John W. Moore

This article provides a historical review and a current perspective on the procedures used to palliate cyanosis in ductal-dependent infants. Eighty years ago, Helen Taussig, Alfred Blalock, and Vivien Thomas developed the first effective treatment. The Blalock–Taussig–Thomas (BTT) shunt is the historical predecessor of both the contemporary-modified BTT shunt and interventional stenting of the Patent Ductus Arteriosus (PDA). The surgical shunt was firmly established therapy before catheterization was born, and PDA stenting was not possible until the technologies designed to address coronary heart disease were developed. Coronary stents and guidewires are currently used in all cases of PDA stenting. The momentum of long-established therapy and the lack of a purpose-built technology have inhibited clinical adoption of PDA stenting. Nevertheless, available clinical outcomes, though limited, appear to favor PDA stenting, and current first-line therapy may be shifting from the modified BTT shunt to PDA stenting. More definitive data should arise from a randomized controlled trial.

This article provides a historical review and a current perspective on the procedures used to palliate cyanosis in ductal-dependent infants. Eighty years ago, Helen Taussig, Alfred Blalock and Vivien Thomas developed the first effective treatment. The Blalock-Taussig-Thomas (BTT) shunt is the historical predecessor of both the contemporary modified BTT shunt and interventional stenting of the Patent Ductus Arteriosus (PDA). The surgical shunt was firmly established therapy before catheterization was born, and PDA stenting was not possible until the technologies designed to address coronary heart disease were developed. The momentum of long-established surgical therapy inhibited clinical development of PDA stenting. Nevertheless, available clinical outcomes, though limited, appear to favor PDA stenting, and first-line therapy may be shifting from the modified BTT shunt to PDA stenting. More definitive data should arise from a randomized controlled trial.

Objective: We compared 5‐year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post‐approval study (PAS) and the investigational device exemption (IDE) trial.Background: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real‐world” environment. The 5‐year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared.Methods: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time‐related outcomes and valve‐related adverse events were compared between the two trials with Kaplan–Meier curves and log‐rank testing.Results: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both.Conclusions: Hemodynamic and time‐related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real‐world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post‐approval studies as part of the regulatory process for Class III medical devices.

Background: Ductal-dependent cyanotic newborns require a secure source of pulmonary blood flow. There has been a recent migration to selective ductal (patent ductus arteriosus [PDA]) stenting for some of these children. Universal (nonselective) ductal stenting for all infants with ductal-dependent pulmonary blood flow is controversial. We examine outcomes from a single center with this practice change. Methods: We compare outcomes of all ductal-dependent pulmonary blood flow infants (2013–2020 [January–June]) in the following treatment eras: Era 1 (selective PDA stenting; 2013–2017) or Era 2 (universal PDA stenting; 2018–2020 [January–June]). Results: Eighty-eight patients (Blalock-Taussig shunt, n=41; PDA stent, n=47) met inclusion criteria. In Era 1, most received Blalock-Taussig shunt (62% [41/66]). In Era 2, all received PDA stents (100% [22/22]). There were more females in Era 2, but otherwise no demographic differences between eras. There were no differences in mortality, treatment failures, complications, or reinterventions between eras. Postprocedure length of stay was shorter in Era 2 (8 versus 22 days, P =0.02). There were less surgical revisions for PDA stent patients (2% versus 20%, P =0.02). Postprocedure recovery surrogate end points favored Era 2 and PDA stenting. Additional analysis revealed PDA stent (compared with Blalock-Taussig shunt) patients had shorter post-procedure (10 versus 29 days, P ≤0.001) length of stay and more symmetrical branch pulmonary arteries (0.9 versus 0.7, P =0.001) at subsequent surgery. Conclusions: PDA stenting for almost all ductal dependent cyanotic newborns can be safe and effective and may have lower morbidity than selective PDA stenting.

Objectives: We intend to describe early experience using a new, commercially available Micro Plug Set for preterm neonate and infant transcatheter patent ductus arteriosus (PDA) occlusion.Background: Transcatheter PDA occlusion in premature neonates and small infants is safe and effective. The procedure is early in its evolution.Methods: Procedural and short‐term outcomes of preterm neonates and infants undergoing transcatheter PDA occlusion with a new, commercially available device were reviewed.Results: Eight preterm neonates and infants born at median 27 weeks gestation (23–36 weeks) underwent transcatheter PDA device closure with the Micro Plug Set. The device is short (2.5 mm) with a range of diameters (3, 4, 5, 6 mm) and delivered through a microcatheter. Procedures were performed at median 41 days of age (12–88 days) and at 1690 g (760–3,310 g). Transvenous PDA device occlusion was performed with fluoroscopic and echocardiography guidance. All procedures were successful with complete PDA occlusion. There were no procedural or short‐term adverse events.Conclusions: Preterm neonate and infant transcatheter PDA device closure with a new, commercially available short and microcatheter delivered device (Micro Plug Set) was safe and effective in a small, early series of patients.

Background: Patent ductus arteriosus (PDA) stenting is evolving as an alternative to surgical aorto‐pulmonary shunts for infants with ductal‐dependent pulmonary blood flow. Given anatomical proximity, the PDA can compress the ipsilateral bronchus. We report a case series of four patients with bronchial compression by a tortuous PDA who underwent PDA stenting.Methods: Our four patients received PDA stents for ductal‐dependent pulmonary blood flow despite preprocedure imaging evidence of bronchial compression. We reviewed the cross‐sectional chest imaging to assess the degree of bronchial compression and the variables that affect it, namely PDA size, PDA tortuosity, and the anatomical relationship between the compressed bronchus and the PDA.Results: Three out of the four patients had postprocedure imaging, and all showed relief of the previously seen bronchial compression. Post‐PDA stenting patients had a smaller and straight PDA with significant lateralization away from the compressed bronchus. None of the four patients developed symptoms of bronchial compression poststenting.Conclusions: Our study suggests that pre‐existing bronchial compression does not preclude PDA stenting. Stent placement in an engorged and tortuous PDA led to significant improvement in pre‐existing bronchial compression. Improvement may be attributed to PDA shrinkage, straightening, and lateralization. Further studies are needed to confirm our findings.

Journal of Structural Heart Disease is the official journal of the PICS Foundation, the organization that runs the largest structural/congenital course of its kind “PICS/AICS” [Pediatric and Adult Interventional Cardiac Symposium,” which will be devoted to all structural and congenital heart diseases.

Journal of Structural Heart Disease is the official journal of the PICS Foundation, the organization that runs the largest structural/congenital course of its kind “PICS/AICS” [Pediatric and Adult Interventional Cardiac Symposium,” which will be devoted to all structural and congenital heart diseases.

Despite few institutions stenting the ascending aorta, it has been discouraged because of the proximity of the aortic valve, the coronary artery orifices, and the aortic arch branches. We describe a small case series of patients having acquired stenosis of the ascending that was relieved successfully by stenting.