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\begin{document}

\title{Minimal access left ventricular reconstruction}



\author[1]{Thasee Pillay}%
\author[2]{Paulo Neves}%
\author[3]{federico benetti}%
\author[1]{Kevin van Bladel}%
\author[1]{Andrew Wechsler}%
\author[1]{Lon Annest}%
\affil[1]{BioVentrix Inc}%
\affil[2]{Centro Hospitalar de Vila Nova de Gaia Espinho EPE}%
\affil[3]{Affiliation not available}%


\vspace{-1em}



  
  \date{May 04, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
The Revivent TC TransCatheter Ventricular Enhancement System
(BioVentrix Inc, San Ramon, CA, USA) is intended for use in heart
failure with cardiac dysfunction a previous myocardial infarction. The
resultant increased left ventricular systolic volume and discrete,
contiguous, non-contractile (akinetic and/or dyskinetic) scar located in
the antero-septal, apical (may extend laterally) region of the left
ventricle (LV) lends itself to Revivent. The procedure, called Less
Invasive Ventricular Enhancement (LIVE), consists of the implantation of
a series of micro-anchors pairs in order to exclude the scarred
myocardium, in order to reduce and reshape the LV. We present the
procedure step-by-step, as team coordination between the cardiac surgeon
and the interventional cardiologist is essential to ensure good
procedural outcomes. This is a novel and new technique to address Heart
Failure secondary to Myocardial Infarction.%
\end{abstract}%



\sloppy


\textbf{Introduction}

At present, over 15 million people are living with heart failure in
Europe. Heart failure is responsible in most westernized economies for
1-2\% of all healthcare expenditures and is the leading cause of
hospitalization in people over the age of 65. The prognosis for HF
patients has remained alarmingly poor over the last twenty years.
Despite some notable improvements in survival rates, approximately 1 in
3 patients admitted to a hospital with HF still die within one year.
This places a huge financial burden on the health care system and
signals the typical downward spiral of the course of this disease. Due
to this fact, there has been a significant paradigm shift in the focus
of cardiac treatment worldwide in last two decades.

It has been common knowledge since the pivotal report by White et al.
that left ventricular (LV) chamber size is the single most important
metric in determining survival post myocardial infarction (MI). Ischemic
cardiomyopathy is a disease process wherein the patient develops HF due
to scar formation and subsequent LV enlargement. Ischemic cardiomyopathy
is the largest cause of HF, comprising approximately two-thirds of all
the 22 million HF patients worldwide. Analysis of the 10-year survival
of these patients based on LV size demonstrates the rapid divergence in
death rate in the initial several years. Hence, developing a safe and
effective approach for volume reduction in this most vulnerable patient
segment is the significant challenge in modern cardiac care.

Ischemic cardiomyopathy is frequently associated with LV scarring where
viable heart tissue has been damaged and is replaced by fibrotic scar,
which results in left ventricular dysfunction. The loss in left
ventricular function most often results in angina, significant dyspnoea,
ventricular arrhythmias, and an increased risk of thromboembolism and
death.

Surgical treatment is an option in advanced HF. Patients with
significantly enlarged LV end-systolic and end-diastolic volume indices
(LVESVI and LVEDVI) appear to benefit most from surgical intervention.
Relative contraindications to surgery include excessive anaesthetic
risk, impaired function of residual myocardium, severely diminished
cardiac index, and lack of a discrete scar with indistinct margins. Left
ventricular surgical treatment usually requires a median sternotomy,
cardiopulmonary bypass, and left ventriculotomy on either a beating or
arrested heart. Adoption of the surgical technique for correction of
this condition has been limited by both the invasiveness of the
procedure and potential for significant subsequent perioperative
morbidity and mortality. BioVentrix has developed the Revivent TC
System to provide devices for the treatment of a left ventricular scar,
utilizing a less invasive, beating heart approach.

Less Invasive Ventricular Enhancement (LIVE) procedure with Revivent TC
reshapes and resizes LV without sternotomy or extracorporeal circulation
through direct plication of the scarred myocardium. The procedure
consists in the implantation of a series of internal (right ventricular
septum) and external titanium microanchors (5 mm \selectlanguage{ngerman}× 25 mm) which are
brought together through a poly-ether-ether-ketone (PEEK) tether (1.7 mm
× 1.0 mm) to approximate LV free wall and the anterior septum,
consequently excluding the scarred myocardium. Septal RV anchors are
deployed by a transcatheter technique, through a venous access on the
neck -- right internal jugular vein.

First-in-human LIVE procedures were performed in September 2013. Since
the device obtained CE mark approval in June 2016, the multicentric
observational BioVentrix\selectlanguage{english} Registry Assessment of Ventricular Enhancement
for the Revivent TC\selectlanguage{english} system (BRAVE-TC) trial has been ongoing in Europe
(1).

In total, 230 cases have been performed with an overall mortality of 18
(7.8\%). 12 cases of mortality occurred during the CE mark trial and 4
prior to changing the procedure to apical snaring (described below).

One-year results of a multicentric study were recently published by
Klein et al. (2), including 86 patients treated with Revivent TC\selectlanguage{english} system
has registered a significant improvement in LV ejection fraction (29 +-
8\% vs 34 +- 9\%, p\textless{}0.005) and an important reduction of LV
volumes - LV end-systolic and end-diastolic volume indexes (LVESVi and
LVEDVi) both decreased: 74 +- 28 mL/m\textsuperscript{2} vs 54 +- 23
mL/m\textsuperscript{2}, p\textless{}0.001 and 106 +- 33
mL/m\textsuperscript{2} vs 80+-26mL/m\textsuperscript{2}, respectively,
p\textless{}0.0001. Mortality was 4.5\% (4 patients) and 12-months
survival was 90.6\%. There was also a documented clinical improvement of
the treated patients. This is the largest series of patients submitted
to LIVE therapy published so far.

In another series of 26 patients submitted to the LIVE\selectlanguage{english} therapy (3),
meaningful LV reduction was achieved - LVSEVi went from 84.8 +- 25.7 to
65.6 +- 24.4 ml/m\textsuperscript{2} and LVEDVi went from 107.8 +- 33.2 to
90.5 +- 31.8 ml/m\textsuperscript{2}, both p\textless{}0.001
(\textbf{Figure 1} ). Additionally, ejection fraction improvement was
observed by CMR: 28.9 +- 8.3\% vs 38.6 +- 10.5\%, p\textless{}0.001. There
was one mortality case reported. Lastly, also the 6-minute walk test was
significantly longer (368.8 +- 40.0 to 461.5 +- 61.2 m, p
\textless{}0.001), endorsing clinical benefit with the technique.

Between July 2018 and January 2020, 47 patients (84.4\% men; mean age 61
+- 12.5 years) were submitted to the LIVE procedure in 16 Institutions in
Europe, North America and Asia. Procedural success was 100\%. There was
no intra-hospital mortality. There was no case of ventricular septal
defect, right ventricular perforation or sternotomy conversion. New
onset tricuspid valve regurgitation was observed in one patient. In the
mean follow-up period of 9.8 months, NYHA class improved a median of 1
grade and there was no late mortality.

We present this approach here, describing it step-by-step.

\textbf{Patient selection}

Any patients suffering from heart failure symptoms with cardiac
dysfunction caused by a previous myocardial infarction resulting in
increased LV systolic volume and in a discrete, contiguous,
non-contractile, (akinetic and/or dyskinetic) scar located in the
antero-septal, apical (may extend laterally) region of the left
ventricle.

Transthoracic echocardiography (TTE) is utilized to assess for LV
dilatation, diminished ejection fraction (EF), LVESVI and LVEDVI,
regional wall akinesis or dyskinesis. It is a useful imaging modality to
guide further investigation to determine suitability for Revivent TC\selectlanguage{english}
and to plan the LV reconstruction.

Cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE)
gives a higher resolution image, clearly indicating scar thickness,
extent and anatomy. It also gives excellent indication of LVESVI, LVEDVI
and EF. LGE is the gold standard for scar determination.

4D cardiac computed tomography (CT) scan carried out with a triphasic
injection of contrast media is a suitable alternative to CMR for
patients unable to undergo the latter.

The following are \textbf{absolute} contra-indications for the LIVE
procedure:

\begin{itemize}
\tightlist
\item
  Myocardial Infarction within 90 days prior to the procedure;
\item
  Previous right neck surgery or previous left chest surgery that
  precludes device placement;
\item
  Thrombus or intra-ventricular mass in the left atrium or ventricle as
  verified by echocardiography or equivalent that has not been
  adequately treated with weeks of anticoagulant at therapeutic levels;
\item
  Calcified ventricular wall in the area of intended scar exclusion as
  verified by one or more appropriate imaging modalities.
\end{itemize}

The following are \textbf{relative} contra-indications for the LIVE
procedure:

\begin{itemize}
\tightlist
\item
  Chronic renal failure with a serum creatinine \textgreater{}2 mg/dL;
\item
  Inoperable coronary disease with significant ischemia;
\item
  Inadequate myocardial viability in regions remote from the scar;
\item
  Cardiac Resynchronization Therapy (CRT) consisting of bi-ventricular
  pacemaker device (i.e., not ICD only) placement \selectlanguage{english}[?] 60 days prior to
  treatment;
\item
  Patient intolerance or unwillingness to take anti-coagulation
  medication;
\item
  Functioning pacemaker leads in antero-apical RV, which, in the opinion
  of the investigator, would interfere with anchor placement;
\item
  Pulmonary Arterial Pressure \textgreater{} 60 mm Hg shown by right
  heart catheterization to be precapillary or unresponsive to
  vasodilator therapy;
\end{itemize}

\textbf{Equipment}

The implantable components consist of a series of titanium anchor pairs
(one Internal and one External in each pair) covered in polyester cloth
(\textbf{Figure 1} ).

The anchor pairs are connected to one another by an adjustable-length
tether made of poly-ether-ether ketone (PEEK). Distance between anchors
is variable and is determined by the position of the External Anchor on
the Tether. The Internal Anchor is hinged to facilitate low profile
passage through a jugular vein catheter that is inserted perpendicularly
to the septum, after which it can be pivoted 90deg to lie flat on the
septum.

The External Anchor is delivered through mini-thoracotomy and houses a
cam-based reversible locking mechanism allowing apposition of the two
anchors at a continuum of positions. Once the proper distance and
appropriate Tether force between the two is established, excess Tether
length is cut and removed.

The Revivent TC\selectlanguage{english} System consists of:

\begin{itemize}
\tightlist
\item
  Internal Anchor Flex Assembly
\item
  External Anchor Assembly
\item
  Curved Needle, LV Apex Anchor
\item
  Introducer Kit
\item
  Trans Thoracic Force Gauge
\end{itemize}

\textbf{Implant procedure}

The patient shall be prepared for cardiac hybrid procedure according to
hospital's standard procedures. Intraoperative transoesophageal
echocardiography (TEE) is required to provide procedural assistance,
monitor LV and valve function, and evaluate myocardial anchor implant
placement.

A cell salvage system, standby cardiopulmonary bypass, external
defibrillator pads, meticulous control of ACT and serum
K\textsuperscript{+} and Mg\textsuperscript{2+} add to patient safety.

We are describing the procedure step-by-step:

\begin{enumerate}
\tightlist
\item
  Percutaneously access the right internal jugular (RIJ) vein.
\item
  Insert a 14F Introducer into RIJ and advance into the superior vena
  cava (SVC) or right atrium (RA) \textbf{(Figure 3).}
\item
  Determine location of incision by placing an instrument under
  fluoroscopy at the desired location and ensure that the position
  allows access to the LV apex and placement of the most basal anchor
  pair. The incision should be placed over the intercostal space that
  gives a direct line from the antero-lateral wall 5-6 cm above the apex
  of the LV and 1-2 cm above the very apex of the RV; in general, the
  medial aspect of the incision should be at the level of the patient's
  areola. This imaging should be repeated before actually entering the
  interspace.
\item
  Perform the thoracotomy.
\item
  Remove extra-pericardial fat and open the pericardium under direct
  vision.
\item
  Identify aneurysm (scar) margins and epicardial landmarks including
  LAD and cardiac apex.
\item
  Place a ``leash'' or tethering mechanism to manipulate the heart. The
  ``leash'' consists of a 2-0 double pledgeted, horizontal mattress
  polypropylene suture with a tourniquet. Suture should be placed in the
  scar tissue of the heart using suture and pledgets appropriately deep
  in the scar to prevent pulling through the wall of the heart. The site
  of the leash should be about half way between the lateral scar margin
  and the LAD at the level of the RV-apical anchor on the LV epicardium.
  Additional leashes may be placed in the scar as necessary to allow
  appropriate cardiac manipulation. Leashes should be placed only in
  scar intended for exclusion.
\item
  Heparinize the patient maintaining an ACT of 300 seconds or greater.
  Float a Swan-Ganz catheter through the 14Fr sheath up to the pulmonary
  artery (PA).
\item
  Advance a 0.025 Jagwire\selectlanguage{english} through the Swan-Ganz catheter and keep it on
  the PA.
\item
  Advance a 7Fr multipurpose (MP) catheter with a EnSnare\selectlanguage{english} endovascular
  snare system inside and open it in the RV apex \textbf{(Figure 4)} .
\item
  Perform a RV gram to confirm the position of the EnSnare\selectlanguage{english}
\item
  Place a 7 cm 18 gauge straight needle on the scarred epicardium to
  identify landmarks and needle puncture direction. (Caution: avoid
  placing needle within healthy myocardium).
\item
  Puncture the needle through the epicardial surface and redirect it
  towards the selected septal site as directed by the EnSare\selectlanguage{english} in the RV
  apex; (confirm LV wave form with pressure measurement). Confirm needle
  is in the RV using injection of contrast within the
  needle\textbf{(Figure 5)} .
\item
  Advance a 0.032'' wire through the needle and snare it with the
  EnSnare\selectlanguage{english} under fluoroscopy.
\item
  At this point, the 14Fr sheath is advanced to the RV, near the
  interventricular septum. The 0.025'' Jagwire\selectlanguage{english} can be also removed.
\item
  Remove the straight needle and advance a 6Fr Brite tip catheter
  through the 0.032'' wire and into the RV (confirm scar location).
  Tactile feedback should reinforce the catheter's passage through scar.
  This is done under fluoroscopy and TEE should be continuously looking
  at any changes in tricuspid regurgitation change from
  baseline\textbf{(Figure 6)} .
\item
  Exchange the 0.032'' wire with a 0.014'' through a 6Fr standard
  multipurpose catheter. This is done in the surgical side.
\item
  At this point, the 6Fr Brite tip catheter must be inside the 14Fr
  sheath.
\item
  Place the Internal Anchor assembly over the 0.014'' guidewire, and
  embed the OWTI tip into the end of the guiding catheter; place a small
  clamp on both exposed ends of the 0.014'' guidewire -- one where it
  exits the OWTI on the jugular side of the patient, and the other where
  the guidewire exits the guiding catheter at its hub. (This maneuver
  creates a single entity out of the OWTI and the guiding catheter so
  they may be advanced from the jugular access on the patient's right
  side, to the epicardial access on the left side).
\item
  Advance the OWTI/guiding catheter combination through the 14Fr, and
  then through the 6Fr Brite tip, which is tranversing two walls of the
  LV. During this maneuver, the 14Fr introducer must be kept in contact
  with the right side of the septum, with the tip of the 6Fr Brite tip
  inside the 14Fr lumen. The 0.014'' guidewire and guiding catheter may
  be removed as soon as any part of the wire becomes exposed outside the
  6Fr Brite tip at the epicardial location \textbf{(Figure 7).}
\item
  The tip of the 14Fr introducer, which has been essentially in contact
  with the septum, is retracted to reveal the anchor when the OWTI has
  been advanced to bring the anchor into immediate proximity of the
  septum.
\item
  Carefully lay down the hinged, retrievable internal anchor onto the
  septum, such that the hinged surface is lying in position on the
  septum. Gentle tension must be maintained continuously on the tether
  from the LV side. With the hinged anchor laying on the septum, the
  OWTI is cut in the rectangular portion of the tether (leaving as much
  of the tether length as possible); remove the 6Fr Brite tip. The
  external anchor is placed over the tether and advanced to the
  epicardial surface. (Bleeding may occur briefly after removal of the
  6Fr sheath; contact between the external anchor and the epicardium
  generally creates hemostasis). Then use the force gauge to bring the
  two walls of the LV into apposition \textbf{(Figure 8).}
\item
  Assess hemodynamics, LV configuration (by TEE), and tricuspid valvular
  function (by TEE); if appropriate, release anchor from Flex Catheter,
  leaving it in position against the right side of the septum.
\item
  Retract the 14Fr sheath at least to within the RA proximal to the
  tricuspid annulus, but ideally to the cavo-atrial junction immediately
  after successful deployment and release of the hinged, retrievable
  internal anchor onto the septum.
\item
  If there are no more RV anchors anticipated, leave the walls in
  contact-plus-1 (one) Newton (using the force gauge). If more are
  planned, release the external anchor to allow separation between the
  endocardial surfaces to avoid distortion of the LV chamber for
  subsequent anchor placement.
\item
  Repeat steps 13-22 for each LV-RV anchor pair.
\item
  When it is determined that the next anchor should be LV-LV (i.e., at
  the LV apex with no further space in the RV apex), retract the
  introducer from the RV, then oppose the walls with existing anchor
  pairs into contact plus 1-2 Newtons, (thus rendering the geometry of
  the final, reshaped LV except for the apex). Caution: Using excessive
  force could lead to tissue erosion or anchor migration, it is critical
  to use the force gauge to ensure proper force to the anchors is being
  applied.
\item
  Using the LV Apical needle in a standard surgical needle holder, load
  the needle such that it is at a 10 to 15-degree angle from the needle
  holder shaft.
\item
  With visibility gained from manipulation of previous anchor pairs,
  drive the LV needle across the cardiac apex from right-to-left.
\item
  Retrieve the needle tip. Lay down the hinged anchor on the right side
  of the apex and cut the tether at or near the needle to allow
  placement of an external anchor for hemostasis. Check all anchor
  positions fluoroscopically for alignment \textbf{(Figure 9).}
\end{enumerate}

\textbf{Discussion}

Both Revivent TC\selectlanguage{english} approaches are essentially less invasive than
conventional SVR. Therapeutic volume reduction was achieved regardless
of delivery method. Interestingly, there was no additional benefit of
adding coronary revascularization to the procedure. This data compares
favourably with the STICH sub-analysis, which established a survival
benefit in patients realizing \textgreater{}30\% reduction in LVESVI
and/or post-operative LVESVI \textless{}60ml/m\textsuperscript{2} (4).

Surgical ventricular reconstruction or SVR, has been applied clinically
in a large number of patients during the past two decades (5-9).In the
STS database, for a 10 year period ending 2017, 2273 SVR procedures were
undertaken. Mortality ranged between 8 and 15\%. During the same period,
7205 LV aneurysm repairs were carried out.

SVR improves heart failure symptoms and long-term survival for patients
with ischemic cardiomyopathy (10). The majority of cases in these
studies underwent standard open-heart surgery via sternotomy with
cardiopulmonary bypass, cardioplegic myocardial arrest, and
ventriculotomy. Concomitant coronary revascularization was performed in
most cases, sometimes also in combination with an intervention to the
mitral valve for functional or secondary mitral valve regurgitation.
Implantation of the Revivent TC\selectlanguage{english} System device does not require
cardiopulmonary bypass, cardioplegic arrest, or a ventriculotomy.
Implantation was initially performed with sternotomy, followed by the
hybrid approach. Both approaches are less-invasive compared to standard
SVR procedures.

The outcomes and the rate of adverse events during and after
implantation of the Revivent TC\selectlanguage{english} System appear to be in an acceptable
range when compared with SVR. The 30 day mortality of 5\% in this group
of patients is within the range of STS mortality. Hospital stay could be
significantly reduced by using the hybrid approach rather than the
initial surgical approach. The observed 1- and 2-year survival of 91\%
and 89\%, respectively, are also comparable to SVR outcomes
(11,12,13,14).

By comparison, the reported survival from the international
Reconstructive Endoventricular Surgery returning Torsion Original Radius
Elliptical shape to the left ventricle (RESTORE) registry of 1,198
post-anterior infarction SVR cases at 2-years was \textasciitilde{}85\%.
Improvement in outcomes after implantation of the Revivent TC\selectlanguage{english} System
should be possible through application of experience gained in selecting
candidates and in the technique of implantation. This might also offer
an alternative in patients at high risk of perioperative complications
or with a frail preoperative condition.

An important element of the Revivent TC\selectlanguage{english} System implantation technique
is that the anchor pairs are set to a configuration parallel to the long
axis of the heart. Each tether and the excluded portion of the scar is
taken from the short axis of the heart. With this configuration,
virtually all volume reduction decreases the radius of the LV and is not
just the result of amputation of an apical aneurysm. Aligning good
functioning myocardium edge to edge optimizes myocardial function. This
is not the case with a Dacron patch which only reduces size of the LV
cavity but offers an akinetic neo LV wall. Reduction in wall tension,
reorientation of myofibers, and improvement in torsional dynamics is,
therefore, the most likely explanation for the functional improvement
observed in the patients.

\textbf{Conclusion}

With Revivent Transcatheter\selectlanguage{english}, Left Ventricular Reconstruction is highly
feasible, safe and efficacious. The avoidance of median sternotomy,
cardiopulmonary bypass and cross clamping with cardioplegia allows for
immediate haemodynamic improvement and shorter recovery and return to
normal activities. The volume reduction is comparable to most surgical
series and fares much better than the STICH values. Ongoing studies will
further demonstrate the value of this approach in this sick group of
heart failure patients.

\textbf{Figure legends}

\textbf{Figure 1} -- Pre and post-procedural cardiac magnetic resonance,
showing LV volume reduction and reshape achieved with Revivent TC\selectlanguage{english}
system.

\textbf{Figure 2} -- The Revivent TC\selectlanguage{english} System consists of titanium
anchors and delivery instrumentation for the anchor placement.

\textbf{Figure 3} -- \emph{step 2} -- Insert a 14F Introducer into RIJ
and advance into the superior vena cava (SVC) or right atrium (RA).

\textbf{Figure 4} -- \emph{step 10} -- Advance a 7Fr multipurpose (MP)
catheter with a EnSnare\selectlanguage{english} endovascular snare system inside and open it in
the RV apex.

\textbf{Figure 5} -- \emph{step 13} -- Puncture the needle through the
epicardial surface and redirect it towards the selected septal site as
directed by the EnSare\selectlanguage{english} in the RV apex.

\textbf{Figure 6} -- \emph{step 16} -- Remove the straight needle and
advance a 6Fr Brite tip catheter through the 0.032'' wire and into the
RV (confirm scar location).

\textbf{Figure 7} -- \emph{step 20} -- Advance the OWTI/guiding catheter
combination through the 14Fr, and then through the 6Fr Brite tip, which
is tranversing two walls of the LV.

\textbf{Figure 8} -- \emph{step 22} -- The external anchor is placed
over the tether and advanced to the epicardial surface. Then use the
force gauge to bring the two walls of the LV into apposition.

\textbf{Figure 9} -- \emph{final step} -- final LV gram assessment and
pre-operative comparison



\textbf{Author contributions}

TP and PN did article drafting and revision, FB did critical revision of
the article, KvB, AW and LA were involved in device development and
proctoring the majority of the procedures.



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