Transcatheter Pulmonary Valve Replacement With “Double-Barrel” Stent-and-Valve Technique in a Dilated Right Ventricular Outflow Tract (original) (raw)
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One-Year Follow-Up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study
JACC: Cardiovascular Interventions, 2014
OBJECTIVES This study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to the historical results established in the initial 5-center Investigational Device Exemption trial. BACKGROUND TPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device. METHODS Patients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient #30 mm Hg, pulmonary regurgitation less than moderate as measured by echocardiography, and freedom from conduit reintervention and reoperation. RESULTS Cardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year. CONCLUSIONS This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates
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.
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.
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.
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.
Medium term follow-up after percutaneous pulmonary valve replacement with the Melody® valve
IJC Heart & Vasculature, 2015
Introduction Data on long term function of the Melody valve are scarce. Patients and methods single institution; percutaneous pulmonary valve implantation (PPVI) from 2006 to 2014. The function of the valved conduit was analyzed by Doppler echocardiography. Annual Chest X-ray after implant and permanent screening for events (eg. Endocarditis). Results 112 Melody valves were implanted in 111 patients; mean age 19.3 years (4.5-81.6). No prestenting of the RVOT was performed (n=4) at first. In the next 107 patients pre-stenting was always performed. In 82 patients 1 pre-stent, 18 patients 2, in 6 patients 3 stents and 1 patient 4 stents were used. The Melody stent was dilated up to 24 mm (n=4), 22 mm (n=72), 20 mm (n=28) and 18 mm (n=6). When stenotic, the Doppler gradient reduced from 67.0 mmHg (SD 13.9) to 18.9 mmHg (SD 10.4) (p<0.001); pulmonary regurgitation (PR) was reduced from median 3.5/4 (range 0-4/4) to none or trivial (p<0.001). There was no significant change in RVOT peak velocity at 5 y (p=0.122)] nor PR (p=0.835)]. Type 1 Stent fractures were observed in 1/4 non-pre-stented patients and in the 5/107 pre-stented (p<0.05). Endocarditis occurred in 8/112 valves; freedom of endocarditis was 85% at 5 years. In 2 patients early surgical replacement was necessary. Six were sterilized with antibiotic treatment; 2 patients required re-stenting and re-PPVI due to residual gradient. Conclusion Adequate pre-stenting of the RVOT before PPVI nearly abolishes or delays stent fracture. Cusp function is well preserved in mid-term follow-up; endocarditis is a significant threat.
Transcatheter pulmonary valve implantation using the edwards SAPIEN™ transcatheter heart valve
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.
Transcatheter heart valve interventions: where are we? Where are we going?
European Heart Journal, 2018
Transcatheter heart valve interventions have transformed the outcomes of patients with valvular heart disease (VHD) who are unfavourable candidates for surgery. Technological advances have allowed extension of these interventions to younger or lower risk patients and those with other forms of VHD and may in the future permit earlier treatment of VHD in less symptomatic patients or those with moderate disease. The balance of risks and benefits is likely to differ between lower and higher risk patients, and more evidence is needed to evaluate the net benefit of transcatheter technology in these groups. As academic researchers, clinicians, industry, and patient stakeholders collaborate to research these broader indications for transcatheter valve interventions, it is essential to address (i) device durability and deliverability, (ii) specific anatomical needs (e.g. bicuspid aortic valves, aortic regurgitation, mitral and tricuspid valve disease), (iii) operator training, and (iv) the reinforced importance of the multidisciplinary Heart Team.