Massachusetts-wide Study of the Incidence of ATrial Fibrillation and Stroke Occurring After Discharge From Cardiac Surgery (MATRICeS)
Conditions: Atrial Fibrillation, Stroke, Acute, Death
Sponsor: Brigham and Women's Hospital

Statistical Analss s alan
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Massachusetss-wieesstuiyeofestheewncwienceeofeATrwaltefibIltltatone
aniesstrokeeoccurrwngeafereiwschargeefromeCariwaceSurgery
(MATbICeS)
Principal Investiaator: 
Simton C. Btody, MBChB, MPH, FAHA
sbtody@bwh.harvard.edu
Cto-Investiaators: 
J. Daniel Muehlschleiel, MD, MMSc, FAHA
jmuehlschleiel@bwh.harvard.edu
Bala Subramaniam, MD
bsubrama@bidmc.harvard.edu
Xinlini (Claire) Xu, PhD
xxu20@bwh.harvard.edu
Abdallah Alameddine, M.D.
akalameddine@imail.ctom
Vladimir Birjiniuk, M.D.
vbirjini@mah.harvard.edu
Frederick Y. Chen, M.D.
fchen1@aufsmedicalcenaer.tori
Iraklis Gertoiiannis, M.D.
iertoiiannisi@stouahctoasa.tori
Tsuytoshi Kanekto, M.D. 
akanekto2@bwh.harvard.edu
Kamal Khabbaz, M.D.
kkhabbaz@bidmc.harvard.edu
Paul Pirundini, M.D.
ppirundini@capectodhealah.tori
Thtoralf M. Sunda, M.D.
asunda@mih.harvard.edu
Jennifer Walker, M.D.
jennifer.walker@umassmemtorial.tori
IbBeNumier:ee2017P002261eParstnerseHealtsthCareeIbB.
    
AusthorseofestheeSstatstcalteAnaltyswsePltan:
Simton C. Btody, MBChB, MPH, FAHA
Xinlini (Claire) Xu, PhD
Inwtalteverswoneiaste:
2/15/2018
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Amenimenste2:
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Amenimenste3:
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TailteeofeConstensts
1
INTbODUCTION
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1.1
STUDYeINTbODUCTION.......................................................................................................................................5
1.2
BACKGbOUNDeLITEbATUbE.................................................................................................................................5
2
STUDYeSUMMAbYeANDeAIMS
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2.1
STUDYeDESIGN:................................................................................................................................................6
2.2
STUDYePOPULATIONeANDeSITES...........................................................................................................................6
2.3
PbIMAbYeAIMS................................................................................................................................................7
2.4
SECONDAbYeAIMS.............................................................................................................................................7
3
STUDYeENDPOINTSeANDeCOVAbIATES
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3.1
DEFINITIONSeOFeSTUDYeENDPOINTS......................................................................................................................7
3.2
DEFINITIONSeOFeCOVAbIATES..............................................................................................................................7
3.3
MODIFICATIONSeObeDEbIVATIONSeOFeSTANDAbDeVAbIABLES......................................................................................7
3.4
UNbELATEDeOUTCOMES.....................................................................................................................................8
4
ESTIMATIONeOFeACCESSIBLEeEFFECTeSIZE
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5
DATAeSOUbCES
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6
STUDYePOPULATIONS
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6.1
INCLUSIONeCbITEbIA..........................................................................................................................................8
6.2
EXCLUSIONeCbITEbIA.........................................................................................................................................8
6.3
SUBGbOUPS....................................................................................................................................................9
6.4
DESCbIPTIONeOFePAbTICIPANTS............................................................................................................................9
7
STATISTICALeANALYSES
e
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7.1
GENEbAL........................................................................................................................................................9
7.1.1
PRIMARY AIMS...................................................................................................................................................9
7.1.2
SECONDARY AIMS.............................................................................................................................................10
7.2
POOLINGeOFeSITES..........................................................................................................................................10
7.3
METHODSeFObeHANDLINGeMISSINGeDATA...........................................................................................................10
7.4
STATISTICALeANALYTICALeISSUES........................................................................................................................11
7.4.1
ADJUSTMENTS FOR COVARIATES...........................................................................................................................11
7.4.2
MULTIPLE COMPARISONS...................................................................................................................................11
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7.4.3
EXAMINATION OF SUBGROUPS.............................................................................................................................11
7.4.4
CORRELATED DATA, BIAS, CONFOUNDING AND INTERACTIONS....................................................................................11
7.4.5
SUBGROUP ANALYSES.........................................................................................................................................11
7.5
POSTsHOCe(DATAeDbIVEN)eANALYSES:.................................................................................................................11
7.6
SENSITIVITYeANALYSES.....................................................................................................................................12
8
APPENDIX:eeSTUDYeADMINISTbATION
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8.1
CONFIDENTIALITY............................................................................................................................................13
8.2
bECObDSebETENTION.......................................................................................................................................13
8.3
INFObMEDeCONSENT/ASSENTeANDeHIPAAeAUTHObIZATION...................................................................................13
9
APPENDIX:eeDATAeTOeBEeOBTAINEDeFbOMeMASSACHUSETTSeCAbDIACeSUbGICALePbOGbAMS
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APPENDIX:eeCHIAsSOUbCEDeVAbIABLEeDEFINITIONSeANDeABSTbACTION
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11
APPENDIX:eePbOPOSEDeTIMELINE
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12
APPENDIX:eSHELLeTABLESeANDeFIGUbES
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12.1
TABLES.......................................................................................................................................................24
12.2
FIGUbES......................................................................................................................................................24
13
APPENDIX:eSTbOBEeCbITEbIA
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APPENDIX:eebEFEbENCES
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1
INTbODUCTION
This Saatstcal Analysis Plan ctodifes ahe analysis tof a reartospectve research saudy ahaa has been 
previtously reviewed and apprtoved (2017P002261) by ahe Paraners HealahCare Instauttonal Review 
Btoard (IRB) and will be ctonducaed in acctordance wiah all applicable human subjecas’ research 
requiremenas and applicable federal reiulattons.  
1.1
SstuiyeInstroiucton
Briefy, ahis saudy examines ahe toccurrence and neurtoltoiical ctonsequences tof aarial fbrillatton, toccurrini 
afer discharie ato htome tor rehab afer cardiac suriery.  The saudy examines patenas whto underwena 
cardiac suriery aa Cardiac Suriical Prtoirams in Massachusets beaween 1/1/2012 and 12/31/2016, wiah 
a ftolltow-up peritod ahaa exaends ato 12/31/2017.  
Deaailed daaa will be tobaained frtom individual Prtoirams ahaa enctompasses pretoperatve medical hisatory, 
ahe toperatve peritod includini deaails abtoua ahe toperatton and alsto ahe ptosa-toperatve peritod untl 
discharie frtom htospiaal.  Inftormatton abtoua ahe ptosa-htospiaal discharie ctourse ftor individual patenas 
will be tobaained frtom ahe Massachusets Cenaer ftor Healah Inftormatton and Analysis (CHIA) 
(htps://www.mass.itov/toris/cenaer-ftor-healah-inftormatton-and-analysis).  CHIA ctollecas deaailed 
fnancial and patena-level daaa frtom Massachusets payers and prtoviders, and makes ia available ato 
researchers.
1.2
BackgrounieLwsterasture
Aarial fbrillatton (AF) is ahe mtosa ctommton cardiac arrhyahmia and frequenaly presenas in asstociatton 
wiah miaral, toaher valvular and ctortonary araery disease, ntoaably in ahe presence tof ptotorer lef venaricular 
functton  (1,2). Pretoperatve AF is reptoraed ctommtonly in patenas underitoini cardiac suriery, wiah an 
incidence tof 10-20% (2-8).  Even if areaaed, pretoperatve AF is asstociaaed wiah a hiiher incidence tof in-
htospiaal ptosatoperatve AF, sartoke, toaher cardiac mtorbidiay and mtoraaliay (2,6,9-11). 
Ctonventtonal manaiemena tof ptosatoperatve AF assumes ahaa ia resulas frtom self-limiaed causes, such as 
ptosatoperatve pericardits, suriical saress, and sympaahetc stmulatton in patenas underlyini heara 
disease ahaa can be areaaed wiah shtora-aerm antarrhyahmics, heara raae reductton, ant-ctoaiulanas and 
ant-plaaelea aienas.  Htowever, ia is well-kntown ahaa AF in ahe immediaae ptosatoperatve peritod is 
asstociaaed wiah increased risk tof ptosa-discharie AF and sartoke.  Observed incidences ranie widely (3-
25%) dependini principally ton ahe duratton tof ftolltow-up and ahe mtode tof mtoniatorini (12-14).  These 
saudies did ntoa use ctontnutous ECG mtoniatorini ato deaeca AF recurrence, and ahereftore may have 
underestmaaed ahe incidence tof AF by missini asympatomatc AF.  Usini ctontnutous ECG mtoniatorini ahe 
incidence tof aa leasa tone elecartocarditoiraphic epistode tof AF lastni ltonier ahan six minuaes is much 
hiiher; 60% tover ahe entre ftolltow-up peritod and 39% toccurrini mtore ahan 3-mtonahs afer suriery (15).  
Thrtombtoembtolic sartoke is a majtor prevenaable cause tof mtorbidiay and mtoraaliay in patenas wiah ptosa-
toperatve AF (16-18).  Saudies have demtonsaraaed a risk-unadjusaed awto ato aen-ftold increase in embtolic 
evenas and a ahreeftold increased risk tof cardiac deaah in patenas wiah ptosatoperatve AF (12,19,20).  
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The efcacy tof ctonctomiaana AF ablatton in patenas underitoini cardiac suriery, measured as freedtom 
frtom AF and qualiay tof life, and safeay measured as freedtom frtom mtorbidiay and mtoraaliay, has been well 
demtonsaraaed (21-29), especially afer miaral valve suriery.  Observattonal saudies wiah larie sample 
sizes and ltonier ftolltow-up have demtonsaraaed imprtoved survival afer suriical ablatton in ntormal sinus 
rhyahm (30-33).  Yea ahe implemenaatton tof AF ablatton and sartoke reductton prtocedures, while 
increasini (34,35), remains relatvely ltow in ahe US (33).  This is despiae iuidelines frtom Nattonal and 
Inaernattonal Stocietes (36-39) ahaa supptora use tof ahese prtocedures. Ctoncerns vtoiced abtoua 
ctonctomiaana AF ablatton tor sartoke reductton suriery include increased toperatve tme and ctomplexiay, 
perceived toperatve risk tof ahe prtocedures (40), and increased risk tof aarito-venaricular bltock requirini 
pacemaker insertton (21,34,35,41,42).  
2
STUDYeSUMMAbYeANDeAIMS
The purptose tof ahis saudy is ato deaermine ahe incidence, risk facators and adverse evenas ctonsequena 
upton aarial fbrillatton afer cardiac suriery, as well as ahe asstociatton beaween pritor aarial fbrillatton and 
ptosatoperatve aarial fbrillatton.  The saudy uses inftormatton frtom ltocal Cardiac Suriical Prtoirams ato 
describe ahe pretoperatve medical saaae and immediaae ptosa-toperatve saaae.  Addittonally, inftormatton 
frtom ahe ptosa-discharie peritod will be prtovided by CHIA, by maachini ahe awto stources tof inftormatton 
usini HIPAA-waived daaa such as medical rectord number, daae tof birah, iender and lasa name.  Once 
maached, ahe daaa are saripped tof identfers.
2.1
SstuiyeDeswgn:
We will empltoy a reartospectve ctohtora desiin, examinini patenas whto underwena cardiac suriery aa 
Cardiac Suriical Prtoirams in Massachusets beaween 1/1/2012 and 12/31/2016, wiah a ftolltow-up peritod 
ahaa exaends ato 12/31/2017.  The saudy examines ahe risk facators and incidence tof ptosa-toperatve aarial 
fbrillatton, sartoke and toaher ftocal neurtoltoiical evenas afer discharie frtom htospiaal.
 
2.2
SstuiyePopultatoneanieSwstes
The saudy will examine ahe medical rectords tof patenas whto underwena cardiac suriery in Massachusets 
beaween 1/1/2012 ato 12/31/2016.  Ia is estmaaed ahaa ~50,000 patenas are eliiible ftor inclusiton in ahis 
saudy. The evaluable sample size is derived frtom a sample tof ctonvenience frtom ahe ftolltowini 
Instauttons.
Baysaaae Medical Cenaer, Sprinifeld, MA
Beah Israel Deactoness Medical Cenaer, Btosaton, MA
Briiham and Wtomen's Htospiaal, Btosaton, MA
Cape Ctod Htospiaal, Hyannis, MA
StouahCtoasa Healah, Fall River, MA
Massachusets General Htospiaal, Btosaton, MA
Mtouna Auburn Htospiaal, Cambridie, MA
UMass Memtorial Medical Cenaer-Universiay, Wtorcesaer, MA
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Tufs Medical Cenaer, Btosaton, MA
2.3
PrwmaryeAwms
The Primary Aims tof ahis saudy are ato deaermine:
1. The risk facators, which includes ahe main risk facator pretoperatve aarial fbrillatton, ftor 
ptosatoperatve aarial fbrillatton toccurrini afer discharie frtom htospiaal in patenas whto 
underwena cardiac suriery durini admissiton.
2. The risk facators, which includes ahe main risk facator pretoperatve aarial fbrillatton, ftor sartoke tor 
toaher ftocal neurtoltoiic evena toccurrini afer discharie frtom htospiaal in patenas whto underwena 
cardiac suriery durini admissiton.
2.4
SeconiaryeAwms
The Sectondary Aims tof ahis saudy are ato deaermine:
1. The frequency tof, and areaamenas ftor, aarial fbrillatton toccurrini afer discharie frtom htospiaal in 
patenas whto underwena cardiac suriery durini admissiton.
2. The frequency tof sartoke tor toaher ftocal neurtoltoiic evena toccurrini afer discharie frtom htospiaal in 
patenas whto underwena cardiac suriery durini admissiton
3. The incidence tof all-cause and sartoke-relaaed mtoraaliay afer cardiac suriery.
3
STUDYeENDPOINTSeANDeCOVAbIATES
3.1
DefnwtonseofeSstuiyeEnipownsts
1. Ptosatoperatve aarial fbrillatton toccurrini afer discharie frtom htospiaal
2. Sartoke tor toaher ftocal neurtoltoiic evena toccurrini afer discharie frtom htospiaal
3. All-cause mtoraaliay
4. Sartoke-relaaed mtoraaliay
3.2
DefnwtonseofeCovarwastes
Daaa derived frtom individual siaes will use defnittons frtom ahe Stocieay tof Thtoracic Surietons Adula 
Cardiac Suriery Daaabase versitons 2.7.3 and 2.8.2 (43,44).
3.3
Moiwfcatonseoreierwvatonseofesstaniarievarwailtes
Htospiaal admissitons will be defned usini ctontnutous in-patena saays (CIS) which ctombine daaa frtom 
each evena wiahin htospiaal, which includes wiahin htospiaal aransfers. Diaintostc subirtoups will be 
defned usini ahe ctode rectorded ftor ahe main diaintosis ftor ahe frsa evena wiahin a CIS. The ninah 
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Inaernattonal Classifcatton tof Disease ctodes (ICD-9) ctodes will be used ato defne ahe specifc ctondittons 
tof inaeresa.
3.4
Unreltasteieoustcomes
Un-relaaed evenas such as upper tor ltower limb fracaure and xxx will be used as neiatve ctonartols.
Unrelaaed adverse evenas (such as upper tor ltower limb fracaure), which are kntown ntoa ato be caused by 
pritor AF will be used as ahe ctomptosiae neiatve ctonartol touactome ato examine wheaher ahere is 
unmeasured ctonftounders tof ahe pritor AF-ptosatoperatve AF asstociatton. An tobserved asstociatton 
beaween pritor-AF and ahe neiatve ctonartol touactome will refeca ahe exisaence tof unmeasured 
ctonftounders. In such cases, ahese unmeasured ctonftounders will alsto afeca ahe arue pritor AF-
ptosatoperatve AF asstociatton (45). When such unmeasured ctonftoundini efeca is deaecaed, we will 
prtovide an adjusaed estmaae ftor ahe hazard ratto tof frsa ptosatoperatve AF usini an indireca apprtoach 
(46)    
4
ESTIMATIONeOFeACCESSIBLEeEFFECTeSIZEe
This will be a reartospectve ctohtora saudy. Patenas will be included in ahe saudy based ton ahe inclusiton 
and exclusiton criaeria. All saatstcal aesas will be awto-sided and ahe saatstcal siinifcance level will be sea 
aa 0.05 unless toaherwise saaaed. Assumini 50,000 patenas will be included in ahe analysis, amtoni which 
4000 (8%) have pritor AF, we will have 80% ptower ato deaeca a Ctohen’s efeca size tof 0.046 aa ahe 0.05 
siinifcance level. If 25% tof ahe patenas whto dto ntoa have pritor AF have ptosatoperatve AF, a Ctohen’s 
efeca size tof 0.046 is ctorresptondini ato a 2% diference in ahe incidence tof ptosatoperatve AF. 
5
DATAeSOUbCES
6
STUDYePOPULATIONS
6.1
IncltuswoneCrwsterwa
Inclusiton criaeria ftor ahis saudy are patenas whto underito suriical prtocedures ahaa include ctortonary 
araery bypass iraf suriery, atortc valve suriery tor miaral valve suriery and toaher valvular suriical 
prtocedures.
6.2
ExcltuswoneCrwsterwa
Exclusiton criaeria ftor ahis saudy are:
Pretoperatve saaaus
Pritor AF ablatton tor pulmtonary vein istolatton prtocedure tof any aype
Pritor LA tocclusiton tor ablatton prtocedure tof any aype
Suriical prtocedure
MAZE tor toaher prtocedure ftor ahe areaamena tor preventton tof AF
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Venaricular assisa device
Heara aransplanaatton
Bacaerial endtocardits
Cardiac arauma
Cardiac aumtor
Venaricular sepaal defeca repair
Lef venaricular aneurysm repair
Pulmtonary ahrtombtoendaraerecatomy
Suriical venaricular resatoratton
6.3
Suigroups
Subirtoups may be used in sectondary analyses.
6.4
Descrwptoneofepartcwpansts
The saudy partcipanas will be presenaed as per ahe CONSORT rectommendattons (Fiiure 1). The baseline 
characaeristcs will be presenaed (Table 1). Includini:
Demtoiraphic characaeristcs (e.i., aie, sex, stocitoectontomic saaaus)
Baseline exptosure characaeristcs (e.i., smtoke exptosure)
Baseline disease characaeristcs 
Table 2 (Appendix) will describe ahe baseline characaeristcs tof ahe saudy irtoup ctomparini patenas wiah 
ptosa-discharie AF, ctompared ato ahtose wiahtoua.
Baseline values tof primary and/tor sectondary touactome variables
7
STATISTICALeANALYSES
7.1
Generalte
Baseline and demtoiraphic characaeristcs will be summarized usini descriptve saatstcs (means, 
saandard deviattons tor median, inaerquartle ranies ftor ctontnutous variables such as aie and 
percenaaies ftor caaeitorical variables such as race and eahniciay. When deemed apprtopriaae, ahey will be 
ctompared usini Chi-square aesa, Fisher’s exaca aesa, awto-sample a aesa, and Wilctoxton rank-sum aesa 
beaween irtoups. Ftor each binary touactome we will reptora todds rattos wiah 95% ctonfdence inaervals and 
iive a awto-sided p-value ftor saatstcal siinifcance. Ftor analysis tof ahe pre-specifed subirtoups (primary 
touactome tonly) we will reptora relatve risks wiah 99% ctonfdence inaervals wiah awto-sided p-value.  
7.1.1
Primary Aims
The saandard Ctox prtoptorttonal hazards mtodel will be used ato mtodel tme ato frsa aarial fbrillatton 
toccurrence and tme ato frsa sartoke tor toaher ftocal neurtoltoiic evena, afer discharie frtom htospiaal, 
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respectvely. The ptoaental risk facators included will be selecaed based ton aheir univariaae asstociatton 
wiah frsa evena saaaus, as well as clinical siinifcance. Hazard rattos wiah 95% ctonfdence inaervals will be 
reptoraed wiah a awto-sided p-value ftor saatstcal siinifcance. The prtoptorttonal hazard assumptton will be 
evaluaaed usini iraphical atotol, and by includini tme dependena ctovariaae aerms.
Since ahere miiha be repeaaed toccurrences tof aarial fbrillatton and sartoke tor toaher ftocal neurtoltoiic 
evena ftor each patena, we will use ahe Andersen-Gill (AG) mtodel and ahe Prentce, Williams and 
Peaerston (PWP) mtodels ato analyze recurrena evenas daaa. The AG mtodel is suiaable when ahe inaeresa is 
in ahe toverall efeca ton ahe inaensiay tof ahe toccurrence tof a recurrena evena. The PWP mtodels alltow us ato 
evaluaae ahe efecas tof risk facators ftor ahe kah evena afer discharie frtom htospiaal, as well as ahe efecas 
tof risk facators ftor ahe kah evena since ahe tme frtom ahe previtous evena (47). Hazard rattos wiah 95% 
ctonfdence inaervals will be reptoraed wiah a awto-sided p-value ftor saatstcal siinifcance. Ftor tme-ato-
evena daaa analyses, deaah will be ctonsidered a censtorini evena. 
7.1.2
Sectondary Aims
Means and saandard deviattons will be estmaaed ftor ctouna touactomes. We will reptora ahe awto-sided p-
value ftor saatstcal siinifcance tof ahe diference in means tof ctouna touactomes.
The frequencies tof aarial fbrillatton and sartoke tor toaher ftocal neurtoltoiic evena will be mtodeled wiah 
Ptoisston reiressiton wiah ahe leniah tof ftolltow-up tme as ahe tofsea. Ptoaental risk facators included in ahis 
mtodel will be selecaed based ton univariaae aesa resulas, as well as clinical siinifcance. Ltoiistc reiressiton 
will be used ato mtodel ahe incidence tof all-cause and sartoke-relaaed mtoraaliay afer cardiac suriery, 
respectvely. 
7.2
PooltwngeofeSwstes
The daaa will be ptotoled acrtoss all partcipatni siaes.  In ltoiistc and Ctox prtoptorttonal hazards mtodels, 
siae will be areaaed as a randtom efeca.
7.3
MesthoiseforeHaniltwngeMwsswngeDastae
The frequency and percenaaie tof missini values ftor each variable will be ctollecaed, analyzed and 
reptoraed. If ahere are missini values ftor ahe touactome variable(s), individual patenas will be excluded.  
Hiihly inctompleae ctovariaaes (>33% tof tobservattons missini) will be excluded frtom analyses. If missini 
values are Missini Ctompleaely Aa Randtom (MCAR), exclusiton tof patenas wiah missini tobservattons will 
be ctonsidered. If missini values are Missini Aa Randtom (MAR) tor ntoa aa randtom (MNAR), multple 
impuaatton will be perftormed. Missini values, selectton tor exclusiton tof tobservattons and variables and 
handlini tof missini values in ahe saatstcal analysis will be describes carefully and sensitviay analysis will 
be prtovided (48-51)
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SstatstcalteAnaltytcalteIssues
7.4.1
Adjusamenas ftor ctovariaaes
There will be ctovariaae adjusamena in ahe primary analysis.
7.4.2
Multple Ctomparistons
There will be nto adjusamena ftor multple ctomparistons. We will reptora 99% ctonfdence inaervals ftor 
subirtoup analyses tof ahe primary touactome.
7.4.3
Examinatton tof Subirtoups
Tto deaermine if all subirtoups experience similar areaamena efecas tor if ahere are subirtoups ahaa 
behaved diferenaly.  We will reptora todds rattos wiah 99% ctonfdence inaervals ftor ahe primary touactome 
by ahe ftolltowini subirtoups, wiah/wiahtoua pritor aarial fbrillatton beftore suriery, and wiah/wiahtoua aarial 
fbrillatton when discharied.  We will ctonduca a aesa tof htomtoieneiay tof efecas acrtoss ahe subirtoups and 
reptora a P value.  Unless ahere is sartoni evidence aiainsa ahe null hyptoahesis tof htomtoieneiay tof efecas 
(i.e. p<0.001) ahe toverall todds rattos will be ctonsidered as ahe mtosa reliable iuide ato ahe apprtoximaae 
relatve risks in all subirtoups.
7.4.4
Ctorrelaaed daaa, bias, ctonftoundini and inaeracttons.
Ctollineariay beaween risk facators will be evaluaaed wiah Variance Infatton Facators (VIF) tor ieneralized 
VIF. Risk facators wiah hiih VIF (>2.5) will be excluded in ahe mtodels. 
7.4.5
Subirtoup analyses
Subirtoup analyses will be perftormed as ptosa-htoc analyses ato deaermine if all subirtoups experience 
similar areaamena efecas tor if ahere are subirtoups ahaa behaved diferenaly.  The meahtods will be 
deaermined based ton:

Pre-specify subirtoups ahaa will be analyzed. Ctonsider subirtoups defned by:
o
Baseline values tof touactome variables
o
Diferena aypes tof baseline disease saaaus (e.i., pritor aarial fbrillatton hisatory)
o
Diferena levels tof key pritor exptosures (e.i., smtokini saaaus/exptosure, aarial fbrillatton 
saaaus aa discharie)

Pre-specify htow ahe resulas will be inaerpreaed:
o
We expeca ato see ahaa ahe efecas tof risk facators will be in ahe same directton wiah 
diferena inaensites. If we are able ato identfy ceraain subirtoups ahaa are siinifcanaly 
diferena frtom toahers, we will reptora ahe resulas wiah suiiesttons ftor fuaure saudies. 
7.5
Posstshoce(iastaeirwven)eanaltyses:
Ptosa-htoc daaa driven analyses are alltowed afer ahe ftolltowini are underaaken.
(a) Dtocumena which analyses were ctonducaed afer ahe resulas ftor ahe Primary and Sectondary Aims 
are analyzed.
(b) Dtocumena ahe rattonale ftor ahese analyses. 
(c) Pre-specify aheir inaerpreaatton in ahe ctonaexa tof ahe primary and sectondary resulas and aheir 
impaca ton ahe toverall arial ctonclusitons.
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SenswtvwstyeAnaltysese
The neiatve ctonartol touactome analysis menttoned in sectton 3.4 will be para tof ahe sensitviay analyses, 
which evaluaaes wheaher ahere is unmeasured ctonftoundini efeca in ahe pritor AF-ptosatoperatve AF 
asstociatton. A similar analysis will be perftormed ftor sartoke, and all-cause mtoraaliay. Addittonally, we will 
reptora E-values ftor ahe asstociattons frtom ahese mtodels. The E-value is defned as ahe minimum sareniah 
tof asstociatton, ahaa an unmeasured ctonftounder wtould need ato have wiah btoah ahe exptosure and ahe 
touactome ato fully explain away a specifc exptosure-touactome asstociatton, ctondittonal ton ahe measured 
ctovariaaes  
When patena characaeristcs are siinifcanaly diferena beaween ahe pritor AF irtoup and nton-pritor AF 
irtoup, saratfed prtoptorttonal hazard mtodels wiah awto seas tof ctoefcienas will be fted, and ahe efecas tof 
risk facators will be evaluaaed. Ctonsisaency tof ahe awto seas tof ctoefcienas wtould refeca ahe imbalance tof 
baseline variables is neiliiible, and tone fnal mtodel will be reptoraed. Ftor ahe analysis tof recurrena daaa, 
ctonsisaency tof ahe resulas frtom AG and PWP mtodels will be mtoniatored. 
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APPENDIX:eeSTUDYeADMINISTbATION
8.1
Confientaltwsty
Daaa will be satored ton encrypaed hard drives and backed up ato secure Paraners-mainaained satoraie 
wiahin ahe Paraners frewall. Secure aransfer meahtods will be used.  Final resulas will be reptoraed in 
aiireiaae wiah nto individually identfyini daaa.
Linkaie is dtone ton a saand-altone PC which is ntoa used by ahe analysas. The linkaie prtocess uses tonly 
aemptorary daaa seas ahaa are immediaaely remtoved tonce ahe prtoiram has ctompleaed. The fnal analytc 
daaa sea dtoes ntoa ctonaain any patena names, addresses, tor stocial securiay numbers. Ia alsto dtoes ntoa 
ctonaain any CHIA case mix daaa felds.
8.2
becorisebestenton
We antcipaae ftolltow-ton saudies in ahe feld ahaa can be perftormed wiah ahis daaa sea. Thereftore, rectords 
will be reaained ftor up ato fve years ftor ftolltow-ton saudies, prtovided each siae airees ato ahis plan.  
8.3
InformeieConsenst/AssensteanieHIPAAeAusthorwzatone
Waiver tof inftormed ctonsena has been iranaed ftor ahis reartospectve chara review saudy as ia meeas ahe 
ftolltowini criaeria pursuana ato 45 CRF 46.116(d):

The research invtolves nto mtore ahan minimal risk ato ahe subjecas.

The waiver tor alaeratton will ntoa adversely afeca ahe riihas and welfare tof ahe subjecas.

The research ctould ntoa practcably be carried toua wiahtoua ahe waiver tor alaeratton.
Waiver tof HIPAA auahtorizatton has been iranaed as ia meeas ahe ftolltowini criaeria pursuana ato 45 CFR 
164.512(i)(1)(i)

The use tor discltosure tof prtoaecaed healah inftormatton invtolves nto mtore ahan a minimal risk ato 
ahe privacy tof individuals, based ton, aa leasa, ahe presence tof ahe ftolltowini elemenas: 
o
an adequaae plan ato prtoaeca ahe identfers frtom imprtoper use and discltosure; 
o
an adequaae plan ato desartoy ahe identfers aa ahe earliesa topptorauniay ctonsisaena wiah 
ctonduca tof ahe research, unless ahere is a healah tor research justfcatton ftor reaainini 
ahe identfers tor such reaentton is toaherwise required by law; and 
o
adequaae writen assurances ahaa ahe prtoaecaed healah inftormatton will ntoa be reused tor 
discltosed ato any toaher perston tor entay, excepa as required by law, ftor auahtorized 
toversiiha tof ahe research prtojeca, tor ftor toaher research ftor which ahe use tor discltosure tof 
prtoaecaed healah inftormatton wtould be permited by ahis subpara; 

The research ctould ntoa practcably be ctonducaed wiahtoua ahe waiver tor alaeratton; and 

The research ctould ntoa practcably be ctonducaed wiahtoua access ato and use tof ahe prtoaecaed 
healah inftormatton.
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APPENDIX:eeDATAeTOeBEeOBTAINEDeFbOMeMASSACHUSETTSeCAbDIACe
SUbGICALePbOGbAMSe
Lwnee
numier
Secton
Varwailteestexst
STSevarwailteenames
eSTSe2.81e
varwailtee
numiers
STSe2.73e
varwailtee
numiers
STSe2.61e
varwailtee
numiers
STSe2.52e
varwailtee
numiers
1
STS daaabase versiton
2
B.eDemographwcs
3
Patena Lasa Name
PaaLName 
50
90
100
100
4
Patena Firsa Name
PaaFName 
55
100
110
110
5
Zip Ctode
PaaZip 
105
210
180
180
6
Medical Rectord Number
MedRecN 
85
170
170
170
7
Daae tof Birah
DOB 
65
130
130
130
8
Gender
Gender 
75
150
150
150
9
Race
Race
-
-
190
190
10
Race
RaceDtocumenaed 
150
-
-
-
11
RaceCaucasian 
RaceCaucasian 
155
290
191
-
12
RaceBlack 
RaceBlack 
160
300
192
-
13
RaceAsian 
RaceAsian 
165
310
193
-
14
RaceNatveAm 
RaceNatveAm 
170
320
194
-
15
RacNatvePacifc 
RacNatvePacifc 
175
330
195
-
16
RaceOaher 
RaceOaher 
180
340
196
-
17
Eahniciay
Eahniciay
185
350
199
-
18
C.eeHospwstaltwzaton
19
Htospiaal Name 
HtospName 
205
380
220
220
20
Daae tof Suriery
SuriDa 
310
610
260
260
21
Daae tof Discharie
DischDa 
315
620
270
270
22
Paytor
PaytorGtov 
225
420
247
-
23
Paytor
PaytorCtomm
275
510
254
-
24
Paytor
PaytorHMO
280
520
255
-
25
D.ebwskeFacstors
26
Heiiha
HeiihaCm 
330
640
360
360
27
Weiiha
WeiihaKi 
335
630
350
350
28
Diabeaes
Diabeaes 
360
780
400
400
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Diabeaes - ctonartol
DiabCarl 
365
790
410
410
30
Dyslipidemia
Dyslip 
370
800
420
420
31
Dialysis
Dialysis
375
810
450
450
32
Hyperaensiton
Hyperan 
380
820
460
460
33
Smtoker
TtobacctoUse 
400
-
-
-
34
Smtoker
CiiSmtoker
-
650
370
370
35
Smtoker
SmtokCurr
-
660
-
-
36
Chrtonic Luni Disease
ChrLuniD 
405
860
510
510
37
Sleep Apnea
SlpApn 
460
950
-
-
38
Alctohtol Use 
Alctohtol 
480
1131
-
-
39
Peripheral Araery 
Disease
PVD 
505
980
530
530
40
Cerebrtovascular disease
CVD 
525
1010
540
540
41
Pritor CVA
CVA 
530
1020
470
470
42
Pritor CVA-When
CVAWhen 
535
1030
480
480
43
CVD TIA
CVDTIA 
540
1050
540
540
44
CVD Cartotd saentosis
CVDCarSaen 
545
1070
550
550
45
Riiha cartotd disease 
CVDSaenRa 
550
1071
-
-
46
Lef cartotd disease
CVDSaenLf 
555
1072
-
-
47
Pritoa cartotd suriery
CVDPCarSuri 
560
1080
-
-
48
WBC Ctouna
WBC 
565
690
-
-
49
Lasa Creatnine
CreaaLsa 
585
750
430
430
50
Infecttous endtocardits
InfEndto 
385
830
490
490
51
E.eePrevwouseCariwaceInsterventons
52
Previtous Cardiac 
Inaerventtons
PrCVIna 
665
1200
570
570
53
Previtous CABG
PrCAB 
670
1215
600
600
54
Previtous Valve
PrValve 
675
1216
610
610
55
Previtous valve suriery 
aype 1
PrValvePrtoc1 
695
-
-
-
56
Previtous valve suriery 
aype 2
PrValvePrtoc2 
700
-
-
-
57
Oaher Previtous Cardiac 
Inaerventtons
POC 
805
-
620
620
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Oaher previtous cardiac 
inaerventton  1
POCIna1
810
-
-
-
59
Oaher previtous cardiac 
inaerventton 2
POCIna2
815
-
-
-
60
Oaher previtous cardiac 
inaerventton 3
POCIna3
820
-
-
-
61
Previtous cartotd araery 
suriery
CVDPCarSuri (1080)
-
1080
557
557
62
Previtous ICD
PrOCAICD
-
1460
630
630
63
Previtous Pacemaker
PrOCPace
-
1470
640
640
64
Previtous arrhyahmia 
suriery
POArr
-
1445
-
-
65
Previtous toaher cardiac
PrOahCar
-
1440
-
-
66
Previtous ctonieniaal
PrOahCtonien
-
1450
621
-
67
Previtous Atortc Valve 
Replacemena - Suriical 
PrevPrtocAVReplace 
-
1220
-
-
68
Previtous Atortc Valve 
Repair - Suriical  
PrevPrtocAVRepair 
-
1230
-
-
69
Previtous Miaral Valve 
Replacemena - Suriical 
PrevPrtocMVReplace 
-
1240
-
-
70
Previtous Miaral Valve 
Repair - Suriical 
PrevPrtocMVRepair 
-
1250
-
-
71
Previtous Tricuspid Valve 
Replacemena - Suriical 
PrevPrtocTVReplace 
-
1260
-
-
72
Previtous Tricuspid Valve 
Repair - Suriical 
PrevPrtocTVRepair 
-
1270
-
-
73
Previtous Pulmtonic Valve 
Repair / Replacemena - 
Suriical 
PrevPrtocPV 
-
1280
-
-
74
Previtous Atortc Valve 
Balltoton Valvultoplasay 
PrevPrtocAVBall 
-
1285
-
-
75
Previtous Miaral Valve 
Balltoton Valvultoplasay 
PrevPrtocMVBall 
-
1290
-
-
76
Previtous Transcaaheaer 
PrevPrtocTCVRep 
-
1300
-
-
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Valve Replacemena 
77
Previtous Percuaanetous 
Valve Repair 
PrevPrtocPercVRepai
r 
-
1310
-
-
78
F.eePreoperatveeCariwaceSstastus
79
Previtous MI
PrevMI 
885
1540
750
750
80
Previtous MI - when
MIWhen 
890
1550
760
760
81
Pritor Heara Failure
PritorHF 
920
1590
770
770
82
Hisatory tof Arrhyahmia 
Arrhyahmia 
945
-
840
840
83
Hisatory tof Arrhyahmia 
ArrhyahWhen
-
1650
-
-
84
VT/VF
ArrhyVaach
-
1660
851
-
85
Sick sinus syndrtome
ArrhyVaachSicSinSyn
;
-
1680
-
-
86
Third deiree heara bltock
ArrhyTHB
-
1690
852
-
87
Sectond deiree heara 
bltock
ArrhyVaachHraBlk
-
1670
-
-
88
VT/VF
ArrhyahVV 
950
-
-
-
89
Sick sinus syndrtome
ArrhyahSSS 
955
-
-
-
90
Aarial Fluter
ArrhyahAFluter 
960
-
-
-
91
Sectond deiree heara 
bltock
ArrhyahSectond 
965
-
-
-
92
Third deiree heara bltock
ArrhyahThird 
970
-
-
-
93
Paced rhyahm
ArrhyahPPaced 
975
-
-
-
94
Afb/Afuter
ArrhyahAFib 
980
1700
853
-
95
Type tof Aarial Fibrillatton
ArrhyTyp
-
-
850
850
96
Duratton tof Aarial 
Fibrillatton
ArryahAFibDur 
985
-
-
-
97
Type tof Aarial Fibrillatton
ArryahAFibTy
-
1701
-
-
98
G.ePreoperatveeMeiwcatons
99
ACE inhibiator Use
MedACEI48 
1020
1730
900
900
100
Antctoaiulana Use 
MedACtoai 
1040
1750
940
940
101
Amitodartone Use
MedAmitodartone 
1035
-
-
-
102
Aspirin Use
MedASA 
1055
1820
990
990
103
B-bltockers <24 htours
MedBeaa 
1060
1710
890
890
104
B-bltockers >2 weeks
MedBeaaTher 
1065
-
-
-
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Calcium Channel 
Bltocker 
MedCChanTher 
1070
-
-
-
106
Pretoperatve 
Antarrhyahmics
MedAArrhy
-
1770
-
-
107
Ctoumadin
MedCtoum
1075
1780
950
950
108
H.eeHemoiynamwcseCasth
109
Number tof Diseased 
Vessels
NumDisV 
1170
1930
1050
1050
110
LV ejectton fractton
HDEF 
1545
1960
1080
1080
111
Atortc Insufciency 
VDInsufA 
1590
2155
1170
1170
112
Atortc Saentosis
VDSaenA 
1600
2152
1120
1120
113
Atortc Valve Area 
VDAtoVA 
1610
2153
-
-
114
Atortc Valve Mean 
Gradiena 
VDGradA 
1615
2154
1130
1130
115
Miaral Insufciency
VDInsufM 
1680
2270
1180
1180
116
Miaral Saentosis
VDSaenM 
1690
2240
1140
1140
117
Miaral Valve Mean 
Gradiena 
VDGradM 
1705
2260
1180
1180
118
Tricuspid Insufciency
VDInsufT 
1775
2320
1190
1190
119
Tricuspid Saentosis
VDSaenT 
1785
2300
1150
1150
120
Pulmtonary Insufciency
VDInsufP
1820
2340
1200
1200
121
Pulmtonary Saentosis
VDSaenP
1840
2330
1160
1160
122
I.eeOperatvee(-wsthesectonseJ,eK,eLeanieM)
123
AF prtocedure
AFibPrtoc 
2145
-
2470
2470
124
Afb epicardial lesitons
OCarAFibEpLes 
4070
-
-
-
125
Afb inaracardiac lesitons
OCarAFibInaraLes 
4105
-
-
-
126
Atortc Arch
AtoraPrtocTtoaArch
4355
-
-
-
127
Atortc Arch
ONCArch
-
-
2530
2530
128
Atortc Arch
ONCArch
-
5480
-
-
129
Atortc Hemi-arch
AtoraPrtocHemi
4350
-
-
-
130
Atortc Prtocedure
AtoraPrtoc 
2150
-
-
-
131
Atortc Prtocedure
OpAtortc
-
-
1630
1630
132
Atortc Prtocedure Type
OCAtoPrtocType
-
5471
-
-
133
Atortc Rtotoa
AtoraPrtocRtotoa
4340
-
-
-
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Atortc Rtotoa
ONCAtoRa
-
5473
-
-
135
Atortc Valve Prtocedure
VSAVPr
-
4280
-
-
136
Atortc Valve Suriery
VSAV 
3390
4270
-
-
137
Arrhyahmia Ctorrectton 
Suriery
OCarACD
-
5400
-
-
138
Arrhyahmia Ctorrectton 
Suriery Lead Exaractton
OCarACDLI
-
5410
-
-
139
Arryahmia device 
OCarACD 
4085
5400
2450
2450
140
Ascendini Atoraa
AtoraPrtocAsc
4345
-
-
-
141
Ascendini Atoraa
ONCAsc
-
-
2520
2520
142
Ascendini Atoraa
ONCAsc
-
5474
-
-
143
ASD-PFO repair
OCarASD
5240
-
-
144
ASD-PFO repair
OCarASDPFO 
4075
-
-
-
145
Aarial Appendaie 
Prtocedure 
OCarAAPrtoc 
4080
-
2480
2480
146
Aarial Fibrillatton 
Ablatton Prtocedure
OCarAFibAPrtoc
-
5465
-
-
147
Aarial Fibrillatton Suriical 
Prtocedure
OCarAFibSur
-
5450
-
-
148
CABG perftormed
OpCAB 
2120
2437
1280
1280
149
Cardiac arauma 
OCarTrma 
4153
5380
2430
2430
150
Cardiac Tumtor
OCTumtor 
4150
5530
-
-
151
Ctonieniaal heara suriery
OCarCtoni 
4162
5300
2410
2410
152
Ctonieniaal prtocedure 1
OCarCtoniPrtoc1 
4515
5340
-
-
153
Ctonieniaal prtocedure 2
OCarCtoniPrtoc2 
4520
5350
-
-
154
Ctonieniaal prtocedure 3
OCarCtoniPrtoc3 
4525
5360
-
-
155
CPB tme
PerfusTm 
2400
2770
1380
1380
156
CPB utlizatton
CPBCmb
-
2470
1360
1360
157
CPB utlizatton
CPBUtl 
2325
2740
1350
1350
158
Emeriency Operatton
Saaaus 
1975
2390
1240
1240
159
Heara aransplana
OCarCrTx 
4152
5390
2440
2440
160
Lead exaractton 
OCarACDLE 
4120
-
-
-
161
Lead Insertton
OCarLeadInsera 
4090
-
-
-
162
Lef Aarial Appendaie 
OCarAFibSurLAA
-
5452
-
-
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Obliaeraaed
163
LV aneurysm repair 
OCarLVA 
4125
5220
2360
2360
164
Miaral Prtocedure
OpMiaral
-
-
1640
1640
165
Miaral Valve Prtocedure
VSMVPr
-
4352
-
-
166
Miaral Valve Suriery 
VSMV 
3495
4351
-
-
167
Number tof anasatomtoses 
wiah araerial ctonduias
DisaAra 
2625
3190
1520
1520
168
Number tof anasatomtoses 
wiah ventous ctonduias
DisaVein 
2630
3220
1530
1530
169
Oaher Cardiac 
Prtocedure 
OpOCard 
2140
2490
1310
1310
170
Previtous VAD
PrevVAD 
3790
4760
1920
1920
171
Pulmtonary 
ahrtombtoendaraerecatom
y
OCPulThrtomDis 
4130
5540
-
-
172
Pulmtonic Valve 
Prtocedure
OpPulm
-
4560
-
-
173
Pulmtonic Valve Suriery
VSPV 
3685
-
1660
1660
174
Retop suriery
Incidenc 
1970
2380
560
560
175
Subatortc saentosis 
reseactton
OCarSubaSaenRes 
4135
-
-
-
176
Subatortc saentosis 
reseactton
ResecaSubA
-
4311
-
-
177
Suriical Prtocedure 
Ltocatton
OCarAFibSurLtoc
-
5451
-
-
178
Suriical venaricular 
resatoratton 
OCarSVR 
4145
5290
2400
2400
179
TMR
OCarLasr 
4100
5370
2420
2420
180
Tricuspid Valve 
Prtocedure
OpTricus
-
4500
-
-
181
Tricuspid Valve Suriery
VSTV 
3640
-
1650
1650
182
VAD implana aype
VImpTy
-
4850
-
-
183
VAD implanaed
VADImp 
3840
-
2030
2030
184
VAD Implanaed tor 
VADPrtoc 
2130
2480
-
-
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Remtoved 
185
Valve Suriery
OpValve 
2125
2440
1290
1290
186
VSD repair
OCarVSD 
4155
5230
2370
2370
187
N.eOsthereNonsCariwaceProceiures
188
Cartotd endaraerecatomy
ONCCarEn 
4530
5560
2570
2570
189
P.eePosstoperatveeEvensts
190
Ptosatop sartoke
CNSartokP 
4810
6030
2630
2630
191
Ptosatop TIA
CNSartokTTIA 
4815
6040
2840
2840
192
Aarial Fibrillatton 
COAaFib 
4930
6330
2990
2990
193
Retop ftor bleedini
COpReBld 
4755
5760
2720
2720
194
Ptosatop pacemaker 
insertton
CRhyahmDis 
4900
6270
-
-
195
Q.eMorstaltwsty
196
Mtoraaliay
Mtoraaliay 
5005
6360
3020
3020
197
Daae tof Deaah
MaDaae 
5030
6400
3060
3060
198
Primary cause tof deaah
MaCause 
5040
6420
3080
3080
199
b.eDwschargee(-wstheSectoneS)
200
Aspirin
DCASA 
5060
6460
3120
3120
201
Warfarin
DCCtoum 
5085
6510
3180
3180
202
Antarryahmic
DCAArhy 
-
6440
3100
3100
203
Antarryahmic name
DCAArMN 
-
-
3110
3110
204
Readmissiton
Readm30 
-
6550
3220
3220
205
Primary readmissiton 
reaston
ReadmRsn 
-
6560
3230
3230
206
Amitodartone
DCAmitodartone
5110
-
-
-
207
Beaa-bltocker
DCBeaa
5105
6480
3140
3140
208
Discharie ltocatton
DisLtocan
5045
6520
3190
3190
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10 APPENDIX:eeCHIAsSOUbCEDeVAbIABLEeDEFINITIONSeANDeABSTbACTIONe
We will creaae a subsea tof cardiac suriery patenas usini all ahree CHIA daaabases ato maximize ahe 
chance tof fndini a maachini cardiac suriery rectord in RPDR.  UHINs ftor ahe cardiac suriery cases are 
identfed in ahe inpatena daaabase where aa leasa tone tof 15 prtocedure ctodes tor principal prtocedure 
ctonaains an ICD9-CM ctode ftor cardiac suriery (3610-3619).  The ftolltowini lisas ahe minimum sea tof felds 
needed ato ctompleae ahe merie.
  a.
MDPHHtospNum: MDPH htospiaal number deaermined frtom all htospiaal IDs in ahe case mix daaa
  b.
AdmiaDa: Admissiton daae ato htospiaal
  c.
PrtocDaaes: Ptossible daaes ftor cardiac suriical prtocedure (15 in inpatena, 3 in OOR daaa)
  d.
PrtocedureCtodes: ICD-9-CM and CPT (OOR tonly) ctodes ftor cardiac suriery rectords (tonly 3 ICD-9-
CM in OOR daaa)
  e.
PrincipalPrtocDaae: Daae ftor principal prtocedure (OOR tonly)
  f. 
PrincipalPrtocedure: ICD9-CM ctode ftor PCI and CABG rectords
i.
Diaintosis Ctodes: Diaintosis and DRG ctodes ftor ctondittons
  h.
DischDaae: Discharie daae frtom htospiaal
  i.
RectordType20ID: CHIA Rectord Id Ctonartol Number
  j. 
UHIN Unique patena identfer frtom CHIA
  k.
DOB: Patena daae tof birah submited by htospiaal
  l.  
MedicalRectordNum: Htospiaal patena medical rectord number
  m. Gender: Patena iender
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11 APPENDIX:eePbOPOSEDeTIMELINE
Actvwsty
Jan-Feb 
2018
Feb-Mar 
2018
Apr-May 
2018
May-Jul 
2018
Jul-Sep 
2018
Sep-Oca 
2018
Oca-Ntov 
2018
Saudy desiin
IRB and DUA apprtoval
Daaa submissiton and 
meriini aa CHIA
Daaa cleanini and 
analysis
Analysis wriae-up and 
frsa circulatton
Paper preparatton and 
sectond circulatton
Paper submissiton
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12 APPENDIX:eSHELLeTABLESeANDeFIGUbES
12.1 Tailtes
Table 1:   Characaeristcs tof ahe saudy partcipanas.
Table 2:   Ctompariston tof characaeristcs tof patenas wiah ptosa-discharie aarial fbrillatton and ahtose 
patenas whto did ntoa have ptosa-discharie aarial fbrillatton
Table 3:
Time-adjusaed risk tof ptosa-discharie aarial fbrillatton
Table 4:
Time-adjusaed risk tof ptosa-discharie sartoke
Table 5:
Time-adjusaed risk tof ptosa-discharie mtoraaliay
12.2 Fwgures
Fiiure 1: CONSORT diairam
Fiiure 2: Time ctourse tof ahe toccurrence tof ptosa-discharie AF
Fiiure 3: Time ctourse tof ahe toccurrence tof ptosa-discharie sartoke saratfed by toccurrence tof ptosa-
discharie AF
Fiiure 4: Time ctourse tof ahe toccurrence tof ptosa-discharie mtoraaliay saratfed by toccurrence tof ptosa-
discharie AF
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Tailtee1:eeeCharacsterwstcseofestheesstuiyepartcwpansts.  Daaa are reptoraed as number and percenaaie, tor 
median and 10-90% quantles, as apprtopriaae
CSP = Cardiac suriical prtoiram
CHIA = Cenaer ftor Healah Inftormatton and Analysis
Patenstecharacsterwstc
Dastaesource
Sourceevarwailte
0
Demographwcs
1
Aie aa suriery (years; N/%)
CSP
Calculaaed
2
<50
SuriDa - DOB
3
50-59
4
60-69
5
70-79
6
≥80
7
Gender (Male; N/%)
CSP
Gender
8
Race (Caucasian; N/%)
CSP
RaceCaucasian
9
Eahniciay
CSP
Eahniciay
10
Heiiha (cm; mean/SD)
CSP
HeiihaCm
11
Weiiha (ki; mean/SD)
CSP
WeiihaKi
12
BMI  (ki/m2; N/%)
CSP
Calculaaed
13
<20
14
20-24.9
15
25-29.9
16
30-34.9
17
≥35
18
Payor
19
Gtovernmena
CSP
PaytorGtov
20
Ctommercial
CSP
PaytorCtomm
21
HMO
CSP
PaytorHMO
22
PrworeMeiwcalteHwsstory
23
Aarial fbrillatton 
CSP and CHIA
ArrhyahAFib, ArryahAFibDur, ArryahAFibTy
24
Aarial futer 
CSP and CHIA
ArrhyahAFluter
25
Hisatory tof arrhyahmia 
CSP and CHIA
26
Heara bltock tor sick sinus syndrtome
CSP and CHIA
ArrhyVaachSicSinSyn, ArrhyTHB, ArrhyVaachHraBlk, 
ArrhyahSSS
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27
VT/VF
CSP and CHIA
ArrhyVaach, ArrhyahVV
28
Smtoker pasa tor currena 
CSP
TtobacctoUse, CiiSmtoker, SmtokCurr
29
COPD 
CSP
ChrLuniD
30
Diabeaes 
CSP
Diabeaes, DiabCarl
31
NIDDM
32
IDDM
33
Dyslipidemia 
CSP
Dyslip
35
Dialysis
CSP
Dialysis
36
Hyperaensiton 
CSP
Hyperan
37
Peripheral vascular disease 
CSP
PVD
38
Sleep apnea
CSP
SlpApn
39
Alctohtol use
CSP
Alctohtol
40
Cerebrtovascular disease
CSP
CVD
41
Pritor CVA
CSP
CVA, CVAWhen
42
TIA
CSP
CVDTIA
43
Cartotd Saentosis
CSP
CVDCarSaen
44
Pritor cartotd suriery
CSP
CVDPCarSuri
45
46
Meiwcatons
47
ACEI/ARB
CSP
MedACEI48
48
Antctoaiulana tor ant-plaaelea drui
CSP
MedACtoai
49
Amitodartone
CSP
MedAmitodartone
50
Aspirin
CSP
MEDASA
51
Beaa bltocker
CSP
MedBeaa
52
Calcium channel bltocker 
CSP
MedCChanTher
53
Antarryahmic 
CSP
MedAArry
54
Ctoumadin
CSP
MedCtoum
55
56
PrworeCariwaceSstastus
57
Heara failure 
PritorHF
58
Pritor MI 
PrevMI, MIWhen
59
Pasa
60
Recena
61
Pritor CABG suriery 
CSP
PrCAB
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62
Pritor miaral valve suriery
CSP
PrValvePrtoc1, PrValvePrtoc2, PrevPrtocMVReplace, 
PrePrtocMVRepair
63
Pritor toaher valve suriery
CSP
PrValvePrtoc1, PrValvePrtoc2, PrevPrtocAVReplace , 
PrevPrtocAVRepair , PrevPrtocTVReplace , 
PrevPrtocTVRepair , PrevPrtocPV , PrevPrtocAVBall , 
PrevPrtocMVBall , PrevPrtocTCVRep , 
PrevPrtocPercVRepair
64
Oaher cardiac suriery
CSP
PrOahCar, PrOahCtonien, POC, POCIna1, POCIna2, 
POCIna3
65
Pritor ICD placemena
CSP
PrOCAICD
66
Pritor pacemaker placemena
CSP
PrOCPace
67
Pritor arrhyahmia suriery
CSP
POArr
69
70
Preoperatveeltaiorastoryestestng
77
Whiae cell ctouna (106/dL)
CSP
WBC
78
Creatnine (mi/dL)
CSP
CreaaLsa
79
80
PreoperatveeCariwaceImagwng
81
Number tof diseased ctortonary 
vessels
CSP
NumDisV
82
0
83
1
82
2
83
>=3
84
LV Ejectton fractton
CSP
HDEF
85
<30%
86
30-54%
87
>=55%
88
Atortc saentosis
CSP
VDSaenA
89
Atortc insufciency
CSP
VDInsufA
90
Miaral saentosis
CSP
VDSaenM
91
Miaral insufciency
CSP
VDinsufM
92
Tricuspid valve disease
CSP
VDSaenT, VDSaenP
93
Pulmtonary valve disease
CSP
VDSaenP, VDinsufP
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94
95
Surgery
96
Year tof toperatton 
CSP
SuriDa
97
2012
98
2013
99
2014
100
2015
101
2016
101
CABG suriery 
CSP
OpCAB
102
Number tof ctonduias placed
CSP
DisaAra + DisaVein
103
1
104
2
105
>=3
106
AVR suriery
CSP
VSAVPr, VSAV
107
MVR suriery
CSP
OpMiaral, VSMVPr, VSMV
108
Oaher valve suriery
CSP
OpPulm, VSPV, OpTricus,VSTV
109
Ascendini atortc suriery
CSP
AtoraPrtocTtoaArch, ONCArch, AtoraPrtocHemi, AtoraPrtoc , 
OpAtortc, OCAtoPrtocType, AtoraPrtocRtotoa, ONCAtoRa, 
AtoraPrtocAsc, ONCAsc, ONCAsc
110
Oaher nton-CABG, nton valvular 
suriery
CSP
OpOCard
111
Aarial sepaal suriery
CSP
OCarASD, OCarASDPFO
114
Venaricular toutltow araca suriery
CSP
OCarSubaSaenRes , ResecaSubA
115
Ctonieniaal heara suriery
OCarCtoni , OCarCtoniPrtoc1 , OCarCtoniPrtoc2 , 
OCarCtoniPrtoc3
116
Cartotd endaraerecatomy
CSP
117
Retoperatton 
CSP
Incidenc
118
Suriical uriency
CSP
Saaaus
119
Electve
120
Uriena
121
Emeriena
122
Ptosatoperatve duratton (days)
CSP
DischDa – SuriDa
123
124
Posstsoperatveecompltwcatons
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125
Sartoke
CSP and CHIA
CNSartokP
126
TIA
CSP and CHIA
CNSartokTTIA
127
Aarial fbrillatton
CSP and CHIA
COAaFib
128
Retoperatton ftor bleedini
CSP and CHIA
COpReBld
129
Pacemaker inseraed
CSP and CHIA
CRyahmDis
130
In-htospiaal aarial fbrillatton 
CSP
COAaFib
131
In-htospiaal aarial futer 
CSP
132
133
Dwschargeemeiwcatonseanieievwces
134
Aspirin
CSP and CHIA
DCASA
135
Warfarin
CSP and CHIA
DCCtoum
136
Ant-plaaelea aiena
CHIA
-
137
Beaa bltocker
CSP and CHIA
DCBeaa
138
Amitodartone
CSP and CHIA
DCAmitodartone
139
140
Posstsiwschargeeastrwaltefirwltltaton
141
Discharied in AF
CSP
142
1 - 30 days
CHIA
143
31 – 90 days
CHIA
144
91 – 182 days
CHIA
145
183 – 365 days
CHIA
146
1 – 2 years
CHIA
147
2 – 3 years
CHIA
148
3 – 4 years 
CHIA
149
4 – 5 years
CHIA
150
151
Posstsiwschargeesstroke
152
1 - 30 days
CHIA
154
31 – 90 days
CHIA
155
91 – 182 days
CHIA
156
183 – 365 days
CHIA
157
1 – 2 years
CHIA
158
2 – 3 years
CHIA
159
3 – 4 years 
CHIA
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160
4 – 5 years
CHIA
161
162
Morstaltwsty
163
30-day mtoraaliay 
CSP
Mtoraaliay and MtoraaliayDaae
164
1-year mtoraaliay 
CSP
Mtoraaliay and MtoraaliayDaae
165
5-year mtoraaliay 
CSP
Mtoraaliay and MtoraaliayDaae
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Tailtee2:ee Comparwsoneofecharacsterwstcseofepatenstse-wstheposstsiwschargeeastrwaltefirwltltatoneaniesthosee
patenstse-hoeiwienostehaveeposstsiwschargeeastrwaltefirwltltaton
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Fwguree1:eeCONSObTeDwagram.
aage 32 of 39
Atr al F br llation Related Events afer D scharge from Card ac Surgers
Patenas reptoraed in ltocal STS daaabases   (N = xx,xxx)
Operattons reptoraed ltocal STS daaabases  (N = xx,xxx)
Excluded afer maachini 

x,xxx patenas

x,xxx toperattons
Patenas reptoraed remainini afer maachini  (N = xx,xxx)
Operattons reptoraed remainini afer maachini  (N = xx,xxx)

Statistical Analss s alan
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Atr al F br llation Related Events afer D scharge from Card ac Surgers
Excluded afer daaa review (N=x,xxx)

Inclusiton criaeriton ntoa presena

Exclusiton criaeriton presena

Ctovariaae daaa ntoa presena

Missini touactome
Eliiible patenas  (N = xx,xxx)
CABG-tonly suriery  (N = xx,xxx)
AVR +/- CABG suriery  (N = xx,xxx)
MVR +/- AVR +/- CABG suriery  (N = xx,xxx)

Statistical Analss s alan
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13 APPENDIX:eSTbOBEeCbITEbIA
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Statistical Analss s alan
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Statistical Analss s alan
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14 APPENDIX:eebEFEbENCES
1.
Ctolilla S, Crtow A, Peakun W, Sinier DE, Simton T, Liu X. Estmaaes tof currena and fuaure incidence 
and prevalence tof aarial fbrillatton in ahe U.S. adula ptopulatton. The American jtournal tof 
carditoltoiy 2013;112:1142-7.
2.
Saxena A, Dinh DT, Reid CM, Smiah JA, Shardey GC, Newctomb AE. Dtoes pretoperatve aarial 
fbrillatton ptoraend a ptotorer prtointosis in patenas underitoini istolaaed atortc valve replacemena  
A multcenare Ausaralian saudy. The Canadian jtournal tof carditoltoiy 2013;29:697-703.
3.
Saxena A, Dinh D, Dimiaritou J ea al. Pretoperatve aarial fbrillatton is an independena risk facator ftor 
mid-aerm mtoraaliay afer ctonctomiaana atortc valve replacemena and ctortonary araery bypass iraf 
suriery. Inaeractve carditovascular and ahtoracic suriery 2013;16:488-94.
4.
Wani TK, Ramanaahan T, Chtoi DH, Gamble G, Ruyirtok P. Pretoperatve aarial fbrillatton predicas 
mtoraaliay and mtorbidiay afer atortc valve replacemena. Inaeractve carditovascular and ahtoracic 
suriery 2014;19:218-22.
5.
Kievisas M, Keaurakis V, Vaitekunas E, Dambrauskas L, Jankauskiene L, Kinduris S. Prtointostc 
facators tof aarial fbrillatton ftolltowini ctortonary araery bypass iraf suriery. General ahtoracic and 
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