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Introduction
Electrical pulmonary venous (PV) disconnection is an effective means to treat patients with paroxysmal atrial fibrillation (AF).1 8 Because of the technical difficulties associated with point-to-point ablation using a standard spot
ablation catheter with the left atrium (LA), there has been a
significant effort in developing alternative ablation catheter
designs to quickly and easily isolate PVs. The first such
device tested clinically was an ultrasound balloon ablation
catheter that delivered energy in a radial fashion at the level
of the diameter of the balloon, hence necessitating that the
balloon catheter be placed within the PV when delivering
energy.9 This balloon design was suboptimal because the
level of electrical isolation typically excluded the proximal
Supported in part by the Deane Institute for AF and Stroke Research,
and an NIH K23 award (HL68064) to Dr. Reddy. Drs. Reddy and Neuzil
have received research grant support from Cryocath Technologies, Inc,
Cardiofocus, Inc, Biosense-Webster, Inc, and St Jude Medical, Inc. Dr.
Kim is an employee of St Jude Medical, Inc. Address reprint requests
and correspondence: Dr. Vivek Y. Reddy, Cardiac Arrhythmia Service,
Massachusetts General Hospital, 55 Fruit Street, GRB-109, Boston, Massachusetts 02114.E-mail address: vreddy@partners.org. (Received May 4,
2007; accepted November 1, 2007.)
Methods
All procedures were performed after written informed consent according to institutional guidelines at the Massachusetts General Hospital and Homolka Hospital. In a total of
50 patients with paroxysmal AF in whom at least 1 membrane-active antiarrhythmic drug had failed, we performed
1547-5271/$ -see front matter 2008 Heart Rhythm Society. All rights reserved.
doi:10.1016/j.hrthm.2007.11.006
354
Figure 1
Catheter cryoballoon ablation system. A: The balloon ablation catheter is shown inflated after having been advanced through a deflectable sheath
(in black). The balloon catheter has a central lumen through which a guidewire can be advanced (as shown). B: Occlusion of the targeted PV ensures
circumferential balloontissue contact, and consequently electrical PV isolation. By injecting contrast through the balloon catheter central lumen, the left
superior PV is highlighted without evidence of periballoon contrast leak. C: In another example, ICE was also helpful to both identify the position of the
balloon catheter as well as to assess for periballoon leak. In this image, the back face of the balloon catheter is seen occluding the left inferior PVflow
from the left superior PV is seen on color flow Doppler. ICE intracardiac echocardiography; PV pulmonary vein.
Ablation procedures
Procedures were performed either with conscious sedation
or under general anesthesia. After standard femoral vascular
access, dual transseptal punctures were performed with fluoroscopic and intracardiac ultrasound (Acunav, SiemensUltrasound, Mountain View, California) guidance. Intravenous heparin was instituted before the transseptal puncture.
EAM of the LA-PVs was performed at baseline using either
a magnetic EAM system (CARTO, Biosense-Webster, Inc,
Diamond Bar, California) or an electrical impedance-based
EAM system (NavX, St Jude Medical, Inc, Minnetonka,
Minnesota). In selected patients, custom software was used
to register and project the electrical information onto a
patient-specific volumetric 3-dimensional image derived
from preacquired computed tomographic (CT) or magnetic
resonance (MR) imaging. Bipolar electrogram voltage amplitude data were displayed.
After baseline mapping, electrical PV isolation of all PVs
was performed using 1 of the 3 balloon ablation technologies as detailed below. Intracardiac echocardiography (ICE)
was used to aid in balloon catheter positioning at the various
PV ostia. Electrical PV isolation was established using a
circular 10-pole or 20-pole multielectrode mapping catheter
(Lasso, Biosense-Webster, Inc) to verify both entrance and
exit conduction block.
Cryoablation
The cryoablation balloon system is a deflectable catheter
with a balloon-within-a-balloon design wherein the cryo
refrigerant (N2O) is delivered within the inner balloon (Figure 1). There is a constant vacuum applied between the
inner and outer balloon to ensure the absence of refrigerant
leakage into the systemic circulation in the event of a breach
in the integrity of the inner balloon. The cryoballoon catheter used was 23 mm in diameter. The deflated balloon
catheter is deployed through a 12F deflectable sheath. Once
within the LA, the inflated balloon is positioned at the PV
ostium (with ICE guidance) to temporarily occlude blood
flow from the targeted PV. Each balloon-based cryoablation
lesion lasts 4 minutes.
Laser ablation
The laser ablation catheter system incorporates an endoscopic visualization capability using a 2F endoscope positioned at a proximal location in the balloon (Figure 2). A
deflectable sheath is also used to deliver this 12F balloon
catheter. Once in the LA, the 20-, 25-, or 30-mm-diameter
balloon is inflated and positioned at the PV ostia under ICE
guidance. The endoscope allows the operator to visualize
the internal face of the balloon and identify areas of balloontissue contact (blanched white) versus blood (red). An
optical fiber that projects a 90 to 150 arc is advanced and
rotated to the desired location for energy delivery. Once the
proper location is identified, a diode laser is used to deliver
laser energy at 980 nm (5.5 to 6.5 W/cm for 60 to 120
seconds/lesion).
HIFU ablation
The HIFU catheter is a 14F system that, once inflated,
consists of a fluid-filled balloon in front of a smaller CO2
filled balloon (Figure 3). Energy from a radially directed
ultrasound transducer reflects off this airfluid interface to
project forward and concentrate energy to deposit just beyond the face of the balloon. Contact with the atrial tissue is
Reddy et al
355
Figure 2 Endoscopic laser balloon ablation system. A: The balloon ablation catheter is shown inflated after having been advanced through a deflectable
sheath (in blue). An aiming beam is projected from an optical fiber as an arc that can be rotated and advanced/retracted. When the proper location is selected,
the laser energy is transmitted via this same optical fiber. The mini-endoscope is located at the proximal end of the balloon catheter (near the white light)
and is facing forward. B: ICE is helpful to identify the position of the balloon catheter relative to the vein; in this image, the balloon is at the ostium of the
left superior PV, as well as straddling the ostium of the left inferior PV. C, D: Two examples of the images seen through the endoscope. Red represents blood,
and white represents the blanched balloontissue contact. The green arc of the aiming beam is manipulated to select the locations to deliver the laser energy.
The endoscopic field of view is partially obstructed (as outlined by the dotted lines) by the central lumen of the balloon catheter. Abbreviations as
in Figure 1.
not necessary for ablation with this catheter. This deflectable catheter is delivered using a nondeflectable 14F sheath.
ICE was used to verify proper positioning of the catheter.
Lesions were delivered using either a 20- or 25-mm-diameter balloon catheter for 40 to 60 seconds per lesion.
Results
Of the 50 patients who underwent balloon catheter ablation, preablation and postablation EAM was performed
on 8, 4, and 2 patients with the cryoablation, laser, and
HIFU balloon catheters, respectively. The average LA size
was 43.6 3.9 mm for the complete patient cohort and
41.5, 46.8, and 45.5 mm for the patients treated with the
cryoballoon, laser balloon, and HIFU balloon catheters,
respectively. The majority of the patient cohort (9 of 14,
64%) had 4 relatively distinct PVs: 4 and 2 patients had
either a discrete left common PV or right middle PVs,
respectively. The individual details for these patients are
shown in Table 1.
Respective examples of use of each of the balloon ablation catheters are shown in Figures 1 to 3. Electrical isolation of the PVs was achieved in 54 of 54 veins, as verified
by using a circular mapping catheter placed just inside (that
is, within the first 2 to 3 mm) of the respective PVs. To
determine the extent of this electrical isolation, electroanatomical bipolar voltage amplitude substrate mapping of the
LA-PVs was performed at baseline and postablation (Figures 4 to 6). Regardless of the balloon ablation energy
source, the extent of isolation included the tubular portions
of each PV. For a quantitative analysis, the bipolar voltage
amplitudes of the electroanatomical points acquired from
each pair of ipsilateral veins was calculated. The preablation
and postablation amplitudes of the left PVs were 0.5 0.8
mV (number of electroanatomical points measured per
patient 56 20) and 0.1 0.2 mV (number of points
61 34), respectively. For the right PVs, the preablation
and postablation amplitudes were 0.8 0.9 mV (number of
356
Figure 3
High-intensity focused ultrasound balloon ablation system. A: Shown in this schematic of the HIFU catheter is the reflective interface created
by the anterior fluid-filled balloon (in blue) and the posterior CO2 gas-filled balloon. The radially directed ultrasound energy is reflected forward to create
a circumferential zone of concentrated ablative energy just beyond the fact of the balloon. B: An ICE catheter is placed within the coronary to visualize the
HIFU catheter positioned at the ostium of the left inferior PV. As shown, the balloon catheter does not need to be in contact with the LA-PV tissue for
effective ablation. HIFU high-intensity focused ultrasound; LA left atrium; other abbreviations as in Figure 1.
Discussion
The key findings of this study are: (1) the 3 balloon ablation
catheter designs are all capable of electrically isolating the
PVs outside the tubular portions of the PVs at the level of
the PV ostia, and (2) the PV antra are left largely unaffected
by this ablation stratagem.
The importance of PV isolation during catheters ablation
of paroxysmal AF has been established as a result of several
key clinical observations.1 8 First was the initial description
that the PVs harbor foci that initiate AF, and that in indi-
Patient no.
Ablation
energy source
Balloon
diameter(s) (mm)
LA size
(mm)
Mapping
system
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Cryo
Cryo
Cryo
Cryo
Cryo
Cryo
HIFU
HIFU
Cryo
Laser
Laser
Cryo
Laser
Laser
23
23
23
23
23
23
20
20,
23
20,
25,
23
25,
20,
41
43
39
48
37
37
43
48
43
46
47
44
47
47
EiEAM
MEAM
MEAM
EiEAM
EiEAM
EiEAM
EiEAM
EiEAM
MEAM
EiEAM
EiEAM
MEAM
EiEAM
EiEAM
25
25
30
30
25
LSPV
LIPV
21
19
LCPV
26
15
21
19
18
20
27
14
18
14
18
15
19
20
17
19
19
17
15
18
14
22
RSPV
RIPV
22
26
16
20
18
13
23
25
16
18
20
21
21
21
15
19
21
23
12
15
17
21
19
18
19
16
20
19
RMPV
6
9
Cryo cryoablation; EiEAM electrical impedance-based electroanatomical mapping; HIFU high-intensity focused ultrasound; LA left atrium; LCPV
left common pulmonary vein; LIPV left inferior pulmonary vein; LSPV left superior pulmonary vein; MEAM magnetic electroanatomical mapping;
PV pulmonary vein; RIPV right inferior pulmonary vein; RMPV right middle pulmonary vein; RSPV right superior pulmonary vein.
Reddy et al
357
Figure 4
Level of electrical isolation using the cryoballoon ablation catheter. Shown are baseline and postablation bipolar voltage amplitude maps of the
LA-PVs. After registering the magnetic electroanatomical mapping data with the patients 3-dimensional magnetic resonance image, the voltage amplitude
electrogram information was projected onto the 3-dimensional image. In the color range shown, red represents low amplitude (0.1 mV) and purple high
amplitude (1 mV). Abbreviations as in Figure 3.
358
Figure 5
Level of electrical isolation using the laser and HIFU balloon ablation catheters. A: Using the electrical impedance-based electroanatomical
mapping system, the LA-PV anatomy was constructed and the projected bipolar voltage amplitude maps are shown after ablation using the laser balloon
catheter (left, anterior view; right, posterior view). B: Similarly, after ablation using the HIFU catheter, posterior views of the baseline and postablation
voltage maps are shown. Abbreviations as in Figure 3.
Reddy et al
359
Figure 6 Level of electrical isolation after standard radiofrequency catheter ablation. In a patient with paroxysmal AF, electrical PV isolation was
performed using a 3.5-mm irrigated-tip radiofrequency ablation catheter under electrical impedance-based electroanatomical mapping guidance to place an
extraostial ablation lesion set. Shown are the baseline (A) and postablation (B) voltage amplitude maps of the LA-PVs. Abbreviations as in Figure 3.
Limitations
Because of the complexity of the LA-PV anatomy, it is
difficult to quantify the level of PV isolation beyond that
described in this report. However, this does not detract from
the main conclusion of this investigation, namely that balloon ablation incorporates electrical isolation of the PV
ostia but not antra.
Table 2
Patient follow-up
Patient Duration of
AADs
Clinical
Repeat
no.
follow-up (days) discontinued? recurrence? procedure?
1
2
3
4
5
6
7
8
9
10
11
12
13
14
609
595
593
574
552
529
408
390
394
394
396
395
310
309
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
No
Yes
No
Yes
No
No
Yes
No
No
No
Yes
No
No
No
No
No
Yes
No
Yes
Yes
Yes
No
No
360
Implicit in this study is the assumption that catheter
ablation using these balloon catheters is technically easier to
perform than point-to-point using a standard spot ablation
catheter. However, this assertion must be proven in a comparative study.
This report does not address the ability to make permanent isolating lesion sets. It has been shown that in paroxysmal AF patients with postradiofrequency ablation clinical recurrences, PV reconnection is a critical factor. As
shown by the patients with clinical recurrences, the predictors of achieving permanent PV isolating lesions with the
balloon-based ablation catheters remain to be identified in
future evaluations.
Conclusion
When treating patients with paroxysmal atrial fibrillation,
balloon ablation catheters are able to isolate the PVs outside
the level of the tubular vein. However, the current generation of balloon ablation catheters leaves the veins proximal
antral regions unablated.
References
1. Haissaguerre M, Jais P, Shah DC, et al. Electrophysiological end point for
catheter ablation of atrial fibrillation initiated from multiple pulmonary venous
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2. Jais P, Weerasooriya R, Shah DC, et al. Ablation therapy for atrial fibrillation
(AF): Past, present and future. Cardiovasc Res 2002;54:337346.
3. Chen S-A, Hsieh M-H, Tai C-T, et al. Initiation of atrial fibrillation by ectopic
beats originating from the pulmonary veins: electrophysiological characteristics,
pharmacological responses, and effects of radiofrequency ablation. Circulation
1999;100:1879 1886.
4. Marrouche NF, Dresing T, Cole C, et al. Circular mapping and ablation of the
pulmonary vein for treatment of atrial fibrillation: Impact of different catheter
technologies. J Am Coll Cardiol 2002;40:464 474.
5. Oral H, Knight BP, Tada H, et al. Pulmonary vein isolation for paroxysmal and
persistent atrial fibrillation. Circulation 2002;105:10771081.
6. Gerstenfeld EP, Guerra P, Sparks PB, et al. Clinical outcome after radiofrequency catheter ablation of focal atrial fibrillation triggers. J Cardiovasc Electrophysiol 2001;12:900 908.
7. Pappone C, Rosanio S, Augello G, et al. Mortality, morbidity, and quality of life
after circumferential pulmonary vein ablation for atrial fibrillation. J Am Coll
Cardiol 2003;42:185197.