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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.,

Why financial planning improves your health

It has been recognized for years that our health can be affected by our wealth, or lack thereof. Stress is a major contributor to both mental and physical health, and financial issues are one of the biggest stressors around.

a man standing in front of a mountain: James M Dahle, MD. Author of The White Coat Investor

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James M Dahle, MD. Author of The White Coat Investor

In my work as an emergency physician, I meet people who feel suicidal nearly every day. While they also cite stress caused by relationships, health problems, family members and work, financial strain is a major contributor.


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Since financial stress  plays such a big part in poor health, it stands to reason that improving financial planning, literacy and discipline will also improve health outcomes. In my work spreading financial literacy among doctors and other high-income professionals at The White Coat Investor, I have often observed a great burden lifted from the shoulders of my readers and listeners as they pay off debt, begin saving for the future and put a plan for financial success in place.

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Perhaps the most significant way that financial stress affects health is that it prevents a patient from seeking medical care or complying with recommended tests, treatments, and medications.

Health care is expensive, particularly for those who fall through the cracks of our fragmented health system and find themselves paying for it on their own. A typical family of four buying health insurance on the open market often finds that it will cost more than $1,000 per month in premiums, and that doesn’t include deductibles, co-pays or co-insurance.

By the time all is said and done, it would not be unusual to spend $20,000 a year on health care—approximately one-third of the median American household income. Government resources, including Medicare, Medicaid and tax subsidies, often lower this cost — if you can manage to navigate the system to get them.

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Without the financial resources to purchase insurance and pay for non-covered care, health is likely to suffer. Preventive care will be missed, diagnoses will be delayed and life-improving — even life-saving —treatments will be postponed or foregone completely.

In addition to the direct purchase of health care, those with more financial resources can afford to eat better, exercise more and live in healthier locales, further preventing disease and improving wellness.

Even if you can still manage to pay for care, exercise and good food, financial stress may still directly affect your health. For example, a 2013 Northwestern study showed that increased levels of debt were correlated with higher diastolic blood pressure among those between ages 24 and 32.

High blood pressure is a risk factor for heart attacks, strokes and kidney failure. Surveys have also shown correlation between debt and

Improving blood sugar in Type 2 diabetes improves cognitive scores, study says

Oct. 5 (UPI) — Controlling blood sugar levels helped people with Type 2 diabetes who were overweight improve cognitive scores, but losing weight, exercise had mixed results, a new study shows.

More than a quarter of U.S. adults 65 or older have Type 2 diabetes, which doubles the risk of cognitive impairment and dementia, including Alzheimer’s disease, according to a statement from the Pennington Biomedical Research Center.

“It’s important to properly control your blood sugar to avoid the bad brain effects of your diabetes,” said study author Owen Carmichael said in a statement.

“Don’t think you can simply let yourself get all the way to the obese range, lose some of the weight, and everything in the brain is fine,” said Carmichael, a professor and director of Biomedical Imaging at Pennington Biomedical Research Center. “The brain might have already turned a corner that it can’t turn back from.”

The study, published in the latest issue of The Journal of Clinical Endrocrinology and Metabolism, analyzed whether markers such as body weight, blood sugar control, and physical activity would be associated with improved cognition in 1,089 participants, age 45 to 76, who have Type 2 diabetes.

Researchers theorized that greater improvements in all three markers would lead to better cognitive test scores, but that turned out to be only partially true. While reducing blood sugar levels improved test scores, losing more weight and exercising more didn’t always do so.

“Every little improvement in blood sugar control was associated with a little better cognition,” Carmichael said. “Lowering your blood sugar from the diabetes range to prediabetes helped as much as dropping from prediabetes levels to the healthy range.”

Meanwhile, results from weight loss varied depending on the mental skill, according to Carmichael. More weight loss improved participants short-term memory, planning, impulse control, attention and the ability to switch tasks, but verbal learning and overall memory still declined.

“The results were worse for people who had obesity at the beginning of the study,” he added.

Similarly, Carmichael said the study showed that increasing physical activity also benefited people who were overweight more than people with obesity.

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