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J Thorac Cardiovasc Surg 2002;123:6-7
© 2002 The American Association for Thoracic Surgery

Editorials

Congenital heart disease outcome analysis: Methodology and rationale

From the Division of Cardiovascular-Thoracic Surgery, Children's Memorial Hospital, Chicago, Ill, and Cardiac-Surgical Associates, All Children's Hospital, University of South Florida, St Petersburg, Fla.

Received for publication July 11, 2001. Accepted for publication July 20, 2001. Address for reprints: Constantine Mavroudis, MD, Division of Cardiovascular-Thoracic Surgery, Children's Memorial Hospital, 2300 Children's Place, m/c 22, Chicago, IL 60614-3394 (E-mail: cmavroudis{at}childrensmemorial.org).

See related article on page 110.

Jenkins and associates ¹ have presented an article describing center-specific mortality differences during the year 1996 based on hospital discharge data from 6 states in which more than 100 operations were performed for congenital heart disease (age < 18 years). They used a consensus-based risk-adjusted scheme, congenital heart surgery-1 (RACHS-1), to stratify procedures for congenital heart disease (procedure driven) in 6 groups (1-6, with 1 indicating easy and 6, difficult).

Jenkins and colleagues ^1-3 are to be congratulated for another significant contribution to the field of outcome analysis in pediatric cardiac surgery. Several previous articles have concluded that both annual surgeon volume and annual hospital volume are significantly (inversely) related to mortality rate. ^2,4-9 However, this conclusion is not universal. ¹⁰ Other studies conclude that there are no data to conclusively indicate that outcomes of cardiac operations are related to a specific minimum number of cases performed annually by a cardiac surgeon ¹¹ or center. ¹⁰ Furthermore, the case mix of a surgeon or program must be carefully considered when evaluating outcomes. ¹² Data validity and accuracy represent additional potentially confounding variables—it has been demonstrated that patients not included in medical audits have a worse outcome than those included. ¹³ In other words, patients not included in an outcomes registry are more likely to have higher mortality and morbidity rates than those included.

Although a general trend may exist that higher volume surgeons and centers have better outcomes than their lower volume counterparts, this trend does not automatically apply to all surgeons and centers. Many lower volume surgeons and centers have excellent results. The Society of Thoracic Surgeons (STS) Congenital Heart Committee agrees that each cardiothoracic surgeon and center should participate in an international database that permits comparison of their outcomes on a risk-adjusted basis with other surgeons or programs for the purpose of improving the quality of care at their own institution. ¹¹ Unless conclusive data become available that link volume to outcome, volume alone should not be used as a criterion for credentialing of cardiac surgeons or hospitals by managed care groups, governmental agencies, or others. Instead, all surgeons and centers should be evaluated on the basis of their individual results.

The STS Congenital Heart Committee also believes that outcome analysis of pediatric cardiac surgery should be physician driven, under the auspices of physician-led societies like the STS, which supports a National and International Congenital Heart Surgery Database. Surgeons and surgical societies, with the assistance of cardiologists, should be responsible for outcome analysis of short-term cardiac surgical results. The effects of longer crossclamp times, the evaluation of new technology, and the implementation of new operations, among others, are best evaluated by surgeons who participate in data analysis, program evaluation, and critical review. Cardiologists and cardiology societies, with the assistance of surgeons, should be responsible for outcome analysis of long-term cardiac surgical results, long-term catheter-based therapeutics, and long-term nonsurgical therapy.

The issue of risk stratification and evaluation of center case mix is a more daunting task. Jenkins and associates have used a consensus-based method for risk adjustment for operations for congenital heart disease. A consensus-based risk-adjusted scheme means that learned and experienced observers give their considered opinion to rank surgical cases in an arbitrary array of numbered categories ranging from easiest to most difficult, in this case 1 to 6, 6 being the most difficult. Lacour-Gayet* has begun a more organized and more surgery-driven consensus-based risk-adjusted scheme. He polled more than 100 senior congenital heart surgeons from Europe and North America to reach a risk-adjusted scheme based on technical difficulty of the operation, expected mortality, expected morbidity, and expected length of stay. These data are being compiled now and will be published within the next year. Of course, the more important data to describe risk stratification will be forthcoming from the organized and prospective format of the STS Congenital Heart Surgery Database Project. Analysis of these data will eventually provide mathematical models for prospective and accurate risk adjustment.

This article is well intentioned and virtuous. Hospital discharge data, however, may not be the best way to evaluate a congenital heart surgery program. Validation of discharge diagnoses, complications, and causes of death are difficult at best. Jenkins and associates have given us a "snapshot" of extant congenital heart programs. More accurate data through organized database programs, which participate in data validation and risk stratification, should replace these kinds of patient discharge-driven analyses.

An international pediatric cardiac surgery database can facilitate these efforts. The field of surgery for congenital heart disease has the unique opportunity to create the first comprehensive international database for a medical subspecialty. Two concepts support this possibility: the demographics of congenital heart disease and the rate of development of computer technology. Surgery-driven validated risk-adjusted outcome analysis can indeed lead to improvements in performance by both individual cardiac surgeons and cardiac surgery centers. The benefits of international data gathering and sharing are global, with the long-term goal of the continued upgrade in the quality of surgery for congenital heart disease worldwide.

The specific mechanisms to achieve these improvements are multifactorial and can be implemented in a number of ways. First and foremost, participating centers should not fear the potentially negative consequences of reporting less than stellar results. The point is to identify the problems and institute improvement initiatives, which can include interinstitutional team visits, mentoring schemes, and educational programs. These kinds of interinstitutional visits have succeeded in improving coronary artery bypass outcomes in northern New England ¹⁴ and can be implemented on a national and international basis. Some North American programs could significantly benefit, especially in neonatal surgery. The opportunity to favorably affect governmental, economic, and social circumstances in developing countries remains an intriguing unknown with a myriad of possibilities. ¹⁵

Footnotes

*Lacour-Gayet. Consensus based risk stratification for congenital heart surgery in association with the European Association of Cardiothoracic Surgery, Society of Thoracic Surgeons, and Congenital Heart Surgeons Society. In preparation.

References

1. Jenkins KJ, Gauvreau K, Newburger JW, Spray TL, Moller JH, Iezzoni LI. Consensus-based method for risk adjustment for surgery for congenital heart disease. J Thorac Cardiovasc Surg. 2002;123:110-8.[Abstract/Free Full Text]
   
2. Jenkins KJ, Newburger JW, Lock JE, Davis RB, Coffman GA, Iezzoni LI. In-hospital mortality for surgical repair of congenital heart defects: preliminary observations of variation by hospital caseload. Pediatrics. 1995;95:323-30.[Abstract/Free Full Text]
   
3. Jenkins KJ, Gauvreau K, Newburger JW, Kyn LB, Iezzoni LI, Mayer JE. Validation of relative value scale for congenital heart operations. Ann Thorac Surg. 1998;66:860-9.[Abstract/Free Full Text]
   
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8. Hannan EL, Kumar D, Racz M, Siu AL, Chassin MR New York State's Cardiac Surgery Reporting System: four years later. Ann Thorac Surg. 1994;58:1852-7.[Abstract]
   
9. Hannan EL, Kilburn H Jr, Bernard H, O'Donnell JF, Lukacik G, Shields EP. Coronary artery bypass surgery: the relationship between in hospital mortality rate and surgical volume after controlling for clinical risk factors. Med Care. 1991;29:1094-107.[Medline]
   
10. Shroyer AL, Marshall G, Warner BA, Johnson RR, Guo W, Grover FL, et al. No continuous relationship between Veterans Affairs hospital coronary artery bypass grafting surgical volume and operative mortality. Ann Thorac Surg. 1996;61:17-20.[Abstract/Free Full Text]
    
11. Crawford FA Jr, Anderson RP, Clark RE, Grover FL, Kouchoukos NT, Waldhausen JA, et al. Volume requirements for cardiac surgery credentialing: a critical examination. The Ad Hoc Committee on Cardiac Surgery Credentialing of The Society of Thoracic Surgeons. Ann Thorac Surg. 1996;61:12-6.[Abstract/Free Full Text]
    
12. Elfstrom J, Troeng T, Stubberod A. Adjusting outcome measurements for case-mix in a vascular surgical register—Is it possible and desirable? Eur J Vasc Endovasc Surg. 1996;12:459-63.[Medline]
    
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This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Constantine Mavroudis Jeffrey P. Jacobs Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mavroudis, C. Articles by Jacobs, J. P. Search for Related Content PubMed PubMed Citation Articles by Mavroudis, C. Articles by Jacobs, J. P. Related Collections Congenital - acyanotic Congenital - cyanotic Professional affairs Related Article