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• W3048381509 abstract "HomeCirculationVol. 142, No. 6Letter by Chieffo et al Regarding Article, “The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBLetter by Chieffo et al Regarding Article, “The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support” Alaide Chieffo, MD, Mario Gramegna, MD and Federico Pappalardo, MD Alaide ChieffoAlaide Chieffo Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (A.C.) Search for more papers by this author , Mario GramegnaMario Gramegna https://orcid.org/0000-0002-9709-6082 Intensive Cardiac Care Unit San Raffaele Scientific Institute, Milan, Italy (M.G.) Search for more papers by this author and Federico PappalardoFederico Pappalardo Department of Anesthesia and Intensive Care, IRCCS ISMETT, Palermo, Italy (F.P.). Search for more papers by this author Originally published10 Aug 2020https://doi.org/10.1161/CIRCULATIONAHA.119.045169Circulation. 2020;142:e74–e75To the Editor:We read with interest the article by Amin et al,1 analyzing trends in 48 306 patients from the Premier Healthcare Database undergoing percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS; ie, intra-aortic balloon pump and microaxial flow pump [Impella, Abiomed, Danvers, MA]), for a variety of indications from 2004 to 2016. When analyzed by time periods or at the hospital/patient level, the use of Impella was associated with higher occurrence of adverse events and costs. In our opinion, these results should be interpreted with caution, because the study is flawed by many limitations and its conclusions might jeopardize access to MCS for critically ill complex patients.First, from a methodological point of view, this is an observational retrospective study analyzing an administrative database based on payer coding data with potential for misclassification; as such, it is impossible to properly perform propensity matching. In addition, many clinically relevant variables were not included in the matching, thus limiting the validity of the results.Second, no difference is made between elective and urgent PCI (ie, performed during acute coronary syndrome complicated with cardiogenic shock [CS]). These are completely different clinical conditions, and the approach of the study recalls the “apples and oranges” concept. Moreover, from 2004 to 2016, the indications for PCI have progressively widened to more complex patients declined from cardiac surgery, adding a further issue in the “evolving landscape” of patients examined in the study. As a matter of fact, despite more anatomic complexity and comorbidities, mortality is stable in this population. “High-risk” PCI has been validated and implemented,2 and this approach has further expanded the role of PCI for patients not suitable for surgery.3In the scenario of primary PCI during acute myocardial infarction and CS, mortality is still high despite introduction of different MCS devices. In this regard, the severity of CS, the timing of MCS, and the type of support might play an important role and are not reported in the article by Amin et al.1 Moreover, more than a single intervention should be evaluated in CS; microaxial flow pumps are an attractive option in CS because they allow escalation and deescalation of support for transition to recovery or to advanced surgical therapies such as left ventricular assist device and heart transplantation.4 If we aim at recovering hearts after an acute ischemic or inflammatory insult, there are no other devices currently on the market other than Impella with such a large background in terms of pathophysiological and clinical evidence.5 Last, we reinforce the value of CS networks with protocols, best practices, and multidisciplinary team–based approaches, which are not taken into account for, eventually, stratifying patients groups in the article.Therefore, in our opinion, the present analysis does not represent an accurate assessment of the Impella device. Nevertheless, adequately powered randomized clinical trials and large registries are warranted to better define patients and strategies that may optimize implementation of MCS in such challenging scenarios.DisclosuresDr Chieffo received lecture fees from Abbott, Abiomed, Cardinal Health and consultant fees from Biosensor and Magenta. The other authors report no conflicts.Footnoteshttps://www.ahajournals.org/journal/circReferences1. Amin AP, Spertus JA, Curtis JP, Desai N, Masoudi FA, Bach RG, McNeely C, Al-Badarin F, House JA, Kulkarni H, et al. The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141:273–284. doi: 10.1161/CIRCULATIONAHA.119.044007LinkGoogle Scholar2. Chieffo A, Ancona MB, Burzotta F, Pazzanese V, Briguori C, Trani C, Piva T, De Marco F, Di Biasi M, Pagnotta P, et al; Collaborators. Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry.EuroIntervention. 2020; 15:e1343–e1350. doi: 10.4244/EIJ-D-19-00428CrossrefMedlineGoogle Scholar3. Chieffo A, Burzotta F, Pappalardo F, Briguori C, Garbo R, Masiero G, Nicolini E, Ribichini F, Trani C, Álvarez BC, et al. Clinical expert consensus document on the use of percutaneous left ventricular assist support devices during complex high-risk indicated PCI.Int J Cardiol. 2019; 293:84–90. doi: 10.1016/j.ijcard.2019.05.065.CrossrefMedlineGoogle Scholar4. Bertoldi LF, Bertoglio L, Pappalardo F. Concomitant use of Impella while on peripheral veno-arterial extracorporeal membrane oxygenation: de-escalate and ambulate.Ann Cardiothorac Surg. 2019; 8:160–162. doi: 10.21037/acs.2018.10.15CrossrefMedlineGoogle Scholar5. Pieri M, Sorrentino T, Oppizzi M, Melisurgo G, Lembo R, Colombo A, Zangrillo A, Pappalardo F. The role of different mechanical circulatory support devices and their timing of implantation on myocardial damage and mid-term recovery in acute myocardial infarction related cardiogenic shock.J Interv Cardiol. 2018; 31:717–724. doi: 10.1111/joic.12569CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails August 11, 2020Vol 142, Issue 6 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.045169PMID: 32776839 Originally publishedAugust 10, 2020 PDF download Advertisement SubjectsCatheter-Based Coronary and Valvular InterventionsPercutaneous Coronary InterventionThrombosis" @default.
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