Kazuhiro Sase

Objectives: To compare the long-term outcomes of initial thoracic endovascular aortic repair (TEVAR) versus initial medical therapy (iMT) in patients with acute uncomplicated type B aortic dissection (uTBAD), using real-world evidence from a nationwide claims database in Japan. This study aligns with stage 4 of the Idea, Development, Exploration, Assessment, and Long-term Study (IDEAL) framework for surgical innovation. Design: A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics. Setting: Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023. Participants: Among 40 229 cases with tentative codes for aortic dissection (International Classification of Diseases-10: I71.0), 4995 met all eligibility criteria for acute uTBAD. Among these patients, 96 underwent TEVAR in the subacute phase (15–90 days post diagnosis), while 4899 were managed with iMT. After PSM, 96 TEVAR cases were matched to 480 iMT cases in a 1:5 ratio. Main outcome measures: The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year. Results: After PSM, the baseline characteristics of both groups were balanced. Median age was 56 years (IQR: 50–62 years) in both groups, and follow-up duration was similar (TEVAR: 31 months; iMT: 28 months, p=0.84). At 60 months, Kaplan-Meier estimates showed an aorta-related event rate of 21.9% (95% CI: 12.6% to 36.4%) for TEVAR and 19.9% (95% CI: 15.6% to 25.2%) for iMT (p=0.99). All-cause mortality was 4.4% (95% CI: 1.4% to 13.6%) for TEVAR and 6.6% (95% CI: 4.0% to 10.6%) for iMT (p=0.70). No significant differences were observed. Conclusions: While aorta-related events accumulated steadily in the crude iMT group, no survival benefit was observed for subacute TEVAR. These findings support ongoing randomized controlled trials and show the utility of claims-based analyses in IDEAL Stage 4.

Objective Adjuvant chemotherapy with trastuzumab improves the postoperative life expectancy of women with early-stage breast cancer. Although trastuzumab is reportedly cardiotoxic, quantification based on real-world evidence is lacking. Therefore, in this study, we aimed to analyse trastuzumab cardiotoxicity using a nationwide claim-based database. Methods In this retrospective study, we used data from a nationwide claims database (Japan Medical Data Center, Tokyo, Japan) under the universal healthcare system. Women with breast cancer who underwent initial surgery were included. Patients with recurrent or advanced-stage breast cancer, with a history of heart failure, receiving neoadjuvant chemotherapy or a preoperative history of less than 6 months were excluded. Propensity score (PS) was calculated using logistic regression based on age, cardiovascular risk factors, radiotherapy and concomitant anthracyclines (AC). Results We identified 12 060 eligible patients (mean age 50.8±8.56 years) between January 2010 and December 2019. After 1:2 PS matching (trastuzumab users, TZ, n=1005; non-users, NT, n=2010), Cox proportional hazards model analysis showed that the rate of heart failure development within 18 months postoperative was significantly higher in the TZ group than in the NT group (adjusted HR 2.28, 95% CI 1.38 to 3.77). Baseline cardiac evaluation in the combined AC/TZ cases was 27.2% preoperative, 66.0% pre-AC and 86.6% pre-TZ, respectively. Conclusion Trastuzumab cardiotoxicity remained relevant in the claim-based analysis adjusted for AC effects. Further collaborative studies in cardio-oncology with real-world data are warranted to improve the rate of baseline cardiovascular risk assessment in patients with cancer scheduled for cardiotoxic cancer treatment.

Objectives Endovascular aortic repair (EVAR) evolved through competition with open aortic repair (OAR) as a safe and effective treatment option for appropriately selected patients with abdominal aortic aneurysm (AAA). Although endoleaks are the most common reason for post-EVAR reintervention, compliance with lifelong regular follow-up imaging remains a challenge. Design Retrospective data analysis. Setting The Japan Medical Data Center (JMDC), a claims database with anonymous data linkage across hospitals, consists of corporate employees and their families of ≤75 years of age. Participants The analysis included participants in the JMDC who underwent EVAR or OAR for intact (iAAA) or ruptured (rAAA) AAA. Patients with less than 6 months of records before the aortic repair were excluded. Main outcome measures Overall survival and reintervention rates. Results We identified 986 cases (837 iAAA and 149 rAAA) from JMDC with first aortic repairs between January 2015 and December 2020. The number of patients, median age (years (IQR)), follow-up (months) and post-procedure CT scan (times per year) were as follows: iAAA (OAR: n=593, 62.0 (57.0–67.0), 26.0, 1.6, EVAR: n=244, 65.0 (31.0–69.0), 17.0, 2.2), rAAA (OAR: n=110, 59.0 (53.0–59.0), 16.0, 2.1, EVAR: n=39, 62.0 (31.0–67.0), 18.0, 2.4). Reintervention rate was significantly higher among EVAR than OAR in rAAA (15.4% vs 8.2%, p=0.04). In iAAA, there were no group difference after 5 years (7.8% vs 11.0%, p=0.28), even though EVAR had initial advantage. There were no differences in mortality rate between EVAR and OAR for either rAAA or iAAA. Conclusions Claims-based analysis in Japan showed no statistically significant difference in 5-year survival rates of the OAR and EVAR groups. However, the reintervention rate of EVAR in rAAA was significantly higher, suggesting the need for regular post-EVAR follow-up with imaging. Therefore, international collaborations for long-term outcome studies with real-world data are warranted.

Opinion statement Lung cancer is the most common form of cancer in humans and the leading cause of cancer-related death worldwide. Traditionally, lung cancer has been diagnosed as either small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). However, recent developments in molecular pathology have revolutionized the diagnosis and treatment of the disease, thus improving patient prognosis and increasing the number of survivors. In advanced NSCLC cases, molecularly targeted drugs for patients with positive driver gene mutation/rearrangement, and immune checkpoint inhibitors for those with a positive biomarker, have changed the standard of care. SCLC is a highly malignant entity. In addition to the chemotherapy and radiotherapy, immune checkpoint inhibitors have recently provided some hope for extended-stage SCLC. Smoking cessation is related to decreased morbidity. However, early metastasis remains a significant challenge. Recently, cancer therapy–related cardiovascular disease (CTRCD) has emerged as diverse pathophysiology, including fulminant myocarditis, fatal arrhythmia, pericarditis, hypertension, and thrombosis, that emerged with modern lung cancer therapies. Cardio-oncology is a new interdisciplinary collaboration to develop methodologies to manage cardiovascular risk factors and CTRCDs with the common goal of minimizing unnecessary interruption of cancer treatment and maximizing outcomes of lung cancer survivors.

Background:The prognosis of cancer survivors has dramatically improved, but effective strategies for cancer treatment-related cardiovascular disorders (CTRCD) remain to be elucidated in the emerging field of cardio-oncology. In this study, we investigated risk factors for CTRCD in breast cancer patients treated with trastuzumab.Methods and Results:We performed a retrospective analysis of 141 consecutive women who received adjuvant trastuzumab, and underwent baseline (BL) and follow-up (FU) echocardiography at Juntendo University between April 2010 and December 2016. The major concomitant treatment was anthracyclines in 94% and radiotherapy in 53%. During the median treatment period of 11 months, there were 22 (15.6%) cardiology consultations, 3 (2.1%) treatment interruptions with irreversible CTRCD, and no deaths. Left ventricular ejection fraction (LVEF) was decreased from a median 67.5% (BL) to 63.4% (FU; P<0.0001), with reduced LVEF noted in 26.2% at FU<90%BL, in 13.5% at FU<BL–10%, and in 5.7% at LVEFFU<53%. A significantly greater percentage of patients with CTRCD (FU<BL–10% and LVEFFU<53%) had cardiovascular risk factors (CVRF; 42.9% vs. 8.2%, P=0.02). On multivariable analysis, CVRF were also significantly associated with CTRCD (OR, 11.96; 95% CI: 1.30–110.34).Conclusions:Adjuvant trastuzumab for early-stage breast cancer was associated with reduced LVEF; and CVRF were an independent predictor for CTRCD. The concomitant effect of anthracyclines should not be underestimated, even at lower doses.