Prof. Holger Thiele
View the Slides from this session in ESC Congress 365
In recent years, multiple new devices for mechanical circulatory support, either for percutaneous or surgical insertion, have been developed to support the failing heart. The current evidence of these devices has been reviewed in this session on mechanical support devices.
Dr. Krishan Sjauw (Amsterdam, The Netherlands) gave an overview on the devices available for percutaneous insertion in the cath lab. The intra-aortic balloon pump (IABP) is still the most widely used device. However, based on the IABP-SHOCK II trial, which did not show a benefit of the IABP in comparison to control, the recent guidelines on myocardial revascularization downgraded the recommendation of the IABP to a class III level of evidence A recommendation for patients in cardiogenic shock. The IABP may only be considered for mechanical complications after acute myocardial infarction. This class III recommendation will surely influence the current use of IABP. Therefore new active devices are required. The TandemHeart and the Impella devices are available, however, there is only very limited evidence for these devices with respect to improvement of clinical outcome. More randomized trials are required and currently there are two ongoing trials assessing the Impella CP device on mortality.
Dr. Alain Combes (Paris, France) reported on the evidence of extracorporeal membrane oxygenation (ECMO) for the treatment of cardiogenic shock, severe septic shock, lung emboli, and for post-CABG patients. There are no randomized trials at all and the evidence is currently based on case series. Multiple open questions remain, such as optimal patient selection, timing of insertion of ECMO, futility and also the optimal prevention of complications which are numerous using this device.
Dr. Emma Jame Birks (Louisville, US) presented a multitude of non-randomized data of surgical devices as a bridge to transplant and as a bridge to recovery. The current dilemma of a lack of donor organs for heart transplantation led to an increase of these devices and current registry data suggest improved survival with left ventricular assist devices (LVAD) in recent years, which is mainly an effect of improvement of these devices with fewer complications. According to registry data, approximately 8-24% recovery has been observed under the treatment with LVAD, which led to successful explantation of the devices. Aggressive unloading and optimal drug therapy are important determinants for potential recovery.
Dr. Stefan Schüler (Newcastle, UK) reported on the current results of LVAD therapy as destination therapy. Also based on the decrease in heart transplantations, there is a growing need in LVAD therapy for heart failure. The milestone trial is the Rematch-trial which has shown improved survival with a LVAD in comparison to conventional therapy. Improvements in devices now have led to an improved survival which is based on registries similar to survival rates reported for heart transplantation. Currently, older age is the main reason for the selection of LVAD therapy as destination therapy.
In summary, there is a significant improvement in circulatory device therapy which led to a reduction in complications and improvement in survival mainly for surgical devices in chronic heart failure. Nevertheless, many open questions remain on selection of the optimal candidates, timing of insertion and in particular for percutaneous devices in the acute setting the evidence with respect to improvement in survival is still not finally determined. Much more evidence is needed to answer these open questions.
Mechanical circulatory support: what is the evidence?
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