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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

FSTCS 2012

Ocean Reef Club –

Key Largo, Florida

Learning from 86,297 Congenital Heart Operations: Where Do I Start?

FSTCS 2012

Ocean Reef Club –

Key Largo, Florida

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

Accomplishments

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

VSD - Robert Anderson

VSD - Van Praagh

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

Accomplishments

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

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

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

100000

120000

Operations

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

1 Abstract at the 2011 Southern Thoracic

1 Abstract at the 2011 AATS

1 Abstract at the 2012 Western Thoracic

EACTS-ECHSA and STS Congenital Database: Publications: 1998 - 2010

STS All

0 to 28

29 days

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

Discharge Mortality 1,097 514 377 206

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

29 days

year Other

STS All

0 to 28

29 days

year Other

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 STS

Accomplishments

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.

% 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

% Mortality

% Mortality 1.6 2.6 4.1 9.9

1 2 3 4Aristotle Basic

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

STAT Mortality Categories

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

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

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

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

100000

150000

200000

250000

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).

STAT Mortality Score

Mortality Score

STAT Mortality Categories

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

• maximize between-category variation

Method of Modeling

Procedures

Model without

patient

covariates

Model with

patient

covariates

Score (2009)

C = 0.787 C = 0.816

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

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

% 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%)

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 + VSD 1

Fontan 0

Truncus repair 4

Norwood 11

Funnel Plots

Funnel Plots - VSD

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.

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%)

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

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

5 Structure Measures

6 Process Measures

10 Outcome Measures

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

– 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

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

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)

`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

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.

True Quality Improvement

Moves the Mean

Reduces Unnecessary

Variation

[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

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

Health

“Science tells us what we can do;

Guidelines what we should do; &

Registries what we are actually

doing.”

pediatric cardiac surgery outcomes€¦ · pediatric cardiac surgery outcomes jeffrey p. jacobs,...

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