Use of left ventricular assist devices (LVAD) both as
bridge-to-transplant and destination therapy has become a standard of care
in advanced heart failure therapy . Technical developments introduced in
past decades as well as improvements of patient and adverse event
management and implant timing strategies have led to
improved survival, quality of life and decrease of adverse event rates
[1, 2]. Nevertheless, therapy with these devices is partially limited by
occurrence of adverse events such as thrombosis, stroke or bleeding,
related to interaction between the device and blood elements .
Therefore, further refinement is required to address and prevent the occurrence
of such events. The novel device, HeartMate 3 (HM3) LVAS
(Abbott, Chicago, IL) is a continuous centrifugal - flow pump with a
fully magnetically levitated rotor. The novel key device features, including
magnetically levitated rotor which eliminates the need for any
bearings, wide blood flow path gaps and fixed automatic
speed modulation which allows for periodical wash-out of the device
may lead to minimization or shear stress on blood elements and prevent
stasis, and thus enhance hemocompatibility and decrease rates of
major adverse events as reported in recent trials [4-6].
First patients implanted at our institution in 2014
were part of the HM3 CE Mark trial and the pump was used as primary choice
LVAD at our center since 2016. Present retrospective study was conducted
to evaluate our single-center experience with Heart-Mate 3 LVAS.
Materials and methods
We retrospectively evaluated a cohort of 150
consecutive patients implanted with HeartMate 3 at our institution between April 2016 and June 2020.
Patients who were implanted with other LVAD during this period or underwent
pump exchange from a different LVAD type were excluded from the
study. All primary HeartMate implantations and planned bi-ventricular
support with HeartMate 3 were included in the study. Implantations of HM3 in
right sided configuration in patients with preexisting LVAD support with
HeartMate 3 are also reported. Institutional ethics committee waived the
need for patient informed consent as this study was designed as
Patient baseline and follow-up data, causes of death
and clinical adverse events were collected retrospectively by review of
the electronic medical records database of Institute of Clinical and
Experimental Medicine in Prague. Follow-up was 100% complete, maximum follow-up
was 1489 days.
Implantation technique. Two different surgical techniques were used. The
device was implanted either via standard median sternotomy, or utilizing
a less-invasive technique by accessing the apex of the heart via left
anterolateral mini-thoracotomy and accessing the ascending aorta by an upper J
mini-sternotomy (fig. 1). The implantations were performed using
cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO)
or, in patients without need of concomitant procedures, the device
was implanted off-pump. In a small series of patients we verified a
feasibility to implant the HeartMate 3 directly from Impella 5-0. In general,
no aortic crossclamping was performed, unless it was necessitated by a
concomitant left-sided procedure. The coring area for the apical cuff was
located under transoesophageal Echo-CC in all cases. The apical sewing ring
was sutured to the apex of the left ventricle using either "core
then sew" or "sew then core" techniques, nevertheless we prefer
the latter mentioned approach at our institution. In this case, the cuff
is attached in the apical position by 2-T felt pledgeted polypropylene
monofilament 3/0 sutures in contralateral segments and is subsequently affixed
by identical nontransmural running sutures without additional felt strips.
In patients with limited pericardial space we performed a V-shape
pericardial incision in the projection of the left ventricle long axis-ventral
to the phrenic nerve . The outflow graft was positioned parallel
to the diaphragm and along the right ventricle and lateral side of the right
atrium upwards to the ascending aorta. In complex redo cases an alternative
strategy was used to tunnel the outflow graft through left pleural space
to reach the ascending aorta .
Fig. 1. Patient after lessinvasive implantation
of HeartMate 3. The pump was implanted via anterolateral thoracotomy and upper mini
sternotomy. Driveline tunnelization was performed using double tunnel technique
Driveline management. Intraoperative tunneling of the driveline was
performed using previously described double-tunnel (C-shape) technique with
the first part of the tunnel located subfascially behind right rectus
abdominis muscle and second part of the tunnel located subcutaneously [8,
9]. The exit site of the driveline was standardly located in upper
left quadrant of the abdomen. The driveline was then covered with a two 3
cm long rubber drains and fixed with two anchoring sutures (fig. 2). The
application of the driveline cover was utilized to prevent the
driveline crimping with fixation stitches. Further stabilization of
the driveline was achieved using a soft anchoring device, the Centurion Foley
Anchor (Centurion Medical, MI, USA), which in outpatient care fully replaces the anchoring
sutures of the driveline (fig. 3). These were removed approximately one month
after implantation according to our institutional driveline care
Fig. 2. Fixation of the driveline with
anchoring sutures at the time of implantation. The driveline is covered with a
two 3 cm long rubber drains and fixed with two anchoring sutures. The
application of the driveline cover is utilized to prevent the driveline
crimping with fixation stitches
Fig. 3. A soft anchoring device (Foley Anchor), used for the fixation of the driveline during the LVAD support
Concomitant procedures. Concomitant tricuspid valve repair was
considered in patients with severe preoperative insufficiency and/or annulus
size ≥40 mm. If more than mild aortic insufficiency was present, the valve
was either replaced with a biological prosthesis or addressed by an aortic
coaptation ("Park's") stitch . In cases of severe aortic
or mitral stenosis, the valve was replaced with biological prosthesis. In
patients with present mechanical aortic valve we replaced the valve with biological prosthesis,
and conversely, re-replacement of functional mechanical (or biological) valve
in mitral position was not performed. Mitral repair with Alfieri stitch
via the apex of the heart was considered in patients with severe mitral
regurgitation indicated for implantation as destination therapy. In
patients with severe carotid stenosis the endarterectomy
was indicated according to current ESC (European Society of Cardiology)
guidelines. Surgical myocardial revascularization was performed in patients
with right ventricular ischemia. We also rigorously addressed the
potential pre-pump risk factors for hemocompatibility adverse events (e.g. pump
thrombosis, systemic embolization). Therefore surgical patent
foramen ovale closure and left atrial appendage exclusion
was performed in patients with history of atrial fibrillation or patent
foramen ovale. In case of presence of intracardiac thrombi these were
removed at the time of implant via the apex of the heart utilizing
"core then sew" technique to inspect the ventricular
Right ventricular (RV)
dysfunction. In case of pre-operative
or perioperative RV dysfunction requiring implantation of temporary mechanical
circulatory support (MCS), we used an implant technique which allows for
mini-invasive explanation in cases of RV recovery as described previously (fig.
4) . In brief, the inflow cannula was inserted percutaneously via the right
femoral vein using the Seldinger technique. A Dacron graft
with diameter of 10mm was anastomosed to main pulmonary artery with a
running suture using Satinsky clamp and the outflow cannula was inserted
to the outflow graft transcutaneously with the exit site in right
subcostal portion of the abdomen. The 10 mm graft diameter allows for
eventual implantation of durable right ventricular assist device (RVAD)
from right thoracotomy using the same graft for outflow anastomosis,
in cases of refractory right heart failure (RHF). A CentriMag circulatory
support system (Abbott, Chicago, IL) was used to support the right ventricle in
most cases of severe RHF. The perioperative decision to implant a
temporary RV support comprised echocardiographic evaluation of RV
function, inability to maintain sufficient LVAD flow and mean arterial
pressure despite more-than moderate dose of inotropic and vasopressoric
support. For a planned temporary RVAD decision we took into
consideration multiple factors, including hemodynamic (CVP, PAPi,
CVP:PCWP ratio), echocardiographic (tricuspid regurgitation, RV: LV EDD
ratio, TAPSE, FAC) and end-organ functions (renal, liver, mechanical
ventilation) [12, 13].
Fig. 4. A patient with simultaneous LVAD
(HeartMate 3) and temporary RVAD (CentriMag) implanted via sternotomy. The
outflow cannula of the RVAD is transcutaneously inserted into a Dacron graft anastomosed
to pulmonary artery. The Dacron graft reaches to subcutaneous portion of the
skin in subxiphoid area. Inflow cannula of the RVAD is inserted through femoral
vein using Seldinger technique. This strategy allows for a mini invasive explantation
of the RVAD. (LVAD: left ventricular assist device; RVAD: right ventricular
Pericardial closure. In all patients we used the Gore Preclude
pericardial membrane (W.L. Gore and Associates Flagstaff AZ, USA) to enwrap the pump
within the pericardium. Ventral closure of the pericardium was also performed
using aforementioned membrane particularly in bridge-to-transplant
cases to facilitate easier sternal re-entry.
Postoperative anticoagulation regimen
Continuous intravenous administration of heparin has
been implemented as a bridge in all procedures until target
anticoagulation range with warfarin has been reached. After implantation,
the aim of anticoagulation therapy was to reach international normalized ratio
(INR) of 2.0-2.7; in patients with trombophilias it was 2.5-3.
Thrombophilias were defined as follows: mutation in factor V (Leiden);
mutation in factor II (prothrombin); homozygosity for
methylentetrahydro-pholate reductase (MTHFR); heterozygosity for
MTHFR accompanied by hyperhomocysteinaemia or presence of lupus
anticoagulant antibodies. Acetylsalicylic acid (ASA) has been administered
as a part of antithrombotic regimen in dose of 100 mg per day. In a subgroup of
patients (n=15) included in a study
aimed on evaluation of low-intensity anti-coagulation, the target INR
was 1.5-1.9. The inclusion and exclusion criteria and anticoagulation
protocol were in detail published previously . In patients (n=11) included in a different study
aimed to evaluate an anti-thrombotic monotherapy with the HeartMate 3, warfarin
was not administered and the patients were treated with a single
anti-thrombotic agent only .
Continuous variables are expressed as mean ± standard
deviation (SD) or median (interquartile range). Discrete variables are
shown as absolute frequencies (percentages). Kaplan-Meier curves have been
used to visualize survival without censoring at the time of heart
transplant. All statistical analyses were performed using SPSS version 22
(IBM SPSS Statistics; IBM Corporation, Chicago, Ill). All
statistical tests and confidence interval were 2-sided with a significance
level of 0.05.
In this single-center retrospective study we reviewed
150 consecutive implantations of HeartMate 3 LVAS performed between April 2016
and June 2020 at Institute for Clinical and Experimental Medicine in
Prague, Czech Republic. Other implanted LVADs (Jarvik 2000; n=3) as well as LVAD exchanges
from different LVAD type to HeartMate 3 (HeartMate II; n=2) were excluded from the analysis.
The study population consisted of 125 (83%) men and 25 (17%) women, aged
57.2±11.9 years. Ischemic heart disease was primary cause of heart failure in
70 (46.7%) patients and dilated cardiomyopathy in 71
(47.3%) patients. Other primary causes of heart failure comprised
hypertrophic cardiomyopathy (n=3;
2%), restrictive cardiomyopathy (n=1;
0.7%) and valvular heart disease (n=5;
3.3%). Device was implanted as bridge to transplantation in 107 (71.3%)
and as destination therapy in 43 (28.7%) patients. Majority of the
patients were classified as INTERMACS profile 3 (n=65; 43.3%). Atrial fibrillation was present in 54 patients
Detailed overview of patient baseline characteristic
and pre-operative risk factors are summarized in tab. 1.
Table 1. Baseline patient characteristics
Pre-implant circulatory support
Thirty-three patients (22%) required preoperative
mechanical circulatory support. Majority of the patients were supported by ECMO
(n=20; 13.3%) and among these
patients 4 required additional device to facilitate left ventricular
unloading. Three of these patients were supported with combination of
ECMO and Impella CP or Impella 5.0 and one patient was supported with
ECMO in combination with intraaortic balloon pump. 8 patients were implanted
from previous CentriMag support in LVAD (n=5) or BiVAD (n=3)
configuration. Impella 5.0 alone was used as bridge to implantation in 4
patients and Intra-Aortic Balloon Pump (IABP) in one patient. Overview of
preimplant MCS is provided in tab. 2.
Table 2. Preoperative mechanical circulatory support
Note. ECMO - Extracorporeal Membrane
Oxygenation; IABP - Intra-Aortic Balloon Pump; LVAD - left ventricular assist
device; BiVAD - bi-ventricular assist device.
Surgical techniques and concomitant procedures
130 (86.7%) patients were implanted via median
sternotomy and in 20 (13.3%) patients the device was implanted using
less-invasive technique through left antero-lateral mini-thoracotomy and
upper J mini-sternotomy. Implantation after previous heart surgery
was performed in 42 (28%) patients. Majority of the procedures was
performed using CPB (n=128; 85%),
while 22 (15%) patients were implanted off pump or directly from ECMO or
Temporary right-ventricular assist device was
implanted in 46 (31%) patients, of which 31 (67%) patients received
temporary RVAD during the primary procedure and 15 (33%) in early
postoperative period. Durable bi-ventricular support with Heart-Mate 3 was
primarily implanted in 5 (3%) patients and three patients received
HeartMate 3 implantation as RVAD in latter phase due to refractory right
A total of 50 (33%) concomitant valvular procedures
were performed of which most frequent was a tricuspid repair alone, or with in
combination with other valvular procedure (n=33; 22%). Aortic valve was replaced in 8 patients, and
aortic coaptation ("Park's") stitch was performed in 5 patients.
Mitral repair was performed in 15 (10%) patients.
Survival and outcomes
The mean duration of support was 15.6±14.5 months. The
follow-up reached a total of 2331.5 patient-months. At the follow-up 32
patients were transplanted, 37 had died, 78 were ongoing and in 3
(2%) patients the therapy with the device was terminated due to myocardial
recovery. In recovery cases a discontinuation of the device therapy
with occlusion of outflow graft with Amplatzer occluder with the pump
left in situ was performed in all 3 recovery patients. The driveline was
terminated and surgically removed to the accessible extent.
The actuarial survival after device implantation was
80.1, 77.6 and 74.6% at 6, 12 and 24 months respectively (fig. 5). long-term
survival at 36 and 48 months was 74.6 and 69.9% respectively.
Fig. 5. Actuarial survival estimates
after HearMate 3 implantation (n=150
patients). Patients were not censored at the time of transplantation
Mean duration of postoperative hospital stay was 40.3±32.3
days. Adverse events observed while on support are listed in tab. 3.
46 (31%) patients required temporary RVAD. Majority of
the patients were successfully weaned from right ventricular support. In two patients the
weaning of RVAD was not feasible due to refractory RV failure, and these
patients were therefore implanted with additional HeartMate 3 for long-term
Table 3. Adverse events during LVAD support
Bleeding complications were noted in 38 (25.3%)
patients and the events occurred predominantly during initial hospital stay.
Gastrointestinal bleeding was noted in 10 (6.7%) patients and was related
to angiodysplazia in 2 patients.
74 (49.3%) patients experienced postoperative
infections. Of these infections 54 (73%) were non-device related. Pulmonary (n=23; 43%) and urinary infections (n=15; 28%) were most frequently observed
Device related infections were observed in 20 (13.3%)
patients, 18 patients developed a driveline infection (DL) and two
patients had a pump pocket infection. Patients were treated by local wound
care, targeted antibiotic therapy and eventually
surgical debridement, vacuum assisted closure therapy and in cases of
DL infection also re-position of the driveline exit site.
Neurological dysfunction was observed in 16 (10.6%)
patients. 5 patients suffered from a transient ischemic attack (TIA), 11 (7.3%)
patients experienced hemorrhagic (n=5;
3.3%) or ischemic (n=6; 4%)
Pump thrombosis occurred in 3 (2%) patients. In 2
patients the cause of the thrombosis was an embolus, which was present during
inspection of the device. 4 (2.6%) patients underwent surgery due
to outflow graft twist, which was de-rotated via lateral thoracotomy.
The most prevalent cause of death in presented patient
population after LVAD implantation was multiorgan failure or RHF (n=16; 10.6%), sepsis (n=8; 5.3%) or cerebro-vascular
accident (n=4; 2.6%). Overview
of causes of death is provided in tab. 4.
Table 4. Primary causes of death
In this retrospective study we present an analysis of
4-year single-center experience with centrifugal magnetically levitated
left ventricular assist device, the HeartMate 3 LVAS, for
treatment of advanced heart failure. The key features of the device
include with wide blood flow pathways, friction free movement of magnetically
levitated rotor and intrinsic pulsatility to reduce shear stress
and blood stasis . As previously demonstrated, Heart-Mate 3 does not
degrade high-molecular weight multimers od Von Willebrand factor to the
extent observed with other devices , which further supports the
enhanced hemocompatibility of the device, and along with low lactate
dehydrogenase levels reported in recent trials, suggesting
lower occurrence of hemolysis . In a largest comparative LVAD trial,
the MOMENTUM 3 the HeartMate 3 showed lower rates of
hemocompatibility-related adverse event and superior survival free of
disabling stroke or reoperation to replace or remove a malfunctioning
device in comparison to its predecessor, the HeartMate II .
In contrast to HeartMate II the small size of
HeartMate 3 allows for intrathoracic placement and also for less invasive
implantations. Minimally invasive procedures could carry some positive
effects such as reduction of trauma, blood loss and infection rates,
or decrease of in-hospital stay and accelerated recovery. Observations in
ELEVATE registry found that bleeding (requiring surgery), infection and
arrhythmias were lower in the group implanted via the less-invasive
surgical approach than those who underwent open heart surgery. Additionally,
using less invasive technique may have a positive effect on
the incidence of postoperative right heart failure as the pericardium
remains intact and right ventricular dilation during onset of the LVAD is
prevented . In our series 20 (13.3%) patients were implanted
using less-invasive technique, via left anterolateral mini-thoracotomy and
upper J mini-sternotomy, utilizing CPB or ECMO. Several groups reported
use of bilateral mini-thoracotomy and off-pump less invasive implantations
In this study a 4-year experience with HM 3 are
presented. Postoperative survival in our patient population was 77.6 and
74.6% at 12 and 24 months respectively. These results are comparable with
results reported in annual reports of Imacs (81.1 and 72.4% respectively)
and INTERMACS (82 and 72% respectively). The 2 year results of overall
survival are comparable not only with the 2-year follow-up in the ELEVATE
registry, but also with two-year survival in MOMENTUM 3 trial (74.5 and
79% respectively) [5, 6]. However, the one-year survival rate for HM
3 patients reported in MOMENTUM 3 trial was slightly higher (86.6%).
This observation may be at least partially contributed to two main reasons.
First, almost one third of our patients underwent previous
cardiac surgery, and second, 22% of the patients
required preoperative mechanical circulatory support (ECMO, Impella
or combination). These factors could have negatively influenced the risk
of perioperative complications and patient outcomes. The long-term survival in
our cohort of patients at 36 and 48 months was 74.6 and 69.9%
respectively. However, despite the observation of favorable patient
survival, the burden of adverse event remained significant.
Right heart failure (RHF) after LVAD implantation is
associated with increased morbidity and mortality and thus remains a
serious concern . The incidence of early RHF varies according to
definitions used. According to data from EUROMACS registry it occurs
in 21.7% cases, the report of 2-year results of ELEVATE registry showed
the incidence of RHF up to 15% . Furthermore, recent meta-analysis
estimated the incidence of RV failure to approximately 35% . On top of
frequent occurrence of RHF, the reliability of prediction scores is questionable
and the RHF consequences are fateful. In our series the incidence of
use mechanical RV support was 31%, in contrast to HM 3 CE Mark Study, ELEVATE
Registry or MOMENTUM 3, where the incidence of temporary RVAD use
varies between 4 and 7% [4-6]. As the addition of temporary RVAD may lead to
improvement of RV recovery and improved patient outcomes, we tend to
be liberal in use of temporary RVAD. The implant technique with inflow cannula
inserted percutaneously through femoral vein and outflow cannula inserted
via Dacron graft anastomosed to pulmonary artery is simple and allows for
mini-invasive explantation, which in our opinion does not create
serious additional burden to the patient.
In past years one the most discussed complications was
the LVAD thrombosis . In our patient population, a suspected or confirmed
pump thrombosis occurred in 3 (2%) patients. In 2 patients an embolus was
present during the pump inspection at explant. In 1 patient the
episode of pump thrombosis was preceded by an ischemic stroke, and
related to a new onset of atrial fibrillation. We believe, that this finding
further supports our strategy to address possible pre-pump factors of
thrombotic adverse events, such as closure of left atrial appendage in
patients with atrial fibrillation, extraction of ventricular thrombi and
closure of patient foramen ovale at the time of device implantation.
Furthermore, with the HeartMate 3 a new advanced diagnostics in the log
files is possible, which could be instrumental in cases of pump thrombosis
as reported recently . Overall, in MOMENTUM 3 trial and primary cohort
of the ELEVATE registry, the rate of suspected or confirmed pump
thrombosis was reported at 1.4 and 1.5% respectively, which is comparable to
our observation. These very encouraging results are very
probably attributed to the novel design features of Heart-Mate 3
(magnetically levitated rotor, wide blood flow paths, and artificial pulse).
The overall hemocompatibility of HeartMate 3 had been proved to
be superior to HeartMate II in a recent sub-analysis of MOMENTUM 3
Nevertheless, bleeding remains a frequent complication
after HeartMate 3 implantation [4-6].
Compared to previously reported results, the rates of
bleeding events were lower in our study (25.8%). On contrary, we have
observed similar rates of gastrointestinal bleeding as reported in ELEVATE
registry results (9.7% at 2 years). The rather favorable bleeding rates in
our study might have been influenced by our ongoing studies focused on low
intensity anticoagulation protocols in HearMate 3 patients [14, 15].
In one of this studies we have shown, that targeted low-intensity
anticoagulation is achievable and safe with HeartMate 3 . Recently,
several groups reported cessation of warfarin in patients who have
suffered from bleeding complications with rather disputable outcomes
[24, 25]. Further studies will have to evaluate also the ASA use in HeartMate 3
patients, as the recent analysis of MOMENTUM 3 showed that the dose
of the ASA did not affect bleeding and thrombotic events rates . The
prospective, randomized, double-blind, placebo-controlled,
international ARIES HM3 (Anti-platelet Removal and Hemocompatibility
Events with the HM3 Pump) will provide a definitive answer to question
whether ASA therapy provides any meaningful therapeutic effect in
HM 3 patients.
Postoperative strokes were reported in MOMENTUM 3 and
ELEVATE Registry in 9.9 and 9.7% respectively at 2-years after implantation. In
our study cohort we have observed slightly favorable stroke rate of 7.3%.
Occurrence of hemorrhagic stroke in almost half of the stroke events may
advocate for reduced anticoagulation trials and protocols, to further
decrease the stroke rates with HeartMate 3.
Infection was a frequent complication after device
implantation. Almost half of the patients suffered from any infection (49.3%),
similarly to other reported patient cohorts [5, 6, 27, 28].
Interestingly, device related infections were observed in 13.3% patients,
which is significantly superior to rates reported in MOMENTUM 3 or ELEVATE
Registry at 2 years. Driveline infection was observed in 12% of patients. At
our institution great attention is dedicated to driveline exit site
management and staff and patient training. Our institutional protocol comprises
meticulous driveline fixation, aseptic dressing exchanges in
early postoperative period or, in latter phase, regular ambulatory visits
to assess the exit site status. Also frequent patient re-trainings ensure
strict adherence of the patients to the dressing protocol.
Nevertheless, occurrence of the driveline infections emphasizes
the need for fully-implantable device.
Retrospective design of the study is a subject to
limitations associated with retrospective studies. Also, reproducibility
may be limited and affected by institutional experience and institutional
specific characteristics, as all the patients were implanted at a
single center. Moreover, this study is focused on a single device only and
is not comparing outcomes of other available devices.
We have observed survival rates comparable with
international registries using the HeartMate 3 LVAS for long-term
circulatory support. The results of the study confirm high reliability of
the system, enhanced hemocompatibility and have showed adverse event rates
comparable or superior to previously published studies. Still, complications
such as infections, bleeding or strokes remain a concern.
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