Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.

BACKGROUND: A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality. OBJECTIVE: To test the association of FDA advisory status with long-term mortality. METHODS: The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advisories on ICD generators were identified. Mortality was determined by using the Social Security Death Index. RESULTS: In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were class I and 532 (32.3%) were class II. ICDs were explanted before advisory notifications in 14.0% of class I and 10.1% of class II advisories. Among ICDs under advisory, 28 (4.0%) advisory-related and 15 non-advisory- related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival rate was 65.6% overall, and 64.2, 61.1, and 69.3% in patients with no, class I, and class II advisories, respectively (P = .17). CONCLUSIONS: ICD advisories impacted 43% of the patients. Advisory-related malfunctions affected 4% within the combined advisory group. Based on a conservative management strategy, ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.

Polysomnography in Australia--trends in provision.

OBJECTIVES: To describe the growth in the use of state-funded (Medicare) polysomnography (PSG) in Australia since 1990 and to compare PSG growth to other common diagnostic procedures and growth in total Medicare payments. METHODS: Interrogation of online database of historical census-level data routinely collected by Medicare. RESULTS: There has been a steady rise in the number of PSGs performed in Australia since 1990; the growth has been faster than overall Medicare-spending growth and faster than growth in comparable diagnostic procedures. However, there are marked interstate differences in growth. Per capita data, available only for 1995 to 2004, shows that nationwide PSG provision has risen from 123 to 308 per 100,000 people enrolled in Medicare. CONCLUSIONS: The provision of PSG in Australia has been growing steadily since publicly funded reimbursement began in 1990. This growth has been faster than the overall population growth and faster than the growth in Medicare funding for other diagnostic procedures and classes of medical interventions. However, the provision of PSG might be expected to continue to increase because the per capita provision (308 per 100,000) is still less than recent estimates from Canada and the United States (370.4 and 427.0 per 100,000, respectively).