Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL)
Arkadiusz Pietrasik, Aleksandra Gąsecka, Tomasz Pawłowski, Jerzy Sacha, Marek Grygier, Gabriel Bielawski, Wojciech Balak, Adam Sukiennik, Paulina Burzyńska, Adam Witkowski, Mateusz Warniełło, Łukasz Rzeszutko, Stanisław Bartuś, Artur Pawlik, Mateusz Kaczyński, Robert Gil, Wiktor Kuliczkowski, Krzysztof Reczuch, Marcin Protasiewicz, Paweł Kleczyński, Piotr Wańczura, Sebastian Gurba, Anna Kochanowska, Michał Łomiak, Andrzej Cacko, Włodzimierz Skorupski, Maciej Zarębiński, Piotr Pawluczuk, Szymon Włodarczak, Adrian Włodarczak, Krzysztof Ściborski, Artur Telichowski, Mieszko Pluciński, Jarosław Hiczkiewicz, Karolina Konsek, Michał Hawranek, Mariusz Gąsior, Jan Z. Peruga, Marcin Fiutowski, Robert Romanek, Piotr Kasprzyk, Dariusz Ciećwierz, Andrzej Ochała, Wojciech Wojakowski, Jacek Legutko, Janusz Kochman
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.