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Published on: October 16, 2021
Clinical outcomes among patients with mitral valve regurgitation undergoing Impella-supported high-risk PCI
Arsalan Abu-Much1, Cindy L Grines2, Shmuel Chen3
1Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.
Background:
Mitral valve regurgitation (MR) is associated with worse outcomes in patients undergoing percutaneous coronary intervention (PCI). We sought to evaluate outcomes of Impella-supported high-risk PCI (HRPCI) patients according to MR severity.
Methods:
Patients from the PROTECT III study undergoing Impella-supported HRPCI were stratified into 4 groups according to MR severity: No or trace MR, mild MR, moderate MR, and severe MR. Immediate PCI-related complications, major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days and death at 1-year were assessed.
Results:
From March 2017 to March 2020, 631 patients who underwent Impella-supported HRPCI in the PROTECT III study had evaluable MR severity at baseline. Patients with severe MR had lower body mass indices, lower left ventricular ejection fractions (LVEFs), and were more frequently diagnosed with heart failure. The incidence of immediate PCI-related complications was similar between groups. Unadjusted 90-day MACCE and 1-year mortality rates were numerically higher in patients with severe MR compared to the other study groups yet without reaching statistical significance. In multivariable analyses, there was no significant association between the presence of severe MR for 90-day MACCE or 1-year mortality compared with other degrees of MR (adj. HR = 1.71, 95% CI [0.73, 3.98], p = 0.21; adj. HR = 1.79, 95% CI [0.86, 3.74], p = 0.12, respectively).
Conclusions:
Impella-supported HRPCI patients with moderate or severe MR exhibited a higher prevalence of heart failure, lower LVEF, and longer hospital stays. Patients with severe MR showed numerically higher unadjusted rates of 90-day MACCE and 1-year mortality compared to other groups, however these differences did not reach statistical significance even after adjustment for potential confounders.
Clinical Trial Information:
Trial Name: The Global cVAD Study (cVAD) ClinicalTrial.govIdentifier:NCT04136392 URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.
Insights
High-risk percutaneous coronary intervention (HRPCI) supported by Impella in patients with severe mitral regurgitation (MR) did not show statistically significant worse outcomes, despite a higher prevalence of heart failure.
Area of Science:
- Cardiology
- Interventional Cardiology
- Cardiac Surgery
Background:
- Mitral regurgitation (MR) is linked to poorer outcomes in patients undergoing percutaneous coronary intervention (PCI).
- Assessing outcomes in high-risk PCI (HRPCI) patients with Impella support stratified by MR severity is crucial.
Purpose of the Study:
- To evaluate the outcomes of Impella-supported HRPCI patients based on the severity of mitral regurgitation (MR).
- To determine if severe MR impacts complications, 90-day MACCE, or 1-year mortality in this patient group.
Main Methods:
- Patients from the PROTECT III study undergoing Impella-supported HRPCI were categorized into four groups based on MR severity.
- Immediate PCI complications, 90-day major adverse cardiovascular and cerebrovascular events (MACCE), and 1-year mortality were assessed.
Main Results:
- Severe MR patients had lower BMI, LVEF, and higher heart failure prevalence.
- Immediate PCI complications were similar across MR severity groups.
- Unadjusted 90-day MACCE and 1-year mortality were numerically higher in severe MR patients but not statistically significant.
Conclusions:
- Impella-supported HRPCI patients with moderate/severe MR had higher heart failure prevalence, lower LVEF, and longer hospital stays.
- Severe MR did not independently predict significantly worse 90-day MACCE or 1-year mortality in multivariable analyses.
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