Nonsurgical pulmonary valve replacement: Why, when, and how? (original) (raw)
Related papers
Transcatheter Pulmonary Valve Replacement
Cardiology and Therapy, 2012
Since first reported in 2000, transcatheter (percutaneous) pulmonary valve (TPV) replacement has become an important tool for the management postoperative right ventricular outflow tract (RVOT) dysfunction in patients with congenital heart disease, either as alternative or adjunct to surgery. Implantation of a pulmonary valve for treatment of RVOT obstruction or pulmonary regurgitation without performing open-heart surgery offers obvious appeal, and short-term results from multiple institutions throughout the world support the effectiveness and safety of this therapy. At present, there are two TPV prostheses available in the U.S.: the Medtronic Melody Ò valve is available commercially, and the Edwards Sapien Ò valve is available at limited centers as part of an investigational protocol. Although TPV therapy is likely to have a major impact on the management of postoperative RVOT dysfunction in patients with congenital heart disease or a Ross procedure, the technology is young and there is much that remains to be learned.
Current Experience with Percutaneous Pulmonary Valve Implantation
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
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.
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
Jacc-cardiovascular Interventions, 2021
OBJECTIVES This study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits #16 mm in diameter. BACKGROUND The Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits $16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits. METHODS The study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was #16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes. RESULTS A total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year). CONCLUSIONS In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.
European Journal of Cardio-Thoracic Surgery, 2006
Objective: Pulmonary valve replacement is performed increasingly late after correction of Tetralogy of Fallot. Most reports deal with pulmonary allografts as the valvar substitute of choice, although late deterioration and reoperation(s) are the rule. Mechanical valves are scarcely reported and if so only because of complications. Although life-long anticoagulation therapy is indicated for mechanical prostheses, the chance of subsequent re-operations can be expected to be low. We report the results of 28 mechanical valve replacements in the pulmonary position. Methods: A mechanical valve was implanted in 27 of 79 patients indicated for pulmonary valve replacement. Tetralogy of Fallot was the most common basic lesion. The results and follow-up were reviewed retrospectively, where death and re-operation were primary end points. Routine outpatient follow-up, including trans-thoracic echocardiography, was performed. Results: Twenty-eight pulmonary valve implantations were done in 27 patients. Thirty-day hospital mortality was 1/28 (3.6%), because of a cerebro-vascular accident. One patient died late (2.8 years postoperatively). Median age was 33 years and the median interval between primary repair and insertion of the prosthesis was 26 years. Freedom from re-operation at 1 year was 100%. One valve had to be replaced 14 years after implantation because of malfunction due to ingrowth of endomyocardial fibrosis. No thrombo-embolic events were observed. Conclusions: Our series do not confirm the bad reputation of mechanical valvar prostheses in the pulmonary position. On the contrary they perform well and result in a much lower re-operation rate than can be expected and in fact is reported after allograft usage. No thrombo-embolic complications were noted. In our experience pulmonary mechanical valve prostheses do well. #
Valved stents for transapical pulmonary valve replacement
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.
Percutaneous pulmonary valve implantation
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