Left bundle branch area pacing with OmniaSecure™ defibrillation lead

Article of interest

Disclosures

OmniaSecure™ defibrillation lead Model 3930M has not been approved by FDA for sensing, pacing, cardioversion, and defibrillation when placed in the left bundle branch area. The safety and effectiveness of the OmniaSecure™ lead for LBBAP has not been established.

The FDA approved use for Model 3930M lead is as follows: Model 3930M lead is intended for use in the right ventricle for sensing, pacing, cardioversion, and defibrillation when a cardiac implantable electronic device is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening tachyarrhythmias.

This includes adolescent pediatric patients who are at least 30 kg and are also at least 12 years of age, and whose cardiac anatomy is conducive to RV coil placement.

Warnings and precautions: The FDA-required labeling contains the following warnings and precautions about this off-label use of OmniaSecure™ defibrillation lead:

Connector compatibility — Although Medtronic lead connectors conform to International Connector Standards, this lead has not been tested for use with non-Medtronic devices. The known potential adverse consequences of using such a combination may include undersensing of cardiac activity, failure to deliver necessary therapy, or an intermittent electrical connection.

Defibrillation and guidewires — Do not defibrillate a patient while a guidewire is in the heart. An electrically conductive guidewire may short the output path and may damage the device or leads. Before taking electrical or defibrillation efficacy measurements, the guidewire must be withdrawn proximal to the defibrillation coils on the lead.

Handling the lead — Handle the lead with care at all times.

• Do not implant the lead if it is damaged. Return the lead to your Medtronic representative.
• Do not attempt to straighten or realign the helix if the helix is deformed. Return the lead to your Medtronic representative.
• Protect the lead from materials that shed particles such as lint and dust. Lead insulators attract these particles.
• Handle the lead with sterile surgical gloves that have been rinsed in sterile water or a comparable substance.
• Do not severely bend, kink, or stretch the lead.
• Do not use surgical instruments to grasp the lead or connector pin.
• Do not immerse leads in mineral oil, silicone oil, or any other liquid, except blood, at the time of implant.
• Use an anchoring sleeve with all leads. Ensure that the anchoring sleeve is positioned close to the lead connector pin to prevent inadvertent passage of the sleeve into the vein.
• If it is necessary to wipe the lead before insertion, ensure that the anchoring sleeve remains in position.
• Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters or leads may cause trauma to the heart. Resistance can be a result of guide catheter occlusion, i.e. kinking, folding, or thrombosis, or that the lead is in contact with cardiac tissue.
• Keep the helix within the guide catheter of the delivery system if passing through the tricuspid valve to prevent damage to the helix, valve, and/or endocardial tissue.

Repositioning or removal of an acute lead — Successfully repositioning the lead depends on recreating the angle and advancement of the catheter present at the time of initial helix deployment at implant (relative to the lead helix and endocardium). Proper orientation helps transfer torque to the helix. This increases the likelihood of successfully disengaging the helix from the endocardium. Improper removal of the lead by pulling may result in avulsion of the endocardium.

Extraction or removal of a chronic lead — Proceed with caution if a chronically implanted lead must be removed or extracted. Lead extraction procedures should be consistent with the most recent editions of HRS or EHRA expert consensus statements regarding cardiovascular implantable electrode device lead management and extraction. Market released extraction tools or clinically recognized techniques may be used to help facilitate extraction. When the risk of lead extraction outweighs the benefit, it may be preferable to abandon unused leads, and leave in place. Return all removed leads, unused leads, or lead sections to Medtronic for analysis.

• Lead removal may result in avulsion of the endocardium, valve, or vein causing internal bleeding, tamponade, and tricuspid valve insufficiency.
• Lead junctions may separate, leaving the lead tip and bare wire in the heart or vein. Careful consideration should be used when deciding if removal is warranted.
• Abandoned leads should be capped to avoid transmitting electrical signals.
• Abandoned severed leads should have the remaining lead end sealed and the lead body sutured to adjacent tissue.

Removal of a chronic lead and the SureScan™ defibrillation system — When implanting a SureScan™ defibrillation system, consider the risks associated with removing previously implanted leads before doing so. Abandoned leads or previously implanted non-SureScan™ labeled leads compromise the ability to safely scan the SureScan™ defibrillation system during MRI scans.

Warning: Do not force the guide catheter or lead if significant resistance is encountered. Use of guide catheters or leads may cause trauma to the heart.

Note: To implant the Model 3930M lead, a compatible delivery system is required, such as a Medtronic delivery system. A compatible delivery system includes a guide catheter and an introducer valve which allows passage through or removal from a DF4 connector. Contact your local Medtronic representative for further information regarding compatible delivery systems.

Potential difficulties associated with Model 3930M lead implant

• Catheter kinks, folds or creases during lead implant, resulting in increased lead resistance during deployment.
• Cardiac perforation from catheter during catheter positioning
• Cardiac perforation during lead fixation
• Excessive force on lead during the slitting process resulting in lead dislodgement

Warning: To minimize the occurrence of perforation and dissection, avoid known infarcted or thin ventricular wall areas.

Warning: If there is reason to believe the patient has an unusually thin wall at the apex of the right ventricle, the implanter may want to consider another site for the placement of the lead.

Warning: Excessive torque or tip pressure may cause acute trauma to the endocardium, including possible perforation. Acute trauma may result in temporary high impedance or threshold values.

Warning: Damage to a guidewire may prevent the guidewire from performing with accurate torque response and control and may cause vessel damage.

Serious, life-threatening, fatal risks: In addition, this off-label use is associated with the following serious, life-threatening, fatal risks described in the labeling:

Note: Implant and usage of this product may result in adverse events, which may lead to injury, death, or other serious adverse reactions.

• Allergic reaction
• AV fistula
• Bradyarrhythmia
• Cardiac arrest
• Cardiac inflammation
• Cardiac perforation
• Cardiac tamponade
• Cardiac valve damage
• Discomfort
• Dislodgement
• Dizziness
• Dyspnea
• Embolism
• Erosion
• Excessive fibrotic tissue growth
• Extracardiac stimulation
• Fever
• Heart block
• Heart failure decompensation (hospitalization)
• Hematoma
• Hemorrhage
• Hemothorax
• Hiccups
• Hospitalization
• Inappropriate shock
• Infection
• Insulation failure
• Lead fracture
• Lethargy
• Loss of capture
• Loss of pacing
• Mental anguish
• Nerve damage
• Oversensing
• Palpitations
• Pericardial effusion
• Pneumothorax
• Return of cardiac symptoms
• Seroma
• Skeletal muscle sensation or twitching
• Skin disorders
• Stroke
• SVC tear
• Syncope
• Tachyarrhythmia
• Threshold elevation
• Thrombosis
• Tissue trauma
• Toxic reaction
• Tricuspid valve regurgitation
• Undersensing
• Vascular tear
• Venous occlusion
• Vessel perforation

Note: If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.

A copy of the FDA approved labeling is available here.

The labeling for OmniaSecure™ defibrillation lead includes the following contraindications:

The Model 3930M lead is contraindicated for use in the following situations:

• Non-right ventricular use — The Model 3930M lead is contraindicated for non-right ventricular implant sites including the His bundle and the atrial side of the tricuspid valve annulus.
• Tricuspid valvular disease or mechanical tricuspid valve — The lead is contraindicated in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
• Steroid use — The lead is contraindicated in patients for whom a single dose of 1.0 mg of dexamethasone acetate may be contraindicated.
• Transient ventricular tachyarrhythmias — If tachyarrhythmias with transient or reversible causes exist, including the following known issues (acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, sepsis).
• Intravenous catheterization — The lead is contraindicated in patients with obstructed or inadequate vasculature for intravenous catheterization.