Incidence and costs of cardiac device infections: retrospective analysis using German health claims data

Abstract

Aim: Estimate incidence and costs of cardiac device infections (CDIs) in Germany. Materials & methods:Patients had an implantable cardioverter defibrillator implanted over 2010-2013 and were followed to December 2014 using German health insurance claims data. A case-controlled analysis was performed using propensity score matching methods. Results: Risk of CDI 12 months post-implant was 3.4% overall, either 2.9% for de novo procedures versus 4.4% for replacement procedures. Mean 3-year incremental expenditure per patient for patients with CDI compared with controls was €31,493 for de novo implant patients and €33,777 for replacement patients. Mean incremental expenditure was €59,419 per patient with a major infection. Conclusion: CDIs are highly expensive to manage, reinforcing the need for strategies to reduce their occurrence. [1]. These devices are recommended for selected patients in guidelines from specialty medical societies and health technology assessment agencies [2][3][4]. There is an extensive body of evidence that demonstrates benefits including prolonged survival, improved quality of life and cost-effectiveness.Implantation of cardiac devices carries a risk of adverse events. These are classifiable as access-related (e.g., pneumothorax, hemothorax and hematoma), lead-related (e.g., perforation, displacement, fracture and endocarditis), generator-related (e.g., generator failure, migration and erosion) and pocket infection. Complete removal of all hardware is recommended in medical society guidelines and other scientific documents for patients with established cardiac device-related infection (CDI), and this includes cases in which a localized pocket infection occurs in the absence of signs of systemic infection, due to high relapse rates observed with retained hardware [5][6][7]. On the other hand, cardiac implantable electronic device (CIED) removal is not required for superficial or incisional infection at the pocket site if there is no involvement of the device.A large randomized controlled trial (DANISH study) recently reported an infection rate of 4.9% in a cohort of 556 ICD/CRT-D patients over a median follow-up of 5.6 years [8]. Serious device infections occurred in 2.7% of patients, defined as requiring lead extraction or lifelong antibiotic treatment or causing death. Worryingly, the number of CDI cases has been increasing: national healthcare data for the USA reported the number of hospitalizations due to CDI rose from 5308 in the year 2003 to 9948 in 2011 [9]. The increase is attributed to multiple factors including increased use of CRT devices (which have three leads and a higher risk of infection),

The never‐ending story of CIED infection prevention: Shall we WRAP‐IT and go?

“…The prospective nature of a registry or a survey raises the awareness of the problem and increases compliance with the preventative strategy, as observed in the PADIT trial, where a trend to decreasing infections in both arms was observed during the study . A similar effect may be hypothesized by comparing the infection rate of the prospective DECODE registry (1.2%) to the retrospective studies by Ludwig et al (3.4%) and by Clémenty et al (2.3% in the ICD/CRTD cohort) in similar populations over 2010 to 2015 . Thus, it seems that physician training and compliance with a strict prevention protocol under a continued surveillance program may lower CIED infections at 1% to 1.2% nowadays .…”

“…Several retrospective registries have tried to capture the infection rate across different populations of CIED recipients, yielding conflicting results that are mainly based on selection process (consecutive vs nonconsecutive patients enrollment), patients profile (age and comorbidities increased in the past 15 years), and procedure complexity (CRTD approaching 50% of high‐power devices nowadays, underrepresented in the past). Overall, infection seems to range from 1% to 4%, being associated with patient‐related factors, procedure‐related factors, and center/operator volume . Thus, the proportion of CRTD recipients, upgrades, CIED revision, patient profile, center characteristics makes a comparison of different studies unreliable.…”

“…At an estimated average cost of $47 885 to $54 926 per patient treatment, the savings stemming from infection prevention would allow TYRX use as a standard of care . Participation in a surveillance program (clinical trial, registry) leads to optimization of performance owing to awareness and compliance with a comprehensive preventative strategy, as unveiled by the randomized PADIT and WRAP‐IT trials and by observational registries . The true benefit of TYRX, estimated around 70% SSI prevention, denies sustainability as a standard of care when a 1% to 1.2% infection rate is to be addressed.…”

“…Pocket infection is prevalent among CIED infections (up to 69% of cases), mostly due to staphylococci species, and prompts clinical efforts to prevent SSI . On the basis of current clinical knowledge, CIED infections range from 1% to 4% being highest at replacements and upgrades (defined as addition of one or more lead/s) and according to specific patient profiles . Pocket seeding by bacteria at the time of CIED surgery is the main mechanism of SSI; biofilm formation on the CIED/lead surface and at nonvascularized pocket tissue is the mechanism of escape to antibiotic activity, and of infection spreading to the circulation and to distant sites .…”

Thrombocytopenia and end stage renal disease are key predictors of survival in patients with cardiac implantable electronic device infections

“…Cardiac implantable electronic device (CIED) infections are associated with a high mortality rate and high treatment costs …”