The off‐versus on‐label use of medical devices in interventional cardiovascular medicine?: Clarifying the ambiguity between regulatory labeling and clinical decision making,Part III: Structural heart disease interventions

The majority of devices used to treat congenital cardiac lesions in the cardiac catheterization laboratory are used on an off‐label basis. This article discusses the predicaments faced by the interventional cardiologist when implanting devices on an off‐label basis, using procedural examples of PFO closure and endovascular stent placement. Strategies that may benefit patient and provider, as well as satisfying regulatory agencies are suggested. © 2008 Wiley‐Liss, Inc.     

Renal allograft biopsies in the era of C4d staining: the need for change in the Banff classification system.

C4d immunostaining in the peritubular capillaries (PTC) is a marker of antibody-mediated rejection (AMR). We evaluated the histopathologic diagnoses of 388 renal transplant biopsies since the implementation of routine C4d immunostaining at our center. Of these, 155 (40%) biopsies had evidence of acute cellular rejection (ACR), out of which 119 (77%) had pure ACR, 31 (20%) had ACR with concomitant features of AMR, and five (3%) had ACR with focal C4d staining. Sixty-four (16%) biopsies exhibited features of AMR [33 (52%) pure AMR, and 31(48%) concomitant AMR and ACR]. One hundred and fifty-five (40%) biopsies had features of interstitial fibrosis and tubular atrophy (IFTA). Of these, 20 (13%) had concomitant AMR [13 (8.5%) had pure AMR and seven (4.5%) had concomitant ACR and AMR]. Creatinine at the time of biopsy was higher in patients with mixed ACR and AMR and the clinical behavior of mixed lesions is more aggressive over time. Despite having a lower serum creatinine at the time of biopsy, patients with IFTA experienced gradual decline in graft function over time. The pathologic findings in renal allograft biopsies are often mixed and mixed lesions appear to have more aggressive clinical behavior. These findings suggest the need for change in the Banff classification system to better capture the complexity of renal allograft pathologies.     

Epidemiologic shift in the prevalence of Hepatitis A virus in Saudi Arabia: a case for routine Hepatitis A vaccination

This study aims to determine the seroprevalence of Hepatitis A among a selected group of Saudi children and thus, identify the best immunization strategy. A school-based seroprevalence study in children 4-18 years of age attending the National Guard schools was done. Of the 25,531 children attending the National Guard schools, 2399 (10%) were randomly selected through a stratified one-stage cluster survey. The overall prevalence of HAV-IgG was 28.9%. The prevalence was almost the same in male and female (28.2% versus 29.5%, respectively). There was a gradual increase in the HAV-IgG with 7% in children (< 8 years), 14% (8-11 years), 30% (12-15 years), and 52% (> 16 years) of age. Since a substantial proportion of this pediatric population confirms a continuing decrease in anti-HAV seroconversion rates, we recommend including Hepatitis A in the schedule of routine childhood vaccinations.     

Patent foramen ovale

Patent foramen ovale is incriminated in patients with cryptogenic stroke; however, concrete evidence that closure of patent foramen ovale using various devices is superior to continued medical therapy is not yet available. Controlled randomized trials are well underway to address this issue.     

Intracardiac echocardiography for the guidance of percutaneous procedures

Interventional cardiology has seen great advances in the past decade. A wide range of interventional procedures has been established as standard therapeutic modalities and more are yet to come. Multiple imaging modalities have been used to guide these procedures. Intracardiac echocardiography (ICE) provides an accurate imaging tool to guide the appropriate performance of many of these procedures. Early studies compared ICE as a new imaging modality to guide interventional closure of atrial communications with other more established imaging techniques, such as transesophageal echocardiography, with excellent accuracy. In this article, we discuss the value of using ICE in guiding some percutaneous interventional procedures. We also discuss the imaging protocol for using ICE to guide atrial level shunt device closure. Our experience in using ICE for guiding percutaneous valve placement is also discussed.