JACC: CARDIOVASCULAR INTERVENTIONS
VOL. 7, NO. 9, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
PUBLISHED BY ELSEVIER INC.
http://dx.doi.org/10.1016/j.jcin.2014.04.014
Periprocedural Intracardiac Echocardiography for Left Atrial Appendage Closure A Dual-Center Experience Sergio Berti, MD,* Umberto Paradossi, MD,* Francesco Meucci, MD,y Giuseppe Trianni, MD,* Apostolos Tzikas, MD,z Marco Rezzaghi, MD,* Miroslava Stolkova, MD,y Cataldo Palmieri, MD,* Fabio Mori, MD,y Gennaro Santoro, MDy
ABSTRACT OBJECTIVES This dual-center study sought to demonstrate the utility and safety of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to transesophageal echocardiography (TEE) during Amplatzer Cardiac Plug device implantation. BACKGROUND Over 90% of intracardiac thrombi in atrial fibrillation originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA percutaneous occlusion. TEE is typically used to guide implantation. METHODS ICE-guided percutaneous LAA closure was performed in 121 patients to evaluate the following tasks typically achieved by TEE: assessment of the LAA dimension for device sizing; guidance of transseptal puncture; verification of the delivery sheath position; confirmation of location and stability of the device before and after release and continuous monitoring to detect procedural complications. In 51 consecutive patients, we compared the measurements obtained by ICE and fluoroscopy to choose the size of the device. RESULTS The device was successfully implanted in 117 patients, yielding a technical success rate of 96.7%. Procedural success was achieved in 113 cases (93.4%). Four major adverse events (3 cardiac tamponades and 1 in-hospital transient ischemic attack) occurred. There was significant correlation in the measurements for device sizing assessed by angiography and ICE (r ¼ 0.94, p < 0.0001). CONCLUSIONS ICE imaging was able to perform the tasks typically provided by TEE during implantation of the Amplatzer Cardiac Plug device for LAA occlusion. Therefore, we provide evidence that the use of ICE offered accurate measurements of LAA dimension in order to select the correct device sizes. (J Am Coll Cardiol Intv 2014;7:1036–44) © 2014 by the American College of Cardiology Foundation.
S
troke is the third cause of mortality in West-
associated with AF are secondary to thromboembo-
ern countries and the first cause of serious
lism arising from the left atrial appendage (LAA).
disability and morbidity (1). Patients with
In a review of 23 studies in which the LAA was
atrial fibrillation (AF) have an increased risk for
examined by autopsy, transesophageal echocardiog-
stroke (2), ranging from 2% to >10% per year, de-
raphy (TEE), or direct intraoperative inspection,
pending on additional risk factors (3). As a result,
intracardiac thrombus was identified in 17% of cases
AF is responsible for 15% to 20% of all ischemic
of nonvalvular AF, of which 91% were located in
strokes
the LAA (5).
(4).
The
majority
of
ischemic
strokes
From the *Adult Cardiology Department, Ospedale del Cuore G. Pasquinucci, Fondazione Toscana G. Monasterio, Massa, Italy; yInterventional Diagnostic Department, Azienda Ospedaliera Universitaria Careggi, Florence, Italy; and the zInterventional Cardiology Department, Interbalkan European Medical Center, Thessaloniki, Greece. Dr. Tzikas is a consultant for St. Jude Medical. Dr. Berti is a proctor for both St. Jude and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received January 31, 2014; revised manuscript received March 28, 2014, accepted April 10, 2014.
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
1037
ICE-Guided Percutaneous LAA Closure
The efficacy of chronic anticoagulation therapy to
of cases, patients had histories of minor
ABBREVIATIONS
prevent ischemic strokes in AF is well established (6),
bleeding (56% of these were on OAC), mostly
AND ACRONYMS
and current guidelines recommend an oral anti-
gastrointestinal bleedings. Also, in 9.1% of
coagulation (OAC) regimen to prevent thromboem-
cases,
bolism to all AF patients at risk of stroke (7,8).
thromboembolic events on warfarin. For the
Management
commonly
remaining cases, there were further con-
administered OAC drug, is complicated by a narrow
traindications to OAC, such as 2 cases of
of
warfarin,
the
most
there
were
histories
of
repeated
ACP = Amplatzer Cardiac Plug AF = atrial fibrillation CS = coronary sinus ICE = intracardiac echocardiography
therapeutic window, the need for frequent moni-
cerebral aneurysm, hematological disorders,
toring, significant drug-to-drug interactions, and the
carcinomas, high HAS-BLED (Hypertension,
increased risk of bleeding, which limit the use of
Abnormal renal and liver function, Stroke,
warfarin for a substantial portion of these patients.
Bleeding, Labile INRs, Elderly, Drugs or
OAC = oral anticoagulant(s)
Despite the introduction of novel OAC drugs, devel-
alcohol) scores, as well as others.
RA = right atrium
oped
to
overcome
these
disadvantages
(9–11),
LAA = left atrial appendage LAAC = LAA Closure
TEE = transesophageal
CHARACTERISTICS
ceive OAC due to their bleeding risk or other contra-
DEVICE. All patients underwent TEE examination
indications. For these patients, the option of LAA
from 2 to 5 days before the procedure to exclude the
occlusion by percutaneous implantation of an occlu-
presence of thrombus in the LAA and to assess the
sive device has shown encouraging results as an
LAA anatomy, ostium and landing zone diameters,
alternative to OAC therapy (12,13).
and length. In all cases, we were able to verify that
SEE PAGE 1045
OF
THE
OCCLUSION
echocardiography
a considerable number of AF patients do not re-
the length of the LAA was $10 mm in order to correctly deploy the device with sufficient space.
The use of imaging techniques is of great relevance
Patients were implanted with the Amplatzer Cardiac
throughout all phases of the implantation procedure
Plug (ACP) device or Amplatzer Cardiac Plug II
for LAA occlusion, specifically helping in the choice of
(Amulet) (St. Jude Medical, Plymouth, Minnesota).
the size of the device and in reducing the complication
The ACP device is designed for immediate occlu-
rate, which is still critical in the preliminary experi-
sion of the LAA and consists of a distal lobe and a
ence (13). The use of general anesthesia, typically
proximal disk connected by an articulating waist
required by TEE, can be avoided by application of
(Figure 1). It is a self-expanding device made of a
intracardiac echocardiography (ICE). As previously
nitinol mesh and 2 patches of polyester sewn into
reported by MacDonald et al. (14), this technique, used
both the lobe and the disk. The lobe of the device has
in LAA evaluation and closure for the first time by the
6 stabilizing wires that help to anchor the device in
investigators without TEE, reduced procedure time
the LAA. The device is available in sizes between 16
and can be performed safely under local anesthesia.
and 30 mm (2-mm size increments, lobe size), and the
We present our dual-center experience regarding
proximal disk is 4 to 6 mm larger than the lobe. The
the utility and safety of ICE-guided percutaneous
lobe has a fixed length of 6.5 mm irrespective of
LAA occlusion as an alternative to implantation under
device size. The ACP device is recommended to be
TEE guidance.
oversized by about 2 to 3 mm with respect to the LAA dimensions. The device has a wide positional
METHODS
adaptability due to the connecting waist, which allows the disk of the system to self-orient from the
Between January 1, 2009 and April 30, 2013, all
lobe and completely occlude the ostium of the LAA.
consecutive patients undergoing LAA transcatheter
The Amulet lobe has 12 stabilizing wires for the
occlusion procedure at the Ospedale del Cuore, Fon-
16- and 18-mm devices, 16 stabilizing wires for the
dazione G. Monasterio in Massa, and at the Azienda
20- to 25-mm devices, and 20 stabilizing wires for the
Ospedaliera Universitaria of Careggi in Florence were
28- and 34-mm devices. Stabilizing wires help to
enrolled in this study. Patients scheduled for percu-
anchor the device in the LAA. The device is available in
taneous LAA occlusion had a history of nonrheumatic
sizes between 16 and 34 mm (2-mm size incre-
AF (chronic, paroxysmal, or persistent), a high stroke
ments lobe size, for the 16- to 22-mm devices and 3-mm
risk, and absolute contraindications to OAC. Contra-
increments, lobe size, for the 22- to 34-mm devices).
indications to OAC that led to LAAC were extremely
The proximal disk is 6 to 7 mm larger than the lobe. The
different in our population of 121 patients. In 42%
lobe length is 6.5 mm for the 16- to 22-mm devices and
of cases, patients had histories of major bleeding
10 mm for the 25- to 34-mm devices. The Amulet device
(47% of these were on OAC), mostly spontaneous
is recommended to be oversized by about 2 to 3 mm
or OAC-related intracranial bleedings. In 26.4%
with respect to the LAA dimensions (Figure 1).
1038
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
ICE-Guided Percutaneous LAA Closure
F I G U R E 1 APC and Amulet
An image of the Amplatzer Cardiac Plug (ACP), the left atrial appendage occlusion device used in this study, seen together with the Amulet.
INTRACARDIAC ECHOCARDIOGRAPHY. The implanta-
The ICE probe was positioned in the right atrium
tion procedures were performed under local anes-
(RA) or in the coronary sinus (CS) position (Figures 2A
thesia and guided by fluoroscopy and ICE monitoring
and 2B). ICE guidance was used in the following ways:
using the AcuNav catheter (Biosense Webster, Inc.,
1) to confirm the absence of LAA thrombus; 2) to
Diamond Bar, California). This system is available
identify the LAA landing zone dimension for the de-
in 2 sizes of 8- and 10.5-F shafts. It works with Se-
vice sizing; 3) to guide the transseptal puncture; 4) to
quoia, Cypress, or Aspen imaging systems, all of
verify the delivery sheath position; 5) to confirm the
which are manufactured by Siemens Medical Solu-
location and stability of the device before and after
tions USA, Inc. (Malvern, Pennsylvania), and VIVID i
release; and 6) to continuously monitor to detect any
(GE Healthcare, GE, Fairfield, Connecticut). The fre-
procedural complication, such as cardiac tamponade.
quency of the transducer varies from 5.5 to 10 MHz.
In the last 51 consecutive patients enrolled in
The catheter can be steered in 4 directions (anterior,
Massa Ospedale del Cuore G. Pasquinucci, ICE was
posterior, left, and right). It also has color flow and
also used to assess the diameter of the LAA by
spectral Doppler capabilities. Once the desired posi-
measuring the transverse diameter 10 mm below the
tion of the catheter tip has been achieved, it can
ostium, called the landing zone of the device. The
be set in that position with a lock mechanism, which
same diameter was then measured by angiography
is located on the catheter handle.
by a different operator.
F I G U R E 2 View of the LAA From the Right Atrium and CS
(A) The figure shows the intracardiac echocardiography view of the left atrium and left atrial appendage (LAA) as seen from the right atrium. The long axis of the LAA, the circumflex artery, the mitral valve, and the interatrial septum can be seen. (B) The LAA as seen from the coronary sinus (CS). View of a pectinate muscle.
Berti et al.
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LAA
OCCLUSION:
ICE-Guided Percutaneous LAA Closure
TECHNIQUE. Based
on
these
on procedure-related aspects and acute treatment
measurements, the size of the device was chosen
results. Specifically, the following endpoints were
following the manufacturer’s recommended sheath
defined: 1) technical success: successful delivery
size. Positioning and deployment of the device was
and deployment of the device; and 2) procedural
performed under combined fluoroscopic and ICE
success: technical success and the absence of major
guidance. The ideal lobe for sheath placement was
adverse events during hospitalization. Major ad-
decided on the basis of fluoroscopic images. The lobe
verse events included death, stroke, embolism,
of the device was placed inside the LAA, reaching
pericardial or other major bleeding requiring inter-
the chosen landing zone while the disk was posi-
vention, device embolization, and major vascular
tioned in order to seal the LAA ostium and achieve
complications.
complete exclusion of the appendage. Appropriate
All statistical analyses were conducted with the
implantation was confirmed by a lobe positioned
StatView statistical package (version 5.0.1, SAS Insti-
completely inside the LAA, aligned with the LAA
tute, Cary, North Carolina). Continuous variables are
landing zone and with a slight deformation of its
presented by mean SD (range) and event rates are
body (tire-shape) (Figures 3A and 3B). The procedure
expressed as percentages. Differences between LAA
has been previously described in detail by Berti et al.
dimensions measured by ICE and fluoroscopy were
(15). Additional indicators for appropriate implanta-
evaluated by paired Student t test. Correlation be-
tion included a clear separation between disk and
tween continuous variables was assessed by means of
lobe and a concave shape of the disk visible by fluo-
Pearson correlation coefficient. Statistical signifi-
roscopy. Contrast fluid was injected through the
cance was defined as p < 0.05 (Figure 5).
sheath to confirm the position of the device and the effective-LAA occlusion. Device stability was verified
RESULTS
by either ICE or fluoroscopy, as device embolization has been reported as a possible complication (12,13). In
A total of 121 patients with a history of non-
all patients, the proximal disk was kept on traction for
rheumatic AF of at least 12 months, CHA2DS 2VASc
at least 3 min to allow the device lobe to anchor within
(Congestive heart failure [or left ventricular systolic
the LAA trabecular anatomy and to verify device
dysfunction], Hypertension: blood pressure consis-
stability (Figures 4A and 4B).
tently >140/90 mm Hg [or treated hypertension on medication], Age $75 years, Diabetes mellitus,
DATA ANALYSIS. The analysis included data col-
previous Stroke or TIA or thromboembolism, Vas-
lected with respect to patient demographics and
cular disease [e.g., peripheral artery disease, myo-
characteristics, procedural data, and complications
cardial infarction, aortic plaque], Age 65 to 74 years,
that occurred during the implantation and subsequent
Sex category [e.g., female sex]) score $2 and abso-
hospitalization. Data were analyzed with emphasis
lute or relative contraindications to OAC were
F I G U R E 3 View of the APC Correctly Implanted Seen by Fluoroscopy and ICE
The device after it has been completely released, demonstrating the occlusion of the left atrial appendage from (A) a fluoroscopy view and (B) intracardiac echocardiography (ICE) view. APC ¼ Amplatzer Cardiac Plug.
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ICE-Guided Percutaneous LAA Closure
F I G U R E 4 Traction Test Seen by Fluoroscopy and ICE
(A) Fluoroscopy view of the Amplatzer Cardiac Plug traction or stability test LAO 40/CRAN 20. (B) The same test as seen by intracardiac echocardiography (ICE) and from the coronary sinus. CRAN ¼ cranial; LAO ¼ left anterior oblique.
included. Mean age was 77 7.6 years old (range
angiography. LAA dimensions measured by ICE and
56 to 93 years) and 69 patients (57%) were men
angiography differed minimally in all patients. The
(Table 1).
mean LAA landing zone for device diameter assessed
The device was successfully implanted in 117
by fluoroscopy was 21.0 3.5 mm (range 14.0 to 29.4
patients, yielding a technical success rate of 96.7%.
mm), whereas by ICE it was 20.6 3.3 mm (range 13.6
LAA access was achieved by transseptal puncture in
to 29.0 mm). The landing zones assessed by an-
118 of 121 (97.5%) of the cases, and in the remaining
giography and ICE were significantly correlated
3 cases (2.5%), a patent foramen ovale was used to
(Pearson correlation coefficient r ¼ 0.94, 2-tailed test
enter the LAA.
p < 0.0001).
In 51 patients, we compared the LAA ostium and landing
zone
diameters
obtained
by
ICE
and
Furthermore, ostium and landing zone measurements by ICE were significantly related to TEE (Pearson correlation coefficient r ¼ 0.94, p < 0.0001;
T A B L E 1 Baseline Characteristics
Patients
121
Male
69 (57)
Age
77 7.6 (56–93)
HAS-BLED score
3.3 1.0
CHA2DS2-VASc score
4.4 1.3
CHF Hypertension
16 (13.2) 108 (89.3)
Diabetes mellitus
29 (24)
Previous stroke/TIA
38 (31.4)
AF pattern Permanent
88 (72.7)
Paroxysmal
25 (20.7)
Unknown
8 (6.6)
Values are n, n (%), mean SD (range), or mean SD.
F I G U R E 5 Regression Plot
Graph showing the significant correlation between the angiographic (ANGIO) and intracardiac echocardiography (ICE) measurements of the landing zones (LZ).
AF ¼ atrial fibrillation; CHA2DS2VASc score ¼ Congestive heart failure (or left ventricular systolic dysfunction), Hypertension: blood pressure consistently >140/90 mm Hg (or treated hypertension on medication), Age $75 years, Diabetes mellitus, previous Stroke or TIA or thromboembolism, Vascular disease (e.g., peripheral artery disease, myocardial infarction, aortic plaque), Age 65 to 74 years, Sex category (e.g., female sex); CHF ¼ congestive heart failure; HASBLED ¼ Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INRs, Elderly, Drugs or alcohol; TIA ¼ transient ischemic attack.
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
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ICE-Guided Percutaneous LAA Closure
F I G U R E 6 LAA Measurements
The ostium (yellow line) and landing zone (red line) from pre-procedural transesophageal echocardiography (A) and periprocedural ICE (B) in the same patient. LA ¼ left atrium; MV ¼ mitral valve; other abbreviations as in Figures 1 and 3.
r ¼ 0.72, p < 0.0001; for ostium and landing zone,
correctly detected by pre-procedural TEE. The cause
respectively). More specifically, in 78.4% of the cases,
of the last technical failure was an insufficiently sized
the device selected based on ICE measurements
landing zone. The most frequent adverse event was
was the same as the device selected based on TEE
cardiac tamponade, which occurred in 3 patients. Two
measurements. In 21.6% of cases, the device was
cardiac tamponades occurred 4 and 8 h, respectively,
1 size larger, and in no cases was it smaller (Figure 6).
after intervention in patients whose procedures were
Of all 121 patients evaluated by TEE, the majority
prolonged due to many device-retrieval attempts;
(67.7%) had a dual-lobe LAA anatomy that originated
both complications were resolved by pericardiocent-
distally 10 mm from the ostium; a single-lobe anatomy
esis. The third cardiac tamponade occurred due to a
was observed in 17.2% of the patients. The mean
LAA perforation and a consequent pulmonary artery
diameter of the device implanted was 24.0 3.5 mm
laceration that was resolved surgically (16). In all
(range 16 to 34 mm). In 89.7% (105 of 117) of pro-
these cases we had good ICE-derived images.
cedures, the first selected device was implanted; in 4 cases, the initial device was replaced by a smaller
No cases of pericardial effusion without tamponade were observed in our cohort.
device; and in 8 other cases, a larger device was used. In all procedures, appropriate device positioning and effective LAA occlusion were accomplished in a single attempt. No obvious relationship was noticed
T A B L E 2 Complications
Major complications
between the number of attempts required and the LAA
Serious pericardial effusion*
3 (2.5)
orifice diameter or the number of LAA lobes. The use of
Device embolization
0 (0)
ICE together with angiography has, in all cases, pro-
Major bleeding†
0 (0)
vided us with an adequate guide, and in no cases did
Procedure-related ischemic stroke‡
1 (0.8)
we need to refer back to the images acquired with TEE.
Hemorrhagic stroke
0 (0)
Minor complications
ADVERSE EVENTS. Among the 121 procedures, 4
Pericardial effusion, without tamponade
adverse events and 3 minor complications occurred
Femoral hematoma§
2 (1.6)
(Table 2). We had 4 cases of technical failure (3.3% of
Others
0 (0)
total). In 3 cases, the anatomy of the LAA was characterized by too many lobes and was not suitable for a device apposition. This was only discovered by angiography images, because they were not
0 (0)
Values are n (%). *Defined as the need of percutaneous or surgical drainage. †Defined as a bleeding event that required $2 units of packed red blood cells or surgery to correct. ‡Transient ischemic attack 24 h after procedure. §One left femoral hematoma and 1 right femoral hematoma.
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JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
ICE-Guided Percutaneous LAA Closure
Another patient experienced a transient ischemic
90% and higher (13,20) compared with 96.7% in this
attack 24 h after the procedure. The brain computed
study.
tomography scan was negative for ischemic lesion,
including significant pericardial effusion, tamponade
and the event spontaneously resolved within a few
and periprocedural stroke, are reported to be be-
hours. The patient was discharged without any
tween 3.7% and 7.7% (13,20). In this study, adverse
sequela. Minor complications included 2 cases of
events occurred in 3.4% of the procedures, including
femoral hematomas. In 1 case, the femoral hematoma
3 pericardial tamponades and 1 transient ischemic
was on left side, the ICE access side. This complica-
attack. Another critical point is the presence of
tion did not require a blood transfusion or reinter-
peridevice leaks after device implantation. Angiog-
vention, only a compression of a major duration
raphy and TEE are undoubtedly more precise than
without a prolonged hospitalization.
ICE in monitoring the presence of any peridevice
Accounting for the 4 major adverse events, the procedural success rate was 93.4% (113 of 121 cases).
Typical
rates
for
major
complications,
leaks. In our experience, it has been established that small leaks that were visible only by angiography did not present a need for device substitution.
DISCUSSION
However, leaks that were visible both with angiography
The use of procedural echocardiography is an essen-
and
ICE
were
motivation
for
device
substitution.
tial requirement for safe and successful percutaneous
As stated by some investigators, there is some
LAA occlusion. Without disputing the value of a pre-
experience of fluoroscopy-only-guided LAAC that
procedural TEE examination to explore the relevant
has demonstrated the reliability of a procedure us-
cardiac anatomy and exclude thrombi, our results
ing local anesthesia and fluoroscopy alone (21). In
suggest that ICE is an acceptable alternative to TEE
our opinion, purely fluoroscopic guidance in LAAC
during implantation of the ACP device.
has significant limitations. Hence, complications
ICE is an imaging technique applied in various
may result from suboptimal catheter handling and
interventional cardiac procedures, including catheter
device performance from undetected thrombus for-
ablation of AF, percutaneous closure of atrial and
mation, bleeding, and wall disruption. Especially
ventricular septal defects, and mitral valvuloplasty
for learning curve centers, we recommend the use
(17,18). For a series of 10 patients, ICE imaging during
of fluoroscopy integrated with echocardiographic
percutaneous LAA occlusion was previously reported
imaging.
to be optimal with the ICE probe positioned in the coronary sinus (19). In 28 of 51 cases, we integrated
Concerning
the
periprocedural
assessment
of
the appropriate device size, a high level of agree-
the images with views both from the CS and the RA.
ment was found between results from fluoros-
While the ICE views from the CS provided good
copy and ICE. The initially selected device was
images, in our experience, this is not fundamental
only exchanged for a differently sized device in 10.3%
because we achieved satisfactory images for all pro-
of the cases. This compares well with results reported
cedural aspects from the standard RA position. Al-
for the same device by operators using TEE (13,22).
though ICE may result in an inferior image quality
Application of TEE and endotracheal intubation
compared with that of TEE, in our experience this is
may contribute to complications such as injuries
not affecting the safety and technical success of the
and bleeding of gastroesophageal and respiratory
implantation procedure, provided that key informa-
tract, laryngospasm and bronchospasm requiring ad-
tion is recorded during the pre-procedural TEE
ditional intervention, and/or prolonged hospitaliza-
examination. In the case of both pre-procedural
tion. The use of ICE eliminates the need for general
TEE and periprocedural ICE, it is fundamental to
anesthesia, which is beneficial for all, especially
find the measures of the LAA ostium and landing
older patients. Moreover, as shown in our study,
zone. It is not easy to evaluate the full length of
left femoral vein hematoma is the only ICE-related
the appendage because of the complex geometry of
complication, a minor complication not requiring
the LAA; however, a critical point is to verify that
any blood transfusion reintervention or prolonged
the minimum length from the neck must be $10 mm
hospitalization. With regard to the percutaneous clo-
in order to have sufficient room for the correct
sure of interatrial communications, ICE, compared
deployment of the device.
with TEE, has been reported to result in less proce-
ICE-guided
percutaneous
LAA
occlusion
is
dural discomfort for the patient and reduced proce-
feasible with similar results to those reported for
dural time and ionizing radiation exposure (23) and
TEE-guided implantation. Technical success rates
to avoid the obstruction of fluoroscopic viewing.
for percutaneous LAA occlusion are reported to be
Although not assessed in our study, it seems
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
ICE-Guided Percutaneous LAA Closure
reasonable to assume that similar benefits exist for
STUDY LIMITATIONS. Our study was a dual-center
percutaneous LAA occlusion.
observational study without a control group, and
The use of ICE instead of TEE does not require
our results may not be extrapolated to other LAA
the presence of an anesthesiologist, and therefore
occlusion devices and other types of ICE catheters.
the amount of global exposure to ionizing radia-
Further investigations are required to fully charac-
tion is also reduced for the operators involved. In
terize the application of ICE during percutaneous LAA
periprocedural use of TEE or ICE, 2 operators are
occlusion, including its impact on safety, the length
always necessary (1 for the implantation and 1
of learning curve, procedural success, and healthcare
for the imaging). The safety issue is the proximity
costs.
of the TEE operator to the x-ray tube and the lack of x-ray screen protection in that position. In peri-
CONCLUSIONS
procedural ICE use, both operators are on the same side as the patient behind the x-ray screen
Although accepted as the guiding tool for percuta-
protection.
neous LAAC device closure procedures and for
It is questionable whether the additional ICE
electrophysiological catheter-based ablations, ran-
probe increases the overall cost of the procedure.
domized multicenter trials on ICE in this context
That cost is probably balanced by the added cost of
are lacking. In our experience, ICE represents a safe
the TEE-experienced echocardiographer, the anes-
and useful ultrasound option for guiding the LAA
thesiology team, and the longer catheterization lab
transcatheter occlusion procedure and for prevent-
occupancy. Furthermore, the use of local anesthesia
ing short- and mid-term complications having the
may reduce direct medication and personnel costs
advantage over TEE of not requiring the support of
(24,25), as well secondary costs related to TEE
general anesthesia and anesthesiology. These factors provide direct benefits to patients. Compared
complications. In our patients, the visualization of the LAA was
with fluoroscopy, ICE also showed a good accuracy
feasible with the ICE using the RA and CS positions,
in assessing LAA dimension in order to select the
and the measurements obtained by angiography and
correct device sizes.
ICE were significantly correlated.
ACKNOWLEDGMENT The authors thank Karin Joan
The LAA dimension is essential for selecting the
Tyack for her linguistic support.
correct size of the device, and we observed that the accuracy of ICE is comparable with angiography
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
in evaluating LAA measurements. ICE may represent
Sergio Berti, Adult Cardiology Department, Ospedale
a valid support for imaging guidance during the
del Cuore, Fondazione Toscana G. Monasterio, Via
percutaneous LAA closure procedure.
Aurelia Sud, 54100 Massa, Italy. E-mail: [email protected].
REFERENCES 1. Sacco RL, Benjamin EJ, Broderick JP, et al. American Heart Association Prevention Conference IV: prevention and rehabilitation of stroke: risk factors. Stroke 1997;28:1507–17. 2. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22: 983–8. 3. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285:2864–70. 4. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke
with atrial fibrillation. Ann Thorac Surg 1996;61: 755–9.
Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139–51.
6. Hart RG, Pearce LA, Aguilar MI. Meta-analysis:
10. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. New Engl J Med 2011;365:
antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857–67. 7. Camm AJ, Kirchhof P, Lip GY, et al., for the European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010;31:2369–429. 8. Camm AJ, Lip GY, De Caterina R, et al., for the ESC Committee for Practice Guidelines. 2012
981–92. 11. Patel MR, Mahaffey KW, Garg J, et al., for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883–91. 12. Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised noninferiority trial. Lancet 2009;374:534–42. 13. Park JW, Bethencourt A, Sievert H, et al. Left
prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285:2370–5.
focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Eur Heart J 2012;33:2719–47.
5. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients
9. Connolly SJ, Ezekowitz MD, Yusuf S, et al., for the RE-LY Steering Committee and Investigators.
14. MacDonald ST, Newton JD, Ormerod OJ. Intracardiac echocardiography off piste? Closure
atrial appendage closure with Amplatzer Cardiac Plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv 2011;77:700–6.
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ICE-Guided Percutaneous LAA Closure
of left atrial appendage using ICE and local anesthesia. Catheter Cardiovasc Interv 2011;77:124–7. 15. Berti S, Santoro G, Palmieri C, Meucci F. Tools and techniques clinical: transcatheter closure of left atrial appendage using the Amplatzer Cardiac Plug. EuroIntervention 2013;9:524–6. 16. Bianchi G, Solinas M, Gasbarri T, et al. Pulmonary artery perforation by plug anchoring system after percutaneous closure of left appendage. Ann Thorac Surg 2013;96:e3–5. 17. Biermann J, Bode C, Asbach S. Intracardiac echocardiography during catheter-based ablation of atrial fibrillation. Cardiol Res Pract 2012;2012: 921746, http://dx.doi.org/10.1155/2012/921746. May 29, 2012 [E-pub ahead of print].
19. Ho IC, Neuzil P, Mraz T, et al. Use of intracardiac echocardiography to guide implantation of a left atrial appendage occlusion device (PLAATO). Heart Rhythm 2007;4:567–71.
23. Bartel T, Konorza T, Neudorf U, et al. Intracardiac echocardiography: an ideal guiding tool for device closure of interatrial communications. Eur J Echocardiogr 2005;6:92–6.
20. Reddy VV, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) clinical trial and
24. Budts W, Troost E, Voigt JU, Gewillig M. Intra-cardiac echocardiography in atrial septal
the Continued Access Registry. Circulation 2011; 123:417–24. 21. Guérios EE, Schmid M, Gloekler S, et al. Left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation. Arq Bras Cardiol 2012;98:528–36.
18. Hijazi ZM, Shivkumar K, Sahn DJ. Intracardiac echocardiography during interventional and elec-
22. Meerkin D, Butnaru A, Dratva D, Tzivoni D. Initial experience with Amplatzer Cardiac Plug for
trophysiological cardiac catheterization. Circulation 2009;119:587–96.
left atrial appendage closure (abstr). J Am Coll Cardiol 2011;57:E1684.
interventions: impact on hospitalization costs. Acta Cardiol 2010;65:147–52. 25. Alboliras ET, Hijazi ZM. Comparison of costs of intracardiac echocardiography and transesophageal echocardiography in monitoring percutaneous device closure of atrial septal defect in children and adults. Am J Cardiol 2004;94: 690–2.
KEY WORDS atrial fibrillation, intracardiac echocardiography, intraprocedural imaging, left atrial appendage occlusion, transesophageal echocardiography
VOL. 7, NO. 9, 2014
ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
PUBLISHED BY ELSEVIER INC.
http://dx.doi.org/10.1016/j.jcin.2014.04.014
Periprocedural Intracardiac Echocardiography for Left Atrial Appendage Closure A Dual-Center Experience Sergio Berti, MD,* Umberto Paradossi, MD,* Francesco Meucci, MD,y Giuseppe Trianni, MD,* Apostolos Tzikas, MD,z Marco Rezzaghi, MD,* Miroslava Stolkova, MD,y Cataldo Palmieri, MD,* Fabio Mori, MD,y Gennaro Santoro, MDy
ABSTRACT OBJECTIVES This dual-center study sought to demonstrate the utility and safety of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to transesophageal echocardiography (TEE) during Amplatzer Cardiac Plug device implantation. BACKGROUND Over 90% of intracardiac thrombi in atrial fibrillation originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA percutaneous occlusion. TEE is typically used to guide implantation. METHODS ICE-guided percutaneous LAA closure was performed in 121 patients to evaluate the following tasks typically achieved by TEE: assessment of the LAA dimension for device sizing; guidance of transseptal puncture; verification of the delivery sheath position; confirmation of location and stability of the device before and after release and continuous monitoring to detect procedural complications. In 51 consecutive patients, we compared the measurements obtained by ICE and fluoroscopy to choose the size of the device. RESULTS The device was successfully implanted in 117 patients, yielding a technical success rate of 96.7%. Procedural success was achieved in 113 cases (93.4%). Four major adverse events (3 cardiac tamponades and 1 in-hospital transient ischemic attack) occurred. There was significant correlation in the measurements for device sizing assessed by angiography and ICE (r ¼ 0.94, p < 0.0001). CONCLUSIONS ICE imaging was able to perform the tasks typically provided by TEE during implantation of the Amplatzer Cardiac Plug device for LAA occlusion. Therefore, we provide evidence that the use of ICE offered accurate measurements of LAA dimension in order to select the correct device sizes. (J Am Coll Cardiol Intv 2014;7:1036–44) © 2014 by the American College of Cardiology Foundation.
S
troke is the third cause of mortality in West-
associated with AF are secondary to thromboembo-
ern countries and the first cause of serious
lism arising from the left atrial appendage (LAA).
disability and morbidity (1). Patients with
In a review of 23 studies in which the LAA was
atrial fibrillation (AF) have an increased risk for
examined by autopsy, transesophageal echocardiog-
stroke (2), ranging from 2% to >10% per year, de-
raphy (TEE), or direct intraoperative inspection,
pending on additional risk factors (3). As a result,
intracardiac thrombus was identified in 17% of cases
AF is responsible for 15% to 20% of all ischemic
of nonvalvular AF, of which 91% were located in
strokes
the LAA (5).
(4).
The
majority
of
ischemic
strokes
From the *Adult Cardiology Department, Ospedale del Cuore G. Pasquinucci, Fondazione Toscana G. Monasterio, Massa, Italy; yInterventional Diagnostic Department, Azienda Ospedaliera Universitaria Careggi, Florence, Italy; and the zInterventional Cardiology Department, Interbalkan European Medical Center, Thessaloniki, Greece. Dr. Tzikas is a consultant for St. Jude Medical. Dr. Berti is a proctor for both St. Jude and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received January 31, 2014; revised manuscript received March 28, 2014, accepted April 10, 2014.
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
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ICE-Guided Percutaneous LAA Closure
The efficacy of chronic anticoagulation therapy to
of cases, patients had histories of minor
ABBREVIATIONS
prevent ischemic strokes in AF is well established (6),
bleeding (56% of these were on OAC), mostly
AND ACRONYMS
and current guidelines recommend an oral anti-
gastrointestinal bleedings. Also, in 9.1% of
coagulation (OAC) regimen to prevent thromboem-
cases,
bolism to all AF patients at risk of stroke (7,8).
thromboembolic events on warfarin. For the
Management
commonly
remaining cases, there were further con-
administered OAC drug, is complicated by a narrow
traindications to OAC, such as 2 cases of
of
warfarin,
the
most
there
were
histories
of
repeated
ACP = Amplatzer Cardiac Plug AF = atrial fibrillation CS = coronary sinus ICE = intracardiac echocardiography
therapeutic window, the need for frequent moni-
cerebral aneurysm, hematological disorders,
toring, significant drug-to-drug interactions, and the
carcinomas, high HAS-BLED (Hypertension,
increased risk of bleeding, which limit the use of
Abnormal renal and liver function, Stroke,
warfarin for a substantial portion of these patients.
Bleeding, Labile INRs, Elderly, Drugs or
OAC = oral anticoagulant(s)
Despite the introduction of novel OAC drugs, devel-
alcohol) scores, as well as others.
RA = right atrium
oped
to
overcome
these
disadvantages
(9–11),
LAA = left atrial appendage LAAC = LAA Closure
TEE = transesophageal
CHARACTERISTICS
ceive OAC due to their bleeding risk or other contra-
DEVICE. All patients underwent TEE examination
indications. For these patients, the option of LAA
from 2 to 5 days before the procedure to exclude the
occlusion by percutaneous implantation of an occlu-
presence of thrombus in the LAA and to assess the
sive device has shown encouraging results as an
LAA anatomy, ostium and landing zone diameters,
alternative to OAC therapy (12,13).
and length. In all cases, we were able to verify that
SEE PAGE 1045
OF
THE
OCCLUSION
echocardiography
a considerable number of AF patients do not re-
the length of the LAA was $10 mm in order to correctly deploy the device with sufficient space.
The use of imaging techniques is of great relevance
Patients were implanted with the Amplatzer Cardiac
throughout all phases of the implantation procedure
Plug (ACP) device or Amplatzer Cardiac Plug II
for LAA occlusion, specifically helping in the choice of
(Amulet) (St. Jude Medical, Plymouth, Minnesota).
the size of the device and in reducing the complication
The ACP device is designed for immediate occlu-
rate, which is still critical in the preliminary experi-
sion of the LAA and consists of a distal lobe and a
ence (13). The use of general anesthesia, typically
proximal disk connected by an articulating waist
required by TEE, can be avoided by application of
(Figure 1). It is a self-expanding device made of a
intracardiac echocardiography (ICE). As previously
nitinol mesh and 2 patches of polyester sewn into
reported by MacDonald et al. (14), this technique, used
both the lobe and the disk. The lobe of the device has
in LAA evaluation and closure for the first time by the
6 stabilizing wires that help to anchor the device in
investigators without TEE, reduced procedure time
the LAA. The device is available in sizes between 16
and can be performed safely under local anesthesia.
and 30 mm (2-mm size increments, lobe size), and the
We present our dual-center experience regarding
proximal disk is 4 to 6 mm larger than the lobe. The
the utility and safety of ICE-guided percutaneous
lobe has a fixed length of 6.5 mm irrespective of
LAA occlusion as an alternative to implantation under
device size. The ACP device is recommended to be
TEE guidance.
oversized by about 2 to 3 mm with respect to the LAA dimensions. The device has a wide positional
METHODS
adaptability due to the connecting waist, which allows the disk of the system to self-orient from the
Between January 1, 2009 and April 30, 2013, all
lobe and completely occlude the ostium of the LAA.
consecutive patients undergoing LAA transcatheter
The Amulet lobe has 12 stabilizing wires for the
occlusion procedure at the Ospedale del Cuore, Fon-
16- and 18-mm devices, 16 stabilizing wires for the
dazione G. Monasterio in Massa, and at the Azienda
20- to 25-mm devices, and 20 stabilizing wires for the
Ospedaliera Universitaria of Careggi in Florence were
28- and 34-mm devices. Stabilizing wires help to
enrolled in this study. Patients scheduled for percu-
anchor the device in the LAA. The device is available in
taneous LAA occlusion had a history of nonrheumatic
sizes between 16 and 34 mm (2-mm size incre-
AF (chronic, paroxysmal, or persistent), a high stroke
ments lobe size, for the 16- to 22-mm devices and 3-mm
risk, and absolute contraindications to OAC. Contra-
increments, lobe size, for the 22- to 34-mm devices).
indications to OAC that led to LAAC were extremely
The proximal disk is 6 to 7 mm larger than the lobe. The
different in our population of 121 patients. In 42%
lobe length is 6.5 mm for the 16- to 22-mm devices and
of cases, patients had histories of major bleeding
10 mm for the 25- to 34-mm devices. The Amulet device
(47% of these were on OAC), mostly spontaneous
is recommended to be oversized by about 2 to 3 mm
or OAC-related intracranial bleedings. In 26.4%
with respect to the LAA dimensions (Figure 1).
1038
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
ICE-Guided Percutaneous LAA Closure
F I G U R E 1 APC and Amulet
An image of the Amplatzer Cardiac Plug (ACP), the left atrial appendage occlusion device used in this study, seen together with the Amulet.
INTRACARDIAC ECHOCARDIOGRAPHY. The implanta-
The ICE probe was positioned in the right atrium
tion procedures were performed under local anes-
(RA) or in the coronary sinus (CS) position (Figures 2A
thesia and guided by fluoroscopy and ICE monitoring
and 2B). ICE guidance was used in the following ways:
using the AcuNav catheter (Biosense Webster, Inc.,
1) to confirm the absence of LAA thrombus; 2) to
Diamond Bar, California). This system is available
identify the LAA landing zone dimension for the de-
in 2 sizes of 8- and 10.5-F shafts. It works with Se-
vice sizing; 3) to guide the transseptal puncture; 4) to
quoia, Cypress, or Aspen imaging systems, all of
verify the delivery sheath position; 5) to confirm the
which are manufactured by Siemens Medical Solu-
location and stability of the device before and after
tions USA, Inc. (Malvern, Pennsylvania), and VIVID i
release; and 6) to continuously monitor to detect any
(GE Healthcare, GE, Fairfield, Connecticut). The fre-
procedural complication, such as cardiac tamponade.
quency of the transducer varies from 5.5 to 10 MHz.
In the last 51 consecutive patients enrolled in
The catheter can be steered in 4 directions (anterior,
Massa Ospedale del Cuore G. Pasquinucci, ICE was
posterior, left, and right). It also has color flow and
also used to assess the diameter of the LAA by
spectral Doppler capabilities. Once the desired posi-
measuring the transverse diameter 10 mm below the
tion of the catheter tip has been achieved, it can
ostium, called the landing zone of the device. The
be set in that position with a lock mechanism, which
same diameter was then measured by angiography
is located on the catheter handle.
by a different operator.
F I G U R E 2 View of the LAA From the Right Atrium and CS
(A) The figure shows the intracardiac echocardiography view of the left atrium and left atrial appendage (LAA) as seen from the right atrium. The long axis of the LAA, the circumflex artery, the mitral valve, and the interatrial septum can be seen. (B) The LAA as seen from the coronary sinus (CS). View of a pectinate muscle.
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JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
LAA
OCCLUSION:
ICE-Guided Percutaneous LAA Closure
TECHNIQUE. Based
on
these
on procedure-related aspects and acute treatment
measurements, the size of the device was chosen
results. Specifically, the following endpoints were
following the manufacturer’s recommended sheath
defined: 1) technical success: successful delivery
size. Positioning and deployment of the device was
and deployment of the device; and 2) procedural
performed under combined fluoroscopic and ICE
success: technical success and the absence of major
guidance. The ideal lobe for sheath placement was
adverse events during hospitalization. Major ad-
decided on the basis of fluoroscopic images. The lobe
verse events included death, stroke, embolism,
of the device was placed inside the LAA, reaching
pericardial or other major bleeding requiring inter-
the chosen landing zone while the disk was posi-
vention, device embolization, and major vascular
tioned in order to seal the LAA ostium and achieve
complications.
complete exclusion of the appendage. Appropriate
All statistical analyses were conducted with the
implantation was confirmed by a lobe positioned
StatView statistical package (version 5.0.1, SAS Insti-
completely inside the LAA, aligned with the LAA
tute, Cary, North Carolina). Continuous variables are
landing zone and with a slight deformation of its
presented by mean SD (range) and event rates are
body (tire-shape) (Figures 3A and 3B). The procedure
expressed as percentages. Differences between LAA
has been previously described in detail by Berti et al.
dimensions measured by ICE and fluoroscopy were
(15). Additional indicators for appropriate implanta-
evaluated by paired Student t test. Correlation be-
tion included a clear separation between disk and
tween continuous variables was assessed by means of
lobe and a concave shape of the disk visible by fluo-
Pearson correlation coefficient. Statistical signifi-
roscopy. Contrast fluid was injected through the
cance was defined as p < 0.05 (Figure 5).
sheath to confirm the position of the device and the effective-LAA occlusion. Device stability was verified
RESULTS
by either ICE or fluoroscopy, as device embolization has been reported as a possible complication (12,13). In
A total of 121 patients with a history of non-
all patients, the proximal disk was kept on traction for
rheumatic AF of at least 12 months, CHA2DS 2VASc
at least 3 min to allow the device lobe to anchor within
(Congestive heart failure [or left ventricular systolic
the LAA trabecular anatomy and to verify device
dysfunction], Hypertension: blood pressure consis-
stability (Figures 4A and 4B).
tently >140/90 mm Hg [or treated hypertension on medication], Age $75 years, Diabetes mellitus,
DATA ANALYSIS. The analysis included data col-
previous Stroke or TIA or thromboembolism, Vas-
lected with respect to patient demographics and
cular disease [e.g., peripheral artery disease, myo-
characteristics, procedural data, and complications
cardial infarction, aortic plaque], Age 65 to 74 years,
that occurred during the implantation and subsequent
Sex category [e.g., female sex]) score $2 and abso-
hospitalization. Data were analyzed with emphasis
lute or relative contraindications to OAC were
F I G U R E 3 View of the APC Correctly Implanted Seen by Fluoroscopy and ICE
The device after it has been completely released, demonstrating the occlusion of the left atrial appendage from (A) a fluoroscopy view and (B) intracardiac echocardiography (ICE) view. APC ¼ Amplatzer Cardiac Plug.
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ICE-Guided Percutaneous LAA Closure
F I G U R E 4 Traction Test Seen by Fluoroscopy and ICE
(A) Fluoroscopy view of the Amplatzer Cardiac Plug traction or stability test LAO 40/CRAN 20. (B) The same test as seen by intracardiac echocardiography (ICE) and from the coronary sinus. CRAN ¼ cranial; LAO ¼ left anterior oblique.
included. Mean age was 77 7.6 years old (range
angiography. LAA dimensions measured by ICE and
56 to 93 years) and 69 patients (57%) were men
angiography differed minimally in all patients. The
(Table 1).
mean LAA landing zone for device diameter assessed
The device was successfully implanted in 117
by fluoroscopy was 21.0 3.5 mm (range 14.0 to 29.4
patients, yielding a technical success rate of 96.7%.
mm), whereas by ICE it was 20.6 3.3 mm (range 13.6
LAA access was achieved by transseptal puncture in
to 29.0 mm). The landing zones assessed by an-
118 of 121 (97.5%) of the cases, and in the remaining
giography and ICE were significantly correlated
3 cases (2.5%), a patent foramen ovale was used to
(Pearson correlation coefficient r ¼ 0.94, 2-tailed test
enter the LAA.
p < 0.0001).
In 51 patients, we compared the LAA ostium and landing
zone
diameters
obtained
by
ICE
and
Furthermore, ostium and landing zone measurements by ICE were significantly related to TEE (Pearson correlation coefficient r ¼ 0.94, p < 0.0001;
T A B L E 1 Baseline Characteristics
Patients
121
Male
69 (57)
Age
77 7.6 (56–93)
HAS-BLED score
3.3 1.0
CHA2DS2-VASc score
4.4 1.3
CHF Hypertension
16 (13.2) 108 (89.3)
Diabetes mellitus
29 (24)
Previous stroke/TIA
38 (31.4)
AF pattern Permanent
88 (72.7)
Paroxysmal
25 (20.7)
Unknown
8 (6.6)
Values are n, n (%), mean SD (range), or mean SD.
F I G U R E 5 Regression Plot
Graph showing the significant correlation between the angiographic (ANGIO) and intracardiac echocardiography (ICE) measurements of the landing zones (LZ).
AF ¼ atrial fibrillation; CHA2DS2VASc score ¼ Congestive heart failure (or left ventricular systolic dysfunction), Hypertension: blood pressure consistently >140/90 mm Hg (or treated hypertension on medication), Age $75 years, Diabetes mellitus, previous Stroke or TIA or thromboembolism, Vascular disease (e.g., peripheral artery disease, myocardial infarction, aortic plaque), Age 65 to 74 years, Sex category (e.g., female sex); CHF ¼ congestive heart failure; HASBLED ¼ Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INRs, Elderly, Drugs or alcohol; TIA ¼ transient ischemic attack.
Berti et al.
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ICE-Guided Percutaneous LAA Closure
F I G U R E 6 LAA Measurements
The ostium (yellow line) and landing zone (red line) from pre-procedural transesophageal echocardiography (A) and periprocedural ICE (B) in the same patient. LA ¼ left atrium; MV ¼ mitral valve; other abbreviations as in Figures 1 and 3.
r ¼ 0.72, p < 0.0001; for ostium and landing zone,
correctly detected by pre-procedural TEE. The cause
respectively). More specifically, in 78.4% of the cases,
of the last technical failure was an insufficiently sized
the device selected based on ICE measurements
landing zone. The most frequent adverse event was
was the same as the device selected based on TEE
cardiac tamponade, which occurred in 3 patients. Two
measurements. In 21.6% of cases, the device was
cardiac tamponades occurred 4 and 8 h, respectively,
1 size larger, and in no cases was it smaller (Figure 6).
after intervention in patients whose procedures were
Of all 121 patients evaluated by TEE, the majority
prolonged due to many device-retrieval attempts;
(67.7%) had a dual-lobe LAA anatomy that originated
both complications were resolved by pericardiocent-
distally 10 mm from the ostium; a single-lobe anatomy
esis. The third cardiac tamponade occurred due to a
was observed in 17.2% of the patients. The mean
LAA perforation and a consequent pulmonary artery
diameter of the device implanted was 24.0 3.5 mm
laceration that was resolved surgically (16). In all
(range 16 to 34 mm). In 89.7% (105 of 117) of pro-
these cases we had good ICE-derived images.
cedures, the first selected device was implanted; in 4 cases, the initial device was replaced by a smaller
No cases of pericardial effusion without tamponade were observed in our cohort.
device; and in 8 other cases, a larger device was used. In all procedures, appropriate device positioning and effective LAA occlusion were accomplished in a single attempt. No obvious relationship was noticed
T A B L E 2 Complications
Major complications
between the number of attempts required and the LAA
Serious pericardial effusion*
3 (2.5)
orifice diameter or the number of LAA lobes. The use of
Device embolization
0 (0)
ICE together with angiography has, in all cases, pro-
Major bleeding†
0 (0)
vided us with an adequate guide, and in no cases did
Procedure-related ischemic stroke‡
1 (0.8)
we need to refer back to the images acquired with TEE.
Hemorrhagic stroke
0 (0)
Minor complications
ADVERSE EVENTS. Among the 121 procedures, 4
Pericardial effusion, without tamponade
adverse events and 3 minor complications occurred
Femoral hematoma§
2 (1.6)
(Table 2). We had 4 cases of technical failure (3.3% of
Others
0 (0)
total). In 3 cases, the anatomy of the LAA was characterized by too many lobes and was not suitable for a device apposition. This was only discovered by angiography images, because they were not
0 (0)
Values are n (%). *Defined as the need of percutaneous or surgical drainage. †Defined as a bleeding event that required $2 units of packed red blood cells or surgery to correct. ‡Transient ischemic attack 24 h after procedure. §One left femoral hematoma and 1 right femoral hematoma.
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JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
ICE-Guided Percutaneous LAA Closure
Another patient experienced a transient ischemic
90% and higher (13,20) compared with 96.7% in this
attack 24 h after the procedure. The brain computed
study.
tomography scan was negative for ischemic lesion,
including significant pericardial effusion, tamponade
and the event spontaneously resolved within a few
and periprocedural stroke, are reported to be be-
hours. The patient was discharged without any
tween 3.7% and 7.7% (13,20). In this study, adverse
sequela. Minor complications included 2 cases of
events occurred in 3.4% of the procedures, including
femoral hematomas. In 1 case, the femoral hematoma
3 pericardial tamponades and 1 transient ischemic
was on left side, the ICE access side. This complica-
attack. Another critical point is the presence of
tion did not require a blood transfusion or reinter-
peridevice leaks after device implantation. Angiog-
vention, only a compression of a major duration
raphy and TEE are undoubtedly more precise than
without a prolonged hospitalization.
ICE in monitoring the presence of any peridevice
Accounting for the 4 major adverse events, the procedural success rate was 93.4% (113 of 121 cases).
Typical
rates
for
major
complications,
leaks. In our experience, it has been established that small leaks that were visible only by angiography did not present a need for device substitution.
DISCUSSION
However, leaks that were visible both with angiography
The use of procedural echocardiography is an essen-
and
ICE
were
motivation
for
device
substitution.
tial requirement for safe and successful percutaneous
As stated by some investigators, there is some
LAA occlusion. Without disputing the value of a pre-
experience of fluoroscopy-only-guided LAAC that
procedural TEE examination to explore the relevant
has demonstrated the reliability of a procedure us-
cardiac anatomy and exclude thrombi, our results
ing local anesthesia and fluoroscopy alone (21). In
suggest that ICE is an acceptable alternative to TEE
our opinion, purely fluoroscopic guidance in LAAC
during implantation of the ACP device.
has significant limitations. Hence, complications
ICE is an imaging technique applied in various
may result from suboptimal catheter handling and
interventional cardiac procedures, including catheter
device performance from undetected thrombus for-
ablation of AF, percutaneous closure of atrial and
mation, bleeding, and wall disruption. Especially
ventricular septal defects, and mitral valvuloplasty
for learning curve centers, we recommend the use
(17,18). For a series of 10 patients, ICE imaging during
of fluoroscopy integrated with echocardiographic
percutaneous LAA occlusion was previously reported
imaging.
to be optimal with the ICE probe positioned in the coronary sinus (19). In 28 of 51 cases, we integrated
Concerning
the
periprocedural
assessment
of
the appropriate device size, a high level of agree-
the images with views both from the CS and the RA.
ment was found between results from fluoros-
While the ICE views from the CS provided good
copy and ICE. The initially selected device was
images, in our experience, this is not fundamental
only exchanged for a differently sized device in 10.3%
because we achieved satisfactory images for all pro-
of the cases. This compares well with results reported
cedural aspects from the standard RA position. Al-
for the same device by operators using TEE (13,22).
though ICE may result in an inferior image quality
Application of TEE and endotracheal intubation
compared with that of TEE, in our experience this is
may contribute to complications such as injuries
not affecting the safety and technical success of the
and bleeding of gastroesophageal and respiratory
implantation procedure, provided that key informa-
tract, laryngospasm and bronchospasm requiring ad-
tion is recorded during the pre-procedural TEE
ditional intervention, and/or prolonged hospitaliza-
examination. In the case of both pre-procedural
tion. The use of ICE eliminates the need for general
TEE and periprocedural ICE, it is fundamental to
anesthesia, which is beneficial for all, especially
find the measures of the LAA ostium and landing
older patients. Moreover, as shown in our study,
zone. It is not easy to evaluate the full length of
left femoral vein hematoma is the only ICE-related
the appendage because of the complex geometry of
complication, a minor complication not requiring
the LAA; however, a critical point is to verify that
any blood transfusion reintervention or prolonged
the minimum length from the neck must be $10 mm
hospitalization. With regard to the percutaneous clo-
in order to have sufficient room for the correct
sure of interatrial communications, ICE, compared
deployment of the device.
with TEE, has been reported to result in less proce-
ICE-guided
percutaneous
LAA
occlusion
is
dural discomfort for the patient and reduced proce-
feasible with similar results to those reported for
dural time and ionizing radiation exposure (23) and
TEE-guided implantation. Technical success rates
to avoid the obstruction of fluoroscopic viewing.
for percutaneous LAA occlusion are reported to be
Although not assessed in our study, it seems
Berti et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1036–44
ICE-Guided Percutaneous LAA Closure
reasonable to assume that similar benefits exist for
STUDY LIMITATIONS. Our study was a dual-center
percutaneous LAA occlusion.
observational study without a control group, and
The use of ICE instead of TEE does not require
our results may not be extrapolated to other LAA
the presence of an anesthesiologist, and therefore
occlusion devices and other types of ICE catheters.
the amount of global exposure to ionizing radia-
Further investigations are required to fully charac-
tion is also reduced for the operators involved. In
terize the application of ICE during percutaneous LAA
periprocedural use of TEE or ICE, 2 operators are
occlusion, including its impact on safety, the length
always necessary (1 for the implantation and 1
of learning curve, procedural success, and healthcare
for the imaging). The safety issue is the proximity
costs.
of the TEE operator to the x-ray tube and the lack of x-ray screen protection in that position. In peri-
CONCLUSIONS
procedural ICE use, both operators are on the same side as the patient behind the x-ray screen
Although accepted as the guiding tool for percuta-
protection.
neous LAAC device closure procedures and for
It is questionable whether the additional ICE
electrophysiological catheter-based ablations, ran-
probe increases the overall cost of the procedure.
domized multicenter trials on ICE in this context
That cost is probably balanced by the added cost of
are lacking. In our experience, ICE represents a safe
the TEE-experienced echocardiographer, the anes-
and useful ultrasound option for guiding the LAA
thesiology team, and the longer catheterization lab
transcatheter occlusion procedure and for prevent-
occupancy. Furthermore, the use of local anesthesia
ing short- and mid-term complications having the
may reduce direct medication and personnel costs
advantage over TEE of not requiring the support of
(24,25), as well secondary costs related to TEE
general anesthesia and anesthesiology. These factors provide direct benefits to patients. Compared
complications. In our patients, the visualization of the LAA was
with fluoroscopy, ICE also showed a good accuracy
feasible with the ICE using the RA and CS positions,
in assessing LAA dimension in order to select the
and the measurements obtained by angiography and
correct device sizes.
ICE were significantly correlated.
ACKNOWLEDGMENT The authors thank Karin Joan
The LAA dimension is essential for selecting the
Tyack for her linguistic support.
correct size of the device, and we observed that the accuracy of ICE is comparable with angiography
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
in evaluating LAA measurements. ICE may represent
Sergio Berti, Adult Cardiology Department, Ospedale
a valid support for imaging guidance during the
del Cuore, Fondazione Toscana G. Monasterio, Via
percutaneous LAA closure procedure.
Aurelia Sud, 54100 Massa, Italy. E-mail: [email protected].
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KEY WORDS atrial fibrillation, intracardiac echocardiography, intraprocedural imaging, left atrial appendage occlusion, transesophageal echocardiography
