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This editorial refers to ‘Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry’†, by L.V.A. Boersma et al . on page 2465 .Randomized clinical trials (RCTs) are considered the standard for determining the benefit–risk balance of medical treatments due to the strength of their internal validity, or the validity of the results in the enrolled population. However, they are often limited in terms of their external validity, or their applicability to the larger patient populations who will receive the treatment in practice. Trials traditionally enrol highly specified patients, employing relatively strict criteria that exclude medically complex individuals either explicitly or implicitly, resulting in populations that can differ substantially from those treated in practice.1 While clinicians may feel comfortable applying the results of trials to patients who meet these enrolment criteria, clinical decision-making becomes more challenging in proportion to the patientu0027s complexity.Trials of technologies have an additional potential limitation: operators involved and the centres in which they practise may be recruited because of their experience, and thus may have greater success with the procedure. Assuming that procedural outcomes in RCTs can be extrapolated to all centres and operators can be hazardous.2 Because of the restricted populations and operators involved in traditional randomized trials, other sources of data are helpful in understanding the procedural and clinical outcomes of medical technologies in the ‘real world.’Observational data are critical complements to RCTs because they provide this broader perspective ( Figure 1 ). Registries have evolved to serve as a critical component of post-market device surveillance in practice.3 In this issue …

The evolution of left atrial appendage occlusion: EWOLUTION and the WATCHMAN in practice