The Journal of Invasive Cardiology (J INVASIVE CARDIOL 2019;31:52-56) publishes a prospective, non-randomized study about the safety and efficacy of elective use of hemodynamic support by the Impella 2.5 (Abiomed) in patients undergoing combined high-risk percutaneous coronary intervention (PCI) and balloon aortic valvuloplasty (BAV), as a bridge to transcatheter aortic valve replacement. The study was conducted by Dr. Carlo Briguori and his team of Clinica Mediterranea Hospital of Naples.
The study starts from the consideration that during percutaneous treatment there could be a risk of hemodynamic instability for patients with both CAD-Coronary Artery Disease and AS-Aortic stenosis.
These complex procedures can receive an important contribution in safety and tolerability from the use of left ventricular assist systems (LVAD): in the past years, some research has shown that the Impella system (Abiomed, Inc) gives superior hemodynamic support in comparison with intra-aortic balloon pump (IABP), also in the presence of aortic stenosis which can, by reducing the size of the valve orifice area, make the passage of the Impella system difficult.
The study enrolled 10 patients, selected from January 2016 to July 2018, among all patients who had ACS and with CAD and severe and symptomatic AS, considered “inoperable” or at high risk.
All included patients also had at least one of the following characteristics:
- Hemodynamic instability
- Complex coronary artery disease
- PCI was carried out through the radial approach in 8/10 patients
- Elective haemodynamic support before PCI
- PCI succeeded in all cases
- After PCI and Impella extraction, BAV performed successfully in all cases
- No major bleeding or hospital death
- Patients discarded in 5 ± 3 days
Surgical treatment of aortic valve replacement associated with concurrent CABG (Coronary Artery Bypass Graft), while representing the “standard of care” for patients with severe AS and concomitant severe CAD, constitutes a procedure with non-negligible risk margins; despite the absence of randomized trials, a consensus has emerged to treat these patients percutaneously which on the other hand can put hemodynamic stability at risk both during PCI and during BAV.
Impella provides excellent hemodynamic support in the absence of significant periprocedural complications and, as already demonstrated in other publications, shows higher safety and efficacy compared to the use of IABP in high-risk PCI patients.
- improves coronary flow,
- discharge the left ventricle e
- protects the myocardium from ischemic damage during PCI.
This study is the first in the literature to evaluate the contribution of Impella to hemodynamic support for patients undergoing combined PCI and BAV.
The present experience suggests that elective use of the Impella 2.5 system is safe and effective when performing PCI and BAV in high-risk patients suffering from acute coronary syndrome and severe aortic stenosis.