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Intra‑aortic balloon pump in heart surgery. 心脏手术中的主动脉内球囊泵。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2024-03-04 DOI: 10.1007/s11748-024-02023-z
Mesut Engin, Tuğba Onur, Anıl Onur
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引用次数: 0
Comprehensive multi-modality treatment of thoracic aorta pseudoaneurysms: a single-center experience. 综合多模式治疗胸主动脉假性动脉瘤:单中心经验。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2023-11-25 DOI: 10.1007/s11748-023-01986-9
Sandra Recicarova, Michael Jonak, Ivan Netuka

Introduction: Thoracic aorta false aneurysms (TAFA) are unexplored complications after cardiac surgery associated with significant morbidity and mortality. Therefore, the purpose of this study was to examine the clinical profiles, surgical techniques, and operative outcomes, of patients treated for TAFA at a single institution.

Methods: From 1996 to 2022, 112 patients were treated for aortic pseudoaneurysm (mean age 55 ± 14 years, 78 patients were male). In the majority of the patients (90%) TAFA developed after previous cardiovascular surgery, the most common diagnosis and surgical procedure preceding the TAFA development was an aortic dissection (52%) and Bentall procedure (47%). In the rest of the cohort, the leading cause was trauma.

Results: Sixty-one percent of patients were indicated for reintervention (surgical reoperation, endoluminal graft implantation, septal occluder implantation, coil embolization, or a combination of procedures). Overall, 52 patients had undergone cardiac reoperation. TAFA was resected and the aorta was repaired in 55% or replaced in 45%. Operative mortality was 5.7%. In postoperative follow-up, a hypoechogenic lesion encircling aortic prosthesis was present in 94%, therefore it was determined as a negative prognostic factor. The mean follow-up was 13.2 ± 19.4 years.

Conclusion: Although there is no specific approach how to prevent TAFA development, maintaining normal blood pressure and regular follow-up should be applied. More frequent follow-ups should be performed in patients with a hypoechogenic lesion encircling and aortic prosthesis. Early detection during long-term postoperative follow-up, an individually tailored approach of a multidisciplinary team is necessary for favorable treatment outcomes.

胸主动脉假性动脉瘤(TAFA)是心脏手术后未发现的并发症,具有显著的发病率和死亡率。因此,本研究的目的是检查在单一机构接受TAFA治疗的患者的临床概况、手术技术和手术结果。方法:1996 ~ 2022年收治的主动脉假性动脉瘤112例,平均年龄55±14岁,男性78例。大多数TAFA患者(90%)是在既往心血管手术后发生的,TAFA发生前最常见的诊断和手术是主动脉夹层(52%)和Bentall手术(47%)。在其余的队列中,主要原因是创伤。结果:61%的患者需要再干预(外科手术、腔内移植物植入、间隔闭塞器植入、线圈栓塞或联合手术)。总共有52例患者接受了心脏再手术。55%的患者切除TAFA,修复主动脉,45%的患者更换主动脉。手术死亡率为5.7%。术后随访中,94%的患者存在环绕主动脉假体的低回声病变,因此确定其为不良预后因素。平均随访时间13.2±19.4年。结论:虽然没有预防TAFA发展的具体方法,但应保持血压正常并定期随访。对于环绕主动脉假体的低回声病变患者,应进行更频繁的随访。术后长期随访期间的早期发现,多学科团队的个性化定制方法对于良好的治疗效果是必要的。
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引用次数: 0
Cardioprotective effect of St. Thomas' Hospital No. 2 solution against age-related changes in aquaporin-7-deficient mice. 圣托马斯医院 2 号溶液对水蒸气素-7 缺陷小鼠心肌的保护作用,可防止与年龄相关的变化。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2023-09-11 DOI: 10.1007/s11748-023-01975-y
Masahiro Fujii, Ryuzo Bessho, Toshio Akimoto, Yosuke Ishii

Objective: This study aimed to investigate whether St. Thomas' Hospital No. 2 solution (STH2) is equally effective in both young and aged aquaporin-7-knockout (AQP7-KO) mice and the mechanisms by which the intra-myocardial adenosine triphosphate (ATP) content is altered during ischemia without aquaporin-7.

Methods: In study 1, isolated hearts of male wild-type (WT) and AQP7-KO mice (< 12 weeks old) were Langendorff perfused with 5-min STH2 prior to a 20-min global ischemia (GI) or 25-min GI without STH2. Similarly, in Study 2, hearts from WT and AQP7-KO mice (≥ 24 weeks old) were subjected to 2-min STH2 infusion prior to GI. In study 3, intra-myocardial ATP content was compared before (sham) and after (control or STH2) ischemia in mature WT and AQP7-KO mice.

Results: In study 1, troponin T levels (ng/g wet weight) of WT and AQP7-KO hearts were significantly lower in the STH2 groups (75.6 ± 45.9 and 80.2 ± 52.2, respectively) than in the GI groups (934.0 ± 341.1 and 1089.3 ± 182.5, respectively). In Study 2, troponin T levels in aged WT and AQP7-KO mice were 566.5 ± 550.0 and 547.8 ± 594.3, respectively (p = 0.9561). In Study 3, ATP levels (μmol/g protein) in the sham, control, and STH2 AQP7-KO mice groups were 4.45, 2.57, and 3.37, respectively(p = 0.0005).

Conclusions: The present study revealed the cardio-protective efficacy of STH2 in an experimental model of isolated AQP7-KO young and aged murine hearts. Further, STH2 preserved intra-myocardial ATP during ischemia with Krebs-Henseleit buffer perfusion in the Langendorff setting.

研究目的本研究旨在探讨圣托马斯医院2号溶液(STH2)对年轻和年老的水传导蛋白-7基因敲除(AQP7-KO)小鼠是否同样有效,以及在没有水传导蛋白-7的缺血过程中心肌内三磷酸腺苷(ATP)含量的改变机制:方法:在研究1中,分离了雄性野生型(WT)和AQP7-KO小鼠的心脏(结果见表2):在研究 1 中,WT 和 AQP7-KO 心脏的肌钙蛋白 T 水平(ng/g 湿重)在 STH2 组(分别为 75.6 ± 45.9 和 80.2 ± 52.2)显著低于 GI 组(分别为 934.0 ± 341.1 和 1089.3 ± 182.5)。在研究 2 中,老龄 WT 小鼠和 AQP7-KO 小鼠的肌钙蛋白 T 水平分别为 566.5 ± 550.0 和 547.8 ± 594.3(p = 0.9561)。在研究 3 中,假小鼠组、对照组和 STH2 AQP7-KO 小鼠组的 ATP 水平(μmol/g 蛋白质)分别为 4.45、2.57 和 3.37(p = 0.0005):本研究揭示了 STH2 在离体 AQP7-KO 年轻和衰老小鼠心脏实验模型中的心脏保护功效。此外,STH2 还能在 Langendorff 环境下用 Krebs-Henseleit 缓冲液灌注心肌缺血时保护心肌内 ATP。
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引用次数: 0
Comparison between Zone 2 and Zone 3 distal anastomoses for aortic arch replacement in terms of invasiveness. 主动脉弓置换术中 2 区和 3 区远端吻合的侵袭性比较。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-29 DOI: 10.1007/s11748-024-02045-7
Mamoru Arakawa, Kei Akiyoshi, Yuichiro Kitada, Atsushi Miyagawa, Homare Okamura

Objectives: Zone 2 anastomosis with total cervical branch reconstruction for acute type A aortic dissection and aortic arch aneurysms became possible after stent-graft introduction. This may be an easier procedure and reduce the risk of recurrent laryngeal nerve palsy. Therefore, this study aimed to compare the outcomes between Zone 2 and Zone 3 distal anastomoses.

Methods: After evaluating the patient data in our institute between April 2016 and April 2022, the patients in whom distal anastomosis was performed at Zone 2 with a stent-graft were defined as the Zone 2 group (n = 70). The patients in whom distal anastomosis was performed at Zone 3 were defined as the Zone 3 group (n = 24).

Results: The incidence of new-onset recurrent nerve palsy was one patient (1.4%) in the Zone 2 group and six patients (25.0%) in the Zone 3 group (p < 0.001). The lower body perfusion arrest time was 44.3 ± 9.1 min in the Zone 2 group and 52.9 ± 12.8 min in the Zone 3 group (p = 0.005). There were no significant differences in in-hospital mortality and morbidities. Multivariable analysis showed that only age was an independent predictor of overall mortality.

Conclusions: Performing distal anastomosis at Zone 2 with a frozen elephant trunk or stent-graft reduced the lower body perfusion arrest time and possibly prevented recurrent nerve palsy.

目的:采用支架移植物后,急性 A 型主动脉夹层和主动脉弓动脉瘤的 2 区吻合术和全颈支重建术成为可能。这可能是一种更简便的手术,并能降低喉返神经麻痹的风险。因此,本研究旨在比较 2 区和 3 区远端吻合的结果:对我院 2016 年 4 月至 2022 年 4 月期间的患者数据进行评估后,将在 2 区使用支架移植物进行远端吻合的患者定义为 2 区组(n = 70)。在3区进行远端吻合的患者被定义为3区组(n = 24):结果:新发复发性神经麻痹的发生率为:Zone 2 组 1 例(1.4%),Zone 3 组 6 例(25.0%)(P 结论:Zone 2 组患者的复发性神经麻痹发生率为 1.4%,Zone 3 组患者的复发性神经麻痹发生率为 25.0%:在 2 区使用冷冻象鼻或支架移植物进行远端吻合缩短了下半身灌注停止时间,并可能预防了复发性神经麻痹。
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引用次数: 0
Prognostic significance of preoperative to postoperative serum carcinoembryonic antigen ratio after lobectomy for lung adenocarcinoma. 肺腺癌肺叶切除术后术前与术后血清癌胚抗原比值的预后意义
IF 1.1 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-28 DOI: 10.1007/s11748-024-02042-w
Go Kamimura, Masaya Aoki, Mihiro Iwamoto, Yusei Tsuneyoshi, Shoichiro Morizono, Tadashi Umehara, Aya Harada-Takeda, Koki Maeda, Toshiyuki Nagata, Kazuhiro Ueda

Introduction: Lung adenocarcinoma with a preoperatively elevated serum carcinoembryonic antigen (CEA) value has a relatively poor postoperative prognosis. Although surgical resection generally results in a reduction in the CEA value, the significance of the change in the CEA value on the prognostic outcome remains unclear.

Methods: Our study included 133 patients who underwent lobectomy with curative intent for lung adenocarcinoma representing a preoperative CEA value > 5.0. Statistical analysis was performed using a receiver operating characteristic analysis and a stepwise Cox proportional hazards analysis.

Results: Both the postoperative CEA value and postoperative-to-preoperative CEA ratio (CEA ratio) significantly affected the survival. Although the CEA ratio was not predictive of the survival in patients with postoperative CEA ≤ 6.2 ng/ml (n = 105), it was predictive in the remaining patients with postoperative CEA > 6.2 ng/ml (n = 28). Patients with postoperative CEA > 6.2 ng/ml and a CEA ratio ≥ 0.39 (n = 7) showed the worst survival outcome. According to the multivariate analysis, the CEA ratio and postoperative nodal status were significant predictors of the survival in overall patients.

Conclusion: The CEA ratio may be a useful prognostic marker in patients who undergo lobectomy for lung adenocarcinoma and show postoperative CEA > 6.2 ng/ml. A high CEA ratio may indicate the presence of a subclinical residual tumor, which may lead to the development of subsequent recurrence.

简介术前血清癌胚抗原(CEA)值升高的肺腺癌术后预后相对较差。虽然手术切除通常会降低 CEA 值,但 CEA 值的变化对预后结果的影响仍不明确:我们的研究纳入了 133 例因肺腺癌接受肺叶切除术的患者,这些患者术前 CEA 值大于 5.0。统计分析采用接受者操作特征分析和逐步式考克斯比例危险度分析:结果:术后CEA值和术后与术前CEA比值(CEA比值)都对生存率有显著影响。虽然 CEA 比值对术后 CEA ≤ 6.2 ng/ml 的患者(105 人)的生存率没有预测作用,但对术后 CEA > 6.2 ng/ml 的其余患者(28 人)有预测作用。术后 CEA > 6.2 ng/ml 且 CEA 比值≥ 0.39 的患者(7 例)生存预后最差。根据多变量分析,CEA比值和术后结节状态是预测所有患者生存率的重要指标:结论:对于接受肺腺癌肺叶切除术且术后CEA>6.2纳克/毫升的患者,CEA比值可能是一个有用的预后指标。高 CEA 比值可能预示着存在亚临床残留肿瘤,这可能导致后续复发。
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引用次数: 0
A modified adventitial inversion with graft insertion technique in acute Type A aortic dissection. 在急性 A 型主动脉夹层中采用改良的前庭倒置和移植物插入技术。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 Epub Date: 2024-01-23 DOI: 10.1007/s11748-024-02008-y
Dai-Song Jiang, Hong-Hua Yue, Wei-Tao Liang, Zhong Wu

Acute type A aortic dissection may originate from a primary intimal tear located in the ascending aorta and often extends retrogradely into the aortic root. How to prevent bleeding in the aortic root and eliminate false lumen is very important in aortic dissection. We have developed a modified anastomotic technique that involves inverting adventitial and graft into aorta and reinforcing with a felt strip on the external border of the aortic wall. Since 2020, 45 consecutive patients with type A aortic coarctation have undergone this aortic root reconstruction procedure, to date, none have been reopened for bleeding or remnant dissection.

急性 A 型主动脉夹层可能源于升主动脉的原发性内膜撕裂,并经常逆行延伸至主动脉根部。如何防止主动脉根部出血并消除假腔对主动脉夹层非常重要。我们开发了一种改良的吻合技术,将主动脉瓣和移植物倒置到主动脉内,并在主动脉壁外缘用毡条加固。自 2020 年以来,已有 45 例 A 型主动脉闭塞患者连续接受了这种主动脉根部重建手术,迄今为止,没有一例患者因出血或残余夹层而再次手术。
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引用次数: 0
Safety and efficacy of aortic valvuloplasty for de novo aortic insufficiency in patients with a left-ventricular assist device. 主动脉瓣成形术治疗左心室辅助装置患者新发主动脉瓣关闭不全的安全性和有效性。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 Epub Date: 2023-09-15 DOI: 10.1007/s11748-023-01974-z
Naoki Tadokoro, Satoshi Kainuma, Naonori Kawamoto, Takashi Kakuta, Kohei Tonai, Hideyuki Shimizu, Tomoyuki Fujita, Satsuki Fukushima

Objectives: Progression of aortic insufficiency during left-ventricular assist device (LVAD) support is a crucial topic. One treatment option is aortic valvuloplasty (AVP); however, there is controversy regarding its safety and efficacy. We investigated the safety and efficacy of AVP using the coaptation stitch method (Park's stitch) performed for de novo aortic insufficiency.

Methods: Between 2013 and 2020, 175 consecutive patients underwent LVAD implantation, of which 7 patients [men, 2 (28.6%); median age, 55 years] underwent late-stage AVP. Two patients underwent AVP within 2 weeks, and the remaining six patients underwent AVP 3, 19, 24, 28, 42, and 49 months, respectively, after LVAD implantation.

Results: Preoperatively, the degree of aortic insufficiency was moderate in 6 (85.7%) patients and severe in 1 (14.3%) patient. AVP was technically successful in 6 (85.7%) patients, while one case of failed plasty was subsequently treated with bioprosthetic valve replacement. A 1-year post-AVP right heart catheterization study revealed a median pulmonary artery wedge pressure of 10.0 mmHg. No deaths or heart failure admissions occurred during the follow-up (median, 38.0 months). There was no aortic insufficiency in 2 (28.6%) patients; however, trivial AI was observed in 3 (42.8%) patients, and mild AI was observed in 1 (14.3%) patient 2 years postoperatively. However, at the 3-year follow-up, two patients developed an increase in AI grade from trivial to mild.

Conclusions: AVP using Park's stitch was safe. It is critical to carefully observe the aortic valve during AVP surgery to ensure that AVP is appropriate.

目的:左心室辅助装置(LVAD)支持期间主动脉瓣功能不全的恶化是一个重要的课题。主动脉瓣成形术(AVP)是一种治疗方法,但其安全性和有效性存在争议。我们研究了针对新发主动脉瓣关闭不全采用合瓣缝合法(Park's 缝合法)进行 AVP 的安全性和有效性:2013 年至 2020 年间,175 名患者连续接受了 LVAD 植入术,其中 7 名患者[男性,2 名(28.6%);中位年龄 55 岁]接受了晚期 AVP。两名患者在 2 周内接受了 AVP,其余 6 名患者分别在 LVAD 植入后 3、19、24、28、42 和 49 个月接受了 AVP:术前,6 名患者(85.7%)的主动脉瓣关闭不全程度为中度,1 名患者(14.3%)为重度。6例(85.7%)患者的主动脉瓣成形术在技术上获得成功,1例成形术失败的患者随后接受了生物人工瓣膜置换术。AVP术后1年的右心导管检查显示,肺动脉楔压的中位数为10.0 mmHg。在随访期间(中位数为 38.0 个月),没有发生死亡或心力衰竭。有 2 名患者(28.6%)未出现主动脉瓣关闭不全,但有 3 名患者(42.8%)出现轻微主动脉瓣关闭不全,1 名患者(14.3%)在术后 2 年出现轻微主动脉瓣关闭不全。然而,在 3 年的随访中,有两名患者的 AI 级别从轻微上升到了轻度:结论:使用 Park 缝合线进行 AVP 是安全的。结论:使用 Park's 缝合线进行 AVP 是安全的,关键是要在 AVP 手术过程中仔细观察主动脉瓣,以确保 AVP 是适当的。
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引用次数: 0
The significance of regular chest computed tomography in postoperative surveillance for surgically resected non-small cell lung cancer based on TNM 8th staging system. 根据 TNM 第 8 分期系统,定期进行胸部计算机断层扫描对手术切除的非小细胞肺癌术后监测的意义。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 Epub Date: 2023-12-25 DOI: 10.1007/s11748-023-01991-y
Jun Suzuki, Tomohiro Miyoshi, Kenta Tane, Ken Onodera, Yutaro Koike, Takashi Sakai, Joji Samejima, Keiju Aokage, Masahiro Tsuboi

Objectives: Although several societies recommend regular chest computed tomography (CT) scans for the surveillance of surgically resected non-small cell lung cancer (NSCLC), there is paucity of evidence to support these statements. This study aimed to clarify whether regular CT scans improved the prognosis of patients with surgically resected NSCLC based on TNM 8th classification.

Methods: Patients with pathologic Stage 0-III NSCLC who underwent complete surgical resection other than sublobar resection procedures were enrolled in the study. For these patients, clinicopathological data and postoperative surveillance data were collected by the retrospective review of medical records. Patients were categorized into the chest X-ray (CXR) group or the CT group according to whether they were followed-up with basic examinations including CXR or basic examinations plus regular chest CT. Postoperative overall survival was compared between the two groups.

Results: Six hundred sixty five patients were categorized into the CXR (n = 245) and CT (n = 420) groups. The clinicopathological backgrounds did not differ to a statistically significant extent. Recurrence was seen in 68 (27.3%) patients in the CXR group and 117 (27.8%) patients in the CT group. The 5-year overall survival rates of the two groups did not differ to a statistically significant extent (CXR, 76.5%; CT, 78.3%, P = 0.22).

Conclusion: Regular chest CT scans may not improve the prognosis of surgically resected NSCLC. Further study is warranted to precisely evaluate the benefit of CT-based postoperative surveillance of NSCLC.

目的:尽管一些学会建议定期进行胸部计算机断层扫描(CT),以监测手术切除的非小细胞肺癌(NSCLC),但支持这些说法的证据并不多。本研究旨在根据 TNM 第 8 分类,明确定期 CT 扫描是否能改善手术切除 NSCLC 患者的预后:研究对象为病理分期为0-III期的NSCLC患者,这些患者均接受了除叶下切除术以外的完全手术切除。这些患者的临床病理数据和术后监测数据都是通过回顾性审查病历收集的。根据患者是否接受了包括 CXR 在内的基本检查或基本检查加定期胸部 CT 的随访,将其分为胸部 X 光(CXR)组和 CT 组。比较了两组患者的术后总生存率:结果:665 名患者被分为 CXR 组(245 人)和 CT 组(420 人)。临床病理背景差异无统计学意义。CXR组有68例(27.3%)患者复发,CT组有117例(27.8%)患者复发。两组患者的 5 年总生存率差异无统计学意义(CXR,76.5%;CT,78.3%,P = 0.22):结论:定期进行胸部 CT 扫描可能不会改善手术切除 NSCLC 的预后。结论:定期进行胸部 CT 扫描可能不会改善手术切除 NSCLC 的预后,因此有必要开展进一步研究,以准确评估基于 CT 的 NSCLC 术后监测的益处。
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引用次数: 0
Performance of the ENSEAL X1 Curved Jaw Tissue Sealer in thoracic procedures in a Japanese cohort: a case series report. ENSEAL-X1弯曲颌骨组织封闭器在日本队列中的胸部手术性能:一个病例系列报告。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 Epub Date: 2023-10-14 DOI: 10.1007/s11748-023-01980-1
Hiroyuki Ito, Masahiro Tsuboi, Kristy Canavan, Paula Veldhuis, Mordechai Goode Sadowsky

Background: Advanced vessel sealing electrosurgical systems have been widely adopted for grasping, cutting, and sealing vessels. Data remain sparse with regard to its use in thoracic procedures. Thus, a prospective case series, utilizing the ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) and its companion energy source, the Generator 11 (GEN11), in thoracic procedures was performed in a Japanese cohort.

Methods: Subjects were recruited at two Japanese surgical sites. The primary endpoint of this post-market study was the achievement of hemostasis (≤ Grade 3) for each thoracic vessel transection. Performance endpoints included scores for tasks completed with X1CJ (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection); hemostasis grading vessel transected; additional products required to achieve hemostasis for Grade 4 vessel transections. Safety was evaluated by evaluating device-related adverse events. All endpoint data were summarized.

Results: Forty subjects (50.0% female) of Asian ethnicity with a mean age of 67.6 ± 11.3 years underwent a lung resection. Estimated mean blood loss was 39.5 mL. Hemostasis was achieved in 97.5% of vessel transections. Thirty-seven vessel sealings resulted in a hemostatic Grade 1 (92.5%). All surgeons reported satisfaction/neutral in terms of tissue grasping (100.0%) while most reported satisfaction/neutral with tissue cutting (95.7%). One device-related serious adverse event was reported (2.5%), a chylothorax requiring an extension of hospitalization. There was no post-operative bleeding or deaths reported during the study period.

Conclusion: The X1CJ demonstrated safe and effective performance without any reports of significant intra-operative or post-operative hemorrhage in thoracic vessel sealing.

背景:先进的血管密封电外科系统已被广泛用于抓取、切割和密封血管。关于其在胸部手术中的应用,数据仍然很少。因此,在一个日本队列中进行了一个前瞻性病例系列,利用ENSEAL X1弯曲颌骨组织封闭器(X1CJ)及其配套能源Generator 11(GEN11)进行胸部手术。方法:受试者在两个日本手术地点招募。该上市后研究的主要终点是止血(≤ 等级3)。表现终点包括X1CJ完成任务的得分(粘连松解、淋巴管或组织束分裂、组织抓取、组织切割或组织剥离);横切止血分级血管;4级血管横断止血所需的额外产品。通过评估器械相关不良事件来评估安全性。总结了所有终点数据。结果:40名亚裔受试者(50.0%为女性),平均年龄67.6岁 ± 11.3年行肺切除术。估计平均失血量为39.5 mL。97.5%的血管断面达到止血状态。37次血管封堵器止血等级为1级(92.5%)。所有外科医生均报告对组织抓取满意/中性(100.0%),而大多数外科医生报告对组织切割满意/中立(95.7%)。报告了一例与器械相关的严重不良事件(2.5%),即乳糜胸需要延长住院时间。研究期间未报告术后出血或死亡。结论:X1CJ显示出安全有效的性能,没有任何手术中或术后胸血管封闭出血的报告。
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引用次数: 0
Real-world safety and effectiveness of inhaled nitric oxide therapy for pulmonary hypertension during the perioperative period of cardiac surgery: a post-marketing study of 2817 patients in Japan. 吸入一氧化氮治疗心脏手术围手术期肺动脉高压的实际安全性和有效性:对日本 2817 名患者进行的上市后研究。
IF 1.2 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 Epub Date: 2023-09-15 DOI: 10.1007/s11748-023-01971-2
Emi Matsugi, Shigeki Takashima, Shuhei Doteguchi, Tomomi Kobayashi, Motohiro Okayasu

Objective: To evaluate the real-world safety and effectiveness of inhaled nitric oxide (INOflo® for Inhalation 800 ppm) for perioperative pulmonary hypertension associated with cardiac surgery in Japan.

Methods: This was a prospective, non-interventional, all-case, post-marketing study of pediatric and adult patients who received perioperative INOflo with cardiac surgery from November 2015-December 2020. Safety and effectiveness were monitored from INOflo initiation to 48 h after treatment completion or withdrawal. Safety outcomes included adverse drug reactions, blood methemoglobin concentrations, and inspired nitrogen dioxide concentrations over time. Effectiveness outcomes included changes in central venous pressure among pediatrics, mean pulmonary arterial pressure among adults, and the partial pressure of arterial oxygen/fraction of inspired oxygen ratio (PaO2/FiO2) in both populations.

Results: The safety analysis population included 2,817 Japanese patients registered from 253 clinical sites (pediatrics, n = 1375; adults, n = 1442). INOflo was generally well tolerated; 15 and 20 adverse drug reactions were reported in 14 pediatrics (1.0%) and 18 adults (1.2%), respectively. No clinically significant elevations in blood methemoglobin and inspired nitrogen dioxide concentrations were observed. INOflo treatment was associated with significant reductions in both central venous pressure among pediatrics and mean pulmonary arterial pressure among adults, and significant improvements in PaO2/FiO2 among pediatrics and adults with PaO2/FiO2 ≤ 200 at baseline.

Conclusions: Perioperative INOflo treatment was a safe and effective strategy to improve hemodynamics and oxygenation in patients with pulmonary hypertension during cardiac surgery. These data support the use of INOflo for this indication in Japanese clinical practice.

目的评估日本吸入一氧化氮(INOflo® 吸入用 800 ppm)治疗心脏手术相关围手术期肺动脉高压的实际安全性和有效性:这是一项前瞻性、非干预性、全病例、上市后研究,研究对象为2015年11月至2020年12月期间接受心脏手术围手术期INOflo的儿童和成人患者。从开始使用INOflo到治疗结束或停药后48小时,对其安全性和有效性进行了监测。安全性结果包括药物不良反应、血液高铁血红蛋白浓度和吸入二氧化氮浓度随时间的变化。疗效结果包括儿科中心静脉压的变化、成人平均肺动脉压的变化以及两种人群的动脉氧分压/吸入氧分压比值(PaO2/FiO2)的变化:安全性分析对象包括 253 个临床站点登记的 2817 名日本患者(儿科,n = 1375;成人,n = 1442)。INOflo的耐受性普遍良好;14名儿科患者(1.0%)和18名成人患者(1.2%)分别报告了15和20例药物不良反应。未观察到血液高铁血红蛋白和吸入二氧化氮浓度有临床意义的升高。INOflo治疗可显著降低小儿中心静脉压和成人平均肺动脉压,并显著改善基线PaO2/FiO2≤200的小儿和成人的PaO2/FiO2:结论:围术期 INOflo 治疗是改善心脏手术肺动脉高压患者血液动力学和氧合的一种安全有效的策略。这些数据支持在日本临床实践中将 INOflo 用于这一适应症。
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General Thoracic and Cardiovascular Surgery
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