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Biomedical subjects

Thomas L Spray

Publications and source records attributed to Thomas L Spray.

At least 19 recordsLinked to original sources

Early results of single-stage biventricular repair of severe aortic hypoplasia or atresia with ventricular septal defect and normal left ventricle.

OBJECTIVE: Biventricular repair of aortic atresia (or severe aortic hypoplasia) is possible in the presence of a ventricular septal defect and normal left ventricle. We considered whether primary biventricular repair was a safe alternative in all cases, even in the presence of interrupted aortic arch. METHODS: This was a retrospective analysis of patients who underwent primary biventricular repair consisting of a combination Norwood-type reconstruction of the aortic arch, baffle of the left ventricle to both semilunar roots, and conduit placement from the right ventricle to pulmonary arteries. RESULTS: Between January 1995 and January 2005, a total of 21 patients underwent primary biventricular repair at a median age of 5 days and a median weight of 3.0 kg. Aortic atresia was present in 7 and aortic stenosis in 14; 6 had interrupted aortic arch. All patients with aortic stenosis had annular diameters 3 mm or smaller. Median circulatory arrest time was 55 minutes, aortic crossclamp time was 56 minutes, and total support time was 99 minutes. In-hospital survival was 100%. Postoperative echocardiography in 19 patients demonstrated no significant outflow tract obstruction. Total stay was a median of 17 days. At midterm follow-up, there has been 1 late death, and reoperation has been necessary in 10 cases. CONCLUSION: Primary biventricular repair is a safe alternative to staged repair in all cases of aortic hypoplasia with ventricular septal defect and normal left ventricle.

Aorta, Thoracic↗

Outcomes of the Fontan procedure using cardiopulmonary bypass with aortic cross-clamping.

BACKGROUND: Avoidance of cardiopulmonary bypass (CPB) and aortic cross-clamping during the Fontan procedure has been advocated to improve outcomes. We continue to use CPB with aortic cross-clamping for the Fontan procedure. METHODS: We performed a review of patients undergoing the Fontan procedure between January 1, 2000 and December 31, 2004. RESULTS: The Fontan procedure was performed in 160 patients. The median age was 2.2 years (range, 1.0 to 29.1 years). Hypoplastic left heart syndrome or a variant was present in 114 patients (71%), and heterotaxy was present in 19 (12%). CPB and modified ultrafiltration were used in all patients. Aortic cross-clamping was used in 154 (96%) of 160 patients and deep hypothermic circulatory arrest (DHCA) in 132 (83%). A lateral tunnel Fontan was performed in 69 patients (43%) and an extracardiac Fontan in 91 (57%). A fenestration was created in 144 patients (90%). Two patients died. Freedom from death or takedown was 98% (157/160). Median duration of pleural drainage was 2 days (range, 1 to 44 days) and was more than 14 days in 16 patients. Median duration of hospitalization was 6 days (range, 3 to 55 days). The small number of deaths precluded assessment of risk factors for mortality. By multivariable analysis, risk factors for pleural drainage longer than 3 days were extracardiac connection (p < 0.001) and increasing mean pulmonary artery pressure before the Fontan procedure (p = 0.033). By multivariable analysis, risk factors for hospitalization for more than 7 days were extracardiac connection (p = 0.003), increasing duration of total support (CPB and DHCA, p = 0.027), and decreasing systemic oxygen saturation before the Fontan procedure (p = 0.048). CONCLUSIONS: The Fontan procedure can be performed using CPB and aortic cross-clamping with low morbidity and mortality.

Adolescent↗

Real-time 3-dimensional echocardiographic imaging of congenital heart disease using matrix-array technology: freehand real-time scanning adds instant morphologic details not well delineated by conventional 2-dimensional imaging.

OBJECTIVE: We sought to investigate whether real-time (RT) 3-dimensional echocardiography (RT3D) using matrix-array technology could resolve a specific morphologic detail that could not be well resolved during conventional 2-dimensional (2D)/Doppler echocardiographic imaging of congenital heart disease. BACKGROUND: Although 2D echocardiography is currently the primary imaging modality of congenital heart disease, there are still some anatomic details that cannot be well delineated by that modality. METHODS: In all, 70 patients underwent RT3D examination using matrix-array transducer. Applying the standard sweeping technique as for 2D imaging, freehand RT imaging was used for immediate feedback. The 2D examinations of the last 23 consecutive patients were used to validate the additional value of RT3D by 3 examiners blinded to the findings of RT3D. RESULTS: The adequacy of 2D imaging to resolve the morphologic detail in question ranged from 30% to 70%, whereas RT3D imaging was considered successful in delineating the morphologic detail in 80% to 100% of patients instantly. The image resolution was superior or equivalent to that obtained by 2D imaging. Heart valves, septal defects, and volumetric valvular and vascular color flow morphologies were well delineated by RT3D. CONCLUSION: Matrix-array RT3D is a significant breakthrough technology that allowed instant visualization of cardiac anatomic details that could not be well delineated by 2D imaging. Further improvements of some technical limitations should make RT3D matrix-array cardiac imaging a significant modality in the field of echocardiographic imaging of congenital cardiac anomalies.

Adolescent↗

Surgical management of aortopulmonary window associated with interrupted aortic arch: a Congenital Heart Surgeons Society study.

OBJECTIVE: The objective was to determine outcomes and risk factors of surgical management of patients with aortopulmonary window associated with interrupted aortic arch. METHODS: From 1987 to 1997, 472 neonates with interrupted aortic arch were enrolled prospectively from 33 institutions. Associated aortopulmonary window was present in 20 patients. Competing risk methodology determined the prevalence of reintervention for postrepair pulmonary artery and aortic arch obstruction. RESULTS: Interrupted aortic arch was type A in 17 patients and type B in 3 patients. Aortopulmonary window morphology was type I (n = 10), type II (n = 5), and type III (n = 5). Associated cardiovascular anomalies were common, including atrial septal defect (n = 13) and systemic venous anomalies (n = 3). Overall survival after initial admission was 91%, 86%, and 84% at 1, 5, and 10 years, respectively. Fifteen patients underwent single-stage repair, and 4 patients underwent staged repair. There was an increased prevalence of patch augmentation of the interrupted aortic arch anastomosis in lower-weight infants (2.3 kg vs 3.1 kg, P = .07). Competing risk analysis estimated that 5 years after repair, 51% had initial arch reintervention, 6% had initial pulmonary artery reintervention, and 43% were alive without reintervention. Reintervention for arch obstruction was more likely for those with interrupted aortic arch type B (P = .08) and for those with higher weight at initial repair (P = .003). CONCLUSIONS: Complete correction of aortopulmonary window in the setting of interrupted aortic arch can be performed with low mortality in the neonatal period. Reinterventions for aortic arch obstruction are the most frequent complication after repair, but pulmonary artery stenosis also occurs. Use of patch augmentation may reduce the need for subsequent arch reintervention.

Aorta, Thoracic↗

Intracardiac temperature monitoring in infants after cardiac surgery.

BACKGROUND: Hyperthermia after cerebral ischemia is associated with worse neurologic outcome. Our goals were 3-fold: (1) to describe the postoperative temperature course in infants after cardiac surgery, (2) to compare intracardiac temperature monitoring with traditional monitoring in infants, and (3) to determine variables that influence the patients' temperatures. METHODS: Longitudinal temperature data were collected for 100 infants undergoing cardiac surgery. Intra-atrial, nasopharyngeal, esophageal, rectal, and axillary temperatures were recorded in all patients. RESULTS: The mean age at the time of operation was 128 +/- 166 days, and the mean weight was 5.1 +/- 2.4 kg. Circulatory arrest was used for 54 patients. In the operating room, the maximum intra-atrial temperature (37.5 degrees C +/- 0.6 degrees C) was significantly greater than both the simultaneous esophageal temperature (36.9 degrees C +/- 1.9 degrees C, P = .03) and nasopharyngeal temperature (36.3 degrees C +/- 2.5 degrees C, P < .001). In the cardiac intensive care unit, intra-atrial temperature was significantly greater than both axillary and rectal temperatures. During the first 24 postoperative hours, intra-atrial temperature was greater than 38 degrees C in 48 (48%) patients, rectal temperature was greater than 38 degrees C in 36 (36%) patients, and axillary temperature was greater than 38 degrees C in 7 (7%) patients. CONCLUSIONS: In patients less than 2 years of age undergoing cardiac surgery requiring cardiopulmonary bypass, intra-atrial temperature peaked 4 to 6 hours after leaving the operating room. Traditional methods of temperature monitoring significantly underestimate core temperature after cardiac surgery in infants. Use of intracardiac temperature monitoring might result in avoidance of cerebral hyperthermia.

Body Temperature↗

Neurodevelopmental outcome after early repair of a ventricular septal defect with or without aortic arch obstruction.

OBJECTIVES: Cross-sectional studies of intermediate-term survivors of infant cardiac surgery have revealed a high frequency of neurodevelopmental disabilities. Few data exist regarding neurodevelopmental outcome of infants undergoing surgical intervention for a ventricular septal defect. The purpose of this study was to evaluate the neurodevelopmental outcome at 1 year of age of children who had surgical repair in infancy of a ventricular septal defect or a ventricular septal defect with aortic arch obstruction. METHODS: Children who underwent repair of a ventricular septal defect or single-stage repair of a ventricular septal defect with aortic arch obstruction at less than 6 months of age were assessed at 1 year of age by using the Bayley Scales of Infant Development II, which yields the Mental Development Index and the Psychomotor Development Index, both with an expected mean of 100 +/- 15. RESULTS: At 1 year, 55 patients (ventricular septal defect alone = 36; ventricular septal defect with aortic arch obstruction = 19) returned for evaluation. The mean Mental Development Index was 92.6 +/- 11.7, with 3 (5%) patients scoring 70 or less. The mean Psychomotor Development Index was 86.1 +/- 16.4, with 10 (18%) patients scoring 70 or less. Patients with a suspected or confirmed genetic syndrome had both a lower Mental Development Index score (P = .011) and a lower Psychomotor Development Index score (P = .001). Mental Development Index and Psychomotor Development Index were independent of anatomic (specifically aortic arch obstruction) and intraoperative factors (specifically deep hypothermic circulatory arrest). CONCLUSIONS: Neurodevelopmental outcome at 1 year of age was within the normal limits for most patients who underwent repair of a ventricular septal defect or a ventricular septal defect with aortic arch obstruction during infancy.

Aortic Arch Syndromes↗

Exercise performance in children and adolescents after the Ross procedure.

OBJECTIVES: The Ross procedure is increasingly utilized in the treatment of aortic valvar disease in children and adolescents. Our purpose was to compare pre- and post-operative exercise state in this population. METHODS: We included patients who underwent the Ross procedure at our institution between January, 1995, and December, 2003, and in whom we had performed pre- and post-operative exercise stress tests. We used a ramp bicycle protocol to measure consumption of oxygen and production of carbon dioxide. Cardiac output was estimated from effective pulmonary blood flow by the helium acetylene re-breathing technique. RESULTS: We studied 26 patients, having a median age at surgery of 15.7 years, with a range from 7.5 to 24.1 years. The primary indication for surgery in two-thirds was combined aortic stenosis and insufficiency. Median time from the operation to the post-operative exercise stress test was 17.4 months, with a range from 6.7 to 30.2 months. There was a trend toward lower maximal consumption of oxygen after the procedure, at 36.3 plus or minus 7.6 millilitres per kilogram per minute (83.9% predicted) as opposed to 38.6 plus or minus 8.4 millilitres per kilogram per minute (88.5% predicted, p equal to 0.06). Patients after the procedure, however, had significantly increased adiposity, so that there was no difference in maximal consumption of oxygen indexed to ideal body weight before and after the operation. In 20 of the patients, aerobic capacity improved or was stable after the operation. There was no post-operative chronotropic impairment. CONCLUSIONS: In the majority of patients following the Ross procedure, exercise performance is stable and within the normal range of a healthy age and sex matched population, despite sedentary lifestyles and increased adiposity.

Adolescent↗

Neo-aortic valvar function after the arterial switch.

OBJECTIVES: The purpose of our study was to assess the prevalence and progression, during childhood and adolescence, of dilation of the neo-aortic root, and neo-aortic valvar regurgitation, and to identify risk factors for such dilation and regurgitation, after the arterial switch operation. METHODS: We included all patients who had undergone an arterial switch operation at The Children's Hospital of Philadelphia, and had been followed for a minimum of 4 years, and had at least 2 postoperative echocardiograms. Neo-aortic valvar regurgitation was quantitatively assessed, and measurements were made of the neo-aortic root at the level of the basal attachment of the leaflets, mid-sinusal level, and the sinutubular junction. RESULTS: We found 82 patients who satisfied the criterions for inclusion, of whom 52 patients had transposition with an intact ventricular septum, and 30 had either an associated ventricular septal defect or double outlet right ventricle. The median follow-up time was 8.8 years (4.1 to 16.4 years). The neo-aortic valve had been replaced in 1 patient. Of the patients, 3 had moderate, 66 had trivial to mild, and 12 had no neo-aortic valvar regurgitation at their most recent follow-up. The regurgitation had progressed by at least 1 grade in 38 of the 82 patients (46.4%). Neo-aortic dilation was noted at the basal attachment of the leaflets, and at mid-sinusal level, which was out of proportion to somatic growth. CONCLUSIONS: At mid-term follow-up, significant neo-aortic valve regurgitation is present in 3.7%, and trivial to mild regurgitation in 81.4% of patients. The regurgitation progressed in almost half of the patients over time. We also noted progressive dilation of the neo-aortic root out of proportion to somatic growth.

Aortic Valve Insufficiency↗

Surgical correction of aortico-left ventricular tunnel.

Aortico-left ventricular tunnel is a rare, paravalvular communication of unclear etiology between the ascending aorta and the left ventricle. The resultant regurgitant diastolic blood flow leads to varying degrees of volume overload and congestive heart failure. Diagnosis is typically made postnatally with echocardiography. Surgical correction is the treatment of choice consisting of either patch closure or primary repair of the aortic orifice. Prognosis is good, although a significant percentage of patients will eventually require valve replacement because of progressive aortic valvular insufficiency.

Aorta↗

Extracorporeal membrane oxygenation after stage I reconstruction for hypoplastic left heart syndrome.

OBJECTIVE: Although extracorporeal membrane oxygenation (ECMO) is an acceptable strategy for children with refractory cardiac dysfunction after cardiac surgery, its role after stage I reconstruction for hypoplastic left heart syndrome and its variants is controversial. Our objective is to describe the outcome of "nonelective" ECMO after stage I reconstruction. DESIGN: Retrospective case series. SETTING: Pediatric cardiac intensive care unit. PATIENTS: Infants placed on ECMO after stage I reconstruction from January 1998 to May 2005. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of the 382 infants who underwent stage I reconstruction during the study period, 36 (9.4%) required ECMO in the postoperative period. There were 22 infants with hypoplastic left heart syndrome. Indications for ECMO included inability to separate from cardiopulmonary bypass in 14 and cardiac arrest in 22. Fourteen infants (38.8%) survived to hospital discharge. Nonsurvivors had longer cardiopulmonary bypass time (150.1 +/- 70.0 mins vs. 103.9 +/- 30.0 mins, p =. 01). 9/14 infants (64%) supported with ECMO> than 24 hrs after stage I reconstruction survived while only 5/22 infants (22%) requiring ECMO< 24 hrs of stage I reconstruction survived (p =. 02). Of note, all five infants diagnosed with an acute shunt thrombosis were early survivors. Mean duration of ECMO was 50.1 +/- 12.5 hrs for survivors and 125.2 +/- 25.0 for nonsurvivors (p =. 01). 7/14 early survivors are alive at a median follow-up of 20 months (2-78 months). CONCLUSIONS: In our experience, ECMO after stage I reconstruction can be life saving in about a third of infants with otherwise fatal conditions. It is particularly useful in potentially reversible conditions such as acute shunt thrombosis and transient depression of ventricular function.

Extracorporeal Membrane Oxygenation↗

Population pharmacokinetics of milrinone in neonates with hypoplastic left heart syndrome undergoing stage I reconstruction.

We performed a blinded, randomized pharmacokinetic study of milrinone in 16 neonates with hypoplastic left heart undergoing stage I reconstruction to determine the impact of cardiopulmonary bypass and modified ultrafiltration on drug disposition and to define the drug exposure during a continuous IV infusion of drug postoperatively. Neonates received an initial dose of either a 100 or 250 microg/kg of milrinone into the cardiopulmonary bypass circuit at the start of rewarming. Postoperatively, milrinone was infused to clinical needs. A mixed-effect modeling approach was used to characterize milrinone pharmacokinetics during cardiopulmonary bypass, modified ultrafiltration, and postoperatively using the NONMEM algorithm. All patients in this study demonstrated a modified ultrafiltration concentrating effect that occurred despite a modified ultrafiltration drug clearance of 3.3 mL x kg(-1) x min(-1). The infants in this study demonstrated an impaired renal clearance during the immediate postoperative period. A constant infusion of 0.5 microg x kg(-1) x min(-1) resulted in drug accumulation during the initial 12 h of drug administration. Postoperatively, milrinone clearance was significantly impaired (0.4 mL x kg(-1) x min(-1)), improved by the 12th postoperative hour, and approached steady-state clearance (2.6 mL x kg(-1) x min(-1)) by postoperative day 4. In the postoperative setting of markedly impaired renal function, an infusion rate of 0.2 microg x kg(-1) x min(-1) should be considered.

Cardiopulmonary Bypass↗

The relationship of postoperative electrographic seizures to neurodevelopmental outcome at 1 year of age after neonatal and infant cardiac surgery.

OBJECTIVE: The occurrence of a seizure after the arterial switch operation is associated with a worse long-term neurodevelopmental outcome. The significance of seizures after neonatal and infant repair of other congenital heart defects is not known. METHODS: A recent study at our institution demonstrated seizures documented by 48-hour electroencephalographic monitoring in 20 (11%) of 178 neonates and infants after surgery for complex congenital heart defects, including hypoplastic left heart syndrome or variants. The developmental outcomes of this cohort were evaluated at 1 year of age by using the Bayley Scales of Infant Development II, which yields 2 scores: the Mental Developmental Index and the Psychomotor Developmental Index. RESULTS: Developmental evaluations were performed in 114 (70%) of 164 survivors, including 36 with hypoplastic left heart syndrome. Postoperative electroencephalographic seizures had occurred in 15 (13%) of 114 of the entire group and in 8 (22%) of 36 of those with hypoplastic left heart syndrome. For the entire cohort, the Mental Developmental Index was 92.3 +/- 13.5, and the Psychomotor Developmental Index was 79.9 +/- 18.8 for patients without seizures, compared with 90.3 +/- 10.7 and 74.4 +/- 19.3 for those with seizures (both P > .5). For the hypoplastic left heart syndrome subgroup, the Mental Developmental Index was 92.3 +/- 14.9, and the Psychomotor Developmental Index was 74.8 +/- 19.3 for patients with seizures, compared with 91.9 +/- 12.4 and 73.9 +/- 18.3 for those without seizures (both P > .5). A frontal onset of seizures was predictive of a lower score on the Psychomotor Developmental Index, but not on the Mental Developmental Index. CONCLUSIONS: The occurrence of a seizure after cardiac operation is a marker of central nervous system injury. However, in this cohort of neonates and infants with complex congenital heart defects, the occurrence of a seizure was not predictive of a worse developmental outcome at 1 year of age as assessed by the Bayley Scales of Infant Development II.

Cardiac Surgical Procedures↗

Intermediate outcomes after the Fontan procedure in the current era.

OBJECTIVE: This study was undertaken to investigate the intermediate outcomes after the Fontan operation in the current era. METHODS: A cross-sectional analysis was performed by using data gathered between October 13, 2003, and February 22, 2005, on all 310 survivors of the Fontan procedure between January 1, 1992, and December 31, 1999. Medical records were reviewed, and a customized questionnaire was administered to caregivers. Outcome variables included failure of the Fontan operation (ie, death, takedown of Fontan, or transplantation), number of cardiac-related rehospitalizations, parental assessment of health, school performance, and cardiac functional status. RESULTS: A total of 332 patients underwent the Fontan procedure during the study period. A lateral tunnel was constructed in 281 (85%), and an extracardiac Fontan procedure was performed in 51 (15%). A total of 210 (63%) children had undergone previous stage I reconstruction, and 162 (49%) had received an initial diagnosis of hypoplastic left heart syndrome. There were 310 hospital survivors of the Fontan procedure (93.4%), with an additional 16 deaths (5.2%) during follow-up and 1 living heart transplant patient before the cross-sectional period. For initial hospital survivors, Kaplan-Meier estimates of freedom from death or transplantation were 98.0% (95% confidence interval, 95.6%-99.1%) at 1 year after the Fontan procedure, 94.9% (91.6%-97.0%) at 5 years, and 93.9% (90.1%-96.2%) at 8 years. Questionnaires were completed for 240 (81.9%) of the 293 available patients. By parental recollection, a total of 130 (54.2%) children required cardiac-related rehospitalization at some point during the follow-up period. At a median follow-up of 8.6 years (range, 4.1-12.8 years), 94.6% of guardians described their child's overall health as excellent or good, and 5.4%, as fair or poor. School performance was described as above average in 30.2%, average in 39.9%, and below average in 29.8%. With regard to cardiac functional status, 34.2% responded that their child had no limitations to physical activity, 52.5% reported a slight limitation, 12.1% reported a significant limitation, and 1.2% reported a severe limitation. CONCLUSIONS: Acceptable survival outcomes have been observed at intermediate follow-up of the Fontan operation in this cohort; a significant proportion of patients had hypoplastic left heart syndrome. Although cardiac-related rehospitalization is common, the parents and guardians believed that overall health, school performance, and cardiac functional status were good to excellent for most patients.

Child↗

Increasing duration of deep hypothermic circulatory arrest is associated with an increased incidence of postoperative electroencephalographic seizures.

OBJECTIVE: Electroencephalographic seizures have been shown to occur in 5% to 20% of neonates and infants after biventricular repair of a variety of cardiac defects. Occurrence of a seizure is a predictor of adverse long-term neurodevelopmental sequelae. The contemporary incidence of postoperative seizures after repair of cardiac defects such as hypoplastic left heart syndrome and other forms of single ventricle is not known. METHODS: A prospective study of 178 patients less than 6 months of age undergoing cardiopulmonary bypass with or without deep hypothermic circulatory arrest (DHCA) was conducted at a single institution from September 2001 through March 2003 to identify postoperative seizures assessed by 48-hour continuous video electroencephalographic monitoring. RESULTS: Cardiac defects included transposition of the great arteries with or without a ventricular septal defect (n = 12), ventricular septal defect with or without coarctation (n = 28), tetralogy of Fallot (n = 24), hypoplastic left heart syndrome or variant (n = 60), other functional single ventricle (n = 14), and other defects suitable for biventricular repair (n = 40). Median age at the time of the operation was 7 days (range, 1-188 days) and was 30 days or less in 110 (62%) patients. DHCA was used in 117 (66%) patients, with multiple episodes in 9 patients. Median total duration of DHCA was 40 minutes (range, 1-90 minutes). Electroencephalographic seizures were identified in 20 (11.2%) patients. Seizures occurred in 15 (14%) of 110 neonates and 5 (7%) of 68 older infants. Seizures occurred in 1 (4%) of 24 patients with tetralogy of Fallot, 1 (8%) of 12 with transposition of the great arteries, and 11 (18%) of 60 with hypoplastic left heart syndrome or variant. By stepwise logistic regression analysis, once increasing duration of total DHCA (P = .001) was considered, no other variable improved prediction of occurrence of a seizure. Patients with DHCA duration of more than 40 minutes had an increased incidence of seizures (14/58 [24.1%]) compared with those with a DHCA duration of 40 minutes or less (4/59 [6.8%], P = .04). The incidence of seizures for patients with a DHCA duration of 40 minutes or less was not significantly different from those in whom DHCA was not used (2/61 [3.3%], P = .38). CONCLUSIONS: In the current era, continuous electroencephalographic monitoring demonstrates early postoperative seizures in 11.2% of a heterogeneous cohort of neonates and infants with complex congenital heart defects. Increasing duration of DHCA was identified as a predictor of seizures. However, the incidence of seizures in children with limited duration of DHCA was similar to that in infants undergoing continuous cardiopulmonary bypass alone.

Adolescent↗

Impact of re-coarctation following the Norwood operation on survival in the balloon angioplasty era.

OBJECTIVES: The objective of this study was to determine the efficacy of balloon angioplasty (BA) by comparing the immediate and long-term outcomes of patients with and without re-coarctation after a Norwood procedure. BACKGROUND: Although BA has become the standard means for treating recurrent coarctation following a Norwood operation, it has been suggested that re-coarctation remains a significant cause of morbidity and mortality. METHODS: Patients who survived a Norwood operation from December 1986 through June 2001 were studied. Differences between groups were evaluated by t test and logistic regression. Survival differences were tested by log-rank tests using Kaplan-Meier survival curves. RESULTS: Fifty-eight of 633 patients underwent treatment for re-coarctation (9.2%). Thirty-five patients underwent BA (before 1988, 23 had surgery). Median age at catheterization was 6.6 months (1.9 to 35.6 months). Balloon angioplasty was successful (gradient <10 mm Hg) in 32 of 35 patients (92%). There were no BA-related deaths or neurologic complications. Recurrent obstruction after BA occurred in seven patients (20%); five underwent re-dilation. Kaplan-Meier estimates of freedom from recurrent obstruction after initial BA were 97% at one month, 79% at one year, and 79% at five years. There were no differences in survival between patients with re-coarctation treated by BA and patients who did not undergo treatment for re-coarctation. CONCLUSIONS: We found that 9.2% of patients underwent treatment for re-coarctation following a Norwood operation. Balloon angioplasty is effective, with low morbidity, no early mortality, and no difference in long-term survival when compared with patients who did not have re-coarctation. Recurrent coarctation following BA occurred in 17% of patients, usually within the first year after BA.

Angioplasty, Balloon, Coronary↗

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↗