Clinical Research & Data, Unloading, Surgical Applications
HFSA 2021: Time for a Paradigm Shift in High-Risk Cardiac Surgery
In his 2021 Heart Failure Society of America (HFSA) virtual presentation titled, “STItCHing and Unloading,” Daniel J. Goldstein, MD, discusses high-risk cardiac surgery and the rationale for a paradigm-shifting clinical trial. Dr. Goldstein is professor and vice chair of cardiovascular surgery and surgical director, heart transplant and mechanical support programs at Montefiore in New York City.
Dr. Goldstein begins his presentation with a review of the landmark STICH trial, which he describes as “really the only large randomized clinical trial in the literature evaluating high-risk cardiac surgery.” Describing the initial 5-year data published in The New England Journal of Medicine in 2011, Dr. Goldstein explains that regarding the primary outcome of all-cause mortality, “Although directionally favoring CABG, there was no statistical significant difference between CABG and the medical treated group.”
In 2016, 10-year extended study results from STICH were published, revealing a very significant difference [p=0.02] in survival with CABG plus medical therapy versus medical therapy alone. “So, STICH established the validity of offering CABG for patients with severe left ventricular dysfunction,” states Dr. Goldstein.
Looking at the greater picture of high-risk surgery in the US, Dr. Goldstein highlights the concern for patients with severe systolic left ventricular dysfunction (LVD) developing post-cardiotomy cardiogenic shock (PCCS) and explores the shortcomings of standard care for these patients, explanations for surgical turndown, and possible care pathways.
To improve outcomes, and perhaps expand access to reparative surgery for these patients, Dr. Goldstein emphasizes, “it seems intuitive to consider a new paradigm and that is the use of technology to fully unload the left ventricle while providing full hemodynamic support.” He discusses the shortcomings of VA ECMO and TandemHeart when it comes to unloading, and explores Impella® devices, which he states, “seem to meet the desired physiological criteria, and that is steep reductions in left ventricular end-diastolic pressure and volume and a reduction in myocardial oxygen consumption.” With Impella, he explains, “we’re effectively addressing the lethal combination of vasoplegia and low output.”
In closing he previews the IMPACT trial (Impella Protected Cardiac Surgery Trial), a pilot trial investigating the prophylactic use of Impella 5.5® with SmartAssist® in high-risk adult cardiac surgery patients. “I strongly believe the time has come to explore a new paradigm: the pre-emptive or prophylactic use of unloading technologies to attempt to improve upon the outcomes of high-risk cardiac surgery in post-cardiotomy shock.”