Year : 2021  |  Volume : 14  |  Issue : 3  |  Page : 281--292

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


Kothandam Sivakumar1, Pramod Sagar1, Shakeel Qureshi2, Worakan Promphan3, Bijulal Sasidharan4, Neeraj Awasthy5, Mahesh Kappanayil6, Pujar Venkatesh Suresh7, Nageswara Rao Koneti8,  
1 Department of Pediatric Cardiology, Institute of Cardiovascular Diseases, Madras Medical Mission, Chennai, Tamil Nadu, India
2 Department of Pediatric Cardiology, Evelina London Children's Hospital, Guy's and St. Thomas' NHS, London, UK
3 Department of Pediatric Cardiology, Queen Sirikit National Institute of Child Health, Bangkok, Thailand
4 Department of Pediatric Cardiology, Sree Chitra Tirunal Institute, Thiruvananthapuram, Kerala, India
5 Department of Pediatric Cardiology, Max Super Specialty Hospital, Delhi, India
6 Department of Pediatric Cardiology, Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala, India
7 Department of Pediatric Cardiology, Narayana Hrudayalaya, Bengaluru, Karnataka, India
8 Department of Pediatric Cardiology, Care Hospital, Hyderabad, Telangana, India

Correspondence Address:
Dr. Kothandam Sivakumar
Department of Pediatric Cardiology, Institute of Cardio Vascular Diseases, Madras Medical Mission, 4A. Dr. J J Nagar, Mogappair, Chennai - 600 037, Tamil Nadu
India

Abstract

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.



How to cite this article:
Sivakumar K, Sagar P, Qureshi S, Promphan W, Sasidharan B, Awasthy N, Kappanayil M, Suresh PV, Koneti NR. Outcomes of Venus P-valve for dysfunctional right ventricular outflow tracts from Indian Venus P-valve database.Ann Pediatr Card 2021;14:281-292


How to cite this URL:
Sivakumar K, Sagar P, Qureshi S, Promphan W, Sasidharan B, Awasthy N, Kappanayil M, Suresh PV, Koneti NR. Outcomes of Venus P-valve for dysfunctional right ventricular outflow tracts from Indian Venus P-valve database. Ann Pediatr Card [serial online] 2021 [cited 2021 Dec 3 ];14:281-292
Available from: https://www.annalspc.com/text.asp?2021/14/3/281/324650


Full Text



 Introduction



Surgical reconstruction of right ventricular outflow tracts (RVOTs) using patches or conduits is an integral part of management of various congenital heart diseases. In 85% of patients, reconstruction involves a transannular patch and in 15% of patients, may involve a conduit.[1] Percutaneous valves are an alternative to surgery for narrowing or regurgitation of the outflow tracts when these patients need a pulmonary valve replacement.[2],[3] Melody valve (Medtronic Inc., Minneapolis, MN) has limited utility in native outflow tracts.[4] Outflows with transannular patches have varied morphology and need a different approach.[5] Various valve designs have been evaluated to address this unmet need.[6],[7],[8] The SAPIEN valve (Edwards Lifesciences, Irvine, CA) has the potential for use in native outflow tracts up to 29 mm.[9]

The Venus P-valve (Venus Medtech, Hangzhou, PRC) is available in two designs. The straight design is used in prestented conduits.[10] The flared design addresses the majority of native outflow tracts with transannular patches.[11],[12],[13] The initial experience has been encouraging for both designs.[10],[11],[12],[13],[14],[15],[16],[17] Reports from China, South America, Thailand, and Europe describe patients implanted with Venus P-valve.[10],[11],[12],[13],[14],[15],[16],[17] The device still awaits approval for clinical use from the regulatory bodies.

We present the procedural details and midterm follow-up of patients in the Indian registry, who underwent percutaneous pulmonary valve implantation (PPVI) with these two designs of Venus P-valve in the past 6 years.

 Methods



This multicenter retrospective observational study evaluated patients who underwent Venus P-valve implantation after obtaining approval for compassionate use from the Indian regulatory body. Indian registry, involving seven institutions, aimed to analyze the safety, efficacy of the procedure and to study the midterm outcome and complications. Ethical committees of all the participating institutions approved the study. Fully informed written consent was obtained from all the patients for the procedure and anonymized reporting of the results. Institutional review boards that included pediatric cardiac surgeons at all participating institutions reviewed each patient details before the procedure.

Initial evaluation

Echocardiography evaluated patients with significant RVOT regurgitation or stenosis. In patients with stenosis, a multislice computed tomography analyzed the diameter and length of the stenotic lumen, extent of circumferential calcification, and relationship to the coronary arteries. In regurgitant outflows, cardiac magnetic resonance imaging (CMR) analyzed the regurgitant fraction, ventricular volumes, and their function. The indication for PPVI was based on standard guidelines.[18],[19],[20]

Stenotic outflow tracts

Echocardiography identified features of systemic venous congestion, right ventricular dysfunction, secondary tricuspid regurgitation, outflow gradients, hilar pulmonary arteries, and other residual lesions. Patients with symptomatic worsening unexplained by other reasons, right ventricular systolic pressures more than two-thirds of systemic pressures, and right ventricular systolic dysfunction underwent stent angioplasty to relieve the obstruction before a straight Venus P-valve implantation.

Stent angioplasty for stenotic outflow

Proximity of conduits to coronary arteries was predicted by computed tomography. After excluding very dense circumferential calcification and patients at risk of coronary occlusion, the remaining patients underwent serial dilatations starting with Mustang Balloons (Boston Scientific, Marlborough, MA) up to 12 mm and later Atlas Gold Balloons (Bard Peripheral Vascular, Tempe, AZ) beyond 14 mm with 2 mm serial increments, under careful angiographic monitoring. After dilating the conduit to more than 80% of its original diameter, selective coronary angiograms were performed during full inflation of the final balloon to exclude interference with coronary flows. Circumferentially calcified conduits were stented with covered cheatham-platinum (CP) (Numed Inc., Hopkinton, NY) or covered AndraStent XXL (Andramed, Reutlingen, Germany) stents. If calcification was noncircumferential, stenting was performed using Palmaz XL (Cordis endovascular, Santa Clara, CA), LD Max (ev3 endovascular Inc., Plymouth, MN), CP or AndraStent XXL stents. Stent recoil was reinforced using one or two additional stents until pressure gradients dropped below 20 mmHg.

Regurgitant dilated outflows

Symptomatic patients and those who met CMR and electrocardiographic criteria for indication for PPVI underwent balloon interrogation before flared Venus P-valve implantation.[5] Outflow tracts larger than 34 mm and pyramidal-shaped Type I outflow tracts were excluded.[5] Lesions warranting corrective surgery, such as resection of RVOT aneurysms, closure of large residual defects, repair or replacement of severely regurgitant tricuspid valves were also excluded. Patients with severe unilateral pulmonary artery stenosis that precluded surgical or interventional rehabilitation were included, provided the outflow anatomy was suitable for Venus P-valve.

Balloon interrogation

The differences between the RVOT dimensions on CMR and balloon interrogation made the latter a mandatory step.[11],[12],[13],[14],[15],[16],[17] After placing a stiff Lunderquist guidewire (Cook medical, Bloomington, IN) to straighten the outflow tract, marker pigtail angiograms were performed in orthogonal projections to measure the RVOT dimensions. Once the hemodynamics was recorded, a long compliant AGA sizing balloon (Abbott, Plymouth, MN) was inflated across the outflow until a right ventriculogram confirmed complete occlusion. Selective coronary angiography during full balloon inflation assessed the risk of compression. The waist was measured after calibration with the marker pigtail placed alongside the sizing balloon. Venus P-valves were customized 2–4 mm larger than the interrogating balloon waist. Patients with balloon waist above 34 mm were excluded.

Venus P-valve

Venus P-valve comprised of a self-expandable nitinol framework with a trileaflet porcine pericardial valve, available in straight and flared designs.[10],[17] Both the designs were available in diameters of 18–36 mm in 2 mm increments. The flared design of the valve went through three modifications from its first design. The first modular design with three sutured components was changed to a unibody with a thin pericardial lining for the struts of the distal flare. In the third design, this thin pericardial lining was removed from the six open cells in the distal flare.[11],[12],[13],[14] The fourth design since 2018 had five open cells in distal flare that connected all the sharp edges to the outer wire frame [Figure 1]. The valve was rinsed to remove the glutaraldehyde preservative and crimped in ice-cold saline to reduce the nitinol memory, using a proprietary compression device and loaded on the delivery system.{Figure 1}

Implantation procedure

The procedure was performed under general anesthesia. Two femoral venous and one arterial accesses were used. In patients with occluded iliac veins on one side, a right internal jugular venous access was used for the marker pigtail angiographic catheter. The valve delivery system was advanced toward the RVOT over a Lunderquist wire parked deep in left pulmonary artery (LPA). The distal flare was exposed in the proximal LPA. The remaining constrained valve was progressively exposed under guidance from repeated right ventriculograms in such a way that the proximal marker coincided with the proximal waist. If an initial attempt from LPA failed, the valve was deployed from right pulmonary artery. When the large profile rigid delivery system failed to advance through a sharp angulated RVOT, a 12–16 mm balloon was inflated in the distal outflow through the second venous access to displace the advancing valve away from the lateral walls of the outflow. A 65 cm long 26F braided sheath, when available, was placed across the outflow to facilitate passage of the delivery system to the desired site.[21] After deployment, right ventricular and pulmonary artery angiogram were performed to assess valve position, competence, and adequacy of flow through the branch pulmonary arteries. Hemostasis was achieved by figure-of-8 suture and manual compression.

Follow-up

Periprocedural antibiotics and low-molecular-weight heparin were continued for 3 days, and patients were discharged on dual antiplatelet therapy that was continued indefinitely. Antibiotic prophylaxis was administered for all major dental and urogenital surgical procedures. Clinical evaluation combined with electrocardiogram, fluoroscopy, and echocardiogram was performed at 1 and 3 months after the procedure and 6 monthly thereafter. In patients who did not receive any ferromagnetic stents, CMR was performed after 6 months.

Statistical analysis

Data were entered in Microsoft Excel and analyzed using SPSS version 23 (IBM Corp, Armonk, NY). The distribution of categorical data was expressed as frequency and percentage. The continuous variables were expressed as mean with standard deviation or median with range. The comparison of the continuous variables was carried out by independent Student's t-test or one-way analysis of variance whichever was appropriate based on the distribution of data and number of groups. All statistical analysis was carried out at 5% level of significance and P < 0.05 was considered as significant.

 Results



Patient population

A total of 35 patients were evaluated with balloon interrogation in the cardiac catheterization laboratory [Figure 2]. Twenty-nine patients selected after balloon interrogation from seven institutions were included for Venus P-valve implantation from March 2014 after excluding 6 patients [Table 1]. The measurements on CMR, catheter angiography, and balloon interrogation influenced the indication and selection of the valve [Table 2]. Seven patients with circumferential conduits, who received straight Venus P-valve, formed Group A [Table 3] and [Table 4] and 22 patients with native outflow tracts reconstructed with transannular patches underwent implantation of flared Venus P-valve and formed Group B [Table 5] and [Table 6].{Figure 2}{Table 1}{Table 2}{Table 3}{Table 4}{Table 5}{Table 6}

Patient inclusion

The conduit stenosis was severe causing elevation of right ventricular pressures to more than two-thirds of systemic pressures in six patients in Group A. One patient in heart failure with right ventricular ejection fraction of 23% had a conduit gradient of 38 mmHg and was included. Two patients in Group B had indexed right ventricular end-diastolic volume <150 ml. While one of these had right ventricular ejection fraction <47%, the other was symptomatic without any other explanations. Among the four included patients with LPA stenosis, one was treated by stent angioplasty and the others had poor left lung arborization. One patient with a residual ventricular septal defect underwent device closure 3 months after valve implantation.

Prestenting of narrowed conduits

Prestenting in seven patients with narrowed conduits in Group A reduced the mean outflow gradient from 74.9 ± 20.7 mmHg (38–100 mmHg) to 12.29 ± 6.87 mmHg (0–20 mmHg). A single stent was used in three patients, two stents in three, and three stents in one patient [Table 3]. The covered stent was used in one patient with dense circumferential conduit calcification, while the others received bare stents. The median duration from prestenting to PPVI was 11 weeks, ranging from 2 to 208 weeks.

Procedural success

Valve implantation was successful in 27 (93%) patients. Seven cases (Group A) received straight Venus P-valve and 20 (Group B) received flared Venus P-valve. Two procedures with flared design failed as the sharp edges from the midsegment of the third generation valve pierced through the nylon sleeve capsule while manipulating the rigid delivery system through a sharply angulated RVOT. A safe uncomplicated withdrawal of the delivery system was followed later by elective surgery.

Procedural details

Three patients in Group B and one patient in Group A had LPA stenosis. The delivery system with nose cone could not be advanced into the LPA in one of these patients despite downsizing the valve from 30 mm to 28 mm. After inflating a balloon in distal outflow tract to reduce friction of the delivery system, the distal flare was opened in proximal LPA leading to successful deployment [Figure 3]. In one further patient with unobstructed LPA, similar difficulties were encountered needing deployment from the right pulmonary artery. Conduit stenosis associated with discrete LPA origin narrowing in a patient was stented using two separate bare CP stents. Five months later, a straight design Venus P-valve implantation was implanted uneventfully, as the nose cone of the short delivery system barely crossed the LPA stent. The recently introduced 65 cm long braided sheath placed across the RVOT to facilitate passage of the rigid valve delivery system was used in only one patient [Figure 4].{Figure 3}{Figure 4}

Procedural complications

A 32 mm flared Venus P-valve migrated proximally in a 17-year-old male causing severe tricuspid regurgitation. The valve was anchored surgically on cardiopulmonary bypass after opening the transannular patch and continued to function well after 6 years of follow-up. A similar less severe migration of another 32 mm flared valve in a 14-year-old male resulted in moderate tricuspid regurgitation that was conservatively followed for 3 years without any progression. A retrospective review of their CMR showed a mild pyramidal shape of the RVOT. Femoral arteriovenous fistula after removal of a 26F sheath used for deploying a 36 mm flared valve needed surgical repair in one patient.

Complications and reinterventions on follow-up

Followup data of all 27 patients were available. At a median follow-up of 46 months (1–85 months), there were no deaths or valve-related reinterventions. A residual ventricular septal defect was closed with a device 3 months after PPVI in one patient. There were no other reinterventions. Transient fever after procedure seen in early patients was prevented later by thorough prolonged rinsing of the valve to remove the preservative. One episode of culture-negative infective endocarditis at 4 years after implantation was successfully treated medically with no change in valve function. Valve wire-frame fracture was seen in 3 (11.4%) patients in Group B, noticed at 1, 12, and 24 months on fluoroscopy, and was confined to the proximal flare without compromising the valve function [Figure 5].{Figure 5}

Follow-up assessment

One-year and 2-years follow-up were completed by 26 (96.3%) and 23 (85.2%) patients, respectively. Seven patients had trivial to mild clinically inaudible pulmonary regurgitation at their last follow-up. There was no paravalvular leak in any of the patients. A repeat CMR in eight patients showed significant reduction in right ventricular volume and regurgitant fraction [Table 7]. All Group B patients had valve gradients <20 mmHg on the last follow-up. The reduction in outflow gradients in conduits persisted on follow-up. All patients had a subjective improvement of symptoms and effort tolerance, but none underwent any cardiopulmonary exercise tests. Antiplatelets were not discontinued in any patient.{Table 7}

 Discussion



Utility of a functioning pulmonary valve

Many patients with reconstructed RVOT need pulmonary valve replacement in adolescence or adulthood.[19] Patient selection is guided by worsening symptoms along with certain hemodynamic, CMR, and electrocardiographic indicators.[18] A consistent reduction in right ventricular volumes, improved left ventricular filling, and improved symptoms are observed after PPVI, although ejection fraction, exercise parameters, and arrhythmia burden are largely unchanged.[19] Stenosed conduits demonstrate reduction in gradients and improved symptoms after PPVI.[19] Chest adhesions, bleeding, cardiac ischemia, and multiorgan dysfunction favor percutaneous valves to surgery.[22] Lack of mortality and life-threatening complications in our group show safety of the percutaneous strategy.

Percutaneous options for dilated outflow tracts

Balloon-expandable valves cater for a minority with narrowed conduits or small outflow tracts. Despite the availability of SAPIEN valves up to 29 mm, two-thirds of RVOT are larger than 26–27 mm and may not be suitable for this valve.[4],[9],[23] The flared Venus P-valve is designed primarily to address these patients.[11],[12],[13],[14],[15],[16],[17],[18] RVOT dimensions exceeded 28 mm in our group. None of the current valves except Venus P could have been considered for such large outflow tracts.[13]

Implantation success

PPVI was successful in 93% of cases. Two failures were related to the sharp edges of the older design that protruded through the nylon sleeve capsule of the delivery system while manipulating an angulated RVOT. They were removed uneventfully. The recent modification of design connected the sharp edges to the outer frame.[13] The present modification eliminated this problem despite using a large 36 mm valve in six subsequent patients. The Chinese Venus P study published the largest experience of 55 patients with 98.2% success, but the largest valve was 32 mm.[14] Procedural success was comparable to the United States Melody valve trial and Compassion trial.[24],[25]

Comparison with other Venus P registries

Delayed referral and advanced hemodynamic derangements are common in developing countries due to social and logistic reasons.[26] The right ventricular volumes in our patients were larger than patients reported in large Chinese, European, South American, and multicenter Venus P registries.[12],[14],[16],[17] The larger balloon waist dimensions in this cohort compared with the other registries mandated valves larger than 28 mm in all the patients with native RVOT. Six out of the twenty patients needed the largest 36 mm valve. Inadequate right ventricular remodeling after delayed interventions should force early recognition and intervention.[27]

Valve deployment

The Venus P-valve is usually deployed from the LPA, which accommodates the distal flare of the valve.[17] A stented or stenotic LPA hindered this deployment and was excluded in two large registries.[14],[17] In our series, LPA stenosis in three patients in Group B was managed with right pulmonary artery deployment in two and balloon-assisted deployment in one [Figure 2]. A stent deployed in the LPA in one Group A patient did not pose any problem as the nose cone of the straight valve delivery system did not protrude beyond the stent. Therefore, a narrow LPA need not be considered as an absolute contraindication for Venus P-valve.

Straight Venus P-valve in stented conduits

Complications

Valve migration in two patients was managed with surgical anchoring in one and conservatively in the other. The reasons for proximal migration may be technical due to non-release of the ear-loop or anatomical due to pyramidal RVOT.[14] Repeated angiographic monitoring and a slow release are key steps to avoid a proximal deployment. There were no distal migrations in our study, which may lead to pulmonary artery occlusion.[17] The Compassion trial reports migration of SAPIEN valve in dilated RVOT.[25] Wireframe fracture in proximal flare in 3 (11%) patients did not affect the valve function. Unlike the Melody valve, in which competence was dependent on the stent-frame integrity, fracture of the proximal flare did not affect the function of the Venus P-valve located in the mid-zone.[17],[28] Infective endocarditis in one patient after 4 years was managed without any impairment of valve function. Incidence of endocarditis in our cohort with a median follow-up of 46 months was relatively less compared to other reports. Early endocarditis after Venus P-valve recorded in 7% of patients in the Chinese study was comparable to an annual risk of 2% in the pooled analysis after Melody valve implantation.[12],[29] In the Chinese study, one mortality and another patient needing surgery among four patients with infective endocarditis is of concern and needs meticulous patient education about dental hygiene and antibiotic prophylaxis.[14],[30] Early withdrawal of aspirin after 6 months in the Chinese study was associated with pulmonary thromboembolism needing urokinase.[14] There were no thromboembolic episodes in our registry while using long-term dual antiplatelet therapy with 150 mg aspirin and 75 mg clopidogrel. Rapid discontinuation of aspirin after 6 months leading to thrombus formation on the valve leaflets is a known risk factor for endocarditis.[31]

Intermediate term valve function

The mean follow-up in our study was 47.8 ± 24.5 months with the longest follow-up of 85 months, without any need for reintervention. The follow-up in this registry was longer than in the previous reports.[14],[16],[17] There was no significant increase in RVOT gradient or occurrence of significant regurgitation, suggesting good durability of the valve. The straight Venus P-valve available in larger sizes is a good alternative to Melody and SAPIEN valve in stented conduits. Continued surveillance is warranted to look for late mechanical disturbances in the valve frame.[32]

Limitations

The study has inherent bias related to any retrospective study. The procedural and follow-up protocols vary among institutions affected the analysis of data. Logistic reasons prevented routine CMR in all the patients and formal cardiopulmonary exercise testing. The parameters used for analysis differed from Group A and Group B patients, but both were presented together as they formed part of the Indian registry.

 Conclusions



The procedural and follow-up experience of patients in this Indian registry showed safety and efficacy of straight and flared Venus P-valves used in appropriate situations. The straight design could be a safe and durable alternative to the Melody valve in prestented conduits. The flared design expanded the scope of percutaneous treatment to larger outflow tracts up to 34 mm. LPA stenosis was not an absolute contraindication. Long-term antiplatelet therapy may be a good strategy against valve thrombosis and endocarditis. The recent modification in the design overcame some of the reasons for previous technical failures. Further studies should focus on long-term durability and late complications.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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