- Email: [email protected]
Issues in regionalization of pediatric cardiovascular care
Progress in Pediatric Cardiology 18 (2003) 49–53
Issues in regionalization of pediatric cardiovascular care James A. Quintessenza*, Jeffrey P. Jacobs, Victor O. Morrell The Congenital Heart Institute of Florida (CHIF), Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital, University of South Florida School of Medicine, 603 Seventh Street South, Suite 450, Cardiac Surgical Associates, St. Petersburg, FL 33701, USA Accepted 4 January 2003
Abstract The care of the pediatric cardiac patient and methods to improve quality of care are constant challenges. One way to optimize care is with the creation of ‘centers of excellence’ with high volumes and optimal outcomes. Comprehensive and coordinated regionalized programs of care may best achieve these goals. Descriptions and reasons for regionalized programs are discussed. Some of the issues relating to physicians, institutions and government in developing regionalized centers are included. The benefits of modern medical informatics are presented. With significant motivation and perseverance, physician leaders can organize to create truly special programs to care for the congenital heart patient. 䊚 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Pediatric cardiac ‘centers of excellence’; Regionalized pediatric cardiac care; Optimal outcomes in pediatric cardiac care; Congenital heart disease
1. Introduction
2. Demographics
The care of the patient with congenital heart disease is one of the most challenging and rewarding aspects of modern medicine. Forty years ago, the diagnosis of ventricular septal defect was nearly a death sentence. Foresight, perseverance and courage of early cardiac caregivers led the way to today’s much improved outcomes. We continuously encounter new challenges, which require new solutions. An important goal today should be the creation of regionalized ‘centers of excellence’ that can improve care beyond what we currently achieve. Regionalization of cardiac care can be defined as the process of creating and maintaining a comprehensive, coordinated cardiac program to provide care to a region or population of patients. This article will discuss issues in the regionalized approach to care of the congenital heart patient, resulting in centers of excellence with high volumes and optimal outcomes: the creation of truly special programs of cardiac care that can ‘take things to the next level’.
Essential to creating a comprehensive regionalized approach to congenital cardiac care is an understanding of the demographics of congenital heart disease. Consideration must be given to population densities, live birth rates and the incidence of the various congenital lesions. The incidence of congenital heart disease in the general population is widely quoted as three to four cases in every 1000 live births (0.3–0.4%) w1–3x, but is occasionally referenced as affecting up to eight per 1000 live births (0.8%) w4,5x. Reviews of multiple case series yield an average rate of confirmed congenital heart disease of four cases per 1000 live births w1x. The risk in younger siblings of a child with congenital heart disease is approximately 2%. The etiology is unknown in most patients. Obviously, the incidence of any given lesion will vary from center to center depending on a variety of factors including institutional expertise and institutional acuity level w6x. Nevertheless, the following 18 diagnoses make up over 90% of surgically significant congenital heart disease: ventricular septal defect, atrial septal defect, patent ductus arteriosus, aortic coarctation, congenital aortic stenosis, tetralogy of Fallot, pulmonary stenosis,
*Corresponding author. Tel.: q1-727-822-6666; fax: q1-727-5510404. E-mail address: [email protected] (J.A. Quintessenza).
1058-9813/03/$ - see front matter 䊚 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S1058-9813(03)00076-6
50
J.A. Quintessenza et al. / Progress in Pediatric Cardiology 18 (2003) 49–53
transposition of the great arteries, pulmonary atresia (pulmonary atresia with intact ventricular septum and pulmonary atresia with ventricular septal defect), atrioventricular septal defect, tricuspid atresia, truncus arteriosus, total anomalous pulmonary venous connection, hypoplastic left heart syndrome, interrupted aortic arch, Ebstein’s anomaly, mitral stenosis, and aortopulmonary window. The numerous remaining lesions of congenital heart disease make up less than 10% of the patient population. A regionalized approach to congenital cardiac care will allow for both the optimum care of the common lesions listed above and the best care for patients with the rarer lesions. Based on population and birth rate data, it is possible to create a scenario of regionalized ‘congenital heart centers of excellence’. Centers can be geographically located with an effort to balance the issues of optimal care for the patient and travel distances for families. A regionalized approach to care requires a unified organization of physicians, institutions and possibly, governmental agencies to be realized. The absolute commitment to care for these patients must be paramount. 3. Rationale for regionalization There are numerous potential advantages in caring for congenital heart patients within a regionalized system. The clinical expertise generated by the large numbers of complex and difficult cases maximizes the clinical abilities of all the caregivers involved. Unusual lesions become routine and rare lesions, more familiar. For the cardiologist, cardiac surgeon, anesthesiologist or critical care specialist, honing volume sensitive skills is optimal. Large numbers of patients in a highly specialized field allow for the super sub-specialist, like the pediatric cardiac intensivist with enough individuals within the group to create reasonable call arrangements. Larger medical groups can afford professional management and allow physicians to focus more on clinical issues. Shear repetition affects a myriad of functions and activities within the institution and enhances overall processes. This principle applies not only to physicians but also nurses, respiratory therapists, social workers, and a variety of other health care professionals. Standards of care can be implemented for the most complex and unusual cases. Additionally, centers of excellence allow rational implementation of very expensive programs that are needed for small numbers of patients like transplantation or robotics. Lower mortality rates have been demonstrated for high volume hospitals caring for congenital heart patients. Jenkins w7–9x has studied the relationship of surgical volume to outcome and has demonstrated lower mortality at institutions with more than 300 cases per year, especially with highly complex cases w7x. Hannon
w10–12x examined the effect of hospital and surgical volume on mortality and showed a correlation with both hospital and surgeon volume, varying inversely with hospital mortality. The concept of regionalization is further supported by experiences outside the United States. Decreased mortality with centralization of pediatric cardiac care in Sweden was reported by Lundsrum w13x. In the early 1990s, for the population of 8.9 million, multiple centers in four cities performed pediatric heart surgery, with a mortality rate of 9.5%. With changes in referral and practice patterns, by the late 1990s, there were two centers in two cities, and mortality dropped to 1.9%. The experience in England, with a detailed inquiry to evaluate high mortality rates in Bristol w14x, supports strongly the concept of coordinated, outcome driven, regionalization to improve outcomes. Besides the practical data discussed in the preceding paragraphs, theoretical analysis supports regionalization. Chang recently examined the effect of regionalization utilizing a theoretical model w15x. This article predicted significant decreases in deaths for children who underwent cardiac surgery in California, by a theoretical reduction in the number of cardiac centers from 20 to 5. This decrease in mortality resulted in an average increase of travel time of only 12.7 miles per family. The current statements from the American Academy of Pediatrics w16x, March, 2002, suggest that although there is no consistent relationship between quality and low volume programs, high volume programs tend to ensure high quality outcomes. Many well known and experienced congenital heart surgeons are in favor of regionalization as a mechanism to provide high volume programs with high quality outcomes w17x. 4. The process of regionalization Creation of a regionalized approach to pediatric cardiovascular care can best be achieved through the cooperative efforts of three groups: 1. Physicians and other health care providers. 2. Hospitals and health care networks. 3. Government. 4.1. Physicians Physicians must come together to create such a regionalized program and must drive the process. This may include the development of mission and vision statements, which define the overall programs objectives. Such a statement could be the creation of the highest quality, highest volume congenital cardiac program for the region within a teaching and research environment. The goal is to improve the delivery of care in a more comprehensive and coordinated manner than was previously obtainable. Improving patient care
J.A. Quintessenza et al. / Progress in Pediatric Cardiology 18 (2003) 49–53
always represents the primary goal. Improved research, teaching, and community service are also very important goals. Depending on the specific circumstances, committed physician groups, such as cardiology, cardiac surgery, critical care, anesthesiology, and neonatology, need to align themselves to achieve the desired organizational structure. Governance and legal organizational items such as the creation of by-laws and a charter document may be necessary. An effective organization requires a strategic plan, evaluating internal and external strengths and weaknesses, opportunities and threats. A plan of action is essential. The application of sound business and management principles to efforts at regionalization may actually enhance the possibilities of realizing the program. Comprehensive congenital cardiac care involves numerous sub-programs of coordinated services. A cardiac center of excellence with a clinically enriched teaching and research environment can support a variety of these programs: 1. Extensive clinical cardiology regional networks. 2. Fetal and perinatal cardiology program. 3. Echocardiography and non-invasive cardiology program. 4. Cardiac catheterization program. a. Diagnostic cardiac catheterization. b. Interventional cardiac catheterization. 5. Electrophysiology program. 6. Transplant program. 7. Molecular cardiology program. 8. Adult congenital program. 9. Advanced neonatalycomplex surgical program. 10. Minimally invasive and robotic program. 11. Perfusion and mechanical support program. a. Basic perfusion services. b. Ventricular assist devices (VAD). c. Extra-corporeal membrane oxygenation (ECMO). 12. Basic science and clinical research program. 13. Graduate teaching and fellowship training program. A variety of impediments exist which can create challenges when trying to achieve this type of regionalized program. Individualistic physician’s desires, biases and wants are some examples. Often there is a sense of extreme differences amongst members of competing groups. In actuality, commonalities are greater. Partnering may be better than competing. Formation of larger physician groups with an inclusive attitude can optimize efficiencies in care by allowing individuals to do what they do best and minimizing duplicative work. Integration of larger physician groups over geographical distances can be enhanced by real time digital echocardiogram and angiogram transmission and video conferencing. Physician rivalries and competitive atti-
51
tudes are often difficult issues to resolve. These attitudes consume significant negative energy rather than allowing us to focus on what is really important. We should be optimizing patient care. 4.2. Hospitals Regionalized high quality programs with all of the components discussed above require unwavering institutional support to afford the optimal infrastructure necessary to deliver care. Design and physical space needs for state of the art catheterization and echocardiography labs, operating rooms, critical care units, and research facilities etc. are essential. Support is needed for excellence in nursing, respiratory therapy, physical therapy, occupational therapy, child life, social services, parent support groups, patient transport, family housing, marketing and contracting, educational conferences and seminars to name a few. Management of in-patient issues utilizing a cardiac service line manager can optimize the relationship between physician’s needs, institutional needs and patient’s needs, and provides continued focus on meeting ever-present daily challenges. Additionally, financial support for capital expenditures, both current and future, will allow the continued growth and development of the program. Patient and family centered care are essential. Creation of this type of environment costs time, energy, effort and money. Many physicians would choose to work in such a regionalized system; however, very few systems exist, especially in the USA. Institutional agendas may very much favor local market share and bottom-line-driven strategic plans. Often institutions desire to provide all services to all patients, despite the duplication of services, physician inefficiencies and lack of comprehensive care. Institutions often have little incentive to create a regionalized program, which can enhance care to a larger population base than the individual institution regards as their own market. Nevertheless, clear benefits to patient care were derived from institutional networking experiences such as the New England regional infant cardiac care program w2x in the late 1960s. This program enhanced interinstitution communication, education and transportation, and later resulted in consolidation of hospital services for pediatric cardiac patients within the region. More recently, the Northern New England Cardiovascular Disease Study Group w18x reported team visits to neighboring adult cardiac centers resulting in decreased mortality and morbidity due to benchmarking and information sharing. Physicians need a solid working relationship and clear lines of communication with administrators in an effort to influence institutional vision and strategic plans. Creative program models may be considered resulting in economies of scale with a positive financial impact. Perhaps these examples and
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J.A. Quintessenza et al. / Progress in Pediatric Cardiology 18 (2003) 49–53
other similar experiences can begin to help individual institutions to have a more regionalized perspective. 4.3. Government Finally, governmental influence can help support efforts at regionalization. Unfortunately, in the USA, lack of involvement in regulating these services is very often the case. Should we allow free market forces to determine the quality of care for something as precious as our children’s lives, especially when dealing with very rare, complex, technically sophisticated, and very expensive services, such as pediatric cardiac care delivery? Can the complex interrelationships of patient referral, delivery of care, and third party payers be controlled by simple supply and demand economics? Some states have a Certificate of Need (CON) program for openheart surgery. CON states determine the number of institutional providers based on demographics with a regional distribution of service in mind. At times, political agendas become quite intense with legal battles creating expensive and lengthy decisions or indecisions. There is some discussion regarding abolishment of such programs. Should this happen, there is significant concern regarding duplication of services, increasing costs, further fragmentation of services, worsening of already severe nursing shortages, and lower quality of care w19x. Florida is the fourth largest state in the USA. An analysis of the issues in regionalization of pediatric cardiovascular care for the State of Florida may shed further light on both the challenges of regionalization and the potential advantages. In Florida, Children’s Medical Service program (CMS), is a state supported, quality assurance program overseeing a variety of special medical need programs including pediatric cardiac care. In the past, CMS utilized a physician advisory counsel with cardiac standards and conducted site visits among member institutions for re-credentialing. It previously supported regionalized care and linked accreditation to state funding of services provided. State funding is no longer directly linked to CMS and the effective influence over delivery of care is markedly reduced. The State of Florida continues to struggle with support of the concept of regionalization vs. the concept of free market forces, in determining institutional and physician providers. Although difficult to accept by some, the most likely way to actually achieve regionalized care would be by state mandated ‘centers of excellence’. One possible scenario would be for an agency such as CMS to again link state funding for service (Medicaid) with credentialing of both institutions and providers. Physician led decisions could be made regarding designation of geographically located future centers of excellence, based on demographics. Current providers would continue to provide service where they currently are located but new provider
applications would be credentialed as needed to fulfill the needs of the designated centers of excellence. Over time, this could result in coordinated regionalized care with appropriate manpower geographically positioned. Physician leaders must be vocal in guiding governmental agendas. With practical realities in mind, they must maintain the focus on the optimal level of care as an ultimate goal for our patients. 5. The role of informatics During the early days of surgery for congenital disease, the goal was merely patient survival. Today, many programs treat all forms of complex congenital heart disease with survival rates of greater than 95%. With this remarkable improvement in patient survival, the needs for a more refined database and more sophisticated outcome measures to assess other quality of life parameters are ever present. These parameters are often more difficult to quantitate, and can be even more challenging to improve upon. Improved measuring tools within a regionalized system of care can most dramatically optimize care. Major advances in information technology can provide validated, complexity adjusted real time outcome analysis. We now have the opportunity to utilize one worldwide dataset for congenital heart disease and to optimize data collection, storage and analysis on a global scale w6,20–22x. An electronic medical record can facilitate the multi-institutional database. The technology is present to create a truly global system for medical information management. The field of congenital heart disease has the opportunity to lead the way with the long-term goal of the continued upgrade in the quality of congenital heart surgery worldwide. A well designed database is necessary to track outcomes and lead quality improvement initiatives as well as research efforts. The Society of Thoracic Surgeons (STS) Congenital Heart Committee 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 w21x. Relational databases with real time accurate data entry and validation, such as CardioAccess (CardioAccess Inc., Saint Petersburg, Florida and Fort Lauderdale, Florida) are essential. Process improvement is driven by multi-institutional outcome analysis with the utilization of a common universal nomenclature and database w22x, appropriate complexity stratification to adjust for variations in case-mix w23,24x, and mechanisms to assure data validity, accuracy and completeness w25x. Moreover, detailed outcome analysis will validate the benefits of regionalization.
J.A. Quintessenza et al. / Progress in Pediatric Cardiology 18 (2003) 49–53
6. Summary Numerous potential advantages support caring for congenital heart patients within a regionalized system. Creation of a regionalized approach to pediatric cardiovascular care can be achieved through the cooperative efforts of physicians, institutions and government. Advances in informatics and computer technology will facilitate these efforts. Many obstacles continue to be present. Physician groups must be motivated by a greater good for their patients, such as the creation of a truly special program for optimal care. Change is incremental and work is exponential. Tremendous positive energy abounds as progress is realized. It can be contagious. It is important to keep focusing on the ‘big picture’, and not allow 10% of the problems to over ride 90% of what is working well. Physician groups can organize to create high volume, high quality congenital heart programs. Problems require individualized solutions, which may be unique to a given geopolitical situation. Data and complexity adjusted outcome analysis should drive process improvement. Most importantly, commitment and perseverance of physician leaders can prevail over the many challenges. References w1x Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, et al. Congenital heart disease: prevalence at live birth—the Baltimore–Washington infant study. Am J Epidemiol 1985;121:31 –36. w2x Fyler DC, Buckley LP, Hellenbrand WE, et al. Report of the New England regional infant cardiac program. Pediatrics 1980;95:377 –461. w3x Spencer FC. Congenital heart disease. In: Schwartz SI, Shires GT, Spencer FC, editors. 5th ed. Principles of Surgery. New York: McGraw-Hill Book Company, 1989. p. 771 –841. w4x Commentary. Rational decision-making about paediatric cardiac surgery. The Lancet. 2000; 355: 948. w5x Gardiner K, Pemberton PJ, Ramsay J. Supraregional neonatal cardiac surgery works in Western Australia. BMJ 1998;317:811. w6x Jacobs JP. Software development, nomenclature schemes and mapping strategies and for an International Pediatric Cardiac Surgery Database System. 2002 Seminars in Thoracic and Cardiovascular Surgery: Pediatr Cardiac Surg Annu. January, 2002; 5(1): 153–162. w7x 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 –330 (Abstract).
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w8x 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 –869. w9x 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 –118 (AbstractyFull Text). w10x 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 – 1107 (Medline). w11x 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 –1857 (Abstract). w12x Hannan EL, Racz M, Kavey RE, Quaegebeur JM, Williams R. Pediatric cardiac surgery: the effect of hospital and surgeon volume on in-hospital mortality. Pediatrics 1998;101:963 –969 (AbstractyFull Text). w13x Lundstrom NR, Berggren H, Bjorkhem G, Jogi P, Sunnegardh J. Centralization of pediatric heart surgery in Sweden. Pediatr Cardiol 2000;21:353 –357 (Medline). w14x www.Bristol-Inquiry.org.uky. w15x Chang AC. How to start and sustain a successful pediatric cardiac intensive care program: a combined clinical and administrative strategy. Pediatr Crit Care Med 2002;3(2):1 –5. w16x Guidelines for pediatric cardiovascular centers. Section on Cardiology and Cardiac Surgery. American Academy of Pediatrics. Pediatrics. March, 2002; 109(3): 544–549. w17x Stark J. Glenn lecture. How to choose a cardiac surgeon. Circulation 1996;94(Suppl 9):II-1 –II-4. w18x O’Connor GT, Plume SK, Olmstead EM, Morton JR, Maloney CT, Nugent WC, et al. A regional intervention to improve the hospital mortality associated with coronary artery bypass graft surgery. The Northern New England Cardiovascular Disease Study Group. J Am Med Assoc 1996;275:841 –846 (Medline). w19x Rosenthal GE, Sarrazin MV. Impact of state certificate of need programs on outcomes of care for patients undergoing coronary bypass surgery. Report to the Florida Hospital Association. January 17, 2002. w20x Moore GE. Cramming more components onto integrated circuits. Electronics 1965;38(8). w21x Mavroudis C, Jacobs JP. Congenital heart disease outcome analysis: methodology and rationale. J Thorac Cardiovasc Surg 2001;123(1):6 –7. w22x Mavroudis C, Jacobs JP. International Congenital Heart Surgery Nomenclature and Database Project. Ann Thorac Surg. April, 2000; Supplement. w23x 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 –463 (Medline). w24x 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. w25x Elfstrom J, Stubberod A, Troeng T. Patients not included in medical audit have a worse outcome than those included. Int J Qual Health Care 1996;8:153 –157 (Abstract).
Issues in regionalization of pediatric cardiovascular care James A. Quintessenza*, Jeffrey P. Jacobs, Victor O. Morrell The Congenital Heart Institute of Florida (CHIF), Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital, University of South Florida School of Medicine, 603 Seventh Street South, Suite 450, Cardiac Surgical Associates, St. Petersburg, FL 33701, USA Accepted 4 January 2003
Abstract The care of the pediatric cardiac patient and methods to improve quality of care are constant challenges. One way to optimize care is with the creation of ‘centers of excellence’ with high volumes and optimal outcomes. Comprehensive and coordinated regionalized programs of care may best achieve these goals. Descriptions and reasons for regionalized programs are discussed. Some of the issues relating to physicians, institutions and government in developing regionalized centers are included. The benefits of modern medical informatics are presented. With significant motivation and perseverance, physician leaders can organize to create truly special programs to care for the congenital heart patient. 䊚 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Pediatric cardiac ‘centers of excellence’; Regionalized pediatric cardiac care; Optimal outcomes in pediatric cardiac care; Congenital heart disease
1. Introduction
2. Demographics
The care of the patient with congenital heart disease is one of the most challenging and rewarding aspects of modern medicine. Forty years ago, the diagnosis of ventricular septal defect was nearly a death sentence. Foresight, perseverance and courage of early cardiac caregivers led the way to today’s much improved outcomes. We continuously encounter new challenges, which require new solutions. An important goal today should be the creation of regionalized ‘centers of excellence’ that can improve care beyond what we currently achieve. Regionalization of cardiac care can be defined as the process of creating and maintaining a comprehensive, coordinated cardiac program to provide care to a region or population of patients. This article will discuss issues in the regionalized approach to care of the congenital heart patient, resulting in centers of excellence with high volumes and optimal outcomes: the creation of truly special programs of cardiac care that can ‘take things to the next level’.
Essential to creating a comprehensive regionalized approach to congenital cardiac care is an understanding of the demographics of congenital heart disease. Consideration must be given to population densities, live birth rates and the incidence of the various congenital lesions. The incidence of congenital heart disease in the general population is widely quoted as three to four cases in every 1000 live births (0.3–0.4%) w1–3x, but is occasionally referenced as affecting up to eight per 1000 live births (0.8%) w4,5x. Reviews of multiple case series yield an average rate of confirmed congenital heart disease of four cases per 1000 live births w1x. The risk in younger siblings of a child with congenital heart disease is approximately 2%. The etiology is unknown in most patients. Obviously, the incidence of any given lesion will vary from center to center depending on a variety of factors including institutional expertise and institutional acuity level w6x. Nevertheless, the following 18 diagnoses make up over 90% of surgically significant congenital heart disease: ventricular septal defect, atrial septal defect, patent ductus arteriosus, aortic coarctation, congenital aortic stenosis, tetralogy of Fallot, pulmonary stenosis,
*Corresponding author. Tel.: q1-727-822-6666; fax: q1-727-5510404. E-mail address: [email protected] (J.A. Quintessenza).
1058-9813/03/$ - see front matter 䊚 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S1058-9813(03)00076-6
50
J.A. Quintessenza et al. / Progress in Pediatric Cardiology 18 (2003) 49–53
transposition of the great arteries, pulmonary atresia (pulmonary atresia with intact ventricular septum and pulmonary atresia with ventricular septal defect), atrioventricular septal defect, tricuspid atresia, truncus arteriosus, total anomalous pulmonary venous connection, hypoplastic left heart syndrome, interrupted aortic arch, Ebstein’s anomaly, mitral stenosis, and aortopulmonary window. The numerous remaining lesions of congenital heart disease make up less than 10% of the patient population. A regionalized approach to congenital cardiac care will allow for both the optimum care of the common lesions listed above and the best care for patients with the rarer lesions. Based on population and birth rate data, it is possible to create a scenario of regionalized ‘congenital heart centers of excellence’. Centers can be geographically located with an effort to balance the issues of optimal care for the patient and travel distances for families. A regionalized approach to care requires a unified organization of physicians, institutions and possibly, governmental agencies to be realized. The absolute commitment to care for these patients must be paramount. 3. Rationale for regionalization There are numerous potential advantages in caring for congenital heart patients within a regionalized system. The clinical expertise generated by the large numbers of complex and difficult cases maximizes the clinical abilities of all the caregivers involved. Unusual lesions become routine and rare lesions, more familiar. For the cardiologist, cardiac surgeon, anesthesiologist or critical care specialist, honing volume sensitive skills is optimal. Large numbers of patients in a highly specialized field allow for the super sub-specialist, like the pediatric cardiac intensivist with enough individuals within the group to create reasonable call arrangements. Larger medical groups can afford professional management and allow physicians to focus more on clinical issues. Shear repetition affects a myriad of functions and activities within the institution and enhances overall processes. This principle applies not only to physicians but also nurses, respiratory therapists, social workers, and a variety of other health care professionals. Standards of care can be implemented for the most complex and unusual cases. Additionally, centers of excellence allow rational implementation of very expensive programs that are needed for small numbers of patients like transplantation or robotics. Lower mortality rates have been demonstrated for high volume hospitals caring for congenital heart patients. Jenkins w7–9x has studied the relationship of surgical volume to outcome and has demonstrated lower mortality at institutions with more than 300 cases per year, especially with highly complex cases w7x. Hannon
w10–12x examined the effect of hospital and surgical volume on mortality and showed a correlation with both hospital and surgeon volume, varying inversely with hospital mortality. The concept of regionalization is further supported by experiences outside the United States. Decreased mortality with centralization of pediatric cardiac care in Sweden was reported by Lundsrum w13x. In the early 1990s, for the population of 8.9 million, multiple centers in four cities performed pediatric heart surgery, with a mortality rate of 9.5%. With changes in referral and practice patterns, by the late 1990s, there were two centers in two cities, and mortality dropped to 1.9%. The experience in England, with a detailed inquiry to evaluate high mortality rates in Bristol w14x, supports strongly the concept of coordinated, outcome driven, regionalization to improve outcomes. Besides the practical data discussed in the preceding paragraphs, theoretical analysis supports regionalization. Chang recently examined the effect of regionalization utilizing a theoretical model w15x. This article predicted significant decreases in deaths for children who underwent cardiac surgery in California, by a theoretical reduction in the number of cardiac centers from 20 to 5. This decrease in mortality resulted in an average increase of travel time of only 12.7 miles per family. The current statements from the American Academy of Pediatrics w16x, March, 2002, suggest that although there is no consistent relationship between quality and low volume programs, high volume programs tend to ensure high quality outcomes. Many well known and experienced congenital heart surgeons are in favor of regionalization as a mechanism to provide high volume programs with high quality outcomes w17x. 4. The process of regionalization Creation of a regionalized approach to pediatric cardiovascular care can best be achieved through the cooperative efforts of three groups: 1. Physicians and other health care providers. 2. Hospitals and health care networks. 3. Government. 4.1. Physicians Physicians must come together to create such a regionalized program and must drive the process. This may include the development of mission and vision statements, which define the overall programs objectives. Such a statement could be the creation of the highest quality, highest volume congenital cardiac program for the region within a teaching and research environment. The goal is to improve the delivery of care in a more comprehensive and coordinated manner than was previously obtainable. Improving patient care
J.A. Quintessenza et al. / Progress in Pediatric Cardiology 18 (2003) 49–53
always represents the primary goal. Improved research, teaching, and community service are also very important goals. Depending on the specific circumstances, committed physician groups, such as cardiology, cardiac surgery, critical care, anesthesiology, and neonatology, need to align themselves to achieve the desired organizational structure. Governance and legal organizational items such as the creation of by-laws and a charter document may be necessary. An effective organization requires a strategic plan, evaluating internal and external strengths and weaknesses, opportunities and threats. A plan of action is essential. The application of sound business and management principles to efforts at regionalization may actually enhance the possibilities of realizing the program. Comprehensive congenital cardiac care involves numerous sub-programs of coordinated services. A cardiac center of excellence with a clinically enriched teaching and research environment can support a variety of these programs: 1. Extensive clinical cardiology regional networks. 2. Fetal and perinatal cardiology program. 3. Echocardiography and non-invasive cardiology program. 4. Cardiac catheterization program. a. Diagnostic cardiac catheterization. b. Interventional cardiac catheterization. 5. Electrophysiology program. 6. Transplant program. 7. Molecular cardiology program. 8. Adult congenital program. 9. Advanced neonatalycomplex surgical program. 10. Minimally invasive and robotic program. 11. Perfusion and mechanical support program. a. Basic perfusion services. b. Ventricular assist devices (VAD). c. Extra-corporeal membrane oxygenation (ECMO). 12. Basic science and clinical research program. 13. Graduate teaching and fellowship training program. A variety of impediments exist which can create challenges when trying to achieve this type of regionalized program. Individualistic physician’s desires, biases and wants are some examples. Often there is a sense of extreme differences amongst members of competing groups. In actuality, commonalities are greater. Partnering may be better than competing. Formation of larger physician groups with an inclusive attitude can optimize efficiencies in care by allowing individuals to do what they do best and minimizing duplicative work. Integration of larger physician groups over geographical distances can be enhanced by real time digital echocardiogram and angiogram transmission and video conferencing. Physician rivalries and competitive atti-
51
tudes are often difficult issues to resolve. These attitudes consume significant negative energy rather than allowing us to focus on what is really important. We should be optimizing patient care. 4.2. Hospitals Regionalized high quality programs with all of the components discussed above require unwavering institutional support to afford the optimal infrastructure necessary to deliver care. Design and physical space needs for state of the art catheterization and echocardiography labs, operating rooms, critical care units, and research facilities etc. are essential. Support is needed for excellence in nursing, respiratory therapy, physical therapy, occupational therapy, child life, social services, parent support groups, patient transport, family housing, marketing and contracting, educational conferences and seminars to name a few. Management of in-patient issues utilizing a cardiac service line manager can optimize the relationship between physician’s needs, institutional needs and patient’s needs, and provides continued focus on meeting ever-present daily challenges. Additionally, financial support for capital expenditures, both current and future, will allow the continued growth and development of the program. Patient and family centered care are essential. Creation of this type of environment costs time, energy, effort and money. Many physicians would choose to work in such a regionalized system; however, very few systems exist, especially in the USA. Institutional agendas may very much favor local market share and bottom-line-driven strategic plans. Often institutions desire to provide all services to all patients, despite the duplication of services, physician inefficiencies and lack of comprehensive care. Institutions often have little incentive to create a regionalized program, which can enhance care to a larger population base than the individual institution regards as their own market. Nevertheless, clear benefits to patient care were derived from institutional networking experiences such as the New England regional infant cardiac care program w2x in the late 1960s. This program enhanced interinstitution communication, education and transportation, and later resulted in consolidation of hospital services for pediatric cardiac patients within the region. More recently, the Northern New England Cardiovascular Disease Study Group w18x reported team visits to neighboring adult cardiac centers resulting in decreased mortality and morbidity due to benchmarking and information sharing. Physicians need a solid working relationship and clear lines of communication with administrators in an effort to influence institutional vision and strategic plans. Creative program models may be considered resulting in economies of scale with a positive financial impact. Perhaps these examples and
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other similar experiences can begin to help individual institutions to have a more regionalized perspective. 4.3. Government Finally, governmental influence can help support efforts at regionalization. Unfortunately, in the USA, lack of involvement in regulating these services is very often the case. Should we allow free market forces to determine the quality of care for something as precious as our children’s lives, especially when dealing with very rare, complex, technically sophisticated, and very expensive services, such as pediatric cardiac care delivery? Can the complex interrelationships of patient referral, delivery of care, and third party payers be controlled by simple supply and demand economics? Some states have a Certificate of Need (CON) program for openheart surgery. CON states determine the number of institutional providers based on demographics with a regional distribution of service in mind. At times, political agendas become quite intense with legal battles creating expensive and lengthy decisions or indecisions. There is some discussion regarding abolishment of such programs. Should this happen, there is significant concern regarding duplication of services, increasing costs, further fragmentation of services, worsening of already severe nursing shortages, and lower quality of care w19x. Florida is the fourth largest state in the USA. An analysis of the issues in regionalization of pediatric cardiovascular care for the State of Florida may shed further light on both the challenges of regionalization and the potential advantages. In Florida, Children’s Medical Service program (CMS), is a state supported, quality assurance program overseeing a variety of special medical need programs including pediatric cardiac care. In the past, CMS utilized a physician advisory counsel with cardiac standards and conducted site visits among member institutions for re-credentialing. It previously supported regionalized care and linked accreditation to state funding of services provided. State funding is no longer directly linked to CMS and the effective influence over delivery of care is markedly reduced. The State of Florida continues to struggle with support of the concept of regionalization vs. the concept of free market forces, in determining institutional and physician providers. Although difficult to accept by some, the most likely way to actually achieve regionalized care would be by state mandated ‘centers of excellence’. One possible scenario would be for an agency such as CMS to again link state funding for service (Medicaid) with credentialing of both institutions and providers. Physician led decisions could be made regarding designation of geographically located future centers of excellence, based on demographics. Current providers would continue to provide service where they currently are located but new provider
applications would be credentialed as needed to fulfill the needs of the designated centers of excellence. Over time, this could result in coordinated regionalized care with appropriate manpower geographically positioned. Physician leaders must be vocal in guiding governmental agendas. With practical realities in mind, they must maintain the focus on the optimal level of care as an ultimate goal for our patients. 5. The role of informatics During the early days of surgery for congenital disease, the goal was merely patient survival. Today, many programs treat all forms of complex congenital heart disease with survival rates of greater than 95%. With this remarkable improvement in patient survival, the needs for a more refined database and more sophisticated outcome measures to assess other quality of life parameters are ever present. These parameters are often more difficult to quantitate, and can be even more challenging to improve upon. Improved measuring tools within a regionalized system of care can most dramatically optimize care. Major advances in information technology can provide validated, complexity adjusted real time outcome analysis. We now have the opportunity to utilize one worldwide dataset for congenital heart disease and to optimize data collection, storage and analysis on a global scale w6,20–22x. An electronic medical record can facilitate the multi-institutional database. The technology is present to create a truly global system for medical information management. The field of congenital heart disease has the opportunity to lead the way with the long-term goal of the continued upgrade in the quality of congenital heart surgery worldwide. A well designed database is necessary to track outcomes and lead quality improvement initiatives as well as research efforts. The Society of Thoracic Surgeons (STS) Congenital Heart Committee 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 w21x. Relational databases with real time accurate data entry and validation, such as CardioAccess (CardioAccess Inc., Saint Petersburg, Florida and Fort Lauderdale, Florida) are essential. Process improvement is driven by multi-institutional outcome analysis with the utilization of a common universal nomenclature and database w22x, appropriate complexity stratification to adjust for variations in case-mix w23,24x, and mechanisms to assure data validity, accuracy and completeness w25x. Moreover, detailed outcome analysis will validate the benefits of regionalization.
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6. Summary Numerous potential advantages support caring for congenital heart patients within a regionalized system. Creation of a regionalized approach to pediatric cardiovascular care can be achieved through the cooperative efforts of physicians, institutions and government. Advances in informatics and computer technology will facilitate these efforts. Many obstacles continue to be present. Physician groups must be motivated by a greater good for their patients, such as the creation of a truly special program for optimal care. Change is incremental and work is exponential. Tremendous positive energy abounds as progress is realized. It can be contagious. It is important to keep focusing on the ‘big picture’, and not allow 10% of the problems to over ride 90% of what is working well. Physician groups can organize to create high volume, high quality congenital heart programs. Problems require individualized solutions, which may be unique to a given geopolitical situation. Data and complexity adjusted outcome analysis should drive process improvement. Most importantly, commitment and perseverance of physician leaders can prevail over the many challenges. References w1x Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, et al. Congenital heart disease: prevalence at live birth—the Baltimore–Washington infant study. Am J Epidemiol 1985;121:31 –36. w2x Fyler DC, Buckley LP, Hellenbrand WE, et al. Report of the New England regional infant cardiac program. Pediatrics 1980;95:377 –461. w3x Spencer FC. Congenital heart disease. In: Schwartz SI, Shires GT, Spencer FC, editors. 5th ed. Principles of Surgery. New York: McGraw-Hill Book Company, 1989. p. 771 –841. w4x Commentary. Rational decision-making about paediatric cardiac surgery. The Lancet. 2000; 355: 948. w5x Gardiner K, Pemberton PJ, Ramsay J. Supraregional neonatal cardiac surgery works in Western Australia. BMJ 1998;317:811. w6x Jacobs JP. Software development, nomenclature schemes and mapping strategies and for an International Pediatric Cardiac Surgery Database System. 2002 Seminars in Thoracic and Cardiovascular Surgery: Pediatr Cardiac Surg Annu. January, 2002; 5(1): 153–162. w7x 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 –330 (Abstract).
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w8x 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 –869. w9x 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 –118 (AbstractyFull Text). w10x 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 – 1107 (Medline). w11x 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 –1857 (Abstract). w12x Hannan EL, Racz M, Kavey RE, Quaegebeur JM, Williams R. Pediatric cardiac surgery: the effect of hospital and surgeon volume on in-hospital mortality. Pediatrics 1998;101:963 –969 (AbstractyFull Text). w13x Lundstrom NR, Berggren H, Bjorkhem G, Jogi P, Sunnegardh J. Centralization of pediatric heart surgery in Sweden. Pediatr Cardiol 2000;21:353 –357 (Medline). w14x www.Bristol-Inquiry.org.uky. w15x Chang AC. How to start and sustain a successful pediatric cardiac intensive care program: a combined clinical and administrative strategy. Pediatr Crit Care Med 2002;3(2):1 –5. w16x Guidelines for pediatric cardiovascular centers. Section on Cardiology and Cardiac Surgery. American Academy of Pediatrics. Pediatrics. March, 2002; 109(3): 544–549. w17x Stark J. Glenn lecture. How to choose a cardiac surgeon. Circulation 1996;94(Suppl 9):II-1 –II-4. w18x O’Connor GT, Plume SK, Olmstead EM, Morton JR, Maloney CT, Nugent WC, et al. A regional intervention to improve the hospital mortality associated with coronary artery bypass graft surgery. The Northern New England Cardiovascular Disease Study Group. J Am Med Assoc 1996;275:841 –846 (Medline). w19x Rosenthal GE, Sarrazin MV. Impact of state certificate of need programs on outcomes of care for patients undergoing coronary bypass surgery. Report to the Florida Hospital Association. January 17, 2002. w20x Moore GE. Cramming more components onto integrated circuits. Electronics 1965;38(8). w21x Mavroudis C, Jacobs JP. Congenital heart disease outcome analysis: methodology and rationale. J Thorac Cardiovasc Surg 2001;123(1):6 –7. w22x Mavroudis C, Jacobs JP. International Congenital Heart Surgery Nomenclature and Database Project. Ann Thorac Surg. April, 2000; Supplement. w23x 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 –463 (Medline). w24x 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. w25x Elfstrom J, Stubberod A, Troeng T. Patients not included in medical audit have a worse outcome than those included. Int J Qual Health Care 1996;8:153 –157 (Abstract).