What is the clinical evidence from this study?

Study design: Observational. Population: Cardiogenic shock and high-risk percutaneous coronary intervention (n=308). Intervention: Impella. Primary outcome: In-hospital mortality (HR-PCI group).

What does this research mean for the field?

In a real-world Polish registry, Impella mechanical circulatory support is safe and effective for high-risk percutaneous coronary interventions, consistent with prior registries, whereas its use in cardiogenic shock is associated with higher mortality than previously reported. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

November 8, 2023Kardiologia Polska15 citationsOpen Access

Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL)

APArkadiusz Pietrasik AGAleksandra Gąsecka TPTomasz Pawłowski

Key Result

In a Polish multicenter registry, Impella use was associated with an 8.3% in-hospital mortality rate during high-risk percutaneous coronary interventions and a 76.4% rate in cardiogenic shock.

Study Design

Type

Observational (n=308)

Multicenter

Yes

Structured PICO

Population

308 patients (55 with cardiogenic shock and 253 undergoing high-risk percutaneous coronary intervention) treated with Impella in 20 Polish interventional cardiological centers

Intervention

Impella percutaneous mechanical circulatory support (predominantly Impella CP)

Outcome

In-hospital mortality, 12-month mortality, and 12-month major adverse cardiovascular and cerebrovascular events (MACCEs) including mortality, rehospitalization for HF, acute MI, repeat revascularization, stroke, LVAD implantation, and heart transplantationhard clinical

In a real-world Polish registry, Impella support during high-risk PCI showed acceptable safety and efficacy, whereas its use in cardiogenic shock was associated with high mortality reflecting a very high-risk patient profile.

Limitations

Retrospective registry design limited by completeness of medical records
Lack of an independent event adjudication committee
No control group of patients treated with IABP, ECMO, or no mechanical circulatory support
Low absolute number of cardiogenic shock patients included in the registry

Abstract

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.

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