Introduction
Real-time 3D transesophageal echocardiography (TEE) with cardiac fluoroscopy X-ray
imaging is well introduced into practice and is used to monitor and assist catheter-based
cardiac operations [1–6].
Cardiac fluoroscopy imaging is useful to monitor and control delivery tools into the
desired site of the heart during transcatheter closure of paravalvular defects [3,
7, 8]. Fluoroscopy is superior to 3D TEE in visualization of the catheters, wires,
devices, and calcified and metallic structures. The main disadvantages of fluoroscopy
are the inability to determine the three-dimensional anatomy of intracardiac tissues,
exposure to radiation and the need for contrast media.
3D TEE is a standard method to visualize intracardiac structural pathology and measure
its hemodynamic significance. It is also used to control intracardiac manipulation
of various instruments as well as paravalvular leak closure devices [8]. 3D TEE provides
spatial intracardiac anatomy imaging in multiple planes, but its advantages are limited
by echo shadowing, which reduces visualization of the catheters and metallic structures.
Also experienced personnel are needed to achieve high quality 3D imaging and guide
the procedures [7].
Merging these two imaging techniques combines the advantages of fluoroscopy and 3D
TEE during paravalvular leak closure. As to date there are no studies comparing mitral
paravalvular leak closure with or without fusion technology, we hypothesize that periprocedural
fusion of cardiac fluoroscopy and real-time 3D TEE may make intracardiac procedures
more controlled, precise and easier. Also it may reduce patients’ and professionals’
exposure to radiation [7].
We present three cases of transapical catheter-based mitral paravalvular leak closure.
All patients were treated with devices specifically designed and manufactured by Occlutech
Holding, Switzerland for paravalvlar leak closure. The Occlutech® Paravalvular Leak
Device represents a novel device with unique rectangular- and square-shaped designs.
Occlutech® Paravalvular Leak Device was CE marked in 2014 and is the first transcatheter
device indicated and approved for aortic and mitral PVL closure. Procedures were performed
with the assistance of fusion (EchoNavigator system, Phillips Medical Systems, Netherlands)
of cardiac fluoroscopy imaging (Phillips AlluraClarity, Phillips Medical Systems,
Netherlands) and real-time 3D TEE (Phillips Epiq7, Phillips Medical Systems, Netherlands).
Procedure description
The procedure was carried out in a hybrid operating room. Standard cardiac surgery
monitoring was used. Prior to surgical draping, two self-adhesive external defibrillator
pads were applied to the patient’s back. With the patient in a supine position under
general anesthesia and single lumen endotracheal intubation, left anterolateral thoracotomy
(5–6 cm) was performed at the level of the left ventricle apex (preoperative TEE guidance).
The pericardium was identified and opened. Blunt dissection of the adhesions was performed.
Stay sutures were placed at both edges of the pericardium and hinged to the edges
of the skin under the retractor. Two “U” shape sutures reinforced with Teflon pledgets
(5 × 15 mm) were placed and secured with the tourniquets perpendicular to each other
at the apex of the heart. Then heparin was intravenously administered (150 U/kg),
aiming for an activated clotting time of 250 to 300 s. A needle puncture between four
pledgets was performed and the guidewire was introduced into the left ventricle with
subsequent short 6 Fr catheter sheath insertion.
The table and C-arm are oriented for the TEE probe to be visible in the fluoroscopy
field; this maneuver allows the fusion software EchoNavigator system to “recognize”
the TEE probe and co-register its position with the table and angulation of the C-arm.
When co-registration is “successful” the C-arm and TEE probe can be manipulated with
the fused images maintained [9]. Real-time 3D TEE is performed to identify and confirm
the exact location, size, depth and shape of the paravalvular leak. The location of
the paravalvular leak is marked in the EchoNavigator system to aid the pathway of
the guidewire crossing the paravalvular leak [10]. A hydrophilic guidewire was used
to pass through the defect with the help of a guiding catheter. The guiding catheter
was advanced through the leak and replaced with a stiff wire. The delivery sheath
was chosen according to the size of the occluder. The guiding catheter is removed
and the delivery sheath is advanced through the defect. The paravalvular leak closure
device was deployed under control of real-time 3D TEE and fluoroscopy. Position, orientation
and hemodynamic effect of the closure device were checked. If the function of the
prosthetic valve was not compromised, occluder discs were fully expanded and the paravalvular
regurgitation closure device detached from the delivery system.
Following a successful paravalvular leak closure, catheters and sheaths were removed
from the left ventricle and protamine sulfate administered. “U” shape sutures were
securely tightened and the pericardium was closed with three or two interrupted sutures,
leaving “communication” with the pleural space to allow blood to drain from the pericardial
cavity. The pleural cavity was drained with one drain; usually it was inserted into
one or two intercostal spaces below the incision. Patients were transferred to the
cardiac intensive therapy unit and monitored for bleeding and hemodynamic instability.
If no complication occurred patients were weaned from the ventilator, extubated and
transferred to the ward on the next postoperative day.
Patients treated
Detailed descriptions of the patients’ demographic, clinical and procedural data are
presented in Table I.
Table I
Patients’ demographic, clinical and procedural data
Patients’ data
Patient 1
Patient 2
Patient 3
Age [years]
61
57
64
Gender
Female
Male
Female
Mitral prosthesis description
27 mmBileaflet mechanical
31 mmBileaflet mechanical
29 mmBileaflet mechanical
6 min walking distance [m]
165
357
480
GFR [ml/min/1.73 m2]
46
79
78
Hemoglobin [g/l]
89
81
85
LDH [U/l]
331
430
818
Haptoglobin [g/l]
0.68
< 0.08
< 0.08
LVEF [%]
40
45
45
Systolic pulmonary artery pressure [mm Hg]
65
50
42
EuroSCORE [%]
10.56
3.7
7.08
PVL dimensions [mm]
9 × 4
8 × 5
2 × 2
4 × 3
2 × 4
3 × 2
PVL location according to the clock and segments of the mitral valve leaflets
3 o’clock(A3)
2 o’clock(A3)
6 o’clock(P2)
11 o’clock(A1)
2 o’clock(A3)
4 o’clock(P3)
Severity of PVL regurgitation
Severe
Severe
Insignificant
Moderate
Mild
Mild
Indications for PVL closure
Heart failure and anemia
Anemia
Anemia
Procedural data:
Occlutech PLD occluder article no.
61PLD12W
61PLD12W
Not closed
60PLD5W
60PLD4W
62PLD3T
Occluder waist size [mm]
12 × 5
12 × 5
5 × 5
5 × 5
3 × 3
Size of the atrial [distal] disc of the occluder [mm]
21
21
14 × 14
13 × 13
11.5 × 11.5
Size of the ventricular (proximal) disc of the occlude [mm]
19
19
12.5 × 12
11.5 × 11.5
10 × 10
Occluder type
Waist
Waist
Waist
Waist
Twist
Occluder shape
Rectangular
Rectangular
Square
Square
Square
Sheath size [F]
9
9
6
6
6
Occluder delivery system Flex Pusher
a
item no.
50FP120 & 50FP120L
50FP120 & 50FP120L
50FP100 & 50FP100L
50FP100 & 50FP100L
50FP100 & 50FP100L
Occluder type
Waist
Waist
Cumulative fluoroscopy time
8 min 27 s
36 min 3 s
29 min 46 s
Total cumulative air kerma [mGy]
70.67
169.69
157.7
GFR – glomerular filtration rate, LDH – lactate dehydrogenase, LVEF – left ventricular
ejection fraction, PVL – paravalvular leak, PLD – a trade name for percutaneous trans-catheter
device for paravalvular leak closure,
a
trade name for delivery system for paravalvular leak closure device.
1st patient
Thirteen years ago the 61-year-old woman underwent mitral valve replacement with a
27 mm bileaflet mechanical valve prosthesis and radiofrequency maze procedure for
severe rheumatic mitral stenosis and long standing persistent atrial fibrillation.
Aspiration of the pleural effusion was complicated by severe bleeding from the lung
and was treated by revision through the right thoracotomy. The patient developed sepsis
(Stenotrophomonas maltophilia) with subsequent severe mitral paravalvular leak. Four
years later the patient underwent redo surgery and mitral valve paravalvular leak
suture repair through a right thoracotomy. Intraoperative TEE did not show any residual
paravalvular leak. Unfortunately at discharge following that surgery on transthoracic
echocardiography a paravalvular leak at the same location with severe mitral regurgitation
was noted. On the basis of the patient’s refusal, redo surgery was declined. For the
following 9 years the patient was managed medically. With the patient’s functional
capacity gradually declining, she agreed to an elective transapical catheter-based
procedure for mitral paravalvular leak.
The patient underwent an uneventful transapical catheter-based mitral paravalvular
leak closure procedure (Figure 1). Immediate intraoperative hemodynamic improvement
was noted; after closure of the paravalvular leak the central venous pressure decreased
from 20 mm Hg to 9 mm Hg, and systolic pulmonary artery (PA) pressure from 65 mm Hg
to 40 mm Hg.
Figure 1
Patient 1 periprocedural fusion of fluoroscopy and real-time 3D TEE. A – Preprocedural
(top) and postprocedural (bottom) 3D TEE images of the mitral prosthesis. The arrows
point to the orifice of the paravalvular leak (PVL) located at 2 o’clock (surgical
view) and the occluder position after the deployment. B – Four fused fluoroscopy and
real-time TEE images. The X-plain color Doppler images of PVL regurgitant flow (top)
are oriented according to C-arm position (left bottom) and are fused with the fluoroscopy
image (bottom). The location of PVL is marked by a red circle. C – Guidewire passage
through the paravalvular defect. The fluoroscopy image (on the bottom) demonstrates
wire crossing the red circle; 3D TEE image (top) confirms the guidewire passage through
the defect. The arrow in the 3D TEE image shows the guidewire crossing the defect
Ao – position of the aorta.
The postoperative course was uneventful and the patient was discharged from hospital
on the 11th postoperative day. Discharge echo showed no paravalvular regurgitation
and good left ventricle systolic function (LVEF > 55%).
2nd patient
A 57-year-old man with previously known moderate aortic stenosis developed infective
endocarditis of the aortic and mitral valves. He underwent aortic and mitral valve
replacement with 21 mm and 31 mm bileaflet mechanical prostheses respectively. Three
weeks after the operation the patient was diagnosed with severe anemia. The cause
of anemia was established following transesophageal echocardiography which revealed
severe mitral regurgitation due to paravalvular leak. The patient was scheduled for
elective transapical catheter-based paravalvular defect closure.
He underwent an uneventful transapical catheter-based mitral paravalvular leak closure
procedure (Figure 2) with complete closure of the defect. On intraoperative TEE no
regurgitant flow across the occluded defect was noted. His postoperative course was
uneventful. The patient was discharged on the 11th postoperative day. Discharge echocardiography
showed good left ventricle systolic function (LVEF > 50%), systolic PA pressure of
55 mm Hg, trivial regurgitation through the occluded defect and trivial regurgitation
through the untreated defect at 6 o’clock.
Figure 2
Patient 2 periprocedural fusion of fluoroscopy and real-time 3D TEE. A – The preprocedural
color flow Doppler (top) and 3D images (bottom) demonstrates bileaflet mechanical
mitral valve prostheses (P) and the paravalvular leak located at 2 o’clock (arrow).
B – Two dimensional X-plain images (top), X-plain echo images are oriented according
to C-arm position (left bottom) and are fused with the fluoroscopy image (right bottom).
Position of the prostheses is marked by a green circle in all images. The red circle
identifies the location of the defect. C – Guidewire passage through the paravalvular
defect. The fluoroscopy image (on the bottom) demonstrates wire crossing the red circle;
3D TEE image (top) confirms the guidewire passage through the defect. The arrow in
the 3D TEE image shows the guidewire crossing the defect
Ao – position of the aorta.
3rd patient
Two years ago a 64-year-old woman underwent aortic and mitral valve replacement with
25 mm and 29 mm mechanical prostheses respectively for rheumatic stenosis. Fourteen
months after surgery she developed hemolytic anemia and presented with symptoms of
general weakness. Transesophageal echocardiography revealed severe mitral regurgitation
due to three paravalvular defects. For the 4 following months she was managed medically
and 18 months after initial surgery the patient underwent a redo conventional operation
and suture repair for mitral paravalvular leak. Unfortunately, discharge transthoracic
echocardiography revealed reoccurrence of severe mitral paravalvular regurgitation.
She was scheduled for elective transapical catheter-based mitral paravalvular leak
closure a month later.
The patient underwent an uneventful transapical catheter-based mitral paravalvular
leak closure procedure (Figure 3) with complete occlusion of all three defects. At
discharge on transthoracic echocardiography no regurgitant flow across the occluded
defects and good left ventricle systolic function were noted. The patient was discharged
on the 6th postoperative day with no postoperative complications.
Figure 3
Patient 3 periprocedural fusion of fluoroscopy and real-time 3D TEE. A – The preprocedural
3D TEE color flow Doppler image (top) and 3D TEE image (bottom) with paravalvular
defects closed with occluders. Arrows point to the defects. B – Real-time 3D TEE image
(top left and bottom left) demonstrating ventricular perspective of the mitral prosthesis
where colored (red, white, green) circles indicate paravalvular defects. Realtime
3D TEE image (top right) demonstrates atrial perspective of the mitral prosthesis
where colored (red, white, green) circles indicate paravalvular defects. Fused fluoroscopy
and real-time TEE image (bottom right) demonstrates wire crossing the green circle;
3D TEE image (top right) confirms the guidewire passage through the defect (arrow
pointing to the guidewire)
Ao – position of the aorta.
Comment
In recent years, catheter-based closure of the mitral paravalvular leak has advanced
globally. Nevertheless, due to the absence of standardized methods to quantify the
regurgitation of the paravalvular leak, disagreement on the definition of success,
tortuous anatomy of the defects and recent absence of dedicated devices for the closure
of paravalvular leaks, the results of this method of treatment were debatable [8,
11–13]. The success rate of catheter-based paravalvular leak closure via the transapical
approach reaches 100% compared to 66–78% in the trans-septal approach [11]. The closure
of a mitral paravalvular leak using the transapical approach and real-time fluoroscopy
and 3D TEE is efficient and safe [14]. Recent technological advances such as the ability
to fuse fluoroscopy and real-time 3D TEE, as well as the development of devices dedicated
to paravalvular leak closure, allow closure of a mitral paravalvular leak to be performed
more conveniently [8, 15]. Fusion is needed to guide the pathway of the pass through
the paravalvular lesion. We have presented three cases of mitral paravalvular leak
closure where this complex approach was applied. All three procedures showed technical
and procedural success.
Conclusions
Fusion of fluoroscopy and real-time 3D TEE is a useful method in catheter-based paravalvular
leak closure via the transapical approach.