Clinical trials of Cry j 1 and Cry j 2 T-cell epitope peptide-expressing rice in patients with Japanese cedar pollinosis.

BACKGROUND: In allergic models, administration of rice that expresses a hybrid peptide consisting of 7 major T cell epitopes of Cry j 1 and Cry j 2 (7Crp), suppressed allergic symptoms, IgE elevation and specific T cell response to Japanese cedar pollen. OBJECTIVE: To evaluate the efficacy and safety of 7Crp-expressing rice in patients with Japanese cedar pollinosis. METHODS: A 24-week randomized, double-blind, placebo-controlled study was performed to see the efficacy of 7Crp on allergic symptoms using scoring systems, in which 45 patients were assigned to take either 5 g, 20 g test rice, or placebo daily. A 96-week open study was also conducted to determine its inhibitory effect on serum IgE and T cell proliferative response for Japanese cedar pollen, in which 10 patients consumed 5 g test rice daily. RESULTS: No adverse events associated with the test rice occurred, and the intake rate was more than 96%. The test rice did not show suppression of symptoms related to Japanese cedar pollinosis within 24 weeks. However, intake of 5 g test rice led to a significant decrease in T cell response to Japanese cedar pollen during and after the second disperse season in a 96-week open trial, whereas the specific IgE titer remained unchanged. CONCLUSIONS: Tolerability and safety of 7Crp-expressing rice was accepted. Daily intake of up to 20 g transgenic rice did not provide beneficial effects on Japanese cedar pollinosis within 24 weeks, however, continuous intake of 5 g rice might reduce allergen specific T cell response.

Long-Term Results of Crossover Bypass for Iliac Atherosclerotic Lesions in the Era of Endovascular Treatment: The Re-ACTION Study (Retrospective Assessment of Crossover Bypass as a Treatment for Iliac LesiONs).

Objective: The aim of this study was to elucidate the long-term results of crossover bypass (CB) for iliac atherosclerotic lesions in the era of endovascular treatment (EVT). Methods: A retrospective multicenter cohort study was performed. CB was performed in 242 patients between 2003 and 2014 by vascular surgeons at multiple medical centers in Japan. Results: Perioperative mortality was 1.7%. Primary patency rates were 86% at 5 years and 82% at 8 years. Univariate analysis showed that critical limb ischemia (Rutherford class 4-6), vein graft, and superficial femoral artery occlusion were significantly associated with low primary patency. In multivariate analysis, only critical limb ischemia influenced primary patency. The secondary patency rate was 87% at both 5 and 8 years. The limb salvage rate was 98% at both 5 and 8 years. The overall survival rates were 71% at 5 years and 49% at 8 years. Conclusion: The long-term results of CB were good in our study, compared with previous reports. Our results suggest that CB remains an option for the arterial reconstruction in unilateral iliac occlusive disease after EVT failed.

Open heart surgery in a paraplegic patient.

We operated on a patient who had been paraplegic since sustaining a spinal cord injury 11 years ago. We made a reversed L-shaped sternum incision and cannulated all tubes for the cardiopulmonary bypass through a wound window. This provided an excellent surgical view without restricting the patient's upper limbs (needed for wheel chair operation), and recovery was good. Just after surgery, however, it was difficult to control blood pressure and the loss of serum albumin. We believe this is the first report of open-heart surgery undertaken in a paraplegic patient and that the reversed L-shaped incision and careful monitoring of hemodynamics each played an important role in the successful outcome. We hope that this report will help in the treatment of other paraplegic patients who need open-heart surgery.

A novel technique for removal of permanent pacemaker leads.

We removed from 4 patients pacemaker leads that had migrated or become infected. Case 1: A 62-year-old man developed uncontrollable infection of the pacing leads. Case 2: A 78-year-old man, whose infected pacemaker was removed, had a second one implanted in the contralateral side; the pacing lead infection from the first procedure, however, was uncontrollable. Case 3: A 56-year-old woman presented with dyspnea and hepatomegaly subsequent to the second implantation of a pacemaker; the pacing leads from the first procedure caused severe stenosis in both the superior and inferior vena cavae. Case 4: A 60-year-old woman had a ruptured and migrated pacing lead in the right ventricle. We operated using a cardiopulmonary bypass and a specially designed plastic tube for removal of the leads. Although Case 2 required reconstruction of the vena cavae, all patients recovered. When removal of pacing leads is necessary, it should be done as soon as possible with cardiopulmonary bypass.

Sudden death under successful medical management of sick sinus syndrome after cardiac pacing discontinuation.

Bacterial infection is a serious complication of permanent pacemaker implantation. A 52-year-old woman with sick sinus syndrome and vasospastic angina developed pacemaker infection 4 years after implantation, with methicillin-resistant Staphylococcus aureus detected in arterial blood cultures. We treated the septicemia with antibiotics and removed the infected pacemaker. We treated sick sinus syndrome with intravenous nitroglycerin followed by oral maintenance isosorbide mononitrate. After cardiac pacing was discontinued following removal of the infected permanent pacemaker, the patient remained well, until her sudden death 3.5 years later. Although the precise cause of death was not clear, we suspected sick sinus syndrome or vasospastic angina, and now consider the outcome may have been more favorable if we had reimplanted a permanent pacemaker before she died.

An operative case of inferior vena cava stenosis due to fibrosis around permanent pacemaker leads.

A 56-year-old woman presented with general fatigue, dyspnea on exercise, and hepatomegaly subsequent to secondary implantation of a pacemaker. On admission, cardiac echo examination showed tricuspid valve regurgitation due to a migrated looped lead. At surgery, there was evidence of severe stenosis at both orifices of the superior and inferior vena cavae due to fibrous tissue around the leads. We removed the fibrous tissue, pacing leads, and generator. New leads were anchored onto the epicardium and a generator was inserted under the rectus muscle. The postoperative course was satisfactory and the symptoms disappeared.