Meta-Analysis and Trial Sequential Analysis Comparing Percutaneous Ventricular Assist Devices Versus Intra-Aortic Balloon Pump During High-Risk Percutaneous Coronary Intervention or Cardiogenic Shock

https://doi.org/10.1016/j.amjcard.2018.07.011Get rights and content

The intra-aortic balloon pump (IABP) and percutaneous ventricular assist devices (pVAD) are commonly used in different clinical scenarios. The goal of this study was to carry out a meta-analysis and Trial Sequential Analysis (TSA) comparing the IABP versus pVAD (TandemHeart and the Impella) during high-risk percutaneous coronary intervention (PCI) or cardiogenic shock (CS). Using PubMed, Cochrane Central Register of Controlled Trials, and EMBASE we searched for randomized clinical trials (RCTs) and nonrandomized studies that compared pVAD versus IABP in patients who underwent high-risk PCI or with CS. We included 5 RCTs and 1 nonrandomized study comparing pVAD versus IABP. Based on the RCTs, we demonstrated no difference in short-term (6 months) (risk ratio [RR] 1.09, 95% confidence interval [CI] 0.79 to 1.52; p = 0.59) or long-term (12 months) (RR 1.00, 95% CI 0.57 to 1.76; p = 1.00) all-cause mortality. The use of pVAD seemed associated with more adverse events (acute kidney injury, limb ischemia, infection, major bleeding, and vascular injury) compared with IABP (RR 1.65, 95% CI 1.14 to 2.39; p = 0.008) but this was not supported by TSA (random-effects RR 1.66, 95% CI 0.89 to 3.09; p = 0.11; TSA-adjusted CI 0.13 to 21.3). In conclusion there were no differences in short or long-term mortality when using IABP versus pVAD for high-risk PCI or CS. IABP showed superiority over pVAD in terms of risk of harm. However, further RCTs are needed to establish more conclusively the role of these modalities of mechanical circulatory support during high-risk PCI or CS.

Section snippets

Methods

Using the PubMed U.S National Library of Medicine, Cochrane Central Register of Controlled Trials, and EMBASE, we searched for RCTs and nonrandomized studies that compared pVAD versus IABP in patients who underwent high-risk PCI or in patients with CS, from inception to January 2018.

We selected RCTs and nonrandomized studies that compared the use of IABP with or to pVAD (Impella, TandemHeart or both) in patients older than 18years, who underwent high-risk PCI in patients with multivessel

Results

A total of 214 abstracts were screened, 186 studies were excluded, and 27 studies were assessed for full-text eligibility. There were 5 RCTs5,19, 20, 21, 22, 23 and 1 nonrandomized study24 included (Figure 1) which compared pVAD (Impella or TandemHeart) versus IABP in patients who underwent high-risk PCI or with CS. For detailed description of the included studies please see Table 1 and Table 2.

All the included RCTs were at high risk of bias mostly because of open-label nature of the included

Discussion

The use of more robust and sophisticated hemodynamic support devices during complex PCI or for patients with established CS does not seem to have decreased the morbidity and mortality associated with these conditions. Despite the lack of evidence showing superiority of pVAD over IABP, there is a notable shift toward an increased use of the first, especially the Impella, in these clinical scenarios.25 Compared with previous meta-analyses of the topic, our study is the largest and the only one

Acknowledgment

This study did not receive any external funding.

Competing Interest

Dr. Deepak L. Bhatt discloses the following relationships—Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount

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      Although percutaneous LVAD technology such as Impella and Tandem heart (Cardiac Assist, Pittsburgh, PA, USA) have become options to support heart failure patients, it has not been proven that these devices provide improved clinical outcomes compared to IABP support [23–26]. A meta-analysis showed that there was no difference in mortality between IABP and percutaneous LVAD for high-risk percutaneous coronary intervention or cardiogenic shock patients, and the use of percutaneous LVAD was associated with more adverse events than IABP [25]. Stroke is a significant complication of axillary IABP.

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    1

    First two co-authors contributed equally.

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