To close or not to close: the very small patent ductus arteriosus.

Patent ductus arteriosus (PDA) accounts for approximately 10% of all congenital heart diseases, with an incidence of at least 2-4 per 1000 term births. Closure of the large, hemodynamically significant PDA is established as the standard of care, and can be performed safely and effectively using either surgical or transcatheter methods. The appropriate management of the very small, hemodynamically insignificant PDA is less clear. Routine closure of such defects has been advocated to eliminate or reduce the risk of infective endocarditis (IE). However, the risk of IE in patients with a small PDA appears to be extremely low, and IE is treatable. Although closure of the small PDA is generally safe and technically successful, it is unknown whether this treatment truly improves the risk:benefit balance compared with observation. In this article, we review the published literature on the natural history and treatment outcomes in individuals with a PDA, the epidemiology and outcomes of IE, particularly in association with PDA, and the rationale and evidence for closure of the very small PDA.

Cardiac troponin increases among runners in the Boston Marathon.

STUDY OBJECTIVE: Studies indicate that running a marathon can be associated with increases in serum cardiac troponin levels. The clinical significance of such increases remains unclear. We seek to determine the prevalence of troponin increases and epidemiologic factors associated with these increases in a large and heterogeneous cohort of marathon finishers. METHODS: Entrants in the 2002 Boston Marathon were recruited 1 to 2 days before the race. Data collected included demographic and training history, symptoms experienced during the run, and postrace troponin T and I levels. Simple descriptive statistics were performed to describe the prevalence of troponin increases and runner characteristics. RESULTS: Of 766 runners enrolled, 482 had blood analyzed at the finish line. In all, 34% were women, 20% were younger than 30 years, and 92% had run at least 1 previous marathon. Most runners (68%) had some degree of postrace troponin increase (troponin T > or = 0.01 ng/mL or troponin I > or = 0.1 ng/mL), and 55 (11%) had significant increases (troponin T > or = 0.075 ng/mL or troponin I > or = 0.5 ng/mL). Running inexperience (< 5 previous marathons) and young age (< 30 years) were associated with elevated troponins. These correlates were robust throughout a wide range of troponin thresholds considered. Health factors, family history, training, race performance, and symptoms were not associated with increases. CONCLUSION: Troponin increases were relatively common among marathon finishers and can reach levels typically diagnostic for acute myocardial infarction. Less marathon experience and younger age appeared to be associated with troponin increases, whereas race duration and the presence of traditional cardiovascular risk factors were not. Further work is needed to determine the clinical significance of these findings.

Age, size, and lead factors alone do not predict venous obstruction in children and young adults with transvenous lead systems.

BACKGROUND: Venous occlusion is a recognized complication of transvenous pacing, and lead cross-sectional area indexed to body surface area (BSA) has been used to predict venous obstruction in children. OBJECTIVE: The aim of this study was to identify the risk factors and incidence of angiographic venous obstruction after transvenous lead implantation in both children and young adults. METHODS: Contrast venography was obtained in 85 of 90 consecutive patients undergoing repeat pacemaker or ICD procedures from 2002 to 2004 at a single cardiac center. Venograms were graded as complete venous obstruction, significant partial obstruction (>70% with collaterals), or patent. RESULTS: The cohort had a median age of 15.0 years at implant and was divided into two age groups: 3-12 years (n = 35) and 13 years and over (n = 50). After a median interval of 6.5 years, complete obstruction was seen in 11 of 85 patients (13%) and partial obstruction in another 10 patients (12%). No significant differences were seen in the incidence of obstruction between the two age groups although younger patients had a larger lead indexed to BSA ratio (6.82 vs 5.05, P = 0.005). There were no significant differences between obstructed and nonobstructed patients in relation to age, size, growth, or lead factors. CONCLUSION: Transvenous lead systems implanted in young children have a similar incidence of venous occlusion compared to older patients. Furthermore, patient age, body size, and lead characteristics at implant do not clearly predict venous occlusion.

The Boston Marathon Study: a novel approach to research during residency.

Resident physicians from a pediatric academic training program developed a hospital-wide research project in an effort to enhance their residency research experience. In this model, residents themselves assumed primary responsibility for each stage of a large prospective clinical research study. The project, which was integrated successfully into the residency program, enabled a large group of residents, with mentorship from a dedicated faculty member, to benefit from a structured clinical research experience while providing the flexibility necessary to meet the demands of a busy residency curriculum. Careful topic selection with a well-defined end point, faculty involvement, resident collegiality, and institutional support were factors identified by study leaders as central to the success of this model.

Comparison of modern steroid-eluting epicardial and thin transvenous pacemaker leads in pediatric and congenital heart disease patients.

OBJECTIVE: Optimal pacemaker lead choice in pediatric patients eligible for either epicardial or transvenous leads remains unclear. We compared performances of modern thin transvenous (TTV) and steroid-eluting epicardial (SEE) leads in patients followed at one pediatric center. METHODS: Retrospective review of patients with qualifying leads implanted from August 1997 to March 2004. Threshold energy (TE) at implant and follow-up, sensing thresholds, lead complications, and repeat pacing-related procedures were analyzed. Lead performances were compared using t-tests, Wilcoxon rank-sum tests and Cox regression. Survival curves were plotted using Kaplan-Meier analysis. RESULTS: A total of 370 implant procedures, 521 leads, and 1549 visits were evaluated. In all, 256 leads were SEE (49%, 184 implants) and 265 were TTV (51%, 186 implants). Median follow-up was 29 months (range 1-80 months). Patients with SEE systems were younger at implant (6 vs. 17 yrs, p < 0.001), and more had congenital heart defects (82% vs. 57%, p < 0.001). At follow-up, ventricular TEs were higher for SEE leads at implant (p < 0.001), 1 month (p < 0.001), and up to 4 years (p = 0.019). When compared across all follow-up durations combined, TTV TEs were significantly lower than SEE TEs for both atrial and ventricular leads (p < 0.001). A total of 70 repeat procedures were performed in 60 patients during the study period, which comprised 18% of SEE and 14% of TTV system patients (p = NS). In all, 18 TTV and 19 SEE leads failed (p = NS). Estimated freedom from lead failure at 1, 3, and 5 years was 97%, 88%, 85% for TTV leads and 96%, 92%, and 58% for SEE leads (log rank P = NS). CONCLUSIONS: Both SEE and TTV leads showed good mid-term performance and survival in our cohort. Higher TEs seen for SEE leads, especially ventricular and unipolar leads, may result in higher current drain and thus more generator replacements than TTV systems. Lead failure rates were comparable across lead types. TTV leads offer a promising alternative to SEE systems in terms of performance for young patients without intracardiac shunting who do not require open-chest surgery for another indication.

Hyponatremia among runners in the Boston Marathon.

BACKGROUND: Hyponatremia has emerged as an important cause of race-related death and life-threatening illness among marathon runners. We studied a cohort of marathon runners to estimate the incidence of hyponatremia and to identify the principal risk factors. METHODS: Participants in the 2002 Boston Marathon were recruited one or two days before the race. Subjects completed a survey describing demographic information and training history. After the race, runners provided a blood sample and completed a questionnaire detailing their fluid consumption and urine output during the race. Prerace and postrace weights were recorded. Multivariate regression analyses were performed to identify risk factors associated with hyponatremia. RESULTS: Of 766 runners enrolled, 488 runners (64 percent) provided a usable blood sample at the finish line. Thirteen percent had hyponatremia (a serum sodium concentration of 135 mmol per liter or less); 0.6 percent had critical hyponatremia (120 mmol per liter or less). On univariate analyses, hyponatremia was associated with substantial weight gain, consumption of more than 3 liters of fluids during the race, consumption of fluids every mile, a racing time of >4:00 hours, female sex, and low body-mass index. On multivariate analysis, hyponatremia was associated with weight gain (odds ratio, 4.2; 95 percent confidence interval, 2.2 to 8.2), a racing time of >4:00 hours (odds ratio for the comparison with a time of <3:30 hours, 7.4; 95 percent confidence interval, 2.9 to 23.1), and body-mass-index extremes. CONCLUSIONS: Hyponatremia occurs in a substantial fraction of nonelite marathon runners and can be severe. Considerable weight gain while running, a long racing time, and body-mass-index extremes were associated with hyponatremia, whereas female sex, composition of fluids ingested, and use of nonsteroidal antiinflammatory drugs were not.

Patient, procedural, and hardware factors associated with pacemaker lead failures in pediatrics and congenital heart disease.

OBJECTIVES: To examine outcomes of children with pacemakers over a 22-year period and identify risk factors for lead failure. BACKGROUND: Small patient size, structural cardiac abnormalities, and growth may complicate pediatric pacemaker management. Better knowledge of risk factors for lead failure in these patients may help improve future outcomes. METHODS: All pacemaker patients followed at one pediatric center 1980-2002 were included. Lead failures were identified retrospectively as leads repaired, replaced, or abandoned due to fracture, insulation break, dislodgement, or abnormalities in pacing or sensing. Risk factors were identified using logistic regression and Cox analyses. RESULTS: A total of 1007 leads were implanted in 497 patients during the study period (5175 lead-years). Median age at implant was 9 years (0-55); 64% of patients had structural congenital heart disease. Median follow-up time was 6.2 years (0-22). Lead failure occurred in 155 leads (15%), and 115 patients (23%), with 28% of patients experiencing multiple failures. Significant independent correlates of lead failure included age <12 years at implant, history of structural congenital heart defects, and epicardial lead placement. Younger patients (<12 years) experienced significantly more lead fractures than older children (P = .005), while patients with congenital heart defects experienced more exit block. Epicardial leads were more likely to fail due to fracture or exit block, while transvenous leads failed more due to insulation breaks or dislodgements. CONCLUSIONS: Pediatric pacing patients have a high incidence lead failures. These occur most commonly in younger patients, structural congenital heart disease, and those with epicardial lead systems. Approaches to pacing system implantation and follow-up in these patients need to be individualized, with special attention to minimizing risk of lead failures. Our findings suggest that expanded utilization of transvenous systems in smaller patients seems justified when anatomy permits.

Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients.

OBJECTIVES: Medication errors in pediatric inpatients occur at similar rates as in adults but have 3 times the potential to cause harm. Error prevention strategies in this setting remain largely untested. The objective of this study was to classify the major types of medication errors in pediatric inpatients and to determine which strategies might most effectively prevent them. METHODS: A prospective cohort study was conducted of 1020 patients who were admitted to 2 academic medical centers during a 6-week period in April and May 1999. Medication errors were characterized by subtype. Physician raters evaluated error prevention strategies and identified those that might be most effective in preventing errors. RESULTS: Of 10 778 medication orders reviewed, 616 contained errors. Of these, 120 (19.5%) were classified as potentially harmful, including 115 potential adverse drug events (18.7%) and 5 preventable adverse drug events (0.8%). Most errors occurred at the ordering stage (74%) and involved errors in dosing (28%), route (18%), or frequency (9%). Three interventions might have prevented most potentially harmful errors: 1) computerized physician order entry with clinical decision support systems (76%); 2) ward-based clinical pharmacists (81%); and 3) improved communication among physicians, nurses, and pharmacists (86%). Interrater reliability of error prevention strategy assignment was good (agreement: 0.92; kappa: 0.82). CONCLUSIONS: Of the assessed interventions, computerized physician order entry with clinical decision support systems; ward-based clinical pharmacists; and improved communication among physicians, nurses, and pharmacists had the greatest potential to reduce medication errors in pediatric inpatients. Development, implementation, and assessment of such interventions in the pediatric inpatient setting are needed.

Major adverse outcomes after percutaneous transluminal coronary angioplasty: a clinical prediction rule.

In this study, we developed and internally validated a clinical model for predicting major adverse outcomes in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) using a multi-institutional prospective cohort study involving all adult patients who underwent PTCA at 12 participating institutions from August 1993 to October 1995. A major adverse outcome, defined as death, renal failure, myocardial infarction, cardiac arrest, stroke, or coma, occurred in 3.3 and 3.2% of patients in the derivation and validation sets, respectively. Death occurred in 1.5% in both sets. Fourteen variables were independently correlated with major adverse outcomes. The rule, which stratifies PTCA patients into six levels of risk based on the severity score, showed excellent discrimination (receiver-operating characteristic curve area 0.82) and calibration (Hosmer-Lemeshow chi-square statistic P =.90) and performed well on internal validation. This rule allows accurate preprocedure stratification of PTCA candidates according to their risk of suffering a major adverse outcome.