18
Phrenic nerve
paralysis
Phrenic nerve paralysis is defined as absent phrenic nerve
function as assessed by a sniff test. A phrenic nerve paralysis is
considered to be permanent when it is documented to be present
12 months or longer following ablation.
Pulmonary vein
stenosis
Pulmonary vein stenosis is defined as a reduction of the diameter
of a PV or PV branch. PV stenosis can be categorized as mild
<50%, moderate 50%–70%, and severe ≥70% reduction in the
diameter of the PV or PV branch. A severe PV stenosis should be
considered a major complication of AF ablation.
Serious adverse
device effect
A serious adverse device effect is defined as a serious adverse
event that is attributed to use of a particular device.
Stiff le atrial
syndrome
Stiff le atrial syndrome is a clinical syndrome defined by
the presence of signs of right heart failure in the presence of
preserved LV function, pulmonary hypertension (mean PA
pressure >25 mm Hg or during exercise >30 mm Hg ), and large
V waves ≥10 mm Hg or higher) on PCWP or LA pressure
tracings in the absence of significant mitral valve disease or PV
stenosis.
Table 7. Definitions of Complications Associated with AF
Ablation (cont'd)
Term Definition
Treatment
