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Efficacy of a Bio-Absorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Subjects.
Kolek, Matthew J; Patel, Neel J; Clair, Walter K; Whalen, S Patrick; Rottman, Jeffrey N; Kanagasundram, Arvindh; Shen, Sharon T; Saavedra, Pablo J; Estrada, Juan C; Abraham, Robert L; Ellis, Christopher R.
Afiliação
  • Kolek MJ; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Patel NJ; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Clair WK; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Whalen SP; Department of Medicine, Cardiology Division, Wake Forest University, Winston-Salem, North Carolina, USA.
  • Rottman JN; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Kanagasundram A; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Shen ST; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Saavedra PJ; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Estrada JC; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Abraham RL; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
  • Ellis CR; Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
J Cardiovasc Electrophysiol ; 26(10): 1111-6, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26222980
ABSTRACT

INTRODUCTION:

Cardiac implantable electronic device (CIED) infections are potentially preventable complications associated with high morbidity, mortality, and cost. A recently developed bio-absorbable antibacterial envelope (TYRX™-A) might prevent CIED infections in high-risk subjects. However, data regarding safety and efficacy have not been published. METHODS AND

RESULTS:

In a single-center retrospective cohort study, we compared the prevalence of CIED infections among subjects with ≥2 risk factors treated with the TYRX™-A envelope (N = 135), the nonabsorbable TYRX™ envelope (N = 353), and controls who did not receive an envelope (N = 636). Infection was ascertained by individual chart review. The mean (95% confidence interval) number of risk factors was 3.08 (2.84-3.32) for TYRX™-A, 3.20 (3.07-3.34) for TYRX™, and 3.09 (2.99-3.20) for controls, P = 0.3. After a minimum 300 days follow-up, the prevalence of CIED infection was 0 (0%) for TYRX™-A, 1 (0.3%) for TYRX™, and 20 (3.1%) for controls (P = 1 for TYRX™-A vs. TYRX™, P = 0.03 for TYRX™-A vs. controls, and P = 0.002 for TYRX™ vs. controls). In a propensity score-matched cohort of 316 recipients of either envelope and 316 controls, the prevalence of infection was 0 (0%) and 9 (2.8%), respectively, P = 0.004. When limited to 122 TYRX™-A recipients and 122 propensity-matched controls, the prevalence of CIED infections was 0 (0%) and 5 (4.1%), respectively, P = 0.024.

CONCLUSIONS:

Among high-risk subjects, the TYRX™-A bio-absorbable envelope was associated with a very low prevalence of CIED related infections that was comparable to that seen with the nonabsorbable envelope.
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Texto completo: Disponível Coleções: Bases de dados internacionais Base de dados: MEDLINE Assunto principal: Marca-Passo Artificial / Infecções Relacionadas à Prótese / Desfibriladores Implantáveis / Implantes de Medicamento / Antibacterianos Tipo de estudo: Estudo de incidência / Estudo de prevalência Limite: Idoso / Feminino / Humanos / Masculino / Meia-Idade País/Região como assunto: América do Norte Idioma: Inglês Revista: J Cardiovasc Electrophysiol Assunto da revista: Angiologia / Cardiologia / Fisiologia Ano de publicação: 2015 Tipo de documento: Artigo País de afiliação: Estados Unidos