Impact of In-Hospital Left Ventricular Ejection Fraction Recovery on Long-Term Outcomes in Patients Who Underwent Impella Support for HR PCI or Cardiogenic Shock: A Sub-Analysis from the IMP-IT Registry

Overview

Journal J Pers Med

Date 2023 May 27

PMID 37240996

Authors

Mario Iannaccone

Luca Franchin

Francesco Burzotta

Giulia Botti

Vittorio Pazzanese

Carlo Briguori

Carlo Trani

Tommaso Piva

Federico De Marco

Giulia Masiero

Maurizio Di Biasi

Paolo Pagnotta

Gavino Casu

Anna Mara Scandroglio

Giuseppe Tarantini

Alaide Chieffo

Affiliations

Soon will be listed here.

Abstract

(1) Background: Percutaneous left ventricle assist devices (pLVADs) demonstrated an improvement in mid-term clinical outcomes in selected patients with severely depressed left ventricular ejection fraction (LVEF) undergoing percutaneous coronary interventions. However, the prognostic impact of in-hospital LVEF recovery is unclear. Accordingly, the present sub-analysis aims to evaluate the impact of LVEF recovery in both cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR PCI) supported with pLVADs in the IMP-IT registry. (2) Methods: A total of 279 patients (116 patients in CS and 163 patients in HR PCI) treated with Impella 2.5 or CP in the IMP-IT registry were included in this analysis, after excluding those who died while in the hospital or with missing data on LVEF recovery. The primary study objective was a composite of all-cause death, rehospitalisation for heart failure, left ventricle assist device (LVAD) implantation, or heart transplantation (HT), overall referred to as the major adverse cardiac events (MACE) at 1 year. The study aimed to evaluate the impact of in-hospital LVEF recovery on the primary study objective in patients treated with Impella for HR PCI and CS, respectively. (3) Results: The mean in-hospital change in LVEF was 10 ± 1% ( < 0.001) in the CS cohort and 3 ± 7% ( < 0.001) in the HR PCI group, achieved by 44% and 40% of patients, respectively. In the CS group, patients with less than 10% in-hospital LVEF recovery experienced higher rates of MACE at 1 year of follow-up (FU) (51% vs. 21%, HR 3.8, CI 1.7-8.4, < 0.01). After multivariate analysis, LVEF recovery was the main independent protective factor for MACE at FU (HR 0.23, CI 0.08-0.64, = 0.02). In the HR PCI group, LVEF recovery (>3%) was not associated with lower MACE at multivariable analysis (HR 0.73, CI 0.31-1.72, = 0.17). Conversely, the completeness of revascularisation was found to be a protective factor for MACE (HR 0.11, CI 0.02-0.62, = 0.02) (4) Conclusions: Significant LVEF recovery was associated with improved outcomes in CS patients treated with PCI during mechanical circulatory support with Impella, whereas complete revascularisation showed a significant clinical relevance in HR PCI.

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References

Sardone A, Franchin L, Moniaci D, Colangelo S, Colombo F, Boccuzzi G . Management of Vascular Access in the Setting of Percutaneous Mechanical Circulatory Support (pMCS): Sheaths, Vascular Access and Closure Systems. J Pers Med. 2023; 13(2). PMC: 9960206. DOI: 10.3390/jpm13020293. View

Chieffo A, Ancona M, Burzotta F, Pazzanese V, Briguori C, Trani C . Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry. EuroIntervention. 2019; 15(15):e1343-e1350. DOI: 10.4244/EIJ-D-19-00428. View

Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R . PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017; 377(25):2419-2432. DOI: 10.1056/NEJMoa1710261. View

Ancona M, Montorfano M, Masiero G, Burzotta F, Briguori C, Pagnesi M . Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy. Eur Heart J Acute Cardiovasc Care. 2021; 10(9):999-1006. DOI: 10.1093/ehjacc/zuab051. View

Neumann F, Sousa-Uva M, Ahlsson A, Alfonso F, Banning A, Benedetto U . 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2018; 40(2):87-165. DOI: 10.1093/eurheartj/ehy394. View

Tarantini G, Masiero G, Burzotta F, Pazzanese V, Briguori C, Trani C . Timing of Impella implantation and outcomes in cardiogenic shock or high-risk percutaneous coronary revascularization. Catheter Cardiovasc Interv. 2021; 98(2):E222-E234. PMC: 8451815. DOI: 10.1002/ccd.29674. View

ONeill W, Anderson M, Burkhoff D, Grines C, Kapur N, Lansky A . Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am Heart J. 2022; 248:139-149. DOI: 10.1016/j.ahj.2022.02.006. View

Iannaccone M, Franchin L, Hanson I, Boccuzzi G, Basir M, Truesdell A . Timing of impella placement in PCI for acute myocardial infarction complicated by cardiogenic shock: An updated meta-analysis. Int J Cardiol. 2022; 362:47-54. DOI: 10.1016/j.ijcard.2022.05.011. View

Thiele H, Zeymer U, Neumann F, Ferenc M, Olbrich H, Hausleiter J . Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013; 382(9905):1638-45. DOI: 10.1016/S0140-6736(13)61783-3. View

10.

Aurigemma C, Burzotta F, Chieffo A, Briguori C, Piva T, De Marco F . Clinical Impact of Revascularization Extent in Patients Undergoing Impella-Protected PCI Enrolled in a Nationwide Registry. JACC Cardiovasc Interv. 2021; 14(6):717-719. DOI: 10.1016/j.jcin.2021.01.017. View

11.

Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D . Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial. JAMA. 2010; 304(8):867-74. DOI: 10.1001/jama.2010.1190. View

12.

Burkhoff D, Sayer G, Doshi D, Uriel N . Hemodynamics of Mechanical Circulatory Support. J Am Coll Cardiol. 2015; 66(23):2663-2674. DOI: 10.1016/j.jacc.2015.10.017. View

13.

DAscenzo F, Gili S, Bertaina M, Iannaccone M, Cammann V, Di Vece D . Impact of aspirin on takotsubo syndrome: a propensity score-based analysis of the InterTAK Registry. Eur J Heart Fail. 2019; 22(2):330-337. DOI: 10.1002/ejhf.1698. View

14.

Panza J, Holly T, Asch F, She L, Pellikka P, Velazquez E . Inducible myocardial ischemia and outcomes in patients with coronary artery disease and left ventricular dysfunction. J Am Coll Cardiol. 2013; 61(18):1860-70. PMC: 3755503. DOI: 10.1016/j.jacc.2013.02.014. View

15.

Iannaccone M, Nombela-Franco L, Gallone G, Annone U, Di Marco A, Giannini F . Impact of Successful Chronic Coronary Total Occlusion Recanalization on Recurrence of Ventricular Arrhythmias in Implantable Cardioverter-Defibrillator Recipients for Ischemic Cardiomyopathy (VACTO PCI Study). Cardiovasc Revasc Med. 2022; 43:104-111. DOI: 10.1016/j.carrev.2022.03.029. View

16.

Iannaccone M, DAscenzo F, Frangieh A, Niccoli G, Ugo F, Boccuzzi G . Impact of an optical coherence tomography guided approach in acute coronary syndromes: A propensity matched analysis from the international FORMIDABLE-CARDIOGROUP IV and USZ registry. Catheter Cardiovasc Interv. 2016; 90(2):E46-E52. DOI: 10.1002/ccd.26880. View

17.

Lemor A, Basir M, Patel K, Kolski B, Kaki A, Kapur N . Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Cardiogenic Shock. JACC Cardiovasc Interv. 2020; 13(10):1171-1178. DOI: 10.1016/j.jcin.2020.03.012. View

18.

Perera D, Clayton T, OKane P, Greenwood J, Weerackody R, Ryan M . Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med. 2022; 387(15):1351-1360. DOI: 10.1056/NEJMoa2206606. View

19.

Panza J, Ellis A, Al-Khalidi H, Holly T, Berman D, Oh J . Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019; 381(8):739-748. PMC: 6814246. DOI: 10.1056/NEJMoa1807365. View

20.

ONeill W, Kleiman N, Moses J, Henriques J, Dixon S, Massaro J . A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012; 126(14):1717-27. DOI: 10.1161/CIRCULATIONAHA.112.098194. View