Sex‐related difference in the use of percutaneous left ventricular assist device in patients undergoing complex high‐risk percutaneous coronary intervention: Insight from the cVAD registry

Abstract

Objective To assess the in‐hospital and short‐term outcome differences between males and females who underwent high‐risk PCI with mechanical circulatory support (MCS). Background Sex differences have been noted in several percutaneous coronary intervention (PCI) series with females less likely to be referred for PCI due increased risk of adverse events. However, data on sex differences in utilization and outcomes of high‐risk PCI with MCS is scarce. Methods Using the cVAD Registry, we identified 1,053 high‐risk patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients with cardiogenic shock were excluded. A total of 792 (75.21%) males and 261 (24.79%) females were included in the analysis with median follow‐up of 81.5 days. Results Females were more likely to be African American, older (72.05 ± 11.66 vs. 68.87 ± 11.17, p < .001), have a higher prevalence of diabetes (59.30 vs. 49.04%, p = .005), renal insufficiency (35.41 vs. 27.39%, p = .018), and peripheral vascular disease (31.89 vs. 25.39%, p of .05). Women had a higher mean STS score (8.21 ± 8.21 vs. 5.04 ± 5.97, p < .001) and lower cardiac output on presentation (3.64 ± 1.30 vs. 4.63 ± 1.49, p < .001). Although women had more comorbidities, there was no difference in in‐hospital mortality, stroke, MI or need for recurrent revascularization compared to males. Females were more likely to have multivessel revascularization than males. Ejection fraction improved in both males and females at the time of discharge (26.59 to 31.40% and 30.75 to 36.05%, respectively, p < .0001). However, females had higher rate of bleeding requiring transfusion compared with males (9.58 vs. 5.30%, p = .019). Conclusion Female patients undergoing high PCI were older and had more comorbidities but had similar outcomes compared to males.

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention

“…Transfusion rates in the four studies in which the majority of transfusions were stated as being performed in the setting of baseline anaemia ranged from 5.0% to 34.3%. 12,23,26,32 Few studies included in our review reported on haemolysis (9 of 23 studies). Of these, 3 studies reported 0% haemolysis rates, 1…”

“…Bleeding complications over time demonstrated that the variability in bleeding risk seen across centres has not changed meaningfully over the last 15 years (Figure 1). 7,[11][12][13][14][15][16][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] Given the broad scope of bleeding complications (comprising both access and non-access-related bleeding during PCI), often complicated by pre-existing anaemia and the inclusion of some urgent HR-PCI patient populations, this variability is not surprising. Likewise, many series reported relatively low numbers of cases over extended time periods, suggesting that any advantages of increased operator skill, using best practices accrued through increasing experience, could not be ascertained.…”

“…33,34 The rate of vascular complications remained consistently low over time ( Figure 2). 7,[11][12][13][14][15][16][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] Transfusion rates suggest a downward trend over time (Figure 3). Thus, in the absence of Level 1 evidence and specific guidelines for pVAD support during HR-PCI, variation in approaches further add to the difficulty in analysing overall procedural risk as well as bleeding risk.…”

“…INTERNATIONALpopulations) encompassing several different bleeding definitions found that, depending on the definition used, the mortality risk from a major bleeding event ranged from a 1.5 to 6.7 times increase 37. In multiple studies identified in this review, all, or a majority of, transfusions were to aid clinical recovery due to baseline anemia 12. 23,26,32 Low baseline haemoglobin levels were one of 10 variables included in a validated bleeding risk model developed by Rao et al to delineate high bleeding risk in patients up to 72 hours after undergoing PCI.…”

Sex Disparities in the Use and Outcomes of Temporary Mechanical Circulatory Support for Acute Myocardial Infarction-Cardiogenic Shock

“…15 It is unclear if similar disparities exist in the clinical profile and outcomes of men and women receiving temporary MCS for AMI-CS in the United States. [16][17][18] In light of these conflicting data, this study sought to assess sex differences in the use and outcomes of MCS in a 12-year nationally representative AMI-CS population. We hypothesized that women would receive MCS less frequently and have higher in-hospital mortality compared with men.…”