Pulmonary Vein Isolation Using a Visually

DOI: 10.1161/CIRCEP.113.000431
Pulmonary Vein Isolation Using a Visually-Guided Laser Balloon Catheter:
The First 200-Patient Multicenter Clinical Experience
Running title: Dukkipati et al.; Visually-Guided AF Ablation
Srinivas R. Dukkipati, MD1; Karl-Heinz Kuck, MD2; Petr Neuzil, MD, PhD3;
Ian Woollett, MD4; Josef Kautzner, MD, PhD5; H.Thomas McElderry, MD6;
Boris Schmidt, MD7; Edward P. Gerstenfeld, MD8; Shephal K. Doshi, MD9;
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Rodney Horton, MD10; Andreas Metzner, MD2; Andre d’Avila,
vil
ila,
a, M
MD,
D P
D,
PhD
hD1;
Jeremy N. Ruskin, MD11; Andrea Natale, MD10; Vivek Y. Red
Reddy,
ed
ddy
d , MD1
1
2
Helmsley
msl
msl
sley
ey
y Electrophysiology
Electro
roph
ro
phhy iolo
phys
io
olo
logy
gyy C
Center,
ente
en
ter,, M
Mount
ount
ou
nt Si
Sinai
inaai School
Sccho
Scho
hool
o of
of Medicine,
Medi
Me
d cinee, New
di
N w York,
Ne
Y rkk, NY;
Yo
NY
Asklepioss Klinik
Klinik St. Georg,
Geo
eorg,, Hamburg,
Hamb
mb
burg,
g Germany;
Gerrman
an
ny; 3H
Homolka
omo
mo
olk
ka Ho
Hospital,
ospitaal,, Pr
Prague,
rague,, Cz
C
Czech
ecch Re
Rep
Republic;
p
4
5
Sentaraa Cardiovascular
Card
Ca
r iovaasc
s ullar Research
Researrch Institute,
In
nst
stittutte, Norfolk,
Norfo
follk, VA;
VA; IK
IKEM,
KEM, P
Prague,
ragu
gue, Czech
gu
Cze
zech Re
Republic;
epub
epu
6
University
r
rsity
of Al
Alabama att B
Birmingham,
i miing
ir
n ham, B
Birmingham,
irmi
irmi
ming
nghham
m, A
AL;
L 7Ca
L;
Cardioangiologisches
Card
rdio
rd
i angiol
olog
ol
ogiisch
og
hes C
Centrum
enttr
8
Bethanien
n - CC
nien
CCB,
B, Frankfurt,
Fraankkfu
furt
rtt, Germany;
G rm
Ge
rman
ny; Un
University
Uni
iver
errsi
sity
ty
y of
of Ca
Cali
California
lifo
li
foornnia San
San Francisco
Fraanc
n is
isco
c S
co
School
choool of
ch
Medicine,
i
icine,
S
San
an Francisco;
F an
Fr
nciisco; 9P
Pacific
acif
ifiic Heart
if
Heart IInstitute,
nstiitute, Santa
Santa
t Monica,
M ni
Mo
n ca, C
CA;
A 10T
A;
Texas
exas Cardiac
Carrdiacc
1
Arrhythmia
r
rhythmia
In
Inst
Institute,
nsttit
itut
ute,
ut
e, Austin,
Aus
usti
tin,
ti
in, TX;
TX;
X 11
Massachusetts
Mass
Ma
sssac
achu
huse
hu
s tt
se
ttss General
Gene
Ge
n raal Ho
ne
Hospital,
Hosp
spit
sp
ittal,
ital
all, Boston,
Bost
Bo
stton
o , MA
Address for Correspondence:
Vivek Y. Reddy, MD
Helmsley Electrophysiology Center
Mount Sinai School of Medicine
One Gustave L. Levy Place, Box 1030
New York, NY 10029
Tel: (212) 241-7114
Fax: (646) 537-9691
E-mail: vivek.reddy@mountsinai.org
Journal Subject Codes: [5] Arrhythmias, clinical electrophysiology, drugs; [22]
Ablation/ICD/surgery
1
DOI: 10.1161/CIRCEP.113.000431
Abstract
Background - Because of the technical difficulty with achieving pulmonary vein (PV) isolation
in the treatment of patients with paroxysmal atrial fibrillation (PAF), novel catheter designs to
facilitate the procedure are in development. A visually-guided laser ablation (VGLA) catheter
was designed to allow the operator to directly visualize target tissue for ablation, and then deliver
laser energy to perform point-to-point circumferential ablation. Single center studies have
demonstrated favorable safety and efficacy. We sought to determine the multicenter feasibility,
efficacy, and safety of performing PV isolation using the VGLA catheter.
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Methods and Results - This study includes the first 200 PAF patients treated with the VGLA
catheter (33 operators, 15 centers). After transseptal puncture, the VGLA
catheter
was
GLA ca
cath
thet
th
eter
et
er w
as uused
as
sed
se
d to
perform PV isolation. Electrical isolation was assessed using a circular
mapping
Using
ar map
ap
ppi
ping
ng ccatheter.
athe
at
hete
he
ter.
te
r U
the VGLA cat
catheter,
athe
at
h ter
he
teer, 98
998.8%
8.88% (95% CI, 97.8-99.5%) of ttargeted
argeted PVss were
weere
r isolated using a mean
mee of
1.07 catheters/patient.
Fluoroscopy
200r54
ters/patient. F
te
luo
uoro
roosc
scop
opyy andd pr
op
pprocedure
occed
durre ttimes
im
mess were
weeree 331r21
1r
r211 (meanrsd)
(me
meean
a rsd
sdd) and
an
nd 20
200
0r55 min
respectively,
improved
with
operator
There
were
instances
TIA,
y an
y,
and impr
prrovved
dw
itth op
per
erator
orr eexperience.
xperrience
xp
iee e. Th
Ther
e ew
ere
ree nno
o in
nstan
ances of sstroke,
an
trrokee, T
atrio-esophageal
h all ffistulas
hageal
isstu
ula
lass or si
ssignificant
gnif
gn
iffican
iccant
ant PV
V sstenosis.
teno
te
noosis.
s. There
s.
The
heree was
was a 2%
2% incidence
inci
in
c de
ci
denc
ncee of cardiac
nc
car
ardi
diac
a
tamponadee and 2.5% incidence
inci
ciidence of phrenic
phrenic nerve ppalsy.
alsyy. At 12 months,
mon
onnths,, the
the drug-free
drugg freee rrate
atte off
freedom from
om atrial
atr
tria
iall arrhythmias
arrh
ar
rhhyt
ythm
h iiaas after
hm
affterr on
afte
onee or two
two procedure
proc
pr
oced
edur
duree was
was 60
60.2%
0.22% (95%
( 5% CI,
(9
CI, 52.7-67.4
552.7-67.4%)
2.77 67.44
Conclusions - In this multicenter experience of the first 200 patients treated with the VGLA
catheter, PV isolation can be achieved in virtually all patients using a single VGLA catheter with
an efficacy similar to radiofrequency ablation.
Key words: atrial fibrillation, catheter ablation, pulmonary vein isolation, lasers, visual guidance
2
DOI: 10.1161/CIRCEP.113.000431
Introduction
Pulmonary vein (PV) isolation is the mainstay of catheter ablative therapy for patients with
paroxysmal atrial fibrillation (AF).1 While conceptually straightforward to consider placing a
series of point-by-point ablation lesions to circumferentially isolate the PVs, in practice, these
procedures are technically challenging to perform. Accordingly, there has been a tremendous
amount of development work in designing various one-size-fits-all ablation catheters to facilitate
PV isolation.2-14 For such devices to be practical, they need to be able to isolate PVs: (i)
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
reproducibly using only a single catheter despite the intra- and inter- pa
ppatient
tient variabilityy in P
PV
size, shape and orientation15, (ii) without requiring the use of ancillaryy catheters
cathe
h ters
he
ters for
for ‘touch-up’
‘touuch
‘t
chi er
iver
eryy, ((iii)
iii)
ii
i) wi
w
th
hout a high rate of complications,
compliccatiions, (iv) wit
itth re
easonable procedure ti
i
energy delivery,
without
with
reasonable
times
and without
ut excessive
ut
ex
xcessive fluoroscopy
fluo
uorosc
scopyy exposure,
expoosure
re, an
and
nd (v)) w
with
ith
th good
gooood clinical
clinic
cl
l call efficacy.
eff
f icacyy.
ff
end, a nov
en
end
ell bballoon-based
all
lloon-ba
based
as visually-guided
vis
isua
is
uall
ua
llyll
y gu
guid
ided
id
ed laser
las
aseer ablation
abl
b attio
i n (VGLA)
(V
VGL
GLA
A) catheter
cathe
th ter hhas
To this end,
novel
recently been
e sh
een
shown
hown in
i single-center
siinngl
gle-center experiences
expperie
i nces to bbee abl
able
ble to safe
safely
feely aand
nd eff
effectively
ffectiively
ff
ly
y iisolate
soolatee
pulmonary veins.
eins
in This
Thiis balloon
Th
ball
llo catheter
thett permits:
mit
its (i
(i)) real-time
real
all ttime
im endoscopic
do
ic visualization
iis ali
li ati
ation
tio off the
tth
h
target tissue via a 2-Fr endoscope, (ii) a maneuverable 30-degree light arc to deliver laser energy
(980 nm) to ablate the target tissue, and (iii) a variable-sized, deformable balloon material to
accommodate variable-sized/shaped PVs.9-14 This novel ablation catheter was approved in
Europe for general clinical use, and is in the midst of FDA investigational trials in the United
States. In this manuscript, we report on the international multicenter experience of the first 200
paroxysmal AF patients treated with this visually-guided laser ablation catheter.
Methods
The study consists of 200 patients (out of a consecutive series of 204 patients) enrolled in 1 US
study (9 clinical sites) and 3 European studies (6 clinical sites). Of note, 4 additional patients
3
DOI: 10.1161/CIRCEP.113.000431
who underwent ablation near the end of the 200 patient series were excluded as baseline
demographics and procedural data were not available at the time of data analysis; however, none
of these excluded patients experienced any procedural complications. All of the studies were
approved by institutional review committees at the participating institutions, and all subjects
gave informed consent. The authors had full access to and take full responsibility for the
integrity of the data. All authors have read and agree with the manuscript as written.
Patient Selection & Study Design: All 4 clinical studies were open label, non-randomized
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
studies of patients with symptomatic, recurrent, paroxysmal AF. There
minimal
re were only
y mini
ima
mal
differences in the inclusion criteria between the studies. Key inclusionn criteria
age
crite
t riia were:
te
were
we
re:: ag
ge 18
118-75
8
years, and recurrent
that
refractory
r cur
rec
urre
r ntt paroxysmal
re
parox
oxxysmal atrial fibrillation th
hat
at was refractor
o y to at least one antiarrhythmicc ddrug
IV).
All
patients
otherwise
ruug (Class I – IV
V). A
lll pati
tiientts were
weeree ot
the
herw
wis
isee deemed
deem
med ttoo bee candidates
candi
diidatess for
foor catheter
caa
ablation. Key
criteria
K exclusion
exc
xclu
lu
lusion
u
crit
iteriia included:
it
inclu
lu
uded:
de a left
de
left
ft ventricular
venttriicular
ullar ejection
eje
jectio
ionn fraction
io
f acti
fr
t onn <30%,
<30%,
% LA
LA diameter
dia
di
ia
>5 cm, PV diameters >32
PVs,
the
major
minor
322 mm (f
(for oval PV
P
s, th
he mean off tthe
he maj
ajoor and
aj
ndd mi
inor ddimensions
imen
ensi
en
s ons were
si
used), the presence off an intracardiac
thrombus,
ablation,
myocardial
intt cardi
dia th
thromb
mb
b s prior
io cardiac
rdi
dia abl
ablation
blati
ti
m ocardial
diall iinfarction
infarctio
nff cti
tio or
cardiac surgery within the prior 3 months, moderate or severe valvular heart disease, or a
stroke/transient ischemic attack within prior 6 months. Pre-procedural CT or MRI scans were
performed to assess LA and PV anatomy and size.
Following the procedure, patients were discharged on oral anticoagulation (warfarin), and
at times, low molecular weight heparin until the international normalized ratio was t2.0.
Following the procedure, anti-arrhythmic medications were typically continued for 1 to 3 months
after which they were completely discontinued. There was a 3 month blanking period following
ablation. Follow-up methods were variable between the four studies and included clinic visits at
3 or 6 month intervals, and either Holter or transtelephonic monitoring at variable intervals.
4
DOI: 10.1161/CIRCEP.113.000431
Recurrence was defined as any atrial arrhythmia, whether symptomatic or not of a duration
exceeding 60 sec. In a subset of patients, a repeat CT or MRI scan was performed at 3 months to
assess for PV stenosis.
One study required that all patients return at three months for PV remapping procedures,
regardless of symptomatology. These patients underwent re-isolation of reconnected PVs with
radiofrequency energy. The results of the PV remapping and one year clinical follow-up in 52 of
these patients have been previously reported.11 A single center experience in an additional 40 of
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
these patients, with one year follow-up was also previously reported.122
The Balloon-Based Visually-Guided Laser Ablation (VGLA) Catheter:
er: The
The co
comp
components
mpon
onen
en
nts
ts of
h te
hete
terr (C
(Car
ardi
ar
d oF
di
Focus, Inc., Marlborough, M
assachusetts)) we
ere previously describe
e in
VGLA catheter
(CardioFocus,
Massachusetts)
were
described
detail.9 Thee V
VGLA
GLA cathe
catheter
eter iiss a var
variable-diameter,
ariablle-ddiaameeteer, co
ar
compl
compliant
p ia
pl
iant
n balloon
nt
baallloonn that
that
att is
is delivered
deeliv
iveereed through
thrro
a
F ssheath.
Fr
h ath.
he
h Wi
With
thin
th
hi the
h central
he
central
all sshaft
haft off th
ha
haft
he ba
ball
lloo
ll
oon iss a 22-Fr
oo
-F
Fr en
ndo
doscope th
tthat
att
deflectable 12-Fr
Within
the
balloon
endoscope
provides real-time
e ime vi
eal-ti
visualization
isuaaliizatiion off the
th
he face off th
the
he ba
bballoon:
lloon: bboth
ll
othh the
thee tissue
th
tiisssue
u andd blood
blo
l od in
in contact
contt
with the balloon.
alloon
all
llo
Additionally,
A
Additionall
ddit
dd
itiio ll within
iithin
thiin the
th
the central
trall shaft
haft
ft are additional
ddit
dd
itiio l llumens
mens for
me
f circulating
circ
ir llating
ati
ti D2O
to cool the balloon, and a maneuverable optical fiber that generates a 30o arc/spot of both visible
and near-infrared ablative light energy. The tip of the VGLA catheter is designed to be flexible
to cause minimal trauma.
The deflectable sheath was positioned at the PV ostium and the VGLA catheter advanced
and inflated to provide good tissue contact. Under endoscopic visualization, the area of tissueballoon contact appears white and blood appears red. The endoscopic field of view is partially
obscured in the region behind the central shaft. This partially obscured region is located 180o
directly opposite a radiopaque marker located on the catheter shaft. The location/orientation of
the radiopaque marker on fluoroscopy is then correlated to the endoscopic image thus defining
5
DOI: 10.1161/CIRCEP.113.000431
superior, inferior, anterior, and posterior directions. The 30o arc of light includes a visible
aiming beam and can be advanced/retracted and rotated to any location on the face of the
balloon. Once an appropriate site for ablation is identified, diode laser energy (980 nm) is
delivered through the same optical fiber that generates the aiming beam to ablate tissue.
Ablation lesions are placed in a contiguous and overlapping manner to achieve electrical
isolation of the PV.
Pulmonary Vein Isolation Procedure: Procedures were performed using either conscious
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
sedation or under general anesthesia per the institution’s clinical practice.
ice. Righ
Right
g t and left
ft ffemoral
e
vein access was obtained. The transseptal puncture was performed in stand
standard
nddar
ardd fa
ffashion
shhion
io wi
with
th an 8Fr sheath and
a d a Brockenbrough
B occke
Br
k nb
nbrrough needle under fluoroscopic
fluoros
osccopic guidance,
os
guidance
c , an
and at some centers w
with
adjunctive intracardiac
intrracardiac ech
in
echo
ho gu
gguidance.
uidan
ance. T
an
The
he 8-F
8-Fr
Fr she
sheath
eath wa
was
as th
then
hen
n excha
exchanged
hangged forr a 112-Fr
2-Frr
deflectablee shea
sheath
ath oover
ver a 00.035”
.03
035”
03
5”” or 00.038”
.03
038” gguidewire.
03
u de
ui
dewiire. Pe
Per
er the
the operator
oper
errattor preference,
prefe
fere
fe
ree
rence,
a secondd
transseptal puncture
p ncture with
pu
wit
ithh a standard
it
standdardd 8-Fr
8-Fr sheath
shheath
th was placed
pllaced
d ffor
or a ddiagnostic
iagn
gnoostiic mapp
mapping
ppin
pp
ingg catheter.
in
caathee
At baseline,
e am
multi-electrode
ltii el
lt
electrode
l trodd ci
circ
circular
i llar mapping
pii catheter
ath
thette was
as used
sed
ed
d to
t assess electrograms
lectt
off all
PVs. Throughout the procedure, intravenous heparin was administered as boluses and a
continuous infusion to maintain an activated clotting time >300 sec.
The deflectable sheath was positioned at the ostium of the target PV and the VGLA
catheter was advanced and inflated. Ablation lesions were placed circumferentially around the
PV in a contiguous and overlapping manner. Although initially not available, the more recent
procedures were performed with custom software that was used to track prior ablation lesions to
minimize gaps. The balloon was then partially deflated, rotated, and re-inflated to allow ablation
in the region behind the partially obscured area. After placing the encircling lesion set, the
multi-electrode circular mapping catheter was again used to assess for PV isolation. If the PV
6
DOI: 10.1161/CIRCEP.113.000431
was not isolated, the VGLA catheter was again used to deliver lesions to the area of anatomical
breakthrough. All PVs were targeted in a similar manner. During ablation of the right sided PVs,
phrenic nerve pacing was performed from the superior vena cava to monitor for impending
injury. In all patients, an esophageal temperature probe was placed in the esophagus to monitor
for excessive heating. Ablation was stopped, if esophageal temperature exceeded 38.5oC. After
30 minutes post-ablation of the last PV, all PVs were reassessed for electrical isolation. A
circular mapping catheter was used to identify entrance block. Exit block was not routinely
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
assessed. For situations when entrance block was ambiguous, pacing from the superior
supperiorr vena
ven
ve
cava (for right superior PVs) and left atrial appendage (for left PVs) was uused
sedd to
se
t ddistinguish
i ti
is
ting
nggui
uish
sh
ar fie
ar-f
ield
ld vvs.
s nnear-field
s.
eaarr field potentials. Isoproter
eren
er
nol and Ade
eno
n siine administration were
werr not
between far-field
Isoproterenol
Adenosine
in any
any of the pprotocols.
rootoco
cols.
mandated in
aser energy usedd w
as 5.
55.5
5W
atts
t x 330
0 seco
sseconds
econdds or
o 88–14
–114 Wa
Watt
t s x 200 seconds
tt
seconn
Thee dosee ooff llaser
was
Watts
Watts
Whe
h n the
th
he area
arrea off balloon/tissue
ball
lloon//tissue contact was not
ll
nott adequate
addequuat
a e enough
en
nough
gh to
to allow
alllo
low
w energy
energ
energg
per lesion. When
triiall tissue
ti
tiss e alone,
alone
lo the
th lowest
llo
o est
stt energy
energ ddose
o (5
((5.5
5 5 Watts/30
Watt
tts/30
/30 sec)) was
as used
sed
ed
d tto
delivery to atrial
simultaneously ablate on tissue and blood that was located at the periphery of the target tissue.
Blood located at the periphery of the target tissue is continually refreshed (not trapped by the
balloon), and ablation at these sites with the lowest energy dose minimizes the risk of thrombus
formation.
Statistics. Categorical variables were compared using Fisher’s exact test. Continuous variables
were first tested for normality using the Shapiro–Wilk test for normality to determine if the data
were normally distributed. All tested continuous variables were determined to have a normal
distribution. Comparisons between groups were tested using Student’s two-sample t-test
(pooled). Continuous data are presented as mean and standard deviation (mean±SD).
7
DOI: 10.1161/CIRCEP.113.000431
Continuous data with skewed distribution are represented as median with interquartile ranges.
Point estimates (i.e. percentage of PVs isolated and percentage of patients free of AF at 12
months) are represented with 95% confidence intervals (95% CI). A two-sided alpha level of
0.05 was used for all superiority testing. Statistical analyses were conducted using SAS version
9.2.
Results
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Patient Demographics: The baseline demographics of the 200 patients are shown in Table 1.
The mean age of the cohort was 57.0 ± 9.9 years (limits 25–75) and 60%
male.
0% we
were
re m
ale.
al
e. Th
Thee
median duration
rationn of sy
symptoms
symp
mp
mpto
ptoms consistent with paroxysmal
paroxxys
ysmal AF was 3.0
3 0 ye
yyears
ars (1
(1.0–7.0,
0 7 0 Q1–Q3).
Q1–Q
Q1 Q
A total of 187
antiarrhythmic
medication.
Transthoracic
187 (93.5%) pa
ppatients
tien
en
ntss failed
faile
leed at lleast
eaast one
nee an
ntiiarrh
rhythm
thm
h ic m
ed
diccatio
io
on. Tr
T
ansttho
an
hora
raci
ra
echocardiograms
178
patients
gram
amss we
am
were
r pperformed
re
erfo
er
form
fo
rmed
rm
e iin
n 17
78 pa
ati
tien
en
ntss and
and demonstrated
dem
emon
onsttra
on
rate
t d a mean
te
mea
e n LA
L diameter
diam
a et
am
e er of
of
4.1r0.5 cm
mean
ventricular
m and
an
nd me
an lleft
eftt ve
ef
vent
ntri
nt
ricu
ri
cula
cu
l r eejection
la
jecctiion fraction
fra
r cttio
ionn (LVEF)
(LVE
(L
VEF)
VE
F off 63r8%.
63r8%
8%.. No ppatients
atie
at
ient
ie
n s were
nt
w ree
we
excluded ddue
PV
>32
ue iinappropriate
napp
na
ppro
ropr
pria
i te P
ia
V anatomy
anat
an
atom
omyy (i.e.,
(i.ee., a PV with
wit
i h average
aver
av
erag
agee diam
ddiameter
di
iamet
eter
er >
3322 mm
mm).
mm)
). Th
These
Thes
esee 200
patients were treated by a total of 33 primary operators at 15 centers.
Procedural Characteristics: A total of 770 PVs were targeted in 200 patients (Tables 2 & 3).
Acute electrical isolation was achieved in 78.4% (95% CI, 75.4-81.3%) of all PVs after
placement of the initial encircling lesion set and ultimately in 98.8% (95% CI, 97.8-99.5%) of
PVs after an average of 1.3 attempts per vein. Of the various PVs, the left common PVs and left
superior PVs were the least likely to be isolated after the first encircling lesion set (Table 3): that
is, although 100% of left common PVs and 98.3% of left superior PVs were ultimately isolated,
only 58.6% and 69.9% were isolated after the first encircling lesion set, respectively. Overall,
the PVs were isolated using an average of only 1.07 catheters per patient. Two catheters were
8
DOI: 10.1161/CIRCEP.113.000431
required in 13 (6.5%) patients; all due to catheter damage during use rather than PV/balloon size
mismatch. No additional catheters were used to provide ‘touch-up’ energy delivery.
The mean procedure and fluoroscopy times were 200r54 min and 31r21 min,
respectively. As shown in Figure 1, these parameters improved with operator experience. With
increased operator experience (first 15 cases performed by an operator vs. cases beyond the first
15), procedure times decreased by 30±55 min (p=0.0005), ablation times decreased by 18±36
min (p=0.001), and fluoroscopy times decreased by 18±19 min (p<0.0001). Four of the 33
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
operators performed more than 15 procedures. Interestingly, the ability
ty
y to el
eelectrically
ectriccal
a ly
y isolate
iso
sola
l a
la
PV after placement of the initial encircling lesion set did not significantly
operator
ntly change
ch
han
ange
ge with
wit
ithh op
oper
e
experience.. Th
That
77%
PVs
hat
a iis,
s ffRURSHUDWRUVSHUIRUPLQJ”
s,
RU RSHUDWRUV SHUIRUPLQJ” procedures,
pro
r cedures, 77
7% of P
Vs were isolated after
aff
the first encircling
those
performing
were
isolated
ci cling lesions
circ
ci
lesionns set,
sett, andd ffor
or th
hosee per
rfoorm
minng >15
>15 procedures,
proce
cedurress, 882%
ce
2% we
ere isola
atedd
(p=0.462).
Clinical Outcomes
Safety:
completed
months
u
utcomes
& Safe
Sa
afe
f tyy: Of the 200 ppatients,
atients,, 181 compl
p eted
d 12 mo
m
nths of follow-up.
folllow
ow-up.
p Of
these, 60.2%
CI, 52
52.7-67.4%)
were free
% (95% CI
7 67 4%) off patients
i
f ffrom AF and
d were off
ff anti-arrhythmic
i h h
drugs (class I or III). After a single procedure 72/123 (58.5%) patients were free of atrial
arrhythmias off anti-arrhythmic drugs (95% CI, 49.3-67.4%), and after two procedures 37/58
(63.8%) were free of atrial arrhythmias off anti-arrhythmic drugs (95% CI, 50.1-76.0%). Of the
19 patients with no outcome data, 7 were lost to follow-up, 6 withdrew from study, and 6 had not
yet achieved 12 months of follow-up.
There was no clinical evidence of PV stenosis in any of the patients. In addition, baseline
and 3 month CT or MRI scans were available for 116 patients (Table 4). At 3 months, the mean
decrease in PV diameter was 3.5%. Mild PV narrowing (1 to 25% decrease in diameter) was
present in 44% of PVs, and moderate PV narrowing (26 to 50% decrease) in 6% of PVs. There
9
DOI: 10.1161/CIRCEP.113.000431
was no significant PV stenosis (>50% decrease). A variable degree of mild to moderate PV
diameter increase was also noted.
Phrenic nerve injury related to the VGLA occurred in 5 patients, 1 of which remain
unresolved at 12 months of follow-up (Table 5). Pericardial effusions were reported in 6
patients, 4 of whom developed hemodynamic compromise / cardiac tamponade. All of these
tamponades occurred during the procedure and were successfully drained. One patient with
cardiac tamponade underwent pericardiocentesis and was ultimately discharged in good
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
condition on the fourth hospital day. Two days after discharge from the
he hospital,
hospi
p tal,, he experienced
ex
xpe
perri
sudden death. Autopsy demonstrated no pericardial effusion, cardiac perfo
perforation,
atrioora
rati
tiion, at
tion
tri
rio-esophageall fist
fistula,
pulmonary
patient
was
s ul
st
ulaa, oorr pu
ulm
lmonary embolization. However,
How
oweever, the pati
ow
tientt w
as found to have
unrecognized,
triple
artery
stress
zed, critical trip
ze
ple vvessel
essell ccoronary
orona
n ry
y arter
erry ddisease
isseasse (aa ppre-procedure
ree-pprocceduure
ure stre
esss ttest
est had
es
hadd
revealed only
reversible
significant).
n a mild
nly
mild rever
mi
siibl
ble apical
al ddefect
efectt aand
nd was thought
thou
th
ough
ght
ht not
nott to
t be
b clinically
cliniica
call
llyy si
ll
ignif
iffic
i an
n
Accordingly,
while
ablation
have
this
ly,
ly,
y whi
hille the
hi
h sstress
tress off the
tr
h AF
A abl
blatiion pr
bl
pprocedure
oced
dure mayy ha
ave ccontributed
o trib
on
ibutted
ib
d tto
o th
hiss death,
deaa an
independent
Safety
Monitoring
ntt Data
Datta S
Safet
affett and
dM
onit
itorii Board
B rdd adjudicated
adj
dj di
dicated
tedd th
that
att this
thiis event
th
e ent
ntt was
as nott related
lattedd
specifically to the laser ablation catheter. The presumed cause of death was felt to be
arrhythmic. There were no patients who manifested transient ischemic attacks, strokes, or atrioesophageal fistulas.
Discussion
In this manuscript we report the international multicenter experience of the first 200 patients
treated with this novel VGLA catheter. In procedures performed by 33 operators at 15 centers,
the compliant, variable diameter VGLA catheter was capable of achieving PV isolation in 99%
of targeted veins utilizing (in the majority of cases) only 1 balloon catheter, irrespective of PV
size and anatomy. With visual guidance alone, 78% of PVs were isolated after placing the first
10
DOI: 10.1161/CIRCEP.113.000431
encircling lesion set. The mean procedure time was relatively long (200r54 min), but did
improve with operator experience, as one would expect with new technology. At 12 months, the
drug-free rate of freedom from atrial arrhythmias was 60%. These results were obtained without
any instances of significant PV stenosis, stroke/TIA, or atrio-esophageal fistula. However, there
was a 2% incidence of pericardial tamponade and a 3% incidence of phrenic nerve injury.
Efficacy of the VGLA catheter: While acute PV isolation was achieved in virtually all targeted
PVs, the observed clinical efficacy was similar to that seen with radiofrequency energy and
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
cryoballoon ablation. As with other technologies, it would seem to reason
a on that
as
thaat clinical
c iniccal
cl
a efficacy
eff
ffic
ic
is limited by chronic PV reconnections. However, in a subset of these pati
patients,
ien
entts, we
we ppreviously
revi
re
vioou
vi
ou
showed that
translated
patients
persistent
a a hi
at
high
gh rrate
ate of acute PV isolation transl
at
lated to 62% off pat
tie
ients having persisten
n PV
isolation off all
months.
ll veins at 3 m
ont
nthhs.111 In tthat
hatt study,
studdy,, reconnected
recconneect
c eedd PVs
V wer
were
ere re
re-isol
re-isolated
latted
dw
with
ithh
e y energy,
ency
y bbut
ut sti
till
ll resul
ulttedd in A
ul
F recurrence iinn 29
29%
% of ppatients
atiients at one year.
radiofrequency
still
resulted
AF
Therefore, PV reconnec
reconnections
ctiions alone are unlikely
y to account for thee 40%
% recurrence aatt on
on ye
one
yyear
e in
O h possibilities
ibili i include
i l d the
h presence off non-PV
PV triggers,
i
d an ostial
i l llevell of
this study. Other
and
electrical isolation that largely excludes areas in the antrum that may be responsible for the
initiation and perpetuation of AF.16, 17 We previously have shown that the level of electrical
isolation with the first generation VGLA catheter is at the PV ostium.2 The level of isolation
with the current generation VGLA catheter has not been systematically evaluated. However,
limited data from cases where electroanatomical mapping was performed with VGLA, suggests
that the level of electrical isolation maybe near the PV ostia.11 Further improvement in chronic
PV isolation rates and clinical efficacy with VGLA may depend upon the use of high-energy
ablation, particularly in areas of increased tissue thickness such as the left atrial appendage ridge,
where PV reconnections commonly occur with VGLA.11, 14
11
DOI: 10.1161/CIRCEP.113.000431
Safety of the VGLA: There were two important safety issues that were observed in this 200patient experience, albeit at a low event rate. The first of these was a 2% rate of pericardial
tamponade. This is possibly due, in part, to the inability to use an over-the-wire technique when
positioning the VGLA catheter. This is still a manageable rate given the uncensored nature of
the data. That is, it is likely that this tamponade rate will decrease after operators have passed
their learning curve. While the VGLA catheter was designed with an atraumatic tip, it has
recently been modified to further decrease its stiffness and render it even less traumatic. Only
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
future data will reveal whether this has the intended effect of decreasing
ngg the incidence ooff ccardiac
a
tamponade.
Thee se
second
200-patient
was
injury
eco
cond
n ssafety
nd
a etty event noted in this 200-pa
af
pati
pa
tient experience
ti
experien
nce w
as phrenic nerve inju
u –
observed in
2.5%
The
majority
year
with
n 2.
.5% of the ppatients.
atieentts. T
he m
ajor
ority ooff these
the
hese hhave
avee rresolved
av
essolved
so d aatt on
oone
ne ye
earr w
ith on
only
y 1/5
patients still
other
l having
ll
hav
vin
ingg persistent
p rsiisttentt injury.
pe
injury.
y. Phrenic
Phreni
nicc nerve
ni
ne
iinjury
nju
j ry hhas
ass been
beeen de
ddescribed
scribe
bedd with
be
t oth
th
ther bballoon
th
catheters, including
n ding the
nclud
th
he cryoballoon.
cryo
cr
y ball
lloon. However,
ll
However, unlike
unllik
ike with
wiith
h the
h cryoballoon
cry
ry
yobbal
allo
l on catheter,
lo
catthe
h te
t r,
r the
the
h
anatomic location
anatomy.
Therefore,
delivery
of
ocation
ati
tio off llesion
io delivery
deli
deli
li er can bbe ttailored
ail
il ed
d according
di tto anatom
att
Th
Therefore
eff
ddeli
eli
li
a more antral lesion set around the right sided PVs in locations that are susceptible to phrenic
nerve injury may help decrease this complication.
While some degree of PV narrowing was observed, there was no significant stenosis
associated with the VGLA catheter in this study. Although repeat CT scans were not performed
on all patients, there were no cases of clinical PV stenosis in any of the patients during one year
of follow-up.
Limitations: This study is a composite of several open-label, non-randomized, clinical studies
and was not a single study with a uniform protocol. Pre- and post-procedural CT scans were not
routinely performed, and when done, were not assessed by a core lab. Therefore, caution should
12
DOI: 10.1161/CIRCEP.113.000431
be exercised in interpreting degree of PV stenosis. However, there were no cases of clinically
significant PV stenosis seen in the study. A major limitation is the non-uniformity in follow-up
and AF monitoring methods that may have lead to an overestimate of the true clinical efficacy.
Multicenter, randomized trials with long-term follow-up are needed to truly assess the clinical
efficacy. There was a 6.5% catheter failure rate; that is, a second ablation catheter was required
in 13 cases. But it should also be noted that this is the initial use of this novel technology and
one could reasonably expect that this failure rate will improve over time. And most importantly,
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
the reason for additional catheters was not due to PV/balloon size mismatch;
additional
match;; that is, addi
diti
di
to
ti
catheters were not required to provide ‘touch-up’ energy delivery.
Conclusions
ns
In this multicenter
the
first
200
patients
with
compliant,
t cen
tic
ente
teer evaluation
eval
ev
a ua
u tiion of
of th
he fi
firs
rsst 20
00 pa
pati
tien
ti
en
nts treated
tre
reat
atted w
itth th
thee co
omp
pli
l an
antt, variable
var
aria
iabble
ia
diameter, visu
balloon
acute
vvisually-guided
uallly
ly-g
-gui
-g
uide
ui
dedd laser
de
laase
serr ba
ball
lloo
ll
ooon catheter,
oon
caath
thet
eter
et
er,, ac
er
cut
utee PV iisolation
s la
so
lati
tion
ti
onn was
was achieved
ach
c ieeve
v d in 999%
9%
% oof
targeted veins
catheter
safe,
eeins
ei
nss with
witth a sing
si
single
i gle
l balloon
ballo
alllo
loon
o catheter.
catthete
heter.. Th
he
Thee ca
cath
thet
th
etter
e aalso
llsso pr
pproved
oved
ov
ed
d ttoo be
b reasonably
rea
easo
sonaabl
b y sa
saf
with no instances of embolic stroke / TIA, PV stenosis, or atrio-esophageal fistula. On the other
hand, there remains a low rate of pericardial tamponade and phrenic nerve injury. The clinical
efficacy was similar to other AF ablation technologies. This favorable experience sets the stage
for truly comparative long-term efficacy and safety studies (versus radiofrequency ablation).
Acknowledgments: Other clinical sites contributing to the study are: San Camillo-Forlanini
Hospital, Rome, Italy, William Beaumont Hospital, Royal Oak, MI, The Methodist Hospital,
Houston, TX, University of Virginia, Charlottesville, VA, and University of Leipzig Heart
Center, Leipzig, Germany.
Funding Sources: This study was supported by CardioFocus, Inc.
Conflict of Interest Disclosures: KHK, PN, IW, JK, HTM, EPG, SKD, RH, and VYR received
13
DOI: 10.1161/CIRCEP.113.000431
research grant support from CardioFocus, Inc. KHK serves as consultant for CardioFocus, Inc.
JNR served on the clinical oversight committee for one of the studies (no compensation). SRD,
KHK, BS, and AM received honoraria from CardioFocus, Inc. The remaining authors report no
conflicts.
References:
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
1. Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijins HJG, Damiano Jr.
RJ, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre
M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchof P,
Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM,
Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C,
Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM,, Wilber D. 2012
HRS/EHRA/ECAS expert consensus statement on catheter and surgical
ablation
al ab
abla
lati
la
tion
ti
on ooff at
aatrial
atr
trial
rial
fibrillation: recommendations for patient selection, procedural techniques,
management
ues, pa
ppatient
tiientt ma
tien
mana
naage
gem
m
and follow-up, definitions, endpoints, and research trial design. Heart Rhythm.
2012;9:632-696.
Rhythm
hm 20
2012
12;9
12
;9
9:6
:6332
32
2. Reddy VY
VY,
P,, d’Avila
Laragy
Malchano
Kralovec
SJ,, Ru
Ruskin
V
Y, Neuzil P
d Avil
d’
Avvil
ilaa A,
A L
arrag
gy M,
M, M
alcchaanoo ZJ
ZJ, Kral
Kr
ral
alov
ovec
ov
ecc S, Ki
Kim
m SJ
S
R
skkin
in JJN.
Balloon Catheter
Paroxysmal
Atrial
Fibrillation:
atheter Ablation
at
Ablatio
on to Treat
Treat
att P
arox
oxyssmal A
trial
al Fib
ibri
ib
rill
ri
llaatio
ll
on: What
Wha
hat is
is the Level
Lev
e el off
Pulmonaryy Venous
Heart
Rhythm.
2008;5:353-360.
Veno
Ve
n us Isolation?
Iso
solaation?? H
so
eaart Rhyt
ythm
yt
m. 200
008;55:35
00
3533 3660.
33. Chun KR,
A,, Ko
Koektuerk
R Schmidt
R,
Scchm
hmid
i t B,
id
B, Metzner
M tz
Me
tzne
n r A,
ne
A, Tilz
T lzz R,
Ti
R, Zerm
Z rm
Ze
m T,
T, Köster
Köst
Kö
s er
st
e I,
I, Fürnkranz
Fürn
Fü
r krran
rn
anzz A
K
ek
ektu
ktu
uer
erkk B,
Konstantinidou
M,
n
nidou
M, Antz
Antz M,
M, Ouyang
Ouya
y ngg F,
F, Kuck
K ck
Ku
k KH.
KH. The
Th 'single
'singl
glle big
biig cryoballoon'
cryo
yoba
ball
ba
lloon'' technique
ll
techn
hniq
hn
ique
iq
u for
foo
acute pulmonary
vein
fibrillation:
m
monary
ve
ein
n iisolation
s la
so
lati
tion
ti
o inn patients
on
ppaati
tien
ents
en
t with
wit
ithh paroxysmal
paro
pa
roxy
ro
xysm
xy
s al
sm
al atrial
atrria
iall fi
fibr
bril
br
illa
il
laation
lati
tiion
on:: a prospective
pros
pr
o pective
observational
study.
Eur Heart
nall single
sii le centre
tr st
t d E
H t J.
J 2009;30:699-709.
22009;30:699
0099;30
00
30:699
699 709
709
4. Kojodjojo P, O'Neill MD, Lim PB, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton NW,
Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Pulmonary venous
isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent
atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary
venous isolation by radiofrequency ablation. Heart. 2010;96:1379-1384.
5. Chun KR, Furnkranz A, Koster I, Metzner A, Tonnis T, Wohlmuth P, Wissner E, Schmidt B,
Ouyang F, Kuck KH. Two versus one repeat freeze-thaw cycle (s) after cryoballoon pulmonary
vein isolation: the ALSTER EXTRA pilot study. J Cardiovasc Electrophysiol. 2012;23:814-819.
6. Schmidt B, Chun KR, Metzner A, Fuernkranz A, Ouyang F, Kuck KH. Pulmonary vein
isolation with high-intensity focused ultrasound: results from the HIFU 12F study. Europace.
2009;11:1281-1288.
7. Sohara H, Takeda H, Ueno H, Oda T, Satake S. Feasibility of the radiofrequency hot balloon
catheter for isolation of the posterior left atrium and pulmonary veins for the treatment of atrial
fibrillation. Circ Arrhythm Electrophysiol. 2009;2:225-232.
14
DOI: 10.1161/CIRCEP.113.000431
8. Reddy VY, Neuzil P, Themistoclakis S, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton
NW, Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Visually-guided
balloon catheter ablation of atrial fibrillation: experimental feasibility and first-in-human
multicenter clinical outcome. Circulation. 2009;120:12-20.
9. Dukkipati SR, Neuzil P, Skoda J, Petru J, d’Avila A. Doshi SK, Reddy VY. Visual balloonguided point-by-point ablation: reliable, reproducible, and persistent pulmonary vein isolation.
Circ Arrhythm Electrophysiol. 2010;3:266-273.
10. Schmidt B, Metzner A, Chun KR, Leftheriotis D, Yoshiga Y, Fuernkranz A, Neven K, Tilz
RR, Wissner E, Ouyang F, Kuck KH. Feasibility of circumferential pulmonary vein isolation
using a novel endoscopic ablation system. Circ Arrhythm Electrophysiol. 2010;3:481-488.
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
11. Dukkipati SR, Neuzil P, Kautzner J, Petru J, Wichterle D, Skoda J, Cihak R, Peichl P, Dello
Russo A, Pelargonio G, Tondo C, Natale A, Reddy VY. The durability
vein
y of pu
ppulmonary
lmonaryy ve
ein
isolation using the visually guided laser balloon catheter: multicenter re
results
resu
sult
su
ltss of ppulmonary
lt
ulmo
ul
mona
mo
naary
y vein
remapping studies. Heart Rhythm. 2012;9:919-925.
12. Metzner
A,, Sc
Schmidt
E,, Tilz RR, Ch
Chun
e A
er
Schm
hmid
hm
i t B,
B, Fuernkranz A, Wissnerr E
hun KR,
KR, Neven K,
Konstantinidou
n dou M, Rillig
nid
Riillig A,
A, Yoshiga
Yosh
Yo
shhig
ga Y,
Y, Mathew
Math
Ma
hew S, Koester
Koesste
terr I,
I, Ouyang
O ya
Ou
yang
ngg F, Kuck
Kuuck
c KH.
KH
H. One-year
Onne-yy
clinical outcome
System
tcome
tc
come after pu
pulmonary
ulm
mona
nary vvein
ein is
iisolation
olat
ationn using
usin
ng the
th
he novel
no En
Endosc
Endoscopic
scoppicc Ab
Ablation
blatio
on Sy
ysste
te in
patients with
fibrillation.
Heart
Rhythm.
2011;8:988-993.
th
h paroxysmal
paroxy
pa
ysm
mall aatrial
triall fibr
bril
br
illa
il
l tiion
o .H
eart Rh
hythm
m. 201
011;;8:9888-9993.
3
13. Schmidt
M,, Ur
Urban
Kulikoglu
Bordignon
dt B,, Gunawardene
Gun
unaw
awar
aw
arde
ar
dene
de
nee M
Urba
b n V,
ba
V K
uliikog
ul
ogglu M,
M, Schulte-Hahn
S hult
Sc
huulttee-Ha
H hn B,
Ha
B, Nowak
Noowa
wakk B,
B B
Bord
ord
S, Chun KJ.
vein
isolation:
J Visually
J.
V sually
Vi
ly guided
guiide
dedd sequential
sequ
q enti
tiial ppulmonary
ulmonary
l
y vei
in is
ollation:: iinsights
nsi
sigh
si
ghtts into
gh
intto techniques
tech
chni
ch
niqu
ni
q es and
qu
predictors of
success.
Cardiovasc
Electrophysiol.
o acute su
succ
cces
cc
ess.
es
s.. J Ca
Card
rdio
rd
i va
io
vasc
scc E
lect
le
ect
ctro
roph
ro
phys
ph
ysio
ys
iol.
io
l. 22012;6:576-582.
l.
0112;6:
2;6 5762;
57657
6-58
582.
58
2.
14. Metzner A, Wissner E, Schoonderwoerd B, Burchard A, Tilz R, Fürnkranz A, Rillig A,
Mathew S, Ouyang F, Kuck KH. The influence of varying energy settings on efficacy and safety
of endoscopic pulmonary vein isolation. Heart Rhythm. 2012;9:1380-1385.
15. Ahmed H, Sohal S, Malchano ZJ, Holmvang G, Ruskin JN, Reddy VY. Three-Dimensional
Analysis of Pulmonary Venous Ostial and Antral Anatomy: Implications for Balloon CatheterBased Pulmonary Vein Isolation. J Cardiovasc Electrophysiol. 2006;17:251-255.
16. Yamaguchi T, Tsuchiya T, Miyamoto K, Nagamoto Y, Takahashi N. Characterization of
non-pulmonary vein foci with an EnSite array in patients with paroxysmal atrial fibrillation.
Europace. 2010;12:1698-1706.
17. Arentz T, Weber R, Bürkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ,
Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial
fibrillation? results from a prospective randomized study. Circulation. 2007;115:3057-3063.
15
DOI: 10.1161/CIRCEP.113.000431
Table 1. Patient Demographics.
N = 200
Age, mean±SD (limits)
57.0±9.9 (25–75)
Gender, M/F (%)
120 (60%) / 79 (40%)
Duration of AF, median years (Q1-Q3)
3.0 (1.0 – 7.0)
Coronary Artery Disease, n (%)
20 (10.0%)
Hypertension, n (%)
112 (56.0%)
Ejection Fraction, mean±SD (limits) *
63±8% (30–88%)
LA Diameter, mean±SD (limits)*
4.1±0.5 cm (2.7–5.6)
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Anti-Arrhythmic Medications†
Class I
1222 (39.5%)
(39.
(3
9 5%)
9.
Class II
85 (27.5%)
(27 5%))
Class III
II
98 (31.7%)
( 1.
(3
1 7%))
Other
4 (1.9%)
%
* Available from
m 1178
78 ppatients.
atie
ient
ie
nts.
nt
s
†
187 patients
t fai
ts
failed
ile
led
d a to
tota
total
tall of 3309
ta
09 aanti-arrhythmic
nti--ar
nt
a rh
r ytthm
hmic
ic medications
med
dic
icat
atio
at
ions
io
ns
Table 2. Ablation Data
N = 200
# PV Isolated (%)
761/770 (98.8%)
# PVs isolated on First Attempt (%)
604 (78.4%)
# Attempts to isolate/PV, mean
1.3
# Ablation Lesions per Patient
147r35
# Catheters per Patient
1.07
Fluoroscopy Time, min (limits)
31r21 (3–135)
Laser Ablation Time, min (limits)
108r36 (34–236)
Procedure Time, min (limits)
200r54 (85–358)
16
DOI: 10.1161/CIRCEP.113.000431
Table 3. Number and Type of Pulmonary Veins Isolated
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
N = 770
PVs Isolated
PVs Isolated on First
Attempt
Left Superior
173
170 (98.3%)
121 (69.9%)
Left Inferior
171
170 (99.4%)
137 (80.1%)
Left Common
29
29 (100%)
17 (58.6%)
Right Superior
195
194 (99.5%)
160 (82.1%)
Right Inferior
194
191 (98.5%)
162 (83.5%)
Right Common
5
4 (80.0%)
4 (80.0%)
Other
3
3 (100%)
3 (1
(100
(100%)
00%)
00
%)
Table 4. Pulmonary
P
Vein
V in Diameter
Ve
Diameter Ch
Change on 3 Mo
M
Months
nths
h Post-Ablation
Post-Ab
t Abblati
tion
i CT
T Scans.
Scans.
Pulmonary
Pulm
Pu
lmon
lm
onar
aryy Ve
Vein
Veins
inss
in
N (%)
PV Diameter Decrease
1 to 25%
26 to 50%
> 50%
168 (43.9%)
24 (6.3%)
0 (0%)
PV Diameter Increase
0 to 25%
26 to 50%
> 50%
180 (47.0%)
9 (2.3%)
2 (0.5%)
17
DOI: 10.1161/CIRCEP.113.000431
Table 5. VGLA-Related Complications
Complication Type
Phrenic Nerve Injury
5 (2.5%)
Transient Ischemic Attack
0 (0%)
Stroke
0 (0%)
Cardiac Tamponade
4 (2%)
Atrio-esophageal Fistula
0 (0%)
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Bleeding
Major
3 (1.5%)
%)
Minor
7 (3.5%)
%)
Figure Legend:
gend
gend
ge
nd::
Figure 1. Procedural Parameters as a Function of Operator Experience. Procedural parameters
are compared for the first 15 procedures performed by operators vs. cases beyond the first 15
(i.e. operators served as their own controls). Procedure time, ablation time, and fluoroscopy time
all improved with increased experience.
18
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Procedural Parameters vs. Operator Experience
_
P = 0.0005
209±60
179±40
P = 0.
0.001
.001
115±39
1
15
5±39
97±28
9
7±28
P < 0.0001
37±22
19±8
Pulmonary Vein Isolation Using a Visually-Guided Laser Balloon Catheter: The First
200-Patient Multicenter Clinical Experience
Srinivas R. Dukkipati, Karl-Heinz Kuck, Petr Neuzil, Ian Woollett, Josef Kautzner, H. Thomas
McElderry, Boris Schmidt, Edward P. Gerstenfeld, Shephal K. Doshi, Rodney Horton, Andreas
Metzner, Andre d'Avila, Jeremy N. Ruskin, Andrea Natale and Vivek Y. Reddy
Downloaded from http://circep.ahajournals.org/ by guest on November 1, 2016
Circ Arrhythm Electrophysiol. published online April 4, 2013;
Circulation: Arrhythmia and Electrophysiology is published by the American Heart Association, 7272 Greenville Avenue,
Dallas, TX 75231
Copyright © 2013 American Heart Association, Inc. All rights reserved.
Print ISSN: 1941-3149. Online ISSN: 1941-3084
The online version of this article, along with updated information and services, is located on the
World Wide Web at:
http://circep.ahajournals.org/content/early/2013/04/04/CIRCEP.113.000431
Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in
Circulation: Arrhythmia and Electrophysiology can be obtained via RightsLink, a service of the Copyright Clearance
Center, not the Editorial Office. Once the online version of the published article for which permission is being
requested is located, click Request Permissions in the middle column of the Web page under Services. Further
information about this process is available in the Permissions and Rights Question and Answerdocument.
Reprints: Information about reprints can be found online at:
http://www.lww.com/reprints
Subscriptions: Information about subscribing to Circulation: Arrhythmia and Electrophysiology is online at:
http://circep.ahajournals.org//subscriptions/