Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods.

Background: Patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) often have a poor understanding of their disease and of related therapeutic risks, benefits, and alternatives. This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients' knowledge of standard consent elements.

Methods: Patients undergoing first-time elective, outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process (group I) or a web-based, audiovisual presentation (group II).

Long-term follow-up assessment of a phase 1 trial of angiogenic gene therapy using direct intramyocardial administration of an adenoviral vector expressing the VEGF121 cDNA for the treatment of diffuse coronary artery disease.

On the basis of studies in experimental animals demonstrating that AdVEGF121, an E1(-)E3(-) serotype 5 adenovirus coding the 121 isoform of vascular endothelial growth factor (VEGF), could mediate the generation of new blood vessels and reverse coronary ischemia, a clinical study of direct myocardial administration of AdVEGF121 was initiated in patients with late-stage, diffuse coronary artery disease. This study provides long-term (median, 11.8 years) follow-up on these patients.

Absence of cognitive decline one year after coronary bypass surgery: comparison to nonsurgical and healthy controls.

Background: Cognitive decline after open-heart surgery has been the subject of a number of conflicting reports in recent years. Determination of possible cognitive impairment due to surgery or use of cardiopulmonary bypass is complicated by numerous factors, including use of appropriate comparison groups and consideration of practice effects in cognitive testing.

Methods: Neuropsychological data were gathered from 46 healthy controls, 42 cardiac patients referred for percutaneous coronary intervention (PCI), and 43 cardiac patients referred for coronary artery bypass grafting (CABG).

Stable cognition after coronary artery bypass grafting: comparisons with percutaneous intervention and normal controls.

Background: Cognitive decline has been associated with coronary artery bypass grafting (CABG), but the extent to which these findings are related to the natural history of cognitive deficits in elderly patients with cardiac disease or have been influenced by the research methods used to determine abnormalities warrants further study.

Methods: After excluding individuals with conditions known to cause brain dysfunction, individuals referred for percutaneous coronary intervention (n = 42) or CABG (n = 35) were compared with an age-matched and education-matched control group without clinical evidence of coronary artery disease (n = 44). These subjects underwent a battery of 14 neurocognitive tests at baseline (preoperatively) and at 3 weeks and 4 months postoperatively.

Neurocognitive functioning in patients undergoing coronary artery bypass graft surgery or percutaneous coronary intervention: evidence of impairment before intervention compared with normal controls.

Background: Cognitive deficits have been reported to occur in a significant proportion of patients undergoing coronary artery bypass grafting (CABG), but the extent to which these deficits were preexistent or related to the natural history of cognitive decline in this patient population remains poorly defined.

Methods: After excluding patients with conditions known to cause brain dysfunction (eg, hepatic dysfunction, stroke), a group of patients referred for percutaneous coronary intervention (PCI) or CABG (n = 82) was compared with an age- and education-matched control group that did not have clinical evidence of coronary artery disease (n = 41). These subjects underwent a battery of neurocognitive and emotional testing.