Great new study prevented sure to boost ICD, CRT sales:\
Philadelphia, PA - Infections with implantable cardioverter defibrillators (ICDs) and pacemakers are on the rise, and these infections are associated with increased hospital lengths of stay and higher financial costs, according to new data analyzing 16-year trends of the infection burden with the devices [1].
In the study, published in the August 30, 2011 issue of the Journal of the American College of Cardiology, Dr Arnold Greenspon (Thomas Jefferson University Hospital, Philadelphia, PA) and colleagues say the higher rate of infection burden is likely the result of the expanding ICD indications and increasing comorbidities in patients who receive cardiac implantable electrophysiological devices.
The new data are derived from an analysis of the Nationwide Inpatient Sample (NIS) discharge records between 1993 and 2008. The implantation of pacemakers and ICDs has increased over recent years, based largely on the results of clinical trials of ICDs for primary prevention, such as MADIT 2 and SCD-HeFT, and also because of the aging population, according to the investigators. Data suggest, however, that infections associated with device implantation might be increasing.
Over the 16-year period, device implantation increased 96%, or 4.7% annually. The majority of the increase was due to ICD implantation, which increased 504% between 1993 and 2008. During this time period, incidence of infection associated with device implantation was 1.61%, increasing from 2660 cases in 1993 to 8230 infections in 2008. During this time, the annual rate of infection was constant from 1993 to 2004, when a marked increase was noted. In 2004, the rate of infection was 1.53% and increased to 2.41% in 2008 (p<0.001).
The four major comorbidities in patients receiving an implantable device were renal failure, respiratory failure, heart failure, and diabetes, and the incidence of these comorbidities remained constant between 1993 and 2004. After 2004, the incidence of the comorbidities increased, as did the risk of mortality from infections in patients with respiratory failure, renal failure, and heart failure. Between 1993 and 2008, the mortality rate due to infection was 4.93%, although this rate increased from 2.91% in 1993 to 4.69% in 2008, an increase of 1% per decade. Hospitalization costs caused by infections also increased, from $75 000 in 1993 to $146 000 in 2008, or approximately 47% per decade.
"Current patients have a high number of clinical comorbidities associated with prolonged hospital stays and an increase in the utilization of medical resources reflected by an increase in hospital charges," write Greenspon and colleagues.
The researchers say the reason for the increase in infection is not clear, although they suspect that it is partially attributable to the increase in ICD and cardiac resynchronization therapy device implantations. These devices have less longevity than pacemakers, and as a result patients will require replacement surgery. Replacement surgery is associated with an increased risk of infection, they note. In addition, patient characteristics, such as increasing comorbidities, likely contribute to the increased infection burden.
Philadelphia, PA - Infections with implantable cardioverter defibrillators (ICDs) and pacemakers are on the rise, and these infections are associated with increased hospital lengths of stay and higher financial costs, according to new data analyzing 16-year trends of the infection burden with the devices [1].
In the study, published in the August 30, 2011 issue of the Journal of the American College of Cardiology, Dr Arnold Greenspon (Thomas Jefferson University Hospital, Philadelphia, PA) and colleagues say the higher rate of infection burden is likely the result of the expanding ICD indications and increasing comorbidities in patients who receive cardiac implantable electrophysiological devices.
The new data are derived from an analysis of the Nationwide Inpatient Sample (NIS) discharge records between 1993 and 2008. The implantation of pacemakers and ICDs has increased over recent years, based largely on the results of clinical trials of ICDs for primary prevention, such as MADIT 2 and SCD-HeFT, and also because of the aging population, according to the investigators. Data suggest, however, that infections associated with device implantation might be increasing.
Over the 16-year period, device implantation increased 96%, or 4.7% annually. The majority of the increase was due to ICD implantation, which increased 504% between 1993 and 2008. During this time period, incidence of infection associated with device implantation was 1.61%, increasing from 2660 cases in 1993 to 8230 infections in 2008. During this time, the annual rate of infection was constant from 1993 to 2004, when a marked increase was noted. In 2004, the rate of infection was 1.53% and increased to 2.41% in 2008 (p<0.001).
The four major comorbidities in patients receiving an implantable device were renal failure, respiratory failure, heart failure, and diabetes, and the incidence of these comorbidities remained constant between 1993 and 2004. After 2004, the incidence of the comorbidities increased, as did the risk of mortality from infections in patients with respiratory failure, renal failure, and heart failure. Between 1993 and 2008, the mortality rate due to infection was 4.93%, although this rate increased from 2.91% in 1993 to 4.69% in 2008, an increase of 1% per decade. Hospitalization costs caused by infections also increased, from $75 000 in 1993 to $146 000 in 2008, or approximately 47% per decade.
"Current patients have a high number of clinical comorbidities associated with prolonged hospital stays and an increase in the utilization of medical resources reflected by an increase in hospital charges," write Greenspon and colleagues.
The researchers say the reason for the increase in infection is not clear, although they suspect that it is partially attributable to the increase in ICD and cardiac resynchronization therapy device implantations. These devices have less longevity than pacemakers, and as a result patients will require replacement surgery. Replacement surgery is associated with an increased risk of infection, they note. In addition, patient characteristics, such as increasing comorbidities, likely contribute to the increased infection burden.