ABSTRACT

Introduction and objectives: Percutaneous closure of ventricular septal defect (VSD) can be an alternative to surgery reducing length of stay, and complications. The high risk of atrioventricular block (AVB) involved during percutaneous closure has encouraged the development of new devices such as the KONAR-MF (Lifetech, China). This device is very flexible and has a low radial force that adapts to the anatomy of the VSD without exerting any pressure to the adjacent structures. This is our early experience with this new device.

Methods: Retrospective review of patients and VSD closure procedures using the KONAR-MF device at 2 Spanish centers from February 2020—date of the first implantation in our country—through September 2021.

Results: A total of 7 closure procedures of VSD were performed being the device successfully implanted in 6 of the 7 patients. A total of 4 native perimembranous VSDs and 3 residual VSDs after tetralogy of Fallot repair were reported. The size of the VSD measured through transesophageal echocardiography and angiography was consistent in all the cases except for 1. In this patient device embolization occurred. At the follow-up [1.2 months (IQR, 0.9-15.5), (maximum 17 months)] we saw worsening atrioventricular conduction in a patient with a previous AVB who required a pacemaker. The immediate residual shunt rate was 83% (5/6) with persistent residual shunt beyond the 1-month follow-up in 1 patient (16%). All patients were discharged from the hospital within the first 48 hours following the intervention.

Conclusions: The percutaneous closure of VSD with the KONAR-MF device is a feasible alternative to surgery in selected patients. An adequate anatomical evaluation of the VSD is one of the keys of successful procedures. The implantation of this device is no stranger to complications like AVB or device embolization.

Keywords: Ventricular septal defect. Catheterizations in congenital heart disease. Ventricular septal defect. Closure devices.

RESUMEN

Introducción y objetivos: El cierre percutáneo de la comunicación interventricular (CIV) puede ser una alternativa a la cirugía y reduce el tiempo de hospitalización y las complicaciones. El alto riesgo de bloqueo auriculoventricular (BAV) en el cierre percutáneo ha incentivado el desarrollo de nuevos dispositivos, como el KONAR-MF (Lifetech, China), muy flexible y con poca fuerza radial para adaptarse a la anatomía de la CIV sin presionar las estructuras adyacentes. Se presenta la experiencia inicial con este nuevo dispositivo.

Métodos: Revisión retrospectiva de pacientes y procedimientos de implante del dispositivo KONAR-MF, en 2 centros españoles, desde febrero de 2020, fecha del primer implante en nuestro país, hasta septiembre de 2021.

Resultados: Se han realizado 7 procedimientos de cierre de CIV con KONAR-MF, implantándolo con éxito en 6 de los casos. Fueron 4 CIV perimembranosas nativas y 3 CIV residuales tras reparación de tetralogía de Fallot. El tamaño de la CIV medido por ecocardiografía transesofágica y angiografía fue concordante en todos los casos salvo en uno; en este paciente se produjo una embolización del dispositivo. En el seguimiento (1,2 meses [rango intercuartílico: 0,9-15,5], máximo 17 meses) se observó un empeoramiento de la conducción auriculoventricular en un paciente con BAV previo, que precisó marcapasos. La tasa de shunt residual inmediato fue del 83% (5/6), persistiendo el shunt residual más allá del mes de seguimiento en 1 paciente (16%). Todos los pacientes recibieron el alta hospitalaria en las primeras 48 horas tras la intervención.

Conclusiones: El cierre percutáneo de CIV con el dispositivo KONAR-MF es una alternativa factible a la cirugía en pacientes seleccionados, siendo la adecuada valoración anatómica de la CIV una de las claves para el éxito del procedimiento. El implante de este dispositivo no está exento de complicaciones, como el BAV y la embolización.

Palabras clave: Comunicación interventricular. Intervencionismo en cardiopatías congénitas. Dispositivos de cierre de comunicación interventricular.

Abbreviations AVB: atrioventricular block. TOE: transesophageal echocardiography. VSD: ventricular septal defect.

INTRODUCTION

Ventricular septal defect (VSD) is one of the most common congenital heart diseases. Its prevalence is 5.3 cases for every 1000 live births.1 It can occur in isolation or as part of a more complex congenital heart disease. Standard therapy is surgical closure with very low morbidity and mortality rates. However, it is no stranger to complications.

Percutaneous closure can be an alternative to surgery in selected anatomies, thus reducing the length of hospital stay, and complications. Both percutaneous and surgical closures have a potential risk of atrioventricular block (AVB)—< 2% for surgical closure, and 0.5% to 6.8% for percutaneous closure.2-5 The high risk of AVB has led to the development of new and more flexible sheaths and devices to close the VSD with less radial strength that minimize the risk of damage to the cardiac conduction system. In this context, the KONAR-MF VSD device occluder (Lifetech, China) was developed. It obtained the CE marking in Europe back in May 2018. It is a low profile, nitinol, self-expanding device with little radial strength and high flexibility in order to adapt to the anatomy of the VSD without exerting any pressure to the adjacent structures. The device is made of 2 discs united at its waist that has a polytetrafluoroethylene membrane. The right disc is simple while the left one has 1 cone attached to it similar the devices that are used to close the ductus arteriosus (figure 1). Each disc has a screw so it can be anchored to the delivery system in such a way that it can be implanted via antegrade (venous) and retrograde (arterial) access. The device comes in several sizes from 5 mm to 14 mm. It is suitable for different VSDs of different sizes, and anatomies (figure 1). The specific sheaths of the delivery system—5-Fr to 7-Fr—are also very flexible, which reduces pressure to the cardiac conduction system during the device implantation maneuvers. Also, it can be implanted through a 7-Fr or 8-Fr guide catheter.


Figure 1. KONAR-MF device (Lifetech, China) with the table of measures available. Data from the device instructions for use.


This is the early experience of 2 Spanish centers using this new device for the closure of VSD.

METHODS

Retrospective review of patients treated with the VSD KONAR-MF occluder device at 2 Spanish centers: Hospital Universitario Ramón y Cajal, Madrid, and Hospital Universitario La Fe, Valencia from February 2020—date of the first implantation procedure in our country—through September 2021. Patients were selected if they had suitable anatomies for percutaneous closure, that is, proper distance to the aortic valve (> 2 mm), lack of posterior prolongation (enough distance to the tricuspid valve), and proportionate size of the devices available. Since this was a short retrospective review, no control group was included.

The patients’ demographic, clinical, and anthropometric data were collected, as well as the echocardiographic anatomy of the defect, the hemodynamic variables of the procedure, and the immediate complications or at the follow-up.

Definitions

Residual shunt was defined as the presence of flow on the color Doppler echocardiography around the device. Flow was categorized into mild (1 mm to 2 mm), moderate (2 mm to 4 mm), or severe (> 4 mm). The presence of flow inside the device was called intradevice shunt and was considered less significant compared to mild shunt.

Complications were categorized as minor or major:

  • – Major complications: death, potentially fatal adverse events, events requiring surgery (embolization, myocardial perforation, vascular rupture, severe residual shunt, severe hemolysis, valvular damage, persistent AVB).

  • – Minor complications: complications that solve spontaneously or with medical therapy and don’t have fatal outcomes (issues with vascular access, mild hemolysis solved with medical therapy, complete transient AVB or other conduction abnormalities that do not require pacemaker implantation, fever, neurapraxias, etc.)

Device implantation was considered successful in the absence of major complications, and severe residual shunt within the next 24 hours.

Description of the procedure

Previous diagnostic cardiac catheterization, and transesophageal echocardiography (TEE) were performed in all the patients. The patients referred for closure had hemodynamic repercussions due to VSD (left ventricular dilatation). Also, the presence of a Qp/Qs ratio ≥ 1.5 was confirmed through a cardiac catheterization performed under general anesthesia while the patient remained intubated.

The size of the device was determined based on the measures of VSD obtained on the TEE, and left ventriculography. The device was 1 mm to 3 mm larger than the defect (figure 2).


Figure 2. Ventricular septal defect (VSD) in a patch in a patient with tetralogy of Fallot. The upper images reveal the presence of the defect both on the transesophageal echocardiography (TEE), and the angiography. The lower images—also from TEE and angiography—reveal the defect being closed after KONAR-MF device implantation (Lifetech, China).


The VSD probing technique, and the device positioning and delivery are not substantially different compared to those used in other device occluders widely discussed in the medical literature.6-9 The interventional procedure was performed under TEE guidance, and the device was released after being properly deployed without severe residual shunt.

Follow-up after closure of ventricular septal defect

Follow-up visits were conducted 1 month, 6 months, and 1 year after closure. After that time, depending on the patient’s baseline condition and clinical situation, follow-up was conducted every 6 or 12 months. Anamnesis, physical examination, electrocardiogram, and echocardiography were performed in these visits. Blood tests were also added to the mix in cases of suspected hemolysis. In the presence of any other symptoms or pathological findings in any of the tests performed, additional studies were conducted like Holter, ergometry or further imaging modalities.

Ethical aspects

In compliance with the current legislation, and since this was a retrospective case review it was not necessary to obtain the patients’ informed consent or approval by the ethics committees of the participant centers.

RESULTS

From February 2020 through June 2021, a total of 7 consecutive procedures of VSD closure were performed at the 2 centers using the KONAR-MF device by successfully implanting this device in 6 out of the 7 patients. Table 1 shows the overall description of the patients. Cases were restrictive defects (native or postoperative) with echocardiographic data of hemodynamic repercussion (left ventricular dilatation) without clinical translation in patients > 8 years.


Table 1. General description of patients treated with percutaneous closure of VSD

Patient Sex Age (years) Weight (kg) Qp/Qs ratio Anatomy Size of VSD on the TEE (LV/RD) Size of VSD on the angiography (LV/RV) Device X-ray imaging time (min)
1 F 8 29.3 1.53 PM 6/4 6/5 7/5 21.2
2 F 14 57.2 1.71 PM ND 8/4.5 8/6 50.4
3 M 19 59 1.5 PR 10/7 11/8 12/10 27
4 F 26 64 2.08 PR 10/7 11/8 12/10 42.3
5 M 9 23 1.58 PM 8/5 4/2 6/4 143
6 M 16 54 2.25 PR 9/8 11/8 12/10 25
7 M 13 51.2 1.66 PM 7/4 7/5 8/6 22

F, feminine; LV, left ventricle; M, masculine; NA, not available; PM, perimembranous; PR, postoperative residual; Qp, pulmonary cardiac output; Qs, systemic cardiac output; RV, right ventricle; TEE, transesophageal echocardiography; VSD, ventricular septal defect.


The anatomy of VSD was:

  • – Native perimembranonus VSD in 4 patients (2 with aneurysmal tissue that partially closed the VSD) without associated disease in 3 patients while the fourth had been treated of coarctation of aorta.

  • – Residual VSD residual after repair of tetralogy of Fallot in 3 patients.

The size of the VSD measured on the TEE and angiography was consistent in all the cases except for 1 with a small VSD covered by an aneurysm.

In all the patients, vascular approach was attempted via femoral access (artery and vein); in 6 of them closure was performed via antegrade access, and in 1 patient via retrograde access. Retrograde access was attempted in 1 patient in whom the proper positioning of the right disc could not fully achieved. Finally, closure was successfully completed from the right ventricle, but with longer x-ray image and procedural times. The median x-ray image time was 27 minutes [IQR, 22-50].

There were no immediate complications in any of the cases reported except for 1 embolization in a small VSD with aneurysmal tissue (case #5) where the size of the VSD measured on the TEE and the angiography did not properly correlate. The device embolized to the left pulmonary artery and was retrieved percutaneously through a bailout procedure. The patient was treated with VSD elective surgery a few months later. No hemolysis or vascular complications were reported in the series with a maximum follow-up time of 17 months (median follow-up, 1.2 months; IQR, 0.9-15.5).

Immediate residual shunt was seen in 5 out of the 6 successfully closed VSDs. Two of the patients showed mild intradevice shunt that closed spontaneously within the first 24 hours; in another 2 patients the shunt disappeared 1 month after the procedure, and in the fifth case moderate residual shunt persisted 1 month after the procedure.

All patients were discharged from the hospital within the first 48 hours after the procedure. Three out of the 7 patients were already on acetylsalicylic acid due to their underlying condition while in the remaining 3 with successful closures, treatment with acetylsalicylic acid was started before discharge. Antibiotic prophylaxis was advised for 6 months after closing the residual shunt.

Regarding the clinical course, in 5 out of the 6 patients with successful device implantation and without previous ECG alterations, no conduction abnormalities were seen after closing the VSD. However, 1 case of progression into long-term preexisting postoperative AVB was reported that required pacemaker implantation. This was the case of a patient with repaired tetralogy of Fallot (case #3) who—before the percutaneous closure of the VSD—had advanced AVB of several years of evolution without an indication for pacemaker implantation. Fourteen months after the procedure, the patient required percutaneous pacemaker implantation because data on atrioventricular conduction worsened in Holter, ergometry, and electrophysiological studies.

DISCUSSION

This is a small and heterogeneous series of occluded VSDs with the KONAR-MF device with a short follow-up too. However, we wanted to share our case since this was the first experience in our country using a device that has joined the therapeutic arsenal of occluder devices available for the percutaneous treatment of VSD. Using this device was technically easy and reproducible from the interventional cardiology standpoint. Also, the echocardiographic visualization of the device was rather good from the imaging standpoint (figure 2).

The percutaneous occlusion of VSD with the KONAR-MF device is feasible and effective with complete closure of VSD rates 1 month after implantation of up to 98%,9-12 which has been associated with the possibility of oversizing the device vs the VSD without damaging any adjacent structures given its flexibility.9-12 In our series of a single patient with residual shunt vs 5 patients without it, the rate of occlusion was 83% 1 month after implantation.

Compared to other devices, the advantages attributed to this device are its flexibility and adaptability to the patient’s anatomy, both favorable to minimize complications and increase the efficacy of occlusion. Also, other advantages are the possibility of implanting this device from the aortic side shortening procedural time.

Although, to this date, literature is scarce and only limited to early series of cases, the experience is growing, particularly in Asia.9-14 It has been used in a wide array of clinical scenarios and patients including breastfed babies13 proving effective and safe overall. However, as it occurs with all invasive procedures, it is not stranger to major complications being embolization the most common of all.10,11

The rates of success and major complications (embolization, AVB, and hemolysis) reported with this device are similar—or somehow lower—compared to those reported with other VSD closure devices.11,15 However, the rates of immediate closure are higher compared to those reported with other devices, which would—theoretically speaking—minimize the risk of complications like hemolysis or endocarditis.11,15

Our results are consistent with the series published to this date without cases of hemolysis being reported. The serious complications reported were 1 embolization, and 1 AVB at the follow-up. In our series, embolization was attributed to the fact that a small device was selected as a consequence of the mismatch reported between the VSD size measured on the TEE and on the angiography. The presence of aneurysmal tissue when trying to measure the defect properly was seen as a setback. Future cases should examine the TEE-angiography correlation when measuring the size of VSD.

The medical literature reports 2 cases of permanent AVB (another transient AVB was reported during the procedure contraindicating implantation13): 1 early AVB in the series of Tanidir et al.10 of 98 patients—a rate of AVB of 1%—plus another case deferred for a week14 that made Leong et al.14 review the rate of AVB described in the medical literature with what they referred to as «new» devices. In our sample no cases of rhythm disorders were reported after the procedure was performed in 5 out of 6 cases. However, it is relevant that in a patient with previous advanced AVB, disease progression was reported, which led to pacemaker implantation after closing the defect. Since this patient had tetralogy of Fallot, the device was implanted in a patch without prior direct compression on the cardiac conduction system. Also, this patient had a hemodynamic disorder with right ventricular overload due to acute respiratory failure, and significant stenosis of pulmonary arteries. Given this baseline situation, the worsening AVB cannot be fully attributed to the device although it cannot be discarded either. In any case, the previous presence of conduction abnormalities should be a warning of possible worsening after percutaneous closure of a VSD.

The results of our series should be interpreted in the context of its own limitations (small number of patients and short follow-up period). Although both the versatility of the device and the successful outcomes are encouraging, the presence of serious complications requires a careful approach. Therefore, larger studies with more cases and longer mid-term follow-ups are required to confirm the device safety profile.

CONCLUSIONS

The percutaneous closure of the VSD with the KONAR-MF device emerges as a proper alternative to occlusion with other devices. Also, it is a feasible alternative to surgery for some patients. Also, it stands as an effective occlusion technique in selected defects being the right anatomical assessment of the VSD one of the keys for success. The rates of complete closure and complications of this early sample should improve with more cases, experience, and longer follow-ups. As it occurs with other devices, implanting this device is associated with complications like AVB, and embolization.

FUNDING

None whatsoever.

AUTHORS’ CONTRIBUTIONS

M. Álvarez-Fuente collected the patients’ data and drafted the manuscript. J.I. Carrasco collected the patients’ data and was involved in the review process of the manuscript. B. Insa drafted the manuscript. M. Toledano was involved in the review process of manuscript. E. Peiró participated in the review process of the manuscript. J.P. Sandoval participated as an advisor in the process of drafting the manuscript, as well as the manuscript final review process. M.J. del Cerro drafted the manuscript.

CONFLICTS OF INTEREST

None reported.

WHAT IS KNOWN ABOUT THE TOPIC?

  • Currently, the percutaneous closure of VSD is starting to become routine in PCI-capable centers specialized in congenital heart disease. However, this technique still cannot be compared to or even replace surgery. Numerous devices for the closure of VSD have been developed. However, not a single one has been found to perform this procedure with enough efficacy and safety.

WHAT DOES THIS STUDY ADD?

  • This is the early experience using a new device to close VSDs with results that are promising enough to think that the interventional procedures performed with it are a reliable alternative to the surgical closure of VSD.

REFERENCES

1. Lindinger A, Schwedler G, Hense HW. Prevalence of congenital heart defects in newborns in Germany:results of the first registration year of the PAN Study (July 2006 to June 2007). Klin Padiatr. 2010;222:321-326.

2. Zhao LJ, Han B, Zhang JJ, et al. Postprocedural outcomes and risk factors for arrhythmias following transcatheter closure of congenital perimembranous ventricular septal defect:a single-center retrospective study. Chin Med J (Engl). 2017;130:516-521.

3. Ergün S, GençSB, Yildiz O, et al. Risk factors for major adverse events after surgical closure of ventricular septal defect in patients less than 1 year of age:a single-center retrospective. Braz J Cardiovasc Surg. 2019;34:335-343.

4. Saurav A, Kaushik M, Mahesh Alla V, et al. Comparison of percutaneous device closure versus surgical closure of peri-membranous ventricular septal defects:a systematic review and metaanalysis. Catheter Cardiovasc Interv. 2015;86:1048-1056.

5. Haas NA, Kock L, Bertram H, et al. Interventional VSD-Closure with the Nit-Occlud((R)) Le VSD-Coil in 110 patients:early and midterm results of the EUREVECO-Registry. Pediatr Cardiol. 2017;38:215-227.

6. Huang X-S, Luo Z-R, Chen Q, et al. A Comparative Study of Perventricular and Percutaneous Device Closure Treatments for Isolated Ventricular Septal Defect:A Chinese Single-Institution Experience. Braz J Cardiovasc Surg. 2019;34:344-351.

7. Nguyen HL, Phan QT, Doan DD, et al. Percutaneous closure of perimembranous ventricular septal defect using patent ductus arteriosus occluders. PLoS One. 2018;13:e0206535.

8. Solana-Gracia R, Mendoza Soto A, Carrasco Moreno JI, et al. Spanish registry of percutaneous VSD closure with NitOcclud Le VSD Coil device:lessons learned after more than a hundred implants. Rev Esp Cardiol. 2021;74:591-601.

9. Haddad RN, Daou LS, Saliba ZS. Percutaneous closure of restrictive-type perimembranous ventricular septal defect using the new KONAR multifunctional occluder:Midterm outcomes of the first Middle-Eastern experience. Catheter Cardiovasc Interv. 2020;1;96:E295-E302.

10. Tanidir IC, Baspinar O, Saygi M, et al. Use of Lifetech™KONAR-MF, a device for both perimembranous and muscular ventricular septal defects:A multicentre study. Int J Cardiol. 2020;1;310:43-50.

11. Sadiq M, Qureshi AU, Younas M, et al. Percutaneous closure of ventricular septal defect using LifeTechTM KONAR-MF VSD Occluder:initial and short-term multi-institutional results. Cardiol Young. 2021;28:1-7.

12. Schubert S, Kelm M, Koneti NR, et al. First European experience of percutaneous closure of ventricular septal defects using a new CE-marked VSD occluder. EuroIntervention. 2019;12;15:e242-e243.

13. Damsky-Barbosa J, Alonso J, Ferrín L, et al. Endovascular VSD Closure with Lifetech KONAR-Multifunctional Occluder - Novel Device. J Struct Heart Dis. 2019;5:237-247.

14. Leong MC, Alwi M. Complete atrio-ventricular heart block, a not to be forgotten complication in transcatheter closure of perimembranous ventricular septal defect –a case report and review of literature. Cardiol Young. 2021;31:2031-2034.

15. Santhanam H, Yang L, Chen Z, et al. A meta-analysis of transcatheter device closure of perimembranous ventricular septal defect. Int J Cardiol. 2018;254:75-83.

* Corresponding authors:

E-mail addresses: maria.alvarezfuente@gmail.com; majecerro@yahoo.es (M. Álvarez-Fuente, and M.J. del Cerro).

ABSTRACT

Introduction and objectives: The Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and the Spanish Society of Pediatric Cardiology Working Group on Interventional Cardiology (GTH-SECPCC) introduce their annual activity report for 2020, the starting year of the pandemic of coronavirus disease (COVID-19).

Methods: All Spanish centers with cath labs and interventional activity in congenital heart diseases were invited to participate. Data were collected online, and analyzed by an external company together with members from the ACI-SEC and the GTH-SECPCC.

Results: A total of 16 centers participated (all of them public) including 30 cath labs experienced in the management of congenital heart diseases, 7 of them (23.3%) dedicated exclusively to pediatric patients. A total of 1046 diagnostic studies, and 1468 interventional cardiac catheterizations were registered. The interventional procedures were considered successful in 93.4% of the cases with rates of major procedural complications and mortality of 2%, and 0.1%, respectively. The most frequent procedures were atrial septal defect closure (377 cases), pulmonary angioplasty (244 cases), and the percutaneous closure of the patent ductus arteriosus (199 cases).

Conclusions: This report is the first publication from the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry. The data recorded are conditioned by the COVID-19 pandemic. Diagnostic cardiac catheterization still plays a key role in this field. Most interventional techniques have reported excellent security and efficacy rates.

Keywords: Congenital heart disease. Cardiac catheterization. Atrial septal defect closure. Coronavirus. COVID-19.

RESUMEN

Introducción y objetivos: La Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) y el Grupo de Trabajo de Hemodinámica de la Sociedad Española de Cardiología Pediátrica y Cardiopatías Congénitas (GTH-SECPCC) presentan el informe de actividad hemodinámica en cardiopatías congénitas de 2020, año de inicio de la pandemia de la enfermedad coronavírica de 2019 (COVID-19).

Métodos: Se invitó a participar a los centros españoles con laboratorio de hemodinámica y actividad intervencionista en cardiopatías congénitas. La recogida de datos se realizó telemáticamente; una empresa externa, junto con miembros de la ACI-SEC y el GTH-SECPCC, los analizó.

Resultados: Participaron 16 centros (todos públicos), que acumulan 30 salas de hemodinámica con actividad en cardiopatías congénitas, 7 (23,3%) de ellas con dedicación exclusiva a pacientes pediátricos. Se registraron 1.046 estudios diagnósticos y 1.468 cateterismos intervencionistas. Los procedimientos terapéuticos fueron exitosos en el 94,9%, con una tasa de complicaciones mayores del 2% y una mortalidad del 0,1%. Las técnicas más frecuentes fueron el cierre de comunicación interauricular (377 casos), la angioplastia pulmonar (244 casos) y el cierre de ductus arterioso (199 casos).

Conclusiones: El presente trabajo representa la primera publicación del Registro Español de Intervencionismo en Cardiopatías Congénitas. La casuística registrada está condicionada por la pandemia de la COVID-19. Los cateterismos diagnósticos siguen teniendo un papel relevante en esta actividad. Para la mayoría de las técnicas intervencionistas se han reportado excelentes datos de seguridad y eficacia.

Palabras clave: Cardiopatia congenita. Cateterismo cardiaco. Cierre de comunicacion interauricular. Coronavirus. COVID-19

INTRODUCTION

Interventional activity in the management of congenital heart disease in Spain has not been properly evaluated or analyzed to date. The collaboration between the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (ACI-SEC) and the Spanish Society of Pediatric Cardiology and Congenital Heart Disease Working Group on Hemodynamics (GTH-SECPCC) has reactivated and updated a registry that includes all procedures performed in patients, of any age, with congenital heart disease since their fetal stage up to their adult age.

The first report resulting from this new stage of the registry included the activity developed in 2019 and was presented in the 31st Annual Congress of ACI-SEC that was held online back in December 3-4 of 2020, and in the online administrative meeting of GT-SECPCC held in December 11, 2020.

The current report presented in this article includes the activity developed in 2020 and is the first one to be published; all the information obtained is extremely useful not only to know the volume and results of this activity, but also for the analysis of the implementation of different interventional techniques in Spain and put them in an international context. The continuity of this work will bring us knowledge of its progress in the coming years.

The provision of data was voluntary and took place through an online database. An external company handled and analyzed all the data collected. Members from the ACI-SEC and the GTH-SECPCC boards of directors were involved in the follow-up and process of revising this database; the involvement of both scientific societies—essential to conduct the registry—initiates a very desirable collaboration that should strengthen synergies among interventional cardiologists who work in adult and pediatric areas.

METHODS

This registry includes diagnostic and interventional procedural data from most Spanish centers with significant interventional activity in the field of congenital heart diseases. The submission of data has not been audited and is voluntary. It was conducted through an online questionnaire that only the person responsible from each center can access through ACI-SEC website.1 An external company (Tride, Spain) handled and analyzed the results from the registry in collaboration with members from ACI-SEC and the GTH-SECPCC boards of directors. In case of conflicting data or outside the routine clinical practice, the lead investigator of each center was contacted to verify the information submitted. Given the methodological characteristics of the study and since it was an activity registry only no approval was necessary from any ethics committees. No informed consent was needed either.

RESULTS

Resources and infrastructure

A total of 16 hospitals participated in this registry, all of them from the public healthcare network (annex 1). A total of 30 cath labs with activity in the management of congenital heart disease were included, 7 of which (23.3%) were for pediatric use only. The regular number of days a month dedicated to performing interventional procedures to treat congenital heart diseases in each hospital had a median of 7.5 (4-15) days. However, in 14 (87.5 %) of these centers, emergency cath lab care has become available on a 24-hour basis for patients of any age with congenital heart diseases.

With regard to the medical personnel, a total of 50 interventional cardiologists are involved in this activity 26 of whom (52%) are trained in adult interventional cardiology and 24 (48%) in pediatric interventional cardiology.

Diagnostic procedures

A total of 1043 diagnostic studies were conducted; 55 (5.3%) in infants < 1 month of age; 111 (10.7%) in patients between 1 month and 1 year, 486 (46.7%) cardiac catheterizations in patients between 1 and 18 years of age, and 399 (37.4%) in patients over 18 years of age.

With regard to the type of studies conducted, only 69 (6.6%) were categorized as emergency studies and the remaining ones as scheduled studies. Only 1 serious complication (cardiac tamponade) and no deaths were reported in this group.

Interventional procedures

A total of 1458 therapeutic cardiac catheterizations grouped into 13 different categories and distributed based on age and frequency were reported: only 1 case (0.1%) during the fetal stage, 141 (9.7%) in infants < 1 month, 257 (17.6%) in patients between 1 month and 1 year, 694 (47.6%) in patients between 1 and 18 years of age, and 367 (25.1%) in patients over 18 years of age (table 1).

Table 1. Number of interventional procedures performed and distribution by age groups

Variable Total Fetal < 1 month 1 month through 1 year 1 through 18 years > 18 years
Interventional procedures 1458 1 (0.1) 141 (9.6) 257 (17.6) 694 (47.6) 365 (25.0)
Congenital aortic valvuloplasty 45 1 (2.2) 7 (15.6) 18 (40.0) 16 (25.6) 3 (6.7)
Congenital pulmonary valvuloplasty 97 0 33 (34.0) 28 (28.9) 25 (25.8) 11 (11.3)
Congenital mitral valvuloplasty 1 - 0 0 1 (100) 0
Pulmonary angioplasty 244 - 11 (4.5) 50 (20.5) 143 (58.6) 40 (16.4)
Aortic angioplasty 109 - 3 (2.8) 25 (22.9) 40 (36.7) 41 (37.6)
Other angioplasties 91 - 22 (24.2) 20 (22.0) 35 (38.5) 14 (15.4)
Closure of interatrial communication/patent foramen ovale 377 - - 2 (0.5)a 155 (41.1) 220 (58.4)
Closure of the patent ductus arteriosus 189 - 7 (3.7) 42 (22.2) 132 (69.8) 8 (4.2)
Closure of interventricular communication 39 - - 3 (7.6)a 29 (74.3) 7 (17.9)
Other occlusions 106 - 3 (2.8) 19 (17.9) 54 (50.9) 30 (28.3)
Removal of foreign body 34 - 2 (5.9) 3 (8.8) 23 (67.6) 6 (17.6)
Atrial septostomy and transseptal puncture 68 - 56 (82.4) 2 (2.9) 10 (14.7) 0
Transcatheter aortic valve implantation 58 - - - 29 (50.0)b 29 (50.0)

a In this case, data < 1 month, and from 1 month through 1 year were not reported separately, which is why the value is < 1 year of age.

b Data correspond to patients under 18 only, which is why the value is exclusive to this group only.

Data are expressed as no. or percentage (%).


A total of 132 of these procedures (9%) were categorized as emergency procedures. A total of 30 serious events directly associated with cardiac catheterization were reported (table 2) including 2 deaths (a 0.1% mortality rate). Also, 17 cases of device embolization were reported 5 of which required surgery.


Table 2. Distribution of complications and deaths reported for each interventional procedure

Interventional procedure N Major complications and deaths
Congenital aortic valvuloplasty 45 2 (4.4)
1 severe aortic regurgitation, 1 death
Congenital pulmonary valvuloplasty 97 2 (2.1)
1 case of severe arrhythmia,
1 tamponade
Congenital mitral valvuloplasty 1 0
Pulmonary angioplasty 244 4 (1.6)
2 embolizations, 1 case of severe arrhythmia, 1 arterial dissection
Aortic angioplasty 109 1 (0.9)
1 femoral artery pseudoaneurysm
Other angioplasties 91 3 (3.3)
1 arterial dissection, 1 neurological event, 1 death
Closure of interatrial communication/patent foramen ovale 377a (330) 6 (1.8)
5 embolizations, 1 removal due to massive residual shunt
Closure of the patent ductus arteriosus 189 5 (2.6)
5 embolizations
Closure of interventricular communication 39 4 (10.2)
3 embolizations, 1 case of severe arrhythmia
Other occlusions 106b (100) 0
Removal of foreign body 34 0
Atrial septostomy and transseptal puncture 68 1 (1.5)
1 embolization
Transcatheter aortic valve implantation 58c (53) 2 (2.8)
1 embolization, 1 coronary artery compression
Total 1.458d (1.401) 30 (2.0)

a Percentages estimated over 330 cases reported.

b Percentages estimated over 100 cases reported.

c Percentages estimated over 53 cases reported.

d Percentages estimated over 1401 cases reported.

Data are expressed as no. or percentage (%).


Percutaneous valvuloplasties

A total of 45 aortic valvuloplasties performed on congenital aortic stenoses were reported including the only case of fetal cardiac intervention in the registry, 25 of these (55.6%) were performed in patients < 1 year 7 of whom (15.6%) were < 1 month, and only 3 (6.7%) were performed in patients > 18 years of age. In 82% of the procedures, the native valves that had not been treated previously were dilated. The procedural success rate was 93.3%, and only 1 death and 1 case of severe aortic regurgitation after dilatation were reported.

A total of 97 pulmonary valvuloplasties were reported. The most numerous age range reported with 61 cases (72.9%) was that of patients < 1 year, 33 of whom (34%) were infants < 1 month, and 11 (11.3%) were patients > 18 years of age. In 95 cases (97.9%) data on the type of valves treated were reported: 80 (84.2%) were native valves, 9 of which (9.4%) were imperforated; only in 3 of these valves ductal stenting was performed to optimize pulmonary output in association with perforation and valvuloplasty. A total of 87 procedures (89.7%) were considered successful. A total of 2 major complications—cardiac tamponade, and arrhythmia with hemodynamic repercussion—were reported. Finally, only 1 case of mitral valvuloplasty was reported on a valve previously treated that turned out a success.

Percutaneous angioplasties

Pulmonary angioplasty is the group with the most cases in this section with 244 cardiac catheterizations; 143 of these (58.6%) were performed in patients between 1 and 18 years of age being this age range the most common one for this procedure. The anatomical substrate of angioplasty was the dilation of branch pulmonary arteries in 176 cases (72.1%), native outflow tract in 38 (15.5%), and the surgical implantation of a pulmonary artery conduit in 30 cases (12.2%). The technical data of 209 procedures were reported (overall percentage, 85.7%): in 55% of these procedures the angioplasty was performed with stenting while in the remaining 45% conventional balloon dilatation was used; no dilatations with cutting balloons were reported. The success rate was 91.4%, and 4 major complications were reported: 2 cases of device embolization, 1 vascular dissection, and 1 case of severe arrhythmia.

A total of 109 aortic angioplasties were reported: in this case the age group with more dilatations was that of patients > 18 years of age with 41 cases (37.6%). A total of 70 procedures (64.2%) were reinterventions while 39 (35.7%) were procedures to treat the native aortic valves. The technical data of 100 cases (overall percentage, 91.7%) were reported with the following distribution: conventional balloon angioplasty, 33%; bare-metal stent implantation, 36%; covered stent implantation, 21%; and redilation of balloon-expandable stent, 10%. A total of 105 procedures (96.3%) were successful. Only 1 case of major complication was reported (1 arterial pseudoaneurysm that required thrombin therapy).

A total of 91 cardiac catheterizations associated with other angioplasties were reported; in this section the anatomical substrate was reported in 63 cases only (69.2%) with special attention to the dilation of the patent ductus arteriosus in 21 cases (33.3%), and surgical fistulae in 5 (7.9%). The success rate reported in this group was 89%; 1 death associated with cardiac catheterization, 1 vascular dissection, and 1 serious neurological event were reported as well.

Shunt closures and other closing procedures

Closure of interatrial communication (CIAC) was the most widely performed interventional procedure in the registry with 377 cases; 220 of these closures (58.4%) were performed in patients > 18 years of age. The type of anatomy of the defect was reported in 374 cases (99.2%): on the one hand, simple CIAC with a single hole, borders > 5 mm, and nonaneurysmal septum in 125 cases (33.4%). On the other hand, complex CIAC and patent foramen ovale in 83 and 166 cases (22.1% and 44.3%, respectively). The most widely used imaging modality to guide the closure was transesophageal ultrasound in 298 procedures (79%) followed by intravascular ultrasound in 56 (14.8%). Angiographic measurement during balloon inflation was used in 79 closures (20.9%). Results were reported in 330 cardiac catheterizations (87.5%) being successful in 97.6% of them; out of the 5 embolizations registered only 1 required surgical bailout.

A total of 199 closures of the patent ductus arteriosus were collected, 132 of which (66.3%) were performed in patients between 1 and 18 years of age, 10 closures (5%) were performed in premature patients, and 8 (4%) in patients > 18 years of age. Occlusion devices were used in 85.2% of the cases reported, and coil-type occlusion devices in the remaining ones. The antegrade venous access was the most widely used of all (69.3%). The success rate reached 96.5% with 5 cases of device embolization, 1 of these eventually requiring surgery.

The third group of shunt closures studied was the closure of interventricular communication (CIVC) including 39 cases, 32 of which (80%) were performed in patients < 18 years of age. This was the distribution of the IVC by anatomical substrate in the 38 closures (97.4%) that included this variable: perimembranous in 26 cases (68.4%), postoperative in 7 (18.4%), and muscular in 5 (13.1%). With regard to the technical data of the procedure, in 56.7% of the cases occluder devices were used while coil-type devices with a controlled release mechanism were used in the remaining ones (40.3%). Only 2 were hybrid procedures. Only 31 cases (79.4%) were considered successful associated with 4 major complications: 3 embolizations (1 of these required surgical bailout), and 1 case of severe arrhythmia as a type of atrioventricular block that prevented the delivery of the occluder device.

Also, data from other occluder devices were collected for a total of 106 cases including the closure of aortopulmonary collaterals in 41 cases (38.6%), the closure of venous collaterals in 18 (16.9%), and the closure of coronary fistulae in 28 cases (26.4%). The materials most widely used were occluder devices (48.5%) followed by coil-type occluder devices (29.1%), and particles (13.5%). The success rate reported reached 99%.

Atrial septostomy

A total of 68 procedures were collected, 56 of which (82.4%) were performed in infants < 1 month. Echocardiography was used as imaging modality guidance in 43 cases (63.3%), and x-ray images in 30 (44.1%). A total of 57 cases (83.8%) were treated with Rashkind balloon atrial septostomy. Also, 8 procedures of septal perforation with radiofrequency, and 7 procedures of septal stenting were reported. The success rate reported reached 100%.

Transcatheter aortic valve implantation

A total of 58 procedures were reported, 29 of which (50%) were performed in patients > 18 years of age. Of these, a total of 55 valves were implanted in the pulmonary position, 2 in the mitral position, and 1 in the tricuspid position. The results of 53 cases (91.4%) were reported with a success rate of 100% and 2 major complications without associated mortality: 1 embolization (that was solved percutaneously) and 1 coronary artery compression.

DISCUSSION

This study is the first one to report on the amount of interventional activity developed in our country for the management of congenital heart disease including pediatric and adult patients. The continuity of this registry and the collaboration between the ACI-SEC and the GTH-SECPCP will improve the quality of this registry in the coming years, and study its evolution in time.

The year 2020 was defined by the COVID-19 pandemic, which also conditioned the way care was provided for the management of cardiovascular disease.2,3 In its annual activity report, the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology Registry of 20204 revealed that the reduction in the activity reported was actually not as significant as the one described within the first weeks of confinement, which would confirm a rebound in the activity reported after the first wave of the pandemic. In this registry, the volume of structural heart procedures like transcatheter aortic valve implantation did not fall that much while the volume of procedures like patent foramen ovale actually increased. In line with this trend, we also present a comparison of the data available from the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry from 2019 and 2020 (figure 1). This comparison shows a slight increase in the number of all interventional procedures performed compared to the previous year with an overall increase of 4.1%. We should mention that in the 2019 registry the participation of hospitals dropped (2 centers left the registry) compared to 2020, which puts this information into context.


Figure 1. Comparison between the number of interventional procedures performed in 2019 and 2020. IVC, interventricular communication.


Diagnostic cardiac catheterization provides relevant anatomical and hemodynamic information to guide the treatment required by patients with congenital heart disease through different stages of the disease. Despite the continuous development of other diagnostic techniques in this field, its significance can be seen in the volume of diagnostic procedures reported (1401 cases), which represent 41.6% of the overall number of cardiac catheterizations included in the registry.

Data from 1458 interventional procedures were collected of which 1093 cases (74.9%) correspond to patients < 18 years of age meaning that this activity is basically performed in the pediatric setting m. Only in the closure of interatrial communication, age range > 18 years was the one that accumulated more cases (overall percentage, 58.4%). On the other hand, only 1 interventional procedure (aortic valvuloplasty) was reported during the fetal stage, indicative that the number of patients treated with prenatal percutaneous therapy in our country is still limited.5

Over the last few years different studies have analyzed the risk of serious adverse events associated with cardiac catheterizations performed in pediatric and adult patients with congenital heart diseases;6,7,8 given the variability of its methodology, the rate of serious adverse events also varies (from 2.5% to 7%) and for this same reason, the mortality rate reported is between 0.1% and 2%. In this registry, results and complications were reported in 96% of all interventional procedures performed. In addition, the rates of serious adverse events (2%) and mortality (0.1%) are consistent with those reported in previously cited international studies. Device embolizations—that mostly solved percutaneously—are among the complications most widely reported.

On the other hand, the overall effectiveness of interventional procedures is close to 94.9% (table 3). The least effective technique (79.4%) is the CIVC that is also associated with a high rate of complications (10.2%). All this could be interpreted as a demonstration of how difficulty and demanding it is to perform this procedure. Recently, the experience in our country with the CIVC using the Nit-Occlud device (PFM AG, Germany)—a coil-type device with a controlled release mechanism—has been published.9 It includes the experience of 16 national centers in the management of 116 patients with an 89% efficacy and a rate of major complications of 6.9%.


Tabla 3. Summary of the efficacy of interventional procedures reported

Interventional procedure N Success Infectious
Congenital aortic valvuloplasty 45 42 (93.3) 3 (6.7)
Congenital pulmonary valvuloplasty 97 87 (89.7) 10 (10.3)
Congenital mitral valvuloplasty 1 1 (100) 0
Pulmonary angioplasty 244 223 (91.4) 21 (8.6)
Aortic angioplasty 109 105 (96.3) 4 (3.7)
Other angioplasties 91 81 (89.0) 10 (11.0)
Closure of interatrial communication/patent foramen ovale 377a (330) 322 (97.6) 8 (2.4)
Closure of the patent ductus arteriosus 189 184 (97.4) 5 (2.6)
Closure of interventricular communication 39 31 (79.4) 8 (20.5)
Other occlusions 106b (100) 99 (99.0) 1 (1.0)
Removal of foreign body 34 33 (97.1) 1 (2.9)
Atrial septostomy and transseptal puncture 68 68 (100) 0
Transcatheter aortic valve implantation 58c (53) 53 (100) 0
Total 1.458d (1401) 1330 (94.9) 71 (5.0)

a Percentage estimated over 330 cases reported.

b Percentage estimated over 100 cases reported.

c Percentage estimated over 53 cases reported.

d Percentage estimated over 1401 cases reported.

Data are expressed as no. or percentage (%).


With regard to valvuloplasties, percutaneous dilatation is the most widely accepted technique to treat congenital pulmonary valvular stenosis. Its efficacy reported in this registry (89.7%) may have been conditioned by certain unfavorable anatomical or genetic scenarios disregarded during data duration. In primary care of congenital aortic stenosis there is still an unsolved ongoing debate on whether to go surgical or percutaneous.10 The results reported on the aortic valvuloplasties performed (with a 93.3% efficacy) back up the convenience of using the percutaneous option in our setting. Finally, we should mention that, to this date, mitral valve valvuloplasty is an unusual technique in the congenital heart disease setting.

Within percutaneous angioplasties, the most widely used procedure was the dilation of branch pulmonary arteries that was also the second most widely performed interventional procedure of all in the registry. On the technique used, we should mention that no cutting balloon was used; instead, stent implantation was predominant. The cases reported of aortic angioplasty were mainly reinterventions and only a third treated the native aortic valve. Angioplasty with stenting was the most widely used procedure. Also, bare-metal stent implantation was more common compared to covered stent implantation.

Closure of interatrial communication (CIAC) is the interventional procedure with most cases reported in the registry especially the closure of the patent foramen ovale. The evidence published over the last few years on its utility in the prevention of strokes anticipates its growth in the years ahead.11,12 Transesophageal ultrasound is the most widely used imaging modality to guide the closure of interatrial shunts compared to intravascular ultrasound that is a minority.

Regarding the closure of the patent ductus arteriosus, the use of occluder devices is predominant. In the pediatric setting, the implementation of this technique in premature patients could grow significantly within the next few years after the publication of different studies that support its safety and efficacy profile.13,14

The evolution of both the technique and the indications for transcatheter pulmonary valve implantation, as well as the availability of new valves15,16 widen the number of anatomical scenarios eligible for this procedure. Therefore, it is expected that more patients with right ventricular outflow tract dysfunction will be treated with interventional procedures.

Limitations

The comparison between data collected from this Cardiac Catheterization in Congenital Heart Diseases Registry and data from the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology Registry (both from 2020)4 reveals a significant underestimate of some interventional procedures performed in patients > 18 years of age. This would undermine the percentual distribution reported for such procedures between children and adults. Future registries should correct this deficiency and open participation to all centers from our country with some kind of interventional activity to patients with congenital heart diseases, especially adults.

From the methodological point of view, the success parameters of some interventional procedures have not been predefined assuming a uniform criterion in all participant centers. On the other hand, grouping certain techniques like the angioplasty of branch pulmonary arteries, the pulmonary artery conduit, and the native outflow tract can be a confounding factor regarding the assessment of its technical peculiarities and results. Finally, extending the information included on the latest techniques available adds a new asset to the registry and should be reevaluated in future editions.

CONCLUSIONS

This study is the first publication of the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry thanks to the collaboration of the ACI-SEC and the GTH-SECPCC.

Diagnostic cardiac catheterization still plays a key role in the management of patients with congenital heart disease. The most widely used interventional procedures are the CIAC, the angioplasty of branch pulmonary arteries, and the closure of the patent ductus arteriosus. The efficacy and safety data reported on the different interventional techniques used are consistent with the medical literature available. The complications most widely described are embolizations. The CIVC is a technique associated with the lowest success rate and the highest rate of complications in our setting.

Future editions of this registry should encourage the participation of hospitals from our country with interventional activity in the management of congenital heart disease and make the resulting information as truthful and honest as possible.

FUNDING

None whatsoever.

AUTHORS’ CONTRIBUTIONS

All authors contributed substantially to data curation and the process of revising this study. F. Ballesteros Tejerizo, F. Coserría Sánchez, and R. Romaguera were also involved in the drafting of this manuscript.

CONFLICT OF INTERESTS

R. Romaguera, and S. Ojeda Pineda are associate editors of REC: Interventional Cardiology; the journal’s editorial procedure to ensure impartial handling of the manuscript has been followed. The remaining authors had no competing interests to declare.

WHAT IS KNOWN ABOUT THE TOPIC?

  • Cardiac catheterization is the cornerstone for the management of patients with congenital heart disease.
  • Excellent success rates have been reported in the medical literature available on the use of interventional techniques with limited morbidity and mortality rates too.
  • In Spain, numerous centers offer interventional procedures to patients with congenital heart diseases both in the pediatric and in the adult settings.
  • The national, multicenter studies on the interventional activity developed for the management of congenital heart diseases published to this date are scarce and only include certain techniques or are limited by age segments.

WHAT DOES THIS STUDY ADD?

  • This is the first publication that evaluates the interventional activity developed in Spain to treat congenital heart disease in patients of any age.
  • Based on the data submitted, diagnostic cardiac catheterization still plays a key role in the management of patients with congenital heart diseases with a significant number of procedures being performed.
  • The interventional techniques that comprise a greater number of cases in our setting are the closure of interventricular communication (CIVC), the angioplasty of branch pulmonary arteries, and the closure of the patent ductus arteriosus.
  • The efficacy and safety results reported on the different techniques used are consistent with the data previously published in the international medical literature.
  • The type of complication most frequently associated with cardiac catheterization is device embolization.


ANNEX 1. List of centers that participated in the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry

Complexo Hospitalario Universitario, A Coruña
Hospital Universitario 12 de Octubre (Instituto Pediátrico del Corazón), Madrid
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario Reina Sofía, Córdoba
Hospital Universitario de Cruces, Barakaldo, Bilbao
Hospital Universitario La Paz, Madrid
Hospital Universitario Son Espases, Palma de Mallorca
Hospital Universitario Virgen de la Arrixaca, Murcia
Hospital Universitario y Politécnico La Fe, Valencia
Hospital Universitario Gregorio Marañón, Madrid
Hospital Universitario Virgen de las Nieves, Granada
Hospital Universitario Virgen del Rocío, Sevilla
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital Regional Universitario de Málaga (Materno-Infantil), Málaga
Hospital Universitari Vall de Hebrón, Barcelona
Hospital Miguel Servet, Zaragoza

REFERENCES

1. Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología. Registro de Actividad ACI-SEC. 2020. Available online:http://www.registroactividadacisec.es. Accessed 21 Jun 2021.

2. Romaguera R, Cruz-Gonzalez I, Jurado-Roman A, et al. Considerations on the invasive management of ischemic and structural heart disease during the COVID-19 coronavirus outbr. Consensus statement of the Interventional Cardiology Association and the Ischemic Heart Disease and Acute Cardiac Care Association of the Spanish Society of Cardiology. REC Interv Cardiol. 2020;2:112-117.

3. Moreno R, Diez JL, Diarte JA, et al. Consequences of canceling elective invasive cardiac procedures during Covid-19 outbr. Catheter Cardiovasc Interv. 2021;97:927-937.

4. Romaguera R, et al. Registro Español de Hemodinámica y Cardiología Intervencionista. XXX Informe Oficial de la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2020) en el año de la pandemia de la COVID-19. Rev Esp Cardiol. 2021;74(12):1095-1105.

5. Galindo A, Gómez-Montes E, Gómez O, et al.Fetal Aortic Valvuloplasty:Experience and Results of Two Tertiary Centers in Spain. Fetal Diagn Ther. 2017;42:262-270.

6. Jayaram N, Spertus JA, Kennedy KF, et al. Modeling major adverse outcomes of pediatric and adult patients with congenital heart disease undergoing cardiac catheterization:Observations From the NCDR IMPACT Registry (National Cardiovascular Data Registry Improving Pediatric and Adult Congenital Treatment). Circulation. 2017;136:2009-2019.

7. Hill KD, Du W, Fleming GA, et al. Validation and refinement of the catheterization RISk score for pediatrics (CRISP score):An analysis from the congenital cardiac interventional study consortium. Catheter Cardiovasc Interv. 2019;93:97-104.

8. Taggart NW, Du W, Forbes TJ, et al. A Model for Assessment of Catheterization Risk in Adults With Congenital Heart Disease. Am J Cardiol 2019;123:1527-1531.

9. Solana-Gracia R, Mendoza Soto A, Carrasco Moreno JI, et al. Registro español de cierre percutáneo de comunicación interventricular con dispositivo NitOcclud LêVSD-Coil. Experiencia tras más de 100 implantes. Rev Esp Cardiol. 2021;74:591-601.

10. Saung MT, McCracken C, Sachdeva R, Petit CJ.Outcomes Following Balloon Aortic Valvuloplasty Versus Surgical Valvotomy in Congenital Aortic Valve Stenosis:A Meta-Analysis. J Invasive Cardiol 2019;31:E133-E142.

11. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032.

12. Turc G, Calvet D, Guerin P, et al. Closure, anticoagulation, or antiplatelet therapy for cryptogenic stroke with patent foramen ovale:systematic review of randomized trials, sequential meta-analysis, and new insights from the CLOSE study. J Am Heart Assoc. 2018;7:e008356.

13. Rodríguez Ogando A, Planelles Asensio I, de la Blanca ARS, et al. Surgical Ligation Versus Percutaneous Closure of Patent Ductus Arteriosus in Very Low-Weight Preterm Infants:Which are the Real Benefits of the Percutaneous Approach?Pediatr Cardiol. 2018 Feb;39:398-410.

14. Shyam K. Sathanandam, Dan Gutfinger, et al. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams. Catheter Cardiovasc Inerv 2020;96:1266-1276.

15. Stotut KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC guideline for the management of adults with congenital heart disease:executive summary:a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2019;139:e637-697.

16. Kim GB, Song MK, Bae EJ, et al. Successful feasibility human trial of a new self-expandable percutaneous pulmonary valve (Pulsta valve) implantation using knitted nitinol wire backbone and trileaflet α-gal-free porcine pericardial valve in the native right ventricular outflow atract. Circulation Cardiovasc Interv. 2018;11:e006494.

* Corresponding author:

E-mail address: fernandoballe@gmail.com (F. Ballesteros)

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