Melodias do Brasil

Catheterization and Cardiovascular Interventions, 2011

The aim of the study was to assess indications, procedural success, complications, echocardiographic, and clinical outcomes of percutaneous pulmonary valve implantation (PPVI) in adult patients with congenital heart disease (CHD). Background: PPVI offers a non-surgical treatment option for failing prosthetic conduits in pulmonary position. However, efficacy and clinical outcomes after PPVI are still underreported. : From January 2008 to March 2016, 25 adult CHD patients with right ventricular outflow tract (RVOT) stenosis and/or pulmonary regurgitation underwent PPVI in our institution. Clinical and echocardiographic data was collected at baseline, at 12 months of follow-up and yearly afterwards. Results: Tetralogy of Fallot and repaired pulmonary atresia were among the most prevalent underlying congenital defects. Twenty-one (84%) received a Medtronic Melody® and four (16%) patients an Edwards Sapien valve prosthesis. The PPVI procedure was successful in all 25 patients. Pre-stenting was performed in all but two (8%) patients. PPVI reduced peak-topeak pulmonary valve gradient from 43 (IQR 28-60) mmHg to 16 (IQR 14-22) mmHg (P < 0.001). Periprocedural complications occurred in two (8%) patients (tricuspid valve damage, pulmonary artery perforation). Over a median follow-up of 43 (IQR 18-58) months all patients were alive. Only two (8%) required re-operation and two (8%) developed stent fractures (one of them had not undergone pre-stenting). NYHA functional class improved significantly, with 20 (80%) patients in NYHA class I on follow-up. : PPVI with Medtronic Melody or Edwards Sapien valve conduits is safe and provides effective relief from right ventricular outflow tract obstruction or pulmonary regurgitation. K E Y W O R D S congenital heart defects, pulmonic stenosis, transcatheter valve implantation 1 | INTRODUCTION Congenital heart defects (CHD) are common. About one percent of all lifeborn are affected. 1 While some congenital heart defects may go Prof Roberto Corti current employer is Heart Clinic, Hirslanden Hospital Zurich, Switzerland.

Annals of Pediatric Cardiology

Percutaneous implantation of valves is a fast evolving field in interventional cardiology. Acquired pulmonary valve disease is uncommon; however, right ventricular outflow tract dysfunction is one of the common indications of reoperations during late follow-up of repaired congenital heart disease. The impact of pulmonary valvular dysfunction on right ventricular function during late follow-up of patients with adult congenital heart disease has led to earlier intervention. The importance of a technique with lower morbidity and mortality, good patient acceptance, and efficacy that is comparable with surgery cannot be underestimated. Percutaneous pulmonary valve implantation uses a valved-stent assembly implanted by means of a double balloon catheter delivery system. The device is a bovine jugular venous valve sutured inside a platinum-iridium. In a series of 58 consecutive patients, we implanted this valve successfully with good clinical and hemodynamic results and no mortality on long-term follow-up. Early device designs led to reintervention by surgical explantation in the early experience, and a second percutaneous pulmonary valve implantation during latter experience. This exciting new technique will lead to review of the current indications and timing of intervention for right ventricular outflow tract dysfunction in late follow-up of congenital heart disease. Semin Thorac Cardiovasc Surg Pediatr Card Surg Ann 9:23-28

Archivos de cardiolog�a de M�xico (English ed. Internet), 2020

Congenital Heart Disease, 2013

Background. Percutaneous pulmonary valve implantation is frequently used as a less invasive method in patients with conduit dysfunction. The common valve type cannot be used in conduits with a diameter larger than 22 mm. There has been limited experience concerning the used of the SAPIEN Transcatheter Heart Valve, produced for use in conduits with a large diameter. This study presents hemodynamic and early follow-up results from a single center in Turkey concerning the use of the SAPIEN Transcatheter Heart Valve in different types of conduits and different lesions. Patients and Method. Between October 2010 and July 2012, seven SAPIEN Transcatheter Heart Valve implantations were performed. There was mixed type 2 pure insufficiency with stenosis and insufficiency in five patients. Three different conduits were used, and one native pulmonary artery process was performed. Patients were followed for hemodynamic findings, functional capacities, valve competence, reshrinking, and breakage in the stent, and the results were evaluated. Results. Implantations were successfully performed in all patients. Right ventricular pressures and gradients were significantly reduced, and there was no pulmonary regurgitation in any patient. Functional capacities evidently improved in all patients except for one with pulmonary hypertension. No major complication was observed. During the mean time of follow-up (7.2 Ϯ 4.7 months), no valve insufficiency or stent breakage was observed. Conclusion. Procedural results and short-term outcomes of the SAPIEN Transcatheter Heart Valve were very promising in the patients included in the study. The SAPIEN Transcatheter Heart Valve can be a good alternative to surgical conduit replacement, particularly in patients with larger and different types of conduits.

Circulation: Cardiovascular Interventions, 2014

T he advent of the Melody Transcatheter Pulmonary Valve (TPV) has had an indelible impact on the field of congenital cardiovascular interventions. However, the magnitude of this impact has been tempered by limitations inherent to this new technology, including delivery system and valve size, the durability of the stent supporting the valve, and the suitability of current TPVs to complex ventricular outflow tracts. 1 In addition, the Melody TPV is approved exclusively for use in dysfunctional, circumferential, surgically placed right ventricle-to-pulmonary artery conduits that were equal to or greater than 16 mm when originally implanted, an indication present in only a small proportion of the patients who would clinically benefit from restoration of a functional right ventricular outflow tract (RVOT), including many who are either poor or nonsurgical candidates.

Catheterization and Cardiovascular Interventions, 2010

Background: Conduits placed in the right ventricular outflow tract (RVOT) have limited longevity which often requires increasingly complex reoperations. Transcatheter pulmonary valve implantation improves conduit hemodynamics through a minimally invasive approach. We present data for 7 patients treated with the Edwards SAPIEN TM transcatheter heart valve (THV). Patients: Patients' ranged in age from 16 to 52 years, one was female, and all had NYHA class II-III symptoms. Patients had pulmonary homografts that had been placed 2-25 years earlier during the Ross procedure (n 5 4), repaired double outlet right ventricle with situs inversus (n 5 1), or Rastelli repair for D-TGA, pulmonary atresia, and ventricular septal defect (n 5 2). Patients had either severe pulmonary stenosis and/or moderate to severe pulmonary regurgitation. Results: All patients had successful percutaneous implantation of the 23 mm SAPIEN TM THV under general anesthesia. Fluoroscopy times ranged from 16 to 49 mins and procedure times ranged from 110 to 237 mins. The RV:systemic pressure ratio decreased from 78 6 18 to 39 6 8%, the RVOT gradient improved from 60.7 6 24.3 to 14.9 6 6.9 mm Hg, no patients had pulmonary insufficiency, and all patients had symptom improvement. At a maximum follow-up of 3.5 years (median 22.5 months), Doppler peak gradients ranged from 7-36 mm Hg, and there is no evidence of late stent fracture or structural valve failure. Conclusion: The SAPIEN TM THV can be used successfully in the treatment of patients with right ventricle to pulmonary artery homograft failure. The valve is durable to at least 3.5 years without stent fracture or regurgitation. Clinical trials are underway to assess the long-term safety and efficacy of this valve. V C 2009 Wiley-Liss, Inc.

Circulation, 2008

pulmonary valve implantation was introduced in the year 2000 as a nonsurgical treatment for patients with right ventricular outflow tract dysfunction. Methods and Results-Between September 2000 and February 2007, 155 patients with stenosis and/or regurgitation underwent percutaneous pulmonary valve implantation. This led to significant reduction in right ventricular systolic pressure (from 63Ϯ18 to 45Ϯ13 mm Hg, PϽ0.001) and right ventricular outflow tract gradient (from 37Ϯ20 to 17Ϯ10 mm Hg, PϽ0.001). Follow-up ranged from 0 to 83.7 months (median 28.4 months). Freedom from reoperation was 93% (Ϯ2%), 86% (Ϯ3%), 84% (Ϯ4%), and 70% (Ϯ13%) at 10, 30, 50, and 70 months, respectively. Freedom from transcatheter reintervention was 95% (Ϯ2%), 87% (Ϯ3%), 73% (Ϯ6%), and 73% (Ϯ6%) at 10, 30, 50, and 70 months, respectively. Survival at 83 months was 96.9%. On time-dependent analysis, the first series of 50 patients (log-rank test PϽ0

Objective: To assess the impact of a percutaneous technique for pulmonary valve implantation on the conventional surgical valve/conduit approach to right ventricular outflow tract re-intervention. Methods: We have retrospectively reviewed our results following surgical or percutaneous re-intervention to the right ventricular outflow tract in both paediatric and adult groups. Between November 1998 and March 2004, 94 patients underwent surgical re-intervention to the right ventricular outflow tract. Percutaneous pulmonary valve implantation was introduced in October 2002 and 35 procedures were performed to March 2004. The median age was 26 years (6-65 years) in the surgical group and 16 years (9-39 years) in the percutaneous group. Tetralogy of Fallot was the commonest original diagnosis (64.9 and 62.9%, respectively). The predominant indication for re-intervention in the surgical group was pulmonary regurgitation (64.9%) compared to the percutaneous group in which it was homograft/conduit stenosis or a mixed lesion (68.6%). Results: There has been one (1.1%) early death reported in the surgical series and none in the percutaneous group. In the surgical group 9 (9.6%) experienced a procedural complication whilst 3 (8.5%) of those undergoing a percutaneous valve experienced a significant procedural event necessitating urgent surgery. Important early morbidity was 8 (8.5%) in the surgical group and 2 (5.7%) in the percutaneous group. Freedom from re-operation at 1 year was 100% in the surgical group and 86.1% in the percutaneous group due to late restenosis. Median hospital stay in the surgical group was 7 (4-114) days and 2 (2-22) days in the percutaneous group. Conclusions: Preliminary data suggests that percutaneous pulmonary valve implantation provides a promising additional and complementary approach to a successful surgical programme. Both approaches are safe with acceptable levels of morbidity and low mortality. With current technology the aneurysmal outflow tract remains a problem for the percutaneous approach. Follow-up remains too short, at present, to prove longevity of the percutaneous conduit. q

The Journal of Thoracic and Cardiovascular Surgery, 2009

Objectives: Pulmonary valve insufficiency remains a leading cause for reoperations in congenital cardiac surgery. The current percutaneous approach is limited by the size of the access vessel and variable right ventricular outflow tract morphology. This study assesses the feasibility of transapical pulmonary valve replacement based on a new valved stent construction concept. Methods: A new valved stent design was implanted off-pump under continuous intracardiac echocardiographic and fluoroscopic guidance into the native right ventricular outflow tract in 8 pigs (48.5 AE 6.0 kg) through the right ventricular apex, and device function was studied by using invasive and noninvasive measures. Results: Procedural success was 100% at the first attempt. Procedural time was 75 AE 15 minutes. All devices were delivered at the target site with good acute valve function. No valved stents dislodged. No animal had significant regurgitation or paravalvular leaking on intracardiac echocardiographic analysis. All animals had a competent tricuspid valve and no signs of right ventricular dysfunction. The planimetric valve orifice was 2.85 AE 0.32 cm 2. No damage to the pulmonary artery or structural defect of the valved stents was found at necropsy. Conclusions: This study confirms the feasibility of direct access valve replacement through the transapical procedure for replacement of the pulmonary valve, as well as validity of the new valved stent design concept. The transapical procedure is targeting a broader patient pool, including the very young and the adult patient. The device design might not be restricted to failing conduits only and could allow for implantation in a larger patient population, including those with native right ventricular outflow tract configurations.

Seminars in Thoracic and Cardiovascular Surgery, 2006

Transcatheter valve replacement has recently been introduced into clinical practice and has the potential to transform the management of valvular heart disease. To date, the largest human experience exists with percutaneous pulmonary valve implantation in patients with repaired congenital heart disease who require re-intervention to the right ventricular outflow tract. The application of this approach, however, is presently restricted to certain right ventricular outflow tract morphologies, because the device needs to be anchored safely to prevent device dislodgement. Early results of percutaneous pulmonary valve implantation show lower morbidity than surgery and significant early symptomatic improvement. In the future, the challenge will be to extend percutaneous pulmonary valve implantation to all patients with a clinical indication to delay or avoid repeat open-heart surgery. Semin Thorac Cardiovasc Surg 18:122-125