Palivizumab Use in Subjects with Congenital Heart Disease

Cohen, Stuart A.; Zanni, Robert; Cohen, Alan H.; Harrington, Molly; VanVeldhuisen, Paul; Boron, Marnie L.

doi:10.1007/s00246-007-9039-5

Cited by 36 publications

(13 citation statements)

References 14 publications

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“…The US outcomes registry [37] documented steadily declining RSVH rates from 2000 (2.9%) to 2004 (0.7%) for all subjects, and 9.1% ( n = 1, 123) had congenital airway anomalies or severe neuromuscular impairments. However, the CARESS database comprises 2,097 (15.8%) patients with a spectrum of serious underlying medical disorders who have received palivizumab, and these infants are likely to have higher breakthrough RSVH rates following immunization, despite optimal adherence to dosing schedules [15, 16, 31, 36]. Apart from striving to achieve 100% compliance, to further reduce RSVH, another potential strategy that can be adopted is a home-based prophylaxis program [36].…”

Section: Discussionmentioning

confidence: 99%

“…However, the CARESS database comprises 2,097 (15.8%) patients with a spectrum of serious underlying medical disorders who have received palivizumab, and these infants are likely to have higher breakthrough RSVH rates following immunization, despite optimal adherence to dosing schedules [15, 16, 31, 36]. Apart from striving to achieve 100% compliance, to further reduce RSVH, another potential strategy that can be adopted is a home-based prophylaxis program [36]. However, operationalizing this concept is administratively demanding and needs to be proven as cost-effective.…”

Section: Discussionmentioning

confidence: 99%

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Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Paes

Mitchell

et al. 2013

Clinical and Developmental Immunology

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Respiratory syncytial virus (RSV) infection occurs commonly in infants aged ≤2 years, and severe infection results in hospitalization with accompanying morbidity and mortality. Palivizumab has been available for prophylaxis for the past 15 years. Prospective data on patients who received palivizumab from 2005 to 2012 has been assembled in the Canadian registry (CARESS) to document utilization, compliance, and health outcomes in both hospital and community settings. Long-term data is necessary to evaluate the impact of palivizumab on the incidence of RSV infections, minimize healthcare resources, and identify which infant subpopulations are receiving prophylaxis. A database search was also conducted for similar information from published registries, and hospitalization rates were compared to results from randomized clinical trials (RCTs).Overall hospitalization rates (percent; range) for respiratory-related illnesses and RSV-specific infection in infants who meet standard indications for prophylaxis were 6.6 (3.3–7.7) and 1.55 (0.3–2.06), respectively, in CARESS, which closely aligns with registry data from 4 other countries, despite the former comprising the largest cohort of complex patients internationally. Overall RSV-related hospitalization rates were lower across registries compared to equivalent patients in RCTs. Registry data provides valuable information regarding real-world experience with palivizumab, while facilitating the genesis of new research themes.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Paes

Mitchell

et al. 2013

Clinical and Developmental Immunology

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“…In the Palivizumab Outcomes Registry (a voluntary report system that does not include all CHD patients receiving palivizumab), the number of subjects with CHD enrolled in the registry increased more than six times from 2000–2001 ( N = 102) to 2003–2004 ( N = 688) [4]. While data after 2004 are not available from the registry, it is likely that the increase in CHD patients continued.…”

Section: Discussionmentioning

confidence: 99%

Impact of Palivizumab on RSV Hospitalizations for Children with Hemodynamically Significant Congenital Heart Disease

Chang

Chen

2009

Pediatr Cardiol

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The objective of this study was to evaluate the impact of palivizumab prophylaxis on respiratory syncytial virus (RSV) hospitalizations among children with hemodynamically significant congenital heart disease (CHD). In 2003, the American Academy of Pediatrics (AAP) revised the bronchiolitis policy statement and recommended the use of palivizumab in children <24 months old with hemodynamically significant CHD (HS-CHD). California statewide hospital discharge data from years 2000–2002 (pre-AAP policy revision) were compared to those from years 2004–2006 (post-AAP policy revision). Hospitalizations due to RSV bronchiolitis for children <2 years of age were identified by IDC-9 CM codes 4661.1, 480.1, and 079.6 as the Principal Diagnosis. Children with CHD and children with HS-CHD were identified by the codiagnoses. The overall RSV hospitalization rate was 71 per 10,000 children <2 years of age. Of all RSV hospitalizations, 3.0% were among children with CHD, and 0.50% among children with HS-CHD. HS-CHD patients accounted for 0.56% of RSV hospitalizations in 2000–2002, compared to 0.46% RSV hospitalizations in 2004–2006. That represents a 19% reduction in RSV hospitalizations among HS-CHD patients after 2003. The 19% decrease in RSV hospitalizations equates to seven fewer hospitalizations (76 hospital days) per year among HS-CHD patients. We conclude that, since the recommendation of palivizumab for children with HS-CHD in 2003, the impact on RSV hospitalizations in California among HS-CHD patients has been limited. Considering the high cost of palivizumab administration, the cost-benefit of RSV prophylaxis with palivizumab warrants further investigation.

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“…This recommendation was also outlined in the revised AAP guidelines in 2009 [33]. The Palivizumab Outcome Registry Group (2008) [34] collected data on 1500 children with CDH accounting for 7.7% of the entire registry cohort of 19548, who received RSV prophylaxis with palivizumab over four seasons (2000-2004). The majority (71%) had acyanotic CDH.…”

Section: Patient Groups At High Risk For Severe Rsv Diseasementioning

confidence: 99%

Risk Factors for Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection

Sommer

Resch²,

Simões³

2011

TOMICROJ

198

183

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RSV infection is a leading cause of lower respiratory tract infection, especially in High-risk infants with a history of prematurity, bronchopulmonary dysplasia (BPD), congenital heart disease (CHD), neuromusculair impairment, immunodeficiency, and Down syndrome. Host related risk factors that have been identified to be associated with severe RSV related lower respiratory tract infection include young age below 6 months at the beginning of RSV season, multiple birth, male sex, low socioeconomic status and parental education, crowded living conditions, young siblings, maternal smoking and indoor smoke pollution, malnutrition/small for gestational age, family history of atopy or asthma, low cord serum RSV antibody titers, and living at altitude.Risk factors increasing the risk of acquisition of RSV have been identified to be birth before and/or during RSV season, day care attendance, presence of older siblings in school or day-care, and lack of breast feeding. Some of these risk factors are discussed controversially and some of them are found continuously throughout the literature.Given the high cost of RSV prophylaxis, especially for the large population of late preterm infants, algorithms and risk score systems have been published that could identify high-risk infants for treatment with palivizumab out of this gestational age group. Several models reported on an average sensitivity and specificity of 70 percent and, thus, are helpful to identify infants at high risk for severe RSV infection and need for prophylaxis with palivizumab.

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Palivizumab Use in Subjects with Congenital Heart Disease

Cited by 36 publications

References 14 publications

Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Impact of Palivizumab on RSV Hospitalizations for Children with Hemodynamically Significant Congenital Heart Disease

Risk Factors for Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection

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