A603e89f 7e12 449d 8c9d 28616061f601

: Pdf A603E89F-7E12-449D-8C9D-28616061F601 a603e89f-7e12-449d-8c9d-28616061f601 9 2017 pdf

Open the PDF directly: View PDF .
Page Count: 2

Case Study:

Staging Bridge™ Occlusion Balloon Mid-Case

Sumit Verma, MD, FACC, Heart Rhythm Center, Baptist Hospital, Pensacola, Florida

Background:

SVC tears during lead extraction are very rare, occurring in less than 0.5%

of procedures. The Bridge Occlusion Balloon was designed to provide

hemostasis in the rare event of a SVC tear, allowing time for surgical repair

and increasing survivability. Dozens of rescues have been supported utilizing

this novel device.1

One of several recommendations for deploying Bridge prophylactically is

for high-risk cases.2 When Bridge is staged in the IVC, it can support rapid

deployment and minimize blood loss. At the onset, some cases may not

appear high risk. Yet, case diculty may increase intra-procedure, and

prophylactic deployment may be considered. This case description details

a lead extraction case performed by Dr. Sumit Verma. Bridge was deployed

mid-case when the perception of risk increased.

Case Description

• Procedure performed in a surgical OR suite with cardiovascular surgeon and

perfusionist on stand by.

• Standard lead extraction protocol (central and arterial lines, femoral vein

and arterial access, intraoperative TEE, blood products in the room).

• Bridge™ Prep Kit was used. A 0.035” super-sti guidewire was advanced

through a 6F peel away sheath from the left femoral vein to the right IJ.

A 12F introducer sheath was on the wire outside of the body in case of

emergent Bridge deployment. The bottom end of the guidewire was

clamped to the drape to maintain position throughout the procedure.

• A 60 cc syringe was lled with contrast and saline mix (per the IFU, 12

cc contrast & 48 cc saline). Bridge™ Occlusion Balloon was immediately

available.

• Temporary pacer was also inserted through the left femoral vein.

• The generator was then removed and access to the left subclavian vein

was secured.

• To create a traction platform, LLD EZ™ locking devices were deployed in

the lumen of each lead and sutures were tied to the insulation.

• In order to minimize the lead-to-sheath gap, a 12F GlideLight™ laser

sheath with a VisiSheath was selected. The sheath was advanced over the

RV lead.

• Signicant lead-on-lead and lead-to-wall binding was encountered at the

innominate/SVC junction and progression stalled.

• Before upsizing to a 14F GlideLight™ laser sheath, Bridge was advanced

into the anatomy as a precaution.

• The 14F laser sheath was advanced from the SVC to the tricuspid valve, at

which point systolic blood pressure dropped from 120 mm to 70 mm and

remained low despite releasing the traction on the lead and immediate

infusion of vasopressors.

• Bridge was deployed, and diagnostics were investigated. TEE showed no

eusion and no tamponade. No hemothorax was seen uoroscopically.

• Once the surgeon was in the room, the balloon was deated and an

angiogram was performed from the right arm. No extravasation was seen.

• The extraction continued and the RV and RA lead were successfully

removed.

Patient and Device History

• 89-year-old male with a dual-chamber

pacemaker implanted in 2009 for atrial brillation

and complete heart block.

• Patient underwent generator change three

weeks prior and developed a pacer site infection,

necessitating extraction of the system.

• No prior CABG or open heart surgery. Previous

atrial utter RFA.

Figure 1. Practicing Bridge

ination prior to an

emergent situation helps

refresh the team on the

workow.

Figure 2. Determining

placement in the SVC

for potential ination

beforehand. Bridge can then

be stationed in the IVC.

Figure 3. Bridge inated after

blood pressure dropped.

Diagnostics determined

no SVC tear. Bridge was

deated and the extraction

completed successfully.

Implanted Leads: Implant Date

Guidant 4087 (RA lead) 2009

Guidant 4088 (RV lead) 2009

Indication for Extraction

Pocket Infection (Class I)

Always Reaching Farther

©2017 Spectranetics. All Rights Reserved. Approved for External Distribution. D038018-00 072017

References

1. SPNC Post Market Surveillance, 2017. Data on File.

2. 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.”

Discussion with Dr. Verma

Prophylactic Deployment Mid-Case

Just looking at the demographics, this patient may not have appeared high

risk. Normally, I would not expect this case to give me any trouble. Yet, as

heavy lead-on-lead and lead-to-wall binding was encountered and greater

traction force was required, the case became higher risk in my mind. The

balloon was inserted as a precaution to support a quick deployment and limit

any potential blood loss.

When the blood pressure dropped and we inated Bridge, it was impressive

to see everyone in the room was composed. We were prepared and felt we

had the situation under control. Bridge has changed the dynamic of the

room—from panic to calm.

In the future, I plan to prophylactically inate Bridge when I feel case diculty

has increased intra-procedure. We have surgical backup that is immediately

available, yet often not in the room. Bridge provides time to stabilize the

patient and transition to surgery.

Patient Prep

Prepping every patient undergoing extraction with a guidewire and

introducer sheath has become our standard. This is part of Bridge Best

Practice Protocol.2 In this case, additional time was required to insert the

guidewire because the right femoral vein was occluded. The guidewire was

alternately placed through the left femoral vein to the right IJ. Also, the

patient had signicant binding in the vessel, and a JR4 catheter was required

to guide the wire past the heart. Trying to place a wire and the balloon in an

emergent situation, instead of beforehand, may have been impossible in this

patient.

It is important for operators to understand that there may be unforeseen

patient characteristics that add time to deployment. It is imperative to

be prepared beforehand. The more you can prepare for immediate

deployment, the better o you are.

Pre-Huddle Timeout

We incorporate Bridge into our pre-case timeout. We know exactly where it

is, and it is always immediately available. Then we decide whether the case is

high-risk and if we want to stage Bridge in the IVC.

Prior to this case, I had prophylactically inated the balloon in order to

become familiar with the device and the workow. It is important for our

team to practice the workow on a regular basis. Dierent extractors and

support sta all need to be familiar with the balloon, patient prep and steps

for deployment.

“There was no tear in this case,

but had there been a tear, we

would have been prepared to

save the patient.”

-- Sumit Verma, MD, FACC

Important Safety Information

Indications for Use

The Bridge Occlusion Balloon Catheter is indicated for use for temporary vessel

occlusion of the superior vena cava in applications including perioperative

occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in these instructions is not

recommended

Contraindications

None Known

Warnings

Lead extraction should be performed at institutions with cardiothoracic surgical

capabilities by physicians knowledgeable in the techniques and devices for

lead or catheter removal. Complication prevention and management protocols

should be in place and routinely practiced. It is strongly suggested that the

recommendations for lead management of the Heart Rhythm Society (HRS) and

European Heart Rhythm Association (EHRA) be followed for best results.

Prior to initiating the lead extraction procedure, a Bridge Occlusion Balloon

Catheter compatible guidewire should be placed through a venous access

site and across the length of the superior vena cava. Attempting to place a

compatible guidewire after a venous tear occurs 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

Do not position the Bridge Occlusion Balloon Catheter in a manner that would

obstruct the right atrium. Obstruction of the atrium could lead to arrhythmias

and/or hemodynamic compromise. Failure to observe recommended ination

techniques may result in the formation of contrast crystals which could prevent

deation.

Do not over-inate the Bridge Occlusion Balloon Catheter after fully occluding

the vessel. Over ination may result in damage to the vessel, rupture of the

balloon, or introduction of air emboli.

Do not exceed the Maximum Ination Volume. Over ination may result in

damage to the vessel, rupture of the balloon, or introduction of air emboli.

Occlusion of the superior vena cava beyond 30 minutes is not recommended as

this may increase the risk of adverse physiologic or neurologic complications.

Do not resterilize or reuse this device, as these actions can compromise device

performance or increase the risk of cross-contamination due to inappropriate

reprocessing.

Reuse of this single use device could lead to serious patient injury or death and

voids manufacturer warranties

Refer to the IFU for additional information.

Case study and discussion provided, reviewed, and approved

by Dr. Sumit Verma, MD FACC 07/2017

“Bridge allows us to perform

the extraction procedure with

more control over potential

complications.”

-- Sumit Verma, MD, FACC