concurrent with the increasing age of the population , the use of cardiac implantable electronic devices ( cieds ) in the united states is growing . a retrospective analysis of the nationwide inpatient sample data set reported that the incidence of cied implants increased by 96% between 1993 and 2008 , with the majority of this growth coming from an exponential increase in implantable cardioverterdefibrillator ( icd ) implantation ( 504% increase).1 most of these patients will require a subsequent generator change in their lifetime . although generator replacements are relatively lowrisk procedures , the development of a pocket hematoma and/or infection are two of the most recognized complications of the procedure.1 , 2 , 3 
  another potential complication during a generatorreplacement procedure is inadvertent damage to of the transvenous leads within the device pocket . lead damage can occur when a sharp instrument mechanically compromises a lead during dissection of the surrounding fibrous tissue or when an electrosurgical instrument melts or causes a dielectric failure of the silicone , polyurethane , or copolymer lead insulation.4 prior retrospective studies enrolling a small number of patients have suggested a relationship among lead damage , the use of traditional monopolar electrosurgical instruments , cied type , number of leads in the pocket , and the material composition of the lead insulation ( eg , polyurethane , silicone , or copolymer).4 because lead failures secondary to damage do not typically present clinically for months following the generatorchange procedure , the incidence and risk factors for occurrence have been poorly characterized to date . in the present study , we sought to determine the incidence of lead damage and the associated total health care utilization costs from clinical management following a ciedreplacement procedure . this retrospective database analysis reviewed health care claims data from the truven health analytics marketscan commercial research database . this data source includes information for > 115  million unique patients in the united states , residing in all census regions since 1995.5 patients are covered with employersponsored private health plans , including employees , early retirees ( including those with medicare advantage plans ) , and dependents . the database contains fully deidentified data sets , with randomized identification numbers applied to all data to protect the identities of both the patients and the sites of care . the database includes details on billed patient claims for outpatient and inpatient visits and for prescription drug fills . medical claims list the dates of service ; the place of service ; the international classification of diseases , ninth revision ( icd9 ) diagnosis codes ; the current procedural terminology ( cpt ) codes ; and total payment . this data source includes only fully adjudicated and paid claims . total payment for an inpatient or outpatient visit ( ie , cost as used throughout this paper ) is the sum of amounts paid to all providers by the insurer plus coinsurance , copayments , and deductibles paid by the patient for the same hospital stay or visit . in addition , an eligibility file includes details on patient enrollment , age , sex , and geographic region . this data source does not provide mortality information ; however , for a subset of patients , mortality can be identified if the discharge disposition from the inpatient visit was listed as we included patients with a pacemaker ( pm ) , an icd , or a cardiac resynchronization therapy defibrillator ( crtd ) who underwent a generatorreplacement procedure . patients with a crtpm device were excluded from the analysis because they composed only 0.7% of the entire study cohort ; therefore , meaningful analysis was not feasible in this cohort . patients were eligible for inclusion if there was a claim ( on an outpatient or inpatient basis ) during the years 20102012 for a cied generator implantation , replacement , or removal procedure ( table  s1 ; figure  1 ) . patients undergoing other major cardiac procedures ( diagnostic procedure of the heart and pericardium , percutaneous coronary intervention , coronary artery bypass grafting surgery , catheter ablation , or heart valve surgery ) during the same index visit were then excluded from analysis ( table  s2 ) , similar to methodology used by reynolds et  al.6 
  study period for analysis . crtd indicates cardiac resynchronization therapy defibrillator ; icd , implantable cardioverterdefibrillator ; pm , pacemaker . next , a 1year baseline period was defined as the 12  months prior to the index visit for device replacement . to ensure that the index cied procedure was a device replacement and not a de novo procedure , all patients were required to have at least 1 visit with an icd9 diagnosis code for history of cardiac device or an icd9 or cpt procedure code for cied monitoring during the 1year baseline period ( table  s3 ) . in addition , to ensure that the index visit for cied replacement was for a true device replacement due to age of the device and not to complications related to a recent visit , patients were excluded if there was evidence of 1 procedure code for lead revision or repair , insertion of a temporary system , or pocket revision during the 1year baseline period ( table  s2 ) . finally , all patients were required to be aged 18 years , to have continuous health plan enrollment for the duration of followup ( with an allowed 1month gap in coverage ) , and not to have a crtpm device type . the duration of followup was limited to this period to ensure that followup visits with codes for lead damage or repair were likely related to the index devicereplacement procedure ( figure  1 ) . we summarized information about each patient 's age , sex , and race at the index visit ( ie , the date of the ciedreplacement procedure ) . comorbidity status was evaluated by calculating a charlson comorbidity index ( cci ) score for each patient . the cci is an objective composite measure of physical health status commonly used in studies of medical claims and chronic disease , principally to predict 10year mortality of patients with a variety of comorbid conditions.7 , 8 we also summarized information about use of relevant prescription drugs such as antiplatelet agents ( with the exception of aspirin , which is an overthecounter medication ) and anticoagulants ( warfarin , dabigatran , rivaroxaban , apixaban ) during the 12  months prior to device replacement . for each ciedreplacement procedure , we determined whether the procedure was performed in an outpatient or inpatient setting . of note , because of the lack of specificity in currently used icd9 and cpt codes , it was not possible to determine whether the ciedreplacement procedure was a generator change alone or was coupled to a procedure requiring the addition of leads ( eg , an upgrade procedure ) . lead damage in the followup period was defined as any outpatient or inpatient visit with an icd9 procedure code for lead revision or repair ( 00.52 , 37.7437.77 , 37.95 , 37.97 ) and with no concurrent icd9 diagnosis code for infection during the same visit ( infection and inflammatory reaction due to cardiac device , implant , and graft [ 996.61 ] , septicemia [ 038.xx ] , or endocarditis [ 421.xx ] ) . patients with a diagnosis of infection were excluded to eliminate the likelihood that leads were removed for infection as opposed to lead damage . the overall incidence of lead damage was defined as the total number of patients with a followup visit for lead revision or repair in the first year following a ciedreplacement procedure divided by the total number of patients in the study cohort . if a patient had both outpatient and inpatient visits for lead damage during followup , the visit was categorized as an inpatient visit only to avoid double counting . finally , we sought to determine health care utilization related to lead damage . in > 90% of instances , lead damage resulted in care provided in the inpatient setting ; therefore , we had insufficient data to assess outpatient costs ( only 12 pm , 23 icd , and 3 crtd patients presented with lead damage in an outpatient setting ) . given that sample sizes were sufficient to summarize total visit cost for patients presenting with lead damage in the inpatient setting , we calculated the total hospitalization cost by summing the amount paid to the hospital by the insurer plus coinsurance , copayments , and deductibles paid by the patient . given the distribution of total hospitalization costs observed , we excluded from cost analyses 19 patients whose total costs fell into the top 5% of the cohort ( greater than $ 73  573 for  the pm cohort , $ 191  042 for icd , and $ 296  320 for the crtd cohort).9 , 10 , 11 , 12 we hypothesized that these patients may have had other major procedures besides just lead revision or repair , resulting in the extreme variance in cost . following exclusion of these patients , the data remained rightwardskewed ; therefore , a nonparametric test of statistical significance ( kruskal  wallis test ) was used for cost comparisons . all costs were adjusted to 2013 us dollars using the medical care component of the consumer price index.13 
  descriptive analyses were conducted for all study measures outlined above , including mean , median , and standard deviation for continuous measures and proportions for binary measures . statistical significance testing comparing outcomes by cied type ( pm , icd , crtd ) were conducted with the chisquare test for categorical variables and the kruskal wallis test for continuous variables ( the nonparametric equivalent of a 1way anova test to account for nonnormality ) . cox proportional hazards models were run to identify factors associated with risk of leadrelated complications emerging during followup , with patients followed from the date of discharge to a leaddamage event , death during an inpatient hospitalization , or the end of followup , whichever occurred first . covariates included patient demographics ( age group , sex , cci , antiplatelet or anticoagulant therapy history ) , index procedure setting ( inpatient versus outpatient ) , and cied type . patients were censored in the model at their date of death ( if an inpatient visit with discharge disposition of  dead  was observed during followup ) or at end of followup , whichever occurred first . a p value of < 0.05 was considered statistically significant . all analyses were performed using the instant health data suite ( boston health economics , inc ) and sas software ( version 9.2 ; sas institute ) . this retrospective database analysis reviewed health care claims data from the truven health analytics marketscan commercial research database . this data source includes information for > 115  million unique patients in the united states , residing in all census regions since 1995.5 patients are covered with employersponsored private health plans , including employees , early retirees ( including those with medicare advantage plans ) , and dependents . the database contains fully deidentified data sets , with randomized identification numbers applied to all data to protect the identities of both the patients and the sites of care . the database includes details on billed patient claims for outpatient and inpatient visits and for prescription drug fills . medical claims list the dates of service ; the place of service ; the international classification of diseases , ninth revision ( icd9 ) diagnosis codes ; the current procedural terminology ( cpt ) codes ; and total payment . this data source includes only fully adjudicated and paid claims . total payment for an inpatient or outpatient visit ( ie , cost as used throughout this paper ) is the sum of amounts paid to all providers by the insurer plus coinsurance , copayments , and deductibles paid by the patient for the same hospital stay or visit . in addition , an eligibility file includes details on patient enrollment , age , sex , and geographic region . this data source does not provide mortality information ; however , for a subset of patients , mortality can be identified if the discharge disposition from the inpatient visit was listed as we included patients with a pacemaker ( pm ) , an icd , or a cardiac resynchronization therapy defibrillator ( crtd ) who underwent a generatorreplacement procedure . patients with a crtpm device were excluded from the analysis because they composed only 0.7% of the entire study cohort ; therefore , meaningful analysis was not feasible in this cohort . patients were eligible for inclusion if there was a claim ( on an outpatient or inpatient basis ) during the years 20102012 for a cied generator implantation , replacement , or removal procedure ( table  s1 ; figure  1 ) . patients undergoing other major cardiac procedures ( diagnostic procedure of the heart and pericardium , percutaneous coronary intervention , coronary artery bypass grafting surgery , catheter ablation , or heart valve surgery ) during the same index visit were then excluded from analysis ( table  s2 ) , similar to methodology used by reynolds et  al.6 
  study period for analysis . crtd indicates cardiac resynchronization therapy defibrillator ; icd , implantable cardioverterdefibrillator ; pm , pacemaker . next , a 1year baseline period was defined as the 12  months prior to the index visit for device replacement . to ensure that the index cied procedure was a device replacement and not a de novo procedure , all patients were required to have at least 1 visit with an icd9 diagnosis code for history of cardiac device or an icd9 or cpt procedure code for cied monitoring during the 1year baseline period ( table  s3 ) . in addition , to ensure that the index visit for cied replacement was for a true device replacement due to age of the device and not to complications related to a recent visit , patients were excluded if there was evidence of 1 procedure code for lead revision or repair , insertion of a temporary system , or pocket revision during the 1year baseline period ( table  s2 ) . finally , all patients were required to be aged 18 years , to have continuous health plan enrollment for the duration of followup ( with an allowed 1month gap in coverage ) , and not to have a crtpm device type . the duration of followup was limited to this period to ensure that followup visits with codes for lead damage or repair were likely related to the index devicereplacement procedure ( figure  1 ) . we summarized information about each patient 's age , sex , and race at the index visit ( ie , the date of the ciedreplacement procedure ) . comorbidity status was evaluated by calculating a charlson comorbidity index ( cci ) score for each patient . the cci is an objective composite measure of physical health status commonly used in studies of medical claims and chronic disease , principally to predict 10year mortality of patients with a variety of comorbid conditions.7 , 8 we also summarized information about use of relevant prescription drugs such as antiplatelet agents ( with the exception of aspirin , which is an overthecounter medication ) and anticoagulants ( warfarin , dabigatran , rivaroxaban , apixaban ) during the 12  months prior to device replacement . for each ciedreplacement procedure , we determined whether the procedure was performed in an outpatient or inpatient setting . of note , because of the lack of specificity in currently used icd9 and cpt codes , it was not possible to determine whether the ciedreplacement procedure was a generator change alone or was coupled to a procedure requiring the addition of leads ( eg , an upgrade procedure ) . lead damage in the followup period was defined as any outpatient or inpatient visit with an icd9 procedure code for lead revision or repair ( 00.52 , 37.7437.77 , 37.95 , 37.97 ) and with no concurrent icd9 diagnosis code for infection during the same visit ( infection and inflammatory reaction due to cardiac device , implant , and graft [ 996.61 ] , septicemia [ 038.xx ] , or endocarditis [ 421.xx ] ) . patients with a diagnosis of infection were excluded to eliminate the likelihood that leads were removed for infection as opposed to lead damage . the overall incidence of lead damage was defined as the total number of patients with a followup visit for lead revision or repair in the first year following a ciedreplacement procedure divided by the total number of patients in the study cohort . if a patient had both outpatient and inpatient visits for lead damage during followup , the visit was categorized as an inpatient visit only to avoid double counting . finally , we sought to determine health care utilization related to lead damage . in > 90% of instances , lead damage resulted in care provided in the inpatient setting ; therefore , we had insufficient data to assess outpatient costs ( only 12 pm , 23 icd , and 3 crtd patients presented with lead damage in an outpatient setting ) . given that sample sizes were sufficient to summarize total visit cost for patients presenting with lead damage in the inpatient setting , we calculated the total hospitalization cost by summing the amount paid to the hospital by the insurer plus coinsurance , copayments , and deductibles paid by the patient . given the distribution of total hospitalization costs observed , we excluded from cost analyses 19 patients whose total costs fell into the top 5% of the cohort ( greater than $ 73  573 for  the pm cohort , $ 191  042 for icd , and $ 296  320 for the crtd cohort).9 , 10 , 11 , 12 we hypothesized that these patients may have had other major procedures besides just lead revision or repair , resulting in the extreme variance in cost . following exclusion of these patients , the data remained rightwardskewed ; therefore , a nonparametric test of statistical significance ( kruskal  wallis test ) was used for cost comparisons . all costs were adjusted to 2013 us dollars using the medical care component of the consumer price index.13 descriptive analyses were conducted for all study measures outlined above , including mean , median , and standard deviation for continuous measures and proportions for binary measures . statistical significance testing comparing outcomes by cied type ( pm , icd , crtd ) were conducted with the chisquare test for categorical variables and the kruskal wallis test for continuous variables ( the nonparametric equivalent of a 1way anova test to account for nonnormality ) . cox proportional hazards models were run to identify factors associated with risk of leadrelated complications emerging during followup , with patients followed from the date of discharge to a leaddamage event , death during an inpatient hospitalization , or the end of followup , whichever occurred first . covariates included patient demographics ( age group , sex , cci , antiplatelet or anticoagulant therapy history ) , index procedure setting ( inpatient versus outpatient ) , and cied type . patients were censored in the model at their date of death ( if an inpatient visit with discharge disposition of  dead  was observed during followup ) or at end of followup , whichever occurred first . a p value of < 0.05 was considered statistically significant . all analyses were performed using the instant health data suite ( boston health economics , inc ) and sas software ( version 9.2 ; sas institute ) . their mean age was 72.213.8  years , and 64% of the cohort was male ( table  1 ) . the median cci was 2 , with nearly 38% of the cohort having a cci > 3 . the 5 most prevalent comorbidities in the study cohort used in the cci calculation were congestive heart failure , diabetes without chronic complications , chronic pulmonary disease , cerebrovascular disease , and renal disease . an anticoagulant ( most commonly warfarin ) was used by 26.5% of patients and an antiplatelet drug by 16.7% . cied indicates cardiac implantable electronic device ; crtd , cardiac resynchronization therapy defibrillator ; icd , implantable cardioverterdefibrillator ; pm , pacemaker . patient demographic and clinical characteristics cied indicates cardiac implantable electronic device ; crtd , cardiac resynchronization therapy defibrillator ; icd , implantable cardioverterdefibrillator ; noac , novel oral anticoagulant ; pm , pacemaker . wallis test for continuous measures and the chisquare test for proportions . only observed if an inpatient admission over followup had the discharge disposition of  dead  ; no social security  linked mortality information was available . among patients with a followup visit for lead damage , a pm generator change was performed in 22  557 ( 50% ) patients , an icd generator change was performed in 20  632 ( 46% ) patients , and a crtd generator change was performed in 2063 ( 5% ) patients . patients with a crtd were more likely to be younger and male , to have a higher cci , to be taking an antiplatelet drug and/or warfarin , and to have undergone generator replacement in an inpatient setting ( table  1 ) . lead damage occurred in 406 ( 0.90% ) patients at a median of 107  days ( interquartile range 35260 days ) following the ciedreplacement procedure . patients with a pm had a 0.46% incidence , which increased to 1.27% in icd patients , and further increased to 1.94% in crtd patients ( p<0.001 ) ( figure  3 ) . mean time to a visit for lead damage ( in either the inpatient or outpatient setting ) ranged from 131 to 158  days ( figure  3 ) . of the 406 patients with lead damage , 368 ( 91% ) presented in an inpatient setting . the median length of stay associated with treatment for lead damage was 3  days and did not significantly differ based on cied type . the mean cost of the management of lead damage over the first year following generator replacement was $ 25  797 , averaged across all generator types ; however , costs were significantly influenced by cied type . specifically , mean total hospitalization costs were $ 19  959 for pm patients , $ 24  885 for icd patients , and $ 46  229 for crtd patients ( p=0.048 ) ( table  2 . hospital length of stay and cost for a followup visit for lead revision or repair kruskal we examined risk factors for lead damage following a ciedreplacement procedure in a cox proportional hazards model ( table  3 ) . controlling for patient demographic and clinical characteristics , icd and crtd patients demonstrated double ( hazard ratio 2.00 , 95% ci 1.572.55 ) and > 2.5 times ( hazard ratio 2.58 , 95% ci 1.733.83 ) the risk of lead damage , respectively , compared with pm patients . cox proportional hazards model of risk factors for lead damage following cied replacement cied indicates cardiac implantable electronic device ; crtd , cardiac resynchronization therapy defibrillator ; hr , hazard ratio ; icd , implantable cardioverterdefibrillator ; noac , novel oral anticoagulant ; pm , pacemaker . reference groups include age 1864 years , female sex , no warfarin or noac use , no antiplatelet use , no comorbid diagnosis , initial outpatient ciedreplacement setting , generatortype pacemaker . in this study of commercial claims data , we estimated the incidence of lead damage following ciedreplacement procedures . lead damage became clinically manifest at a median of 107  days following the ciedreplacement procedure . the incidence of followup visits for lead damage increased with device complexity : 0.46% for pms , 1.27% for icds , and 1.94% for crtd devices . this increasing risk of lead damage is likely attributable to the greater number and complexity of leads in patients with icds and crtds compared with patients with pms . furthermore , followup visits for lead repair and revision were associated with substantial mean total inpatient hospitalization costs , ranging from $ 19  959 for patients with a pm to $ 46  229 among those with a crtd . prior studies have failed to adequately assess the incidence of lead damage following a ciedreplacement procedure . in a retrospective analysis of 5918 patients in the danish pacemaker and icd registry , the authors evaluated the incidence of complications within 6  months of a primary or replacement cied procedure . the incidence of leadrelated reintervention was 1.2% following pm or crtpm procedures and 2.4% following an icd or crtd procedure14 ; however , the time to event , associated costs , and the issue necessitating reintervention were all undefined . separately , the ontario icd registry evaluated the incidence of complications occurring within 45  days of an icdreplacement procedure in 5176 patients.15 during this shortterm followup , 15 ( 1.4% ) patients required a lead replacement and 9 ( 0.8% ) patients required lead extraction ; however , no specific information was provided as to what necessitated lead replacement or extraction.15 our data show that lead damage typically occurs outside the 45day postprocedure window . two italian centers reported , in a retrospective chart review study , the incidence of lead failure in 2671 patients undergoing a ciedimplant procedure.16 over a mean followup of 27  months , lead failure was observed in only 19 ( 0.42% ) patients16 ; however , 57% of patients had undergone initial cied implant , thus the population of patients undergoing a replacement procedure was quite small relative to our study . finally , in a singlecenter austrian study , the authors evaluated the impact of surgical instrument and technique during pocket dissection on lead damage.17 the authors reported historical incidences of lead damage of 0.59% and 5.11% following pm and icd replacement , respectively , using a purely sharp dissection technique . the study , however , comprised only 611 patients , nearly threefourths of which had a pm , and followup was limited to 6  months.17 
  this study had several limitations . first , claims data may contain coding errors and incompletely capture all relevant patient data . second , given the limitations in existing billing codes , we could not differentiate between generatorreplacement procedures alone versus those in which leads were added . our study used icd9based procedure codes ; whether icd10 procedure codes can overcome some of the encountered limitations merits further investigation . third , cost ( insurance payment ) information in the marketscan commercial research database analyzed for this study was available only at the visit level , with no detail on line item or cost center costs . consequently , the cost associated with lead damage outlined in this study includes more than just the cost of a replacement lead itself but rather the total visit cost , which likely includes other provided services . further studies may also validate our estimates of lead damage with data sources specifically weighted and designed to be nationally representative , such as the nationwide inpatient sample . fourth , we had no information about the manufacturer or model of leads , the number of leads in the pocket , the duration during which the leads had been present since initial implantation , or the surgical tools used during the generatorchange procedure . fifth , because social security  linked mortality information was not available in the current analysis , this study is at risk of possible censoring bias for mortality ; however , this bias results in the estimated incidence of lead damage being conservative . mortality was observed only if a patient was rehospitalized in followup and the discharge status was  dead . the risk of mortality censoring bias is greatest in the crtd cohort ( the cohort with the greatest mean cci and thus the sickest population ) . regardless , the highest incidence of lead damage was observed in the crtd population , even with the shorter time of risk for lead damage in followup because of greater mortality risk . finally , with the advent of icd10 procedure codes in the united states , future studies will be able to assess the location ( right versus left ) of the damaged lead and the surgical approach ( percutaneous endoscopic versus open ) . there do not , however , appear to be procedure codes that are specific to leaddamage events , merely codes that identify repair or replacement of leads , similar to what was available in the present study with icd9 procedure code information . prior studies have failed to adequately assess the incidence of lead damage following a ciedreplacement procedure . in a retrospective analysis of 5918 patients in the danish pacemaker and icd registry , the authors evaluated the incidence of complications within 6  months of a primary or replacement cied procedure . the incidence of leadrelated reintervention was 1.2% following pm or crtpm procedures and 2.4% following an icd or crtd procedure14 ; however , the time to event , associated costs , and the issue necessitating reintervention were all undefined . separately , the ontario icd registry evaluated the incidence of complications occurring within 45  days of an icdreplacement procedure in 5176 patients.15 during this shortterm followup , 15 ( 1.4% ) patients required a lead replacement and 9 ( 0.8% ) patients required lead extraction ; however , no specific information was provided as to what necessitated lead replacement or extraction.15 our data show that lead damage typically occurs outside the 45day postprocedure window . two italian centers reported , in a retrospective chart review study , the incidence of lead failure in 2671 patients undergoing a ciedimplant procedure.16 over a mean followup of 27  months , lead failure was observed in only 19 ( 0.42% ) patients16 ; however , 57% of patients had undergone initial cied implant , thus the population of patients undergoing a replacement procedure was quite small relative to our study . finally , in a singlecenter austrian study , the authors evaluated the impact of surgical instrument and technique during pocket dissection on lead damage.17 the authors reported historical incidences of lead damage of 0.59% and 5.11% following pm and icd replacement , respectively , using a purely sharp dissection technique . the study , however , comprised only 611 patients , nearly threefourths of which had a pm , and followup was limited to 6  months.17 first , claims data may contain coding errors and incompletely capture all relevant patient data . second , given the limitations in existing billing codes , we could not differentiate between generatorreplacement procedures alone versus those in which leads were added . our study used icd9based procedure codes ; whether icd10 procedure codes can overcome some of the encountered limitations merits further investigation . third , cost ( insurance payment ) information in the marketscan commercial research database analyzed for this study was available only at the visit level , with no detail on line item or cost center costs . consequently , the cost associated with lead damage outlined in this study includes more than just the cost of a replacement lead itself but rather the total visit cost , which likely includes other provided services . further studies may also validate our estimates of lead damage with data sources specifically weighted and designed to be nationally representative , such as the nationwide inpatient sample . fourth , we had no information about the manufacturer or model of leads , the number of leads in the pocket , the duration during which the leads had been present since initial implantation , or the surgical tools used during the generatorchange procedure . fifth , because social security  linked mortality information was not available in the current analysis , this study is at risk of possible censoring bias for mortality ; however , this bias results in the estimated incidence of lead damage being conservative . mortality was observed only if a patient was rehospitalized in followup and the discharge status was  dead . the risk of mortality censoring bias is greatest in the crtd cohort ( the cohort with the greatest mean cci and thus the sickest population ) . regardless , the highest incidence of lead damage was observed in the crtd population , even with the shorter time of risk for lead damage in followup because of greater mortality risk . finally , with the advent of icd10 procedure codes in the united states , future studies will be able to assess the location ( right versus left ) of the damaged lead and the surgical approach ( percutaneous endoscopic versus open ) . there do not , however , appear to be procedure codes that are specific to leaddamage events , merely codes that identify repair or replacement of leads , similar to what was available in the present study with icd9 procedure code information . this study estimated the incidence of lead damage following ciedreplacement procedures using us health care claims data . incidence ranged from 0.46% following pm replacements to 1.27% for icds and 1.94% for crtds . inpatient visits for lead revision or repair were associated with substantial increases in cost to the health care system . these findings suggest that new care algorithms are needed to mitigate these events , which impose substantial burdens on patients , physicians , and payors . this study was funded by medtronic advanced energy , with two of the authors ( nichols and vose ) being fulltime employees . dr mittal has received fees from medtronic for speaking and consulting agreements on various topics ; however , he did not receive any fees or other compensation for the analysis reported in this manuscript . medtronic advanced energy owns the peak plasmablade , a novel electrosurgical device ; however , specific analysis of this device was not included in the present manuscript as no devicespecific information was available in the truven health insurance claims dataset . patient selection codes , additional inclusion criteria to ensure index visit for device replacement click here for additional data file .
backgroundinadvertent damage to leads for transvenous pacemakers , implantable cardioverterdefibrillators , and cardiac resynchronization therapy defibrillators is an important complication associated with generatorreplacement procedures . we sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement.methods and resultsusing the truven health analytics marketscan commercial research database , we identified health care claims between 2009 and 2013 for lead damage following generator replacement . 
 patients were identified by claims with a procedure code for cardiac implantable electronic device replacement and then evaluated for 1  year . 
 all followup visits for lead damage were identified , and incidence , risk factors , and hospitalization costs were determined . 
 a total of 22  557 patients with pacemakers , 20  632 with implantable cardioverterdefibrillators , and 2063 with cardiac resynchronization therapy defibrillators met selection criteria . 
 incidence of lead damage was 0.46% for pacemaker replacement , 1.27% for implantable cardioverterdefibrillator replacement , and 1.94% for cardiac resynchronization therapy defibrillator replacement procedures ( p<0.001 ) . after adjusting for patient characteristics , patients with implantable cardioverterdefibrillators and cardiac resynchronization therapy defibrillators demonstrated risk of lead damage that was , respectively , double ( hazard ratio 2.00 , 95% ci 1.572.55 ) and > 2.5 times ( hazard ratio 2.58 , 95% ci 1.733.83 ) that of patients with pacemakers . 
 lead revision or repair procedures were associated with increased inpatient hospitalization costs ( mean $ 19  959 for pacemaker , $ 24  885 for implantable cardioverterdefibrillator , and $ 46  229 for cardiac resynchronization therapy defibrillator ; p=0.048 , kruskal 
 wallis test).conclusionsthese findings establish the first objective assessment of the incidence , risk factors , and economic burden of lead damage following cardiac implantable electronic device replacement in the united states . 
 new care algorithms are warranted to avoid these events , which impose substantial burdens on patients , physicians , and payors .