Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS)—A Pilot Trial

<b>Background:</b> The decision-making process to use percutaneous mechanical circulatory support in the context of elective high-risk percutaneous coronary intervention (HRPCI) is complex and evolving. The aim of this study is to evaluate the left ventricular end-diastolic pressure (LVEDP) as a parameter to identify patients that may benefit from a protected HRCPI (pHRPCI) procedure. <b>Methods:</b> Overall, 62 patients (pHRPCI <i>n</i> = 31 vs. non-pHRPCI <i>n</i> = 31) with a complex coronary artery disease and a left ventricular ejection fraction (LVEF) ≤35% were included. The primary endpoint was defined as a change in LVEDP and its correlation with laboratory measurements. The secondary safety endpoint was a composite of the incidence of major in-hospital adverse cardiac and cerebrovascular events (MACCE). <b>Results:</b> Baseline characteristics were similar, including age (pHRPCI 72.8 ± 8.8 vs. non-pHRPCI 75.0 ± 10.4; <i>p</i> = 0.408), male (pHRPCI 83.9% vs. non-pHRPCI 96.8; <i>p</i> = 0.195), pre-PCI Syntax Score (pHRPCI 33.9 ± 13.1 vs. non-pHRPCI 35.4 ± 12; <i>p</i> = 0.643), post-PCI Syntax Score (pHRPCI 7.4 ± 6.2 vs. non-pHRPCI 9.6 ± 8.4; <i>p</i> = 0.239) and baseline LVEDP between the groups (pHRPCI 18.5 ± 10.5 mmHg vs. non-pHRPCI 15.7 ± 8.1 mmHg; <i>p</i> = 0.237). There was a trend to a lower LVEF in the pHRPCI group (26.4 ± 6.7% vs. 29.4 ± 5%; <i>p</i> = 0.051). The primary endpoint analysis revealed a significant change in LVEDP (pHRPCI -4.7 ± 9 mmHg vs. non-pHRPCI +3.1 ± 7.5 mmHg; <i>p</i> < 0.001) that did not correlate with changes in creatinine (<i>p</i> = 0.285), NT-proBNP (<i>p</i> = 0.383) or troponin (<i>p</i> = 0.639) concentrations within 24 h. Overall, low rates of in-hospital (pHRPCI 6.5% vs. non-pHRPCI 3.2%; <i>p</i> = 0.999) and 90-days (pHRPCI 12.9% vs. non-pHRPCI 12.9%; <i>p</i> = 0.999) MACCE were observed in both groups. <b>Conclusions:</b> Protected HRPCI leads to a significant reduction in LVEDP without influencing biomarkers of myocardial damage. There was no difference in MACCE rates between the groups.