key: cord-0709008-p6fdwezj
authors: Ho, Jacky Y. K.; Bashir, Mohamad; Teh, Gloria; Jakob, Heinz; Wong, Randolph H. L.
title: Launching the E‐vita Open Neo amid COVID—Challenges and strategies
date: 2021-02-08
journal: J Card Surg
DOI: 10.1111/jocs.15197
sha: 6383edb01b21556700d896a4f540a55f743d88cb
doc_id: 709008
cord_uid: p6fdwezj

nan

Aortic arch disease commonly involves multiple segments, leading to the needs of multistaged procedures and the intraoperative selective perfusion of arch branches. The total aortic arch replacement with frozen elephant trunk (TAR FET) technique was developed over the past decades. It has become one of the mainstream options with acceptable risk profiles. [1] [2] [3] [4] It could offer a single-stage treatment in selected arch aneurysm cases and, more importantly, it facilitates second-stage treatments of descending pathologies with endovascular repair 1, 2, 5 and open replacement. 1, 2, 6 In October 2020, the E-vita Neo Open was introduced in Hong Kong as a third commercially available hybrid arch prosthesis. Introducing a new medical device requires multi-levels of co-ordination to ensure patient's safety and outcome, especially under the challenges of COVID-19 with travel restrictions and social distancing, we would like to report the feasibility and importance of virtual proctorship. The patient involved had an informed consent form signed according to the institutional requirement.

In Asia, before the commercially available hybrid TAR FET device, the "frozen elephant trunk" involved off-label implantation of a conventional thoracic aortic stent graft into the descending thoracic aorta followed by anastomosis with another piece of vascular graft for the arch vessels reimplantation and ascending aortic replacement. This approach was the most widely practiced TAR FET in Asia. 7, 8 The problems with this "improvised" approach are long and bulky aortic Open stent graft (Japan Lifeline) 10 and Frozenix (Japan Lifeline) 11 in Japan. All prostheses have shown acceptable outcomes as proven in a recent meta-analysis. 12, 13 In Hong Kong, the number of TAR FET was relatively limited compared to the usage in Europe. In the past Our institute adopted an arch branched graft version of E-vita Open Neo. The approach of our TAR FET technique was previously reported, principally with the distal-proximal-supra-aortic sequence of anastomosis under moderate hypothermic circulatory arrest and selective antegrade cerebral perfusion to all supra-aortic vessels. 17 The distance between the sewing collar and the third (left subclavian artery) side branch of the E-vita Open Neo was 20 mm when compared with that of 5 mm in Thoraflex™ hybrid stent graft, which provides longer anastomosis space to left subclavian artery and lowers the risk of graft kinking.

Higher spinal cord injury when compared with floating elephant trunk has been a concern surrounding the adoption of FET. The growing evidence in balancing between sealing of distal re-entry and spinal cord injury has led to the reduction in length of stent graft.

Studies in type I/III aortic dissection patients with the use of intraoperative angioscope were able to identify the position of distal reentry sites found within 5 cm in 73% of patients distally to the origin of the left subclavian artery and 31% in the 6-10 cm. 15 The design of the 120 mm E-vita stent-graft would be able to seal off most of the re-entry even with a zone 2 anastomosis. Furthermore, the stentgraft portion of the E-vita Open Neo has adopted the traditional endovascular stent design without a distal ring. Follow-up data would allow a reflection of distal stent induced new entry, which has significant implications for second stage operations. 1 

Surgical innovation and advancement over the decades have brought outstanding outcomes in aortic arch surgery. The newly available E-vita Open Neo hybrid system offers additional FET options, the use of virtual proctoring allowed its introduction to our patients amid challenging time during COVID-19. Virtual proctoring maintained international collaboration and skills sharing, which could become the "New Normal" in face of global pandemics.

Total aortic arch replacement with frozen elephant trunk technique: results from two European institutes

Multicentre experience with two frozen elephant trunk prostheses in the treatment of acute aortic dissection

Extensive aortic replacement using 'elephant trunk' prosthesis

Current status and recommendations for use of the frozen elephant trunk technique: a position paper by the vascular domain of EACTS

Endovascular fenestration for distal aortic sealing after frozen elephant trunk with Thoraflex

Open descending aortic replacement after Thoraflex™ hybrid graft implantation

Cerebral dysfunction after endovascular stent-grafting via a median sternotomy: the frozen elephant trunk procedure

Long-term results of the frozen elephant trunk technique for extended aortic arch disease

Should the "elephant trunk" be skeletonized? Total arch replacement combined with stented elephant trunk implantation for Stanford type A aortic dissection

The results of total arch graft implantation with open stent-graft placement for type A aortic dissection

Frozen elephant trunk with Frozenix prosthesis

Which is the optimal frozen elephant trunk? A systematic review and meta-analysis of outcomes in 2161 patients undergoing thoracic aortic aneurysm surgery using E-vita Open Plus Hybrid Stent Graft versus Thoraflex™ hybrid prosthesis

A systematic review and meta-analysis on the safety and efficacy of the frozen elephant trunk technique in aortic arch surgery

Frozen versus conventional elephant trunk technique: application in clinical practice

Which frozen elephant trunk offers the optimal solution? Reflections from Essen Group

Frozen elephant trunk with straight vascular prosthesis

Multimodality imaging assessment for Thoraflex hybrid total arch replacement