The effect of pre-ECLS ventilation time on survival and respiratory morbidity in the neonatal population.

Although mechanical ventilation for more than 7 to 10 days has been considered a contraindication to the application of extracorporeal life support (ECLS) in neonates, the outcome and respiratory morbidity for newborns placed on ECLS after more than 7 days of ventilation have not been well characterized. The purpose of this study was to determine the impact of pre-ECLS ventilation time on the rate of survival, the likelihood of the development of bronchopulmonary dysplasia (BPD), and the need for supplemental oxygen at the time of discharge. Examination of the Extracorporeal Life Support Organization (ELSO) Registry showed that 6,110 neonates were treated for respiratory failure with a pre-ECLS ventilation time of less than 14 days between January 1990 and May 1995. Gestational age (GA), birth weight (BW), indication for ECLS, and diagnosis were compared with the rate of survival, the discharge diagnosis of BPD, and the need for home oxygen. The GA and BW of neonates placed on ECLS during the first week of life (n = 5,888) did not differ significantly from those of neonates whose ECLS was begun in the second week of life (n = 222). The neonates were divided into two groups (early, ventilation time of 3 to 6 days; late, ventilation time of 7 to 10 days) to determine the odds ratios for survival, BPD, and home oxygen. Logistic regression analysis was used to develop a model to predict the rate of survival, the risk for the development of BPD, and the need for home oxygen given the length of pre-ECLS ventilation time. The late group was less likely to survive (odds ratio, 1.8; 95% confidence interval [CI], 1.21 to 2.68). The late group also had approximately twice the risk for the development of BPD (odds ratio, 1.9; 95% CI, 1.2 to 3.04) and a trend toward an increased incidence of home oxygen use (odds ratio, 1.55; 95% CI, 0.92 to 2.60). The authors conclude that (1) there is a greater risk of mortality and BPD and a trend toward an increased need for home oxygen with increased time on the ventilator before ECLS; (2) at 14 days the predicted probability of survival is still 53% (95% CI, 31% to 74%); (3) at 14 days the predicted probability of BPD is 54% (95% CI, 28% to 78%); and (4) based on these data, it is reasonable to consider application of ECLS to patients who have had mechanical ventilation for up to 14 days.

A matched pairs analysis of venoarterial and venovenous extracorporeal life support in neonatal respiratory failure.

It has been suggested that venovenous (VV) extracorporeal life support (ECLS) confers a survival advantage over venoarterial (VA) ECLS. These results have been confounded by differences in patient populations. In this study, a matched pairs comparison of survival and complication rates in neonatal respiratory failure patients managed with VA or VV ECLS was performed. Retrospective matching of 643 VA and VV patient pairs from the Extracorporeal Life Support Organization Registry was performed. Pairs were matched by same year, same diagnosis, gestational age +/- 1 week, birth weight +/- 0.3 kg, and oxygenation index +/- 5. Further matching for hemodynamic status was possible for 272 pairs and included pre ECLS CPR, use of epinephrine, and arterial pH +/- 0.1. Statistical significance was defined for outcome and selected complication rates using McNemar's chi-square analysis with correction for multiple comparisons. A survival advantage for VV was significant when matching for respiratory failure (83.8% VA versus 91.5% VV), but was not significant when matching for hemodynamic failure (90.4% VA versus 94.5% VV). In the latter match, hemolysis (10.7% VA versus 23.5% VV) and cannula kinking (0.4% VA versus 10.6% VV) were more common with VV ECLS. The incidence of intracranial hemorrhage did not significantly differ between groups (6.3% VA versus 7.4% VV). Survival is not significantly greater with VV ECLS when patients are matched for degree of respiratory and hemodynamic failure. Hemolysis and cannula kinking are more common with VV ECLS. There is no identified difference in the incidence of intracranial hemorrhage.

Extracorporeal Life Support Organization 1994.

The annual report of the Extracorporeal Life Support Organization is presented for 1994. The aggregate experience of neonatal, pediatric pulmonary, and neonatal/pediatric cardiac patients treated with extracorporeal membrane oxygenation is presented for data collected to April 1994. In addition, the Registry now includes a large number of adult extracorporeal membrane oxygenation cases. Rates of survival for each patient group remained unchanged from previous years with 81% neonatal, 50% pediatric, and 44% cardiac survival. Complete data are available through 1992, with increasing case numbers each year as a basis for this growing registry.

Extracorporeal life support for neonatal respiratory failure. A 20-year experience.

OBJECTIVE: The authors reviewed their experience with extracorporeal life support (ECLS) in neonatal respiratory failure; they define changes in patient population, technique, and outcomes. SUMMARY BACKGROUND DATA: Extracorporeal life support has progressed from laboratory research to initial clinical trials in 1972. Following a decade of clinical research, ECLS is now standard treatment for neonatal respiratory failure refractory to conventional pulmonary support techniques. Our group has the longest and largest experience with this technique. METHODS: Between 1973 and 1993, 460 neonates with severe respiratory failure were treated using ECLS. The records of all patients were reviewed. RESULTS: Overall survival was 87%. Primary diagnoses were meconium aspiration syndrome (MAS; 169 cases [96% survival]), respiratory distress syndrome/hyaline membrane disease (91 cases [88% survival]), persistent pulmonary hypertension of the newborn (37 cases [92%]), pneumonia/sepsis (75 cases [84% survival]), congenital diaphragmatic hernia (CDH; 67 cases [67% survival]), and other diagnoses (21 cases [71% survival]). Common mechanical complications included clots in the circuit (136; 85% survival); air in the circuit (67; 82% survival); cannula problems (65; 83% survival) and oxygenator failure (34; 65% survival). Patient-related complications included intracranial infarct or bleed (54 cases; 61% survival), major bleeding (48 cases; 81% survival), seizures (88 cases; 76% survival), metabolic abnormalities (158 cases; 71% survival) and infection (21 cases; 48% survival). Since 1989, treatment groups have been expanded to include premature infants (13 cases; 62% survival), infants with grade I intracranial hemorrhage (28 cases; 54% survival) and "non-honeymoon" CDH patients (15 cases; 27% survival). Since 1990, single-catheter venovenous access has been used in 131 patients (97% survival) and currently is the preferred mode of access. Follow-up ranges from 1 to 19 years; 80% of patients are growing and developing normally. CONCLUSIONS: Extracorporeal life support has become standard treatment for severe neonatal respiratory failure in our center (460 cases; 87% survival), and worldwide (8913 cases; 81% survival). The availability of ECLS makes the evaluation of other innovative methods of treatment, such as late elective repair of diaphragmatic hernia and new pulmonary vasodilators, possible. The application of ECLS is now being extended to premature and low-birth weight infants as well as older children and adults.

Complications of neonatal extracorporeal membrane oxygenation. Collective experience from the Extracorporeal Life Support Organization.

Since 1973, 7667 neonates have been treated with extracorporeal membrane oxygenation for severe respiratory failure and their cases reported to the Extracorporeal Life Support Organization Registry. The overall survival was 81% in these neonates, who were thought to have a survival of 20% without extracorporeal membrane oxygenation. A total of 4322 mechanical complications (0.56 +/- 0.84 per case) and 13,827 patient complications (1.80 +/- 2.12 per case) were reported overall. The most common mechanical complications included clots in the circuit (19%), cannula placement (9%), oxygenator failure (4%), and others (9%). Common patient complications included cardiopulmonary (43%), neurologic (35%), bleeding (35%), metabolic (32%), renal (25%), and renal (25%), and infectious (9%). From the initial experience to 1988 the average number of mechanical complications per case was 0.27 per case and this significantly increased during 1990 to 1992 to 0.75 per case (p < 0.05). Likewise, from 1973-1985 to 1988 the average patient complications per case were 1.44 per case and this significantly increased during 1990 to 1992 to 2.10 per case. During the same periods, patient survival significantly decreased from 84% (1973-1985 to 1988, n = 2463) to 80% (1990 to 1992, n = 4005). Venovenous double-lumen single cannula extracorporeal membrane oxygenation had a higher survival than venoarterial extracorporeal membrane oxygenation (91% versus 81%) and a lower rate of major neurologic complications. The incidence and survival with seizures (6% and 89% venovenous versus 13% and 61% venoarterial) or cerebral infarction (9% and 69% venovenous versus 14% and 46% venoarterial) was significantly lower with the venovenous method and appeared to have a substantial impact on overall survival. The correlation of patient complication rate and total complication rate with survival was highly significant, however, causality cannot be established. Explanations for the increase in complications, relative to a decrease in survival, despite a growing nationwide experience include (1) increased complexity of cases as many programs expand entry criteria (more premature infants, infants with grade 1 or 2 intracranial hemorrhage, and complex congenital diaphragmatic hernia), (2) a growing number of programs with fewer cases per program, yet greater accessibility, (3) less reluctance to report complications encountered during extracorporeal membrane oxygenation as group experience grows, and (4) changes in the Extracorporeal Life Support Organization data form to be more inclusive of more minor complications.

Extracorporeal Life Support Organization 1993.

This is the annual report of the Extracorporeal Life Support Organization. It concerns the aggregate experience of all reported patients treated with extracorporeal membrane oxygenation as of April 1993. The patients are either neonatal, pediatric pulmonary, or neonatal/pediatric cardiac. A survival rate of 81% (neonatal), 48% (pediatric), and 45% (cardiac) is reported in patients thought to have at least an 80% mortality likelihood.

Benefits of a multidisciplinary approach to breast care.

The University of Michigan Breast Care Center (BCC) was established in 1985 to provide comprehensive, multidisciplinary diagnosis and treatment of benign and malignant breast disease. This work presents an overview of our experience in the BCC and assesses the clinical, academic, financial, and educational effectiveness of the program. A database was used to generate a list of all patients seen in the BCC between February 1, 1985 and December 31, 1991. Participating departments provided information regarding outpatient, inpatient, clinical and consultative activities, and referral patterns attributable to BCC endeavors. BCC educational and academic activities were reviewed and profiled. Clinical information was culled from the BCC database, hospital records, and the hospital tumor registry. The BCC has resulted in a fivefold increase in breast care related activity at the University of Michigan Medical Center. Over half of the patients treated in the BCC with primary operable breast cancer receive breast-conserving therapy. The BCC performs a unique educational function, providing the primary breast care experience for house staff as well as one third of the third year medical school class. The BCC supports over 20 clinical research protocols, and patient enrollment in clinical trials has increased dramatically since 1985. The BCC also provides support to basic science researchers receiving over 2.5 million dollars in peer reviewed direct cost support. These data suggest that a multidisciplinary approach to patient care as embodied by the BCC can be clinically, financially, and academically superior and productive. This model warrants further investigation not only in the field of breast care, but also in other clinical situations that require multidisciplinary input and therapy.