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\begin{document}

\title{Minimally-invasive surgical explantation of a partially detached
Cardioband device}



\author[1]{Serdar Akansel}%
\author[2]{Simon Suendermann}%
\author[1]{Markus Kofler}%
\author[1]{Anna Emmerich}%
\author[1]{Volkmar Falk}%
\author[1]{Jörg Kempfert}%
\affil[1]{Deutsches Herzzentrum Berlin}%
\affil[2]{Charité Universitätsmedizin Berlin}%


\vspace{-1em}



  
  \date{May 23, 2024}


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\selectlanguage{english}
\begin{abstract}
Transcatheter repair systems are becoming increasingly popular as a
potential solution for high-risk and inoperable patients with mitral
regurgitation. The Cardioband (Edwards Lifesciences, Irvine, California)
is a transcatheter direct annuloplasty device, based on the concept of
an undersized ring annuloplasty. We report a case of minimally invasive
surgical explantation of a failed Cardioband device 21 months after its
implantation. Intraoperatively, it was found that3 anchors of the
Cardioband device were detached from the posterior annulus at P2. In
this report, a ``cut and unscrew'' technique with some tips and tricks
is presented for the removal of the device.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Functional mitral regurgitation (FMR) is characterized by mitral annular
dilatation, inadequate leaflet coaptation and tethering of the mitral
valve leaflets resulting from left ventricular dysfunction and
remodeling {[}1{]}.

The increased risk of surgical annuloplasty in the setting of FMR, and
the unclear benefits of this procedure {[}2{]} has encouraged the search
for alternative, innovative catheter-based and minimally invasive
solutions such as indirect annuloplasty, direct annuloplasty and
transcatheter mitral valve repair (TMVR).

The Cardioband (Edwards Lifesciences, Irvine, California) is a
transcatheter direct annuloplasty device, which is based on the surgical
concept of an undersized ring annuloplasty. Since its clinical use
started in 2014, several procedural complications have been reported,
such as complete atrioventricular block and device dehiscence during or
immediately after the intervention {[}3,4{]}. In this report, a ``cut
and unscrew'' technique is presented for surgical explantation of a
dehiscent Cardioband device 21 months after the implantation.

\textbf{Case Presentation}

A 75-year-old female, with systemic hypertension, atrial fibrillation,
renal failure and ischemic cardiomyopathy, presented with progressive
dyspnoea (New York Heart Association functional class III) 21 months
after a TMVR with the Cardioband for FMR at another institution.

During the cinching phase of the device implantation, a detachment of an
anchor had been visualised at the P2 level. Periprocedural
transesophageal echocardiography (TEE) revealed a residual mild MR at
the end of the procedure. The patient had remained symptom-free with
mild to moderate MR documented at outpatient follow-up visits until the
21st month post-implantation.

On admission, TEE showed left ventricular systolic dysfunction (ejection
fraction 45\%), dehiscence of the Cardioband at P2 and severe MR with
two jets originating from the anterior and posterior aspect of dehiscent
part of the device (Figures 1A and 1B). After multidisciplinary heart
team discussion, the patient was scheduled for a minimally invasive
mitral valve replacement, with a STS-PROM score of 6.08\%.

A minimally invasive approach through a right anterolateral
minithoracotomy was performed and the mitral valve was visualized using
a three-dimensional (3D) endoscope. An endocardial ablation procedure
was performed using AtriCure Cryo Module (AtriCure, Inc., West Chester,
OH),. Intraoperatively, it was found that 3 anchors of the Cardioband
were detached from the posterior annulus at P2 and the remaining part
was highly endothelized (Figure 2A). The highly-endothelized part of the
Cardioband was dissected from the surrounding annular tissue via scalpel
and electrocautery (Figure 2B). Care was taken to avoid injuries of the
adjacent structures such as the coronary sinus and the circumflex
coronary artery; every effort was made to maintain the annular structure
to avoid atrioventricular groove disruption. The time consuming part of
the procedure was the removal of the Cardioband by applying a ``cut and
unscrew'' technique. To facilitate the removal, the Cardioband was cut
between the anchors and the anchors were then unscrewed by
counter-clockwise rotation (Figures 2C and 2D). These manoeuvres were
performed repeatedly until the last anchor was removed. Since the
likelihood of successful miral repair was considered low, due to the
valvular morphology, a St. Jude Medical Epic bioprosthetic mitral heart
valve (St Jude Medical, Inc, St Paul, Minn) was implanted and fixed
using Cor Knots (LSI SOLUTIONS, Victor, New York, USA).

The pre-discharge transthoracic echocardiography revealed a normal
function of the mitral valve with a low gradient and absence of
paravalvular leakage. The patient was discharged after an uneventful
post-operative course.

\textbf{Discussion}

TMVR systems are becoming increasingly popular as they represent a
potential solution for high-risk and inoperable patients with MR.
Percutaneous mitral leaflet repair with the Mitraclip (Abbot Vascular,
Santa Rosa, CA) has revolutionized TMVR, but it is far from providing a
stand-alone solution to FMR with mitral annular dilatation as the
leading pathology. It has been advocated that the absence of a
concomitant annuloplasty long term may result in an inadequate reduction
or recurrence of regurgitation in patients with FMR. The Cardioband is a
transcatheter direct annuloplasty device implanted transvenously,
transseptally in patients with FMR in case surgical and medical
treatment options are limited.

Since the first-in-man implantation of the Cardioband, a few studies
have reported safety, efficacy and the short-term results of the
technique {[}5, 6{]}. In a multicenter study, Zeitoun et al. reported 1
year outcomes of the system with a technical success rate of 97\%.
Partial device dehiscence due to anchor disengagement was reported in
16.6\% of patients immediately after implantation {[}5{]}. Eschenbach et
al. has also reported an anecdoatal explantation of the Cardioband three
days after the intervention {[}4{]}.

In the presented patient, although a detachment of one of the anchors
was found already during the procedure, two more dehiscent anchors were
confirmed during the operation. This may have resulted from
``unscrewing'' of the anchors over time under high tension during
cardiac contractions, especially at the P2 segment where annular
displacement has the highest amplitude. This challenging problem may be
overcome with procedural modifications such as increasing the number of
implanted anchors at this segment.

The Cardioband is a promising device for TMVR in patients at high
surgical risk. However, the lack of long-term results and the limited
short-term reports with several complications might discourage surgeons
and interventionalists from wide adoption. Mitral surgery after
Cardioband implantation is technically demanding as anchor removal from
the mitral annulus is not easily accomplished. A longer interval between
the implantation and explantation of the device makes surgical
explantation more challenging due to the risk of a potential
complication during removal of the highly-endothelized device. In these
cases, care must also be taken to prevent damage to adjacent structures.
We believe that the suggested ``cut and unscrew'' technique may reduce
the risk of procedure related complications..

\textbf{Conclusion}

In summary we report a ``cut and unscrew'' technique for the removal of
a failed Cardioband device 21 months after implantation. This report
demonstrates that the cut and unscrew technique may be performed safely
during removal, even for highly-endothelized device, while preserving
the mitral annular integrity.

\textbf{References}

\begin{enumerate}
\tightlist
\item
  Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart
  failure: pathophysiology, prognosis, and therapeutic considerations. J
  Am Coll Cardiol 2015;65:1231--1248.
\item
  Goldstein D, Moskowitz AJ, Gelijns AC, et al. Two-year outcomes of
  surgical treatment of severe ischemic mitral regurgitation. N Engl J
  M. 2016 Jan 28;374(4):344-53.
\item
  Sorini Dini C, Landi D, Meucci F, Di Mario C. Unexpected delayed
  complete atrioventricular block after Cardioband implantation. Cathet
  Cardiovasc Diagn. 2018;00:1--4.
\item
  Eschenbach LK, Prinzing A, Herold U, Erlebach M, Bleiziffer S.
  Surgical Explantation of a Dehiscent Cardioband. JACC Cardiovasc
  Interv. 2019;13;12:e79.
\item
  Messika-Zeitoun D, Nickenig G, Latib A, et al. Transcatheter mitral
  valve repair for functional mitral regurgitation using the Cardioband
  system: 1 year outcomes. Eur Heart J. 2019 Feb 1;40(5):466-72.
\item
  Carrel T, Eberle B, Pasic M. Cardioband to treat functional mitral
  regurgitation: a word of caution. Eur Heart J. 2019 Feb 1;40(5):490.
\end{enumerate}

\textbf{Figure 1:} 3D transesophageal echocradiographic image shows a
partially detached device at P2 (A). Severe mitral regurgitation with
two jets originating from the anterior and posterior aspect of dehiscent
device (B).

\textbf{Figure 2:} Intraoperative findings: A detachment of the 3
anchors of the Cardioband at P2 (A). The highly-endothelized part of the
device was dissected from the surrounding annular tissue via scalpel
(B). The Cardioband was cut between the anchors and the anchors were
unscrewed by counter-clockwise rotation (C, D).\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-1/Figure-1}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-2/Figure-2}

\end{center}
\end{figure}

\selectlanguage{english}
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