{
  "abstract": "Percutaneous ventricular assist devices (pVADs) provide short-term mechanical circulatory support and therefore have potential utility during elective, high-risk percutaneous coronary intervention (PCI). However, the evidence base remains insufficient to support routine use. In the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1) trial, 301 high-risk PCI patients were randomised to routine intra-aortic balloon pump (IABP) versus no mechanical support, with no short-term benefit in the major adverse cardiovascular events (MACEs).1 In the Prospective, Randomised Clinical Trial of Haemodynamic Support With Impella 2.5 Versus IABP in Patients Undergoing High-Risk PCI (PROTECT II) trial, patients with complex three-vessel and/or unprotected left main disease and left ventricular ejection fraction (LVEF) ≤35% were randomised to Impella 2.5 versus IABP. The trial was terminated early for futility. The 30-day MACE risk was not significantly different, although a 90-day post hoc analysis favoured Impella (40.0% vs 51.0%; p=0.023), a finding that should be interpreted in view of its post-hoc nature.2 The subsequent non-randomised PROTECT III prospective registry enrolled a PROTECT II–like high-risk population treated with contemporary Impella 2.5/CP and showed lower 90-day MACE compared with the historical PROTECT II cohort.3 Based on these data, the 2021 American Heart Association and 2024 European Society of Cardiology guidelines give a recommendation that prophylactic mechanical support or microaxial pumps may be considered in selected high-risk PCI patients (Class IIb). Subsequently, at the 2025 Transcatheter Cardiovascular Therapeutics conference, three trials, including NyokAssist Small-Bore pVAD versus IABP in Elective High-Risk PCI (SAVE-PCI), Interventional Ventricular Assist System for PCI in Complex High-Risk Indicated PCI Patients (REC-CHIPMCS) and Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-Risk PCI (PERSIST III), were presented, demonstrating that pVAD was non-inferior to IABP or venoarterial extracorporeal membrane oxygenation for 30-day MACE risk. Two randomised controlled trials (RCTs) of Impella-assisted high-risk PCI are ongoing. Controlled Trial of High-risk Coronary Intervention with Percutaneous Left Ventricular Unloading (CHIP-BCIS3) plans to enrol 300 patients with extensive coronary artery disease (CAD), LVEF ≤35% and planned complex PCI. Impella-Supported PCI in High-Risk Patients With Complex CAD and Reduced Left Ventricular Function (PROTECT IV) trial plans to enrol 1252 high-risk patients with complex CAD and reduced LVEF to compare Impella-assisted PCI with standard PCI. Both studies include at least 1 year’s follow-up (figure 1).",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiology, Tianjin Medical University General Hospital, Tianjin, China",
        "Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore"
      ],
      "name": "Linjie Li"
    },
    {
      "affiliations": [
        "Department of Cardiology, National University Heart Centre, National University Health System, Singapore",
        "Yong Loo Lin School of Medicine, National University of Singapore, Singapore"
      ],
      "name": "Mark Y Chan"
    },
    {
      "affiliations": [
        "Department of Cardiology, Tianjin Medical University General Hospital, Tianjin, China"
      ],
      "name": "Qing Yang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Tianjin Medical University General Hospital, Tianjin, China"
      ],
      "name": "Xin Zhou"
    }
  ],
  "title": "Percutaneous ventricular assist devices in high-risk PCI for older adults: evidence and next steps",
  "uid": "42f4a7cd-e89b-5dcd-8db2-1247f9a10dff"
}