Quality Control for Intravascular Intrauterine Transfusion Using Cumulative Sum (CUSUM) Analysis for the Monitoring of Individual Performance

Abstract

Introduction: Intravascular intrauterine transfusion (IUT) is an effective and relatively safe method for the treatment of fetal anemia. Although implemented in centers all over the world in the 1980s, the length and strength of the learning curve for this procedure has never been studied. Cumulative sum (CUSUM) analysis has been increasingly used as a graphical and statistical tool for quality control and learning curve assessment in clinical medicine. We aimed to test the feasibility of CUSUM analysis for quality control in fetal therapy by using this method to monitor individual performance of IUT in the learning phase and over the long term. Methods: IUTs performed in the Dutch referral center for fetal therapy from 1987 to 2009 were retrospectively classified as successful or failed. Failed was defined as no net transfusion or the occurrence of life-threatening procedure-related complications. The CUSUM statistical method was used to estimate individual learning curves and to monitor long-term performance. Four operators who each performed at least 200 procedures were included. Results: Individual CUSUM graphs were easily assessed. Both operators pioneering IUT in the late 1980s had long learning phases. The 2 operators learning IUT in later years in an experienced team performed acceptably from the start and reached a level of competence after 34 and 49 procedures. Discussion: CUSUM analysis is a feasible method for quality control in fetal therapy. In an experienced setting, individual competence may be reached after 30 to 50 IUTs. Our data suggest that operators need at least 10 procedures per year to keep a level of competence.

The near disappearance of fetal hydrops in relation to current state‐of‐the‐art management of red cell alloimmunization

“…A more advanced gestational age at birth in later years of the study and/or advancements in prenatal and especially neonatal management in the past decades may have contributed, as well as a decrease in IUT complications . Centralization of fetal therapy and neonatal care in large volume centers is increasingly important for quality of care …”

“…6 Centralization of fetal therapy and neonatal care in large volume centers is increasingly important for quality of care. 30 Infants born alive after treatment with IUT(s) seem to be in better neonatal condition nowadays, being less anemic at birth (despite longer intervals between the last transfusion and birth) and needing less exchange transfusions. We found that both additional intraperitoneal transfusion, in adjunct to intravascular transfusion, and more advanced gestational age at birth were independently associated with higher neonatal hemoglobin.…”

Intrauterine transfusion and non-invasive treatment options for hemolytic disease of the fetus and newborn – review on current management and outcome

“…Refraining from fetal paralysis, arterial and free loop needling were found to be important risk factors for adverse outcome [29]. Furthermore, operators should perform at least 10 IUTs per year to retain their competence [67].…”

Intrauterine Blood Transfusion: Current Indications and Associated Risks

“…In the literature, procedure-related fetal loss ranges from 0.9 to 4.9% per procedure [7,50,51,52,53,54] and was found to be associated with fetal hydrops [54,55], early gestational age [50,51], failing to use fetal paralysis during IUT [7], transfusion at a free loop of cord or arterial puncture [7,52], experience of the operator [52,56] and severity of fetal anemia [53]. Interestingly, preterm premature rupture of membranes after transfusion appears extremely rare, e.g.…”