https://doi.org/10.1007/s00392-025-02737-x
1Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin, Kardiologie und Intensivmedizin Dresden, Deutschland; 2Herzzentrum Dresden GmbH an der TU Dresden Dresden, Deutschland; 3Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin und Kardiologie Dresden, Deutschland
Background: Patients undergoing high-risk percutaneous coronary intervention (HRPCI) are characterized by complex coronary artery disease, severe comorbidities, and adverse hemodynamics, including reduced left ventricular ejection fraction (LV-EF). We investigated the optimal cut-off of LV-EF in patients undergoing microaxial flow pump (mAFP)-supported HRPCI to predict survival, clinical functional outcomes, and a PROTECT IV-like composite endpoint, and aimed to evaluate the impact of complete revascularization in patients with LV-EF≤40% versus LV-EF>40%.
Methods: We used a prospective single-center registry including 225 patients undergoing mAFP-supported HRPCI. Receiver operating curve analysis determined the optimal LV-EF cut-off for predicting 3-year survival. The primary endpoint was 3-year survival; safety was assessed by ARC-2 and VARC-3 definitions. Secondary endpoints included PROTECT IV-like composite outcomes and functional status (NYHA, CCS, LV-EF). The interaction between complete revascularization and LV-EF status was analyzed.
Results: Receiver operating curve analysis identified an LV-EF cut-off of 40% for predicting 3-year survival. Patients were stratified into LV-EF≤40% (n=123) and LV-EF>40% (n=102) groups. LV-EF≤40% patients were younger, exhibited more severe heart failure symptoms, and had higher STS scores (median 7.0% vs. 4.3%, p<0.001). The prevalence of 3-vessel disease (~80%), baseline SYNTAX score (32 (IQR 24; 40), and BCIS Jeopardy Score (12 (IQR 8; 12) were high in both groups without significant differences. However, the rate of any CTO was higher, and left main disease was less frequent in LV-EF≤40%.
Complete revascularization (residual BCIS Jeopardy Score <4) was numerically less frequent in LV-EF≤40% (69.1% vs. 76.5%, p=0.218). Duration of mAFP support was comparable. Major access-site complications occurred more often in the LV-EF>40% group (26.5% vs. 13.1%, p=0.011), while rates of myocardial infarction, stent thrombosis, stroke, acute kidney injury, and bleeding were similar.
Three-year survival was significantly lower in LV-EF≤40% (53.7% vs. 70.6%, p=0.002). In multivariate Cox regression analysis, LV-EF≤40% was independently associated with increased 3-year mortality (HR 1.76; 95% CI 1.11-2.81). Complete revascularization had no survival benefit in LV-EF>40% (68.4% vs. 73.9%, p=0.556) but was associated with improved survival in LV-EF≤40% (59.5% vs. 39.5%, p=0.014; p-value for interaction <0.001).
At a median follow-up of 977 (IQR 426–1826) days, NYHA and CCS class III/IV symptoms were reduced by 68.5% and 75.2%, respectively. Reverse LV remodeling was more pronounced in LV-EF≤40% (10.0% vs. 0.5%, p<0.001). The PROTECT IV-like composite endpoint at 3 years favoured LV-EF>40% (54.9% vs. 45.5%, p=0.025).
Conclusion: In patients undergoing mAFP-supported HRPCI, a LV-EF≤40% was associated with poor 3-year survival. Complete revascularization led to a higher 3-year survival in patients with LV-EF≤40%, but had no impact on patients with LV-EF>40%. The LV-EF≤40% population appears suitable for studying the effects of a mAFP-guided HRPCI strategy aimed at achieving complete revascularization in randomized controlled trials, such as the PROTECT IV study.