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Percutaneous ventricular assist devices yield similar periprocedural outcomes in high-risk PCI
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A new meta-analysis highlights similar periprocedural outcomes between two percutaneous ventricular assist devices in patients undergoing high-risk PCI.
Researchers systematically reviewed electronic databases to identify prospective controlled trials and cohort studies of patients who received hemodynamic support from the Impella (Abiomed) or TandemHeart (CardiacAssist) percutaneous VADs (PVADs) for high-risk PCI procedures. The primary outcomes were 30-day all-cause mortality, 30-day MI, and periprocedural major bleeding and vascular complications. In total, the researchers identified 12 studies of patients (n = 1,346), who underwent PCI with the support of an Impella 2.5 L device and eight cohort studies of patients (n = 205) who were implanted with the TandemHeart device for high-risk PCI.
Use of the Impella device was associated with a pooled clinical 30-day mortality rate of 3.5% (95% CI, 2.2-4.8; I2 = 20%) and a pooled 30-day MI rate of 3.3% (95% CI, 1.4-5.3; I2 = 79%). This heterogeneity became nonsignificant in a subgroup analysis in which one trial, the PROTECT II study, was excluded, according to the researchers. The pooled rate of clinical major bleeding was 7.1% (95% CI, 4.3-9.9), with significant heterogeneity between studies (I2 = 63%), mainly owing to the higher rates of bleeding in the USPella registry and the PROTECT II study, the researchers wrote. The Impella device was associated with a pooled vascular complication rate of 4.9% (95% CI, 2.3-7.6), with significant heterogeneity between studies (I2= 78%), due primarily to differences in the definition of vascular complications, according to the researchers.
Use of the TandemHeart device was associated with a pooled clinical 30-day mortality rate of 8% (95% CI, 2.9-13.1; I2 = 55%) and a pooled 30-day MI rate of (95% CI, 0-7.8; I2 = 0%). MI rates after TandemHeart support were reported in only four studies (n = 89). The pooled rate of clinical major bleeding with use of TandemHeart was 3.6% (95% CI, 1.1-6.1; I2 = 0%). The pooled rate of vascular complications was 6.5% (95% CI, 3.2-9.9), without significant heterogeneity (P = .09 for heterogeneity; I2 = 0%), due primarily to differences in the definitions of vascular complications.
In a sensitivity analysis based on the quality assessment of individual studies, rates of 30-day mortality, major bleeding, MI and vascular complications were similar between the two PVADs after exclusion of a high risk of bias study.
According to the researchers, selection of an appropriate device for the individual patient should be the subject of further research.
“Both devices [in this meta-analysis] are associated with comparable periprocedural outcomes,” the researchers wrote. “Apart from the technical issues associated with PVAD use, future studies should provide data to guide interventionalists to which device is optimally selected for a particular patient at high risk.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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