Language：English   Publisher：(一社)日本心臓病学会  

カテーテルアブレーション(CA)後の医原性心房中隔欠損(iASD)の発症率と予測因子を検討した。2005年5月～2018年6月に当院で心房細動(AF)に対して初回CAを施行された639例(男性489例、女性150例、平均60.2±10.7歳)を対象に後ろ向き研究を行った。全例に対して術前経食道心エコー(プレTEE)、術前経胸部心エコー(プレTTE)、術後TTE(ポストTTE)を実施し、CAから6ヵ月後のiASDの発症率を評価した。プレTTEにおける平均左房径(LAD)は41.0±6.5mm、平均左室駆出率(LVEF)は64.6±10.3%、左室拡張末期径は30.1±5.8mmであり、高周波CAを行った453例のうち複雑性分裂心房電位(CFAE)アブレーションが258例、CFAEアブレーション+肺静脈隔離術(PVI)が109例、PVI単独が86例、クライオアブレーションが44例であった。ポストTTEでのiASDの検出率は59.6%(497例中296例)、6ヵ月後TTEでは4.6%(23例)であり、年齢、BMI、AFのタイプ、BNP値、プレTTE上のLAD、左房容積、LVEF、右室収縮期圧(RVSP)に関してiASD群と非iASD群との間に有意差はなかった。一方、iASDの発症率は高周波アブレーション群が3.3%、クライオアブレーション群が18.2%とクライオアブレーション群の方が有意に高く、高周波アブレーション群では2シース法の方が1シース法よりiASDの発症率が有意に高値を示していた。単変量解析ではiASD発症の有意な関連因子としてシース径、単一穿刺における2シースの使用が抽出された。

Language：Japanese   Publisher：Trials  

Background: Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts. Methods: The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator’s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs. Discussion: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population. Trial registration: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

DOI： 10.1186/s13063-024-08373-6

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PubMed

Language：Japanese   Publisher：Scientific Reports  

Atrial fibrillation (AF) is an arrhythmic disease. Prediction of AF development in healthy individuals is important before serious complications occur. We aimed to develop a risk prediction score for future AF using participants’ data, including electrocardiogram (ECG) measurements and information such as age and sex. We included 88,907 Japanese participants, aged 30–69 years, who were randomly assigned to derivation and validation cohorts in a ratio of 1:1. We performed multivariate logistic regression analysis and obtained the standardised beta coefficient of relevant factors and assigned scores to them. We created a score based on prognostic factors for AF to predict its occurrence after five years and applied it to validation cohorts to assess its reproducibility. The risk score ranged from 0 to 17, consisting of age, sex, PR prolongation, QT corrected for heart rate prolongation, left ventricular hypertrophy, premature atrial contraction, and left axis deviation. The area under the curve was 0.75 for the derivation cohort and 0.73 for the validation cohort. The incidence of new-onset AF reached over 2% at 10 points of the risk score in both cohorts. Thus, in this study, we showed the possibility of predicting new-onset AF using ECG findings and simple information.

DOI： 10.1038/s41598-024-60219-y

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PubMed

Language：Japanese   Publisher：Trials  

Background: With the increasing popularity of endoscopic ultrasound (EUS)-guided transmural interventions, walled-off necrosis (WON) of the pancreas is increasingly managed via non-surgical endoscopic interventions. However, there has been an ongoing debate over the appropriate treatment strategy following the initial EUS-guided drainage. Direct endoscopic necrosectomy (DEN) removes intracavity necrotic tissue, potentially facilitating early resolution of the WON, but may associate with a high rate of adverse events. Given the increasing safety of DEN, we hypothesised that immediate DEN following EUS-guided drainage of WON might shorten the time to WON resolution compared to the drainage-oriented step-up approach. Methods: The WONDER-01 trial is a multicentre, open-label, superiority, randomised controlled trial, which will enrol WON patients aged ≥ 18 years requiring EUS-guided treatment in 23 centres in Japan. This trial plans to enrol 70 patients who will be randomised at a 1:1 ratio to receive either the immediate DEN or drainage-oriented step-up approach (35 patients per arm). In the immediate DEN group, DEN will be initiated during (or within 72 h of) the EUS-guided drainage session. In the step-up approach group, drainage-based step-up treatment with on-demand DEN will be considered after 72–96 h observation. The primary endpoint is time to clinical success, which is defined as a decrease in a WON size to ≤ 3 cm and an improvement of inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, and recurrence of the WON. Discussion: The WONDER-01 trial will investigate the efficacy and safety of immediate DEN compared to the step-up approach for WON patients receiving EUS-guided treatment. The findings will help us to establish new treatment standards for patients with symptomatic WON. Trial registration: ClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022.

DOI： 10.1186/s13063-023-07377-y

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PubMed

Language：Japanese   Publisher：Jacc Asia  

Background: The prognosis and later fatal arrhythmia in cardiac sarcoidosis (CS) with relatively preserved cardiac function were unclear. Objectives: This study aimed to evaluate the prognosis and arrhythmic events in patients with CS and mildly impaired cardiac function. Methods: Data were collected from a nationwide Japanese cohort survey conducted in 57 hospitals (n = 420); 322 patients with CS with left ventricular ejection fraction (LVEF) >35% were investigated. Results: Ventricular tachycardia (VT) manifestation was present in 50 patients (16%) and absent in 272 (84%), of whom 36 (72%) and 46 (17%), respectively, had an implantable cardioverter-defibrillator (ICD). Over a median of 5 years, 23 all-cause deaths and 31 appropriate ICD discharges were observed. In Kaplan-Meier analysis, all-cause death did not differ between patients with and without VT manifestation (P = 0.660), although appropriate ICD therapy was significantly less used in patients without VT manifestation than in those with VT manifestation (P < 0.001). Of the 272 patients without VT manifestation, 18 had ventricular arrhythmic events (VAEs), including 3 sudden cardiac deaths and 15 appropriate ICD discharges. In multivariate analysis, concomitant nonsustained ventricular tachycardia (NSVT) with atrioventricular block (AVB), lower LVEF, abnormal gallium-67 scintigraphy or ¹⁸F-fluorodeoxyglucose positron emission tomography of the heart (Ga/PET), and concomitant NSVT with abnormal Ga/PET at CS diagnosis were independent predictors of VAEs (P = 0.008, P = 0.021, P = 0.049, and P = 0.024, respectively). Conclusions: If concomitant NSVT with AVB, concomitant NSVT with abnormal Ga/PET, or abnormal Ga/PET is observed in patients with CS and mildly impaired cardiac function (LVEF >35%), ICD should be considered as primary prevention.

DOI： 10.1016/j.jacasi.2023.07.006

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PubMed

Language：Japanese   Publisher：Diagnostic Cytopathology  

Background: As liquid-based cytology (LBC) specimens harbor high-quality DNA, genomic analysis using LBC specimens is beneficial for integrative diagnosis. This study aimed to clarify the feasibility of LBC specimens for a bimodal application of DNA- and RNA-based next-generation sequencing (NGS) panels. Methods: LBC specimens were prepared from cultured human cancer HEC59 cells using commercially available fixatives (Cellprep, CytoRich Red, and SurePath solutions), and were subjected to NGS for a feasibility study. Clinical LBC specimens of thyroid and salivary gland tumors were prepared using CytoRich Red solution. After DNA and RNA extraction, NGS analyses were performed in a single run using combined DNA- and RNA-based custom-made cancer panels for the detection of gene mutations and fusions. Results: High-quality DNA and RNA were obtained, and the expected gene mutations and fusions were detected in HEC59 cells using all types of LBC fixatives. Most available clinical cases (18 out of 20) exhibited pathogenic gene mutations (15 cases) and fusion genes (3 cases) using the bimodal DNA- and RNA-based panels. Overall, 18 cases (90%) showed oncogenic mutations or fusion genes of diagnostic values. Conclusion: Simultaneous application of bimodal DNA- and RNA-based gene panels was useful in NGS analysis using residual LBC specimens for integrative diagnosis. Residual LBC specimens for genomic analysis, including fusion gene analysis, are particularly useful for obtaining genomic information before surgical resection.

DOI： 10.1002/dc.25149

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PubMed

Language：English   Publisher：International Heart Journal Association  

<p>Arterial stiffness has been reported to cause left atrial (LA) remodeling due to increased left ventricular filling pressure, resulting in atrial fibrillation (AF). This study aimed to evaluate the association between LA reverse remodeling (LARR) after AF ablation and cardio-ankle vascular index (CAVI), an indicator of arterial stiffness.</p><p>This study included 333 patients with AF (171 with paroxysmal AF and 162 with nonparoxysmal AF) and LA enlargement (LA volume index ≥ 34 mL/m²) who underwent AF ablation between December 2008 and July 2021. CAVI was evaluated preoperatively during AF (<i>n</i> = 155, 46.5%) or sinus rhythm (<i>n</i> = 178, 53.5%). Participants were divided into groups with LARR (<i>n</i> = 133, 39.9%) and without LARR (<i>n</i> = 200, 60.1%) according to whether the degree of decrease in LA volume index on transthoracic echocardiography 6 months after ablation was ≥ 15% or < 15%, respectively.</p><p>Sinus rhythm was maintained in 168 (50.5%) patients within 3-6 months after the index procedure. Univariate analysis revealed that preoperative CAVI (7.80 ± 1.22 versus 8.57 ± 1.09, <i>P</i> < 0.001) was significantly lower, and the maintenance of sinus rhythm (61.6% versus 43.0%, <i>P</i> = 0.0011) was higher in the group with LARR. Multivariate logistic regression analysis revealed that preoperative CAVI was independently associated with LARR (odds ratio, 0.60, 95% confidence interval, 0.46-0.78, <i>P</i> < 0.001).</p><p>In patients with AF and LA enlargement, CAVI is independently associated with LA reverse remodeling after catheter ablation.</p>

DOI： 10.1536/ihj.23-072

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CiNii Research

Language：English   Publisher：(一社)インターナショナルハートジャーナル刊行会  

カテーテルアブレーションを施行した左房拡大を示す心房細動(AF)患者を対象に、術前の心臓足首血管指数(CAVI)がアブレーション後の左房リバースリモデリング(LARR)と関連するかどうか検討した。対象は左房容積係数が34mL/m2以上のAF患者333例で、171例が発作性AF、162例が非発作性AFであった。アブレーション施行から6ヵ月後に経胸壁心エコー検査を実施し、左房容積係数が15%以上減少した症例をLARRと定義した。患者をLARR陽性群133例(男性74.4%、平均60.1±9.3歳)と陰性群200例(男性71.0%、平均64.6±8.8歳)の2群に分類した。術前のCAVIはLARR陽性群(7.80±1.22)の方が陰性群(8.57±1.09)より有意に低かった(P<0.001)。洞調律を維持した患者は陽性群(61.6%)の方が陰性群(43.0%)より有意に多かった(P<0.001)。重回帰ロジスティック分析で術前のCAVIはアブレーション後のLARRを予測する独立因子であった(OR 0.60、95%CI 0.46～0.78、P<0.001)。

Language：English   Publisher：(一社)インターナショナルハートジャーナル刊行会  

持続性心房細動(PerAF)においてアブレーション前の直流カルディオバージョンがアブレーション後のAF再発に及ぼす影響を検討した。欧州不整脈学会スコアが無症状から軽度のPerAF患者を対象とした。患者383例を、直流カルディオバージョン後に洞調律が24時間以上維持されたDC-SR群281例(73%)と維持されなかったDC-AF群102例(27%)に分類した。直流カルディオバージョン後、195例にてカテーテルアブレーション(CA)が施行された。CA施行患者195例を、DC-SR CA群161例(83%)とDC-AF CA群34例(17%)に分類した。その結果、初回CA後、中央値15(10～25)ヵ月の追跡期間中の3年AF無再発生存率は、DC-SR CA群(61.5%)の方がDC-AF CA群(38.3%)より有意に高かった(log-rank検定 P<0.0001)。多変量解析の結果、DC-SR CA群(HR:0.45、95%CI:0.21～0.99、P=0.047)およびAF診断時年齢高値(HR:0.95、95%CI:0.91～1.00、P=0.039)がCA後のAF無再発の独立予測因子であった。以上より、PerAF患者において直流カルディオバージョン施行後の24時間洞調律維持がCA後の長期AF無再発を予測する可能性が示唆された。

Language：Japanese   Publisher：(一社)日本心臓病学会  

Language：Japanese   Publisher：Journal of Arrhythmia  

DOI： 10.1002/joa3.12747

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PubMed

Language：English   Publisher：(一社)日本不整脈心電学会  

症例は16歳男性で、再発する動悸エピソードを呈して当院に紹介された。12誘導心電図では洞律動中にデルタ波は検出されず、動悸発現中に左脚ブロック型wide QRS頻拍が認められた。電気生理学的検査では、洞律動中の周期長(CL)は760ms、心房-ヒス束間隔は81ms、ヒス束-心室(HV)間隔は39msであり、A-QRS間隔の延長、HV間隔の短縮、QRS間隔の延長によって心室期外刺激が生じていた。また、ヒス束電位は順行性であったものが逆行性へと変化し、逆行性心房刺激の早発部位はヒス領域に限定されており、傍ヒス束ペーシングによって房室結節伝導パターンが示された。CL 356msの頻拍中、右房外側よりCL 340msのエントレインメントを施行し、長期伝導によってQRS群の形成が認められ融合は観察されなかった。ペーシング後間隔(PPI)は362ms、PPI-頻拍CLは8msを示し、バイスタンダー副伝導経路を介した心房結節リエントリー頻拍ではなく、心房束経路を介した逆方向性房室回帰性頻拍であると考えられた。三尖弁輪の前外側領域に高周波アブレーションを施行し、その後は頻拍の発症は認めていない。

Language：Japanese   Publisher：臨床心臓電気生理研究会  

Language：Japanese   Publisher：BMJ Open  

Introduction Neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy (NAC/NACRT) for resectable/borderline resectable pancreatic cancers was recently performed to improve clinical outcomes and led to good results, although it remains controversial whether NAC/NACRT is beneficial for resectable pancreatic cancer. A few recent studies revealed longer patency and lower cost related to the stent occlusion of a metal stent than those of a plastic stent during NAC/NACRT. It also remains controversial which type of self-expandable metal stent (SEMS) is the most suitable for patients with resectable/borderline resectable pancreatic cancer during NAC/NACRT: an uncovered SEMS (USEMS), a fully covered SEMS (FCSEMS) or a partially covered SEMS (PCSEMS). So far, two randomised controlled trials indicated that a USEMS and an FCSEMS were similar in preoperative stent dysfunction and adverse event rate. Thus, we aimed to verify the non-inferiority of a PCSEMS to a USEMS in this multicentre randomised controlled trial. Methods and analysis We designed a multicentre randomised controlled trial, for which we will recruit 100 patients with resectable/borderline resectable pancreatic cancer and distal biliary obstruction scheduled for NAC/NACRT from 13 high-volume institutions. Patients will be randomly allocated to the PCSEMS group or USEMS group. The primary outcome measure is the preoperative biliary event rate. Data will be analysed after completion of the study. We will calculate the 95% CIs of the incidence of preoperative biliary events in each group and analyse whether the difference between them is within the non-inferiority margin (10%). Ethics and dissemination This study has been approved by the institutional review board of Hokkaido University Hospital. The results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal. Trial registration number UMIN000041737; jRCT1012200002.

DOI： 10.1136/bmjopen-2020-045698

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PubMed

Language：Japanese   Publisher：Gut  

Objective Stenting is an established endoscopic therapy for malignant gastric outlet obstruction (mGOO). The choice of stent (covered vs uncovered) has been examined in prior randomised studies without clear results. Design In a multicentre randomised prospective study, we compared covered (CSEMS) with uncovered self-expandable metal stents (UCSEMS) in patients with mGOO; main outcomes were stent dysfunction and patient survival, with subgroup analyses of patients with extrinsic and intrinsic tumours. Results Overall survival was poor with no difference between groups (probability at 3 months 49.7% for covered vs 48.4% for uncovered stents; log-rank for overall survival p=0.26). Within that setting of short survival, the proportion of stent dysfunction was significantly higher for uncovered stents (35.2% vs 23.4%, p=0.01) with significantly shorter time to stent dysfunction. This was mainly relevant for patients with extrinsic tumours (stent dysfunction rates for uncovered stents 35.6% vs 17.5%, p<0.01). Subgrouping was also relevant with respect to tumour ingrowth (lower with covered stents for intrinsic tumours; 1.6% vs 27.7%, p<0.01) and stent migration (higher with covered stents for extrinsic tumours: 15.3% vs 2.5%, p<0.01). Conclusions Due to poor patient survival, minor differences between covered and uncovered stents may be less relevant even if statistically significant; however, subgroup analysis would suggest to use covered stents for intrinsic and uncovered stents for extrinsic malignancies.

DOI： 10.1136/gutjnl-2020-320775

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PubMed

Language：English   Publisher：(一社)日本循環器学会  

総合診療医がフレイルや認知機能障害を有する高齢患者などの高リスク患者にribaroxabanを処方した場合の有効性と安全性について検討した。総合診療医にrivaroxabanを処方された非弁膜症性心房細動(NVAF)患者(男性3704名、女性2013名、平均年齢73.9歳)を対象に、最長3年(平均2.0年)追跡する多施設共同前向き研究を実施した。主要評価項目である脳卒中/全身性塞栓症(SE)の複合評価項目の発生率は1.23/100人・年であった。重大出血の発生率は0.63/100人・年であった。多変量解析の結果、脳卒中/SEの有意なリスク因子は年齢が75歳以上と虚血性脳卒中の既往であり、重大出血性イベントの有意なリスク因子は重大出血の既往とwarfarin使用であった。認知機能障害またはフレイルと脳卒中/SEまたは重大出血性イベントの間に相関関係は認めなかった。

Language：Japanese   Publisher：臨床心臓電気生理研究会  

症例は50代女性。多形性心室期外収縮(PVC)に対しアブレーションを施行。大半のPVCは右脚ブロック型で右軸偏位と左軸偏位を示すが、各々さまざまなQRS波形を呈し、また一部PVCは正常QRS様波形であった。両心室でのHis-脚近位部電位記録では、左脚近位部にてPurkinje様電位(P1)に続いて右脚ブロック型PVCが出現し、先行する正常調律でのHis(H0)からP1までの間隔(H0-P1)はほぼ一定であった。P1からPVCまでの間隔はさまざまで、短縮すると右軸偏位の、延長すると左軸偏位のPVCが出現する傾向を呈した。また正常QRS様波形のPVCではHis電位が先行した。P1の最早期部は左脚最近位部であったが通電するも無効。Verapamil投与により途中H0-P1間隔の延長を伴わずP1消失に伴い右脚ブロック型PVCは消失し、続いてその他のPVCも消失した。希有な症例と考えられ報告する。(著者抄録)

Language：Japanese   Publisher：(株)医学書院  

＜文献概要＞Point　・実臨床で,心房細動患者のうち半数以上が75歳以上の後期高齢者であり,高齢者に対する心房細動治療の重要性が以前よりも増してきている.・心房細動の薬物療法は,抗凝固療法,レートコントロール,リズムコントロールに分けられるが,高齢者ではまず抗凝固療法とレートコントロールを目指し,リズムコントロールを行うかどうかを慎重に判断する必要がある.・高齢者における薬物療法の問題点は,肝腎機能低下やポリファーマシーに伴う副作用の増加,認知機能低下による服薬アドヒアランスの低下などが挙げられ,注意深い使用が重要である.

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