Subjects: Currently, hemostatic materials made from human blood components and animalderived collagen is used for controlling operative hemorrhage in the cardiovascular surgery field. In this study, we focused on an entirely synthetic self-assembling peptide (development code: TDM-621) that gels when in contact with blood or other bodily fluids and stops bleeding upon contact with a wound site. We investigated its usefulness as a hemostatic material in animal and clinical studies. Methods: Before we began the clinical study, we demonstrated the hemostasis efficacy and safety of TDM-621 in animal experimental models. Twenty-five patients (22 men, 3 women) were enrolled in the clinical study, and the following procedures were performed: 1) coronary artery bypass graft (CABG) (n = 9), 2) abdominal aortic graft replacement (n = 4), and 3) peripheral artery bypass (n = 12). The TDM-621 material was applied to a total of 33 vascular anastomotic graft sites (some patients received material at more than one site). Both hemostatic efficacy and safety were examined. Results: A total of 33 anastomotic graft sites in 25 patients were evaluated, and the averaged primary and secondary efficacy rate was 94.5%. No postoperative bleeding or adverse events (including serious adverse events) with a causal relationship to treatment were observed. Conclusion: This study indicated that TDM-621 is a more effective and reliable hemostat than commonly-used general hemostatic agents and, therefore, will be very useful in several cardiovascular surgery applications.
Background Since long-term administrations of anti-hyperlipidemic
agents result in reduction in % stenosis or increase in
minimum lumen diameter (MLD) of stenotic coronary
segments, it is generally believed that anti-hyperlipidemic agents
stabilize vulnerable coronary plaques. However, recent pathologic
and angioscopic studies revealed that vulnerability of coronary
plaques is not related to severity of stenosis and the rims rather
than top of the plaques disrupt, and therefore, angiography is not
adequate for evaluation of vulnerability.
Angioscopy enables macroscopic pathological evaluation of the coronary plaques.
Therefore, we carried out a prospective angioscopic open trial for evaluation of the
stabilizing effects of bezafibrate on coronary plaques.
Methods From April, 1997 to December, 1998, 24 patients underwent
coronary angioscopy of the plaques in the non-targeted vessels
during coronary interventions and 6 months later. The patients
were divided into control (10 patients, 14 plaques) and
bezafibrat (14 patients, 21 plaques) groups. Oral
administration of bezafibrate (Bezatol SR, 400mg/day) was
started immediately after the interventions and was continued for
6 months. The vulnerability score was determined based on
angioscopic characteristics of plaques and it was compared before
and 6 months later.
Results Six months later, vulnerability score was reduced
(from 1.6 to 0.8;p < 0.05) in bezafibrate group and
unchanged (from 1.4 to 1.3; NS) in control group. In
bezafibrate group, the changes in vulnerability score was not
correlated with those in % stenosis or MLD.
Conclusion The results indicate that bezafibrate can stabilize coronary plaques.
SUMMARYTo evaluate the stabilizing effects of an antilipemic agent, bezafibrate, on coronary plaques, we carried out a prospective angioscopic and angiographic open trial. From April 1997 to December 1998, 24 patients underwent coronary angioscopy of plaques in nontargeted vessels during coronary interventions and then again 6 months later. The patients were divided into control (10 patients, 14 plaques) and bezafibrate (14 patients, 21 plaques) groups. Oral administration of bezafibrate (400 mg/day) was started immediately after the intervention and was continued for 6 months. The vulnerability score was determined based on the angioscopic characteristics of plaques and compared before and 6 months later. Six months later, the vulnerability score was reduced (from 1.6 to 0.8; P<0.05) in the bezafibrate group and unchanged (from 1.4 to 1.3; NS) in the control group. In the bezafibrate group, the changes in the vulnerability score were not correlated with those in % stenosis or minimal lumen diameter. The plasma total cholesterol level (T-C) was unchanged, triglyceride level (TG) was decreased, and high density lipoprotein cholesterol level (HDL-C) was increased in the bezafibrate group, but were unchanged in the control group. In the bezafibrate group, T-C and TG were decreased and HDL-C was increased in patients with a reduced vulnerability score but were unchanged in those with an unchanged score. These results indicate that 6 month administration of bezafibrate stabilizes coronary plaques and that the stabilization is not correlated with angiographic changes. (Jpn Heart J 2002; 43: 319-331)
We report a rare case of type A dissection involving a right-sided aortic arch with an aberrant left subclavian artery originating from Kommerell’s diverticulum in a 76-year-old woman. Endovascular treatment for Kommerell’s diverticulum including intimal tear of the dissection was performed. At the 5-year follow-up, the patient was doing well, with no endoleak or dilatation of the Kommerell’s diverticulum.
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