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Esophageal Injury Risk Factors in Patients With Atrial Fibrillation Undergoing Catheter Ablation 房颤导管消融患者食管损伤的危险因素。
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-09 DOI: 10.1002/joa3.70259
Yun Young Choi, Hyuk Soon Choi, Joo Hee Jeong, Chang Ok Seo, Yun Gi Kim, Jaemin Shim, Jong-Il Choi, Young-Hoon Kim

Background and Aims

Esophageal injury (EI) is a potentially serious complication of catheter ablation (CA) for atrial fibrillation (AF). However, data on its incidence and risk factors, particularly after radiofrequency catheter ablation (RFCA) and cryoballoon ablation (CBA), remain limited. This study aimed to identify predictors of EI in patients undergoing RFCA and CBA.

Methods

In this retrospective study, patients with AF who underwent de novo RFCA or CBA between December 2019 and April 2022 were evaluated. All underwent EGD within 2 days post-ablation. EI severity was graded, and clinical predictors were analyzed using multivariate logistic regression.

Results

Among 584 patients (mean age 62.8 ± 11.2 years, 68.6% male), 30 (5.1%) developed EI (RFCA: 5.0%, CBA: 6.3%). Most injuries were mild (Class I), and all resolved with proton pump inhibitor therapy. Compared with those without EI, affected patients had significantly lower body mass index (BMI) (24.5 ± 3.9 vs. 25.9 ± 3.4 kg/m2, p = 0.030) and reduced ejection fraction (EF) (48.9% ± 8.7% vs. 52.8% ± 6.8%, p = 0.023). Multivariate analysis identified BMI ≤ 24 kg/m2 (odds ratio [OR], 3.67; 95% confidence interval [CI], 1.69–7.96) and EF ≤ 40% (OR, 4.08; 95% CI, 1.54–11.56) as independent risk factors.

Conclusions

Esophageal injury after catheter ablation for atrial fibrillation is not rare, but usually mild. Lower BMI and reduced LVEF were independent risk factors, regardless of ablation type. These results support selective endoscopic screening in high-risk patients to enable early detection and prevent severe complications.

背景和目的:食管损伤(EI)是心房颤动(AF)导管消融(CA)的潜在严重并发症。然而,关于其发病率和危险因素的数据,特别是射频导管消融(RFCA)和低温球囊消融(CBA)后的数据仍然有限。本研究旨在确定RFCA和CBA患者EI的预测因素。方法:在这项回顾性研究中,对2019年12月至2022年4月期间接受新手术RFCA或CBA的AF患者进行评估。所有患者均在消融后2天内行EGD检查。对EI严重程度进行分级,并采用多因素logistic回归分析临床预测因素。结果:584例患者(平均年龄62.8±11.2岁,男性68.6%)中有30例(5.1%)发生EI (RFCA: 5.0%, CBA: 6.3%)。大多数损伤是轻微的(I级),并通过质子泵抑制剂治疗全部解决。与未患EI的患者相比,患者的身体质量指数(BMI)显著降低(24.5±3.9 vs. 25.9±3.4 kg/m2, p = 0.030),射血分数(EF)显著降低(48.9%±8.7% vs. 52.8%±6.8%,p = 0.023)。多因素分析确定BMI≤24 kg/m2(比值比[OR], 3.67; 95%可信区间[CI], 1.69 ~ 7.96)和EF≤40% (OR, 4.08; 95% CI, 1.54 ~ 11.56)为独立危险因素。结论:房颤导管消融后食管损伤并不罕见,但通常较轻。无论消融类型如何,较低的BMI和较低的LVEF都是独立的危险因素。这些结果支持对高危患者进行选择性内窥镜筛查,以实现早期发现和预防严重并发症。
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引用次数: 0
One-Year Outcome of Japanese Patients With Atrial Fibrillation: Insights From APHRS-AF Registry 日本房颤患者的1年预后:来自APHRS-AF登记的见解
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-08 DOI: 10.1002/joa3.70287
Kenji Yodogawa, Yu-ki Iwasaki, Yasuo Okumura, Koichi Nagashima, Koichi Inoue, Nobuaki Tanaka, Kengo Kusano, Koji Miyamoto, Masahiko Takagi, Kyoko Soejima, Yuichi Momose, Tomohiro Sakamoto, Hideharu Okamatsu, Toyoaki Murohara, Yasuya Inden, Keiichi Fukuda, Seiji Takatsuki, Yasuki Kihara, Yukiko Nakano, Teiichi Yamane, Michifumi Tokuda, Masayoshi Ajioka, Hiroyuki Osanai, Kazuhiro Satomi, Hiroyuki Tsutsui, Akihiko Shimizu, Satoru Sakagami, Eiichi Watanabe, Nobuhisa Hagiwara, Mitsuharu Kawamura, Naohiko Takahashi, Yoshinori Kobayashi, Hirofumi Tomita, Hiroshi Tada, Kazutaka Aonuma, Yukihiro Koretsune, Takanori Ikeda, Masahiko Goya, Wataru Shimizu

Background

The Asia-Pacific Heart Rhythm Society Atrial Fibrillation (APHRS-AF) Registry is a prospective study in Asian metropolitan cities, which provides important information on the baseline characteristics, therapeutic patterns, and 1-year clinical outcomes in patients with atrial fibrillation (AF). This report describes data from Japanese patients recruited in this registry.

Methods and Results

A total of 4666 patients with AF were enrolled. Of these, 794 patients were recruited from 28 large cardiovascular centers in Japan between 2015 and 2017. We analyzed 1-year follow-up outcome of these patients. Mean age at recruitment was 65.7 years and 69.0% were males. Major comorbidities were hypertension (37.5%), lipid disorder (29.0%), heart failure (15.9%), and diabetes mellitus (15.0%). Mean CHADS2 score, CHA2DS2-VASc score, and HAS-BLED score were 1.0, 2.0, and 1.1, respectively. At baseline, use of oral anticoagulants was 81%, including 7% prescribed a vitamin K antagonist (VKA) and 74% a direct oral anticoagulant (DOAC). Majority of the patients (N = 459, 57.8%) were planned to undergo catheter ablation. One-year follow-up was conducted in 743 patients. One-year all-cause mortality was 0.1% (n = 1) and the incidence of stroke/thromboembolic events was also 0.1% (n = 1). Major bleeding events were observed in 5 patients (0.7%), including 3 intracranial hemorrhages.

Conclusion

In this 1-year analysis, a high prevalence of oral anticoagulant use was recorded. A low mortality rate and a low incidence of stroke/thromboembolic events were observed in Japanese patients of the APHRS-AF Registry.

背景:亚太心律学会房颤(APHRS-AF)登记是一项在亚洲大都市进行的前瞻性研究,它提供了关于房颤(AF)患者的基线特征、治疗模式和1年临床结果的重要信息。本报告描述了该登记处招募的日本患者的数据。方法与结果:共纳入4666例房颤患者。其中,在2015年至2017年期间,从日本28个大型心血管中心招募了794名患者。我们分析了这些患者1年的随访结果。入职时平均年龄65.7岁,男性占69.0%。主要合并症为高血压(37.5%)、脂质紊乱(29.0%)、心力衰竭(15.9%)和糖尿病(15.0%)。CHADS2评分、CHA2DS2-VASc评分和HAS-BLED评分的平均值分别为1.0、2.0和1.1。在基线时,口服抗凝剂的使用率为81%,其中7%使用维生素K拮抗剂(VKA), 74%使用直接口服抗凝剂(DOAC)。大多数患者(N = 4559, 57.8%)计划行导管消融。对743例患者进行1年随访。一年全因死亡率为0.1% (n = 1),卒中/血栓栓塞事件发生率也为0.1% (n = 1)。大出血5例(0.7%),其中颅内出血3例。结论:在这1年的分析中,记录了口服抗凝剂使用的高流行率。在aprs - af登记的日本患者中观察到低死亡率和低卒中/血栓栓塞事件发生率。
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引用次数: 0
Initial Capture Failure With Delayed Resolution in Atrial Leadless Pacemaker Implantation: A Case of ATTR Amyloidosis With Sinus Node Dysfunction. 心房无导联起搏器植入术中初始捕获失败并延迟消退:一例ATTR淀粉样变性伴窦房结功能障碍。
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-08 eCollection Date: 2026-02-01 DOI: 10.1002/joa3.70288
Yasuyuki Takada, Junichi Kamoshida, Muryo Terasawa, Kazuhiro Satomi, Yoshinao Yazaki

ATTR amyloidosis patient with initial atrial capture failure showed delayed threshold improvement over time. Stable current of injury and impedance guided expectant management, avoiding unnecessary device repositioning while achieving successful outcomes.

初始心房俘获失败的ATTR淀粉样变性患者随着时间的推移表现出延迟的阈值改善。稳定的损伤电流和阻抗引导预期治疗,避免不必要的器械重新定位,同时取得成功的结果。
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引用次数: 0
Double Transition in Left Bundle Branch Area Pacing. 左束支区起搏的双重过渡。
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-06 eCollection Date: 2026-02-01 DOI: 10.1002/joa3.70290
Sudipta Mondal, Nadeem Afroz Muslim

This case discusses the differential diagnosis of the double transition sign during bipolar threshold testing following conduction system pacing and delves into the details of electrophysiologic parameters of successful left bundle capture.

本病例讨论了传导系统起搏后双极阈值测试中双过渡征的鉴别诊断,并深入研究了成功捕获左束的电生理参数的细节。
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引用次数: 0
Catheter Ablation and Device Therapy in Patients With Transthyretin Amyloid Cardiomyopathy: A Review of Non-Pharmacological Therapy 转甲状腺素淀粉样心肌病的导管消融和器械治疗:非药物治疗的综述。
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-06 DOI: 10.1002/joa3.70281
Hisanori Kanazawa, Tadashi Hoshiyama, Shozo Kaneko, Yusei Kawahara, Yuichiro Tsuruta, Yuta Tsurusaki, Kohei Matsunaga, Shunsuke Tamanoi, Naoto Kuyama, Hiroki Usuku, Eiichiro Yamamoto, Yasuhiro Izumiya, Kenichi Tsujita

In recent years, the number of cases diagnosed with wild-type transthyretin amyloid cardiomyopathy (ATTRwt-CM) has been increasing. However, ATTRwt-CM frequently coexists with atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT), often necessitating management for arrhythmias. Additionally, ventricular arrhythmias sometimes occur, or conduction disturbances often develop, requiring management for bradycardia, frequently needing device therapy such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resynchronization therapy defibrillators. Therefore, for arrhythmia specialists, who primarily focus on non-pharmacological treatments, arrhythmias associated with ATTRwt-CM are unavoidable encounters, and becoming proficient in their management is increasingly important and considered essential. However, we sometimes encounter AF, AFL, or AT that are extremely difficult to treat with catheter ablation, and there are many situations to struggle with: how to manage each arrhythmia and whether catheter ablation should be performed at all. Furthermore, while the usefulness of ICDs for primary prevention of sudden cardiac death remains a subject of debate, we occasionally encounter patients with ventricular arrhythmias in fact. This review primarily addresses and focuses on catheter ablation therapy for atrial arrhythmias associated with ATTRwt-CM, as well as device therapy for bradyarrhythmias and ventricular arrhythmias, aiming to provide insights for treatment planning in the future as a total management approach to arrhythmia in ATTRwt-CM patients, especially for arrhythmia specialists.

近年来,诊断为野生型转甲状腺素淀粉样心肌病(ATTRwt-CM)的病例数量不断增加。然而,attrt - cm经常与心房颤动(AF)、心房扑动(AFL)和房性心动过速(AT)共存,通常需要对心律失常进行治疗。此外,有时会发生室性心律失常,或经常出现传导障碍,需要对心动过缓进行管理,经常需要设备治疗,如起搏器、植入式心律转复除颤器(ICDs)或心脏再同步治疗除颤器。因此,对于主要关注非药物治疗的心律失常专家来说,与attrt - cm相关的心律失常是不可避免的,精通其管理变得越来越重要,并且被认为是必不可少的。然而,我们有时会遇到房颤、AFL或AT,这些都很难通过导管消融治疗,并且有许多情况需要努力解决:如何处理每一种心律失常以及是否应该进行导管消融。此外,虽然icd在初级预防心源性猝死方面的作用仍然是一个有争议的话题,但事实上我们偶尔会遇到室性心律失常的患者。这篇综述主要讨论并关注与attrt - cm相关的心房心律失常的导管消融治疗,以及慢速心律失常和室性心律失常的器械治疗,旨在为未来attrt - cm患者心律失常的全面管理方法提供治疗计划,特别是心律失常专家。
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引用次数: 0
Annual Trends and Regional Disparities in Transvenous Lead Extractions in Japan: Insights From the Nationwide Japanese Registry of All Cardiac and Vascular Diseases-Diagnostic Procedure Combination Data 日本经静脉铅提取的年度趋势和地区差异:来自日本全国所有心脏和血管疾病注册-诊断程序组合数据的见解
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-05 DOI: 10.1002/joa3.70286
Toshihiro Nakamura, Koji Fukuzawa, Yoko Sumita, Koshiro Kanaoka, Kimitake Imamura, Mitsuru Takami, Hiromasa Otake

Background

The increasing use of cardiovascular implantable electronic devices (CIEDs) has heightened the need for transvenous lead extraction (TLE). Although Japan has a certification system for TLE-capable hospitals, nationwide trends and regional disparities remain unclear.

Methods

We retrospectively analyzed the Japanese Registry of All Cardiac and Vascular Diseases Diagnosis Procedure Combination/Per Diem Payment System, including patients undergoing TLE or other CIED-related procedures between April 2015 and March 2022.

Results

Among 3573 TLE cases from 108 hospitals, procedure volumes steadily increased. The median patient age increased from 74 to 77 years, and comorbidity burden also rose over time. During this period, the proportion of non-infectious indications rose from 17.0% in 2015 to 38.9% in 2021. Cardiac tamponade was the most frequent complication, and advanced age and renal disease independently predicted complications or in-hospital death. Marked regional disparities were observed in CIED implantation patterns, TLE volume, and indications across Japan.

Conclusions

Non-infectious TLEs have increased safely in Japan, contributing to an overall growth in TLE procedures. However, substantial regional disparities persist in both procedural volume and indications. Standardized care strategies addressing these disparities are warranted to optimize TLE practice nationwide.

背景:心血管植入式电子装置(CIEDs)的使用日益增加,对经静脉铅提取(TLE)的需求也随之增加。尽管日本对具备能力的医院有认证体系,但全国趋势和地区差异仍不明朗。方法:我们回顾性分析了日本所有心血管疾病诊断程序组合/每日付款系统登记,包括2015年4月至2022年3月期间接受TLE或其他cied相关程序的患者。结果:108家医院3573例TLE病例中,手术量稳步增长。患者年龄中位数从74岁增加到77岁,合并症负担也随着时间的推移而增加。在此期间,非感染性指征的比例从2015年的17.0%上升到2021年的38.9%。心包填塞是最常见的并发症,高龄和肾脏疾病独立预测并发症或院内死亡。在全日本,CIED植入方式、TLE体积和适应症存在明显的地区差异。结论:在日本,非传染性的TLE安全增加,促进了TLE手术的总体增长。然而,在手术数量和指征方面,仍然存在很大的区域差异。解决这些差异的标准化护理策略有必要在全国范围内优化TLE实践。
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引用次数: 0
Temporal Variability and Influence of Measurement Conditions of AI-Based Atrial Fibrillation Risk Estimation. 基于人工智能的房颤风险评估测量条件的时间变异性及影响
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-05 eCollection Date: 2026-02-01 DOI: 10.1002/joa3.70280
Satomi Hamada, Miki Amemiya, Mie Ochida, Susumu Tao, Iwanari Kawamura, Tetsuo Sasano

Background: Although artificial intelligence (AI) has been developed to identify patients with paroxysmal atrial fibrillation (PAF) during sinus rhythm, information on its variability remains limited. We evaluated the reproducibility and effect of recording condition on the estimation of AF risk using an electrocardiography (ECG) machine equipped with an AI-based program.

Methods: We extracted two ECG data from a single ECG test in 149 patients to evaluate reproducibility within 4 min. We also recorded ECG signals under 12 conditions (standard, two conditions shifting precordial electrodes, five conditions moving limb electrodes to the torso, three conditions contaminating noise, and reproducibility over 15 min) in 30 participants to evaluate changes from the standard. The results of the AF risk estimation are expressed at four levels.

Results: The rate of participants within one level of error was 95% for reproducibility within 4 min and 87% for reproducibility over 15 min. Shifting the precordial electrodes upward or downward and replacing the left leg electrode with the torso electrode frequently caused a two- or three-level change. In clinical information, increased brain natriuretic peptide tended to increase the variability.

Conclusions: The AF risk estimated by the AI-based program exhibited temporal variability. Shifting the precordial electrodes influenced AI-based AF risk estimation.

背景:虽然人工智能(AI)已经发展到可以识别窦性心律期间的阵发性心房颤动(PAF)患者,但关于其变异性的信息仍然有限。我们使用配备人工智能程序的心电图(ECG)机评估记录条件对AF风险估计的再现性和效果。方法:我们从149例患者的单次心电图检查中提取两份心电图数据,以评估4分钟内的可重复性。我们还记录了30名参与者在12种情况下的心电图信号(标准,2种情况下将心前电极移动,5种情况下将肢体电极移动到躯干,3种情况下污染噪音,重复性超过15分钟),以评估与标准的变化。房颤风险评估结果分为四个层次。结果:1个误差水平内的受试者在4 min内的重现性为95%,在15 min以上的重现性为87%。将心前电极向上或向下移动,并用躯干电极代替左腿电极,通常会引起两到三层的变化。在临床资料中,脑利钠肽的增加倾向于增加变异性。结论:基于人工智能的程序估计的房颤风险表现出时间变异性。移动心前电极会影响基于人工智能的房颤风险评估。
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引用次数: 0
Correction to ‘Comment on “The Crucial Role of Physical Activity Index in Predicting the Incidence of Pacemaker Syndrome”’ 更正“关于“身体活动指数在预测心脏起搏器综合征发生率中的关键作用”的评论”。
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-02 DOI: 10.1002/joa3.70272

A. Yılmaz, “Comment on “The Crucial Role of Physical Activity Index in Predicting the Incidence of Pacemaker Syndrome”,” Journal of Arrhythmia 42, no. 1 (2026): e70261, https://doi.org/10.1002/joa3.70261.

In the published article, References 1, 2, 3, 4, and 6 contained errors. The corrected references are provided below.

The corrected references are as follows:

Citation 1: G. A. Lamas, E. J. Orav, B. S. Stambler, K. A. Ellenbogen, E. B. Sgarbossa, S. K. S. Huang, and B. L. Wilkoff, “Quality of Life and Clinical Outcomes in Elderly Patients Treated With Ventricular Pacing as Compared With Dual-Chamber Pacing,” New England Journal of Medicine 338, no. 16 (1998): 1097–1104.

Citation 2: S. J. Connolly, C. R. Kerr, M. Gent, R. S. Roberts, S. Yusuf, A. M. Gillis, and D. M. Newman, “Effects of Physiologic Pacing Versus Ventricular Pacing on the Risk of Stroke and Death due to Cardiovascular Causes,” New England Journal of Medicine 342, no. 19 (2000): 1385–1391.

Citation 3: M. S. Link, A. S. Hellkamp, N. M. Estes, E. J. Orav, K. A. Ellenbogen, B. Ibrahim, and MOST Study Investigators, “High Incidence of Pacemaker Syndrome in Patients With Sinus Node Dysfunction Treated With Ventricular-Based Pacing in the Mode Selection Trial (MOST),” Journal of the American College of Cardiology 43, no. 11 (2004): 2066–2071.

Citation 4: M. Glikson, J. C. Nielsen, M. B. Kronborg, Y. Michowitz, A. Auricchio, I. M. Barbash, and K. K. Witte, “2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy: Developed by the Task Force on Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology (ESC) With the Special Contribution of the European Heart Rhythm Association (EHRA),” EP Europace 24, no. 1 (2022): 71–164.

Citation 6: V. Somma, F. J. Ha, S. Palmer, U. Mohamed, and S. Agarwal, “Pacing-Induced Cardiomyopathy: A Systematic Review and Meta-Analysis of Definition, Prevalence, Risk Factors, and Management,” Heart Rhythm 20, no. 2 (2023): 282–290.

We apologize for this error.

[这更正了文章DOI: 10.1002/joa3.70261.]。
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引用次数: 0
Supraventricular Tachycardia Ablation in the Elderly—Characteristics and Outcomes 老年人室上性心动过速消融的特点和结果。
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-01 DOI: 10.1002/joa3.70283
Yi Yi Chua, Julian Cheong Kiat Tay, Eric Tien Siang Lim, Germaine Jie Min Loo, Wei Sheng Jonathan Ong, Xuanming Pung, Daniel Thuan Tee Chong, Kah Leng Ho, Chi Keong Ching

Background

Catheter ablation is an effective treatment for symptomatic supraventricular tachycardia (SVT). Most studies target the general adult population; data on the elderly are less robust. We studied the clinical and procedural characteristics and outcomes in elderly patients undergoing SVT ablation.

Methods

All patients undergoing atrioventricular nodal re-entry tachycardia (AVNRT), atrioventricular re-entry tachycardia (AVRT), and/or atrial tachycardia (AT) ablation between May 2011 and May 2022 at a tertiary center were included. Cases with concurrent ablation of atrial flutter, atrial fibrillation, and ventricular arrhythmias were excluded. Clinical and procedural characteristics and outcomes were compared between patients aged ≥ 70 years and those aged < 70 years.

Results

There were 1758 cases of SVT ablation; 1608 patients were < 70 years old, and 150 patients were ≥ 70 years old. Elderly patients were more likely to have underlying structural heart disease and/or ischemic heart disease, more likely to have AVNRT and less likely to have AVRT (p < 0.001). Consequently, elderly patients were more likely to undergo right-sided ablation (p < 0.001). The use of stereotaxis, intracardiac echocardiography, and electroanatomical mapping did not differ significantly. Procedure time, radiofrequency application time and fluoroscopy time were shorter in elderly patients (p < 0.05). Importantly, immediate complication and success rates did not differ significantly.

Conclusion

In our study, the acute success rates are high, and complication rates are low across both cohorts despite differences in clinical and procedural characteristics. SVT ablation should be considered for symptomatic patients regardless of age. Further data including patient comorbidities and longer-term outcomes may help patient selection.

背景:导管消融是治疗症状性室上性心动过速(SVT)的有效方法。大多数研究针对的是普通成年人;关于老年人的数据就不那么可靠了。我们研究了接受SVT消融的老年患者的临床、手术特点和结果。方法:纳入2011年5月至2022年5月在三级中心接受房室结再入性心动过速(AVNRT)、房室再入性心动过速(AVRT)和/或房性心动过速(AT)消融的所有患者。排除同时消融心房扑动、心房颤动和室性心律失常的病例。比较年龄≥70岁和年龄≥70岁患者的临床、手术特点和结局。结果:SVT消融1758例;结论:在我们的研究中,尽管临床和手术特点存在差异,但两组患者的急性成功率高,并发症发生率低。对于有症状的患者,不论年龄,均应考虑SVT消融。包括患者合并症和长期预后在内的进一步数据可能有助于患者的选择。
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引用次数: 0
Cost-Effectiveness of an Antibacterial Envelope in Patients at High Risk of Cardiac Implantable Electronic Device Infection in the Australian Public Healthcare System 抗菌包膜在澳大利亚公共卫生系统心脏植入式电子设备感染高风险患者中的成本效益
IF 1.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-01 DOI: 10.1002/joa3.70282
Michelle Hill, Behnoosh Hosseinloui Khalaj, Md Shajedur Rahman Shawon, Liesl Strachan, Gabrielle Challis, Kate King, Louisa Jorm, Reece Holbrook

Background

The Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) demonstrated a 40% reduction of major cardiac implantable electronic device (CIED) infection with the use of an absorbable antibacterial envelope in patients at high risk of infection. The objective of this analysis was to determine the cost-effectiveness of this envelope in a high-risk patient population treated in the Australian public healthcare system.

Methods

A decision tree model compared the use of an antibacterial envelope versus no envelope over the lifetime of a patient with a high risk of infection as defined in WRAP-IT. Detailed clinical outcomes were based on 12-month data from WRAP-IT and other local inputs derived from local sources including linked-administrative data in New South Wales (NSW).

Results

The use of an antibacterial envelope results in a cost saving of A$157 at 12 months and an incremental cost of A$62 over a lifetime. Incremental quality-adjusted life-years (QALYs) with the envelope were 0.00144 at 12 months and 0.00872 over a lifetime. Both the 12 month and the lifetime cost/QALY gained resulted in an ICER that was “dominant.” That is, the envelope did not result in a significant increased cost over a lifetime; however, it resulted in increased QALYs.

Conclusions

An antibacterial envelope is a dominant strategy in patients at high risk of infection. Use of the envelope was essentially cost neutral to the Australian public healthcare system, and increases the quality and length of life of the patient.

背景:全球随机抗生素包膜感染预防试验(WRAP-IT)表明,在感染高危患者中使用可吸收抗菌包膜可减少40%的主要心脏植入式电子设备(CIED)感染。本分析的目的是确定在澳大利亚公共医疗保健系统治疗的高危患者人群中使用该包膜的成本效益。方法:一个决策树模型比较使用抗菌包膜与不使用包膜的患者一生中感染的高风险定义在WRAP-IT。详细的临床结果基于来自WRAP-IT的12个月数据和来自新南威尔士州(NSW)相关行政数据等当地来源的其他当地投入。结果:使用抗菌信封可在12个月内节省157澳元的成本,在一生中增加62澳元的成本。包膜的增量质量调整生命年(QALYs)在12个月时为0.00144,在整个生命周期中为0.00872。获得的12个月和终生成本/质量都导致ICER“占主导地位”。也就是说,在整个生命周期中,信封不会导致成本的显著增加;然而,它导致了QALYs的增加。结论:抗菌包膜是高危感染患者的主要治疗策略。信封的使用基本上对澳大利亚公共医疗保健系统的成本是中性的,并提高了患者的质量和寿命。
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Journal of Arrhythmia
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