Abstract Background This study aimed to evaluate the safety and effectiveness of the Kanshas drug-coated balloon (DCB) with paclitaxel for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA) over a 3-year period. Results A prospective, multicenter, single-arm trial enrolled 121 patients with symptomatic lower extremity artery disease (LEAD). At 3 years, the primary patency rate was 63.4%, and freedom from clinically driven target lesion revascularization (CD-TLR) was 83.2%. Sustained improvements were observed in Rutherford classification, ankle brachial index (ABI), and walking impairment questionnaire (WIQ) scores. No device- or procedure-related deaths or major amputations occurred. Conclusions The Kanshas DCB showed favorable safety and effectiveness for treating atherosclerotic lesions in the SFA and/or proximal PA over 3 years. Trail registration Registration ID: UMIN000034122. Registration Date: September 13, 2018. Registration site URL: https://center6.umin.ac.jp/cgi-openbin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J . Graphical Abstract
Treatment-free remission (TFR) is an emerging goal for patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI). However, long-term TFR durability in real-world settings remains understudied. The J-SKI study, a large observational study, was conducted to evaluate long-term TFR outcomes in Japanese patients with CML. This interim analysis included 795 eligible patients from the prospective (n = 283) and retrospective (n = 512) cohorts. With a median follow-up of 32 months (range 0.8–168) after TKI discontinuation, the 5-year TFR rate was 65.2
Cerebrospinal fluid drainage (CSFD) is recommended during open or endovascular thoracic aortic repair. However, the incidence of CSFD complications is still high. Recently, CSF pressure has been kept high to avoid complications, but the efficacy of CSFD at higher pressures has not been confirmed. We hypothesize that CSFD at higher pressures is effective for preventing motor deficits. This prospective observational study included 14 hospitals that are members of the Japanese Society of Cardiovascular Anesthesiologists. Patients who underwent thoracic and thoracoabdominal aortic repair were divided into four groups: Group 1, CSF pressure around 10 mmHg; Group 2, CSF pressure around 15 mmHg; Group 3, CSFD initiated when motor evoked potential amplitudes decreased; and Group 4, no CSFD. We assessed the association between the CSFD group and motor deficits using mixed-effects logistic regression with a random intercept for the institution. Of 1072 patients in the study, 84 patients (open surgery, 51; thoracic endovascular aortic repair, 33) had motor deficits at discharge. Groups 1 and 2 were not associated with motor deficits (Group 1, odds ratio (OR): 1.53, 95
BACKGROUND AND AIMS:Atrial functional mitral regurgitation (AFMR) commonly affects elderly and frail individuals. The prognostic impact of transcatheter edge-to-edge repair (TEER) for AFMR has not been investigated. METHODS:Patients with AFMR who underwent TEER were selected from the OCEAN-Mitral registry, and medically managed controls were selected from the REVEAL-AFMR registry, using an identical AFMR definition. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization. The secondary endpoint was all-cause mortality. RESULTS:A total of 1081 patients (mean age 80.1 ± 8.2 years, 60.5% female) with moderate or severe AFMR were included, of whom 441 underwent TEER and 640 remained on medical treatment. Overlap weighting based on the propensity score yielded well-balanced characteristics (n = 441 vs 640; all standardized mean differences <0.01), where TEER was associated with a lower incidence of the primary (hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.43-0.99, P = .044) and secondary endpoints (HR 0.58, 95% CI 0.35-0.99, P = .044). In an exploratory subgroup analysis, favourable outcomes might be pronounced in patients with ≤mild residual AFMR after TEER, while event rates in those with ≥ moderate residual AFMR were comparable with the medication group. As sensitivity analyses, inverse probability of treatment weighting (n = 158 vs 173), propensity score matching (n = 104 vs 104), and multivariable Cox regression (n = 441 vs. 640) all confirmed favourable associations of TEER with both endpoints. CONCLUSIONS:In real-world data, TEER for patients with moderate or severe AFMR were associated with a lower incidence of adverse events compared with medical treatment.
Background:Atrial fibrillation (AF) prevalence has increased with Japan's aging population. Data on cryoballoon ablation (CBA) for persistent AF (PsAF) in Japan is limited. This study reports CBA clinical outcomes in PsAF patients in Japan from the prospective Cryo Global Registry. Methods:Data was analyzed from 60 Japanese centers with 1226 PsAF patients that underwent CBA. The primary endpoints were serious adverse events and freedom from atrial arrhythmia (AA) recurrence, at 12 months. The effect of ablation strategy (pulmonary vein isolation [PVI] or PVI with additional ablations [PVI+]) was evaluated. Quality-of-life (QoL) was measured by EQ-5D-3L questionnaire. Results:The patient mean age was 68 ± 10 years and 29.0% were female. The overall 12-months Kaplan-Meier (KM) estimate for freedom from AA recurrence was 84.4% (95% CI: 82.2%-86.3%). Among PVI+ patients, 33.0% received cavotricuspid isthmus (CTI) and 34.6% received non-CTI ablation (majority being left-atrial roofline [27.2%]). The 12-months KM estimate for freedom from AA recurrence was higher for PVI+ subgroup (86.6% [CI: 83.6%-89.1%]) than PVI subgroup (82.0% [CI: 78.6%-84.9%]) (HR adj = 1.40, p = 0.025). Twenty-two serious adverse events were reported in 1.6% patients. At 12 months, compared to baseline, QoL improved with a mean summary-index score difference of 0.03 ± 0.16 (p < 0.001) and a mean EQ visual analogue scale score difference of 7.9 ± 18.5 (p < 0.001). Conclusion:This study showed CBA is safe and effective for PsAF treatment in real-world use in Japan. Trial Registration:Cryo Global Registry, ClinicalTrials.gov ID NCT02752737.
