Results of the multicenter early feasibility study (EFS) of the Renata Minima stent as treatment for branch pulmonary artery stenosis and coarctation of aorta in infants.

BACKGROUND: Stent implantation has become standard of care in older children and adults for treatment of branch pulmonary artery stenosis (BPAS) and coarctation aorta (CoAo). There are no stents approved or available for infants that have the potential to be dilated to adult diameters. The Minima stent was designed to fulfill this unmet need. METHODS: Multicenter, prospective, nonrandomized early feasibility study evaluating safety and effectiveness of the Minima stent for treatment of BPAS and CoAo. Primary endpoints included: (1) successful deployment across lesion, (2) stenosis relief defined by an increase in angiographic diameter of >50% and (3) freedom from stent explant, embolization or migration at 30 days and 6 months. RESULTS: Between 2/2022 and 5/2022, 10 pts underwent Minima stent implantation with a median age and weight of 9 months (4-43 months) and 7.6 kg (5.1-16.9 kg). Procedural success and predefined stenosis relief was achieved in all cases (CoAo [n = 4], BPAS [n = 6]). Adverse events occurred in 3 pts: transient diminished lower extremity pulse (n = 2), distal stent on-balloon displacement successfully managed in the catheterization suite (n = 1). There were no deaths or major adverse events. All patients were free from stent explant and migration at 30 days and 6 months with no evidence for significant restenosis at latest follow-up. CONCLUSIONS: Implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during early follow-up. Based on these early results, an expanded study with longer follow-up is warranted.

Evaluation of short and mid-term clinical outcomes in patients with aortic coarctation treated with self-expandable stents.

The present study aimed to evaluate the outcomes of percutaneous treatment of aortic coarctation using self-expandable uncovered Nitinol stents. We conducted a retrospective clinical data review of all patients with aortic coarctation and treated with self-expandable uncovered Nitinol stents at our institution between 2009 and 2019. The gradient pressure across the coarctation site was measured using aortography. Follow-up echocardiography and computed tomography angiography were performed to assess possible stent complications. A total of 127 stents were successfully implanted in 125 patients (64.8% males) with a mean age of 35.36 ± 11.9 years. The gradient across the coarctation site decreased significantly from 67.48 ± 14.79 to 5.04 ± 3.01 mmHg (P < 0.001) after self-expandable stent implantation. Systolic blood pressure (SBP) decreased significantly from 175.53 ± 15.99 to 147.22 ± 12.83 mmHg (P < 0.001) after self-expandable stenting. There were no major technical or clinical complications, including balloon rupture, aneurysmal formation, infection, secondary stent migration, thrombosis, death during the procedure, and in-hospital mortality. On a mean follow-up of 48 ± 23.6 months (12-120 months), the gradient [from 59.43 ± 15.42 to 3.72 ± 1.38 mmHg (P < 0.001)] and SBP [from 175.53 ± 15.99 to 127.99 ± 7.82 mmHg (P < 0.001)] decreased significantly. There was no mortality, aneurysmal formation in the stent site, dislocation, or aortic re-stenosis requiring intervention during mid-term follow-up. Treatment of aortic coarctation using a self-expandable uncovered nitinol stent is safe and effective with promising mid-term outcomes.

Follow-up outcomes and effectiveness of stent implantation for aortic coarctation: A systematic review and meta-analysis.

BACKGROUND: The authors aim to investigate the clinical implications of stent use for the management of CoA. METHODS: All observational studies on stent implantation for the treatment of aortic coarctation and the relevant RCTs were systematically retrieved. Outcomes included the immediate success rate, pre- and post-stent gradient, survival, minor and major complications, restenosis, post-stent systolic blood pressure, and reintervention rate. The analysis was further stratified by CoA type, stent type, and the mean age of the patients. RESULTS: Our meta-analysis incorporated 66 eligible studies involving 3,880 patients. The success rates for stent placement, defined as achieving post-treatment gradients of ≤20 mmHg and 10 mmHg, 0.96 (95% CI: 0.95 - 0.97; I2 = 59.83%) and 0.92 (95% CI: 0.89 - 0.95, I2 = 77.63%) respectively. The complication rates were quite low, with minor and major complication rates of 0.017 (95% CI: 0.013 - 0.021) and 0.007 (95% CI: 0.005 - 0.009), respectively. Unplanned reinterventions were required at a rate of 0.021 (95% CI: 0.015 - 0.026). At a mean follow-up of 2.9 years, 97% of the patients survived and 28% remained on antihypertensive therapy. While immediate effectiveness was consistent across age groups, complications were more prevalent in patients aged <20 years, and long-term efficacy was lower in those aged >20 years. Encouragingly, in neonates and infants, CoA stenting yielded results comparable to those observed in older children. CONCLUSION: These findings underscore the overall favorable outcomes of stent placement for aortic coarctation, with considerations for age-related variations in complications and long-term efficacy.

Transcatheter management of acquired atresia of aorta.

A 24-year-old man was referred to our tertiary care center for the management of uncontrolled hypertension secondary to severe coarctation of aorta.

Tratamento intervencionista das cardiopatias congênitas: estado da arte / Interventionist treatment of congenital heart defects: state of the art

Os avanços na tecnologia nas últimas décadas em relação ao tratamento intervencionista das cardiopatias congênitas têm permitindo excelentes resultados, em termos de morbimortalidade, a curto e longo prazo para este grupo especial de pacientes.Este artigo descreve os principais tratamentos disponíveis realizados com cateterismo intervencionista neste grupo de pacientes.

Technological advances in recent decades, in relation to interventionist treatment of congenital heart defects, have enabled excellent short- and long-term results for this group of patients, in terms of morbidity and mortality. This article describes the main treatmentsavailable involving interventionist catheterization in this group of patients.

Uso de stents recobertos no tratamento da coarctação da aorta / Use of covered stents in the treatment of aortic coarctation

Introdução: A ampla variedade morfológica das coarctações da aorta (CoA) e algumas complicações derivadasdo implante de stents convencionais tornam desejáveis a utilizaçào de stents recobertos (SR). Descrevemos aexperiência com o uso de SR para tratar CoA em crianças e adultos. Métodos: Foram revisados, retrospectivamente, os registros dos pacientes nos quais foram utilizados os SR. Os procedimentos foram realizados segundo a técnica consagrada. Foram estudados casos em que os SRforam utilizados como primeiro tratamento e também aqueles realizados em complicações derivadas doprocedimento inicial. Resultados: Entre 2007 e 2014, foram utilizados SR em 14 pacientes, sendo 9 (64,3%) do sexo masculino. A média de idades foi 19,5 ± 10,5 anos, e a média dos pesos, 61,7 ± 25,5 kg. Valva aórtica bicúspide estavapresente em 74% dos casos, e dois apresentaram persistência do canal arterial. Coarctações subatréticasforam encontradas em cinco pacientes. Onze pacientes apresentaram hipertensão arterial sistêmica, e73% normalizaram as cifras tensionais após a dilatação com stents. O implante foi possível em todos os casos. Foram realizados implantes primários em dez (71,4%) pacientes portadores de coarctações nativas e em quatro como segundo dispositivo, para corrigir problemas derivados de procedimentos anteriores. O tempo médio de seguimento foi de 51,7 ± 29,8 meses. Três complicações menores estiveram relacionadas aos procedimentos, e não houve registro de óbito. Conclusões: O uso de SR foi seguro e eficaz na nossa pequena série de casos. Mais estudos, enfocando a evolução de longo prazo e a possibilidade de redilatação dos SR, são necessários para corroborar seu uso em crianças.

Background: The wide morphological variety of coarctation of the aorta (CoA) and some complications resulting from the implantation of conventional stents has made the utilization of covered stents (CS) desirable. We describe our experience with the use of CS to treat CoA in children and adults. Methods: The records of patients that received CS were retrospectively reviewed. The procedures were performed according to the established technique. Use of CS as primary treatment were assessed, as well as those deployed due to complications resulting from the initial procedure. Results: Between 2007 and 2014, CS were used in 14 patients, 9 (64.3%) of whom were males. The meanage was 19.5 ± 10.5 years, and the mean weight 61.7 ± 25.5 kg. Bicuspid aortic valve was present in 74% ofcases, and two patients had patent ductus arteriosus. Subatretic aortic coarctations were found in five patients. Eleven patients had systemic arterial hypertension, and 73% had normalized blood pressure levelsafter stent dilation. Implantation was possible in all cases. Primary implants were performed in ten (71.4%)patients with native coarctation and in four patients as a second device to correct problems originating from previous procedures. The mean time of follow-up was 51.7 ± 29.8 months. Three minor complicationswere related to procedures, and there were no deaths. Conclusions: The use of CS was safe and effective in this small case series. Further studies focusing on the long-term evolution and the possibility of CS redilation are needed to support its use in children.

Coartación aórtica compleja y síndrome de PHACE / Complex aortic coarctation and PHACE syndrome

La asociación de malformaciones de la fosa posterior, hemangiomas cervicofaciales y vasculares, coartación y alteraciones oculares es conocida con el acrónimo PHACE. Presentamos un análisis de 4 casos de este síndrome, caracterizados por coartación aórtica compleja que necesita no sólo estudio ecocardiográfico preoperatorio, sino además técnicas como resonancia magnética y angiografía. El tratamiento quirúrgico es también complejo. El pronóstico está dado por las complicaciones cardiovasculares y arteriales cerebrales propias del síndrome (AU)

In PHACE syndrome, the acronym PHACE stands for the association of posterior fossa malformations, cervicofacial hemangiomas, arterial anomalies, coarctation and eye anomalies. We report our findings in four patients with this syndrome, in whom it was characterized by complex aortic coarctation that required not only preoperative echocardiographic investigation, but also the use of techniques such as magnetic resonance imaging and angiography. Surgical treatment was also complex. Prognosis in this condition depends primarily on cardiovascular and cerebral artery complications associated with the syndrome (AU)

Corrección de ductus arterioso pesistente no diagnosticado durante el tratamiento endovascular de coartación de aorta / No disponible

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Cardiopatías congénitas del adulto: procedimientos terapéuticos percutáneos / Percutaneous interventions in adults with congenital heart disease

Dos grandes grupos de cardiopatías congénitas se presentan al cardiólogo intervencionista: simples, que incluyen comunicación interauricular, estenosis pulmonar, ductus persistente, comunicación interventricular, estenosis aórtica, etc., y complejas, generalmente consecuencia de operaciones paliativas o correctoras en la edad pediátrica (estenosis de ramas pulmonares, obstrucciones de conductos protésicos, dehiscencias de cierres previos, neoformaciones venosas o arteriales). En ambos grupos, la cirugía es eficaz, aunque con morbimortalidad e incomodidad para el paciente, a veces operado varias veces y pendiente de más cirugías futuras. El cateterismo terapéutico en este creciente grupo de pacientes aporta soluciones que evitan un procedimiento quirúrgico. El cierre de la comunicación interauricular, ductus persistente y malformaciones venosas o arteriales evita por completo la cirugía. En otras enfermedades, como la coartación de aorta y la estenosis aórtica, retrasan la cirugía o resuelven sus complicaciones. Los stents en ramas pulmonares permiten tratar lesiones casi inaccesibles al cirujano. Múltiples dehiscencias se ocluyen con prótesis o dispositivos. La ecocardiografía, la resonancia magnética y la tomografía computarizada son herramientas imprescindibles (AU)

There are two major groups of congenital heart lesions that are often referred for percutaneous intervention: simple lesions, such as atrial or ventricular septal defects, pulmonary or aortic stenosis, and patent ductus arteriosus; and complex lesions, which generally result from palliative or corrective surgery carried out during childhood (e.g. pulmonary branch stenosis, prosthetic conduit obstruction, dehiscence following surgical closure, and arterial or venous malformations). In both groups, surgery is effective, but there is some associated morbidity and mortality and patient discomfort, repeat surgery may be necessary at times, and additional surgery can be anticipated in the future. Percutaneous intervention provides an alternative to invasive surgery in this growing group of patients. In fact, surgery can be completely avoided in the treatment of atrial septal defects, patent ductus arteriosus, and arterial and venous malformations. In other conditions, such as coarctation of the aorta and aortic stenosis, surgery can be postponed and complications can be resolved. And, it is possible to treat lesions that are almost inaccessible to the surgeon by stent placement in arterial branches. Multiple leaks can be closed using stents or occlusion devices. Echocardiography, nuclear magnetic resonance and axial computed tomography are essential diagnostic tools (AU)

Primary stenting in a young adult with aortic coarctation

A young male adult with significant aortic coarctation was initially referred to our clinics due to uncontrolled blood pressures. On evaluation the diagnosis of aortic coarctation was evident and confirmed with Magnetic Resonance Angiography (MRA). After discussing treatment options with the patient and his parents they opted for the least invasive procedure possible. Primary stenting of a simple discrete aortic coarctation was performed successfully. The following is a report on the methods used and immediate results.

Coartación de aorta: posibles soluciones a un complejo problema / Aortic coarctation: current solutions for a complex condition

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Cardiopatías congénitas en el adulto: hacia un intervencionismo no quirúrgico / Congenital heart defects in the adult: towards nonsurgical interventionism

El tratamiento de las cardiopatías congénitas en el paciente adulto ha sido tradicionalmente la cirugía. Desde los trabajos de Rashkind y Grüntzig se ha desarrollado la cardiología intervencionista como terapéutica en las cardiopatías congénitas y adquiridas. Comentamos la aplicación actual de este tratamiento y comunicamos la experiencia de nuestro grupo en la terapéutica mediante cateterismo percutáneo de las cardiopatías congénitas del adulto, como la estenosis valvular pulmonar, la estenosis valvular aórtica, la coartación de aorta, la recoartación posquirúrgica, la estenosis de las ramas de la arteria pulmonar, la comunicación interauricular, la comunicación interventricular, el ductus arterioso persistente y las embolizaciones arteriales. Concluimos que el tratamiento intervencionista en las cardiopatías congénitas del adulto es un procedimiento factible y de bajo riesgo; sus indicaciones son cada vez más frecuentes, algunas de primera elección, y es posible realizarlo a cualquier edad, incluso en pacientes de alto riesgo. Como en todo procedimiento intervencionista, la curva de aprendizaje es insoslayable (AU)

The classical treatment for congenital heart defects in adult patients has been surgical correction. Since the publication of Rashkind and Grüntzig’s studies, interventional cardiology approaches have been developed to treat congenital and acquired heart defects. We discuss the current applications of this form of treatment and communicate our experience with percutaneous transcatheter procedures in adult patients for pulmonary valve stenosis, aortic valve stenosis, native coarctation, postsurgical coarctation, peripheral pulmonary artery stenosis, atrial septal defect, ventricular septal defect, ductus arteriosus and embolization therapy. We conclude that interventional treatment in adults with congenital heart defects is safe and feasible, that the indications for this approach to treatment are increasing, that it can be undertaken in patients of any age including highrisk patients, and that as with all interventional procedures, the learning curve must be successfully surmounted (AU)

Análise dos resultados imediatos e tardios do tratamento percutâneo da coartação da aorta em adolescentes e adultos: comparação entre balões e stents / Analysis of the immediate and late results of percutaneous treatment of coarctation of the aorta in adolescents and adults: comparison between balloons and stents

Mais informações são necessárias para definir se o tratamento percutâneo da coartação da aorta com stents é superior à angioplastia com cateter-balão. De julho de 2000 a maio de 2003, 21 adolescentes e adultos com coartação da aorta focal e média de idade de 24 anos (DP 11 anos) foram submetidos, consecutivamente, a implante de stents (grupo 1). Os resultados foram comparados com os obtidos em um grupo histórico de 15 pacientes com média de idade de 18 anos (DP 10 anos) (p = 0,103) submetidos a angioplastia (grupo 2) nos últimos 18 anos. Após o procedimento, a redução do gradiente sistólico foi maior (99% [DP 2%] versus 87% [DP 17%]; p = 0,015), o gradiente residual foi menor (0,4 mmHg [DP 1,4 mmHg] versus 5,9 mmHg [DP 7,9 mmHg]; p = 0,019), o ganho no local da coartação foi maior (333% [DP 172%] "versus" 190% [DP 104%]; p = 0,007) e o diâmetro da coartação foi maior (16,9 mm [DP 2,9 mm] versus 12,9 mm [DP 3,2 mm]; p < 0,001) no grupo 1. Alterações da parede da aorta, incluindo dissecções, abaulamentos e aneurismas, foram observadas em oito pacientes do grupo 2 (53%) e em um do grupo 1 (7%) (p < 0,001). Não houve complicações maiores. Cateterismo (n = 33) ou ressonância magnética (n = 2) de controle foram realizados em seguimento mediano de um ano para o grupo 1 e um ano e meio para o grupo 2 (p = 0,005). A redução do gradiente sistólico persistiu em ambos os grupos; entretanto, gradientes tardios mais altos foram observados no grupo 2 (mediana de 0 mmHg para o grupo 1 versus 3 mmHg para o grupo 2; p = 0,014). Não houve perdas no diâmetro da coartação no grupo 1 e houve ganho tardio no grupo 2 (16,7 mm [DP 2,9 mm] versus 14,6 mm [DP 3,9 mm]; p = 0,075). No grupo 1, dois pacientes necessitaram de novo implante de stent em decorrência da formação de aneurisma ou fratura da malha do stent. No grupo 2, as anormalidades da parede aórtica não progrediram e um paciente necessitou de redilatação em decorrência da recoartação. A pressão arterial sistêmica...

More information is needed to define whether stenting is superior to balloon angioplasty for coarctation of the aorta. From July/2000 to May/2003, 21 adolescents and adults with discrete coarctation underwent consecutive stent implantation at a mean age of 24 years (SD 11 years) (group 1). The results were compared to those achieved by balloon angioplasty performed in the last 18 years in a historical group of 15 patients at a mean age of 18 years (SD 10 years) (p = 0.103) (group 2). After the procedure, systolic gradient reduction was higher (99% [SD 2%] vs. 87% [SD 17%]; p = 0.015), residual gradients lower (0.4 mmHg [SD 1.4 mmHg] vs. 5.9 mmHg [SD 7.9 mmHg); p = 0.019), gain at the coarctation site higher (333% [SD 172%] vs. 190% [SD 104%]; p = 0.007) and coarctation diameter larger (16.9 mm [SD 2.9 mm] vs.12.9 mm [SD 3.2 mm]; p < 0.001) in group 1. Aortic wall abnormalities, including dissections, bulges and aneurysms, were observed in eight patients in group 2 (53%) and in one in group 1 (7%) (p < 0.001). There was no major complication. Repeat catheterization (n = 33) or magnetic resonance imaging (n = 2) was performed at a median follow-up of 1.0 year for group 1 and 1.5 year for group 2 (p = 0.005). Gradient reduction persisted in both groups, although higher late gradients were observed in group 2 (median of 0 mmHg for group 1 vs. 3 mmHg for group 2; p = 0.014). There was no late loss in the coarctation diameter in group 1 and there was a late gain in group 2 (16.7 mm [SD 2.9 mm] for group 1 vs. 14.6 mm [SD 3.9 mm] for group 2; p = 0.075). Two patients required late stenting due to aneurysm formation or stent fracture in group 1. Aortic wall abnormalities did not progress and one patient required redilation due to recoarctation in group 2. Blood pressure was similar in both groups at follow-up (systolic: 126 mmHg [SD 12 mmHg] in group 1 vs. 120 mmHg [SD 15 mmHg] in group 2; diastolic: 81 mmHg...