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\begin{document}

\title{Paving the way for E-vita open NEO hybrid prosthesis implantation for
complex aortic arch disease in Asia-Pacific}



\author[1]{Heinz Jakob}%
\author[2]{Jacky YK Ho}%
\author[2]{Hung Leung Randolph Wong}%
\author[3]{Mohammed Idhrees}%
\author[3]{Bashi Velayudhan}%
\author[4]{George Matalanis}%
\author[5]{Daniel- Sebastian  Dohle}%
\author[6]{Klaus Görlinger}%
\author[7]{Mohamad Bashir}%
\affil[1]{Diagnosticum Mülheim}%
\affil[2]{Prince of Wales Hospital}%
\affil[3]{SRM Institutes for Medical Science Vadapalani}%
\affil[4]{Austin Hospital}%
\affil[5]{Johannes Gutenberg Universitat Mainz}%
\affil[6]{Tem Innovations GmbH}%
\affil[7]{Royal Blackburn Teaching Hospital}%


\vspace{-1em}



  
  \date{May 08, 2024}


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\selectlanguage{english}
\begin{abstract}
We report first in man implantations of the newly designed
Evita-open-NEO hybrid prosthesis (HP) for complex aortic arch disease
from 3 different countries in Asia-Pacific including suggestions on how
to proceed with optimized perioperative coagulation.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Frozen elephant trunk (FET) has evolved over the years in technology and
techniques. The new generation E-vita-Open-NEO (JOTEC CryoLife), is now
available in 3 variations. We report first in man implantations from 3
different countries in Asia-Pacific with a note on perioperative
coagulation management

The article does not represent a clinical trial or an international
multicentre study. It is a direct case reporting reporting of experience
and outcomes, henceforth, IRB approval~ was note required. Further
informed conset from each of the three patients has has been
individually obtained. Moreover, institutional approval for use of
Evita-open-NEO (CE market approval, March 2020) has been approved
locally by governance boards at every reporting centres.

\textbf{Case Reports (Table 1)}

\textbf{Hong Kong:} A 60 year, female diagnosed with a Type III Aortic
dissection (AD) and arch aneurysm who underwent total arch replacement
(TAR) with FET using a branched Evita-open-NEO. Patient details are
provided in table 1. There was no significant oozing encountered after
protamine administration. Transfusion was according to
thromboelastometry guided coagulation management (TGCM) with no further
postoperative transfusion was required. She was neurologically intact
and discharged on day 12.

\textbf{Chennai:} A 54-year male was diagnosed to have ascending and
aortic arch aneurysm~(5.2cm at zone 1) with Type B AD. Patient details
are provided in table 1. After protamine administration there was
continuous oozing from the polyester segment of the prosthesis. Oozing
was controlled by covering the prosthesis with~Surgicel-Fibrillar
(Johnson \& Johnson)~and pressurized packing with gauze for few minutes.
Blood transfusion and postoperative drain as in table 1. He was
discharged on the 10\textsuperscript{th} postoperative day and follow-up
CT aortogram was done (Figure 1A/B).

\textbf{Melbourne:} An 81 year old male underwent TAR with FET technique
using trifurcate 30/40/180mm E-vita-Open-NEO HP. In addition he received
a Bioprosthetic Bentall's procedure and coronary artery bypass graft
(Left internal mammary artery and Left Radial).~Patient details are
provided in table 1.~Blood and products were transfused according to
TGCM. No excessive oozing from the fabric of the graft or any of its
links has been observed, and drain losses were minimal. Postoperative
details elaborated in Table 1. Palliation was instituted as per family
wishes (Figure 1C/D).

\textbf{DISCUSSION}

HP for FET is constantly evolving through the years ever since the first
device - `Essen I prosthesis' (2005)~(1). Given the success of
Evita-open-plus across the globe, researchers have developed the next
generation HP: Evita-open-NEO. The new generation prosthesis is
available in three variations, making it suitable to be implanted in
zone 0 to 3, and the supraaortic-arch-vessels can be reimplanted
individually or en-bloc. This provides a wide range of applicablity for
the surgeons emcomprising different pathological situations. The low
profile delivery system and a shapeable shaft, is atraumatic and helps
in precise deployment (2).

Evita-open-NEO prostheses are not impregnated with gelatin or collagen,
hence some discrete oozing through pores of the tightly woven polyester
during heparinization can be expected but easily controlled by sump
suction.

This oozing is self-limiting and stops once the protamine is
administered after weaning of cardiopulmonary bypass (CPB) supported by
packing the mediastinum with sponges and towels for 10-15 minutes. Blood
collected in mediastinum can be efficiently managed with cell saver. In
patients who undergo FET under prolonged deep hypothermic circulatory
arrest, coagulopathy has to be considered. In that case, graft oozing
through the pores may appear excessive but can be quickly fixed by TGCM
during and after CPB (Video 1).

Thromboelastometry provides important information about hemostasis,
particularly in regard to fibrin polymerization and platelet function,
and can already be initiated at crossclamp release. Accordingly,
cryoprecipitate can timely be prepared if fibrinogen concentrate is not
available. Adequate fibrin and platelet contribution to the clot
firmness are essential for the formation of an internal fibrin layer to
seal the prosthesis (3). In contrast, low fibrinogen levels
(\textless{}2-4 g/L) have been shown to be an independent risk-factor
for severe bleeding, 24-hour mortality, in-hospital mortality, and
neurological complications in patients with acute AD (3- 6).

The algorithm of TGCM for major aortic surgery is by using a trigger of
EXTEM A5 \textless{}40 mm and FIBTEM A5 \textless{}12 mm, and a target
of EXTEM A5 [?]40 mm and FIBTEM A5 [?]15 mm for fibrinogen substitution (3,
7). Notably, this can only be achieved by administering fibrinogen
concentrate (20 g /l) or cryoprecipitate (8-16 g/l) but not by FFP
containing only 2g fibrinogen/l) (8). Some patients require platelet
transfusion and/or prothrombin complex concentrate administration in
addition.

In contrast, Czerny and colleagues recently reported devastating oozing
and severe blood loss in 3 patients after implantation of E-vita open
NEO (9). Those patients, characterized by continuous acetylic acid
monotherapy preoperatively, obviously mandated differentiated
coagulation management during and after CPB. Here, FFP transfusion with
its low fibrinogen concentration is certainly not appropriate and may
cause pulmonary complications, right ventricular failure, and increased
RBC transfusion (10, 12).

\textbf{Conclusion}

In combination with TGCM, the new Evita-open-NEO HP can easily and
safely be implanted with minimal blood loss.

\textbf{Conflict of Interest:} Heinz Jakob is consultant to
JOTEC/CryoLife, former inventor and recipient of royalties until 2019;
Klaus G\selectlanguage{ngerman}örlinger is the medical director of Tem Innovations GmbH, Munich,
Germany

\textbf{Reference}

\begin{enumerate}
\tightlist
\item
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\item
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\item
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\end{enumerate}

\textbf{Legend}

\textbf{Figure 1:} (A)Preoperative CT aortogram showing the ascending \&
aortic arch aneurysm. (B)Postoperative~image depicting a well expanded
true lumen and thrombosed false lumen without distal stent induced new
entry (DSINE).~ (C)Preoperative CT scan demonstrating a 9 cm distal arch
aneurysm and a heavily calcified aortic valve. (D)Postoperative CT scan
demonstrating the Bentall root replacement and full exclusion of distal
arch aneurysm without DSINE.

\textbf{Figure 2:} Algorithm TGCM in major aortic surgery {[}modified
from (7){]}

\textbf{Video 1:} Demonstrating the effect of TCGM (A)Without TGCM:
prolonged oozing (B)With TGCM: hemostasis achieved within 30 minutes of
protamine administration.\selectlanguage{english}
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