Speakers Consider the Efficacy of Hemodynamic Support for Cardiogenic Shock After Acute MI
Use of percutaneous ventricular assist devices (LVADs) among patients with cardiogenic shock following acute MI continues despite a lack of supporting data and evidence of an increase in adverse events, including leg ischemia, severe bleeding, and fever or sepsis, experts noted during a didactic symposia at TCT 2015.
Holger Thiele, MD, of the Medical Clinic II (Cardiology/Angiology/Intensive Care), University Heart Center, in Lübeck, Germany, reported that while a few randomized controlled trials have demonstrated better hemodynamic profiles for a percutaneous LVAD compared with an intra-aortic balloon pump (IABP), this has not conferred improvement in 30-day survival.
In a meta-analysis of randomized controlled trials published in the European Heart Journal examining the effect of percutaneous LVAD use on hemodynamics and survival 30 days post-procedure, patients in the percutaneous LVAD group exhibited higher cardiac indexes, higher mean arterial pressures and lower pulmonary capillary wedge pressures than did those in the IABP group.
Thiele cited results from the IABP-SHOCK II trial, in which 600 patients with cardiogenic shock expected to undergo early revascularization were randomized to receive optimal medical therapy with or without IABP. For the primary endpoint of 30-day mortality, there were no significant differences observed between the two treatment groups (Figure).
“Based on data from these randomized trials, there is no sign that these devices can reduce mortality,” Thiele said. “What we have to keep in mind about these devices, at least in some of these trials, is that there was an increase in bleeding, which was significant, increased fever and sepsis, as well as one trial which noted an increase in limb ischemia.”
Use of RVADs explored
However, in a presentation highlighting the benefit of a percutaneous right ventricular assist device (RVAD; Impella RP, Abiomed), William W. O’Neill, MD, of Henry Ford Hospital, in Detroit, Mich, cited evidence from the RECOVER RIGHT trial, a multicenter, single-arm study intended to evaluate the safety and benefit of the device in patients with right ventricular failure who require hemodynamic support.
The study enrolled 30 patients and categorized them into two groups: Cohort A included patients who developed right ventricular failure within 48 hours following implantation of an RVAD and Cohort B included patients who developed RV failure within 48 hours of post-cardiotomy shock or post-acute MI shock. Its primary endpoint was patient survival at 30 days, hospital discharge, or progression to the next therapy, including heart transplant or surgical RVAD.
Overall, the survival rate was 73% in the entire population at 30 days (83.3% in Cohort A and 58.3% in Cohort B). However, significant adverse events included bleeding and hemolysis.
“This is the first percutaneous RVAD FDA study, and the use of the Impella device proved to be reliably deliverable and safe, improved the hemodynamics and led to favorable outcomes,” O’Neill said. “The Impella RP may play a pivotal role in the treatment of [RV failure] patients in need of hemodynamic support. However, I would emphasize that the best management of cardiogenic shock is prevention.”
- O’Neill reports receiving consultant/honoraria fees from Edwards Lifesciences and Medtronic.
- Thiele reports no relevant conflicts of interest.