Cardiac Implanted Electronic Device-Related Infective Endocarditis: Clinical Features, Management, and Outcomes of 80 Consecutive Patients DAVID H. KIM, M.D.,* JESALYN TATE, B.S.,* WILLIAM F. DRESEN, M.D.,† FRANK C. PAPA JR., PH.D.,* KAREN C. BLOCH, M.D., M.P.H.,‡,§ SPYROS A. KALAMS, M.D.,‡ CHRISTOPHER R. ELLIS, M.D.,* MICHAEL T. BAKER, M.D.,* DANIEL J. LENIHAN, M.D.,* and LISA A. MENDES, M.D.* From the *Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; †Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; ‡Division of Infectious Disease, Vanderbilt University Medical Center, Nashville, Tennessee; and §Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
Background: The use of cardiac implantable electronic devices (CIEDs) has expanded dramatically over the past decade, but net clinical benefit has been curtailed by increasing infectious complications. In particular, CIED-related infectious endocarditis (IE) is a serious condition with significant morbidity and mortality. Methods: We performed a single-center, retrospective study between July 2006 and February 2011 with CIED-related IE, defined by either lead vegetations detected on echocardiography or by fulfilling Duke criteria for definite endocarditis. Clinical parameters and outcomes were detailed by electronic medical record review and vital status was confirmed by the Social Security Death Index. Results: Eighty patients (median age 67, interquartile range 56–75, 58 M/22 F) were diagnosed with CIED-related IE. Overall mortality was 36% with a median time to death of 95 days from presentation. Over half (52%) of the deaths were infection related with a median time to death of 29 days. Multivariate analysis showed methicillin-resistant Staphylococcus aureus (MRSA) infection (odds ratio [OR] 0.158; 95% confidence interval [CI], 0.047–0.534; P = .003) and concomitant valve endocarditis (OR 0.141, CI 0.041–0.491, P = .002) independently predicted mortality. Conclusion: In this contemporary series, all-cause mortality in patients with CIED-related IE was high with a short time to death from onset of infection. MRSA and concomitant valve infection were the most powerful independent predictors of mortality. (PACE 2014; 37:978–985) endocarditis, pacemaker, ICD, echocardiography
Introduction Cardiac implantable electronic devices (CIEDs), including permanent pacemakers (PPMs) and implantable cardioverter defibrillators (ICDs), Disclosures: Christopher R. Ellis: 1. Research grants (significant): Boston Scientific, Thoratec and Heartmate, Boehringer, Ingelheim. 2. Consulting fees: TyRx Pharmaceuticals. Daniel J. Lenihan: 1. Research grants (significant): Acorda. 2. Consultant fees: Roche, Astrazeneca, Onyx, Oncomed, Singulex. Michael T. Baker, David H. Kim, Jesalyn Tate, William F. Dresen, Frank C. Papa, Karen C. Bloch, Spyros A. Kalams, Lisa A. Mendes: None. Address for reprints: David H Kim, M.D., Division of Cardiology, Vanderbilt Heart and Vascular Institute, 5414 Medical Center East, Nashville, TN 37232-8802. Fax: 615-9361872; e-mail: [email protected] Received February 14, 2014; revised April 16, 2014; accepted May 26, 2014. doi: 10.1111/pace.12452
have had a dramatic increase in utilization since 2000, owing largely to broader indications for device implantation as well as an aging population.1–6 Between the years of 1993 and 2008, 4.2 million primary devices were implanted7 ; however, clinical benefits have been offset by cardiac device infections, which range from 0.7% to 7.0% of all implanted devices.8 The number of cardiac device infections has increased by 210% from 1993 to 2008, outpacing the 96% increase in device implantation rate over the same period, largely owing to repeated device pocket entry and manipulation for generator changes and device upgrades.7,9–11 CIED-related infectious endocarditis (IE) is a particularly serious infectious complication with significant morbidity and mortality,10,12 being present in up to 23% of all cardiac device infections. Reported mortality rates of CIED-related IE range from 10.0% to 23.2%.8,12,13 The objective of this observational study is to examine the clinical
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characteristics and outcomes of CIED-related IE in a contemporary, tertiary referral center experience. Methods We performed a retrospective review of the medical records of patients with CIED-related IE treated at Vanderbilt University Medical Center between July 2006 and February 2011. The cases were identified through the Allscripts (TSI) Decision Support System, which provides a direct access to audited clinical, financial, and operational data across Vanderbilt University Hospital. The study protocol was approved by the Vanderbilt Institutional Review Board. Patient Selection and Data Collection Patients were identified by discharge diagnosis according to the International Classification of Diseases—9th Revision-Clinical Modification (ICD-9-CM) code of 996.61, which denotes infection and inflammatory reaction due to a cardiac device, implant, or graft. Each record was individually reviewed and adult patients (age >18 years) with definite endocarditis in the setting of a cardiac device were included in the study. Native or prosthetic valve endocarditis in the absence of a cardiac device, and pocket infections without evidence of bloodstream infection, were excluded. Study data included 187 variables that were collected and managed using the Research Electronic Data Capture (REDCap) database, a secure, web-based application designed to support data capture for research studies hosted at Vanderbilt University.14 Clinical characteristics included demographics and comorbid conditions, such as congestive heart failure (HF), coronary artery disease, diabetes mellitus (DM), and endstage renal disease (ESRD). Records of recent dental work or indwelling catheter exposure as well as information regarding cardiac devices or prosthetic valves were collected. Details of the infection including symptoms, microbiology, antibiotics, echocardiographic findings, complications, management, and outcomes were recorded. Survival was followed in the medical record and confirmed by the Social Security Death Index. Definitions CIED-related IE was defined as either the presence of a lead and/or valvular vegetation on echocardiographic imaging or meeting modified Duke Criteria for definite infective endocarditis.15 An indwelling catheter was defined as a central venous catheter, long-term venous tunneled, or port catheter inserted within 6 months of the index infection. The onset of infection was defined as either the date of echocardiographic evidence
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of a lead/valvular vegetation or the first positive blood culture. Infection-related death was defined as loss of life directly related to complications of infective endocarditis, or all-cause death in the setting of persistent bacteremia or while on antibiotic therapy. Infection eradication was defined as resolution of symptoms and clearance of blood cultures following a completed course of antibiotics, at least 6 weeks following infection date. Statistical Analysis Data are presented as median with interquartile range for continuous variables and as percentages for categorical variables. Data were analyzed by analysis of variance for continuous variables or in two-by-two tables using the χ 2 test or Fisher exact test for categorical variables. A P value of
Background: The use of cardiac implantable electronic devices (CIEDs) has expanded dramatically over the past decade, but net clinical benefit has been curtailed by increasing infectious complications. In particular, CIED-related infectious endocarditis (IE) is a serious condition with significant morbidity and mortality. Methods: We performed a single-center, retrospective study between July 2006 and February 2011 with CIED-related IE, defined by either lead vegetations detected on echocardiography or by fulfilling Duke criteria for definite endocarditis. Clinical parameters and outcomes were detailed by electronic medical record review and vital status was confirmed by the Social Security Death Index. Results: Eighty patients (median age 67, interquartile range 56–75, 58 M/22 F) were diagnosed with CIED-related IE. Overall mortality was 36% with a median time to death of 95 days from presentation. Over half (52%) of the deaths were infection related with a median time to death of 29 days. Multivariate analysis showed methicillin-resistant Staphylococcus aureus (MRSA) infection (odds ratio [OR] 0.158; 95% confidence interval [CI], 0.047–0.534; P = .003) and concomitant valve endocarditis (OR 0.141, CI 0.041–0.491, P = .002) independently predicted mortality. Conclusion: In this contemporary series, all-cause mortality in patients with CIED-related IE was high with a short time to death from onset of infection. MRSA and concomitant valve infection were the most powerful independent predictors of mortality. (PACE 2014; 37:978–985) endocarditis, pacemaker, ICD, echocardiography
Introduction Cardiac implantable electronic devices (CIEDs), including permanent pacemakers (PPMs) and implantable cardioverter defibrillators (ICDs), Disclosures: Christopher R. Ellis: 1. Research grants (significant): Boston Scientific, Thoratec and Heartmate, Boehringer, Ingelheim. 2. Consulting fees: TyRx Pharmaceuticals. Daniel J. Lenihan: 1. Research grants (significant): Acorda. 2. Consultant fees: Roche, Astrazeneca, Onyx, Oncomed, Singulex. Michael T. Baker, David H. Kim, Jesalyn Tate, William F. Dresen, Frank C. Papa, Karen C. Bloch, Spyros A. Kalams, Lisa A. Mendes: None. Address for reprints: David H Kim, M.D., Division of Cardiology, Vanderbilt Heart and Vascular Institute, 5414 Medical Center East, Nashville, TN 37232-8802. Fax: 615-9361872; e-mail: [email protected] Received February 14, 2014; revised April 16, 2014; accepted May 26, 2014. doi: 10.1111/pace.12452
have had a dramatic increase in utilization since 2000, owing largely to broader indications for device implantation as well as an aging population.1–6 Between the years of 1993 and 2008, 4.2 million primary devices were implanted7 ; however, clinical benefits have been offset by cardiac device infections, which range from 0.7% to 7.0% of all implanted devices.8 The number of cardiac device infections has increased by 210% from 1993 to 2008, outpacing the 96% increase in device implantation rate over the same period, largely owing to repeated device pocket entry and manipulation for generator changes and device upgrades.7,9–11 CIED-related infectious endocarditis (IE) is a particularly serious infectious complication with significant morbidity and mortality,10,12 being present in up to 23% of all cardiac device infections. Reported mortality rates of CIED-related IE range from 10.0% to 23.2%.8,12,13 The objective of this observational study is to examine the clinical
©2014 Wiley Periodicals, Inc. 978
August 2014
PACE, Vol. 37
CARDIAC DEVICE-RELATED ENDOCARDITIS
characteristics and outcomes of CIED-related IE in a contemporary, tertiary referral center experience. Methods We performed a retrospective review of the medical records of patients with CIED-related IE treated at Vanderbilt University Medical Center between July 2006 and February 2011. The cases were identified through the Allscripts (TSI) Decision Support System, which provides a direct access to audited clinical, financial, and operational data across Vanderbilt University Hospital. The study protocol was approved by the Vanderbilt Institutional Review Board. Patient Selection and Data Collection Patients were identified by discharge diagnosis according to the International Classification of Diseases—9th Revision-Clinical Modification (ICD-9-CM) code of 996.61, which denotes infection and inflammatory reaction due to a cardiac device, implant, or graft. Each record was individually reviewed and adult patients (age >18 years) with definite endocarditis in the setting of a cardiac device were included in the study. Native or prosthetic valve endocarditis in the absence of a cardiac device, and pocket infections without evidence of bloodstream infection, were excluded. Study data included 187 variables that were collected and managed using the Research Electronic Data Capture (REDCap) database, a secure, web-based application designed to support data capture for research studies hosted at Vanderbilt University.14 Clinical characteristics included demographics and comorbid conditions, such as congestive heart failure (HF), coronary artery disease, diabetes mellitus (DM), and endstage renal disease (ESRD). Records of recent dental work or indwelling catheter exposure as well as information regarding cardiac devices or prosthetic valves were collected. Details of the infection including symptoms, microbiology, antibiotics, echocardiographic findings, complications, management, and outcomes were recorded. Survival was followed in the medical record and confirmed by the Social Security Death Index. Definitions CIED-related IE was defined as either the presence of a lead and/or valvular vegetation on echocardiographic imaging or meeting modified Duke Criteria for definite infective endocarditis.15 An indwelling catheter was defined as a central venous catheter, long-term venous tunneled, or port catheter inserted within 6 months of the index infection. The onset of infection was defined as either the date of echocardiographic evidence
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of a lead/valvular vegetation or the first positive blood culture. Infection-related death was defined as loss of life directly related to complications of infective endocarditis, or all-cause death in the setting of persistent bacteremia or while on antibiotic therapy. Infection eradication was defined as resolution of symptoms and clearance of blood cultures following a completed course of antibiotics, at least 6 weeks following infection date. Statistical Analysis Data are presented as median with interquartile range for continuous variables and as percentages for categorical variables. Data were analyzed by analysis of variance for continuous variables or in two-by-two tables using the χ 2 test or Fisher exact test for categorical variables. A P value of
