Percutaneous pulmonary valve implantation (PPVI) is a routine treatment for dysfunctional right ventricular outflow tract. Infective endocarditis (IE) is a major concern.
To report French experience ...with the Melody™ valve (Medtronic Inc., Minneapolis, MN, USA).
All patients who underwent PPVI were recorded in a multicentre French national survey. Demographic and procedural data were collected from patients with IE. Bacterial identification, diagnostic tools and outcome were recorded.
Forty-five cases of IE were diagnosed in 43 patients. The cumulative IE incidence was 11.8% (95% confidence interval CI 8.5–15.9). The annualized IE incidence was 3.6% (95% CI 0–4.8). Freedom from IE was 96.3% and 85.8% at 12 months and 60 months, respectively. IE incidence did not change during the study period. The mean interval between PPVI and IE was 2.6±2.1 years (range, 5 days to 7.3 years). Fifteen patients with IE required intravenous antibiotics only. Seven patients had early interventional cardiac catheterization to relieve severe right ventricular outflow tract obstruction. Twenty-four patients had surgical valve replacement (six urgently; nine semi-urgently; nine electively). Staphylococcus aureus IE required surgery in all but one patient. Three patients died before any treatment. Three additional patients died, giving a mortality rate of 14%. Global survival in the total cohort of patients who received a Melody valve was excellent (96.5% at 5 years). When comparing survival curves between the IE and non-IE groups, death and cardiovascular events were statistically significantly higher in the IE group (log-rank P<0.0001).
Melody valve IE is a severe complication following PPVI. The annualized IE incidence in this cohort was similar to rates reported in other studies. With rapid diagnosis and adequate treatment, outcome has improved, and unfavourable outcome is mainly associated with S. aureus.
La valvulation pulmonaire percutanée est un traitement de routine de la dysfunction de la voie d’éjection droite. L’endocardite infectieuse (EI) est une préoccupation majeure.
Rapporter l’expérience française des endocardites infectieuses après implantation de valve Mélody (Medtronic Inc., Minneapolis, MN, États-Unis).
Tous les patients ayant eu une valvulation pulmonaire avec une Mélody ont été inclus dans une série multicentrique française. Les données démographiques et de cathétérisme ont été récoltées pour les patients ayant eu une EI. L’identification bactérienne, les moyens diagnostics et le devenir des patients ont été analysés.
Quarante-cinq épisodes d’EI ont été diagnostiqués chez 43 patients. L’incidence cumulée d’EI était de 11,8 % (intervalle de confiance 95 % IC 8,5–15,9). L’incidence annualisée d’EI était de 3,6 % (95 % IC 0–4,8). L’absence d’EI était respectivement de 96,3 % et 85,8 % à 12 et 60 mois. L’incidence d’EI n’a pas changé durant la période étudiée. La durée moyenne entre l’implantation et l’EI était de 2,6±2,1 ans (5jours à 7,3 ans). Quinze patients ont été traités par antibiothérapie intraveineuse uniquement. Sept patients ont eu un cathétérisme interventionnel pour lever l’obstruction sévère de la voie droite. Vingt-quatre patients ont eu un remplacement valvulaire chirurgical (six en urgence, neuf en semi-urgence et neuf de manière élective). Les EI à S. aureus ont nécessité de la chirurgie chez tous les patients sauf un. Trois patients sont décédés avant tout traitement. Trois autres patients sont décédés. La mortalité dans l’EI est de 14 %. La survie globale de la population implantée avec une Mélody était excellente (96,5 % à 5 ans). La mortalité et les évènements cardiovasculaires étaient statistiquement plus élevés dans le groupe de patients avec EI (log-rank P<0.0001).
L’EI est une complication sévère après valvulation percutanée. L’incidence annualisée dans cette cohorte est similaire à celle rapportée dans d’autres séries. Avec un diagnostic rapide et un traitement approprié, le pronostic s’améliore. Les issues défavorables sont essentiellement dues aux EI à S. aureus.
Transcatheter perimembranous ventricular septal defect (pmVSD) closure remains challenging and is seldom used in France given the risk of atrioventricular block (AVB). pmVSD closure with the ...Nit-Occlud Lê VSD coil was recently introduced in France as an alternative to occluder devices.
To study the safety and feasibility of pmVSD closure with the Nit-Occlud Lê VSD coil.
All consecutives cases of pmVSD closure with the Nit-Occlud Lê VSD coil in 20 tertiary French centres were included between January 2015 and December 2018.
Among 46 procedures in five centres, indications for pmVSD closure were left ventricle overload (76.1%), exertional dyspnoea (17.4%), history of infective endocarditis (4.3%) and mild pulmonary hypertension (2.2%). The median (interquartile IQR) age of the patients was 13.9 (5.7–31.8) years. Aneurismal tissue was identified in 91.3% of patients. VSD median (IQR) size was 8 (7–10) mm on the left ventricle side and 5 (4–6) mm on the right ventricle side. Implantation was successful in 40 patients (87.0%; 95% confidence interval CI 73.7–95.1%). Severe complications occurred in six patients (13.0%, 95% CI 4.9–26.3%), mainly severe haemolysis (8.7%, 95% CI 2.4–20.8%). One aortic valve lesion required surgical aortic valvuloplasty. Occurrence of severe complications was significantly related to the presence of haemolysis (P=0.001), residual shunt (P=0.007) and multi-exit VSD (P=0.005). Residual shunt was observed in 40% of cases with the implanted device shortly after closure and 15% after a median follow-up of 27 months. No immediate or delayed device embolization or complete AVB was recorded.
pmVSD closure with the Nit-Occlud Lê VSD Coil is feasible in older children and adults. However, residual shunting (leading to haemolysis) is a dreaded complication that should not be tolerated. pmVSD closure with the Nit-Occlud Lê VSD as a therapeutic strategy remains controversial and is limited to selected patients.
La fermeture percutanée des communications interventriculaires peri-membraneuses (CIVpm) demeure un challenge et est peu utilisée en France en raison d’un risque de bloc atrio-ventriculaire (BAV). L’utilisation du coil Nit-Occlud Lê VSD a été récemment débutée en France et représente une alternative aux occluders.
Buts Étudier la faisabilité et la sécurité d’emploi de la fermeture percutanée de la CIVpm avec le Nit-Occlud Lê VSD.
Toutes les procédures de fermeture de CIVpm réalisées en France entre janvier 2015 et décembre 2018 dans les vingt centres spécialisés de prise en charge des cardiopathies congénitales complexes (réseau maladies rare M3C) ont été incluses rétrospectivement et analysées.
Au total, 46 procédures ont été réalisées dans cinq centres. Les indications de fermeture étaient la surcharge diastolique du ventricule gauche (76 %), une dyspnée à l’effort (17,4), un antécédent d’endocardite (4,3) et une hypertension artérielle pulmonaire modérée (2,2 %). L’âge médian (interquartile) était de 13,9 (5,7–31,8) ans. Un anévrysme du septum interventriculaire a été observé dans 91,3 % des cas. La taille médiane (interquartile) des CIV était de 8 (7–10)mm sur le versant ventriculaire gauche et 5 (4–6)mm sur le versant ventriculaire droit. Le taux de réussite d’implantation de la prothèse était de 87,0 % (IC 95 %, 73,7–95.1 %). Des complications sévères ont été observées chez six patients (13,0 %, IC 95 %, 4,9–26,3 %). L’hémolyse persistante était la complication sévère la plus fréquente (8,7 %, IC 95 % 2,4–20,8 %). Une lésion de la valve aortique a nécessité une valvuloplastie aortique chirurgicale. La survenue de complications est liée à la présence de l’hémolyse (p=0,001) d’un shunt résiduel (p=0,007) et la présence de CIV avec anévrysme multi-perforée (p=0,005). Un shunt résiduel a été documenté dans 40 % des cas juste après l’intervention et 15 % durant le suivi (durée médiane de suivi de 27 mois). Aucun cas de migration de prothèse ni de bloc atrioventriculaire de haut grade n’a été rapporté.
La fermeture percutanée de CIVpm avec le coil Nit-Occlud Lê VSD est réalisable chez les grands enfants et les adultes. La présence d’un shunt résiduel important provoquant une hémolyse parfois sévère est une complication redoutable et ne doit pas être tolérée. La place de cette prothèse dans l’algorithme de prise en charge des CIVpm reste controversée.
Over the past twenty years, progress of cardiac surgery has been such that actual life expectancy of a patient with congenital heart disease (CHD) approaches that of the average for the general ...population. The current challenge is no longer to decrease cardiac surgery's mortality rate, but rather to manage morbidity and a child's overall development regarding nutrition and neurodevelopment. Malnutrition is a common cause of morbidity in infants with CHD, especially before the age of one. It can easily be explained by an increased metabolic demand linked to cardiac failure, hypoxemia or pulmonary hypertension. Secondly, food intake is frequently not optimal in this population and the infant's growth is insufficiently examined by paediatric cardiologists. Another factor is that much needed therapeutics such as diuretic drugs for example, often lead to weight loss. Ultimately, malnutrition in infants with CHD increases surgical risk, morbidity (infections, …), hospital stay, and alters long-term cognitive development.
This study reports prevalence and associated factors of malnutrition on short and long-term follow-up of a large cohort of patients with various CHD, and who underwent cardiac surgery before the age of one.
We conducted a retrospective and multicentre study that included infants from the North of France with CHD who underwent cardiac surgery before the age of one, between 2013 and 2017. To determine malnutrition, anthropometric measures (weight and height) were collected on the day of the surgery and during follow-up until 3 years after surgery to calculate Z-score for weight, height and weight/height. To test the statistical significance of the association between nutritional status and risk variables, univariate analysis was done applying Chi-square test. All variables significant at 0.1 in univariate analysis were included in the multivariate logistic regression analysis. The study was approved by French national ethic committee Commission national de l’informatique et des libertés (CNIL) and by the GFHGNP ethic committee (Groupe francophone d’hépatologie–gastro-entérologie et nutrition pédiatrique). The author declares that he has no competing of interest.
In total, 331 patients with CHD who underwent their first cardiac surgery (palliation or repair) before the age of one were included. Table 1 lists the cardiac diagnosis of patients included in the study. Demographic and clinical characteristics are summarised in Table 2. Caesarean section was performed in 23.5% of cases. Only 38% infants were breastfed after maternity stay. An important part of our population was treated with diuretic drugs before surgery for congestive heart failure (38.5%). 69 (21%) infants needed a gastric tube before surgery. Feeding difficulties (including need for dietary enrichment and/or presence of a gastric tube) represented 35% of our population at the day of surgery. Only 39 (12%) were specifically assessed by speech therapist for feeding problems.
Concerning surgery, 246 (74.5%) infants had undergone a biventricular repair, 51 (15.5%) infants had undergone a palliative intervention before a biventricular repair and 33 (10%) had a palliative intervention before a univentricular repair. 84 (26%) were cyanotic after their first surgery, 104 (32%) needed at least a second intervention. 49 (15%) infants had postoperative complications and 84 (26%) infants were treated by diuretics for congestive heart failure one month after surgery. 19 (5.9%) infants needed intravenous (IV) nutrition for more than 7 days. There were 19 (6%) deaths.
Regarding nutritional status, at the time of the surgery, 14% of the infants presented moderate to severe growth failure (with a Z score weight for age<−2SD) and 26% presented minor growth failure (with a Z scoreweight for age between −2 and −1 SD). Thus, 40% of our cohort presented minor to severe growth failure the day of the surgery. Regarding the ratio weight for height, 17% presented moderate to severe malnutrition (with a Z score weight for height<−2SD) and 30% minor malnutrition (with a Z scoreweight for height between −2 and −1 SD). Because we had a severe lack of data for height, percentages were calculated on 319 patients concerning growth failure and on 211 patients concerning malnutrition at the time of surgery. We thus, concentrated on growth failure in follow-up. At one month after surgery, 45% infants still presented feeding difficulties. Overall, 20 (6%) had a gastrostomy for feeding difficulties.
During follow-up, between six months and 12months after surgery, moderate to severe growth failure persisted in 16% of the study population and minor growth failure in 24%. In other terms, 40% of our cohort presented a persistent minor to severe growth failure. Figs. 1 and 2 summarize evolution of growth failure and malnutrition respectively during follow-up from 15days to 3years after surgery. Nineteen patients died during follow-up. A significant proportion of patients had impaired somatic growth or malnutrition at the end of the follow-up.
Several associated factors of persistent growth failure 6 to 12months after surgery were identified in univariate analysis: prenatal diagnosis, presence of genetic syndrome, birth weight≤3kg, complex CHD (CHD with 2 or more significative lesions or double outlet right ventricule or single ventricule physiology), surgery after 30days from birth, and diuretic therapy before surgery and/or still necessary one month after surgery. The results of multivariate logistic regression analysis are summarized in Table 3. CHD types were divided in 4 groups regarding anatomy and complexity, using TGA, Fallot and coarctation of Aorta as referent CHD with low impact on infant growth away from the day of surgery. The presence of a feeding tube at the day of surgery was not associated with growth failure 6 to 12months after.
Growth failure in infants with CHD who undergo cardiac surgery before the age of one persists between 6 and 12months after surgery. This should be taken into account as it can have serious consequences on children's health and development. Highlighting predictive factors will allow medical staff to identify vulnerable infants at birth and during the period of surgery and therefore increase nutritional care to combat malnutrition and growth failure.
The Coaguchek INRange® is a self-testing meter to measure the INR, that is reimbursed in France since August 2017 for patients with mechanical valve.
We evaluated the use of this anticoagulation ...method in a French population of GUCH (Grown-Up patients with Congenital Heart Disease) with mechanical valve.
Since September 2018, 52 patients of 37±11 years old were asked to attend a training course of 2hours on anticoagulation and Coaguchek INRange® use, provided by specialized nurses, before getting home with the device. Patients had to attend a 3 months’ medical re-evaluation appointment. 29 (56%) patients had an aortic mechanical valve, 12 (23%) a mitral one, 8 (15%) a double aortic and mitral one, 2 (4%) a double aortic and pulmonary one and 1 (2%) a tricuspid one. 28 patients (54%) had a mechanical valve for≥10 years (group 1). In group 1, patients were older (41±10 years old vs. 34±10, P=0.01). Fluindione was the preferred oral anticoagulant (30 patients, 57%), and was more frequent in group 1 (18 patients, 64%). In group 1, 61% of patients usually managed themselves dosage adjustment whereas in the other group, 52% of patients referred to their doctor. Thirty-one patients (62%) had a higher target of INR than recommended in last European guidelines. Concerning follow-up, 26 patients (50%) did not attend the 3 months appointment and had to be rescheduled or contacted by phone. 8 patients (15%) did not use the device at 3 months: 5 for variation>15% compared to laboratory plasma technique and 3 for not trusting the new device. INR at 3 months was obtained in only 40 (77%) patients, and was in the attended target in 62% of cases.
GUCH patients with mechanical valves, especially when present for≥10 years, seem to validate Coaguchek, even though evaluation remains hard since a great proportion of them did not attend follow-up appointment, stick to their old INR target and did not use the device as often as recommended.
Summary Background Single-centre experience in transcatheter closure of atrial septal defect (ASD) using the Figulla® ASD Occluder (FSO; Occlutech GmbH, Jena, Germany) and the Amplatzer® Septal ...Occluder (ASO; Saint-Jude Medical, Zaventem, Belgium) has been reported. Aim To perform a retrospective comparison of the two occluders. Methods From September 2009 to December 2012, 131 consecutive patients underwent percutaneous ASD occlusion: One hundred with the ASO device; 31 with the FSO device. Results There were no significant differences between the two groups regarding patient characteristics, stretched diameter, age and device size. In the ASO group, implantation succeeded in all but two patients because of deficient rim. Another patient had device embolization in the aorta retrieved percutaneously. During follow-up, 86 patients had no residual shunt and nine patients had a residual shunt (small in seven; moderate in two). Two other patients had persistent interatrial small shunt caused by an adjacent ASD close to the device. In the FSO group, implantation succeeded in all but two patients: one because of deficient posterior rim; and one because of complete atrioventricular block that resolved after device extraction. During follow-up, no shunt was observed in all but one patient. At late follow-up (up to 36 months), full occlusion was observed in 88 (88.0%) patients in the ASO group and 28 (90.3%) patients in the FSO group (with no significant difference between groups). Conclusion Transcatheter closure of ASD with the FSO is feasible and safe. FSO results compare favorably with ASO results. However, additional long-term studies that include more patients are mandatory.
This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve.
The Edwards SAPIEN valve, initially designed for ...percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported.
From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively.
The primary efficacy outcome was met for 87,1% patients after a mean follow-up of 55±21 months, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8–95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular insufficiency was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01–2.00%). At 5 years freedom from infective endocarditis was 98.4% (95% CI 89.1–99.8%) (Fig. 1). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35.
This study confirms the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.
Even though several devices have been developed to facilitate occlusion of cardio vascular structures in adults, only a few types of plugs have been approved in selected pediatric indications. ...However, apart from patent ductus arteriosus (PDA) closure, little data has been published in children, particularly with regard to the heterogeneity of the procedures and outcomes.
To describe the efficacy, safety, and characteristics of the utilization of the Amplatzer Vascular Plug (AVP) II and IV for cardiovascular percutaneous occlusions in children under 10years.
Retrospective multicenter (2006–2020, 6 academic centers) observational review of pediatric transcatheter occlusions using AVP II or IV.
A total of 125 consecutive children (60<1year, 145 lesions) underwent 136 successive procedures using 175 different devices (112 AVP IV, 63 AVP II) with a success rate of 98.5%. The mean device diameter was 7.7±3.2mm (4–20mm). The median age and weight at implantation were 1.0year (0.01–9.98years) and 9.1kg (1–69kg), respectively. Procedures involved 55 PDA, 28 arterial bronchial or aorto-pulmonary collaterals, 18 sequestrations or Scimitar syndrome, 16 arteriovenous or veinovenous fistulae, 6 coronary fistulae, 6 vertical veins, 6 conduits, 5 ventricular septal defect, and 7 miscellaneous occlusions. The occlusion rate at Day1 was 96.3% and 100%, 6 months after, without hemolysis. Major adverse events (MAE) occurred in 5.1% mainly the need for surgery, without any related death. MAE was related to a lower weight (P=0.04), a younger age (P=0.02) and large PDA closure using AVP II (P<0.01).
AVP II and IV are safe and effective for the percutaneous treatment of numerous cardiovascular lesions in children under ten. In our multicenter experience, such devices represent a real “off-label” pediatric alternative in well-selected patients.
Summary Background The relationship between pulmonary arterial hypertension-specific drug therapy (PAH-SDT) and mortality in Eisenmenger syndrome (ES) is controversial. Aims To investigate outcomes ...in patients with ES, and their relationship with PAH-SDT. Methods Retrospective, observational, nationwide, multicentre cohort study. Results We included 340 patients with ES: genetic syndrome ( n = 119; 35.3%); pretricuspid defect ( n = 75; 22.1%). Overall, 276 (81.2%) patients received PAH-SDT: monotherapy (endothelin receptor antagonist ERA or phosphodiesterase 5 inhibitor PDE5I) 46.7%; dual therapy (ERA + PDE5I) 40.9%; triple therapy (ERA + PDE5I + prostanoid) 9.1%. Median PAH-SDT duration was 5.5 years 3.0–9.1 years. Events (death, lung or heart-lung transplantation) occurred in 95 (27.9%) patients at a median age of 40.5 years 29.4–47.6. The cumulative occurrence of events was 16.7% 95% confidence interval 12.8–21.6% and 46.4% 95% confidence interval 38.2–55.4% at age 40 and 60 years, respectively. With age at evaluation or time since PAH diagnosis as time scales, cumulative occurrence of events was lower in patients taking one or two PAH-SDTs ( P = 0.0001 and P = 0.004, respectively), with the largest differences in the post-tricuspid defect subgroup ( P < 0.001 and P < 0.02, respectively) versus patients without PAH-SDT. By multivariable Cox analysis, with time since PAH diagnosis as time scale, New York Heart Association/World Health Organization functional class III/IV, lower peripheral arterial oxygen saturation and pretricuspid defect were associated with a higher risk of events ( P = 0.002, P = 0.01 and P = 0.04, respectively), and one or two PAH-SDTs with a lower risk of events ( P = 0.009). Conclusions Outcomes are poor in ES, but seem better with PAH-SDT. ES with pretricuspid defects has worse outcomes despite the delayed disease onset.
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