Sex-specific outcomes of patients undergoing Impella-supported high-risk percutaneous coronary intervention

Alexander Laupp (Dresden)1, F. Woitek (Dresden)1, A. Conrad (Dresden)1, S. Haussig (Dresden)1, J. Mierke (Dresden)1, E. B. Winzer (Dresden)1, R. Höllriegel (Dresden)1, S. Jellinghaus (Dresden)1, A. Linke (Dresden)1, N. Mangner (Dresden)1

1Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin, Kardiologie und Intensivmedizin Dresden, Deutschland


Background: Females are generally underrepresented in cardiovascular clinical trials. Data are in particular limited for women undergoing high-risk percutaneous coronary interventions (HRPCI) with mechanical circulatory support. We investigated sex-specific outcomes in patients undergoing Impella-supported HRPCI.

Methods: We used an ongoing single-center registry to examine 52 (28%) female and 135 (72%) male patients undergoing Impella-supported HRPCI. The primary outcomes were 30-day and 3-year survival and safety was assessed according to ARC-2 and VARC-III definitions.

Results: Female and male patients were comparable with regard to age (81 (IQR 75; 84) vs 79 (IQR 69; 84) years, p=0.375), median left ventricular ejection fraction (LV-EF 38% (IQR 30; 54) vs 39% (IQR 29; 48), p=0.550) and the rate of relevant comorbidities. The STS score was slightly higher in females compared to males (6.4 (4.3; 12.9) vs 5.3 (IQR 4.3; 12.9), p=0.066) There were no significant differences with regard to ischemic (CCS 3/4: 28.8% vs 37.1%) and heart failure symptoms (NYHA III/IV: 64.0% vs 56.9%). The rate for 3-vessel (78.8% vs 78.4%) and left main disease (75.0% vs 79.9%) was also comparable between females and males leading to a comparable median Syntax score (34 (IQR 28; 37) vs 33 (IQR 28; 37), p=0.942).

A median of 3 lesions was treated in both groups without significant differences (p=0.121). The time of Impella support was also not different between groups. There was a numerically higher rate of VARC-defined vascular access site complications in females (34.6% vs 22.0%, p=0.077), mainly minor complications. The rates of myocardial infarction, BARC-defined bleeding as well as VARC defined stroke and acute kidney injury were not different.

The Kaplan-Meier estimated 30-day (76.7% (95%-CI 62.2; 94.6) vs. 77.1% (95%-CI 68.2; 87.1), p=0.685) and 3-year survival (23.0% (95%-CI 8.7; 60.7) vs. 36.8 (95%-CI 25.4; 53.4), p=0.553) was high but not different between female and male patients. In a multivariate Cox regression analysis, sex was not associated with early and late mortality whereas a higher STS score (per 1% increase HR 1.05 (95%-CI 1.03; 1.07)), COPD (HR 2.47 (95%-CI 1.16; 5.29)) and a reduced LV-EF (per 10% decrease HR 1.29 (95%-CI 1.03; 1.61)) were associated with a higher 3-year mortality. In contrast, more severe ischemic symptoms at baseline (CCS 3/4 HR 0.40 (85%-CI 0.21; 0.77)) and presence/treatment of a left main lesion (HR 0.46 (95%-CI 0.23; 0.95)) were associated with a lower 3-year mortality.

Conclusion: In patients undergoing Impella-supported HRPCI, no significant differences with regard to survival and safety were detected between female and male patients indicating that those therapies should not be withheld from women. Increased long-term mortality was predicted by the baseline risk profile of the patients, whereas the treatment of patients with more severe ischemic symptoms and prognostic-relevant lesions led to improved survival.

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