Outcomes of Impella‐supported high‐risk nonemergent percutaneous coronary intervention in a large single‐center registry

Abstract

Objectives: We aimed to evaluate the early and one-year outcomes of Impellasupported high-risk nonemergent percutaneous coronary intervention (PCI). Background: The evidence for the use of mechanical circulatory support (MCS) devices in high-risk nonemergent PCI is limited and nonconclusive. Methods: We performed a single-center retrospective study including all patients who underwent high-risk nonemergent PCI supported by Impella 2.5/CP at our institution between January 2009 and June 2018. This patient population was propensity score matched with subjects undergoing PCI with no MCS. The primary endpoint was major adverse cardiac events (MACE: all-cause death, myocardial infarction [MI], and target lesion revascularization) at one-year follow-up. Results: Two-hundred fifty patients undergoing Impella-supported nonemergent PCI were matched to 250 controls. The two groups were well balanced in terms of clinical and angiographic characteristics. Left main PCI was performed more frequently among Impella-supported patients (26% vs. 11%, p < .001), who also had numerically higher prevalence of rotational atherectomy use (44% vs. 37%, p = .10) and a higher number of vessels treated (1.8 ± 0.8 vs. 1.3 ± 0.6, p < .001), compared with controls. Impella-supported patients suffered a higher incidence of periprocedural MI (14.0% vs. 6.4%, p = .005), major bleeding (6.8% vs. 2.8%, p = .04), and need for blood transfusions (11.2% vs. 4.8%, p = .008). However, at one-year follow-up there were no differences in the rates of MACE (31.2% vs. 27.4%, p = .78) or any of its individual components between Impella-supported patients and controls. Conclusions: Although Impella-supported patients suffer a higher incidence of periprocedural adverse events (partially linked to more aggressive PCI), the incidence of one-year MACE was similar between the Impella and control group.

The Role of Hemodynamic Support in High-risk Percutaneous Coronary Intervention

“…More extensive revascularization was associated with improved 90-day MAE compared Also, the comparison of mortality and adverse event rates across these studies is challenging given the variable baseline patient characteristics and the threshold for device usage. Nonetheless, the allcause mortality at 1-year among patients supported with Impella during HR-PCI were similar at 15.6% in the IMP-IT registry58 and 15.3% in the analysis by Azzalini et al21 Burzotta et al investigated the effect of extent of revascularization on LVEF and survival in 86 patients undergoing Impella-supported PCI in the Roma-Verona registry 59. At a mean follow-up of 14 months, the all-cause mortality rate was 10%.…”

“…Despite the ability for optimization of hemodynamics, the risks associated with the large-bore access for all these mechanical support devices include bleeding and vascular complications. [18][19][20][21][22]…”

“…45,46 PROTECT III is an ongoing, prospective, FDA post-approval study of Impella-supported HR-PCI patients. Between 2017 and 2019, a total of 898 Superior hemodynamic support during HR-PCI 45 Supports longer rotational atherectomy procedures during HR-PCI 48 Improved clinical outcomes up to 90 days after HR-PCI 45,[49][50][51] Extensive revascularization with Impella associated with improved outcomes 53 Protects against in-hospital acute kidney injury 55,56 Improved survival and ejection fraction in the long term 21,[57][58][59] Beneficial in patients with LVEF >35% undergoing HR-PCI 61 In Protect II, Impella provided superior hemodynamic support compared to IABP (maximal decrease in cardiac power of 0.04 ± 0.24 W with Impella versus 0.14 ± 0.27 W with IABP; p=0.001). 45 Only 6% of Impella patients were discharged from the catheterization lab on the device, compared to 37% of IABP patients.…”

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

“…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.…”