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Commentary: Treating atrial fibrillation in women: Guidelines versus Reality 评论:治疗女性心房颤动:指南与现实。
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2024.07.026
Irsa Hasan MD , Ibrahim Sultan MD
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引用次数: 0
Adaptation of cold preservation techniques to partial heart transplant 低温保存技术对部分心脏移植的适应性。
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2024.08.013
V. Reed LaSala MD, Elizabeth M. Cordoves BA, David M. Kalfa MD, PhD
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引用次数: 0
Invest in the Future
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/S0022-5223(24)01194-2
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引用次数: 0
Adult Articles in AATS Journals
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/S0022-5223(24)01160-7
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引用次数: 0
Navigating the future of pediatric cardiovascular surgery: Insights and innovation powered by Chat Generative Pre-Trained Transformer (ChatGPT).
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2025.01.022
Rittal Mehta, Justus G Reitz, Alyssia Venna, Arif Selcuk, Bishakha Dhamala, Jennifer Klein, Christine Sawda, Mitchell Haverty, Can Yerebakan, Aybala Tongut, Manan Desai, Yves d'Udekem

Introduction: Interdisciplinary consultations are essential to decision-making for patients with congenital heart disease. The integration of artificial intelligence (AI) and natural language processing into medical practice is rapidly accelerating, opening new avenues to diagnosis and treatment. The main objective of this study was to consult the AI-trained model Chat Generative Pre-Trained Transformer (ChatGPT) regarding cases discussed during a cardiovascular surgery conference (CSC) at a single tertiary center and compare the ChatGPT suggestions with CSC expert consensus results.

Methods: In total, 37 cases discussed at a single CSC were retrospectively identified. Clinical information comprised deidentified data from the last electrocardiogram, echocardiogram, intensive care unit progress note (or cardiology clinic note if outpatient), as well as a patient summary. The diagnosis was removed from the summary and possible treatment options were deleted from all notes. ChatGPT (version 4.0) was asked to summarize the case, identify diagnoses, and recommend surgical procedures and timing of surgery. The responses of ChatGPT were compared with the results of the CSC.

Results: Of the 37 cases uploaded to ChatGPT, 45.9% (n = 17) were considered to be less complex cases, with only 1 treatment option, and 54.1% (n = 20) were considered more complex, with several treatment options. ChatGPT correctly provided a detailed and systematically written summary for each case within 10 to 15 seconds. ChatGPT correctly identified diagnoses for approximately 94.5% (n = 35) cases. The surgical intervention plan matched the group decision for approximately 40.5% (n = 15) cases; however, it differed in 27% cases. In 23 of 37 cases, timing of surgery was the same between CSC group and ChatGPT. Overall, the match between ChatGPT responses and CSC decisions for diagnosis was 94.5%, surgical intervention was 40.5%, and timing of surgery was 62.2%. However, within complex cases, we have 25% agreement for surgical intervention and 67% for timing of surgery.

Conclusions: ChatGPT can be used as an augmentative tool for surgical conferences to systematically summarize large amounts of patient data from electronic health records and clinical notes in seconds. In addition, our study points out the potential of ChatGPT as an AI-based decision support tool in surgery, particularly for less-complex cases. The discrepancy, particularly in complex cases, emphasizes on the need for caution when using ChatGPT in decision-making for the complex cases in pediatric cardiovascular surgery. There is little doubt that the public will soon use this comparative tool.

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引用次数: 0
Significance of isolated postoperative atrial fibrillation in thoracic aortic aneurysm repair 胸主动脉瘤修复术后孤立性心房颤动的意义
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2023.12.023
Megan M. Chung BA , Cheryl Pan BA , Hideyuki Hayashi MD , Viswajit Kandula MD , Yanling Zhao MS , Dov Levine MD , Patra Childress MD , Lauren Sutherland MD , Syed T. Raza MD, MA , Paul Kurlansky MD , Craig R. Smith MD , Hiroo Takayama MD, PhD

Objective

Although postoperative atrial fibrillation has been shown to be associated with worse survival after thoracic aortic surgery, its effect on outcomes independently from other postoperative complications is not well understood.

Methods

This is a single-center retrospective study of patients who underwent open thoracic aortic aneurysm repair between March 2005 and March 2021. Postoperative atrial fibrillation was defined as new-onset atrial fibrillation that developed during the index hospital stay. Patients with preoperative atrial fibrillation were excluded. Postoperative major complications included reoperation for bleeding, respiratory failure, acute renal failure, and stroke. Variables associated with postoperative atrial fibrillation were analyzed with multivariable regression. Survival of patients without major complications was compared between patients without atrial fibrillation and patients with postoperative atrial fibrillation after propensity score matching for baseline and intraoperative characteristics.

Results

Of 1454 patients, 520 (35.8%) were observed to have postoperative atrial fibrillation. Patients with postoperative atrial fibrillation had a higher rate of postoperative major complications than those without atrial fibrillation (20.2% vs 12.2%, P < .001). Ten-year survival was 82.0% in patients with postoperative atrial fibrillation and 87.0% in patients without atrial fibrillation (P = .008). In the cohort of patients without complications, 10-year survival was similar between patients with and without postoperative atrial fibrillation after propensity score matching (83.6% vs 83.8%, P = .75).

Conclusions

Postoperative atrial fibrillation is common after open proximal thoracic aortic aneurysm repair. Although development of major postoperative complications is associated with postoperative atrial fibrillation and decreased long-term survival, isolated postoperative atrial fibrillation does not appear to influence long-term survival.
方法 这是一项单中心回顾性研究,研究对象为 2005 年 3 月至 2021 年 3 月间接受开胸主动脉瘤修复术的患者。POAF定义为在指数住院期间新发的心房颤动(AF)。不包括术前有房颤的患者。术后主要并发症包括因出血、呼吸衰竭、急性肾功能衰竭和中风而再次手术。通过多变量回归分析了与 POAF 相关的变量。在对基线和术中特征进行倾向评分匹配后,比较了无房颤患者和有 POAF 患者无主要并发症的生存率。POAF 患者的术后主要并发症发生率高于无 AF 患者(20.2% 对 12.2%,P<0.001)。POAF患者的十年生存率为82.0%,无房颤患者为87.0%(P=0.008)。在无并发症的患者队列中,经过倾向评分匹配后,有 POAF 和无 POAF 患者的 10 年生存率相似(83.6% vs. 83.8%,p=0.75)。虽然术后主要并发症的发生与 POAF 和长期生存率下降有关,但孤立的 POAF 似乎并不影响长期生存率。
{"title":"Significance of isolated postoperative atrial fibrillation in thoracic aortic aneurysm repair","authors":"Megan M. Chung BA ,&nbsp;Cheryl Pan BA ,&nbsp;Hideyuki Hayashi MD ,&nbsp;Viswajit Kandula MD ,&nbsp;Yanling Zhao MS ,&nbsp;Dov Levine MD ,&nbsp;Patra Childress MD ,&nbsp;Lauren Sutherland MD ,&nbsp;Syed T. Raza MD, MA ,&nbsp;Paul Kurlansky MD ,&nbsp;Craig R. Smith MD ,&nbsp;Hiroo Takayama MD, PhD","doi":"10.1016/j.jtcvs.2023.12.023","DOIUrl":"10.1016/j.jtcvs.2023.12.023","url":null,"abstract":"<div><h3>Objective</h3><div>Although postoperative atrial fibrillation<span><span> has been shown to be associated with worse survival after thoracic aortic surgery, its effect on outcomes independently from other </span>postoperative complications is not well understood.</span></div></div><div><h3>Methods</h3><div><span>This is a single-center retrospective study of patients who underwent open thoracic aortic aneurysm repair between March 2005 and March 2021. Postoperative atrial fibrillation was defined as new-onset atrial fibrillation that developed during the index hospital stay. Patients with preoperative atrial fibrillation were excluded. Postoperative major complications included </span>reoperation<span><span><span> for bleeding, respiratory failure, </span>acute renal failure, and stroke. Variables associated with postoperative atrial fibrillation were analyzed with multivariable regression. Survival of patients without major complications was compared between patients without atrial fibrillation and patients with postoperative atrial fibrillation after </span>propensity score matching for baseline and intraoperative characteristics.</span></div></div><div><h3>Results</h3><div>Of 1454 patients, 520 (35.8%) were observed to have postoperative atrial fibrillation. Patients with postoperative atrial fibrillation had a higher rate of postoperative major complications than those without atrial fibrillation (20.2% vs 12.2%, <em>P &lt; .</em>001). Ten-year survival was 82.0% in patients with postoperative atrial fibrillation and 87.0% in patients without atrial fibrillation (<em>P = .</em>008). In the cohort of patients without complications, 10-year survival was similar between patients with and without postoperative atrial fibrillation after propensity score matching (83.6% vs 83.8%, <em>P = .</em>75).</div></div><div><h3>Conclusions</h3><div>Postoperative atrial fibrillation is common after open proximal thoracic aortic aneurysm<span> repair. Although development of major postoperative complications is associated with postoperative atrial fibrillation and decreased long-term survival, isolated postoperative atrial fibrillation does not appear to influence long-term survival.</span></div></div>","PeriodicalId":49975,"journal":{"name":"Journal of Thoracic and Cardiovascular Surgery","volume":"169 2","pages":"Pages 617-626.e7"},"PeriodicalIF":4.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139375969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimized strategy to improve the outcomes of acute type A aortic dissection with malperfusion syndrome 改善急性 A 型主动脉夹层伴灌注不良综合征预后的优化策略
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2024.01.006
Shuangkun Chen MD , Hua Peng MD , Hui Zhuang MD , Juxiang Wang MD , Pianpian Yan MD , Weiqun Zhang MD , Weiliang Zheng BS , Mingyu Li PhD , Xijie Wu MD, PhD

Background

The mortality of acute type A aortic dissection (ATAAD) with malperfusion syndrome (MPS) is high. However, the management strategy remains controversial. We aimed to evaluate the strategy for MPS at our institution.

Methods

Among 724 patients with ATAAD, 167 patients with MPS were treated with immediate central repair (first stage) or an optimized strategy (second stage). In the second stage, the optimized strategy used was based on 6-hour threshold from symptom onset. For MPS with symptom onset within 6 hours, immediate central repair was performed, followed by endovascular reperfusion if malperfusion persisted. With symptom onset beyond 6 hours, individualized delayed central repair was performed. We compared outcomes between the first and second stages.

Results

The in-hospital mortality of ATAAD was significantly decreased when the optimized strategy was used (4.3% in the second stage vs 12.5% in the first stage; P < .01). In the second stage, the in-hospital mortality for MPS was decreased (10.2% vs 33.9%; P < .01). Moreover, the in-hospital mortality for MPS with symptom onset within 6 hours and beyond 6 hours decreased from 24% to 7.5% and from 41.2% to 11.8%, respectively. The operative mortality of MPS in the second stage was comparable to that in patients without MPS (4.0% vs 2.4%; P > .05).

Conclusions

The optimized strategy significantly improved the outcomes of MPS. The 6-hour threshold from symptom onset could be very useful in determining the timing of central repair. For patients with MPS symptom onset within 6 hours, immediate central repair is reasonable; for those with symptom onset beyond 6 hours, individualized delayed central repair should be considered.
{"title":"Optimized strategy to improve the outcomes of acute type A aortic dissection with malperfusion syndrome","authors":"Shuangkun Chen MD ,&nbsp;Hua Peng MD ,&nbsp;Hui Zhuang MD ,&nbsp;Juxiang Wang MD ,&nbsp;Pianpian Yan MD ,&nbsp;Weiqun Zhang MD ,&nbsp;Weiliang Zheng BS ,&nbsp;Mingyu Li PhD ,&nbsp;Xijie Wu MD, PhD","doi":"10.1016/j.jtcvs.2024.01.006","DOIUrl":"10.1016/j.jtcvs.2024.01.006","url":null,"abstract":"<div><h3>Background</h3><div><span>The mortality of acute type A aortic dissection (ATAAD) with </span>malperfusion syndrome (MPS) is high. However, the management strategy remains controversial. We aimed to evaluate the strategy for MPS at our institution.</div></div><div><h3>Methods</h3><div>Among 724 patients with ATAAD, 167 patients with MPS were treated with immediate central repair (first stage) or an optimized strategy (second stage). In the second stage, the optimized strategy used was based on 6-hour threshold from symptom onset. For MPS with symptom onset within 6 hours, immediate central repair was performed, followed by endovascular reperfusion if malperfusion persisted. With symptom onset beyond 6 hours, individualized delayed central repair was performed. We compared outcomes between the first and second stages.</div></div><div><h3>Results</h3><div>The in-hospital mortality of ATAAD was significantly decreased when the optimized strategy was used (4.3% in the second stage vs 12.5% in the first stage; <em>P</em> &lt; .01). In the second stage, the in-hospital mortality for MPS was decreased (10.2% vs 33.9%; <em>P</em><span> &lt; .01). Moreover, the in-hospital mortality for MPS with symptom onset within 6 hours and beyond 6 hours decreased from 24% to 7.5% and from 41.2% to 11.8%, respectively. The operative mortality of MPS in the second stage was comparable to that in patients without MPS (4.0% vs 2.4%; </span><em>P</em> &gt; .05).</div></div><div><h3>Conclusions</h3><div>The optimized strategy significantly improved the outcomes of MPS. The 6-hour threshold from symptom onset could be very useful in determining the timing of central repair. For patients with MPS symptom onset within 6 hours, immediate central repair is reasonable; for those with symptom onset beyond 6 hours, individualized delayed central repair should be considered.</div></div>","PeriodicalId":49975,"journal":{"name":"Journal of Thoracic and Cardiovascular Surgery","volume":"169 2","pages":"Pages 562-573.e2"},"PeriodicalIF":4.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139456432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Robotic-assisted extended thymectomy for large resectable thymoma: 21 years’ experience 机器人辅助扩展胸腺切除术治疗大面积可切除胸腺瘤:21 年的经验。
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2024.08.005
Luyu Huang MD , Zhongmin Li MD , Feng Li MD , Hongbin Zhang MD , Wenqiang Zhang MD , Aron Elsner MD , Julia Strauchmann MD , Marco Nicolas Andreas MD , Tomasz Dziodzio MD , Aina Lask MD , Jens Neudecker MD , Mahmoud Ismail MD , Daipeng Xie MD , Haiyu Zhou MD, PhD , Andreas Meisel MD, PhD , Jens-C. Rueckert MD, PhD

Objective

This study aims to evaluate the perioperative and midterm oncological outcomes of robotic-assisted thoracic surgery extended thymectomy for patients with large resectable thymomas compared with small thymomas.

Methods

This retrospective single-center study included 204 patients with thymomas who underwent robotic-assisted thoracic surgery extended thymectomy between January 2003 and February 2024. Patients were divided into 2 groups based on the thymoma size (5-cm threshold).

Results

The study comprised 114 patients (55.9%) in the small thymoma group and 90 patients (44.1%) in the large thymoma group. No significant differences were found between the groups regarding gender, age, proportion of elderly patients, or pathologic high-risk classifications. Apart from a longer operative time (P = .009) in the large thymoma group, no differences were observed between the 2 groups regarding surgical parameters and postoperative outcomes. No deaths occurred within 30 days in either group. During a median follow-up of 61.0 months (95% CI, 48.96-73.04), 4 patients experienced recurrence (1.96%). No significant differences in the 5-year overall survival (P = .25) or recurrence-free survival (P = .43) were observed between groups.

Conclusions

Robotic-assisted thoracic surgery extended thymectomy is technically feasible, safe, and effective for treating large resectable thymomas. Moreover, midterm outcomes for patients with completely resected large thymomas were comparable to those with small thymomas during a median follow-up period of up to 5 years.
研究目的本研究旨在评估与小胸腺瘤相比,机器人辅助胸腔镜手术(RATS)扩展胸腺瘤切除术对大型可切除胸腺瘤患者的围手术期和中期肿瘤治疗效果:这项回顾性单中心研究纳入了2003年1月至2024年2月期间接受RATS扩展胸腺切除术的204例胸腺瘤患者。根据胸腺瘤大小(5 厘米阈值)将患者分为两组:小型胸腺瘤(ST)组有 114 名患者(55.9%),大型胸腺瘤(LT)组有 90 名患者(44.1%)。两组患者在性别、年龄、老年患者比例或病理高危分类方面无明显差异。除了LT组的手术时间较长(P=0.009)外,两组在手术参数和术后效果方面均无差异。两组患者均未在30天内死亡。在中位随访 61.0 个月(95% CI:48.96-73.04)期间,有四名患者复发(1.96%)。两组患者的五年总生存率(OS)(P=0.25)或无复发生存率(RFS)(P=0.43)无明显差异:结论:RATS扩展胸腺切除术在治疗可切除的巨大胸腺瘤方面技术可行、安全有效。此外,在长达五年的中位随访期内,完全切除大胸腺肿瘤患者的中期疗效与小胸腺肿瘤患者相当。
{"title":"Robotic-assisted extended thymectomy for large resectable thymoma: 21 years’ experience","authors":"Luyu Huang MD ,&nbsp;Zhongmin Li MD ,&nbsp;Feng Li MD ,&nbsp;Hongbin Zhang MD ,&nbsp;Wenqiang Zhang MD ,&nbsp;Aron Elsner MD ,&nbsp;Julia Strauchmann MD ,&nbsp;Marco Nicolas Andreas MD ,&nbsp;Tomasz Dziodzio MD ,&nbsp;Aina Lask MD ,&nbsp;Jens Neudecker MD ,&nbsp;Mahmoud Ismail MD ,&nbsp;Daipeng Xie MD ,&nbsp;Haiyu Zhou MD, PhD ,&nbsp;Andreas Meisel MD, PhD ,&nbsp;Jens-C. Rueckert MD, PhD","doi":"10.1016/j.jtcvs.2024.08.005","DOIUrl":"10.1016/j.jtcvs.2024.08.005","url":null,"abstract":"<div><h3>Objective</h3><div>This study aims to evaluate the perioperative and midterm oncological outcomes of robotic-assisted thoracic surgery extended thymectomy for patients with large resectable thymomas compared with small thymomas.</div></div><div><h3>Methods</h3><div>This retrospective single-center study included 204 patients with thymomas who underwent robotic-assisted thoracic surgery extended thymectomy between January 2003 and February 2024. Patients were divided into 2 groups based on the thymoma size (5-cm threshold).</div></div><div><h3>Results</h3><div>The study comprised 114 patients (55.9%) in the small thymoma group and 90 patients (44.1%) in the large thymoma group. No significant differences were found between the groups regarding gender, age, proportion of elderly patients, or pathologic high-risk classifications. Apart from a longer operative time (<em>P =</em> .009) in the large thymoma group, no differences were observed between the 2 groups regarding surgical parameters and postoperative outcomes. No deaths occurred within 30 days in either group. During a median follow-up of 61.0 months (95% CI, 48.96-73.04), 4 patients experienced recurrence (1.96%). No significant differences in the 5-year overall survival (<em>P =</em> .25) or recurrence-free survival (<em>P</em> = .43) were observed between groups.</div></div><div><h3>Conclusions</h3><div>Robotic-assisted thoracic surgery extended thymectomy is technically feasible, safe, and effective for treating large resectable thymomas. Moreover, midterm outcomes for patients with completely resected large thymomas were comparable to those with small thymomas during a median follow-up period of up to 5 years.</div></div>","PeriodicalId":49975,"journal":{"name":"Journal of Thoracic and Cardiovascular Surgery","volume":"169 2","pages":"Pages 469-483.e10"},"PeriodicalIF":4.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142005701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of macitentan in Fontan-palliated patients: 52-week randomized, placebo-controlled RUBATO Phase 3 trial and open-label extension 马西替坦在方坦患者中的疗效和安全性:为期52周的随机、安慰剂对照RUBATO 3期试验和开放标签扩展。
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2024.08.039
Paul Clift MD , Felix Berger MD , Lars Sondergaard MD, MDSc , Petra Antonova MD , Patrick Disney MD , Jeremy Nicolarsen MD , Jean-Benoît Thambo MD , Lidia Tomkiewicz Pajak MD , Jou-kou Wang MD , Annette Schophuus Jensen MD, PhD , Michela Efficace MSc , Michael Friberg PhD , Diana Haberle PharmD, PhD , Verena Walter Diplom-Mathematikerin (FH) , Yves d’Udekem MD

Objectives

The efficacy and safety of macitentan, an endothelin receptor antagonist, were assessed in a 52-week, prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent patients (RUBATO-DB) and an open-label extension trial (RUBATO-OL).

Methods

Patients aged 12 years and older with New York Heart Association functional class II or III underwent total cavopulmonary connection more than 1 year before screening and showed no signs of Fontan failure/clinical deterioration. In RUBATO-DB, the primary efficacy end point was change in peak oxygen consumption from baseline to week 16; secondary end points were change from baseline over 52 weeks in peak oxygen consumption and change in mean count/minute of daily physical activity via accelerometer from baseline to week 16. Safety was assessed throughout both studies.

Results

In RUBATO-DB, 137 patients were randomized to macitentan 10 mg (n = 68) or placebo (n = 69); 92.7% completed 52-week double-blind treatment. At week 16, mean ± SD change in peak oxygen consumption was −0.16 ± 2.86 versus −0.67 ± 2.66 mL/kg/minute with macitentan versus placebo (median unbiased treatment difference estimate, 0.62 mL/kg/minute [99% repeated CI, −0.62 to 1.85]; P = .19). No treatment effect was observed in either of the secondary end points. During RUBATO-DB, most common adverse events with macitentan were headache, nasopharyngitis, and pyrexia. Across RUBATO-DB and RUBATO-OL, most common adverse events were COVID-19, headache, and fatigue. RUBATO-OL was prematurely discontinued because RUBATO-DB did not meet its primary or secondary end point.

Conclusions

The primary end point of RUBATO-DB was not met; macitentan did not improve exercise capacity versus placebo in patients with Fontan palliation. Macitentan was generally well tolerated over long-term treatment.
研究目的在一项为期52周的多中心、随机、安慰剂对照、双盲试验(RUBATO-DB)和一项开放标签扩展试验(RUBATO-OL)中,评估了内皮素受体拮抗剂马西替坦(macitentan)在丰坦患者中的疗效和安全性:患者年龄≥12岁,纽约心脏协会功能分级II/III级,接受全腔肺连接术>1年,无丰坦失败/临床恶化迹象。在RUBATO-DB研究中,主要疗效终点是峰值氧耗量(VO2)从基线到第16周的变化;次要终点是峰值氧耗量从基线到第16周的52周变化,以及通过加速度计(PA-Ac)进行的每日体力活动平均次数/分钟从基线到第16周的变化。两项研究均对安全性进行了评估:在RUBATO-DB中,137名患者随机接受了马西替坦10毫克(68人)或安慰剂(69人)治疗;92.7%的患者完成了为期52周的双盲治疗。第 16 周时,马西替坦与安慰剂相比,峰值 VO2 的平均(标度)变化为 -0.16 (2.86) mL/kg/min 与 -0.67 (2.66) mL/kg/min(无偏差治疗差异估计中值:0.62 mL/kg/min [99% 重复置信区间 -0.62; 1.85],P=0.19)。次要终点均未观察到治疗效果。在RUBATO-DB期间,马西替坦最常见的不良反应是头痛、鼻咽炎和发热。在 RUBATO-DB 和 RUBATO-OL 中,最常见的不良反应是 COVID-19、头痛和疲劳。由于 RUBATO-DB 未达到主要或次要终点,RUBATO-OL 提前终止:结论:RUBATO-DB的主要终点没有达到;与安慰剂相比,马西替坦没有改善丰坦患者的运动能力。在长期治疗中,马西替坦的耐受性总体良好。
{"title":"Efficacy and safety of macitentan in Fontan-palliated patients: 52-week randomized, placebo-controlled RUBATO Phase 3 trial and open-label extension","authors":"Paul Clift MD ,&nbsp;Felix Berger MD ,&nbsp;Lars Sondergaard MD, MDSc ,&nbsp;Petra Antonova MD ,&nbsp;Patrick Disney MD ,&nbsp;Jeremy Nicolarsen MD ,&nbsp;Jean-Benoît Thambo MD ,&nbsp;Lidia Tomkiewicz Pajak MD ,&nbsp;Jou-kou Wang MD ,&nbsp;Annette Schophuus Jensen MD, PhD ,&nbsp;Michela Efficace MSc ,&nbsp;Michael Friberg PhD ,&nbsp;Diana Haberle PharmD, PhD ,&nbsp;Verena Walter Diplom-Mathematikerin (FH) ,&nbsp;Yves d’Udekem MD","doi":"10.1016/j.jtcvs.2024.08.039","DOIUrl":"10.1016/j.jtcvs.2024.08.039","url":null,"abstract":"<div><h3>Objectives</h3><div>The efficacy and safety of macitentan, an endothelin receptor antagonist, were assessed in a 52-week, prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent patients (RUBATO-DB) and an open-label extension trial (RUBATO-OL).</div></div><div><h3>Methods</h3><div>Patients aged 12 years and older with New York Heart Association functional class II or III underwent total cavopulmonary connection more than 1 year before screening and showed no signs of Fontan failure/clinical deterioration. In RUBATO-DB, the primary efficacy end point was change in peak oxygen consumption from baseline to week 16; secondary end points were change from baseline over 52 weeks in peak oxygen consumption and change in mean count/minute of daily physical activity via accelerometer from baseline to week 16. Safety was assessed throughout both studies.</div></div><div><h3>Results</h3><div>In RUBATO-DB, 137 patients were randomized to macitentan 10 mg (n = 68) or placebo (n = 69); 92.7% completed 52-week double-blind treatment. At week 16, mean ± SD change in peak oxygen consumption was −0.16 ± 2.86 versus −0.67 ± 2.66 mL/kg/minute with macitentan versus placebo (median unbiased treatment difference estimate, 0.62 mL/kg/minute [99% repeated CI, −0.62 to 1.85]; <em>P</em> = .19). No treatment effect was observed in either of the secondary end points. During RUBATO-DB, most common adverse events with macitentan were headache, nasopharyngitis, and pyrexia. Across RUBATO-DB and RUBATO-OL, most common adverse events were COVID-19, headache, and fatigue. RUBATO-OL was prematurely discontinued because RUBATO-DB did not meet its primary or secondary end point.</div></div><div><h3>Conclusions</h3><div>The primary end point of RUBATO-DB was not met; macitentan did not improve exercise capacity versus placebo in patients with Fontan palliation. Macitentan was generally well tolerated over long-term treatment.</div></div>","PeriodicalId":49975,"journal":{"name":"Journal of Thoracic and Cardiovascular Surgery","volume":"169 2","pages":"Pages 385-394.e5"},"PeriodicalIF":4.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The risk and reward of surgical aortic valve replacement 主动脉瓣置换手术的风险与回报。
IF 4.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1016/j.jtcvs.2024.01.028
Joseph E. Bavaria MD
{"title":"The risk and reward of surgical aortic valve replacement","authors":"Joseph E. Bavaria MD","doi":"10.1016/j.jtcvs.2024.01.028","DOIUrl":"10.1016/j.jtcvs.2024.01.028","url":null,"abstract":"","PeriodicalId":49975,"journal":{"name":"Journal of Thoracic and Cardiovascular Surgery","volume":"169 2","pages":"Pages 595-598"},"PeriodicalIF":4.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139566320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of Thoracic and Cardiovascular Surgery
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