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Biomedical subjects

Bohdan Maruszewski

Publications and source records attributed to Bohdan Maruszewski.

At least 19 recordsLinked to original sources

Risk of surgery for congenital heart disease in the adult: a multicentered European study.

BACKGROUND: Surgery for congenital heart disease (CHD) has changed considerably during the last three decades. The results of primary repair have steadily improved, to allow treating almost all patients within the pediatric age; nonetheless an increasing population of adult patients requires surgical treatment. The objective of this study is to present the early surgical results of patients who require surgery for CHD in the adult population within a multicentered European study population. METHODS: Data relative to the hospital course of 2,012 adult patients (age > or = 18 years) who required surgical treatment for CHD from January 1, 1997 through December 31, 2004 were reviewed. Nineteen cardiothoracic centers from 13 European countries contributed to the data collection. RESULTS: Mean age at surgery was 34.4 +/- 14.53 years. Most of the operations were corrective procedures (1,509 patients, 75%), followed by reoperations (464 patients, 23.1%) and palliative procedures (39 patients, 1.9%). Six hundred forty-nine patients (32.2%) required surgical closure of an isolated ostium secundum atrial septal defect. Overall hospital mortality was 2%. Preoperative cyanosis, arrhythmias, and NYHA class III-IV, proved significant risk factors for hospital mortality. Follow-up data were available in 1,342 of 1,972 patients (68%) who were discharged home. Late deaths occurred in 6 patients (0.5%). Overall survival probability was 97% at 60 months, which is higher for corrective procedures (98.2%) if compared with reoperations (94.1%) and palliations (86.1%). CONCLUSIONS: Surgical treatment of CHD in adult patients, in specialized cardiac units, proved quite safe, beneficial, and low-risk.

Adult↗

What is operative mortality? Defining death in a surgical registry database: a report of the STS Congenital Database Taskforce and the Joint EACTS-STS Congenital Database Committee.

The most concrete and universal outcome measure used in databases, whether governmental, professional society, research, or third-party payer, is operative mortality. To assure congruous data entry by multiple users of The Society of Thoracic Surgeons and the European Association for Cardiothoracic Surgery congenital heart surgery databases, operative mortality must be clearly defined. Traditionally, operative mortality has been defined as any death, regardless of cause, occurring (1) within 30 days after surgery in or out of the hospital, and (2) after 30 days during the same hospitalization subsequent to the operation. Differing hospital practices result in problems in use of the latter part of the definition (eg, the pediatric hospital that provides longer-term care will have higher mortality rates than one which transfers patients to another institution for such care). In addition, because of the significant number of pediatric multiple operation hospitalizations, issues of assignment of mortality to a specific operation within the hospitalization, calculation of operative mortality rates (operation based vs patient admission based), and discharge other than to home must be addressed and defined. We propose refinements to the definition of operative mortality which specifically meet the needs of our professional societies' multi-institutional registry databases, and at the same time are relevant and appropriate with respect to the goals and purposes of administrative databases, government agencies, and the general public.

Cardiac Surgical Procedures↗

The nomenclature, definition and classification of hypoplastic left heart syndrome.

The hypoplastic left heart syndrome encompasses a spectrum of cardiac malformations that are characterized by significant underdevelopment of the components of the left heart and the aorta, including the left ventricular cavity and mass. At the severe end of the spectrum is found the combination of aortic and mitral atresia, when the left ventricle can be close to non-existent. At the mild end are the patients with hypoplasia of the aortic and mitral valves, but without intrinsic valvar stenosis or atresia, and milder degrees of left ventricular hypoplasia. Although the majority of the patients are suitable only for functionally univentricular repair, a small minority may be candidates for biventricular repair. The nature of the syndrome was a topic for discussion at the second meeting of the International Working Group for Mapping and Coding of Nomenclatures for Paediatric and Congenital Heart Disease, the Nomenclature Working Group, held in Montreal, Canada, over the period January 17 through 19, 2003. Subsequent to these discussions, the Nomenclature Working Group was able to create a bidirectional crossmap between the nomenclature initially produced jointly on behalf of the European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons, and the alternative nomenclature developed on behalf of the Association for European Paediatric Cardiology. This process is a part of the overall efforts of the Nomenclature Working Group to create a comprehensive and all-inclusive international system of nomenclature for paediatric and congenital cardiac disease, the International Paediatric and Congenital Cardiac Code. In this review, we discuss the evolution of nomenclature and surgical treatment for the spectrum of lesions making up the hypoplastic left heart syndrome and its related malformations. We also present the crossmap of the associated terms for diagnoses and procedures, as recently completed by the Nomenclature Working Group.

Diagnosis, Differential↗

Initial application in the STS congenital database of complexity adjustment to evaluate surgical case mix and results.

BACKGROUND: The analysis of the second harvest (1998-2001) of the Society of Thoracic Surgeons Congenital Heart Surgery Database included the first attempt by the STS to apply a complexity-adjustment method to evaluate congenital heart surgery results. METHODS: This data harvest represents the first STS multiinstitutional experience with software utilizing the international nomenclature and database specifications adopted by the STS and the European Association for Cardio-Thoracic Surgery (April 2000 Annals of Thoracic Surgery) and the first STS Congenital Database Report incorporating a methodology facilitating complexity adjustment. This methodology, allowing for complexity adjustment, gives each operation a basic complexity score (1.5 to 15) and level (1 to 4) based upon the work of the EACTS-STS Aristotle Committee, a panel of 50 expert surgeons. The complexity scoring, based on the primary procedure (from the EACTS-STS International Nomenclature Procedures Short List), estimates complexity through three factors: mortality potential, morbidity potential, and technical difficulty. RESULTS: This STS harvest includes data from 16 centers reporting 12,787 cases, with discharge mortality known for 10,246 cases. The basic complexity score has been applied to the outcomes analysis of these cases and a new equation has been proposed to evaluate one aspect of performance: Aristotle Performance Index = Outcome x Complexity = (Survival) x (Mean Complexity Score) CONCLUSIONS: The complexity analysis represents a basic complexity-adjustment method to evaluate surgical results. Complexity is a constant precise value for a given patient at a given point in time; performance varies between centers. Future STS congenital data harvests will incorporate a second step, the Comprehensive Aristotle Score, utilizing additional patient specific complexity modifiers to allow a more precise complexity adjustment.

Databases, Factual↗

Current status of the European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons Congenital Heart Surgery Database.

BACKGROUND: After utilizing separate congenital databases in the early 1990s, the Society of Thoracic Surgeons (STS) and the European Association for Cardio-Thoracic Surgery (EACTS) collaborated on several joint database initiatives. METHODS: In 1998, the joint EACTS-STS International Congenital Heart Surgery Nomenclature and Database Project Committee was created and a common nomenclature and common core minimum database dataset were adopted and published by the STS and the EACTS. In 1999, the joint EACTS-STS Aristotle Committee was created and the Aristotle Score was adopted and published as a method to provide complexity adjustment for congenital heart surgery. Collaborative efforts involving the EACTS and STS are underway to develop mechanisms to verify data completeness and accuracy. RESULTS: Since 1998, this nomenclature, database, and methodology of complexity adjustment have been used by both the STS and EACTS to analyze outcomes of over 40,000 patients. A huge amount of data have been generated which allow comparison of practice patterns and outcomes analysis between Europe and North America. The aggregate data from the first 5 years of data collection not only make for interesting comparison but also allow examination of regional difference in practice patterns. For example, in the EACTS, out of 4,273 neonates, 885 (20.7%) underwent arterial switch procedures and 297 (6.95%) underwent Norwood stage 1 procedures. In the STS, out of 3,988 neonates, 472 (11.8%) underwent arterial switch procedures and 575 (14.4%) underwent Norwood stage 1 procedures. CONCLUSIONS: This analysis of the EACTS-STS multi-institutional outcomes database confirms that in both Europe and North America, case complexity and mortality is highest among neonates, then infants, and then children. Regional differences in practice patterns are demonstrated, with the overall goal being the continued upgrade in the quality of surgery for congenital heart disease worldwide.

Databases, Factual↗

An attempt at data verification in the EACTS Congenital Database.

OBJECTIVE: The multi-national and multi-institutional collection of data on outcomes in Congenital Heart Surgery (CHS) provides the possibility of analysis of results of treatment and may result in further improvement of the quality of care. The verification of data as far as the completeness and accuracy is necessary to give confidence to all sides--the patients, centers and regulatory authorities. The source data verification (SDV), although difficult, appears possible even in such a large-scale database. METHODS: Out of 5.274 patients and 5.612 procedures data of 2003, collected in the database, 1.703 (32.3%) and 1.895 (33.8%), respectively, have been verified at five sites on following fields: IPPV time, date of birth, date of admission, date of surgery, date of discharge/mortality, body weight, case category, CPB time, AoX time, Circulatory arrest time. SDV was performed at five sites by two database officers using the sources of information different to the local copy of the database (patients' files, operation notes, perfusion charts, OR Books). Verification was performed between June 1st and July 31st 2004. Statistical analysis was performed using R-project software, ver. 2.0.0. and Welch's t-test for comparison of continuous variables. P-value >0.05 was used as statistically significant difference between groups. RESULTS: Pre- and post-verification mortalities in all groups showed no significant differences although seven deaths out of 68 (10.27%) were missed. None of the other verified fields showed significant differences after verification. CONCLUSIONS: Source Data Verification showed no statistically significant differences between verified and non-verified data on 30 days mortality, LOS, age, body weight, CPB time, AoX and Circulatory arrest time. IPPV time was not available in 58.6% procedures.

Data Collection↗

Computerized outcomes analysis for congenital heart disease.

PURPOSE OF REVIEW: This paper reviews the past year's literature on computerized outcomes analysis for congenital heart disease. RECENT FINDINGS: This review focuses on recent advances in four areas of computerized outcomes analysis for congenital heart disease: nomenclature, database, complexity adjustment, and data verification. A common nomenclature, along with a common core minimal dataset, were adopted by the European Association for Cardio-thoracic Surgery and the Society of Thoracic Surgeons and published in 2000 in the Annals of Thoracic Surgery; the thrust towards the establishment of an international nomenclature is now being developed further by the International Society for Nomenclature of Pediatric and Congenital Heart Disease [http://www.IPCCC.net]. This common nomenclature and common minimum database dataset, created by the International Congenital Heart Surgery Nomenclature and Database Project, are now used by the European Association for Cardio-thoracic Surgery and Society of Thoracic Surgeons since 1998, this nomenclature and database have been used to analyze outcomes of over 40 000 patients. Two major multi-institutional efforts have attempted to measure case complexity: the Risk Adjustment in Congenital Heart Surgery-1 and the Aristotle Complexity Score. Collaborative efforts involving the European Association for Cardio-thoracic Surgery and Society of Thoracic Surgeons are underway to develop mechanisms to verify data completeness and accuracy. SUMMARY: Methods of congenital heart disease outcomes analysis continue to evolve, with continued advances in four areas: nomenclature, database, complexity adjustment, and data verification.

Child↗

Lessons learned from the data analysis of the second harvest (1998-2001) of the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database.

OBJECTIVE: The analysis of the second harvest of the STS Congenital Heart Surgery Database produced meaningful outcome data and several critical lessons relevant to congenital heart surgery outcomes analysis worldwide. METHODS: This data harvest represents the first STS multi-institutional experience with software utilizing the nomenclature and database requirements adopted by the STS and EACTS (April 2000 Annals of Thoracic Surgery). Members of the STS Congenital Heart Committee analyzed the STS data. RESULTS: This STS harvest includes data from 16 centers (12787 cases, 2881 neonates, 4124 infants). In 2002, the EACTS reported similar outcome data utilizing the same database definitions (41 centers, 12736 cases, 2245 neonates, 4195 infants). Lessons from the analysis include: (1) Death must be clearly defined. (2) The Primary Procedure in a given operation must be documented. (3) Inclusionary and exclusionary criteria for all diagnoses and procedures must be agreed upon. (4) Missing data values remain an issue for the database. (5) Generic terms in the nomenclature lists, that is terms ending in Not Otherwise Specified (NOS), are redundant and decrease the clarity of data analysis. (6) Methodology needs to be developed and implemented to assure and verify data completeness and data accuracy. 'Operative Mortality' and 'Mortality Assigned to this Operation' were defined by the STS and EACTS; these definitions were not utilized uniformly. 'Thirty Day Mortality' was problematic because some centers did not track mortality after hospital discharge. Only 'Mortality Prior to Discharge' was consistently reported. Designation of Primary Procedure for a given operation determines its location for analysis. Until Complexity Scores lead to automated methodology for choosing the Primary Procedure, the surgeon must designate the Primary Procedure. Inclusionary and exclusionary criteria for all diagnoses and procedures have been developed in an effort to define acceptable concomitant diagnoses and procedures for each analysis. Improvements in data completeness can be achieved using a variety of techniques including developing more functional techniques of data entry at individual institutions and software improvements. Future versions of the STS Congenital Database will request that the coding of diagnoses and procedures avoid the terms ending in NOS. CONCLUSIONS: Lessons from this data harvest should improve congenital heart surgery outcome analysis.

Databases, Factual↗

The Aristotle score for congenital heart surgery.

The aim of the Aristotle project was to develop a new method of evaluation of quality of care in congenital heart surgery based on the complexity of the surgical procedures. Involving a panel of expert surgeons, the project started in 1999 and included 50 pediatric surgeons from 23 countries representing International Scientific Societies. The complexity was based on the procedures as defined by the Society of Thoracic Surgeons (STS)/European Association for Cadiothoracic Surgery (EACTS) International Nomenclature and was undertaken in two steps: The first step was establishing the Basic Score, which adjusts only the complexity of the procedures and is based on three factors: the potential for mortality, the potential for morbidity, and the anticipated technical difficulty. The second step was the development of the Comprehensive Score, which further adjusts the complexity according to the specific patient characteristics. The Aristotle score allows precise scoring of the complexity for 145 congenital heart surgery procedures. One interesting concept coming out of this study is that complexity is a constant and precise value for a given patient regardless of the center where he is operated. The Aristotle method allows proposing the following equation of quality of care: Complexity FN Outcome = Performance. The Aristotle score, electronically available, was introduced in the EACTS and STS databases. A validation process, designed to evaluate its predictive value, is being developed.

Cardiac Surgical Procedures↗

Congenital heart surgery nomenclature and database project. Update and proposed data harvest.

In 1998, the first report of the Society of Thoracic Surgery (STS) National Congenital Heart Surgery Database defined clinical features for 18 congenital heart disease categories, providing a significant amount of important information and pinpointing database strengths and weaknesses. Following this report, the STS Congenital Heart Surgery Committee, working with the European Association of Cardio-Thoracic Surgery and the European Congenital Heart Surgeons Foundation, initiated the International Congenital Heart Surgery and Nomenclature Database Project. To standardize nomenclature and reporting strategies and establish a foundation for an international congenital heart surgery database. The project's first report was published in the Annals of Thoracic Surgery in April 2000. The current report outlines modifications to the minimal dataset and diagnosis and procedure short lists.

Databases, Factual↗

Congenital Heart Surgery Nomenclature and Database Project: update and proposed data harvest.

The first report of The Society of Thoracic Surgeons (STS) National Congenital Heart Surgery Database in 1998 reported the clinical features of 18 congenital heart categories. The report provided a significant amount of important information and also highlighted the strengths and weaknesses of the existing database. Following this report the STS Congenital Heart Surgery Committee in cooperation with the European Association of Cardio-Thoracic Surgery and the European Congenital Heart Surgeons Foundation initiated the International Congenital Heart Surgery Nomenclature and Database Project. The goal was to begin the standardization of nomenclature reporting strategies and establish the foundations for an international congenital heart surgery database. The first report of the International Congenital Heart Surgery Nomenclature Project was published in The Annals of Thoracic Surgery in April 2000. The current report outlines modifications to the minimum dataset as well as the diagnoses and procedure short lists. Plans for the next STS National Congenital Heart Surgery Database harvest are also presented.

Cardiac Surgical Procedures↗