SUCCESS AND OUTCOMES
The Heart Rhythm Society 2017 consensus document was used to define
procedural success and outcome 10. Complete procedural
success was defined as removal of all targeted leads and all lead
material from the vascular space, with the absence of any permanently
disabling complication or procedure related death. Clinical success was
regarded as removal of all targeted leads and lead material from the
vascular space with the exception of small portion (<4 cm)
retention of the lead that does not negatively impact the outcome goals
of the procedure including perforation, embolic events or infection
perpetuation, etc. Partial success was defined as clinical success when
most of the lead was removed, leaving at the most 4 cm of coil and/or
insulation and/or lead tip.
Complications were classified using the 2017 HRS conventional criteria10 and were attributed to the extraction method used
at the time the complication was observed. Complications were
continuously recorded until hospital discharge. Major complications were
those that imposed immediate life threat and included procedure-related
death, need for pericardiocentesis, vascular tear, severe tricuspid
regurgitation (TR) (defined as either TR requiring intervention, or TR
resulting in lifelong disability), stroke or requirement of urgent
surgery occurring during the TLE procedure. Complications that did not
meet the major complication criteria were classified as minor
complications.
All-cause mortality and current patient status were updated from
Israel’s national population registry updated on a regular basis.