View the Slides from this session in ESC Congress 365
Rolf Kern (Mannheim, Germany) provided an update on pharmacological reperfusion therapy (IV thrombolysis), the development of endovascular stroke therapy and the “bridging concept”. He explained the merits and limitations of thrombolytic therapy, including a low recanalization rate and a narrow time window. He highlighted the importance of imaging-guided stroke therapy. In terms of endovascular therapy, he discussed the history of this therapy and mechanical thrombectomy devices used thus far. He also mentioned the controversy about recent trials in endovascular stroke therapy and gave a roadmap to evidence-based endovascular therapy.
Saibal Kar (Los Angeles, USA) presented the trials regarding left atrial closure vs oral warfarin therapy for stroke prevention in detail. He showed the data from two randomised studies, PROTECT AF (long-term data) and PREVIAL (initial data set) done by Watchman Device and 5 single arm registries: the ASAP study using Watchman device, the CAP and CAP2 trials using Watchman device, the European registry using ACP device, the single center or multicenter experience using the Lariat device, Wavecrest study and EXCLUDE study using the Atriclip device.
The PROTECT study showed that among patients with non-valvular atrial fibrillation, the use of the WATCHMAN device for left atrial appendage ligation is feasible. This device demonstrated a non-inferior rate of cardiovascular death, stroke, or systemic embolism, compared to warfarin alone, which was sustained through the 5-year follow-up. The rate of all strokes (ischemic or hemorrhagic) was non-inferior between the groups, and there was significantly less hemorrhagic strokes in the device group.
Adverse outcomes were higher in the device group due to a high occurrence of pericardial effusion. The procedural (and long-term) safety of this device will need to be balanced against the reduction in hemorrhagic strokes afforded from discontinuation of warfarin. It is also possible that this device may reduce ischemic strokes, however, long-term follow-up will be needed to assess this.
Compared with the earlier PROTECT AF trial, in the PREVIAL study there was improved procedural implant success with reduced device-related complications. Percutaneous closure of the left atrial appendage (LAA) was non-inferior to warfarin at preventing stroke or systemic embolism from 7 days to 18 months. However, non-inferiority was unable to be established with regard to cardiovascular/unexplained death, stroke, or systemic embolism at 18 months. Failure to achieve non-inferiority with this particular outcome may have partly been due to a lower than expected event rate in the control arm.
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