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“With SVC perforations, time

is of the essence. Any scenarios

that may delay deployment of

Bridge should be avoided.”1

Bridge Best Practice Protocol1 Checklist

Prepare: Every Patient, Every Extraction

Consensus from 30 Extracting Physicians

Prepare (all patients)

1. Place 0.035” super sti guidewire from right

femoral vein to right IJ.

2. Insert introducer sheath: 12F or 6F peel away

3. Prelled syringe (48 cc saline with 12 cc

contrast) & Bridge immediately available

Practice

4. Bridge familiarity

5. Bridge

competence

6. Bridge prophylaxis

Perform

7. Immediate

deployment when

SVC tear is suspected,

including tamponade

and/or hemothorax

¨Place 0.035” super sti guidewire, 260 cm length.

¨Place from right femoral vein to right internal jugular.

·Alternative access: left femoral vein and right or left subclavian vein. If femoral access is not

possible, a wire and sheath can be placed from a superior venous approach.

· Use of ultrasound to facilitate access is highly recommended.

¨Clamp the wire just outside the introducer and/or to the drape cloth to prevent movement.

¨Insert introducer sheath. 12F required for Bridge delivery.

· Alternatively, a 6F peel away with 12F pre-loaded on the wire may be utilized.

¨Pre-ll syringe with 80/20 saline & contrast mix.

¨Pre-ll 60cc syringe with 48 cc saline and 12 cc contrast, with the two-way stopcock attached.

¨Conrm Bridge Occlusion Balloon is immediately available.

¨Review anatomical markers for potential balloon deployment.

¨Team communication: roles and emergent deployment workow.

¨Discuss workow with the anesthesiologist, surgeon and team.

¨Determine steps for diagnosis and treatment if a pericardial eusion is suspected.

¨Plan how uids will be delivered. (Meds/uids delivered superior to Bridge will not be eective.)

¨Determine when uoroscopy will be moved to make way for

opening the chest.

¨Select team member(s) for:

¨Managing the guidewire while Bridge is advanced.

¨Giving chest compressions.

¨Managing the pocket if hemostasis is required.

Best Practice Protocol Summary

Bridge Occlusion Balloon Important Safety Information

The Bridge Occlusion Balloon is indicated for use for temporary vessel occlusion of the superior vena cava in applications including

perioperative occlusion and emergency control of hemorrhage. Use of the Bridge Occlusion Balloon in procedures other than those

indicated is not recommended.

The adverse events associated with an occlusion balloon procedure include, but are not limited to allergic reactions, death,

embolization, hematoma, hemorrhage, sepsis/infection, short-term hemodynamic deterioration, thromboembolic episodes,

vascular thrombosis, vessel dissection, vessel perforation, vessel spasm.

In order to facilitate rapid delivery, it is recommended that a guidewire is in place in the superior vena cava prior to beginning the

lead extraction procedure. Attempting to place the guidewire after a tear has occurred may:

• Result in an inability to traverse the superior vena cava with the guidewire

• Result in the guidewire exiting the vasculature at the tear site

• Result in an inability to place the Bridge Occlusion Balloon catheter

• Delay or prevent the ability to achieve occlusion

This information is not intended to replace a discussion with your healthcare provider on the benets and risks of this procedure to

you.

Refer to spectranetics.com for Bridge IFU.

1. Wilko BL, Kennergren C, Love CJ, Kutalek SP, Epstein LM, Carrillo R, Bridge to Surgery: Best Practice Protocol Derived From Early

Clinical Experience with the Bridge Occlusion Balloon. Heart Rhythm (2017), doi: 10.1016/j.hrthm.2017.07.008.

Situations that may warrant staging Bridge in the IVC:

¨Have several initial practice deployments been conducted?

¨Has the team practiced the workow recently in a non-emergent setting?

¨Is this a high-risk case?

¨Combined lead age >10 Years

¨Low BMI

¨Low LV ejection fraction

¨ICD leads

¨Intra-procedure: Has the perceived risk increased and made the case high-risk?

¨Have multiple extraction tools been used?

Practice: Prophylaxis Considerations

Perform: Bridge Emergent Deployment

©2017 Spectranetics. All rights reserved. Approved for external distribution. D030338-03 072017

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NOTE: Guidewire must stay in place

during Bridge positioning and ination

¨Immediate deployment as soon as SVC tear is suspected, including cardiac

tamponade, hemothorax, or both.

¨Remove protector before loading onto the wire. No ushing or prep required.

¨Advance balloon over wire until proximal marker band on balloon is at SVC/RA junction.

¨Maintain wire control and ensure wire does not pull back.

¨Remove extraction sheath.

¨Inate with 30-60 cc of uid and close stopcock on syringe to prevent deation. Guidewire should not be removed

while Bridge is inated.

¨Do not position balloon too low; it may block atrial preload and increase risk of migration.

¨Diagnostics

¨Pericardiocentesis (ONLY if it does not delay surgery)

¨Perform surgical repair

¨Multiple implanted leads (≥4)

¨Female patients

¨Dual Coil ICD leads

NOTE: The availability of Bridge in no way obviates the need for emergent cardio thoracic

surgical backup. Delay to denitive treatment is potentially life-threatening.