CIEDs Infection: Lead Extraction, First or Last option?

Transcription

1 CIEDs Infection: Lead Extraction, First or Last option?

2 More CRM Systems & Leads 600,000 new devices annually 1.2 million new leads annually Sources: 1) Medtronic CRDM Product Performance Report, Jan ) Boston Scientific CRM Product Performance Report, Q ) St. Jude Medical CRM Product Performance Report, April ) IDATA Research, US Markets for Cardiac Rhythm Management, Electrophysiology, and Ablation Devices 2008.

3 Indications for lead extraction Infection 1% 2-7% infection rate for replacements/upgrades 0.5% infection rate for new implants Malfunction 2.5% 1.65%-20% annual ICD lead failure based on age Occlusion - 0.5% 9-12% of device replacement or upgrade Redundant leads 1% 1. Wilkoff, Bruce L., et al. How to treat and identify device infections. Heart Rhythm, Vol 4, No 11, 2007, Hauser, Robert, et. al., The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failuree, Heart Rhythm, Vol. 6, No 5, May Kleeman Thomas, et al. Annual Rate of Transvenous Defibrllation Lead Defect in Implantable Cardioverter-Defibrillators over a Period of >10 Years. Circulation 2007; 115: Fields, Michael E., et al. How to select patients for lead extraction. Heart Rhythm, Vol 4, No 7, July 2007.

4 62 Y/O male, dual chamber PPM implanted 5 years earlier for SSS Pocket infection one year after implantation Pocket revision twice?? Attempt of lead removal New lead implanted? Sinus and discharge from incision site

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9 Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H.,et al. (2009). Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management. Retrieved May 13, 2009, from

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33 Factors may affect the difficulty Device Choice: Single vs. dual vs. triple chamber Lead choice: Single vs. dual coil ICD lead Active vs. passive fixation StarFix LV lead Site of implantation: Right vs. Left High incision or Low incision Vein of choice: Cephalic vs. axillary vs. subclavian

34 Wazni et al. JACC Vol. 55, No. 6, 2010 Feb 9, 2010:579 86

35 Wazni et al. JACC Vol. 55, No. 6, 2010 Feb 9, 2010:579 86

36 Wazni et al. JACC Vol. 55, No. 6, 2010 Feb 9, 2010:579 86

37 Safety Laser Lead Extraction 2.50% 2.00% 1.50% 1.00% 0.50% 0.00% Clinically Proven Safety of Laser Assisted Lead Extraction % 1.9% 0.65% 0.60% 1.4% PLEXES 153 pts / 9 centers SLS Total US 1684 pts / 89 centers 0.28% LExiCon 1449 pts / 13 centers SLS II Procedural MAEs Procedural Mortality * 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 an MAE by the 2009 HRS Expert Consensus Document.

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39 Comparative Complication Rates 6% 5.9% 5% 4% 4-5% Procedural MAEs Procedural Mortality 3% 2.2% 2% 1-2% 1.4% 1% 0% % A-Fib Ablation PCIs High volume centers Lead Addition/Revision 0.78% 0.27% Lead Removal (LExICon) 1. Wilkoff, Bruce L., et al. How to treat and identify device infections. Heart Rhythm, Vol 4, No 11, 2007, Hauser, Robert, et. al., The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failuree, Heart Rhythm, Vol. 6, No 5, May Kleeman Thomas, et al. Annual Rate of Transvenous Defibrllation Lead Defect in Implantable Cardioverter-Defibrillators over a Period of >10 Years. Circulation 2007; 115: Fields, Michael E., et al. How to select patients for lead extraction. Heart Rhythm, Vol 4, No 7, July % DFT 0.07%

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48 Factors to Consider Patient age and gender Overall health Previous cardiac surgery Number of leads in the intravascular space Duration of the implant Fragility, condition, and physical characteristics of the lead Experience of the physician Desires of the patient

49 Potential Drawbacks of Abandoning Non-Infected ICD Leads Lead chatter causing spurious shocks Insulation breach in pocket causing electrical shorting during high-voltage shock and generator damage Large diameter could promote venous obstruction (SVC syndrome) or TR Extraction will be very difficult if needed down the road

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53 ArashAryana, MS, MDa,*, Kristi D. Sobota, MDb, Dennis J. Esterbrooks, MDc, and Andrew I. Gelbman, DO, PhDd. Am J Cardiol2007;99:

54 Annals of Pediatric Cardiology 2013 Vol 6 Issue 1

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56 Consider the Long Term Risk Profile for Each Individual Patient Risk Future failed removal Erosion/infection Venous thrombosis/occlusion Tricuspid regurgitation Inappropriate shocks Risk Procedural MAEs/mortality 1.4% (0.78% high volume)/ 0.27% 1 1. Wazni, Oussauma, et al. The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions. Heart Rhythm, Vol 6, Issue 5, Supp May 2009, Ab AB 39-5.

57 For Many Patients, the Long Term Risks of Capping may be Greater than for Lead Removal Risk Future failed removal Erosion/infection Venous thrombosis/occlusion Tricuspid regurgitation Inappropriate shocks Risk Procedural MAEs/mortality 1.4% (0.78% high volume)/ 0.27% 1 1. Wazni, Oussauma, et al. The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions. Heart Rhythm, Vol 6, Issue 5, Supp May 2009, Ab AB 39-5.

58 Starfix lead

59 Starfix lead

60 Starfix lead

61 Conclusion Clear indications Safe procedure First option

62 Thank you