LEAD EXTRACTION GOOD LEAD MANAGEMENT. An update on how to achieve well functioning CIED hardware with a special focus on risk-benefit analysis

Transcription

1 LEAD EXTRACTION GOOD LEAD MANAGEMENT An update on how to achieve well functioning CIED hardware with a special focus on risk-benefit analysis ESC, Stockholm Stockholm Charles Kennergren, MD, PhD, FETCS FHRS Charles Kennergren MD PhD FHRS FETCS Sahlgrenska University Hospital Sahlgrenska University Hospital Göteborg, Sweden Gothenburg, Sweden

2 Disclosures I have presented on behalf of, performed studies with, or advised: Biotronic Boston Scientific Ela Medical Medtronic Mentice Spectranetics St. Jude Vitatron 2

3 Background Transvenous PM and ICD leads undergo fibrotic encapsulation by activation of intra and extra cellular processes Lead fibrosis typically increases over time and usually develops more quickly in younger patients Lead bodies as well as lead tips can grow deep into surrounding tissue and lead extravasation may occur

4 Background During the first decades of transvenous pacing a treatment paradigm developed: Since leads were difficult and potentially dangerous to remove, the accepted treatment was to cap and abandon all redundant leads, with the exception of leads associated with sepsis or endocarditis refractory to antibiotic treatment

5 Background The need for lead extraction is rapidly increasing due to: Growth of device treatment globally (higher incidence) Higher lead prevalence due to increased life expectancy CIED modes requiring more leads per patient New indications for device treatment Upgrading of device systems becoming more frequent Lead recalls

6 Background 2008 Estimated prevalence: 2.75 million CRM devices worldwide 5 million leads worldwide 2008 Estimated incidence: 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.

7 Background Infection ~ 1% 2-7% infection rate for replacements/upgrades 1 0.5% infection rate for new implants 1 Malfunction ~ 2.5% 1.65%-20% annual ICD lead failure based on age 2,3 Occlusion ~ 0.5% 9-12% of device replacement or upgrade 4 Redundant leads 4 ~ 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

8 Background Estimated annual complication rate: very approx. 5% CONCLUSION: The need for lead extraction is rapidly increasing despite improving lead quality

9 Indications Indications for transvenous lead removal were originally described by the Byrd Classification (Mandatory, Necessary and Discretionary) In 2000, indications were refined and published by NASPE (HRS) in the format established for the American College of Cardiology/American Heart Association s methodology for practice guidelines (Class I, Class II and Class III) In 2009 HRS published revised and updated recommendations. Levels of Evidence (A, B, C) and Class IIB indications were added EHRA plan to present European recommendations for lead extraction during the ESC 2010 meeting

10 Definitions (as per ACC, AHA, HRS) Class I : Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective Class II: Conditions for which there is conflicting evidence and/or divergence of opinion about the usefulness/efficacy of a procedure or treatment Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy Class IIb: Usefulness/efficacy is less well established by evidence/opinion Class III: Conditions of which there is evidence and/or general agreement that the procedure/treatment is not useful or effective, and in some cases may be harmful

11 HRS 2009 Indications; Caveat Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes

12 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes INFECTION Class I 1. Complete device and lead removal is recommended in all patients with definite CIED system infection, as evidenced by valvular endocarditis, lead endocarditis or sepsis. (Level of evidence: B) 2. Complete device and lead removal is recommended in all patients with CIED pocket infection as evidenced by pocket abscess, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system. (Level of evidence: B)

13 Chronic local infection Courtesy Bengt Frisk MD

14 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes INFECTION Class I 3. Complete device and lead removal is recommended in all patients with valvular endocarditis without definite involvement of the lead(s) and/or device. (Level of evidence: B) 4. Complete device and lead removal is recommended in patients with occult gram-positive bacteremia (not contaminant). (Level of evidence: B)

15 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes INFECTION Class IIa 1. Complete device and lead removal is reasonable in patients with persistent occult gram-negative bacteremia. Level of evidence: B)

16 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes INFECTION Class III 1. CIED removal is not indicated for a superficial or incisional infection without involvement of the device and/or leads. (Level of evidence: C) 2. CIED removal is not indicated to treat chronic bacteremia due to a source other than the CIED, when long term suppressive antibiotics are required. (Level of evidence: C)

17 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes CHRONIC PAIN Class IIa 1. Device and/or lead removal is reasonable in patients with severe chronic pain, at the device or lead insertion site, that causes significant discomfort for the patient, is not manageable by medical or surgical techniques and for which there is no acceptable alternative. (Level of evidence: C)

18 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes THROMBOSIS OR VENOUS STENOSIS Class I 1. Lead removal is recommended in patients with clinically significant thromboembolic events associated with thrombus on a lead or a lead fragment. (Level of evidence: C) 2. Lead removal is recommended in patients with bilateral subclavian vein or SVC occlusion precluding implantation of a needed transvenous lead. (Level of evidence: C) 3. Lead removal is recommended in patients with planned stent deployment in a vein already containing a transvenous lead, to avoid entrapment of the lead. (Level of evidence: C)

19 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes THROMBOSIS OR VENOUS STENOSIS Class I 4. Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms. (Level of evidence: C) 5. Lead removal is recommended in patients with ipsilateral venous occlusion preventing access to the venous circulation for required placement of an additional lead when there is a contraindication for using the contralateral side (e.g. contralateral AV fistula, shunt or vascular access port, mastectomy). (Level of evidence: C)

20 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes THROMBOSIS OR VENOUS STENOSIS Class IIa 1. Lead removal is reasonable in patients with ipsilateral venous occlusion preventing access to the venous circulation for required placement of an additional lead, when there is no contraindication for using the contralateral side. (Level of evidence C)

21 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes FUNCTIONAL LEADS Class I 1. Lead removal is recommended in patients with life threatening arrhythmias secondary to retained leads. (Level of evidence: B) 2. Lead removal is recommended in patients with leads that, due to their design or their failure, may pose an immediate threat to the patients if left in place (e.g. Telectronics ACCUFIX J wire fracture with protrusion). (Level of evidence: B)

22 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes FUNCTIONAL LEADS Class I 3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices. (Level of evidence: B) 4. Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery). (Level of evidence: C)

23 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes FUNCTIONAL LEADS Class IIb 1. Lead removal may be considered in patients with an abandoned functional lead that poses a risk of interference with the operation of the active CIED system. (Level of evidence: C) 2. Lead removal may be considered in patients with functioning leads that due to their design or their failure pose a potential future threat to the patient if left in place. (e.g. Telectronics ACCUFIX without protrusion) (Level of evidence: C) 3. Lead removal may be considered in patients with leads that are functional but not being used. (i.e. RV pacing lead after upgrade to ICD) (Level of evidence: C)

24 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes FUNCTIONAL LEADS Class IIb 4. Lead removal may be considered in patients who require specific imaging techniques (e.g. MRI) that can not be imaged due to the presence of the CIED system for which there is no other available imaging alternative for the diagnosis. (Level of evidence: C) 5. Lead removal may be considered in patients in order to permit the implantation of an MRI conditional CIED system. (Level of evidence: C

25 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes FUNCTIONAL LEADS Class III 1. Lead removal is not indicated in patients with functional but redundant leads if patients have a life expectancy of less than one year. (Level of evidence: C) 2. Lead removal is not indicated in patients with known anomalous placement of leads through structures other than normal venous and cardiac structures, (e.g. subclavian artery, aorta, pleura, atrial or ventricular wall or mediastinum) or through a systemic venous atrium or systemic ventricle. Additional techniques including surgical backup may be used if the clinical scenario is compelling. (Level of evidence: C)

26 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes NON FUNCTIONAL LEADS Class I 1. Lead removal is recommended in patients with lifethreatening arrhythmias secondary to retained leads or lead fragments. (Level of evidence: B) 2. Lead removal is recommended in patients with leads that, due to their design or their failure, may pose an immediate threat to the patients if left in place. (e.g. Telectronics ACCUFIX J wire fracture with protrusion) (Level of evidence: B)

27 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes NON FUNCTIONAL LEADS Class I 3. Lead removal is recommended in patients with leads that interfere with the operation of implanted cardiac devices. (Level of evidence: B) 4. Lead removal is recommended in patients with leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery). (Level of evidence: C)

28 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes NON-FUNCTIONAL LEADS Class IIa 1. Lead removal is reasonable in patients with leads that due to their design or their failure pose a threat to the patient, that is not immediate or imminent if left in place. (e.g. Telectronics ACCUFIX without protrusion) (Level of evidence C) 2. Lead removal is reasonable in patients if a CIED implantation would require more than 4 leads on one side or more than 5 leads through the SVC. (Level of evidence C)

29 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes NON-FUNCTIONAL LEADS Class IIa 3. Lead removal is reasonable for patients that require specific imaging techniques (e.g. MRI) and can not be imaged due to the presence of the CIED system for whom there is no other available imaging alternative for the diagnosis. (Level of evidence: C)

30 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes NON-FUNCTIONAL LEADS Class IIb 1. Lead removal may be considered at the time of an indicated CIED procedure, in patients with non-functional leads, if contraindications are absent. (Level of evidence C) 2. Lead removal may be considered in order to permit the implantation of an MRI conditional CIED system. (Level of evidence: C)

31 HRS 2009 Indications Recommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes NON-FUNCTIONA LEADS, Class III 1. Lead removal is not indicated in patients with non-functional leads if patients have a life expectancy of less than one year. (Level of evidence C) 2. Lead removal is not indicated in patients with known anomalous placement of leads through structures other than normal venous and cardiac structures, (e.g. subclavian artery, aorta, pleura, atrial or ventricular wall or mediastinum) or through a systemic venous atrium or systemic ventricle. Additional techniques including surgical backup and techniques may be used if the clinical scenario is compelling. (Level of evidence: C)

32 Traditional extraction methods Traction with weights Traction with forceps (by tensioning the lead) Manual traction Open chest extraction

33 Extraction with weights or forceps Should be avoided at this point of time: High incidence of incomplete lead removal Increased risk of complication Increased morbidity Extended admission and subsequently increased cost

34 Presently available methods Manual lead removal Mechanical sheaths Revolving mechanical sheaths EDS (electrocauthery dissection sheaths) Laser assisted lead extraction Open chest extraction Hybrid methods (i.e. laser and open chest)

35 Manual Traction Courtesy Dr Charles Love Charles Love

36 Manual Traction Manual traction without special tools can successfully remove 25-33% of transvenous leads Leads implanted < 1 year can usually be manually removed Isodiametric leads (active fixation) can often be removed when implanted 1-3 years

37 Open chest extraction

38 Open chest extraction -during concomitant heart surgery -if vegetations are too large or pedunculated -when extravasation of a lead is known or suspected

39 Mechanical sheath extraction Outer Sheath Inner Sheath Targeted Lead

40 Mechanical sheath extraction -well proven method, still very much in use -single sheath or telescoping sheaths technique -locking stylets enhance results (with all methods) -excellent results can be achieved -may require long op and fluoroscopic times -sheaths can be made of different materials with different stiffness (i.e. polyethylene, polypropylene, stainless steel or braided) -the leading end of sheaths can be either beveled or flat

41 COOK - Wilkoff (Side-lock)

42 COOK - Wilkoff (Side-lock)

43 Cook Liberator

44 VascoExtor Viper Version

45 Spectranetics LLD

46 Spectranetics LLD

47 Revolving mechanical sheath extraction (Evolution )

48 Revolving mechanical sheath extraction (Evolution ) - propelled progress of sheath -ablation forces directed laterally -limited experience: -initial experience indicate excellent efficiency -safety data only available from a few very experienced centers Refs; Initial experience with the Evolution mechanical dilator sheath for lead extraction: Safety and efficacy Hussein AA, Wilkoff BL, Martin DO, Karim S, Kanj M, Callahan T, Baranowski B, Saliba WI, Wanzi OM Heart Rhythm Mar 23. Byrd CL Experience with the new Cook Evolution lead extraction sheath Abstract AB 15-1 at HRS 2008

49 Electrosurgical dissection sheaths (EDS)

50 Electrosurgical dissection sheaths (EDS) -employs 2 sheaths that are worked successively to mechanically disrupt bonds -the inner Teflon sheath has two tungsten electrodes at the tip for added electrosurgical dissection -conventional electrosurgical energy is used -conventional outer mechanical sheaths and locking stylets are used -EDS sheaths are available in 7, 9, 11 and 13 Fr sizes -EDS now seems to decrease in popularity and to be replaced by revolving mechanical sheaths (Evolution )

51 Laser assisted lead extraction

52 Excimer Laser Assisted Lead Extraction -excimer Laser is a xenon chloride laser with a wavelength of 308 nm -maximum fluence is 60 mj/mm, 40 Hz repetition rate -this is a cool cutting laser; the temperature of the emitted light is approximately 50 C -tissue absorption depth: 64% absorbed at 0.06 mm and 95% absorbed at 0.18 mm -it acts by breaking tissue bonds in fat and protein -it vaporizes fibrosis surrounding targeted leads without damaging other leads -energy is emitted from the tip of flexible, fiber optic 12, 14 or 16 Fr sheaths

53 53

54 Passive PM lead extracted with laser technique

55 Femoral extraction -successful method for some atrial and free-floating leads -special sheaths, devices and snares are needed -typically requires two incisions for non free-floating leads -RV leads are usually difficult to extract due to an acute curve into the RV -typically requires more op and fluoroscopy time than superior methods -published results of conseqeutive femoral lead extraction are rare -femoral extraction is still a necessary complement to other methods

56 Right jugular vein extraction -very useful for free-floating and heavily fibrosed leads -leads are cut at the left subclavian vein, pulled down to the femoral vein and then pulled out and extracted through the right jugular vein -very successful even for very fibrosed and calcified leads by avoiding sharp lead curves -usually requires 3 incisions (left subclavian, femoral and right jugular) -long OR/Lab and fluoroscopy times

57 Hybrid methods -may be the best solution for some difficult, high risk cases -an open chest approach is used for better control -allows instant treatment of potential perforations -avoids deleterious hypovolemia in patients with low EF -transvenous techniques (i.e. laser or mechanical sheaths) can be used by introducing sheaths through SVC and/or atrial walls -a sternotomy without going on cardiopulmonary bypass is associated with limited risk and morbidity

58 Lead extraction; Results -Clinical success rate is typically in the 98-99% range in high volume extraction centers -Most series show a clear learning curve in the first cases, still notable after several hundred cases -Excellent results can be achieved with both laser and mechanical sheaths Refs; Bongiorni, Boveda, Byrd, Carillo, Defaye, Epstein, Kennergren, Klug, Kutalek, Love, Rinaldi, Schaerf, Willkoff

59 Lead extraction complications and mortality with laser 2.0% 1.5% 1.0% PLEXES Total US LExICon 153 pts 1684 pts 1449 pts 9 centers 1 89 centers 2 13 centers 3 2.0% 1.9% 1.4% 1.1% * Procedural MAEs Procedural Mortality 0.5% % 0.6% % 1. Wilkoff, Bruce, L., et al. Pacemaker Lead Extraction with the Laser Sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. JACC, Vol 33, No. 6, May Byrd, Charles, et al. Clinical Study of the Laser Sheath for Lead Extraction: The Total Experience in the United States. Journal of Pacing and Electrophysiology. Vol l25, No. 5, May Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55: Note: 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

60 Comparative Complication Rates 6% 5.9% 1 5% 4% 4-5% 3 Procedural MAEs Procedural Mortality 3% 2% 1-2% 3 2.2% 4 1.4% 5 1% 0% % 2 A-Fib Ablation PCIs Lead Addition/Revision 1.1%^ 0.28% 5 Lead Removal (LExICon) 0.4% % 6 * See References on Page 25 ^ 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 DFT

61 Complications; summary -The rate of serious complications (mainly perforations) is below 1% in high volume centers -The rate of serious complications is 2-3% in less experienced centers -The mortality rate in high volume centers is 0-0,3% and below 1% in most centers

62 FAQ -what size infectious vegetations can safely and successfully be removed by transvenous extraction? -how many extractions must be performed to establish and maintain a high quality extraction center? -how many extractions should I perform to be an independent extractor? -what extraction method(s) should I choose? -what precautions are needed to safely do transvenous lead extraction?

63 FAQ -can lead extraction be used to open up occluded veins? -does lead extraction induce vein occlusion? -how many transvenous leads are too many? -is extracting right sided subclavian or jugular veins leads more difficult and dangerous than left sided? -are CS leads difficult to extract? -should Sprint Fidelis leads be prophylactically extracted?

64 Summary The need for lead extraction is rapidly increasing Indications for lead extraction are well defined Well proven lead extraction techniques are available Results are excellent, training and high volume are however prerequisites Complications are infrequent, specially in comparison with other invasive procedures Mortality is unusual, proper safety precautions are however mandatory

65 THANK YOU FOR YOUR ATTENTION!