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.