Early clinical experience with a novel self‐expanding percutaneous stent‐valve in the native right ventricular outflow tract

Cao, Qi; Kenny, Damien; Zhou, Daxin; Pan, Wenzhi; Guan, Lihua; Ge, Junbo; Hijazi, Ziyad M.

doi:10.1002/ccd.25544

Cited by 96 publications

(67 citation statements)

References 8 publications

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“…We have reproduced the encouraging results reported by Cao and Prompham in 11 patients with Tetralogy of Fallot repaired using the transannular patch technique [5, 6]. We report an additional 10 patients with satisfactory results and have demonstrated a significant reduction of the right ventricular end-diastolic volume index and sustainable valve integrity on follow-up MRI.…”

Section: Discussionsupporting

confidence: 75%

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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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Section: Discussionsupporting

confidence: 75%

“…It has already been tested [5, 6] with satisfactory and encouraging results but is still not CE certified or FDA approved. The aim of this study was to report our initial experience on the feasibility and results of percutaneous implantation of the Venus P‑valve in the pulmonary position in patients with native RVOT.…”

Section: Introductionmentioning

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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“…Later called the Native Outflow Tract device (Medtronic, Minneapolis, Minnesota, USA), it has recently completed enrolment in an Investigation Device Exemption trial. The Venus-P valve (Venus Medtech, Shanghai, China) is a novel self-expanding percutaneous stent valve (diameters 20–32 mm) with flailed ends to conform to a dilated RV outflow tract 23. Initial experience of this native RV outflow tract device has shown short-term procedural success and no evidence of stent fracture 24…”

Section: Percutaneous Pvrmentioning

confidence: 99%

Approach to residual pulmonary valve dysfunction in adults with repaired tetralogy of Fallot

Kim

Ruckdeschel

2016

Heart

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Residual right ventricular outflow tract and pulmonary valve disease is common in adults with repaired tetralogy of Fallot. Chronic severe pulmonary regurgitation as a result of surgical repair can lead to myriad complications including right ventricular dysfunction, decreased exercise tolerance, right heart failure and symptomatic arrhythmias. The aim of restoring pulmonary valve integrity is to preserve right ventricular size and function with the intent of mitigating the development of symptoms and poor long-term outcomes. Right ventricular size thresholds by cardiac MRI have emerged beyond which reverse right ventricular remodelling after pulmonary valve replacement is less likely. Though pulmonary valve replacement has been shown to improve right ventricular dimensions and symptoms, no consistent improvement in right ventricular ejection fraction or objective measures of exercise capacity have been demonstrated. Furthermore, there are no long-term studies showing that normalisation of right ventricular size results in improved clinical outcomes. New transcatheter techniques of percutaneous pulmonary valve replacement have emerged with good short-term and mid-term outcomes, further adding to the complexity in determining 'when' and 'how' right ventricular outflow tract and pulmonary valve intervention should occur. With improved survival of these patients, the trend towards earlier pulmonary valve replacement at smaller right ventricular size and rapidly evolving transcatheter pulmonary valve techniques, the clinician must balance the goals of preserving right ventricular size and function in an attempt to prevent untoward outcomes with risks of multiple interventions in a patient's lifetime.

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“…The first clinical human experience using a self-expanding percutaneous stent valve (Venus P-valve) was reported by Cao et al [20]. In this study, five patients (four females) with a mean weight of 54.9 kg were selected for attempted valve deployment.…”

Section: Clinical Experiencementioning

confidence: 99%

“…The Venus P-valve (Venus Medtech, Shanghai, China) is a recently developed self-expanding transcatheter heart valve designed to adapt to a dilated RVOT [20].…”

Section: Self-expanding Platform Design (The Venus P-valve)mentioning

confidence: 99%

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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Early clinical experience with a novel self‐expanding percutaneous stent‐valve in the native right ventricular outflow tract

Abstract: The Venus P Valve provides excellent short-term pulmonary valvar function in the native RVOT of patients with surgically induced chronic severe PR.

Cited by 96 publications

References 8 publications

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

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

Approach to residual pulmonary valve dysfunction in adults with repaired tetralogy of Fallot

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

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