Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve – German experience

Lehner, Anja; Dashkalova, Tsvetina; Ulrich, Sarah; Rodrı́guez, Sergio; Mandilaras, Guido; Jakob, André; Dalla‐Pozza, Robert; Fischer, Marcus; Schneider, Heike; Tarusinov, G.; Kampmann, Christoph; Hofbeck, Michael; Dähnert, Ingo; Kanaan, M.; Haas, Nikolaus A.

doi:10.1080/17434440.2019.1653180

Cited by 15 publications

(8 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…To avoid the sequelae of longterm pulmonary regurgitation and/or residual pulmonary stenosis on right ventricular function PPVI has become the preferred treatment option for many of these patients [2][3][4]. Excellent results have been reported both with the Melody™ and with the SAPIEN valves [4,12,13]. According to the data based on 845 patients from the post-approval MELODY Registry, this treatment option is associated with a low risk of major complications (4.2%) and a low incidence of procedure-related deaths (0.5%) [4].…”

Section: Discussionmentioning

confidence: 99%

Coronary Artery Anomalies and Their Impact on the Feasibility of Percutaneous Pulmonary Valve Implantation

et al. 2021

Self Cite

View full text Add to dashboard Cite

One of the major obstacles preventing successful percutaneous pulmonary valve implantation (PPVI) is related to the close proximity of coronary artery branches to the expected landing zone. The aim of this study was to assess the frequency of coronary artery anomalies (CAAs) especially those associated with major coronary branches crossing the right ventricular outflow tract (RVOT) and to describe their relevance for the feasibility of percutaneous pulmonary valve implantation (PPVI). In our retrospective single-center study 90 patients were evaluated who underwent invasive testing for PPVI in our institution from 1/2010 to 1/2020. CAAs were identified in seven patients (8%) associated with major branches crossing the RVOT due to origin of the left anterior descending (LAD) or a single coronary artery from the right aortic sinus. In 5/7 patients with CAAs balloon testing of the RVOT and selective coronary angiographies revealed a sufficiently large landing zone distal to the coronary artery branch. While unfavorable RVOT dimensions prevented PPVI in one, PPVI was performed successfully in the remaining four patients. The relatively short landing zone required application of the “folded” melody technique in two patients. All patients are doing well (mean follow-up 3 years). CAAs associated with major coronary branches crossing the RVOT can be expected in about 8% of patients who are potential candidates for PPVI. Since the LAD crossed the RVOT below the plane of the pulmonary valve successful distal implantation of the valve was possible in 4/7 patients. Therefore these coronary anomalies should not be considered as primary contraindications for PPVI.

show abstract

Section: Discussionmentioning

confidence: 99%

Coronary Artery Anomalies and Their Impact on the Feasibility of Percutaneous Pulmonary Valve Implantation

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…The Sapien 3 valve expands the valve sizes with a 20 mm option with the Commander valve delivery system which allows better delivery into the RVOT. Data from a series of 56 patients from Germany suggested excellent procedural success and no reinterventions were needed up to two years of follow‐up 19 …”

Section: Available Valve System For Rvot Conduits and Outcomesmentioning

confidence: 99%

“…Data from a series of 56 patients from Germany suggested excellent procedural success and no reinterventions were needed up to two years of follow-up. 19 The COMPASSION multicenter clinical trial enrolled 81 patients and implanted the Sapien XT THV in 69 with a 93.7% freedom from reintervention at 3 years. 4 There are ongoing clinical trials for post-market approval surveillance on the use of this valve.…”

Section: The Edwards Sapien Xt and Sapien S3 Valvesmentioning

confidence: 99%

Transcatheter pulmonary valve replacement in congenital heart diseases

Chau

2022

Pediatric Investigation

View full text Add to dashboard Cite

Surgical repair of a variety of congenital heart diseases involves repair of the right ventricular outflow tract (RVOT) with valved or non-valved conduit to connect the right ventricle (RV) to the pulmonary artery (PA) or just patch enlargement of the native RVOT. With time, this RV-PA conduit will degenerate with deterioration of function, either causing pulmonary stenosis or pulmonary regurgitation. This RVOT dysfunction may result in RV dilation, RV dysfunction, and eventual RV failure and arrhythmias. Multiple surgical pulmonary valve replacement (PVR) is often required throughout the patient's lifetime. Patients are subjected to increased risks with each additional cardiac operation. Transcatheter PVR (TPVR) has been developed over the past two decades as a valuable non-surgical alternative to restore the RVOT and RV function, and hence reduce patients' lifetime risks related to surgery. This article will discuss the long-term results of TPVR which are demonstrated to be comparable to surgical results and the latest development of large pulmonary valves which will allow TPVR to be performed on native or larger RVOT.

show abstract

“…The Sapien 3 expands the valve sizes with a 20 mm option–the Commander valve delivery system is also believed to be better suited for delivery into the RVOT. Data from a series of 56 patients from Germany suggests excellent procedural success and no reinterventions were needed up to 2 years of follow up[ 29 ].…”

Section: Available and Upcoming Valve Systemsmentioning

confidence: 99%

Transcatheter pulmonic valve implantation: Techniques, current roles, and future implications

Law¹,

Chatterjee²

2021

WJC

View full text Add to dashboard Cite

Right ventricular outflow tract (RVOT) obstruction is present in a variety of congenital heart disease states including tetralogy of Fallot, pulmonary atresia/stenosis and other conotruncal abnormalities etc. After surgical repair, these patients develop RVOT residual abnormalities of pulmonic stenosis and/or insufficiency of their native outflow tract or right ventricle to pulmonary artery conduit. There are also sequelae of other surgeries like the Ross operation for aortic valve disease that lead to right ventricle to pulmonary artery conduit dysfunction. Surgical pulmonic valve replacement (SPVR) has been the mainstay for these patients and is considered standard of care. Transcatheter pulmonic valve implantation (TPVI) was first reported in 2000 and has made strides as a comparable alternative to SPVR, being approved in the United States in 2010. We provide a comprehensive review in this space–indications for TPVI, detailed procedural facets and up-to-date review of the literature regarding outcomes of TPVI. TPVI has been shown to have favorable medium-term outcomes free of re-interventions especially after the adoption of the practice of pre-stenting the RVOT. Procedural mortality and complications are uncommon. With more experience, recognition of risk of dreaded outcomes like coronary compression has improved. Also, conduit rupture is increasingly being managed with transcatheter tools. Questions over endocarditis risk still prevail in the TPVI population. Head-to-head comparisons to SPVR are still limited but available data suggests equivalence. We also discuss newer valve technologies that have limited data currently and may have more applicability for treatment of native dysfunctional RVOT substrates.

show abstract

Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve – German experience

Cited by 15 publications

References 24 publications

Coronary Artery Anomalies and Their Impact on the Feasibility of Percutaneous Pulmonary Valve Implantation

Coronary Artery Anomalies and Their Impact on the Feasibility of Percutaneous Pulmonary Valve Implantation

Transcatheter pulmonary valve replacement in congenital heart diseases

Transcatheter pulmonic valve implantation: Techniques, current roles, and future implications

Contact Info

Product

Resources

About