ABSTRACT
Background
Cardiac implantable electronic device (CIED) infections are a growing concern due to their associated high morbidity, mortality, and healthcare costs. Current guidelines given complete device and lead removal for CIED infection a class I recommendation, yet adherence to these guidelines is low with delays in extraction associated with poor adverse clinical events.
Obejctives
To determine the effect of implementation of quality improvement (QI) interventions on patients with CIED infections, including rates of extraction and time to extraction.
Methods
This is a prospective interventional study conducted across 3 U.S. health systems that employs QI interventions aimed at increasing early identification of CIED infections. The study will have a retrospective review of treatment of CIED infection patients, followed by a 6-month QI intervention period, and a 12-month prospective data collection period after the QI intervention. Eligible patients will have a CIED and a presumed CIED infection (pocket or systemic infection). The primary endpoints are the change in the number of extractions performed for CIED infections and the time to extraction during the study.
Conclusions
The REview and improvement of Cardiac implanTable device InFection qualitY initiative (RECTIFY) is a multi-center demonstration project aimed to identify and address health system-wide barriers to timely diagnosis and guideline-driven management of CIED infections.
Trial Registration: The trial was registered with the U.S. National Library of Medicine at the National Institutes of Health (NCT05471973).
Rationale for rectify: CIED infection demonstration project
Indications for cardiac implantable electronic devices (CIED) and rates of implantation have increased rapidly over the last 2 decades with more than 400,000 patients receiving new CIED implants every year in the United States (US) alone. , As the rates of CIED implantation have increased, so have device infections. CIED infections result in increased patient morbidity, mortality, and impose a significant financial burden on the US health-care system, averaging $55,000 per infection. ,
Cardiac implantable electronic device infections may manifest either systemically, with involvement of the bloodstream, or locally, involving the generator pocket. Systemic infections can present as occult bacteremia without evidence of vegetations on echocardiography or signs of pocket inflammation, as overt bacteremia, or as lead-associated endocarditis characterized by vegetations on intracardiac leads or valves. Pocket infections may remain confined to the device pocket, but they can also occur alongside bacteremia and/or be associated with vegetations involving leads or valves. , The diagnostic approach to CIED infections is inherently multi-modal and requires integration of physical examination of the device pocket, inflammatory markers, blood cultures, and imaging studies. Both transthoracic and transesophageal echocardiography can be used, and in some cases, more advanced imaging—such as fluorine-18-fluorodeoxyglucose positron emission tomography (FDG-PET) and radiolabeled white blood cell (WBC) scintigraphy—may be used enhance diagnostic sensitivity. Staphylococcal species account for 60% to 80% of device-related infections, whereas gram-negative bacilli are responsible for fewer than 10% of cases. Coagulase-negative staphylococci are the most common culprit pathogens in pocket infections and tend to be less virulent, often presenting with localized symptoms and minimal systemic involvement. In contrast, Staphylococcus aureus is the most virulent organism, frequently associated with more aggressive and systemic manifestations. Staphylococcal species are also capable of forming a protective biofilm on device surfaces, which significantly impairs antibiotic penetration and precludes infection eradication with medical therapy alone.
Once a diagnosis of CIED infection is established, clinical management becomes similarly complex and necessitates coordination among a multidisciplinary team, including specialists in cardiac electrophysiology, cardiac imaging, infectious diseases, and internal medicine. Antibiotic treatment alone for CIED infections is ineffective and may lead to adverse outcomes, including higher rates of infection relapse and mortality. ,, Complete device and lead removal in patients with definite CIED infection—whether confined to the local pocket, occult bacteremia, or infective endocarditis—is standard of care and carries Class I recommendations in clinical practice guidelines. ,, Despite these guidelines, it has been well documented that guideline adherence is suboptimal in daily practice. An analysis of Medicare beneficiaries revealed that more than 8 of 10 patients were not managed with a full system extraction, in adherence with Class I guidelines. Moreover, delayed extraction of the device for management of both systemic and pocket infections, defined as occurring more than 7 days after diagnosis, is associated with increased mortality, higher incidence of acute kidney injury, respiratory failure, and decompensated heart failure. ,
Understanding and overcoming barriers to definitive CIED infection management is crucial to improve patient outcomes and reduce health care costs. The American College of Cardiology conducted a survey to assess physicians’ current practices in diagnosis and management of CIED infections and to identify barriers to appropriate care. The survey found physicians are unfamiliar with best practices across all stages of CIED infection care from diagnosis to management. Specific barriers included identification and appropriate management of device infection, knowledge of when to refer for extraction, access to extraction, and perceived risk of complications.
Appropriate management of CIED infection is multi-faceted and includes surveillance, diagnosis, interim antibiotic management, appropriate timely referral, extraction, and postextraction care. Numerous potential barriers and gaps exist throughout this care pathway, which often result in suboptimal adherence to clinical guidelines. While some studies have demonstrated isolated improvements in specific aspects of the CIED infection care continuum, few have involved stakeholders in designing sustainable quality improvement (QI) interventions. ,,
Healthcare systems have the opportunity to operationalize improvements for CIED infection management across the care continuum by engaging stakeholders, leveraging the electronic health record, and streamlining appropriate diagnosis and definitive treatment. In turn, these steps can lead to improved patient outcomes and lower costs of care. The REview and improvement of Cardiac implanTable device InFection qualitY initiative (RECTIFY) is a multi-center demonstration project designed to address the multifactorial barriers within health systems. RECTIFY aims to facilitate prompt and definitive extraction of infected CIEDs by modeling best practices for system-wide QI efforts. If successful, RECTIFY will serve as a model for CIED infection quality improvement initiatives for other health systems nationwide leading to improved clinical outcomes.
Methods
Study overview
As a multi-center prospective interventional study, RECTIFY aimed to evaluate the implementation of QI interventions targeted at increasing early identification of CIED infections (systemic and pocket), decreasing time to complete device extraction, and minimizing delays in outside hospital referrals. Sites were chosen to mirror the diverse spectrum of health systems in the U.S, encompassing academic, community, and integrated of the two ( Table 1 ). Prior to intervention start date, each of the 3 sites completed an initial retrospective review of prior devices extracted for infection indications. This review served as the sites’ historical control. Simultaneously, hospital stakeholders were engaged to identify site-specific barriers and potential solutions to delays in infection management. Following this preparatory phase, a six-month period of multi-faceted quality improvement interventions were undertaken that were address previously identified barriers. Subsequently, a twelve-month prospective data collection period was conducted to evaluate the fidelity of the interventions ( Figure 1 ).
Table 1
RECTIFY CIED infection sites.
| Institution | Institution type | Primary hospital bed number | Average CIED (infection and noninfection) extractions annually |
|---|---|---|---|
|
Northwestern memorial hospital
Chicago, Illinois |
Academic | 894 bed | 60 |
|
Moses cone memorial hospital
Greensboro, North Carolina |
Community | 628 bed | 25 |
|
Atrium health
Charlotte, North Carolina |
Integrated | 874 bed | 100 |
RECTIFY demonstration project design.
To comprehensively address the management of CIED infections, from diagnosis to treatment, and to ensure the sustainability of interventions, each participating site established a multidisciplinary improvement team. These teams consisted of the site’s principal investigator, study coordinators, healthcare quality leaders, heart service line administrators, infectious disease physicians, and pharmacists. The improvement team members were responsible for overseeing project activities at their respective sites and served as champions to drive the initiative within their health systems. The Coordinating center, based at the Duke Clinical Research Institute, was led by physicians and healthcare quality leaders. This central team collaborated closely with the improvement teams at each site to ensure consistency in intervention implementation and data collection. Guidance and oversight of the demonstration project were provided by a Steering Committee composed of leaders in CIED infections and implementation. This committee was instrumental in shaping the project’s strategic direction and ensuring alignment with best practices in clinical care and quality improvement.
Study population
To be included in the study, patients were required to be 18 years or older with a CIED in situ and a presumed CIED infection. A presumed CIED infection was defined by either the presence of at least two positive blood cultures for typical skin flora, such as coagulase-negative Staphylococci, Corynebacterium species, or Propionibacterium species, or 1 positive blood culture for all other pathogens without other cause to explain bacteremia or by definite evidence of a pocket infection (characterized by localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage). Patients considered unsuitable for device extraction were excluded from the study. This included patients with a “do not resuscitate” order, those not receiving therapies intended to prolong survival, or cases where extraction is unlikely to alter the overall prognosis. Additionally, patients who died within 1 week of CIED infection diagnosis prior to device extraction were excluded from the study. Patients with left ventricular assist devices were also excluded, as not all sites initially interested in participating in the demonstration project managed patients with ventricular assist devices ( Table 2 ).
Table 2
Key inclusion and exclusion criteria.
| Patient inclusion criteria |
Adults with presumed CIED infection, as defined by:
1. Age ≥18 y 2. CIED in place 3. Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or 1 positive blood culture for all other microorganisms), with no other source is identified to explain the bacteremia. 4. Cases with definite evidence of pocket infection, if treated with antibiotics before culture, even with negative culture, will be considered device infection. |
| Exclusion criteria |
1. DNAR with patient decision to not undergo procedures
2. Lack of ability to follow-up through the institutional/health system EHR (ie, moved from region <3 mo after positive blood culture) 3. Other clear cause of positive blood culture 4. Sepsis or multisystem organ failure at time of and following positive blood culture interfering with device extraction 5. Death within 1 wk of positive blood culture such that there was not opportunity for definitive treatment 6. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement and/or the need for CIED removal should not be considered as CIED infection. |
Multi-faceted quality improvement interventions
During the retrospective phase, each participating site was responsible for collecting retrospective data and preparing for the upcoming intervention phase. Following the formation of the improvement team at each site, team members convened to identify site-specific barriers to the timely diagnosis and extraction of infected devices. To support this process, the Coordinating Center provided each site with process map templates and cause-and-effect diagram templates, accompanied by examples of common barriers. These tools were intended to facilitate the systematic identification of barriers that could be addressed during the demonstration project. Additionally during the retrospective phase, each site developed and refined a daily electronic health record (EHR) report to identify hospitalized patients with suspected CIED infections, based on the RECTIFY inclusion criteria. Notably, prior to RECTIFY, none of the sites utilized EHR-based surveillance tools to identify potential CIED infection cases. The development of the EHR reports was a collaborative effort involving local site teams, the RECTIFY steering committee, and institutional information technology specialists. Through oversight by the steering committee and the Coordinating Center, core data elements—such as patient name, date of birth, laboratory results, and date of positive blood cultures—were standardized across sites. However, the reports varied by institution with respect to the report recipients, methods of delivery, and integration into local clinical workflows. The reports were tailored to each site and integrated into the daily workflow of the EP consult team, extraction scheduler, and nursing staff. This process facilitated the identification of patients with suspected device infections, leading to comprehensive chart reviews and, when appropriate, the initiation of an inpatient consultations for device extraction and infectious disease. A new workflow was developed to clearly define responsibilities for reviewing daily reports and ensuring that patients are assessed by an extractor or improvement team member. Once the daily workflow and responsibilities were clearly defined, the electronic health report went live at the end of the retrospective phase. In conjunction, each site was responsible for promoting awareness of the RECTIFY project within their institution and among referral hospitals through educational initiatives. During the retrospective phase the Coordinating Center provided an initial on-site consultation to each of the 3 participating sites. The consultation aimed to introduce team members, review identified barriers, and discuss possible site-specific interventions.
In parallel with the principal intervention, site-specific multi-faceted interventions were implemented to address identified barriers. These site-specific interventions may have included, but were not limited to, the creation of weekly blocked time in the operating room for CIED infection extractions, development of clinical pathways, and leveraging opinion leaders to educate clinician colleagues. Each site was also provided with a recommended clinical pathway based on the 2017 Heart Rhythm Society (HRS) Consensus Statement, supplemented with additional guidance on the involvement of other medical specialties—such as infectious diseases—along with recommendations for timing of echocardiography, antibiotic duration, and device extraction ( Figure 2 ). , The implementation team at each site was required to have an infectious disease partner, and sites were encouraged to consult the infectious disease team at the time of CIED infection identification. The QI initiative did not specify the procedural resources that were needed for extraction cases. However, the QI initiative encouraged the extraction team (made up of electrophysiologists and cardiac surgeons at the 3 sites) to meet and discuss protocols for resources for extraction cases. The Coordinating Center also provided each site a RECTIFY Toolkit consisting of latest publications, sample intervention plan, a library of provider education presentation slides, process map examples, a value-dossier, patient education materials to facilitate accurate and effective dissemination of information ( Figure 3 ; Supplementary materials).
