Multicenter Study Finds 100% Procedural Success for Hybrid Pulmonary Valve Implantation

A multicenter observational study of 102 patients with moderate-to-severe pulmonary regurgitation and large, morphologically complex native right ventricular outflow tracts found that hybrid transcatheter pulmonary valve implantation achieved 100% procedural success across 11 Chinese centers. All procedures were completed without an intraoperative death, and one high-risk patient died on postoperative day 12 after right ventricular rupture during surgery and subsequent low cardiac output. The approach combined surgical access with transcatheter delivery of a self-expanding Salus pulmonary valve, with operations tailored to the anatomy and associated abnormalities in each patient.

The findings address a setting in which the right ventricular outflow tract had become large, irregular or otherwise difficult to treat through a fully percutaneous procedure. Patients previously repaired for congenital heart disease can develop pulmonary regurgitation as the reconstructed outflow tract dilates. A large landing zone may leave inadequate support for a transcatheter valve, while aggressive oversizing can increase the risk of coronary compression, valve displacement or tricuspid injury.

In this series, each multidisciplinary heart team independently decided on treatment as part of routine clinical care, and the retrospective analysis then applied common eligibility criteria to consecutive hybrid TPVI recipients treated between June 2021 and December 2023. Participants ranged from 9 to 66 years old. Their mean age was 22.37 ± 11.15 years, and 56.9% were male.

Ninety-nine of the 102 patients had previously undergone one or two cardiac reoperations, and the mean time since the most recent operation was 15.22 ± 5.14 years. Eligibility was based on symptoms attributed to right ventricular outflow tract dysfunction, moderate-to-severe functional tricuspid regurgitation, ventricular enlargement or dysfunction, or QRS duration of at least 160 milliseconds. Excluded patients included those with a right-ventricular-to-pulmonary-artery conduit, residual obstruction requiring surgery, or anatomical inadequacy such as a high risk of coronary artery compression.

Preoperative imaging was used to characterize the implantation zone in detail. ECG-gated computed tomography measured the length, diameter and changing configuration of the right ventricular outflow tract and pulmonary trunk throughout the cardiac cycle. The investigators classified the anatomy into five types: pyramidal, recorded in 38 patients, or 37.2%; tubular, in 31, or 30.4%; funnel, in 16, or 15.7%; hourglass, in 11, or 10.8%; and lantern, in six, or 5.9%.

Mean right ventricular outflow tract length was 36.80 ± 7.43 mm, and mean pulmonary trunk length was 26.40 ± 6.83 mm. CT was also used to evaluate the distance between the intended landing zone and adjacent coronary arteries. Patients with an interarterial distance below 5 mm underwent coronary angiography with test-balloon inflation at the intended landing-zone diameter.

The Salus valve consists of three bovine pericardial leaflets mounted on a self-expanding nitinol hourglass-shaped stent. Its mid-section, where the leaflets attach, was available in diameters from 18 to 32 mm, while its inflow and outflow diameters ranged from 22 to 36 mm; the delivery system required a 22–24 Fr sheath. Surgical access depended on outflow tract morphology and the need to treat other abnormalities.

Median sternotomy was used in 67 cases, the subxiphoid approach in 12, a left intercostal approach in 12, a substernal incision in 10, and a combined xiphoid and intercostal approach in one. Mean operating time was 239 ± 121 minutes. For a dilated or irregular landing zone, surgeons could constrict the main pulmonary artery with a 1-cm-wide, 10-cm-long Gore-Tex band to create a circular landing zone, then suture the band, arterial wall and valve stent together to limit migration.

Concomitant procedures were needed in 54 cases, or 52.9%. Main pulmonary artery constriction was performed in 24 patients, and 10 required plication for paravalvular leakage. Ten patients underwent pulmonary artery branch interventions: five branch arterioplasties, four balloon dilatations with plication for septiform stenosis and one left pulmonary artery stent.

Three patients received tricuspid valvuloplasty, three underwent balloon dilation for diaphragm-like pulmonary trunk stenosis, and two with intraoperative hemorrhage required pulmonary artery and right ventricular repair. Cardiopulmonary bypass supported 20 procedures. It was planned for seven patients requiring tricuspid or branch pulmonary artery surgery and initiated in 13 for intraoperative events, including valve dislodgement, hemorrhage and tricuspid chordal injury.

Ten intraoperative valve dislodgements occurred, but all were managed without reported long-term sequelae. In three centers that each performed at least 10 procedures, accounting for 72 cases, nine of the ten dislodgements occurred; seven of those nine took place during the first half of each center’s cumulative experience. Within those centers, dislodgement occurred in seven of 36 earlier procedures and two of 36 later procedures, a difference that did not reach conventional statistical significance.

These events were attributed to the learning curve of a technically demanding cohort. The authors noted that computed-tomography-based sizing, greater use of main pulmonary artery constriction or plication, and fixation sutures likely contributed to fewer later events, although the retrospective design could not establish the effect of any technical modification. Cardiac magnetic resonance imaging showed measurable improvement in right ventricular volume at one year.

Among 99 patients with paired preoperative and postoperative imaging, mean right ventricular end-diastolic volume index declined from 147.72 ± 45.69 to 109.73 ± 32.00 mL/m², while end-systolic volume index fell from 84.27 ± 32.67 to 61.61 ± 24.24 mL/m²; both changes were statistically significant. Mean QRS duration shortened from 149.74 ± 31.94 to 137.06 ± 30.74 milliseconds, and mean right ventricular voltage decreased from 2.01 ± 1.07 to 1.72 ± 0.93 mV, also significant changes. Right ventricular ejection fraction did not change significantly, increasing from 42.67 ± 9.17% to 44.02 ± 9.82%.

Three patients without postoperative MRI were followed with echocardiography and clinical assessment. No deaths occurred after discharge during the reported follow-up, and the investigators observed no coronary artery compression, valve embolization or stent fracture. One patient with persistent low-grade fever for two weeks was treated at a local clinic without available blood cultures or echocardiography during the COVID-19 pandemic.

Empirical second-generation cephalosporin therapy resolved the fever, and antibiotics were continued for four weeks, but the diagnosis remained unconfirmed. Thus, the series included one suspected, unconfirmed case of endocarditis rather than a confirmed case. The absence of stent fracture over one year likewise does not establish long-term durability.

Median follow-up was one year, leaving valve deterioration, late endocarditis, reintervention and other delayed complications insufficiently studied. Several features limit the conclusions that can be drawn from the retrospective series. Patient selection depended partly on local clinical judgment, and procedural techniques and postoperative management varied among institutions.

Imaging and echocardiography were interpreted locally rather than by a central core laboratory, while interobserver variability was not systematically assessed. The analyses were exploratory, no adjustment was made for multiple comparisons and no prospective power calculation was performed. Subgroup comparisons, including the analysis of cardiopulmonary bypass, may have been underpowered and confounded; the bypass group was small and had worse preoperative right ventricular volumes.

Tricuspid regurgitation was not a prespecified endpoint, and the data cannot yet establish the long-term performance of the Salus valve.

Subject of Research: Hybrid transcatheter pulmonary valve implantation for severe pulmonary regurgitation with large, complex native right ventricular outflow tracts

Article Title: Multicenter experience of hybrid transcatheter pulmonary valve implantation in patients with a large right ventricular outflow tract

Article References: Dong, J., Su, J., Liu, A., Wen, S., Fan, T., An, Q., Jia, B., Ye, M., Zhang, G., Jin, Y., Li, Y., Zhou, C., Zheng, B., & Xu, J. (2026). Multicenter experience of hybrid transcatheter pulmonary valve implantation in patients with a large right ventricular outflow tract. Frontiers in Cardiovascular Medicine, 13, Article 1815136. https://doi.org/10.3389/fcvm.2026.1815136

Image Credits: AI Generated

DOI: 10.3389/fcvm.2026.1815136

Keywords: hybrid transcatheter pulmonary valve implantation, pulmonary regurgitation, right ventricular outflow tract, self-expanding valve, right ventricular remodeling, cardiac magnetic resonance imaging, cardiopulmonary bypass, congenital heart disease, multicenter observational study, Multicenter, experience, hybrid