Closure

闭合
  • 文章类型: Journal Article
    背景:卵圆孔未闭(PFO)影响20-34%的成年人,并与中风和其他疾病有关。PFO相关中风的常规治疗是闭合手术。金属装置与一些不良事件有关。
    目的:我们的目的是研究在接受肺静脉隔离术(PVI)的房颤(AF)患者中使用冷冻消融术进行PFO封堵术的有效性和安全性。
    方法:我们将22例经冷冻消融术行PVI的PFO和AF患者分为两组:标准PVI+房间隔(AS)冷冻消融术组(第1组,n=11)和标准PVI组(第2组,n=11)。导丝通过PFO进入左心房,在手术过程中没有AS穿刺。通过冷冻消融进行标准PVI。将冷冻球囊缩回至右心房并在PVI后对AS充气。第1组患者冷冻消融120-150秒,而第2组患者接受假消融术.共同的主要终点是PFO闭合率和AF复发和卒中/短暂性脑缺血发作(TIA)事件的复合。
    结果:两组间手术相关不良事件无差异。两组在1年随访时都没有缺血性卒中报告。第1组6个月时PFO闭合率明显高于第2组[7(63.6%)vs.1(9.1%),P=0.002]。消融后房颤复发在3个月时两组具有可比性[3(27.3%)与1(9.1%),P=0.269],六个月(0vs.0),和十二个月[2(18.2%)与1(9.1%),随访P=0.534]。
    结论:冷冻消融术是一种安全有效的方法,可在接受PVI的房颤患者中通过一次手术关闭PFO。
    BACKGROUND: Patent foramen ovale (PFO) affects 20%-34% of adults and is associated with strokes and other disorders. The conventional treatment of PFO-related strokes is a closure procedure. The metal device is associated with some adverse events.
    OBJECTIVE: Our aim was to investigate the efficacy and safety of PFO closure using cryoablation without implantation in patients with atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI).
    METHODS: We divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. Standard PVI via cryoablation was performed. The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI. Patients in group 1 had cryoablation for 120-150 seconds, whereas patients in group 2 received sham ablation. The co-primary end points were the PFO closure rate and a composite of AF recurrence and stroke/transient ischemic attack (TIA) events.
    RESULTS: There were no differences in procedure-related adverse events between the 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up.
    CONCLUSIONS: Cryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.
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  • 文章类型: Journal Article
    背景:在垂体手术期间,脑脊液漏通常通过鞍内填塞治疗,使用肌肉或脂肪移植物。然而,这种策略可能会干扰术后MRI的解释,并可能影响二次手术的切除质量,由于存在额外的纤维组织。我们提出了一种替代技术,使用异源海绵结合纤维蛋白原和凝血酶(TachoSil)进行隔膜重建,适用于选定的低流量脑脊液渗漏患者。这项研究调查了采用这种策略治疗的患者的手术结果。
    方法:从2011年6月至2023年6月通过内镜经鼻入路进行垂体手术的2231例患者队列中,详细介绍了55例患者(2.6%)使用TachoSil补片进行diaphragm肌修复的手术技术,术后6个月分析闭合失败率。不使用鞍内包装,并尽可能进行鞍底重建。将术后CSF泄漏的发生率与以前三篇也使用TachoSil贴片技术的出版物中报道的发生率进行了比较。
    结果:患者大多为女性(F/M比:1.2),中位年龄为53.6岁。无功能腺瘤需要手术治疗,库欣病,肢端肥大症,和Rathke'sleft囊肿在38/55(69.1%),6/55(10.9%),5/55(9.1%)和6/55(10.9%)患者。术后脑脊液漏发生率为1.8%(n=1/55),这与文献中三个队列中报道的没有显着差异(2.8%,p>0.05)。没有记录到术后脑膜炎。
    结论:在高度选择的与小的局灶性隔膜缺损相关的低流量CSF泄漏患者中,使用TachoSil补片进行膈肌重建可能是一种安全且有价值的替代方法。
    BACKGROUND: During pituitary surgery, CSF leaks are often treated by intrasellar packing, using muscle or fat grafts. However, this strategy may interfere with the interpretation of postoperative MRI and may impact the quality of resection in cases of second surgery, due to the existence of additional fibrous tissue. We present an alternative technique, using a diaphragm reconstruction with a heterologous sponge combining fibrinogen and thrombin (TachoSil), applied in selected patients with low-flow CSF leaks. This study investigates the surgical outcome of patients treated with this strategy.
    METHODS: From a cohort of 2231 patients treated from June 2011 to June 2023 by endoscopic endonasal approach for pituitary surgery, the surgical technique of diaphragm repair with TachoSil patch performed in 55 patients (2.6%) was detailed, and the rate of closure failure was analyzed at 6 months postoperatively. No intrasellar packing was used and sellar floor reconstruction was performed whenever possible. The rate of postoperative CSF leak was compared with that reported in three previous publications that also used the TachoSil patch technique.
    RESULTS: Patients were mostly women (F/M ratio: 1.2) with a median age of 53.6 years. Surgery was indicated for non-functioning adenomas, Cushing\'s disease, acromegaly, and Rathke\'s cleft cysts in 38/55 (69.1%), 6/55 (10.9%), 5/55 (9.1%) and 6/55 (10.9%) patients respectively. The rate of postoperative CSF leak was 1.8% (n = 1/55), which was not significantly different from that reported in the three cohorts from the literature (2.8%, p > 0.05). No postoperative meningitis was recorded.
    CONCLUSIONS: In highly selected patients with low-flow CSF leaks related to small focal diaphragm defects, diaphragm reconstruction using a TachoSil patch can be a safe and valuable alternative to intrasellar packing.
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  • 文章类型: Journal Article
    目的:内镜手缝合术(EHS)是一种用于在内镜粘膜下剥离术(ESD)后闭合粘膜缺损的新技术。我们使用改良的柔性透镜针固定器研究了结直肠EHS的技术可行性。
    方法:这是一项前瞻性多中心研究,于2022年6月至2023年4月在两个转诊中心进行。这项研究包括位于乙状结肠或直肠的20-50毫米大小的结直肠肿瘤。一种改进的柔性透镜针架,增加下巴的宽度,以方便针的抓握,用于结直肠EHS。主要终点是术后第3-4天进行二次内窥镜检查(SLE)的持续闭合率和结直肠EHS的缝合时间。次要终点包括完全闭合率和延迟不良事件。
    结果:我们在20例患者中纳入了20例结直肠肿瘤,包括4名接受抗血栓治疗的患者.肿瘤位置如下:直肠下部(n=8),上直肠(n=2),直肠乙状结肠(n=4),和乙状结肠(n=6),中位粘膜缺损大小为37mm(范围,21-65毫米)。完全闭合率为90%(18/20[95%置信区间(CI)68.3-98.8%]),缝合时间中位数为49分钟(范围,23-92分钟[95%CI35-68分钟])。SLE的持续闭合率为85%(17/20[95%CI62.1-96.8%])。未观察到延迟不良事件。
    结论:EHS显示出较高的持续闭合率。考虑到缝合时间长、技术难度大,EHS应保留给具有延迟不良事件高风险的病例。
    OBJECTIVE: Endoscopic hand suturing (EHS) is a novel technique for closing a mucosal defect after endoscopic submucosal dissection (ESD). We investigated the technical feasibility of colorectal EHS using a modified flexible through-the-scope needle holder.
    METHODS: This was a prospective multicenter study conducted at two referral centers between June 2022 and April 2023. This study included colorectal neoplasms 20-50 mm in size located in the sigmoid colon or rectum. A modified flexible through-the-scope needle holder, with an increased jaw width to facilitate needle grasping, was used for colorectal EHS. The primary end-points were sustained closure rate on second-look endoscopy (SLE) performed on postoperative days 3-4 and suturing time for colorectal EHS. Secondary end-points included complete closure rate and delayed adverse events.
    RESULTS: We enrolled 20 colorectal neoplasms in 20 patients, including four patients receiving antithrombotic agents. The tumor location was as follows: lower rectum (n = 8), upper rectum (n = 2), rectosigmoid colon (n = 4), and sigmoid colon (n = 6), and the median mucosal defect size was 37 mm (range, 21-65 mm). The complete closure rate was 90% (18/20 [95% confidence interval (CI) 68.3-98.8%]), and the median suturing time was 49 min (range, 23-92 min [95% CI 35-68 min]). Sustained closure rate on SLE was 85% (17/20 [95% CI 62.1-96.8%]). No delayed adverse events were observed.
    CONCLUSIONS: EHS demonstrated a high sustained closure rate. Given the long suturing time and technical difficulty, EHS should be reserved for cases with a high risk of delayed adverse events.
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  • 文章类型: Journal Article
    摄影是一种艺术形式,其中人类的视觉感知和心理体验的整合导致审美愉悦。本研究利用眼动追踪来探讨摄影中格式塔的特性对人们视觉认知过程的影响,以了解摄影欣赏的心理过程和模式。这项研究发现,具有格式塔质量的图像可以显着影响固定,视线分布,以及对美学和复杂性的主观评价。闭合构图图像似乎使认知更简单,导致最少的固定和扫视次数,固定时间较长,更集中的视线表明更强烈的美感,虽然描绘相似性的图像会导致最大的注视和扫视,最长的扫视持续时间,视线散射更大,表明复杂和看不见的感觉。本研究成果与艺术设计理论密切相关,对摄影理论和应用具有参考价值。
    Photography is an art form where integration of the human visual perception and psychological experiences result in aesthetic pleasure. This research utilizes eye tracking to explore the impact of the properties of Gestalt in photography on people\'s visual cognitive process in order to understand the psychological processes and patterns of photography appreciation. This study found that images with Gestalt qualities can significantly affect fixation, sightline distribution, and subjective evaluation of aesthetics and complexity. Closure composition images seem to make cognition simpler, resulting in the least number of fixation and saccades, longer fixation duration, and more concentrated sightline indicating stronger feeling of beauty, while images which portray similarity results in the greatest fixation and saccades, longest saccade duration, and greater scattering of sightline, indicating feelings of complexity and unsightliness. The results of this research are closely related to the theories of art and design, and have reference value for photography theory and application.
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  • 文章类型: Randomized Controlled Trial
    背景技术用于心导管插入的桡动脉近端(pRA)通路是安全的,但是由于闭塞而可能危及动脉的后续使用。解剖鼻烟盒中的桡动脉远端(dRA)通道保留了桡动脉,但对手部功能的安全性和潜在有害影响尚不清楚。方法和结果在DIPRA(远端与近端桡动脉介入治疗)研究中,单中心试验,300例患者通过dRA或pRA以1:1的比例随机分配至心导管插入术。从基线到30天手功能变化的主要终点是QuickDASH(手臂快速残疾,肩和手)问卷,手握测试,和拇指食指捏测试。次要终点包括通路可行性和并发症;300例患者中有254例在30天完成随访;其中,128例随机分配至dRA,126例随机分配至pRA,具有平衡的人口统计学和程序特征。两组的通路部位出血率相似(dRA0%对pRA1.4%;P=0.25)。6例dRA患者未能获得治疗,而2例pRA患者未能获得治疗。2pRA中发生radial动脉闭塞,dRA中没有。在手功能的改变上没有显著差异,中位握力(dRA0[-3.2,3.3]对pRA0.7[-2.3,3.3]kg;P=0.21),捏夹(dRA-0.3[-1.2,0.5]对pRA0[-0.9,0.9]kg;P=0.09),和QuickDASH(dRA0[-4.6,2.3]对pRA0[-4.6,2.3]点,P=0.96)。pRA和dRA之间手功能的复合没有显着差异。结论dRA是一种安全的心导管插入策略,并发症发生率低。与pRA相比,30天时手部功能障碍的风险没有增加.注册网址:https://www。ClinicalTrials.gov.唯一标识符:NCT04318990。
    Background Proximal radial artery (pRA) access for cardiac catheterization is safe but can jeopardize subsequent use of the artery because of occlusion. Distal radial artery (dRA) access in the anatomical snuffbox preserves the radial artery, but safety and potential detrimental effects on hand function are unknown. Methods and Results In the DIPRA (Distal Versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention) study, a single-center trial, 300 patients were randomized 1:1 to cardiac catheterization through dRA or pRA. The primary end point of change in hand function from baseline to 30 days was a composite of the QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) questionnaire, hand-grip test, and thumb forefinger pinch test. Secondary end points included access feasibility and complications; 254 of 300 patients completed follow-up at 30 days; of these, 128 were randomized to dRA and 126 to pRA with balanced demographic and procedural characteristics. Both groups had similar rates of access site bleeding (dRA 0% versus pRA 1.4%; P=0.25). Six patients with dRA failed access compared with 2 patients with pRA. Radial artery occlusion occurred in 2 pRA versus none in dRA. There were no significant differences in change in hand function, median hand-grip (dRA 0 [-3.2, 3.3] versus pRA 0.7 [-2.3, 3.3] kg; P=0.21), pinch-grip (dRA -0.3 [-1.2, 0.5] versus pRA 0 [-0.9, 0.9] kg; P=0.09), and QuickDASH (dRA 0 [-4.6, 2.3] versus pRA 0 [-4.6, 2.3] points, P=0.96). There was no significant difference in the composite of hand function between pRA and dRA. Conclusions dRA is a safe strategy for cardiac catheterization with a low complication rate. Compared with pRA, there is no increased risk of hand dysfunction at 30 days. Registration URL: https://www.ClinicalTrials.gov. Unique identifier: NCT04318990.
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  • 文章类型: Journal Article
    传统上,全喉切除术后咽缺损的闭合是通过手动缝合技术进行的,该技术虽然有效,但使粘膜边缘倒置。然而这很耗时。最近,提倡使用吻合装置成功闭合全喉切除术后的咽部缺损,以缩短手术时间,特别是在高危癌症患者中,延长手术时间不是首选。本研究旨在以前瞻性随机方式比较吻合器辅助全喉切除术与缝合闭合全喉切除术。这是一项前瞻性的临床研究,在亚历山大大学主要医院接受全喉切除术的60名患者中进行,埃及。肿瘤延伸至下咽或舌根的患者被排除在研究之外。手术时间缩短,住院时间缩短,术后并发症发生率不增加。在接受全喉切除术的患者中,使用吻合器在技术上易于执行,并且与传统的新咽缝合技术一样有效。
    Closure of the pharyngeal defect after total laryngectomy had been traditionally performed with manual suturing techniques that invert the mucosal edge this technique though effective, yet it is time-consuming. Recently the use of stapling devices to successfully close the pharyngeal defect after total laryngectomy has been advocated to shorten the operative time, especially in the high-risk cancer patients where a prolonged operative time is not preferred. The present study aimed at comparing stapler assisted total laryngectomy to suture closure total laryngectomy in a prospective randomized manner. This is a prospective clinical study conducted on 60 patients undergoing total laryngectomy at Alexandria Main University Hospital, Egypt. Patients with tumor extension to the hypopharynx or base of the tongue were excluded from the study. The surgical time is reduced with shorter hospital stays and no increase in postoperative complications rate. The use of the stapler is technically easy to perform and as equally as effective as the traditional neopharyngeal suturing techniques in patients undergoing total laryngectomy.
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  • 文章类型: Observational Study
    UNASSIGNED:手术部位感染(SSI)是造口闭合后最常见的并发症之一。迄今为止,对于理想的造口伤口闭合技术以最大程度地减少术后SSI,目前尚无共识,并提出了多种技术.我们进行了这项研究,以评估“初级线性闭合”(PC)和“周向包线近似”(CPA)技术后伤口愈合的临床结果。
    UNASSIGNED:这项前瞻性观察研究纳入了我们三级护理中心的所有患者,在2018年3月1日至2020年3月1日期间,符合择期造口关闭的纳入标准,我们对造口关闭后的伤口愈合情况进行了前瞻性研究,以比较PC组和CPA组的SSI率差异,并讨论患者对伤口愈合满意度的差异.以下研究对荷包组36例患者和线性闭合组66例患者进行。
    UNASSIGNED:仅在24%的患者中观察到手术部位感染(SSI),而在荷包闭合组中观察到0%。(p=0.039)。虽然线性闭合组伤口的平均愈合时间明显少于荷包线组(分别为10.76±5.68天和14.17±2.04天)。钱包组总满意度得分较高。荷包串闭合组对疤痕/美容外观的期望表现出明显更高的满意度得分,术后疼痛程度及伤口护理难度(p>0.05)。
    未经批准:在我们的研究中,就SSI率和更好的患者总体满意度而言,“周向包线逼近”是一种优于主要线性闭合的造口逆转技术。注册会计师是一个很好的替代选择,但在得出明确的结论之前,有必要进行更多患者的前瞻性随机试验.
    UNASSIGNED: surgical site infection (SSI) is one of the most common complications that can occur after stoma closure. To date, there is no consensus on the ideal closure technique of the stoma wound to minimize postoperative SSI and multiple techniques have been proposed. We performed this study to assess the clinical outcome of wound healing after \'Primary Linear Closure\' (PC) and \'Circumferential Purse-String Approximation\' (CPA) techniques.
    UNASSIGNED: this prospective observational study included all patients admitted to our tertiary care center, fulfilling the inclusion criteria for elective stoma closure from 1st March 2018 to 1 March 2020 and prospective study was conducted on wound healing after stoma closure to compare difference in SSI rate between the PC group and the CPA group and to discuss the differences in patient satisfaction with wound healing. The following study was carried out with 36 patients in purse-string group and 66 patients in linear closure group.
    UNASSIGNED: surgical site infection (SSI) was observed only in primary linear closure group in 24% patients as opposed to 0% in purse string closure group. (p=0.039). Although the mean healing time of wound in linear closure group was significantly less than the purse string group (10.76 ± 5.68 days and 14.17 ± 2.04 days respectively), the overall total satisfaction score was higher in the purse string group. The purse string closure group showed significantly higher satisfaction score for expectations regarding appearance of scar/cosmesis, level of postoperative pain and difficulty of wound care (p>0.05).
    UNASSIGNED: in our study, \'Circumferential Purse-String Approximation\' is a superior technique than Primary Linear Closure for Stoma reversal in terms of rate of SSI and better overall patient satisfaction. CPA is a good alternative option, but further prospective randomized trials involving more patients are necessary before a definitive conclusion can be drawn.
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  • 文章类型: Randomized Controlled Trial
    经导管二尖瓣边缘到边缘修复术(M-TEER)后的医源性房间隔缺损(iASD)与预后受损相关我们调查了M-TEER后从左到右分流的相关iASD的自然史,在M-TEER后1至6个月间iASD自发闭合的预测因子,和结果(心力衰竭[HF]住院)的患者自发关闭与那些持续iASD后6个月M-TEER。M-TEER术后1个月有相关iASD的患者,在随机对照MITHRAS试验中接受保守治疗,M-TEER术后6个月接受临床随访,包括经食管超声心动图检查。总的来说,36名患者(中位数77[四分位数范围65-81]年;36%的女性)完成了6个月的随访。6名(17%)患者的iASD自发闭合。M-TEER后1个月iASD的偏心指数是自发闭合的最强预测指标(赔率比3.78;95%置信区间1.26-11.33,p=0.01),而<1.9的偏心指数在M-TEER后6个月内对iASD持久性的特异性为83%时提供了77%的敏感性(曲线下面积0.83,p<0.001)。在后续行动中,自发性闭合和残余分流组之间HF住院终点的数值差异(0%vs.20%,观察到p=0.25)。iASD的偏心是1个月时自发闭合的最强预测因子,偏心指数<1.9与M-TEER后6个月的高持续率相关。临床试验注册ClinicalTrials.govhttps://clinicaltrials.gov/ct2/show/NCT03024268标识符:NCT03024268。a(红色)反映市长的纵向尺寸,b(蓝色)反映市长的倾斜尺寸。偏心指数是通过将a除以b来计算的。(空心圆)描绘了圆形iASD的示例,而(空心菱形)是M-TEER后1个月的偏心iASD的示例。
    Persisting iatrogenic atrial septal defects (iASD) after transcatheter mitral edge-to-edge repair (M-TEER) are associated with impaired outcomes. We investigated the natural history of relevant iASDs with left-to-right shunting post-M-TEER, predictors of spontaneous closure of iASD between 1 and 6 months post-M-TEER, and outcomes (heart failure [HF] hospitalization) in patients with spontaneous closure versus those with persistent iASD 6 months post-M-TEER. Patients with a relevant iASD 1-month post-M-TEER, who were treated conservatively in the randomized controlled MITHRAS trial, underwent clinical follow-up including transesophageal echocardiography 6 months post-M-TEER. Overall, 36 patients (median 77 [interquartile range 65-81] years; 36% women) completed the 6-months follow-up. Six (17%) patients had a spontaneous closure of the iASD. The eccentricity index of the iASD 1-month after M-TEER was the strongest predictor for spontaneous closure (Odds ratio 3.78; 95% confidence interval 1.26-11.33, p = 0.01) and an eccentricity index of < 1.9 provided a sensitivity of 77% at a specificity of 83% for iASD persistence (Area under the curve 0.83, p < 0.001) within 6-months post M-TEER.At follow-up, a numerical difference in the endpoint of HF hospitalization between the spontaneous closure and the residual shunt group (0% vs. 20%, p = 0.25) was observed. The eccentricity of the iASD was the strongest predictor for spontaneous closure at 1-months and an eccentricity index of < 1.9 is associated with a high persistence rate for 6 month after M-TEER. Clinical Trial Registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03024268 Identifier: NCT03024268. a (red) is reflecting the mayor lengthwise dimension and b (blue) the mayor oblique dimension. The eccentricity index is calculated by dividing a through b. (Open circle) is depicting an example for a round iASD and (Open rhombus) an example for an eccentric iASD 1 month after M-TEER.
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  • 文章类型: Systematic Review
    目的:通过一项随机对照试验(RCT)的个体参与者数据(IPD)研究,确定特发性全厚度黄斑裂孔(iFTMHs)手术患者症状持续时间对预后的影响。评估的结果是初次iFTMH闭合和术后最佳矫正视力(BCVA)。
    结论:特发性全厚度黄斑裂孔是视力致残的,患病率高达0.5%。未处理的BCVA通常降低到20/200。手术可以闭合孔并改善视力。症状持续时间被认为会影响手术的结果,但效果尚不清楚。
    方法:一项系统评价确定了合格的随机对照试验,包括iFTMH患者接受玻璃体切除术伴气体填塞,其中症状持续时间,主iFTMH闭包,记录术后BCVA。在书目数据库中搜索了2000年至2020年之间发表的文章。从符合条件的研究中要求个体参与者数据。
    结果:确定了20个合格的随机对照试验。从所有研究中要求数据,并从12个研究中获得,总共代表940只眼。中位症状持续时间为6个月(四分位距,3-10).81.5%的眼睛实现了初次闭合。预测的闭合概率和症状持续时间之间存在线性关系。多水平logistic回归显示,持续时间每增加一个月,闭合几率降低0.965倍(95%置信区间[CI],0.935-0.996,P=0.026)。内限膜(ILM)剥离,ILM皮瓣使用,更好的术前BCVA,面朝下定位,较小的iFTMH大小与初次闭合几率增加相关.获得初次闭合的眼睛的术后BCVA中位数为最小分辨率角(logMAR)的0.48对数(20/60)。对于达到原发性iFTMH闭合的眼睛,显示了多水平逻辑回归,症状持续时间的每增加一个月与BCVA恶化0.008logMAR单位相关(95%CI,0.005-0.011,P<0.001)(即~1早期治疗糖尿病视网膜病变研究信丢失每2个月)。ILM襟翼,使用长效气体的眼内填塞,更好的术前BCVA,较小的iFTMH尺寸,和phokic状态也与术后BCVA改善相关。
    结论:在接受iFTMH手术的患者中,症状持续时间与解剖和视觉结果独立相关。应尽量减少手术时间,并为此设计护理途径。
    OBJECTIVE: To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full-thickness macular holes (iFTMHs) by means of an individual participant data (IPD) study of randomized controlled trials (RCTs). The outcomes assessed were primary iFTMH closure and postoperative best-corrected visual acuity (BCVA).
    CONCLUSIONS: Idiopathic full-thickness macular holes are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect is unclear.
    METHODS: A systematic review identified eligible RCTs that included adults with iFTMH undergoing vitrectomy with gas tamponade in which symptom duration, primary iFTMH closure, and postoperative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. Individual participant data were requested from eligible studies.
    RESULTS: Twenty eligible RCTs were identified. Data were requested from all studies and obtained from 12, representing 940 eyes in total. Median symptom duration was 6 months (interquartile range, 3-10). Primary closure was achieved in 81.5% of eyes. There was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% confidence interval [CI], 0.935-0.996, P = 0.026). Internal limiting membrane (ILM) peeling, ILM flap use, better preoperative BCVA, face-down positioning, and smaller iFTMH size were associated with increased odds of primary closure. Median postoperative BCVA in eyes achieving primary closure was 0.48 logarithm of the minimum angle of resolution (logMAR) (20/60). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI, 0.005-0.011, P < 0.001) (i.e., ∼1 Early Treatment Diabetic Retinopathy Study letter loss per 2 months). ILM flaps, intraocular tamponade using long-acting gas, better preoperative BCVA, smaller iFTMH size, and phakic status were also associated with improved postoperative BCVA.
    CONCLUSIONS: Symptom duration was independently associated with both anatomic and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery should be minimized and care pathways designed to enable this.
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  • 文章类型: Journal Article
    探讨非瓣膜性心房颤动(NVAF)患者应用第二代左心耳封堵术(LAAC)超声封堵术的可行性和安全性。
    带有第一代Ultraseal设备的LAAC(Cardia,伊根,明尼苏达州)已被证明是NVAF患者的可行治疗选择。然而,关于新型第二代Ultraseal设备的数据很少。
    2018年2月至2020年9月期间接受第二代Ultraseal设备植入的所有NVAF患者均纳入多中心国际注册。通过6个月的随访收集围手术期和出院后事件。共同主要疗效终点是器械成功和技术成功,而主要安全终点是院内主要不良事件(MAE)发生。
    共纳入52例患者:平均年龄75±8岁,30.8%为女性,平均HAS-BLED3±1。该装置已成功植入所有患者体内。50例患者(96.1%)获得了技术成功。3例患者发生院内MAEs(5.8%)。6个月全因死亡和大出血发生率分别为11.6%和2.1%,分别。没有中风,短暂性脑缺血发作,全身栓塞,出院后报告或装置栓塞。
    第二代Ultraseal器械植入成功率高,围手术期并发症发生率低。需要更大的研究和更长时间的随访,以进一步评估该设备的安全性和有效性。尤其是长期随访。
    To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF).
    LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device.
    All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence.
    A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge.
    Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.
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