We aim to clarify the efficacy of early palliative balloon pulmonary valvuloplasty (BPV) in neonates and young infants (< 60 days) with tetralogy of Fallot (TOF). We performed palliative BPV in 31 subjects, regardless of the presence of cyanosis, with Z score of the pulmonary valve diameter (PVD) less than − 2.00. Primary and secondary endpoints were to avoid early surgical interventions for subjects within 6 months of age and to undergo the pulmonary valve-sparing procedure at corrective surgery, respectively. We studied factors associated with these outcomes among them. BPV was performed at 19 days (14–33) of age and with a weight of 3.34 kg (3.02–3.65). Systemic oxygen saturation, Z score of the PVD, and pulmonary arterial index (PAI) were 87% (81–91), − 3.56 (− 4.15 to − 2.62), and 128 mm2/m2 (102–157), respectively. There were 16 and 13 subjects who avoided early surgical interventions and transannular repair, respectively. At the primary endpoint, there was no significant difference in age, weight, systemic oxygen saturation, and Z score of the PVD and PAI between the groups. However, there was a significant difference in the infundibular morphology (severe: mild-to-moderate, 8:8 vs 13:2, P = 0.029) between the groups. We performed prophylactic BPV within 30 days after birth in 7 acyanotic TOF patients with severe infundibular obstruction, among whom 5 avoided early surgical intervention. At the secondary endpoint, there were no significant difference in weight, systemic oxygen saturation, but in sex, age at BPV, and Z score of the PVD. Early palliative BPV prevented early surgical intervention in half of the neonates and young infants with TOF, which depended upon the degree of infundibular obstruction. However, early palliative BPV did not contribute to avoid transanular patch right-ventricular outflow repair among them.
This is a preview of subscription content, log in to check access.
Compliance with ethical standards
Conflict of interest
The authors have no conflicts of interest to declare.
All procedures performed in this study involving human participants were in accordance with the Institutional Ethics Committee of Kyushu Hospital, Japan Community Healthcare Organization and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all patients or their guardians included in the study.
Roche SL, Greenway SC, Redinton AN (2013) Tetralogy of Fallot with pulmonary stenosis and tetralogy of Fallot with absent pulmonary valve. In: Allen HD, Dricroll DJ, Shaddy RE, Feltes TF (ed) Moss and Adams’ Heart disease in infants, children, and adolescents, including the fetus and young adult. 8th edn. Lippincott Williams & Wilkins, Philadelphia, pp 969Google Scholar
Al Habib HF, Jacobs JP, Mavroudis C, Tchervenkov CI, O'Brien SM, Mohammadi S, Jacobs ML (2010) Contemporary patterns of management of tetralogy of fallot: data from the society of thoracic surgeons database. Ann Thorac Surg 90:813–819CrossRefPubMedGoogle Scholar
Jacobs JP, Jacobs ML, Maruszewski B, Lacour-Gayet FG, Clarke DR, Tchervenkov CI, Gaynor JW, Spray TL, Stellin G, Elliott MJ, Ebels T, Mavroudis C (2005) Current status of the European association for cardio-thoracic surgery and the society of thoracic surgeons congenital heart surgery database. Ann Thorac Surg 80:2278–2283CrossRefPubMedGoogle Scholar
Qureshi SA, Parsons JM, Tynan M (1990) Percutaneous transcatheter myectomy of subvalvar pulmonary stenosis in tetralogy of fallot: a new palliative technique with an atherectomy catheter. Br Heart J 64:163–165CrossRefPubMedGoogle Scholar
Sreeram N, Saleem M, Jackson M, Peart I, McKay R, Arnold R, Walsh K (1991) Results of balloon pulmonary valvuloplasty as a palliative procedure in tetralogy of Fallot. J Am Coll Cardiol 18:159–165CrossRefPubMedGoogle Scholar
Sluysmans T, Neven B, Rubay J, Lintermans J, Ovaert C, Mucumbitsi J, Shango P, Stijns M, Vliers A (1995) Early balloon dilatation of the pulmonary valve in infants with tetralogy of fallot risks and benefits. Circulation 91:1506–1511CrossRefPubMedGoogle Scholar
Godart F, Rey C, Prat A, Muilwijk C, Francart C, Vaksmann G, Brevière GM (1998) Early and late results and the effects on pulmonary arteries of balloon dilatation of the right ventricular outflow tract in tetralogy of fallot. Eur Heart J 19:595–600CrossRefPubMedGoogle Scholar
Massoud I, Imam A, Mabrouk A, Boutros N, Kassem A, Daouod A, El Hakem MA (1999) Palliative balloon valvoplasty of the pulmonary valve in tetralogy of fallot. Cardiol Young 9:24–36CrossRefPubMedGoogle Scholar
Wu ET, Wang JK, Lee WL, Chang CC, Wu MH (2006) Balloon valvuloplasty as an initial palliation in the treatment of newborns and young infants with severely symptomatic tetralogy of fallot. Cardiology 105:52–56CrossRefPubMedGoogle Scholar
Lizano Santamaria RW, Gillespie MJ, Dori Y, Rome JJ, Glatz AC (2015) Palliative balloon pulmonary valvuloplasty for infants with unrestrictive ventricular septal defect or single ventricle associated with severe pulmonary stenosis. Catheter Cardiovasc Interv 86:829–833CrossRefPubMedGoogle Scholar
Cholkraisuwat E, Lertsapcharoen P, Khongphatthanayothin A, La-orkhun V, Vithessonthi K, Benjacholamas V, Namchaisiri J (2010) Balloon pulmonary valvuloplasty in tetralogy of fallot: effects on growth of pulmonary annulus and transannular patch. J Med Assoc Thai 93:898–902PubMedGoogle Scholar
Boni L, Garcia E, Aguilar JM, Nuila L, Melo M (2017) Tetralogy of Fallot repair: surgical approach to RVOTO. J Pediatr Cardiol Card Surg 1:37–41Google Scholar
Sandoval JP, Chaturvedi RR, Benson L, Morgan G, Van Arsdell G, Honjo O, Caldarone C, Lee KJ (2016) Right ventricular outflow tract stenting in tetralogy of fallot infants with risk factors for early primary repair. Circ Cardiovasc Interv 9:e003979CrossRefPubMedGoogle Scholar
Sarris GE, Comas JV, Tobota Z, Maruszewski B (2012) Results of reparative surgery for tetralogy of fallot: data from the European association for cardio-thoracic surgery congenital database. Eur J Cardiothorac Surg 42:766–774CrossRefPubMedGoogle Scholar
Kanter KR, Kogon BE, Kirshbom PM, Carlock PR (2010) Symptomatic neonatal tetralogy of fallot: repair or shunt? Ann Thorac Surg 89:858–863CrossRefPubMedGoogle Scholar
Karl TR, Sano S, Pornviliwan S, Mee RB (1992) Tetralogy of fallot: favorable outcome of nonneonatal transatrial, transpulmonary repair. Ann Thorac Surg 54:903–907CrossRefPubMedGoogle Scholar
Fraser CD Jr, McKenzie ED, Cooley DA (2001) Tetralogy of fallot: surgical management individualized to the patient. Ann Thorac Surg 71:1556–1561CrossRefPubMedGoogle Scholar
Giannopoulos NM, Chatzis AK, Karros P, Zavaropoulos P, Papagiannis J, Rammos S, Kirvassilis GV, Sarris GE (2002) Early results after transatrial/transpulmonary repair of tetralogy of fallot. Eur J Cardiothorac Surg 22:582–586CrossRefPubMedGoogle Scholar
Sfyridis PG, Kirvassilis GV, Papagiannis JK, Avramidis DP, Ieromonachos CG, Zavaropoulos PN, Sarris GE (2013) Preservation of right ventricular structure and function following transatrial-transpulmonary repair of tetralogy of fallot. Eur J Cardiothorac Surg 43:336–342CrossRefPubMedGoogle Scholar
Kim G, Ban GH, Lee HD, Sung SC, Kim H, Choi KH (2016) Effects of balloon pulmonary valvuloplasty as preoperative palliation for tetralogy of fallot. Congenit Heart Dis 11:315–322CrossRefPubMedGoogle Scholar
Chong BK, Baek JS, Im YM, Park CS, Park JJ, Yun TJ (2016) Systemic-pulmonary shunt facilitates the growth of the pulmonary valve annulus in patients with tetralogy of fallot. Ann Thorac Surg 102:1322–1328CrossRefPubMedGoogle Scholar