Venus P-valve Research Articles

Rupture of a calcified right ventricle to pulmonary artery homograft by balloon dilation– emergency rescue by venus P-Valve

BackgroundPercutaneous pulmonary valve implantation (PPVI) is a recognized alternative treatment to surgery for patients with dysfunctional right ventricular outflow tracts. Patient selection is essential to avoid serious complications from attempted treatment, such as rupture or dissection, especially of the calcified outflow tracts. We describe a case with an unexpected rupture of a calcified homograft valve and main pulmonary artery, which was treated successfully by emergency implantation of a self-expanding Venus P-Valve (Venus MedTech, Hangzhou, China) without the need for pre-stenting with a covered stent.Case detailsA 13-year-old boy had two previous operations of tetralogy of Fallot, one a total repair and the other a homograft valved conduit for pulmonary regurgitation. He presented with dyspnea and severe right ventricular outflow tract obstruction (RVOTO) and had a calcified outflow tract and main pulmonary artery. In the catheter laboratory, a non-compliant balloon dilation resulted in a contained rupture of the conduit. The patient remained hemodynamically stable, and the rupture was treated with a self-expandable Venus P-Valve without the need for a covered stent combined with a balloon-expandable valve or a further surgical procedure.DiscussionPreprocedural evaluation with an inflating balloon is necessary to examine tissue compliance and determine suitability for PPVI. However, this condition is accompanied by a risk of conduit rupture. Risk factors of this complication are calcification and homograft use. These ruptures are mostly controlled with a prophylactic or therapeutic covered stent, with a low rate of requiring surgery. However, there are severe ruptures which lead to hemothorax and death. In the available literature, there was no similar reported case of conduit rupture, which a self-expandable Pulmonary valve stent has managed. It seems that fibrosis and collagen tissue around the heart, formed after open surgeries, can contribute to the control of bleeding in these cases.Conclusion (clinical Learning Point)The suitability of patients for the PPVI procedure should be examined more carefully, specifically patients with homograft and calcification in their conduit. Furthermore, conduit rupture might be manageable with self-expandable artificial pulmonary valves, specifically in previously operated patients, and the applicability of this hypothesis is worth examining in future research.

Hemodynamics of the VenusP Valve System™-an in vitro study.

This study aims to evaluate the fluid dynamic characteristics of the VenusP Valve System™ under varying cardiac outputs in vitro. A thorough hemodynamic study of the valve under physiological cardiac conditions was conducted and served as an independent assessment of the performance of the valve. Flow fields downstream of the valve near the pulmonary bifurcation were quantitatively studied by two-dimensional Particle Image Velocimetry (PIV). The obtained flow field was analyzed for potential regions of flow stasis and recirculation, and elevated shear stress and turbulence. High-speed en face imaging capturing the leaflet motion provided data for leaflet kinematic modeling. The experimental conditions for PIV studies were in accordance with ISO 5840-1:2021 standard, and two valves with different lengths and different orientations were studied. Results show good hemodynamics performance for the tested valves according to ISO 5840 standard without significant regions of flow stasis. Observed shear stress values are all well below established hemolysis limits.

Initial experience with the new percutaneous pulmonary self-expandable Venus P-valve

Initial experience with the new percutaneous pulmonary self-expandable Venus P-valve

Five-year follow-up after percutaneous pulmonary valve implantation using the Venus P-valve system for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract.

Percutaneous pulmonary valve implantation (PPVI) with the self-expandable Venus P-valve system is a promising treatment for patients with pulmonary regurgitation (PR) and a native right ventricular outflow tract (RVOT). However, limited data is available regarding its midterm outcomes. This study assessed the midterm clinical and echocardiographic outcomes following Venus P-valve implantation. From 2013 to 2018, 55 patients with moderate or severe PR after surgical RVOT repair with a transannular or RVOT patch were consecutively enrolled from six hospitals in China. Five-year clinical and echocardiographic outcomes were collected and evaluated. The primary endpoint was a freedom from all-cause mortality and reintervention. At 5 years, the primary endpoint was met for 96% of patients, corresponding to a freedom from all-cause mortality of 96% (95% confidence interval [CI]: 86%-99%) and freedom from reintervention of 98% (95% CI: 87%-100%). Endocarditis was reported in five patients (four patients within 1 year and one patient at 5 years) following PPVI. Transpulmonary gradient and stent orifice diameter remained stable compared to at discharge (p＞0.05). No paravalvular leak was reported while only 1 patient gradually increased to moderate PR during follow-up. Significant improvement of RV diameter and LVEF(p＜0.001) sustained over the 5-year follow-up, in consistent with remarked improved New York Heart Association(NYHA) functional class (p＜0.001). The 5-year results of the China VenusP Study demonstrated the midterm benefits of Venus P-valve implantation in the management of patients with severe PR with an enlarged native RVOT by providing sustained symptomatic and hemodynamic improvement.

In vitro bench testing using patient-specific 3D models for percutaneous pulmonary valve implantation with Venus P-valve.

Due to the wide variety of morphology, size, and dynamics, selecting an optimal valve size and location poses great difficulty in percutaneous pulmonary valve implantation (PPVI). This study aimed to report our experience with in vitro bench testing using patient-specific three-dimensional (3D)-printed models for planning PPVI with the Venus P-valve. Patient-specific 3D soft models were generated using PolyJet printing with a compliant synthetic material in 15 patients scheduled to undergo PPVI between July 2018 and July 2020 in Central China Fuwai Hospital of Zhengzhou University. 3D model bench testing altered treatment strategy in all patients (100%). One patient was referred for surgery because testing revealed that even the largest Venus P-valve would not anchor properly. In the remaining 14 patients, valve size and/or implantation location was altered to avoid valve migration and/or compression coronary artery. In four patients, it was decided to change the point anchoring because of inverted cone-shaped right ventricular outflow tract (RVOT) ( n = 2) or risk of compression coronary artery ( n = 2). Concerning sizing, we found that an oversize of 2-5 mm suffices. Anchoring of the valve was dictated by the flaring of the in- and outflow portion in the pulmonary artery. PPVI was successful in all 14 patients (absence of valve migration, no coronary compression, and none-to-mild residual pulmonary regurgitation [PR]). The diameter of the Venus P-valve in the 3D simulation group was significantly smaller than that of the conventional planning group (36 [2] vs. 32 [4], Z = -3.77, P <0.001). In vitro testing indicated no need to oversize the Venus P-valve to the degree recommended by the balloon-sizing technique, as 2-5 mm sufficed.

Self-Expanding Pulmonary Valves in 53 Patients With Native Repaired Right Ventricular Outflow Tracts.

Self-expanding pulmonary valve grafts have been designed for percutaneous pulmonary valve implantation (PPVI) in patients with native repaired right ventricular (RV) outflow tracts (RVOTs). However, their efficacy, in terms of RV function and graft remodelling remain unclear. Patients with native RVOTs who received Venus P-valve (N=15) or Pulsta valve (N= 38) implants between 2017 and 2022 were enrolled. We collected data on patient characteristics and cardiac catheterization parameters as well as imaging and laboratory data before, immediately after, and 6 to 12 months after PPVI and identified risk factors for RV dysfunction. Valve implantation was successful in 98.1% of patients. The median duration of follow-up was 27.5 months. In the first 6 months after PPVI, all patients exhibited resolution of paradoxical septal motion and a significant reduction (P < 0.05) in RV volume, N-terminal pro-B-type natriuretic peptide levels, and valve eccentricity indices (-3.9%). Normalization of the RV ejection fraction (≥ 50%) was detected in only 9 patients (17.3%) and was independently associated with the RV end-diastolic volume index before PPVI (P= 0.03). Nine patients had residual or recurrent pulmonary regurgitation or paravalvular leak (graded as ≥ mild), which was associated with a larger eccentricity index (> 8%) and subsided by 12 months postimplantation. We identified the risk factors likely to be associated with RV dysfunction and pulmonary regurgitation following PPVI in patients with native repaired RVOTs. RV volume-based patient selection is recommended for PPVI of a self-expanding pulmonary valve, along with monitoring of graft geometry.

Outcomes of Self-Expanding Transcatheter Pulmonary Valves: Extended Follow-Up of a Prospective Trial

<b>Background:</b> The Venus-P valve was the first self-expanding valve used world-wide for transcatheter pulmonary valve replacement (TPVR) in patients with severe pulmonary regurgitation (PR). We intended to report the extended follow-up results from the prospective trial (No. NCT02590679). <b>Methods:</b> A total of 38 patients with severe PR (mean age 24.2 ± 13.2) were included. Follow-up data were obtained after implanted at 1, 6, and 12 months and yearly after. The frame geometry was assessed on post-implant computer tomography (CT) scanning by calculating the non-circularity [circularity ratio (minimum diameter/maximum diameter) < 0.9] and under-expansion [expansion ratio (derived external valve area/nominal external valve area) < 0.9). Adverse events (all-cause mortality, reintervention, valve dysfunction, stent fracture and endocarditis) were recorded. <b>Results:</b> All valves were implanted successfully with normal function at discharge. Geometric CT analysis showed under-expanded valve was detected in 22 patients (63%) and non-circular valve was seen in 16 patients (46%). During a median follow-up of 4.8 years (range 0.3–8.1), there were 1 death and 1 surgical explant, both resulting from endocarditis. Five-year freedom from valve dysfunction and stent fracture were 84.8% (95%CI 74.8–94.7) and 83.5% (95%CI 73.8–93.2). Endocarditis occurred in 3 patients at a median time of 7 months. Stent fracture was more common in patients with non-circularity stents. <b>Conclusion:</b> TPVR using Venus-P valve is associated with favorable outcomes at 5 years. Non-circular shapes in the valve level may have a higher risk of stent fracture.

A Hybrid Strategy for Geometrical Reshaping of the Main Pulmonary Artery and Transcatheter Pulmonary Valve Replacement.

Transcatheter pulmonary valve replacement has become an attractive alternative to surgical approach in patients with dysfunctional right ventricular outflow tract. However, in certain cases, an unfavorable anatomy might complicate optimal valve deployment and stability. Several techniques have been described to reshape the landing zone and allow proper implantation of the transcatheter valve. Among them, the hybrid approach has gained attention as an interesting method for off-pump pulmonary valve replacement in patients with dilated right ventricular outflow tract. But to date, there is no standardized method to resize and reshape the landing zone for the stented valve. Here, we describe a reproducible method based on simple geometric rules to allow adequate remodeling of the main pulmonary artery to the desired dimensions in a single attempt, followed by perventricular implantation of a Venus P-valve.

Outcomes of Venus P-valve for dysfunctional right ventricular outflow tracts from Indian Venus P-valve database.

Background :Balloon-expandable pulmonary valves are usually not suitable for dilated native outflow tracts.Methods :Indian Venus P-valve registry was retrospectively analyzed for efficacy, complications, and midterm outcomes. Straight valve was used in prestented conduits in patients with right ventricular pressure above two-thirds systemic pressure and/or right ventricular dysfunction. Flared valve 1–4 mm larger than balloon waist was used in native outflow in symptomatic patients, large ventricular volumes, and ventricular dysfunction.Objectives :A self-expanding porcine pericardial Venus P-valve is available in straight and flared designs..Results :Twenty-nine patients were included. Straight valve was successful in all seven conduits, reducing gradients significantly, including one patient with left pulmonary artery (LPA) stent. Flared valve was successfully implanted in 20 out of 22 native outflow tracts. Sharp edges of the older design contributed to two failures. Complications included two migrations with one needing surgery, endocarditis in one, insignificant wire-frame fractures in three, and groin vascular complication in one patient. There were no deaths or valve-related reinterventions at a mean follow-up of 47.8 ± 24.5 months (1–85 months). Modifications of technique succeeded in three patients with narrow LPA. There was significant improvement in symptoms, right ventricular volume, and pulmonary regurgitant fraction.Conclusion :Straight and flared Venus P-valves are safe and effective in appropriate outflow tracts. Straight valve is an alternative to balloon-expandable valves in stenosed conduits. Flared valve is suitable for large outflows up to 34 mm, including patients with LPA stenosis. Recent design modifications may correct previous technical failures. Studies should focus on durability and late complications.

Explantation of the Venus P-valve: a first in-human experience.

Explantation of the Venus P-valve: a first in-human experience.

TRANSCATHETER VENUS P VALVE IMPLANTATION AT PULMONARY POSITIONPOST TOF REPAIR WITH SEVERE PR- INITIAL CASE IN PAKISTAN

After total correction for tetrolgy of fallot (TOF), right ventricle behaves in an unpredictable manner depending on type of right ventricular outflow tract (RVOT) reconstruction and surgical expertise of infundibular muscle resection. We are reporting a 23 years old girl who underwent total correction at two years of age. RVOT was reconstructed with native pericardial patch. Gradually she developed breathlessness and occasional chest pain. Echocardiograghy revealed hugely dilated right ventricle (RV) with gross pulmonary regurgitation and RV dysfunction. Cardiac MRI also calculated right ventricular end systolic volume (RVESV) 57 ml/m2 and right ventricular end diatolic volume (RVEDV) 157ml/m2.We decided to implant transcatheter venus p-valve at pulmonary position. The procedure went successful having competent pulmonary valve and improved RV function. Total fluoro time was 36.4 minutes and total procedural time was two hours. This procedure was done first time in Pakistan with optimal results.

Use of the GORE�DrySeal Flex Introducer Sheath to Facilitate Implantation of the Transcatheter Venus P-valve

Objectives: We report our experience of using the 65 cm large diameter GORE® DrySeal Flex Introducer sheath to facilitate transcatheter implantation of the Venus P-valve in the pulmonary position. Background: Transcatheter implantation of pulmonary valves can be difficult due to rigidity of the valve delivery system or the anatomy of the RVOT and pulmonary artery bifurcation and the risk of iatrogenic damage to the tricuspid valve support apparatus. Using long sheaths to pass and protect the tricuspid valve may facilitate the procedure. Methods: Multi-centre registry of patients who underwent transcatheter pulmonary valve implantation of the Venus P-valve using the GORE® DrySeal Flex introducer sheath to facilitate passage of the valve to the right ventricular outflow tract. Procedural success, time to valve implantation and radiation safety parameters were analyzed. These data were compared to a control group of subjects treated between July 2014 and May 2016 with the same valve but without the use of GORE® DrySeal. Results: Between December 2016 and September 2018, the Venus P-valve was successfully deployed through the GORE® DrySeal in 12 patients. There were no procedure-related complications. As a control group, 10 subjects treated between July 2014 and May 2016 were included. Total procedure time was significantly shorter in the GORE® DrySeal group compared to the control group 96 ± 27 min vs. 164 ± 12 min (p < 0.001). Total screening time was significantly shorter in the GORE® DrySeal group (24 ± 11 min) when compared with the control group (32 ± 14 min, p < 0.001). Conclusions: We describe a modification to the previously described techniques of implanting the Venus P-valve in the pulmonary position after surgical repair of congenital heart disease. In our experience, the GORE® DrySeal sheath has considerably facilitated the procedure and reduced the potential risks.

Prognostic markers in patients undergoing transcatheter implantation of Venus P-valve: Experience in Taiwan

Prognostic factors remain unclear in patients undergoing transcatheter implantation of Venus P-valve for their severe pulmonary regurgitation associated with native right ventricular (RV) outflow tract. Between January 2017 and October 2018, we prospectively collected data of patient characteristics, cardiac magnetic resonance imaging, cardiopulmonary exercise testing, and levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) before and 6-12 months after valve graft implantation. Fifteen patients (male: 8, median age: 24.8 years) were enrolled. The procedure success rate was 100%. The median follow-up was 16.3 months without any dysfunction of the valve graft. The cohort demonstrated a significant improvement in cardiac index (from 3.3 to 3.9L/min/m2) and increase of percentage of New York Heart Association functional class I (P<10-3), reduction in RV end-diastolic volume index (P=0.008), and reductions in NT-proBNP levels (from 78.9 to 45.8pg/mL, P=0.040). However, the peak oxygen consumption (VO2) dropped from 50.2% to 48.5% of the predicted value. Interestingly, we determined that patients with NT-proBNP levels below 70pg/mL and left ventricular end-diastolic pressure (LVEDP) below 11mmHg had a significantly higher chance of exhibiting improvement in peak VO2 compared with those without (3/4 vs 1/10, P=0.041). In the small cohort with severe pulmonary regurgitation, implantation of a Venus P-valve led to promising reductions in RV volume. However, no definite improvement in cardiopulmonary exercise capacity or RV ejection fraction was achieved. Levels of NT-proBNP and LVEDP may be helpful for refining the indications of the Venus P-valve implantation.

Multicenter Comparison of Percutaneous and Surgical Pulmonary Valve Replacement in Large RVOT

A percutaneous approach for pulmonary valve replacement (PVR) is a feasible alternative to surgical PVR in selected patients with severe pulmonary regurgitation after repair of tetralogy of Fallot. However, large right ventricular outflow tract (diameter ≥ 25 mm) remains challenging. This retrospective multicenter study enrolled consecutive patients with large right ventricular outflow tract who underwent percutaneous PVR (Venus P-valve, Venus MedTech Inc, Hangzhou, China) (n= 35) or surgical PVR (homograft valve; n= 30) between May 2014 and April 2017. Patients were followed up at 1, 3, 6, and 12 months, and yearly thereafter. Main study outcomes were pulmonary valve function and right ventricular function at discharge and midterm follow-up. PVR was successful in all patients. Percutaneous compared with surgical PVR group had: similarly distributed baseline characteristics; shorter hospitalization, intensive care unit stay, and endotracheal intubation duration; lower cost; lower pulmonary valve gradient before discharge; lower pulmonary valve regurgitant grade (mean difference, -0.63; 95% CI -1.11 to -0.20, P= .022), pulmonary valve gradient (mean difference, -5.7 mm Hg; 95% CI -9.4 to -2.2 mm Hg, P= .005), and right ventricular end-diastolic volume index (mean difference, -9.5 mL/m2; 95% CI -16.9 to -3.1 mL/m2, P= .022); and greater right ventricular ejection fraction (mean difference, 5.4%; 95% CI 2.4%-8.3%, P= .002) at median 36 months follow-up, without deaths in either group. Percutaneous PVR using Venus P-valve appeared to be a safe, efficacious and minimally invasive alternative to surgical PVR in selected patients with large right ventricular outflow tract yielding better right ventricular and pulmonary valve function at midterm follow-up.

Percutaneous Pulmonary Valve Implantation.

Percutaneous pulmonary valve implantation (PPVI) is recognized as a feasible and low risk alternative to surgery to treat dysfunctional right ventricular outflow tract (RVOT) in usually pluri-operated patients. Evolving technology allowed to develop different kind of prosthesis and to go from an initial treatment exclusively of stenotic conduit to an actual approach extended also to wide native RVOT. The Melody transcatheter pulmonary valve (TPV) and the Edwards Sapien valve are nowadays the most commonly implanted prostheses. However, other devices have been developed to treat large RVOT (i.e., the Venus p-valve, the Medtronic Harmony TPV, the Alterra Adaptive Prestent, and the Pulsta valve). Indications for PPVI are the same as for surgical interventions on pulmonary valve, with limits related to the maximum diameter of the available percutaneous prosthesis. Therefore, an accurate preoperative evaluation is of paramount importance to select patients who could benefit from this procedure. The overall periprocedural mortality incidence is around 1.4%, while freedom from RVOT reintervention ranges from 100% at 4 months to 70% at 70 months, according to the different published studies.

Novel use of a 3D printed heart model to guide simultaneous percutaneous repair of severe pulmonary regurgitation and right ventricular outflow tract aneurysm

We describe percutaneous repair of severe pulmonary regurgitation and a right ventricular outflow tract pseudoaneurysm in a 19-year-old patient after repair of pulmonary atresia, ventricular septal defect, and major aortopulmonary collaterals. A 3D printed model of his heart was used to simulate percutaneous repair with a closure device in the aneurysm neck and a Venus P-valve in the right ventricular outflow tract. The encouraging findings from the simulation allowed us to plan the complex procedure effectively with a successful outcome and avoidance of surgery.

Percutaneous Implantation of Venus P-Valve and Melody Valve in a Patient with Dysfunctional Native and Artificial Right Ventricular Outflow Tracts

Percutaneous Implantation of Venus P-Valve and Melody Valve in a Patient with Dysfunctional Native and Artificial Right Ventricular Outflow Tracts

Medium-term results of percutaneous pulmonary valve implantation using the Venus P-valve: international experience.

The aim of this study was to assess the international procedural and short-term to midterm experience with the new percutaneous Venus P-valve. Retrospective data of patient characteristics, clinical and imaging follow-up of Venus P-valve implantation outside China were collected. Thirty-eight patients underwent attempted Venus P-valve implantation between October 2013 and April 2017. Thirty-seven valves were successfully implanted during 38 procedures. There was one unsuccessful attempt and there were two valve migrations, one of which required surgical repositioning. The mean follow-up was 25 months with no short-term or midterm valve failure or deterioration in performance. Frame fractures occurred in 27% of patients. The cohort demonstrated a statistically significant reduction in pulmonary regurgitation fraction and indexed right ventricular diastolic volumes at six and 12 months. Implantation of the Venus P-valve has provided satisfactory short-term to midterm results with high success and low complication rates in an inherently challenging patient substrate.

A self-expanding percutaneous valve for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract: one-year results.

The aim of the study was to evaluate the midterm safety and efficacy of a self-expanding valve (Venus P-valve) in the treatment of patients with pulmonary regurgitation and a native right ventricular outflow tract (RVOT) in China. Patients who had moderate or severe pulmonary regurgitation after surgical repair of the RVOT with a transannular or RVOT patch were included in the study. Fifty-five patients (67% female; average age 28.7±12.4 years) from six different hospitals in China were enrolled. The procedure success rate was 98.2%. In the one failure, the patient experienced valve dislodgement two days after the procedure. During the 12-month follow-up, two patients died, one due to infective endocarditis. Three other patients developed infective endocarditis. Two patients developed atrial flutter, and one patient had a pulmonary embolism. Echocardiography examinations at 12 months showed that two patients had mild pulmonary regurgitation, and 19 patients had trace pulmonary regurgitation. No paravalvular regurgitation occurred. The mean peak pulmonary gradient was 16.3±7.4 (range 4-38) mmHg. Compared with the baseline data, the right ventricular end-diastolic volume index (RVEDVI) was reduced from 137.6±15.8 mL/m2 to 83.9±16.0 mL/m2 (p<0.001), and the New York Heart Association (NYHA) class was significantly improved (p<0.01). The one-year results of the China Venus P-valve study show considerable promise for a hitherto unmet need in patients with pulmonary regurgitation and an enlarged native RVOT.

Early European experience with the Venus P-valve®: filling the gap in percutaneous pulmonary valve implantation.

Our aim was to report the first five cases of percutaneous implantation of the Venus P-valve® in Europe. We successfully implanted Venus P-valves in five consecutive cases in patients whose anatomy was thought to be unfavourable for currently available percutaneous valve prostheses and who had relative contraindications to surgical valve replacement. The procedures were performed at Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom. The primary diagnosis was variable with variable pulmonary artery morphology. The median age was 14 years (range 12-62 yrs). There was no mortality and no major morbidity, with satisfactory haemodynamic and angiographic outcomes in all patients. Post-procedural follow-up (median follow-up 8.5 months, range three to 15 months) with echocardiography and magnetic resonance imaging showed no restenosis or regurgitation with significant improvement in the right ventricular end-diastolic volumes. Preliminary results show that the Venus P-valve can be safely and efficaciously used in dilated right ventricular outflow tracts of varying morphology. Rigorous trials will be required to evaluate this valve before more widespread use.