When and why a functioning lead should be extracted ? Andrzej Kutarski Medical University Hosp. of Lublin The Pope John Paul II Province Hospital of Zamosc
Poland a_kutarski@yahoo.com
When and why a functioning lead should be extracted Definition: Lead having
acceptable pacing / sensing / impedance parameters, normal colour and typical / correct it intravenous and intra-cardiac route – which can be still used now or (potentially) in the future Keeping in mind phenomenon of lead corrosion can we consider as „functional” PM leads > 20y and ICD leads > 10y ?
Functional lead may (during unit re-implantation or even upgrading): 1. to serve longer in case of unit replacement or non-problematic upgrading (VVI –> DDD, DDD>CRT-P) 2. consist a key for venous access in case of venous occlusion and necessity a new lead implantation 3. to serve as a key for venous access for management of symptomatic venous occlusion of great chest veins by means venoplasty and stenting
When and why a functioning lead should be extracted „Functional lead” today may to consist the reasons of future complications as: 1. Apparence of venous occlusion especially if global number of leads is high
2. Interference with active CIED system 3. Interference with therapy of breast or lung cancer 4. Old models may by estimated as contra-indication for MRI 5. May to stay the reason of chronic pain et device insertion side
6. May by trigger of life threatening arrhythmias with different mechanism 7. May pose a potential future threat to the patient due to dangerous lead construction (it design or risk of failure)
8. May pose a potential future threat to the patient doe to potentially dangerous intravenous or intracardiac lead body course (lead in conflict with tricuspid / pulmonary valve) 9. Missed tip location (out of standard position fe. LA., LV)
10. May to stay recalled leads (frequent controls or necessary replacement) 11. May wear away – ageing of leads (mean ICD lead durability is < 10 y, PM lead < 20y) and to create different troubles and stay more and more difficult for extraction (functioning lead = functional relatively “young” lead?) 12. Never adapts to pt. body growth (strained lead due to growth of the body) in child and young patient 13. May to have externalized conductors (different clinical consequences) 14. May to have external tube abrasions (different clinical consequences) 15. May to stay unnecessary in case of recession of pacing indication (lack of device indication)
When and why a functioning lead should be extracted When to extract ? We still have HRS Experts Consensus from 2009 (Wilkoff BL at al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management Heart Rhythm. 2009 Jul;6:1085-104)
General goals of lead removal: 1.
Elimination of infection (1)
2. Recapture of venous access (creation of venous access in an occluded vessel and preservation of desired pacing mode) (1 / 2a) 3. Prevention of late side-effects of abandoned non-functional lead. Elimination of an identified risk (perforation, arrhythmia) produced by a lead or portion of a lead ((2b) 4. Maintenance contralateral (chest) venous system for another medical procedures in the future (2b) a_kutarski@yahoo.com www.usuwanieelektrod.pl
When and why a functioning lead should be extracted
Simplest and shortest one circumstription of the general goal of lead management
„The patient should have so many properly implanted, properly functioning leads - as many he needs and no more”
Charles Byrd – personal communication.
IDSS Jerusalem
1995 a_kutarski@yahoo.com
When and why a functioning lead should be extracted When to extract ? We still have HRS Experts Consensus from 2009 (Wilkoff BL at al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management Heart Rhythm. 2009 Jul;6:1085-104)
Functional and non-functional lead extraction Chronic Pain lead removal is reasonable in patients with: 1. 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. (Class IIa; LoE : C) Thrombosis or Venous Stenosis Lead removal is recommended in patients with: 1. Clinically significant thromboembolic events associated with thrombus on a lead or a lead fragment. (Class I; LoE : C) 2. Bilateral subclavian vein or SVC occlusion precluding implantation of a needed transvenous lead. (Class I; LoE : C) 3. Planned stent deployment in a vein already containing a transvenous lead, to avoid entrapment of the lead. (Class I; LoE : C) 4. Superior vena cava stenosis or occlusion with limiting symptoms. (Class I; LoE : C) 5. 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). (Class I; LoE : C) 6. Ipsilateral venous occlusion preventing access to the venous circulation for required placement of an additional lead, when there is no contraindication for using the a_kutarski@yahoo.com contralateral side. (Class IIa LoE C)
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When and why a functioning lead should be extracted When to extract ? We still have HRS Experts Consensus from 2009 (Wilkoff BL at al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management Heart Rhythm. 2009 Jul;6:1085-104)
Functional leads lead extraction
Class I Lead removal is recommended in patients with: 1. life threatening arrhythmias secondary to retained leads. (LoE: B) 2. 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). (LoE: B) 3. leads that interfere with the operation of implanted cardiac devices. (LoE: B) 4. leads that interfere with the treatment of a malignancy (radiation/reconstructive surgery). (LoE: C) Class IIb. Lead removal may be considered in patients with: 1. an abandoned functional lead that poses a risk of interference with the operation of the active CIED system. (LoE: C) 2. 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) (LoE: B) 3. leads that are functional but not being used. (i.e. RV pacing lead after upgrade to ICD) (LoE: B) 4. 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. in order to permit the implantation of an MRI conditional CIED system. (LoE: B) Class III Lead removal is not indicated in patients with: 1. functional but redundant leads if patients have a life expectancy of less than one year. (LoE: B) 2. 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. (LoE: B)
When and why unnecessary today but still functioning lead should not be abandoned ? When to extract ? We still have HRS Experts Consensus from 2009 (Wilkoff BL at al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management Heart Rhythm. 2009 Jul;6:1085-104)
Functional but not necessary today lead: Abandon or not to abandon ? The HRS guidelines were and published in 2009 but prepared in 2008 – we can to say – they contains knowledge 10 years old. What we have learned during last 10 years that:
1. Leads has limited durability (PM < 20 Y, ICD < 10 years). The myth: “one lead for whole patients live” was rebut many years ago 2. In spite of progress in lead construction, present-day thin leads has higher failure rate than old lead models 3. We know much more about phenomenon of lead isolation abrasion (from out-side and from inside)
4. We have enough of papers about lead to lead abrasion in they intra-cardiac parts 5. We have (still not enough of papers) about lead to lead interaction 6. We have increasing number of reports about mechanisms lead dysfunction in growing children and young patients 7. We have no reports but our long-term experience indicate that there is very-very small chance to
utilise abandoned functional lead in the future 8. Phrase: “Functional (today) lead which may to be utilised in future” - seems today be reduced into background a_kutarski@yahoo.com www.usuwanieelektrod.pl
When and why a functioning lead should be extracted
When and why a functioning lead should be extracted? The new, strongly discussible personal ideas
The goal of TLE (treatmemnt of complications but also prevention of future complication): 1. 2.
Elimination of infection (1) Recapture of venous approach (1 / 2a)
3.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
4.
Preservation of opposite chest side for another medical procedures in the future (2b)
To long lead loop(s) in the heart; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (endocarditis, LDTVD)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1. 2.
Elimination of infection (1) Recapture of venous approach (1 / 2a)
3.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
4.
Preservation of opposite chest side for another medical procedures in the future (2b)
To long lead loop(s) in the heart; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (endocarditis, LDTVD)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1. 2.
Elimination of infection (1) Recapture of venous approach (1 / 2a)
3.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
4.
Preservation of opposite chest side for another medical procedures in the future (2b)
To long lead loop(s) in the heart; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (endocarditis, LDTVD)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine …
The goal of TLE (treatment of complicationa but also prevention of future complication): 1. 2.
Elimination of infection (1) Recapture of venous approach (1 / 2a)
3.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
4.
Preservation of opposite chest side for another medical procedures in the future (2b)
To long lead loop(s) in the heart; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (endocarditis, LDTVD)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1. 2.
Elimination of infection (1) Recapture of venous approach (1 / 2a)
3.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
4.
Preservation of opposite chest side for another medical procedures in the future (2b)
To long lead loop(s) in the heart; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (endocarditis, LDTVD)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Abnormal intravenous lead route with first symptoms of beginning of VCS syndrome.
Begnning of SCV syndrome ??? !!!
•
To observe and to wait for full clinical manifestation ?
•
To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place”
•
Prevention seems be important in whole medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Strained lead due to body growth
„Mineralisation”
„Ossification”
Strained lead due to body growth; what to do if the lead remain still functioning ? • •
To observe and to wait for severe complications (endocarditis, LDTVD, lead dysfunction)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in whole medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Strained lead due to body growth
Strained lead due to body growth; what to do if the lead remain still functioning ? • •
To observe and to wait for severe complications (endocarditis, LDTVD, lead dysfunction)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in whole medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
2.
Preservation of opposite chest side for another medical procedures in the future (2b)
Mid degree but asymptomatic TVD is frequent findings in such pta with strained leads. Mineralisation and calcification consists â&#x20AC;&#x17E;normalâ&#x20AC;? finding Late TLE alvays consist challenge for the operator
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Abandoned (?) technique of lead implantation in children. Planned lead loop. It does not work ! Only challenge for TLE operator !
Planned lead loop during implantation. It does not work ! Only strong connection to RA wall with scar; what to do if the lead remain still functioning ? •
To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” ??? Prevention seems be important in whole medicine …
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Incorrect lead route and tim location. Faulty LV pacing; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (systemic embolism)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine … CLASS III !!! Especial scenario necessary !
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Incorrect lead route and tim location. Faulty LV pacing; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (systemic embolism)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine … CLASS III !!! Especial scenario necessary !
The goal of TLE (treatment of complications but also prevention of future complication): 1.
Prevention of aftertime consequences abandoned (functioning / not functioning) lead having threatening route (1, 2b)
Incorrect lead route and tim location. Faulty LV pacing; what to do if the lead remain still functioning ? • • •
To observe and to wait for severe complications (systemic embolism)? To recognise „functioning leads that due to their threatening route pose a potential future threat to the patient if left in place” Prevention seems be important in medicine … CLASS III !!! Especial scenario necessary !
When and why a functioning lead should be extracted? The new, strongly discussible personal ideas Inpending erosion (bulk in pocket but not only)
No infection ! Indication for unit replacement only To wait for infection ? Lead related pocket threat („decubitus imminens”) Very thin skin over the leads but at the moment still before besore and infection. •
To recognise „Inpending erosion” that due lead intracutaneous threatening route pose a potential future threat to the patient if left in place” ??? Prevention seems be important in whole medicine …
Abandoned lead
(functioning / not-functioning - no differences)
related
complications Infections (PI, LRIE) (different mechanisms but abandoned lead consists known risk factor of infections)
Venous occlusion (different mechanisms but abandoned lead consists known risk factor of infections)
LDTD (dysfuncion of TV) (different mechanisms ) Lead to lead interaction (insulation abrasions and sizless) More difficult TLE (risk factor of major TLE complications) Problems with MRI Bulk in pocket (risk of skin erosion) „An abandoned lead as an abandoned mistress will take revenge sooner or later” E@
When and why unnecessary today but still functioning lead should not be abandoned ? When to extract ? We still have HRS Experts Consensus from 2009 (Wilkoff BL at al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management Heart Rhythm. 2009 Jul;6:1085-104)
Functioning but not necessary today lead: Abandon or not to abandon ?
Functioning / non-functioning lead – what differences in aspects of it side effects and it management ? There is growing number of papers aboud abandoned lead related complications and TLE difficulties. But … nobody divided abandoned leads for functioning / nonfunctioning.
Probably nobody tried to examine condition (P/S/I) of abandoned lead during extraction (before preoperative examination – impossible of course) In recent literature abandoned lead (functional / non-functional) were analysed together In my opinion lead course (route) in preoperative chest X-ray examination
seems be more important a_kutarski@yahoo.com
One of most frequently cited papers because it indicate risk of abandonment of leads. Not so big population, but first prospective study. Abandoned lead related complications are not so rare and the problem exist.
Small material. 60 lead abandonment vs 21 TLE Mean FU 4 years â&#x20AC;&#x201C; no differences. Conclusion = ? But we have to keep in mind that survival longevity of such pts. may by significantly longer ď &#x152;
a_kutarski@yahoo.com www.usuwanieelektrod.pl
American survey on practical utility HRS guidelines in pediatric patients and young adult with congenital heart diseases: „Whether we extract
or we abandon ?”
IIa 50-70% TLE (replacement) IIb 20-40% TLE (replacemen)
In 50 % of children and young pts the problem is delayed „for later” = is postponed for cardiologists and cardiac surgeons for adult patients
MRI & abandoned (capped!) lead tip heating Numerous case-reports indicates that MRI can be performed without complicastions even in patients with conventional models of PM leads. Here: PHYSICS. Phantom examination. Results Connection of lead with PM is protective in aspect of heating of the tip. Abandoned (capped) lead longevity and distance tip to proximal ending has contrary effect.
Temperature of the tip can to rise for 28 centigrade (up to 64o C)
MRI & abandoned lead. Following „PHYSICS’s” paper. More exact examination (using phantom of course). Abandoned (capped and uncapped) lead tip heating Important not the chest side but lead longevity and distance tip to proximal ending (right side - worse!)
In the aspect of heating of tip of abandoned lead much better if proximal ending remain uncapped !!! Worst: single lead Right side ! Heating consists small part o the problem; most important remain rapid pacing induced by MR!
Abandonment of unnecessary functional PM lead and future problems with ICD lead. Mind about mutual lead abrasion, lead to lead interference (sizles) and secondary ICD dysfunction ! Better to prevent of the problem than do solve them 7 years later !
â&#x20AC;&#x17E;An abandoned lead as an abandoned mistress will take revenge sooner or laterâ&#x20AC;? E@
One system to far … Strange upgrading DDD system to „ICD-DDD” in pt. with venous occlusion. „Functional” PM RV lead remained functional 5 years only. Like as the new ICD lead as well
„An abandoned lead as an abandoned mistress will take revenge sooner or later” E@
a_kutarski@yahoo.com
Lead to lead interference – simultaneous „sizzles” in two channels indicates mutual lead abrasion 39 y, F pt, HCM, 5 SCD in family. 5 years ago implanted DDD-ICD (Photon DR, HV lad: TVL – active and Tendril 52 cm active. 5 y FU - OK. and ... No symptoms of lead damage in the pocket
Lead to lead interference – simultaneous „sizzles” in two channels indicates mutual lead abrasion Both leads were extracted and the 2 new were implanted with maintenance the same venous approach
Simultaneous „sizzles” in both channels – indicates possibility of mutual external tube lead abrasion
First retrospective analysis of pts with infective complications
Am.J.Cardiol 2012; 110:1143-1149
If 10-15-y register is not possible â&#x20AC;Ś remain retrospective analysis. Implantation, sometimes additional lead implantation and after years indications for TLE will appear. And we have big population which permit retrospective analysis (history, comorbidities, system, replacements, TLE indications)
Biggest pts. group from biggest TLE Center (Cleveland) 1386 infections !!!!
If 10-15-y register is not possible â&#x20AC;Ś remain retrospective analysis. Implantation, sometimes additional lead implantation and after years indications for TLE will appear. And we have big population which permit retrospective analysis (history, comorbidities, system, replacements, TLE indications)
Abandoned Abandoned Abandoned Abandoned Abandoned
lead = more infections (PI & LRIE), more and bigger vegetations lead = more TLE complications !!!! lead = more difficult and more complex TLE lead = less effective TLE Abandoned lead = worse clinical outcome TLE
â&#x20AC;&#x17E;An abandoned lead as an abandoned mistress will take revenge sooner or laterâ&#x20AC;? E@
lead =
Abandoned leads: clinical consequences and theirs influence on effectiveness TLE procedure Wojciech JacheÄ&#x2021;, Anna Polewczyk, Andrzej Kutarski. Zabrze, Kielce, Lublin (In press) Personal experience (2049 TLE, 289 abandoned leads)
Abandoned leads: clinical consequences and their influences on effectiveness TLE procedure Wojciech JacheÄ&#x2021;, Anna Polewczyk, Andrzej Kutarski. Zabrze, Kielce, Lublin (In press)
Abandoned lead consist independenf risk factor all of infections
An abandoned lead consist risk factor of:
Abandoned leads: negative clinical consequences and influence on effectivenes TLE procedure An abandoned lead remain independent risk factor of : • • • • • •
All 2049 pts
Without abandoned lead
With abandoned lead
Any system infection Lead related venous occlusion tricuspid valve dysfunction Technical problems during TLE Major TLE complications More frequent lack of procedural success Slightly higher mortality after RLE
549 pts with lead related endocardiis
Without abandoned lead
With abandoned lead
days days
Our „Bermuda Triangle”
ABANDONED LEAD
Infections
(functioning or not functioning – no differences)
Death
Technical problems during TLE
Major complication
Lack of effectivity Secondary technical problem
Supplementary cardiac surgery
Permanently disabling complication
Rescue cardiac surgery
We lost some patients in our Bermuda Rtiangle
a_kutarski@yahoo.com www.usuwanieelektrod.pl
When and why a functioning lead should be extracted? The new, strongly discussible personal ideas We have good guidelines. They are still actual. But … I afraid that some small supplementation will be indicated in the future. Some my consideration are listed below. I afraid that last two postulations may seems to be to much „revolutionary” (?). May be today is to early for such suggestions but … TLE procedure stays more and more popular, we have more and more experienced operators. What was impossible yesterday will be possible tomorrow or after tomorrow
When and why a functioning lead should be extracted? The new, strongly discussible personal ideas Why prophylactic ICD lead replacement (during second unit replacement = about after 10 years)? Only doctors performing TLE know condition of a lot „functional” ICD leads extracted due to infection. Some parts of „functional” leads can be in very poor condition
CONCLISIONS (1): 1. HRS (2009) guidelines on lead management however binding – will need some updates in aspects of strategy „functioning lead” extraction 2. There is very small chance that today still „functional lead” due to phenomenon of lead wear / corrosion with the time – will can be utilised after several or a dozen of so - years 3. If possible we should not to abandon of unnecessary „functional lead” (with reasonable exception of course) 4. Division of unnecessary lead for functional / non-functional lost significance (very not sharp criterions of the division) and this criterion for lead abandonment should not be used
Beginning of internal corrosion of stil „functional” ICD lead
CONCLISIONS (2): 5. “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)” – OK (add Riata, Sprint Fidelis) but addition one extension as: “functioning leads that due to their intravenous or intra-cardiac route pose a potential future threat to the patient if left in place” (conflict with tricuspid valve et cetera). 6. May be separate non-infective indication as Lead Related Tricuspid Valve Dysfunction . 7. We should to pay more attention to future problems with lead abnormal route (unnecessary loops, strained leads) which favours severe difficulties of extraction in future, abrasions of external tube with following clinical consequences 8. Above quoted arguments suggests nearly similar handling of superfluous functioning and non-functioning leads in aspects indication for extraction
„An abandoned lead as an abandoned mistress will take revenge sooner or later” E@
Thanks for your attention It is much better to remove superfluous lead now – than 5-10-15 years later
a_kutarski@yahoo.com