Cardiac device implantation and device usage in Fabry and hypertrophic cardiomyopathy

Abstract Background Fabry disease (FD) is a treatable X-linked condition leading to progressive cardiac disease, arrhythmia and premature death. We aimed to increase awareness of the arrhythmogenicity of Fabry cardiomyopathy, by comparing device usage in patients with Fabry cardiomyopathy and sarcomeric HCM. All Fabry patients with an implantable cardioverter defibrillator (ICD) implanted in the UK over a 17 year period were included. A comparator group of HCM patients, with primary prevention ICD implantation, were captured from a regional registry database. Results Indications for ICD in FD varied with 72% implanted for primary prevention based on multiple potential risk factors. In FD and HCM primary prevention devices, arrhythmia occurred more frequently in FD over shorter follow-up (HR 4.2, p < 0.001). VT requiring therapy was more common in FD (HR 4.5, p = 0.002). Immediate shock therapy for sustained VT was also more common (HR 2.5, p < 0.001). There was a greater burden of AF needing anticoagulation and NSVT in FD (AF: HR 6.2, p = 0.004, NSVT: HR 3.1, p < 0.001). Conclusion This study demonstrates arrhythmia burden and ICD usage in FD is high, suggesting that Fabry cardiomyopathy may be more ‘arrhythmogenic’ than previously thought. Existing risk models cannot be mutually applicable and further research is needed to provide clarity in managing Fabry patients with cardiac involvement.

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Cardiac Device Implantation and Device Usage in Fabry and Hypertrophic Cardiomyopathy

10.21203/rs.3.rs-927265/v1 ◽

2021 ◽

Author(s):

Ravi Vijapurapu ◽

William Bradlow ◽

Francisco Leyva ◽

James C Moon ◽

Abbasin Zegard ◽

...

Keyword(s):

Primary Prevention ◽

Premature Death ◽

Shock Therapy ◽

Risk Models ◽

Icd Implantation ◽

Cardiac Device ◽

Device Implantation ◽

Potential Risk Factors ◽

The Uk

Abstract BackgroundFabry disease (FD) is a treatable X-linked condition leading to progressive cardiac disease, arrhythmia and premature death. We aimed to increase awareness of the arrhythmogenicity of Fabry cardiomyopathy, by comparing device usage in patients with Fabry cardiomyopathy and sarcomeric HCM. All Fabry patients with an implantable cardioverter defibrillator (ICD) implanted in the UK over a 17 year period were included. A comparator group of HCM patients, with primary prevention ICD implantation, were captured from a regional registry database. ResultsIndications for ICD in FD varied with 82% implanted for primary prevention based on multiple potential risk factors. In FD and HCM primary prevention devices, arrhythmia occurred more frequently in FD over shorter follow-up (HR 4.2,p<0.001). VT requiring therapy was more common in FD (HR 4.5,p=0.002). Immediate shock therapy for sustained VT was also more common (HR 2.5,p<0.001). There was a greater burden of AF needing anticoagulation and NSVT in FD (AF: HR 6.2,p=0.004, NSVT: HR 3.1,p<0.001). ConclusionThis study demonstrates arrhythmia burden and ICD usage in FD is high, suggesting that Fabry cardiomyopathy may be more ‘arrhythmogenic’ than previously thought. Existing risk models cannot be mutually applicable and further research is needed to provide clarity in managing Fabry patients with cardiac involvement.

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ICD implantation and device therapy: Fabry vs hypertrophic cardiomyopathy

European Heart Journal ◽

10.1093/ehjci/ehaa946.0404 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

R Vijapurapu ◽

A Zegard ◽

F Leyva ◽

W Bradlow ◽

A Jovanovic ◽

...

Keyword(s):

Hypertrophic Cardiomyopathy ◽

Primary Prevention ◽

Shock Therapy ◽

Left Ventricular ◽

Device Therapy ◽

Icd Implantation ◽

Device Implantation ◽

Cardiac Devices ◽

Lv Mass

Abstract Background Cardiac involvement of Fabry disease (FD) includes left ventricular hypertrophy (LVH), inflammation, arrhythmia and sudden death. There are limited data regarding potential risk predictors and no definitive criteria exist to guide implantation of cardiac devices for primary prevention. Despite phenotypic similarities between FD and hypertrophic cardiomyopathy (HCM), FD is specifically excluded from the ESC sudden cardiac death risk prediction tool used for HCM. Purpose To evaluate differences in device implantation and arrhythmic burden between advanced Fabry cardiomyopathy and HCM. Methods This multi-centre, retrospective study including genetically confirmed FD and age/gender-matched HCM patients all of whom had an implantable cardioverter defibrillator (ICD). Data was collected prior to device implantation on disease characteristics, biomarkers and CMR imaging. Arrhythmia burden and changes in therapy were captured following implantation. Results Of the UK FD population under follow-up, 50/880 had an ICD implanted (80% males, 51% non-classical mutation, mean age at device implantation 57±12 years). A comparator group included 64 age- and gender-matched HCM patients (67% males, mean age at implant 46±39 years). Baseline LV mass was greater in FD (291±97g/m2 vs 218±78g/m2, p=0.012). FD patients had higher troponin (95 vs 19ng/l, p<0.001) but similar NT-pro-BNP (1687 vs 888ng/l, p=0.086) levels. Indications for ICD insertion in FD included: presumed HCM dual pathology 14%, symptomatic NSVT 18%, asymptomatic NSVT 24%, co-existing long QT 2%, CRT-D 14%, no clear indication (primary prevention in the presence of multiple potential arrhythmic risk factors) 28%. All HCM patients were risk stratified and underwent device implantation based on an estimated 5-year SCD risk >4%. All FD patients had a SCD risk >4% using this risk calculator. Arrhythmia were more common in FD over shorter follow-up (37/50, 74% over 4.3±3.0 years vs 28/64 in HCM, 44% over 6.5±2.9 years, p=0.001). Notably, VT requiring anti-tachycardia pacing (ATP) +/− defibrillation therapy from the ICD was more frequent (FD: 14/50, 28% vs HCM: 8/64, 12%, p=0.055), as was immediate shock therapy for sustained VT (p=0.009, figure panel B). FD patients with arrhythmia were often older, had greater LV mass, a larger left atrium and a broader QRS duration. These clinical features tended to occur more frequently in FD than in the HCM group. Conclusion This study has shown that delivery of device therapy in Fabry cardiomyopathy is higher than in HCM. Despite similar rates of asymptomatic NSVT, a higher rate of ventricular arrhythmia requiring ATP/defibrillation therapy occurred in FD. Although both FD and HCM had similar risk percentages according to the ESC calculator, active troponitis in FD was double that of HCM. Funding Acknowledgement Type of funding source: None

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Abstract 15967: Risk of Ventricular Tachyarrhythmias Following Ejection Fraction Improvement in Patients With Implantable Cardiac Defibrillators Implanted for Primary Prevention of Sudden Cardiac Death

Circulation ◽

10.1161/circ.130.suppl_2.15967 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Jayasree Pillarisetti ◽

Rakesh Gopinathannair ◽

Matthew Haney ◽

Madhu Reddy ◽

Sandeep Reddy ◽

...

Keyword(s):

Primary Prevention ◽

Sudden Cardiac Death ◽

Ejection Fraction ◽

Cardiac Death ◽

High Volume ◽

Icd Implantation ◽

Cardiac Device ◽

Inappropriate Shocks ◽

Social Security Death Index

Introduction: In patients who undergo cardiac device (ICD) implantation for primary prevention of sudden cardiac death (SCD), data is unclear if their generator needs to be replaced at end of life if their ejection fraction improves. Despite improvement in EF however, the underlying scar may remain the same. Methods: A retrospective study was performed at two high volume centers. Data on 280 patients who underwent ICD implantation for primary prevention of SCD was obtained after excluding patients with incomplete follow-up data. These patients were followed until November 2013 for any improvement in EF and if they underwent a generator change at device ERI. All arrhythmic events and appropriate and inappropriate shocks/ATP were all recorded. Mortality records were obtained from social security death index and chart review. Results: Thirty percent (n=86/280) of patients improved their EF to > 35% of which 41% (n=36) underwent a generator change by the study ending period for ERI/lead malfunction/infection issues with the rest not yet at ERI. Mean baseline EF in patients with and without EF improvement was 26±7% and 23±7%, p=0.2. Data for arrhythmic events was unavailable in n=25 patients in those with EF improvement and n =39 patients in those without EF improvement. Among the remaining 61 patients, appropriate events (shock+ATP) were noted in 22% of patients (n=14/61) and inappropriate shocks and ATP in 6% of (n=4/61) patients after their EF improved to > 35%. Two patients received a prior shock when their EF was low. In contrast, in patients who had no improvement in EF, 31% (n=48/155) received an appropriate event (p=<0.01) while 14% (n=22/155) (p<0.02) received inappropriate shocks and ATP. All-cause mortality in patients without subsequent improvement in EF versus those with EF improvement (38% vs. 17% (p=.006). Mean time to EF improvement was 44±35 months and mean duration of follow-up since EF improvement was 38±27 months. Conclusions: Although patients with improvement in EF had fewer total events (ATP+shock) than those without improvement, the percentage of patients with ICD therapy post EF improvement with no prior ICD discharges is high enough (20%, n=12/59) to warrant an ICD despite EF improvement.

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Abstract 107: Predictors and Frequency of ICD Implantation for Primary Prevention in ICD Eligible Patients: Results from a Prospective Multicenter Registry

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.5.suppl_1.a107 ◽

2012 ◽

Vol 5 (suppl_1) ◽

Author(s):

Rory Hachamovitch ◽

Benjamin Nutter ◽

Manuel D Cerqueira ◽

Keyword(s):

Heart Failure ◽

Primary Prevention ◽

Left Ventricular ◽

Myocardial Imaging ◽

Left Ventricular Ejection ◽

Study Cohort ◽

Icd Implantation ◽

Ventricular Ejection Fraction ◽

Multicenter Registry

Background . The use of implantable cardiac defibrillators has been associated with improved survival in several well-defined patient (pt) subsets. Its utilization for primary prevention in eligible pts, however, is unclear. We sought to examine the frequency of ICD implantation (ICD-IMP) for primary prevention in a cohort prospectively enrolled in a prospective, multicenter registry of ICD candidates. Methods . We identified 961 pts enrolled in the AdreView Myocardial Imaging for Risk Evaluation in Heart Failure (ADMIRE-HF) study, a prospective, multicenter study evaluating the prognostic usefulness of 123I-mIBG scintigraphy in a heart failure population. Inclusion criteria limited patients to those meeting guideline criteria for ICD implantation; these criteria included left ventricular ejection fraction ≤35% and New York Heart Association functional class II-III. We excluded pts with an ICD at the time of enrollment, leaving a study cohort of 934 patients. Pts were followed up for 24 months after enrollment. Pts undergoing ICD-IMP after enrollment for secondary prevention were censored at the time of intervention. The association between ICD-IMP utilization and demographic, clinical, laboratory, and imaging data was examined using Cox proportional hazards analysis (CPH). Results . Of 934 pts, 196 (21%) were referred for ICD-IMP over a mean follow-up of 612±242 days. Implantations occurred 167±164 days after enrollment. Patients referred for ICD were younger (61±12 vs. 63±12), but did not differ with respect to proportion female (17% vs. 21%), African-American race (12% vs. 15%), diabetics (37% vs. 36%) (All p=NS). The frequency of ICD-IMP did not differ as a function of age, race, sex, LVEF, or imaging result (All p=NS). CPH revealed that a model including age, race, sex, diabetes, smoking, BMI, NYHA class, hypertension, heart failure etiology, and prior MI identified none of these as predictive of ICD-IMP. Conclusion: This analysis of prospective registry data reveals that in patients who are guideline-defined candidates for ICD-IMP, only about one in five receive an ICD over a two year follow-up interval. Multivariable modeling failed to identify any factor associated with ICD use.

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Abstract 1158: Sudden Death in Children with Cardiomyopathy: Long Term Follow-Up from a National Population-Based Study of Childhood Cardiomyopathy

Circulation ◽

10.1161/circ.118.suppl_18.s_651-b ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Tara Bharucha ◽

Andrew M Davis ◽

Christian Turner ◽

Robert Justo ◽

Terry Robertson ◽

...

Keyword(s):

Risk Factors ◽

Primary Prevention ◽

Sudden Death ◽

Systolic Dysfunction ◽

Population Based ◽

Z Score ◽

Icd Implantation ◽

Population Based Study ◽

Increased Risk

Introduction Better data regarding the incidence and risk factors for sudden cardiac death (SCD) in children with cardiomyopathy (CM) is critical in defining appropriate primary prevention strategies. Methods The National Australian Childhood Cardiomyopathy Study is a prospective cohort study, including all children in Australia with primary CM diagnosed at 0 – 10 years of age, between 1987–1997. SCD was defined as sudden and unexpected death in children who were not hospitalized and not in congestive heart failure at the time of death. Nine subjects with sudden death as presenting symptom were excluded. Indexed echocardiographic measurements at latest follow-up were compared between subjects with SCD and survivors. Results Study criteria were met by 291 children. Mean duration of follow-up was 9.2 years. The incidence of sudden death relative to each CM type, for all cases and as a proportion of deaths, is shown in the Table : Incidence of SCD by CM type. SCD incidence was significantly associated with CM type, for all cases ( p = 0.006) and when only those subjects who died were considered ( p = 0.005), with LVNC and RCM having up to 4 times the risk of other CM types. Children with familial DCM had a significantly higher rate of SCD than subjects with non-familial CM (12% vs 3%; p = 0.028), however, familial CM was not a risk factor in other CM types. DCM SCD subjects had larger LVEDd Z score than survivors (median 5.53 vs 1.16; p <0.0001) and lower FS Z score (median −9.23 vs −0.51; p = 0.0025). HCM SCD subjects had thicker LVPW dimension Z scores than survivors (median 4.63 vs 1.18; p = 0.007). Twelve subjects (2 DCM, 8 HCM and 2 LVNC) underwent ICD implantation (8/12 for primary prevention). Conclusions: This population based study defines new risk factors for sudden death in children with CM. RCM is well known to have a high incidence of SCD. In addition, children with LVNC and those with DCM who have severe dilatation, systolic dysfunction or familial DCM are at increased risk of sudden death.

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Study of indications for cardiac device implantation and utilisation in Fabry cardiomyopathy

Heart ◽

10.1136/heartjnl-2019-315229 ◽

2019 ◽

Vol 105 (23) ◽

pp. 1825-1831 ◽

Cited By ~ 3

Author(s):

Ravi Vijapurapu ◽

Tarekegn Geberhiwot ◽

Ana Jovanovic ◽

Shanat Baig ◽

Sabrina Nordin ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ventricular Tachycardia ◽

Fabry Disease ◽

Premature Death ◽

Sustained Ventricular Tachycardia ◽

Implantable Cardioverter Defibrillators ◽

Imaging Data ◽

Cardiac Device ◽

Device Implantation ◽

Cardiac Devices

BackgroundFabry disease is a treatable X-linked condition leading to progressive cardiomyopathy, arrhythmia and premature death. Atrial and ventricular arrhythmias contribute significantly to adverse prognosis; however, guidance to determine which patients require cardiovascular implantable electronic devices (CIEDs) is sparse. We aimed to evaluate indications for implantation practice in the UK and quantify device utilisation.MethodsIn this retrospective study, we included demographic, clinical and imaging data from patients in four of the largest UK Fabry centres. Ninety patients with Fabry disease were identified with CIEDs implanted between June 2001 and February 2018 (FD-CIED group). To investigate differences in clinical and imaging markers between those with and without devices, these patients were compared with 276 patients without a CIED (FD-control).ResultsIn the FD-CIED group, 92% of patients with permanent pacemakers but only 28% with implantable cardioverter-defibrillators had a class 1 indication for implantation. A further 44% of patients had defibrillators inserted for primary prevention outside of current guidance. The burden of arrhythmia requiring treatment in the FD-CIED group was high (asymptomatic atrial fibrillation:29%; non-sustained ventricular tachycardia requiring medical therapy alone: 26%; sustained ventricular tachycardia needing anti-tachycardia pacing/defibrillation: 28%). Those with devices were older, had greater LV mass, more scar tissue and larger atrial size.ConclusionsArrhythmias are common in Fabry patients. Those with cardiac devices had high rates of atrial fibrillation requiring anticoagulation and ventricular arrhythmia needing device treatment. These are as high as those in hypertrophic cardiomyopathy, supporting the need for Fabry-specific indications for device implantation.

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Implantable cardioverter defibrillators in adult congenital heart disease: long-term follow up of therapies, complications and clinical events

EP Europace ◽

10.1093/europace/euab116.502 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

V Ferreira ◽

M Cruz Coutinho ◽

G Portugal ◽

P Silva Cunha ◽

B Valente ◽

...

Keyword(s):

Congenital Heart Disease ◽

Heart Disease ◽

Primary Prevention ◽

Congenital Heart ◽

Septal Defect ◽

Long Term Outcomes ◽

Icd Implantation ◽

Heart Defect

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Adults with congenital heart disease (ACHD) at increased risk for sudden cardiac death (SCD) often undergo implantable cardioverter defibrillator (ICD) implantation at young ages. Data evaluating the long-term outcomes of ICD in this population remain scarce. We aimed to characterize the population with ACHD and an ICD. Methods Consecutive ACHD submitted to an ICD implantation in a single tertiary center were evaluated. Data on baseline clinical features, heart defect, indication for ICD, type of device, ICD-related complication and therapies and mortality during follow-up were collected. Results A total of 34 patients (P) were evaluated. Median age at implant was 39.3 years (interquartile range [IQR] 29-5-53.6) and median left ventricular ejection fraction (LVEF) was 43.5% (IQR 28.0-53.3). The most common heart defect was tetralogy of Fallot (11P;32,3%), followed by dextro-transposition of the great arteries, ostium secundum atrial septal defect (ASD) and ventricular septal defect (Figure 1). All P were submitted to surgical correction (median age at surgery 12.5 years [IQR 3.0-29.1]). Sixteen P underwent ICD implantation for primary prevention of SCD, owing to complex cardiopathy and ventricular dysfunction, and 18P due to spontaneous ventricular tachyarrhythmias. The implantable devices were a single-chamber ICD in 55.9%, a double-chamber ICD in 17.6%, a subcutaneous ICD in 20.6% and a CRT-D in 5.9%. During a median follow-up of 4.5 years (IQR 2.1-8.8), 52.9% of the P received appropriate ICD therapies, corresponding to 37.5% and 66.7% of primary and secondary prevention P, respectively. Median time to first arrhythmic event was 25.3 months (IQR 13.7-52.9). Six P (17.6%) suffered ICD-related complications and 20.6% received inappropriate therapies due to supraventricular tachyarrhythmias. During follow-up, 8.8% were submitted to heart transplant and 29.4% died (Table 1). ICD therapies were associated with a composite of death, cardiac transplantation and hospital admission (OR 5.0, 95% CI 1.0-24.3). Conclusion ACHD with ICD experience high rate of appropriate therapies, including those implanted for primary prevention. The long-term burden of ICD-related complications and inappropriate shocks underlines the need for careful risk stratification and close monitoring. The increased survival of this population justifies collecting data on long-term outcomes to improve its care. Abstract Figure.

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Combined vascular and neurologic injury after cephalic vein cutdown approach for ICD implantation

Case Reports in Internal Medicine ◽

10.5430/crim.v4n1p75 ◽

2017 ◽

Vol 4 (1) ◽

pp. 75 ◽

Cited By ~ 1

Author(s):

Jack Xu ◽

Peyton Davis Card ◽

Evan Watts ◽

Guillermo A. Escobar ◽

Gareth Tobler ◽

...

Keyword(s):

Brachial Plexus ◽

Literature Search ◽

Brachial Plexus Injury ◽

Cephalic Vein ◽

Neurologic Injury ◽

Icd Implantation ◽

Cardiac Device ◽

Cardioverter Defibrillator ◽

Device Implantation ◽

First Case

In this article we discuss two cases that highlight possible complications of cardiac device implantation. In particular, our first case involves a patient who, during implantable cardioverter defibrillator (ICD) implantation, sustained injuries to her subclavian artery and vein and subsequently developed a self-resolving neuropraxia of the brachial plexus. In our second case, the patient, also during ICD implantation, had his left cephalic vein nicked during cutdown. Post-op he then developed a hematoma-induced left brachial plexus injury that also eventually self-resolved. A literature search has not shown other incidences of iatrogenic brachial plexus injuries from ICD implantation as described.

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Abstract 16238: Mortality and Predictors of Appropriate ICD Therapy in Japanese Primary Prevention Patients: A 13-year Experience Based on the MADIT2 Criteria

Circulation ◽

10.1161/circ.130.suppl_2.16238 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Yoshimori An ◽

Kenji Ando ◽

Michio Nagashima ◽

Masato Fukunaga ◽

Kenichi Hiroshima ◽

...

Keyword(s):

Primary Prevention ◽

Cox Regression ◽

Biventricular Pacing ◽

Nyha Class ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Icd Implantation ◽

Ventricular Ejection Fraction ◽

Icd Therapy

Background: There are still limited data on the mortality for a long-term follow-up and the clinical factors influencing appropriate therapies in Japanese patients with implantable cardioverter-defibrillator (ICD) for primary prevention, who satisfied the criteria in Multicenter Automatic Defibrillator Implantation Trial 2 (MADIT2). Methods: Between January 2000 and December 2012, a total of 436 patients without prior ventricular arrhythmic event underwent ICD implantation for primary prevention at our institution. Among these patients, we enrolled consecutive 122 patients (69±10 years, male: 84%, biventricular-pacing: 54%, median follow-up: 1390 days) who met the MADIT2 criteria; left ventricular ejection fraction (LVEF) ≤30% with ischemic heart disease, more than 4 weeks after myocardial infarction. Results: At the 3 years of follow-up, the mortality rate (21%) was comparable with that of the original MADIT2 ICD group (20%). The Kaplan-Meier event rate for appropriate ICD therapy (shock and anti-tachycardia pacing therapy) (35%) was also similar to that of the original MADIT2 ICD group (32%). Multivariate analysis by Cox regression model revealed that left ventricular diastolic diameter (LVDd) ≥60mm (Hazard Ratio [HR]: 1.65, 95% Confidence Interval [CI]: 1.16-2.14, P=0.004) and non-sustained ventricular tachycardia (NSVT) (HR: 1.55, 95%CI: 1.13-2.15, P=0.007) were independent predictors for appropriate ICD therapy. On the other hand, LVEF, NYHA class, biventricular-pacing, amiodarone or inducibility of ventricular arrhythmia was not associated with appropriate ICD therapy. Conclusion: Appropriate ICD therapy was delivered in Japanese primary prevention patients as often as in the original MADIT2 ICD group and strongly predicted by dilated left ventricle and NSVT.

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Abstract 86: Rates and Association of Risk Factors with Device Infection in Veterans Undergoing Cardioverter-Defibrillator Implantation Enrolled in the OVID Registry

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.6.suppl_1.a86 ◽

2013 ◽

Vol 6 (suppl_1) ◽

Author(s):

Preston M Schneider ◽

David F Katz ◽

Cara N Pelligrini ◽

Paul A Heidenreich ◽

Ryan G Aleong ◽

...

Keyword(s):

Proportional Hazards ◽

A Priori ◽

Cox Proportional Hazards ◽

Icd Implantation ◽

Cardiac Device ◽

Cardioverter Defibrillator ◽

Increased Risk ◽

Device Infection ◽

Social Security Death Index

Introduction: Implanted cardiac device infections are a source of significant morbidity, mortality, and cost. The rates and predictors of device infection among patients undergoing implantable cardioverter defibrillator (ICD) implantation in the VA population have not been previously described. Methods: Among veterans enrolled in the Outcomes among Veterans with Implantable Defibrillators (OVID) registry between 2003 and 2009, 3,918 were identified as within 3 months of initial ICD implantation. Baseline clinical characteristics and clinical outcomes were abstracted from the electronic medical record and social security death index. The rates of device infection were calculated per 100 person years and a priori specified predictors of device infection were examined for association with device infection using Cox proportional hazards regression. Results: Over 11,290 person years of follow up, only 76 device infections were identified for a rate of 0.67 per 100 person years (95% CI 0.54 to 0.84). Among these, 21 (27.6%) occurred within 30 days of implantation, 19 (25.0%) occurred 30 to 90 days after implantation, 8 (10.5%) occurred 90 days to 1 year after implantation, and 28 occurred greater than 1 year after implantation. The most common type of infection was a pocket infection and it was most likely to occur within 30 days of implantation. Of the examined a priori specified predictors (age, generator change, diabetes mellitus, warfarin use, chronic kidney disease and congestive heart failure), only generator change was statistically significantly associated with device infection when adjusted for comorbidities (adjusted HR 2.95; 95% CI 1.42 - 6.12). The rate of device infection among those with a generator change was 1.26 per 100 person years compared to 0.60 per 100 person years for those without a generator change. Conclusions: The overall rate of device infection in this population is lower than previously published rates and only generator change was associated with an increased risk of device infection.

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