Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry.

OBJECTIVES: The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position. BACKGROUND: The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI). METHODS: From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included. RESULTS: The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and 3 patients had undergone surgical reintervention (44%). CONCLUSIONS: Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success.

Infective Endocarditis Risk After Percutaneous Pulmonary Valve Implantation With the Melody and Sapien Valves.

OBJECTIVES: This study compared the risk of infective endocarditis (IE) after percutaneous pulmonary valve implantation (PPVI) with the Sapien and Melody valves. BACKGROUND: The incidence of IE after PPVI is estimated at 3% per year with the Melody valve. The Sapien valve is a more recently marketed valve used for PPVI. METHODS: We retrospectively included consecutive patients who underwent PPVI at a single center between 2008 and 2016. IE was diagnosed using the modified DUKE criteria. RESULTS: PPVI was performed in 79 patients (Melody valve, 40.5%; Sapien valve, 59.5%). Median age was 24.9 years (range 18.1 to 34.6). IE occurred in 8 patients (10.1%) at a median of 1.8 years (minimum: 1.0; maximum: 5.6) after surgery. Causative organisms were methicillin-sensitive Staphylococcus aureus (n = 3), Staphylococcus epidermidis (n = 1), Streptococcus mitis (n = 1), Aerococcus viridans (n = 1), Corynebacterium striatum (n = 1), and Haemophilus influenzae (n = 1). All 8 cases occurred after Melody PPVI (25.0% vs. 0.0%). The incidence of IE was 5.7% (95% confidence interval: 2.9% to 11.4%) per person-year after Melody PPVI. The Kaplan-Meier cumulative incidence of IE with Melody PPVI was 24.0% (95% confidence interval: 12.2% to 43.9%) after 4 years and 30.1% (95% confidence interval: 15.8% to 52.5%) after 6 years, compared with 0.0% with the Sapien PPVI after 4 years (p < 0.04 by log-rank test). There was a trend toward a higher incidence of IE in the first 20 patients with Melody PPVI (who received prophylactic antibiotics during the procedure only) and in patients who had percutaneous interventions, dental care, or noncardiac surgery after PPVI. CONCLUSIONS: IE after PPVI may be less common with the Sapien compared with the Melody valve.

Closure of Isolated Congenital Coronary Artery Fistula: Long-Term Outcomes and Rate of Re-intervention.

Long-term outcome after closure of isolated congenital coronary artery fistula (ICCAF) is poorly documented. To assess late outcome after ICCAF closure, a 1983-2013 retrospective study included all patients who attempted an ICCAF closure and whose follow-up was ≥1 year. ICCAF was diagnosed in 23 patients [median age 6.9 years (0.1-70.5 years), 13 children]. ICCAF was symptomatic in 12 patients (52.2 %). First intervention was either a transcatheter embolization (n = 19 patients, 82.6 %) or a surgical ligation (n = 4 patients, 17.4 %). After a follow-up of 9.0 years (2.8-33.5), neither death nor late ischemic event occurred but one patient was transplanted, because of postoperative myocardial infarction. Late ICCAF recanalization occurred in eight patients, leading to successful embolization of the shunt in all patients after a delay of 9.8 years (5.7-13.8 years) from the first intervention. Re-intervention occurred later in children (p = 0.0027), with a 50 and 37.5 % freedom from re-intervention in adults compared to a 100 and 89.0 % in children, respectively, at 1 and 6 years of follow-up. At last follow-up, coronary artery diameter had decreased from a mean z score of 12.0 ± 7.7 to a mean z score of 6.0 ± 6.0 (p = 0.002). Long-term outcome after ICCAF closure is excellent, with neither death nor late ischemic event, and a significant decrease in coronary artery diameter with time. Late follow-up is of paramount importance, as one-third of patients will require a re-intervention for late shunt recanalization.

Catheter-based interventions for modified Blalock-Taussig shunt obstruction: a 20-year experience.

Thrombotic occlusion of a modified Blalock-Taussig (BT) shunt is rare, leading to life-threatening hypoxemia. Rescue percutaneous interventions may allow recanalization of the systemic-to-pulmonary shunt but data on large patients' scales are lacking. We aimed to describe safety and effectiveness of catheter-based interventions to restore modified BT shunt patency. All patients who attempted transcatheter intervention for thrombotic occlusion of a modified BT shunt at our Institution from 1994 to 2014 were reviewed. Characteristics, management, and outcomes of the 28 identified patients were analyzed. Thirty-three procedures were performed at a median age of 0.6 years old (range 0.03-32.1 years) and a median weight of 5.8 kg (range 2.2-82 kg). Percutaneous intervention consisted in 33 balloon angioplasty (100 %) and 14 stent implantations (42.4 %). Thrombolytic agents were also used in 6.1 % cases. No peri-procedural death occurred but complications were observed in five patients (15.2 %), including one catheter-induced transient complete atrioventricular block, one cardiac tamponade, and one massive thrombo-embolic stroke. Early procedural success was obtained in 28 patients (84.8 %) and remained long-lasting in 26 patients (78.8 %). A young age and a low body-weight at the time of the procedure were significantly associated with procedural failure (p = 0.0364 and p = 0.0247, respectively). Although technically challenging and carrying potential major complications, transcatheter intervention can be considered as an efficient rescue strategy to restore patency in case of thrombotic obstruction of a modified BT shunt.

Closure of tubular patent ductus arteriosus with the Amplatzer Vascular Plug IV: feasibility and safety.

BACKGROUND: Closure of tubular patent ductus arteriosus remains a challenging procedure. Anecdotal use of Amplatzer Vascular Plug IV for tubular ductus closure has been reported but feasibility and safety in a consecutive patients' series remain unknown. METHODS: We performed a monocenter prospective study at the Marie Lannelongue Hospital in Paris, France. From 2009 to 2014, a total of 47 patients (39 infants, 3 children, and 5 adults) underwent ductus closure with the Plug IV. RESULTS: Ductus morphology was a type E in 34 (72.3%) patients and a type C in 13 (27.7%) patients. Ductus closure occurred in 39 (83.0%) infants at a median age of seven months (range: 3-23 months) and a median weight of 6.9 kg (range: 4.1-17.0 kg). A past history of prematurity and very low birth weight was found in 33 (70.2%) of them. Twelve (25.5%) patients had pulmonary hypertension. Mean Plug IV diameter was 1.9 ± 0.1 mm larger than the mean maximal ductus diameter. Early complete closure of the ductus was obtained in all patients. Early migration of an undersized Plug IV occurred in one (2.1%) patient and was suitable for percutaneous device retrieval. After a mean follow-up of 3.4 ± 1.4 years, all patients are alive and asymptomatic, no late complication occurred. CONCLUSION: Transcatheter closure of tubular ductus with the Amplatzer Vascular Plug IV can be safe and effective, with a 100% early occlusion rate. This device, suitable for a 4F sheath, is a new alternative for tubular ductus closure in low-body-weight infants.

[Management of the traumatic aortic blunt injury in 2014]. / Traitement des ruptures traumatiques de l'isthme aortique en 2014.

Diagnosis of blunt thoracic aortic injury (BAI) should be considered in any serious polytrauma. The diagnosis is mainly based on the CT scan at baseline. Life-threatening lesions are often associated with BAI. Hospital mortality is mainly due to associated lesions. Except the complete rupture of the aorta, treatment should be initiated after hemodynamic and respiratory stabilization of the patient and after the treatment of a lesion involving the immediate prognosis. Endovascular treatment of BAI became the treatment of choice, especially for patients with severe associated injuries and bleeding risk. Additional data on the long-term stents are necessary in these young patients. Conventional surgical treatment is always indicated for young subjects with stable hemodynamic, low risk of bleeding and when surgery may be delayed several hours.

Transcatheter tricuspid valve implantation: a multicentre French study.

BACKGROUND: Transcatheter valve-in-valve (VIV) implantation in failing bioprosthesis is an emerging field in cardiology. AIM: To report on a French multicentre experience and a literature review of tricuspid VIV implantation. METHODS: We approached different institutions and collected 10 unpublished cases; a literature review identified 71 patients, including our 10 cases. Clinical aspects and haemodynamic data are discussed. RESULTS: Among our 10 unpublished cases, the reason for implantation was significant tricuspid stenosis (n = 4), significant tricuspid regurgitation (n = 1) or mixed lesion (n = 5). Implantation was performed under general anaesthesia at mean age 28 ± 17 years. The 22 mm Melody valve was implanted in seven patients; the Edwards SAPIEN valve was implanted in three patients. The procedure succeeded in all cases, despite two embolizations in the right cardiac chambers; in both cases, the valve was stabilized close to the tricuspid annulus using a self-expandable stent, before implantation of a second Edwards SAPIEN valve. Functional class improved in all but one case. Mean diastolic gradient decreased from 9 ± 2.45 mmHg to 3.65 ± 0.7 mmHg (p = 0.007); no more than trivial regurgitation was noticed. Among the published cases, the Melody valve was implanted in 41 patients, the Edwards SAPIEN valve in 29 patients and the Braile valve in one patient. Short-term results were similar for our 10 cases, but mid-term results are not yet available. CONCLUSIONS: Tricuspid VIV implantation using the Melody or Edwards SAPIEN valves is a feasible and effective procedure for selected patients with failing bioprosthesis.

[Surgical treatment of chronic thromboembolic pulmonary hypertension]. / Traitement chirurgical de l'hypertension pulmonaire post-embolique.

Chronic thromboembolic pulmonary hypertension is a rare but underdiagnosed disease. The development of imaging played a crucial role for the screening and the decision of operability over the past few years. Indeed, chronic thromboembolic pulmonary hypertension is the only type of pulmonary hypertension with a potential curative treatment: pulmonary endarterectomy. It is a complexe surgical procedure performed under cardiopulmonary bypass with deep hypothermia and circulatory arrest. The aim of the procedure is to completely remove the scar tissue inside the pulmonary arteries down to the segmental and sub-segmental levels. Compared to lung transplantation, which carries a postoperative mortality of 15-20% and a 5-year survival of 50%, pulmonary endarterectomy is a curative treatment with a postoperative mortality of less than 3%. However, lung transplantation remains an option for young patients with inoperable distal disease or after pulmonary endarterectomy failure. Considering that medical history of deep venous thrombosis or pulmonary embolism is lacking in 25 to 50%, the diagnosis of chronic thromboembolic pulmonary hypertension remains challenging. The lung V/Q scan is useful for the diagnosis showing ventilation and perfusion mismatches. Lesions located at the level of the pulmonary artery, the lobar or segmental arteries may be accessible to surgical removal. The pulmonary angiogram with the lateral view and the pulmonary CT scan help to determine the level of the intravascular lesions. If there is a correlation between the vascular obstruction assessed by imaging and the pulmonary resistance, pulmonary endarterectomy carries a postoperative mortality of less than 3% and has a high rate of success. If the surgery is performed at a later stage of the disease, pulmonary arteriolitis developed mainly in unobstructed territories and participated in the elevated vascular resistance. At this stage, postoperative risk is higher.

Complications of congenital portosystemic shunts in children: therapeutic options and outcomes.

BACKGROUND AND OBJECTIVE: Congenital portosystemic shunts are rare vascular malformations that lead to severe complications. Their management is controversial. The aim of this study was to propose a clear definition of the risks and management of congenital portosystemic shunts in children according to our experience and a review of the literature. PATIENTS AND METHODS: Twenty-two children with a complicated congenital portosystemic shunt were studied in our institution. When necessary, management included portal pressure measurement and portal vein angiography during an occlusion test and closure of the shunt by surgical and/or endovascular methods. RESULTS: Five neonates with intrahepatic shunts presented with cholestasis that resolved spontaneously, and 17 older children presented with liver tumors (13) and/or hepatopulmonary syndrome (2), pulmonary artery hypertension (3), portosystemic encephalopathy (3), heart failure (1), and glomerulonephritis (1). The portosystemic shunt was extrahepatic (11) or intrahepatic (6). Portosystemic shunts were closed by endovascular methods in 5 children and surgically in 10, 4 of whom had portal pressure during occlusion above 35 mmHg and extremely hypoplastic or undetectable portal veins requiring banding of the fistula before closure. Shunt closure resulted in restoration of intrahepatic portal flow in all, with complete or partial regression of benign liver masses, and regression or stabilization of pulmonary, cardiac, neurological, and renal complications. CONCLUSIONS: Congenital portosystemic shunt carries risks of severe complications in children. Closure of a shunt persisting after age 2 years should be considered preventively. Intrahepatic portal flux restoration can be expected, even when intrahepatic portal veins are extremely hypoplastic or undetectable.

Multicenter safety and efficacy analysis of assisted closure after antegrade arterial punctures using the StarClose device.

PURPOSE: To evaluate the safety and efficacy of the StarClose device for closure of antegrade punctures following infrainguinal endovascular interventions. METHODS: A retrospective review was conducted of 221 consecutive patients treated with the StarClose device in a 12-month period at 5 centers (4 French and 1 British). Of these, 107 patients (69 men; median age 75 years, range 44-93) were from the UK cohort (111 closures), and 94 patients (75 men; median age 67 years, range 32-95) were from the French cohort (111 closures). Technical success, complication rates, demographic data, medical history, and procedural details were gathered for all patients. Residual bleeding and the requirement for additional manual compression were recorded when the device failed. Clinical evaluation was performed at discharge; color-coded duplex ultrasonography was done in a subset of French patients. RESULTS: The overall technical success rate was 94.6% (210/222; 95% CI 3.1%-9.2%). The results were similar in the 2 cohorts: 95.5% (106/111; 95% CI 1.9%-10.1%) in the UK and 93.7% (104/111; 95% CI 3.1%-12.4%) in France. The 12 failures (5 UK and 7 France) were due to several mechanisms: device failure (n=5), obesity (n=1), groin scarring (n=2), and unexplained (n=4). In 2 failed cases, open surgical closure of the arteriotomy was performed because pressure hemostasis failed. Two pseudoaneurysms were observed: one after immediate failure was successfully treated by prolonged pressure; the other, after apparent success of the device, required surgical therapy. The incidence of serious vascular complication was 1.8% (4/222; 95% CI 0.7%-4.5%); 2 patients from each cohort. CONCLUSION: The StarClose device safely and effectively closes antegrade punctures after infrainguinal endovascular intervention, even in patients who would be considered to be at high risk for puncture-site bleeding. However, a randomized trial would be required to support any definitive recommendations.

Acute myocardial infarction early viability assessment by 64-slice computed tomography immediately after coronary angiography: comparison with low-dose dobutamine echocardiography.

OBJECTIVES: Early evaluation of myocardial viability in acute myocardial infarction is useful to guide therapy. Therefore, we assessed 64-slice computed tomography (CT) immediately after coronary angiography in this setting. BACKGROUND: Recent preliminary studies have shown the promising usefulness of late hyperenhancement multislice computed tomography (MSCT) for non-viability assessment. METHODS: Thirty-six patients admitted for a first acute myocardial infarction had a coronary angiogram early after admission followed by 64-slice CT without iodine reinjection. The 16 segments of the left ventricle depicted by the American Society of Echocardiography were graded: no, subendocardial, or transmural hyperenhancement. No or subendocardial hyperenhancement were expected to reflect viability. Two to 4 weeks later, the same segments' contractility was evaluated at rest. Low-dose dobutamine echocardiography was performed in case of akinetic segment at rest. RESULTS: Mean delay between coronary angiography and MSCT was 24 +/- 11 min (range 7 to 51 min). We compared 576 segments evaluated by each method. Agreement was noted for 560 segments (97%) and disagreement for 16 segments (3%). Thus, 64-slice CT after coronary angiography for an acute myocardial infarction had 98% sensitivity, 94% specificity, 97% accuracy, and 99% positive and 79% negative predictive values for detecting viable myocardial segments at a very early stage of an acute myocardial infarction. On a per-patient analysis, sensitivity, specificity, accuracy, and positive and negative predictive values were 92%, 100%, 94%, and 100% and 85%, respectively. CONCLUSIONS: A 64-slice CT after coronary angiography for an acute myocardial infarction is a promising method for early evaluation of viable myocardium.

Coronary stenosis detection by 16-slice computed tomography in heart transplant patients: comparison with conventional angiography and impact on clinical management.

OBJECTIVES: We sought to find a non-invasive alternative to conventional coronary angiography (CCA) for serial detection and follow-up of coronary stenosis due to cardiac allograft vasculopathy in heart transplant patients. BACKGROUND: Cardiac allograft vasculopathy is the main factor limiting long-term success of heart transplantation. It is usually detected by CCA. Multislice computed tomography (MSCT) coronary angiography has recently proven effective for the diagnosis of coronary stenosis in non-transplant patients. METHODS: Fifty-three consecutive heart transplant patients underwent MSCT within 24 h before or after their annual routine CCA. Only angiographic segments >1.5 mm were considered for analysis; the coronary arterial tree was divided into nine segments. Three patients were excluded because of technical failure. RESULTS: Of the 450 angiographic coronary segments, 432 (96%) were evaluable by MSCT. Of the nine coronary stents in seven patients, only three, including one intrastent restenosis, were correctly evaluated by MSCT, and two intrastent restenoses were missed. Complete analysis of the coronary tree was possible for 44 (88%) of the 50 patients. For detection of coronary stenosis >50%, sensitivity was 83%, specificity 95%, positive predictive value 71%, negative predictive value 95%, and accuracy 93%. In the 22 patients with strictly normal MSCT, no stenosis was found by CCA. CONCLUSIONS: Our study suggests the following guidelines already applied in our institution: 16-slice MSCT can replace CCA in de novo heart transplant patients and patients with strictly normal MSCT at follow-up. Significant wall or lumen changes observed on annual MSCT or stents require further investigation by CCA.