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Evaluation of LVEDP change during high-risk PCI with and without Impella Support (ELVIS) – A pilot trial

https://doi.org/10.1007/s00392-025-02625-4

Jürgen Leick (Trier)1, A. Gjata (Trier)1, J. Pulz (Köln)2, T. Weisbarth (Köln)2, K. Richter (Köln)2, T. Krause (Trier)1, A. Haneya (Trier)3, M. L. Saad (Trier)1, J.-M. Sinning (Köln)2, N. Werner (Trier)1

1Krankenhaus der Barmherzigen Brüder Trier Innere Medizin III Trier, Deutschland; 2Cellitinnen Krankenhaus St. Vinzenz Köln Innere Medizin III - Kardiologie Köln, Deutschland; 3Krankenhaus der Barmherzigen Brüder Trier Klinik für Herz- und Thoraxchirurgie Trier, Deutschland

 

Background: 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 was to evaluate the left ventricular end diastolic pressure (LVEDP) as a parameter to identify patients that may benefit from a protected HRCPI (pHRPCI) procedure.

 

Methods: Overall, 62 patients (pHRPCI n=31 vs. non-pHRPCI n=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).

 

Results: Baseline characteristics were similar, including pre-PCI Syntax Score (pHRPCI 33.9±13.1 vs. non-pHRPCI 35.4±12; p=0.643), post-PCI Syntax Score (pHRPCI 7.4±6.2 vs. non-pHRPCI 9.6±8.4; p=0.239) and baseline LVEDP between the groups (pHRPCI 18.5±10.5 mmHg vs. non-pHRPCI 15.7±8.1 mmHg; p=0.237). There was a trend to a lower LVEF in the pHRPCI group (26.4±6.7% vs. 29.4±5%; p=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; p<0.001) that did not correlate with changes in creatinine (p=0.285), NT-proBNP (p=0.383) or troponin (p=0.639) concentrations within 24 hours. Overall, low rates of in-hospital MACCE were observed in both groups (pHRPCI 6.5% (n=2) vs. non-pHRPCI 3.2% (n=1); p=0.999).

 

Conclusion: Protected HRPCI leads to a significant reduction in LVEDP without influencing biomarkers of myocardial damage. There was no difference in MACCE rate between the groups.

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