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ransvenous Lead Extraction: Heart Rhythm Societyxpert Consensus on Facilities, Training, Indications, andatient Management

his document was endorsed by the American Heart Association (AHA).

ruce L. Wilkoff, MD, FHRS,* Charles J. Love, MD, FHRS,† Charles L. Byrd, MD,‡

aria Grazia Bongiorni, MD,§ Roger G. Carrillo, MD, FHRS,� George H. Crossley, III, MD, FHRS,¶

aurence M. Epstein, MD,# Richard A. Friedman, MD, MBA, FHRS,**"

harles E. H. Kennergren, MD, PhD, FHRS,†† Przemyslaw Mitkowski, MD,‡‡

aymond H. M. Schaerf, MD, FHRS,§§ Oussama M. Wazni, MD*

Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, OH, †Ohio State University, Division ofardiovascular Medicine, Columbus, OH, ‡Broward General Medical Center, Fort Lauderdale, FL, §University Hospital,ivision of Cardiovascular Medicine, Pisa, Italy, �University of Miami, Cardiothoracic Surgery, Miami, FL, ¶St. Thomasesearch Institute, University of Tennessee College of Medicine, Nashville, TN, #Brigham and Women’s Hospital, Boston,A, **Baylor College of Medicine, Pediatrics and Texas Children’s Hospital, Houston, TX, ††Sahlgrenska Universityospital, Gothenburg, Sweden, ‡‡University of Medical Sciences, Poznan, Poland, §§Providence St. Joseph Medical
enter, Burbank, CA, "American Heart Association Representative.
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reamblen May 15, 2008, the lead extraction community convened to

ritically review the prior April 2000 NASPE policy statementn Recommendations for Extraction of Chronically Implantedransvenous Pacing and Defibrillator Leads: Indications, Fa-ilities, Training.1 This gathering was held as a co-sponsoredatellite symposium* during the Heart Rhythm Society’s 29th

nnual Scientific Sessions to examine ways to revise andmplement effective lead management standards.2

This writing committee, appointed by the Heart Rhythmociety, is a representative group of international experts inevice and lead management from North America and Eu-ope. Each of these physicians is an expert concerning theanagement of leads used with cardiovascular implantable

lectronic devices (CIEDs) including transvenous lead ex-raction. We were charged with the development of a con-ensus document for the lead extraction community regard-ng standards for safe and effective lead management.entral to this effort was a focus on transvenous lead ex-

raction, including standards for training, and standards forhe evaluation of new tools and techniques. Although the

This document was approved by the Board of Trustees of the Hearthythm Society on May 6, 2009. It can be found on the Heart Rhythmociety website at www.HRSonline.org/Policy/ClinicalGuidelines. Ad-ress reprint requests and correspondence: Donna Goldberg, MPH,eart Rhythm Society, 1400K Street, NW, Suite 500, Washington DC00005. E-mail address: [email protected].

*Co-sponsored by Cleveland Clinic Center for Continuing Educationnd the Heart Rhythm Society, supported by unrestricted educationalrants from Spectranetics, Cook Vascular Inc, Medtronic, Boston Scien-

mific, St. Jude Medical, Biotronik and ELA Medical Inc.

547-5271/$ -see front matter © 2009 Heart Rhythm Society. All rights reserved

ajor intervention discussed in this document is trans-enous lead extraction, it was strongly recommended thathis document should focus on the management of theatient, and in particular the management of the leads.2

The writing group consisted of nine cardiac electrophysi-logists and three cardiothoracic surgeons, who specializen CIED implantation and extraction. This statement repre-ents expert consensus of the writing committee based on aeview of the literature, their own experience in treatingatients and input from the extraction community gatheredt the symposium. It is directed to all health care profes-ionals and health care institutions that are involved in theare of patients with CIEDs.

The document represents the strong consensus of the writ-ng committee, which was developed as a result of commentsollected at the 2008 satellite symposium; as well as during aeparate face-to-face all day writing group meeting, multiplenternational conference calls, and three web based question-aires. In writing a “consensus” document, it is recognized thatonsensus does not mean that there was complete agreementmong all writing group members. We identified those aspectsf transvenous lead extraction for which a true “consensus”ould be identified. Surveys of the entire writing group weresed to identify these areas of consensus. For the purposes ofhis Consensus Document we defined a consensus as 83% orreater agreement by the authors of this document.

When using or considering the guidance given in thisocument, it is important to remember that there are nobsolutes with regard to many clinical situations. The ulti-ate judgment regarding care of a particular patient must be
ade by the health care provider and patient in light of all
. doi:10.1016/j.hrthm.2009.05.020

http://www.HRSonline.org/Policy/ClinicalGuidelines

mailto:[email protected]

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1086 Heart Rhythm, Vol 6, No 7, July 2009

he circumstances presented by that patient, the manage-ent options available as well as the relative risks and

enefits. Indicated procedures are appropriate reasons foronsidering an intervention. This document focuses on pa-ient and lead management, and not just lead extraction inrder to place the indications for intervention in the contextf the contraindications, timing, training, facilities and per-onnel.

ABLE OF CONTENTSntroduction....................................................................1086efinitions......................................................................1086xtraction Tools ............................................................1087utcomes: Defining Technical and Clinical Success...1087ABLE 1: Classification of Complications..................1088ersonnel, Roles and Responsibilities ..........................1089ABLE 2: Required Personnel .....................................1089hysician Qualifications and Training ..........................1090ndications for Lead Removal.......................................1094ABLE 3: Indications for Transvenous Lead

Extraction.................................................................1096ABLE 4: Principles for CIED Replacement

following Infected Removal....................................1097egistry and Data Management....................................1099ew Devices and Techniques.......................................1099ecommendation for Clinical Evaluation of Lead

Extraction Devices...................................................1099onclusion .....................................................................1099ppendix........................................................................1100eferences......................................................................1101

ntroductionerceptions of lead reliability, performance, complicationsnd approaches to management have evolved dramaticallyince the inception of pacemaker and implantable defibril-ator therapy. At various points since the first implantableacemaker was placed in 1958, conductors, insulation ma-erials, lead construction, implantation techniques, infectionnd venous occlusion have been the source of significantlinical problems.3,4,5,6,7,8,9,10,11,12 However, not until theate 1980s was a serious attempt made to develop tools andechniques to safely remove problematic leads. Inspectionf these leads after extraction contributed substantially to annderstanding of clinical and mechanical failure modes. Ithus resulted in iterative improvements in the design ofeads and implantation techniques in the pursuit of im-roved patient management. The techniques of transvenousead extraction have been detailed elsewhere.13,14,15,16,17,18

The penetration of transvenous lead extraction techniquesnto general use was slow due to the potential for fatal com-lications and the limited training in the tools and techniques.he North American Society of Pacing and Electrophysiology

NASPE, which is now the Heart Rhythm Society (HRS)]onvened a policy conference on May 11, 1997, during the
8th Annual Scientific Sessions to formalize standards: for n
raining of physicians in extraction techniques; for equipmentnd emergently needed support staff at each institution; and forndications and contra-indications for lead extraction. Thesetandards were published as a guidance document in April000.1

Since the publication of this document, the community ofhysician experts in the management of lead problems andransvenous lead extraction has grown substantially. How-ver, the safety and effectiveness of transvenous lead ex-raction as well as the application of indications varyidely. The training of physicians and the extraction team

till lags behind demand. It has become the consensus of thehysician community that transvenous lead extraction is aentral treatment in patients with pathologic lead condi-ions. It is also recognized that lead extraction is only one ofhe tools available to physicians in what is more properlydentified as lead management. Lead management requires aroad understanding of the pathophysiology of the mechan-cal and clinical issues associated with lead dysfunction, andprimary commitment to measuring outcomes and quality.

efinitionsithin the general category of “lead removal,” distinctionsust be made between simple procedures that can be per-

ormed via the implant vein without specialized tools (“leadxplant”), and removal of leads involving more complexrocedures (“lead extraction”). This is necessary when de-igning training programs, for classification of proceduresn registries and databases, for assuring a uniform definitionn the literature, for determining the personnel and facilitiesor the procedure, as well as for the goal of appropriateeimbursement levels for the different procedures. Althougheads with less than one year of implantation can sometimese challenging to remove, it is the exception. The standardsor lead extraction, including surgical backup, personnel,acilities, training and outcomes, pertain to leads implantedor at least one year or requiring the assistance of special-zed equipment that is not included as part of the typicalmplant tool set. Even so, extreme caution should be usedhen removing any lead.Lead Removal: Removal of a pacing or defibrillator

ead using any technique.Lead Explant: A lead removal using simple traction

echniques (no locking stylet, telescoping sheaths or femo-al extraction tools).

Lead Extraction: Removal of a lead that has been im-lanted for more than one year, or a lead regardless ofuration of implant requiring the assistance of specializedquipment that is not included as part of the typical implantackage, and/or removal of a lead from a route other thania the implant vein. Implantable cardioverter defibrillatorICD) leads may require specialized extraction equipmentven when implantation duration is less than one year.

Lead Extraction Approach: Leads are usually removedia the same transvenous access by which they were in-erted, termed the implant vein. However, sometimes alter-
ative venous access is required from a non-implant vein.

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1087Wilkoff et al Transvenous Lead Extraction: HRS Expert Consensus

xamples of alternative lead extraction approaches includerom the femoral, jugular or subclavian veins.19,20,21,22,23

n occasion, the leads need to be removed via a trans-atrialr via a ventriculotomy approach.24,25,26

xtraction toolsimple Traction: Manipulation of the lead so that the leadxits the vasculature via the implant vein using tools typi-ally supplied for lead implant, with the addition of traction.hese tools include such items as standard stylets (non-

ocking), and fixation screw retraction clips.13,16,27

Traction Devices: Specialized locking stylets, snares,utures, grasping or other devices used to engage or entrapnd remove the lead or lead fragments. Locking stylets arespecial type of a traction device designed to hold onto the

nside of the conductor coil along its length or near the distaltimulating electrode, improve tensile properties and pre-ent elongation of the lead body during traction.13,16,27

Mechanical Sheaths: Sheaths composed of metal, Te-onTM, polypropylene or other materials that require manualdvancement over the lead and rely on the mechanical prop-rties of the sheath to disrupt fibrotic attachments.3,16,27,28,45

Laser Sheaths: Sheaths that employ fiberoptics to transmitaser light to disrupt the fibrotic attachments.3,16,27,29,30,31

Electrosurgical Sheaths: Sheaths that use radiofre-uency energy (such as found in an electrosurgical unit)mitted between two electrodes at the sheath tip to disrupthe fibrotic attachments.3,16,27,32,33

Rotating Threaded Tip Sheath: Sheaths that arequipped with a rotationally powered mechanism that borehrough and disrupt fibrotic attachments with a threadedcrew mechanism at the sheath tip.27,34

Telescoping Sheaths: Any extraction sheath that can besed as a single sheath or may be paired with a secondheath. The use of two sheaths takes advantage of theexibility of the inner sheath and the stiffness of the outerheath to prevent kinking and to improve the effectivenessf advancement over the lead without overstressing the lead.he outer sheath is usually mechanical, even when the innerheath uses some other technology such as laser, electro-urgical or rotating threaded tip.13,16,27

utcomes: Defining technical and clinicaluccessransvenous lead extraction has been effectively accom-lished in many centers, many operators and with variousechniques. Despite the provision of standard definitions inhe NASPE policy statement in 2000, the results have beenariously reported.23,26,27,28,29,30,31,32,35,36,37,38,39,40,41,42,43

roblems with the interpretation of these results are relatedo how the cases were selected for inclusion as well as theefinition of success and failure. Extraction centers from theontinental United States, Hawaii and Europe voluntarilyubmitted data for a national registry between December988 and December 1999.44,45 The most recently publishedata from 1996 included data from 226 centers, 2,338 pa-
ients and 3,540 leads; these data demonstrated major com- ●
lications in 1.4%, �1% for centers with �300 extractionrocedures.46 Although these data are not retrievable, thenal public report of this registry, which was presented at

he XIth World Symposium on Cardiac Pacing and Elec-rophysiology in Berlin and at Cardiostim, Nice, France inune of 2000, included 7,823 extraction procedures with2,833 leads. Multivariate analysis of the data from 1994–999 demonstrated four predictors of major complicationssing the definitions described in the NASPE recommenda-ions document.1 The major complication rate was 1.6%.he four predictors of major complications were: 1) implanturation of oldest lead, 2) female gender, 3) ICD leademoval and, 4) use of laser extraction technique.47 Most ofhese data represented non-laser assisted extraction but alsoepresented an earlier version of the laser hardware and thehysician learning curve for laser use.

The prospectively collected PLEXES and early lasereported results can be used to reasonably estimate theurrently reported overall safety and effectiveness of leadxtraction. The PLEXES trial was a randomized prospectivelinical trial comparing the first iteration of the 12-Frenchaser sheath to a non-laser cohort in 301 subjects with 465hronic pacemaker leads. The procedural success in theaser group was 94% with an associated major complicationate of 1.96%.29 Subsequently, when the total initial expe-ience in the United States was reported, Byrd et al.43

eported on the laser lead extraction of 2,561 pacing andefibrillator leads 1,684 patients at 89 sites. The proceduraluccess rate was 90% with a major complication rate of.9% with an in-hospital death rate of 0.8%.

Though most leads are removed safely and completely,ome portion of the lead may be left in situ. In manynstances the retained fragment still allows for the desiredlinical outcome, which may include multiple clinical goals.he success of lead extraction is based on the achievementf the desired clinical outcome. Procedural success rate �equals) number of clinically successful procedures/(di-ided by) number of procedures performed. This is calcu-ated as complete procedural success rate and clinical pro-edural success rate calculated using the complete removalf all targeted leads or the achievement of all targetedlinical goals for the procedure. Failure to remove all com-onents of intravascular leads in a patient with systemicnfection is a failure to achieve complete or clinical proce-ural success, while the same result in a noninfected patientchieves clinical but not complete procedural success.eaving a tip in a case of local infection is not a failure butopefully a clinical success.

Lead clinical success rate � (equals) number of leadsemoved with clinical success/(divided by) total number ofeads attempted.

These targeted clinical outcomes may include one orore of the following:

Elimination of infection (pocket infection, device relatedendocarditis)
Creation of venous access in an occluded vessel

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Elimination of an identified risk (perforation, arrhythmia)produced by a lead or portion of a leadPreservation of desired pacing modeRemoval of all non-functional leadsResolution of all pocket related symptoms (i.e. pain)

Complete Procedural Success: Removal of all targetedeads and all lead material from the vascular space, with thebsence of any permanently disabling complication or pro-edure related death.

Clinical Success: Removal of all targeted leads and leadaterial from the vascular space, or retention of a small

ortion of the lead that does not negatively impact theutcome goals of the procedure. This may be the tip of theead or a small part of the lead (conductor coil, insulation, orhe latter two combined) when the residual part does notncrease the risk of perforation, embolic events, perpetua-ion of infection or cause any undesired outcome.

Failure: Inability to achieve either complete proceduralr clinical success, or the development of any permanentlyisabling complication or procedure related death.

efining complicationsecording all complications is crucial for quality assess-ent and quality improvement. The assessment of compli-

ations requires both a time frame and a level of severity.his is complicated by the fact that several procedures maye performed on the patient in succession during the samer closely spaced hospitalizations. For example, one willypically remove a system from an infected site on one day,nd implant a replacement system a few days later. Becausehe cause of the complication cannot always be attributed to

specific procedure, reporting consistency is needed. Thetandard methodology used to classify surgical complica-ions is by the time of occurrence. The definitions for timerames are:

ABLE 1 Classification of complications

lassification Examples

ajor Complication 1. Death2. Cardiac avulsion or tear requ3. Vascular avulsion or tear (re4. Pulmonary embolism requirin5. Respiratory arrest or anesthe6. Stroke7. Pacing system related infect

inor Complication 1. Pericardial effusion not requ2. Hemothorax not requiring a3. Hematoma at the surgical si4. Arm swelling or thrombosis5. Vascular repair near the imp6. Hemodynamically significant7. Migrated lead fragment with8. Blood transfusion related to9. Pneumothorax requiring a ch

10. Pulmonary embolism not requiring

Intra-procedural complication: Any event related tohe performance of a procedure that occurs or becomesvident from the time the patient enters the operating roomntil the time the patient leaves the operating room. Thisncludes complications related to the preparation of theatient, the delivery of anesthesia, and opening and closinghe incision.

Post-procedural complication: Any event related to therocedure that occurs or becomes evident within 30 daysollowing the intra-procedural period. Extraction events arelassified as major complications, minor complications, orbservations, according to their severity, as described be-ow. Examples of classifications using these definitions arehown in Table 1.

Major complication: Any of the outcomes related to therocedure which is life threatening or results in death. Inddition, any unexpected event that causes persistent or signif-cant disability, or any event that requires significant surgicalntervention to prevent any of outcomes listed above.

Minor complication: Any undesired event related to therocedure that requires medical intervention or minor pro-edural intervention to remedy, and does not limit persis-ently or significantly the patient’s function, nor does ithreaten life or cause death.

ead management environmenthe number of lead extractions that need to be performednnually continues to increase. Given the technical chal-enges and risk of life threatening complications, physicianshould only seek training, and hospitals should only providehis service, when there is an ongoing commitment to arocedural volume adequate to maintain the skills of thehysician and team. In addition to volume, it is essential thathere be an upfront sustained commitment by the physiciannd the hospital to maintain the proficiency of the entire

horacotomy, pericardiocentesis, chest tube, or surgical repairthoracotomy, pericardiocentesis, chest tube, or surgical repair)

ical interventionated complication leading to prolongation of hospitalization

a previously non-infected siteericardiocentesis or surgical interventiontubeiring reoperation for drainage

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xtraction team, and to track outcomes of both device im-lantation and lead extraction.

Transvenous lead extraction is a grouping of techniquesrimarily designed to solve cardiac pacemaker and ICD leadanagement problems. A commitment to lead extraction pro-

edures requires a commitment to quality and continuous qual-ty improvement. This commitment to clinical outcome mea-urement is fundamental to the performance of transvenousead extraction, in part because it is essential to an accuratenformed consent process. Only when the risks of both doingnd not doing the procedure are accurately understood by bothhe physician and the patient can an appropriate informedecision be made. In addition, it is not enough to estimate theypothetical risk of a procedure done by a hypothetical phy-ician and hospital, but it is important to estimate what the risks for this patient under the proposed conditions.

There are additional principles that are also fundamental touality outcomes, and these principles provide the context forhe remainder of this document. Examples in subsequent sec-ions of this document include adequate initial and continuingraining in both the physical and cognitive aspects of leadanagement, maintaining an adequate volume of device im-

lantation and extraction activities, ongoing assessments of thedequacy of the facilities, techniques and personnel required toafely perform the procedure, as well as the systematic mea-urement of the outcomes with internal and sometimes externaleview of outcomes. The outcomes measures should includeoth implantation and extraction outcomes. It is essential thathe reported outcomes employ standardized definitions, andhould be focused in the best tradition of a local morbidity andortality review which looks for root causes and opportunities

or improvement.Hospitals offering lead extraction and personnel participat-

ng in these programs must have a protocol for emergencyesponse when the need arises. There should be a mechanismn place to activate a rapid operating room response team thats capable of performing emergency surgery. This “disasterlan” should be regularly tested on a scheduled basis so thatach member of the team knows exactly what to do and howo accomplish their role. This plan must be recorded as part ofhe written standard operating procedure of every extractionaboratory or operating room.

Finally, the lead extraction team must be committed to openeview of complications and continuous improvement process.f physician and institutional expertise is not available locally,t is in the best interest of an individual patient to be referred tocenter with the appropriate training and expertise.

ersonnel, roles and responsibilitieshe development of a successful lead extraction program

equires a team approach. Each member of the team isrucial to successful outcomes, a low complication rate andhe rescue of a patient should a complication occur. Auccessful lead extraction program requires a wide range ofools and techniques. The staff involved in these proceduresust be familiar with the equipment required and its loca-

ion and use. In addition, the clinical situation during an n

xtraction procedure can change rapidly and the team muste prepared to deal with any eventuality. This can onlyome with proper planning and training.

Centers planning to develop a lead extraction programhould identify a team of providers, procedures, equipmentnd plans for emergent response. In addition to becomingamiliar with the indications for and complications of leadxtraction, the team must understand the operation and usef all equipment potentially required. It is essential that theeam observe procedures at an experienced center prior toaunching an extraction program. Industry representativesre not a substitute for appropriately trained staff and mustlways function under the direction and responsibility of thettending physician. A list of required personnel can beound in Table 2.

Primary Operator: The physician performing lead ex-raction should meet the qualifications and training de-cribed below. In some centers a single physician trained inIED therapy (most often an electrophysiologist or cardiac

urgeon) performs the extraction. However, in some centersteam approach is taken with physicians all trained in CIED

herapy (again most often an electrophysiologist and a car-iac surgeon) working together, each with their individualxpertise. Given that this procedure is part of the biggericture of “lead management”, the physician should be wellersed in cardiac device implantation and management.

Cardiothoracic Surgeon: In some centers the primaryperator is a CIED trained cardiothoracic surgeon, while inthers a CIED trained cardiologist and surgeon will operateogether. In centers where the primary operator is a CIEDrained cardiologist, a cardiothoracic surgeon must be im-ediately available to manage any of the life threatening

omplications that may require surgical intervention. In thevent of a significant complication, time is of the essence.e therefore strongly recommend that the surgeon is aware

f the procedure, especially in smaller hospitals that mayot have operating rooms and support staff available at allimes. The surgeon must be well versed in all the potential

ABLE 2 Required personnel*

rimary Operator: A physician performing the lead extractionwho is properly trained and experienced in deviceimplantation, lead extraction and the management ofcomplications.

ardiothoracic surgeon well versed in the potentialcomplications of lead extraction and techniques for theirtreatment, on site and immediately available

nesthesia supportersonnel capable of operating fluoroscopic equipmentScrubbed” assistant (nurse/technician/physician)on “scrubbed” assistantchocardiographer

*Depending on the environment, one person can hold expertise ineveral areas and satisfy the requirements (eg. the extractor could be theardiothoracic surgeon), but at least 5 people (1 – airway and sedationanagement 2 - scrubbed and 2 - non scrubbed) need to be in the roomt all times with the immediate availability of additional personnel as
eeded.

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omplications of lead extraction and re-implantation, andnderstand the required surgical approach to each anatomicnjury that is likely to occur. For example, the surgicalpproaches to a superior vena cava tear, right ventricularear or coronary sinus tear are each very different.

Anesthesia Support: Some centers perform lead extrac-ions in an operating room under general anesthesia. Otherenters perform lead extractions in catheterization laborato-ies under intravenous sedation. In the event of a compli-ation requiring further surgical intervention, immediatenesthesia support must be available. This includes thebility to manage a patient undergoing open-heart surgery.

Fluoroscopic Support: Given that lead extraction re-uires the use of fluoroscopy to guide the procedure, per-onnel must be present who can operate and troubleshoothe fluoroscopic equipment.

Scrub Personnel: Lead extraction procedures often re-uire a variety of equipment and technologies. In order toafely perform the procedure, a minimum of two “scrubbed”ersonnel must be available - the primary operator and anssistant. In centers where the cardiologist and surgeonerform the procedure together, an additional scrub nurse/ech may or may not be desired. In other centers, an addi-ional “scrubbed” person is required to assist during therocedure. This could be an additional physician, physicianssistant, nurse or technician. These team members shoulde trained so that they are familiar with the procedure,quipment and potential complications and emergency re-ponse protocols.

Non-Scrub Personnel: Depending on the center andocation of the procedure, two or more “non-scrubbed”ersonnel must be available during the procedure. If one ofhese is responsible for monitoring sedation (e.g. a nurse) ahird non-scrubbed person must be available to providequipment and assist in an emergency. These personnelust be trained so that they are familiar with the procedure,

quipment and potential complications. Most importantlyor these staff members, they must know how to activate themergency protocols and whom to call.

Echocardiography: Emergent echocardiography (trans-horacic and/or transesophageal) may be required to rapidlyiagnose a complication. A physician capable of performingnd interpreting these studies must be immediately avail-ble. This may be the physician performing the procedure orhe anesthetist involved in the case. In centers where theres not a physician skilled in echocardiography in attendanceuring the procedure, an additional physician must be avail-ble to perform and interpret these studies.

It is also recommended that a designated “extractionoordinator” be identified to coordinate the procurement,torage, maintenance and reordering of the extraction equip-ent. There should also be a person (possibly the same

erson) responsible for maintaining protocols in concertith the hospital’s requirements that ensure patient safety

hroughout the procedure. t

hysician qualifications and trainingead extraction is an invasive procedure that requires train-

ng and experience to consistently deliver safe and effectiveare. Physicians wishing to perform this procedure shoulde properly trained in extraction techniques and manage-ent of complications.The simple combined acts of watching an instructional

ideo demonstration and observing an operator perform therocedure are not adequate. Other procedures with similarperator skill requirements and patient risk (e.g., percuta-eous angioplasty of coronary or peripheral vessels) requiret least an additional year of training. Unfortunately therere limited data available for procedural volumes requiredor training and ongoing competency for transvenous leadxtractions. Therefore, recommendations are based on theseimited data as well as data available for other intravascularrocedures.

Analysis of lead extraction outcomes suggests that therequency of complete procedural success improves dramat-cally after the first 10–20 procedures have been per-ormed.48,49,50 Even physicians with many years of experi-nce have a reduced frequency of complete proceduraluccess when 60 or fewer laser assisted lead extractionrocedures were accomplished over the prior 4 years.80

ower complication rates are associated with a prior expe-ience of 30 procedures.47,51 These studies demonstratedhe steepest decline in complications over the first 30ases. It is also important to note that the complicationate continued to decline throughout the study (up to00 cases). These findings are consistent with guidanceocuments that delineate the training requirements for themplantation of pacemakers, ICDs and cardiac resynchroni-ation devices, which require 25 procedures of each deviceype.52 A review of the Medicare database revealed that forCD implantation, mechanical complications decreased af-er a minimum volume of 10 implantations per year, andnfections were reduced for implanters performing at least0 implants per year.53 Given the relationship demonstratedetween lead extraction experience and safety and efficacy,nd since these techniques are much more technically de-anding and are associated with a much larger opportunity

or failure and complications, it was the consensus of theriting group that a volume of extraction procedures, sim-

lar to those required for device implantation, should beequired.

imulator programrocedures that require technical expertise can only be learned

hrough careful training, repetition and practice. However, thebility to provide adequate “hands-on” training, especially out-ide of formal fellowship programs, is limited. Even withinormal fellowship programs, the number of “high volume”enters where fellows or practitioners could gain adequatelinical experience is inadequate. Simulators of surgical andatheter procedures are now a part of medical training in aariety of areas. Simulation allows practitioners to make mis-
akes in a “risk free” environment and gain experience not

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ossible in actual practice. Studies have demonstrated an ac-elerated learning curve and a reduction in complications withimulator training.54,55,56,57,58,59,60 In addition, simulation of aide range of clinical scenarios allows for team building and

nhanced response to emergent situations.The success of a lead extraction program, as the mainstay

f a lead management strategy, requires experience. Thesekills, for both the operator and the other members of theead extraction team, must be obtained and maintainedhrough repetition. Preliminary tests (n � 36) of a simulatorn 6 previously inexperienced trainees, which incorpo-ated real time feedback of extraction forces along withhe use of locking stylets, extraction sheaths and fluoros-opy, produced measureable improvement in technique.lthough the current experience is preliminary, it was the

onsensus of the writing committee that continued devel-pment and testing of lead extraction simulators withealistic scenarios is likely to become an important futureomponent of the initial training and maintenance ofxtraction skills.

ecommendations on minimum training and volume

Physicians being trained in this technique should extracta minimum of 40 leads as the primary operator under thedirect supervision of a qualified training physician. Ex-posure to various venous entry sites as well as femoralretrieval techniques should be included. In addition thetrainee should be exposed to the wide variety of extrac-tion tools and techniques. These are minimum require-ments, recognizing that volume alone does not guaranteecompetency.A minimal number of procedures should be performed onan annual basis to maintain skills. This is crucial tomaintain one’s acquired skills and team preparedness. Inaddition, expertise in lead extraction is clearly developedwith each and every procedure performed. We thereforerecommend the extraction of a minimum of 20 leadsannually per operator.Physicians who have already extracted over 40 leads as aprimary operator and maintain the minimum volume of20 leads extracted annually are considered as meeting thetraining and volume requirements.Training should be obtained at centers with adequatevolume, experience, and expertise. The supervisor shouldhave extracted 75 leads, performed with an efficacy andsafety record that is consistent with published data.

We realize that outside of a formal fellowship trainingrogram at a high volume center, even this minimal require-ent will be very difficult to achieve. However, the diffi-

ulty of receiving adequate training should not be viewed asreason to reduce the minimum requirements. This issue

ighlights the need for the development of an adequateimulator that would allow for a supplemental pathway to
chieve and maintain competency. a
It is recognized that in the pediatric population, a veryimited number of lead extractions are performed. It isherefore suggested that extractions for this population beeferred to centers that have the personnel and expertise toafely and effectively manage this specialized group. Itould also be beneficial to develop a partnership between aediatric center and a higher volume adult center. This willllow a team approach to manage the issues unique toounger patients (often with complex congenital abnormal-ties), and at the same time provide input and assistancerom a physician with more extraction experience. Theseatients may require the expertise of physicians with expe-ience in congenital heart disease device management spe-ific skills. Although the pediatric specialists may not havehe opportunity to extract at least 20 leads per year on anngoing basis due to the reduced volume of CIED implan-ation in this population, the experience gained as a primaryperator in the extraction of 40 leads is still an appropriatexpectation. In circumstances like this, extra precautionsncluding the consistent use of a simulator to practice thectual extraction scenario might be used to augment thexposure to volume in lieu of 20 annual lead extractions.sing general anesthesia and having the surgical team in the

oom and scrubbed are additional advanced precautions.

Performing a specific number of procedures does notguarantee proficiency, competency, or safety; outcomesdata are necessary to assess performance. A quality-ori-ented database should be maintained at each institution todocument procedure activities and outcomes.Given the acknowledged learning curve for this proce-dure, even through hundreds of cases, it is recommendedthat a staged approach be used when starting an extractionprogram. While one can never predict the ease of extrac-tion in any given individual, strong consideration shouldbe given to starting with less challenging or risky cases.Examples would include patients with prior cardiac sur-gery, which reduces the risk of serious bleeding but in-creases the difficulty of surgical rescue. Additional ex-amples are patients with a single lead of relatively shortimplantation duration or patients with relatively “young”non-ICD leads. More complex cases, with multiple leadsand long implant duration, should be avoided initially andreferred to experienced centers. As a physician’s and acenter’s experience grows, so can the degree of difficultyof the cases increase.

New extractors must realize that there is a community ofead extractors who are available for ongoing mentoring.iscussions around difficult clinical situations can be veryaluable and allow clinicians to arrive at the most appro-riate treatment approach. When beginning a new program,mentor or mentors should be identified.

acility and equipments discussed in the above section, a successful lead extrac-

ion program requires a coordinated, team approach. In
ddition to appropriate and adequately prepared personnel,

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center must have the required facilities and equipment toerform lead extractions safely and effectively. There muste a commitment to ensuring the availability and function-lity of all facilities and equipment on an ongoing basis.his is especially true for equipment used only rarely, but

equired without delay in life threatening situations.

acilityead extraction procedures must only be performed at cen-

ers with accredited cardiac surgery and cardiac catheteriza-ion programs. As stated previously, a cardiothoracic sur-eon must be physically on site and capable of initiating anmergent procedure promptly. In addition, the cardiac sur-ery team, equipment and facilities must be readily avail-ble. Through the external review of fatal cases around theorld, it was the strong consensus that when the superiorena cava was torn or perforated, delays from the injury toaving open access to the heart of more than 5-10 minutesere often associated with a fatal outcome. Rescue efforts ini-

iated within this time period have been usually successful.rocedures can be performed in either operating rooms, orrocedural laboratories specifically designed for device im-lantation procedures. The room must be of adequate size tollow for emergent interventions such as thoracotomy andternotomy. The room must be equipped with a ventilationystem designed to prevent surgical infections and to handlenesthetic gases.

quipmentelow is a review of the minimal equipment and supply

equirements and is by no means inclusive. With experi-nce, active extraction centers continually add equipmenthey find useful in performing these procedures.

High-quality fluoroscopy: The value of a high-qualityuoroscopy system cannot be overstressed. Visualization ofmall lead components (such as fixation screws on leadsith retractable screws, migrated lead fragments and piecesf elongated conductor coil) is necessary for the safe per-ormance of lead extraction techniques. This may be a fixeduoroscopic system or a “high-quality” mobile C-arm.

Surgical instruments: These include instruments appro-riate for transvenous lead extraction and device implanta-ion. In addition, surgical instruments to perform vascularepairs, thoracotomy, sternotomy and cardio-pulmonary by-ass must be immediately available and in good functionalrder.

Extraction tools: There is a wide variety of lead extrac-ion tools. While we do not promote one over the other, it isidely accepted that having a broad variety of extraction

ools increases the chance of success and limits complica-ions. Essential tools include locking stylets, mechanicaltelescoping” sheaths, and “powered” sheaths.13,27,61

Extraction snares: In cases with “free floating” leads,n approach from other than the implant vein is required.his is also true when lead disruption occurs during therocedures. Tools for retrieval from the non-implant vein
ust be available. These include large sheaths (worksta- a
ions) with a hemostatic valve, and a variety of grasping andnaring devices. Venous access for these snares can be fromhe femoral, internal jugular, subclavian or trans-atrial sites.

CIED implantation tools: Stylets, wrenches, fixationools, repair kits, adapters, sterile sleeves for the program-er, pin plugs, lead anchoring sleeves, and lead end caps

hould be available. Also required are the standard implan-ation equipment including, but not limited to, a variety ofntroducer sheaths, guide wires, and venous entry needles.

Transthoracic and transesophageal echocardiogra-hy: The ability to perform both transthoracic echocardiogra-hy and transesophageal echocardiography must be immedi-tely available. In some centers intracardiac echocardiographys employed.62

Additionally required supplies and equipment include annesthesia cart for general anesthesia, invasive and nonin-asive arterial pressure monitoring, oxygen saturation andO2 monitoring, pericardiocentesis tray, water seal/vacuumontainers for chest tube drainage (2 recommended), tem-orary transvenous pacemaker and connectors, transcutane-us temporary pacing and defibrillation equipment, intrave-ous contrast agents, fluids, pressors, and other emergencyedications in the procedure room and equipment for car-

io-pulmonary bypass must be readily available.

atient preparationince this procedure may result in life threatening compli-ations, it is imperative that the patient be properly andhoroughly prepared so that if emergent intervention is re-uired there is no delay.

istory and physical examinationcomplete patient history and physical exam must be

btained. Understanding the indications for the initial de-ice implantation, and co-morbidities that may affect there-, intra- and post-procedure care are critical. For exam-le, the need for anticoagulation and “bridging” around therocedure must be determined for all patients. All medica-ions must be reviewed. All allergies must be identified,specially contrast allergies since use of the latter may beequired during the procedure and premedication can bedministered if the allergy is identified. A comprehensivehysical examination with specific attention to anatomicetails that may influence the procedure is required. Theperator should look for findings that may affect thelanned procedure. For example, the presence of extensiveenous collaterals of the chest wall suggests central venouscclusion. This is especially important in patients scheduledor a device “upgrade’ with the planned addition of ipsilat-ral leads. A pre-procedure venogram may be indicated toetermine the patency of the implant vein and the potentialeed for venoplasty or lead extraction.

nformed consentritten informed consent, including pertinent elements of

he planned procedure, should be discussed with patient,referably in the presence of a family member. The patient
nd family must understand that lead extraction is a poten-

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ially life threatening procedure and this must be placed intoocal context by informing the patient about the hospital’sxtraction volume and outcomes, and the operator’s per-onal level of experience and outcomes. As extraction isften one option in a complex device procedure; all reason-ble alternatives must be discussed. This is particularlymportant when considering extraction versus abandonmenturing an upgrade procedure.

lanned procedure and treatmentrior to undertaking an extraction procedure, a clear plan foranagement of co-morbidities, the need for ongoing CIED

herapy, and how that therapy will be provided must beormulated.

atients with CIED related infectionplan for pre-, intra-, and post-operative antibiotics must

e formulated, including the type, route and duration ofntibiotics. The need for additional testing, such as trans-sophageal echocardiography to evaluate for the presencend/or size of vegetations, must be determined as this willelp determine the most appropriate approach (transvenousr open surgical) for the extraction.63,64 An active fixationemporary pacing lead should be considered in patientsequiring pacing support during the interval before the re-lacement permanent CIED is implanted.65 In addition, theiming and need for device re-implantation must be deter-ined prior to the procedure (see discussion and Table 4 in

he indications section).97

evice and lead locationhe vast majority of explanted leads were originally intro-uced transvenously and advanced to a typical pacing/sens-ng position in the right atrium, right ventricle, coronaryinus or cardiac veins. However, in some cases leads mayave been advanced into one or both left heart chambers viapatent foramen ovale, atrial septal defect, ventricular sep-

al defect, or arterial access.66 This is most often donenintentionally; however there are some leads that arelaced into the left heart chambers for the purpose of pres-ure monitoring or cardiac resynchronization.67,68,69 Leadsay also perforate the myocardium and penetrate into peri-

ardium or be entrapped in the tricuspid valvular appara-us.70,71,72 The pre-procedure chest X-ray must be exam-ned. If there is any question about device or lead locationr anatomy, additional imaging such as transesophagealchocardiography (TEE) and/or computed tomographyCT) scanning may be required for confirmation.73

evice, lead and adapter information (Connected andbandoned)rior to performing the procedure, the operator must beware of all device and lead hardware present, includinghose in use and previously abandoned. Simply asking theatient is not adequate because he/she is often unaware ofrior abandoned leads and current device configurations.very attempt should be made to review prior operative

eports and to obtain device registration information from p

evice manufacturers. The pre-procedure chest X-ray maye the only way to determine the number and location ofeads. The operator should determine the models and im-lantation dates for all leads and the pulse generator. Theperator must also be familiar with the physical and struc-ural characteristics of each lead. For example, it is notdequate to only determine that the lead’s fixation mecha-ism is active or passive. Some active fixation leads requirepecial “fixation stylets” to retract the fixation mechanisme.g., Telectronics ACCUFIX, some Guidant (Boston Sci-ntific) ICD leads]. Knowing that a patient has one of theseeads and having the appropriate tools are important touccess and safety. The operator must also be familiar withhe physical characteristics of each lead including insulationaterial and lead design (coaxial, co-radial, cable, etc.).

eed for pacing support during the proceduret is crucial to determine if the patient is pacemaker depen-ant and will require temporary pacing support during therocedure. Pacemaker dependent patients should have aemporary pacing wire placed prior to extraction. The tem-orary wire must be readily accessible during the procedureecause it may be dislodged and require rapid repositioning.atients who are not pacemaker dependent prior to therocedure may become so during the procedure. This isspecially true in patients with sinus node dysfunction afterhe initiation of general anesthesia. It is therefore recom-ended, in non-pacemaker dependent patients, that the de-

ice be reprogrammed to a pacing rate below the patient’sate (i.e. VVI 40). By doing so, when the device is discon-ected from the leads the operator is not surprised to find theatient has become pacemaker dependent. A venous sheath,laced in one of the femoral veins, allows for the rapideployment of a temporary pacing wire should it be re-uired.

evice interrogation and reprogrammingll devices should be interrogated prior to the procedure.he settings and lead parameters should be documented.his will allow for reprogramming of the current device (orrogramming of a new device) to the appropriate settingsfter re-implantation. In addition, the functioning of pre-erved leads can be compared to the pre-procedure values tonsure that no damage to any reused (“bystander”) leadccurred. It is also recommended that rate responsivenesshould be turned off to prevent rapid pacing with manipu-ation of the device. Tachycardia devices must have detec-ions turned off to prevent inappropriate therapies.

eed for ongoing device therapyhe original indication for system implantation must be

eviewed as should changes in the patient’s condition sincehat procedure. A decision needs to be made and reviewedrior to the extraction as to the need for re-implantation andhe timing, route and technique for both temporary and
ermanent placement.

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rocedure preparationirect preparation of the patient in the extraction laboratory

ncludes the availability of baseline blood tests (metabolicrofile, CBC and coagulation profile) and blood that haseen typed and cross-matched. For most procedures, at leastunits should be available, while for some “high risk”

rocedures some blood should be in the procedure room.btaining large bore (18 gauge or larger) venous access is

equired, and femoral venous access is strongly encouragedince it provides venous access, facilitates temporary pac-ng, and provides a femoral access route for extraction andelivery of fluids, blood and drugs in the advent of a vas-ular emergency. The patient will require continuous elec-rocardiographic and blood pressure monitoring. Thoughhe blood pressure may be monitored using noninvasiveethods, invasive monitoring provides faster recognition of

hanges and is preferred by most experts. The patient’s skinhould be prepared with antiseptic solution in such a manners to allow for an emergent pericardiocentesis, thoracotomy,ternotomy and cardio-pulmonary bypass. The ability toerform transcutaneous pacing and defibrillation using pre-pplied adhesive pads is essential.

ndications for lead removalndications for transvenous lead removal have previouslyeen described by the clinically framed “Byrd Classifica-ion”74 (Mandatory, Necessary and Discretionary). In 2000,hese were refined and published in the format establishedor the American College of Cardiology/American Heartssociation’s methodology for practice guidelines (Class I,lass II and Class III).1,137 Since the original policy con-

erence in 1997 and its publication in 2000 there has been aubstantial increase in the number of CIED implants, theireads and the inevitable CIED complications.75,76,77,78,79

qually important to note is the maturation of the tech-iques, technologies, and experience with transvenous leadxtraction and with the long-term management of theseeads. This has led to an expanded understanding of leadanagement issues, risks, benefits, indications and contra-

ndications, permitting a clarification and update of thesendications. Unless otherwise noted, the references to leademoval in Table 3 relate to transvenous lead removal andot to surgical techniques.24,25,26

When considering the indication for any procedure orherapy, it is important to relate the strength of the clinicalndication for transvenous lead extraction to the early andhe long-term value of the outcome and the risk of thentervention evaluated on an individualized patient basis.he risk of transvenous lead extraction is highly dependentn the training and experience of the practitioner and thextraction team. Even the strongest indication should beonsidered contraindicated when the extraction team hasittle experience or inadequate tools.1,46,47,80 The indica-ions listed in Table 3 assume that the extraction envi-onment conforms to the standards set forth in thisocument. Alternative lead extraction environments such
s surgical extraction by thoracotomy or median sternot- w
my, despite the obvious clear morbidity associated withhese techniques, may be more appropriate approaches toead removal in hospitals without an extraction programdhering to the guidelines in this document.

Alternative lead placements are also without sufficientata to make firm recommendations. There is a growingiterature that supports that many cardiac venous leads im-lanted for cardiac resynchronization therapy can be safelyemoved.81,82 However, caution should be applied to leademoval and extraction of leads that promote tissue in-rowth that are placed into the cardiac veins.83,84 There areo data to address the removal of leads from the azygousein and this and other creative approaches to lead place-ent need to be approached with extreme caution.85

Certain clinical situations such as patients who require car-iac surgery for another unrelated indication or those witharge infected vegetations may be better served using nontrans-enous techniques. Every patient’s situation should be evalu-ted for life-long consequences, considering the implicationsf current decisions on the ultimate outcomes and future man-gement of the patient. There are no specific rules for the sizef a vegetation before a decision is made to remove the leadsnd vegetation with open surgical techniques. Vegetation size,hape, friability, presence or absence of a patent foramenvale, ASD or VSD, other surgical indications and goals,ealth or hemodynamic instability of the patient, pacemakerependency, need for ICD or LV leads and plans for re-mplantation all need to be considered when making this de-ision.64,86,87 Sometimes, a patient with a modest sized vege-ation (�2 cm) still should be taken to the operating room forpen removal and debridement, especially if the patient isacemaker dependent or requires early transvenous re-implan-ation. Alternatively, re-implantation can be done with an epi-ardial pacing lead after transvenous extraction. Patients witharger vegetations (�3 cm) will more commonly require openebridement. These decisions impact the duration and type ofntibiotic therapy and the time of device re-implantation. Tem-orary pacing and wearable defibrillators are often consider-tions for these patients.65,88,89

CIED associated infections are the strongest indicationor complete CIED system removal; however, theseatients can present with a broad range of clinicalcenarios.90,91,92,93,94,95,96 Infection can present withothing more than pain in the CIED pocket. However,hen an infection is identified, this produces a strong

ndication for removal of all components of the CIEDystem including the device, lead, adapters, caps, suturesnd as much of the infected tissue as possible in order toonsistently resolve the infection.97,98 Occasionally a pa-ient’s overall prognosis will be so poor as to favorhronic suppression instead of extraction, but this is anxception.99 Documentation of device related infections,lthough sometimes obvious with fever, bacteremia, veg-tations and sepsis, is also often difficult to diagnose or tossociate with the implantable device. Even in patients
ith documented device related infection, cultures can be

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ABLE 3 Indications for transvenous lead extraction*

ecommendations for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks whenassessed based on individualized patient factors and operator specific experience and outcomes.

nfectionClass I

1. Complete device and lead removal is recommended in all patients with definite CIED system infection, as evidenced by valvularendocarditis, 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 ofthe lead system. (Level of evidence: B)

3. Complete device and lead removal is recommended in all patients with valvular endocarditis without definite involvement ofthe 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). (Levelof evidence: B)

Class IIa1. Complete device and lead removal is reasonable in patients with persistent occult gram-negative bacteremia. (Level of evidence: B)

Class III1. 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)hronic PainClass IIa

1. Device and/or lead removal is reasonable in patients with severe chronic pain, at the device or lead insertion site, that causessignificant discomfort for the patient, is not manageable by medical or surgical techniques and for which there is noacceptable alternative. (Level of evidence: C)

hrombosis or Venous StenosisClass I

1. Lead removal is recommended in patients with clinically significant thromboembolic events associated with thrombus on a leador 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 neededtransvenous lead. (Level of evidence: C)

3. Lead removal is recommended in patients with planned stent deployment in a vein already containing a transvenous lead, toavoid entrapment of the lead. (Level of evidence: C)

4. Lead removal is recommended in patients with superior vena cava stenosis or occlusion with limiting symptoms. (Level ofevidence: C)

5. Lead removal is recommended in patients with ipsilateral venous occlusion preventing access to the venous circulation forrequired placement of an additional lead when there is a contraindication for using the contralateral side (e.g. contralateral AVfistula, shunt or vascular access port, mastectomy). (Level of evidence: C)

Class IIa1. 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)unctional LeadsClass 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)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)Class IIb

1. Lead removal may be considered in patients with an abandoned functional lead that poses a risk of interference with theoperation 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 potentialfuture 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 afterupgrade to ICD) (Level of evidence: C)

4. Lead removal may be considered in patients who require specific imaging techniques (e.g. MRI) that can not be imaged due to thepresence 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)

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egative. This may occur in the setting of preoperativentibiotic therapy, but may occur even in the absence ofntibiotic therapy. Delaying the definitive operation withemoval of all of the components of the CIED system cane a fatal choice for the patient.100 Dy Chua and col-eagues101 documented that the best yield for document-ng the pathologic bacteria required culture of the tissueebrided from the pulse generator pocket fibrosis. How-ver, even this yielded positive results in only 69% of thelinically infected patients. In addition, patients whoresent with signs and symptoms of pocket infectionsually have involvement of the intravascular compo-ents of the system. Klug et al.102 demonstrated that thereas evidence of intravascular lead involvement in 88.4%f patients presenting with clinical pocket infections byxamining the intravascular segments of the lead. Theleveland Clinic series noted that only in the 4 patients

ABLE 3 Indications for transvenous lead extraction* - continu

Class III1. Lead removal is not indicated in patients with functional

one year. (Level of evidence: C)2. Lead removal is not indicated in patients with known ano

venous and cardiac structures, (e.g. subclavian artery, aosystemic venous atrium or systemic ventricle. Additionalscenario is compelling. (Level of evidence: C)

on Functional LeadsClass I

1. Lead removal is recommended in patients with life threat(Level of evidence: B)

2. Lead removal is recommended in patients with leads thatto the patients if left in place. (e.g. Telectronics ACCUFIX

3. Lead removal is recommended in patients with leads thatevidence: B)

4. Lead removal is recommended in patients with leads that(radiation/reconstructive surgery). (Level of evidence: C)

Class IIa1. Lead removal is reasonable in patients with leads that du

not immediate or imminent if left in place. (e.g. Telectro2. Lead removal is reasonable in patients if a CIED implanta

leads through the SVC. (Level of evidence C)3. Lead removal is reasonable in patients that require specifi

presence of the CIED system for which there is no otherClass IIb

1. Lead removal may be considered at the time of an indicacontraindications are absent. (Level of evidence C)

2. Lead removal may be considered in order to permit the imClass III

1. Lead removal is not indicated in patients with non-funct(Level of evidence C)

2. Lead removal is not indicated in patients with known anovenous and cardiac structures, (e.g. subclavian artery, aosystemic venous atrium or systemic ventricle. Additionalscenario is compelling. (Level of evidence: C)

CIED(s): cardiovascular implantable electronic device(s)Legend for Table 3 can be found underneath Table 4.

Note: Assigning a level of Evidence B or C should not be construed addressed in this document either do not lend themselves to experimentaf this document felt it was important to include all recommendations.

ith incomplete extraction, out of a total of 123 patients, o

id recurrent infection develop.97,103 This is consistentith the pathophysiology of staphylococcal bacteria, theredominant pathogen in device infections, in that theyorm a protective biofilm.104 This biofilm, which adhereso the plastic and metal of the devices and leads, makeshese infections resistant to antibiotics and the body’smmune defense system. Consequently, when pocket pains severe enough to require intervention yet there is novert evidence of infection, it was the consensus of theriting committee that strong consideration should beade to treat the patient as if the cause is infectious. This

hould also include the use of antibiotics and delayinge-implantation to another day and at a different anatomicocation.105

A single positive blood culture without other clinicalvidence of infection should not result in removal of theIED system. However, when there are positive cultures

dundant leads if patients have a life expectancy of less than

s placement of leads through structures other than normaleura, atrial or ventricular wall or mediastinum) or through aques including surgical backup may be used if the clinical

arrhythmias secondary to retained leads or lead fragments.

o their design or their failure, may pose an immediate threate fracture with protrusion) (Level of evidence: B)ere with the operation of implanted cardiac devices. (Level of

ere with the treatment of a malignancy

eir design or their failure pose a threat to the patient, that isCCUFIX without protrusion) (Level of evidence C)ould require more than 4 leads on one side or more than 5

ging techniques (e.g. MRI) and can not be imaged due to thele imaging alternative for the diagnosis. (Level of evidence: C)

D procedure, in patients with non-functional leads, if

ation of an MRI conditional CIED system. (Level of evidence: C)

ads if patients have a life expectancy of less than one year.

s placement of leads through structures other than normaleura, atrial or ventricular wall or mediastinum) or through aques including surgical backup may be used if the clinical

ng that the recommendation is weak. Many important clinical questionshave not yet been addressed by high quality investigations; the authors

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hen there is no clear source of the positive culture in theeart, on the leads or from another part of the body despitecomplete evaluation (occult infection), transvenous lead

xtraction should be strongly considered.100 Superficial orncisional erythema or infection is not clear evidence ofIED system infection, but the patient should be closely

ollowed for progression to a deeper infection, which wouldequire extraction.106 Gram-negative bacteremia is lessommonly a pathogen in CIED related infections and per-istence of the bacteremia should be documented past thereatment of other sources of the bacteria before extractions contemplated.97,98,107

CIED re-implantation after removal for an infection pro-ides little tolerance for strategic error. The implantationpproaches are limited (only 2 pectoral sites) and re-implan-ation at the site of CIED and lead removal, when doneefore the infection has been eradicated, can be associatedith an early or late recurrence of the infection. Table 4rovides recommendations or principles to be followed foriming device re-implantation, but there are little publishedata and no firm consensus about the best approach to

ABLE 4 Principles for CIED replacement following infected rem

ecommendations for lead extraction apply only to those patientassessed based on individualized patient factors and operator s

lass I1. Each patient should be carefully evaluated to determine if t2. The replacement device implantation should not be ipsilate

contralateral side, iliac vein, trans-atrial and epicardial implass IIa1. A new CIED system can be implanted into patients who hav

blood cultures, when there is no further clinical evidence oCIED system removal remain negative for at least 72 hours

2. A new CIED system can be implanted into patients who havcultures, when there is no further clinical evidence of systesystem removal remain negative for at least 72 hours (Level

3. A new CIED system can be implanted into patients who havand positive blood cultures, when there is no further clinica24 hours of CIED system removal remain negative for at lea

4. It is reasonable to delay transvenous re-implantation of a nvegetations for at least 14 days after CIED system removal.of the vegetations and epicardial lead implantation. (Level

CIED(s): cardiovascular implantable electronic device(s)Legend for Table 3 and Table 4: Classification of Recommendations andeart Association format:137

Classification of Recommendationslass I: Conditions for which there is evidence and/or general agreementlass II: Conditions for which there is conflicting evidence and/or a diver● IIa: Weight of evidence/opinion is in favor of usefulness/efficacy● IIb: Usefulness/efficacy is less well established by evidence/opinion.

lass III: Conditions for which there is evidence and/or general agreemenmay be harmful.Level of Evidence

evel of Evidence A: Data derived from multiple randomized clinical trialsevel of Evidence B: Data derived from a single randomized trial, or non-evel of Evidence C: Consensus opinion of experts, case studies, or stand

Note: Assigning a Level of Evidence B or C should not be construed addressed in this document either do not lend themselves to experimentauthors of this document felt it was important to include all recommenda

atient management. When there is concern for ongoing d

nfection, alternatives to early re-implantation (after 2–3ays) include wearable defibrillators, epicardial lead im-lantation and surgical debridement of vegetations.88,89

owever, it is clear that in the absence of intracardiacegetations, when there is no further evidence of systemicnfection, that relatively early (3 days) transvenous implan-ation can usually be done without concern for infectionecurrence.97 Although there are no clinical trials that haveested the minimal duration of antibiotic therapy or when its appropriate to switch from IV to PO antibiotics, there isver 20 years of experience using guidelines similar to thatsed for non CIED related endocarditis.14,97 It is generallygreed that 2-6 weeks of IV or sometimes oral antibioticsay still required depending on the microbiologic isolate,

ntibiotic sensitivities and clinical scenario.Transvenous lead extraction for patients without infection is

more controversial topic. It is often possible to abandon aailed or no longer required lead and/or implant the neededeads through the same or alternative implantation route. Sincet is less common for a patient to exhibit symptoms or be at riskf death from the abandonment of non infected leads, it is more

om the benefits of lead removal outweigh the risks whenexperience and outcomes.

a continued need for a new CIED. (Level of evidence: C)he extraction site. Preferred alternative locations include theon. (Level of evidence: C)

alvular or lead associated vegetations but preoperative positivemic infection and the blood cultures drawn within 24 hours ofof evidence: C)alvular or lead associated vegetations but positive lead tipfection and the blood cultures drawn within 24 hours of CIEDdence: C)alvular or lead associated vegetations but preoperative sepsisence of systemic infection and the blood cultures drawn withinours (Level of evidence: C)D system into patients with valvular or lead associateder there are options to reduce this delay including debridementence: C)

Evidence are expressed in the American College of Cardiology/American

given procedure or treatment is useful and effective.of opinion about the usefulness/efficacy of a procedure or treatment.

the procedure/treatment is not useful or effective, and in some cases

a-analysesized studiesareng that the recommendation is weak. Many important clinical questionshave not yet been addressed by high quality investigations; the

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n these patients. Therefore when these indications are consid-red, it is crucial to balance the risk of the intervention, includ-ng the experience of the lead extraction operator, with theatient’s situation.108,109,110,111

There are several other important observations that favorarlier lead extraction instead of abandonment. Leads, wheneft behind, are more difficult to remove and when removedre associated with an increased risk of major complica-ions, which progresses as the implantation duration pro-ongs.14,46,80 Therefore it is difficult to anticipate how tak-ng risk now versus later is to be best assessed. Thesextraction risks increase as the inter-lead fibrosis thickensnd covers more of the surface of the lead, especially whenhere are multiple leads.3,6 Also proportional to implanturation is lead fragility, which increases with the body’shemical and mechanical stresses and reduces the likelihoodf complete lead removal.11,14,46,80 The risks are furtherncreased with even modest calcification of the fibrosis.6

herefore, in a 20 year old patient with complete heart blocknd two failed leads, implanting new leads without extract-ng the old ones, although feasible, is usually inadvisable.lternatively, in a 90 year old patient with one failed lead or

n occluded vessel precluding the reuse of the ipsilateralubclavian vein, it may be more reasonable to consider thatailure to remove the lead would never become a clinicalssue for the patient. It is also important to consider howong the lead had been implanted, the fragility or tensileobustness of each particular lead, and the ease or difficultyf extraction of the particular lead model. The indications inable 3 were developed on the basis of the complete con-ensus of the document writing committee, and take intoccount the relative safety and effectiveness of transvenousead extraction when done in conformance with the stan-ards in this document.

For each of the indications listed for noninfected leadxtraction, there must be a clinical goal that balances theisk of removal and reasonable alternatives should beonsidered. Although there are no clinical trials provinghe relative advantage of lead extraction, there is a liter-ture that supports the rationale for extraction. Severehronic pain for which there is not alternative therapy isometimes infection related but is most commonly re-ponsive to generator and lead removal in the experiencef the authors.

Venous thrombosis alone is not an indication for leadxtraction, but when there are symptoms or when the oc-lusion prevents the application of pacemaker, ICD or otherherapies it is often appropriate to extract the leads tochieve the clinical goal.112 For example, it is inappropri-te to stent open a vein, trapping the pacing leads againsthe vein wall and preventing future safe lead extrac-ion.110,113,114,115 Other approaches such as allowing collat-rals to develop over time, use of limb elevation, anticoag-lation or venoplasty are effective in alleviating symptomsnd should be considered prior to lead extraction. Removal
f the leads can also be associated with thrombosis and e
cclusion, but acute occlusions with thrombus usually re-ponds to anticoagulation, while chronic occlusion that de-elops into a fibrosis does not.

Leads can sometimes induce life threatening arrhythm-as, pose physical risk to a patient such as the TelectronicsCCUFIX lead with a fracture, interfere with the normal detec-

ion of arrhythmias by an ICD or get in the way of radiationherapy or required surgery.108,109,116,117,118,119,120,121,122,123 Al-ernatives to lead extraction are sometimes available andhould be considered, such as moving a newly implanted leadurther from the chronically implanted lead that had causednterference with arrhythmia detection.

Magnetic Resonance Imaging (MRI) scanning is for-ally contraindicated in patients with pacemakers and

CDs; however not all patients with indications for MRIcanning have reasonable alternatives.124,125,126 The Amer-can Society for Testing and Materials (ASTM) and the U.S.ood and Drug Administration (FDA) have classified pace-aker systems as either MRI safe, MRI condition�al orRI unsafe.127,128 Even with new pacemaker or ICD sys-

ems that are considered MRI safe or MRI conditional, thereill continue to be some situations where it will be appro-riate to extract leads from patients to permit appropriatecanning of patients. However, all other alternatives shoulde explored before choosing to extract the leads.

The removal of functional and nonfunctional leads thatre not being employed for the CIED depends on the pa-ient’s clinical situation. As discussed above, there is someisk to leaving leads in, although when the risk will comento play is uncertain.129,130,131,132,133 A long-term perspec-ive is required to allow the appropriate decision to be made,ince over the first few years it would be rare for the risk ofeaving the lead implanted would outweigh the potentialisks of lead extraction.134,135 Not all abandoned leadshould be removed and there must be another clinical indi-ation for the CIED procedure to overcome the risks asso-iated with opening the device pocket such as infection.136

here should be an additional clinical indication for openinghe pocket when there is a safety alert for the lead while theead is still functional and as such does not pose a manifestisk to the patient. This is supported by the experience withhe Telectronics ACCUFIX extractions.108

Finally, removal of leads when there are multiple (4 orore) leads implanted through a single vein or 5 or more

hrough the superior vena cava is not only more difficult butlso more dangerous. This appears to be most important inedium to small sized patients (body mass index � 25)ho had a 3.7 times higher major adverse event rate (2.6%

bsolute rate) than larger patients in the Lexicon study.80

his is also consistent with the 7% major complication raten women with 3 or more leads extracted, which was also.7 times higher than women with one lead and 7 timesigher than men with one lead extracted as reported fromhe multivariate analysis of the Cook voluntary national
xtraction registry.46,47

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egistry and data managementhe lead management environment, as discussed earlier in

his document, requires a commitment to quality throughhe collection and review of personal and institutional out-omes for device implantation and transvenous lead extrac-ion. In addition to the local collection and review of out-omes, a mechanism needs to be developed to benchmarkocal outcomes to national and international outcomes. Thisill require a pragmatic registry with low barriers for col-

ecting, reporting, analyzing and benchmarking the out-omes. This tool needs to be accessible to all committedead management centers, and requires clear definitions,implified data collection tools and transparent administra-ion. Although the data are not primarily to be a source ofesearch, the publication of these data is fundamental to theoal of quality. The support for this registry should includehysicians, hospitals, manufacturers of implantable devices,anufacturers of extraction and lead management devices

nd national regulatory bodies.It is the consensus of the writing committee that there

hould be a coordinated effort to make this lead manage-ent registry a reality. The effort should be supported byIED and extraction equipment manufacturers, but shoulde administered by a third party such as the Heart Rhythmociety. Data collection would be done by each medicalenter. Use of a web based data collection tool would meethe criteria for accessibility. Each center would be able toccess only their own data and benchmarked summary datarom the entire dataset. These un-audited data should beupplemented with additional benchmark summary datarom a set of core centers that would submit to periodic dataudits. These data would then be published and serve torovide for core data elements for the evaluation of newechnologies, and would advance the standards for qualityeasures.

ew devices and techniqueshe introduction of new devices and their use is regulated in

he United States by the Food and Drug Administration. Theurpose of this regulation is to assure that newly releasedevices are safe and effective when used according to theevice labeling. The successful extraction of leads associ-ted with a CIED often requires the use of multiple toolsnd techniques. Therefore, it must be understood that aingle device or technique is unlikely to be proven safe andffective in all situations. Rather, as with many surgicalechniques, the instruments used are chosen in a givenituation due to the specific needs as they present during therocedure. Further, devices are often used in combination,uch as locking stylets and telescoping sheaths, or in tan-em, such as laser sheaths followed by polymer sheaths orotating cutting sheaths. This makes the design of a clinicalrial to test a new device or technique very difficult becausehe effects of the new device or technique alone may bempossible to separate from the effects of all the devices andechniques used as a group. It would be most unwise to
evise a clinical trial that mandated that only the new tool o
ould be used or that the new tool had to be compared to aingle existing tool. The interpretation of results from suchrials is further complicated by difficulties in the definitionsf success and complications, by the lack of adequate data,y sources of bias (such as unbalanced crossover), and byatient selection criteria. Therefore, it is essential that sys-ematic principles are applied to the technical and clinicalvaluation of both new techniques and new tools.

ecommendation for clinical evaluation of leadxtraction devicesew devices typically follow a path from a proof of concept

tage (phase 1) to preclinical studies (phase 2) and only theno clinical studies (phase 3). We provide the followingecommendations for these trials:

The clinical trial (phase 3) to examine safety and effective-ness should not be initiated until a stable technique or toolhas been established with phase 1 and phase 2 evaluations.The initial evaluation (phase 1) should involve bench andanimal testing and the proof of concept clinical testing. Thephase 2 evaluation should be done in 3 to 5 centers havingprolonged and documented experience with lead extraction.The goal is to document the utility of the tool, provide forminor modifications in the design and technique, and toconfirm the lack of predictable harm.The phase 3 clinical trial design should be appropriate toassess the marginal effects of a new device on safety andeffectiveness, given the combined use with existing de-vices.Given that lead extraction is now a relatively maturescience with standard tools available, it is appropriate thatnew tools for lead extraction be submitted to randomiza-tion in prospective controlled trials.The phase 3 clinical trial design should have a statisticalplan addressing adequate sample size, stratification (e.g.,ICD vs pacing lead), crossover bias if applicable, assess-ment of covariates, and appropriate methods for hypoth-esis testing.All of these studies should use the definitions of indica-tions, successes, and complications that have been delin-eated in this document.

onclusionhe procedure of lead extraction has now become part of

he larger concept of lead management. While extractionas matured into a definable, teachable art with its ownpecific tools and techniques, there remain challenges inur ability to impart these skills to physicians so that safend effective transvenous lead extraction is available toatients around the world While the authors stronglyndorse the indications as described, we also recognizehe unique circumstances surrounding each patient andlinical situation. What cannot be accepted is the appli-ation of these techniques by those not adequatelyrained, or by those practicing at institutions that do notrovide the level of support required to assure the safety
f the patient during an extraction procedure. This up-

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ated document is intended to serve as a resource and setf guidelines to define and support the development ofhis safe medical environment.

It is also no longer acceptable to treat most CIED infec-ions in a “conservative” manner. Curative therapy nearlylways requires removal of the foreign bodies from thenfected site, with re-implantation of a new system at anlternate site. The use of suppressive antibiotics should beeserved for special cases as noted in the text of this docu-ent, and there is rarely (if ever) a place for pocket revision

y reimplanting an eroded or infected device in the sameocket that has been debrided.

Complications will periodically occur, even in the mostxperienced hands and centers, during transvenous leadxtraction and the survival of the patient requires that the
perator and extraction support team be prepared. It is the n
apid response of the physician, extraction team, and the sur-ical backup that will give the patient the greatest chance ofurviving.

The fundamental precept in the provision of quality iseasurement. We have precisely provided definitions for

ndications, clinical and procedural success and complica-ions. It is just as clear what personnel and the facilityequirements that are required to assemble, train and main-ain the extraction team. However, implementation of theseecommendations will require significant effort and coop-ration from practicing physicians, medical societies, hos-ital administrations, and industry. The final, missing andequired element in order for each extraction program andperator to measure quality is to have a tool for each centero collect, review and compare its individual outcomes to
ational benchmark data.
ppendixhe writing group would like to thank the Heart Rhythm Society members, and the representatives of the American Collegef Cardiology and the American Heart Association, for their thoughtful reviews of this document.

uthor Disclosures

uthorsConsultant Fees/Honoraria

Speaker’sbureau Research grant

Fellowshipsupport

Board mbr/Stockoptions/Partner Other

aria Grazia Bongiorni, MD Boston ScientificMedtronicSt. Jude Medical*Sorin Group

None None None None None

harles L. Byrd, MD Cook Medical,Inc.Medtronic

None None None Cook Medical,Inc.

None

oger G. Carrillo, MD Spectranetics*Tycos


eorge H. Crossley, III, MD Boston ScientificMedtronic*St. Jude Medical

None Medtronic*St. Jude Medical

None None None

aurence M. Epstein, MD Boston Scientific*GE MedicalHansen MedicalMedtronic*St. Jude Medical*Spectranetics*

None Boston Scientific*Medtronic*St. Jude Medical*

Biosense WebsterBoston Scientific*Medtronic*St. Jude Medical*

Carrot Medical None

ichard A. Friedman, MD None None None Medtronic* None Noneharles E. H. Kennergren,MD, PhD

Boston ScientificMedtronicMenticeSt. Jude MedicalSpectranetics*

None BiotronikBoston ScientificELA MedicalMedtronicSt. Jude MedicalSpectranetics

None None None

harles J. Love, MD BiotronikBoston ScientificCook VascularMedtronic*St. Jude MedicalSorin/ELASpectraneticsTyRx

None BiotronikBoston ScientificMedtronic*St. Jude Medical

None None None

A

P

R

O

B

*

g

R


uthorsConsultant Fees/Honoraria

Speaker’sbureau Research grant

Fellowshipsupport

Board mbr/Stockoptions/Partner Other

rzemyslaw Mitkowski, MD BiotronikBoston ScientificHammerMedMedtronic*

None MedtronicSpectranetics

None None None

aymond H. M. Schaerf,MD

None None None None None None

ussama M. Wazni, MD Boston ScientificMedtronicSt. Jude Medical


ruce L. Wilkoff, MD Boston ScientificInner PulseLifeWatch*MedtronicSt. Jude MedicalSorinSpectranetics

None Biotronik*Boston Scientific*Medtronic*St. Jude Medical*Spectranetics*

None None Medtronic*– PatentRoyalty

SignificantA relationship is considered to be “significant” if (1) the person receives $10,000 or more during any 12-month period or 5% or more of the person’s

ross income; or (2) the person owns 5% or more of the voting stock or share of the entity or owns $10,000 or more of the fair market value of the entity.
A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
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19. Jarwe M, Klug D, Beregi JP, Le Franc P, Lacroix D, Kouakam C, Guedon-Moreau L, Zghal N, Kacet S. Single center experience with femoral extractionof permanent endocardial pacing leads. Pacing Clin Electrophysiol 1999;22:1202–1209.

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66. Trohman RG, Wilkoff BL, Byrne T, Cook S. Successful percutaneous extractionof a chronic left ventricular pacing lead. Pacing and Clinical Electrophysiology;1991;14(10):1448–1451.

67. Garrigue S, Jais P, Espil G, Labeque JN, Hocini M, Shah DC, Haissaguerre M,Clementy J. Comparison of chronic biventricular pacing between epicardial andendocardial left ventricular stimulation using Doppler tissue imaging in patientswith heart failure. Am J Cardiol 2001;88:858–862.

68. Faris OP, Evans FJ, Dick AJ, Raman VK, Ennis DB, Kass DA, McVeigh ER.Endocardial versus epicardial electrical synchrony during LV free-wall pacing.Am J Physiol Heart Circ Physiol 2003;285:H1864–870.

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71. Laborderie J, Barandon L, Ploux S, Deplagne A, Mokrani B, Reuter S, Le GalF, Jais P, Haissaguerre M, Clementy J, Bordachar P. Management of subacuteand delayed right ventricular perforation with a pacing or an implantable car-dioverter-defibrillator lead. Am J Cardiol 2008;102:1352–1355.

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82. Kasravi B, Tobias S, Barnes MJ, Messenger JC. Coronary sinus lead extractionin the era of cardiac resynchronization therapy: single center experience. PacingClin Electrophysiol 2005;28:51–53.

83. Nagele H, Azizi M, Hashagen S, Castel MA, Behrens S. First experience witha new active fixation coronary sinus lead. Europace 2007;9:437–441.

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88. Reek S, Geller JC, Meltendorf U, Wollbrueck A, Szymkiewicz SJ, Klein HU.Clinical efficacy of a wearable defibrillator in acutely terminating episodes ofventricular fibrillation using biphasic shocks. Pacing Clin Electrophysiol 2003;26:2016–2022.

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90. Uslan DZ, Sohail MR, St Sauver JL, Friedman PA, Hayes DL, Stoner SM,Wilson WR, Steckelberg JM, Baddour LM. Permanent pacemaker and implant-able cardioverter defibrillator infection: a population-based study. Arch InternMed 2007;167:669–675.

91. Sohail MR, Uslan DZ, Khan AH, Friedman PA, Hayes DL, Wilson WR,Steckelberg JM, Stoner SM, Baddour LM. Risk factor analysis of permanentpacemaker infection. Clin Infect Dis 2007;45:166–173.

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96. Wilkoff BL. How to treat and identify device infections. Heart Rhythm 2007;4:1467–1470.

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06. Ibid., p. 884–6.07. Uslan DZ, Sohail MR, Friedman PA, Hayes DL, Wilson WR, Steckelberg JM,

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13. Chan AW, Bhatt DL, Wilkoff BL, Roffi M, Mukherjee D, Gray BH, Baizer CT,Yadav JS. Percutaneous treatment for pacemaker-associated superior vena cavasyndrome. Pacing Clin Electrophysiol 2002;25:1628–1633.

14. Worley SJ, Gohn DC, Pulliam RW. Over the wire lead extraction and focusedforce venoplasty to regain venous access in a totally occluded subclavian vein.J Interv Card Electrophysiol 2008;23:135–137.

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http://www.acc.org/qualityandscience/quality/quality.htm

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