EF Improvement Following Contemporary High-Risk PCI

RESTORE EF shows EF improved by 29% from overall baseline of 35% to 45% in high-risk PCI patients supported with Impella® heart pumps¹

RESTORE EF was designed to validate contemporary best practices in high-risk PCI, including complete revascularization in a single setting, use of atherectomy and large-bore access techniques.

Near Normal EF Patients Improved Heart Failure and Anginal Symptoms

Patients with near normal EF (>45%) experienced an 82% relative reduction in NYHA Class III and IV symptoms and a 97% relative reduction in CCS angina Class III and IV symptoms. High-risk PCI patients without depressed EF are likely to have more complex PCI and a high prevalence of comorbidities, according to data supporting the FDA's expanded indication for Impella use in high-risk PCI patients with or without depressed ejection fraction.¹

Complete Revascularization is Associated with Greater Improvement in LVEF at 90-Day Follow-Up

Contemporary Practices for Impella®-Supported Complete Revascularization

Jason Wollmuth, MD, FACC, reviews the first case he enrolled in the RESTORE EF study, which highlights best practices and contemporary techniques to improve symptoms as well as ejection fraction in these complex patients.

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LVEF, Heart Failure Symptom and Anginal Symptom Improvements Demonstrated in Impella-Supported High-Risk PCI Patients

Case Study Epitomizing Results from RESTORE EF

Aditya Bharadwaj, MD, an investigator for the RESTORE EF study, presents a case study epitomizing the results from the trial.

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LVEF at 90 Days

RESTORE EF is a prospective multicenter study that assessed 90-day LVEF improvement as the primary endpoint and changes in NYHA HF and CCS angina symptom classification as the secondary endpoint. It found significant LVEF improvement at 90 days and significant reduction in NYHA HF and CCS angina Class III/IV symptoms.

More Pronounced EF Improvement in Severe and Moderately Depressed EF Patients

51%

of the patients in RESTORE EF had near-normal ejection fraction or moderately depressed EF¹
49%

of patients had severely depressed EF¹

The EF improvement benefit was more pronounced in patients with severe and moderately depressed EF.

RESTORE EF & PROTECT III demonstrate the continuous safety improvement in patients treated with Impella heart pumps resulting in low major bleeding rates in non-emergent HRPCI patients

Continuous Safety Improvement Over Time in High-Risk PCI Patients Treated with Impella Heart Pumps

The safety improvement in non-emergent HRPCI is not isolated to the more experienced operators. Analysis of the National Inpatient Sample published in 2020 showed that the safety and efficacy of high-risk PCI supported by Impella heart pumps translated broadly across the entire country.

RESTORE EF Investigators Implemented Numerous Best Practices in the Areas of:

Patient Selection and Case Planning

including use of RHC and assessment of the feasibility of complete revascularization

Optimized Vascular Access Techniques

including ultrasound and fluoroscopic guidance and the use of single-access technique

Large-Bore Closure

including mandated cath lab removal

Planned Support Pre-PCI

to help avoid the need for bailout support

Complete Revascularization

including the use of intravascular imaging, lesion prep, and proven bifurcation strategies

Optimized Medical Therapy

Is Your Patient a Candidate for Protected PCI?

Use this tool to determine if a patient may be appropriate to receive a Protected PCI procedure.

RESTORE EF demonstrates that contemporary best practices in high-risk PCI, including more complete revascularization with hemodynamic support from Impella, are associated with significant improvements in LVEF, heart failure symptoms, and angina symptoms at 90-day follow-up in patients with and without depressed ejection fraction.

References

Wollmuth, J., Patel, M. et al. (2022). JSCAI, 100350. https://doi.org/10.1016/j.jscai.2022.100350

NPS-2993