Impella versus Non-Impella for Non-Emergent High-Risk Percutaneous Coronary Intervention.

The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc., Danvers, MA) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared to historical data (PROTECT II) but lacks a direct comparison to the HR-PCI cohort without Impella support. We retrospectively identified patients meeting PROTECT III inclusion criteria for HR-PCI and compared this group (NonIMP) to the outcomes data from the PROTECT III registry (IMP). Baseline differences were balanced using inverse propensity weighting (IPW). The co-primary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 high-risk patients who did not receive Impella support; 200 patients had at 90-day event ascertainment and were included in the IPW analysis and compared with 504 patients in the IMP group. After calibration, few residual differences remained between groups. The primary outcome was not different in-hospital (3.0% vs. 4.8%, p=0.403) but lower in NonIMP at 90 days (7.5% vs. 13.8%, p=0.033). Periprocedural vascular complications, bleeding, and transfusion rate were not different between groups; however, acute kidney injury occurred more frequently in the NonIMP group (10.5% vs. 5.4%, p=0.023). In conclusion, under identical HR-PCI inclusion criteria for Impella use in PROTECT III, an institutional non-Impella-supported HR-PCI cohort demonstrated similar MACE in-hospital but lower MACE at 90 days, while there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for HR-PCI patients.

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Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Hayder D. Hashim reports a relationship with Abbott Vascular Inc that includes: consulting or advisory and speaking and lecture fees. Hayder D. Hashim reports a relationship with Boston Scientific Corp that includes: consulting or advisory and speaking and lecture fees. Hayder D. Hashim reports a relationship with Philips that includes: consulting or advisory and speaking and lecture fees. Toby Rogers reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Toby Rogers reports a relationship with Medtronic that includes: consulting or advisory. Toby Rogers reports a relationship with Boston Scientific Corp that includes: consulting or advisory. Toby Rogers reports a relationship with Transmural Systems that includes: equity or stocks. Ron Waksman reports a relationship with Abbott Vascular Inc that includes: consulting or advisory. Ron Waksman reports a relationship with Boston Scientific Corp that includes: consulting or advisory. Ron Waksman reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Ron Waksman reports a relationship with Philips that includes: consulting or advisory and funding grants. Ron Waksman reports a relationship with Pi-Cardia Ltd. that includes: consulting or advisory. Ron Waksman reports a relationship with Append Medical that includes: consulting or advisory. Ron Waksman reports a relationship with Biotronik AG that includes: consulting or advisory and funding grants. Ron Waksman reports a relationship with JC Medical that includes: consulting or advisory. Ron Waksman reports a relationship with Cordis Corporation that includes: consulting or advisory. Ron Waksman reports a relationship with SIS Medical AG that includes: consulting or advisory. Ron Waksman reports a relationship with Transmural Systems Inc. that includes: consulting or advisory and equity or stocks. Toby Rogers has patent issued to National Institutes of Health. Ron Waksman is a member of the Editorial Board of The American Journal of Cardiology. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.