Congenital Cardiac Surgery Database

Congenital Cardiac Surgery Database
AMERICAN SOCIETY OF EXTRACORPOREAL TECHNOLOGY (AmSECT) 53rd International Conference April 14-18, 2015 • Marriott Tampa Waterside • Tampa, FL Congenital Cardiac Surgery Database Jeffrey P. Jacobs, M.D., FACS, FACC, FCCP Professor of Surgery, Johns Hopkins University Director, Andrews/Daicoff Cardiovascular Program, Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs, Johns Hopkins All Children’s Heart Institute

AMERICAN SOCIETY OF EXTRACORPOREAL TECHNOLOGY (AmSECT)
53rd International Conference April 14-18, 2015 • Marriott Tampa Waterside • Tampa, FL Ethics in ECLS Care Jeffrey P. Jacobs, M.D., FACS, FACC, FCCP Professor of Surgery, Johns Hopkins University Director, Andrews/Daicoff Cardiovascular Program, Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs, Johns Hopkins All Children’s Heart Institute

Congenital Cardiac Surgery Database
AMERICAN SOCIETY OF EXTRACORPOREAL TECHNOLOGY (AmSECT) 53rd International Conference April 14-18, 2015 • Marriott Tampa Waterside • Tampa, FL Congenital Cardiac Surgery Database Jeffrey P. Jacobs, M.D., FACS, FACC, FCCP Professor of Surgery, Johns Hopkins University Director, Andrews/Daicoff Cardiovascular Program, Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs, Johns Hopkins All Children’s Heart Institute

The STS Congenital Heart Surgery Database as a Platform for Research
AMERICAN SOCIETY OF EXTRACORPOREAL TECHNOLOGY (AmSECT) 53rd International Conference April 14-18, 2015 • Marriott Tampa Waterside • Tampa, FL The STS Congenital Heart Surgery Database as a Platform for Research Jeffrey P. Jacobs, M.D., FACS, FACC, FCCP Professor of Surgery, Johns Hopkins University Director, Andrews/Daicoff Cardiovascular Program, Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs, Johns Hopkins All Children’s Heart Institute

The STS Congenital Heart Surgery Database as a Platform for Research
AMERICAN SOCIETY OF EXTRACORPOREAL TECHNOLOGY (AmSECT) 53rd International Conference April 14-18, 2015 • Marriott Tampa Waterside • Tampa, FL The STS Congenital Heart Surgery Database as a Platform for Research Jeffrey P. Jacobs, MD and Marshall L. Jacobs, MD

Meaningful Multi-institutional Outcomes Analysis
Requirements Common Language = Nomenclature Mechanism of Data Collection (Database - Registry) Mechanism of Evaluating Case Complexity Mechanism to Verify Data Validity and Accuracy Collaboration Between Subspecialties Longitudinal Follow-Up and Linked Databases Quality Improvement

Meaningful Multi-institutional Outcomes Analysis
Accomplishments Common Language = Nomenclature Mechanism of Data Collection (Database - Registry) Mechanism of Evaluating Case Complexity Mechanism to Verify Data Validity and Accuracy Collaboration Between Subspecialties Longitudinal Follow-Up and Linked Databases Quality Improvement

Congenital Heart Disease Meaningful Multi-institutional Outcomes Analysis
Accomplishments Common Language = Nomenclature Mechanism of Data Collection (Database - Registry) Mechanism of Evaluating Case Complexity Mechanism to Verify Data Validity and Accuracy Collaboration Between Subspecialties Longitudinal Follow-Up and Linked Databases Quality Improvement .

8 centers in Canada perform pediatric and congenital heart surgery
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.

Jacobs JP, Jacobs ML, Mavroudis C, Tchervenkov CI, Pasquali SK
Jacobs JP, Jacobs ML, Mavroudis C, Tchervenkov CI, Pasquali SK. Executive Summary: The Society of Thoracic Surgeons Congenital Heart Surgery Database – Twenty-first Harvest – (July 1, 2010 – June 30, 2014). The Society of Thoracic Surgeons (STS) and Duke Clinical Research Institute (DCRI), Duke University Medical Center, Durham, North Carolina, United States, Fall 2014 Harvest.

STS Database Penetrance in USA
The STS Congenital Heart Surgery Database (STS-CHSD) is the largest clinical database in the world for congenital and pediatric cardiac surgery. The Report of the 2010 STS Congenital Heart Surgery Practice and Manpower Survey, undertaken by the STS Workforce on Congenital Heart Surgery, documented that 125 hospitals in the United States of America and 8 hospitals in Canada perform pediatric and congenital heart surgery. The STS-CHSD contains data from 120 of the 125 hospitals (96% penetrance by hospital) in the United States of America and 3 of the 8 centers in Canada.

The Growth in JCCVSD

Complexity stratification
Complexity stratification is a method of analysis in which the data are divided into relatively homogeneous groups (called strata).

Two traditional methodologies for Complexity Adjustment
Risk Adjustment in Congenital Heart Surgery-1 (RACHS-1 ) 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 /s

STS 2006 Congenital Database 45,635 cases
RACHS-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 /s

STS 2006 Congenital Database 45,635 cases
Aristotle 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 /s

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 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.

STAT Mortality Categories
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 operations

Procedure-specific mortality rate estimates were calculated using a Bayesian model that adjusted for small denominators.

Operations were sorted by increasing risk and grouped into 5 categories that were designed to minimize within-category variation and maximize between-category variation

Combined EACTS and STS Congenital Heart Surgery Databases: 111,494 index cardiac operations
STAT Category Jacobs JP, Jacobs ML, Maruszewski B, Lacour-Gayet FG, Tchervenkov CI, 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. Eur J Cardiothorac Surg Nov;42(5): doi: /ejcts/ezs026. Epub 2012 Jun 14. PMID:

Database Audit In 2013, the audit of the STS Congenital Heart Surgery Database documented the following rates of completeness and accuracy for the specified fields of data: Primary Diagnosis Completeness = 100%, Accuracy = 96.2% Primary Procedure Completeness = 100%, Accuracy = 98.7% Mortality Status at Hospital Discharge Completeness = 100%, Accuracy = 98.8%

Research Projects Using the STS Congenital Heart Surgery Database Marshall L. Jacobs MD AQO, October 2014 no disclosures

STS Database Research in 2014
11 peer reviewed manuscripts based on analysis of data in the STS-CHSD have been published, 3 more accepted and currently in press. Additional presentations of research based on analysis of data in the STS-CHSD include 2 papers at the 2014 CHSS 4 at the 2014 STSA 3 at the American Heart Association Scientific Sessions 2 at STS 2015

2006 – 2010 Nine benchmark operations

Benchmark Operations Complication Rates, PLOS, and Cost

Average excess cost per case in patients with any postoperative complication compared with those without a complication was $56,584 and ranged from $16,097 (ASD repair) to $146,571 (truncus arteriosus repair). Average excess cost per case associated with major complications was higher ($132,483), ranging from $52,127 (VSD repair) to $261,188 (truncus arteriosus repair).

Excess Cost associated with Specific Complications

Excess Cost associated with longer PLOS

STS-CHSD : 2399 patients underwent repair of Complete Atrioventricular Septal Defect Median age at surgery was 4.6 months (IQR, ) 11.8% (n = 284) aged ≤ 2.5 months. Pulmonary artery band removal at CAVSD repair was performed in 122 patients (4.6%). Major complications occurred in 9.8% including permanent pacemaker implantation in 2.7%. Median postoperative length of stay (PLOS) was 8 days (interquartile range, 5-14 days). Overall hospital mortality was 3.0%

Median weight at surgery was 5.0 kg (IQR, 4.3-5.8)
6.3% (n = 151) weighing <3.5 kg.

Repair of CAVSD

Repair of CAVSD Prevalence of 1 of the major preoperative factors was greater in patients undergoing repair at age ≤ 2.5 months (14% vs 4%, P<.0001) Largely due to a higher frequency of preoperative mechanical ventilatory support (14% vs 3%; P<.0001). A better understanding of the associations between extremes of weight and age at repair and outcomes will require multi-variable analysis

STS CHSD Neonates undergoing Arterial Switch Operation for TGA +/- VSD 2,357 patients (84 centers, 155 surgeons) Median annual center ASO volume was 4 (range, 1 to18) Median annual surgeon ASO volume was 2 (range, 0.1 to 11) Multivariable logistic regression with adjustment for patient factors and ventricular septal defect closure was used to evaluate relationships between annual center and surgeon volume and a composite end-point (in-hospital mortality or major complications)

ASO: Influence of Surgeon and Center Case Volume

Patients younger than 1 year of age in the STS-CHSD ( ) Index operations were classified on the basis of 7 major diagnostic groups and 10 specific diagnoses The study included 23,379 patients (94 centers). Septal defects (26.2%) were the most frequently reported diagnostic group, and tetralogy of Fallot (10.6%) was the most frequent specific diagnosis.

MAJOR DIAGNOSTIC GROUPS SPECIFIC DIAGNOSES
1. Septal defects 2. Pulmonary venous anomalies 3. Right heart lesions 4. Left heart lesions 5. Single ventricle 6. Transposition of the great arteries and double-outlet ventricles 7. Coronary artery anomalies

Region assigned on the basis
of patient residence Significant variation across geographic regions with respect to relative prevalence was noted for all seven major diagnostic groups, and for 7 of the 10 specific diagnosis examined.

More Questions than Answers….
Are these differences meaningful from a public health perspective? Is there a need to better investigate the impact of environmental and socioeconomic factors, which may be associated with geographic regions? Could economic or payer mix variables impact approval for surgical intervention within certain regions? Could a better understanding of these patterns allow for more informed approaches toward regional and national programmatic planning and resource allocation?

Costello et al, Summary Neonates in the Society of Thoracic Surgeons Congenital Heart Surgery Database who underwent cardiac surgery Multivariable logistic regression was used to evaluate the association of gestational age at birth with in-hospital mortality, post-operative length of stay and complications, adjusting for other important patient characteristics. Of 4,784 included neonates (92 hospitals), 48% were born prior to 39 weeks gestation, including 31% at weeks.

Costello et al, Summary Compared with a 39.5 week gestational age reference level, birth at 37 weeks gestational age was associated with higher in-hospital mortality, with an adjusted odds ratio (95% C.I.) of 1.34 ( , p=0.02). Complication rates were higher and postoperative length of stay was significantly prolonged for those born at 37 and 38 weeks gestation (adjusted p<0.01 for all). Late-preterm births (34-36 weeks gestation) also had greater mortality and postoperative length of stay (adjusted p ≤ for all).

Conclusions In neonates who undergo cardiac surgery, optimal early outcomes are associated with delivery at weeks gestation. These data challenge the commonly held perception that delivery at any time during term gestation is equally safe and appropriate, and question the related practice of elective delivery of fetuses with complex congenital heart disease at early term. In the absence of fetal or maternal indications for earlier delivery, the potential advantages and risks of scheduling the elective delivery of fetuses with congenital heart disease prior to 39 weeks gestation should be carefully considered.

Methods: Patients (aged<18 years) in the STS Congenital Heart Surgery Database ( ) were included. Characteristics and outcomes of those receiving postoperative MCS were described, and Bayesian hierarchical models were used to examine variations in the adjusted MCS rates across institutions. Results: Of 96,596 operations (80 centers), MCS was used in 2.4%. The MCS patients were younger (13 vs 195 days, P<.0001) and more often had STS-defined preoperative risk factors (57.2% vs 32.7%, P<.0001).

Variation in Adjusted MCS rates Across Hospitals
Varied from 0.6% to 9.3% across the 80 hospitals included in this study (15-fold variation). Variation in post-operative MCS rates across hospitals, adjusted for any differences in patient characteristics and case mix, was evaluated. As displayed here, the median hospital-level adjusted MCS rate was 2.5%, and varied from 0.6% to 9.3% across the 80 hospitals included in this study (15-fold variation).

MCS Rate and Center Volume
Both high and low volume hospitals appeared to have substantial variation in MCS rates. Adjusted post-operative MCS rates are listed for each hospital in order of increasing average annual total cardiac surgical volume with low volume centers on the left and high volume centers on the right (black box represents adjusted estimate and lines indicate 95% confidence intervals). The horizontal dotted line indicates the post-operative MCS rate in the overall cohort. This plot of each hospital’s MCS rate vs. total surgical volume did not demonstrate a clear overall relationship. Both high and low volume hospitals appeared to have substantial variation in MCS rates.

Conclusions: Perioperative MCS use varied widely across centers.
The MCS rates were greatest overall for the Norwood procedure and complex biventricular repairs. Although MCS can be a life-saving therapy, more than one half of MCS patients will not survive to hospital discharge, with mortality > 70% for some operations.

Infants (≤ 60 days) in STS CHSD (2010-2012) : initial palliation for HLHS
1728 patients at 100 centers 1496 patients (87%) underwent an index Norwood 232 patients (13%) underwent an index hybrid procedure. Preoperative patient risk factors were more prevalent hybrid procedure group

Only 13 of 100 institutions were high hybrid users (≥ 50%), and these tended to have lower annual hypoplastic left heart syndrome index case volume. Unadjusted in-hospital mortality was higher for the hybrid compared with the Norwood procedure (30%vs 16%; P<.001). In-hospital mortality for the hybrid procedure was not associated with hybrid use (26% among institutions with low use vs 28% among institutions with high use). However, centers with high hybrid use had higher mortality after the Norwood (43%) compared with centers with low hybrid use (16%).

Conclusions Few centers currently select the hybrid procedure for most infants with HLHS. Although unadjusted in-hospital hybrid mortality is higher than Norwood mortality, potential risk factors are more prevalent among hybrid cases. Institutions with higher hybrid use have lower HLHS case volume and higher Norwood mortality

STS Database Research in 2014
11 peer reviewed manuscripts based on analysis of data in the STS-CHSD have been published, 3 more accepted and currently in press. Additional research based on analysis of data in the STS-CHSD include 2 papers at the 2014 CHSS 4 at the 2014 STSA 3 at the American Heart Association Scientific Sessions 2 at STS 2015

“Science tells us what we can do; Guidelines what we should do; &
Registries what we are actually doing.”

11/16/2018

Vyas Kartha

Congenital Cardiac Surgery Database

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