EDITORIAL Euro Intervention

2020;15: e 1312- e ublished online 1314

p Haemodynamic support for cardiogenic shock and high-risk PCI: what can observational data tell us? e -edition 2020 February Ajay J. Kirtane*, MD, SM

Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA

The rise of modern interventional was ushered in by role following cases of abrupt closure during PCI, these devices the revolutionary performance of the first coronary have undergone iterative developmental changes over the years. procedure by Andreas Gruentzig over 40 years ago. Since then, Reflection on a seminal review by Lincoff et al in 19912 dem- interventional cardiology has experienced several additional revo- onstrates that many of the devices proposed and conceived of lutions, including the introduction of primary angioplasty for acute at that time are the same devices (albeit refined) at our disposal myocardial infarction, the advent of intracoronary stent techno- today (Table 1). The Impella family of transaxial support devices logy, and the most recent rise of structural intervention. Long (Abiomed, Danvers, MA, USA) is one such type of device that is gone, however, are the days of percutaneous coronary interven- implanted using large-bore arterial access, directly unloading the tion (PCI) on focal 80% lesions such as the one first treated by left ventricle and ejecting blood into the aorta. Depending upon Gruentzig. In fact, it seems that the proportion of these types of the specific device used, haemodynamic support of ~4 L/min can lesion decreases year after year, to the point where it is often hard be provided with the typical percutaneous insertion of an Impella to remember the last time a patient with a chronic coronary syn- in the cath lab. Given these device characteristics, the two most drome and a focal type A stenosis presented to the cardiac cath lab common indications for the use of the left-sided Impella devices for PCI. Instead, what the modern day interventionalist is increas- are for cardiogenic shock and for high-risk PCI. For a variety of ingly faced with are cases of either increasing clinical acuity or reasons, the use of this device has undergone significant growth advanced patient and lesion complexity (or both)1. It is remarkable over the past several years. The manuscript by Chieffo and col- that, despite dramatically increasing clinical/anatomic complexity, leagues details this growth among a number of Italian sites within the range of adjunctive tools and devices at our disposal is now so the IMP-IT registry3. D

OI: OI: advanced that we are able to tackle these types of cases routinely Article, see page 1343

10.4244/EIJV15I15A239 in the cath lab. Notably, while the use of the device increased significantly One such category includes percutaneously implanted devices over time within this observational registry, the absolute numbers for haemodynamic support. Initially used with a temporising of devices used at the 17 included sites within the study period

*Corresponding author: 161 Fort Washington Ave, 6th Floor, New York, NY 10032, USA. E-mail: [email protected]

© Europa Digital & Publishing 2020. All rights reserved. The opinions expressed in this article are not necessarily those of the Editors of EuroIntervention or of the European Association of Percutaneous Cardiovascular Interventions. e1312 EuroIntervention 2020;15: 1312- 1314

e e 1313 e - - Observational data for haemodynamic support haemodynamic for data Observational , particularly in the absence of robust randomised , particularly 4,5 In spite of the exemplary efforts of the study investigators to study investigators of the efforts of the exemplary In spite support devices with a signi- bore haemodynamic For all larger trial evidence of device benefit. Where we go next from here is at benefit. evidence of device trial note of how other careful but we should take present uncertain, myocardial PCI for acute such as primary practices revolutionary and the infarction, the introduction of coronary stent technology, only through to fruition came intervention heart rise of structural trials. It behoves us to the conduct of serial randomised clinical consider strongly how these precedents were established if we characterise the usage and outcomes of Impella within this regis- within of Impella usage and outcomes the characterise of analyses observational of all one of the common limitations try, or “anchor” relates to how to benchmark as Impella devices such to a putative events in relation rates of adverse these observed support or with haemodynamic (either without control group com- Rendering within-study and cross-study device). a different differ there are probably is that parisons even more challenging as and site level, the physician usage at ing thresholds for device combined over time of the device well as increasing availability and complication implantation for device with a learning curve in more utilisation studies of device Observational management. reassuring (and some- to be appear times can at markets mature with the device), but some to a learning curve times attributed of indication may in fact be reflective of the improved outcomes as those with bet- such of patients cohort expansion to a different Look: High- III First (Popma JJ. PROTECT fraction ter ejection Presented Patients. Risk PCI Outcomes in 800 Impella-Supported This is 2019). CA, USA, 27 September, San Francisco, TCT, at study designs – and with observational problem the fundamental wish as we might As much device. specific this to just isolated not it is hard to data, to draw stronger conclusions from observational nature of descriptive be definitive about anything other than the patterns and gross rates of device uptake as well as the practice to the in part be attributable (some of which may events adverse itself). to the device substrate in addition patient underlying selec patient careful complications, rate of device-related ficant implantation/management/ to attention meticulous and tion adverse mitigating in elements critical are technique removal - provided addi have certainly devices many of these While events. additionally is it patients, sickest of our some for options tional are most ide- which populations of patients to identify imperative - to assume the effi ally suited for them. It is not enough simply benefits and risks. have offsetting cacy of devices that clearly a clinical comes usage patterns Hand in hand with rising overall “protected” are actually which patients to identify responsibility derive may on the contrary with these devices, and which patients being exposed to while at the same time from them lesser benefits data cannot provide observational harm. Unfortunately, potential answer for these types of questions. In some cases, the definitive outcomes between differentiate to challenging incredibly be can it to a specific device, and outcomes related to directly attributable for whom that device is of the patients inherent characteristics it appears that we are learning this lesson chosen. Increasingly, the hard way - device Current-day IABP Obviated due to intracoronary stents Investigational ECMO/CPS Axial flow devices (Impella, PHP) TandemHeart 2 Application proposedApplication in 1991 by Lincoff et al in 1991 by Prophylactic support inProphylactic supporthigh-risk PCI; before CABG after PCI complication Prolonged balloon inflations; support before CABG after abrupt closure Prolonged balloon inflations in high-risk patients Prophylactic support in high-risk PCI; severe haemodynamic compromise after PCI complication Investigational Investigational Among shock patients in IMP-IT with a median duration of duration with a median in IMP-IT Among shock patients Predicate device Intra-aortic balloon counterpulsation Coronary sinus retroperfusion Cardiopulmonary support Other: Hemopump Other: partial left heart bypass Anterograde perfusion (perfusion balloon) Table 1. Evolution of support devices for high-risk or complicated for high-risk devices of support 1. Evolution Table PCI. remained small on an absolute scale, with a maximal usage of with a maximal scale, on an absolute small remained shock and ~45 devices for high- devices for cardiogenic ~70 total and acuity of clinical was a high level There risk PCI in 2017. across with this device, treated of patients complexity procedural cardiogenic shock and high-risk PCI. presentations, both clinical avail recent of the relatively This is reassuring, and indicative of On the other hand, examination in Italy. device of the ability of demonstrates that the majority of device utilisation the timing subopti- shock had the device (perhaps patients with cardiogenic was device in high-risk PCI, the PCI; even after implanted mally) proportion of patients. after PCI in a substantial implanted were INTERMACS support of 72 hours, the majority Impella in- and overall fraction, depressed ejection severely I, with level the Among high-risk PCI patients, was 47%. mortality hospital majority had severe multivessel coronary artery disease with fraction of 31%. Unlike unsta- ejection a mean left ventricular (and high-risk the in outcomes the patients, shock cardiogenic ble with an in-hos- PCI cohort were better, non-emergent) presumably outcomes, the study of 5.7%. Beyond mortality pital mortality rate and for the collection investigators should also be commended adverse relevant of additionally adjudication clinical especially complications including device-related events within the registry, and haemolysis. such as bleeding events, vascular complications, complications device-related of rate overall the analyses, these In was of life- 37.1% in cardiogenic shock, with a 15.7% incidence insen- by the relatively or severe bleeding adjudicated threatening rate bleeding scale. For high-risk PCI, the overall sitive GUSTO 5.1% a with 10.7%, at lower was complications device-related of despite a duration of or severe bleeding, rate of life-threatening of 1.5 hours. support of only a median Impella

f AM, Popma JJ, Ellis SG, Vogel RA, Topol EJ. Percutaneous support support Percutaneous EJ. Topol RA, Vogel SG, Ellis JJ, AM, Popma f TE: Increased Rate of Mortality in Patients Receiving Abiomed Abiomed Mortality in Patients Receiving TE: Increased Rate of AP, Spertus JA, Curtis JP, Desai N, Masoudi FA, Bach RG, McNeely C, C, Bach RG, McNeely Desai N, Masoudi FA, Spertus JA, Curtis JP, AP, fo A, Ancona MB, Burzotta F, Pazzanese V, Briguori C, Trani C, C, Trani C, Briguori V, Pazzanese F, Ancona MB, Burzotta A, fo Lincof Chief UPDA Amin

J Am Coll Cardiol. Am J angioplasty. risk or complicated coronary devices for high M, G, Giustino G, Montorfano Casu P, Di Biasi M, Pagnotta De Marco F, T, Piva of multicentre registry G; Collaborators. Observational Tarantini Pappalardo F, mechanical circulatory support device in ITaly: patients treated with IMPella 2020;15:e1343-50. EuroIntervention. registry. the IMP-IT 4. Health Care Providers. 2 December 2019. System - Letter to Impella RP https://www.fda.gov/medical-devices/letters-health-care-providers/ at: Available update-increased-rate-mortality-patients-receiving-abiomed-impella-rp-system- letter-health-care 5. The Evolving Landscape of House JA, Kulkarni H, Rao SV. Al-Badarin F, Percutaneous Among Patients Undergoing States Impella® Use in the United Mechanical Circulatory Support. Circulation. Coronary Intervention with 2. 1991;17:770-80. 3. 2020;141:273-84. Kirtane

1. D, Karmpaliotis NK, Kapur N, Uriel N, Beohar Palacios IF, MG, Cohen A, Shroff of Treatment Moses JW. Parikh MA, Stone GW, Dangas GD, W, Lombardi for Revascularization: Evolution an Indication With Patients Higher-Risk WW, OhmanEM,O’Neill AJ, DoshiD,LeonMB,LasalaJM, Percutaneous Coronary Intervention. the Field of Contemporary Within 2016;134:422-31. Circulation. References Conflict of interest statement Conflict University funding to Columbia institutional declares The author from Medtronic, Foundation Research Cardiovascular and/or CSI, CathWorks, Abiomed, Vascular, Abbott Scientific, Boston ReCor Medical. Siemens, Philips, and believe that applications for percutaneous haemodynamic support support haemodynamic percutaneous for applications that believe within our field. revolutions of the next major represent one

EuroIntervention 2020;15:e1312-e1314 1314 e