Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
To the Editor: Dr Connolly and colleagues1 found that pacemaker therapy did not reduce the
risk of recurrent syncope in patients with vasovagal syncope. Patients in
the control group all underwent pacemaker implantation, but their pacemakers
were set for sensing only, without pacing in the event of a dysrhythmia. The
authors justified this nontherapeutic surgical intervention by noting that
control patients could have their devices activated for pacing once the study
had been completed. Although there is controversy about the ethical aspects
of such sham surgery,2,3 this
study is unique in that the patients were left with an implanted device.
Heckerling PS. Ethical Aspects in Trials of Implantable Medical Devices. JAMA. 2003;290(12):1579. doi:10.1001/jama.290.12.1579-a