Article
Adult congenital heart disease
REC Interv Cardiol. 2022;4:173-180
Spanish cardiac catheterization in congenital heart diseases registry. First official report from the ACI-SEC and the GTH-SECPCC (2020)
Registro Español de Intervencionismo en Cardiopatías Congénitas. Primer Informe Oficial de la ACI-SEC y el GTH-SECPCC (2020)
aServicio de Cardiología Pediátrica, Hospital General Universitario Gregorio Marañón, Madrid, Spain
bServicio de Cardiología Pediátrica, Hospital Universitario Virgen del Rocío, Sevilla, Spain
cServicio de Cardiología, Hospital Universitari de Bellvitge, IDIBELL, Universitat de Barcelona, L’Hospitalet de Llobregat, Barcelona, Spain
dServicio de Cardiología Infantil, Hospital Universitario La Paz, Madrid, Spain
eDepartamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
fCentro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
gServicio de Cardiología Pediátrica, Hemodinámica Pediátrica, Hospital Universitari Vall d’Hebron, Barcelona, Spain
hSección de Hemodinámica-Cardiología, Hospital Universitario de Cruces, Barakaldo, Bilbao, Spain
iServicio de Cardiología Pediátrica y Unidad de Cardiopatías Congénitas, Hospital Universitario Ramón y Cajal, Madrid, Spain
jInstituto Pediátrico del Corazón, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria 12 de Octubre (imas12), Madrid, Spain
kSección de Hemodinámica-Cardiología, Hospital Universitario Son Espases, Palma de Mallorca, Spain
lSección de Cardiología Infantil, Hospital Universitario y Politécnico La Fe, Valencia, Spain
mSección de Cardiología Infantil, Hospital Miguel Servet, Zaragoza, Spain
nSección de Cardiología Pediátrica, Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
oServicio de Cardiología, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica (IMIBIC), Universidad de Córdoba, Córdoba, Spain
pUnidad de Cardiopatías Congénitas, Servicio de Pediatría, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain
qServicio de Cardiología, Hospital Universitario Virgen de las Nieves de Granada, Granada, Spain
rServicio de Cardiología, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Universidad Complutense de Madrid, Madrid, Spain
sSección de Cardiología Pediátrica, Hospital Regional Universitario de Málaga, Málaga, Spain
ABSTRACT
Introduction and objectives: The Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and the Interventional Working Group of the Spanish Society of Pediatric Cardiology (GTH-SECPCC) present their annual activity report for 2022.
Methods: All Spanish centers with catheterization laboratories and interventional activity in congenital heart diseases were invited to participate. Data were collected online and analyzed by an external company, together with the members of the ACI-SEC and the GTH-SECPCC.
Results: A total of 22 centers participated (19 public and 3 private). Interventional data on adult congenital diseases contributed by another 99 hospitals to the Registry of Cardiac Catheterization and Interventional Cardiology of the ACI-SEC in 2022 were incorporated into the analysis. A total of 1141 diagnostic studies (4.3% more than in 2021) and 2508 interventional catheterizations (61.5% more than in 2020) were registered. The most frequent procedures were atrial septal defect closure (1135 cases), percutaneous closure of patent ductus arteriosus (262 cases), and pulmonary branch artery angioplasty (234 cases). The most significant increases in volume were related to balloon aortic valvuloplasty (48.9%), atrial septal defect closure (45.2%), and ventricular septal defect closure (40.7%). Interventional procedures were successful in 97.6%, with major procedural complications occurring in 1.4% and in-hospital mortality in 0.2%.
Conclusions: This report is the third publication of the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry. Both diagnostic and interventional procedures substantially increased, particularly in balloon aortic valvuloplasty, atrial septal defect closure, and ventricular septal defect closure. Most interventional techniques continue to demonstrate excellent safety and effectiveness outcomes.
Keywords: Atrial septal defect closure. Cardiac catheterization. Congenital heart disease. Percutaneous valve implantation.
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 su informe anual de actividad hemodinámica en cardiopatías congénitas correspondiente al año 2022.
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 mediante un cuestionario telemático. Una empresa externa analizó los resultados, que fueron revisados por miembros de la ACI-SEC y el GTH-SECPCC.
Resultados: Participaron en el registro 22 centros (19 públicos y 3 privados). Se incorporaron al análisis los datos de intervencionismo en cardiopatías congénitas del adulto aportados por otros 99 hospitales al Registro de Hemodinámica y Cardiología Intervencionista de la ACI-SEC del año 2022. Se registraron 1.141 estudios diagnósticos (un 4,3% más que en 2021) y 2.508 cateterismos intervencionistas (un 61,5% más que en 2021). Las técnicas con mayor casuística fueron el cierre de defectos interauriculares (1.135 casos), el cierre de ductus arterioso (262 casos) y la angioplastia de ramas pulmonares (234 casos). El incremento más significativo se comunicó en la valvuloplastia aórtica (48,9%), el cierre de defectos interauriculares (45,2%) y el cierre de comunicación interventricular (40,7%). La tasa de éxito en los procedimientos intervencionistas fue del 97,6%, con una tasa de complicaciones mayores del 1,4 % y una mortalidad intrahospitalaria del 0,2%.
Conclusiones: El presente trabajo es la tercera publicación del Registro Español de Intervencionismo en Cardiopatías Congénitas. Se ha comunicado un aumento muy significativo de la mayoría de los procedimientos terapéuticos, destacando el incremento de la valvuloplastia aórtica, del cierre de defectos interauriculares y del cierre de comunicación interventricular. Todas las técnicas intervencionistas han reportado excelentes datos de seguridad y eficacia.
Palabras clave: Cardiopatías congénitas. Cateterismo cardiaco. Cierre de comunicación interauricular. Implante percutáneo de válvula aórtica.
INTRODUCTION
The collaborative effort between the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and the Interventional Working Group of the Spanish Society of Pediatric Cardiology (GTH-SECPCC), which was initiated in 2019, allowed the reactivation of a Spanish registry of cardiac catheterizations and interventional cardiology in patients with congenital heart diseases. The results of this collaboration have been published in the first 2 reports of the activity conducted from 2020 to 2021.1,2 The main weakness highlighted in both reports is the inadequate estimation of interventional procedures performed in patients older than 18 years. Despite being highly representative of pediatric activity, the number of participating centers, did not seem sufficient to accurately reflect the activity carried out in adult congenital heart diseases in Spain.3,4
This article analyzes the current report, focusing on the activity conducted in 2022, and aims to consolidate the objective of reliably measuring the scope of interventional procedures to treat congenital heart diseases in all age groups. The results of this report were made public at the XXXIV ACI-SEC Congress held in Santander, Spain on June 7th, 2022.
METHODS
The data presented come from a retrospective, voluntary, unaudited, and annually updated registry. This year, a substantial and coordinated change has been made to the section on interventional procedures for the treatment of congenital heart diseases of the ACI-SEC Spanish Registry of Cardiac Catheterization and Interventional Cardiology to standardize data from the 2 registries and facilitate their incorporation into the study of its interventional activity in patients older than 18 years.5
All hospitals already participating in the ACI-SEC Spanish Registry of Cardiac Catheterization and Interventional Cardiology were invited to participate, as well as all pediatric hospitals represented in the GTH-SECPCC. Data were collected by the investigator of each participating hospital through the official website of the ACI-SEC.6
The registry results were managed and cleaned by an external company (Tride, Madrid, Spain), and were subsequently reviewed and compared with those obtained in previous years by members of the GTH-SECPCC and the ACI-SEC board. If the data were discordant, the center in question was contacted for clarification and error minimization.
Due to the methodological characteristics of the study and the fact that it was purely an activity registry, there was no requirement for approval from an ethics committee or processing of informed consent forms.
RESULTS
Resources and infrastructure
Twenty-two hospitals participated (6 more than in 2021), 19 from the publicly-funded health sector and 3 from the private sector (appendix 1 of the supplementary data). Data on cardiac catheterizations in adult congenital heart diseases from 2022 were provided by another 99 hospitals to the ACI-SEC Spanish Registry of Cardiac Catheterization and Interventional Cardiology of the and were included in the analysis (appendix 2 of the supplementary data).
Thirty-four cath labs with interventional activity for congenital heart diseases were included in the registry, of which 7 (20.8%) are pediatric cardiac cath labs exclusively; 9 of them with biplane image-guided systems and 14 with the possibility of implementing rotational angiography. The median number of monthly days dedicated by each hospital to interventional procedures for congenital heart disease was 6 [3-17] days vs 7 days in 2021. Fifteen (68.1%) of these hospitals have round-the-clock catheterization services, even for pediatric patients.
Data on medical staffing revealed that 67 interventional cardiologists with full-time dedication to the specialty were registered, of which 37 (55.3%) treated adults and 30 (44.7%) pediatric patients.
Diagnostic procedures
A total of 1141 diagnostic studies were reported, representing a 4.3% increase compared with the previous year. Age distribution was as follows: 37 (3.2%) cardiac catheterizations were performed in infants younger than 1 month, 127 (11.1%) in patients aged from 1 month to 1 year, 578 (50.7%) in patients from 1 to 18 years, and 399 (35.5%) in patients older than 18 years.
Sixty cardiac catheterizations (5.4%) were classified as emergency procedures. Regarding morbidity, 7 (0.6%) cases of serious complications were reported: 4 arrhythmias (2 with severe hemodynamic instability and cardiac arrest), 1 vascular event, and 1 cardiac tamponade; there was 1 procedure-related death.
Interventional procedures
The activity reported in this section increased by 61.5% compared with the previous year. In all, 2508 therapeutic catheterizations were reported and grouped into 13 categories with the following age distribution: 3 procedures (0.1%) were performed in the fetal period, 163 (6.4%) in infants younger than 1 month, 208 (8.3%) in patients aged from 1 month to 1 year, 754 (30.1%) in patients aged from 1 to 18 years, and 1380 (55%) in patients older than 18 years, of which 903 were added by incorporating data from the ACI-SEC Spanish Registry of Cardiac Catheterization and Interventional Cardiology of the (table 1 and table 2).
Variable | Total | Fetal | < 1 month | 1 month to 1 year | 1 to 18 years | > 18 years |
---|---|---|---|---|---|---|
Interventional procedures | 2508 | 3 (0.1) | 163 (6.4) | 208 (8.3) | 754 (30.1) | 1380 (55.0) |
Congenital aortic valvuloplasty | 67 | 2 (3.0) | 9 (13.4) | 14 (20.9) | 22 (32.8) | 20 (29.9) |
Congenital pulmonary valvuloplasty | 138 | 1 (0.7) | 34 (24.6) | 39 (28.3) | 34 (24.6) | 30 (21.7) |
Congenital mitral valvuloplasty | 0 | - | 0 | 0 | 0 | 0 |
Pulmonary angioplasty | 135 | - | 0 | 7 (5.2) | 75 (55.6) | 53 (39.3) |
Pulmonary branch angioplasty | 234 | - | 2 (0.9) | 45 (19.2) | 136 (58.1) | 51 (21.8) |
Aortic angioplasty | 126 | - | 3 (2.4) | 28 (22.2) | 40 (31.7) | 55 (43.7) |
Other angioplasty procedures | 100 | - | 26 (26.0) | 22 (22.0) | 37 (37.0) | 15 (15.0) |
Atrial septal defect/patent foramen ovale closure | 1135 | - | - | 2 (0.2)a | 130 (11.5) | 1003 (88.4) |
Patent ductus arteriosus closure | 262 | 24 (9.2)b | 17 (6.5)b | 30 (11.5)b | 147 (56.1) | 44 (16.8) |
Ventricular septal defect closure | 38 | - | - | 1 (2.6)a | 23 (60.5) | 14 (36.8) |
Other occlusions | 91 | - | 2 (2.2) | 8 (8.8) | 39 (42.9) | 42 (46.2) |
Foreign body removal | 23 | - | 3 (13.0) | 0 | 18 (78.3) | 2 (8.7) |
Atrial septostomy | 72 | - | 43 (59.7) | 12 (16.7) | 17 (23.6) | 0 |
Transcatheter aortic valve implantation | 87 | - | - | - | 36 (41.4)c | 51 (58.6) |
a In this case, infants younger than 1 month and from 1 month to 1 year are not shown separately and consequently the value corresponds to infants younger than 1 year. b In patent ductus arteriosus closure, groups are premature (fetal), < 6 months (< 1 month), and 6 months to 1 year (1 month to 1 year). c Reported as participants younger than 18 years and consequently the value corresponds to participants younger than 18 years. Data are expressed as n (%). |
Variable | > 18 years | ||
---|---|---|---|
Total | RICCa | RHCIb | |
Interventional procedures | 1380 | 477 | 903 |
Congenital aortic valvuloplasty | 20 | 19 | 1 |
Congenital pulmonary valvuloplasty | 30 | 12 | 18 |
Congenital mitral valvuloplasty | 0 | 0 | 0 |
Pulmonary angioplasty | 53 | 21 | 32 |
Pulmonary branch angioplasty | 51 | 26 | 25 |
Aortic angioplasty | 55 | 33 | 22 |
Other angioplasty procedures | 15 | 10 | 5 |
Atrial septal defect/patent foramen ovale closure | 1003 | 221 | 782 |
Patent ductus arteriosus closure | 44 | 11 | 33 |
Ventricular septal defect closure | 14 | 4 | 10 |
Other occlusions | 42 | 18 | 24 |
Foreign body removal | 2 | 2 | 0 |
Atrial septostomy | 0 | 0 | 0 |
Transcatheter aortic valve implantation | 51 | 51 | 0 |
a Data provided by the 22 centers participating in ACI-SEC Spanish Cardiac Catheterization in Congenital Heart Diseases Registry (RICC) and the GTH-SECPCC (2022). b Data provided by the 96 centers participating in the 2022 ACI-SEC Spanish Registry of Cardiac Catheterization and Interventional Cardiology Registry (RHCI). Data are expressed as n. |
A total of 148 cardiac catheterizations were classified as urgent (9.7% of all procedures performed with this reported datum). The number of interventional procedures reported by each center was distributed as follows: 5 hospitals (21.7%) reported more than 150 catheterizations, 3 (13%) between 75 and 150 interventions, and 8 (47.1%) less than 75 catheterizations. The overall effectiveness of the various interventional techniques used was 97.6%, with most centers reporting effectiveness of more than 95% (table 3).
Interventional procedures | n | Cases with success/inefficacy data | Success | Inefficacy |
---|---|---|---|---|
Congenital aortic valvuloplasty | 67 | 46 (68) | 43 (93.5) | 3 (6.5) |
Congenital pulmonary valvuloplasty | 138 | 118 (85) | 117 (99.2) | 1 (0.8) |
Congenital mitral valvuloplasty | 0 | - | - | - |
Pulmonary angioplasty | 135 | 95 (70) | 90 (94.7) | 5 (5.3) |
Pulmonary branch angioplasty | 234 | 205 (87.6) | 199 (97.1) | 6 (2.9) |
Aortic angioplasty | 126 | 108 (85.7) | 106 (98.1) | 2 (1.9) |
Other angioplasty procedures | 100 | 95 (95) | 91 (95.8) | 4 (4.2) |
Atrial septal defect/patent foramen ovale closure | 1135 | 1024 (90.2) | 1003 (97.9) | 21 (2.1) |
Patent ductus arteriosus closure | 262 | 251 (95.8) | 248 (98.8) | 3 (1.2) |
Ventricular septal defect closure | 38 | 30 (78.9) | 29 (96.7) | 1 (3.3) |
Other occlusions | 91 | 66 (72.5) | 65 (98.5) | 1 (1.5) |
Foreign body removal | 23 | 23 (100) | 22 (95.7) | 1 (4.3) |
Atrial septostomy | 72 | 72 (100) | 70 (97.2) | 2 (2.8) |
Transcatheter aortic valve implantation | 87 | 87 (100) | 84 (96.6) | 3 (3.4) |
Total | 2508 | 2220 (88.5) | 2167 (97.6) | 53 (2.4) |
Data are expressed as n. |
Percutaneous valvuloplasty procedures
Sixty-seven aortic valvuloplasty procedures were reported to treat congenital aortic stenosis (a 48.9% increase compared with 2021), including 2 fetal valvuloplasty procedures. Forty-two (62.6%) of these procedures were performed in patients older than 1 year, of which 20 (29.9%) were older than 18 years. Previously untreated native valves were dilated in 70% of cases.
In all, 138 pulmonary valvuloplasty procedures were reported, including 1 fetal valvuloplasty, representing a 32.7% increase compared with the previous year. Technical data were reported in 104 cases (85%): 95 (90%) were native valves; 7 (4.8%) were imperforate valves; and in 2 cases (1.9%), the procedure was associated with ductal stenting.
Lastly, there were no cases of mitral valvuloplasty that year.
Percutaneous angioplasty procedures
A total of 135 right ventricular outflow tract dilatations were reported (a 25% increase compared with 2021). Technical and anatomical data were reported for 96 (72.7%) procedures: surgical conduit angioplasty was performed in 62% of procedures and native tract angioplasty in the remaining 38%. Stent implantation was performed in 51% of cases, conventional balloon dilation in 43%, and cutting balloon in 5%.
There were 234 pulmonary branch angioplasty procedures. Technical data were obtained from 205 (87.6%) interventions: proximal branches were dilated in 191 interventions (93.1%) and peripheral arteries (lobar-segmental) in the remaining procedures. Stent implantation was performed in 102 (49.7%) catheterizations, conventional balloon dilation in 98 (47.8%), and cutting balloon dilation in 5 (2.4%).
Of 126 aortic angioplasty procedures, anatomical data were reported for 104 (82.5%) procedures: 70 (67.3%) were reinterventions and 34 (32.6%) were treatments on native aortas. The dilation substrate was the aortic arch/isthmus in all cases except for 1 angioplasty of the ascending aorta. The distribution of the technique used was as follows: conventional balloon angioplasty in 29%, implantation of uncovered stents in 18.5%, implantation of covered stents in 37.9%, and redilatation with a previously implanted stent balloon in 14.5%.
A further 100 catheterizations were reported in the category of “other angioplasty procedures,” representing a decrease in their frequency by 9.1% compared with the previous year. The anatomical substrate of the angioplasty was reported in 73 cases, highlighting patent ductus arteriosus dilation in 25 cases, systemic veins in 16, Fontan conduits in 10, and surgical fistulas in 8. Fifty-five percent of the procedures were associated with stent implantation.
Shunt closure and other occlusive procedures
There were 1135 atrial septal defect closures: 782 (68.8%) came from the incorporation of data from the ACI-SEC Spanish Registry of Cardiac Catheterization and Interventional Cardiology of the same year (table 2). Consequently, the volume of patients older than 18 years who underwent this technique was 83.8% overall. The predominant anatomical substrate of the defect was patent foramen ovale, with 705 (62.1%) cases. A total of 72.1% of atrial septal defects (ASD) were classified as complex, and the remaining ASD as simple. Data on procedure guidance were reported in 348 cases (28.3%): transesophageal echocardiography was used in 80.4%, intracardiac echocardiography in 12.6%, and angiographic measurements with balloon in 6.8%.
Patent ductus arteriosus closure accounted for 262 catheterizations. More than half of all procedures (56.1%) were performed in patients aged 1 to 18 years, while 9.2% were performed in premature infants (24 cases). The route of choice was antegrade venous access in 70% of closures. Occlusive devices were used in 88.4% of cases and controlled-release coil devices in the remainder.
Thirty-eight catheterizations for ventricular septal defect (VSD) closures were reported, increasing their frequency by 40.7% compared with the previous year. Data on the anatomical substrate of the VSD were reported in 28 (73.6%) cases, with the following distribution: 20 (71.4%) perimembranous, 6 (21.4%) muscular, and 2 (7.1%) postoperative. Occlusive devices were used in 89.2% of cases and coil-type occluders in the remainder. Two devices were implanted via a hybrid approach and the remaining devices via transcatheter access (93.3%).
Ninety-one catheterizations fell within the category “various occlusive procedures”. Data on the type of occlusion were reported in 65 (71.4%) cases, with closure of systemic-to-pulmonary collateral vessels in 40 (61.5%) cases, venous collaterals in 13 (20%), coronary fistulas in 3 (4.6%), and Fontan fenestrations in 2 (3%). The most widely used material was coil-type occluders (38.8%), followed by occlusive devices (36.1%), and particles as the only material or in combination with others (25%).
Atrial septostomy
Seventy-two atrial septostomy procedures were reported (a 33.3% increase compared with the previous year). Echocardiography was used for imaging guidance in 22.5% of cases, fluoroscopy in 28%, and a combination of the 2 imaging modalities in 49.2%. Forty-nine (68%) interventions were balloon atrial septoplasty procedures (Rashkind). There were also 7 procedures with radiofrequency-guided septal perforation, 7 with needle perforation, and 15 with septal stent implantation.
Percutaneous valve implantations
Eighty-seven procedures were reported, of which 51 (58.6%) were performed in patients older than 18 years. The hybrid approach was used in 2 cases, while the fully percutaneous approach was used in the remaining cases. The pulmonary position was predominant (96.5%), with 2 successful valve implantations being performed in the tricuspid position and 1 in the mitral position. The anatomical substrate of implantation in the pulmonary position had the following distribution: 33 in the surgical conduit, 31 in the native tract, followed by 20 valve-in-valve procedures.
Complications
Morbidity and mortality data were reported for 2401 interventional procedures, with 35 serious adverse events (table 4), including 6 deaths, which translated into a rate of major complication of 1.4% and a mortality rate of 0.2%. The categories associated with higher morbidity rates were percutaneous valve implantation (8%), other angioplasty procedures (6%), and VSD closure (5.2%). The most common complications were device embolizations (8 cases): 4 in ASD closures, 2 in patent ductus arteriosus closures, and 2 stents implanted in the setting of pulmonary angioplasty procedures; surgical removal of the embolized valve was required in only 1 case of ASD closure. Less frequent were vascular complications (6 cases), 3 of them being associated with pulmonary angioplasty procedures. There were 4 cases of severe arrhythmias, including 2 cases of cardiac arrest requiring bailout extracorporeal membrane oxygenation.
Procedure | n | Major complications | Deaths |
---|---|---|---|
Congenital aortic valvuloplasty | 67 | 3 (6.5) – 1 severe aortic regurgitation – 1 unspecified – 1 death |
1 |
Valvuloplastia pulmonar congénita | 138a (111) | 2 (1.8) – 1 tricuspid valve rupture – 1 unspecified |
0 |
Valvuloplastia mitral congénita | 0 | 0 | 0 |
Angioplastia pulmonar | 135b (102) | 1 (0.9) – 1 unspecified |
0 |
Angioplastia ramas pulmonares | 227c (202) | 6 (2.9) – 3 vascular dissections – 1 pulmonary hemorrhage – 2 stent embolizations |
0 |
Angioplastia aórtica | 124d (102) | 3 (2.9) – 2 vascular dissections – 1 death |
1 |
Otras angioplastias | 100 | 6 (6) – 1 coronary thrombosis – 1 CPR-ECMO – 1 vascular dissection – 1 neurological event – 2 deaths |
2 |
Cierre de comunicación interauricular/foramen oval | 1135 | 5 (0.4) – 4 embolizations (1 required surgery) – 1 neurological event |
0 |
Cierre de conducto | 262 | 3 (1.1) – 2 embolizations not requiring surgery – 1 death |
1 |
Cierre de comunicación interventricular | 38 | 2 (5.2) – 1 atrioventricular block – 1 CPR-ECMO |
0 |
Otras oclusiones | 91 | 0 | 0 |
Retirada de cuerpo extraño | 23 | 0 | 0 |
Atrioseptostomía | 72 | 1 (1.3) – 1 unspecified |
0 |
Implantación de válvula percutánea | 87 | 4 (8.0) – 1 vascular dissection – 1 pulmonary duct dissection – 1 ventricular tachycardia – 1 death |
1 |
Total | 2508e (2401) | 35 (1.4) | 6 (0.2) |
CPR, cardiopulmonary resuscitation; ECMO, extracorporeal membrane oxygenation. a Percentages calculated based on 111 reported cases. b Percentages calculated based on 102 reported cases. c Percentages calculated based on 202 reported cases. d Percentages calculated based on 102 reported cases. e Percentages calculated based on 2411 reported cases. Data are expressed as n (%). |
DISCUSSION
To date, one of the main weaknesses of this registry has been its limitations in adequately assessing the interventional activity carried out in the context of adult congenital heart disease. For this reason, and as the most significant novel addition to this report, we included data from 99 hospitals reporting their activities in adult congenital heart disease to the 2022 Spanish Registry of Cardiac Catheterization and Interventional Cardiology in the analysis of the various interventional categories. This has resulted in a significant increase in catheterization volume, totaling 3649 procedures (1002 more than in 2021). Their comparison with the activity conducted in previous years and the significant increase in registered procedures should be analyzed considering this methodological difference, and taking into account the increase in participating centers, 6 more than in 2021 (figure 1).
The total number of registered interventional procedures was 2508, with notable increases in techniques such as ASD closure, aortic and pulmonary valvuloplasty, atrial septostomy, and VSD closure. A total of 55% of cardiac catheterizations were performed in patients older than 18 years (compared with 32% in 2021), demonstrating an improvement in the representation of interventional procedures for adult congenital heart diseases. Once again, in the pediatric setting, we noted that fetal interventional activity in Spain is very limited, with only 3 reported cases (2 aortic valvuloplasty procedures and 1 pulmonary valvuloplasty procedure), despite evidence of its value and effectiveness in these and other prenatal scenarios, such as pulmonary atresia with intact ventricular septum and hypoplastic left heart syndrome.7
The reported data on the effectiveness of various interventional techniques yielded an overall success rate of 97.6% (compared with 95% in 2021) and a mortality rate of 0.2% (the same as in 2021), with 6 procedure-related deaths. These results are consistent with those reported from most international studies to date.8,9 The rate of serious adverse events of 1.4% is the lowest reported so far (2% in 2020 and 2.7% in 2022), with a decrease in the frequency of all types of complications reported. Device embolizations continue to account for the highest number of cases, amounting to 22.5% overall, followed by vascular complications (20% overall).
The volume of valvuloplasty procedures has significantly increased with respect to 2021: a 48.9% increase in aortic valvuloplasty and a 32.7% increase in pulmonary valvuloplasty. For the first time, most cases involving one of these 2 techniques involved patients older than 1 year. In aortic valvuloplasty, the rate of serious events (6.5%) decreased compared with the previous year (11.1%), although with 1 associated death. The report shows that pulmonary valvuloplasty has become established as one of the techniques with the best results, with a 99.2% efficacy rate and a 1.8% complication rate. These data support the value of pulmonary valvuloplasty as the technique of choice in congenital pulmonary valve stenosis in our setting. However, its mid- and long-term outcomes may be influenced by unspecified anatomical and genetic factors.10
Both in pulmonary angioplasty procedures (of native tract or ducts) and pulmonary branch angioplasty procedures, stent implantation has surpassed conventional balloon dilation as the technique of choice, which has again reduced the use of cutting balloons. The most widely performed aortic angioplasty procedures continue to be aortic arch and isthmus dilatation, which are performed in almost all patients; of note, in this context, the increase in covered stent implantation, which, for the first time, has surpassed other dilation techniques. This increase could be explained by the intention to improve the safety of the procedure by reducing damage to the aortic wall in certain scenarios.11 Furthermore, the availability of covered stents with lower implantation profiles has facilitated their use in pediatric patients of increasingly lower weight and younger age.12
ASD closure remained the most widely performed interventional technique in the registry (45.2% of all interventional catheterizations). The inclusion of patent foramen ovale closure as a procedure within this category and its classification as a congenital heart disease may be controversial but can be reevaluated in future reports. Its rarity in the pediatric setting contrasts with its increasing application in adults, confirming the maturity of the technique and the widespread acceptance of the scientific evidence supporting its use.13 Transesophageal echocardiography guidance remains the usual imaging modality for ASD closure; both intracardiac echocardiography and balloon sizing of the defect are infrequent.
A notable finding was the increasing use of patent ductus arteriosus closure in the group of premature newborns (9.4% overall), as well as confirmation of the preference for the transcatheter option over surgery for these pediatric patients in our setting.14 Antegrade venous access and the use of occlusive devices remain widespread procedures in a consolidated technique that has one of the best effectiveness rates in the registry (98.9%).
The reported data on the safety and efficacy of VSD closure show substantial improvement compared with previous reports: the major complication rate decreased from 18% in 2021 to 5.2% in 2022, while the success rate increased from 77.3% in 2021 to 96.7% in 2022. These figures reflect a change in trend, which could be related to the introduction of new closure devices, and the adoption of technical changes facilitating their approach.15-17 All of this would facilitate the widespread use of the procedure, whose frequency has increased significantly by up to 40.7% compared with the previous year. The increase in the number of cases registered in patients older than 18 years was notable, reaching 38% overall (compared with 22% in 2021).
A 16% volume increase and a significant improvement in the reported safety and efficacy data of transcatheter aortic valve implantation were also reported, of which approximately 60% were performed in patients older than 18 years. There was a decrease in the tricuspid position as the anatomical substrate for implantation (from 10 cases in 2021 down to only 2 cases in 2022), at a time when transcatheter aortic valve implantation has reached an unprecedented growth as a structural heart procedure in Spain.5 Access to new valves—especially self-expanding valves—and the continuous publication of scientific evidence endorsing the results of this technique, continue to enhance the expectations of the percutaneous management of patients with right ventricular outflow tract dysfunction in all anatomical scenarios.18,19
Limitations
The characteristics of this registry may be weakened by its retrospective, voluntary, and unaudited design. Expanding the collected data on certain techniques of special interest would help improve its quality and should be considered in future reports.
CONCLUSIONS
The main finding of this report is the significant increase in the number of interventional procedures recorded compared with previous years, which was closely related to the increase in participating centers. There has been significant growth in aortic valvuloplasty, ASD closure, and VSD closure procedures. The data obtained provide a realistic overview of interventional activity in congenital heart diseases in Spain among all age groups. The reported safety and efficacy results demonstrate the consolidation of most techniques in our setting and are consistent with those published in other international studies.
The incorporation of a greater number of centers with interventional activity in congenital heart diseases into the registry will optimize the quality and reliability of the information generated.
FUNDING
None declared.
ETHICAL CONSIDERATIONS
Due to the methodological characteristics of the study and its nature as solely an activity registry, there was no requirement for approval from ethics committees or signing of informed consent forms.
The characteristics of the present work exclude the consideration of possible variables of sex and gender.
STATEMENT ON THE USE OF ARTIFICIAL INTELLIGENCE
No artificial intelligence tools were used in the preparation of this article.
AUTHORS’ CONTRIBUTIONS
All authors contributed substantially to data collection and the critical review of this work. F. Ballesteros Tejerizo and F. Coserría Sánchez wrote the article.
CONFLICTS OF INTEREST
S. Ojeda Pineda is an associate editor of REC: Interventional Cardiology; the journal’s editorial procedure to ensure the impartial processing of the manuscript has been followed. The remaining authors declare no conflicts of interest.
WHAT IS KNOWN ABOUT THE TOPIC?
- Cardiac catheterization remains an indispensable procedure in the management of patients with congenital heart diseases.
- The existence of a national registry of pediatric percutaneous procedures and adult congenital heart diseases is essential to understand the current panorama of interventional cardiology in Spain and generate valuable information for professionals, patients, and families.
- The continuity of this registry allows understanding the level of implementation and results of various techniques, as well as their variation over time.
WHAT DOES THIS STUDY ADD?
- Some methodological changes and the gradual increase in the number of centers participating in the registry have enabled the collection of more realistic information on interventional activity for congenital heart diseases among all age groups in Spain.
- A highly significant increase in interventional procedures performed in 2022 was reported, with ASD and VSD closure and aortic valvuloplasty procedures being the techniques experiencing the greatest growth.
- The most widely performed procedures continue to be ASD closure, patent ductus arteriosus closure, and pulmonary artery branch angioplasty.
- The most frequent procedure-related adverse events were device embolizations and vascular complications.
REFERENCES
1. Ballesteros Tejerizo F, Coserría Sánchez F, Romaguera R, et al. Spanish Cardiac Catheterization in Congenital Heart Diseases Registry. First Official Report from ACI-SEC and GTH-SECPCC (2020). REC Interv Cardiol. 2022;4:173-180.
2. Ballesteros Tejerizo F, Coserría Sánchez F, Freixa X, et al. Spanish cardiac catheterization in congenital heart diseases registry. Second official report from the ACI-SEC and the GTH-SECPCC (2021). REC Interv Cardiol. 2023;5:185-192.
3. Romaguera R, Ojeda S, Cruz-González I, et al. Spanish Cardiac Catheterization and Coronary Intervention Registry. 30th Official Report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2020) in the year of the COVID-19 pandemic. Rev Esp Cardiol. 2021;74:1096-1106.
4. Freixa X, Jurado-Roman A, Cid B, et al. Spanish cardiac catheterization and coronary intervention registry. 31st Official Report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2021). Rev Esp Cardiol. 2022;75:1040-1049.
5. Jurado-Román A, Freixa X, Cid B, et al. Spanish cardiac catheterization and coronary intervention registry. 32nd Official Report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2022). Rev Esp Cardiol. 2023;76:1021-1031.
6. Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología. Registro de Actividad ACI-SEC. Available at:http://www.registroactividadacisec.es. Accessed 21 Jun 2023.
7. Friedman KG, Tworetzky W. Fetal cardiac interventions:Where do we stand?Arch Cardiovasc Dis. 2020;113:121-128.
8. Kevin D, Wei Du, 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.
9. Quinn BP, Ye M, Gauvreau K, et al. Procedural Risk in Congenital Cardiac Catheterization (PREDIC3T). J Am Heart Assoc. 2022;11:022832.
10. Hansen RL, Naimi I, Wang H, et al. Long-term outcomes up to 25 years following balloon pulmonary valvuloplasty:a multicenter study. Congenit Heart Dis. 2019;14:1037-1045.
11. Stassen J, De Meester P, Troost E, et al. Covered stent placement for treatment of coarctation of the aorta:immediate and long-term results. Acta Cardiol. 2021;76:464-472.
12. Al Balushi A, Pascall E, Jones MI, Qureshi S, Butera G. Initial experience with a novel ePTFE-covered balloon expandable stent in patients with near-atretic or severe aortic coarctation and small femoral arterial access. Cardiol Young. 2021;31:224-228.
13. Saver JL, Carroll JD, Thaler DE, et al.;RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017;377:1022-1032.
14. Rodríguez-Ogando A, Ballesteros Tejerizo F, Blanco Bravo D, et al. Transcatheter Occlusion of Patent Ductus Arteriosus in Preterm Infants Weighing Less Than 2 kg With the Amplatzer Duct Occluder II Additional Sizes Device. Rev Esp Cardiol. 2018;71:861-876.
15. Alvarez-Fuente M, Carrasco JI, Insa B, et al. Percutaneous closure of ventricular septal defect with the KONAR-MF device. REC Interv Cardiol. 2022;4:181-185.
16. Rasines Rodri?guez A, Aristoy Zabaleta MM, Abelleira Pardeiro, et al. Retrograde closure of perimembranous ventricular septal defects. A paradigm shift. REC Interv Cardiol. 2023;5:73-75.
17. Nistor IA, Mesa Rubio D, Pan Álvarez-Ossorio M. Percutaneous VSD closure with the KONAR-MF occluder:fusion helps. Rev Esp Cardiol. 2023;77:106.
18. A?lvarez-Fuente M, Toledano M, Hernández I, et al. Initial experience with the new percutaneous pulmonary self-expandable Venus P-valve. REC Interv Cardiol. 2023;5:263-269.
19. Hascoët S, Bentham JR, Giugno L, et al. Outcomes of transcatheter pulmonary SAPIEN 3 implantation:an international registry. Eur Heart J. 2024;45:198-210.
* Corresponding author.
E-mail address: fernandoballe@gmail.com (F. Ballesteros Tejerizo).
ABSTRACT
Introduction and objectives: Percutaneous pulmonary valve implantation is currently a common procedure in patients with congenital heart disease with a dysfunctional right ventricular outflow tract. Until April 2022, there were only balloon-expandable valves available in Europe, which did not cover the needs of the different anatomies of the right ventricular outflow tract. Since that date we have available the self-expandible Venus P-valve (Venus MedTech, China). We present the initial experience with this new percutaneous pulmonary valve in our center.
Methods: Description of the valve implants with the new self-expandible valve performed between September and November 2022.
Results: Eight valve implants have been performed, all successful and without severe complications during the procedure. All patients had severe pulmonary regurgitation with a dilated right ventricle and severe dilatation of the pulmonary trunk and were not good candidates for percutaneous balloon-expandable valves. Five patients had a tetralogy of Fallot. In 7 patients, the implant was performed through the femoral vein and in one through jugular access. As a safety measure, all valves were implanted through a DrySeal sheath (Gore, W.L. Gore & Associates, Inc., United States). The mean hospital stay was 3-day.
Conclusions: Valve implantation with the new self-expandible Venus P-valve was, in our preliminary experience, a safe and feasible procedure, allowing us to treat very dilated right outflow tracts, not suitable for the current balloon-expandable valves.
Keywords: Percutaneous valve implantation. Venus P-valve. Tetralogy of Fallot. Pulmonary regurgitation. Pulmonary valve. Congenital heart disease.
RESUMEN
Introducción y objetivos: El implante percutÁneo de vÁlvula pulmonar es, actualmente, un procedimiento habitual en pacientes con cardiopatías congénitas con un tracto de salida del ventrículo derecho disfuncionante. Hasta abril de 2022, en Europa solo estaban disponibles las vÁlvulas expandibles con balón, que no cubrían las necesidades de las distintas anatomías del tracto de salida derecho. Desde esa fecha estÁ disponible la vÁlvula autoexpandible Venus P ( Venus MedTech, China). Presentamos la experiencia inicial en nuestro centro con esta nueva vÁlvula pulmonar para implante percutÁneo.
Métodos: Descripción de los implantes valvulares con la nueva vÁlvula autoexpandible realizados entre septiembre y noviembre de 2022.
Resultados: Se han realizado 8 implantes valvulares, todos con éxito y sin complicaciones graves durante el procedimiento. Todos los pacientes presentaban insuficiencia pulmonar grave con repercusión sobre el ventrículo derecho y dilatación del tronco pulmonar, y no eran buenos candidatos para las vÁlvulas expandibles con balón. Cinco pacientes tenían una tetralogía de Fallot de base. En 7 pacientes el implante se llevó a cabo por vía femoral y en 1 por vía yugular. Como medida de seguridad, en todos los pacientes el implante se hizo a través de una vaina DrySeal (Gore, W.L. Gore & Associates, Inc., Estados Unidos). La media de tiempo de ingreso fue de 3 días.
Conclusiones: El implante de la nueva vÁlvula autoexpandible Venus P fue, en nuestra experiencia preliminar, un procedimiento seguro y factible, que permite valvular tractos de salida derechos muy dilatados con contraindicación para las actuales vÁlvulas expandibles con balón.
Palabras clave: Implante percutÁneo valvular. VÁlvula pulmonar Venus P. Tetralogía de Fallot. Insuficiencia pulmonar. VÁlvula pulmonar. Cardiopatías congénitas.
Abbreviations CT: computed tomography. LMCA: left main coronary artery. MRI: magnetic resonance imaging. PAT: pulmonary arterial trunk. RV: right ventricle. RVOT: right ventricular outflow tract.
INTRODUCTION
Currently, transcatheter pulmonary valve implantation is a common procedure in patients with congenital heart disease and dysfunctional right ventricular outflow tract (RVOT).1 Transcatheter balloon-expandable pulmonary valves (Melody by Medtronic Inc., United States, and Sapien by Edwards Lifescience, United States, both with CE marking) have an indication for conduit, native tract, and prosthetic valve implantation.1,3 However, a large number of patients—most with tetralogy of Fallot—who require pulmonary valve implantation are treated with transannular repair or post-commissurotomy pulmonary regurgitation or valvuloplasty for pulmonary valve stenosis. These patients have very pulsatile outflow tracts with larger sizes compared to the ones of current balloon-expandable valves (22 mm and 29 mm for Melody and Edwards, respectively).4 Not even the 32 mm Myval device (Meril Life Sciences Pvt. Ltd., India) without an indication for pulmonary valve implantation would be adequate for the largest RVOTs out there.
Back in April 2022, the self-expanding Venus P-valve (Venus MedTech, China) achieved the CE marking, and became an actual alternative for the largest native tracts.
This is our initial experience with this new transcatheter pulmonary valve at our center and in our country.
METHODS
Valve description
The structure of the Venus-P valve consists of a nitinol stent. Both the leaflets, and the stent coverage are made of porcine pericardium. Nitinol provides the stent with some sort of shape memory so it can adapt to the pulmonary arterial trunk (PAT) without compressing neighboring structures. This valve is available in sizes from 28 mm to 36 mm in diameter with 2 mm increases (figure 1). It can be used with the largest caliber native tracts.5 The Venus P-valve stent has a diabolo-shaped configuration and adds 10 mm to the borders of the central region (figure 1). It is wider in its borders because it has been designed for tubular PAT implantation without distal or pulmonary artery stenosis. Both the central region and the proximal border are covered with porcine pericardium to prevent paravalvular leak. The distal border remains uncovered to avoid occluding the pulmonary arteries (figure 2).6 The stent has radiopaque marks in the distal border of its tubular region and in its proximal border both indicative of the degree of the porcine valve implantation. The valve crimping system on its delivery system is performed under ice water. In these conditions, nitinol becomes softer and can be crimped onto the delivery system (figure 3). The valve is then fixed to the delivery system through 2 small hooks (figure 2). Once the valve has been attached and its size reduced, it is covered with the delivery sheath capsule in such a way that the valve enters the patient fully covered (figure 3 and figure 4) [22-Fr sheaths in 28 mm and 30 mm valves, and 24-Fr sheaths in the largest ones (> 30 mm)]. Once in the pulmonary tree and in the desired location, the delivery sheath capsule will be retracted so the valve can regain its diabolo-shaped configuration when entering blood flow at 36 ºC to 37 °C temperature.
Procedural description
Cardiac catheterization was performed under general anesthesia while the patient remained intubated and with heparinization at 100 U/kg. Two femoral veins where cannulated, 1 for diagnostic catheterization, cutting, and advance of the valve delivery system, and the other one to perform the follow-up angiography with a pigtail catheter in the RVOT during valve implantation (figure 4). The coronary arteries of all the patients were interrogated through aortograms or selective coronary angiographies with the same 34 mm cutting balloon (Sizing Balloon, AGA Medical Corp., United States) inflated in the RVOT to discard the risk of coronary compression during the procedure (figure 5B). Similarly, the RVOT was cut with the same 34 mm balloon to see if the anatomy was viable and choose the right valve diameter and length. Cutting was considered occlusive when aortic pressure dropped during balloon inflation and the lack of right ventricular (RV) flow to the pulmonary arteries was angiographically confirmed through an intracoronary injection of contrast into the RV during the balloon peak inflation rate (figure 5A).
Although the imaging modalities performed while planning (computed tomography scan [CT] with or without magnetic resonance imaging (MRI)] inform us on the most appropriate valvular size for each patient, size was picked based on angiography measurements (30° lateral and 30°cranial right anterior oblique), and on the diameter and location of the notch seen in the balloon during occlusive cutting. Balloon cutting allows us to assess the compliance of the PAT, something that is merely suggested on the MRI. Therefore, this is an essential step that should be made before selecting the size of the valve. We select a 2 mm-to-4 mm larger valve compared to the waist of the cutting balloon with a length that should leave the distal border at pulmonary bifurcation level, and the diabolo proximal border at RV level.
The Venus P-valve is implanted without the need for previous stenting to create a landing zone. A Lunderquist high-support guidewire is placed (Cook Medical, Denmark) preferably in the left pulmonary artery. In the presence of stenosis, hypoplasia or unfavorable angle, the guidewire is placed in the right pulmonary artery. The delivery system is advanced through a 65 cm 26-Fr or 24-Fr Dryseal sheath (Gore, W.L. Gore & Associates, Inc., United States) for valves > 30 mm or < 30 mm in diameter, respectively. Once the Dryseal sheath is in position into the selected pulmonary artery, the Venus P-valve delivery system is advanced. Afterwards, the Dryseal sheath is retracted and the correct position of the capsule into the pulmonary artery is verified. Then, the valve is slowly uncovered by withdrawing the capsule (with a clockwise twist of the wheel of the delivery system). As it gradually enters the patient’s bloodstream, the valve regains its normal diabolo-shaped configuration. When its most distal border has been partially adapted to the pulmonary branch, the whole system is then smoothly removed to the PAT and the valve is slowly uncovered while checking—through pigtail catheter injections into the RVOT—that the valve is in position (figure 4). The valve has 2 lines of radiopaque markers to guide implantation. The distal marks that indicate the distal border of the stent tubular region will remain at bifurcation level. The proximal ones should remain at PAT narrowest region or native annulus level (in the location of the notch seen during balloon cutting), thus reducing the risk of embolization. The valve proximal region—10 mm larger than the central one—will remain, in most cases, in the infundibulum of the RV.
Procedure should be performed through a Dryseal sheath to facilitate the maneuverability of the valve delivery system and guarantee safe valve recapture should repositioning be required. The valve can be recaptured until half of its structure has been uncovered.
An aortogram was performed at the end of all procedures (preferably 30° caudal and 20º left anterior oblique) to confirm the lack of coronary artery compression (figure 6).
Patient selection
A previous study through diagnostic catheterization or MRI with or without CT scan was conducted to see whether the anatomy of potentially eligible patients with valve implantation criteria according to the clinical practice guidelines published by the ESC7,8 was ripe for Venus P-valve implantation (figure 7). CT or MRI acquired images were analyzed by Venus Medtech image technicians who video-called our hospital heart team to discuss the convenience of valve implantation and proper valvular size that best suited the patient’s RVOT size. However, the final size was not decided until balloon cutting was used during cardiac catheterization.
This first imaging study discarded 5 patients with unsuitable anatomies for this kind of valve: 2 patients with stents and pulmonary artery stenoses, 2 patients with larger RVOTs compared to the sizes recommended for this kind of valve, and 1 patient with pyramid-shaped right ventricular outflow tract.
Study description
This was a prospective study of the first patients treated with Venus P-valve implantation conducted at our center from September 20th through November 4th, 2022. These are the very first implantations of this type of valve ever performed in our country.
Inclusion criteria
This study included patients with dysfunctional native RVOTs and an indication for pulmonary valve implantation in whom diagnostic catheterization and cutting test allowed such procedure.
Variables
Demographic and anthropometric data were collected, as well as imaging modality and procedural data to conduct a descriptive analysis of our own experience.
Definitions
Complications were categorized as minor or major. The later were death, potentially life-threatening adverse events, and events requiring surgery (embolization, myocardial perforation, vascular rupture, residual PR, hemolysis, valvular lesion). The former were complications that resolve spontaneously or subside with clinical treatment without potentially fatal outcomes (vascular access problems, fever, neuroapraxias, etc.). Implantation was considered successful in the absence of major complications 24 hours after the procedure.
RESULTS
A total of 8 Venus P-valves were implanted in 8 patients at our center from September 20th through November 4th, 2022. The underlying conditions were tetralogy of Fallot (5 patients), pulmonary atresia with ventricular septal defect (1 patient), atrial septal defect with pulmonary stenosis (1 patient), and ventricular septal defect and pulmonary artery banding (1 patient) who required RVOT dilatation in its configuration. All the patients had a transannular patch. Also, all patients had severe pulmonary regurgitation with RV repercussion and PAT dilatation, and were ineligible for transcatheter balloon-expandable valve implantation due to the size of their RVOTs. table 1 shows a overall description of the patients.
Patient | Sex | Age (years) |
Weight (kg) |
RV (mlLm2) |
PAT (mm) MRI |
PAT (mm) CT |
PAT (mm) angiography |
Cutting balloon (mm) |
Valvular size |
---|---|---|---|---|---|---|---|---|---|
1 | W | 41 | 56 | 122 | 28 | NA | 26 | 26 | 30-25 |
2 | M | 34 | 62 | 164 | 28 | 27 | 28 | 28 | 32-25 |
3 | W | 25 | 66 | NA | NA | NA | 28 | 28 | 32-25 |
4 | M | 33 | 90 | NA | NA | 33 | 31 | 32 | 36-25 |
5 | M | 34 | 68 | 134 | 31 | NA | 26 | 27 | 34-25 |
6 | M | 17 | 63 | 173 | 29 | 31 | 31 | 31 | 34-25 |
7 | M | 45 | 68 | NA | NA | 34 | 26 | 32 | 34-30 |
8 | W | 43 | 42 | 130 | 25 | NA | 24 | 24 | 28-25 |
CT, computed tomography scan; M, man; MRI, magnetic resonance imaging; NA, not available; PAT, pulmonary arterial trunk; RV, right ventricle; W, woman. |
All patients had dilated PATs as seen on the CT scan or MRI—meaning they were suboptimal candidates for balloon-expandable valve implantation—and tubular PATs without stenoses in, at least, 1 pulmonary artery.
The valves were successfully and uneventfully implanted in all the patients with optimal valvular competence immediately after implantation. A total of 7 implantations were performed via femoral access, and 1 via right jugular vein due to bilateral femoral venous thrombosis. High-support guidewires were placed in the left pulmonary artery (6 cases), and right pulmonary artery (2 cases, 1 due to moderate left pulmonary artery stenosis, and the other one because it was a jugular access). In 7 and 1 cases, respectively, 26-Fr and 24-Fr Dryseal sheaths were used through which implantation occurred. The length of the valves implanted was 25 mm (n = 7) and 30 mm (n = 1).
The median fluoroscopy time was 34 min (interquartile range, 32-37), and the mean radiation dose, 307 mGy/m2 (standard deviation, 64.4). We saw an adequate correlation between the CT and MRI measurements of the PAT and the angiography measurements and the cutting balloon.
No severe complications were reported in any of the cases. In 1 case, while the valve was being deployed, 1 of the proximal hooks got trapped in the delivery system due to incomplete removal of the capsule covering the valve. It, however, resolved uneventfully (figure 8). A total of 3 patients had mild thoracic pain 24 hours after implantation not showing elevated troponin levels or ECG abnormalities. Also, 1 patient complained of right scapula pain. One of the patients had common ventricular extrasystole that started right after valve implantation and subsided spontaneously within the next 48 hours not requiring any therapy at discharge. One patient broke a fever 48 hours after implantation without elevation of acute phase reactants.
The mean length of stay was 3 days (range 2-4). All patients were discharged on acetylsalicylic acid.
DISCUSSION
Transcatheter pulmonary valve implantation is, currently, a procedure widely performed in the cath labs of congenital coronary care units. Up until now, the valves available—with sizes up to 29 mm—left a significant number of patients without transcatheter therapeutic options available. In some cases, off-label techniques were used (several stents implanted in the PAT to reduce its caliber, stent landing in the left pulmonary artery, etc.) or larger sized balloon-expandable valve implantation with an indication for the aorta (32 mm Myval valve), but not approved for the RVOT.9
Among the main advantages of the Venus P-valve is the possibility or performing one-stage diagnostic catheterizations and valve implantations since previous stenting is not required to create a landing zone (as it was the case with the Melody and Edwards valves in several native tracts). In the most dilated pulmonary arterial trunks (> 24 mm-to-26 mm) one-stage stenting is the gold standard. Then, wait for, at least, 6 weeks until endothelization occurs to minimize the risk of embolization while the valve is being implanted, which requires a second catheterization to implant the valve. Another advantage of the Venus P-valve is how easy it is to use. It is a short procedure with 34 min fluoroscopy times in our cases (shorter to the times reported in our series of native RVOTs and other valves between 40 min and 50 min).
The flexibility of the valve allows PAT adaptation without exerting radial strength on adjacent structures, which is a plus for cases of coronary RVOT-related anatomies.
The short 25 mm valve was used in 7 cases since these patients’ PAT anatomy allowed such length. With longer length, less flexibility for the valve and higher risk of long-term fractures. Up until today, a rate of fractures between 11% and 27% has been reported without associated complications or loss of valvular competence associated with the fractures.5,10
We should pay special attention to the complete removal of the capsule at the end of valve deployment because, if removal is incomplete as it happened with our case (figure 8), hooks can’t be released, and the valve does not get deployed with the corresponding risk of RV embolization.11 To make sure that the system has been released, the hooks should be checked in, at least, 2 different views or projections.6
The diabolo-shaped configuration makes this valve unsuitable for all RVOT anatomies. In cases of distal stenosis at PAT level or at the origin of pulmonary arteries this valve is ill-advised because such stenoses would be limiting the opening of the valve distal border. Regarding this shape—wider in its borders—the onset of transient ventricular extrasystole due to contact with the infundibulum proximal border has been reported. However, to this date, no arrhythmias have ever been reported requiring ablation or cardioversion. In our own experience, only 1 patient had frequent extrasystoles, yet no sustained ventricular arrhythmias were ever reported.
The clinical trial (NCT 02846753) conducted to obtain the CE marking revealed the presence of isolated endocarditis (incidence rate of 1.2%). When long-term follow-up results become available, the actual rates of endocarditis, fractures, and valvular dysfunction will be assessed.
Limitations
The short follow-up of patients is this study main limitation. We’ve been closely monitoring these patients including the use of Holter monitor and imaging modalities (echocardiography, CT scan, and MRI) to properly assess the mid- and long-term evolution of valve implantation. Another limitation is the lack of a control surgical group, which means that comparison can only be made with a historic cohort.
CONCLUSIONS
In conclusion, valve implantation with the new self-expanding Venus P-valve was, in our own preliminary experience, a safe and feasible procedure for valve implantation in very dilated RVOTs with a contraindication for the current balloon-expandable valves with CE marking.
FUNDING
None whatsoever.
AUTHORS’ CONTRIBUTIONS
All the authors contributed to the management and follow-up of the patients, data mining, and approved the manuscript final version for publication. M. Álvarez-Fuente, and M.J. del Cerro designed the study, analyzed data, and drafted the manuscript. HernÁndez, and I. García OrmazÁbal also drafted the manuscript.
CONFLICTS OF INTEREST
None reported.
WHAT IS KNOWN ABOUT THIS TOPIC?
- Transcatheter pulmonary valve implantation is a common procedure in patients with congenital heart diseases. However, the current valves available are not suitable for all anatomical variants or sizes of the pulmonary arterial trunk.
- New self-expanding valves with larger diameters to solve this problem are currently in the pipeline.
WHAT DOES THIS STUDY ADD?
- The early experience with the new self-expanding pulmonary Venus P-valve has been satisfactory in the first 8 implantations performed at our center.
- It allowed transcatheter studies of patients whose anatomies would have required surgery.
- This new valve allows one-stage implantations and is easy to use.
REFERENCES
1. McElhinney DB, Hellenbrand WE, Zahm EM, et al. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010;122:507-516.
2. Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet. 2000;356:1403-1405.
3. Boone RH, Webb JG, Horlick E, et al. Transcatheter pulmonary valve implantation using the Edwards SAPIEN transcatheter heart valve. Catheter Cardiovasc Interv. 2010;75:286-294.
4. Schievano S, Coats L, Migliavacca F, et al. Variations in right ventricular outflow tract morphology following repair of congenital heart disease: implications for percutaneous pulmonary valve implantation. J Cardiovasc Magn Reson. 2007;9:687-695.
5. Sivakumar K, Sagar P, Qureshi S, et al. Outcomes of Venus P-valve for dysfunctional right ventricular outflow tracts from Indian Venus P-valve database. Ann Pediatr Cardiol. 2021;14:281-292.
6. Garay F, Pan X, Zhang YJ, Wang C, Springmuller D. Early experience with the Venus p-valve for percutaneous pulmonary valve implantation in native outflow tract. Neth Heart J. 2017;25:76-81.
7. Alvarez-Fuente M, Garrido-Lestache E, Fernandez-Pineda L, et al. Timing of Pulmonary Valve Replacement: How Much Can the Right Ventricle Dilate Before it Looses Its Remodeling Potential? Pediatr Cardiol. 2016;37:601-605.
8. Baumgartner H, De Backer J, Babu-Narayan SV, et al.; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021;42:563-645.
9. Rodríguez Ogando A, Ballesteros F, Martínez JLZ. Pulmonary percutaneous valve implantation in large native right ventricular outflow tract with 32 mm Myval transcatheter heart valve. Catheter Cardiovasc Interv. 2022;99:E38-E42.
10. Morgan G, Prachasilchai P, Promphan W, et al. Medium-term results of percutaneous pulmonary valve implantation using the Venus P-valve: international experience. EuroIntervention. 2019;14:1363-1370.
11. Promphan W, Prachasilchai P, Siripornpitak S, Qureshi SA, Layangool T. Percutaneous pulmonary valve implantation with the Venus P-valve: clinical experience and early results. Cardiol Young. 2016;26:698-710.
* Corresponding authors.
E-mail addresses: maria.alvarezfuente@gmail.com (M. Álvarez-Fuente); majecerro@yahoo.es M.J. del Cerro).
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.
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).
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.
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).
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.
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.
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%.
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.
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)
Debate
Debate: ECMO in patients with cardiogenic shock due to myocardial infarction
A researcher’s perspective
aHeart Center Leipzig at Leipzig University, Department of Internal Medicine/Cardiology, Leipzig, Germany
bLeipzig Heart Science, Leipzig, Germany
A clinician’s perspective
Unidad de Cuidados Agudos Cardiológicos, Servicio de Cardiología, Hospital Universitario la Paz, IdiPAZ, Madrid, Spain
Editorials
Clinical evaluation requirements under the new European Union medical device regulation
Centro Nacional de Certificación de Productos Sanitarios, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain
Review Articles
Scientific letters
Practical concepts of catheter-directed aspiration thrombectomy in ECMO-supported patients
aServicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain
bServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain