Author + information
- Evan Shlofmitz, DO∗ ( and )
- Richard Shlofmitz, MD
- ↵∗Northwell Health, Department of Cardiology, 300 Community Drive, Manhasset, New York 11030
We read with great interest the paper by Atkinson et al. (1) regarding an algorithm for percutaneous mechanical circulatory support (MCS) selection in patients undergoing high-risk percutaneous coronary intervention (HRPCI). Although the stated objective of the paper is for selection of MCS, the investigators left out the important consideration that not all HRPCI patients require MCS, and MCS may remain an option for standby when performing HRPCI. The algorithm essentially calls for Impella (Abiomed, Danvers, Massachusetts) use for all patients being treated with HRPCI, whenever technically anatomically feasible.
There is a clear role for protected percutaneous coronary intervention, yet we must proceed with caution. Although hemodynamic support devices, including the Impella percutaneous left ventricular assist device (PLVAD) or intra-aortic balloon pumps, may provide support during HRPCI, we must keep in mind the limitations. PROTECT II (A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI) was stopped early and failed to meet its primary endpoint (reduction in 30-day composite major adverse events). It showed significant reduction in a composite of 10 endpoints at 90-day follow-up, driven by a difference in revascularization, with no significant differences in mortality and myocardial infarction (2). PROTECT II compared the Impella with an intra-aortic balloon pump, a support device that has historically failed to show any significant benefit in HRPCI.
The hemodynamic benefits of PLVAD are not without risk. In a real-world Impella database, the vascular complication rate was 17%, with need for amputation in 4.4% (3). The composite of major bleeding, hemolysis, and pericardial tamponade occurred in 37.8% of patients in the Impella-EUROSHOCK registry (4). Eleven percent of patients treated in the USpella registry required blood transfusions. Vascular complications requiring surgery occurred in 2.5% of USpella registry patients (5). In PROTECT II, there was a 68.8% composite of adverse events in patients treated with rotational atherectomy with Impella support.
MCS can improve hemodynamic status, but it has not been shown to improve any periprocedural outcomes in this complex higher-risk indicated patient cohort. The use of PLVAD is on the rise, as we work to optimize management of high-risk patients, but this is based largely not on randomized controlled data but on registry experience. We must be mindful that the benefits of PLVAD come with a cost, in the form of both procedural complications for patients and significant financial costs.
Although there is a role for protected percutaneous coronary intervention in appropriate patients, overuse should be avoided until there are additional data. Patients undergoing elective HRPCI should be referred to high-volume centers with operators specializing in treatment of complex higher-risk indicated patients. The algorithm is an excellent start once MCS has been selected, but there should be emphasis on assessing each individual patient’s need for MCS when undergoing HRPCI. Rather than indicating that the Impella should be used whenever technically feasible for all HRPCI patients, perhaps the guidance should recommend that MCS be considered. MCS shows great promise in advancing the field, but it is not without risk, and we must proceed with caution, remembering that with each patient encounter, “first, do no harm.”
Please note: Both authors have received consulting fees from CSI.
- American College of Cardiology Foundation
- Atkinson T.,
- Ohman E.M.,
- O’Neill W.W.,
- et al.
- O’Neill W.,
- Kleiman N.,
- Moses J.,
- et al.
- Lauten A.,
- Engström A.E.,
- Jung C.,
- et al.