Results of a large-scale, real-world analysis of US Centers for Medicare & Medicaid Services (CMS) data on the rates of guideline adherence and associated mortality in patients with cardiac implantable electronic device (CIED) infection show that only around one in five patients with a CIED infection had their devices explanted.
This is despite guideline recommendations giving device removal a Class I level of evidence in the case of CIED infection. The finding was highlighted by Sean Pokorney (Duke University School of Medicine, Durham, USA), who presented the results of the analysis during a late-breaking trial session at the 2022 American College of Cardiology conference (ACC.22, 2–4 April, Washington DC, USA).
The study examined 1,065,549 patients in Medicare in the USA who received a CIED between 1 January 2006 and 31 December 2019. Patients included in the CIED infection group were those that had an implant greater than 12 months old, had a primary diagnosis for infection of a device implant, and had documented antibiotic therapy.
According to Pokorney, the data reveal that a high volume of patients presenting with CIED infection are according to Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA) consensus recommendations and guidelines for CIED infection, which advocate full system extraction.
Moreover, complete hardware removal within six days was associated with a 42.9% lower risk of death compared with patients who did not undergo extraction the investigators claim.
Further to the headline finding, which indicates that as many as four in five patients may not be receiving guideline-directed care, Pokorney’s presentation has also revealed that female and Black patients were also less likely to undergo device extraction.
Among the study’s conclusions was that “quality improvement initiatives and care redesign programmes are needed in order to improve the guideline-based care that CIED patients receive within health systems”.
The study was an independent analysis conducted by Duke University and supported by a research grant from the Philips. In a press release highlighting the results, Philips said that it had no role in the design or conduct of the analysis.
“This study highlights the life-threatening nature of device infections and the significant opportunities to improve care in these complex patients. The findings also emphasise the importance of timely diagnosis and complete treatment. Making things better for patients tomorrow will require working with clinicians across various specialties to advance education to help diagnose CIED infections and deliver timely care,” said Jonathan Piccini, the lead investigator of the study (Duke Heart Center, Durham, USA). “The opportunity to ensure all patients have access to guideline recommended care is not only imperative, but life-saving for patients across the world.”
“The need for greater awareness and education for physicians, patients, and caregivers is clearly shown by the results of this study,” said Trudie Lobban, founder of Arrhythmia Alliance, a global non-profit patient advocacy group, commenting on the study’s results. “So when early signs of infection present, action that is consistent with guidelines is taken quickly.”