for clinical trials in shock?
This session will be chaired by Dr. George Dangas, and Dr. Navin Kapur. Dr. Dangas is Director of Cardiovascular Innovation at The Mount Sinai Hospital in New York, USA. Dr. Navin Kapur is Director of Cardiac Biology Research Center, at the Molecular Cardiology Research Institute (MCRI), at Tufts Medical Center, in Boston, MA, USA.
The effects of the different types of devices on hemodynamics and cardiac work differ substantially. These devices have pros and cons. ECMO is a method to rapidly stabilize a patient in acute CS, it should generally be a short-term solution, because it does not reduce the work of the left ventricle. The TandemHeart provides adequate hemodynamic support, but it requires puncture of the atrial septum for insertion. The Impella can fully “unload” the left ventricle, thereby critically reducing the work of the heart. But deciding which device to use depends on many factors, such as individual patient needs, local expertise, anatomic factors, and physiologic considerations. This session will provide an in-depth look at these factors. We will then go beyond what we currently know and look to the future of clinical trials in CS, including the optimal design, selection of appropriate outcomes, and adjudication challenges.
Speakers include: Sripal Bangalore (New York, USA), Holger Thiele (Leipzig, GER), Sunil Rao (Durham, USA), Donald Cutlip (Boston, USA). A regulatory point of view on the challenges for device approval will be presented by John Sapirstein from the US FDA. Stay logged on for the discussion and Q & A session in the moderated multi-stake holders debate.