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Background: In patients undergoing balloon pulmonary angioplasty (BPA) for inoperable chronic thromboembolic pulmonary hypertension (CTEPH), single-centre series from expert centres have recognized a learning curve for the magnitude of haemodynamic benefits., Objective: To report our 7-year experience with BPA, focusing on haemodynamic effects, complication rates and radiation exposure over time., Methods: Patients with CTEPH who were treated with BPA between May 2013 and February 2020 were analysed during the 'initial period' versus the 'recent period' (split date: March 2017)., Results: Among 192 patients who underwent at least one BPA procedure, 156 were included in the safety/radiation analysis and 119 were included in the efficacy analysis. During the 'recent period' versus the 'initial period', the median [interquartile range] number of procedures per patient was higher (4.5 [4.0-6.0] vs. 4.0 [3.0-4.0]; P=0.03), as was the number of dilated vessels per procedure (4.0 [3.5-5.0] vs. 3.5 [3.0-4.0]; P=0.002). Changes in haemodynamic parameters were also greater (mean pulmonary artery pressure: -22% [-31% to -14%] vs. -37% [-44% to -29%]; P=0.001; pulmonary vascular resistance: -38% [-51% to -8%] vs. -53% [-69% to -33%]; P=0.002); complication rates were similar (5.7% vs. 9.3% of procedures; P=0.38); and radiation exposure was lower (effective dose per patient: 43.9 [31.6-66.5] vs. 67.8 [47.9-101.9] mSv; P<0.001)., Conclusion: Our analysis is consistent with a learning curve for the magnitude of haemodynamic improvements. The complication rate was low and did not change over time, but radiation exposure decreased., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Background: Transcatheter closure of a patent ductus arteriosus in children is widely performed to reduce symptoms and decrease the risk of endocarditis. Most arterial ducts are closed successfully with dedicated devices. However, in a tubular or "type C" patent ductus arteriosus with congestive heart failure, the occlusion is more challenging with these devices, with a higher risk of complications, such as aortic or left pulmonary stenosis and device embolization., Aim: To report our experience with muscular ventricular septal defect devices for patent ductus arteriosus occlusion in small children., Methods: Retrospective observational series of patients weighing<10kg, with a tubular patent ductus arteriosus (typeC) and congestive heart failure, who underwent transcatheter closure with a muscular ventricular septal defect device between 2017 and 2019., Results: Eight patients were included. The mean age and weight at closure were 6.3 months (range 1-18 months) and 5.3kg (range 2.4-8.2kg), respectively. All patent ductus arteriosus were occluded successfully using Occlutech® (N=3) or Amplatzer® (N=5) muscular ventricular septal defect devices. In four cases, the muscular ventricular septal defect device was used after failure to close the patent ductus arteriosus with a dedicated patent ductus arteriosus device. Two patients had mild left pulmonary artery stenosis, with a maximum velocity on continuous Doppler of 3m/s and 2.7m/s, respectively. After a mean follow-up of 28 months (range 14-41 months), all patients were asymptomatic with excellent results. The mild pulmonary stenosis improved, with a maximum velocity of 2.3m/s in both patients., Conclusions: Closure of tubular patent ductus arteriosus in small children with congestive heart failure using a muscular ventricular septal defect device is safe in this preliminary experience. Further studies with more patients are warranted., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Acute pulmonary embolism is a frequent cardiovascular emergency with an increasing incidence. The prognosis of patients with high-risk and intermediate-high-risk pulmonary embolism has not improved over the last decade. The current treatment strategies are mainly based on anticoagulation to prevent recurrence and reduce pulmonary vasculature obstruction. However, the slow rate of thrombus lysis under anticoagulation is unable to acutely decrease right ventricle overload and pulmonary vasculature resistance in patients with severe obstruction and right ventricle dysfunction. Therefore, patients with high-risk and intermediate-high-risk pulmonary embolism remain a therapeutic challenge. Reperfusion therapies may be discussed for these patients, and include systemic thrombolysis, catheter-directed therapies and surgical thrombectomy. High-risk patients require systemic thrombolysis, but may have contraindications as a result of the high risk of bleeding. In addition, intermediate-high-risk patients should not receive systemic thrombolysis, despite its high efficacy, because of prohibitive bleeding complications. Recently, percutaneous reperfusion techniques have been developed to acutely decrease pulmonary vascular obstruction with lower-dose or no thrombolytic agents and, thus, potentially higher safety than systemic thrombolysis. Some of these techniques improve key haemodynamic variables. Cardiac surgical techniques and venoarterial extracorporeal membrane oxygenation as temporary circulatory support may be useful in selected cases. The development of pulmonary embolism centres with multidisciplinary pulmonary embolism teams is mandatory to enable adequate use of reperfusion and improve outcomes. We aim to present the state of the art regarding reperfusion therapies in pulmonary embolism, but also to provide guidance on their indications and patient selection., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: The indications for percutaneous pulmonary valve implantation (PPVI) have been extended to include large dysfunctional right ventricular outflow tracts (RVOTs). Prestenting of the RVOT is commonly performed before PPVI in order to ensure a stable landing zone. The AndraStent XXL (AndraMed GmbH, Reutlingen, Germany), a cobalt-chromium stent with semi-open cell design, has unique mechanical properties in this indication but is no longer available in France., Aims: To assess the efficiency of AndraStent XXL before PPVI., Methods: In this retrospective multicentre cohort study, 86 AndraStents XXL were implanted in 77 patients in 6 centres., Results: PPVI was indicated mainly for pulmonary regurgitation (75.3%) in native or patched RVOT (88.3%). The stents were manually mounted on balloon catheters and delivered through sheaths using a conventional femoral approach. PPVI was performed successfully in 97.4% of patients after successful prestenting, generally during the same procedure (77.9%). There were no deaths associated with stent implantation, and four patients experienced five complications, mainly stent embolization, including one requiring surgery. Neither stent fracture nor dysfunction were observed in any patient during a mean follow-up of 19.2±8.7months. Stent analysis showed an excellent maximal stent expansion (97.1%) regardless of balloon size. A 22.3%±3.4 stent shortening with a 30mm balloon was observed., Conclusions: Implantation of large cobalt-chromium AndraStent XXL stents is efficient for prestenting before PPVI., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: Percutaneous pulmonary valve implantation (PPVI) is a routine treatment for dysfunctional right ventricular outflow tract. Infective endocarditis (IE) is a major concern., Aim: To report French experience with the Melody™ valve (Medtronic Inc., Minneapolis, MN, USA)., Methods: 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., Results: 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)., Conclusion: 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., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Background: Percutaneous paravalvular leak (PVL) closure has emerged as a palliative alternative to surgical management in selected high-risk patients. Percutaneous procedures are challenging, especially for mitral PVL. Accurate imaging of the morphologies of the defects is mandatory, together with precise guidance in the catheterization laboratory to enhance success rates., Aims: To describe imaging modalities used in clinical practice to guide percutaneous PVL closure and assess the potential of new imaging tools., Methods: Data from the 'Fermeture de Fuite paraprothétique' (FFPP) register were used. The FFPP register is an international multi-institutional collaborative register started in 2017 with a retrospective and a prospective part. A descriptive analysis of multimodality imaging used to guide PVL closure in clinical practice was performed., Results: Data from 173 procedures performed in 19 centres from three countries (France, Belgium and Poland) were collected, which included eight cases of PVL following transcatheter valve replacement. Transoesophageal echocardiography was used in 167 cases (96.5%) and 3D echocardiography in 87.4% of cases. In one case, 3D-echocardiography was fused with fluoroscopy images in real time using echonavigator software. Details about multimodality imaging were available from a sample of 31 patients. Cardiac computed tomography (CT) was performed before 10 of the procedures. In one case, fusion between preprocedural cardiac CT angiography data and fluoroscopy data was used. In two cases, a 3D model of the valve with PVL was printed., Conclusion: Echocardiography, particularly the 3D mode, is the cornerstone of PVL imaging. Other imaging modalities, such as cardiac CT and cardiac magnetic resonance imaging, may be of complementary interest. New techniques such as imaging fusion and printing may further facilitate the percutaneous approach of PVLs., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Nowadays, guidelines are derived from the findings of randomized controlled therapeutic trials. However, an overall significant P value does not exclude that some patients may be harmed by or will not respond to the therapeutic agent being studied. Trials in patients with a low risk of events and/or a limited chance of providing significant differences in therapeutic effects require a large patient population to demonstrate a beneficial effect. Composite efficacy endpoints are often employed to obviate the need for a large patient population when low rates of events or limited therapeutic efficacy are anticipated. Results of randomized controlled therapeutic trials are commonly expressed in terms of relative risk reduction, whereas absolute risk reduction allows the calculation of the "number needed to treat" to prevent an adverse outcome. The number needed to treat is a far more clinically relevant variable than relative risk reduction. The clinician's mission is to match treatment to patient with the goal of achieving optimal therapeutic response. Drug-safety monitoring is also of major importance to avoid exposing patients to irreversible adverse effects. Unfortunately, drug-safety monitoring is often overlooked in routine clinical practice. Finally, the lack of long-term therapeutic data (>5-10 years) is an unsolved dilemma, as most trials are limited to a duration of a few months or years., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

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., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Background: Compliance with guidelines for the management of ST-segment elevation myocardial infarction (STEMI) may be difficult in hard-to-access areas., Aims: to analyse the characteristics, management and outcome of STEMIs occurring at altitude in the French Alps and managed by mobile medical emergency units., Methods: From January 2006 to December 2008, from the prospective RESURCOR registry, 114 patients with a STEMI of less than 12 hours' duration, occurring in a ski resort or at high altitude and managed by the RESURCOR care system, were identified. Baseline characteristics, treatments and in-hospital outcomes were analysed., Results: Ninety-three per cent of patients were men; the mean age was 57 years. STEMIs occurred during or less than 1 hour after physical activity in 76.3% of cases (mainly during or after alpine/cross-country skiing). Killip class greater or equal to 2 and cardiac arrest were observed in 35% and 7.9% of cases, respectively. Fifty-two (45.6%) patients underwent thrombolysis and 62 (54.4%) had percutaneous coronary intervention (PCI). Median delays were: first call to treatment, 82 min (17-230 min); symptoms to treatment, 165 min (52-770 min). All delays were significantly longer for PCI than for thrombolysis. First call to treatment delay was less than 120 min in 98.1% of patients who underwent thrombolysis and in 51.6% who had PCI (P<0.0001). In-hospital survival was 96.5%., Conclusion: Altitude STEMIs happen mainly during sporting activities. Clinical presentation is often severe, but an emergency coronary care network allows rapid reperfusion. These findings emphasize the need for an efficient network for STEMI management in geographically difficult-to-access areas., (2010 Elsevier Masson SAS. All rights reserved.)