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Restore EF Study Demonstrates Impella-Supported High-Risk PCI Improves Left Ventricular Ejection Fraction

The Restore EF Study demonstrates the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at follow up. The interim analysis was presented today by Mitul Patel, MD, an interventional cardiologist at UC San Diego Health, at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation.

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Figure 1 (Graphic: Business Wire)

The ongoing, multi-center, prospective, single-arm study enrolled 193 consecutive qualified patients who underwent a Protected PCI procedure with Impella between September 2019 and September 2020 at 19 hospitals in the United States, representing a variety of hospital settings including rural, urban, community and academic centers. The interim analysis showed:

  • Significant median LVEF improvement from baseline to 90-day follow up (31% to 45% p<0.0001). LVEF improvement at 90 days is the study‚Äôs primary endpoint. (see figure 1)

  • Significant reduction of heart failure symptoms with 80% reduction in New York Heart Association (NYHA) classification III/IV at follow up (54% to 11% p<0.001). (see figure 2)

  • Significant reduction of anginal symptoms with 99% reduction in Canadian Cardiovascular Society (CCS) classification III/IV at follow up (70% to 1% p<0.0001). (see figure 3)

“Restore EF demonstrates Impella-supported PCI patients have shown a significant LVEF improvement at 90 days. The study also found a significant improvement in heart failure and anginal symptoms assessed with NYHA and CCS functional classifications,” said Dr. Patel. “Taken together, this data validates best practices for treating high-risk PCI patients, including the use of Impella to achieve a complete revascularization in a single setting.”

“High-risk PCI patients often pose a revascularization challenge due to patient comorbidities, poor LV function, and adverse hemodynamics, which drive worse outcomes. This research demonstrates the rationale for using Impella support during high-risk PCI to maintain coronary perfusion and support hemodynamics during periods of myocardial ischemia during long or repeated balloon inflations or atherectomy runs. This allows providers to achieve complete functional revascularization and the best possible outcomes for our patients,” said Jason Wollmuth, MD, an interventional cardiologist at Providence Health and Vascular Institute and a co-principal investigator of the Restore EF Study.

Restore EF is part of a growing body of evidence demonstrating Protected PCI with Impella is associated with improvements in LVEF and heart failure symptoms. That research includes:

  • Burzotta et al., which found Protected PCI with Impella is associated with LVEF improvement in complex high-risk patients at 90 days (27% vs. 33%, p<0.001). The authors also found more complete revascularization is associated with increased LVEF and survival.

  • PROTECT II Randomized Controlled Trial, which found Protected PCI with Impella led to a 58% improvement in NYHA class III and IV heart failure symptoms at 90 days (p<0.001). The trial also found, during follow up after Protected PCI with Impella, patients had a 22% improvement in LVEF (p<0.001).

  • Maini et al.,

AHA News: Scenes of Childhood Hunger Left Lasting Impression | Health News

(HealthDay)

TUESDAY, Oct. 13, 2020 (American Heart Association News) — While growing up in the Philippines, Lady Dorothy Elli witnessed childhood hunger and poverty that left her with lasting impressions.

She has made it her mission to address the problem of food insecurity and the negative impact it can have on the academic and personal well-being of students of all ages.

“Health inequity plays a big role in this,” said Lady Dorothy, 19, now a sophomore at the University of Arizona. “If health equity is present in the world, you wake up not having to worry about having an empty stomach and then going to school.”

Food insecurity is defined in a 2020 report by the federal Office of Disease Prevention and Health Promotion as a “disruption of food intake or eating patterns because of lack of money and other resources.” A 2019 study in the journal Pediatrics said that for children, “household food insecurity was related to significantly worse general health.”

A first-generation immigrant to the United States, Lady Dorothy said she felt fortunate to be able to eat two to three meals a day as a child. But she took to heart the stories her mother, Fatima Elli, recounted about her own childhood growing up in a household with 10 siblings in which there wasn’t always enough to eat.

In the Philippines, Lady Dorothy volunteered for the Red Cross and took an interest in helping to develop young leaders. She also would accompany her mother to outreach events like food donations in poor, rural areas.

The youngest of three daughters, Lady Dorothy is 10 years younger than her next oldest sibling.

“The age gap left her with me all the time,” her mother, Fatima, said. “She came with me whenever I went to outreach programs. That’s where she learned the idea of touching the lives of other people through providing basic necessities.”

The family arrived in the United States three years ago and settled in Tucson, Arizona, where she soon learned food insecurity also was a problem in the United States. At the time, a 2015 report from the U.S. Department of Agriculture found that about 8% of U.S. households with children, or about 3 million homes, were considered food insecure.

“I want to help bridge that gap and make sure that everyone is able to get access to nutritious and healthy food,” Lady Dorothy said.

A year ago, she started the Nutrition Talks program, speaking to school-age children at churches and middle schools in the Tucson area about the importance of a nutritious diet and lifestyle. She was inspired by a similar program at a library at which she interned that provided free lunch to children.

She bought healthy snacks and created a presentation “that the kids could understand, emphasizing exercises and activities that they could do to actually realize what healthy living means.”

For now, Nutrition Talks are canceled because of the COVID-19 pandemic, though Lady Dorothy is staying in touch with school districts as she