Infection relapse occurs in 50% to 100% of cases with partial removal or antibiotic treatment alone, compared to relapse of 0% to 4.2% with complete system removal.1-5
When treated with antibiotics alone, mortality rates can be as high as 31% to 66% in device related endocarditis cases.2
$56,470 potential increased cost per patient with delayed CIED removal.23
Patients may also swirl in the hospital system on multiple rounds of antibiotics and see multiple physicians.7 HRS guidelines state it is a Class I indication to refer a patient to a lead extractor for consultation with documented CIED infection.
Click here to find a physician that specializes in lead extraction.
Watch the video to hear a patient story on delayed treatment
“Delaying the definitive operation with removal of all of the components of the CIED system can be a fatal choice for the patient” - HRS consensus documents24
Click here to learn more about how antibiotics alone are ineffective.
Antibiotics or partial device removal are often the first lines of defense with device infection. In many cases, however, these infections are caused by antibiotic-resistant staphylococcal bacteria that live in bacterial colonies called biofilm.8-9 The biofilm forms a thick coating around the device or leads that is nearly impossible to cure with antibiotic treatment alone.10-11 Biofilms that cause antibiotic resistance are present in up to 85% of microbial infections.22 A recent multicenter study13 attempted to find clinical factors for device salvage with CIED infection and found: Click here to download a free summary of the study.
Click here to hear Dr. Roger Carrillo’s perspective on the risks of relapse with antibiotics therapy alone
Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality.12 Immediate system removal is associated with a 3-fold decrease in 1-year mortality compared to preliminary antibiotic treatment and delayed system removal.12 Mortality rates in patients with endocarditis who had systems removed are less than 18%, compared with up to 66% with antibiotics alone.3
Early removal reduces length of hospital stay and increases survival.20-21 – $52,000-$146,000 - Cost to treat a single CIED infection patient17-18 – $72,000 - Average cost of a hospital-acquired infection17 – Patients extracted within 10 days may save the hospital system $56,470 in costs due to shorter hospital stays23
Quickly diagnosing CIED infection and extracting all hardware is vital to reducing hospital costs.
Click here to download a brochure on the costs of CIED infection.
| <10 days | >10 days |
Length of hospital stay (LOHS)20 | 18+13 | 44+38 |
Survival (at one year)20 | 83.1% | 66.1% |
Length of hospital stay (LOHS)20 | 18+13 (Timing of lead removal <10) | 44+38 (Timing of lead removal >10) |
Survival (at one year)20 | 83.1% (Timing of lead removal <10) | 66.1% (Timing of lead removal >10) |
$56,470 potential cost of delayed treatment *Difference between average hospital days (x) $2,157 average inpatient per day hospital cost (U.S)
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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
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