A practical Approach to Quality Control in Cardiovascular Surgery
Paul R. Vogt
Cardiovascular Centre Zurich, Switzerland
Quality Control: my Motivation • Interest in the Topic • Zurich City Government Request: – Distribution of cardiac Surgery in Zurich? – Distribution of specific Procedures over different Centres? – Proper Quality Control possible?
Why is Quality Control important?
• It is our Responsibility to our Patients • We can not improve, if we don’t know our Results • We will loose our Power in economical – political Struggle over Health Care Cost
…what Patients usually get to know… • Centre
Today, every Hospital calls to be a Centre of Competence….
• Expert
Today, everyone is an Expert
• No of Surgeries
Today, every Surgeon is a high-Volume Surgeon
• Education
All have educational Credits
• Media
Do I see my Surgeon in TV?
…what Patients - and we - should know… • Do I really need Surgery?
Indication
• Is it possible to die from Surgery?
Mortality
• Will I suffer from Complication?
Morbidity
• Will I get an Infection?
Infection
• Will I have a neurological Defect?
Stroke
• Is one Operation enough?
Redo
Cardiovascular Surgery and Flight Business
• Every Crash will be investigated • Critical Incident Reporting System • Flight Safety Experts are invited to our surgical Meetings….give an nice talk… • …and everything seems to be good ???
Bypass Surgery is safe
True?
Who performs great?
USA: national Survey • Operative Mortality Rate in Bypass Surgery: ~2% • Every Day, 13 Patients die in USA from Bypass Surgery
Flights
30‘000 Flights/Day 2`900`000 Passengers
600 Crashes would happen every Day 30’000 People would die every Day
…Quality Control in Switzerland… • Does this exist? • Can everyone do what he likes?
No
• Are published medical Data honest? • Is there Betrayal?
No
Yes Yes
• Why do they betray? Money, Fame • Are Politicians able to do the right Thing? No
There is no Quality Control in Switzerland and‌ ‌Money has become the primary and absolute Driver in all politicaleconomical Decisions towards our Profession!
Proper Management provided, cardiovascular Surgery can take the Lead and set the Stage in Quality Control in Medicine, because we measure hard, clear and comparable Outcome Data!
Why is there no Quality Control?
• The most frequent Answer:
An adequate Quality Control in Medicine is not possible, which of course is not true
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 EuroScore • EuroScore is an European scoring System to define the Risk of an individual Patient with individual Characteristics to die from a specific operative Procedure • Numbers have been collected from several Thousands of Operations in Europe and represent the average Performance of an average Surgeon in Europe • Go to “google” and look: ”EuroScore”
74y, otherwise healthy Women: aortic Valve Replacement
74y, otherwise healthy Women: aortic Valve Replacement and Replacement of the ascending Aorta
74y, otherwise healthy Women: aortic Valve Replacement and Replacement of the ascending Aorta
74y, otherwise healthy Women: aortic Valve Replacement and Replacement of the ascending Aorta: REOPERATION
Average Risk: the Results, which we predict • 100 74y AVR
5.46%
• 100 74y AVR + ascending Aorta
15.56%
• 100 74y AVR + Aorta + REDO
33.44%
= Average operative Mortality for these 300 Patients would be
18%
= 18/100 or 54/300 will not survive
After 300 Operations: Results we observe
If we have done all 300 Operations, there are only 3 Possibilities: • We performed exactly according to the Prediction: 54 Patients died • We performed better: <54 Patients died • We performed worse: >54 Patients died
Cumulative Survival Curve: CUSUM
If we loose a Patient with a 5% Risk = our Curve is going down 0.95 If we safe a Patient with an 80% Risk, our Curve is going up 0.80
If we loose a BypassPatient with a 1% Risk = our Curve is going down 0.99 If we safe a Bypass -Patient with an 1% Risk, our Curve is going up 0.01
How to loose and how to win
Cumulative Survival Curve: CUSUM
CUSUM: all Operation between 08/2006 and 10/2009
Operative Mortality Juni 2008 – Mai 2010
• „Predicted“ Mortality: 8.08% • „Observed“ Mortality: 0.49% = Performance 16x better than predicted by EuroScore
CUSUM: AVR Mortality all Patients 08/2006 to 10/2009
Predicted Mortality: 9.4% Observed Mortality: 1.8%
CUSUM: AVR Mortality in Patients with EuroSore >20% 08/2006 to 10/2009
Predicted Mortality: 36% Observed Mortality: 8% Stroke Rate:
0%
Mortality per Year or per Surgeon (SA, SB, SC) or per Hospital
3.2%
1.7% alle
2007 SA
1.3% 2008
0.6%
SB 2009 SC
CUSUM: all Operations per Year or e.g. per Surgeon or Hospital
A Hospital changing his Staff
What is about your ICU-Doctor?
What is about your ICU-Doctor?
Isolated Coronary Surgery • Elective Surgery: – „Predicted“ Mortality:
4.80%
– „Observed Mortality“:
0.3%
• Acute coronary Syndrome: – „Predicted“ Mortality if EuroScore >10: – „Observed“ Mortality: – „Predicted“ Mortality if Euro Score >20: – „Observed“ Mortality:
26% 3.8% 37% 2.7%
Quality Control: yes, you can….
…evaluate Results Risk-adjusted …compare Risks, Procedures, Surgeons …compare Years, Hospitals, Regions …document Problems …prove Progress
Patients rejected from Surgery • 74y: Infarction VSD – EuroScore 98.4% – GOT/GPT >2000 – RV-Failure
• 72y: mitral Valve Repair – Continued severe Alcohol Consumption – Child C Liver Cirrhosis – Renal Failure – Unable to explain Procedure
EuroScore: Criticism • Risk Estimation not proper • Not all Patients included; e.g. Patients with Liver cirrhosis. True! But the number of Child C Patients is too low to influence overall Results in a large Patient Population • If some one wants betray, he can always, even with the EuroScore
EuroScore: MOST IMPORTANT • All the Data you have seen, have been evaluated by an independent outside Group of Experts, even Calculation of EuroScore for the individual Patient! • This independent Expert Group – evaluates Hospitals periodically – the Time of Evaluation is not known
…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 Control
NSQIP: Mortality before Check of first Hospital
NSQIP: Morbidity before Check of first Hospital
Morbidity • You can not measure everything • Check Complications which are economically important – An infected Wound is only a Problem, if secondary Wound Care increases Costs – A neurological Complication is only a Problem, if it increases Costs
Morbidity • …because only a Complication, which is economically not important, is not a political Problem… …but, of course, it is the Problem between the Surgeon and the Patient
Conclusion • Results can be measured objectively • You can compare everything you like • Primary Importance: Mortality • Secondary Importance: Morbidity • Use EuroScore „observed“ vs. „predicted“ • Use CUSUM
• Independent Data and independent Analysis
Quality Control is important for us • The Politicians can not do it • The Economists can not do it • BUT WE CAN AND MUST DO IT: – For our Patients that they can trust us – For us – To make Politicians and Economists to decide in our Interests
Quality Control must be simple • There are more sophisticated Tools for Quality Control. • However, Quality Control must be simple. Otherwise Politicians will ignore this and will not believe us. • The Patient must be able to understand our Quality Control, otherwise, he will not trust. • In the future, we will have well informed Patients being widely documented by Internet, as already seen.
Example of the well informed Patient • 94-year old male Patient with abdominal aortic Aneurysm: Open Repair or EVAR? • Patient sent from Family Physician for open Repair. He did not know Possibility of EVAR before Admittance to Hospital. • Patient again leaves Hospital and takes a 14-day Break to think about which Technique he should prefer • Patient looks on Internet, comes back and chooses….. …..open Repair, because he “could not find documented longterm Results of EVAR in Internet”
Trust: a Problemâ&#x20AC;Ś
Trust: is a major Problemâ&#x20AC;Ś
I wish you a pleasant Flight