HHS Public Access Author manuscript Author Manuscript
JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09. Published in final edited form as: JACC Clin Electrophysiol. 2017 June ; 3(6): 632–634. doi:10.1016/j.jacep.2017.01.013.
Periprocedural Antibiotic Prophylaxis for Cardiac Implantable Electrical Device Procedures: Results From a Heart Rhythm Society Survey Anuj Basil, MD, Steven A. Lubitz, MD, MPH, Peter A. Noseworthy, MD, Matthew R. Reynolds, MD, MSc, Howard Gold, MD, David Yassa, MD, and Daniel Kramer, MD, MPH*
Author Manuscript
*Richard
and Susan Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, 4th Floor, Suite 440, Boston, Massachusetts 02215 Cardiac implantable electrical device (CIED) infections are morbid and costly, with incidence estimates ranging up to 2.0% to 3.0% or more (1,2). Use of perioperative antibiotics is the standard of care for CIED implantation (3), but there are no high-quality data supporting antibiotic prophylaxis after the closure of the incision for CIED implantation or any other surgical procedure (4). Thus, guidelines recommend only a single dose of preincision prophylactic antibiotics for CIED placement (3,5). However, actual practice patterns are not clear. Given the urgent need for careful stewardship of antimicrobial agents, we aimed to characterize antibiotic practice surrounding CIED procedures.
Author Manuscript
Physician members of the Heart Rhythm Society were eligible for survey participation and were recruited by e-mail (no honorarium). The study was approved by the Beth Israel Deaconess Medical Center Institutional Review Board.
Author Manuscript
The survey presented hypothetical cases of new pacemaker or implantable cardioverterdefibrillator (ICD) implantation, subcutaneous ICD implantation, pacemaker or ICD replacement, and implantable loop recorder implantation. For each scenario, physicians were asked to indicate whether their practice included any of the following: pre-incision intravenous antibiotics; antibiotic-impregnated pouch; pocket irrigation with antibiotic solution; and post-procedure intravenous, oral, or topical antibiotics. Next, we asked physicians to indicate clinical factors that influence decisions to extend antibiotics use, as well as circumstances in which agents targeting methicillin-resistant Staphylococcus aureus (MRSA) would be selected. Lastly, physicians were asked whether or not they believed postprocedure antibiotics to be the standard of care for either new or replacement CIED procedures, and if fear of medicolegal consequences influenced their practice. The survey was sent to 2,174 physicians, of whom 871 opened the e-mail and 164 completed the survey. Characteristics of study participants and selected responses to survey questions
Please note: Dr. Lubitz has received consulting fees from St. Jude Medical and research support from Biotronik and Boehringer Ingelheim. Dr. Reynolds has received consulting fees from Medtronic and St. Jude Medical. Dr. Kramer is supported by the Paul Beeson Career Development Award program (NIH-NIA K23045963) and the Greenwall Faculty Scholars in Bioethics program. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Basil et al.
Page 2
Author Manuscript
are noted in Table 1. Use of antibiotics after wound closure was considered to be the standard of care for both new pacemaker and ICD implants by 28% of respondents, and by 32% for replacement procedures, with 14% “not sure” for both scenarios. Only 10% of respondents identified medicolegal concerns as influencing decision making. Of note, 66% of providers indicated that they would not provide MRSA-active prophylaxis in patients with nares screens positive for MRSA. Actual practice for antibiotics use according to different procedures is noted in Figure 1. Pre-incision prophylaxis for new and replacement pacemakers and ICD was nearly universal, but less common for subcutaneous ICD (92%) or implantable loop recorders (70%). Pocket irrigation with antibiotic solution (most commonly gentamicin, vancomycin, or both) was common (53% to 62%), whereas use of an antibiotic-impregnated pouch was more frequent for replacement procedures (16% vs. 6% for new implants).
Author Manuscript
A substantial proportion of physicians indicated that they would use additional postprocedure intravenous (25% to 50%) or oral (22% to 36%) antibiotics after closure of the wound. For implantable loop recorder implants, 70% used pre-incision antibiotics, but 29% used no antibiotics at all. Despite the morbidity of CIED infections and the need for meticulous adherence to evidence-based prevention, there is no high-quality evidence to support the practices of postprocedure antibiotic administration and antibiotic irrigation identified in our survey (3,4,6). Approaches to managing suspected MRSA-colonization—a risk factor for MRSA infection —similarly conflict with guidelines (3).
Author Manuscript
Though limited by our response rate and sample restriction to Heart Rhythm Society members, these findings resonate with a recent Centers for Disease Control report arguing for immediate implementation of more rational use of antibiotics across all specialties, aimed at reducing the more than 50% of all antibiotics use currently estimated to be inappropriate (7). As seen in other studies (6,8), current cardiology practice appears to vary widely and commonly includes usage contrary to the recommended single dose at the time of the procedure. This apparent overuse of antibiotics may contribute to bacterial resistance while needlessly exposing patients to adverse drug effects (9). Ongoing studies will hopefully provide further clarity on the utility of infection prophylaxis strategies (6,10), our study suggests that current practice is diffuse and greatly in need of standardization.
Author Manuscript
Acknowledgments The authors thank Alfred Buxton, MD, Westyn Branch-Elliman, MD, and Linda Valsdottir, MS, for their comments during survey development and the Heart Rhythm Society for its support in administration of the project.
References 1. Prutkin JM, Reynolds MR, Bao H, et al. Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation. 2014; 130:1037–43. [PubMed: 25081281]
JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
Basil et al.
Page 3
Author Manuscript Author Manuscript
2. Da Costa A, Kirkorian G, Cucherat M, et al. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation. 1998; 97:1796–801. [PubMed: 9603534] 3. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013; 70:195–283. [PubMed: 23327981] 4. Padfield GJ, Steinberg C, Bennett MT, et al. Preventing cardiac implantable electronic device infections. Heart Rhythm. 2015; 12:2344–56. [PubMed: 26142295] 5. de Oliveira JC, Martinelli M, Nishioka SA, et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009; 2:29–34. [PubMed: 19808441] 6. Connolly SJ, Philippon F, Longtin Y, et al. Randomized cluster crossover trials for reliable, efficient, comparative effectiveness testing: design of the Prevention of Arrhythmia Device Infection Trial (PADIT). Can J Cardiol. 2013; 29:652–8. [PubMed: 23702356] 7. Centers for Disease Control and Prevention. [Accessed March 10, 2016] Antibiotic Resistance Threats in the United States. 2013. Available at: http://www.cdc.gov/drugresistance/ threatreport-2013/pdf/ar-threats-2013-508.pdf 8. Uslan DZ, Gleva MJ, Warren DK, et al. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012; 35:81–7. [PubMed: 22077194] 9. Spellberg B, Srinivasn A, Chambers HF. New societal approaches to empowering antibiotic stewardship. JAMA. 2016; 315:1229–30. 10. Tarakji KG, Mittal S, Kennergren C, et al. Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT). Am Heart J. 2016; 180:12–21. [PubMed: 27659878]
Author Manuscript Author Manuscript JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
Basil et al.
Page 4
Author Manuscript Author Manuscript FIGURE 1. Infection Prophylaxis Strategies
Proportion of physicians indicating use of each of the listed approaches to infection prophylaxis for the indicated procedures. ICD = implantable cardioverter-defibrillator; PM = pacemaker; SQ-ICD = subcutaneous implantable cardioverter-defibrillator.
Author Manuscript Author Manuscript JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
Basil et al.
Page 5
TABLE 1
Author Manuscript
Characteristics of Survey Participants and Responses to Selected Queries Regarding Antibiotics Practice Percentage Response Participant Characteristics Geographic area United States
56.0
Europe
15.1
Number of years in practice 0–5
29.8
6–10
26.7
>10
42.5
Personal volume of annual pacemaker and/or ICD procedures
Author Manuscript
0–25
7.5
26–50
5.0
51–100
28.0
>100
59.6
Board certifications Internal medicine
42.9
Cardiovascular diseases
75.8
Clinical cardiac electrophysiology
78.9
Surgical specialty
2.5
Factors Influencing Extended Use of Antibiotics
Author Manuscript
No factor changes practice
40.6
Prior endovascular infection
36.9
Immunosuppression
33.8
Elderly patient
3.8
Diabetes
15.6
Artificial heart valve
14.4
Long-standing existing intravascular PM/ICD leads
8.8
Anticoagulation
2.5
Perceived high risk for infection
31.3
Situations in Which Operator Would Use Anti-MRSA Antibiotics
Author Manuscript
Allergy to cefazolin
62.5
Allergy to penicillins
57.5
Known history of MRSA infection
66.3
Hospital inpatient with stay >48 h
36.3
Positive nasal screen for MRSA
44.4
Long-standing intravascular PM/ICD leads
11.3
ICD = implantable cardioverter-defibrillator; MRSA = methicillin-resistant Staphylococcus aureus; PM = pacemaker.
JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09. Published in final edited form as: JACC Clin Electrophysiol. 2017 June ; 3(6): 632–634. doi:10.1016/j.jacep.2017.01.013.
Periprocedural Antibiotic Prophylaxis for Cardiac Implantable Electrical Device Procedures: Results From a Heart Rhythm Society Survey Anuj Basil, MD, Steven A. Lubitz, MD, MPH, Peter A. Noseworthy, MD, Matthew R. Reynolds, MD, MSc, Howard Gold, MD, David Yassa, MD, and Daniel Kramer, MD, MPH*
Author Manuscript
*Richard
and Susan Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, 4th Floor, Suite 440, Boston, Massachusetts 02215 Cardiac implantable electrical device (CIED) infections are morbid and costly, with incidence estimates ranging up to 2.0% to 3.0% or more (1,2). Use of perioperative antibiotics is the standard of care for CIED implantation (3), but there are no high-quality data supporting antibiotic prophylaxis after the closure of the incision for CIED implantation or any other surgical procedure (4). Thus, guidelines recommend only a single dose of preincision prophylactic antibiotics for CIED placement (3,5). However, actual practice patterns are not clear. Given the urgent need for careful stewardship of antimicrobial agents, we aimed to characterize antibiotic practice surrounding CIED procedures.
Author Manuscript
Physician members of the Heart Rhythm Society were eligible for survey participation and were recruited by e-mail (no honorarium). The study was approved by the Beth Israel Deaconess Medical Center Institutional Review Board.
Author Manuscript
The survey presented hypothetical cases of new pacemaker or implantable cardioverterdefibrillator (ICD) implantation, subcutaneous ICD implantation, pacemaker or ICD replacement, and implantable loop recorder implantation. For each scenario, physicians were asked to indicate whether their practice included any of the following: pre-incision intravenous antibiotics; antibiotic-impregnated pouch; pocket irrigation with antibiotic solution; and post-procedure intravenous, oral, or topical antibiotics. Next, we asked physicians to indicate clinical factors that influence decisions to extend antibiotics use, as well as circumstances in which agents targeting methicillin-resistant Staphylococcus aureus (MRSA) would be selected. Lastly, physicians were asked whether or not they believed postprocedure antibiotics to be the standard of care for either new or replacement CIED procedures, and if fear of medicolegal consequences influenced their practice. The survey was sent to 2,174 physicians, of whom 871 opened the e-mail and 164 completed the survey. Characteristics of study participants and selected responses to survey questions
Please note: Dr. Lubitz has received consulting fees from St. Jude Medical and research support from Biotronik and Boehringer Ingelheim. Dr. Reynolds has received consulting fees from Medtronic and St. Jude Medical. Dr. Kramer is supported by the Paul Beeson Career Development Award program (NIH-NIA K23045963) and the Greenwall Faculty Scholars in Bioethics program. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Basil et al.
Page 2
Author Manuscript
are noted in Table 1. Use of antibiotics after wound closure was considered to be the standard of care for both new pacemaker and ICD implants by 28% of respondents, and by 32% for replacement procedures, with 14% “not sure” for both scenarios. Only 10% of respondents identified medicolegal concerns as influencing decision making. Of note, 66% of providers indicated that they would not provide MRSA-active prophylaxis in patients with nares screens positive for MRSA. Actual practice for antibiotics use according to different procedures is noted in Figure 1. Pre-incision prophylaxis for new and replacement pacemakers and ICD was nearly universal, but less common for subcutaneous ICD (92%) or implantable loop recorders (70%). Pocket irrigation with antibiotic solution (most commonly gentamicin, vancomycin, or both) was common (53% to 62%), whereas use of an antibiotic-impregnated pouch was more frequent for replacement procedures (16% vs. 6% for new implants).
Author Manuscript
A substantial proportion of physicians indicated that they would use additional postprocedure intravenous (25% to 50%) or oral (22% to 36%) antibiotics after closure of the wound. For implantable loop recorder implants, 70% used pre-incision antibiotics, but 29% used no antibiotics at all. Despite the morbidity of CIED infections and the need for meticulous adherence to evidence-based prevention, there is no high-quality evidence to support the practices of postprocedure antibiotic administration and antibiotic irrigation identified in our survey (3,4,6). Approaches to managing suspected MRSA-colonization—a risk factor for MRSA infection —similarly conflict with guidelines (3).
Author Manuscript
Though limited by our response rate and sample restriction to Heart Rhythm Society members, these findings resonate with a recent Centers for Disease Control report arguing for immediate implementation of more rational use of antibiotics across all specialties, aimed at reducing the more than 50% of all antibiotics use currently estimated to be inappropriate (7). As seen in other studies (6,8), current cardiology practice appears to vary widely and commonly includes usage contrary to the recommended single dose at the time of the procedure. This apparent overuse of antibiotics may contribute to bacterial resistance while needlessly exposing patients to adverse drug effects (9). Ongoing studies will hopefully provide further clarity on the utility of infection prophylaxis strategies (6,10), our study suggests that current practice is diffuse and greatly in need of standardization.
Author Manuscript
Acknowledgments The authors thank Alfred Buxton, MD, Westyn Branch-Elliman, MD, and Linda Valsdottir, MS, for their comments during survey development and the Heart Rhythm Society for its support in administration of the project.
References 1. Prutkin JM, Reynolds MR, Bao H, et al. Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation. 2014; 130:1037–43. [PubMed: 25081281]
JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
Basil et al.
Page 3
Author Manuscript Author Manuscript
2. Da Costa A, Kirkorian G, Cucherat M, et al. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation. 1998; 97:1796–801. [PubMed: 9603534] 3. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013; 70:195–283. [PubMed: 23327981] 4. Padfield GJ, Steinberg C, Bennett MT, et al. Preventing cardiac implantable electronic device infections. Heart Rhythm. 2015; 12:2344–56. [PubMed: 26142295] 5. de Oliveira JC, Martinelli M, Nishioka SA, et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009; 2:29–34. [PubMed: 19808441] 6. Connolly SJ, Philippon F, Longtin Y, et al. Randomized cluster crossover trials for reliable, efficient, comparative effectiveness testing: design of the Prevention of Arrhythmia Device Infection Trial (PADIT). Can J Cardiol. 2013; 29:652–8. [PubMed: 23702356] 7. Centers for Disease Control and Prevention. [Accessed March 10, 2016] Antibiotic Resistance Threats in the United States. 2013. Available at: http://www.cdc.gov/drugresistance/ threatreport-2013/pdf/ar-threats-2013-508.pdf 8. Uslan DZ, Gleva MJ, Warren DK, et al. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012; 35:81–7. [PubMed: 22077194] 9. Spellberg B, Srinivasn A, Chambers HF. New societal approaches to empowering antibiotic stewardship. JAMA. 2016; 315:1229–30. 10. Tarakji KG, Mittal S, Kennergren C, et al. Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT). Am Heart J. 2016; 180:12–21. [PubMed: 27659878]
Author Manuscript Author Manuscript JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
Basil et al.
Page 4
Author Manuscript Author Manuscript FIGURE 1. Infection Prophylaxis Strategies
Proportion of physicians indicating use of each of the listed approaches to infection prophylaxis for the indicated procedures. ICD = implantable cardioverter-defibrillator; PM = pacemaker; SQ-ICD = subcutaneous implantable cardioverter-defibrillator.
Author Manuscript Author Manuscript JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
Basil et al.
Page 5
TABLE 1
Author Manuscript
Characteristics of Survey Participants and Responses to Selected Queries Regarding Antibiotics Practice Percentage Response Participant Characteristics Geographic area United States
56.0
Europe
15.1
Number of years in practice 0–5
29.8
6–10
26.7
>10
42.5
Personal volume of annual pacemaker and/or ICD procedures
Author Manuscript
0–25
7.5
26–50
5.0
51–100
28.0
>100
59.6
Board certifications Internal medicine
42.9
Cardiovascular diseases
75.8
Clinical cardiac electrophysiology
78.9
Surgical specialty
2.5
Factors Influencing Extended Use of Antibiotics
Author Manuscript
No factor changes practice
40.6
Prior endovascular infection
36.9
Immunosuppression
33.8
Elderly patient
3.8
Diabetes
15.6
Artificial heart valve
14.4
Long-standing existing intravascular PM/ICD leads
8.8
Anticoagulation
2.5
Perceived high risk for infection
31.3
Situations in Which Operator Would Use Anti-MRSA Antibiotics
Author Manuscript
Allergy to cefazolin
62.5
Allergy to penicillins
57.5
Known history of MRSA infection
66.3
Hospital inpatient with stay >48 h
36.3
Positive nasal screen for MRSA
44.4
Long-standing intravascular PM/ICD leads
11.3
ICD = implantable cardioverter-defibrillator; MRSA = methicillin-resistant Staphylococcus aureus; PM = pacemaker.
JACC Clin Electrophysiol. Author manuscript; available in PMC 2017 August 09.
