Purpose: Malfunction of totally implantable venous access devices is a common complication. The purpose was to identify definitions used to describe malfunction and to investigate the incidence of malfunction in different types of port and catheter designs.
Methods: Relevant studies were identified in PubMed that were published between January 1993 and February 2011. Empirical studies reporting functional outcomes in adults and where, at least 95% of the studied population consisted of onco-hematology patients with a newly inserted chest or arm port, were selected. The following data were extracted: patient and totally implantable venous access devices (TIVAD) characteristics, study design, definitions of malfunction, and functional outcomes. Two independent reviewers assessed the methodological quality of the series.
Results: Of the 4,886 potentially relevant articles, 57 were selected, involving 14,311 TIVADs. Twenty-nine percent of the studies explicitly defined malfunction. Malfunction incidence rates were expressed in six different ways, including the proportion of affected devices per inserted devices (incidence 0-47%); the number of affected devices per 1,000 catheter days (incidence 0-2.24 per 1,000 catheter days); and the number of malfunctions over the total number of accessing attempts (incidence 0-26%).
Conclusions: Heterogeneity in the definitions used to describe device malfunction was evident. A broad range in the reported incidence of malfunction and in the kind of calculation and reporting methods was also found. Methodological quality of the studies was often poor. Standardization of definitions and accurate outcome measurement is needed. Calculation and report of malfunction incidence should be based on prospective data collected at the moment of an accession attempt.