Improving Safety of Lead Extraction Procedures by Traction Force Sensing

Use of force no greater than 8 pounds of tension will improve lead extraction and minimize
lead displacement compared to current standard of care methods which do not limit the force
applied. Among subjects undergoing lead extraction procedures for CIED infection,
bidirectional rail (superior and inferior) and traction force objective feedback using Force
gauge is associated with minimal displacement (<1cm) of the leads (surrogate marker) on
fluoroscopy compared to conventional lead extraction. • The research nature of the protocol
is explicitly explained to the patient and an informed consent is explained obtained from the
patient prior to the procedure. Only patients with CIED infections requiring lead extraction
are enrolled in the study. Patients are risk stratified based on our current risk
stratifications scheme. Multiple superior and inferior venous accesses are obtained during
the procedure. The leads are prepared using locking stylets. Baseline fluoroscopic image of
the position of the leads is stored. A deflectable sheath and traction forceps are deployed
from the groin to provide downward rail in the force feedback arm. Locking stylet from the
lead is in turn attached to a Force gauge (McMaster-Carr Santa Fe Springs, CA). The procedure
is performed using continuous fluoroscopic image save tool during the procedure for post
procedural viewing and analysis. The patients are randomized to the active arm (to keep force
around 8 lb) or the control arm (tactile force discretion based on the operator. The
investigator is blinded to the force gauge reading for half of the patients enrolled in the
study. For the other half of the patients, the operator optimizes the force to prevent
overexertion (<8-9 pounds). Three point along the lead course evaluated during the study.
Position of downward turn of the lead in the SVC, heel of the lead (only in case of RV lead)
and the lead tip positions are evaluated. The investigators postulate that there will be at
least 5 cine-fluoroscopic views per every lead. The investigators hypothesize that use of
bidirectional rail and force feedback is associated with minimal displacement of the lead on
fluoroscopy.

Inclusion criteria:

• Patients with CIED infection requiring extraction

Exclusion criteria:

- Age <18 years

- Noninfectious reasons for extraction

- Patients with cognitive impairment, who are unable to consent.