Professional Documents
Culture Documents
003862
Abhishek Deshmukh, MD1; Nileshkumar J. Patel, MD2; Sadip Pant, MD1; Neeraj Shah, MD2;
Ankit Chothani, MD3; Kathan Mehta, MD4; Peeyush Grover, MD5; Vikas Singh, MD5;
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1
Universiity
University y ooff Ar
Arkansas
rkans
kans
nsas
as ffor
or M
or Medical
edi
d cal
cal ScScie
Sciences,
i ncess, LLittle
itttlee R
Rock,
ock,
oc k, A R; 2S
AR; Staten
taaten
n Island
Isl
slan
an
nd University
Uniiver
Un ersi
ersity
si ty
3
Hospital,
Hosp
Ho s ital, Staten
Sttat
a en n Island,
Islan
nd, NY;
NY; Me Medstar
Medsdsta
tarr IInstitute,
nstiituute, W
Washington
ashi
hiing
ngto
tonn Ho
to Hospital
ospitall C
Center,
ente
en terr, Wa
Washington,
ashhin
hingtton, D DC;
C;
5
University
Univ
Un i er
iv e si
sity
ty of
of MiM
Miami
iam
am
mi - Mi
Mill
Miller
l err S
ll School
cho
hoolol O Off Me
Medi
Medicine,
diccine, Mi
M
Miami,
am
mi,, F L; 4Dr
FL; Drexel
D exel el University
Uniive
v rssitityy College
Colleg
Coll eg
ge of
Medi
Me
Medicine,
dici
di cinne,
ci ne, Philadelphia,
Phil
Ph illad
adel
delph
ph
hia, PA; 6Wa
ia PA; Wayne
Way yne State
Stat
St atee University
at Univer
Univ ersi
sity
ity Detroit,
Det
etro
roiit, MI; 7Em
it MI Emory
E mor oryy Un
Univ
University,
iveersi
iv sity
ty, At
Atla
Atlanta,
lant
nta,
ta,
GA 8Uni
GA; University
U niver
iv rsisity
ty off Kansas,
Ka as,, Kansas
Kansas Kansas City,
Kans City,
ity, KS
KS
1
DOI: 10.1161/CIRCULATIONAHA.113.003862
Abstract
Background—AF ablation has tremendous progress with respect to innovation, efficacy and
safety. However limited data exists regarding burden and trends in adverse outcomes arising
from this procedure. The aim of our study was to examine frequency of adverse events due to
Atrial Fibrillation (AF) ablation and influence of operator and hospital volume on outcomes.
Methods and Results—Using the Nationwide Inpatient Sample (NIS) we identified AF patients
treated with catheter ablation. We investigated common complications including cardiac
perforation and/or tamponade, pneumothorax, stroke, transient ischemic attack (TIA), vascular
access complication (consisting of hemorrhage/hematoma, vascular complication requiring
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surgical repair, and accidental arterial puncture), and in-hospital death described with AF
y validated International Classification of Diseases ((9th Edition))
ablation and defined them by
Clinical Modification (ICD-9-CM) diagnosis codes. An estimated 93,801 AF abl
blat
atio
ionns w
io
ablations eree
er
were
from the 2000 to 2010. The overall frequency of complications was 6.29% with combined
cardiac comp
plications (2.54%) being the most frequ
complications q ent. It was followed by vascular
frequent.
co
omp
mpli
liccati
tion
complicationsonns (1.53%),
(1
1.5
.53%
3%),
), respiratory
res
espi
p raato
tory
y complications
com
mpl
plicatio
i ns (1.3%)
(1.3%
%) and
an neurological
neeur
urolog
ogic
ical
a complications
com
ompl
plicatio
ions
ns
1.002%
2 ). The in-hospital
(1.02%). in-
n-hoosp
spit
i all mortality
it morrta
tali
lity
ty
y was
was 0.46%.
0.46%
6%
%. Annual
Annnuall operator
ope
perrato
ratorr (<25
(<
<25 pprocedures)
ro
oce
cedu
dure
du res)
s)) aand
nd hhospital
ospi
pita
ita
t l
vo
olu
ume
m (<500 procedures)
volume p oceedur
pr edurress) were
weeree significantly
sig
igni
nifi
ni ficcant
cantly
ly
y associated
ass
ssoc
occiaate
tedd with
with
h adverse
adv
dverrse outcomes.
ouutccom
comes.
mes. There
Ther
here was
was
as a
mal
alll (n
small (non
n-sig
s gni
nifica
cant
nt) ri
(non-significant) ise inn ov
rise over
e all co
overall omp
mpli
liccati
tion
complication o rat
ates
es.
rates.
Conclusion
ns—
s Th
Thee overall
Conclusions—The over
ov erral
a l complication
comp
co mpli
l caation
li on rate
rat
atee was
was 6.29%
6.29
29%% in ppatients
atie
ati ntts un
ie unde
derg
de r oi
rg oing
undergoing ng
gA F ab
AF ablation.
There was a significant association between operator and hospital volume on adverse outcomes.
This suggests a need for future research into identifying the safety measures in AF ablations and
instituting appropriate interventions to improve overall AF ablation outcomes.
Key words: catheter ablation, complication, fibrillation, fibrillation, Operator volume, Operator
volume, Hospital volume, Hospital volume
2
DOI: 10.1161/CIRCULATIONAHA.113.003862
The past decade has seen catheter ablation of atrial fibrillation (AF) transition from a new
throughout the world.1 Catheter ablation of AF has also evolved into a mainstay of therapy for
patients with drug-refractory symptomatic AF.2, 3 Recently, catheter ablation has been proposed
strategies that eliminate AF triggers via pulmonary vein (PV) isolation produce a single
procedure success of 65% at up to 1 year.5, 6 Due to expanding training programs, the numbers of
operators performing this complex procedure are increasing worldwide. The complications of
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this procedure vary widely, with most studies suggesting major complication rates between 1%
and 8%.2, 6-12 The majority of data regarding the safety of AF ablation comes from
om
m sselected
elec
el e te
ec tedd
academic centers and operators with extensive expertise in catheter ablation. Real world data
regarding
ega
gard
rdin
rd ingg co
in ccomplications
mpli
liica
cati itted.13
t ons off AF ablation are limit
limited.
The principal
prrin
inci
c pal
pal ob
oobjective
ject
jectiv
ctiv
ve off tthis
hi na
his nationwide
ation
nwidee ccohort
ohoortt sstudy
tu
udy
dy w
was
as tto
o in
iinvestigate
vest
vest
stig
igat
igatee th
thee fr
freq
frequency
que
uenc
ncyy
nc
and
nd predictors
an pred
pr e ic
ed icto
torrs
to rs of
of in-hospital
in
n-h
-hos
ospi
p ta
pi t l complications
c mp
co mpli
lica
li onss in
cattion
tion in an
an ‘everyday
‘evvery
‘e dayy clinical
ryda
ry da iniical practice’
cllin praacttice’ population
ice’ pop
opuula on of
ulatio
patients undergoing
under
errgo
goin
in
ng AF
A ablation,
abl
blat
bl atio
at i n, to
to determine
d te
de term
rmin
rminee in-hospital
in i -h
in hosspi
pita
tall mortality
ta mort
mortal
rt alit
al i y associated
asssooci
ciat
ated
at ed
d with
wit
ithh AF
A ablation
and to assess the association between annual operator volume and hospital volume on adverse
outcomes. We were unable to assess the complications typically observed after discharge such as
delayed tamponade, pulmonary vein stenosis and atrio-esophageal fistula due to the nature of the
dataset.
Methods
Data source
The data were obtained from the Nationwide Inpatient Sample (NIS) data set from 2000 to
3
DOI: 10.1161/CIRCULATIONAHA.113.003862
Healthcare Cost and Utilization Project in collaboration with the participating states. It is the
largest all-payer inpatient data set in the United States and includes a 20% sample of United
States community hospitals that approximates 20% of all United States community hospitals.15
Each entry contains information on demographic details, including age, gender, race, insurance
status, primary and secondary procedures, hospitalization outcome, total cost, and length of stay.
The NIS database contains clinical and resource use information, with safeguards to protect the
privacy of patients, physicians, and hospitals. The NIS database results have been shown to
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
correlate well with other hospitalization discharge databases in the United States.16 It has also
been used to explain trends in other acute medical and surgical conditions.17, 18 Th
The
he in
inst
institutional
stit
itut
utio
ional
review
eview board of the University of Arkansas for Medical Sciences approved the study.
Study
St
tud
udyy population
popu
popu
pula
lation
la on
Our
Ourr ta
ttarget
rget pop
population
pul
ulat
atio
ionn co
consisted
onssiste
iste
tedd off ppatients
atiiennts w
at who
ho uunderwent
ndderwe
went
we nt ca
catheter
atheeteer ab
athe ablation
bla
l tion
onn ffor
or A
AFF fr
ffrom
om tthe
he
years
year
ye arss 20
ar 22000
00
0 tto
o 20
2010
2010.
0. T
There
here
ere iss nno
o un
uniq
unique
ique
iquee pprocedure
roccedu
ro dure
du ree ccode
odde fo
forr AF
F aablation.
b at
bl atio
i n. W
io Wee se
searched
ear
arch
cheed ffor
ch orr hhospital
ospi
pita
t
admissions with
wit
ithh a principal
prin
pr in
nci
c paal diagnosis
d agn
di gnos
gn osis
os i of
is of AF (International
(In
Inte
teern
nat
a io
iona
nall Classification
na C as
Classi
sifica
si cati
ca tion
ti on of
of Di
Diseases,
ise
seas
ases
as es,, 9th
es
Revision, Clinical Modification, code (ICD-9-CM 427.31) during which a catheter ablation
procedure (code 37.34) was performed. We excluded patients having a secondary diagnosis of
complexes. Also, to avoid inclusions of patients undergoing only ablation of the AV junction, we
excluded patients with diagnostic or procedural codes indicating prior or current implantation of
during the hospitalization also were excluded. Similar methodology has been utilized previously
4
DOI: 10.1161/CIRCULATIONAHA.113.003862
to identify patients undergoing AF ablation from large administrative databases.13, 19 The ICD-9-
CM codes used to identify each of these diagnoses and procedures are listed in the
Supplementary Table 1.
Outcomes
ablation procedures. These complications were also described in other AF ablation studies.9, 12
Complications available for this analysis included cardiac complications (iatrogenic cardiac
bl
loood tr
blood tran
an
nsf
sfus
usio
on,
transfusion, n vvascular
ascular complication requiri
ing
n ssurgical
requiring urgical repair
r),
) pos
repair), osst-
t-ooperative infectious
post-operative
co
omplications
mp s and
complications an
nd in-hospital
in
n-h
- os
ospi
pita
pi tall death.
ta deat
deat
athh.
h. These
Theese complications
complliccation
onss were
on were selected
selleccte
tedd based
bassed on
on re
evi
view
ew ooff
review
pert
pe rtin
rt in
nen
pertinente t clinical
cllin
inic
ical
all literature
liiter
iteraatuure
ure and
n identified
nd ide
dent
ntif
nt ifiied
ied from
from corresponding
corr
orresppond
pond
ndiing
ing ICD-9-CM
ICD-
ICD--9-
9 CM diagnosis
dia
iagn
gnos
gnossis and
annd
procedure co
ode
dess as uutilized
codes tiiliize
z d by oother
ther
therr iinvestigators
nv
vessti
tiga
gato
ga tors
torss tto
o ma
ain
inta
tain
tain cconsistency
maintain onsiist
on s en cy99,, 13 (S
ency (Supplementary
(Sup
uppl
up plem
pl e entary
Table 2). Procedural complications were further identified by Patient Safety Indicators (PSIs),
which have been established by the Agency for Healthcare Research and Quality to monitor
preventable adverse events during hospitalization. These indicators are based on ICD-9-CM
codes and Medicare severity Diagnosis-Related Groups and each PSI has specific inclusion and
exclusion criteria.20, 21 PSI individual measure technical specifications, Version 4.4, March 2012
was used to identify and define preventable complications viz. iatrogenic pneumothorax, post-
procedure respiratory failure, accidental puncture or laceration, and post- procedure infectious
complications which included post-procedure sepsis & central venous catheter related
5
DOI: 10.1161/CIRCULATIONAHA.113.003862
bloodstream infection.22
complications, requiring open heart surgery, other iatrogenic respiratory complications (which
attack (TIA) and other vascular complications were identified using ICD-9-CM codes (listed in
Supplementary Table 2) in any secondary diagnosis field. Vascular complications were defined
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
as PSI code for accidental puncture or ICD-9-CM codes for injury to blood vessels, creation of
other vascular complications not elsewhere classified. “Any complications” was defined as
oc
ccu
curr
rrrence
ence ooff on
occurrence ne or
one or more post-procedure complications
comp
pli
licaations listed inn Su
S pp
ple
lementary Table 2.
Supplementary
Atri
riial
a -esophag
geaal fistula
Atrial-esophageal fist
stul
u a an
andd pulm
ppulmonary
ulm
mona
nary
ry
y vein
veiin stenosis
sten
nosis were
wer
eree not
not included
incl
clud
udded
e inn this
this analysis
analy
naly
lysi
s s gi
si ggiven
ive
veen
hat tthey
that heyy ty
he typi
pica
pi call
llly occur
typically occcur
oc cur well
w lll beyond
we beyo
beyond
yon the
nd the index
ind
ndex
ex
x procedural
proc
rocedura
dura
rall ho
hosp
s ital
spitalliz
izat
attio
ion.
hospitalization. n. C om
mpl
plic
iccatio
io
Complicationsons
ns w eree
er
were
complication rates. We also examined length of stay (LOS) for the procedure and difference is
disposition.
Definition of variables
We used NIS variables to identify patient age, gender and race. We divided race into white and
nonwhites. We divided age into five sub-groups - age 18 to 34, age 35 to 49 age 50-64, age 65-
79 and age 80 and above. We defined severity of co-morbid conditions using Deyo’s
6
DOI: 10.1161/CIRCULATIONAHA.113.003862
with differential weights. The score ranges from 0 to 33, with higher scores corresponding to
greater burden of co-morbid diseases. Facilities were considered to be teaching hospitals if they
had an American Medical Association approved residency program, were a member of the
Council of Teaching Hospitals, or had a fulltime equivalent interns and residents to patient’s
ratio of 0.25 or higher. Hospital location (rural/urban) and bed size were also recorded. The bed
size cutoff points into small, medium and large have been done so that approximately one-third
of the hospitals in a given region, location, and teaching status combination would fall within
each bed size category.23 The unique physician-identifying number is specific to dataset and this
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
allowed us to track the number of AF ablations an operator performed in a given year. The
operator identification numbers in NIS do not correlate across years, and hence the
th
he same
s me
sa
operator performing the procedure in different years may be recorded under a different identifier
identifier,
but
bu
ut wi
with
within
thin
th in tthe
he sam
same
am
me year, the operator identifierss do
o not change. D
Due
ue tto
o the
th above reason, annual
operator
oper
erat
a or volume
volum
me was
wass calculated
calc
ca lcul
ulat
lat
ated
ed on
on a year
yeaar too year
yearr basis
baasiss by
by matching
matc
ma tchhinng
ng the
the
h operator
opeera
rato
torr id
iidentification
enti
enti
tifiicati
cation
ion
number
numb
nu mber
mbe related
er rellat ed to
ated to a particular
paarttic u arr procedure
i ul prroc e urre to the
oced
ed thee total
tottall number
num
umbe
umberr of procedures
be proc
pr oced
oc es recorded
e urees
ed rec
e or under
o deed un that
ndeer th
hatt
operator identification
ident
nttif
ific
i at
ic atio
ionn nu
io nnumber
mber
mb e iin
n th
the
he gi
give
given
venn ye
ve ar.13 Moreover,
year
year.
ar Mor
oreo
eove
eover,
ve r nnot
r, o aall
ot ll hhospitals
ospi
os pita
tals
ls aallow
llow
ll ow tthe
h release
he
of operator specific data. Hence, operator volume data were available for 52.71% (n=49443) of
the population. Operator identification numbers were released in only 23 states, which includes
AZ, CO, FL, GA, IA, KS, KY, MD, MI, MN, MO, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA,
WA &WV. Annual hospital volume was determined on a year-to-year basis using the unique
7
DOI: 10.1161/CIRCULATIONAHA.113.003862
procedures for those who undergo fellowships in clinical cardiac electrophysiology.20 Based on
this, we divided the annual operator volume as more than 50 procedures, between 50-25 and less
than 25. Similarly comparisons of high and low volume centers suggest that that have performed
more than 100 AF ablations.2 Hence, we divided the annual hospital volume as more than 100,
Statistical Analysis
We used the weights provided with the NIS to generate national estimates of the number of
admissions during each year. We used chi-square test to compare categorical variables between
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
patients with and without complications. We compared continuous variables like LOS using
Wilcoxon Sign rank sum test since they were not normally distributed. Hierarchical
Hierarch
hiccall mixed
mix
ixed
ed
effects logistic regression models were generated in order to identify the independent
mult
mu ltiv
lt ivaaria
iv aria
iate
multivariate te ppredictors
reedi
diccto
ctors of post-procedural comp
pli
lica
caations. Two lev
complications. vel
e hhierarchical
level ieera
rarchical models (with
pati
ien
e t level factors
patient fact
fa cttorrs nnested
estted within
witthi
hinn hospital
hosppital llevel
ho evel ffactors)
ev actorrs) w eree cr
were crea
ate
tedd wi
created w th tthe
with he uunique
niqu
ni quue ho
hosspit
spit
ital
hospitalall
den
enti
tifi
ti fica
fi cati
tiion nnumber
identification um
mbe
b r in
nco
corp
porat
ated
incorporateded aass ra
rrandom
ndom
nd om eeffects
fffec
ectts w ithi
it hinn th
hi
within thee mo
mode
d l. R
de
model. acce wa
Race w
wass misssin
ng in
missing n
were done in urban hospitals, we did not include rural/urban location of hospital in the model. In
all multivariate models, we included hospital level variables like hospital bed size, hospital
region (Northeast, South, Midwest with West as referent), teaching vs. non-teaching hospital and
patient level variables like age, sex, Deyo modification of CCI, median household income &
volume or operator procedure volume or both .The effects of hospital volume and operator
volume were studied separately by creating separating models incorporating each without the
other. Subsequently a third model was created incorporating both hospital and operator volume
8
DOI: 10.1161/CIRCULATIONAHA.113.003862
with a term to adjust for interaction effect between hospital and operator volume. Hospital ID
was incorporated as a random effect in the model to account for the effect of hospital clustering
(meaning that patients treated at the same hospital may experience similar outcomes as a result
of other processes of care). Since operator ID did not remain constant across the years, we could
not incorporate it as a random effect in the model. We used Stata IC 11.0 (Stata-Corp, College
Station, TX) for all analyses. P-value of less than 0.05 was considered significant.
Results
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
We identified 93,801 catheter ablation procedures for AF performed between the years 2000-
were performed. A total of 5,909 (6.29%) complications were reported. The number of
prrocced
eduures
ures iincreased
procedures ncreeas
ased
e from 3,367 in the year 2000
00 tto
o 12,006 in th
he year
the arr 22010.
0 0. The majority of the
01
procced
e ures wer
procedures eree pperformed
were erfforme
medd in m
me en,, ag
en
men, ge grou
age up betw
group tweenn 50-80,
tw
between 50-80,
50- 0, C au
uca
casi
sian
si ns, hhypertensive,
Caucasians, yperte
yper t nsiv
tensiv
ive,, ppatients
atieents
at
wiith lless
with e s co
es omo
morb
rb
bid
dit
ityy bu
comorbidity urd
rden
n, ho
burden, hosp
spiital
sp italss wi
hospitals with
th la
arg
rgee bbed,
large edd,
d, uurban
rban
rb an
n llocation,
occattio
ion,
n,, aacademic
c de
ca dem
mic se
mic setttin
ng an
setting andd
ocated in the
located he ssouthern
o th
ou ther
e n re
er rregion
gion
gi on of
of the
t e US.
th US
S. Most
Most the
the procedures
pro
r ceedur
ures
e ((81%)
es 8 %) w
81 eree performed
er
were p rf
perfor
orme
ormedd by
me
operators doing less than 25 AF ablations a year and in hospitals with annual volume less than 50
The overall frequency of complications per 100 ablation procedures was 5.33 in 2000 and
7.48 in 2010. However, no uniform trend was noted for this overall rise in complication
acute myocardial infarction) were the most frequent adverse outcomes (2.54 %). It was followed
9
DOI: 10.1161/CIRCULATIONAHA.113.003862
complications (1.02%) (Figure 1). Specifically, pericardial complications and post operative
stroke/TIA showed an increasing trend over the past decade. The trends of each complication
Catheter ablation of AF in older patients (age >80) was associated with a higher total
complication rate (9.37 %) (Figure 2) when compared to younger patients (age <80, p<0.001).
Women had overall higher complications compared to men (7.51% vs. 5.49%, p<0.001).
AF ablations in patients with diabetes, renal disease, prior stroke, heart failure, peripheral
vascular disease, anemia and depression had significantly higher complications (table 1).
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
There was a significant association between operator and hospital volume on adverse outcomes.
In
n unadjusted analysis, annual operator volume (less than 25) and annual hospital
all vvolume
olum (less
umee (l
(les
es
es
than
han 50) were associated with higher complications (p<0.001) (Figure 3 and 4). In multivariate
regression
egr
gres
essi
es sion
si onn annual
nnuaal operator
ann op volume between 25 to 50
50 (OR, 0.51; 95%
5 CI,
95% I, 0.33-0.80, p<0.004) and
CI,
more
re than 50 ((OR,
morre 0.38;
OR, 0.
OR, 0.38
3 ; 95
38 95%% CI, 0.21-0.69,
CI 0.
0.21 0.699, pp<0.002)
21-0
-0 were
<0.0002) w eree sign
er ssignificantly
ign
nif
ific
ican
antl associated
t y as
asso
soci
so ciat with
atted w lless
i h les
it ess
ss
complications
co
omp
mpli
lica
li cati onss ((Table
tion
on Tabl
Ta blee 3). Annual
). A nn hospital
nuaal ho spiital vvolume
hosp olum
umee did
um not
di no aachieve
ot achi
chi
hiev
eve st
ev statistical
stat
a istiica
at significance.
call si
ign
gnif
ifficcan
nce. order
ce. In or
rd
rde
annual operator volume as a covariate and found that hospital volume between 50 to 100 (OR,
0.64; 95% CI, 0.51-0.81, p<0.001) and more than 100 (OR, 0.67; 95% CI, 0.50-0.90, p<0.001)
The occurrence of any complication after catheter ablation of AF was associated with
longer LOS (2.54 ± 3.10 days vs. 7.03 ± 8.36 days, p <0.001).
Discussion
Utilizing the largest national hospitalizations database in United States, herein we report
10
DOI: 10.1161/CIRCULATIONAHA.113.003862
frequency of complications associated with AF ablations in the US. The main findings of our
analysis are: 1) overall frequency of complications was 6.29% 2) there were approximately 4.2
in-hospital deaths per 1,000 AF ablations; 3) cardiac complications were the most frequent
adverse outcomes followed by vascular complications; and 4) annual operator and hospital
volume was significantly associated with overall frequency of complications. This is the largest
sample of AF ablations analyzed so far, utilizing data from across the country, including low and
Multiple studies have reported complication rates following catheter ablation for AF, but
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
nearly all the studies were conducted at centers with expertise and high volume operators.
Periprocedural complication rates following AF ablation have ranged from 1% tto % iin
o 8% smaller
n sm
smal
alle
ler
tudies of high-volume centers.2, 7-9, 11, 13 Using large administrative databases, the complication
studies
atee w
rate as 99.1%
as
was .1%
.1 % in
n a sstudy
tudy of Medicare beneficiar
rie
ies aand
beneficiaries nd 5 % from
m tthe
h C
he alif
al i ornia State Inpatient
California
9, 13
Database.
Dattabase.
ta We
We rreport
epo
poortt tthe
he ccomplications
omplliccat
ompl atio
ionns ffrom
rom 993,801
rom 3,8011 aablation
blat
bl atio
i n pr
io procedures,
roc
oced
eduuress, th
ed thee la
larg
largest
rg
ges
estt ti
til
till
ll ddate
ll atte
from
fr
rom United
Uni
nite
teed States.
Stattess. This
Stat Thiss cohort
cohhor
o t represents
repr
re pres
pr esen
ents
en ts more
mor
oree representative
reppre
presen
esen
nta
tattive
ve of
of the
the “real
“reeal
eal world”
worl
wo r d”” AF
rl AF ablation
ab
bla
lati
tiion
n
The reported in hospital mortality from the Medicare beneficiaries and California state study was
0.5 and 0.4 respectively. Recent update of the Medicare data suggests 30 day mortality of 0.8
%.19 Our findings of in hospital mortality of 0.42% from all US hospitals are essentially
consistent with earlier findings. This gives a better perspective of mortality and has important
We found that AF ablations performed in age>80 years was associated with significantly
higher number of complications. A single-center study from 2008 reported major complication
11
DOI: 10.1161/CIRCULATIONAHA.113.003862
rates of 1.7% and 2.9% and minor complication rates of 3% and 6% in patients aged 65–74 years
complication rates between age > 80 vs. age <80.26 This cohort is underrepresented in clinical
studies to assess efficacy and safety of AF ablations but faces the maximum burden of AF and
Complication rates after AF ablation have been reported to be higher in women compared
to men.13, 27 Our results confirmed this previously reported finding. Although women are getting
less AF ablations procedures compared to men, this gender difference in complications argues
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
ignificant racial association. These are likely driven by overwhelming numbers of AF ablations
significant
inn w hite
hi tess an
te
whites andd un
nde
derr utilizations off other racial sub
under suub groups
groups for AF
F ablations.
a laati
ab tion
ons. Patients with lesser
on
co
omorbidities
mo
comorbidities had mo
ha mor
re cchances
more hanc
ha nces
nc es ooff co
ccomplications,
mplicaatiionss, aagain
mp gaain
n a ffinding
in
ndi
dinng
ng hhighlighted
ighhlightted bby
ig y un
unev
ev
ven
unevenn bbalance
a ance
al an
be
etw
twee
eenn AF aablations
ee
between blaatio
bl io
ons inn si
sick
ker ggroup
sicker rouup
ro up (more
(mo
more
re comorbidity).
com
omoorb
orbiddity
dity
y).
Card
diaac ta
Cardiac tamp
mpon
mp onad
on
tamponadea e iss the
he most
s ccommon
most ommo
om monn li
mo llife-threatening
f -t
fe -thr
hrea
eate
ea teni
te n ng aacute
ni cu
ute complication
com
ompl
p iccat
pl atio
ionn seen
io s en in
se
patients undergoing AF ablation.6 In the worldwide survey, the incidence was 1.2%.7 Overall
complications around 1.52 %; however it has shown a significant increasing trend. Possible
between 0% and 7%.6 Thromboembolic events typically occur within 24 hours of the ablation
procedure with the high risk period extending for the first two weeks following ablation.28 Our
12
DOI: 10.1161/CIRCULATIONAHA.113.003862
analysis showed a combined frequency of stroke and TIA as 1.02 %. As we are reporting in
hospital occurrence of stroke and TIA after AF ablation, these numbers are consistent with early
thromboembolic events as suggested by Oral et al.28 Significant vascular complications can lead
to substantial morbidity, such as the need for blood transfusion, and percutaneous or open
surgical vascular repair, which in turn may prolong the LOS. The published incidence of
puncture) vascular complication rate of 3.38%; however an increasing trend was noted over the
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
last decade.
Our study has several limitations. First of all, the NIS is a de-identified ad
administrative
dmi
mini
niisttra
rati
tive
tiv
ve
database making it impossible to validate individual ICD-9 codes. This affects significantly the
enssit
itiv
ivit
ivityy an
it
sensitivity aand
d sp
pecif
eci icity when applying the diag
specificity agnoostic codes. St
ag
diagnostic tud
u iees based
Studies ba on data mining are
susceptible
usccep
e tible to errors
errrors related
relaate
re tedd to coding.
cod
din
ng. Further,
Furth
herr, wee ccould
ou
uld
d nnot
ot eeliminate
lim
li minate
mina te th
the
he eeffect
he ffec
ff ectt of uunmeasured
nm
measu
easuureed
confounders
co
onf
n ou
ound
nder
errs th
that
att m
might
ighht hhave
ig avee co
av cont
contributed
ntri
nt ribu
ri b teed to tthe
bu hee rreporting
epo
port
or ing
ing of aadverse
d erse
dv se eeffects.
ffeccts
ff ts. Th
Thee ad
adm
administrative
minnisstra
strattive
tivee
characteristics and full assessment of comorbidities (i.e., including outpatient diagnoses) were
unavailable for the analyses. This limitation is counterbalanced by the larger sample size and the
absence of reporting bias introduced by selective publication of results from specialized centers.
techniques, fluoroscopy time, medication use, and type of AF (i.e. paroxysmal or persistent)
were unavailable. Changes in clinical practice over time could have also affected our findings as
well. The creation of billing codes specific for AF ablation would improve investigators' ability
to use claims data to monitor utilization and outcomes of this procedure. Most ablation
13
DOI: 10.1161/CIRCULATIONAHA.113.003862
procedures are not coded as inpatient procedures for billing purposes, based on decisions by
payers to pay for ablation only as outpatient procedures. Some of these patients may have been
changed from outpatient to inpatient status if they had a complication. However, this database
allows capturing all patients that were in the hospital regardless of their admission status
(observation vs. inpatient). Finally, two of the most feared complications of catheter ablation of
AF, PV stenosis and atrio-esophageal fistula, were not available for the analysis due to the fact
that they do not arise during the index hospitalization. We were also unable to assess the
occurrence of late pericardial tamponade beyond the hospitalization, as only the events captured
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
in the index hospitalization were recorded. NIS does not permit longitudinal follow up. Minor
complications like groin hematoma if not coded for could not be assessed and m
may
ay bbee
ay
substantially
ubstantially underrepresented.
In conclusion,
In con
onclus io our analysis demonstratess that
usiion,
us thaat utilization of
of AF
F ablations
l tions has increased
abla
significantly
i icantly in the
ignnif the last
asst decade.
las deca
de de. The
cade
de he major
Th majoor complication on rates
coompliicaatioon rattes have
have steadily
stea
st y increased.
eaadily inc
ncre
reas
ased
as ed. Apart
ed Apar
Ap artt from
frrom
age,
ag e, gender
gen derr and
e de and comorbidities;
co
omo
morb
rbid
idit s annual
i iees; ann ual operator
nnuual opper or aand
eraator hospital
nd ho
ospi
pita
pi volume
tall vo
ta ume hhas
volu
lu as eemerged
merg
me rg d aass an
ged n iimportant
m orttant
mp ta
factor predicting
predict ingg adverse
ctin
in adve
ad rsee outcomes.
vers
ve rs outc
ou tcom
tc mes Measures
e . Me
eas
asur
ures
ur es sshould
ho u d bee ttaken
oul akeen to acc
ak account
ccou
ccount
ou nt ffor
o a vvolume
or o um
ol ume thresholdd
considered optimum to temper the enthusiasm of less experienced operators and enhance safety
of the procedure.
Conflict of Interest Disclosures: Dr. Mitrani has a consultant agreement with St Jude Medical
(Modest), Medtronic (Modest) and Lifewatch, Inc (Modest). Dr. Kowalski had a consultant
agreement with Medtronic. (Modest). None of the other authors have any disclosures relevant to
the content of the manuscript. The authors are solely responsible for the study design, conduct
and analyses, drafting and editing of the manuscript and its final contents.
14
DOI: 10.1161/CIRCULATIONAHA.113.003862
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17
DOI: 10.1161/CIRCULATIONAHA.113.003862
No Any
P
Demographic variable Overall complications complications
value
(%) (%)
Total no. of atrial fibrillation
93801 93.69% 6.29%
ablation procedures
Patient level variables
Age <0.001
18-34 1.68 1.74 0.74
35-49 11.47 11.76 7.15
50-64 37.24 37.49 33.44
65-79 37.9 37.68 41.15
>=80 11.72 11.33 17.52
Gender <0.001
Downloaded from http://circ.ahajournals.org/ by guest on May 21, 2018
18
DOI: 10.1161/CIRCULATIONAHA.113.003862
19
DOI: 10.1161/CIRCULATIONAHA.113.003862
Overall 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 P value
Any procedural complications 6.29 5.33 5.53 6.01 7.17 6.32 5.10 6.17 6.66 5.93 6.49 7.48 0.108
In hospitalization death 0.42 0.44 0.55 0.63 0.30 0.61 0.15 0.45 0.53 0.27 0.52 0.47 0.492
Vascular complications 1.53 0.89 0.66 1.16 1.12 0.95 1.31 0.60 0.97 1.02 0.97 1.33 0.500
1) Postop-hemorrhage 3.38 1.78 2.54 2.53 2.39 3.38 2.77 3.13 3.52 3.75 3.46 4.90 <0.001
2) Postop-hemorrhage
p g requiring
q g
0.58 0.30 0.22 0.32 0.30 0.61 0.34 0.45 0.87 0.
0.65
655 0.44
0.4
.444 1.03
1.033
1.0 0.020
0.
transfusion
fusion
scular complications including
3) Vascular 1.01 0.30 0.11 0.21 0.22 0.26 0.34 0.05 0.10 0..03
0
0.03 0.0.04
0.0404 00.0
.044
.0
0.04 00.060
.
iac complications
Cardiac 2.54 1.63 1.66 1.37 2.69 2.42 1.90 1.69 2.90 2.90
9 33.06
.06 3.53
3.53
5 <
<0
<0.001
1) Iatrogenic
rogenic cardiac complications 1.18 1.33 0.88 0.63 1.19 1.13 0.83 0.90 1.54 1.33 0.93 1.76 0.
0.050
ricardid al compl
2) Pericardial liccatio
complications ons 1.52 0.74 0.44 0..63
0.63 1.49 0.87 1.31 1.000
1.00 11.83
.83 1.84 2.14 2.24 <0.001
<0
yoocaard
3) Myocardialrdia
iall infarction
ia infa
infa
farc
r ti
rction 0.37 0.30 0.55 0.32
3
32
0.32 0.60 0.69 0.29299 0.3
.30
0.3030 0.34
0.34 0.37 0.32 0.26 0.
0.650
uir
irin
r ng open heart
Requiring heart
ar surgery
sur
urge
g ry
ge 0.28
0.28 0.44
0.444 00.22
0.2
.222 0
0.11 0.0707 0.09
0.0 0.24
0.224 0.30
0. 30 0.24
24 0.24
0.24 0.36
0.3
.366 0.47
0.477
0.4 0.460
0.
irator
ir to y complications
Respiratory complica atiion
ons 13
1.
1.3 1.48
1. 48 1.66
6 1. 27
27
1.27 11.79
.779 1.2
. 1
1.21 11..12
1.12 11.59
.559 11.79
.779 1.1
.16
16
1.16 1.0
1.09 0 77
0. 7
0.77 0.
0.109
eumo-
mo thorax
1) Pneumo-thorax 0.39 9 0.59
0. 59 0.666 0. 63
0.63 0.882
0.82 00.52
0.5
. 2
.5 00.44
.44
4 00.50
.5
50 00.29
.29
.2 00.31
.311 0.
0.2424
24 0. 04
0.04 4 0.
0.020
sto
top-
op reresp
spirat
2) Postop-respiratory ator
orry fafail
ilur
ue
failure 00.77
0..77
77 00.74
.7
74 00.88
.88 00.53
.533
.5 0..75
7
0.75 0.61
0. 61 00.49
.499
.4 0. 90
0.90 1.16
1. 1
16 0. 68
0.688 00.85
.8
85 00.73
.733
.7 00.575
.
3) Other
her iiatrogenic
attro
roge
oge
geni
nicc resp
ni respiratory
pir
irat
ator
toryy
0.18
0 188
0. 0.15
0.15 00.33
.33
33 0.1
00.11
11 0.30
0 30 0.09
0. 0 09 0.24
0. 0.224 00.20
.20
2 0.
00.43
433 0.20
0 20 0.00
0. 0.000 0.00
0.000 0.030
0
0.
lica
li cati
ca tion
ti
complications onss
on
Neurological
ological Complications
Compl p ic
pl icat
atio
at i ns
io n ((Postop-
Post
Posttop
op--
1.02
1.02 0.89
0.8
.899 1.1
11.11
.111 1.7
11.79
.799 1.57
1.57 1.13
1.13 0.68
0.6
.688 1.
1.39
39 0.
0.53
53 0.78
0.78 0.93
0.9
.933 1.20
1.200
1.2 0.013
0.
0.
Stroke/TIA)
k /T/TIA
IA))
Postop infectious complications 0.38 0.15 0.11 0.21 0.45 0.43 0.29 0.50 0.72 0.24 0.40 0.43 0.235
20
DOI: 10.1161/CIRCULATIONAHA.113.003862
Table 3. Independent predictors of in-hospital complications after atrial fibrillation ablation procedure.
Variable
OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value
Hospital annual procedure volume
<50 1 Referent 1 Referent
50-100 0.64 (0.51-0.81) <0.001 0.80 (0.58-1.09) 0.16
>100 0.67 (0.50-0.90) 0.007 0.84 (0.51-1.39) 0.52
Annual
ual operator volume
<25
25 1 Referent 1 R
Referent
efer
ef eren
er ent
5-50
25-50 0.45 (0.30-0.71) <0.001 0.51 (0.33
33-0
- .8
-0 80))
(0.33-0.80) 00.004
.0
004
0
>50
50 0.33 (0.20-0.55) <0.001 0.38 (0.21-0 .6
69)
(0.21-0.69) 0.0002
0.002
* Model
el 1 was adjusted for age, sex, Charlson score, primary payer, Median house hold income, Hospital bed size, hospital region, Teaching status of the
al, Hospital procedure volume.
hospital,
† Model was
el 2 wa as adjusted
adju d for
justed o alll variables
for var iables in model 1 with one exception Operatorr vo
aria volume
lume was used instead of hospital
volu hospi
pita pprocedure
tall pr ocedure volume.
‡ Model wass ad
ell 3 wa
w adjusted
adju
just
justed
sted ffor
o aall
or lll vvariables
riables as described above with operator and hospital
aria ho
hosp
osp
s ital were
ta procedure volume we
w included
re inc
nclu
lude
ded
e at the same
a time.
21
DOI: 10.1161/CIRCULATIONAHA.113.003862
Figure Legends:
22
Figure 1
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Figure 2
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Figure 3
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Figure 4
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Inhospital Complications Associated with Catheter Ablation of Atrial Fibrillation in the United
States between 2000-2010: Analysis of 93,801 Procedures
Abhishek Deshmukh, Nileshkumar J. Patel, Sadip Pant, Neeraj Shah, Ankit Chothani, Kathan Mehta,
Peeyush Grover, Vikas Singh, Srikanth Vallurupalli, Ghanshyambhai T. Savani, Apurva Badheka,
Tushar Tuliani, Kaustubh Dabhadkar, George Dibu, Y. Madhu Reddy, Asif Sewani, Marcin
Kowalski, Raul Mitrani, Hakan Paydak and Juan F. Viles-Gonzalez
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Supplementary table 1: International Classification of Disease, Version 9 (ICD-9) Codes Used for Atrial
position)
Wolf-Parkinson-White 426.7
Lown-Ganong-Levine 426.81
37.89
complications.
requiring transfusion
8709 (PSI)
-AV fistula-447
39.79
997.7
complications
2) Pericardial complications 423.0-Hemopericardium 296 1.52
423.3-Cardiac temponade
37.0-Pericardiocentesis
Requiring open heart surgery 35.10, 35.11, 35.12, 35.13, 35.14, 51 0.28%
35.33,35.34, 35.35,35.42,
respiratory complications
Neurological Complications
438.0, 4381.0,
4384.1, 4384.2,