3
As a result of the risk of complications, doctors highly experienced in this procedure have advised the
following:
PREPARATIONS
• Obtain a thorough patient history, including patient blood type. Appropriate blood products should
be rapidly available.
• Ascertain the manufacturer, model number, and implant date of the catheter/lead to be removed.
• Perform radiographic/echocardiographic evaluation of catheter/lead condition, type, and position.
Use a procedure room that has high quality fluoroscopy, pacing equipment, defibrillator, thoracotomy
tray, and pericardiocentesis tray.
• Echocardiography and cardiothoracic surgery should be rapidly available.
• Prep/drape the patient’s chest for possible thoracotomy; prep/drape the patient’s groin for femoral
approach or possible femoral approach.
• Establish back up pacing as necessary.
• Have available an extensive collection of sheaths, Lead Control Devices (Locking Stylet and Lead
Extender), stylets to unscrew active fixation leads, snares, and accessory equipment.
PROCEDURE
• Use fluoroscopic monitoring during ALL catheter/lead and sheath manipulations. Monitor ECG and
arterial blood pressure continuously throughout the procedure and during recovery.
• If using sheaths or sheath sets, including the Evolution® Shortie RL Controlled-Rotation Dilator
Sheath Set, the following precautions should be followed:
• Prior to using sheaths including the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set it is
essential to carefully inspect the extravascular catheter/lead tract to ensure removal of all suture sleeves,
sutures, and tie-down materials.
• When advancing sheaths including the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set,
use proper sheath technique and maintain adequate tension on the catheter/lead (via a Locking Stylet
or directly) to prevent damage to vessel walls.
• If excessive scar tissue or calcification prevents safe advancement of sheaths, consider an alternate
approach.
• Excessive force with sheaths used intravascularly may result in damage to the vascular system
requiring surgical repair.
• If the catheter/lead breaks, evaluate fragment; retrieve as indicated.
• If hypotension develops, rapidly evaluate; treat as appropriate.
• Due to rapidly evolving catheter/lead technology, this device may not be suitable for the removal of
all types of catheters/leads. If there are questions or concerns regarding compatibility of this device with
particular catheters/leads, contact the catheter/lead manufacturer.
POTENTIAL ADVERSE EVENTS
Potential adverse events related to the procedure of intravascular extraction of catheters/leads include
(listed in order of increasing potential effect):
dislodging or damaging nontargeted catheter/lead
chest wall hematoma
thrombosis
arrhythmias
acute bacteremia
acute hypotension
pneumothorax
stroke
migrating fragment from catheter/object
pulmonary embolism
laceration or tearing of vascular structures or the myocardium
hemopericardium/pericardial effusion
cardiac tamponade
hemothorax
cardiac arrest
death
