Cardiologists trying to navigate the proper course of care for cardiac patients who might benefit from percutaneous mechanical circulatory support received a helping hand in the form of a consensus statement published online April 7. The document provides a roadmap for physicians until there is sufficient high-level evidence to inform guidelines.
“There is very little data, yet people need guidance,” lead author Charanjit S. Rihal, MD, told Cardiovascular Business. Use of commercially available devices such as CardiacAssist’s TandemHeart and Abiomed’s Impella has skyrocketed—by one account by much as a 30-fold increase over six years. Just a few weeks ago, the FDA opened the door for the Impella 2.5 heart pump to be used in high-risk PCIs.
“You have the patient, you have the devices and you have national guidelines, which are relatively silent because there is a dearth of high-quality data,” said Rihal, chair of the cardiovascular diseases division at the Mayo Clinic in Rochester, Minn. “What do you do? This is where our patient-oriented consensus statement, we hope, will be helpful.”
The writing committee consisted of a multidisciplinary group of cardiologists and is a collaboration of the Society for Cardiovascular Angiography and Interventions, American College of Cardiology, Heart Failure Society of America and the Society of Thoracic Surgeons. It has been endorsed by the American Heart Association and several cardiology societies outside the U.S.
The statement offers 11 recommendations for treating high-risk patients with left atrial or left ventricle to aorta assist technologies, devices for extracorporeal membrane oxygenation (ECMO) and methods for right-sided support. They also looked at data on intra-aortic balloon pumps and based their consensus statement on the available scientific evidence for these diverse devices.
“The clinical data supporting the use of these devices and exactly in which situations is only now beginning to emerge,” Rihal said. He noted that it is challenging to conduct randomized clinical trials in a critically ill patient population and obtain the numbers needed to achieve a statistically significant finding. As a result, there are gaps in the knowledge base for all subsets of patients.
The consensus document recommends percutaneous mechanical circulatory support over medical pharmacologic therapy; early use of mechanical circulatory support in patients in cardiogenic shock who fail to stabilize despite revascularization or pharmacological therapies; possible use of mechanical circulatory support in some high-risk PCIs; continuous flow pumps and possibly ECMO in cases of profound cardiogenic shock; early use in some patients with decompensated heart failure and possible use to wean patients off cardiopulmonary bypass. It also makes a case for registries and trials to compare different clinical strategies and cost-effectiveness analyses.
The statement is designed to serve as a frame of reference for what they anticipate will be a growing evidence base. “If new data come out in cardiogenic shock, then this paper will allow the reader to immediately compare the new data to the previous data and perhaps figure out how it may fit into their practice,” Rihal said.
The statement was published in Catheterization and Cardiovascular Interventions, the Journal of the American College of Cardiology and the Journal of Cardiac Failure.