The Effects of Respiratory syncytial virus prophylaxis Application Protocol on Patient Compliance and Clinical Outcomes in Congenital Heart Diseases

Abstract

Introduction: Palivizumab is a well tolerated, safe monoclonal antibody in the prevention of respiratuar syncytial virus (RSV) in high-risk children. The adaptation of the parents is extremely important for patients to be able to receive timely and full dose prophylaxis. There are articles evaluating patient compliance and clinical outcomes in RSV prophylaxis. Each clinic has its own follow-up and administration protocol, but there are no studies on the protocols used, patient compliance and dose completion.

Material and Methods: A total of 60 patients with hemodynamically significant congenital heart disease who had RSV prophylaxis in the pediatric cardiology outpatient clinic between October 2016 and March 2018 were retrospectively reviewed. The patients who received prophylaxis in 2 different seasons and were followed up with 2 different protocols were compared with each other in terms of compliance and clinical results

Results: In the October 2016- March 2017 season, the mean dose was 1 ± 0.2 in the 5-month period and full patient compliance was 10%. Dose intervals were 37.2 ± 6.15 days. 10 patients (40%) were hospitalized. After the protocol change was made in the October 2017-March 2018 season, patient compliance was evaluated as 100%

Conclusion: In palivizumab prophylaxis, increasing the dose and increasing the compliance of the interval significantly decreases hospitalizations due to RSV. Detailed and well-organized follow-up and application protocols are extremely important in increasing compliance.

Keywords

• Respiratory syncytial virus,Congenital Heart Diseases,Compliance

Konjenital Kalp Hastalıklarında Respiratuar Sinsisyal Virus Proflaksisinde Uygulama Protokolünün Hasta Uyumu Üzerine Etkisi ve Klinik Sonuçları

Öz

Giriş: Palivizumab, yüksek riskli çocuklarda respiratuar sinsisyal virüs (RSV) önlenmesinde iyi tolere edilen, güvenli bir monoklonal antikordur. Hastaların zamanında ve tam doz proflaksi alabilmeleri için anne ve babanın uyumu son derece önemlidir. RSV proflaksisinde hasta uyumunu ve klinik sonuçlarını değerlendiren makaleler bulunmaktadır. Her kliniğin kendi takip ve uygulama protokolü bulunmaktadır ancak kullanılan protokoller, hasta uyumu ve doz tamamlanması ile ilgili bir çalışma bulunmamaktadır.

Hastalar ve Yöntem: Ekim 2016-Mart 2018 tarihleri arasında çocuk kardiyoloji polikliniğinde RSV proflaksisi endikasyonu almış hemodinamik olarak anlamlı KKH’na sahip 2 yaş altı toplam 60 hastaya ait veriler çocuk kardiyoloji poliklinik ve servis kayıtlarından retrospektif olarak incelendi.  2 farklı sezonda, proflaksi endikasyonu alan ve 2 farklı protokol ile takip edilen hastalar uyum ve klinik sonuçlar açısından birbiriyle karşılaştırıldı. Tam uyum, sezon boyunca 5 aylık dönemde, 30 gün aralarla en az 4 doz palivizumab uygulaması yapılması olarak tanımlandı.

Bulgular: Ekim 2016- Mart 2017 sezonunda, 5 aylık dönemde uygulan ortalama doz 1 ± 0.2 doz idi ve tam hasta uyumu %10 olarak bulundu. Doz aralıkları 37.2 ± 6.15 gün olarak bulundu. 10 hastada (% 40) ASYE nedeniyle hastaneye yatış ve RSV izolasyonu mevcuttu. Ekim 2017-Mart 2018 sezonunda yapılan protokol değişikliği sonrası, hasta uyumu %100 olarak değerlendirildi, ASYE nedeniyle acil servis başvurusu ve hastaneye yatış gereksinimi tespit edilmedi.

Sonuç: Palivizumab proflaksisinde doz tamamlanması ve aralığı uyumunu arttırmak RSV’ye bağlı hastane yatışlarını önemli ölçülde azaltmaktadır. Detaylı ve iyi organize edilmiş takip ve uygulama protokolleri hazırlanmak uyumu arttırmada son derece önemlidir. 

Anahtar Kelimeler

• Respiratuar Sinsisyal Virus,Konjenital Kalp Hastalıkları,, Uyum

References

1. Glezen WP, Taber LH, Frank AL, Kasel J. Risk of primary infection and reinfection with respiratory syncytial virüs. Am J Dis Child. 1986; 140: 543-546.
2. Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virüs in young children: a systematic review and meta-analysis. Lancet. 2010; 375: 1545-1555.
3. MacDonald NE, Hall CB, Suffin SC, Alexson C, Harris PJ, Manning JA. Respiratory syncytial viral infection in infants with congenital heart disease. N Engl J Med 1982; 307: 397-400.
4. Wang EE, Law BJ, Robinson JL, et al. PICNIC (Pediatric Investigators Collaborative Network on Infections in Canada) study of the role of age and respiratory syncytial virus neutralizing antibody on respiratory syncytial virus illness in patients with underlying heart or lung disease. Pediatrics 1997; 99: E4.
5. Altman CA, Englund JA, Sunnegardh J, et al. Evaluating national guidelines fort he prophylactic treatment of respiratory syncytial virüs in children with congenital heart disease. Acta Paediatr. 2014; 103: 840-845.
6. Khongphatthanayothin A, Wong PC, Samara Y, et al. Impact of respiratory syncytial vırus infection on surgery for congenital heart disease: a contemporary look at epidemiology and success of preoperative screening. Pediatr Cardiol. 2000; 21: 433-438.
7. Mullins Ja, La Monte AC, Brsee JS, Anderson LJ. Substantial variability in community respiratory syncytial vırus season timing. Pediatr Infect Dis J. 2003; 22: 857-862.
8. Impact- RSV Study Group. Palivizumab, a human respiratory syncytial vırus monoclonal antibody, reduces hospitalization from respiratory syncytial vırus infection in high risk infants. Pediatrics. 1998; 102; 531-537.

9. Feltes TF, Cabalka AK, Meissner HC, et al. Cardiac Synagis Study Group. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial vırus in young children with hemodinamically significant congenital heart disease. J Pediatr. 2003; 143: 532-540.
10. Feltes TF, Sondheimer HM, Tulloh RM, et al. Motavizumab Cardiac Study Group. A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial vırus disease in children with hemodinamically significant congenital heart disease. Pediatr Res. 2011; 70: 186-191.
11. Subramanian KN, Weisman LE, Rhodes T, et al. Safety and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial vırus in prematüre infants with bronchopulmonary dysplasia. Pediatr Infect Dis J. 1998; 17: 110-115.
12. Frogel MP, Stewart DL, Hoopes M. A systematic review of compliance with palivizumab administration for RSV ımmunoprophylaxis. JMCP. 2010; 16: 46-56.
13. Borecka R, Lauterbach R, Helwich E. Factors related to compliance with palivizumab prophylaxis for respiratuar syncytial virus infection-Data Poland. Dev Perıod Med. 2016; 3:181-190.
14. Li A, Wang D, Lanctot K. Comparing first and second year palivizumab prophylaxis in patients with hemodynamically significant congenital heart disease in cares database (2005-2015). Pediatr Infect Dis J. 2017; 36: 445- 450.
15. Langkamp DL, Hlavin SM, Bowen M. Compliance with palivizumab. Pediatr Res. 2002; 51:297 A. Poster presented at American pediatric Society/ Society for Pediatric Research Annual Meeting. May 4-7.2002. Baltimore.
16. Krilov LR, Masaquel AS, Weiner LB, Smith DM, Wade SW, Mahadevia PJ. Partial palivizumab prophylaxis and increased risk of hospitalization due to respiratory syncytial virus in a Medical population: a retrospective cohort analysis. BMC Pediatr. 2014; 14: 261-261.
17. Oh PI, Lanctot KI, Yoon A, et al. Palivizumab prophylaxis for respiratory syncytial virus in Canada: utilization and outcomes. Pediatr Infect Dis J. 2002; 21: 512-518.
18. Stewart DI, Ryan KJ, Seare JG, Pinsky B, Becker L, Frogel M. Association of RSV- related hospitalization and non-compliance with palivizumab among commercially insured infants: a retrospective analysis. BMC Infect Dis J. 2008; 53: 175-176.
19. Pignotti MS, Indolli G, Donzelli G. Factors impacting compliance with palivizumab prophylaxis. Pediatr Infect Dis J. 2004; 23: 186-187.