Clinical Research & Data, Complete Revascularization, Patient Identification, Protected PCI
RESTORE EF Study: Impact on EF at 60-180 days after High-Risk PCI
Jason Wollmuth, MD, and Thom Dahle, MD, two of the principal investigators in the RESTORE EF study, share their thoughts on the trial with Seth Bilazarian, MD. “It is an important study that hopefully will provide further depth of knowledge and body of evidence and support our findings that we’re seeing on an everyday basis,” Dr. Dahle states. “I think this hopefully will further support the evidence that high-risk PCI in very vulnerable patients can lead to improvement in outcomes,” Dr. Wollmuth tells Dr. Bilazarian. “Another hope of mine is that this study will basically show people what is possible.”
The RESTORE EF study aims to evaluate ejection fraction (EF) and clinical status in more than 500 patients at 60 to 180 days following high-risk PCI supported with Impella® heart pump. The study was prompted by evidence of improvement in LV function in patients undergoing high-risk PCI in the PROTECT II study, the USpella registry, and the recent Burzotta Roma-Verona study.
When asked why Impella support may be useful in this patient population compared to other strategies for revascularization, Dr. Wollmuth explains, “This is really a patient population that hasn’t been historically treated percutaneously. Now we have this incredible tool that we can use to support these patients through very long and complex revascularization procedures.” Dr. Dahle states, “When we use this device and we do Protected PCI, it does give you a sense of calm during the procedure, the hemodynamic stability, where you can take the time to do atherectomy… and make sure that not only do you have a complete revascularization, but you have the absolute, best, optimized revascularization you could have.”
Dr. Dahle attributes the improvements seen in EF to the amount of complete revascularization achieved. “I think what we’ll find here is that using Protected PCI and using Impella will likely lead to more complete revascularization in these patients. And that results in improvement in their LV function.”
Dr. Wollmuth believes that many patients are being underserved by not being offered high-risk PCI and that providers taking care of these patients may not understand the potential clinical impact. “So I think if we can further the data set that shows that these patients do better both from an LV function standpoint, but also, importantly, from a clinical standpoint, that there will be more belief in the value of these procedures in these very vulnerable patients and that potentially this is going to be offered to more and more patients who are in need.”
Dr. Wollmuth tells Dr. Bilazarian that he is excited to be part of the RESTORE EF study and “to be able to pool our patient data with other high-level sites across the country to see if what we are seeing on a local level really is happening on a more broad scale.”