Objec&ves

1.  Review the importance of QI in thyroid & thyroidcancersurgery

2.  Be aware of contemporary complica&on rates forthyroid/thyroidcanceropera<ons

3.  AppreciatepostopRAIuptake,Tglevel,andLNyieldasthyroidcancersurgeryQIs

4.  Understand the importance of surgeon volume inthyroidsurgery&thyroidcancersurgeryoutcomes

WhatIsHealthcareQuality?

The degree to which health services forindividuals and popula<ons increase thelikelihoodof desiredhealth outcomes and areconsistentwithcurrentprofessionalknowledge.

(Lohr et al N Eng J Med 1990;322;707-712)

Revolu&onaryThyroidSurgicalQualityImprovement:

Kocher’sThyroidectomyTechnique

CurrentthyroidsurgicaltechniquewaspioneeredbyEmilTheodorKocherthatledtoareduc&oninmortalityfrom

12.8%in1883tolessthan0.5%15yearslater

ThyroidectomySurgicalQIs:Complica&ons•  Are important thyroid surgical quality

outcomes and thyroid surgeons should beaware of their own complica&on rates andhow they compare to current reportedoutcomes

•  ThyroidectomySpecificComplica&ons–  RecurrentLaryngealNerveInjury(Scope)–  Hypoparathyroidism(Measurement)

•  NonspecificSurgicalComplica&ons–  Pneumonia–  MyocardialInfarc<on–  RenalFailure–  WoundInfec<on–  BloodLoss/TransfusionRequirement–  UrinaryTractInfec<on–  Postopera<veHemorrhage/ReturntoOR

•  Objec<ve:Iden&fyopera&onsneedingmoreQI

•  10 procedures evaluated in ACS NSQIP databasebetween2008-20015(1.2millionopera<ons)

(Liu et al JACS 2018;226;1:30-36)

ThyroidectomyQIs:WhatAreContemporaryComplica&onRates?

ThyroidectomyCurrentComplica&onRates:BenchmarksForThyroidSurgeryQI

(Liu et al JACS 2018;226;1:30-36)

ThyroidectomyForCancerQIs:WhatAreContemporaryComplica&onRates?

•  Objec<ve:– Todeterminethyroidcancersurgicalcomplica&onratesandiden&fyatriskpopula&ons

•  SEERdatabase(1998-2011)–  22,867pa<ents30dayand1yearcomplica<onratesinDTC(97.2%)&MTC(2.8%)cases

•  Complica<onsSeparatedinto:»  General(Fever/Infec<on/Hematoma/Pneumonia/

Intuba<on/Trach/MI/PE/DVT)

»  ThyroidectomySpecific(Hypoparathyroidism/VCparalysis)(Star<ngat31dayspostop)

(Papaleontiou et al JCEM; 2017;102:2543-2551)

– OverallComplica<onRates:•  General(6.5%)•  ThyroidectomySpecific(12.3%)

–  1152casesofvocalcordparalysis–  2553casesofhypoparathyroidism

(Papaleontiou et al JCEM; 2017;102:2543-2551)

ThyroidectomyForCancerQI:Complica&ons

•  Retrospec<ve review of Na<onwide Inpa<entSample (2003-2009) to evaluate thyroidectomycomplica<ons and the effect of surgeonexperience/volume

•  62,722thyroidectomiesevaluated•  57.9%TotalThyroidectomy/42.1%Lobectomy•  3.3%Graves,60.8%BenignDisease,35.9%Cancer•  0.4%NeckDissec<on

•  SurgeonVolumeClassifica&on•  Low(<10)-50.2%•  Intermediate(10-99)–44.8%•  High(>99)–5.0%

(Hauch et al; Ann Surg Onc 2014;21:3844-3852)

ThyroidectomyQIs:WhatIsTheInfluenceofSurgeonVolumeOnComplica&ons?

(Hauch et al; Ann Surg Onc 2014;21:3844-3852)

•  Higher complica&on riskacerTotal Thyroidectomy (20.8%) compared toLobectomy(10.8%)(p<0.0001):

•  Hypocalcemia(7.1%vs16.1%,p<0.0001)•  RespiratoryComplica<ons(0.84%vs1.34%,p<0.0001)•  Bleeding(0.15%vs0.23%,p=0.0403)•  Hematoma(1.24vs1.54%,p=0.0027)•  Tracheostomy(0.004%vs0.024%,p=0.0493)•  VocalCordParalysis(0.59vs1.33%,p<0.001)

•  Evenhighvolumesurgeonshaveahighercomplica&onriskforTotalThyroidectomycomparedtoLobectomy

•  Lowvolume surgeonsweremore likely tohave complica&ons thenhighvolumesurgeons(OR1.53,95%CI1.12,2.11,p=0.0083)–  TrueforbothLobectomyandTotalThyroidectomy

EvenHighVolumeSurgeonsHaveComplica&ons

ThyroidectomyQIs:InfluenceofSurgeonVolumeOnComplica&ons

TotalThyroidectomySurgicalQIs:Complica&ons&InfluenceofSurgeonVolume

•  Retrospec<ve reviewofNa<onwide Inpa<entSample (1998-2009) to evaluate totalthyroidectomycomplica<onsandtheeffectofsurgeonexperience/volume

•  16,954TotalThyroidectomiesevaluated•  47%ThyroidCancer,53%BenignDisease•  Medianannualsurgeonvolumewas7cases•  51%ofsurgeonsperformed1case/year

(Abdelgadir et al; Ann Surg 2017;265:402-407)

TotalThyroidectomySurgicalQIs:InfluenceofSurgeonVolumeOnComplica&ons

•  Likelihood of experiencing a complica<ondecreased with increasing surgeon volume up to26cases/year(p<0.01)

•  Pa<ents undergoing thyroidectomy by lowcomparedtohighvolumesurgeonswere:

•  Morelikelytoexperiencecomplica&ons(OR1.51,p=0.002)•  Havelongerhospitaladmissions(+12%,P=0.006)

(Abdelgadir et al; Ann Surg 2017;265:402-407)

WhatisQualityCancerCare?

“Theprovisionofevidence-based,pa<ent-centeredservices throughout the con<nuum of care in a&mely and technically competent manner, withgood communica<on, shared decisionmaking, andcultural sensi<vity, with the aim of improvingclinical outcomes, including pa&ent survival andhealth-relatedqualityoflife”

(NIHPublica<onNo.03e4373.Bethesda:U.S.DepartmentofHealthandHumanServices,Na<onalIns<tutesofHealth;2002)

QualityImprovementForCancerPa&entsIsChallenging

•  Ongoingandcon<nuousmodifica&onofcancertreatmentplan

•  Mul&disciplinarytreatmentparadigm

•  Lengthy&meintervalsforoutcomes

(Albert et et al; I J Rad Onc 2012;83:773-780)

WhatAreCancerCareQualityIndicators?

•  Diseasespecific,reliable,scien<ficallyvalidated/evidence or consensus based measures thatreflect quality of care and can be u&lized toguidecancerpa&ent&caregiver:

Ø AssessmentØ BenchmarkingØ Accredita&onØ Creden&alingØ ReimbursementØ QualityImprovement

(Albert et et al; I J Rad Onc 2012;83:773-780)

•  Diversityinpathophysiology/prognos<cators/treatmentsfordifferentcancertypesandsoQIsmustbetailoredtothecancertype

•  QIdevelopmenthasfocusedoncancertypes:»  HighMortality/RecurrenceRisk»  HighRiskOpera&ons» MostCommonOpera&ons

SurgicalQualityIndicatorsInCancerPa&ents

ThyroidCancerSurgicalQI:Challenges•  ThyroidCancertendsto:

– Haveanexcellentprognosis•  Mortalityisuncommon

»  PoorQIOutcomeMeasure

– Mayrecuroverdecades•  Recurrencemaybehardtotrack

»  QIOutcomeMeasureofinterest

– Mostconsidered‘lowrisk’•  MayNOTrequire:

»  TotalThyroidectomy»  CentralNeckNeckDissec<on»  RAItreatment

(Mazzaferri at al. Journal Clin Endocin and Metab 2001)

•  Goal of the surgeon when performing athyroidectomyforcancer is tosafely removeallthyroid cancer/&ssue (including primary tumorand nodal disease) on the side that is beingoperatedupon

•  Thyroid cancer surgical QIs are based oncompleteness of thyroid/thyroid cancerresec&on

•  None of these oncological QIs are consideredstandardofcarecurrently

ThyroidCancerSurgicalQIs

NotAllThyroidectomiesAreTotal•  Theremnantofthyroid<ssuethatisinten&onally lec by the surgeon inthe thyroid bed in order to reducethe risk of RLN and Parathyroidinjury is influenced by mul<plefactors:

Ø SurgicalIndica&onØ ClinicalSelngØ SurgicalAnatomyØ Surgeon

–  Training–  Comfort–  Experience–  Judgment

•  Near-totalthyroidectomy(<1g)

TheRealityRegardingThyroidRemnants

•  Incomplete thyroid/cancer resec&on predicts aworse outcome (reduced survival and increasedrecurrencerisk)

•  LargerthyroidremnantsmaynotadequatelybeablatedbypostopRAI–  S<mulated WBS (5 mCi iodine-131) 6-12 monthspostoppredictedsuccessofremnantabla<onby100mCiiodine-131

(Hayetal.Surgery1998)(Rosario et al Clin Nuc Med;2004;6;358-361)

MACISSCORE

ProposedThyroidCancerSurgicalQIs

1.   RemnantThyroidUptakeofRAI

2.   Postopera&veThyroglobulinLevel

3.   Metasta&cLymphNodeRa&o

RemnantThyroidRAIUptake•  Post-radioac<veiodineabla<ontreatmentawholebodyscan iscarriedout3-7dayslater to evaluate for remnant thyroid&ssue&thepresenceofregional/distantmetastases

•  Remnant thyroid radioiodine uptake(RTRU) is calculated as a % of the totalradioisotopegiventhatisdetectedinthethyroidbedaceradjus&ngfordecay

RemnantThyroidRAIUptake•  RTRU correlateswith volume of residual thyroid&ssuepresentwhenevaluatedbyneckUS

– 66 thyroidectomy pa<ents (benign) had remnantvolumeanduptakeevaluatedbyUS,TSH,andRAIscan1monthpostop

(Erbil et al JLO;2008;122;615-622)

•  Retrospec<vereviewofcasesundergoingTTandpostopRAIforthyroidcancertreatment

•  Remnant uptake analyzed as ra<o of the % uptake ofdose received (UDR) andevaluated for associa<onwithrecurrence

•  21/223pa<entsrecurred(FU25mo)

•  Pa&entswithrecurrencehada10xhigherUDRthenthosethatdidn’trecur•  ThehigherUDR,thehighertherecurrencerisk

RemnantThyroidTissueRAIUptake

(Schneider et al Thyroid;2013;23;1269-76)

IsThereAnInfluenceOfSurgeonVolumeOnRTRU?•  Surgeonsclassifiedashigh(3)orlow(5)volume(definedby20thyroidopera<ons/year)

•  UDRs of high volume surgeonswere significantly lower thenlowvolumesurgeons

•  Overall33complica&ons(24temporary/9permanent)

•  High volume surgeons had significantly lower permanentcomplica&ons,evenathighUDR

•  Lowvolumesurgeons,hadastepwiseincreaseincomplica<onsasUDRrises

UDR

COMPLICAT

IONS

(Schneider et al Thyroid;2013;23;1269-76)

GrowingLiteratureEvalua&ngRemnantThyroidTissueRAIUptakeAsAThyroidectomyQI

(Liu & Wiseman; Exp Rev Anticancer Ther; 2016;16;919-928)

RemnantThyroidRAIUptakeAsAQI•  RTRUmayserveasaQIforthyroidcancersurgerybecauseitcorrelateswith

‘completenessofthyroidectomy’andrecurrencerisk

•  Thoughts&Limita<ons–  Cannotbeu&lizedinlobectomy(LowRisk)pa&ents–  U&litylimitedinRAInon-avidrecurrence–  Notappropriateforlocallyadvanced/completelyresectablecases–  Notaccurateinthepresenceofsignificantmetasta&cdisease–  Influenceofotherconcurrentthyroiddisease(ie.Graves)–  Whatisan“acceptable”RTRU?–  ShouldRTRUinfluencepostopera<vesurveillanceandfollowup?–  IsthereaRTRUthatmandatesreopera<onorrepeatRAItreatment?

Doyouknowyourpa&ent’sRTRU?

Postopera&veThyroglobulinLevel•  Tg isaglycoprotein,aprohormone,onlysynthesizedby thyrocytes stored in colloid, that’s produc<on iss<mulatedbyTSH

•  S<mulatedanduns<mulatedTgmeasurementisusedforpostopsurveillanceofallthyroidcancerpa<ents

•  Tg measu rement ace r To ta lThyroidectomy correlates withvolumeof remnant thyroid&ssue&/or cancerandmay serve as a thyroidcancersurgicalQI

Postopera&veThyroglobulinLevel

(ATA Guidelines 2015)

Nomen&onofearlypostopera&veserumTgmeasurement

•  Retrospec<ve review of all thyroid opera<ons(DTC≥1cm) during 2011 in a regional healthsystem(UPit)

•  42surgeons/volumeevaluatedfor:– Extentofini&alopera&on– %uptakeonI123pre-RAITSHs&mulateduptakescan– Pre-abla&onTSH-s&mulatedTglevel– DoseofI131administered

(Adkisson et al; Surgery; 2014;156;1453-60)

IsThereAnInfluenceOfSurgeonVolumeOnPostopera&veThyroglobulinLevel?

HigherSurgeonVolume>30ThyroidORs/Year

–  TotalThyroidectomy–  More‘complete’

%uptakeonI123S&mulatedTgAdministeredI131dose

–  Fewercomplica&ons>50ThyroidORs/YearForStage3&4Disease

–  More‘complete’%uptakeonI123

SurgeonVolume&ThyroidCancerSurgicalQIs

(Adkisson et al; Surgery; 2014;156;1453-60)

GrowingLiteratureEvalua&ngPostopera&veThyroglobulinLevelAsAQI

(Liu & Wiseman; Exp Rev Anticancer Ther; 2016;16;919-928)

•  PostopTgmayserveasaQIforthyroidcancersurgerybecauseitcorrelateswith‘completenessofthyroidectomy’andrecurrencerisk

•  Thoughts&Limita<ons–  U&lityinlobectomy(LowRisk)pa&entsunknown–  Notusefulfortumorsthatdon’tsynthesizeTg–  Notappropriateinlocallyadvanced/notcompletelyresectablecancers–  Notaccurateinthepresenceofbulkymetasta&cdisease–  Influenceofotherconcurrentthyroiddisease(ie.Hashimoto’s)?–  Whatistheop<mal<mingofTgmeasurementrela<vetosurgeryandRAI?–  Whatisanacceptablepostopera<veTglevel?–  ShouldTginfluencepostopera<vesurveillanceandfollowup?–  IsthereaTglevelthatmandatesreopera<onorrepeatRAItreatment?

Doyouknowyourpa&ent’spostopera&veTglevel?

Postopera&veThyroglobulinLevelAsAQI

Central Neck Dissection For Thyroid Cancer •  Varia&on in surgical prac&ce regarding

CNDforthyroidcancertreatment

•  Centralnecklymphnodemetastasescanbedetectedin20-50%ofcases

•  Lymph node metastases increase risk ofcancerrecurrence

•  TheAHNSdefinesacentralneckdissec<onacomprehensiveremovalof:

NECKNODELEVELVI•  Prelaryngeal(Delphian)LymphNodes•  PretrachealLymphNodeand•  Lev +/or Right Paratracheal Lymph

Nodes+/-

NECKNODELEVELVII(Agrawal et al; Head Neck;2017;39;1269-1279)

CentralNeckDissec&on:ATAGuidelines

Therapeu&cCNDProphylac&cCNDNoCND

(ATA Guidelines 2015)

What Is Metastatic Lymph Node Ratio? •  ProposedasaQIforthyroidcancersurgery

•  Reflectsthesuccessofthesurgeonincentralneckcompartmentlymphadenectomy

#Metasta&cLymphNodesTotal#ofLymphNodes(LymphNodeYield)

•  Evalua<onofMLNRin10,955DTCpa<entswith>3LNremovedintheSEERdatabase(1988-2007)(medianfollowup25months)

•  MLNRwasstronglyassociatedwithDSM(HR4.33,95%CI1.68-11.18,p<0.01)

•  MLNR≥0.42separatedcasesbasedondiseasespecificmortality

Metastatic Lymph Node Ratio

1.72%

0.65%

(Schneider et al; Ann Sug Onc;2013;20;1906-1911)

GrowingLiteratureEvalua&ngMetasta&cLymphNodeRa&oAsAQI

(Liu & Wiseman; Exp Rev Anticancer Ther; 2016;16;919-928)

•  MLNRmay serve as a QI for thyroid cancer surgery because it correlateswith‘completenessoflymphadenectomy’andrecurrencerisk

•  Thoughts&Limita<ons–  U<lityinthesexngofbulkydiseaseispoor(cannotachievealowra<o)–  Surgicalinten<on:Therapeu<cvsProphylac<cmustbeconsidered–  Impactofnodalmetastasessize/extranodalextensionunknown–  Influenceofotherconcurrentthyroiddisease(ie.Hashimoto’s)–  Whatisan“acceptable”MLNR?–  ShouldMLNRinfluencepostopera<vesurveillanceandfollowup?

Doyouknowyourpa&ent’sMLNR?

Metasta&cLymphNodeRa&oAsAQI

•  Could address difficulty withfindingthyroidcancersurgeryQIsforLowRiskpa<ents

•  Guidelines are Guidelines andconstantly changing based uponnewevidence

•  Should not following guidelinesbe an i nd i ca to r o f pooroncologicalsurgicalquality?

FinalThoughts:ShouldGuidelineAdherenceBeConsidered

AThyroidSurgicalQI?

FinalThoughts:HowManyHighVolumeSurgeonsWouldItTakeToPerformAllThe

ThyroidectomiesInTheUSAAnnually?Realis&c?

Es<mate:Total#ThyroidectomiesInUS/Year=150,000

HighVolumeSurgeon>99Thyroidectomies/YearTotal#HighVolumeThyroidSurgeonsNeeded=1,500

HighVolumeSurgeon>24Thyroidectomies/Year

Total#HighVolumeThyroidSurgeonsNeeded=6,000

(Hauch et al; Ann Surg Onc 2014;21:3844-3852) (Al-Qurayashi et al; JAMA Oto HNS 2016;142:32-39)

Conclusions•  ThyroidsurgicalQIsarefocusedonsurgicalcomplica&ons

•  Thyroid cancer surgical QIs allow for evalua<on of thecompletenessof:

•  Thyroidectomy– RemnantThyroidUptakeofRAI– Postopera&veThyroglobulinLevel

• CentralNeckLymphadenectomy– Metasta&cLymphNodeRa&o

•  Applica<on of these QIs is largely limited to pa<ents whohaveundergoneatotalthyroidectomy+/-RAI

(primarilyHighRisk)

Conclusions

•  Despite no specific QI currently considered standard, and furtherstudy being needed, surgeons who perform thyroid opera<onsshouldbeawareoftheir:

Ø  Pa<ent’sthyroidsurgicalQIsØ Morbidity&MortalityØ RecurrenceRisk

Ø  Pa<ent’sthyroidcancersurgicalQIsØ PostopRAIuptakeØ PostopTGØ MLNRØ Other?

Ø  Ownthyroidectomysurgicalvolumes

•  This informa<on is readily available, quan&fiable, is associatedwith surgicalandoncological outcomes, andallows forquality improvement (NOWHOWDOWEAPPLYTHESEQIsINTHEREALWORLD???)