Perioperative sildenafil therapy for pulmonary hypertension in infants undergoing congenital cardiac defect closure

Midany, Ashraf A.H. El; Mostafa, Ezzeldin A.; Azab, Sherif; Hassan, Ghada A.M.

doi:10.1093/icvts/ivt353

Cited by 28 publications

(44 citation statements)

References 24 publications

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“…However, in the intensive care setting oral medications have the disadvantage of unpredictable absorption. Prophylactic use of sildenafil before surgical correction of CHD has been proven to be useful 30. The administration of intravenous sildenafil has been described31 32 but its effectiveness has not been clearly determined.…”

Section: Therapy Of Acute Ph In the Icumentioning

confidence: 99%

Pulmonary hypertension in the intensive care unit. Expert consensus statement on the diagnosis and treatment of paediatric pulmonary hypertension. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK

Kaestner

Schranz

Warnecke

et al. 2016

Heart

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Acute pulmonary hypertension (PH) complicates the course of several cardiovascular, pulmonary and other systemic diseases in children. An acute rise of RV afterload, either as exacerbating chronic PH of different aetiologies (eg, idiopathic pulmonary arterial hypertension (PAH), chronic lung or congenital heart disease), or pulmonary hypertensive crisis after corrective surgery for congenital heart disease, may lead to severe circulatory compromise. Only few clinical studies provide evidence on how to best treat children with acute severe PH and decompensated RV function, that is, acute RV failure. The specific treatment in the intensive care unit should be based on the underlying pathophysiology and not only be focused on so-called 'specific' or 'tailored' drug therapy to lower RV afterload. In addition therapeutic efforts should aim to optimise RV preload, and to achieve adequate myocardial perfusion, and cardiac output. Early recognition of patients at high risk and timely initiation of appropriate therapeutic measures may prevent the development of severe cardiac dysfunction and low cardiac output. In patients not responding adequately to pharmacotherapy, (1) novel surgical and interventional techniques, temporary mechanical circulatory support with extracorporeal membrane oxygenation, (2) pumpless lung assist devices (3) and/or lung or heart-lung transplantation should be timely considered. The invasive therapeutic measures can be applied in a bridge-to-recovery or bridge-to-lung transplant strategy. This consensus statement focuses on the management of acute severe PH in the paediatric intensive care unit and provides an according treatment algorithm for clinical practice.

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Section: Therapy Of Acute Ph In the Icumentioning

confidence: 99%

Pulmonary hypertension in the intensive care unit. Expert consensus statement on the diagnosis and treatment of paediatric pulmonary hypertension. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK

Kaestner

Schranz

Warnecke

et al. 2016

Heart

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“…In the first study treatment with oral sildenafil two weeks prior to surgery was not superior to postoperative therapy in reducing mean pulmonary arterial pressure in a randomised controlled trial of VSD patients [17]. Nevertheless patients treated with sildenafil preoperatively had a shorter ICU stay.…”

Section: Discussionmentioning

confidence: 96%

A Prospective Randomised Study of Postoperative Prophylactic Application of Sildenafil After Pediatric Cardiac Surgery

Heschl¹,

Grohmann²,

Dolzer³

et al. 2015

J Clin Exp Cardiolog

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Postoperative aggravation of pulmonary hypertension after pediatric cardiac surgery due to temporary endothelial dysfunction may lead to sudden pulmonary arterial pressure rise with compromise of right ventricular function. Though treatment with inhaled nitric oxid (NO) has been successful, rebound pulmonary hypertension has been observed after NO withdrawal due to supression of endogenous NO sythase. Sildenafil has been shown to prevent this reaction and is widely used after pediatric cardiac surgery. The aim of our study was to evaluate the effectively of postoperative administration of oral sildenafil (1 mg/kg/day) in preventing postoperative pulmonary hypertensive crises. 21 patients after repair of complete atrioventricular canal (n=10) or ventricular septal defect (n=11) were randomly assigned to the study group or control group. The study group received sildenafil after surgery via nasogastric tube every eight hours for 48 hours, the control group received placebo. The primary outcome parameter was the number of pulmonary hypertensive events (spontaneous pulmonary arterial pressure rise to or above systemic arterial pressure). Secondary outcome parameters were: need for inotropic drugs, fluid balance, urinary output, days on the ventilator or in the intensive care unit (ICU). There was no difference in the number of pulmonary hypertensive events between both groups: median (IQR); 2 (0-6,5) sildenafil, 1 (0-2) placebo, p=0,67. Neither inotrope score, time on the ventilator, ICU length of stay, nor fluid balance differed significantly. Urinary output was significantly lower in the sildenafil group.

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“…Two of these reported that children who received sildenafil pre-and postoperatively had no crises or fewer crises than children who did not receive sildenafil (P = .02) 48 or who received sildenafil postoperatively only. 27 One trial reported that transient postoperative PH crises were more common in the sildenafil group than in the combination (sildenafil + milrinone) group (P = .02) and the milrinone-only group. 28 Three observational studies (1 prospective, 2 retrospective) in children with PH secondary to CHD included cases in which sildenafil was used to facilitate withdrawal of other pulmonary 26 Unaffected by sildenafi l: no sequelae and no hypotension with sildenafi l.…”

Section: Are Pde5 Inhibitors Effective In Improving Clinical Outcomesmentioning

confidence: 98%

“…El Midany et al (2013) 27 AE in both groups: pneumonia, need for reintubation, PH crises, renal failure requiring peritoneal dialysis. AE in sildenafi l pre-and postoperative group only: hematemesis.…”

Section: Are Pde5 Inhibitors Effective In Improving Clinical Outcomesmentioning

confidence: 99%

“…The 3 RCTs that studied systemic hypotension and the need for inotropic support during sildenafil therapy showed mixed results, 21,23,35 with only 1 reporting the use of increased circulotropic therapies with sildenafil (P = .002). 27 In each of these trials, the patients had differing etiologies of PH. Similarly, the 4 retrospective observational studies that reported on this outcome each included patients with differing etiologies of PH.…”

Section: Are Pde5 Inhibitors Effective In Improving Clinical Outcomesmentioning

confidence: 99%

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Pulmonary Hypertension Therapy and a Systematic Review of Efficacy and Safety of PDE-5 Inhibitors

Unegbu¹,

Noje²,

Coulson

et al. 2017

Pediatrics

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Pulmonary hypertension (PH) is a syndrome that is of growing concern to pediatricians worldwide. Recent data led to concerns about the safety of phosphodiesterase type 5 (PDE5) inhibitors in children and a US Food and Drug Administration safety advisory. Our objective is to provide insight into therapies for PH in children and to systematically review the comparative effectiveness and safety of PDE5 inhibitors in the management of pediatric patients with PH. We searched the following databases through February 2015: Medline, Embase, SCOPUS, and the Cochrane Central Register of Controlled Trials. We included studies that examined PDE5 inhibitor use in children with PH. Allowed comparators were either no medication or other classes of medication for management of PH. Study inclusion was via a 2-stage process with 2 reviewers and a predesigned form. Of 1270 papers identified by the literature search, 21 were included: 8 randomized controlled trials and 13 observational studies (9 retrospective, 4 prospective). There is strong evidence that PDE5 inhibitor use improves echocardiography measurements, cardiac catheterization parameters, and oxygenation compared with baseline or placebo in pediatric patients with PH. Evidence suggests that low- and moderate-dose sildenafil are safe regimens for children. There are a relatively small number of randomized controlled trials that address use of PDE5 inhibitors in pediatric patients with PH. PDE5 inhibitors are effective agents for cardiovascular and oxygenation end points in pediatric PH and important components of a multimodal pharmacotherapeutic approach to this growing challenge. Additional studies are needed to define optimal PH therapy in childhood.

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Perioperative sildenafil therapy for pulmonary hypertension in infants undergoing congenital cardiac defect closure

Cited by 28 publications

References 24 publications

Pulmonary hypertension in the intensive care unit. Expert consensus statement on the diagnosis and treatment of paediatric pulmonary hypertension. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK

Pulmonary hypertension in the intensive care unit. Expert consensus statement on the diagnosis and treatment of paediatric pulmonary hypertension. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK

A Prospective Randomised Study of Postoperative Prophylactic Application of Sildenafil After Pediatric Cardiac Surgery

Pulmonary Hypertension Therapy and a Systematic Review of Efficacy and Safety of PDE-5 Inhibitors

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