Paul R. VogtPaul R. Vogt

Cardiovascular Centre Cardiovascular Centre Zurich, SwitzerlandZurich, Switzerland

A practical Approach to Quality A practical Approach to Quality Control in Cardiovascular SurgeryControl in Cardiovascular Surgery

• Interest in the TopicInterest in the Topic

• Zurich City Government Request:Zurich City Government Request:– Distribution of cardiac Surgery in Zurich?Distribution of cardiac Surgery in Zurich?

– Distribution of specific Procedures over Distribution of specific Procedures over different Centres? different Centres?

– Proper Quality Control possible?Proper Quality Control possible?

Quality Control: my MotivationQuality Control: my Motivation

• It is our Responsibility to our PatientsIt is our Responsibility to our Patients

• We can not improve, if we don’t know our We can not improve, if we don’t know our ResultsResults

• We will loose our Power in economical – We will loose our Power in economical – political Struggle over Health Care Costpolitical Struggle over Health Care Cost

Why is Quality Control important?Why is Quality Control important?

• CentreCentre Today, every Hospital calls to Today, every Hospital calls to

be a be a Centre of CompetenceCentre of Competence….….• ExpertExpert Today, everyone is an ExpertToday, everyone is an Expert• No of Surgeries No of Surgeries Today, every Surgeon is a Today, every Surgeon is a

high-Volume Surgeonhigh-Volume Surgeon• EducationEducation All have educational Credits All have educational Credits• Media Media Do I see my Surgeon in TV?Do I see my Surgeon in TV?

……what Patients usually get to know…what Patients usually get to know…

• Do I really need Surgery?Do I really need Surgery? IndicationIndication• Is it possible to die from Surgery?Is it possible to die from Surgery? MortalityMortality• Will I suffer from Complication?Will I suffer from Complication? MorbidityMorbidity• Will I get an Infection?Will I get an Infection? InfectionInfection• Will I have a neurological Defect?Will I have a neurological Defect? StrokeStroke• Is one Operation enough?Is one Operation enough? RedoRedo

……what Patients - and we - should know…what Patients - and we - should know…

• Every Crash will be investigatedEvery Crash will be investigated

• Critical Incident Reporting SystemCritical Incident Reporting System

• Flight Safety Experts are invited to our Flight Safety Experts are invited to our surgical Meetings….give an nice talk…surgical Meetings….give an nice talk…

• ……and everything seems to be good ???and everything seems to be good ???

Cardiovascular Surgery and Flight BusinessCardiovascular Surgery and Flight Business

Bypass Surgery is safeBypass Surgery is safe

True?True?

Who performs great?

• Operative Mortality Rate in Bypass Operative Mortality Rate in Bypass

Surgery: Surgery: ~2%~2%

• Every Day, 13 Patients die in USA Every Day, 13 Patients die in USA

from Bypass Surgeryfrom Bypass Surgery

USA: national SurveyUSA: national Survey

30‘000 Flights/Day30‘000 Flights/Day

2`900`000 Passengers2`900`000 Passengers

FlightsFlights

600 Crashes would happen every Day600 Crashes would happen every Day30’000 People would die every Day30’000 People would die every Day

• Does this exist? Does this exist? NoNo• Can everyone do what he likes? Can everyone do what he likes? YesYes• Are published medical Data honest?Are published medical Data honest? NoNo• Is there Betrayal?Is there Betrayal? YesYes• Why do they betray?Why do they betray? Money, Fame Money, Fame• Are Politicians able to do the right Thing? Are Politicians able to do the right Thing? NoNo

……Quality Control in Switzerland…Quality Control in Switzerland…

There is no Quality Control in There is no Quality Control in

Switzerland and…Switzerland and…

……MoneyMoney has become the primary and has become the primary and

absolute absolute DriverDriver in all political- in all political-

economical economical DecisionsDecisions towardstowards our our

Profession! Profession!

Proper Management provided, Proper Management provided, cardiovascular Surgery can take the cardiovascular Surgery can take the

Lead and set the Stage in Quality Lead and set the Stage in Quality Control in Medicine, because we Control in Medicine, because we

measure hard, clear and measure hard, clear and comparablecomparable Outcome Data! Outcome Data!

• The most frequent Answer:The most frequent Answer:

An adequate Quality Control in An adequate Quality Control in Medicine is not possible,Medicine is not possible,

which of course is not truewhich of course is not true

Why is there no Quality Control?Why is there no Quality Control?

Moreover…..

• In cardiovascular Surgery, an

adequate and fair Quality Control is

so simple, that even a non-medical

Person can see the Differences…..

Quality Control according to EuroScoreQuality Control according to EuroScore

• EuroScore is an European scoring System to define the EuroScore is an European scoring System to define the

Risk of an individual Patient with individual Risk of an individual Patient with individual

Characteristics to die from a specific operative Characteristics to die from a specific operative

ProcedureProcedure

• Numbers have been collected from several Thousands of Numbers have been collected from several Thousands of

Operations in Europe and represent the average Operations in Europe and represent the average

Performance of an average Surgeon in EuropePerformance of an average Surgeon in Europe

• Go to “google” and look: ”EuroScore”Go to “google” and look: ”EuroScore”

74y, otherwise healthy Women: 74y, otherwise healthy Women: aortic Valve Replacementaortic Valve Replacement

74y, otherwise healthy Women: 74y, otherwise healthy Women: aortic Valve Replacementaortic Valve Replacement and and Replacement of the ascending AortaReplacement of the ascending Aorta

74y, otherwise healthy Women: 74y, otherwise healthy Women: aortic Valve Replacementaortic Valve Replacement and and Replacement of the ascending AortaReplacement of the ascending Aorta

74y, otherwise healthy Women: 74y, otherwise healthy Women: aortic Valve Replacementaortic Valve Replacement and and Replacement of the ascending Aorta: Replacement of the ascending Aorta: REOPERATIONREOPERATION

Average Risk: the Results, which Average Risk: the Results, which we predictwe predict

• 100 74y AVR100 74y AVR 5.46% 5.46%

• 100 74y AVR + ascending Aorta 100 74y AVR + ascending Aorta 15.56% 15.56%

• 100 74y AVR + Aorta + REDO 100 74y AVR + Aorta + REDO 33.44% 33.44%

= Average operative Mortality = Average operative Mortality

for these 300 Patients would befor these 300 Patients would be 18%18%

= 18/100 or 54/300 = 18/100 or 54/300 willwill not survive not survive

After 300 Operations: Results After 300 Operations: Results we observewe observe

If we have done all 300 Operations, there are If we have done all 300 Operations, there are only 3 Possibilities: only 3 Possibilities:

• We performed exactly according to the We performed exactly according to the Prediction: 54 Patients diedPrediction: 54 Patients died

• We performed better: <54 Patients diedWe performed better: <54 Patients died

• We performed worse: >54 Patients diedWe performed worse: >54 Patients died

Cumulative Survival Curve: CUSUMCumulative Survival Curve: CUSUM

If we loose a Patient with If we loose a Patient with a 5% Risk = our Curve a 5% Risk = our Curve is going down 0.95is going down 0.95

If we safe a Patient with If we safe a Patient with an 80% Risk, our an 80% Risk, our Curve is going up 0.80Curve is going up 0.80

If we loose a Bypass-If we loose a Bypass-Patient with a 1% Patient with a 1% Risk = our Curve is Risk = our Curve is going down 0.99going down 0.99

If we safe a Bypass -If we safe a Bypass -Patient with an 1% Patient with an 1% Risk, our Curve is Risk, our Curve is going up 0.01going up 0.01

How to loose and how to win

Cumulative Survival Curve: CUSUMCumulative Survival Curve: CUSUM

CUSUM: all Operation between 08/2006 and 10/2009

Operative Mortality Juni 2008 – Mai 2010

• „„Predicted“ Mortality: 8.08%Predicted“ Mortality: 8.08%

• „„Observed“ Mortality: 0.49%Observed“ Mortality: 0.49%

= Performance 16x better than = Performance 16x better than predicted by EuroScorepredicted by EuroScore

CUSUM: AVR Mortality all Patients 08/2006 to 10/2009

Predicted Mortality: 9.4% Predicted Mortality: 9.4% Observed Mortality: 1.8%Observed Mortality: 1.8%

CUSUM: AVR Mortality in Patients with EuroSore >20% 08/2006 to 10/2009

Predicted Mortality: 36% Predicted Mortality: 36% Observed Mortality: 8% Observed Mortality: 8%

Stroke Rate:Stroke Rate: 0% 0%

Mortality per Year or per Surgeon (SA, SB, SC) or per Hospital

allealle

20072007

SASA

20082008

SBSB

20092009

SCSC

1.7%1.7%

3.2%3.2%

1.3%1.3%

0.6%0.6%

CUSUM: all Operations per Year or e.g. per Surgeon or Hospital

A Hospital changing his StaffA Hospital changing his Staff

What is about your ICU-Doctor?What is about your ICU-Doctor?

What is about your ICU-Doctor?What is about your ICU-Doctor?

• Elective Surgery:Elective Surgery:– „„Predicted“ Mortality:Predicted“ Mortality: 4.80%4.80%

– „„Observed Mortality“:Observed Mortality“: 0.3%0.3%

• Acute coronary Syndrome:Acute coronary Syndrome: – „„Predicted“ Mortality if EuroScore >10:Predicted“ Mortality if EuroScore >10: 26%26%

– „„Observed“ Mortality: Observed“ Mortality: 3.8% 3.8%

– „„Predicted“ Mortality if Euro Score >20:Predicted“ Mortality if Euro Score >20: 37%37%

– „„Observed“ Mortality: Observed“ Mortality: 2.7% 2.7%

Isolated Coronary SurgeryIsolated Coronary Surgery

Quality Control: yes, you can….Quality Control: yes, you can….

……evaluate Results Risk-adjustedevaluate Results Risk-adjusted

……compare Risks, Procedures, Surgeonscompare Risks, Procedures, Surgeons

……compare Years, Hospitals, Regionscompare Years, Hospitals, Regions

……document Problemsdocument Problems

……prove Progressprove Progress

• 74y: Infarction VSD74y: Infarction VSD– EuroScore 98.4%EuroScore 98.4%– GOT/GPT >2000GOT/GPT >2000– RV-FailureRV-Failure

• 72y: mitral Valve Repair72y: mitral Valve Repair– Continued severe Alcohol ConsumptionContinued severe Alcohol Consumption– Child C Liver CirrhosisChild C Liver Cirrhosis– Renal FailureRenal Failure– Unable to explain ProcedureUnable to explain Procedure

Patients rejected from SurgeryPatients rejected from Surgery

• Risk Estimation not properRisk Estimation not proper

• Not all Patients included; e.g. Patients with Not all Patients included; e.g. Patients with

Liver cirrhosis. True! But the number of Child Liver cirrhosis. True! But the number of Child

C Patients is too low to influence overall Results C Patients is too low to influence overall Results

in a large Patient Populationin a large Patient Population

• If some one If some one wantswants betray, betray, he can alwayshe can always, even , even

with the EuroScorewith the EuroScore

EuroScore: CriticismEuroScore: Criticism

• All the Data you have seen, have been All the Data you have seen, have been

evaluated by an evaluated by an independent outside independent outside

Group of Experts, Group of Experts, even Calculation of even Calculation of

EuroScore for the individual Patient!EuroScore for the individual Patient!

• This independent Expert GroupThis independent Expert Group– evaluates Hospitals periodicallyevaluates Hospitals periodically

– the Time of Evaluation is not known the Time of Evaluation is not known

EuroScore: MOST IMPORTANTEuroScore: MOST IMPORTANT

…it does work, there is Proof…

• Die NSQIP – Story („national surgical Quality Improvement Program“)

• Veterans Administration Hospital• Cardiovascular and general Surgery• Marked Decrease of Mortality and

Morbidity

NSQIP Risk-adjusted Quality ControlNSQIP Risk-adjusted Quality Control

NSQIP: Mortality before Check of first HospitalNSQIP: Mortality before Check of first Hospital

NSQIP: Morbidity before Check of first HospitalNSQIP: Morbidity before Check of first Hospital

• You can not measure everythingYou can not measure everything

• Check Complications which are Check Complications which are

economically importanteconomically important

– An infected Wound is only a Problem, if An infected Wound is only a Problem, if

secondary Wound Care increases Costssecondary Wound Care increases Costs

– A neurological Complication is only a Problem, A neurological Complication is only a Problem,

if it increases Costsif it increases Costs

MorbidityMorbidity

• ……because only a Complication, which because only a Complication, which

is economically not important, is not a is economically not important, is not a

political Problem…political Problem…

……but, of course, it is the Problem but, of course, it is the Problem

between the Surgeon and the Patientbetween the Surgeon and the Patient

MorbidityMorbidity

• Results can be measured objectivelyResults can be measured objectively

• You can compare everything you likeYou can compare everything you like

• Primary Importance: MortalityPrimary Importance: Mortality

• Secondary Importance: MorbiditySecondary Importance: Morbidity

• Use EuroScore „observed“ vs. „predicted“Use EuroScore „observed“ vs. „predicted“

• Use CUSUMUse CUSUM

• Independent Data and independent AnalysisIndependent Data and independent Analysis

ConclusionConclusion

• The Politicians can not do itThe Politicians can not do it

• The Economists can not do itThe Economists can not do it

• BUT WE CAN AND MUST DO IT:BUT WE CAN AND MUST DO IT:

– For our Patients For our Patients that they can trust usthat they can trust us

– For usFor us

– To make Politicians and Economists to To make Politicians and Economists to

decide in our Interestsdecide in our Interests

Quality Control is important for usQuality Control is important for us

• There are more sophisticated Tools for Quality Control.There are more sophisticated Tools for Quality Control.

• However, Quality Control must be simple. Otherwise However, Quality Control must be simple. Otherwise

Politicians will ignore this and will not believe us.Politicians will ignore this and will not believe us.

• The Patient must be able to understand our Quality The Patient must be able to understand our Quality

Control, otherwise,Control, otherwise, he will not trust. he will not trust.

• In the future, we will have well informed Patients being In the future, we will have well informed Patients being

widely documented by Internet, as already seen.widely documented by Internet, as already seen.

Quality Control must be simpleQuality Control must be simple

• 94-year old male Patient with abdominal aortic Aneurysm: 94-year old male Patient with abdominal aortic Aneurysm:

Open Repair or EVAR?Open Repair or EVAR?

• Patient sent from Family Physician for open Repair. He did Patient sent from Family Physician for open Repair. He did

not know Possibility of EVAR before Admittance to Hospital.not know Possibility of EVAR before Admittance to Hospital.

• Patient again leaves Hospital and takes a 14-day Break to Patient again leaves Hospital and takes a 14-day Break to

think about which Technique he should preferthink about which Technique he should prefer

• Patient looks on Internet, comes back and chooses…..Patient looks on Internet, comes back and chooses…..

……..open Repair, because he “could not find documented long-..open Repair, because he “could not find documented long-

term Results of EVAR in Internet”term Results of EVAR in Internet”

Example of the well informed PatientExample of the well informed Patient

Trust: a Problem…Trust: a Problem…

Trust: is a Trust: is a majormajor Problem… Problem…

I wish you a pleasant Flight