Lead management

Doctor and patient around a table, checking a paper

Treatment and management options

"We’ve seen too many late consults that were too advanced to save. Using Epic as an adjunct to the consult system for device bacteremia detection has great potential. It will save lives – period.

Jude Clancy, MD

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Class I indication
All major cardiac society guidelines recommend complete system removal of all hardware and leads. Extractor consult for CIED patients with documented infection is also a Class I indication.1

Realistic heart icon

Proven safety

Lead extraction has a 97.7% clinical success rate and 99.72% procedural safety rate.2 With the Bridge occlusion balloon, SVC tear survival has increased from 50% to 88.2%.5

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Improved patient care pathway

Implementing EMR (electronic medical records), hospital and community education, and setting up a process for streamlining patient identification and can help patients get the care they need.6

Roger Carillo
Click here to hear Dr. Roger Carrillo’s discussion on treatment options and Class I guidance

Device + infection = removal

 

With early diagnosis and appropriate treatment, cardiac device infections can be cured.

Expert guidelines mandate (Class I indication1):

  1. Extractor consult for device patients with documented infection. (To find a physician that specializes in lead extraction, please click here and select “lead extraction” as a specialty in the search criteria)
     
  2. Complete device removal for CIED infection.

Click here to download the 2017 HRS Consensus Pocket Guide, which include diagnosis charts for identifying device infection.

Clinically proven safety of laser assisted lead extraction.2-4

*The LExiCon study reports a procedural MAE rate of 1.4% as defined by the 2000 NASPE Policy Statement. However, 0.3% (n=4) of the MAEs were bleeding requiring transfusion which is no longer defined as a MAE by the 2009 HRS Expert Consensus Document.

Safety of lead extraction

 

Lead extraction, when indicated, is a highly successful, potentially life-saving procedure, with a clinical success rate of 97.7% and a procedural safety rate of 99.72%.2

 

Click here to see how laser lead extraction works.

Click here to see how the Bridge occlusion balloon works for supporting SVC tear rescue.

 

Philips is committed to safe, predictable, and responsible Lead Management.

Electronic medical records and protocols

 

EMR can help make a significant impact to the hospital and patient care for little to no cost with an existing EMR program. The concept is to set-up an alert in the system when a patient has a positive blood culture and a CIED. The alert can be directed to an extractor and other HCP teams as needed for your hospital set-up. Click here to see the steps for how Yale has implemented EMR.

 

In one center, EMR was shown to reduce days to device removal by 27% and reduce days to cardiology consult by 71%.6 Click here to download a one-page summary of the study.

 

Protocols

In addition, having block time and supportive surgical back-up may further streamline extractions.

 

Click here to see best practices for block time and surgical back-up that can help support a Lead Management program

EMR study shows streamlined treatment pathway6

4.9 to 1.4 days is a
71% reduction
Time to cardiology consult may equal $7,500 in hospital savings*
3.6 to 1.4 days is a
61% reduction
Time to infectious diseases consult may equal $4,750 in hospital savings*
7.8 to 5.7 days is a
27% reduction
Time to device removal may equal $4,500 in hospital savings*
*Difference between average hospital days (x) $2,157 average inpatient per day hospital cost (U.S.)

Hospital and community education

 

It is also key to educate the community on how to identify and refer patients for potentially life-saving lead extraction, which may include:

  • Referring EP and cardiologists
  • Cardiac surgeons
  • Infectious disease
  • Nephrology
  • Device clinic staff
  • Hospital administration
  • Other: ER staff, primary care physicians, risk management, etc.

 

Potential educational meetings could include hospital grand rounds and cardiology sectional grand rounds or presentations.

Click here to download a CIED infection presentation.

Patient Education

 

Educating patients is also key so they know when to raise concerns. Click here to see the Heart Rhythm Society patient page on CIED management that includes resources to provide to patients, as well as a physician finder.

 

Key resources to provide patients to help them know what to keep an eye out for include:

Download “What’s in your pocket” brochure to help patients spot infection.

Download a one-page infographic of important information for patients.

Sign up for updates and help fight device infection

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Infection plus device equals to removal
  1. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.
  2. Wazni, O. et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational RetrospectiveStudy of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586.
  3. Wilkoff, B.L., et al. (1999). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33(6).
  4. Byrd, C., et al. (2002). Clinical study of the laser sheath for lead extraction: The total experience in the United States. Journal of Pacing and Electrophysiology, 25(5).
  5. Ryan Azarrafiy, BA; Darren C. Tsang, BS; Bruce L. Wilkoff, MD, FHRS; Roger G. Carrillo, MD, MBA, FHRS. The Endovascular Occlusion Balloon for Treatment of Superior Vena Cava Tears During Transvenous Lead Extraction: A Multi-Year Analysis and An Update to Best Practice Protocol. Circulation: Arrhythmia and Electrophysiology, August 2019.
  6. Paz Rios, Luis, et al. “Effect Of An Electronic Medical Alerts For Patients With Positive Cultures And Cardiovascular Implantable Electronic Devices.” Moderated ePoster Presentation. 2020 Heart Rhythm Society Annual Abstract Presentations Online.

 

GlideLight laser sheath

The GlideLight laser sheath is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the GlideLight laser sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the GlideLight laser sheath.

 

Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung. Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death.

 

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

 

Bridge occlusion balloon

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 benefits and risks of this procedure to you.

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