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). Preconsent and postconsent questionnaires were administered to evaluate changes in patients' self-reported understanding of standard consent elements. RESULTS: One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys (group I=48; group II=54). Changes in patient comprehension rates were similar between groups for risk and benefit consent elements, but group II had significantly greater improvement in the identification of treatment alternatives than group I (p=0.028). Independent of intervention, correct identification of all risks and alternatives increased significantly after consent (p<0.05); 4 of 5 queried risks were correctly identified by greater than 90% of respondents. However, misperceptions of benefits persisted after consent; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83% and 46% of respondents, respectively. CONCLUSIONS: Although both scripted verbal and audiovisual informed consent improved patient comprehension, important patient misperceptions regarding PCI-related outcomes and alternatives persist, independent of informed consent approach, and considerable challenges still exist in educating patients about contemplated medical procedures. Future research appears warranted to improve patient comprehension.

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. From 1997 to 1999, AdVEGF121 was administered by direct myocardial injection to an area of reversible ischemia in 31 patients with severe coronary disease, either as an adjunct to conventional coronary artery bypass grafting (group A) or as minimally invasive sole (MIS) therapy, using a minithoracotomy (group B). There was no control group; the study participants served as the control subjects. The 5- and 10-year survival was 10 of 15 (67%) and 6 of 15 (40%) for the group A patients, and 11 of 16 (69%) and 5 of 16 (31%) for group B sole therapy patients, respectively. In comparison, maximal medical therapy in comparable groups in the literature have a 3- to 5-year survival rate of 52 to 59%. For the survivors, the angina score for group A was 3.4±0.5 at time 0 and 1.9±1.0 at last follow-up, and for group B it was 3.4±0.6 and 2.0±1.1, respectively. The incidences of malignancy and retinopathy were no greater than that expected for the age-matched general population. We conclude that adenovirus-mediated VEGF direct myocardial administration to patients with severe coronary artery disease is safe, and future larger trials are warranted to assess efficacy.

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). Fourteen cognitive function tests were utilized at baseline and at three time points after surgery (3 weeks, 4 months, 1 year). Measures showing acceptable test-retest reliability based on intraclass correlations were compared using regression-based reliable change indices. RESULTS: No clear pattern of group differences or change at follow-up emerged. A greater percentage of CABG patients than controls worsened in seven tests (three at 1 year), but a greater percentage of PCI patients than controls also worsened in seven tests (three at 1 year). Generalized estimating equations showed only two tests (Wechsler Adult Intelligence Scale, Third Edition, Digit Symbol, and Hopkins Verbal Learning Test, Revised, Total Recall) to be significantly different between groups from baseline to 1 year. Interestingly, compared with healthy controls, more PCI patients than CABG patients worsened in the former of those two tests, whereas more PCI and CABG patients improved on the latter. CONCLUSIONS: Using healthy controls and a relevant nonsurgical comparison group to contend with important methodological considerations, current CABG procedure does not appear to create cognitive decline.

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. RESULTS: The majority of test scores for all three cohorts were within nonimpaired ranges at baseline and 3 weeks later. Change in impairment status from baseline to 3-week assessment was not associated statistically with type of treatment as referenced to clinical norms, and was associated with type of treatment on only one measure as referenced to control group performances. A further overall improvement in impairment status from 3 weeks' to 4 months' follow-up was seen in both CABG and percutaneous coronary intervention patients. Mean test scores were significantly worse in CABG patients versus percutaneous coronary intervention patients in 4 of 13 measures at 3 weeks' follow-up, but significant de novo impairment at 3 weeks' follow-up in the CABG group compared with the percutaneous coronary intervention and control groups was present in only one test. As assessed by reliable change methodology, impairment was statistically associated with type of treatment for only 1 of 13 measures. CONCLUSIONS: As compared with changes seen in repeat testing of healthy control subjects and individuals who underwent percutaneous coronary intervention, clinically meaningful cognitive deterioration was not observed after CABG.

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. RESULTS: Test score means for 5 of 14 different measures were significantly greater (impaired) in cardiac compared with control group subjects. Of cardiac subjects, 20% demonstrated clinical impairment (test result > or = 1 SD worse than mean for normative standards) in 6 of 14 tests, compared with 10% of the controls. By clinical standards, 46% of cardiac subjects would be considered to be impaired (score 1 SD or more below the control group mean) on 3 or more neuropsychologic measures, compared with 29% of the controls. By this (control group mean) standard, cardiac subjects demonstrated impaired scores on 3.06 +/- 2.6 tests compared with impairment in 2.0 +/- 2.35 tests for the control group (p = 0.01). CONCLUSIONS: Even excluding patients at high risk for brain dysfunction, cognitive impairment is found in patients with coronary artery disease before interventional therapy. Baseline impairment must be considered when evaluating outcomes after intervention.