Infection within 180 Days of Cardiac Implantable Electronic Device (CIED) Implantation,

Measure Specification

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, coronary sinus lead, device upgrade/malfunction as the last surgery, peri-ICD implant complications, and non-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 et al, 2006; Cabell et al, 2004; Voigt et al, 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, 2011; Borleffs et al, 2010; Sohail et al, 2007; Bloom et al, 2006; Baddour et al, 2010; Le KY 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 et al, 2006; Cabell et al, 2004; Voigt et al, 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, 2011; 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.

This measure contains two strata defined by two submission criteria. This measure produces a single performance rate using a weighted average. There are 2 Submission Criteria for this measure: 1) Patients, regardless of age, with a new CIED OR 2) Patients, regardless of age, with a replaced or revised CIED Additional submitting stratification categories may be useful; however, these stratifications are not required for purposes of QPP submission: • Device class (e.

g., pacemaker, ICD) and type (e.g., single chamber, dual chamber); • Advanced renal disease (CKD stages 4 and 5, ESRD); • Diabetes; • CIED infection requiring device removal within 180 days prior to index CIED procedures; and • CIED-related surgical procedure within 180 days prior to current CIED procedure. For the purposes of MIPS implementation, this patient-process measure is submitted a minimum of once per patient for the performance period.

The most advantageous QDC will be used if the measure is submitted more than once. This is an inverse measure which means a lower calculated performance rate for this measure indicates better clinical care or control. The “Performance Not Met” numerator option for this measure is the representation of the better clinical quality or control. Submitting that numerator option will produce a performance rate that trends closer to 0%, as quality increases.

For inverse measures, a rate of 100% means all of the denominator eligible patients did not receive the appropriate care or were not in proper control. Include only patients that have had CIED implantation, replacement, or revision performed by June 30, 2026. This timeframe allows for evaluation of infection required within 180 days within the performance period.

This will allow the evaluation of infection status post CIED implantation, replacement, or revision within the performance period. Infection rates for new implants shall be calculated and submitted separately from device replacements and revisions. A new device would be either the first device OR a device implanted with new functionality.