CRT-700.34 Short-Term Outcomes Among Aortic Valve Stenosis Patients Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention

Background: Among patients undergoing percutaneous coronary intervention (PCI), severe aortic stenosis (AS) is associated with an increased risk of adverse outcomes. Although the use of mechanical circulatory support with Impella has been shown to improve 90-day outcomes in patients undergoing high-risk PCI (HRPCI), there is little information about the safety of this approach in pts with severe AS. We, therefore, sought to evaluate the efficacy and safety outcomes of Impella-supported HRPCI among patients with varying severity of AS. Methods: We studied patients enrolled in PROTECT III—a multicenter study of patients undergoing Impella-supported HRPCI. Patients were classified according to the severity of AS: none/trivial, mild, moderate, and severe. The primary outcome was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 90 days, defined as the composite of all-cause death, MI, stroke/ TIA, and revascularization. Secondary outcomes included in-hospital PCI-related complications, stroke/TIA, and vascular complications requiring surgery. Results: Of 596 patients with echocardiographic data, 490 had no/trivial AS, and 34, 27, and 45 had mild, moderate, or severe AS, respectively. Patients with AS were older, less likely to have diabetes, more likely to have left main disease, and had higher left ventricular ejection fractions (Table). Severely calcified lesions and the use of atherectomy were more frequent among patients with moderate or severe AS. There were no differences in rates of PCI-related complications, stroke/TIA, 30-day MACCE, or 90-day MACCE according to AS severity. Rates of transfusion were higher among patients with AS—regardless of severity. Conclusion: Among patients undergoing Impella-supported HRPCI, PCI-related complications and 90-day outcomes did not differ based on AS status or severity

CRT-700.05 Impella Utilization in High-Risk Percutaneous Coronary Intervention Mitigates the Risks of Procedural and Clinical Adverse Events Independent of Left Ventricular Ejection Fraction: The Protect III Study

Background: Left ventricular (LV) dysfunction is associated with an increased risk of adverse events in patients undergoing percutaneous coronary intervention (PCI). However, the impact of LV ejection fraction (LVEF) on the outcomes of Impella-supported high-risk PCI (HRPCI) is unknown. Methods: Patients enrolled in the prospective, multicenter, and observational PROTECT III study from March 2017 to March 2020 who underwent Impella-supported HRPCI at the operator’s discretion (non-cardiogenic shock). Patients were divided into three tertiles (T) based on baseline LVEF: T1 (the lowest), T2, and T3 (the highest). The primary outcome is the rate of 90-day major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeated revascularization as adjudicated by an independent CEC. Results: Of 1237 patients, 940 with available baseline LVEF were analyzed. T1 included 353 patients (mean LVEF 19.6±4.7), T2 included 274 patients (mean LVEF 32.2±3.5), and T3 included 313 patients (mean LVEF 52.6±9.2). Patients in the higher tertiles were older, more likely to be females, presented more with acute coronary syndrome, and had more frequent left main disease. Also, severely calcified lesions and atherectomy utilization were more frequent in the higher tertiles. The rates of 90-day MACCE were comparable across all tertiles. Furthermore, PCI-related complications and 1-year mortality were also comparable (Table). After multivariable adjustment, 90-day MACCE was not significantly different between the LVEF tertiles (p=0.32). Conclusion: In patients with HRPCI supported by Impella, the rates of in-hospital adverse events, PCI-related complications, 90-day MACCE, and 1-year mortality were comparable among the different LVEF tertiles

Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study.

BACKGROUND: Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). OBJECTIVES: The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study. METHODS: We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization. RESULTS: From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex. CONCLUSIONS: In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392)

Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study

BACKGROUND: Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). OBJECTIVES: The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study. METHODS: We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization. RESULTS: From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex. CONCLUSIONS: In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences