Massachusetss … · 2018. 3. 8. · beaween 1/1/2012 ato 12/31/2016. Ia is estmaaed ahaa ~50,000...

Statistical Analss s alan Vers on 1.0 03/01/2018

Massachusetss-wieesstuiyeofestheewncwienceeofeATrwaltefibIltltatone

aniesstrokeeoccurrwngeafereiwschargeefromeCariwaceSurgery

(MATbICeS)

Principal Investiaator:

Simton C. Btody, MBChB, MPH, FAHA [email protected]

Cto-Investiaators:

J. Daniel Muehlschleiel, MD, MMSc, FAHA [email protected]

Bala Subramaniam, MD [email protected]

Xinlini (Claire) Xu, PhD [email protected]

Abdallah Alameddine, M.D. [email protected]

Vladimir Birjiniuk, M.D. [email protected]

Frederick Y. Chen, M.D. [email protected]

Iraklis Gertoiiannis, M.D. [email protected]

Tsuytoshi Kanekto, M.D. [email protected]

Kamal Khabbaz, M.D. [email protected]

Paul Pirundini, M.D. [email protected]

Thtoralf M. Sunda, M.D. [email protected]

Jennifer Walker, M.D. [email protected]

IbBeNumier:ee2017P002261eParstnerseHealtsthCareeIbB.

AusthorseofestheeSstatstcalteAnaltyswsePltan:

Simton C. Btody, MBChB, MPH, FAHA

Xinlini (Claire) Xu, PhD

Inwtalteverswoneiaste: 2/15/2018

aage 1 of 39 Atr al F br llation Related Events afer D scharge from Card ac Surgers

mailto:[email protected]










Amenimenste1:

Amended versiton daae:

Chanies in Amendmena:

Amenimenste2:



Amenimenste3:



Amenimenste4:



Amenimenste5:





TailteeofeConstensts

1 INTbODUCTIONe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e...............................................................................................................................................e e5ee

1.1 STUDYeINTbODUCTION.......................................................................................................................................51.2 BACKGbOUNDeLITEbATUbE.................................................................................................................................5

2 STUDYeSUMMAbYeANDeAIMSe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e..........................................................................................................................e e6ee

2.1 STUDYeDESIGN:................................................................................................................................................62.2 STUDYePOPULATIONeANDeSITES...........................................................................................................................62.3 PbIMAbYeAIMS................................................................................................................................................72.4 SECONDAbYeAIMS.............................................................................................................................................7

3 STUDYeENDPOINTSeANDeCOVAbIATESe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e.............................................................................................................e e7ee

3.1 DEFINITIONSeOFeSTUDYeENDPOINTS......................................................................................................................73.2 DEFINITIONSeOFeCOVAbIATES..............................................................................................................................73.3 MODIFICATIONSeObeDEbIVATIONSeOFeSTANDAbDeVAbIABLES......................................................................................73.4 UNbELATEDeOUTCOMES.....................................................................................................................................8

4 ESTIMATIONeOFeACCESSIBLEeEFFECTeSIZEe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e........................................................................................................e e8ee

5 DATAeSOUbCESe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e...............................................................................................................................................e e8ee

6 STUDYePOPULATIONSe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e......................................................................................................................................e e8ee

6.1 INCLUSIONeCbITEbIA..........................................................................................................................................86.2 EXCLUSIONeCbITEbIA.........................................................................................................................................86.3 SUBGbOUPS....................................................................................................................................................96.4 DESCbIPTIONeOFePAbTICIPANTS............................................................................................................................9

7 STATISTICALeANALYSESe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e...................................................................................................................................e e9ee

7.1 GENEbAL........................................................................................................................................................97.1.1 PRIMARY AIMS...................................................................................................................................................97.1.2 SECONDARY AIMS.............................................................................................................................................107.2 POOLINGeOFeSITES..........................................................................................................................................107.3 METHODSeFObeHANDLINGeMISSINGeDATA...........................................................................................................107.4 STATISTICALeANALYTICALeISSUES........................................................................................................................117.4.1 ADJUSTMENTS FOR COVARIATES...........................................................................................................................117.4.2 MULTIPLE COMPARISONS...................................................................................................................................11



7.4.3 EXAMINATION OF SUBGROUPS.............................................................................................................................117.4.4 CORRELATED DATA, BIAS, CONFOUNDING AND INTERACTIONS....................................................................................117.4.5 SUBGROUP ANALYSES.........................................................................................................................................117.5 POSTsHOCe(DATAeDbIVEN)eANALYSES:.................................................................................................................117.6 SENSITIVITYeANALYSES.....................................................................................................................................12

8 APPENDIX:eeSTUDYeADMINISTbATIONe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e...........................................................................................................e e13e e

8.1 CONFIDENTIALITY............................................................................................................................................138.2 bECObDSebETENTION.......................................................................................................................................138.3 INFObMEDeCONSENT/ASSENTeANDeHIPAAeAUTHObIZATION...................................................................................13

9 APPENDIX:eeDATAeTOeBEeOBTAINEDeFbOMeMASSACHUSETTSeCAbDIACeSUbGICALePbOGbAMSe eeeeeeeeeeeeeeeeeeeeeeeee e....................e e14e e

10 APPENDIX:eeCHIAsSOUbCEDeVAbIABLEeDEFINITIONSeANDeABSTbACTIONe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e....................................................e e22e e

11 APPENDIX:eePbOPOSEDeTIMELINEe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e................................................................................................................e e23e e

12 APPENDIX:eSHELLeTABLESeANDeFIGUbESe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e......................................................................................................e e24e e

12.1 TABLES.......................................................................................................................................................2412.2 FIGUbES......................................................................................................................................................24

13 APPENDIX:eSTbOBEeCbITEbIAe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e......................................................................................................................e e33e e

14 APPENDIX:eebEFEbENCESe eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee e.............................................................................................................................e e35e e



1 INTbODUCTIONThis 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 SstuiyeInstroiuctonBriefy, 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 BackgrounieLwsterastureAarial 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).


https://www.mass.gov/orgs/center-for-health-information-and-analysis


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 STUDYeSUMMAbYeANDeAIMSThe 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 SstuiyePopultatoneanieSwstesThe 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



Tufs Medical Cenaer, Btosaton, MA

2.3 PrwmaryeAwmsThe 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 SeconiaryeAwmsThe 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 STUDYeENDPOINTSeANDeCOVAbIATES3.1 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 DefnwtonseofeCovarwastesDaaa 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 MoiwfcatonseoreierwvatonseofesstaniarievarwailtesHtospiaal 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



Inaernattonal Classifcatton tof Disease ctodes (ICD-9) ctodes will be used ato defne ahe specifc ctondittons

tof inaeresa.

3.4 UnreltasteieoustcomesUn-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 ESTIMATIONeOFeACCESSIBLEeEFFECTeSIZEeThis 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 STUDYePOPULATIONS6.1 IncltuswoneCrwsterwaInclusiton 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 ExcltuswoneCrwsterwaExclusiton criaeria ftor ahis saudy are:Pretoperatve saaaus

Pritor AF ablatton tor pulmtonary vein istolatton prtocedure tof any aypePritor LA tocclusiton tor ablatton prtocedure tof any aype

Suriical prtocedureMAZE tor toaher prtocedure ftor ahe areaamena tor preventton tof AF



Venaricular assisa deviceHeara aransplanaattonBacaerial endtocarditsCardiac araumaCardiac aumtorVenaricular sepaal defeca repairLef venaricular aneurysm repairPulmtonary ahrtombtoendaraerecatomySuriical venaricular resatoratton

6.3 SuigroupsSubirtoups may be used in sectondary analyses.

6.4 DescrwptoneofepartcwpanstsThe 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 STATISTICALeANALYSES7.1 GeneralteBaseline 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 AimsThe 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,



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 AimsMeans 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 PooltwngeofeSwstesThe 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 MesthoiseforeHaniltwngeMwsswngeDastaeThe 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)



7.4 SstatstcalteAnaltytcalteIssues

7.4.1 Adjusamenas ftor ctovariaaesThere will be ctovariaae adjusamena in ahe primary analysis.

7.4.2 Multple CtomparistonsThere 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 SubirtoupsTto 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 analysesSubirtoup 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.



7.6 SenswtvwstyeAnaltyseseThe 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.



8 APPENDIX:eeSTUDYeADMINISTbATION8.1 ConfientaltwstyDaaa 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 becorisebestentonWe 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/AssensteanieHIPAAeAusthorwzatoneWaiver 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.



9 APPENDIX:eeDATAeTOeBEeOBTAINEDeFbOMeMASSACHUSETTSeCAbDIACeSUbGICALePbOGbAMSe

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



29 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



58

Oaher previtous cardiac

inaerventton 1 POCIna1 810 - - -

59



60



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


Repair - Suriical PrevPrtocAVRepair - 1230 - -

69

Previtous Miaral Valve

Replacemena - Suriical PrevPrtocMVReplace - 1240 - -

70


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


Balltoton Valvultoplasay PrevPrtocAVBall - 1285 - -

75


Balltoton Valvultoplasay PrevPrtocMVBall - 1290 - -

76 Previtous Transcaaheaer PrevPrtocTCVRep - 1300 - -



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 - - -



105

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 - - -



134 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 - -



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 - -



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 - -



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



10 APPENDIX:eeCHIAsSOUbCEDeVAbIABLEeDEFINITIONSeANDeABSTbACTIONeWe 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



11 APPENDIX:eePbOPOSEDeTIMELINE

ActvwstyJan-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



12 APPENDIX:eSHELLeTABLESeANDeFIGUbES

12.1 TailtesTable 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 FwguresFiiure 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



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 CHIAArrhyahAFib, ArryahAFibDur, ArryahAFibTy

24 Aarial futer CSP and CHIAArrhyahAFluter

25 Hisatory tof arrhyahmia CSP and CHIA

26 Heara bltock tor sick sinus syndrtome CSP and CHIA ArrhyVaachSicSinSyn, ArrhyTHB, ArrhyVaachHraBlk,

ArrhyahSSS



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/ARBCSP

MedACEI48

48 Antctoaiulana tor ant-plaaelea druiCSP

MedACtoai

49 AmitodartoneCSP

MedAmitodartone

50 AspirinCSP

MEDASA

51 Beaa bltockerCSP

MedBeaa

52 Calcium channel bltocker CSP

MedCChanTher

53 Antarryahmic CSP

MedAArry

54 CtoumadinCSP

MedCtoum

55

56 PrworeCariwaceSstastus

57 Heara failure PritorHF

58 Pritor MI PrevMI, MIWhen

59 Pasa

60 Recena

61 Pritor CABG suriery CSP PrCAB



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 fracttonCSP

HDEF

85 <30%

86 30-54%

87 >=55%

88 Atortc saentosisCSP

VDSaenA

89 Atortc insufciencyCSP

VDInsufA

90 Miaral saentosisCSP

VDSaenM

91 Miaral insufciencyCSP

VDinsufM

92 Tricuspid valve diseaseCSP

VDSaenT, VDSaenP

93 Pulmtonary valve diseaseCSP

VDSaenP, VDinsufP



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



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 daysCHIA

146 1 – 2 yearsCHIA


148 3 – 4 years CHIA


150

151 Posstsiwschargeesstroke

152 1 - 30 daysCHIA

154 31 – 90 days CHIA

155 91 – 182 days CHIA

156 183 – 365 daysCHIA



159 3 – 4 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



Tailtee2:ee Comparwsoneofecharacsterwstcseofepatenstse-wstheposstsiwschargeeastrwaltefirwltltatoneaniesthosee

patenstse-hoeiwienostehaveeposstsiwschargeeastrwaltefirwltltaton



Fwguree1:eeCONSObTeDwagram.


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)



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)


13 APPENDIX:eSTbOBEeCbITEbIA



14 APPENDIX:eebEFEbENCES

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8. Quader MA, McCarahy PM, Gillintov AM ea al. Dtoes pretoperatve aarial fbrillatton reduce survival afer ctortonary araery bypass irafini The Annals tof ahtoracic suriery 2004;77:1514-22; discussiton 1522-4.

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16. Lee R, McCarahy PM, Wani EC ea al. Midaerm survival in patenas areaaed ftor aarial fbrillatton: a prtopensiay-maached ctompariston ato patenas wiahtoua a hisatory tof aarial fbrillatton. The Jtournal tof ahtoracic and carditovascular suriery 2012;143:1341-51; discussiton 1350-1.

17. Lim E, Barltow CW, Htosseinptour AR ea al. Infuence tof aarial fbrillatton ton touactome ftolltowini miaral valve repair. Circulatton 2001;104:I59-63.

18. Mairuder JT, Ctollica S, Belmusaaktov S ea al. Predicators tof Laae-Onsea Aarial Fibrillatton Ftolltowini Istolaaed Miaral Valve Repairs in Patenas Wiah Preserved Ejectton Fractton. Jtournal tof cardiac suriery 2016;31:486-92.

19. Mariscalcto G, Klersy C, Zantobini M ea al. Aarial fbrillatton afer istolaaed ctortonary suriery afecas laae survival. Circulatton 2008;118:1612-8.

20. Htorwich P, Buah KJ, Leiare JF. New tonsea ptosatoperatve aarial fbrillatton is asstociaaed wiah a ltoni-aerm risk ftor sartoke and deaah ftolltowini cardiac suriery. Jtournal tof cardiac suriery 2013;28:8-13.

21. Al-Aaassi T, Kimmaliardjuk DM, Daienais C, Btourke M, Lam BK, Rubens FD. Shtould We Ablaae Aarial Fibrillatton Durini Ctortonary Araery Bypass Grafini and Atortc Valve Replacemena The Annals tof ahtoracic suriery 2017;104:515-522.

22. Elbadawi A, Oiunbayto GO, Eliendy IY ea al. Impaca tof Lef Aarial Appendaie Exclusiton ton Carditovascular Ouactomes in Patenas Wiah Aarial Fibrillatton Underitoini Ctortonary Araery Bypass Grafini (Frtom ahe Nattonal Inpatena Sample Daaabase). The American jtournal tof carditoltoiy 2017;120:953-958.

23. Endto D, Kaato TS, Iwamura T ea al. The impaca tof suriical lef aarial appendaie ampuaatton/liiatton ton sartoke preventton in patenas underitoini tof-pump ctortonary araery bypass irafini. Heara and vessels 2017;32:726-734.

24. Gillintov AM, Gelijns AC, Parides MK ea al. Suriical ablatton tof aarial fbrillatton durini miaral-valve suriery. The New Eniland jtournal tof medicine 2015;372:1399-409.

25. Rankin JS, Lerner DJ, Braid-Ftorbes MJ, Feriuston MA, Badhwar V. One-year mtoraaliay and ctosas asstociaaed wiah suriical ablatton ftor aarial fbrillatton ctonctomiaana ato ctortonary araery bypass irafini. Eurtopean jtournal tof cardito-ahtoracic suriery : tofcial jtournal tof ahe Eurtopean Asstociatton ftor Cardito-ahtoracic Suriery 2017;52:471-477.

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27. Bltomsartom-Lundqvisa C, Jtohansston B, Berilin E ea al. A randtomized dtouble-blind saudy tof epicardial lef aarial crytoablatton ftor permanena aarial fbrillatton in patenas underitoini miaral



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28. Chevalier P, Leiztortovicz A, Maureira P ea al. Lef aarial raditofrequency ablatton durini miaral valve suriery: a prtospectve randtomized multcenare saudy (SAFIR). Archives tof carditovascular diseases 2009;102:769-75.

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30. Ad N, Htolmes SD, Priachard G, Shuman DJ. Asstociatton tof toperatve risk wiah ahe touactome tof ctonctomiaana Ctox Maze prtocedure: a ctompariston tof resulas acrtoss risk irtoups. The Jtournal tof ahtoracic and carditovascular suriery 2014;148:3027-33.

31. Damianto RJ, Jr., Lawrance CP, Saina LL ea al. Deaectton tof Aarial Fibrillatton Afer Suriical Ablatton: Ctonventtonal Versus Ctontnutous Mtoniatorini. The Annals tof ahtoracic suriery 2016;101:42-7; discussiton 47-8.

32. Melto J, Santaito T, Aiuiar C ea al. Suriery ftor aarial fbrillatton in patenas wiah miaral valve disease: resulas aa fve years frtom ahe Inaernattonal Reiisary tof Aarial Fibrillatton Suriery. The Jtournal tof ahtoracic and carditovascular suriery 2008;135:863-9.

33. Badhwar V, Rankin JS, Ad N ea al. Suriical Ablatton tof Aarial Fibrillatton in ahe Uniaed Saaaes: Trends and Prtopensiay Maached Ouactomes. The Annals tof ahtoracic suriery 2017;104:493-500.

34. Ad N, Barnet S, Lefrak EA ea al. Impaca tof ftolltow-up ton ahe success raae tof ahe crytosuriical maze prtocedure in patenas wiah rheumatc heara disease and enlaried aaria. The Jtournal tof ahtoracic and carditovascular suriery 2006;131:1073-9.

35. Gammie JS, Haddad M, Milftord-Beland S ea al. Aarial fbrillatton ctorrectton suriery: lesstons frtom ahe Stocieay tof Thtoracic Surietons Nattonal Cardiac Daaabase. The Annals tof ahtoracic suriery 2008;85:909-14.

36. Calkins H, Kuck KH, Cappaato R ea al. 2012 HRS/EHRA/ECAS expera ctonsensus saaaemena ton caaheaer and suriical ablatton tof aarial fbrillatton: rectommendattons ftor patena selectton, prtocedural aechniques, patena manaiemena and ftolltow-up, defnittons, endptoinas, and research arial desiin: a reptora tof ahe Heara Rhyahm Stocieay (HRS) Task Ftorce ton Caaheaer and Suriical Ablatton tof Aarial Fibrillatton. Develtoped in paranership wiah ahe Eurtopean Heara Rhyahm Asstociatton (EHRA), a reiisaered branch tof ahe Eurtopean Stocieay tof Carditoltoiy (ESC) and ahe Eurtopean Cardiac Arrhyahmia Stocieay (ECAS); and in ctollabtoratton wiah ahe American Ctolleie tof Carditoltoiy (ACC), American Heara Asstociatton (AHA), ahe Asia Pacifc Heara Rhyahm Stocieay (APHRS), and ahe Stocieay tof Thtoracic Surietons (STS). Endtorsed by ahe itovernini btodies tof ahe American Ctolleie tof Carditoltoiy Ftoundatton, ahe American Heara Asstociatton, ahe Eurtopean Cardiac Arrhyahmia Stocieay, ahe Eurtopean Heara Rhyahm Asstociatton, ahe Stocieay tof Thtoracic Surietons, ahe Asia Pacifc Heara Rhyahm Stocieay, and ahe Heara Rhyahm Stocieay. Heara rhyahm 2012;9:632-696 e21.

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