Characteristics and outcomes of elderly patients undergoing protected percutaneous coronary intervention with impella mechanical circulatory support

Abstract Background/Introduction In high-risk patients, percutaneous coronary intervention (PCI) with Impella mechanical circulatory support has become an important part of the revascularization strategy. However, data regarding the impact of age in patients undergoing Impella-supported PCI are limited. Purpose The aim of this study was to describe the characteristics and outcomes of Impella mechanical circulatory support in patients ≥75 years of age undergoing high-risk PCI. Methods Using the PROTECT III study, a prospective, multicenter, FDA-audited cohort of the Catheter-based Ventricular Assist Device (cVAD) registry, we compared baseline characteristics and clinical outcomes of patients ≥75 years of age with those of patients 75 years of age treated with Impella-supported high-risk PCI. Rates of major adverse cardiovascular and cerebral events (MACCE), defined as the composite of all-cause death, myocardial infarction (MI), stroke/transient ischemic attack, and revascularization, were assessed at 30 days and 90 days, and mortality was assessed to 1 year. A multivariable Cox regression model (including covariates significant in univariable analysis) was used to examine associations between age and clinical outcomes. Results A total of 1237 patients (26.8% female) were included in the analysis; of whom 493 (39.9%) were ≥75 years of age. Patients ≥75 years of age had lower body mass index (27 kg/m² vs. 30 kg/m²), a lower prevalence of diabetes (49% vs. 61%) and prior MI (37% vs. 43%), and lower estimated glomerular filtration rates (eGFR, 60 vs. 74 mL/min/1.73 m²). They more often suffered from severe valvular heart disease (17% vs. 7%), and more frequently underwent left main PCI (58% vs. 39%). Left ventricular ejection fraction was higher in patients ≥75 years of age (37.7±15.9% vs. 32.0±14.5%). (p0.05 for all comparisons). Baseline SYNTAX scores did not differ among groups. Rates of death and MACCE did not differ between age groups at either 30 days or 90 days (Figure 1). Mortality at 1 year was 24.0% in patients ≥75 years of age and 17.9% in those 75 years of age. Age ≥75 years was associated with an increased risk of mortality at 1 year (unadjusted HR 1.40, 95% CI 1.05-1.86, p=0.02) and the association remained significant after multivariable adjustment (adjusted HR 1.99, 95% CI 1.24-3.18, p=0.004; Figure 2). Conclusion(s) This study demonstrates that increased age ≥75 years was not associated with a higher risk of mortality or MACCE at 30 or 90 days following protected PCI with Impella mechanical circulatory support, suggesting that protected high-risk PCI in elderly patients is safe and feasible. However, age ≥75 years remained an independent predictor for 1-year mortality after protected PCI.30-day and 90-day MACCE1-year All-cause death