Safety and Efficacy of Mini-invasive left atrial appendage closure : a propensity score analysis.

BACKGROUND: Left atrial appendage closure (LAAC) for stroke prevention is validated in patients with non-valvular atrial fibrillation (NVAF) contraindicated to oral anticoagulation. General anesthesia (GA) is often used for procedural guidance by trans-oesophageal echocardiography (TEE); however, its use may be challenging in some patients. The aim of the study was to evaluate the safety and the mid-term efficacy of a mini-invasive LAAC strategy using micro-TEE under procedural sedation. METHODS: Comparison by propensity score of two cohorts of consecutive patients who underwent LAAC: standard TEE-guided LAAC (3D-TEE under GA) and, mini-invasive LAAC strategy (micro-TEE under procedural sedation). The primary endpoint was a composite of embolic or bleeding events, significant per-procedural complication, and cardiovascular deaths within 3 months after LAAC. RESULTS: In total, 432 patients were included (78.7±8 years old, 32.4% of women, CHA2DS2VASC score:4.9±1.1); 127 patients underwent mini-invasive LAAC strategy and were compared to 305 patients standard TEE-guided LAAC. The mini-invasive strategy was acheived in 122/127 (96.1%) planned patients. The primary endpoint occurred in 11.2% of patients from the mini-invasive LAAC strategy group and in 10.3% of patients from the standard TEE group (absolute difference = 0.9%[-6.4; 4.5], hazard-ratio=1.11[0.56; 2.19], p=0.76). Procedural times, fluoroscopy duration and hospital stays were shorter in the mini-invasive LAAC strategy group (p<0.001). CONCLUSIONS: The mini-invasive LAAC strategy is safe and effective compared to the standard TEE-guided LAAC strategy. A mini-invasive LAAC strategy may also be an important tool to help physicians to treat more patients as LAAC indications evolve in the future.

Early hybrid cardiac rehabilitation in congenital heart disease: the QUALIREHAB trial.

BACKGROUND AND AIMS: Cardiopulmonary fitness in congenital heart disease (CHD) decreases faster than in the general population resulting in impaired health-related quality of life (HRQoL). As the standard of care seems insufficient to encourage and maintain fitness, an early hybrid cardiac rehabilitation programme could improve HRQoL in CHD. METHODS: The QUALIREHAB multicentre, randomized, controlled trial evaluated and implemented a 12-week centre- and home-based hybrid cardiac rehabilitation programme, including multidisciplinary care and physical activity sessions. Adolescent and young adult CHD patients with impaired cardiopulmonary fitness were randomly assigned to either the intervention (i.e. cardiac rehabilitation) or the standard of care. The primary outcome was the change in HRQoL from baseline to 12-month follow-up in an intention-to-treat analysis. The secondary outcomes were the change in cardiovascular parameters, cardiopulmonary fitness, and mental health. RESULTS: The expected number of 142 patients was enroled in the study (mean age 17.4 ± 3.4 years, 52% female). Patients assigned to the intervention had a significant positive change in HRQoL total score [mean difference 3.8; 95% confidence interval (CI) 0.2; 7.3; P = .038; effect size 0.34], body mass index [mean difference -0.7 kg/m2 (95% CI -1.3; -0.1); P = .022; effect size 0.41], level of physical activity [mean difference 2.5 (95% CI 0.1; 5); P = .044; effect size 0.39], and disease knowledge [mean difference 2.7 (95% CI 0.8; 4.6); P = .007; effect size 0.51]. The per-protocol analysis confirmed these results with a higher magnitude of differences. Acceptability, safety, and short-time effect of the intervention were good to excellent. CONCLUSIONS: This early hybrid cardiac rehabilitation programme improved HRQoL, body mass index, physical activity, and disease knowledge, in youth with CHD, opening up the possibility for the QUALIREHAB programme to be rolled out to the adult population of CHD and non-congenital cardiac disease.

Corrigendum: Left Ventricular Strains and Myocardial Work in Adolescents With Anorexia Nervosa.

[This corrects the article DOI: 10.3389/fcvm.2022.798774.].

Cardiovascular events in perimembranous ventricular septal defect with left ventricular volume overload: a French prospective cohort study (FRANCISCO).

The long-term prospective multi-centre nationwide (French) observational study FRANCISCO will provide new information on perimembranous ventricular septal defect with left ventricular overload but no pulmonary hypertension in children older than 1 year. Outcomes will be compared according to treatment strategy (watchful waiting, surgical closure, or percutaneous closure) and anatomic features of the defect. The results are expected to provide additional guidance about the optimal treatment of this specific population, which is unclear at present. BACKGROUND: The management of paediatric isolated perimembranous ventricular septal defect (pmVSD) with left ventricle (LV) volume overload but no pulmonary arterial hypertension (PAH) remains controversial. Three therapeutic approaches are considered: watchful waiting, surgical closure, and percutaneous closure. We aim to investigate the long-term outcomes of these patients according to anatomic pmVSD characteristics and treatment strategy. METHODS: The Filiale de Cardiologie Pediatrique et Congénitale (FCPC) designed the FRANCISCO registry, a long-term prospective nationwide multi-centre observational cohort study sponsored by the French Society of Cardiology, which enrolled, over 2 years (2018­2020), patients older than 1 year who had isolated pmVSD with LV volume overload. Prevalent complications related to pmVSD at baseline were exclusion criteria. Clinical, echocardiographic, and functional data will be collected at inclusion then after 1, 5, and 10 years. A core lab will analyse all baseline echocardiographic data to depict anatomical pmVSD features. The primary outcome is the 5-year incidence of cardiovascular events (infective endocarditis, sub-aortic stenosis, aortic regurgitation, right ventricular outflow tract stenosis, tricuspid regurgitation, PAH, arrhythmia, stroke, haemolysis, heart failure, or death from a cardiovascular event). We plan to enrol 200 patients, given the 10% estimated 5-year incidence of cardiovascular events with a 95% confidence interval of ±5%. Associations linking anatomical pmVSD features and treatment strategy to the incidence of complications will be assessed. CONCLUSIONS: The FRANSCICO study will provide the long-term incidence of complications in patients older than 1 year with pmVSD and LV volume overload. The results are expected to improve guidance for treatment decisions.

Patent foramen ovale closure in children without cardiopathy: Child-PFO study.

BACKGROUND: Closure of patent foramen ovale is well-managed in adults, but is performed less frequently in children. AIM: To analyse all patent foramen ovale closures performed in the past 20 years in French paediatric centres. METHODS: Retrospective study of patent foramen ovale closures in children without cardiopathy in nine centres between 2000 and 2019. RESULTS: Forty-one procedures were carried out in children (median age: 14.9 years). Thirty-one patent foramen ovales were closed after a transient ischaemic attack or stroke, six for a left-to-right shunt and four for other reasons. Transthoracic echocardiography was used for 72.2% of the diagnoses and transoesophageal echocardiography for 27.8%. A substantial degree of shunting was found in 42.9% of patients and an atrial septal aneurysm in 56.2%. General anaesthesia with transoesophageal echocardiography guidance was performed in 68.3% of the procedures; local anaesthesia and transthoracic echocardiography or intracardiac echocardiography was performed in 31.7%. The success rate was 100%. The median fluoroscopy time was 4.14minutes: 3.55minutes with transoesophageal echocardiography; and 4.38minutes with transthoracic echocardiography (P=0.67). There was only one periprocedural complication (2.4%). Postoperatively, 80,5% of patients were treated with aspirin and 12,2% with an anticoagulant. The rate of complete occlusion was 56.8% immediately after the procedure, 68.6% at 1 year and 92.3% at the last follow-up. There were no delayed complications or cases of recurrent stroke during follow-up (median follow-up: 568 days). CONCLUSION: Closure of patent foramen ovale in children appears to be safe and effective, as we noted a low rate of immediate complications, no delayed complications and no stroke recurrence in this indication.

Percutaneous closure of patent ductus arteriosus in premature infants: A French national survey.

BACKGROUND: Transcatheter closure of patent ductus arteriosus (PDA) in premature infants has been shown to be feasible in small series. Outcomes in larger series are currently lacking. MATERIAL: All premature infants (< 36 weeks GA) who underwent transcatheter PDA closure were included in a multicenter French national survey. Demographic data (gestational age [GA], birth weight [BW]) and procedural data (weight [PW], age at procedure [AP], procedural success, fluoroscopy time, and type of device) were collected. Outcomes and procedural complications were reviewed. RESULTS: Between September 2013 and June 2017, 102 patients were included. In 71 cases, PDA pharmacological closure had been attempted. Mean GA was 27 ± 2.9 weeks. Mean BW and PW were 1,040 ± 715 g and 1,543 ± 698 g, respectively. Mean AP was 39 ± 26 days. Number of premature infants <1 kg, between 1 and 2 kg, and > 2 kg was 21, 59, and 22, respectively. Mean fluoroscopic time was 6.5 min. Success rate was 99%. Device- or procedure-related complications were reported in nine patients (8.9%) including three LPA stenoses (requiring surgery in two and balloon dilatation in one), two neo-coarctations (one requiring subsequent surgery), and three instances of tricuspid valve regurgitation at follow-up. Seven deaths were reported, none being related to the procedure. Mean follow-up was 39.75 ± 13.1 months. CONCLUSION: In this large series of premature infants undergoing transcatheter PDA closure, it was demonstrated that this procedure can be performed successfully in the vast majority of patients with an acceptable complication rate. Future efforts should focus on minimizing complications, particularly device-related vascular stenoses.

Validation of intracardiac shunt using thoracic bioimpedance and inert gas rebreathing in adults before and after percutaneous closure of atrial septal defect in a cardiology research unit: study protocol.

INTRODUCTION: Intrathoracic shunt quantification is a major factor for appropriate clinical management of heart and pulmonary diseases. Intracardiac shunts quantified by pulmonary to systemic output ratio (Qp/Qs) are generally assessed by Doppler echocardiography, MRI or catheterisation. Recently, some authors have suggested the concomitant use of thoracic bioimpedance (TB) and inert gas rebreathing (IGR) techniques for shunt quantification. The purpose of this study is to validate the use of this approach under conditions where shunt fraction is directly quantified such as in patients with isolated atrial septal defect (ASD). METHODS AND ANALYSIS: This trial is a prospective, observational single-centre, non-blinded study of adults seen for percutaneous closure of ASD. Qp/Qs ratio will be directly measured by Doppler echocardiography and direct Fick. IGR and TB will be used simultaneously to measure the cardiac output before and after closure: the ratio of outputs measured by IGR and TB reflecting the shunt fraction. The primary outcome will be the comparison of shunt values measured by TB-IGR and Doppler echocardiography. ETHICS AND DISSEMINATION: The study has been approved by an independent Research Ethics Committee (2017-A03149-44 Fr) and registered as an official clinical trial. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03437148; Pre-results.

Usefulness of intracardiac echocardiography for the diagnosis of infective endocarditis following percutaneous pulmonary valve replacement.

Infective endocarditis is a serious complication occurring after percutaneous pulmonary valve replacement with a Melody valve; it is of uncertain incidence, and presents a challenging diagnosis. Vegetations may be difficult to visualise with transthoracic and transoesophageal echocardiography. We report the role of intracardiac echocardiography in this condition by confirming the prosthesis involvement.

Stenting in paediatric and adult congenital heart diseases: A French multicentre study in the current era.

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.

Effect of pulmonary valve replacement on left ventricular function in patients with tetralogy of Fallot.

Pulmonary valve regurgitation is the most common complication after complete repair of tetralogy of Fallot. The benefits of pulmonary valve replacement (PVR) on right ventricular (RV) volumes is well established. However, the effect on left ventricular (LV) function is still debated. We aimed to determine the evolution of LV function after PVR and assess the contribution of the interventricular septum (IVS) motion. A total of 21 patients (mean age 30.1 ± 14.1 years) presenting with a history of complete repair of tetralogy of Fallot and requiring PVR prospectively underwent cardiac magnetic resonance imaging before and after PVR to measure the end-diastolic volume (EDV), end systolic volume, and ejection fraction for the LV and RV chambers. Maximal excursion of the IVS was also calculated to quantify abnormal septal motion. The LV-EDV and LV-end systolic volume was 80 ± 27 and 40 ± 19.5 ml/m(2) before PVR and 81.5 ± 23 and 35 ± 14 ml/m(2) after PVR, respectively, leading to a significant increase in LV ejection fraction of 6.1 ± 4.9% (51 ± 8.2% before and 57 ± 6.8% after PVR, p = 0.0003). Also, a significant reduction in RV-EDV (p = 0.0001) and RV end-systolic volume (p = 0.0001) was seen but without improvement in the RV ejection fraction. The maximum IVS excursion decreased after PVR (9.2 ± 3.4 mm before and 6.8 ± 3.6 mm after; p = 0.002). LV ejection fraction improvement correlated with RV-EDV before PVR (ρ = 0.43; p = 0.049). The maximum IVS excursion correlated with RV-EDV before and after PVR but was independent of LV ejection fraction improvement. In conclusion, the results of the present study have demonstrated a significant improvement in LV ejection fraction after PVR that correlated with the pre-PVR RV-EDV but was independent of IVS motion improvement.