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Abstract

Background

To evaluate hemodynamic performance and midterm durability of the Inspiris Resilia Valve (IRV) in pulmonary position in patients with different cardiac anomalies.

Methods

We retrospectively reviewed the medical records of 45 patients who underwent pulmonary valve implantation with IRV between January 2018 and August 2023. Demographic data included primary diagnosis, age at surgery, intraoperative data, and follow-up (FU). Primary outcomes are bioprosthesis dysfunction (BD) and prosthesis-related reintervention. BD was defined as moderate or severe bio-prosthesis insufficiency or trans-prosthesis peak gradient >50 mmHg.

Results

Most common primary diagnosis was Tetralogy of Fallot (28 patients). Indication for surgery was severe pulmonary regurgitation with significant right ventricle (RV) dilatation, with median RV end-diastolic volume of 164 (151–174) ml/m². Median age and weight at surgery were 18 years (interquartile range [IQR] 15–30) and 62 kg (IQR 47–72). Most common IRV size implanted was 25 mm (31 patients), followed by 27 mm (11 patients). After a median FU time of 33 months (IQR 18–45), 6 patients (13.3%) developed BD and 1 required trans-catheter reintervention. All patients who developed BD had a 25 mm IRV implanted. Our statistical analysis showed that higher peak gradient and higher RV systolic pressure were associated with increased BD occurrence (p value < 0.001); moreover, bioprosthesis regurgitation was a more significant cause of BD than stenosis (p value < 0.001).

Conclusions

Despite short–medium-term FU, our results suggest that IRV durability in the pulmonary position is concerning. Further discussion and collaboration are needed to evaluate this prosthesis for pulmonary valve replacement on a larger scale and with a longer FU.

Central Illustration

Keywords

biological prosthesis pulmonary valve right ventricular outflow tract reconstruction

Key Point

Population & Methods	45 patients; pulmonary valve implantation with Inspiris Resilia Valve (IRV) between 2018–2023; median age 18 years; most with Tetralogy of Fallot.
Implant Details	Most frequent valve size: 25 mm (31/45 patients).
Follow-up	Median 33 months (IQR 18–45).
Outcomes	- 13.3% (6 patients) developed bioprosthesis dysfunction (BD). - One transcatheter reintervention. - BD occurred exclusively in 25 mm IRV.
Risk Factors	Higher transvalvular gradients and RV systolic pressure associated with BD (p < 0.001).
Mechanism	Regurgitation more frequent than stenosis as cause of BD (p < 0.001).
Conclusion	Midterm durability of IRV in pulmonary position raises concerns; longer follow-up and multicenter evaluation required.

Background

Implantation of a prosthetic valve is indicated for patients with pulmonary regurgitation who have previously undergone right ventricular outflow tract (RVOT) reconstruction.^1–3 Pulmonary valve replacement (PVR) is among the most common congenital procedures performed, and several options currently exist for off-label PVR in patients beyond infancy (bioprosthesis, mechanical valve, or valve conduit). However, there is no consensus on whether it represents the best choice for this procedure. Bioprosthesis valves are likely the most widely used due to their availability and the fact that they do not require permanent anticoagulation therapy, which is particularly advantageous for young patients. Stented bioprosthetic valves have been designed for use in the aortic position but are also extensively implanted in the pulmonary position. The Inspiris Resilia Valve (IRV) (Edwards Lifesciences LLC) is a new bioprosthesis that utilizes innovative tissue preservation technology aimed at enhancing long-term durability. Resilia tissue is bovine pericardial tissue treated with a special integrity preservation technology that selectively eliminates free aldehydes, a key factor in tissue calcification, while also protecting and preserving the tissue. In adult patients, this bioprosthesis, when used in the aortic position, has demonstrated a good safety profile with excellent hemodynamic performance over 5 years of follow-up, showing 100% freedom from structural valve degeneration.^4–6 Moreover, IRV features a unique hinge mechanism in valves <27 mm, allowing radial dilation without fracturing the stent frame during future transcatheter valve-in-valve (ViV) procedures. Recently, IRV has begun to be implanted in the pulmonary position, and reports have already shown varying concerns regarding the bioprosthesis’ performance.^7–9 Edwards Lifesciences has initiated a prospective, nonrandomized, single-arm, multicenter trial (COMMENCE-P) to study the efficacy of the Inspiris valve in the pulmonary position.¹⁰ This study aims to evaluate the hemodynamic performance and midterm durability of IRV implanted in the pulmonary position in our patients.

Methods

Study Population

We retrospectively reviewed the medical records of all pediatric and adult patients diagnosed with congenital heart disease who underwent PVR with IRV between January 2018 and August 2023 at Bambino Gesù Children's Hospital and Gemelli University Hospital. During the study period, all patients undergoing surgical PVR at our institutions received the IRV with no other types of prostheses or valved conduits used. The Institutional Review Board of both hospitals approved the current study. Collected demographic data included primary diagnosis, age at surgery, previous surgeries, cardiopulmonary bypass (CPB) time, aortic cross-clamping (X-Clamp) time, associated surgical procedures, and follow-up data. Follow-up was completed in all patients (100%), and all data were collected using the clinical and echocardiographic database. Routine transthoracic echocardiograms (TTEs) and cardiac magnetic resonance imaging (cMRI) were performed to determine the timing of interventions, and computed tomography was conducted in selected patients for reoperative planning. Preoperative comprehensive echocardiography is routinely performed and reported in the Cardiac Surgery Echo lab. Chamber quantification, comprehensive assessment of right ventricle (RV) geometry and systolic function, and the severity of valve dysfunction were graded according to a multiparametric approach and were performed following current recommendations.¹¹ Specifically, indications for PVR were related to symptoms and/or evidence of right ventricular chamber enlargement (right ventricular end-diastolic volume [RVEDV] ≥ 150 mL/m²) determined by cMRI. The size of the bioprosthetic was selected based on RVOT size with the aim of implanting a bioprosthesis large enough for potential transcatheter PVR. After implantation, patients underwent antiplatelet therapy consisting of 3 to 6 months of aspirin 100 mg, after which continuation was left to the discretion of the referring cardiologist.

All patients had a discharge TTE and at least 1 follow-up TTE; no patients were excluded due to unavailable imaging data.

Study End-Points

The primary endpoint of the analysis was freedom from bioprosthetic dysfunction (BD), while the secondary endpoint was freedom from prosthesis-related reintervention. BD was defined based on transthoracic echocardiography performed at the last available clinical follow-up and included evidence of either stenosis or regurgitation. Stenosis was defined as a transvalvular peak gradient >50 mmHg or a peak velocity of approximately >3.5 m/s. Regurgitation was graded as trivial, mild, moderate, or severe, in accordance with current echocardiographic valve assessment guidelines.^12,13 Prosthesis-related reintervention was defined as any surgical or transcatheter procedure performed on the pulmonary valve due to dysfunction of the IRV.

Operative Technique

Two approaches were used in our study according to the presence of previous sternotomies. In case of redo-sternotomy, CPB was instituted by central aorto-bicaval cannulation except in 2 instances where, due to strong mediastinal adhesion, we used peripheral cannulation by groin vessel in 1 case and neck vessel in the other patient according to our approach.¹⁴ After the previous transannular patch was longitudinally incised and the native leaflet was completely resected. The posterior sewing ring of the bioprosthesis was secured with a running suture along the native pulmonary annulus. We position the IRV such that there is a slight posterior angulation in relation to the native annulus, thereby achieving a more natural lie within the pulmonary trunk. A large bovine pericardial patch was then used to reconstruct the anterior wall of the pulmonary artery and the remaining anterior prosthesis sewing ring. The remaining part of the patch was finally used to complete the RVOT reconstruction with another running suture. The other technique was used in 5 patients with no previous surgery, where we performed a minimally invasive approach through a J-ministernotomy at the 4th intercostal space with aorto-right atrial cannulation (Figure 1). The native pulmonary artery was incised, and the pulmonary leaflets were resected. The bioprosthesis was then secured to the native pulmonary ring with a running suture similar to the technique previously described.

Figure 1.

J Ministernotomy Incision at the 4th Intercostal Space for Pulmonary Valve Replacement.

Statistical Analysis

Data were summarized as absolute counts and percentages if related to categorical items and by median, interquartile range (IQR), and range for quantitative variables. The association between the presence of dysfunction (primary endpoint) and categorical factors was assessed through the chi-square test, while the difference in distribution of quantitative variables between patients with or without dysfunction was measured by the nonparametric Mann–Whitney U test. All analyses were performed using IBM-SPSS v.28.0 software.

Results

Our population study included 45 patients: 32 males and 13 females. The most common primary diagnosis was Tetralogy of Fallot (TOF) in 28 patients, followed by valvular/supravalvular pulmonary stenosis (PS) in 10 patients, pulmonary atresia with intact ventricular septum (PAIVS) in 3 patients, and pulmonary atresia with ventricular septal defect (PA/VSD) in another 2 patients; the remaining 2 patients were diagnosed with Fallot canal and transposition of the great arteries, respectively (Table 1). Indication for surgery was severe pulmonary regurgitation with severe RV dilatation in all patients, with a median preoperative RVEDV of 164 (151–174) mL/m². The median age and weight at surgery were 18 years (IQR 15–30) and 62 kg (IQR 47–72). Associated surgical procedures were performed on 19 patients and included pulmonary artery reconstruction (6 patients), residual atrial septal defect closure (6 patients), tricuspid valve repair (4 patients), pacemaker replacement (1 patient), residual ventricular septal defect closure (1 patient), and innominate artery reimplantation (1 patient). The most common size of the IRV implanted was 25 mm (31 patients, 68.9%), followed by 27 mm (11 patients, 24.4%) and 23 mm (3 patients, 6.7%). In 31 patients, implantation was performed on a beating heart, whereas in 14 patients, the aorta was cross-clamped. The mean CPB and cross-clamp time (when necessary) were 90 min (IQR 63–118) and 35 min (IQR 22–85), respectively. All patients, except for 5, underwent at least 1 previous sternotomy. At the median follow-up time of 33 months (IQR 18–45), no deaths or IRV endocarditis occurred, and 6 patients (13.3%) developed bioprosthesis degeneration (BD). Among these, 1 patient, after 62 months, required a percutaneous ViV procedure for severe bioprosthesis stenosis and bioprosthesis regurgitation (BR); 1 child developed severe BR 15 months postsurgery, and 4 children presented moderate BR at 33, 73, 31, and 19 months following surgery. All patients who developed BD underwent implantation of a 25 mm IRV. No valve thrombosis episodes were detected. All follow-up data are reported in Table 2. Our univariable analysis did not show significant associations between gender and the size of the bioprosthesis or IRV dysfunction. Additionally, age at surgery is not a predictive factor for bioprosthesis degeneration (Table 3). BR, primary diagnosis, and tricuspid regurgitation at follow-up are associated with IRV dysfunction (P < 0.001, P < 0.001, and P = 0.024, respectively). Furthermore, bioprosthesis peak gradient and right ventricular systolic pressure (RVSP) are linked to an increased risk of IRV dysfunction (P < 0.001) (Table 4).

Table 1.

Preoperative and Intraoperative Data.

	Total	Dysfunction Yes	Dysfunction No	P Value
Age at surgery in years	Median, IQR, range 18 (15–30) (7; 47)	17.3 (13.1–19.9)	17.7 (15.6–31.1)	0.3
Weight at surgery in kg	Median, IQR, range 62 (47–72) (13; 95)	Median 47.5, IQR range 35–70	Median 62.75, IQR range 50–75	0.49
Gender	N (%)	N	N	1,0
Male	32 (71.1)	4 (66,6)	28 (71.7)
Female	13 (28.9)	2 (33.4)	11 (28.3)
Diagnosis	N (%)	N	N	0.011
PAIVS	3 (6.7)	3	0
TOF	28 (62.2)	3	25
PS	10 (22.2)		10
PA/VSD	2 (4.4)		2
TGA	1 (2.2)		1
CAV/TOF	1 (2.2)		1
Indications for surgery	N (%)	N	N	1
Severe PR	44 (97.8)	6	38
Severe PS	1 (2.2)		1
Pre-operative RVEDV (mL/m²)	median, IQR, range
Pre-operative RVEDV (mL/m²)	164 (151–174) (77; 234)
Number of previous sternotomies	N (%)	N	N	0.29
0	5 (11.1)	1	4
1	30 (66.7)	4	26
2	10 (22.2)	0	10
Associate procedures	N (%)	N	N	1
No	26 (57.8)	3	23
Yes	19 (42.2)	3	16
IRV size	N (%)	N	N	0.21
23	3 (6.7)	0	3
25	31 (68.9)	6	25
27	11 (24.4)	0	11
Beating surgery	N (%)	N	N	0.22
No	11 (24.4)	3	9
Yes	34 (75.6)	3	31
ECC timing	median, IQR, range 90 (63–118) (25;230)
X-Clamp timing	median, IQR, range (evaluated on 14 pts)
X-Clamp timing	35 (22–85) (7; 119)

Abbreviations: IRV, Inspirs Resilia Valve; PR, pulmonary regurgitation; PS, pulmonary stenosis; RVEDV, right ventricle end-diastolic volume; ECC, extracorporeal circulation; X-Clamp, aortic cross-clamping; PAIVS, pulmonary atresia with intact ventricular septum; TOF, Tetralogy of Fallot; PS, valvular/supravalvular pulmonary stenosis; PA/VSD, pulmonary atresia with ventricular septal defect; CAV/TOF, Fallot canal and transposition of great arteries; TGA, thermogravimetric analysis.

Table 2.

Follow-up Data.

Follow-up in months: median, IQR, range 33 (18–45) (0; 73)	Total	Dysfunction Yes	Dysfunction No
Bioprosthesis stenosis (peak gradient/mmHg)	N (%)
≤25	32 (73.3)	0	32
26–40	10 (22.3)	3	7
41–60	2 (2.2)	2	0
61–80	1 (2.2)	1	0
TV regurgitation	N (%)
None	1 (2.2)	0	1
Trivial	3 (6.7)	0	3
Mild	37 (82.2)	4	33
Mild to moderate	2 (4.4)	1	1
Moderate	2 (4.4)	1	1
RVSP (mmHg)	N (%)
≤30	17 (37.8)	0	17
≤45	22 (48.9)	2	20
≤60	5 (11.1)	3	2
≤80	1 (2.2)	1	0
IVR dysfunction	N (%)
No	39 (86.7)	0	39
Yes (after a median of 32 months, range: 15–73)	6 (13.3)	6	6
Reintervention	N (%)
No	44 (97.8)	0	44
Yes	1 (2.2)	1	0

Abbreviations: IQR, interquartile range; IRV, Inspirs Resilia Valve; TV, tricuspid valve; RVSP, right ventricular systolic pressure; IVR, interactive voice response.

Table 3.

Risks Factors for Dysfunction.

	Dysfunction N (%)	P value
GenderMaleFemale	4 (12.5)2 (15.4)	0.80
Size IRV232527	06 (19.4)0	0.21
PV regurgitationNone, trivial, mildModerate, severe	06 (54.5)	<0.001
TV regurgitationNone, trivial, mildModerate, severe	4 (9.8)2 (50.0)	0.024

Abbreviations: IRV, Inspirs Resilia Valve; TV, tricuspid valve; PV, pulmonary regurgitation; RV, right ventricle.

We report dysfunction frequencies in different subgroups; the p-value is calculated with the chi-square test. IRV: Inspirs Resilia Valve; TV: tricuspid valve; RV: right ventricle.

Table 4.

Statistical Analysis

	Dysfunction Yes	Dysfunction No	P value
Age at surgery	17.3 (13.1–19.9)	17.7 (15.6–31.1)	0.30
RVEDV	168 (158–172)	164 (151–176)	0.59
Time follow-up (months)	32 (19–62)	33 (16–44)	0.53
Peak gradient (mmHg)	37.5 (30–55)	20 (15–23)	<0.001
RVSP (mmHg)	57 (45–60)	35 (30–40)	<0.001

Abbreviations: IQR, interquartile range; RVEDV, right ventricular end-diastolic volume; RVSP, right ventricular systolic pressure.

We report median values and interquartile range of 2 groups: dysfunction YES and dysfunction NO; the P value is calculated with the Mann-Whitney test.

Discussion

Currently, valve selection remains dependent on the surgeon or institution. The choice of pulmonary bioprostheses often relies on data from adult aortic valve replacement (AVR) studies. The IRV is a relatively new bovine pericardial prosthesis used for surgical AVR, featuring several innovative modifications designed to prevent oxidation and calcifications, facilitate dry storage, and enhance prosthesis durability.⁴ The Inspiris valve is secured with overlapping cobalt chromium alloy bands and a polyester shrink sleeve, allowing the valve frame to expand with balloon valvuloplasty to enable future valve-in-valve replacement without compromising the effective orifice area.⁵ This bioprosthesis has recently been adopted for PVR, with several groups reporting their experiences with contradictory results. Some recent studies involving a small number of patients (6–21 patients) indicated good outcomes with the IRV in the pulmonary position, showing no evidence of dysfunction in short-term follow-up.^15,16 In contrast, other groups have started to highlight early concerns about outcomes with this device. Said et al¹⁷ found that BR had progressed in 48% of patients at a mean follow-up of 16 ± 8 months Ragheb et al⁹ compared outcomes of IRV and mosaic valves and discovered that significant BR was markedly more common after PVR with IRV. In our population study, the rate of patients who developed BD (13.3%) is noteworthy, particularly considering the lack of follow-up time; thus, according to a recent report, analysis of risk factors and potential mechanisms for this development is warranted. Our statistical analysis indicated a correlation between BD and BR more than stenosis. This data is intriguing as it suggests that dysfunction may not be strictly related to leaflet degeneration or calcification, reaffirming the excellent bioprosthesis hemodynamic profile already documented when implanted in the aortic position. Several theories can be proposed to explain the early development of BR. Some authors suggest that the relatively flexible frame of IRV may permit distortion during implantation within the unsupported RVOT,^7,17 unlike aortic implantation in the supported left ventricular outflow tract, which can explain the favorable results of IRV in AVR. Indeed, the aortic annulus resides within the fibrous skeleton of the heart, whereas the pulmonary root lacks a fibrous annulus and originates directly from the RV infundibulum. Additionally, the pulmonary root is a highly distensible structure, with its external diameter shown to increase by a mean of 33% under normal RV pressures.¹⁸ Thus, in cases of elevated RV pressure (as seen with RVOT obstruction), the absence of a rigid annulus to support the expandable IRV stent frame may lead to an increase in the internal pulmonary annulus, resulting in leaflet malcoaptation. Our statistical analysis indeed revealed a correlation between BD and high preoperative RV pressure. Therefore, it could be speculated, as previously reported, that the intended benefit of an expandable support structure of IRV may contribute to long-term instability, leading to PVR failure.¹⁹ Expandable VFit technology is available in valve sizes 19 to 25 mm, and all of our patients who experienced dysfunction were implanted with the 25 mm Inspiris Resilia, while no failures have been noted thus far in patients with the IRV 27 size (10 patients). Although these results are not statistically significant, they align with findings from other studies.^17,20 According to Said et al,¹⁷ we can speculate that rapid geometric RV remodeling post-PVR led to changes in the prosthesis sewing ring over time, resulting in restricted leaflet mobility and the subsequent development of significant BR. Furthermore, Knox et al²⁰ suggest that valve angulation during implantation via a minimally invasive approach (left anterior mini-thoracotomy) might cause prosthetic distortion; however, this explanation does not clarify the early failures in cases of full sternotomy implantation, as observed in our series. From a surgical point of view, we implanted IRV only by continuous running suture and, despite potential benefits reported in other studies with interrupted suture, we don’t use this approach. Another proposed failure mechanism relates to the IRV leaflets’ function in pulmonary circulation.⁷ These leaflets are thicker than those of other bioprostheses, which may result from the multiple chemical treatments utilized to minimize calcification. While this characteristic might be inconsequential in stable, high-pressure aortic circulation, the lower pressure in pulmonary circulation may render it insufficient to adequately close the prosthetic leaflets, especially following the normalization of right-sided pressures during initial follow-up. According to this idea, all our IRV regurgitation is central and not peripheral. Although not used in our cohort, oral anticoagulation for 3 months postoperatively, as recommended by some guidelines, is used to prevent thrombosis or dysfunction. Indefinite antiplatelet therapy may reduce subclinical thrombosis, and this merits further study. Lastly, despite the well-documented utility of Inspiris valve frame enlargement in AVR, transcatheter PVR is presently associated with limited case reports.^7,21 One patient in our series underwent transcatheter valve implantation without frame enlargement but through stent fracture, similar to other bioprostheses. It may be hypothesized that early regurgitation of the IRV results from a combination of factors, including valve design and the anatomic and physiologic characteristics of the pulmonary root. Further discussion and collaboration, along with the use of advanced cross-sectional imaging, are needed to better evaluate the performance of this prosthesis in the pulmonary position on a larger scale and over a longer follow-up period. More data is crucial to develop innovative approaches in terms of tissue engineering and/or identify preventive treatments to mitigate structural bioprosthetic valve degeneration development and progression, and, in turn, significantly improve biological valve durability according to Sallè et al.²²

Limitations

Limitations of this study include its retrospective methodology and short duration of follow-up due to the relatively recent adoption of the Inspiris prosthesis. Our theories about the mechanisms of IRV failure remain theoretical, as we have not yet had any explanted Inspiris valve specimens for pathologic analysis.

Conclusions

Based on our mid-term results, we have currently suspended the use of the IRV for routine PVR. Our preferred choice for surgical PVR now includes the Epic Max prosthesis valve (Abbott, Santa Clara, Calif). Our study included a relatively small number of patients with short- to mid-term follow-up and should therefore be considered preliminary. However, our findings raise concerns regarding the durability of the IRV in the pulmonary position.

Footnotes

ORCID iD

Gianluigi Perri

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported in part by the Italian Ministry of Health with “Current Research funds.”

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

Lee

Jacobs

Lee

Kwak

Chai

Quintessenza

. Surgical pulmonary valve insertion—when, how, and why. Cardiol Young. 2012;22(6):702-707. doi:10.1017/S1047951112001722

Emani

. Options for prosthetic pulmonary valve replacement. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2012;15(1):34-37.

Kogon

Rosenblum

Mori

. Current readings: issues surrounding pulmonary valve replacement in repaired tetralogy of Fallot. Semin Thorac Cardiovasc Surg. 2015;27(1):57-64. doi:10.1053/j.semtcvs.2015.02.010

De La Fuente

Wright

Olin

, et al. Advanced integrity preservation technology reduces bioprosthesis calcification while preserving performance and safety. J Heart Valve Dis. 2015;24:101-109.

Puskas

Bavaria

Svensson

, et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017;52(3):432-439. doi:10.1093/ejcts/ezx158

Bavaria

Griffith

Heimansohn

, et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with RESILIA tissue. Ann Thorac Surg. 2023;115(6):1429-1436. doi:10.1016/j.athoracsur.2021.12.058

Nguyen

Vinogradsky

Sevensky

Crystal

Bacha

Goldstone

. Use of the Inspiris valve in the native right ventricular outflow tract is associated with early prosthetic regurgitation. J Thorac Cardiovasc Surg. 2023;166(4):1210-1221.e8. doi:10.1016/j.jtcvs.2023.04.018

Sengupta

Pastuszko

Zaidi

Murthy

. Early outcomes of pulmonary valve replacement with the Edwards Inspiris Resilia pericardial bioprosthesis. World J Pediatr Congenit Heart Surg. 2024;15(1):52-59. doi:10.1177/21501351231178750

Ragheb

Martin

Jaggi

, et al. Short- and mid-term results of pulmonary valve replacement with the Inspiris valve. Ann Thorac Surg. 2024;117(6):1203-1210.

10.

COMMENCE pulmonary: clinical evaluation of Edwards pericardial aortic bioprosthesis (model 11000A) for pulmonary valve replacement (COMMENCE-P). ClinicalTrials.gov identifier: NCT02656290.2023. Accessed March 13, 2023.

11.

Vahanian

Beyersdorf

Praz

, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease: developed by the task force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Rev Esp Cardiol (Engl Ed). 2022;75(6):524.

12.

Kwon

Baird

. Surgical valve choices for pulmonary valve replacement. Semin Thorac Cardiovasc Surg. 2023;35(1):94-104. doi:10.1053/j.semtcvs.2022.01.006

13.

Maeda

Lui

Zhang

, et al. Durability of pulmonary valve replacement with large diameter stented porcine bioprostheses. Semin Thorac Cardiovasc Surg. 2022;34(3):994-1000. doi:10.1053/j.semtcvs.2021.03.044

14.

Brancaccio

Perri

Della Porta

, et al. Use of carotid artery cannulation during redo sternotomy in congenital cardiac surgery: a single-centre experience. Interact Cardiovasc Thorac Surg. 2021;33(1):119-123. doi:10.1093/icvts/ivab060

15.

Subramanian

Nento

Reyes

. Early experience with the Inspiris Resilia valve in pulmonary valve replacement for congenital heart disease. J Struct Heart Dis. 2020;4:2.

16.

Arribas-Leal

Garcia-Vieites

Jimenez-Aceituna

, et al. Results of pulmonary valve replacement with a newly introduced bioprosthesis in children and young adults with congenital heart disease. J Struct Heart Dis. 2021;5:75-78.

17.

Said

Hiremath

Aggarwal

, et al. Early concerning outcomes for the Edwards Inspiris Resilia bioprosthesis in the pulmonary position. Ann Thorac Surg. 2023;115:1000-1007.

18.

Nagy

Fisher

Walker

Watterson

. The in vitro hydrodynamic characteristics of the porcine pulmonary valve and root with regard to the Ross procedure. J Thorac Cardiovasc Surg. 2000;120:284-289. 10.1067/mtc.2000.107473

19.

MacIver

Overman

DM.

Inspiris resilia valve in the pulmonary position: Modify or abandon?

Ann Thorac Surg. 2023; S0003-4975(23).

20.

Knox

Gimpel

Baker

Crouch

Bennetts

. Inspiris Resilia in the pulmonary position: The need for discussion and collaboration of results. Ann Thorac Surg. 2023;116(3):651. doi:10.1016/j.athoracsur.2023.01.038

21.

Batlivala

Hagel

Hirsch

Shahanavaz

. Transcatheter pulmonary valve-in-valve implantation within the expandable Inspiris Resilia bioprosthetic valve. Catheter Cardiovasc Interv. 2022;99(4):1157-1160.

22.

Sallé

Guimbretière

Toquet

, et al. New insights into the pathophysiology of structural bioprosthetic valve degeneration. J Heart Valve Soc. 2025;2(1):95-110.

Mid-Term Results of New Heart Valve Tissue Bioprosthesis for Pulmonary Valve Replacement

Abstract

Background

Methods

Results

Conclusions

Keywords

Key Point

Background

Methods

Study Population

Study End-Points

Operative Technique

Statistical Analysis

Results

Discussion

Limitations

Conclusions

Footnotes

ORCID iD

Funding

Declaration of Conflicting Interests

References