cVAD Registry Pursues Best Practices for Cardiogenic Shock

November 1, 2016

Although percutaneous circulatory support has seen exponential growth over the last decade, there is a need for real-world data on complex patients to develop best practices, aid research and improve outcomes.

But large randomized clinical trials involving cardiogenic shock patients are difficult to conduct, so the global cVAD registry was created, said Brij Maini, MD, FACC, the regional medical director of transcatheter therapies for Tenet Healthcare Corp.

“Well-designed and conducted clinical registries are critical in providing clinical evidence, especially in the setting of diseases where randomized clinical trials are not feasible,” Dr. Maini said during a presentation at TCT 2016.

Begun in 2009, the registry collects data by reviewing existing medical records and conducting periodic patient follow-up interviews by telephone after the implant of Impella, a percutaneous ventricular assist device (PVAD). To participate in the registry, medical centers had to agree on data elements and definitions, such as how to define “cardiogenic shock.”

The hope is that the cVAD registry will generate best practices to improve outcomes in AMI and cardiogenic shock, among other diseases.

At this point, the registry includes only Impella devices, the family of PVADs made by Abiomed Inc., which provides financial backing for the registry, Dr. Maini said.

“Eventually, we want to include all PVADs,” he added.

He said he also would like to see broader industry support, as well as support from such organizations as the American College of Cardiology and the American Heart Association.


To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/

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