Transcatheter native pulmonary valve and tricuspid valve replacement with the sapien <scp>XT</scp>: Initial experience and development of a new delivery platform

Levi, Daniel S.; Sinha, Siddhartha; Salem, Morris; Aboulhosn, Jamil

doi:10.1002/ccd.26398

Cited by 36 publications

(24 citation statements)

References 17 publications

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“…Similar results were reported for the Sapien valve [16]. The 29-mm Sapien XT was recently used successfully for large native or patched RVOT with excellent results [17]. Although several reports of other challenging techniques using the two approved valves describe good immediate hemodynamic results, no data on long-term follow-up are available.…”

Section: Limitation Of Currently Available Devicessupporting

confidence: 70%

Transcatheter Pulmonary Valve Replacement: The Venus P valve-Current Status

Alkashkari¹,

AlRahimi²,

Albugami³

et al. 2018

jshd

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There is growing appreciation for the long-term adverse impact of right-sided dysfunction of the pulmonary valve in patients with congenital heart disease. Although pulmonary valve stenosis or regurgitation is often tolerated over the short and intermediate terms, the long-term consequences are numerous and include, but are not limited to, right-sided heart failure, arrhythmias, and sudden cardiac death. Surgical right ventricular outflow tract (RVOT) interventions have been performed for many decades as an initial therapy, but comorbidities associated with repeated surgeries are a concern. Transcatheter pulmonary valve replacement is safe, effective, and performed at an increasing number of centers around the world. It offers an alternative to traditional surgical techniques and may potentially alter the decision-making process whereby valvular replacement is performed prior to the development of long-term sequelae of RVOT dysfunction. However, only ~15% of potential patients with RVOT dysfunction are suitable for currently approved implantable valves (i.e., Melody valve from Medtronic and Edwards Sapien valves from Edwards Lifesciences). These two valve systems are designed and approved for patients with a conduit or bioprosthetic valve between the right ventricle and pulmonary artery, and they exclude most patients who undergo transannular patch repair techniques. The Venus P-valve (Venus Medtech, Shanghai, China) is a recently developed self-expanding transcatheter heart valve designed to adapt to a dilated RVOT and in such it provide patients with a percutaneous interventional option after tran-

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Section: Limitation Of Currently Available Devicessupporting

confidence: 70%

Transcatheter Pulmonary Valve Replacement: The Venus P valve-Current Status

Alkashkari¹,

AlRahimi²,

Albugami³

et al. 2018

jshd

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show abstract

“…Coronary and aortic compression have been described and are of concern with TPVR in large native RVOTs . It is recommended that either rotational angiography or an aortogram in an RAO angulation be routinely performed with balloon sizing to assess for aortic compression .…”

Section: Discussionmentioning

confidence: 99%

Initial results from the off‐label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi‐institutional experience

Sinha

Aboulhosn

Asnes

et al. 2018

Cathet Cardio Intervent

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Objectives To describe a multi‐center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. Background Off‐label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. Methods A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow‐up data were collected to evaluate acute and short‐term results. Results A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into “native RVOTs”, measuring 24–32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1–9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). Conclusions TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short‐term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.

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“…Before the currently available percutaneous pulmonary valves (Melody and Sapien) can be used in a native RVOT it is necessary to first implant a large stent to transform the native RVOT into a rigid conduit [7, 8]. For a native RVOT up to 26–27 mm, pre-stenting followed by implantation of any of these valves can be performed during the same procedure or in a staged approach.…”

Section: Discussionmentioning

confidence: 99%

Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract

Garay

et al. 2016

Neth Heart J

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IntroductionThe Venus p‑valve (MedTech, Shanghai, China) is a self-expanding percutaneous heart valve designed to be implanted in a native patched right ventricle outflow tract. The worldwide clinical experience with this valve is just beginning and the results have so far been encouraging. We present our initial early experience implanting the Venus p‑valve in the native right ventricle outflow tract of patients with Tetralogy of Fallot repaired with a transannular patch.MethodsIn 10 selected patients a procedure for percutaneous pulmonary valve implantation was performed using the Venus p‑valve. The patients mean age was 32 years (13–57), mean weight 59.6 kg (40–80). All patients had Tetralogy of Fallot with moderate to severe pulmonary regurgitation and an indication for pulmonary valve replacement.ResultsThe implantation procedure was successful in all the patients resulting in an immediately functional valve. No procedure-related complications were observed. Follow-up after 12 months (4–21) resulted in an improvement in NYHA class. There was a reduction of the mean right ventricle diastolic volume from 139 ml/m2 (105–179) to 78 ml/m2 (65–100) and improvement in the regurgitation fraction from 42% (29–58) to 1% (0–5), as seen on routine cardiac magnetic resonance 6 months after the implantation. No stent fractures have been observed so far.ConclusionPercutaneous pulmonary valve implantation with the Venus p‑valve resulted in a safe and effective procedure. The valve has predictable and sustained functional competence, resulting in clinical improvement in the patients.

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Transcatheter native pulmonary valve and tricuspid valve replacement with the sapien XT: Initial experience and development of a new delivery platform

Cited by 36 publications

References 17 publications

Transcatheter Pulmonary Valve Replacement: The Venus P valve-Current Status

Transcatheter Pulmonary Valve Replacement: The Venus P valve-Current Status

Initial results from the off‐label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi‐institutional experience

Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract

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