Survival trends and patient characteristics between 2004 and 2016 for breast cancer in Japan based on the National Clinical Database-Breast Cancer Registry.

This is a prognostic report by the Japanese Breast Cancer Society on breast cancer extracted from the National Clinical Database-Breast Cancer Registry of Japan. Here, we present a summary of 457,878 breast cancer cases registered between 2004 and 2016. The median follow-up duration was 5.6 years. The median age at the start of treatment was 59 years (5-95%: 38-82 years) and increased from 57 years between 2004 and 2008 to 60 years between 2013 and 2016. The proportion of patients with Stage 0-II disease increased from 74.5% to 78.3%. The number of cases with estrogen and progesterone receptor positivity increased from 74.8% to 77.9% and 60.5% to 68.1%, respectively. Regarding (neo-)adjuvant chemotherapy, the taxane (T) or taxane-cyclophosphamide (C) regimen increased by 2.4% to 8.2%, but the (fluorouracil (F)) adriamycin (A)-C-T/(F) epirubicin (E)C-T and (F)AC/(F)EC regimens decreased by 18.6% to 15.2% and 13.5% to 5.0%, respectively. Regarding (neo-)adjuvant anti-human epidermal growth factor-2 (HER2)-targeted therapy, the use of trastuzumab increased from 4.6% to 10.5%. The rate of sentinel lymph node biopsy increased from 37.1% to 60.7%, while that of axillary dissection decreased from 54.5% to 22.6%. Improvements in disease-free and overall survival were observed in patients with HER2-positive breast cancer, but there was no apparent trend in patients with hormone receptor-positive, HER2-negative, or triple-negative breast cancers.

The accuracy and characteristics of gastric cancer treatment information in the national data of the hospital-based cancer registry.

OBJECTIVE: The hospital-based cancer registry is used extensively for research to support cancer control activities by providing an overview of how cancer treatments are provided nationwide. This study aimed to shed light on the quality and characteristics of treatment data in the hospital-based cancer registry using the linked dataset on gastric cancer. METHODS: Using the nationally linked data of the hospital-based cancer registry and the health services utilization data, the treatment data in the hospital-based cancer registry for patients who were newly diagnosed with gastric cancer in 2016 and 2017 and received the first course of treatment at their own institutions were examined. The agreement rates between registry data and utilization data were analyzed by stage, treatment, age, period from the date of diagnosis to the date of treatment and hospital type. RESULTS: The sensitivity of open surgery, laparoscopic surgery and endoscopic treatment tended to decrease in advanced stages, whereas the sensitivity of chemotherapy and radiation therapy increased. Specificity was high for all treatments and stages, at ˃90%. Sensitivity by age was slightly different for chemotherapy and radiation therapy, but specificities did not differ.For all treatments, the longer the time from diagnosis to treatment implementation, the higher the coverage rate. CONCLUSIONS: The hospital-based cancer registry recorded the treatment performed appropriately. It is necessary to interpret the data from the hospital-based cancer registry whilst keeping in mind that, chemotherapy and radiation therapy are registered less frequently than surgical treatments administered.

Short Interpregnancy Intervals Among Women Experiencing Homelessness in Colorado.

Importance: Short interpregnancy intervals (SIPIs) are associated with increased risk of adverse maternal and neonatal outcomes. Disparities exist across socioeconomic status, but there is little information on SIPIs among women experiencing homelessness. Objective: To investigate (1) differences in rates and characteristics of SIPIs between women experiencing homelessness and domiciled women, (2) whether the association of homelessness with SIPIs differs across races and ethnicities, and (3) whether the association between SIPIs of less than 6 months (very short interpregnancy interval [VSIPIs]) and maternal and neonatal outcomes differs between participant groups. Design, Setting, and Participants: This cohort study used a Colorado statewide database linking the Colorado All Payer Claims Database, Homeless Management Information System, death records, and infant birth records. Participants included all women who gave birth between January 1, 2016, and December 31, 2021. Data were analyzed from September 1, 2022, to May 10, 2023. Exposures: Homelessness and race and ethnicity. Main Outcomes and Measures: The primary outcome consisted of SIPI, a binary variable indicating whether the interval between delivery and conception of the subsequent pregnancy was shorter than 18 months. The association of VSIPI with maternal and neonatal outcomes was also tested. Results: A total of 77 494 women (mean [SD] age, 30.7 [5.3] years) were included in the analyses, of whom 636 (0.8%) were women experiencing homelessness. The mean (SD) age was 29.5 (5.4) years for women experiencing homelessness and 30.7 (5.3) years for domiciled women. In terms of race and ethnicity, 39.3% were Hispanic, 7.3% were non-Hispanic Black, and 48.4% were non-Hispanic White. Associations between homelessness and higher odds of SIPI (adjusted odds ratio [AOR], 1.23 [95% CI, 1.04-1.46]) were found. Smaller associations between homelessness and SIPI were found among non-Hispanic Black (AOR, 0.59 [95% CI, 0.37-0.96]) and non-Hispanic White (AOR, 0.57 [95% CI, 0.39-0.84]) women compared with Hispanic women. A greater association of VSIPI with emergency department visits and low birth weight was found among women experiencing homelessness compared with domiciled women, although no significant differences were detected. Conclusions and Relevance: In this cohort study of women who gave birth from 2016 to 2021, an association between homelessness and higher odds of SIPIs was found. These findings highlight the importance of conception management among women experiencing homelessness. Racial and ethnic disparities should be considered when designing interventions.

2020 Annual Report of National Clinical Database-Breast Cancer Registry: 10-year mortality of elderly breast cancer patients in Japan.

The Japanese Breast Cancer Society initiated the breast cancer registry in 1975, which transitioned to the National Clinical Database-Breast Cancer Registry in 2012. This annual report presents data from 2020 and analyzes the ten-year mortality rates for those aged 65 and older. We analyzed data from 93,784 breast cancer (BC) cases registered in 2020 and assessed 10-year mortality rates for 36,279 elderly patients diagnosed between 2008 and 2012. In 2020, 99.4% of BC cases were females with a median age of 61. Most (65%) were diagnosed at early stages (Stage 0 or I). Breast-conserving surgery rates varied with stages: 58.5% at cStage I, 30.8% at cStage II, and 13.1% at cStage III. Sentinel lymph node biopsy was done in 73.6% of cases, followed by radiotherapy in 70% of those post-conserving surgery and chemotherapy in 21.1% post-surgery. Pathology showed that 63.4% had tumors under 2.0 cm, 11.7% had pTis tumors, and 77.3% had no axillary lymph node metastasis. ER positivity was seen in 75.1%, HER2 in 14.3%, and 30% had a Ki67 positivity rate above 30%. Across all stages and subtypes, there was a trend where the 10-year mortality rates increased for individuals older than 65 years. In Stage I, many deaths were not directly linked to BC and, for those with HER2-type and triple-negative BC, breast cancer-related deaths increased with age. Within Stage II, patients older than 70 years with luminal-type BC often experienced deaths not directly linked to BC, whereas patients below 80 years with HER2-type and triple-negative BC, likely had breast cancer-related deaths. In Stage III, breast cancer-related deaths were more common, particularly in HER2 and triple-negative BC. Our prognostic analysis underscores distinct mortality patterns by stage, subtype, and age in elderly BC patients. It highlights the importance of personalized treatment strategies, considering subtype-specific aggressiveness, age-related factors, and comorbidities.

Prognostic factors after open and endovascular repair for infective native aneurysms of the abdominal aorta and common iliac artery.

OBJECTIVE: Infective native aneurysms (INAs) of the abdominal aorta and iliac arteries are uncommon, but potentially fatal. Endovascular aneurysm repair (EVAR) has recently been introduced as a durable treatment option, with outcomes comparable to those yielded by conventional open repair. However, owing to the rarity of the disease, the strengths and limitations of each treatment remain uncertain. The present study aimed to separately assess post-open repair and post-EVAR outcomes and to clarify factors affecting the short-term and late prognosis after each treatment. METHODS: Using a nationwide clinical registry, we investigated 600 patients treated with open repair and 226 patients treated with EVAR for INAs of the abdominal aorta and/or common iliac artery. The relationships between preoperative or operative factors and postoperative outcomes, including 90-day and 3-year mortality and persistent or recurrent aneurysm-related infection, were examined. RESULTS: Prosthetic grafts were used in >90% of patients treated with open repair, and in situ and extra-anatomic arterial reconstruction was performed in 539 and 57 patients, respectively. Preoperative anemia and imaging findings suggestive of aneurysm-enteric fistula were independently associated with poor outcomes in terms of both 3-year mortality (hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.01-2.62; P = .046, and HR, 2.24; 95% CI, 1.12-4.46; P = .022, respectively) and persistent or recurrent infection (odds ratio [OR], 2.16; 95% CI, 1.04-4.49; P = .039, and OR, 4.96; 95% CI, 1.81-13.55; P = .002, respectively) after open repair, whereas omental wrapping or packing and antibiotic impregnation of the prosthetic graft for in situ reconstruction contributed to improved 3-year survival (HR, 0.60; 95% CI, 0.39-0.92; P = .019, and HR, 0.53; 95% CI, 0.32-0.88; P = .014, respectively). Among patients treated with EVAR, abscess formation adjacent to the aneurysm was significantly associated with the occurrence of persistent or recurrent infection (OR, 2.24; 95% CI, 1.06-4.72; P = .034), whereas an elevated preoperative white blood cell count was predictive of 3-year mortality (HR, 1.77; 95% CI, 1.00-3.13; P = .048). CONCLUSIONS: Profiles of prognostic factors differed between open repair and EVAR in the treatment of INAs of the abdominal aorta and common iliac artery. Open repair may be more suitable than EVAR for patients with concurrent abscess formation.

Annual report of the Japanese Breast Cancer Registry for 2019.

This is an annual report by the Japanese Breast Cancer Society regarding the clinical data on breast cancer extracted from the National Clinical Database-Breast Cancer Registry (NCD-BCR) of Japan. Here, we present an updated summary of 98,300 breast cancer cases registered in 2019. The median age at cancer diagnosis was 61 years (interquartile range 49-72 years), and 30.6% of the breast cancer patients were premenopausal. Of the 93,840 patients without distant metastases, 14,118 (15.0%) and 42,047 (44.8%) were diagnosed with stage 0 and I disease, respectively. Breast-conserving surgery was performed in 42,080 (44.8%) patients. Regarding axillary procedures, 62,677 (66.8%) and 7371 (7.9%) patients underwent sentinel node biopsy and axillary node dissection after biopsy, respectively. Whole breast irradiation was administered to 29,795 (70.8%) of the 42,080 patients undergoing breast-conserving surgery. Chest wall irradiation was administered to 5524 (11.1%) of the 49,637 patients who underwent mastectomy. Of the 6912 clinically lymph node-negative patients who received preoperative therapy, 5250 (76.0%) and 427 (6.2%) underwent sentinel node biopsy and axillary node dissection after biopsy, respectively; however, 602 (8.7%) patients initially underwent axillary node dissection without biopsy.

No difference in the incidence of postoperative pulmonary complications between abdominal laparoscopy and laparotomy for minimally invasive thoracoscopic esophagectomy: a retrospective cohort study using a nationwide Japanese database.

INTRODUCTION: There remains a lack of evidence regarding the optimal abdominal approach, including laparoscopy, hand-assisted, and open laparotomy for minimally invasive thoracoscopic esophagectomy. We aimed to compare the incidence of postoperative complications, particularly pulmonary complications, between laparoscopy and open laparotomy for minimally invasive thoracoscopic esophagectomy using nationwide Japanese databases. METHODS: Data from patients in the National Clinical Database (NCD) who underwent thoracoscopic esophagectomy for esophageal cancer were analyzed. The incidence of pulmonary complications was compared between abdominal laparoscopy and laparotomy after matching the propensity scores (PS) from preoperative factors to account for confounding bias. Laparoscopic-assisted surgery (LAS) was also compared to hand-assisted laparoscopic surgery (HALS). RESULTS: Of the 24,790 patients who underwent esophagectomy between 2018 and 2021, data from 12,633 underwent thoracoscopic procedure. The proportion of patients who experienced pulmonary complications did not significantly differ between the laparoscopy group and the laparotomy group after matching (664/3195 patients, 20.8% versus 702/3195 patients, 22.0%; P = 0.25). No difference in the incidence of pulmonary complications was observed among patients treated using the laparoscopic approach (508/2439 patients, 20.8% in the LAS group versus 498/2439 patients, 20.4% in the HALS group; P = 0.72). CONCLUSIONS: We observed no significant difference in the incidence of postoperative pulmonary complications between laparoscopy and laparotomy for thoracoscopic esophagectomy. Short-term outcomes were similar between the laparoscopic-assisted approach and the hand-assisted approach. This study provides valuable insights into the optimal abdominal approach for thoracoscopic esophagectomy using data from a nationwide database that reflect real-world clinical practice.

Inventory of real-world data sources in Japan: Annual survey conducted by the Japanese Society for Pharmacoepidemiology Task Force.

PURPOSE: The Database Task Force of the Japan Society for Pharmacoepidemiology began its annual surveys of databases available for clinico and pharmacoepidemiological studies in 2010. In this report, we summarize the characteristics of the databases available in Japan based on the results of our 2021 survey to illustrate the recent developments in the infrastructure for database research in Japan. METHODS: We included 20 major databases from the academia, government, or industry that were accessible to third parties. We used a web-based questionnaire to ask the database providers about their characteristics, such as their organization, data source(s), numbers of individuals enrolled, age distribution, code(s) used, and average follow-up periods. RESULTS: We received responses from all 20 databases approached: eight hospital-based databases, six insurer-based databases, four pharmacy-based databases, and two in the "other" category. Among them, 17 contained information from medical claims, pharmacy claims, and/or Diagnosis Procedure Combination data. Most insurer databases contained health check-up data that could be attached to the claims component. Some hospital-based databases had data from electronic medical records. Most insurer-based databases collected data from the insurers of working-age employees and therefore had limited coverage of older people. Most databases coded their medication data using the Japanese reimbursement codes, and many provided Anatomical Therapeutic Chemical Classification codes. CONCLUSIONS: The number of databases available for clinico and pharmacoepidemiological research and the proportion of the population they cover are increasing in Japan. The differences in their characteristics mean that the appropriate database must be selected for a particular study purpose.

Open Versus Zone 0/1 Endovascular Aortic Repair for Arch Aneurysm: A Propensity Score-Matched Study from the National Clinical Database in Japan.

BACKGROUND: Although open surgical repair (OSR) is the gold standard for treating arch aneurysms, thoracic endovascular aortic repair (TEVAR) may be a less invasive alternative. However, it remains unclear which of the 2 methods yields better outcomes. In this study, we compared the perioperative outcomes of both procedures for arch aneurysms using a nationwide surgical database. METHODS: Data of patients who underwent elective aortic repair for true arch aneurysms were extracted from the National Clinical Database of Japan. Patients who underwent OSR and Zone 0/1 TEVAR were matched in a 1:1 ratio using propensity scores and their mortality and morbidity rates were compared. RESULTS: A total of 2,815 and 1,125 patients underwent OSR and Zone 0/1 TEVAR, respectively. After propensity score matching, 1,058 patients were included in both groups. Compared with OSR, Zone 0/1 TEVAR was associated with a significantly higher incidence of stroke (5.8 vs. 10.0%, P < 0.001) and paraplegia/paraparesis (1.6 vs. 4.4%, P < 0.001). However, there were no significant differences in the 30-day and operative mortality rates between the 2 groups (2.2 vs. 2.7% and 4.5 vs. 5.4%, respectively). In the Zone 0/1 TEVAR group, postoperative computed tomography was performed in 92.4% of patients, and types I and III endoleaks were identified in 6.4% and 1.1% of patients, respectively. CONCLUSIONS: Zone 0/1 TEVAR has higher incidences of stroke and paraplegia/paraparesis than OSR, with a risk of postoperative endoleaks. Resolving these problems is the key for expanding the application of Zone 0/1 TEVAR and in the meantime OSR remains the gold standard for surgically fit patients.

Current status of surgical treatment for acute aortic dissection in Japan: Nationwide database analysis.

OBJECTIVE: To clarify the current status of surgical treatment of acute aortic dissection (AAD) in Japan through the Japan Cardiovascular Database analysis. METHODS: In total, 7194 patients who underwent surgical treatment for AAD in 2021, including type A (TAAAD) (n = 6416) and type B (TBAAD) (n = 778), were investigated. RESULTS: The median age was 70 years, with patients older than age 80 years constituting 21.7% and 23.4% of TAAAD and TBAAD cases. Emergency admission was 88.5% and 78.5%. Shock was found in 11.8% and 6.0%. Rupture/impending rupture occurred in 10.7%/6.0% and 24.0%/11.1%, respectively. Branch malperfusion was complicated in 10.4% and 25.2%. Open repairs were performed in 97.7% and 20.3%, whereas endovascular repairs were performed in 2.3% and 79.7%, respectively. In the increased prevalence of endografting procedures, neurological complications and renal failure occurred frequently after open repair with frozen elephant trunk for 29.9% and 50.3%. The operative mortality rate was 9.8% and 11.5% for open repair and 8.1% and 10.0% for endovascular repair. In patients with TAAAD, age older than 80 years, preoperative critical comorbidities, classical dissection, and coexisting chronic vital organ diseases were independent risk factors for mortality. In frozen elephant trunk procedures, neurologic complications and renal failure were frequent. The operative mortality was higher during the superacute phase within 1 or 2 hours from onset to arrival and between arrival and surgery. CONCLUSIONS: The current status of surgical treatments for AAD including the increased prevalence of endografting of thoracic endovascular aortic repair and frozen elephant trunk were demonstrated with favorable outcomes in the Japan Cardiovascular Database analyses.

Procedural Volume and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement: From a Japanese Nationwide Registry.

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p = 0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p = 0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p = 0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume.

Comparative cardiovascular safety of LABA/LAMA FDC versus LABA/ICS FDC in patients with chronic obstructive pulmonary disease: a population-based cohort study with a target trial emulation framework.

BACKGROUND: Use of combinations of long-acting ß2 agonists/long-acting muscarinic antagonists (LABA/LAMA) in patients with chronic obstructive pulmonary disease (COPD) is increasing. Nevertheless, existing evidence on cardiovascular risk associated with LABA/LAMA versus another dual combination, LABA/inhaled corticosteroids (ICS), was limited and discrepant. AIM: The present cohort study aimed to examine comparative cardiovascular safety of LABA/LAMA and LABA/ICS with a target trial emulation framework, focusing on dual fixed-dose combination (FDC) therapies. METHODS: We identified patients with COPD who initiated LABA/LAMA FDC or LABA/ICS FDC from a nationwide Taiwanese database during 2017-2020. The outcome of interest was a hospitalized composite cardiovascular events of acute myocardial infarction, unstable angina, heart failure, cardiac dysrhythmia, and ischemic stroke. Cox regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for composite and individual cardiovascular events after matching up to five LABA/LAMA FDC initiators to one LABA/ICS FDC initiator using propensity scores (PS). RESULTS: Among 75,926 PS-matched patients, use of LABA/LAMA FDC did not show a higher cardiovascular risk compared to use of LABA/ICS FDC, with a HR of 0.89 (95% CI, 0.78-1.01) for the composite events, 0.80 (95% CI, 0.61-1.05) for acute myocardial infarction, 1.48 (95% CI, 0.68-3.25) for unstable angina, 1.00 (95% CI, 0.80-1.24) for congestive heart failure, 0.62 (95% CI, 0.37-1.05) for cardiac dysrhythmia, and 0.82 (95% CI, 0.66-1.02) for ischemic stroke. The results did not vary substantially in several pre-specified sensitivity and subgroup analyses. CONCLUSION: Our findings provide important reassurance about comparative cardiovascular safety of LABA/LAMA FDC treatment among patients with COPD.

The volume-outcome relationship in free-flap reconstruction: A nationwide study based on the Clinical Database.

BACKGROUND: The association between successful reconstructive surgery with a free flap and hospital volume has not been well established. This study was designed to retrospectively analyze the outcome of free-flap surgery registered in a nationwide surgical registration system in Japan to clarify the relationship between free-flap survival and facilities' average annual number of free-flap surgeries. METHODS: We analyzed data from 19,482 free flaps performed during 2017-2020 at 407 facilities throughout Japan. After adjusting for sex, age, and disease classification that differ between the groups, we examined the differences in the flap survival rates among the different facilities in terms of the average number of free-flap surgeries performed annually. RESULTS: The total overall necrosis rate was 2.8%. Of all procedures, 14.9%, 12.9%, 33.4%, and 38.8% were performed at facilities with an average number of free-flap procedures <10, 10-19, 20-49, and ≥ 50 per year, respectively, and the respective rates of total necrosis were 6.0%, 3.8%, 2.1%, and 1.7%, respectively. The odds ratios and 95% confidence intervals of flap necrosis for facilities with ≥ 50 cases per year relative to those <10 were 2.70 (1.98-3.68) for nonbreast reconstruction cases and 5.72 (2.77-11.8) for breast reconstruction cases. CONCLUSION: This analysis of a nationwide plastic surgery database showed that free-flap surgeries in institutions with a low average annual number of free-flap surgeries had a higher risk of total necrosis. Measures should be taken to either aggregate cases into high-volume centers or improve management at low-volume centers.

Analysis of prognosis in different subtypes of invasive lobular carcinoma using the Japanese National Cancer Database-Breast Cancer Registry.

PURPOSE: Many studies have shown that the prognosis of invasive lobular carcinoma (ILC) is better than that of invasive ductal carcinoma (IDC). However, both disorders exhibit different prognoses according to molecular subtype, and the prognosis of ILC subtypes might depend on their hormone receptor positivity rate. This study clarified the prognosis of ILC and IDC in each subtype and examined the effectiveness of adjuvant chemotherapy (CT) in luminal ILC. METHODS: We planned the analysis using data from the Breast Cancer Registry in Japan. Because it was presumed that there are differences in characteristics between ILC and IDC, we created matched cohorts using exact matching to compare their prognoses. We compared the prognosis of ILC and IDC for each subtype. We also compared the prognosis of luminal ILC between the CT and non-CT groups. RESULTS: For all subtypes, the disease-free survival (DFS) and overall survival (OS) of ILC were poorer than those of IDC. In the analysis by each subtype, no statistically significant difference was found in DFS and OS in luminal human epidermal growth factor 2 (HER2), HER2, and triple-negative cohorts; however, luminal ILC had significantly poorer DFS and OS than luminal IDC. The CT effects on the prognosis of luminal ILC were greater in more advanced cases. CONCLUSION: Luminal ILC had a poorer prognosis than luminal IDC, contributing to the worse prognosis of ILC than that of IDC in the overall cohort. Different therapeutic approaches from luminal IDC are essential for a better prognosis of luminal ILC.

Initial Triple Combination Therapy Including Intravenous Prostaglandin I2 for the Treatment of Patients with Severe Pulmonary Arterial Hypertension.

Upfront combination therapy including intravenous prostaglandin I2 (PGI2-IV) is recognized as the most appropriate treatment for patients with severe pulmonary arterial hypertension (PAH). This retrospective study aimed to determine reasons why this therapy is not used for some patients with severe PAH and describe the hemodynamic and clinical prognoses of patients receiving initial combination treatment with (PGI2-IV+) or without (PGI2-IV-) PGI2-IV.Data for patients with severe PAH (World Health Organization Functional Class III/IV and mean pulmonary arterial pressure [mPAP] ≥ 40 mmHg) were extracted from the Japan Pulmonary Hypertension Registry. Overall, 73 patients were included (PGI2-IV + n = 17; PGI2-IV- n = 56). The PGI2-IV+ cohort was younger than the PGI2-IV- cohort (33.8 ± 10.6 versus 52.6 ± 18.2 years) and had higher mPAP (58.1 ± 12.9 versus 51.8 ± 9.0 mmHg), greater prevalence of idiopathic PAH (88% versus 32%), and less prevalence of connective tissue disease-associated PAH (0% versus 29%). Hemodynamic measures, including mPAP, showed improvement in both cohorts (post-treatment median [interquartile range] 38.5 [17.0-40.0] for the PGI2-IV + cohort and 33.0 [25.0-43.0] mmHg for the PGI2-IV - cohort). Deaths (8/56) and lung transplantation (1/56) occurred only in the PGI2-IV - cohort.These Japanese registry data indicate that older age, lower mPAP, and non-idiopathic PAH may influence clinicians against using upfront combination therapy including PGI2-IV for patients with severe PAH. Early combination therapy including PGI2-IV was associated with improved hemodynamics from baseline, but interpretation is limited by the small sample size.

One-year outcome of transcatheter aortic valve replacement for bicuspid aortic valve stenosis: a report from the Japanese Nationwide registry (J-TVT registry).

The outcome of transcatheter aortic valve replacement (TAVR) for patients with bicuspid aortic valve (BAV) remains unclear, particularly among Asian patients that are known to have different valvular morphology and lower body habitus. This study investigated patient characteristics, procedural and 1-year outcome of TAVR for BAV within national TAVR registry in Japan. The patient-level data were extracted from the J-TVT (Japanese Transcatheter Valvular Therapy) registry between August 2013 and December 2018; overall, there were 423 patients (2.5%) with BAV and 16,802 patients with tricuspid aortic valve (TAV). At baseline, patients with BAV were younger and had less arteriosclerotic comorbidities. There was no statistically significant difference between BAV and TAV groups in conversion to surgery (0.5% vs. 1.1%, p = 0.34) and 30-day mortality (0.5% vs. 1.3%, p = 0.18). Cumulative all-cause survival and survival from major adverse events were analyzed. Cox proportional hazard regression model was used to estimate the hazard ratio. All-cause mortality and major adverse event rate at 1 year were comparable between the two groups. Relative hazard for all-cause mortality for BAV compared to TAV was 1.01 (0.70-1.45; p = 0.96), and for major adverse event was 0.94 (0.69-1.27; p = 0.67). From the Japanese nationwide TAVR registry, procedural and 1-year outcome of TAVR in BAV was as favorable as TAVR in TAV.

Annual Report for 2019 by the Japanese Association for Coronary Artery Surgery.

PURPOSE: Continuous annual reporting on coronary artery bypass grafting (CABG) surgical practice is key for quality control and improvement of clinical results. In this report, Japanese nationwide features and trends in the extent of coronary artery disease and the characteristics of those undergoing CABG procedures in 2019 are presented. Clinical results of related ischemic heart disease are also presented. METHODS AND RESULTS: The Japanese Cardiovascular Surgery Database (JCVSD) is a nationwide surgical case registry system. Data regarding CABG cases in the year 2019 (1 January-31 December) were captured with questionnaires regularly administered by the Japanese Association for Coronary Artery Surgery (JACAS). We analyzed trends in the number and types of grafts selected according to the number of diseased vessels in patients undergoing CABG. We also analyzed descriptive clinical results of those undergoing surgery for acute myocardial infarction or ischemic mitral regurgitation. CONCLUSIONS: This is the second publication summarizing the results following the JACAS annual report based on JCVSD Registry data from the year 2019. Clinical outcomes and surgical strategy trends were relatively stable. Further accumulation of information with a similar data collection system is expected.