Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS)— One-Year Follow-Up

A. Gjata (Trier)¹, J. Pulz (Köln)², T. Weisbarth (Köln)², K. Richter (Köln)², T. Krause (Trier)¹, L. Saad (Trier)¹, J.-M. Sinning (Köln)², N. Werner (Trier)¹, J. Leick (Trier)^1
1Krankenhaus der Barmherzigen Brüder Trier Innere Medizin III Trier, Deutschland; ²Cellitinnen Krankenhaus St. Vinzenz Köln Innere Medizin III - Kardiologie Köln, Deutschland

Background:
The ELVIS pilot trial investigated the effect of percutaneous left ventricular assist device support on left ventricular end-diastolic pressure (LVEDP) during high-risk percutaneous coronary intervention (HRPCI). The study demonstrated that Impella support (protected HRPCI; pHRPCI) was associated with greater hemodynamic stability and a more favorable LVEDP profile compared to PCI without mechanical circulatory support (non-pHRPCI), while having no measurable impact on cardiac injury biomarkers. 

Objective:
The objective of this follow-up study was to assess the clinical outcomes one year after HRPCI with or without Impella support, and to evaluate the prognostic value of intraprocedural LVEDP changes for long-term patient outcomes. 

Methods:
This one-year follow-up of the ELVIS pilot trial included 62 patients with complex coronary artery disease and a left ventricular ejection fraction (LVEF) ≤35% (pHRPCI n = 31 vs. non-pHRPCI n = 31) who underwent HRPCI. Patients were contacted by telephone to assess adverse events such as myocardial infarction, stroke, cardiac death, all-cause mortality, access site complications, and MACCE. Outcomes were compared between the Impella-supported and unsupported groups. 

Results:
At one-year follow-up, the incidence of MACCE was lower in the pHRPCI group 6,5 % versus 16,1% in the non-pHRPCI group, but without statistical significance (p = 0,425). Cardiac mortality rates did not differ significantly between the two groups (pHRPCI 6,5% vs. non-pHRPCI 12,9%; p = 0,668). Similarly, all-cause mortality showed no statistically significant difference (pHRPCI 6,5% vs. non-pHRPCI 22,6%; p = 0,149). 

Conclusion:
Although LVEDP measurement in decision making may offer important prognostic insights for individual patients, our findings suggest that it does not significantly affect long-term mortality in our cohort, underscoring the need to consider LVEDP alongside other clinical factors when guiding patient management.

Keywords: 
Left ventricular end-diastolic pressure (LVEDP); High-risk percutaneous coronary intervention (HRPCI); Follow-up; Major adverse cardiac and cerebrovascular events (MACCE)