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Total aortic arch replacement using the Thoraflex Hybrid device: evolution from investigational to federally approved use in the United States. 使用Thoraflex Hybrid装置的全主动脉弓置换:在美国从研究到联邦批准使用的演变。
IF 3.1 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-07-31 Epub Date: 2025-07-29 DOI: 10.21037/acs-2025-evet-0070
Vicente Orozco-Sevilla, Joseph S Coselli, Susan Y Green, Veronica A Glover, Ricardo de Jesus Avendaño Garnica, Anna H Xue, Lauren K Barron, Marc R Moon

Background: After the US Food and Drug Administration (FDA) approved the Thoraflex Hybrid device in April 2022, hybrid devices to facilitate total arch replacement (TAR) became commercially available in the United States. However, little is known about how the Thoraflex device has been used since then. We present our experience (2016-2025) with this device.

Methods: At our practice, 62 patients [median age, 65 (54-73) years] underwent frozen elephant trunk (FET) TAR with the Thoraflex device: 14 under an investigational device exemption (IDE) (2016-2018) and 48 after FDA approval (2022-2025). Both Ante-Flo (straight) and Plexus (branched) models were used.

Results: Patients with aortic dissection were common (n=38; 61%). Many patients had prior open or endovascular aortic repair (n=28; 45%). Initial cannulation was commonly done via the innominate artery (n=30; 48%) or the right axillary artery (n=22; 36%). Both branched and island strategies were used to reattach the brachiocephalic arteries. Selectively, left subclavian artery (LSCA) bypass was performed before TAR in 18 patients (29%). The distal anastomosis was performed proximal to the LSCA in 27 repairs (43%). A short (10-cm) endograft extension was used in most cases (n=49; 79%). Eight (13%) patients underwent concomitant aortic root replacement. Overall, four patients (7%) had operative deaths, and three (5%) were discharged with stroke or persistent need for renal dialysis. Two patients had spinal cord deficits that resolved before discharge. Twenty-five downstream extensions (12 open, 13 endovascular) were needed in 22 patients; two patients underwent more than one repair. After discharge, seven additional patients died within one year of surgery.

Conclusions: TAR is a complex procedure. Patients requiring such repair tend to have substantial disease that often eventually necessitates subsequent downstream aortic repair, especially when dissection is present. Using the Thoraflex Hybrid device in TAR results in good early outcomes and provides a reliable base for extension.

背景:在美国食品和药物管理局(FDA)于2022年4月批准Thoraflex Hybrid设备后,用于全弓置换术(TAR)的混合设备在美国开始商业化。然而,从那时起,人们对Thoraflex设备的使用情况知之甚少。我们将介绍我们使用该设备的经验(2016-2025)。方法:在我们的实践中,62例患者[中位年龄65(54-73)岁]使用Thoraflex装置进行了冷冻象鼻(FET) TAR: 14例处于研究器械豁免(IDE)阶段(2016-2018),48例获得FDA批准(2022-2025)。采用Ante-Flo(直)和Plexus(分支)两种模型。结果:主动脉夹层患者常见(n=38;61%)。许多患者先前进行过主动脉切开或血管内修复(n=28;45%)。初始插管通常通过无名动脉(n=30;48%)或右腋窝动脉(n=22;36%)。分支策略和岛状策略均用于重新连接头臂动脉。18例(29%)患者在TAR术前选择性行左锁骨下动脉(LSCA)旁路手术。27例(43%)在LSCA近端进行远端吻合。大多数病例采用短(10厘米)内移植物延伸(n=49;79%)。8例(13%)患者同时行主动脉根置换术。总体而言,4名患者(7%)手术死亡,3名患者(5%)因中风或持续需要肾透析而出院。2例患者在出院前出现脊髓缺损。22例患者需要25例下游延伸手术(12例开放,13例血管内);两名患者接受了不止一次的修复。出院后,又有7名患者在手术一年内死亡。结论:TAR是一个复杂的手术。需要这种修复的患者往往有严重的疾病,最终往往需要后续的下游主动脉修复,特别是当存在夹层时。在TAR中使用Thoraflex Hybrid装置可获得良好的早期效果,并为后续手术提供可靠的基础。
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引用次数: 0
The reverse frozen elephant trunk: the Thoracoflo® hybrid-graft. 反向冷冻象鼻:Thoracoflo®杂交移植物。
IF 3.1 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-07-31 Epub Date: 2025-07-18 DOI: 10.21037/acs-2025-evet-0029
Sabine Helena Wipper, Julia Dumfarth, Florian Enzmann, Tilo Kölbel, Sebastian Debus
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引用次数: 0
The development of the Siena graft. 锡耶纳移植物的发展。
IF 3.1 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-07-31 Epub Date: 2025-07-14 DOI: 10.21037/acs-2025-evet-0039
Eugenio Neri

The evolution of surgical replacement of the aortic arch has been shaped by advances in surgical techniques and ancillary technologies. From the early pioneering attempts in the 1950s by Ho Ju Lin, Cooley, and DeBakey, which preceded the advent of cardiopulmonary bypass (CPB), the development of perfusion, cerebral protection, and surgical techniques, along with the evolution of prosthetic grafts, has progressively enabled surgeons to address these challenging conditions with greater confidence. Despite these remarkable advancements, aortic arch surgery still remains one of the most technically challenging procedures in cardiac surgery. A major turning point was the introduction of the elephant trunk technique by Borst in 1983. This approach allowed for staged treatment of diffuse aneurysmal disease, including both degenerative and post-dissection cases, and reduced the overall surgical risk across multiple procedures. Initially met with skepticism, the technique has since been universally adopted by centers specializing in aortic pathology. At the same time, numerous modifications to the technique have emerged. Each modification has addressed specific technical challenges or enabled the integration of new technologies. The development of the Siena graft in the early 2000s was driven by the need to harness the growing potential of endovascular devices, which had been evolving since the 1990s, and to address critical technical issues. These included the use of multi-branched prostheses and the introduction of an anastomotic collar to facilitate secure distal anastomoses, even in less-than-ideal anatomical conditions. The design of the Siena graft, now widely adopted by most manufacturers for arch grafts, required close collaboration with industry partners to ensure a reliable product from its inception. Today, the Siena graft remains a highly relevant platform for the treatment of diffuse aneurysmal disease that requires the elephant trunk technique. This paper describes the evolution and design of the graft, the technical approach, including pitfalls and safeguards, and our clinical experience.

主动脉弓手术置换术的发展是由外科技术和辅助技术的进步所决定的。从20世纪50年代Ho Ju Lin, Cooley和DeBakey的早期开创性尝试开始,在体外循环(CPB)出现之前,灌注,脑保护和外科技术的发展,以及假体移植的发展,逐渐使外科医生能够更有信心地解决这些具有挑战性的问题。尽管取得了这些显著的进步,主动脉弓手术仍然是心脏手术中技术上最具挑战性的手术之一。一个重要的转折点是1983年博斯特引入的象鼻技术。这种方法允许分期治疗弥漫性动脉瘤疾病,包括退行性和夹层后病例,并降低了多个手术的总体手术风险。这项技术最初受到怀疑,后来被专门从事主动脉病理学的中心普遍采用。与此同时,对该技术的许多修改已经出现。每次修改都解决了特定的技术挑战,或者实现了新技术的集成。自20世纪90年代以来,血管内装置一直在不断发展,为了利用其不断增长的潜力,并解决关键的技术问题,Siena移植物在21世纪初得到了发展。这些包括使用多分支假体和引入吻合环以促进安全的远端吻合,即使在不太理想的解剖条件下。Siena接枝的设计现在被大多数制造商广泛采用,需要与行业合作伙伴密切合作,以确保从一开始就提供可靠的产品。今天,锡耶纳移植仍然是一个高度相关的平台,弥漫性动脉瘤疾病的治疗需要象鼻技术。本文介绍了移植物的发展和设计,技术方法,包括陷阱和保障措施,以及我们的临床经验。
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引用次数: 0
Establishing a robotic aortic valve replacement program in Spain: growing opportunities for Europe. 在西班牙建立机器人主动脉瓣置换术项目:为欧洲带来越来越多的机会。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-29 DOI: 10.21037/acs-2025-ravr-0003
Elena Sandoval, Daniel Pereda

Background: The natural history of aortic valve disease commonly eventuates in percutaneous or open surgical treatment. Percutaneous treatment has been expanding its indication from high-risk patients to low- and moderate-risk patients; however, there are certain groups of patients who are not good candidates for percutaneous treatment, such as those with bicuspid valve disease or pure aortic regurgitation patients. Robotic surgery, as an evolution from traditional approaches, has been gradually expanding its indications in cardiac surgery. The use of a lateral approach, common to robotic mitral procedures, may become a valid alternative for several patients undergoing aortic valve procedures. The aim of the present study was to evaluate and discuss the characteristics, challenges and early results of a newly created robotic aortic valve replacement program.

Methods: This was a retrospective study analysing prospectively collected data of all patients who have undergone robotic aortic valve replacement (RAVR) in Hospital Clínic Barcelona from December 2021 to October 2024.

Results: Since December 2021, 25 consecutive patients have undergone RAVR. Sixty-eight percent of the cohort were males and the median age was 66 years [interquartile range (IQR), 58.5-71.8 years]. Severe aortic stenosis was the predominant lesion in 76% of patients, and degenerative calcification was the aetiology in 52% of patients. Median cardiopulmonary bypass time was 129 minutes (IQR, 113-145.5 minutes) and median ischemic time was 91 minutes (IQR, 78-105 minutes). Three patients required a re-exploration for bleeding, which was performed through the same approach, and one patient suffered an ischemic cerebro-vascular accident (CVA) with complete recovery. Median intensive care unit (ICU) length of stay and hospital length of stay were 1 and 4 days, respectively.

Conclusions: Our initial experience shows that expanding a robotic program to include RAVR is feasible, safe, and can provide excellent clinical outcomes in selected patients.

背景:主动脉瓣疾病的自然病史通常发生在经皮或开放手术治疗中。经皮治疗的适应症从高危患者扩大到中低危患者;然而,也有一些特定的患者不适合经皮治疗,如患有二尖瓣疾病或单纯的主动脉反流患者。机器人手术作为传统手术方式的一种进化,在心脏外科手术中的适应症逐渐扩大。使用机器人二尖瓣手术常见的外侧入路,可能成为一些接受主动脉瓣手术的患者的有效选择。本研究的目的是评估和讨论新创建的机器人主动脉瓣置换术的特点、挑战和早期结果。方法:这是一项回顾性研究,分析了2021年12月至2024年10月在Clínic巴塞罗那医院接受机器人主动脉瓣置换术(RAVR)的所有患者的前瞻性数据。结果:自2021年12月以来,连续25例患者接受了RAVR。68%的队列为男性,中位年龄为66岁[四分位数间距(IQR), 58.5-71.8岁]。76%的患者以严重主动脉狭窄为主要病变,52%的患者以退行性钙化为病因。中位体外循环时间为129分钟(IQR, 113 ~ 145.5分钟),中位缺血时间为91分钟(IQR, 78 ~ 105分钟)。3例患者因出血需要再次探查,经相同入路,1例患者发生缺血性脑血管意外(CVA)后完全恢复。重症监护病房(ICU)住院时间和住院时间的中位数分别为1天和4天。结论:我们的初步经验表明,将机器人程序扩展到RAVR是可行的,安全的,并且可以在选定的患者中提供良好的临床结果。
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引用次数: 0
Robotic aortic valve replacement and aortic root enlargement for optimal prosthesis selection. 机器人主动脉瓣置换术和主动脉根部扩大的最佳假体选择。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-29 DOI: 10.21037/acs-2024-ravr-0183
Ali Darehzereshki, Lawrence Wei, J Hunter Mehaffey, Goya Raikar, Vinay Badhwar
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引用次数: 0
Robotic endoscopic aortic valve replacement with rapid deployment valve: technique and outcomes. 机器人内窥镜主动脉瓣置换术与快速部署瓣膜:技术和结果。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-20 DOI: 10.21037/acs-2025-ravr-10
Hiroto Kitahara, Sarah Nisivaco, Yazan Al Jamal, Husam H Balkhy
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引用次数: 0
Single incision right transaxillary robotic valve and coronary artery bypass grafting: a future therapy. 单切口右腋窝机器人瓣膜和冠状动脉旁路移植术:一种未来的治疗方法。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-28 DOI: 10.21037/acs-2025-ravr-0050
Ghulam Murtaza, Vinay Badhwar
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引用次数: 0
Lateral access fully robotic aortic valve replacement "RAVR": from novel to normal. 侧入路全机器人主动脉瓣置换术“RAVR”:从新奇到正常。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-29 DOI: 10.21037/acs-2025-ravr-0049
Ghulam Murtaza, Lawrence Wei

Right lateral access robotic aortic valve replacement (RAVR) may represent a significant advancement in minimally invasive cardiac surgery. This review examines RAVR's development, technical specifications, clinical outcomes, and future trajectory in cardiac surgery. Multicenter RAVR experiences have demonstrated promising results with low rates of operative mortality (0.9%), stroke (0.9%), and permanent pacemaker placement (2.9%). In propensity-matched comparisons with transcatheter aortic valve replacement (TAVR), RAVR had significantly lower rates of paravalvular leak (0.7% vs. 21.5%) and one-year mortality (1.4% vs. 12.5%). With a 3-cm working incision at the level of the anterior axillary line, the lateral access approach offers distinct advantages including improved surgical visualization, reduced tissue trauma, and standardization potential across various cardiac procedures. While learning curve considerations exist, these are minimal for experienced robotic mitral teams. RAVR programs have expanded to include implementation of complex procedures such as aortic root enlargement. As robotic systems become more prevalent and surgical expertise grows, RAVR shows promise to evolve from an innovative technique to a standard therapeutic option in aortic valve surgery. This evolution, supported by growing clinical evidence and technological advancement, positions RAVR as a potentially transformative development in cardiac surgery, offering patients the benefits of minimally invasive approaches while maintaining the durability of traditional surgical valve replacement.

右外侧通道机器人主动脉瓣置换术(RAVR)可能代表着微创心脏手术的重大进步。本文综述了RAVR的发展、技术规格、临床结果和心脏外科的未来发展轨迹。多中心的RAVR经验显示出有希望的结果,手术死亡率(0.9%)、卒中(0.9%)和永久性起搏器放置(2.9%)的发生率较低。在与经导管主动脉瓣置换术(TAVR)倾向匹配的比较中,RAVR的瓣旁漏率(0.7% vs. 21.5%)和一年内死亡率(1.4% vs. 12.5%)显著降低。侧入路在腋窝前线水平有一个3cm的工作切口,具有明显的优势,包括改善手术可视化,减少组织创伤,以及在各种心脏手术中标准化的潜力。虽然存在学习曲线方面的考虑,但对于经验丰富的机器人二尖瓣团队来说,这些都是最小的。RAVR项目已经扩展到包括主动脉根部扩大等复杂手术的实施。随着机器人系统的普及和手术技术的发展,RAVR有望从一项创新技术发展为主动脉瓣手术的标准治疗选择。在越来越多的临床证据和技术进步的支持下,这一演变将RAVR定位为心脏外科的潜在变革发展,为患者提供微创方法的好处,同时保持传统手术瓣膜置换术的耐久性。
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引用次数: 0
Advancing robotic aortic valve replacement beyond isolated therapy: a platform for multivalve therapy. 推进机器人主动脉瓣置换术超越孤立治疗:多瓣膜治疗平台。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-29 DOI: 10.21037/acs-2025-ravr-12
Lawrence M Wei, Vinay Badhwar

The application of robotic cardiac surgery has long been considered the pinnacle of surgical care for an isolated procedure. This has been for good reason, as the quality and reproducibility of isolated procedures like mitral valve (MV) repair and robotic-assisted, minimally invasive, direct coronary artery bypass have grown steadily across the globe with shrinking learning curves. Once a robotic team's learning curve has crested, however, additional opportunities may be explored that may include concomitant procedures. Following the core surgical principles of safety and procedural homogeneity with open operations, robotic cardiac surgery may be extended in a stepwise fashion to multi-valve operations, concomitant maze procedures, aortic root enlargement, septal myectomy, and even valve and coronary bypass operations, all via the same transaxillary working incision. We will review the development and operative techniques of concomitant procedures that may be utilized in conjunction with robotic aortic valve replacement (RAVR).

机器人心脏手术的应用一直被认为是孤立手术护理的顶峰。这是有充分理由的,因为二尖瓣(MV)修复和机器人辅助、微创、直接冠状动脉搭桥术等孤立手术的质量和可重复性在全球范围内稳步提高,学习曲线也在缩小。然而,一旦机器人团队的学习曲线达到顶峰,可能会探索包括伴随程序在内的其他机会。遵循与开放手术的安全性和程序同一性的核心手术原则,机器人心脏手术可以逐步扩展到多瓣膜手术,伴随的迷宫手术,主动脉根扩大,间隔肌切除术,甚至瓣膜和冠状动脉搭桥手术,所有这些手术都通过相同的腋窝工作切口。我们将回顾可能与机器人主动脉瓣置换术(RAVR)联合使用的伴随手术的发展和手术技术。
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引用次数: 0
Robotic aortic valve replacement with simultaneous ventricular septal myectomy: a minimally invasive solution. 机器人主动脉瓣置换术并发室间隔肌切除术:一种微创解决方案。
IF 3.3 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-05-31 Epub Date: 2025-05-29 DOI: 10.21037/acs-2024-ravr-0186
Taylor Pickering, Cody Dorton, Ali Darehzereshki, Robert L Smith, Lawrence Wei
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引用次数: 0
期刊
Annals of cardiothoracic surgery
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