ABSTRACT
OBJECTIVES: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. BACKGROUND: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. METHODS: We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. RESULTS: Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4%; 95% confidence interval: 0.0% to 0.9%), significantly lower than the 12-month benchmark rate of 2.2% (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7% compared with an infection rate of 1.0% and 1.3% (p = 0.38 and p = 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2% compared with the published benchmark of 2.2% (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6%; 95% confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6%. CONCLUSIONS: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [Centurion]; NCT01043861/NCT01043705).
Subject(s)
Anti-Bacterial Agents/administration & dosage , Cardiac Resynchronization Therapy/adverse effects , Defibrillators, Implantable/adverse effects , Minocycline/administration & dosage , Prosthesis-Related Infections/prevention & control , Rifampin/administration & dosage , Aged , Aged, 80 and over , Delayed-Action Preparations , Female , Follow-Up Studies , Hematoma/etiology , Humans , Male , Middle Aged , Prospective Studies , Reoperation , Risk Factors , Surgical MeshABSTRACT
BACKGROUND: Recent miniaturization of an insertable cardiac monitor (ICM) may make it possible to move device insertion from a hospital to office setting. However, the safety of this strategy is unknown. OBJECTIVES: The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment. Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician questionnaire. METHODS: Five hundred twenty-one patients indicated for an ICM were randomized (1:1 ratio) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study (ClinicalTrials.gov identifier NCT02395536). Patients were followed for 90 days. RESULTS: ICM insertion was successful in all 482 attempted patients (office: 251; hospital: 231). The untoward event rate (composite of unsuccessful insertion and ICM- or insertion-related complications) was 0.8% (2 of 244) in the office and 0.9% (2 of 227) in the hospital (95% confidence interval, -3.0% to 2.9%; 5% noninferiority: P < .001). In addition, adverse events occurred during 2.5% (6 of 244) of office and 4.4% (10 of 227) of hospital insertions (95% confidence interval [office minus inhospital rates], -5.8% to 1.9%; 5% noninferiority: P < .001). Physicians indicated that for procedures performed in an office vs a hospital, there were fewer delays >15 minutes (16% vs 35%; P < .001) and patient response was more often "very positive." Physicians considered the office location "very convenient" more frequently than the hospital location (85% vs 27%; P < .001). CONCLUSION: The safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment. These results may expand site of service options for LINQ insertion.
Subject(s)
Arrhythmias, Cardiac/diagnosis , Electrocardiography, Ambulatory , Miniaturization/methods , Postoperative Complications/epidemiology , Prosthesis Implantation , Aged , Ambulatory Surgical Procedures/instrumentation , Ambulatory Surgical Procedures/methods , Electrocardiography, Ambulatory/instrumentation , Electrocardiography, Ambulatory/methods , Environment , Female , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Patient Preference/statistics & numerical data , Prosthesis Implantation/adverse effects , Prosthesis Implantation/methods , United StatesABSTRACT
Despite numerous epidemiologic studies, few data exist on recent trends in admissions to United States hospitals of patients with atrial fibrillation (AF) as a primary diagnosis and on the determinants of outcome of these hospitalizations. In the present study, we investigated recent trends in the incidence of AF admissions to United States hospitals from 1996 to 2001 using a representative sample of all acute-care hospital admissions in the United States provided by the Centers for Disease Control, with special attention to the importance of age, gender, race, and other determinants of outcome, namely, in-hospital mortality.
