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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’s 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.,

MA Town-By-Town Coronavirus Stats: 23 High-Risk Communities

MASSACHUSETTS — Twenty-three communities were designated high-risk in the new town-by-town data released by the state Wednesday, up from 15 the week before. New rules announced by the state Wednesday mean that those towns, plus others that were high-risk in the last two updates, cannot move on to the next phase of reopening.

The communities were marked high-risk, or red, due to more than eight confirmed COVID-19 cases per 100,000 residents over the past two weeks.

The latest step forward reopens indoor performance venues; expands capacity at outdoor performance venues, gyms, museums, driving and flight schools; reopens more indoor activities; and permits fitting rooms to open in all retail stores. It also allows for increased outdoor gatherings at events and in public settings.

With Wednesday’s update, the following 29 communities do not qualify to move forward: Attleboro, Avon, Boston, Chelsea, Dedham, Everett, Dracut, Framingham, Haverhill, Holliston, Lowell, Lawrence, Lynn, Lynnfield, Marlborough, Methuen, Middleton, Monson, Nantucket, New Bedford, North Andover, Plainville, Revere, Saugus, Springfield, Tynsborough, Winthrop, Worcester and Wrentham.

The 11 new communities added to the list were: Attleboro, Avon, Boston, Dracut, Haverhill, Lowell, Lynnfield, Methuen, Middleton, North Andover and Springfield.

Over one-third of Massachusetts communities reported rising positive coronavirus test rates over the last two weeks and three towns reported rates above 5 percent. Statewide, the positive test rate was 1.0 percent, up from 0.8 percent in early September.

There were 510 new COVID-19 cases and 32 deaths reported Wednesday. There have been 9,242 deaths and 129,753 confirmed cases statewide since the pandemic reached the Bay State in March.

A University of Massachusetts model projects that the state’s death total could reach 9,769 by Oct. 24. That’s higher than what the closely-watched IHME projected for the state in early August, when it said the state could suffer 9,600 deaths by election day.

The latest town-by-town data showed the positive test rate over the last two weeks increased in 121 — or 34.5 percent — of the 351 communities in the state. The rate fell in 82 — or 23.4 percent — communities and held steady in the remaining 148.

Health officials say positive test results need to stay below 5 percent for two weeks or longer and, preferably, be closer to 2 percent, for states to safely ease restrictions. Three towns had positive test rates at or above 5 percent over the last two weeks: Lawrence, Monroe and Windsor.

Twenty-nine communities had positive rates between 2 and 5 percent.

The state reported 14,404 tests conducted Wednesday, bringing the number of completed tests to 4.05 million.

The data includes coronavirus cases for all Massachusetts communities, except for those with populations under 50,000 and fewer than five cases. The department said the stipulation was designed to protect the privacy of patients in those towns and cities.

The state is continuing to release town-by-town testing data, including the number of people tested, the testing rate, the positive test rate, cases and infection rates.

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