Summary
Background
Many stents are used “off-label” during the management of congenital heart diseases (CHD).
Aims
To describe indications for, results of, and adverse events associated with stenting in CHD in current practice.
Methods
Participation in this study was proposed to all catheterization laboratories that specialize in CHD in France (M3C network). All paediatric and adult CHD cases with stent implantation in 2013 were included retrospectively.
Results
Overall, 207 stents were implanted in 151 patients across 11 centres. Median age was 13.7 years (range, 5 days to 70.1 years). Main procedure indications were branch pulmonary artery angioplasty ( n = 46, 29.1%), aortic (re)coarctation stenting ( n = 43, 27.2%), percutaneous pulmonary valve implantation ( n = 32, 20.2%) and ductus arteriosus stenting ( n = 14, 8.9%). The main stents implanted were the CP Stent™ ( n = 61, 29.5%), the Max™ LD stent ( n = 43, 20.8%), the Valeo ® stent ( n = 28, 13.5%) and valved stents ( n = 30, 14.5%). Procedures were considered successful in 96.8% of cases (95% confidence interval [CI] 92.8–99.0%). Adverse events were observed in 23 procedures (14.7%, 95% CI 9.5–21.0%). Ductus arteriosus stenting (odds ratio 12.4, 95% CI 2.0–77.5; P < 0.01) and pulmonary revalvulation (odds ratio 5.9, 95% CI 1.1–32.3; P = 0.04) were risk markers for stent-related adverse events.
Conclusions
Stents are used in various CHD catheterization procedures, from infancy to adult age. The adverse events rate is significant and is related to the type of procedure.
Résumé
Contexte
De nombreux stents sont utilisés off-label pour le traitement interventionnel des cardiopathies congénitales.
Objectifs
L’objectif principal de cette étude est de décrire les indications, les résultats et les événements indésirables des stents implantés pour le traitement des cardiopathies congénitales en pratique courante.
Méthodes
La participation à cette étude a été proposée à tous les centres français de cardiologie interventionnelle pédiatrique et congénitale (réseau M3C). Parmi 11 centres participants, tous les procédures avec stents, sur une année en 2013 ont été analysés rétrospectivement.
Résultats
Deux cents sept stents ont été implantés chez 151 patients. L’âge médian était de 13,7 ans (min : 5 jours ; max : 70,1 ans). Les indications principales des procédures étaient l’angioplastie des branches pulmonaires ( n = 46, 29,1 %), l’angioplastie de l’isthme aortique ( n = 43, 27,2 %), la revalvulation pulmonaire percutanée ( n = 32, 20,2 %), et le stenting de canal artériel ( n = 14, 8,9 %). Les principaux stents utilisés étaint le CP Stent™ ( n = 61, 29,5 %), l’eV3 Max™ LD ( n = 43, 20,8 %), le Valeo ® ( n = 28, 13,5 %) et les stents valvés ( n = 30, 14,5 %). Les procédures ont été réussies dans 96,8 % (IC 95 % 92,8–99,0 %). Des événements indésirables ont été observés dans 23 procédures (14,7 %, IC 95 % 9,5–21,0 %). Le stenting du canal artériel (OR 12,4, IC 95 % 2,0–77,5 ; p < 0,01) et la revalvulation pulmonaire (OR 5,9, IC 95 % 1,1–32,3 ; p = 0,04) étaient des marqueurs de risque de complications reliées au stent.
Conclusion
Les stents sont utilisés dans de multiples procédures du cathétérisme interventionnel des cardiopathies congénitales, de l’enfance à l’âge adulte. Le risque de complications est significatif et semble relié au type de procédure.
Background
Since the first report of transcatheter balloon dilation of pulmonary stenosis in 1953 , balloon angioplasty has been widely used for many valvular and vascular congenital lesions . However, ineffective relief of obstruction and vessel damage has been observed . A “stent” is a tubular meshed endoprosthesis that has contributed to overcome some of these issues, whether in acquired or congenital lesions . We recently published an extended review of stent types and indications in the treatment of congenital heart diseases (CHD) . However, we were unable to describe the distribution of indications and stents used in current practice. Moreover, new stents are available , but few devices are authorized for use in congenital heart lesions, and many stents are currently implanted in “off-label” indications. As the field of congenital and interventional cardiology is rapidly evolving, the safety and efficiency of these procedures have to be investigated. In this French multicentre study, we aimed to describe the current types of stents used to treat congenital heart lesions, assess the indications for these procedures, evaluate their efficiency, and underline early complications after stenting and associated risk factors.
Methods
Participation in this retrospective observational multicentre study was proposed on a voluntary basis to all catheterization laboratories that specialize in the treatment of CHD in France (M3C network). Finally, 11 centres agreed to participate. All catheterization procedures involving stent implantation in children or adults with CHD performed in these centres between January 2013 and December 2013 were reviewed. Procedures with stent implantation in peripheral vascular lesions or in renal arteries in children were excluded. Hybrid procedures with stent implantation during cardiac surgery were included. Catheterizations were performed by paediatric cardiologists specialized in the interventional treatment of CHD. In three centres with less experience in stenting, procedures were performed in partnership with an expert from another centre.
Stenting procedures were performed according to operator and institutional practice. Variables collected included demographic data (age, weight and height), clinical data (diagnosis, catheterization indication), procedural data (type, diameter and localization of stents implanted, and results) and early complications. Early complications were defined as complications occurring during the initial stenting procedure, during the index hospitalization or during the first 30 days after the procedure. CHD were characterized according to the “anatomical and clinical classification of congenital heart defects (ACC-CHD)” for the main diagnosis . The indication for stent implantation was collected and classified as follows : stenting to increase the efficiency of balloon angioplasty; stenting to increase the safety of balloon angioplasty; stenting to occlude a shunt; stenting to maintain shunt patency; or stenting as a support for percutaneous valve replacement.
Stents were classified according to their diameter at the implantation site, as previously described: small (3–6 mm), medium (7–11 mm), large (12–17 mm), extra-large (18–25 mm) and extra-extra-large (> 25 mm) . Stent implantation was considered successful when the following criteria were met: if the stent was implanted and stable in the target localization and if the stent fulfilled its main objective (no significant residual gradient if the indication was to relieve an obstruction; no parietal lesion for a safety indication; no residual shunting if the indication was to occlude a shunt; shunt patency if it was the main objective; successful valved stent implantation).
Procedural and 30 days post-procedure adverse events were classified according to the Congenital Cardiac Catheterization Project (C3PO) .
The term “adverse events” was inclusive of all adverse events from severity levels 1 to 5. High-severity adverse events were defined as any level 3, 4 or 5 adverse events. If stent implantation was the most likely cause leading to a complication, the latter was recorded as a stent-related adverse event. Each procedure with an adverse event was reviewed by the main investigator and local investigators. The study database was registered and approved by the National Commission for Data Processing and Freedoms (n o 1809711 v 0).
Statistical analysis
Statistical analysis was performed using Stata ® 11.2 software (StataCorp, College Station, TX, USA). Quantitative measurements are expressed as medians with interquartile ranges and minimal and maximal values. Qualitative data are expressed as counts and percentages. A descriptive analysis of demographic data, pathology, stent types, stent indications and adverse events was performed, displaying percentages and 95% confidence intervals (CIs). Potential determinants of outcome were then investigated through a logistic regression analysis, including all procedures. Outcome measures were all procedural adverse events, stent-related adverse events, and high-severity adverse events. The following variables were incorporated separately into the model: operator, centre, age, weight, genetic syndrome, stent type, stent size and procedure type. Unadjusted odd ratios, their 95% CIs and P values are reported. The model, including the procedure type, was forced with the operator variable to account for its effect. Adjusted odd ratios (ORs) are reported. A P value < 0.05 was considered to be significant.
Results
A total of 207 stents were implanted during 158 procedures in 151 patients across 11 centres. The patients’ median age was 13.7 years (range, 5 days to 70.1 years). Nineteen patients (12.6%) were aged under 1 year and 41 (27.2%) were aged over 18 years. The main diagnoses were tetralogy of Fallot and variants ( n = 55, 36.7%) and aortic (re)coarctation ( n = 40, 26.5%). Demographic data and procedure types are detailed in Table 1 .
| Demographic data | |
| Age (years) | 13.7 (6.5–21.7) [5 days; 70.1 years] |
| Age ≤ 1 month | 15 (9.9) |
| Age > 18 years | 41 (27.2) |
| Weight (kg) | 45.0 (18.7–62.0) [2.7; 97.0] |
| Weight ≤ 5 kg | 16 (10.7) |
| Weight ≤ 20 kg | 39 (26.0) |
| Genetic syndrome | 9 (4.9) |
| Procedure type (n = 158) | |
| Stenting coarctation ( n = 28); recoarctation ( n = 15) | 43 (27.2) |
| PA stenosis ( n = 46); thrombosis ( n = 1) | 47 (29.7) |
| PPVI | 32 (20.2) |
| RV-to-PA conduit stenting | 10 (6.3) |
| DA stenting | 14 (8.9) |
| BT shunt stenosis ( n = 1); thrombosis ( n = 2) | 3 (1.9) |
| Coronary lesions | 3 (1.9) |
| Mustard baffle stenosis; vena cava stenosis | 2 (1.3) |
| Potts shunt occlusion | 1 (0.6) |
| Cavopulmonary conduit stenosis ( n = 1); fenestration occlusion ( n = 2) | 3 (1.9) |
| TTVI | 1 (0.6) |
Stenting indications
Stents were used to increase the efficacy of balloon dilation ( n = 87, 42.0%), as part of percutaneous valve implantation ( n = 60, 29.0%), for a safety reason ( n = 32, 15.5%), to maintain shunt patency ( n = 20, 9.7%) or to close shunt patency ( n = 3, 1.4%) ( Fig. 1 and Fig. 2 ). Main indications were branch pulmonary artery angioplasty ( n = 46, 29.1%), aortic (re)coarctation stenting ( n = 43, 27.2%), percutaneous pulmonary valve implantation (PPVI) ( n = 32, 20.2%) and ductus arteriosus (DA) stenting ( n = 14, 8.9%) ( Fig. 2 ). Procedural indications, stent types and stent sizes are displayed in Table 2 .
| Stents ( n = 207) | Number (%) | Implantation final diameter (mm) | Indications | Stent-related adverse event rate (95% CI) |
|---|---|---|---|---|
| Extra-extra-large stents | ||||
| Valiant ® thoracic (self-expandable) a | 1 (0.5) | 34 | Potts shunt occlusion ( n = 1) | 0.0 (0.0–97.5) |
| Sinus-XL 34–60 mm b | 1 (0.5) | 29 | PTVI landing zone ( n = 1) | 0.0 (0.0–97.5) |
| Large and extra-large stents | ||||
| CP Stent™ c | 61 (29.5) m | 8–28 | PPVI landing zone ( n = 13), PTVI landing zone ( n = 1), native coarctation ( n = 17), aortic recoarctation ( n = 12), PA stenosis ( n = 13), cavopulmonary conduit fenestration occlusion ( n = 2), RV-to-PA conduit ( n = 2), superior vena cava stenosis ( n = 1) | 8.2 (2.7–18.1) |
| Max™ LD d | 43 (20.8) | 12–28 | PPVI landing zone ( n = 16) PTVI landing zone ( n = 1), native coarctation ( n = 8), aortic recoarctation ( n = 1), PA stenosis ( n = 12), cavopulmonary conduit stenosis ( n = 1), RV-to-PA conduit ( n = 3), Mustard baffle stenosis ( n = 1) | 4.7 (0.6–15.8) |
| Advanta V12™ (covered) e | 6 (2.9) | 10–20 | Native aortic coarctation ( n = 4) or aortic recoarctation ( n = 2) | 0.0 (0.0–45.9) |
| Protege ® GPS™ (self-expendable) d | 1 (0.5) | 14 | PA thrombosis ( n = 1) | 0.0 (0.0–97.5) |
| Medium stents | ||||
| Valeo ® f | 28 (13.5) | 5–12 | Branch PA stenosis ( n = 17), DA stenting ( n = 11) | 17.9 (6.1–36.9) |
| Genesis ® g | 13 (6.3) | 6–15 | Branch PA stenosis ( n = 10), BT shunt stenosis ( n = 1), RV-to-PA conduit ( n = 2) | 7.7 (0.2–36.0) |
| Palmaz ® g | 4 (1.9) | 6–26 | PPVI landing zone ( n = 2), RV-to-PA conduit stenosis ( n = 2) | 0.0 (0.0–60.2) |
| Assurant Cobalt ® a | 2 (1.0) | 6–9 | Branch PA stenosis ( n = 2) | 0.0 (0.0–84.2) |
| Omnilink Elite ® h | 1 (0.5) | 9 | Branch PA stenosis ( n = 1) | 0.0 (0.0–97.5) |
| Sinus-SuperFlex (self-expandable) b | 1 (0.5) | 7 | PA thrombosis ( n = 1) | 0.0 (0.0–97.5) |
| Small stents | ||||
| Coronary stents (bioresorbable, n = 2) i | 13 (6.3) | 2.25–6 | DA stenting ( n = 6), branch PA stenosis ( n = 2), coronary artery stenosis ( n = 4), BT shunt thrombosis ( n = 1) | 7.7 (0.2–36.0) |
| Formula™ j | 1 (0.5) | 4 | Branch PA stenosis ( n = 1) | 0.0 (0.0–97.5) |
| Dynamic renal k | 1 (0.5) | 6 | BT shunt thrombosis ( n = 1) | 0.0 (0.0–97.5) |
| Valved stents | ||||
| Melody ® valve a | 16 (7.7) | 18–22 | PPVI ( n = 16) | 0.0 (0.0–20.6) |
| Edwards SAPIEN™ valve l | 14 (6.8) | 16–29 | PPVI ( n = 13), PTVI ( n = 1) | 14.3 (1.8–42.8) |
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