1.Oral Beraprost Sodium as a Prostaglandin I2 Analogue for Vascular Events in Patients with Peripheral Arterial Disease : Meta-Analysis of Two Placebo-Controlled Randomized Trials
Hideki ORIGASA ; Yasuo IKEDA ; Kazuyuki SHIMADA ; Hiroshi SHIGEMATSU
Japanese Journal of Pharmacoepidemiology 2004;9(2):45-51
Objective : To evaluate the effect of beraprost sodium (beraprost) on the vascular events occurring in patients with peripheral arterial disease (PAD) in a meta-analysis of placebo-controlled, randomized trials.
Design : Meta-analysis
Methods : Among the clinical trials of beraprost in patients with intermittent claudication associated with PAD, placebo-controlled, randomized trials with vascular events as outcome measures were selected. Two trials met the criteria, each of which was a comparative trial of beraprost (40 μg t.i.d.) and placebo (t.i.d.), with a six-month follow-up period.
Results : With both trials combined, the analysis included 594 patients in the beraprost group and 590 in the placebo group. The risk ratio was 0.608 (95%CI : 0.41 to 0.90, p =0.012), demonstrating the efficacy of beraprost on all vascular events. The risk ratio for lower limb deterioration was 0.598 (95% CI : 0.34 to 1.06, p =0.079), which was similar to that for all vascular events. A statistically insignificant but similar result was also obtained for cardio/cerebrovascular events with a risk ratio of 0.619 (95%CI : 0.36 to 1.07, p = 0.085). Heterogeneity between the two studies was not found for any of the events.
Conclusion : The results demonstrated the efficacy of beraprost on the vascular events in patients with PAD. The potential benefit of beraprost on vascular events will require evaluation in a larger prospective investigation.
2.Successful Two-Staged Surgical Treatment for a Thoracoabdominal Aortic Aneurysm Combined with an Aberrant Right Subclavian Artery, Kommerell's Diverticulum, and Angina Pectoris
Yasunori Iida ; Yukio Obitsu ; Naozumi Saiki ; Nobusato Koizumi ; Hiroshi Shigematsu
Japanese Journal of Cardiovascular Surgery 2008;37(5):302-305
A 72-year-old man with a thoracoabdominal aortic aneurysm combined with an aberrant right subclavian artery, Kommerell's diverticulum, and angina pectoris during follow-up for peripheral arterial disease was successfully treated surgically by two-staged operation. First, we performed total arch replacement using cardiopulmonary bypass, systemic hypothermia, selective cerebral perfusion, and coronary artery bypass grafting. Secondly, we performed replacement of the thoracoabdominal aortic aneurysm using a partial cardiopulmonary bypass. The postoperative course was uneventful. This is apparently the first case of repair for the thoracoabdominal aortic aneurysm combined with an aberrant right subclavian artery and Kommerell's diverticulum.
3.Risk Assessment for a Learning Curve in Endovascular Abdominal Aortic Aneurysm Repair with the Zenith Stent-Graft: The First Year in Japan
Takashi Azuma ; Satoshi Kawaguchi ; Taro Shimazaki ; Kenji Koide ; Masataka Matsumoto ; Hiroshi Shigematsu ; Akihiko Kawai ; Hiromi Kurosawa
Japanese Journal of Cardiovascular Surgery 2008;37(6):311-316
In Japan, doctors inexperienced stent-graft new devices are required to secure agreement on criteria and choice of the device size in endovascular aneurysm repair (EVAR) from experienced doctors. It was hoped that strict patient selection might reduce the learning curve for initial successes in given procedures. In a leading center in Japan, a number of cases which were scheduled for operation at other institutes were evaluated anatomically. We surveyed the initial success of Zenith AAA system implantation in the remaining cases by inexperienced doctors and evaluated the results. This study aimed to verify the validity of strict patient selection in improving the success rate of inexperienced doctors. We enrolled 112 consecutive patients from 19 institutes, who were scheduled for repair between January and October in 2007. All patients were evaluated on the basis of a less-than-3mm reconstructed CT image. Mean patient age was 76±5.7 years. All cases satisfied the Zenith's anatomic prerequisites. Fifteen cases were excluded for various reasons, the major reason being insufficiency of the proximal landing zone (LZ) length, angle and contour. The second reason was difficulty to approach via the iliac artery. Ninety seven cases were included, of which 17 cases were low-risk candidates for EVAR. Medium-risk seventy two cases requiring some advice to avoid problems with device size, technique of implantation and choice of main-body side. Eight cases were high-risk, requiring the presence of an experienced surgeon. Excluded cases had significantly shorter proximal LZ, larger aortic diameters 15mm below the renal artery and tortuous access routes on preliminary measurement by inexperienced doctor. Perioperative mortality was 0%, while the major complications were injury to the iliac artery in one high-risk case and thromboembolism of the superficial femoral artery in another. Perioperative proximal type I endoleak occurred in 5 cases. In 3 of these cases, the endoleak was eliminated by implantation of a Palmatz stent. In the other 2 cases, it disappeared within a month without additional procedures. These cases had a significantly greater angle between the proximal LZ and the suprarenal aorta and significant amount of mural thromboses in the proximal LZ. Perioperative type III endoleak occurred in 3 cases. In all cases the endoleak was eliminated by additional procedure. Perioperative type II endoleak occurred 8 cases. In 3 of these cases, the endoleak disappeared within a month. In the 5 other cases, the endoleak did not disappear. Mid-term results showed iliac leg thromboembolism in one case and new type II endoleaks in 3 cases. Type II endoleak occurred in cases which had significantly greater angles between the proximal LZ and the aneurysm. The results which were evaluated in our center had excellent perioperative and mid-term outcomes. We think this evaluation system is effective for risk assessment and reduces the learning curve in EVAR. In anatomically marginal cases, it is possible for proximal type I endoleak and injury of the iliac artery to occur. It is impossible to exclude these marginal cases if treatment need for EVAR is a priority. In these cases, lessexperienced operators should be trained in troubleshooting techniques in advance.
4.An 84-year-old Case of Abdominal Aortic Aneurysm with Three-vessel Coronary Artery Disease.
Hiroaki Nozawa ; Hiroshi Shigematsu ; Ichihiro Kobayashi ; Tetsuichiro Muto ; Keita Tanaka ; Yutaka Kozuka ; Akira Furuse ; Takeshi Serizawa
Japanese Journal of Cardiovascular Surgery 1996;25(1):46-49
An 80-year-old male patient had complained of left abdominal pain since 1990, and an abdominal aortic aneurysm (AAA) 5.3cm in diameter was diagnosed by computed tomography (CT). The patient was NYHA class III with complaints of chest pain during exercise. Coronary arteriography showed that he had three-vessel disease. At that time, aneurysmectomy was not anticipated due to his age and because the AAA showed no tendency to enlarge. However, in October 1993, CT showed that the AAA rapidly enlarged to 6.8cm in diameter. Due to the greater risk of rupture of the AAA, aneurysmectomy was considered necessary. The operative mortality associated with aneurysmectomy in patients with coronary artery disease (CAD) is higher than that in patients without CAD. Therefore, coronary artery bypass grafting (CABG) was indicated prior to aneurysmectomy. The patient underwent CABG (two vessels) in December 1993, and aneurysmectomy was successfully performed in February 1994. He was discharged uneventfully 17 days after the operation.
5.Lymphopenia at 4 Days Postoperatively Is the Most Significant Laboratory Marker for Early Detection of Surgical Site Infection Following Posterior Lumbar Instrumentation Surgery.
Eiichiro IWATA ; Hideki SHIGEMATSU ; Akinori OKUDA ; Yasuhiko MORIMOTO ; Keisuke MASUDA ; Hiroshi NAKAJIMA ; Munehisa KOIZUMI ; Yasuhito TANAKA
Asian Spine Journal 2016;10(6):1042-1046
STUDY DESIGN: Case control study. PURPOSE: To identify the most significant laboratory marker for early detection of surgical site infection (SSI) using multiple logistic regression analysis. OVERVIEW OF LITERATURE: SSI is a serious complication of spinal instrumentation surgery. Early diagnosis and treatment are crucial. METHODS: We retrospectively reviewed the laboratory data of patients who underwent posterior lumbar instrumentation surgery for degenerative spinal disease from January 2003 to December 2014. Six laboratory markers for early SSI detection were considered: renewed elevation of the white blood cell count, higher at 7 than 4 days postoperatively; renewed elevation of the C-reactive protein (CRP) level, higher at 7 than 4 days postoperatively; CRP level of >10 mg/dL at 4 days postoperatively; neutrophil percentage of >75% at 4 days postoperatively; lymphocyte percentage of <10% at 4 days postoperatively; and lymphocyte count of <1,000/µL at 4 days postoperatively. RESULTS: Ninety patients were enrolled; five developed deep SSI. Multivariate regression analysis showed that a lymphocyte count of <1,000/µL at 4 days postoperatively was the sole significant independent laboratory marker for early detection of SSI (p=0.037; odds ratio, 11.9; 95% confidence interval, 1.2–122.7). CONCLUSIONS: A lymphocyte count of <1,000/µL at 4 days postoperatively is the most significant laboratory marker for early detection of SSI.
Biomarkers*
;
C-Reactive Protein
;
Case-Control Studies
;
Early Diagnosis
;
Humans
;
Leukocyte Count
;
Leukocytes
;
Logistic Models
;
Lymphocyte Count
;
Lymphocytes
;
Lymphopenia*
;
Neutrophils
;
Odds Ratio
;
Retrospective Studies
;
Spinal Diseases
;
Surgical Wound Infection*
6.Lymphopenia and Elevated Blood C-Reactive Protein Levels at Four Days Postoperatively Are Useful Markers for Early Detection of Surgical Site Infection Following Posterior Lumbar Instrumentation Surgery.
Eiichiro IWATA ; Hideki SHIGEMATSU ; Munehisa KOIZUMI ; Hiroshi NAKAJIMA ; Akinori OKUDA ; Yasuhiko MORIMOTO ; Keisuke MASUDA ; Yasuhito TANAKA
Asian Spine Journal 2016;10(2):220-225
STUDY DESIGN: Case-control study. PURPOSE: To identify the characteristics of candidate indexes for early detection of surgical site infection (SSI). OVERVIEW OF LITERATURE: SSI is a serious complication of spinal instrumentation surgery. Early diagnosis and treatment are crucial for the welfare of the patient postoperation. METHODS: We retrospectively reviewed laboratory data of patients who underwent posterior lumbar instrumentation surgery for degenerative spine disease. The sensitivity and specificity of six laboratory markers for early detection of SSI were calculated: greater elevation of the white blood cell count at day 7 than at day 4 postoperatively, greater elevation of the C-reactive protein (CRP) level at day 7 than at day 4 postoperatively, a CRP level of >10 mg/dL at 4 days postoperatively, neutrophil percentage of >75% at 4 days postoperatively, a lymphocyte percentage of <10% at 4 days postoperatively, and a lymphocyte count of <1,000/µL at 4 days postoperatively. Statistical analysis was via Fisher's exact test and a p-value of <0.05 was considered significant. RESULTS: In total, 85 patients were enrolled. Of these, five patients developed deep SSI. The sensitivity and specificity of each index were as follows: index 1, 20.0% and 77.5%; index 2, 20.0% and 83.8%; index 3, 40.0% and 97.5%; index 4, 40.0% and 86.3%; index 5, 0% and 96.3%; and index 6, 80.0% and 80.0%. A significant difference was noted for indexes 3 and 6. CONCLUSIONS: A CRP level of >10 mg/dL at 4 days postoperatively would be useful for definitive diagnosis of SSI, and a lymphocyte count of <1,000/µL at 4 days postoperatively would be a useful screening test for SSI. Although laboratory markers for early detection of SSI have been frequently reported, we believe that it is important to understand the characteristics of each index for a precise diagnosis.
Biomarkers
;
C-Reactive Protein*
;
Case-Control Studies
;
Diagnosis
;
Early Diagnosis
;
Humans
;
Leukocyte Count
;
Lymphocyte Count
;
Lymphocytes
;
Lymphopenia*
;
Mass Screening
;
Neutrophils
;
Retrospective Studies
;
Sensitivity and Specificity
;
Spine
7.Lymphopenia and Elevated Blood C-Reactive Protein Levels at Four Days Postoperatively Are Useful Markers for Early Detection of Surgical Site Infection Following Posterior Lumbar Instrumentation Surgery.
Eiichiro IWATA ; Hideki SHIGEMATSU ; Munehisa KOIZUMI ; Hiroshi NAKAJIMA ; Akinori OKUDA ; Yasuhiko MORIMOTO ; Keisuke MASUDA ; Yasuhito TANAKA
Asian Spine Journal 2016;10(2):220-225
STUDY DESIGN: Case-control study. PURPOSE: To identify the characteristics of candidate indexes for early detection of surgical site infection (SSI). OVERVIEW OF LITERATURE: SSI is a serious complication of spinal instrumentation surgery. Early diagnosis and treatment are crucial for the welfare of the patient postoperation. METHODS: We retrospectively reviewed laboratory data of patients who underwent posterior lumbar instrumentation surgery for degenerative spine disease. The sensitivity and specificity of six laboratory markers for early detection of SSI were calculated: greater elevation of the white blood cell count at day 7 than at day 4 postoperatively, greater elevation of the C-reactive protein (CRP) level at day 7 than at day 4 postoperatively, a CRP level of >10 mg/dL at 4 days postoperatively, neutrophil percentage of >75% at 4 days postoperatively, a lymphocyte percentage of <10% at 4 days postoperatively, and a lymphocyte count of <1,000/µL at 4 days postoperatively. Statistical analysis was via Fisher's exact test and a p-value of <0.05 was considered significant. RESULTS: In total, 85 patients were enrolled. Of these, five patients developed deep SSI. The sensitivity and specificity of each index were as follows: index 1, 20.0% and 77.5%; index 2, 20.0% and 83.8%; index 3, 40.0% and 97.5%; index 4, 40.0% and 86.3%; index 5, 0% and 96.3%; and index 6, 80.0% and 80.0%. A significant difference was noted for indexes 3 and 6. CONCLUSIONS: A CRP level of >10 mg/dL at 4 days postoperatively would be useful for definitive diagnosis of SSI, and a lymphocyte count of <1,000/µL at 4 days postoperatively would be a useful screening test for SSI. Although laboratory markers for early detection of SSI have been frequently reported, we believe that it is important to understand the characteristics of each index for a precise diagnosis.
Biomarkers
;
C-Reactive Protein*
;
Case-Control Studies
;
Diagnosis
;
Early Diagnosis
;
Humans
;
Leukocyte Count
;
Lymphocyte Count
;
Lymphocytes
;
Lymphopenia*
;
Mass Screening
;
Neutrophils
;
Retrospective Studies
;
Sensitivity and Specificity
;
Spine
8.Preliminary Screening Method for Low Bone Mineral Density Using a Self-Reported Questionnaire among Peri- and Postmenopausal Women
Yudai YANO ; Eiichiro IWATA ; Takuya SADA ; Yuki UENO ; Yoshinobu HYAKUDA ; Sachiko KAWASAKI ; Akinori OKUDA ; Hideki SHIGEMATSU ; Kota UEMATSU ; Hiroshi YAJIMA ; Yasuhito TANAKA
Asian Spine Journal 2022;16(6):927-933
Methods:
We retrospectively reviewed the medical records of 198 women aged 40–70 years who underwent mass screening for osteoporosis at our hospital between 2016 and 2019. The BMD values and the following data were collected: age, body mass index, fracture history, lower back pain, height loss, kyphosis, history of fragility fracture, family history of vertebral or hip fracture, and menopause. The reliability of each data point for the young adult mean <80% was calculated using discriminant analysis. Variables with large weight coefficients were selected and scored. This scoring tool was examined, and a cutoff score for predicting the young adult mean <80% was determined.
Results:
Sixty-four participants (32.3%) had a young adult mean <80%. According to the weight coefficients, the following five variables were scored as follows: age ≥60 years 3 points, body mass index <22 kg/m2 3 points, lower back pain 1 point, height loss (cm) 1 point, and menopause 1 point. The area under the receiver operating characteristic curve was 0.738 (95% confidence interval, 0.669–0.807). At cutoff scores of ≥5 and <5, the sensitivity was 82.8%, with specificity of 52.0%.
Conclusions
The scoring tool performed well for predicting young adult mean <80% among perimenopausal and postmenopausal women in Japan. This tool may be useful to screen for low BMD.