Early reopening and recanalization after successful coil occlusion of the patent ductus arteriosus

doi:10.1067/mhj.2002.122174

American Heart Journal

Volume 143, Issue 5, May 2002, Pages 889-893

https://doi.org/10.1067/mhj.2002.122174 Get rights and content

Abstract

Background Controversy exists regarding early reopening and recanalization after successful (complete) coil occlusion of the patent ductus arteriosus (PDA). Methods Patients with successful PDA coil occlusion were reviewed with regard to PDA size and type, coil size, number of coils, and delivery technique. Follow-up echocardiograms at <24 hours, 6 months, and >12 months were reviewed for residual PDA shunt, left pulmonary artery (LPA) stenosis, and aortic obstruction. Results Successful coil occlusion was achieved in 94 patients. On the initial (<24 hours) echocardiogram, 76 of 92 (83%) had complete PDA occlusion, 5 of 92 (5%) had mild LPA stenosis, and no patient had aortic obstruction. Follow-up at 6 months was available in 70 patients, 57 with complete occlusion on the initial echocardiogram. PDA reopening was found in 3 of 57 patients (5%). Larger PDA diameter was associated with residual shunt (2.40 ± 0.40 mm versus 1.87 ± 0.53 mm; P <.01). Disagreement between the initial and 6-month echocardiogram was found in 11 of 70 patients (16%). Intermediate follow-up (median, 30 months; range, 12 months to 5.3 years) was available in 46 patients, 38 with complete occlusion on the 6-month echocardiogram. No patient (0 of 38) with a normal echocardiogram at 6 months developed recanalization, LPA stenosis, or aortic obstruction. Conclusion These data suggest that: (1) routine echocardiography immediately after PDA coil occlusion is unnecessary; (2) early PDA reopening is uncommon; and (3) PDA recanalization does not occur if complete echocardiographic closure is documented 6 months after coil occlusion. Additional follow-up examination in these patients may not be necessary. (Am Heart J 2002;143:889-93.)

Section snippets

Study population

All patients who underwent successful PDA coil occlusion at Children's Hospital of Michigan from March 1994 to March 2000 were included in the study. The procedure was considered successful if: 1, the coil was positioned properly across the ductus arteriosus; 2, complete PDA occlusion or no more than a trivial angiographic leak (no discrete jet) was present on the postcoil aortogram; and 3, no more than mild left pulmonary artery (LPA) stenosis and no aortic obstruction were noted. Each patient

Patients

Successful PDA coil occlusion was achieved in 94 patients. The median patient age was 29 months (range, 3 months to 18.6 years), and the median weight was 12.5 kg (range, 3.3 to 105 kg). Younger and smaller patients were symptomatic from significant left-to-right shunts and needed earlier intervention. Angiographic classification showed 74 (79%) type A, 5 (5%) type B, 5 (5%) type C, and 10 (11%) type E PDAs. No type D ductus was found. Coils were delivered with retrograde freehand technique in

Discussion

Despite numerous publications that have reported excellent immediate results after PDA coil occlusion,1, 2, 3, 4, 5, 6 conflicting data exist regarding early reopening and recanalization of the coiled PDA. Patel et al⁶ reported no reopening or recanalization at a median follow-up period of 3 years in a large series of patients after PDA occlusion with coils or with the Gianturco-Grifka vascular occlusion device (Cook Inc).¹⁷ Alternatively, Daniels et al¹⁰ found a 25% incidence of new PDA

Acknowledgements

We thank Drs Zia Farooki, Bahman Joorabchi, Anu Prabhu, and Nestor Truccone for supplying patient data and Dr Ronald Thomas for providing statistical expertise.

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Cited by (17)

Incremental cost-effectiveness of surgical vs. percutaneous treatment of patent ductus arteriosus with the Amplatzer™ duct occluder in children: A systematic review
2014, Revista Brasileira de Cardiologia Invasiva
Patent ductus arteriosus (PDA) is a relatively common congenital heart disease and the alternatives for the treatment of PDA > 2.5 mm are surgery or percutaneous occlusion with plugs. The latter, although considered the method of choice, are not provided by the Brazilian National Health System (Sistema Único de Saúde –SUS). Our objective was to compare the incremental cost-effectiveness ratio (ICER) of both strategies.
Systematic review of clinical outcomes and development of a decision-making algorithm to evaluate the ICER of Amplatzer™ Duct Occluder (ADO) vs. surgical treatment for the closure of PDA. Costs for both methods were calculated based on the reimbursement figures paid by the SUS in 2010 and the cost of the percutaneous kit (device + support materials) was estimated at R$ 10,000.00. We used as a threshold the willingness to pay the equivalent of three times the Brazilian Gross Domestic Product, i.e., R$ 57,000.00 per year of life saved.
Both techniques were safe and effective with less morbidity and shorter hospitalization time for percutaneous closure. Adjusted life expectancy was similar in both groups, and slightly better for the ADO group. Total cost was calculated as R$ 8,507 for surgery and R$ 11,000.00 for ADO. ICER was calculated as R$ 71,380.00 per year of life saved. A threshold analysis showed that a reduction of R$ 492.65 in the cost of the ADO kit would reduce the ICER to an acceptable value for the incorporation of this technology by the SUS.
Percutaneous occlusion was associated with less morbidity and shorter hospital stay with similar incremental effectiveness when compared to the surgical treatment. With the direct costs used in this study and considering that the entire population with PDA is treated with the ADO, percutaneous occlusion was less cost-effective. However, a slight reduction in the costs of the percutaneous kit would result in a aceptable ICER threshold for possible incorporation by the SUS.
Ductus arteriosus, patent, Heart defects, congenital, Surgery, Prostheses and implants, Cost-benefit analysis.
Custo-Efetividade Incremental do Tratamento Cirúrgico vs. Percutâneo da Persistência do Canal Arterial com o Amplatzer® Duct Occluder em Crianças: Revisão Sistemática
A persistência do canal arterial (PCA) é uma cardiopatia congênita relativamente comum e as alternativas para o tratamento de canais > 2,5 mm são a cirurgia ou a oclusão percutânea com próteses do tipo rolha. Essas últimas, apesar de consideradas o método de escolha, não estão previstas pelo Sistema Único de Saúde (SUS). Nosso objetivo foi comparar a razão de custo-efetividade incremental (RCEI) de ambas as estratégias.
Revisão sistemática em relação a desfechos clínicos e criação de modelo de decisão para avaliação da RCEI do Amplatzer® Duct Occluder (ADO) em comparação ao tratamento cirúrgico, para o fechamento da PCA. Os custos para ambos os métodos foram aqueles reembolsados pelo SUS em 2010, e o custo do conjunto (dispositivo + materiais de apoio) foi estimado em R$ 10.000,00. Foi considerado como limiar uma disposição para pagar equivalente a três vezes o Produto Interno Bruto brasileiro, resultando em R$ 57.000,00 por ano de vida salvo.
As duas técnicas foram seguras e eficazes, com menor morbidade e tempo de internação no fechamento percutâneo. A expectativa de vida ajustada foi similar nos dois grupos, sendo um pouco melhor para o ADO. O custo total foi calculado em R$ 8.507,00 para cirurgia e em R$ 11.000,00 para o ADO. A RCEI foi calculada em R$ 71.380,00 por ano de vida ganho. Uma análise de limiar demonstrou que a redução do valor do conjunto completo do ADO em R$ 492,65 traria a RCEI para o limiar aceitável para incorporação ao SUS nos dias de hoje.
O tratamento percutâneo apresentou morbidade e tempo de internação menores, além de efetividade incremental semel- hante áquela do tratamento cirúrgico. Com os valores diretos estipulados neste estudo e partindo do pressuposto de que toda a população de pacientes com PCA seria tratada com o ADO, o fechamento percutâneo foi menos custo-efetivo. Entretanto, com pequena redução nos valores do conjunto, o procedimento percutâneo estaria dentro de um limiar aceitável da RCEI para possível incorporação.
Permeabilidade do canal arterial, Cardiopatias congênitas, Cirurgia, Próteses e implantes, Análise custo-benefício.
What is the optimal device for closure of a persistently patent ductus arteriosus?
2012, Progress in Pediatric Cardiology
Citation Excerpt :
Turner et al. showed that 5% of patients who had immediate, complete PDA closure had recanalization of the PDA at the 6 month follow-up echocardiogram. Conversely, no patient with a closed PDA at 6 months developed PDA recanalization at intermediate follow-up (mean 30 months) [3]. Finally, cost will be considered.
Transcatheter closure of persistently patent ductus arteriosus (PDA) has been performed since the early 1990s. Over the past 15 years, there have been significant developments in the devices used to close PDA. The currently available devices in the United States that are or will soon be approved for PDA closure are: embolization coils, Amplatzer Duct Occluders I/II, and the Product For Medicine Nit-Occlud devices. Each device has its strengths and limitations. Three criteria will be used to determine which device is superior to close PDA. Safety, including the occurrence of hemolysis, pulmonary artery and/or aortic obstruction, vascular complications, and frequency of device embolization will be evaluated for each device. Efficacy will be determined at 6 month echo follow-up regarding residual shunt. Finally, overall cost will be considered. After evaluating each device on these merits, we will conclude which device, if any, is superior for closure of PDA.
Esophageal stethoscope: An old tool with a new role, detection of residual flow during video-assisted thoracoscopic patent ductus arteriosus closure
2010, Journal of Pediatric Surgery
Citation Excerpt :
However, the immediate residual patency was 41%, and it is unknown how much time it takes for complete occlusion to occur. Persistent residual shunt seems to occur more often in larger-sized PDAs [19-21]. Concerns about ductal patency as the most common complication have led us and others to pursue the use of intraoperative diagnostic tools during the VATS procedure to ascertain complete ductal closure in the operating room and minimize the incidence of residual patency.
Video-assisted thoracoscopic surgery (VATS) has emerged as an innovative and popular procedure for closure of a patent ductus arteriosus (PDA), but is associated with a minute rate of residual or recurrent duct patency. This study aims to analyze the efficacy of intraoperative esophageal stethoscopic monitoring in reducing the incidence of residual ductal flow during PDA clipping by VATS.
Between June 1997 and October 2009, we retrospectively assessed 2000 consecutive patients with PDA who underwent VATS. During the procedure, heart sounds were monitored by the anesthesiologist through an esophageal stethoscope. Changes in continuous cardiac murmurs were recorded before and after the PDA clipping and were confirmed to disappear completely. Color flow Doppler echocardiography was performed immediately before discharge, and patients were followed monthly for 3, 6, and 12 months and then annually to confirm the absence of residual or recurrent shunt.
Mean age was 6.0 years (range, 1 month-35 years), mean weight was 11.1 kg (range, 6-65 kg), and mean PDA diameter was 5.5 mm (range, 3-9 mm). Ninety-two percent of patients showed no ductal flow after a single clipping. In the other 8% of patients, residual flow was detected intraoperatively after a single clipping, but was eliminated by the second clipping. Twelve patients (0.6%) presented with residual ductal flow immediately after the operation (detected by color Doppler echocardiography), which was eliminated by thoracotomy before discharge. All patients left the hospital with echocardiography documenting no evidence of residual PDA. At follow-up, the incidence of residual patency was 0.2% (4 of 2000).
Our results demonstrate that the intraoperative esophageal stethoscope provides a remarkably effective technique for monitoring and evaluating PDA ligation by VATS, thus avoiding reintervention and the complications associated with residual ductal flow in most cases.
Percutaneous closure of patent ductus arteriosus in adults using different devices
2010, Revista Espanola de Cardiologia
El cierre quirúrgico del conducto arterioso en adultos implica riesgos debido a sus cambios anatómicos e histológicos. Desde octubre de 1992 hasta agosto de 2008, fueron referidos a nuestro servicio 23 pacientes con conducto arterioso persistente aislado; edad, 16-75 años (mediana, 25,5); peso, 52-80 kg (mediana, 57); diámetro pulmonar, 1,8-5,8 mm (media, 3,5); presión media en la arteria pulmonar, 9-72 mmHg (media, 15). Las tasas de oclusión fueron del 85,7% con los dispositivos Rashkind- PDA y del 100% con Amplatzer Duct-Occluder y Nit- Occlud coil. Tiempo medio de internación y seguimiento: 24 h y 2 años respectivamente. La única complicación inmediata fue un hematoma inguinal; no hubo complicaciones alejadas. En adultos, el cierre del conducto arterioso con diferentes dispositivos, especialmente los de última generación, resultó seguro y eficaz, independientemente de su morfología y estado histológico.
Surgical closure of patent ductus arteriosus in adults involves a number of risks because there are associated anatomic and histologic alterations. Between October 1992 and August 2008, 23 patients were referred to our department with isolated patent ductus arteriosus. Their age ranged from 16-75 years (median 25.5 years) and their weight from 52-80 kg (median 57 kg). The pulmonary diameter ranged from 1.8-5.8 mm (mean 3.5 mm), and pulmonary artery pressure, from 9-72 mmHg (mean 15 mmHg). The rate of ductal occlusion achieved with the Rashkind patent ductus arteriosus occluder was 85.7%, and it was 100% with the Amplatzer duct occluder and the Nit-Occlud coil. The average hospitalization time and followup duration were 24 hours and 2 years, respectively. The only immediate complication was an inguinal hematoma, and there were no late complications. In adults, closure of patent ductus arteriosus using a number of different devices, especially the latest generation devices, was safe and effective, regardless of morphologic and histologic characteristics.
A strategic approach to transcatheter closure of patent ductus: Gianturco coils for small-to-moderate ductus and Amplatzer duct occluder for large ductus
2006, International Journal of Cardiology
To investigate the effectiveness of the strategy of transcatheter occlusion with the Gianturco coil for small-to-moderate sized ductus and with Amplatzer duct occluder (ADO) for large ductus.
For ductus closure, the following strategy was applied: ADO was used in large ductus: infants and young children weighing < 15 kg with a ductus diameter ≧ 3 mm and in older children or adults with a ductus diameter ≧ 4 mm and coils were employed in patients with small-to-moderate sized ductus. During a 3-year period, this strategy was applied in 136 patients. The results were compared between 214 patients (group I) undergoing ductus closure using only coil before application of this strategy and strategic closure in 136 patients (group II). Each group was divided into 2 subgroups: subgroup A with large ductus and subgroup B with small-to-moderate ductus. There were 54 patients in subgroup IA, 160 in subgroup IB, 33 in subgroup IIA and 103 in subgroup IIB, respectively.
In group I, PDA occlusion was successful in 207 (96.7%) and failed in 7 (6 of group IA and 1 of group IB). In group II, ductus closure was successful in 134 patients (98.5%) (32/33 with ADO and 102/103 with coils).There was no significant difference in success rate between group I and II. Distal embolization occurred in 19 patients of group I and in 2 of group II, respectively (19/214 vs. 2/136, P < 0.01). There was no significant difference in success rate between group IA and IIA but the distal embolization rate was higher in group IA than IIA (13/54 vs. 1/33, P = 0.014). Left pulmonary artery stenosis was found exclusively in 9 patients of group I at the 6-month follow-up (P < 0.05). Nine patients in group I required second intervention to achieve complete occlusion.
The strategy of ductus closure worked well by reducing embolization rate, incidence of left pulmonary artery stenosis and the need of second intervention.
Modified extrapleural ligation of patent ductus arteriosus: A convenient surgical approach in a developing country
2005, Annals of Thoracic Surgery
Citation Excerpt :
As reported by others [19–23], we are equally convinced that the modification of the original SEP technique for closure of a PDA, including a limited skin- and muscle-sparing incision and triple occlusion of the PDA, is a safe technique that offers a valid alternative, in selected patients, to other more recent minimally invasive techniques. Video-assisted thoracoscopic surgery, according to numerous reports [5–18], offers excellent operative results for PDAs smaller than 1 cm in diameter. However, video-assisted thoracoscopic equipment is not yet available in our unit because of cost considerations.
Minimally invasive surgery for the closure of a large patent ductus arteriosus (PDA) using an extrapleural technique offers an alternative to other minimally invasive approaches such as video-assisted thoracoscopic surgery or interventional cardiologic procedures.
Between August 1999 and December 2003, 513 patients with PDA were admitted to Unidad de Cirugia Cardiovascular de Guatemala, of whom 327 (64%) were considered surgical candidates. Of these, 218 (67%) were selected for surgical extrapleural (SEP) closure initially by weight (< 10 kg) and a ductal diameter at the pulmonary end of greater than 4 mm. Subsequently, we included also patients who weighed more than 10 kg. Median age at operation was 51 months (range 5 days to 38 years).
Median operating time was 32 minutes (range 23 to 52 minutes). All 218 patients had SEP closure and were extubated in the operating room. There were no hospital deaths. Two patients required a blood transfusion. Two additional patients bled postoperatively, requiring reoperation. A pneumothorax occurred in 3 patients that required a chest tube. The 6-month follow-up revealed residual ductal shunts in 2 patients that were closed percutaneously with a coil. The treatment of the remaining 295 patients included a surgical transpleural (STP) approach in 109 (37%) and transcatheter closure in 186 (63%), with a coil in 110 (37%) and an Amplatzer device in 76 (26%).
Minimally invasive closure of a PDA through a short, 3-cm to 5-cm skin and muscle-sparing posterior thoracotomy and an SEP approach provides a convenient and safe technique with a low incidence of complications and also a cost-saving option compared with other invasive techniques.

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^*: Reprint requests: Daniel R. Turner, MD, Division of Cardiology, Children's Hospital of Michigan, 3901 Beaubien Blvd, Detroit, MI 48201-2196.

^**: E-mail: [email protected]

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Clinical Investigations: Valvular and Congenital Heart DiseaseEarly reopening and recanalization after successful coil occlusion of the patent ductus arteriosus*,**

Abstract

Section snippets

Study population

Patients

Discussion

Acknowledgements

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Clinical Investigations: Valvular and Congenital Heart Disease
Early reopening and recanalization after successful coil occlusion of the patent ductus arteriosus*,**