Post on 04-Jul-2020
Pediatric Cardiac Surgery Outcomes
Jeffrey P. Jacobs, M.D.
All Children’s Hospital
Johns Hopkins Medicine
The Congenital Heart Institute of Florida (CHIF)
Saint Petersburg, Tampa, and Orlando, Florida, United States of America
FSTCS 2012
Ocean Reef Club –
Key Largo, Florida
Friday, July 13, 2012
Variation in Outcomes of Pediatric Cardiac Operations
Jeffrey P. Jacobs, M.D.
All Children’s Hospital
Johns Hopkins Medicine
The Congenital Heart Institute of Florida (CHIF)
Saint Petersburg, Tampa, and Orlando, Florida, United States of America
FSTCS 2012
Ocean Reef Club –
Key Largo, Florida
Friday, July 13, 2012
Learning from 86,297 Congenital Heart Operations: Where Do I Start?
Jeffrey P. Jacobs, M.D.
All Children’s Hospital
Johns Hopkins Medicine
The Congenital Heart Institute of Florida (CHIF)
Saint Petersburg, Tampa, and Orlando, Florida, United States of America
FSTCS 2012
Ocean Reef Club –
Key Largo, Florida
Friday, July 13, 2012
Disclosure
1. Chair of the STS Congenital Heart Surgery Database Taskforce
2. Chair of the STS Database Task Force on Longitudinal Follow-up and External Linkages
3. Chair of the STS Database Public Reporting Task Force
Objectives
1. Background – STS Database
2. Pediatric Cardiac Surgery Outcomes
3. Transcatheter Pulmonary Valves
Congenital Heart Disease Meaningful Multi-institutional Outcomes Analysis
Accomplishments
1) Common Language = Nomenclature
2) Mechanism of Data Collection (Database - Registry)
3) Mechanism of Evaluating Case Complexity
4) Mechanism to Verify Data Validity and Accuracy
5) Collaboration Between Subspecialties
6) Longitudinal Follow-Up
7) Quality Improvement
Congenital Heart Disease Meaningful Multi-institutional Outcomes Analysis
Accomplishments
1) Common Language = Nomenclature
2) Mechanism of Data Collection (Database - Registry)
3) Mechanism of Evaluating Case Complexity
4) Mechanism to Verify Data Validity and Accuracy
5) Collaboration Between Subspecialties
6) Longitudinal Follow-Up
7) Quality Improvement
VSD - Traditional
VSD - Robert Anderson
VSD - Van Praagh
Ventricular Septum
Jacobs JP, Burke RP, Quintessenza JA, Mavroudis C. Congenital Heart Surgery Nomenclature and Database Project: Ventricular Septal Defect. The Annals of Thoracic Surgery April 2000 Supplement, The Annals of Thoracic Surgery, 69(4 Suppl):S25-35, April 2000.
VSD - Traditional
Jacobs JP, Burke RP, Quintessenza JA, Mavroudis C. Congenital Heart Surgery Nomenclature and Database Project: Ventricular Septal Defect. The Annals of Thoracic Surgery April 2000 Supplement, The Annals of Thoracic Surgery, 69(4 Suppl):S25-35, April 2000.
VSD - Robert Anderson
Jacobs JP, Burke RP, Quintessenza JA, Mavroudis C. Congenital Heart Surgery Nomenclature and Database Project: Ventricular Septal Defect. The Annals of Thoracic Surgery April 2000 Supplement, The Annals of Thoracic Surgery, 69(4 Suppl):S25-35, April 2000.
VSD - Van Praagh
Jacobs JP, Burke RP, Quintessenza JA, Mavroudis C. Congenital Heart Surgery Nomenclature and Database Project: Ventricular Septal Defect. The Annals of Thoracic Surgery April 2000 Supplement, The Annals of Thoracic Surgery, 69(4 Suppl):S25-35, April 2000.
Unified VSD Nomenclature
♥ VSD, NOS
♥ VSD, Multiple
♥ VSD, Type 1 (Subarterial) (Supracristal) (Conal septal defect)
♥ VSD, Type 2 (Perimembranous) (Paramembranous)
(Conoventricular)
♥ VSD, Type 3 (Inlet) (Perimembranous inlet) (AV Canal type)
♥ VSD, Type 4 (Muscular)
♥ VSD, Type: Mixed
Jacobs JP, Burke RP, Quintessenza JA, Mavroudis C. Congenital Heart Surgery
Nomenclature and Database Project: Ventricular Septal Defect. The Annals of Thoracic Surgery April 2000 Supplement, The Annals of Thoracic Surgery, 69(4 Suppl):S25-35, April 2000.
The International Working Group for Mapping and Coding of Nomenclatures for Paediatric and Congenital Heart Disease (Nomenclature Working Group)
Joint collaborative international effort between pediatric cardiologists and pediatric cardiac surgeons to further standardize nomenclature
International Pediatric and Congenital Cardiac Code (IPCCC) based on the EACTS-STS nomenclature and the AEPC
nomenclature www.ipccc.net Proposed at The World Congress in Toronto in 2001 Presented at World Congress in Argentina in 2005 Matured and Evolved at World Congress in Australia in 2009 WHO - ICD-11
Congenital Heart Disease Meaningful Multi-institutional Outcomes Analysis
Accomplishments
1) Common Language = Nomenclature
2) Mechanism of Data Collection (Database - Registry)
3) Mechanism of Evaluating Case Complexity
4) Mechanism to Verify Data Validity and Accuracy
5) Collaboration Between Subspecialties
6) Longitudinal Follow-Up
7) Quality Improvement
The Report of the 2005 STS Congenital Heart Surgery Practice and Manpower Survey
♥ undertaken by the Society of Thoracic Surgeons Workforce on Congenital Heart Surgery
♥ 122 centers in the United States of America perform pediatric and congenital heart surgery
♥ 8 centers in Canada perform pediatric and congenital heart surgery
Jacobs ML, Mavroudis C, Jacobs JP, Tchervenkov CI, Pelletier GJ. Report of the 2005 STS Congenital Heart Surgery Practice and Manpower Survey: A Report from The STS Workforce on Congenital Heart Surgery. The Annals of Thoracic Surgery, 82(3):1152-8, 1159e1-5; discussion 1158-9, September 2006.
The Report of the 2010 STS Congenital Heart Surgery Practice and Manpower Survey
♥ undertaken by the Society of Thoracic Surgeons Workforce on Congenital Heart Surgery
♥ 125 centers in the United States of America perform pediatric and congenital heart surgery
♥ 8 centers in Canada perform pediatric and congenital heart surgery
Jacobs ML, Daniel M, Mavroudis C, Morales DLS, Jacobs JP, Fraser CD, Turek JW, Mayer JE, Tchervenkov C, Conte JV. Report of the 2010 Society of Thoracic Surgeons Congenital Heart Surgery Practice and Manpower Survey. The Annals of Thoracic Surgery, 2011;92:762–9, August 2011.
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Participating Centers 16 18 21 34 47 58 68 79 93 96
0
20
40
60
80
100
120
Growth in the STS Congenital Heart Surgery Database
Partici…
Jacobs JP, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov CI. Executive Summary:
The Society of Thoracic Surgeons Congenital Heart Surgery Database - Fourteenth Harvest
– (January 1, 2007 – December 31, 2010). The Society of Thoracic Surgeons (STS) and Duke
Clinical Research Institute (DCRI), Duke University Medical Center, Durham, North Carolina,
United States, Spring 2011 Harvest.
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Participating Centers 16 18 21 34 47 58 68 79 93 103
0
20
40
60
80
100
120
Growth in the STS Congenital Heart Surgery Database
Partici…
Operations per averaged 4 year data collection cycle
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Operations 12787 16461 28351 37093 45635 61014 72002 91639 103664 111354
0
20000
40000
60000
80000
100000
120000
Growth in the STS Congenital Heart Surgery Database
Operations
Jacobs JP, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov CI. Executive Summary:
The Society of Thoracic Surgeons Congenital Heart Surgery Database - Fourteenth Harvest
– (January 1, 2007 – December 31, 2010). The Society of Thoracic Surgeons (STS) and Duke
Clinical Research Institute (DCRI), Duke University Medical Center, Durham, North Carolina,
United States, Spring 2011 Harvest.
Jacobs JP, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov CI. Executive Summary:
The Society of Thoracic Surgeons Congenital Heart Surgery Database - Fourteenth Harvest
– (January 1, 2007 – December 31, 2010). The Society of Thoracic Surgeons (STS) and Duke
Clinical Research Institute (DCRI), Duke University Medical Center, Durham, North Carolina,
United States, Spring 2011 Harvest.
Cumulative operations over time
Jacobs JP, Maruszewski B, Kurosawa H, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov
CI, Walters H 3rd, Stellin G, Ebels T, Tsang VT, Elliott MJ, Murakami A, Sano S, Mayer JE Jr,
Edwards FH, Quintessenza JA. Congenital heart surgery databases around the world: do we
need a global database? Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):3-
19.PMID: 20307856
www.eactscongenitaldb.org
The Japan Congenital Cardiovascular Surgery Database (JCCVSD)
Jacobs JP, Maruszewski B, Kurosawa H, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov
CI, Walters H 3rd, Stellin G, Ebels T, Tsang VT, Elliott MJ, Murakami A, Sano S, Mayer JE Jr,
Edwards FH, Quintessenza JA. Congenital heart surgery databases around the world: do we
need a global database? Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):3-
19.PMID: 20307856
167 Publications
91 publication 2006 – 2010
1 Abstract at the 2007 STS
2 Abstracts at the 2007 AATS
1 Abstract at 2008 STS
1 Abstract at the 2008 Western Thoracic
2 Abstracts at the 2010 STS
2 Abstracts at the 2011 STS
1 Abstract at the 2011 Southern Thoracic
1 Abstract at the 2011 AATS
2 Abstracts at the 2012 STS
1 Abstract at the 2012 Western Thoracic
EACTS-ECHSA and STS Congenital Database: Publications: 1998 - 2010
STS All
0 to 28
days
29 days
to 1
year Other
Eligible Patients 18,928 3,988 6,152 8,788
Discharge Mortality 825 487 202 136
Discharge Mortality % 4.40% 12.20% 3.30% 1.50%
Basic Complexity Score 7.1 8.6 7 6.5
EACTS
Eligible Patients 21,916 4,273 7,316 10,327
Discharge Mortality 1,097 514 377 206
Discharge Mortality % 5.40% 13.30% 5.56% 2.10%
Basic Complexity Score 6.5 7.6 6.6 5.9
Jacobs JP, Jacobs ML, Maruszewski B, Lacour-Gayet FG, Clarke DR, Tchervenkov CI, Gaynor
JW, Spray TL, Stellin G, Elliott MJ, Ebels T, Mavroudis C. Current status of the European
Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons Congenital
Heart Surgery Database. Ann Thorac Surg. 2005 Dec;80(6):2278-83; discussion 2283-4.
STS All
0 to 28
days
29 days
to 1
year Other
Eligible Patients 18,928 3,988 6,152 8,788
Discharge Mortality 825 487 202 136
Discharge Mortality % 4.40% 12.20% 3.30% 1.50%
Basic Complexity Score 7.1 8.6 7 6.5
EACTS
Eligible Patients 21,916 4,273 7,316 10,327
Discharge Mortality 1,097 514 377 206
Discharge Mortality % 5.40% 13.30% 5.56% 2.10%
Basic Complexity Score 6.5 7.6 6.6 5.9
Jacobs JP, Jacobs ML, Maruszewski B, Lacour-Gayet FG, Clarke DR, Tchervenkov CI, Gaynor
JW, Spray TL, Stellin G, Elliott MJ, Ebels T, Mavroudis C. Current status of the European
Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons Congenital
Heart Surgery Database. Ann Thorac Surg. 2005 Dec;80(6):2278-83; discussion 2283-4.
STS All
0 to 28
days
29 days
to 1
year Other
Eligible Patients 18,928 3,988 6,152 8,788
Discharge Mortality 825 487 202 136
Discharge Mortality % 4.40% 12.20% 3.30% 1.50%
Basic Complexity Score 7.1 8.6 7 6.5
EACTS
Eligible Patients 21,916 4,273 7,316 10,327
Discharge Mortality 1,097 514 377 206
Discharge Mortality % 5.40% 13.30% 5.56% 2.10%
Basic Complexity Score 6.5 7.6 6.6 5.9
Jacobs JP, Jacobs ML, Maruszewski B, Lacour-Gayet FG, Clarke DR, Tchervenkov CI, Gaynor
JW, Spray TL, Stellin G, Elliott MJ, Ebels T, Mavroudis C. Current status of the European
Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons Congenital
Heart Surgery Database. Ann Thorac Surg. 2005 Dec;80(6):2278-83; discussion 2283-4.
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
EACTS and STS Data 2002 and 2003
EACTS STS
# of centers with data in both 2002 and 2003 28 19
Centers with zero Norwood procedures 5 0
Centers with 1-10 Norwood procedures per year 18 12
Centers with >10 Norwood procedures per year 5 7
Discharge mortality for neonatal Norwood procedures 35.5% 26.0%
Discharge mortality for neonatal ASO procedures 5.2% 7.4%
Mean age for Glenn procedures (years) 2.4 0.9
Median age for Glenn procedures (years) 0.9 0.5
Mean age for Fontan procedures (years) 6.3 5.2
Median age for Fontan procedures (years) 4.17 3
Percentage of Infant TOF undergoing palliation 70.0% 61.6%
Percentage of Infant TOF undergoing complete repair 30.0% 38.4%
Mean age for TOF complete repair procedures (years) 2.5 1.1
Median age for TOF complete repair procedures (years) 0.9 0.4
Mean age for Complete AV Canal (CAVSD) repair procedures (years) 0.9 0.6
Median age for Complete AV Canal (CAVSD) repair procedures (years) 0.4 0.4
Congenital Heart Disease Meaningful Multi-institutional Outcomes Analysis
Accomplishments
1) Common Language = Nomenclature
2) Mechanism of Data Collection (Database - Registry)
3) Mechanism of Evaluating Case Complexity
4) Mechanism to Verify Data Validity and Accuracy
5) Collaboration Between Subspecialties
6) Longitudinal Follow-Up
7) Quality Improvement
Complexity Level 1
Complexity Level 2
Complexity Level 3
Complexity Level 4
Complexity Level 5 to 6
Two traditional methodologies for Complexity Adjustment
1) Risk Adjustment in Congenital Heart Surgery-
1 (RACHS-1 )
2) Aristotle Complexity Score
– Aristotle Basic Complexity Score (ABC Score)
– Aristotle Comprehensive Complexity Score Jacobs JP, Jacobs ML, Lacour-Gayet FG, Jenkins KJ, Gauvreau K, Bacha EA, Maruszewski
B, Clarke DR, Tchervenkov CI, Gaynor JW, Spray, TL, Stellin G, O'Brien SM, Elliott MJ,
Mavroudis C. Stratification of Complexity Improves Utility and Accuracy of Outcomes
Analysis in a Multi-institutional Congenital Heart Surgery Database – Application of the
RACHS-1 and Aristotle Systems in the STS Congenital Heart Surgery Database.
Pediatric Cardiology, 2009, DOI 10.1007/s00246-009-9496-0.
0
5
10
15
20
25
% Mortality
% Mortality 0.6 1.4 4.1 8.7 20.2
1 2 3 4 5 & 6RACHS-1 Level
Jacobs JP, Jacobs ML, Lacour-Gayet FG, Jenkins KJ, Gauvreau K, Bacha EA, Maruszewski B, Clarke DR,
Tchervenkov CI, Gaynor JW, Spray, TL, Stellin G, O'Brien SM, Elliott MJ, Mavroudis C. Stratification of
Complexity Improves Utility and Accuracy of Outcomes Analysis in a Multi-institutional Congenital Heart
Surgery Database – Application of the RACHS-1 and Aristotle Systems in the STS Congenital Heart
Surgery Database. Pediatric Cardiology, 2009, DOI 10.1007/s00246-009-9496-0.
STS 2006 Congenital Database
45,635 cases
0
2
4
6
8
10
% Mortality
% Mortality 1.6 2.6 4.1 9.9
1 2 3 4Aristotle Basic
Level
Jacobs JP, Jacobs ML, Lacour-Gayet FG, Jenkins KJ, Gauvreau K, Bacha EA, Maruszewski B, Clarke DR,
Tchervenkov CI, Gaynor JW, Spray, TL, Stellin G, O'Brien SM, Elliott MJ, Mavroudis C. Stratification of
Complexity Improves Utility and Accuracy of Outcomes Analysis in a Multi-institutional Congenital Heart
Surgery Database – Application of the RACHS-1 and Aristotle Systems in the STS Congenital Heart
Surgery Database. Pediatric Cardiology, 2009, DOI 10.1007/s00246-009-9496-0.
STS 2006 Congenital Database
45,635 cases
O'Brien SM, Clarke DR, Jacobs JP, Jacobs ML, Lacour-Gayet FG, Pizarro CP, Welke KF,
Maruszewski B, Tobota Z, Miller WJ, Hamilton L , Peterson ED, Mavroudis C, Edwards FH. An
empirically based tool for analyzing mortality associated with congenital heart surgery.
The Journal of Thoracic and Cardiovascular Surgery, 2009 Nov;138(5), November 2009.
From Subjective Probability to Objective Data
STAT Mortality Score
The Society of Thoracic Surgeons - European Association
for Cardio-Thoracic Surgery Congenital Heart Surgery
Mortality Score
and
STAT Mortality Categories
The Society of Thoracic Surgeons - European Association
for Cardio-Thoracic Surgery Congenital Heart Surgery
Mortality Categories
STAT Category Operation
STAT Category 1 ASD repair, Patch
STAT Category 2 TOF repair, Ventriculotomy, Transannular patch
STAT Category 3 AVC (AVSD) repair, Complete
STAT Category 4
Arterial switch procedure and VSD repair + aortic
arch repair
STAT Category 5 Norwood procedure
Method of Modeling
Procedures
Model without
patient
covariates
Model with
patient
covariates
STS-EACTS Congenital Heart Surgery Mortality
Score (2009)
C = 0.787 C = 0.816
STS-EACTS Congenital Heart Surgery Mortality
Categories (2009)
C = 0.778 C = 0.812
RACHS-1 Categories C = 0.745 C = 0.802
Aristotle Basic Complexity Score C = 0.687 C = 0.795
O'Brien SM, Clarke DR, Jacobs JP, Jacobs ML, Lacour-Gayet FG, Pizarro CP, Welke KF,
Maruszewski B, Tobota Z, Miller WJ, Hamilton L , Peterson ED, Mavroudis C, Edwards FH. An
empirically based tool for analyzing mortality associated with congenital heart surgery.
The Journal of Thoracic and Cardiovascular Surgery, 2009 Nov;138(5), November 2009.
From Subjective Probability to Objective Data
Richard E. Clark Paper: Variation in Outcomes for Benchmark Operations: An
analysis of the STS Congenital Heart Surgery Database
Jeffrey Phillip Jacobs MD, Sean M. O’Brien, PhD, Sara K. Pasquali, MD,
Marshall Lewis Jacobs MD, Francois G. Lacour–Gayet, MD,
Christo I. Tchervenkov, MD, Erle H. Austin, III, MD, Christian Pizarro, MD,
Kamal K. Pourmoghadam, MD, Frank G. Scholl, MD, Karl F. Welke, MD,
Constantine Mavroudis, MD
47th Annual Meeting
Society of Thoracic
Surgeons
San Diego,
California
January 31, 2011
Background 1. The STS Congenital Heart Surgery Database of (STS–CHSDB) the largest database in North America that tracks the outcomes of pediatric and congenital cardiac surgery.
2. As of November 1, 2011, participants in the STS–CHSDB include 100 of the 125 congenital cardiac surgical programs in the United States.
Jacobs JP, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov CI. Executive
Summary: The Society of Thoracic Surgeons Congenital Heart Surgery Database -
Fifteenth Harvest – (July 1, 2007 – June 30, 2011). The Society of Thoracic Surgeons
(STS) and Duke Clinical Research Institute (DCRI), Duke University Medical Center,
Durham, North Carolina, United States, Fall 2011 Harvest.
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Participating Centers 16 18 21 34 47 58 68 79 93 101
0
20
40
60
80
100
120
Growth in the STS Congenital Heart Surgery Database
ParticipatingCenters
Cumulative operations over time
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Cumulative Operations 4237 9747 16537 26404 39988 58181 79399 98406 119266 148110 179697 213416
0
50000
100000
150000
200000
250000
Growth in the STS Congenital Heart Surgery Database
Cumulative Operations
Jacobs JP, Jacobs ML, Mavroudis C, Lacour-Gayet FG, Tchervenkov CI. Executive
Summary: The Society of Thoracic Surgeons Congenital Heart Surgery Database -
Fifteenth Harvest – (July 1, 2007 – June 30, 2011). The Society of Thoracic Surgeons
(STS) and Duke Clinical Research Institute (DCRI), Duke University Medical Center,
Durham, North Carolina, United States, Fall 2011 Harvest.
Background
One of the major goals of the STS Congenital Heart Surgery Database is to facilitate the improvement of quality in pediatric cardiac surgical programs in North America.
Jacobs JP, O'Brien SM, Pasquali SK, Jacobs ML, Lacour-Gayet FG, Tchervenkov CI, Austin EH 3rd, Pizarro C, Pourmoghadam KK, Scholl FG, Welke KF, Mavroudis C. Richard E. Clark Paper: Variation in Outcomes for Benchmark Operations: An analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database. Richard Clark Award recipient for best use of the STS Congenital Heart Surgery Database. The Annals of Thoracic Surgery 2011 Dec;92(6):2184-92, PMID: 22115229.
Jacobs JP, O'Brien SM, Pasquali SK, Jacobs ML, Lacour-Gayet FG, Tchervenkov CI, Austin EH, , Pizarro C, Pourmoghadam KK, Scholl FG, Welke KF, Gaynor JW, Clarke DR, Mayer JE, Mavroudis C. Variation in Outcomes for Risk-stratified Pediatric Cardiac Surgical Operations: An analysis of the STS Congenital Heart Surgery Database. The Annals of Thoracic Surgery. Accepted for publication, in press.
Background We evaluated outcomes for 8 common operations and all complexity stratified operations in the STS Congenital Heart Surgery Database to provide contemporary benchmarks and examine variation between centers. .
Purpose The purpose of these analyses is to document current outcomes for common operations in the STS–CHSDB in order to:
(1) provide contemporary benchmarks and
(2) examine variation in outcomes between centers.
Methods (1) • Patients undergoing surgery from 2005 – 2009 were
included.
• Centers with > 10% missing data were excluded.
• Discharge mortality and postoperative length of stay (PLOS) were calculated for:
1. eight benchmark operations of varying complexity
2. all operations complexity stratified
Methods (2)
• Power for analyzing between-center variation in outcome was determined for each operation.
• Variation was evaluated using
– funnel plots and
– Bayesian hierarchical modeling.
8 Common Operations: 1. Ventricular septal defect repair (VSD)
2. Tetralogy of Fallot repair (TOF)
3. Complete atrioventricular canal repair (AVC)
4. Arterial switch (ASO)
5. ASO + VSD
6. Fontan
7. Truncus repair
8. Norwood
Complexity stratification
Complexity stratification is
a method of analysis in
which the data are divided
into relatively
homogeneous groups
(called strata).
O'Brien SM, Clarke DR, Jacobs JP, Jacobs ML, Lacour-Gayet FG, Pizarro CP, Welke KF,
Maruszewski B, Tobota Z, Miller WJ, Hamilton L , Peterson ED, Mavroudis C, Edwards FH. An
empirically based tool for analyzing mortality associated with congenital heart surgery.
The Journal of Thoracic and Cardiovascular Surgery, 2009 Nov;138(5), November 2009.
From Subjective Probability to Objective Data
STAT Mortality Score
The Society of Thoracic Surgeons - European Association
for Cardio-Thoracic Surgery Congenital Heart Surgery
Mortality Score
and
STAT Mortality Categories
The Society of Thoracic Surgeons - European Association
for Cardio-Thoracic Surgery Congenital Heart Surgery
Mortality Categories
Methods
STAT Mortality Score and Categories
were previously developed based on
analysis of
77,294 operations entered in the STS
Congenital Heart Surgery Databases
and the EACTS Congenital Heart
Surgery Database
• EACTS = 33,360 operations
• STS = 43,934 patients
Methods
Procedure-specific mortality rate
estimates were calculated using a
Bayesian model that adjusted for small
denominators.
Methods
Operations were sorted by increasing
risk and grouped into 5 categories that
were designed to
• minimize within-category variation
and
• maximize between-category variation
Method of Modeling
Procedures
Model without
patient
covariates
Model with
patient
covariates
STS-EACTS Congenital Heart Surgery Mortality
Score (2009)
C = 0.787 C = 0.816
STS-EACTS Congenital Heart Surgery Mortality
Categories (2009)
C = 0.778 C = 0.812
RACHS-1 Categories C = 0.745 C = 0.802
Aristotle Basic Complexity Score C = 0.687 C = 0.795
O'Brien SM, Clarke DR, Jacobs JP, Jacobs ML, Lacour-Gayet FG, Pizarro CP, Welke KF,
Maruszewski B, Tobota Z, Miller WJ, Hamilton L , Peterson ED, Mavroudis C, Edwards FH. An
empirically based tool for analyzing mortality associated with congenital heart surgery.
The Journal of Thoracic and Cardiovascular Surgery, 2009 Nov;138(5), November 2009.
From Subjective Probability to Objective Data
STS-EACTS Category Total Index Operations
Total Index Operations who died
before Hospital
Discharge
Discharge Mortality Percent
1 37,206 290 0.78%
2 32,310 679 2.1%
3 15,108 514 3.4%
4 22,812 1,947 8.5%
5 4,058 809 19.9%
Total Cases 111,494 4,239 3.8%
Combined STS and EACTS Data: 2006 - 2009
0
5
10
15
20
% Mortality
% Mortality 0.78 2.1 3.4 8.5 19.9
1 2 3 4 5STAT Category
Combined EACTS and STS Congenital Heart Surgery
Databases: 111,494 index cardiac operations
Jacobs JP, Jacobs ML, Maruszewski B, Lacour–Gayet FG, Tchervenkov CI, O’Brien
SM, Tobota Z, Stellin G, Kurosawa H, Murakami A, Gaynor JW, Pasquali SK, Clarke DR,
Austin EH 3rd, Mavroudis C. Initial Application in the EACTS and STS Congenital
Heart Surgery Databases of an Empirically Derived Methodology of Complexity
Adjustment to Evaluate Surgical Case Mix and Results. The European Journal of
Cardiothoracic Surgery, Accepted for publication. In Press.
RESULTS for
8 Benchmark Operations
Results (1)
18,375 index operations at 74 centers were included in the analysis of eight
benchmark operations.
Results (2) – Discharge Mortality
Operation Aggregate Range
VSD repair 0.6% (0%–5.1%)
TOF repair 1.1% (0%–16.7%)
AVC repair 2.2% (0%–20%)
ASO 2.9% (0%–50%)
ASO + VSD 7.0% (0%–100%)
Fontan 1.3% (0%–9.1%)
Truncus repair 10.9% (0%–100%)
Norwood 19.3% (2.9%–100%)
Results (2) – Discharge Mortality
Operation Aggregate Range
VSD repair 0.6% (0%–5.1%)
TOF repair 1.1% (0%–16.7%)
AVC repair 2.2% (0%–20%)
ASO 2.9% (0%–50%)
ASO + VSD 7.0% (0%–100%)
Fontan 1.3% (0%–9.1%)
Truncus repair 10.9% (0%–100%)
Norwood 19.3% (2.9%–100%)
Results (3) – Funnel Plots
Funnel plots revealed the number of centers characterized as outliers.
Results (4) – Funnel Plots: Centers characterized as outliers
VSD repair 0
TOF repair 0
AVC repair 1
ASO 3
ASO + VSD 1
Fontan 0
Truncus repair 4
Norwood 11
Funnel Plots
Funnel Plots - VSD
Funnel Plots - Norwood
Funnel Plots - Norwood
Funnel Plots
Results (5) – Power for analyzing between-center variation: Sample size required for 50% power to detect 2x increase in mortality
VSD repair 599
TOF repair 338
AVC repair 172
ASO 131
ASO+VSD 48
Fontan 304
Truncus repair 31
Norwood 17
Results (6) • Power calculations showed statistically
meaningful comparisons of mortality rates between centers could only be made for Norwood:
– Bayesian-estimated range (95% Probability Interval) was
7.0% (3.7-10.3%) to 41.6% (30.6-57.2%)
• The highest mortality rate is approximately 6-fold higher than the lowest
Results (7) - PLOS
• Between-center variation in PLOS was analyzed for all operations and was larger for more complex operations
Implications
Even with the use of 5 years of data, because of the relatively small datasets for many operations at most centers, it is not possible to perform statistically meaningful comparisons between centers of mortality after benchmark operations.
Grouping of operations into strata of similar complexity may further facilitate inter-institutional comparisons.
RESULTS for
Complexity Stratified
Operations
Results (1)
58,506 index operations at 73 centers were included in this analysis of complexity-stratified operations.
Results (2) – Discharge Mortality
Interquartile STAT Category Aggregate Range
1 0.55% (0.0%-0.9%)
2 1.7% (1.0%-2.2% )
3 2.6% (1.1%-4.4%)
4 8.0% (5.7%-10.9%)
5 18.4% (12.0%-28.6%)
Results (2) – Discharge Mortality
Interquartile STAT Category Aggregate Range
1 0.55% (0.0%-0.9%)
2 1.7% (1.0%-2.2% )
3 2.6% (1.1%-4.4%)
4 8.0% (5.7%-10.9%)
5 18.4% (12.0%-28.6%)
Results (3) – Funnel Plots
Funnel plots revealed the number of centers characterized as outliers.
Funnel Plots - VSD
Funnel Plots - Norwood
Funnel Plots
Results (4) – Funnel Plots: Centers characterized as outliers
STAT Category Outliers High Performing
1 3 0
2 1 0
3 7 2
4 13 4
5 13 7
Results (5) - PLOS
• Between-center variation in PLOS was analyzed for all operations and was larger for more complex operations
Conclusions (1) This analysis documents
(1) contemporary benchmarks for a) common pediatric cardiac surgical operations of
varying levels of complexity and
b) all complexity-stratified pediatric cardiac surgical operations
(2) the range of outcomes among centers.
Conclusions (2)
Variation in outcome was most prominent for more complex operations.
Conclusions (3)
Funnel plots of mortality after benchmark operations can help to identify outliers.
Grouping of operations into strata of similar complexity facilitates inter-institutional comparisons.
Conclusions (4)
These data can aid in quality assessment and quality improvement initiatives.
IMPLICATION
Variation in outcomes across centers demonstrates opportunities for multi–institutional collaboration to improve quality.
STS Congenital Heart Surgery Database Quality Module
• Optional Web-based Supplementary Module
• Went Live February 2012
21 Quality Measures for Pediatric and Congenital Cardiac Surgery
Jacobs JP, Jacobs ML, Austin EH, Mavroudis M, Pasquali SK, Lacour–Gayet FG, Tchervenkov CI, Walters III HW, Bacha EA, del Nido PJ, Fraser CD, Gaynor JW, Hirsch JC, Morales DLS, Pourmoghadam KK, Tweddell JT, Prager RL, Mayer JE. Quality Measures for Congenital and Pediatric Cardiac Surgery. The World Journal for Pediatric and Congenital Heart Surgery 2012 Volume 3, Issue 1, Pages 32-47, DOI 10.1177/2150135111426732, January 2012.
STS NQF Proposed National Quality Forum Indicators for Pediatric and Congenital Cardiac Surgery
1. The STS Task Force to develop National Quality Forum
Indicators for Pediatric Cardiac Surgery
2. The STS Congenital Database Task Force
3. The STS Congenital Heart Surgery Work Force
4. The STS Council on Quality, Research & Patient Safety,
5. The Society of Thoracic Surgeons (STS) Executive
Committee
21 Quality Measures for Pediatric and Congenital Cardiac Surgery
5 Structure Measures
6 Process Measures
10 Outcome Measures
21 Quality Measures for Pediatric and Congenital Cardiac Surgery
Jacobs JP, Jacobs ML, Austin EH, Mavroudis M, Pasquali SK, Lacour–Gayet FG, Tchervenkov CI, Walters III HW, Bacha EA, del Nido PJ, Fraser CD, Gaynor JW, Hirsch JC, Morales DLS, Pourmoghadam KK, Tweddell JT, Prager RL, Mayer JE. Quality Measures for Congenital and Pediatric Cardiac Surgery. The World Journal for Pediatric and Congenital Heart Surgery 2012 Volume 3, Issue 1, Pages 32-47, DOI 10.1177/2150135111426732, January 2012.
5 Structure Measures 1. Participation in a National Database for Pediatric and
Congenital Heart Surgery
2. Multidisciplinary rounds involving multiple members of the healthcare team
3. Availability of Institutional Pediatric ECLS (Extracorporeal Life Support) Program
4. Surgical volume for Pediatric and Congenital Heart Surgery: Total Programmatic Volume and Programmatic Volume Stratified by the Five STS-EACTS Mortality Categories
5. Surgical Volume for Eight Pediatric and Congenital Heart Benchmark Operations
Eight Pediatric and Congenital Heart Benchmark Operations
1. VSD Repair
2. TOF Repair
3. Complete AV Canal Repair
4. Arterial Switch
5. Arterial Switch + VSD repair
6. Fontan
7. Truncus Repair
8. Norwood
6 Process Measures 6. Multidisciplinary preoperative planning conference to plan
pediatric and congenital heart surgery operations
7. Regularly Scheduled Quality Assurance and Quality Improvement Cardiac Care Conference, to occur no less frequently than once every two months
8. Availability of intraoperative transesophageal echocardiography (TEE) and epicardial echocardiography
9. Timing of Antibiotic Administration for Pediatric and Congenital Cardiac Surgery Patients
10. Selection of Appropriate Prophylactic Antibiotics and Weight-Appropriate Dosage for Pediatric and Congenital Cardiac Surgery Patients
11. Use of an expanded pre-procedural and post-procedural “time-out”
3 Process Measures 11. Use of an expanded pre-procedural and post-procedural “time-out” that includes
the following elements:
1. The conventional pre-procedural “time-out”, which includes identification of patient, operative site, procedure and history of any allergies.
2. A pre-procedural briefing wherein the surgeon shares with all members of the operating room team the essential elements of the operative plan; including diagnosis, planned procedure, outline of essentials of anesthesia and bypass strategies, anticipated or planned implants or device applications, and anticipated challenges.
3. A post-procedural debriefing wherein the surgeon succinctly reviews with all members of the operating room team the essential elements of the operative plan, identifying both the successful components and the opportunities for improvement. This debriefing should take place prior to the patient leaving the operating room or its equivalent, and may be followed by a more in-depth dialogue involving team members at a later time. (The actual debriefing in the operating room is intentionally and importantly brief, in recognition of the fact that periods of transition may be times of instability or vulnerability for the patient.)
4. A briefing or hand-off protocol at the time of transfer (arrival) to the Intensive Care Unit at the end of the operation, involving the anesthesiologist, surgeon, physician staff of the Intensive Care Unit (including critical care and cardiology) and nursing
11 Outcome Measures
12.New post-operative renal failure requiring dialysis
13.New post-operative neurological deficit persisting at discharge
14.Arrhythmia necessitating permanent pacemaker insertion
15.Paralyzed diaphragm (possible phrenic nerve injury)
16.Need for Postoperative mechanical circulatory support (IABP, VAD, ECMO, or CPS)
17.Unplanned reoperation and/or interventional cardiovascular catheterization procedure
11 Outcome Measures
18.Operative Mortality Stratified by the Five
STS-EACTS Mortality Levels
19.Operative Mortality for Eight Benchmark
Operations
20.Index Cardiac Operations Free of Mortality
and Major Complication
21.Operative Survivors Free of Major
Complication
Transcatheter Pulmonary Valve
• Dr. Philip Bonhoffer reported in 2000
• First in animals and then in humans
• Proof of Concept
Approval Process Current Valve and Delivery System
• Europe, CE mark Oct 2006
• Canada, Dec 2006
• US FDA/HDE approval Jan 2010
Results of US Trial
♥ 136 pts enrolled
♥ Attempted in 124
♥ Successful implant in 100%
♥ 1 Death related to procedure not implant
♥ 1 Emergency Surgery for conduit rupture
♥ Overall Major AE’s in 6%
♥ 1 Year freedom from reintervention 93.5%
♥ Stent fractures in 20%
Transcatheter Pulmonary Valve Replacement
As of October 2011
Has been implanted in >600 people in USA
>2000 people worldwide
=>71 Implanting centers in USA
Transcatheter Pulmonary Valve Replacement
• 22 French Delivery System
• Can be delivered from the femoral vein or the jugular vein
Bovine Jugular Vein Transcatheter Pulmonary Valve Replacement
♥ Can be used for most dysfunctional RV to PA conduit >16mm at time of implant
♥ 5 years freedom from re-intervention is >70%
♥ Procedural Major AE rate is 2-3%
♥ Allows patients to at least prolong life of existing conduit
Who’s a Candidate
♥ Dysfunctional conduit with stenosis (mean echo
gradient >35mmHg) and/or moderate or more
PR
– Needs to be someone you would be sending
to surgery
♥ Conduit > 16mm at time of implant
♥ There must be a place in bigger conduit<22mm
to safely land the valve
♥ There cannot be a coronary that is compressed
by compliance balloon, sorted out at procedure
♥ Patient size >15kg
Who Else Is a Candidate Off-Label Use
♥ Most US centers have gotten added local
IRB authorization for extended indications
♥ Including
– Selected additional patients with pulmonary
valve dysfunction BUT without a conduit
– Selected patients with a dysfunctional
tricuspid valve
– Selected patients with a dysfunctional mitral
valve
Procedure
♥ 16-18 Fr venous access from start
♥ 4-5 Fr arterial access
♥ Right and left heart catheterization
♥ Angiograms in RV, MPA, Branch PA’s
♥ AAO angiogram during conduit compliance
testing
♥ Pre-stent most patients, keep pre-stenting until
no stent recoil (may need 1-4 stents)
♥ Load and deliver valve (often easier than conduit
preparation)
Preliminary Angiograms
• Measure conduit
• Select landing zone
• Ensure conduit is only source of stenosis
Compliance Testing
• Make sure conduit responds and can safely get big enough
• Make sure no coronary is close to the conduit
Conduit Preparation Pre-stenting
May take several stents Minimize recurrent stenosis
Conduit Preparation Pre-stenting
2nd Pre-Stent After 2nd Pre-stent
Valve Delivery
Valve Deployment Post Dilate
Post Dilation
• Post-dilation with less compliant balloon if gradient >10mmHg
• Make stents on short axis look round
Final Result
• Take your time with preparation
• It simplifies delivery
• It’s likely to maximize valve function and durability
CHIF Results
♥ First implant April 2011
♥ 20 patients to lab
♥ 4 found to have coronary issues
♥ 16/16 successful implant
♥ All patients well thus far with up to 1 yr
follow up
How the STS database can help us Rescue our patients
Jeffrey P. Jacobs, M.D.
All Children’s Hospital
Johns Hopkins Medicine
The Congenital Heart Institute of Florida (CHIF)
Saint Petersburg, Tampa, and Orlando, Florida, United States of America
20th annual
Baffes visiting
Professor
Chicago, Illinois
May 18, 2012
How the STS database can help us Rescue our patients
1. Identify Variation in Outcome Across Centers
2. Offer tools to Improve Quality and Outcome
Traditional “Quality Assurance”:
A focus on the tail
better worse Quality
QA threshold (standard)
A B
`acceptable' quality `unacceptable' quality
Courtesy of Robert Beekman, MD
Focus on the Tail to
Assure Quality
. . . assumes that, if serious failures (the tail)
are eliminated, what remains is somehow
excellent…….
Eliminating the lower 5%
does little to affect overall
system quality
Courtesy of Robert Beekman, MD
To Truly Improve Quality
the System Must……
1) Eliminate unnecessary variation* (e.g. standardize processes)
2) Achieve & document continuous improvement (in care processes & outcomes)
* Reinertsen JL. Zen and the Art of Physician Autonomy Maintenance.
Ann Intern Med. (2003);138:992-992.
Courtesy of Robert Beekman, MD
True Quality Improvement
Moves the Mean
AND
Reduces Unnecessary
Variation
Courtesy of Robert Beekman, MD
[http://www.sts.org/sites/default/files/documents/DatabaseMap%20-
%20CONGENITAL%2012.31.2010.pdf]. Accessed June 4, 2011
[http://www.sts.org/sites/default/files/documents/Database%20Map%20-
%20ADULT%20-12.31.2010.pdf]. Accessed June 4, 2011
[http://www.sts.org/sites/default/files/documents/DatabaseMap%20-
%20THORACIC%2012.31.2010.pdf]. Accessed June 4, 2011
Health care
QI
Basic
research
Translational
Research
Clinical
Trials
Outcomes
Research
Healthcare QI is essential if we are to bring medical breakthroughs to patients reliably &
effectively
Courtesy of Robert Beekman, MD and John Bucuvalas, MD
The Congenital Heart Institute of Florida (CHIF) Cardiac Surgical Associates (CSA)
JeffJacobs@msn.com
Improving
Child
Health
“Science tells us what we can do;
Guidelines what we should do; &
Registries what we are actually
doing.”