Percutaneous Pulmonary Valve Implantation Impact of Evolving Technology and Learning Curve on Clinical Outcome (original) (raw)
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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
International journal of cardiology, 2015
Pulmonary regurgitation (PR) following surgery of the right ventricular outflow tract (RVOT) is not innocent and leads to significant right heart dysfunction over time. Recent studies have demonstrated that percutaneous valves can be implanted in conduit free outflow tracts with good outcomes. To evaluate in patients with severe PR - anticipated to require future pulmonary valve replacement - the feasibility and safety of pre-stenting dilated non-stenotic patched conduit-free right ventricular outflow tracts before excessive dilation occurs, followed by percutaneous pulmonary valve implantation (PPVI). Twenty seven patients were evaluated, but only 23 were deemed suitable based on the presence of an adequate retention zone ≤24mm defined by semi-compliant balloon interrogation of the RVOT. A 2 step procedure was performed: first the landing zone was prepared by deploying a bare stent, followed 2months later by valve implantation. RVOT pre-stenting with an open cell bare metal stent (...
Annals of Thoracic Surgery, 2003
Methods. Between April 1964 and January 2001, 1270 patients underwent operation with conduit placement from the PV to PA. The present study evaluates late outcome of 1095 patients (612 males, 483 females) having an operation before July 1992. Mean age was 9.6 ؎ 8.2 years old. Diagnoses included pulmonary atresia/ tetralogy of Fallot (459), transposition of the great arteries (TGA) (232), truncus arteriosus (193), double outlet right ventricle (DORV) (121), corrected TGA (49), septated univentricular heart (36), and other (5). A porcine-valved Dacron conduit was used in 730, homograft in 239, and non-valved conduit in 126.
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.
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
Percutaneous insertion of the pulmonary valve
Journal of the American College of Cardiology, 2002
We report our experience of percutaneous valve insertion in pulmonary position in humans. Over the past 40 years, prosthetic conduits have been developed to surgically establish continuity between the right ventricle and the pulmonary artery. However, stenosis and insufficiency of the conduit due to valvular degeneration or panus ingrowth frequently occur, limiting patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; lifespan. Percutaneous stenting of conduits has recently emerged as a technique for delaying surgical replacement, but it creates a pulmonary regurgitation when crossing the valve. Seven children and one adult with stenosis and/or insufficiency of the pulmonary graft underwent percutaneous implantation of a bovine jugular valve in pulmonary position. Percutaneous pulmonary valve (PV) replacement was successful in all patients. No complications occurred in early follow-up. Angiography, hemodynamic studies and echocardiography after the procedure showed no significant regurgitation of the implanted valve. Implantation was effective in relieving the obstruction in five patients. All patients showed improvement in their clinical status at the latest follow-up (mean 10.1 months). Non-surgical insertion of the PV is possible without any major complications. This new technique may have an important role in the management of conduit obstructions and pulmonary regurgitation.
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.
JACC: Cardiovascular Interventions, 2017
Method of Participation and Receipt of CME/MOC Certificate To obtain credit for this CME/MOC activity, you must: 1. Be an ACC member or JACC: Cardiovascular Interventions subscriber. 2. Carefully read the CME/MOC-designated article available online and in this issue of the journal. 3. Answer the post-test questions. At least 2 out of the 3 questions provided must be answered correctly to obtain CME/MOC credit. 4. Complete a brief evaluation. 5. Claim your CME/MOC credit and receive your certificate electronically by following the instructions given at the conclusion of the activity. CME/MOC Objective for This Article: At the end of the activity the reader should be able to: 1) appraise that recurrent right ventricular outflow tract obstruction and stent fracture are important adverse outcomes in patients undergoing transcatheter pulmonary valve replacement therapy; 2) identify the significance of right ventricular outflow tract preparation by pre-stenting a pre-existing stentless right ventricular outflow tract conduit when transcatheter pulmonary valve replacement is planned; and 3) recognize that ongoing surveillance is important to detect transcatheter pulmonary valve structural failure.
Nonsurgical pulmonary valve replacement: Why, when, and how?
Catheterization and Cardiovascular Interventions, 2004
Patients with surgery on the right ventricular outflow tract for congenital heart disease constitute the most common group for reoperations during late follow-up. Surgical pulmonary valve replacement can be performed with low mortality; however, it sets up a substrate for future operations. Also, the risk of cardiopulmonary bypass, infection, bleeding, and ventricular dysfunction remains. A transcatheter technique is likely to have more acceptance and may expand the indications for early intervention for right ventricular outflow tract dysfunction. Catheter Cardiovasc Interv 2004;62:401-408.