CIED lead extraction is life-saving, yet patients are undertreated

Data from JAMA Cardiology shows that over 80% of patients needing CIED infection treatment do not receive Class 1 guideline-recommended care. Yet, lead extraction within six days of diagnosis reduces mortality risk by 42.8%.¹ Identifying the infection sources can be challenging, but with infections rising, ² investigating the device is crucial.

AHA data from November 2022 highlights a gap in guideline awareness: only 29% of cardiologists know CIED infection guidelines, and only 30% of institutions have management protocols. ¹ Early diagnosis and proper treatment can cure infections³, with lead extraction achieving a 97.7% success rate and 99.72% procedural safety. ^4,5 

Antibiotic-resistant staphylococcal bacteria often form biofilm around devices and is nearly impossible to cure with antibiotic treatment alone.⁶ Without complete system removal, infection relapses occur in 50-100% of cases, compared to 0-4.2% with full extraction.^7-11 Patients treated with antibiotics alone face a sevenfold increase in 30-day mortality, while lead extraction within six days lowers the death rate by 42.9%.^3,7

Featured Technology

	GlideLight Laser Sheath Versatility – No two lead removal procedures are the same. Each binding site is unique, lead designs vary, and every patient’s anatomy is different. Efficiency – Stalled progression during lead removal procedures can lengthen the time they take to complete. GlideLight Laser Sheath may enable smoother and more consistent progression. Control – GlideLight Laser Sheath provides critical control when progressing through binding sites. Safely and efficiently removing leads depends on tools that give you versatility and control. Discover more GlideLight features >>
	TightRail Mechanical Rotating Dilator Sheath With TightRail, flexibility meets unparalleled control. The tool’s flexible shaft helps physicians remain coaxial to the lead while maintaining forward progression through tortuous vasculature. The dilating blade remains shielded until activated, putting physicians in control and allowing counter-traction at the targeted lead’s distal tip. Discover more TightRail features >>
	Bridge Occlusion Balloon A tear in the superior vena cava (SVC) during a lead extraction procedure is rare, occurring in just 0.5% of cases, but when a tear does occur, the Bridge Occlusion Balloon can be quickly deployed to stop blood loss and allow time for transition to surgical repair. Investigate the life-saving design of the Bridge Occlusion Balloon >>
	ACC 2023 CIED Infection Data Update >> COGNITO Data One-Pager >>

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References

1 Pokorney SD, Zepel L, Greiner MA, et al. Lead Extraction and Mortality Among Patients With Cardiac Implanted Electronic Device Infection. JAMA Cardiol. Published online October 18, 2023. doi:10.1001/jamacardio.2023.3379

2 Tarakji KG, Wazni OM, Harb S, Hsu A, Saliba W, Wilkoff BL. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace doi:10.1093/Europace/euu147.

3 Data on file, D021403-04 Infection InfoGraphic

4 Pokorney SD. Low Rates Of Guideline Directed Care Associated With Higher Mortality In Patients With Infections Of Pacemakers And Implantable Cardioverter Defibrillators.American College of Cardiology (ACC) Late Breaking Clinical Trials. Washington, DC, USA April 2022 [presentation].

5 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)

6 Kusumoto, et al. (2017). 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart rhythm, 14(12),e503-e551

7 Tarakji, K, et al. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol. 7, No. 8, 2010: 1043-7.

8 Chen L. and Wen, Y. “The role of bacterial biofilm in persistent infections and control strategies.” Int J Oral Sci, 2011, DOI: 10.4248/IJOS11022

9 Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608.

10 Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latentsystemic infection. Heart, 90(8), 882-886.

11 Margey, R. et al. Contemporary management of and outcomes from cardiac device related infections Europace (2010) 12 (1): 64-70 first published online November 11, 2009 doi:10.1093/europace/eup362

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