Key result
Severe MR during Impella-supported high-risk PCI is not linked to increased 90-day MACCE.
Why the study?
Mitral valve regurgitation is associated with worse outcomes in patients undergoing PCI, but outcomes in Impella-supported high-risk PCI stratified by MR severity had not been evaluated.
Does severe mitral regurgitation worsen outcomes in patients undergoing Impella-supported high-risk PCI?
Observational (n=631)
Yes
Does severe mitral regurgitation worsen outcomes in patients undergoing Impella-supported high-risk PCI?
Effect estimate: adj. HR 1.71 (95% CI 0.73-3.98)
p-value: p=0.21
In patients undergoing Impella-supported high-risk PCI, severe mitral regurgitation was not independently associated with worse 90-day MACCE or 1-year mortality after multivariable adjustment.
Severe MR should not yet alter Impella use in high-risk PCI; leaves open need for prospective confirmation.
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.
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Abu‐Much et al. (2024) conducted an observational in Mitral valve regurgitation in patients undergoing Impella-supported high-risk PCI (n=631). Severe mitral regurgitation vs. No/trace, mild, or moderate mitral regurgitation was evaluated on 90-day MACCE (all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) (adj. HR 1.71, 95% CI 0.73-3.98, p=0.21). Severe mitral regurgitation during Impella-supported high-risk PCI was not significantly associated with 90-day MACCE compared to lesser MR (adj. HR 1.71; 95% CI 0.73-3.98; p=0.21).
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