Thoracic endovascular aortic repair migration and aortic elongation differentiated using dual reference point analysis.

OBJECTIVE: We evaluated images of patients undergoing a thoracic endovascular aortic repair procedure using two reference points as a means for differentiating stent graft migration from aortic elongation. Conventional standards define migration of a stent graft as an absolute change in the distance from the distal graft ring to a distal landmark ≥10 mm compared with a baseline measurement. Aortic elongation occurs over time in both healthy individuals and patients with aortic disease. Aortic elongation in patients with stent grafts may result in increased distal thoracic aortic lengths over time. False-positive stent graft migration would be defined when these patients meet the standard definition for migration, even if the stent has not moved in relation to the elongating aorta. METHODS: This retrospective study evaluated the aortic length of 23 patients treated with the conformable GORE TAG thoracic endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) in three clinical trials (dissection, traumatic injury, and aneurysm). Patients who met the standard definition for migration were selected. A standardized protocol was used to measure aortic centerline lengths, including the innominate artery (IA) to the most distal device ring, the IA to the celiac artery (CA), and the distal ring to the CA. Baseline lengths obtained from the first postoperative image were compared with length measurements obtained from the first interval at which they met the standard definition for migration. The conventional standards for migration using a single reference point were compared with the use of dual reference points. RESULTS: Of the 23 patients with endograft changes, 20 were deemed to have aortic elongation rather than true migration. The remaining three patients were deemed to have migration on the basis of the IA to distal ring position compared with the IA to CA length change. The IA to CA interval length change was markedly greater in those with elongation compared with migration (23.8 ± 8.4 mm vs -3.5 ± 5.4 mm, respectively; P < .05). The distal ring to CA interval length change was greater in patients showing elongation rather than migration (18.5 ± 6.6 mm vs -9.8 ± 5.4 mm, respectively; P < .05). The distance between the IA and distal ring was similar for elongation and migration. CONCLUSIONS: These results highlight the dynamic changes that can occur in the aorta as a natural consequence of age. Employing two landmarks can account for these changes and proves to be an important factor, among others, in the differentiation of aortic elongation from true stent graft migration.

Assessing state stem cell programs in the United States: how has state funding affected publication trends?

Several states responded to federal funding limitations placed on human embryonic stem cell research and the potential of the field by creating state stem cell funding programs, yet little is known about the impact of these programs. Here we examine how state programs have affected publication trends in four states.

Risk disclosure and the recruitment of oocyte donors: are advertisers telling the full story?

This study analyzes 435 oocyte donor recruitment advertisements to assess whether entities recruiting donors of oocytes to be used for in vitro fertilization (IVF) procedures include a disclosure of risks associated with the donation process in their advertisements. Such disclosure is required by the self-regulatory guidelines of the American Society for Reproductive Medicine (ASRM) and by law in California for advertisements placed in the state. We find very low rates of risk disclosure across entity types and regulatory regimes, although risk disclosure is more common in advertisements placed by entities subject to ASRM's self-regulatory guidelines. Advertisements placed in California are more likely to include risk disclosure, but disclosure rates are still quite low. California-based entities advertising outside the state are more likely to include risk disclosure than non-California entities, suggesting that California's law may have a modest "halo effect." Our results suggest that there is a significant ethical and policy problem with the status quo in light of the known and unknown risks of oocyte donation and the importance of risk disclosure to informed consent in the context of oocyte donation.

Comparison of thoracic aortic diameter changes after endograft placement in patients with traumatic and aneurysmal disease.

OBJECTIVE: The purpose of this study was to evaluate acute changes in aortic size before and after endograft placement for traumatic injury and aneurysmal disease. We hypothesize that there are inherent differences between trauma and aneurysm populations undergoing thoracic endovascular aortic repair (TEVAR) and that these factors may affect device choice and sizing for each group. METHODS: This retrospective study evaluated the existing digital imaging of traumatic injury and aneurysmal patients enrolled in the 0802 and 0803 multi-site trials that received the GORE Conformable TAG thoracic device. Pre- and post-treatment imaging was available for 70 traumatic injury and 54 aneurysmal patients. Post-treatment imaging was defined as being complete within 30 days of treatment. A standardized protocol was used to complete measurements of the proximal and distal maximum neck diameters through the use of the orthogonal view before imaging and at 30-day imaging. The resultant changes in diameter for each group were analyzed by means of t-tests. RESULTS: Mean increases in proximal (3.0 mm vs 2.0 mm; P < .05) and distal neck diameters (2.9 mm vs 0.7 mm; P < .01) after TEVAR are significantly greater in traumatic injury patients than in aneurysm patients between pretreatment and 30-day imaging. In both study populations, smaller pretreatment aortic neck diameters showed a larger change in neck diameter than did larger pretreatment aortic diameters. Aneurysm patients were oversized significantly more than were trauma patients at the proximal neck (9.1% vs 4.5%; P < .05). However, at the distal neck, the trauma patients were oversized more than were the aneurysm patients (17.5% vs 13.6%; P = .06). A strong correlation was found between the percentage of oversizing and change in the distal neck diameter after TEVAR in both patient groups. CONCLUSIONS: The results suggest that there are differences between trauma and aneurysm populations. Careful device selection may contribute to the avoidance of complications related to both undersized and oversized devices. Short-term analysis shows that TEVAR can be successfully accomplished in both trauma and aneurysm groups over a wide sizing range. Further data regarding long-term device complications are needed to better characterize this relationship.

Differences in aortic arch radius of curvature, neck size, and taper in patients with traumatic and aortic disease.

BACKGROUND: The purpose of this study was to determine the differences in aortic morphology that would potentially affect the management of thoracic endovascular aneurysm/aortic repair between trauma and aneurysm patients. MATERIALS AND METHODS: This was a prospective analysis of the pretreatment digital imaging of 98 traumatic injury patients and 63 aneurysm patients enrolled in multicenter regulatory studies of the Conformable GORE TAG Thoracic Device (CTAG Device) (manufactured by W.L. Gore and Associates, Flagstaff, AZ). A standardized protocol was used to perform an independent assessment of the images and measurements of the radius of curvature and proximal and distal neck diameters. The radius of curvature was measured using axial images and the proximal and distal intimal neck diameter measurements were completed using the orthogonal "centerline" view. Taper was measured over the entire treated aorta and was calculated by subtracting the distal neck diameter measurement from the proximal neck diameter. The results were analyzed with independent t-tests. RESULTS: The trauma patients had a significantly smaller radius of curvature than aneurysm patients. There was a significant difference in the aortic neck size, with trauma patients having smaller proximal and distal intimal neck diameters. Taper was noted in trauma patients but not in aneurysm patients. CONCLUSIONS: The aortic anatomy varies between treated aortic pathologies. Aneurysm patients have a wider arch and larger aortas when compared with trauma patients. Aneurysm patients have less taper than trauma patients. Despite these differences, both of these cohorts of patients are treatable under the broader oversizing ranges of the CTAG Device.

Compliance with donor age recommendations in oocyte donor recruitment advertisements in the USA.

IVF using donated oocytes offers benefits to many infertile patients, yet the technique also raises a number of ethical concerns, including worries about potential physical and psychological risks to oocyte donors. In the USA, oversight of oocyte donation consists of a combination of federal and state regulations and self-regulatory guidelines promulgated by the American Society for Reproductive Medicine. This study assesses compliance with one of these self-regulatory guidelines - specifically, ASRM's preferred minimum age for donors of 21. To assess compliance, 539 oocyte donor recruitment advertisements from two recruitment channels (Craigslist and college newspapers) were collected and evaluated. Of these, 61% in the Craigslist dataset and 43% in the college newspaper dataset listed minimum ages between 18 and 20, which is inconsistent with ASRM's preferred minimum age recommendation of 21. Advertisements placed by oocyte donor recruitment agencies were more likely than advertisements placed by clinics to specify minimum ages between 18 and 20. These results indicate that ASRM should evaluate and consider revising its donor age guidelines. IVF using donated human eggs can help many patients who have difficulty having children. However, the technique also raises ethical concerns, including concerns about potential physical and psychological harms to egg donors. In the USA, oversight of egg donation relies on a combination of federal and state regulation and professional self-regulation. Governmental regulations address only limited aspects of egg donation, such as the potential spread of infectious diseases and the reporting of success rates, leaving voluntary guidelines developed by an association of medical professionals to address most issues, including ethical concerns raised by the practice. One of these voluntary guidelines recommends that egg donors should be at least 21 years of age. In this article, we analysed 539 egg donor recruitment advertisements published on Craigslist and in college newspapers to see whether fertility clinics and egg donor recruitment agencies follow this recommendation. We found that 61% of advertisements in the Craigslist dataset and 43% of advertisements in the college newspaper dataset listed minimum ages between 18 and 20 and, thus, did not follow the recommendation that egg donors be at least 21 years of age. Advertisements placed by egg donor recruitment agencies were more likely than advertisements placed by fertility clinics to list minimum ages between 18 and 20. These results indicate that the American Society for Reproductive Medicine should evaluate and consider revising its donor age guidelines.