Short-term Outcomes of Elective High-risk PCI With Extracorporeal Membrane Oxygenation Support: a Single-centre Registry

NCT ID: NCT05387902

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2022-03-22

Brief Summary

Background Revascularization of complex coronary artery disease, including multivessel coronary artery disease, left main stenosis, bifurcation stenosis and chronic total occlusions (CTO) can be performed by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG), according to current guidelines.[1] In order to decide whether to revascularize by either CABG or PCI, patient characteristics, the presence of comorbidities, including diabetes, and coronary lesion complexity (e.g. SYNTAX) should be taken into consideration. Because of the ageing population with a higher incidence of comorbidities and higher surgical risk scores, high-risk PCI in complex coronary disease with high risk for periprocedural cardiogenic shock is increasingly performed.[2, 3] Mechanical Circulatory Support (MCS) devices for elective high-risk PCI can provide hemodynamic support, preventing hemodynamic failure during PCI. Several studies are performed using Intra-Aortic Balloon Pump (IABP) and co-axial left cardiac support device (Impella device (Abiomed, Danvers, USA)), showing no clear benefits in patients with high-risk PCI.[4-6] Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) is a recent addition to mechanical support options, providing more extensive hemodynamic support in patients with potential or ongoing failure of circulation. This concept is already demonstrated in the setting of Extracorporeal Cardiopulmonary Resuscitation (ECPR).[7, 8] ECMO has the additional benefits of right ventricular unloading and blood oxygenation as opposed to IABP and Impella.[9] Our experience with fully percutaneous VA-ECMO in cardiogenic shock and for ECPR combined with the experience for Transcatheter Aortic Valve Replacement (TAVR) with local anaesthesia and mild sedation resulted in the selection of VA-ECMO as our preferred method in high risk PCI. Studies investigating the use of VA-ECMO support during high-risk PCI are however limited.[10-13]

Objective The aim of this study is to provide additional data concerning the short-term outcomes of elective high-risk PCI with VA-ECMO in a single PCI centre.

Methods Design We will perform a single-centre, retrospective registry, using data collected from medical records of included patients.

Inclusion criteria

• Patients older than 18 years, who underwent high-risk PCI with VA-ECMO support.
• The use of mechanical circulatory support (MCS) is indicated by HeartTeam based on patient and lesion characteristics described in the expert consensus on the use of MCS Devices for high-risk PCI. [14]

Exclusion criteria

• Non-elective PCI with VA-ECMO support, primarily applied for cardiogenic shock or ECPR.

Study Procedures All patients older than 18 years who underwent high-risk PCI with VA-ECMO support will be included in the registry. Baseline patient and angiographic characteristics, ECMO characteristics and short-term outcomes, described in the paragraph 'Study Endpoints and Definitions' will be collected from medical records.

The Dutch Act on Medical Research involving Human Subjects (WMO) does not apply to this study, because of the retrospective design of the study using only medical records and consequently patients are not subjected to additional procedures. Therefore, no written informed consent will be obtained from patients or legal representatives as well.

Data Collection All data will be collected in a cloud-based electronic case report form (eCRF, Castor Electronic Data Capture), which will be developed and managed by investigators in the Radboudumc. Only members of the study team will have access to the patient eCRFs and will be allowed to enter data in the system. The study team exists of the investigators mentioned earlier. The study team will collect the data from medical records and enter the data in Castor. All patient data will be encoded. Only the investigators involved will have access to the patient identification key.

Study Endpoints and Definitions Successful revascularization is defined as final residual stenosis <50% with a TIMI flow grade 3, achieved in at least one of the target vessels. Procedural success is defined as angiographic success without the occurrence of peri-procedural MACE, including death and myocardial infarction (MI). Additionally, MACE will be assessed during hospital stay and within 60-days follow-up after discharge and defined as a composite of death, MI, Target Vessel Revascularization (TVR) by PCI or CABG and clinical bleeding, assessed by the Bleeding Academic Research Consortium (BARC) scale. Bleeding complications of type 2 and higher are included.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

ECMO

Patients receiving hemodynamic support with ECMO during high-risk PCI

Extracorporeal Membrane Oxygenation

Intervention Type: DEVICE

Patients with high-risk PCI receive mechanical circulatory support with ECMO.

ECMO Standby

Patients with ECMO standby during high-risk PCI

No interventions assigned to this group

Interventions

Extracorporeal Membrane Oxygenation

Patients with high-risk PCI receive mechanical circulatory support with ECMO.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients older than 18 years, who underwent high-risk PCI with VA-ECMO support.
• The use of mechanical circulatory support (MCS) is indicated by HeartTeam based on patient and lesion characteristics described in the expert consensus on the use of MCS Devices for high-risk PCI.

Exclusion Criteria

• Non-elective PCI with VA-ECMO support, primarily applied for cardiogenic shock or ECPR.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Jan van Geuns

OTHER

Sponsor Role: lead

Responsible Party

Robert Jan van Geuns

Prof. dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Jan M van Geuns, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Medical Centre

Nijmegen, , Netherlands

Countries

Netherlands

References

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

Reference Type: BACKGROUND

PMID: 30165437 (View on PubMed)

Valgimigli M, Tebaldi M, Borghesi M, Vranckx P, Campo G, Tumscitz C, Cangiano E, Minarelli M, Scalone A, Cavazza C, Marchesini J, Parrinello G; PRODIGY Investigators. Two-year outcomes after first- or second-generation drug-eluting or bare-metal stent implantation in all-comer patients undergoing percutaneous coronary intervention: a pre-specified analysis from the PRODIGY study (PROlonging Dual Antiplatelet Treatment After Grading stent-induced Intimal hyperplasia studY). JACC Cardiovasc Interv. 2014 Jan;7(1):20-8. doi: 10.1016/j.jcin.2013.09.008. Epub 2013 Dec 11.

Reference Type: BACKGROUND

PMID: 24332420 (View on PubMed)

Waldo SW, Secemsky EA, O'Brien C, Kennedy KF, Pomerantsev E, Sundt TM 3rd, McNulty EJ, Scirica BM, Yeh RW. Surgical ineligibility and mortality among patients with unprotected left main or multivessel coronary artery disease undergoing percutaneous coronary intervention. Circulation. 2014 Dec 23;130(25):2295-301. doi: 10.1161/CIRCULATIONAHA.114.011541. Epub 2014 Nov 12.

Reference Type: BACKGROUND

PMID: 25391519 (View on PubMed)

Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, de Belder A, Redwood S; BCIS-1 Investigators. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):867-74. doi: 10.1001/jama.2010.1190.

Reference Type: BACKGROUND

PMID: 20736470 (View on PubMed)

Perera D, Stables R, Clayton T, De Silva K, Lumley M, Clack L, Thomas M, Redwood S; BCIS-1 Investigators. Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention. Circulation. 2013 Jan 15;127(2):207-12. doi: 10.1161/CIRCULATIONAHA.112.132209. Epub 2012 Dec 6.

Reference Type: BACKGROUND

PMID: 23224207 (View on PubMed)

Henriques JP, Remmelink M, Baan J Jr, van der Schaaf RJ, Vis MM, Koch KT, Scholten EW, de Mol BA, Tijssen JG, Piek JJ, de Winter RJ. Safety and feasibility of elective high-risk percutaneous coronary intervention procedures with left ventricular support of the Impella Recover LP 2.5. Am J Cardiol. 2006 Apr 1;97(7):990-2. doi: 10.1016/j.amjcard.2005.10.037. Epub 2006 Feb 13.

Reference Type: BACKGROUND

PMID: 16563902 (View on PubMed)

Bougouin W, Dumas F, Lamhaut L, Marijon E, Carli P, Combes A, Pirracchio R, Aissaoui N, Karam N, Deye N, Sideris G, Beganton F, Jost D, Cariou A, Jouven X; Sudden Death Expertise Center investigators. Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest: a registry study. Eur Heart J. 2020 Jun 1;41(21):1961-1971. doi: 10.1093/eurheartj/ehz753.

Reference Type: BACKGROUND

PMID: 31670793 (View on PubMed)

Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.

Reference Type: BACKGROUND

PMID: 33197396 (View on PubMed)

Spiro J, Doshi SN. Use of left ventricular support devices during acute coronary syndrome and percutaneous coronary intervention. Curr Cardiol Rep. 2014 Dec;16(12):544. doi: 10.1007/s11886-014-0544-x.

Reference Type: BACKGROUND

PMID: 25326728 (View on PubMed)

Vainer J, van Ommen V, Maessen J, Geskes G, Lamerichs L, Waltenberger J. Elective high-risk percutaneous coronary interventions supported by extracorporeal life support. Am J Cardiol. 2007 Mar 15;99(6):771-3. doi: 10.1016/j.amjcard.2006.10.034. Epub 2007 Jan 22.

Reference Type: BACKGROUND

PMID: 17350362 (View on PubMed)

Shaukat A, Hryniewicz-Czeneszew K, Sun B, Mudy K, Wilson K, Tajti P, Stanberry L, Garberich R, Sandoval Y, Burke MN, Chavez I, Gossl M, Henry T, Lips D, Mooney M, Poulose A, Sorajja P, Traverse J, Wang Y, Bradley S, Brilakis ES. Outcomes of Extracorporeal Membrane Oxygenation Support for Complex High-Risk Elective Percutaneous Coronary Interventions: A Single-Center Experience and Review of the Literature. J Invasive Cardiol. 2018 Dec;30(12):456-460.

Reference Type: BACKGROUND

PMID: 30504514 (View on PubMed)

van den Brink FS, Meijers TA, Hofma SH, van Boven AJ, Nap A, Vonk A, Symersky P, Sjauw KD, Knaapen P. Prophylactic veno-arterial extracorporeal membrane oxygenation in patients undergoing high-risk percutaneous coronary intervention. Neth Heart J. 2020 Mar;28(3):139-144. doi: 10.1007/s12471-019-01350-8.

Reference Type: BACKGROUND

PMID: 31782108 (View on PubMed)

Tomasello SD, Boukhris M, Ganyukov V, Galassi AR, Shukevich D, Haes B, Kochergin N, Tarasov R, Popov V, Barbarash L. Outcome of extracorporeal membrane oxygenation support for complex high-risk elective percutaneous coronary interventions: A single-center experience. Heart Lung. 2015 Jul-Aug;44(4):309-13. doi: 10.1016/j.hrtlng.2015.03.005. Epub 2015 Apr 23.

Reference Type: BACKGROUND

PMID: 25913808 (View on PubMed)

Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burke JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T; Society for Cardiovascular Angiography and Interventions (SCAI), Heart Failure Society of America (HFSA), Society of Thoracic Surgeons (STS), American Heart Association (AHA), and American College of Cardiology (ACC). 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencionista; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol. 2015 May 19;65(19):2140-1. doi: 10.1016/j.jacc.2015.02.043. Epub 2015 Apr 7. No abstract available.

Reference Type: BACKGROUND

PMID: 25861962 (View on PubMed)

Griffioen AM, Van Den Oord SCH, Van Wely MH, Swart GC, Van Wetten HB, Danse PW, Damman P, Van Royen N, Van Geuns RJM. Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry. J Interv Cardiol. 2022 Sep 16;2022:7245384. doi: 10.1155/2022/7245384. eCollection 2022.

Reference Type: DERIVED

PMID: 36189196 (View on PubMed)

Other Identifiers

113382

Identifier Type: -

Identifier Source: org_study_id