Skip to main content

The AHRQ National Quality Measures Clearinghouse (NQMC, qualitymeasures.ahrq.gov) Web site will not be available after July 16, 2018 because federal funding
through AHRQ will no longer be available to support the NQMC as of that date. For additional information, read our full announcement.
  • Measure Summary
  • NQMC:010881
  • Dec 2015

Cardiovascular implantable electronic device (CIED): infection rate following CIED device implantation, replacement, or revision.

Heart Rhythm Society (HRS). HRS-9: infection within 180 days of cardiac implantable electronic device (CIED) implantation, replacement, or revision. Washington (DC): Heart Rhythm Society (HRS); 2015 Dec 18. 11 p.

This is the current release of the measure.

Primary Measure Domain

Clinical Quality Measures: Outcome

Secondary Measure Domain

Does not apply to this measure

Description

This measure is used to assess the infection rate following cardiovascular implantable electronic device (CIED) device implantation, replacement, or revision.

This measure is to be reported a minimum of once per reporting period for patients with a CIED device implantation, replacement, or revision performed from January 1, 2016 through June 30, 2016 of the reporting period. This measure may be reported by clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.

Infection rates for new implants shall be calculated and reported separately from device replacements and revisions.

There are two reporting criteria for this measure:

  1. Patients, regardless of age, with a new CIED
  2. Patients, regardless of age, with a replaced or revised CIED

Rationale

The rate of implantable cardioverter-defibrillator (ICD) infections has been increasing faster than that of device implantation and is associated with substantial morbidity, mortality, and financial cost. A recent study including over 200,000 ICD implant patients found 2 percent of patients undergoing ICD implantation experienced a device-related infection. Patients who developed an ICD infection were likely to have more comorbidity burden, warfarin use, and coronary sinus lead, device upgrade/malfunction as the last surgery, peri-ICD implant complications, and non-eligible professional (EP) trained operator. The evidence demonstrates the need to measure performance in this area.

In recognition that there is an absence of applicable physician-level performance measures for the profession of cardiac electrophysiology, the Heart Rhythm Society (the international professional society focused on the care of patients with heart rhythm disorders) convened a Performance Measures Development Task Force to consider and develop potential physician-level measures for cardiac electrophysiologists. The task force consisted of thought leaders in 1) implantation of cardiac implantable electronic devices (CIEDs) including pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization devices (pacemaker or ICD); and implantable loop recorders (ILRs), 2) cardiovascular health policy, 3) performance measures development, 4) clinical outcomes, and 5) population science. The process for consideration of the evidence included review of the relevant literature referenced within this document and in the knowledge of the members of the task force (Voigt, Shalaby, & Saba, 2006; Cabell et al., 2004; Voigt, Shalaby, & Saba, 2010; Greenspon et al., 2011; Sohail et al., 2011; Nery et al., 2010; Ferguson et al., 1996; Uslan et al., 2007; Lee et al., 2010; Klug et al., 2007; Alter et al., 2005; Al-Khatib et al., 2008; de Oliveira et al., 2009; Uslan et al., 2012; Borleffs et al., 2010; Sohail et al., 2007; Bloom et al., 2006; Baddour et al., 2010; Le et al., 2011; Johansen et al., 2011; Al-Khatib et al., 2005; Tarakji et al., 2010).

The number of CIED-related infections in the United States continues to increase out of proportion to the increase in the CIED implantation rates (Voigt, Shalaby, & Saba, 2006; Cabell et al., 2004; Voigt, Shalaby, & Saba, 2010). This infection burden is associated with increased mortality, prolonged hospital stays and high financial costs (Greenspon et al., 2011; Sohail et al., 2011; Ferguson et al., 1996). Collectively, the incidence of CIED infection has ranged from 0.3% to 2.9% across the literature evaluated (Greenspon et al., 2011; Sohail et al., 2011; Nery et al., 2010; Uslan et al., 2007; Lee et al., 2010; Klug et al., 2007; Alter et al., 2005; Al-Khatib et al., 2008; Uslan et al., 2012; Bloom et al., 2006; Baddour et al., 2010; Johansen et al., 2011). In the vast majority of patients, CIED infection is preventable, and an association between a higher volume of ICD implants and a lower rate of infections has been demonstrated (Tarakji et al., 2010). This is why a performance measure that could lower the risk of CIED infection is critically needed.

Evidence for Rationale

Al-Khatib SM, Greiner MA, Peterson ED, Hernandez AF, Schulman KA, Curtis LH. Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002-2005. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):240-9. PubMed External Web Site Policy

Al-Khatib SM, Lucas FL, Jollis JG, Malenka DJ, Wennberg DE. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol. 2005 Oct 18;46(8):1536-40. PubMed External Web Site Policy

Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol. 2005 Sep;28(9):926-32. PubMed External Web Site Policy

Baddour LM, Epstein AE, Erickson CC, Knight BP, Levison ME, Lockhart PB, Masoudi FA, Okum EJ, Wilson WR, Beerman LB, Bolger AF, Estes NA 3rd, Gewitz M, Newburger JW, Schron EB, Taubert KA, American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in Young, Council on Cardiovascular Surgery and Anesthesia, Council on Cardiovascular Nursing, Council on Clinical Cardiology, Interdisciplinary Council on Quality of Care, American Heart Association. Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association. Circulation. 2010 Jan 26;121(3):458-77. PubMed External Web Site Policy

Bloom H, Heeke B, Leon A, Mera F, Delurgio D, Beshai J, Langberg J. Renal insufficiency and the risk of infection from pacemaker or defibrillator surgery. Pacing Clin Electrophysiol. 2006 Feb;29(2):142-5. PubMed External Web Site Policy

Borleffs CJW, Thijssen J, de Bie MK, van Rees JB, van Welsenes GH, van Erven L, Bax JJ, Cannegieter SC, Schalij MJ. Recurrent implantable cardioverter-defibrillator replacement is associated with an increasing risk of pocket-related complications. Pacing Clin Electrophysiol. 2010 Aug;33(8):1013-9. PubMed External Web Site Policy

Cabell CH, Heidenreich PA, Chu VH, Moore CM, Stryjewski ME, Corey GR, Fowler VG Jr. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999. Am Heart J. 2004 Apr;147(4):582-6. PubMed External Web Site Policy

de Oliveira JC, Martinelli M, Nishioka SA, Varejao T, Uipe D, Pedrosa AA, Costa R, D'Avila A, Danik SB. 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 Feb;2(1):29-34. PubMed External Web Site Policy

Ferguson TB Jr, Ferguson CL, Crites K, Crimmins-Reda P. The additional hospital costs generated in the management of complications of pacemaker and defibrillator implantations. J Thorac Cardiovasc Surg. 1996 Apr;111(4):742-51; discussion 751-2. PubMed External Web Site Policy

Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. PubMed External Web Site Policy

Heart Rhythm Society (HRS). HRS-9: infection within 180 days of cardiac implantable electronic device (CIED) implantation, replacement, or revision. Washington (DC): Heart Rhythm Society (HRS); 2015 Dec 18. 11 p.

Johansen JB, Jørgensen OD, Møller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. 2011 Apr;32(8):991-8. PubMed External Web Site Policy

Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S, PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007 Sep 18;116(12):1349-55. PubMed External Web Site Policy

Le KY, Sohail MR, Friedman PA, Uslan DZ, Cha SS, Hayes DL, Wilson WR, Steckelberg JM, Baddour LM, Mayo Cardiovascular Infections Study Group. Clinical predictors of cardiovascular implantable electronic device-related infective endocarditis. Pacing Clin Electrophysiol. 2011 Apr;34(4):450-9. PubMed External Web Site Policy

Lee DS, Krahn AD, Healey JS, Birnie D, Crystal E, Dorian P, Simpson CS, Khaykin Y, Cameron D, Janmohamed A, Yee R, Austin PC, Chen Z, Hardy J, Tu JV, Investigators of the Ontario ICD Database. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010 Feb 23;55(8):774-82. PubMed External Web Site Policy

Nery PB, Fernandes R, Nair GM, Sumner GL, Ribas CS, Menon SM, Wang X, Krahn AD, Morillo CA, Connolly SJ, Healey JS. Device-related infection among patients with pacemakers and implantable defibrillators: incidence, risk factors, and consequences. J Cardiovasc Electrophysiol. 2010 Jul;21(7):786-90. PubMed External Web Site Policy

Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011 Nov 14;171(20):1821-8. PubMed External Web Site Policy

Sohail MR, Uslan DZ, Khan AH, Friedman PA, Hayes DL, Wilson WR, Steckelberg JM, Stoner SM, Baddour LM. Risk factor analysis of permanent pacemaker infection. Clin Infect Dis. 2007 Jul 15;45(2):166-73. PubMed External Web Site Policy

Tarakji K, Chan EJ, Cantillon DJ, Doonan AL, Hu T, Schmitt S, Fraser TG, Kim A, Gordon SM, Wilkoff BL. Cardiac implantable electronic device infections: presentation, management, and patient outcomes. Heart Rhythm. 2010 Aug;7(8):1043-7. PubMed External Web Site Policy

Uslan DZ, Gleva MJ, Warren DK, Mela T, Chung MK, Gottipaty V, Borge R, Dan D, Shinn T, Mitchell K, Holcomb RG, Poole JE. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012 Jan;35(1):81-7. PubMed External Web Site Policy

Uslan DZ, Sohail MR, St Sauver JL, Friedman PA, Hayes DL, Stoner SM, Wilson WR, Steckelberg JM, Baddour LM. Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. Arch Intern Med. 2007 Apr 9;167(7):669-75. PubMed External Web Site Policy

Voigt A, Shalaby A, Saba S. Continued rise in rates of cardiovascular implantable electronic device infections in the United States: temporal trends and causative insights. Pacing Clin Electrophysiol. 2010 Apr;33(4):414-9. PubMed External Web Site Policy

Voigt A, Shalaby A, Saba S. Rising rates of cardiac rhythm management device infections in the United States: 1996 through 2003. J Am Coll Cardiol. 2006 Aug 1;48(3):590-1.

Primary Health Components

Cardiovascular implantable electronic device (CIED) implantation, replacement, or revision; infection rate

Denominator Description

Reporting Criteria 1: All patients with a new cardiovascular implantable electronic device (CIED) from January 1 through June 30 of the reporting period

Reporting Criteria 2: All patients with replacement or revision of a CIED from January 1 through June 30 of the reporting period

See the related "Denominator Inclusions/Exclusions" field.

Numerator Description

Reporting Criteria 1: The number of patients from the denominator admitted with an infection requiring device removal or surgical revision within 180 days following cardiovascular implantable electronic device (CIED) implantation, replacement, or revision

Reporting Criteria 2: The number of patients from the denominator admitted with an infection requiring device removal or surgical revision within 180 days following CIED implantation, replacement, or revision

See the related "Numerator Inclusions/Exclusions" field.

Type of Evidence Supporting the Criterion of Quality for the Measure

  • A formal consensus procedure, involving experts in relevant clinical, methodological, public health and organizational sciences
  • One or more research studies published in a National Library of Medicine (NLM) indexed, peer-reviewed journal

Additional Information Supporting Need for the Measure

Unspecified

Extent of Measure Testing

Unspecified

State of Use

Current routine use

Current Use

Internal quality improvement

Pay-for-reporting

Public reporting

Measurement Setting

Hospital Inpatient

Hospital Outpatient

Professionals Involved in Delivery of Health Services

Physicians

Least Aggregated Level of Services Delivery Addressed

Individual Clinicians or Public Health Professionals

Statement of Acceptable Minimum Sample Size

Does not apply to this measure

Target Population Age

All patients, regardless of age

Target Population Gender

Either male or female

National Quality Strategy Aim

Better Care

National Quality Strategy Priority

Making Care Safer
Prevention and Treatment of Leading Causes of Mortality

IOM Care Need

Living with Illness

IOM Domain

Effectiveness

Safety

Case Finding Period

January 1 through June 30 of the reporting period

Denominator Sampling Frame

Patients associated with provider

Denominator (Index) Event or Characteristic

Encounter

Institutionalization

Therapeutic Intervention

Denominator Time Window

Does not apply to this measure

Denominator Inclusions/Exclusions

Inclusions
Reporting Criteria 1: All patients with a new cardiovascular implantable electronic device (CIED) from January 1 through June 30 of the reporting period

Denominator Criteria (Eligible Cases) Reporting Criteria 1:

All patients, regardless of age

AND

Codes for CIED implantation, replacement, or revision (refer to the original measure documentation for International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM], International Classification of Diseases, Tenth Revision, Procedure Coding System [ICD-10-PCS] procedure codes)

AND/OR

Patient encounter during reporting period (refer to the original measure documentation for Current Procedural Terminology [CPT] codes)

AND

New CIED

AND NOT

Patients undergoing heart transplantation (refer to the original measure documentation for ICD-10-PCS procedure codes)

Reporting Criteria 2: All patients with replacement or revision of a CIED from January 1 through June 30 of the reporting period

Denominator Criteria (Eligible Cases) Reporting Criteria 2:

All patients, regardless of age

AND

Codes for CIED implantation, replacement, or revision (refer to the original measure documentation for ICD-10-CM, ICD-10-PCS procedure codes)

AND/OR

Patient encounter during reporting period (refer to the original measure documentation for CPT codes)

AND

Replaced or revised CIED

AND NOT

Patients undergoing heart transplantation (refer to the original measure documentation for ICD-10-PCS procedure codes)

Note:

  • CIEDs encompassed for this measure are the following devices:
    • Pacemaker devices (single or dual chamber);
    • Implantable cardioverter-defibrillators (ICDs, single or dual chamber);
    • Cardiac resynchronization devices (pacemaker or ICD);
    • Implantable loop recorders (ILRs)
  • Include only patients that have had CIED implantation, replacement, or revision performed by June 30. This timeframe allows for evaluation of infection requiring within 180 days within the reporting period. This will allow the evaluation of infection status post CIED implantation, replacement, or revision within the reporting year.

Exclusions
None

Exclusions/Exceptions

None

Numerator Inclusions/Exclusions

Inclusions
Reporting Criteria 1: The number of patients from the denominator admitted with an infection requiring device removal or surgical revision within 180 days following cardiovascular implantable electronic device (CIED) implantation, replacement, or revision

Reporting Criteria 2: The number of patients from the denominator admitted with an infection requiring device removal or surgical revision within 180 days following CIED implantation, replacement, or revision

Note: Refer to the original measure documentation for administrative codes.

Exclusions
None

Numerator Search Strategy

Fixed time period or point in time

Data Source

Administrative clinical data

Registry data

Type of Health State

Adverse Health State

Instruments Used and/or Associated with the Measure

  • 2016 Registry Individual Measure Flow: PQRS #393: HRS-9: Infection Within 180 Days of Cardiac Implantable Electronic Device (CIED) Implantation, Replacement, or Revision - Reporting Criteria One
  • 2016 Registry Individual Measure Flow: PQRS #393: HRS-9: Infection Within 180 Days of Cardiac Implantable Electronic Device (CIED) Implantation, Replacement, or Revision - Reporting Criteria Two

Measure Specifies Disaggregation

Measure is disaggregated into categories based on different definitions of the denominator and/or numerator

Basis for Disaggregation

There are two reporting criteria for this measure:

Reporting Criteria 1: Patients, regardless of age, with a new cardiovascular implantable electronic device (CIED)

  • Denominator: All patients with a new CIED from January 1 through June 30 of the reporting period
  • Numerator: The number of patients from the denominator admitted with an infection requiring device removal or surgical revision within 180 days following cardiovascular CIED implantation, replacement, or revision

Reporting Criteria 2: Patients, regardless of age, with a replaced or revised CIED

  • Denominator: All patients with replacement or revision of a CIED from January 1 through June 30 of the reporting period
  • Numerator: The number of patients from the denominator admitted with an infection requiring device removal or surgical revision within 180 days following CIED implantation, replacement, or revision

Scoring

Rate/Proportion

Interpretation of Score

Desired value is a lower score

Allowance for Patient or Population Factors

Unspecified

Standard of Comparison

External comparison at a point in, or interval of, time

External comparison of time trends

Internal time comparison

Original Title

HRS-9: infection within 180 days of cardiac implantable electronic device (CIED) implantation, replacement, or revision.

Submitter

Heart Rhythm Society - Disease Specific Society

Developer

Heart Rhythm Society - Disease Specific Society

Funding Source(s)

Unspecified

Composition of the Group that Developed the Measure

Unspecified

Financial Disclosures/Other Potential Conflicts of Interest

Unspecified

Measure Initiative(s)

Physician Quality Reporting System

Adaptation

This measure was not adapted from another source.

Date of Most Current Version in NQMC

2015 Dec

Measure Maintenance

Unspecified

Date of Next Anticipated Revision

Unspecified

Measure Status

This is the current release of the measure.

Source(s)

Heart Rhythm Society (HRS). HRS-9: infection within 180 days of cardiac implantable electronic device (CIED) implantation, replacement, or revision. Washington (DC): Heart Rhythm Society (HRS); 2015 Dec 18. 11 p.

Measure Availability

Source not available electronically.

For more information, contact the Heart Rhythm Society (HRS) at 1325 G Street, NW, Suite 400, Washington, DC 20005; Phone: 202-464-3400; Fax: 202-464-3401; E-mail: info@HRSonline.org; Web site: www.hrsonline.org External Web Site Policy.

NQMC Status

This NQMC summary was completed by ECRI Institute on June 21, 2016. The information was verified by the measure developer on July 7, 2016.

Copyright Statement

This NQMC summary is based on the original measure, which is subject to the measure developer's copyright restrictions.

NQMC Disclaimer

The National Quality Measures Clearinghouse™ (NQMC) does not develop, produce, approve, or endorse the measures represented on this site.

All measures summarized by NQMC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public and private organizations, other government agencies, health care organizations or plans, individuals, and similar entities.

Measures represented on the NQMC Web site are submitted by measure developers, and are screened solely to determine that they meet the NQMC Inclusion Criteria.

NQMC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or its reliability and/or validity of the quality measures and related materials represented on this site. Moreover, the views and opinions of developers or authors of measures represented on this site do not necessarily state or reflect those of NQMC, AHRQ, or its contractor, ECRI Institute, and inclusion or hosting of measures in NQMC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding measure content are directed to contact the measure developer.

About NQMC Measure Summaries

NQMC provides structured summaries containing information about measures and their development.

Measure Summary FAQs


Measure Summaries

New This Week

View more and sign up for our Newsletter

Get Adobe Reader