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November 8, 2023Kardiologia Polska16 citationsOpen Access

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

APArkadiusz PietrasikAGAleksandra GąseckaTPTomasz 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

P
Population
308 patients (55 with cardiogenic shock and 253 undergoing high-risk percutaneous coronary intervention) treated with Impella in 20 Polish interventional cardiological centers
I
Intervention
Impella percutaneous mechanical circulatory support (predominantly Impella CP)
O
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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Cite This Study

Pietrasik et al. (2023) conducted an observational in Cardiogenic shock and high-risk percutaneous coronary intervention (n=308). Impella was evaluated on In-hospital mortality (HR-PCI group). 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.

synapsesocial.com/papers/6a0edf5c950456576347d6a3https://doi.org/10.33963/v.kp.97218
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