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• W1799166765 abstract "HomeCirculationVol. 132, No. 20Ongoing Evolution of Outcomes Analysis for Pediatric and Congenital Cardiac Catheterization Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBOngoing Evolution of Outcomes Analysis for Pediatric and Congenital Cardiac Catheterization Kevin D. Hill, MD, MS and Jeffrey P. Jacobs, MD Kevin D. HillKevin D. Hill From Duke University Children’s Hospital, Durham, NC (K.D.H.); Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD (J.P.J.); and Division of Cardiovascular Surgery, Department of Surgery Johns Hopkins All Children’s Heart Institute, All Children’s Hospital and Florida Hospital for Children, Saint Petersburg, Tampa, and Orlando, FL (J.P.J.). Search for more papers by this author and Jeffrey P. JacobsJeffrey P. Jacobs From Duke University Children’s Hospital, Durham, NC (K.D.H.); Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD (J.P.J.); and Division of Cardiovascular Surgery, Department of Surgery Johns Hopkins All Children’s Heart Institute, All Children’s Hospital and Florida Hospital for Children, Saint Petersburg, Tampa, and Orlando, FL (J.P.J.). Search for more papers by this author Originally published19 Oct 2015https://doi.org/10.1161/CIRCULATIONAHA.115.019132Circulation. 2015;132:1853–1855Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: November 17, 2015: Previous Version 1 Jayaram and colleagues are to be congratulated for their important manuscript in this issue of Circulation.1 The IMproving Pediatric and Adult Congenital Treatment Registry (IMPACT) of the National Cardiovascular Data Registry (NCDR) of the American College of Cardiology is the largest registry, to date, collecting information on pediatric and adult patients with congenital heart disease undergoing diagnostic or interventional cardiac catheterization. Jayaram and colleagues used the IMPACT Registry to develop and internally validate a model to predict the occurrence of a major adverse event following cardiac catheterization, using a cohort of 19 608 cardiac catheterizations that were performed at 58 US centers between January 2011 and March 2013. A major adverse event occurred in 378 (1.9%) of all cases. After multivariable adjustment, 8 variables were identified as critical for risk-standardization: patient age, renal insufficiency, single-ventricle physiology, procedure-type risk group, low systemic saturation, low mixed venous saturation, elevated systemic ventricular end diastolic pressure, and elevated main pulmonary artery pressures. The model had good discrimination (C-statistic of 0.70), confirmed by bootstrap validation (validation C-statistic of 0.69).Article see p 1863The development by IMPACT of this model to predict the occurrence of a major adverse event following pediatric or adult congenital cardiac catheterization represents an important contribution that enhances the rapidly expanding armamentarium of tools available to analyze the outcomes and assess the quality of pediatric and congenital cardiac care. Just recently, the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) published an updated risk model for congenital heart surgery.2,3 Similar to the IMPACT risk model, the STS-CHSD risk model improved on previous procedural risk models by incorporating patient level risk factors as covariates.Empirically-based risk models such as these are particularly important in the field of pediatric and adult congenital cardiac care because of the tremendous heterogeneity in our patient population, both in terms of baseline demographics and risk factors, and in the complexity of diagnoses and procedures. Consider, for example, that the STS-CHSD includes 205 different diagnostic codes and 207 different surgical procedures.4 Center-level differences in case-mix significantly complicate efforts to develop appropriate performance measures, a problem that is further compounded by the variable impact of patient age on outcomes. The IMPACT database is the first nationally representative pediatric catheterization database in the United States and it was designed first and foremost as a quality improvement initiative.5 Participants in the registry receive quarterly reports describing their procedural volumes and outcomes relative to other programs. With the aid of this current risk model, participants may soon be able to compare their outcomes to appropriately risk-adjusted national benchmarks. These data can serve as a powerful stimulus for quality improvement.Beyond benchmarking, the IMPACT risk model also provides data regarding baseline patient risk that can be used to facilitate decisions to proceed with a catheterization procedure or an intervention. For example, the current model demonstrates the significantly increased risk of a catheterization-related major adverse event for a neonate (adjusted odds = 1.81 when compared to infants [95% CI, 1.20, 2.70]), a patient with baseline renal insufficiency (adjusted odds = 2.61 [95% CI, 1.69, 4.01]) or a patient with functionally univentricular physiology (adjusted odds = 1.37 [95% CI, 1.07, 1.75]). An added benefit of a catheterization-based risk model is the ability to incorporate baseline hemodynamic data into the risk assessment.There is 1 major caveat to the current risk model. The primary end point of the model represents a composite outcome measure, including: cardiac arrest, tamponade, embolic stroke within 72 hours of the catheterization, device malposition or thrombus requiring surgery, device embolization, new requirement for dialysis, event requiring ECMO, event requiring LVAD, and unplanned cardiac or vascular surgery due to a catheterization complication or subsequent catheterization due to a catheterization complication. These variables were specifically and appropriately chosen as they represent adverse events that are both collected by the database and that can be directly attributed to the catheterization procedure. Notably absent is procedural mortality. This decision to exclude mortality as an end point was made because the IMPACT registry currently has no means to differentiate whether hospital mortality after a catheterization is a direct result of the catheterization procedure or a consequence of some other unrelated factor (eg, a postcatheterization surgical procedure). In a prior analysis from IMPACT, in-hospital mortality occurred after 2.1% of all catheterization procedures but only 4% of these mortalities were intraprocedural and 64% occurred more than 7 days after the catheterization.6 Thus, it is likely that many of the deaths in the IMPACT registry are not directly attributed to the catheterization procedure. Recognizing this observation, the investigators chose to exclude mortality as an end point in the current model. Reassuringly, they performed a sensitivity analysis including all-cause mortality with similar model discrimination (C-statistic = 0.77). Plans are already in place to modify the elements of data in IMPACT so as to better differentiate procedural mortality from all-cause mortality, although admittedly this differentiation is not always as simple as it may sound.This current IMPACT model builds on previous work and a risk model developed using the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry.7 The C3PO Catheterization for Congenital Heart Disease Adjustment for Risk Method (CHARM) identified threshold values for hemodynamic vulnerability and also helped define and validate the subset of 4 procedural risk groups (ranked from lowest to highest risk) that were incorporated into the current model. Some may question whether we need another pediatric catheterization risk-model. The CHARM risk model had a similar discriminatory ability to the current risk model (C-statistic = 0.737), was published just 4 years ago, and incorporated many of the same covariates as the current risk model. However, risk models inherently represent processes in evolution, requiring continuous refinement and optimization to reflect current patterns of practice, as well as the patients and centers represented in the database. The CHARM risk model was based on data from only 8 centers, all representing larger interventional programs. These CHARM data may not appropriately reflect outcomes across a broader spectrum of centers, and a clear need therefore exists to use IMPACT-specific data to evaluate appropriate model covariates for the IMPACT database.Although the need for an IMPACT-specific risk model is clear, it is notable that the database has already evolved significantly since development of the present model; currently, almost twice as many centers submit data (an increase from 58 centers at the time of this analysis to 94 at present) and more than 4 times as many procedures are in IMPACT (an increase from 19 608 procedures at the time of this analysis to greater than 85 000 procedures at present). This growth of IMPACT highlights the tremendous success of the database but also suggests that the current risk model will require on-going fine-tuning to ensure that it continues to represent the optimal risk-adjustment algorithm. The IMPACT registry is a relatively young registry, and previous analyses have identified a need to refine the variables collected, in particular those related to adverse events.6 Moreover, the field of pediatric and adult congenital catheterization is evolving rapidly with expected continued evolution of interventional techniques, devices, and approaches. Indeed the authors were careful to identify as their primary objective “…to begin development of a risk-standardization tool for the NCDR IMPACT registry.”1 Such evolution in risk-modeling is not unusual, and the STS-CHSD has undergone a similar process. Tools for risk stratification in STS-CHSD were previously published in 2009 and 2013.8–10 New risk models for pediatric and congenital cardiac surgery were published by STS this year, incorporating new patient level risk factors.2,3 This STS-CHSD Risk Model will be recalibrated semiannually (with every Feedback Report) to ensure that the model accurately reflects current practices. Moreover efforts are on-going to add morbidity as an outcome to these pediatric and congenital cardiac surgical risk models.From a broader perspective, there are potential longer-term implications for the field of pediatric and adult congenital interventional cardiology. With development of a national database for pediatric cardiac catheterization, and now a mechanism for fair comparison across institutions and providers, procedural outcomes will become an increasingly important benchmark for programs.Healthcare is embarking on a new era of increased transparency11–13 and public reporting of outcomes. It is possible, perhaps even likely, that these outcomes of interventional cardiology will eventually be publicly reported and also incorporated into national rating scales like the ranking of hospitals published by US News & World Report, just as pediatric cardiac surgical outcomes are currently publicly reported and included in the ranking of hospitals published by US News & World Report. With this possibility in mind, it is important to recognize that measurement of morbidity as an outcome represents only 1 component of performance. Efficacy is of course similarly important, and in this respect, catheterization, because it encompasses both a diagnostic and interventional component, may differ subtly from congenital cardiac surgery.In conclusion, this risk-model developed by Jayaram and colleagues has the potential to change the field of pediatric and adult congenital interventional cardiology. Interventionalists will be waiting eagerly for the first IMPACT quarterly report that documents their risk-adjusted outcomes. For the first time, programs will be able to accurately compare their risk-adjusted outcomes to national aggregate data. This model is therefore an important and logical next step furthering the original objectives of the IMPACT database: to provide the framework for quality improvement efforts in the field of congenital interventional cardiology.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Jeffrey P. Jacobs, MD, FACS, FACC, FCCP, Division of Cardiovascular Surgery, John Hopkins All Children’s Heart Institute, 601 Fifth St S, Saint Petersburg, FL 33701. E-mail [email protected]References1. Jayaram N, Beekman RH, Benson L, Holzer R, Jenkins K, Kennedy KF, Martin GR, Moore JW, Ringel R, Rome J, Spertus JA, Vincent R, Bergersen L. Adjusting for risk associated with pediatric and congenital cardiac catheterization: a report from the NCDR IMPACT Registry.Circulation. 2015; 132:1863–1870. doi: 10.1161/CIRCULATIONAHA.114.014694.LinkGoogle Scholar2. Jacobs JP, O’Brien SM, Pasquali SK, Gaynor JW, Mayer JE, Karamlou T, Welke KF, Filardo G, Han JM, Kim S, Quintessenza JA, Pizarro C, Tchervenkov CI, Lacour-Gayet F, Mavroudis C, Backer CL, Austin EH, Fraser CD, Tweddell JS, Jonas RA, Edwards FH, Grover FL, Prager RL, Shahian DM, Jacobs ML. The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model: Part 2-Clinical Application.Ann Thorac Surg. 2015; 100:1063–1070. doi: 10.1016/j.athoracsur.2015.07.011.CrossrefMedlineGoogle Scholar3. O’Brien SM, Jacobs JP, Pasquali SK, Gaynor JW, Karamlou T, Welke KF, Filardo G, Han JM, Kim S, Shahian DM, Jacobs ML. The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model: Part 1-Statistical Methodology.Ann Thorac Surg. 2015; 100:1054–1062. doi: 10.1016/j.athoracsur.2015.07.014.CrossrefMedlineGoogle Scholar4. The Society of Thoracic Surgeons Congenital Heart Surgery Database Data Collection Form Version 3.22. http://www.sts.org/node/518. Accessed October 1, 2015.Google Scholar5. Martin GR, Beekman RH, Ing FF, Jenkins KJ, McKay CR, Moore JW, Ringel RE, Rome JJ, Ruiz CE, Vincent RN. The IMPACT registry: IMproving Pediatric and Adult Congenital Treatments.Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010; 13:20–25. doi: 10.1053/j.pcsu.2010.02.004.CrossrefMedlineGoogle Scholar6. Vincent RN, Moore J, Beekman RH, Benson L, Bergersen L, Holzer R, Jayaram N, Jenkins K, Ringel R, Rome J, Martin GR. Procedural characteristics and adverse events in diagnostic and interventional catheterisations in paediatric and adult CHD: initial report from the IMPACT Registry.Cardiol Young. 2015:1–9.Google Scholar7. Bergersen L, Gauvreau K, Foerster SR, Marshall AC, McElhinney DB, Beekman RH, Hirsch R, Kreutzer J, Balzer D, Vincent J, Hellenbrand WE, Holzer R, Cheatham JP, Moore JW, Burch G, Armsby L, Lock JE, Jenkins KJ. Catheterization for Congenital Heart Disease Adjustment for Risk Method (CHARM).JACC Cardiovasc Interv. 2011; 4:1037–1046. doi: 10.1016/j.jcin.2011.05.021.CrossrefMedlineGoogle Scholar8. O’Brien SM, Clarke DR, Jacobs JP, Jacobs ML, Lacour-Gayet FG, Pizarro C, 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.J Thorac Cardiovasc Surg. 2009; 138:1139–1153. doi: 10.1016/j.jtcvs.2009.03.071.CrossrefMedlineGoogle Scholar9. 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, 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. 2012; 42:775–9; discussion 779. doi: 10.1093/ejcts/ezs026.CrossrefMedlineGoogle Scholar10. Jacobs ML, O’Brien SM, Jacobs JP, Mavroudis C, Lacour-Gayet F, Pasquali SK, Welke K, Pizarro C, Tsai F, Clarke DR. An empirically based tool for analyzing morbidity associated with operations for congenital heart disease.J Thorac Cardiovasc Surg. 2013; 145:1046–1057.e1. doi: 10.1016/j.jtcvs.2012.06.029.CrossrefMedlineGoogle Scholar11. Jacobs JP, Cerfolio RJ, Sade RM. The ethics of transparency: publication of cardiothoracic surgical outcomes in the lay press.Ann Thorac Surg. 2009; 87:679–686. doi: 10.1016/j.athoracsur.2008.12.043.CrossrefMedlineGoogle Scholar12. Shahian DM, Edwards FH, Jacobs JP, Prager RL, Normand SL, Shewan CM, O’Brien SM, Peterson ED, Grover FL. Public reporting of cardiac surgery performance: Part 1–history, rationale, consequences.Ann Thorac Surg. 2011; 92(3 Suppl):S2–11. doi: 10.1016/j.athoracsur.2011.06.100.CrossrefMedlineGoogle Scholar13. Shahian DM, Edwards FH, Jacobs JP, Prager RL, Normand SL, Shewan CM, O’Brien SM, Peterson ED, Grover FL. Public reporting of cardiac surgery performance: Part 2–implementation.Ann Thorac Surg. 2011; 92(3 Suppl):S12–S23. doi: 10.1016/j.athoracsur.2011.06.101.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Lasa J, Alali A, Minard C, Parekh D, Kutty S, Gaies M, Raymond T, Guerguerian A, Atkins D, Foglia E, Fink E, Roberts J, Duval-Arnould J, Bembea M, Kleinman M, Gupta P, Sutton R and Sawyer T (2019) Cardiopulmonary Resuscitation in the Pediatric Cardiac Catheterization Laboratory, Pediatric Critical Care Medicine, 10.1097/PCC.0000000000002038, 20:11, (1040-1047), Online publication date: 1-Nov-2019. Harolds J (2018) Quality and Safety in Health Care, Part XLI, Clinical Nuclear Medicine, 10.1097/RLU.0000000000002107, 43:11, (815-817), Online publication date: 1-Nov-2018. November 17, 2015Vol 132, Issue 20 Advertisement Article InformationMetrics © 2015 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.115.019132PMID: 26481777 Originally publishedOctober 19, 2015 Keywordsoutcome and process assessmentqualityquality assessmentEditorialsoutcomePDF download Advertisement SubjectsQuality and Outcomes" @default.
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