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1.
Japanese Journal of Cardiovascular Surgery ; : 353-360, 2023.
Article in Japanese | WPRIM | ID: wpr-1006973

ABSTRACT

Background: A review committee for unapproved and off-label drugs with high medical needs determined that the indication of fibrinogen concentrate for cardiovascular surgery would be publicly acceptable in 2021. However, the Japanese Society of Cardiovascular Surgery is required the conduct of several surveys demonstrating that fibrinogen concentrate can be used properly in medical settings. A questionnaire concerning the use of fibrinogen concentrate in cardiovascular surgery was one such required survey. Methods: A questionnaire concerning the use of fibrinogen concentrate was conducted in December 2021 at 551 certified training facilities of the Japanese Board of Cardiovascular Surgery, and responses were received from 375 facilities (68%). Results: Fibrinogen concentrate was used in 98 centers (26%). Aortic surgery (thoracic/thoracoabdominal) (50%) and cardiac redo surgery (24%) were eligible common surgeries requiring fibrinogen concentrate, and the intraoperative measurement of fibrinogen levels was performed in 77% of centers. The triggers for the use of fibrinogen concentrate were a fibrinogen level <150 mg/dl in 30%, <100 mg/dl in 20% and massive bleeding tendency in 40%. Of note, only 39 facilities (10%) were able to prepare cryoprecipitate in-hospital, and 34 centers (9%) used it for cardiovascular surgery. One hundred and seven centers (29%) planned to apply for facility accreditation for the use of fibrinogen concentrate, and 40 facilities (10%) answered that they would decide based on the situation. The expected number of annual cases in which fibrinogen concentrate would be used for cardiovascular surgery reached 4,860 cases: <10 cases in 52 centers, 10-19 cases in 50 centers, 20-49 cases in 31 centers, 50-99 cases in 12 centers and ≥100 cases in 2 centers. Conclusion: We conducted a questionnaire on the use of fibrinogen concentrate. Intraoperative fibrinogen level measurement was performed at approximately 80% of institutions, and the annual number of cases likely to use fibrinogen concentrate was predicted to reach about 5,000 cases. However, only 10% of centers used cryoprecipitates prepared in-hospital.

2.
Japanese Journal of Cardiovascular Surgery ; : 169-179, 2020.
Article in Japanese | WPRIM | ID: wpr-825973

ABSTRACT

Purpose : The current status of treatment for thoracic/thoracoabdominal aortic diseases in Japan was analyzed. Methods : Using the Japan Cardiovascular Surgery Database (JCVSD), the number of cases, operative mortality and major morbidities (stroke, renal failure, pneumonia, paraplegia) of thoracic and thoracoabdominal aortic surgery in 2017 and 2018 were analyzed by surgical site (root-ascending, arch, descending, thoracoabdominal aorta), surgical procedure and age group. Results : The total number of cases was approximately 40,000 and aortic dissection and non-dissection were almost the same. The number of cases was highest in the 70s, and in the elderly, the rates of root replacement (particularly valve-sparing operation) in the root-ascending aorta and open-chest surgery (prosthetic graft replacement, OAR ; open stent graft, Open SG) in the arch, descending and thoracoabdominal aorta were lower. The outcome by procedure showed the lowest mortality and morbidity rate of valve-sparing in the root-ascending region, and lower mortality and morbidity (cerebral infarction, renal failure, and pneumonia) in non-open-chest procedures (TEVAR with/without branch reconstruction) than those in open-chest procedures in the arch, descending and thoracoabdominal regions. Unlike other complications, the incidence of paraplegia in the arch was lower in OAR than in non-open-chest procedures. With regards to age, the operative mortality in patients aged 80 or older was significantly higher than those under 80 for all surgical procedures in the root-ascending, arch and descending regions. Conclusions : Thoracic and thoracoabdominal aortic surgery in Japan was most often performed in elderly patients in their 70s with an overall good mortality rate of 5.3%. Mortality and postoperative morbidity in patients aged 80 or older were still high. Further improvement of surgical results is required.

3.
Japanese Journal of Cardiovascular Surgery ; : 160-168, 2020.
Article in Japanese | WPRIM | ID: wpr-825972

ABSTRACT

Objectives : We sought to present data relative to valvular heart surgeries from the Japan Cardiovascular Surgery Database in 2017 and 2018 to show current status and trend in Japan. Methods : We extracted data relative to cardiac valve surgeries performed in 2017 and 2018 from the Japan Cardiovascular Surgery Database. We obtained total number of aortic valve replacement procedures and showed trend for these 6 years from 2013 to 2018. The operative mortality rates were shown for representative valve procedures stratified by age group with the aim of showing a bench mark of Japan. Data regarding minimally invasive procedures and transcatheter aortic valve implantation which the Japan Cardiovascular Surgery Database can provide were also presented. Results : Despite dramatic increase of number of transcatheter aortic valve implantation in 2017 and 2018 compared to in 2015 and 2016, surgical aortic valve replacement also increased from 26,054 to 28,202. Regarding the operative mortality of first time valve procedures, it was 1.8% in isolated aortic valve replacement, 0.9% in isolated mitral valve repair, 8.2% in mitral valve replacement with biological prostheses, and 4.6% with mechanical prostheses. For first time valve procedures with concomitant coronary artery bypass, the operative mortality was 5.2% in aortic valve replacement, 4.9% in mitral valve repair. Regarding prosthetic valve selection, 72.6% of patients had biological prosthesis for aortic valve replacement procedures in their 60's, showing trend of increasing percentages of biological valve choice. Regarding minimally invasive procedure, 31.8% of first time isolated mitral valve plasty were performed via right thoracotomy. Though patients who underwent surgery via right thoracotomy had better clinical outcomes, it was also apparent that the patients who underwent surgery via right thoracotomy had lower operative risk profile. Aortic clamp time and cardiopulmonary bypass time were longer in the right thoracotomy patients. 6.3% of the patients who had isolated aortic valve replacement underwent surgery via right thoracotomy. The right thoracotomy aortic valve replacement patients had better clinical outcomes and had more percentage of lower risk profile. The overall mortality of transcatheter aortic valve implantation and surgical aortic valve replacement were 1.5% and 1.8%, respectively. Conclusion : We reported data related to heart valve surgery in 2017 and 2018 from the Japan Cardiovascular Surgery Database.

4.
Japanese Journal of Cardiovascular Surgery ; : 155-159, 2020.
Article in Japanese | WPRIM | ID: wpr-825971

ABSTRACT

Data on isolated coronary artery bypass grafting (CABG) performed in 2017 and 2018, and registered in the Japan Cardiovascular Surgery Database were reviewed for preoperative characteristics, postoperative outcomes, and choice of graft material for the left anterior descending artery (LAD). Isolated CABG was performed off-pump in 54.6% (n=14,684) of all CABG cases (n=26,913), and graft material for the LAD was left internal thoracic artery in 76.4% and right internal thoracic artery in 19.0%. Operative mortality was 1.5% in elective cases (On-pump CABG : ONCAB 1.9%, off-pump CABG : OPCAB 1.2%, p<0.001), 7.4% in emergency cases (ONCAB 10.2%, OPCAB 4.3%, p<0.001), and 2.5% overall. Postoperative morbidity was low in almost all aspects in OPCAB, and average JapanSCORE II is elevating every year. Overall short-term operative results for isolated CABG is stable, and operative candidates are shifting to higher-risk patients.

5.
Japanese Journal of Cardiovascular Surgery ; : 151-154, 2020.
Article in Japanese | WPRIM | ID: wpr-825970

ABSTRACT

Objectives : We analyzed the mortality and morbidity of congenital heart surgery in Japan by using Japan Cardiovascular Surgery Database (JCVSD). Methods : The congenital heart surgery performed between January 2017 to December 2018 were obtained from JCVSD. From the data obtained, the most frequent twenty procedures were selected, and the mortalities and major morbidities were analyzed. In addition, all the procedures were classified into STAT Mortality Categories and mortalities in each category were also analyzed. Results : The mortality of ASD repair and VSD repair were 0% and 0.2% respectively. The mortality of TOF repair, complete AVSD repair, Rastelli operation, CoA complex repair, bidirectional Glenn, TCPC were 2-3%. The mortality of systemic to pulmonary shunt was 4.9%, and the mortality of TAPVC repair and Norwood procedure were 11.1% and 15.7% respectively and not different from the results of 2015-2016. The mortalities according to the STAT categories 1-5 were 0.3%, 2.7%, 2.9%, 5.9% and 15.5% respectively and comparable to those of STS database (2013-2016). Conclusion : The analysis of the JCVSD-congenital data revealed the mortality rate of major surgical procedures for congenital heart disease performed in Japan in 2017-2018, the frequency of complications, and the mortality rate by STAT Mortality Categories. We believe that these statistics will play an important role as a basis for trends in Japan and for comparison of results with other countries.

6.
Japanese Journal of Cardiovascular Surgery ; : 6-10, 2019.
Article in Japanese | WPRIM | ID: wpr-738312

ABSTRACT

We reviewed the data of the isolated coronary artery bypass grafting (CABG) procedures performed in 2015 and 2016, as registered in the Japan Cardiovascular Surgery Database, for preoperative characteristics, surgical outcomes, and the choice of graft material used for the left anterior descending artery (LAD). Isolated CABG was performed off-pump in 55.0% (n = 16,173) of all CABG cases (n = 29,392). The left internal thoracic artery and the right internal thoracic artery were used as the graft materials in 72.1 and 17.4% cases respectively. The operative mortality rates remained unchanged since the last report, with 1.7% for elective cases, 8.8% for emergency cases, and 3.0% overall. In elective cases, the operative mortality rate was 1.1% for off-pump CABG (OPCAB) compared with 2.5% for on-pump CABG. The morbidity rates for all OPCAB cases were significantly better except for those falling in the ‘readmission <30 days’ group.

7.
Japanese Journal of Cardiovascular Surgery ; : 18-24, 2019.
Article in Japanese | WPRIM | ID: wpr-738304

ABSTRACT

Background : Thoracic and thoracoabdominal aortic diseases are treated using operative procedures like open aortic repair (OAR), thoracic endovascular aortic repair (TEVAR) or even hybrid aortic repair (HAR), a combination of OAR and TEVAR. The surgical approach to aortic repair is evolving over the decades. The purpose of this study was to examine the current trends in treatment. Methods : We extracted the nationwide data of aortic repair procedures performed between 2015 and 2016 from the Japan Cardiovascular Surgery Database (JCVSD). In addition to estimating the number of cases, we also classified the cases based on various criteria such as operative mortality, associated major morbidities (e.g. stroke, spinal cord insufficiency, renal failure), disease pathology (e.g. acute dissection, chronic dissection, ruptured aneurysm, unruptured aneurysm), site of operative repair (e.g. aortic root, ascending aorta, aortic root to arch, aortic arch, descending aorta, thoracoabdominal aorta) and the preferred surgical approach (i.e. OAR, HAR or TEVAR). Results : The total number of cases studied was 35,427, with an overall operative mortality rate of 7.3%. Among the 3 procedures, 64% of patients were treated with OAR. In comparison to the data in our previous report (also derived from the JCVSD in 2013 and 2014), the total number of cases and numbers of OAR, HAR, and TEVAR have increased by 17.0%, 2.4%, 126.1% and 34.9%, respectively. While the overall stroke rates following aortic arch surgical repair with HAR, OAR, and TEVAR were 10.1%, 8.4%, and 7.3% respectively. OAR was found to have the lowest stroke rate when limited to cases presenting with a non-dissected/unruptured aorta. The incidence rates of paraplegia following descending/thoracoabdominal aortic surgical repair using HAR, OAR, and TEVAR were 6.3%/10.4%, 4.3%/8.9% and 3.4%/4.6%, respectively. TEVAR was found to be associated with the lowest incidence of postoperative renal failure. Conclusions The number of operated thoracic and thoracoabdominal aortic diseases has increased, though the rate of operations using an OAR approach has decreased. While TEVAR showed the lowest mortality and morbidity rates, OAR demonstrated the lowest postoperative stroke rate for non-dissecting aortic arch aneurysms.

8.
Japanese Journal of Cardiovascular Surgery ; : 11-17, 2019.
Article in Japanese | WPRIM | ID: wpr-738303

ABSTRACT

Objectives : Data of valvular heart surgeries from the Japan Cardiovascular Surgery Database in 2015 and 2016 were analyzed to demonstrate the associated mortality and morbidity rates and choice of surgical procedures. Methods : We used the Japan Cardiovascular Surgery Database to extract data of cardiac valve replacement procedures performed in 2015 and 2016. The cases were further evaluated depending upon the type of procedure, and prosthesis used at each site. The rate of bio-prosthesis usage was derived for each valve position and age groups. The rates of operative mortality and morbidity were calculated for each valve position and type of procedures. Results : In total, 26,054 aortic valve replacements were performed in 2015 and 2016, showing a slight increase in number since the last report(2013-2014). A total of 3,305 transcatheter aortic valve replacements, 5,652 mitral valve replacements, and 12,024 mitral valve repair procedures were performed. The rate of bio-prosthesis usage in aortic valve replacement was 96.5%, 92.7% and 63.5% for patients in their 80s, 70s and 60s, respectively, demonstrating an increase in usage since 2013-2014. Mechanical valves were preferred in patients on chronic hemodialysis. The mortality rates of aortic valve replacement, mitral valve replacement, mitral valve repair, and tricuspid valve replacement procedures were 4.1%, 7.1%, 2.2%, and 10.5%, respectively. Conclusion : We evaluated recent trends in valvular heart surgery in Japan with respect to the type of procedure and prosthesis preferred and the postoperative outcomes. We found that bio-prosthesis usage was the most common.

9.
Japanese Journal of Cardiovascular Surgery ; : 1-5, 2019.
Article in Japanese | WPRIM | ID: wpr-738302

ABSTRACT

Methods : We collated the nationwide data on congenital heart operations performed between January 2015 and December 2016 from the Japan Cardiovascular Surgery Database (JCVSD). The mortality and morbidity data for the 20 most-frequently performed procedures were analyzed. We also classified the surgical centers into three groups, according to the number of cardiopulmonary cases over a year and estimated the institution-wise distribution of major operations. Results : The mortality rate of the ASD and VSD repair procedures was <1%, while the mortality rate of procedures including TOF repair, complete AVSD repair, Rastelli operation, CoA complex repair, bidirectional Glenn and TCPC was found to be between 2-3%. The mortality rate of surgeries such as the Norwood procedure and TAPVC repair was comparably higher (>10%). These complicated procedures were mainly performed at the surgical institutes handling a large volume of cases. Conclusion : Using the JCVSD, the nationwide data of congenital heart surgery, including postoperative complications, were analyzed.

10.
Japanese Journal of Cardiovascular Surgery ; : 205-211, 2017.
Article in Japanese | WPRIM | ID: wpr-379332

ABSTRACT

<p><b>Background</b> : Although open aortic repair (OAR) is still considered to be a standard treatment for thoracic aortic diseases, recently the indication of thoracic endovascular treatment (TEVAR) /hybrid aortic repair (HAR) is expanding. The purpose of this study is to review the current status of treatment of thoracic aortic diseases. <b>Methods</b> : The data concerning surgery for diseases in thoracic/thoracoabdominal aorta in 2013 and 2014 are extracted from the Japan Cardiovascular Surgery Database (JCVSD). The number of cases and operative mortality are evaluated for pathology (acute dissection, chronic dissection, ruptured aneurysm, un-ruptured aneurysm), treatment modality (OAR, HAR, TEVAR), JapanSCORE (<5%, 5 to 10%, 10 to 15%, 15%≦) and their combination. <b>Results</b> : The total number of cases included in this study was 30,271 and the overall operative mortality was 5.9%. Among 3 types of treatment, 73.2% of patients underwent OAR (root, 98.3% ; ascending, 97.4% ; root to arch, 95.5% ; arch, 81.7% ; descending, 34.2% ; thoracoabdominal, 64.4%). Although the rate of OAR was in negative correlation with JapanSCORE (JS) in treatment for thoracoabdominal region (JS<5%, 80.4% ; 5%≦JS<10%, 67.6% ; 10%≦JS<15%, 58.8% ; 15%≦JS, 55.7%), such relation was not observed in other regions. The operative mortality of OAR was well reflected by JS (JS<5%, 2.1% ; 5%≦JS<10%, 5.5% ; 10%≦JS<15%, 10.2% ; 15%≦JS, 20.3%), however, those of TEVAR/HAR was less than the range of JS. <b>Conclusions</b> : The distribution of treatment differs depending on site of diseases and is not much influenced by JS. It has become clear that JapanSCORE is a reliable tool for estimating operative mortality in OAR. However, the observed operative mortality was lower than JS in TEVAR/HAR and a new risk score for TEVAR/HAR should be established.</p>

11.
Japanese Journal of Cardiovascular Surgery ; : 199-204, 2017.
Article in Japanese | WPRIM | ID: wpr-379331

ABSTRACT

<p><b>Objective</b> : To demonstrate the mortality rate and the choice of surgical procedures, especially the selection of the valve prosthesis, in each position of the valve in each age of the patients and the effects of the preoperative complications to the mortality and prosthetic valve selection, the data from JCVSD in 2013 and 2014 are analyzed. <b>Methods</b> : The proportion of each surgical procedure is compared in each age of the patients in the aortic, the mitral and the tricuspid position. <b>Results</b> : The proportion of the mechanical valve prostheses was 23.1, 40.5 and 11.4% in the aortic, mitral and tricuspid position respectively and it was higher in hemodialysis patients than in non-hemodialysis patients. The operative mortality rate was 4.3, 11.7, 15.8 and 5.6% in all cases, the hemodialysis patients, the patients with liver dysfunction and the patients with atrial fibrillation and flutter, respectively in AVR, and 4.0, 14.4, 11.2 and 4.1%, respectively in each group listed above after mitral surgery. <b>Conclusion</b> : These results clarify the status of cardiac valvular surgery in Japan.</p>

12.
Japanese Journal of Cardiovascular Surgery ; : 195-198, 2017.
Article in Japanese | WPRIM | ID: wpr-379330

ABSTRACT

<p><b>Objective and Methods</b> : Data on isolated coronary artery bypass grafting (CABG) performed in 2013 and 2014, and registered in the Japan Cardiovascular Surgery Database were reviewed for preoperative characteristics, postoperative outcomes, and choice of graft material for the left anterior descending artery (LAD). <b>Results</b> : Isolated CABG was performed off-pump in 54.7% of cases, and graft material for the LAD was left internal thoracic artery in 74.3% and right internal thoracic artery in 15.6%. Operative mortality was 2.0% in elective cases, 8.2% in emergency cases, and 3.0% overall. In elective cases, operative mortality was 1.1% for off-pump CABG compared with 3.0% for on-pump CABG. <b>Conclusions</b> : Clinical results of our isolated CABG was reasonable and acceptable.</p>

13.
Japanese Journal of Cardiovascular Surgery ; : 191-194, 2017.
Article in Japanese | WPRIM | ID: wpr-379329

ABSTRACT

<p><b>Objectives</b> : We analyzed the mortality and morbidity of congenital heart surgery in Japan by using the Japan Cardiovascular Surgery Database (JCVSD). <b>Methods</b> : Data regarding congenital heart surgery performed between January 2013 and December 2014 were obtained from JCVSD. The 20 most frequent procedures were selected and the mortality rates and major morbidities were analyzed. <b>Results</b> : The mortality rates of atrial septal defect (ASD) repair and ventricular septal defect (VSD) repair were less than 1%, and the mortality rates of tetralogy of Fallot (TOF) repair, complete atrioventricular septal defect (AVSD) repair, bidirectional Glenn, and total cavopulmonary connection (TCPC) were less than 2%. The mortality rates of the Norwood procedure and total anomalous pulmonary venous connection (TAPVC) repair were more than 10%. The rates of unplanned reoperation, pacemaker implantation, chylothorax, deep sternal infection, phrenic nerve injury, and neurological deficit were shown for each procedure. <b>Conclusion</b> : Using JCVSD, the national data for congenital heart surgery, including postoperative complications, were analyzed. Further improvements of the database and feedback for clinical practice are required.</p>

14.
Japanese Journal of Cardiovascular Surgery ; : 187-190, 2017.
Article in Japanese | WPRIM | ID: wpr-379328

ABSTRACT

<p>In the year 2000, the Japan Cardiovascular Surgery Database (JCVSD) was created with the support of the Society of Thoracic Surgeons (STS). STS database software was translated to Japanese with the same definitions and in 2001, the data entry of adult cardiac surgeries was initiated online using University Hospital Medical Information Network, UMIN. In 2008, entry of the data of congenital heart surgeries was initiated in the congenital section of JCVSD and preoperative expected mortality (JapanSCORE) in adult cardiovascular surgeries was first calculated using the risk model of JCVSD. In 2011, the Japan Surgical Board system merged with JCVSD and all cardiovascular surgical data could be registered in JCVSD from 2012. The reports resulting from the analyses of data from JCVSD (Current Status of Cardiovascular Surgery in Japan, 2013 and 2014 : A report based on the JCVSD) will encourage further improvements in the quality of cardiovascular surgeries, patient safety, and medical care for patients in Japan.</p>

15.
Japanese Journal of Cardiovascular Surgery ; : 101-104, 2014.
Article in Japanese | WPRIM | ID: wpr-375448

ABSTRACT

A 72-year-old woman was admitted to our department with a diagnosis of severe aortic stenosis was also diagnosed Inherited antithrombin deficiency was also diagnosed after she suffered from a pulmonary thromboembolic event 10 years previously and had been taking warfarin since then. On admission, her antithrombin activity was 53% of normal, and her PT-INR level was maintained around 2.5. Preoperative management of anticoagulation therapy included discontinuation of warfarin, and supplementation of antithrombin with heparin infusion. On the day of operation, antithrombin activity was maintained above 80% by administering antithrombin, and aortic valve replacement with a mechanical valve prosthesis was carried out under standard cardiopulmonary bypass support using heparin. Heparin infusion was continued with antithrombin supplementation until PT-INR recovered to round 2.5 with warfarin. Her intra- and postoperative courses did not show any thromboembolic events, and she was discharged 14 days after the surgery.

16.
The Korean Journal of Thoracic and Cardiovascular Surgery ; : 437-443, 2014.
Article in English | WPRIM | ID: wpr-45106

ABSTRACT

The JCVSD (Japan Cardiovascular Surgery Database) was organized in 2000 to improve the quality of cardiovascular surgery in Japan. Web-based data harvesting on adult cardiac surgery was started (Japan Adult Cardiovascular Surgery Database, JACVSD) in 2001, and on congenital heart surgery (Japan Congenital Cardiovascular Surgery Database, JCCVSD) in 2008. Both databases grew to become national databases by the end of 2013. This was influenced by the success of the Society for Thoracic Surgeons' National Database, which contains comparable input items. In 2011, the Japanese Board of Cardiovascular Surgery announced that the JACVSD and JCCVSD data are to be used for board certification, which improved the quality of the first paperless and web-based board certification review undertaken in 2013. These changes led to a further step. In 2011, the National Clinical Database (NCD) was organized to investigate the feasibility of clinical databases in other medical fields, especially surgery. In the NCD, the board certification system of the Japan Surgical Society, the basic association of surgery was set as the first level in the hierarchy of specialties, and nine associations and six board certification systems were set at the second level as subspecialties. The NCD grew rapidly, and now covers 95% of total surgical procedures. The participating associations will release or have released risk models, and studies that use 'big data' from these databases have been published. The national databases have contributed to evidence-based medicine, to the accountability of medical professionals, and to quality assessment and quality improvement of surgery in Japan.


Subject(s)
Adult , Humans , Asian People , Certification , Evidence-Based Medicine , Japan , Patient Safety , Quality Improvement , Social Responsibility , Thoracic Surgery
17.
Japanese Journal of Cardiovascular Surgery ; : 76-79, 2012.
Article in Japanese | WPRIM | ID: wpr-363065

ABSTRACT

A 44-year-old man who received left ventricular assist device (LVAD) implantation for end-stage heart failure due to dilated cardiomyopathy suffered from mediastinitis. Computed tomography confirmed mediastinitis. His mediastinum was reopened and irrigated. Negative pressure wound therapy (NPWT) was applied to the wound without closing the chest. This system enabled the patient to receive early physical rehabilitation. One year after LVAD implantation, under NPWT, the patient could walk in the general ward, and was waiting for cardiac transplantation. We used some useful materials for NPWT including a coatable non-alcoholic film, flexible sealing sheet, soft exudate absorber, in order to control wound clean, keep air-tight, prevent damage to the skin and to reduce mediastinal instability. LVAD implantation is usually performed as a bridge to transplantation or recovery. One of the most critical complications is intractable mediastinitis. We described a successful infection control of LVAD related mediastinitis with the NPWT.

18.
Japanese Journal of Cardiovascular Surgery ; : 1-7, 2012.
Article in Japanese | WPRIM | ID: wpr-376889

ABSTRACT

Recently, the use of databases for clinical trials is being promoted. We used the Japan Adult Cardiovascular Surgery Database (JACVSD) data was used as a historical control in a clinical trial, and we analyzed following : the processes of using data and the efficiency of data collection, available variables for statistical analysis, and query functions for missing and invalid data. We chose available variables of JACVSD data and created rules for merging JACVSD data with interventional group data, in addition to analyzing the data collection processes for clinical trials. Subjects were selected from cases registered in the JACVSD. On statistical analysis, 63% of 76 variables were used ; variables related to the patients' symptoms had to be collected separately. Missing and invalid data were effectively excluded. We could conduct data collection efficiently by using the JACVSD as a historical control for clinical trials. Selecting subjects from the JACVSD could reduce the burden of selecting subjects from hospitals and prevent selection bias.

19.
Asian Nursing Research ; : 57-63, 2010.
Article in English | WPRIM | ID: wpr-31969

ABSTRACT

PURPOSE: The aim of this study was to evaluate the validity and reliability of the Seattle Angina Questionnaire, Japanese version (SAQ-J) as a disease-specific health outcome scale in patients with coronary artery disease. METHODS: Patients with coronary artery disease were recruited from a university hospital in Tokyo. The patients completed self-administered questionnaires, and medical information was obtained from the subjects' medical records. Face validity, concurrent validity evaluated using Short Form 36 (SF-36), known group differences, internal consistency, and test-retest reliability were statistically analyzed. RESULTS: A total of 354 patients gave informed consent, and 331 of them responded (93.5%). The concurrent validity was mostly supported by the pattern of association between SAQ-J and SF-36. The patients without chest symptoms showed significantly higher SAQ-J scores than did the patients with chest symptoms in 4 domains. Cronbach's alpha ranged from .51 to .96, meaning that internal consistency was confirmed to a certain extent. The intraclass correlation coefficient of most domains was higher than the recommended value of 0.70. The weighted kappa ranged from .24 to .57, and it was greater than .4 for 14 of the 19 items. CONCLUSIONS: The SAQ-J could be a valid and reliable disease-specific scale in some part for measuring health outcomes in patients with coronary artery disease, and requires cautious use.


Subject(s)
Humans , Asian People , Coronary Artery Disease , Coronary Vessels , Informed Consent , Medical Records , Reproducibility of Results , Thorax , Tokyo , Surveys and Questionnaires
20.
Japanese Journal of Cardiovascular Surgery ; : 184-192, 2009.
Article in Japanese | WPRIM | ID: wpr-361913

ABSTRACT

In Japan, few surveys have evaluated the structure and clinical process of cardiovascular surgery programs. We mailed a questionnaire to all 149 facilities participating in the Japan Adult Cardiovascular Database as of April 1st 2007. We received responses from 129 facilities (response rate 86.6%). For CABG surgery, many facilities regard “IMA use (95.3%) ” and “off-pump surgery” is the first choice as a facility and recommend “discharge antiplatelets (89.9%) ” and “discharge antilipid (47.3%) ”. On the other hand most facilities did not made any recommendation regarding “preoperative beta blockers (72.9%) ” and “discharge beta blockers (60.5%) ”. The usage rates of preoperative beta blockers and discharge beta blockers were very low in Japan though their usage rates were relatively high in the United States.

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