HTA on temporary percutaneous mechanical circulatory support devices released in Spain

In January 2022, the Basque Office for Health Technology Assessment (OSTEBA) released an HTA report aiming to assess and compare the efficacy, effectiveness, and safety of the mechanical circulatory support devices (MCSDs) most used in the healthcare setting for the treatment and prevention of cardiogenic shock (CS), including Impella® devices, intra-aortic balloon pumps, and extracorporeal membrane oxygenation. Specific objectives included a comparison of the clinical effects of different MCSDs in the treatment of patients with refractory CS and in high-risk percutaneous coronary interventions (PCIs).

The quality/reliability of the available evidence was mainly low or very low. Only the studies comparing intra-aortic balloon pumps (IABPs) with usual care alone or with Impella® (Abiomed) devices in high-risk PCI cases were of high quality and reliability.

The following key conclusions were provided:

• There are no significant differences in 30-day mortality between CS patients treated with an IABP and those receiving standard medical care;
• After 90 days of follow-up, in high-risk PCIs, Impella 2.5® devices are associated with lower rates of major adverse effects than IABPs. In patients with three-vessel disease and low ventricular ejection fraction, the rate of irreversible adverse effects is lower with circulatory support using an Impella 2.5® device during PCI than with an IABP. No differences have been shown in in-hospital mortality, in the medium or long-term, between Impella 2.5® devices and IABPs. Regarding the results on safety, the risk of complications is similar with both percutaneous devices.

The full details in Spanish can be found here.

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