Sophie Malekzadeh-Milani

Melody® transcatheter pulmonary valve implantation: Results from a French registry

BACKGROUND Percutaneous implantation of pulmonary valves has recently been introduced into clinical practice. AIM To analyse data of patients treated in France between April 2008 and December 2010. METHODS Prospective, observational, multi-centric survey by means of a database registry of the Filiale de cardiologie pédiatrique et congénitale. RESULTS Sixty-four patients were included, with a median (range) age of 21.4 (10.5-77.3) years. The majority (60.9%) of the patients were New York Heart Association (NYHA) class II. The most common congenital heart disease was tetralogy of Fallot with or without pulmonary atresia (50%). Indication for valve implantation was stenosis in 21.9%, regurgitation in 10.9% and association of stenosis and regurgitation in 67.2%. Implantation was successful in all patients. Pre-stenting was performed in 96.9% of cases. Median (range) procedure time was 92.5 (25-250) minutes. No significant regurgitation was recorded after the procedure, and the trans-pulmonary gradient was significantly reduced. Early minor complications occurred in five cases (7.8%). Three patients died during a median follow-up of 4.6 (0.2-5.2) years, two from infectious endocarditis and one from end-stage cardiac failure. Surgical reintervention was required in three patients. Follow-up with magnetic resonance imaging demonstrated significant improvements in right ventricular volumes and pulmonary regurgitation in mixed and regurgitant lesions. CONCLUSIONS Transcatheter pulmonary valve implantation is highly feasible and mid-term follow-up demonstrates sustained improvement of right ventricular function. Late endocarditis is of concern, therefore longer follow-up in more patients is urgently needed to better assess long-term outcome. CLINICAL TRIAL REGISTRATION NCT01250327.

Incidence and predictors of Melody ® valve endocarditis: A prospective study

BACKGROUND Percutaneous pulmonary valve replacement (PPVR) has achieved standard of care for the management of dysfunctional right ventricular outflow tract. AIM Because of increasing reports of Melody(®) valve (Medtronic, Inc., Minneapolis, MN, USA) infective endocarditis (IE), we aimed to evaluate its incidence and predictors of occurrence. METHODS We collected data on all patients who received a Melody valve in the pulmonary position from 2009 to 2012. RESULTS A total of 86 consecutive patients underwent PPVR from 2009 to 2012; of these, five developed IE (5.8%). Freedom from IE was 91% at 50 months. Baseline demographics, type of conduit, PPVR procedural success, residual gradients and in situ duration of Melody valve were similar in IE and non-IE patients. A significant number of IE patients had additional unprotected invasive procedures during follow-up and abruptly discontinued antiplatelet therapy (P=0.0139 and P=0.002, respectively). The cumulative probability of survival without cardiovascular events for IE patients was 20% at 20 months, compared with 98.1% for non-IE patients (P<0.0001). Death was statistically associated with IE. CONCLUSION Early- and late-onset IE of the Melody valve is emerging as a catastrophic complication of PPVR. Abrupt aspirin discontinuation and additional unprotected invasive procedures during follow-up are significant predictors of Melody valve IE. Owing to its rapidly progressive nature, aggressive invasive management should not be delayed.

Incidence and outcomes of right-sided endocarditis in patients with congenital heart disease after surgical or transcatheter pulmonary valve implantation

OBJECTIVES To evaluate right-sided endocarditis and compare the incidence, clinical presentations, and outcomes in patients with a surgical and percutaneous pulmonary valve. METHODS All patients with infective endocarditis occurring between January 2009 and June 2013 were identified and studied. All consecutive patients who received a pulmonary valve surgically or by percutaneous pulmonary valve implantation (PPVI) during the same period were also evaluated for endocarditis. RESULTS During the study period, 31 patients were identified with right-sided endocarditis: 13 had valves implanted during the study period and 18 before. The person-time incidence rates of endocarditis were 1.2 and 3.9 cases/100 person-years in the surgical and PPVI groups, respectively (P=.03). Clinical presentations, microbiology, and outcomes were comparable in both groups. The implantation-endocarditis time interval was much shorter in the patients in the PPVI group (P=.0065). A past history of endocarditis was found to correlate with endocarditis (P=.004). Infective endocarditis was more frequent in patients with bovine jugular vein valves compared with others (7.1% vs 0.84%, P=.0117; odds ratio, 9). Probability of survival at 12, 24, and 36 months was 99.5%, 93.8%, 93.8% in the surgical group and 98.9%, 96.8%, 92.3% in the PPVI group, respectively (P=.6). Event-free probability including endocarditis was comparable (P=.1). CONCLUSIONS There is a higher incidence of endocarditis in patients with PPVI compared with surgical pulmonary valves. Clinical and biological features were comparable in both groups. The role of bovine jugular veins in the development of endocarditis is concerning. However, despite a higher incidence of endocarditis in the PPVI group, the probabilities of survival and event-free survival were similar to the surgical group.

Coronary artery compression during intention to treat right ventricle outflow with percutaneous pulmonary valve implantation: Incidence, diagnosis, and outcome

Evaluate the incidence, diagnosis, and outcome of coronary compression (CC) during right‐ventricular outflow tract interventions.

Results of transcatheter pulmonary valvulation in native or patched right ventricular outflow tracts

BACKGROUND Although widely accepted worldwide, indications for percutaneous valve replacement are limited to treatment of dysfunction of prosthetic conduits inserted in the right ventricular outflow tract (RVOT). There has been little evaluation of the use of the Melody(®) valve for patched non-circular pulmonary pathways. AIM To evaluate the outcomes of Melody valve insertion in patients with a patched non-circular RVOT. METHODS We analysed procedural and outcomes data from 34 patients who underwent Melody valve implantation for a non-circular RVOT. RVOT preparation was done in all patients, using different techniques (conventional, Russian doll and/or PA jailing). Melody valve insertion was performed concomitantly in most patients. RESULTS All procedures were successful. Sixteen patients had complex additional procedures, including the jailing technique (n=5), the Russian doll technique (n=6) and multiple stent implantations (Russian jailing; n=5). The remaining patients were treated using the conventional technique with systematic prestenting. Three early complications occurred: one haemoptysis; one residual RVOT obstruction needing recatheterization 48 hours after percutaneous pulmonary valve implantation; and one stent embolization during advancement of the Ensemble(®) delivery system. The mean follow-up period was 2.6 years postprocedure. There was no stent fracture, migration or embolization. Two patients developed a significant paraprosthetic leak and one received a second Melody valve. CONCLUSIONS Careful patient selection, balloon sizing and RVOT preparation with prestenting are required to create a safe landing zone for the Melody valve. Short-term follow-up shows excellent results with no stent fracture or migration and appears promising.

Patent Ductus Arteriosus Stenting (Transcatheter Potts Shunt) for Palliation of Suprasystemic Pulmonary Arterial Hypertension A Case Series

Idiopathic pulmonary arterial hypertension (IPAH) continues to be a progressive and fatal disease.1 Patients with congenital heart disease and PAH constitute a separate subset with Eisenmenger syndrome where the life expectancy is significantly better than patients with IPAH. Prior surgical series have reported improved survival after converting severe and refractory IPAH into an Eisenmenger physiology using a Potts shunt with direct side-to-side anastomosis.2–4 We describe a similar approach using a transcatheter technique by stenting residual or probe-patent ductus arteriosus (PDA) to establish a stable communication between descending thoracic aorta and left pulmonary artery in patients with severe suprasystemic PAH. During the past 5 years, we have performed cardiac catheterization in 28 IPAH patients and found 4 with a small or probe-patent PDA. One of these patients had infrasystemic PA pressures and did not undergo PDA stenting. The other 3 patients, whose data are summarized in the Table, had the PDA stented. Patient 1 was diagnosed with idiopathic PAH at the age of 6 months. Transthoracic echocardiography at the time of the diagnosis showed an atrial septal defect with left-to-right shunt and a small PDA. He remained stable on oral medications until 9.7 years of age when he presented with recurrent syncope. Severe right ventricular dilatation and bowing of the interventricular septum to the left were noted on transthoracic echocardiogram. Cardiac catheterization confirmed suprasystemic PAH and the presence of a small PDA shunting right-to-left with significant restriction (Figure 1). Figure 1. Angiographic views from the first case. A , Aortography in lateral view, showing …

Predictors and outcomes of right ventricular outflow tract conduit rupture during percutaneous pulmonary valve implantation: a multicentre study.

AIMS Conduit rupture is a serious complication encountered during percutaneous pulmonary valve implantation (PPVI). We sought to evaluate the incidence and predictors of conduit rupture during right ventricular outflow tract (RVOT) transcatheter treatment. METHODS AND RESULTS All consecutive patients who underwent transcatheter RVOT treatment from May 2008 to December 2011 were prospectively studied. Baseline demographics along with incidence, predictors and outcomes of conduit rupture with various transcatheter therapies were reviewed. Conduit rupture occurred in nine out of 99 patients (9.09%). All conduit ruptures occurred during balloon dilatation. Significant risk factors included heavy calcification (p<0.05, OR=16 [1.87-357]), and conduit type (homograft/others; p<0.05, OR=4.37 [1.1-17.8]). Other factors such as prolonged time interval between prior surgical RVOT repair and interventions, use of high-pressure balloons, balloon diameter, and overexpansion of conduit statistically failed to show any association. All patients were managed in the cardiac catheterisation laboratory. There were no delayed complications during a mean follow-up period of 2.3±0.95 years. CONCLUSIONS Conduit rupture is a serious complication. Heavy calcification and homograft conduit were significant predictors. Immediate diagnosis with the use of targeted interventional therapies should be attempted before proceeding with PPVI.

A new percutaneous pulmonary valve implantation technique for complex right ventricular outflow tracts: the "folded melody valve".

This article sought to describe a new modification of the Melody valve that allows percutaneous pulmonary valve implantation (PPVI) in complex outflow tracts.

Hyperacute flash pulmonary oedema after transcatheter pulmonary valve implantation: The melody of an overwhelmed left ventricle

Percutaneous transcatheter Melody Valve implantation has achieved standard of care for the management of certain patients with right ventricular outflow tract dysfunction. With its widespread use, some rare and potentially fatal complications, such as right ventricular outflow tract rupture and coronary artery compression, have been reported. We report hyperacute flash pulmonary oedema after Melody Valve implantation for the first time in two patients and describe some possible predictors.

Percutaneous valvulation of failing Fontan: Rationale, acute effects and follow-up

BACKGROUND Fontan circulation is fragile and unfavourable evolution is frequent. Fontan physiology largely depends on respiration and gravity. The hypothesis for valvulation is that valvulation of the circuit reduces the effects of respiration and the proclive position, and increases anterograde flow towards the systemic circulation, with increasing exercise capacity and benefits for enteropathy. Because it originates from the bovine jugular vein, the Melody(®) valve (Medtronic, Minneapolis, MN, USA) is naturally designed to work in a low-pressure environment. AIMS To report our experience of percutaneous valvulation of refractory failing Fontan circulation. METHODS We reviewed all patients who received a Melody valve in Fontan circulation in our unit. RESULTS Four patients were included: two had severe and refractory protein-losing enteropathy; one had severe oedema and ascites; and one had very severe lower limb venous insufficiency. The Melody valve was successfully implanted in all patients. Central venous pressure and inferior vena cava pressure did not change after valvulation. There were no early complications. At follow-up, no acute or mid-term thrombosis was noted. Two patients had intracardiac echocardiography 6 and 24 months after valvulation: the Melody valve was found not to be functioning in both cases. One patient died 3 months after valvulation; the cause was unrelated to the procedure. CONCLUSION Percutaneous valvulation of Fontan circulation is technically feasible. More clinical studies are needed before considering this treatment as an option.