20

18
16
14
12 Performance Improvement in a
lactate (mmol/L)

10 Congenital Heart Surgical Program:

8 Measuring and Improving Outcomes
6 after Congenital Heart Surgery
4 Anthony F. Rossi, MD
Director, Cardiac Intensive Care Program
2 Miami Children’s Hospital, Miami, FL USA
0
0 10 20 30 40 50
One Program
Two Campuses
A Single Vision

FLA
 Congenital Heart Surgical Outcomes: STS Data
Harvest of Outcomes for Congenital Heart Surgery
in Large Volume Centers 2001-2004

6
3.9% is the
average
5
mortality for
patients
4 undergoing
congenital heart
3 surgery
according to the
m
%

STS. Over ½ of
liy o
rta

2
the large
1 volume
programs in the
STS exceed this
0
mortality rate.

Surgical Center

The performance of individual cardiac surgical programs is blinded to all reviewers. As of today,
accurate and timely outcomes data for individual congenital heart surgery programs is
unavailable to the consumer, except in states such as New York or California.
Improving Outcomes after CHS

 Be blessed with an outstanding CV

surgeon
 Hire a second!

Redmond Burke and Robert Hannan, congenital heart surgeons

at Miami Children’s Hospital. You can not have excellence in a
congenital heart surgical program without outstanding surgery.
 “WHY NOT ZERO PERCENT
MORTALITY?”
Mortality is not, and will never be, an acceptable
outcome for any patient after CHS, at any time.
This philosophy must be the cornerstone of all
congenital heart surgery programs.
Unfortunately, mortality as an outcome is far too
often accepted as a necessary evil in some
programs.

Redmond Burke, 2000

Improving Performance in a Congenital
Heart Surgery Program
 Performance Assessment/Performance
Improvement Relationship
 Point of Care Testing-Goal Directed
Medical Therapy
 Electronic Medical Record and
Information Technology
 Team Resonance
You want to be an Olympic 1500 meter
Champ. You should:
 Run hard every day. Measure nothing. Show
up for the race. Hope for the best.
 Measure your 1500 m time once a year and
race.
 Measure your 1500 m time repeatedly over the
year.
 Measure your 1500 m time, your split times,
your technique repeatedly. Make adjustments
in technique accordingly and repeatedly.
You want to have the best outcomes
after CHS. You should:
 Try hard every day. Measure nothing. Submit
your raw data to the STS. Hope for the best.
 Measure your mortality data once a year and
submit your data to the STS.
 Measure your mortality data repeatedly over
the year.
 Measure your mortality data, your LOS, your
technique, and any objective outcome variable
repeatedly over the year and in real-time.
Make adjustments in technique accordingly and
repeatedly.
Real-Time Performance Assessment

 Continued quality improvement requires

continued outcome assessment
 You can’t know where you’re going until
you know where you’ve come from
 Outcome assessment must be timely
(real-time)
 Accurate and unbiased
Measuring Performance in a Cardiac
Surgical Program
 Performance Improvement can only
come as the result of the accurate,
objective and timely measurement of
data.
 Performance Assessment can be of an
individual procedure or programmatic
performance assessment.
 Performance Outcomes must be
transparent and easily accessible to all
team members and the public.
 May 7, 2004 -- ALBANY - A groundbreaking state study of pediatric
heart surgery in New York shows University Hospital of Brooklyn had the
worst mortality rate in the state - in a program that has since been halted.
The state Health Department's report covering the years 1997-1999
summarizes risk factors and outcomes for pediatric patients undergoing
surgery to correct congenital heart defects.
According to the report, 11 out of 92 children who underwent congenital
heart surgery at University Hospital of Brooklyn during the study period
died.
The hospital's mortality rate when adjusted for risk was 17.08 percent, the
highest in the state and significantly higher than the 5.35 percent
statewide rate.

This report was released in 2004. It reports the outcomes of patients

operated on years earlier. Don’t we owe it to our patients to make these
decisions and review that data in a more timely fashion?
Mortality as outcome measure is reported in real-time
from web-based medical record. The data must be
transparent to ALL!

Every American should have access to a full

range of information about the quality of
their health care options. HHS Secretary
James Leavitt 2006
 Miami Children’s
Hospital has taken a
Leading role in
outcomes reporting.
Data from our web
based medical record
is reported in real-time
when the outcomes
Access to our real-time reporting page is
outcomes reporting page opened.
is available with a single
mouse click.
Risk adjusted outcomes may be reported in real-time
from medical record, for programmatic performance
assessment
Miami Children’s
Hospital real-time
outcomes report.

From
pediatricheartsurgery.com
MCH CUSUM Mortality 1995-2004: The CUSUM mortality graph allows you
to track the performance of your congenital heart program. Aberrations in
performance are readily apparent in this graphic representation, much more
readily than might be apparent to the casual observer. Our database calculates a
CUSUM graph of our performance in real-time.

CUSUM MORTALITY 1995-2004

100
4% Mortality
90

80
1/1/01 2% Mortality
70
mortality number

60

50

40

30

20

10

0
0 500 1000 1500 2000 2500 3000
case number

The value of this technique for evaluating congenital heart outcomes was first described by professor Marc De
Leval in 1994.De Leval MR, et al. Analysis of a cluster of surgical failures. Application to a series of neonatal
arterial switch operations. J Thorac Cardiovasc Surg 1994;107: 914-23.
CUSUM data may be used to access performance of an individual
or program over time. Deviation from accepted norms are
readily apparent.

2.9% mortality

4.9% mortality

Zone of Acceptable Performance MCH CUSUM 2/02-12/06

Zone of Enhanced Performance

STS CHS 2006 data harvest: 3.9% mortality
Effect of Various Changes in Programmatic
Philosophy on CHS Outcomes

CUSUM MCH CHS

mortality number

60

50

40 ERA 1
ERA 2
30
ERA 3
20 ERA 4
10

0
0 500 1000 1500 2000
case number

ERA 1: 6/95-12/2000 STS 2006 data harvest avg mortality NA (3.9%)

ERA 2: new ICU Leadership 2% mortality line
ERA 3: point of care testing introduced
ERA 4: i-rounds EMR introduced
 Tracking Outcomes in a Visibly
Intuitive Fashion

Interval b/w Death after CHS

250
cases b/w mortality

200

150

100

50 R2 = 0.1377

0
1 7 13 19 25 31 37 43 49 55 61 67 73 79 85 91 97 103 109
Mortality Num ber

MCH CHS deaths: 1995-2007

Improving Outcomes

 Performance Assessment/performance
Improvement relationship
 Point of care testing-goal directed
therapy
 EMR/IT
 Team Resonance
 bombarded with clinical data, often confusing
an already complicated problem. This can
often lead to the dreaded : Paralysis of
Analysis
Ultimately, two questions are paramount:
• “Are we good?”
• “Are we headed in the right direction?”
Traditional MCH ICU Lab Services: What a
mess!

Nurse
Placed in Tube Ward Clerk
Blood Drawn
From Pt. Pt care Tube Packaged
altered as needed Transporter
Doctor
Reviews Lab Results Transported to Lab
-7 STEPS
Lab Clerk -5 CAREGIVERS
Lab Enters Lab Performs Test
Test Result Lab Tech
i-Stat POC: Introduced to all MCH ICU’s in
2001

Nurse
Doctor
-Blood Drawn Results
From Pt. To
-Test Run at Doctor

-Bedside
-2 STEPS
-2 Caregivers
Pt care
altered as
needed
Common Cardiac Surgical Procedures

 Arterial switch operation

 Repair of tetralogy of Fallot
 VSD closure
 ASD closure
 AVC repair
 Rastelli operation
 Norwood operation
 Bi-Glenn
 Fontan
 Repair IAA
 BTS
 Central shunt
 Ross
 MV replacement
 AV replacement
 Aortic Valvotomy
 Konno
 Ross-Konno
 Repair TAPVC
 Repair coarctation
 Repair DORV
 Senning
 Mustard
 Double switch
Single Goal of PO Care

• Maintain optimal tissue oxygen delivery

The constant tug of war
between DO2 and VO2
DO2/VO2: Relationship of oxygen delivery to oxygen
onsumption

O2

O2 O2
O2 O2 O2

We normally deliver 5 times as much oxygen to our tissues than we use

 Relation of DO2 to VO2

* 5/1
2/1
VO2
critical point of DO2
(VO2 , lactate )

DO2

* Decreasing CV Reserve
Can You Measure DO2 Following CHS?

 DO2=CI x Hb x SaO2
 CI usually impossible to measure
because of intracardiac shunting
 small patient size makes CI
measurements impractical
Use indirect measures of DO2
Lactate is Predictive of Outcome
after CHS

Children after cardiac surgery

• Initial lactate > 4.2 mmol/l - mortality 100%
(Siegel et al.1996)
• Initial lactate > 4.5 mmol/l - mortality 79%
(Hatherhill et al.1997)
Infants after cardiac surgery
• Initial lactate > 7mmol/l - mortality 55%
• Maximum lactate > 9mmol/l - mortality 86%
(Chefitz et al. 1997)
In 2001, we asked ourselves
the following questions:

• If lactate is useful in predicting

outcomes in pts after CHS could
lactate be used as a target goal for
medical management in this pt
population?
• Can GDT be applied to pts after
CHS?
January 2001: The Premise

 Establish near patient testing of routine

critical care lab values with rapid turn-
around-time
 Clinician can react quickly to changing physiologic
conditions
 Establish blood lactate measurement as
objective indicator of oxygen debt
 Establish clinical guidelines which are
directed at normalizing blood lactate levels
(thereby minimizing oxygen debt)
 The combination of the above would increase
survival after congenital heart surgery
 Lactate Management
Protocol
Initial Lactate > 2.2
Repeat q4hrs x 4

No Change Increase in Lactate Decrease in Lactate

<5 >5 Escalate Medical Rx Repeat Q 4 Hrs

Repeat in 4 hrs Escalate Medical Rx Repeat in 4 hrs

Repeat in 4 hrs Lactate > 10

Lactate < 5 Lactate 5-10 Consider CPS

Repeat in 4 hrs Escalate Medical Rx

CPS = Cardiopulmonary Support

Lactate Management

Lactate Normal
or No Changes
Diminishing
Lactate Management
pH normal?

pCO2 appropriate?

Lactate Elevated Hb appropriate?

Or
CVP appropriate?
Rising
HR appropriate?
BP appropriate?

Increase Oxygen Delivery

Patients

ERA Age Weight Total <1 > 1 mth

Range Range Pts mth
Median Median

6/95- 0.5-127
6/01 0-72 yrs kg
1656 321 1335
311 d 7.9 kg

7/01- 0-72 yrs 0.4-114

7/01-
10/03 166 d kg 1810 445
12/07 710 203 507
P< 5.8 kg
0.01 P < 0.01

Point of Care Testing and Goal Directed Therapy Improve Outcomes

after Congenital Heart Surgery. Rossi et al. Intensive Care Med.
2005
Effect of GDT and POC on 30d Mortality

Hospital
% Mortality Pre/Post i-Stat

14 P=0.008 Mortality
12
7/01-12/07
10
neonate 6.5%
8
6/95-6/01
s
P<0.05 7/01-703 infants 1.2%
6

NS all pts 2.6%

4 2007 1.7%
2

0
all pts >1 mth < 1 mth
Rossi et al. Intensive Care Med 2005

all pts > 1 mth < 1 mth

% mortality 6/95-6/01 4.7 2.6 13
(% reduction) 7/01-12/07
7/01-10/03 2.1 (55%)
1.8% 1.5 (42%) 4.2 4%
(68%)
Improving Outcomes

 Performance Assessment/performance
Improvement relationship
 POCT/GDT
 EMR/IT
 Team Resonance
 Advances in IT in the CICU

1995 CHS Excel Database

1997 Cardioaccess Database 1997 Emtek System

2000 Palm Pilot

2001 CICU Component

2001 POC I-stat Cardioaccess

2002 I-rounds
2003 Tablet PC
Real-time database
For decades, tracking the performance of an individual patient through their hospital course
was done on a series of hand written index cards. All of the patients most valuable
information, potentially life saving information was kept on these. Is this how we should
track human performance today, with stakes as high as life and death? We wouldn’t do it for
our bank accounts, we shouldn’t do it with patients lives. Sadly, many hospitals continue to
track data like this today.
Tracking the performance of an individual patient at MCH today: A visual representation of a patient’s
postoperative progression. I-stat (Abbott) allows the blood lactate level to be obtained and measured in the
operating room and at the bedside. The data is downloaded into our LIS and displayed graphically and in real-
time (i-Rounds, Teges).
Tracking the performance of an individual patient. I-stat (Abbott) allows
the blood lactate level to be obtained and measured at the bedside. The
data is downloaded into our LIS and displayed graphically and in real-
time (i-rounds, Teges).
Tracking the performance of an individual patient. A graphic representation
of a patient’s postoperative progression. Data is available in real-time,
anywhere in the world internet access is available.
This is how data is often shared between clinicians in a busy hospital. Can the risk for a serious
medical error be more apparent?
Click through to critical information: This is how data is
shared at Miami Children’s Hospital utilizing the i-Rounds
web-based medical record.

 Data captured automatically or entered

at the point of care.
The Visual Representation of Data

 Our methods for sharing and displaying data

have been based on the inspired work of
Edward Tufte
 Certain methods for displaying and analyzing
data are better than others
 Superior methods are more likely to produce
truthful, credible and precise findings
 “Inspired design can actually cause the
meaningful right numbers to flash out from
statistical murk”
 Edward Tufte
Visual Representation of Performance: First 500 vs.
Last 500 Cases: It is readily apparent that our
performance has improved dramatically
Sparklines in CHS

 Data Intense, Simple, Word-Sized

Graphics
 High resolution graphics embedded in a
context of words, numbers and images
 Sparklines give us some chance to learn
from the flood of data generated by
modern scientific monitoring and
surveillance technologies
Edward Tufte, 2004
 Sparkline data analysis is used to graphically display data over time

Sparkline of vital
signs data,
available to
clinician in real-
time via
an i-phone

Sparklines: Data-intense, small, high resolution graphics (Tufte 2006)

 Sparkline
representing current
and past
performance of a
congenital heart
surgical program.

Current

1996
Improving Outcomes

 Performance Assessment/performance
Improvement relationship
 POCT/GDT
 EMR
 Team Resonance
 There is no I in “TEAM”
We share equally in the success and failure of
every patient as an individual
and the Program as a whole
Team Resonance
 Team Resonance

CICU CVS
PA ANP ANP

nurse
pharmacist
fellow
Team Resonance