Biological valves

What is RESILIA tissue and how did it get here?

Presenter: Angela De La Fuente

5 Mid-term outcomes of INSPIRIS RESILIA valve compared to Magna Ease valve

Presenter: Prof. Onorati

7-year COMMENCE trial data

Presenter: Dr. Bavaria

Durability of bioprosthetic valves in patients under the age of 60 years.

Presenter: Prof. De Paulis

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years – 1-year follow-up from the prospective INDURE registry

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Meuris B, Roussel JC, Borger MA et al.

Interdisciplinary CardioVascular and Thoracic Surgery. 2023; doi:10.1093/icvts.ivad115.

Key points:

The 1-year data from the INSPIRIS RESILIA Durability Registry (INDURE) demonstrate good safety outcomes with surgical aortic valve replacement (SAVR) in young patients characterised by a high rate of bicuspid aortic valve (BAV) and aortic regurgitation; survival rates at 1 year were better than predicted and quality of life (QoL) was fully restored within 3–6 months.

Background information

Bioprosthetic valves have gained popularity in younger patients due to their durability, decreased reoperation risk and the possibility of transcatheter valve-in-valve procedures, as supported by retrospective studies and current guidelines.¹
The INSPIRIS RESILIA aortic valve, made of bovine pericardial tissue, has shown promising haemodynamic and anticalcification properties in preclinical and clinical studies, including excellent safety and effectiveness at 5 years.^2–8 However, data specifically focusing on patients under 60 years of age are limited.

Aim

To assess 1-year safety and clinical outcomes in patients under 60 years of age undergoing SAVR with the INSPIRIS RESILIA aortic valve.

Type of study

A prospective, open-label, multicentre international registry with centres across Europe and Canada.

Endpoints

Primary endpoint:
– Time-related valve safety at 1 year: freedom from specific events according to Valve Academic Research Consortium (VARC)-2 criteria, including repeat procedure, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events (e.g. stroke) and life-threatening bleeding.
Secondary endpoints:
–Haemodynamic performance assessment.
– Durability evaluation of INSPIRIS RESILIA aortic valve (composite endpoint of time-related valve safety [VARC-2; adjudicated by an independent clinical events committee] and structural valve deterioration [SVD] stage 3 [VARC-3; based on a standardised Core Lab adjudicated assessment]).
– Clinical outcomes: all cause, cardiovascular and valve-related mortality; valve-related dysfunction; need for repeat procedures; permanent pacemaker implantation; acute kidney injury stage 2 or 3; and New York Heart Association (NYHA) functional class.
– Evaluation of QoL using Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form-12 Health Survey (SF-12v2).

Methods

421 patients who underwent SAVR with the INSPIRIS RESILIA aortic valve at 21 sites across nine countries were included.
Inclusion criteria included planned native valve replacement based on preoperative evaluation.
Exclusion criteria included inability to implant valve per device Instructions for Use, active endocarditis/myocarditis within last 3 months, previous aortic valve replacement, Bentall procedure or surgery on other valves, and life expectancy of less than 12 months.

Results

Baseline and procedural characteristic
• Common comorbidities included arterial hypertension, coronary artery disease and type II diabetes.
Table 1: Patient baseline and procedural characteristics

Early (30 days) and 1-year outcomes

At 30 days, 3 patients (0.7%) died due to cardiovascular causes. No valve-related mortality was reported in the 1-year follow-up.
Valve-related safety events occurred in 25 patients (5.9%) within 30 days and in 9 patients (2.2% per valve-years) from 30 days to 1 year.
Within 1 year, 7 patients (1.7%) died, with 5 deaths related to cardiovascular causes. No patients had SVD stage 3 (VARC-3).
Severe patient–prosthesis mismatch was observed in 1.0% of patients.
The majority of patients showed improvement in NYHA functional class, with 81.8% in class I and only 3.6% in class III/IV at 1 year, compared with 21.9% and 27.2% at baseline.
No cases of prosthetic valve leakage were reported.

Quality-of-life outcomes

SF-12v2 physical summary score showed improvements at 3–6 months and 1 year compared with baseline (Table 2). Patients returned to the expected QoL of the general population, achieving a mean score of 50 points within 3–6 months.
KCCQ total symptom score and clinical summary score increased at 3–6 months and 1 year, with a notable increase in overall summary score at 1 year (Table 2). Patients scored 75–100 points (= good to excellent health status) within 3–6 months.

Table 2: Quality of life outcomes at baseline, 3–6 months and 1 year

Limitations

The study did not include an active control group, so comparisons between different bioprosthetic valves could not be made and selection bias cannot be excluded. Furthermore, there was no comparison with the outcomes and performance of mechanical valves.
These results are based on 1-year data, so may not reflect long-term safety outcomes, although the cohort will be followed for 5 years.

Conclusions

The results of this study demonstrate good outcomes in terms of safety, early improvement in QoL and high survival rates at 1 year for patients under the age of 60 who received the INSPIRIS RESILIA valve.

References

Christ T, Grubitzsch H, Claus B et al. Stentless aortic valve replacement in the young patient: Long-term results. J Cardiothorac Surg. 2013; 8: 68.
Flameng W, Hermans H, Verbeken E et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015; 149: 340–5.
Puskas JD, Bavaria JE, Svensson LG et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017; 52: 432–9.
Bartus K, Litwinowicz R, Kusmierczyk M et al. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: One-year outcomes. Kardiol Pol. 2018; 76: 618–24.
Bartus K, Litwinowicz R, Bilewska A et al. Intermediate term outcomes after aortic valve replacement with a novel RESILIA™ tissue bioprosthesis. J Thorac Dis. 2019; 11: 3039–46.
Useini D, Schlomicher M, Haldenwang P et al. Early results after aortic valve replacement using last generation bioprosthetic aortic valve. Heart Surg Forum. 2021; 24: E598–962.
Bavaria JE, Griffith B, Heimansohn DA et al. Five year outcomes of the COMMENCE trial investigating aortic valve replacement with RESILIA tissue. Ann Thorac Surg. 2022; 115: 1429–36.
Fukunaga N, Yoshida S, Shimoji A et al. Hemodynamic performance of INSPIRIS RESILIA aortic bioprosthesis for severe aortic stenosis: 2 year follow-up in Japanese cohort. J Artif Organs. 2022; 25: 323–8.
This document is a summary of the Meuris B et al. paper
and covers key information including aim, type of study,
methods, results and conclusion.

The full publication is available at:

doi.org/10.1093/icvts/ivad115

Abbreviations

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential
adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Refer to device instructions for use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in valve procedures. VFit technology is available on sizes 19–25 mm.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, NSPIRIS, RESILIA, RESILIA and VFit are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years – 1-year follow-up from the prospective INDURE registry

Authors: Meuris B, Roussel JC, Borger MA et al.

PERIMOUNT Magna Ease vs INSPIRIS RESILIA valve: A PS-matched analysis of the hemodynamic performances in patients below 70 years of age

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Francica A, Tonelli F, Rossetti C, Galeone A, Perrone F, Luciani GB and Onorati F.

Journal of Clinical Medicine. 2023; 12: 2077.

Key points

This is the first propensity-matched analysis comparing the haemodynamic performance of the INSPIRIS RESILIA valve with the Carpentier-Edwards PERIMOUNT Magna Ease valve at mid-term follow-up in patients under 70 years of age.
For up to 3 years post surgery, the haemodynamic performance was comparable between the two valve types in this patient population; however, the INSPIRIS RESILIA valve was associated with lower intraventricular septum thickness measurements and systolic pulmonary artery pressure.

Background information

The PERIMOUNT Magna Ease valve has been implanted worldwide during the last 10 years and has achieved excellent long- erm clinical and haemodynamic outcomes.
The INSPIRIS RESILIA valve was introduced with the aim of improving valve durability by reducing calcification; ¹ but how the haemodynamics of this valve compare with the PERIMOUNT Magna Ease valve has not previously been evaluated.

Aim

To compare the haemodynamic performance of the PERIMOUNT Magna Ease valve with the INSPIRIS RESILIA valve in patients under 70 years.

Type of study

A retrospective single-centre study with propensity-matched analysis.

Endpoints

The primary endpoint was to compare the short- and mid-term haemodynamic performances of the PERIMOUNT Magna Ease valve and the INSPIRIS RESILIA valve.
Secondary endpoints included:
– Haemodynamic performance stratified by prosthetic valve size.
– Postoperative outcomes.

Results

Baseline characteristics

The two propensity score-matched populations were similar in age (mean 57.4 ± 10.1 years) and risk profile (EuroSCORE II 2.7 ± 2.4%).
The most common comorbidity was hypertension (54.5%), and 31.6% of patients were in New York Heart Association functional class III or IV.

Postoperative outcomes

Postoperative outcomes were comparable between the two populations.
The overall incidence of major complications was low:
– No procedural or periprocedural mortality.
– Permanent pacemaker implantation: 3.3% PERIMOUNT Magna Ease valve versus 1.6% INSPIRIS RESILIA valve (p=0.4).
– Type 1 stroke: 0.8% in both groups.
– Paroxysmal atrial fibrillation was the most common complication (22.1% PERIMOUNT Magna Ease valve vs 24.6% INSPIRIS RESILIA valve, p=0.88).

Haemodynamic performance

PERIMOUNT Magna Ease valve and INSPIRIS RESILIA valve showed similar haemodynamic performance at 1-year and 3-year follow-up in terms of peak and mean gradient (Figure 1) and left ventricular volumes and diameters.

Methods

The study population consisted of patients who were aged between 18 and 70 years and underwent aortic valve replacement (AVR) at the Division of Cardiac Surgery, University of Verona.
– Between January 2010 and December 2012, 238 patients underwent AVR with a PERIMOUNT Magna Ease valve.
– Between September 2017 and January 2022, 192 patients underwent AVR with an INSPIRIS RESILIA valve.
A propensity score-matched analysis was performed to account for baseline differences, resulting in 122 matched pairs.
Echocardiographic data was collected 1 and 3 years post surgery.
At 1 year, patients with INSPIRIS RESILIA valves had lower intraventricular septum thickness measurements (12.1 ± 2.0 mm vs 13.2 ± 2.1 mm, p=0.011) and systolic pulmonary artery pressure (26.8 ± 7.6 mmHg vs 34.3 ± 9.3 mmHg, p=0.001) than those with PERIMOUNT Magna Ease valves.
Severe structural valve deterioration occurred in four patients (all <50 years old) with PERIMOUNT Magna Ease valve and no patients with INSPIRIS RESILIA valve.
When stratified by valve size, there were no differences in haemodynamic behaviour between the two valves for any valve size category.

Limitations

This was a retrospective study.
The two patient groups were treated almost 10 years apart, and patients with INSPIRIS RESILIA valves had a shorter follow-up.
There was no standardised protocol for echocardiography, although all labs complied with guidelines.
Data retrieval was challenging due to the study taking place during the COVID-19 pandemic.

Conclusion

The INSPIRIS RESILIA valve achieved the same efficacy and safety outcomes as the PERIMOUNT Magna Ease valve at mid-term follow-up in this propensity-matched analysis of patients under 70 years of age.

Reference

Flameng W, Hermans H, Verbeken E et al.
A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015; 149: 340–5.

This document is a summary of the Francica A et al. paper and covers key information including aim, type of study, methods, results and conclusion.

The full pubblication is available at:

doi: 10.3390/jcm12052077

Abbreviations

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, Carpentier-Edwards PERIMOUNT Magna Ease, Magna, Magna Ease, PERI, PERIMOUNT and PERIMOUNT Magna are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

PERIMOUNT Magna Ease vs INSPIRIS RESILIA valve: A PS-matched analysis of the hemodynamic performances in patients below 70 years of age

Authors: Francica A, Tonelli F, Rossetti C, Galeone A, Perrone F, Luciani GB and Onorati F.

Assessment of a new bioprosthetic valve to treat young patients with bicuspid aortic valve

Presenter: Dr. Kalavrouziotis

Lifetime management of aortic valve disease: key considerations in valve selection

Presenter: Prof. D’Onofrio

Long-term economic savings associated with sAVR using RESILIA tissue bioprostheses

Presenter: Dr. Nguyen

Health economic considerations for using tissue valves for AVR

Presenter: Prof. Meuris

Minimally invasive SAVR with a biological valve via right anterior mini-thoracotomy

Presenter: Prof. Grunenfelder

Live in a box: Minimally invasive AVR with annular enlargement

Presenter: Prof. Treede

Not all biological valves are equal: a single-center experience

Presenter: Prof. Anselmi

Single center experience with INSPIRIS RESILIA aortic valve

Presenter: Prof. D’Onofrio

One-year clinical outcomes following Edwards INSPIRIS RESILIA aortic valve implantation in 487 young patients with severe aortic stenosis: A single-centre experience

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Porto A, Stolpe G, Badaoui R et al.

Frontiers in Cardiovascular Medicine. 2023; doi:10.3389/fcvm.2023.1196447.

Key points:

The management of aortic stenosis in young patients is an important topic.
The INSPIRIS RESILIA valve demonstrated encouraging survival, clinical and haemodynamic outcomes at 1-year follow-up in a large, single-center prospective study of consecutive young patients with severe aortic stenosis (AS).

Background information

Aortic bioprostheses are increasingly being used in younger patients with severe AS, despite the risk of accelerated structural valve deterioration (SVD) and subsequent need for reintervention, especially in patients under 65 years of age.
The INSPIRIS RESILIA valve, a bovine pericardial tissue valve with a special integrity preservation technology, represents a promising solution to SVD.
Early clinical experience with the INSPIRIS RESILIA valve has shown encouraging results in terms of early safety and efficacy of aortic valve replacement (AVR).
Intermediate-term outcomes have shown the absence of early thrombosis events and non-calcific valve deterioration.^1-2

Aim

To evaluate the 1-year outcomes of the INSPIRIS RESILIA aortic valve in a population of young patients who underwent AVR for severe AS.

Type of study

A prospective single-centre study.

Results

Baseline and procedural characteristics

Mean (± standard deviation [SD]) age was 58.2 ± 11.5 years and 75.2% were male.
Most of the interventions were elective (endocarditis 18.7%; 14.5% redo surgery; and 31.2% AS without aortic regurgitation), with a mean (± SD) EuroSCORE II of 4.8 ± 7.9%.
Patients 50 years of age or younger had a higher EuroSCORE II (5.3 ± 9.6%) and were more likely to present with preoperative IE (29.2% vs 18.5% for the 50<65 group and 12.5% for the ≥65 group).
210 patients (43.1%) had a concomitant procedure performed perioperatively:
– 23.4% had aortic replacement.
– 9.2% had mitral valve surgery replacement or repair.
– 7.4% had coronary artery bypass graft.

Clinical outcomes at 1 year

The Kaplan–Meier estimated survival rate was 96.4%.
There was no significant difference in either overall or cardiac mortality, or major cardiac events between the three age groups (Table 1).

Endpoints

The primary endpoint was overall mortality at 1 year.
Secondary endpoints included:
– Cardiovascular mortality.
– Major adverse cardiac events (defined by rehospitalisation for congestive heart failure, stroke or myocardial infarction).
– Evolution of New York Heart Association (NYHA) functional status.
– Haemodynamic follow- up.
– Mortality and morbidity of infective endocarditis (IE).

All outcomes were defined according to the Valve Academic Research Consortium-2 consensus document.

Methods

A total of 487 consecutive patients with severe AS who received the INSPIRIS RESILIA valve between June 2017 and July 2021 at La Timone Hospital in Marseille, France, were included in the study.
Clinical assessment and transthoracic echocardiography were performed preoperatively and at 1 year postoperatively.
Subgroup analyses were conducted based on age (≤50 years, 50<65 years and ≥65 years) and preoperative IE status.

Figure 1: Change in NYHA class from baseline to 1-year follow-up in patients treated with the INSPIRIS RESILIA valve

Functional status was significantly improved (p<0.0001) (Figure 1).
Severe patient–prosthesis mismatch and severe intravalvular regurgitation occurred in 1.2% and 0.6% of patients, respectively.

Haemodynamic properties

Haemodynamic performance was significantly improved (baseline vs 1-year postoperative data; median [interquartile range]; p<0.001 for all):
– Aortic valve area index: 0.4 (0.4, 0.5) versus 1.0 (0.8, 1.3).
– Mean gradient: 49 mmHg (43, 55) versus 9 mmHg (7, 12).
– Peak velocity: 4.4 m/s (4.0, 4.9) versus 2.1 m/s (1.8, 2.4).
There were no significant differences in these parameters between the age groups.

Table 1: Mortality and morbidity outcomes at 1 year among patients treated with the INSPIRIS RESILIA valve

Infective endocarditis

The Kaplan–Meier estimated survival rates at 1 year were 97.9% for the IE-free group and 89.5% for the IE group.
Excluding IE-related causes, no SVD and valve failure requiring redo surgery were reported.

Limitations

This was a single-arm study without comparative groups.
Patients were only followed up for 1 year; therefore, long-term durability cannot be fully assessed.
There was a high prevalence of preoperative IE in patients 50 years and younger, which explains the high rate of adverse events in this cohort.
– While the data seem to favour the INSPIRIS RESILIA valve in this population, the number of patients is too low to draw any conclusions.

Conclusions

The INSPIRIS RESILIA valve provides encouraging clinical outcomes with excellent 1-year survival rates and good haemodynamic performance.
Further studies are needed to assess long-term valve durability.

References

Bartuś K, Litwinowicz R, Kuśmierczyk M et al. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: One-year outcomes.
Kardiol Pol. 2018; 76: 618–24.
Johnston DR, Griffith BP, Puskas JD et al. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg. 2021; 162: 1478–85.

This document is a summary of the Porto A et al. paper
and covers key information including aim, type of study,
methods, results and conclusions

The abstract is available at:

doi: 10.3389/fcvm.2023.1196447

Abbreviations

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, Carpentier-Edwards PERIMOUNT Magna Ease, EDWARDS INTUITY, EDWARDS INTUITY Elite, INSPIRIS, INSPIRIS RESILIA, Magna, Magna Ease, PERI,

PERIMOUNT, PERIMOUNT Magna and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

One-year clinical outcomes following Edwards INSPIRIS RESILIA aortic valve implantation in 487 young patients with severe aortic stenosis: A single-centre experience

Authors: Porto A, Stolpe G, Badaoui R et al.

Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center

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El-Sayed Ahmad A, Giammarino S, Salamate S, Fehske W, Sirat S, Amer M, Bramlage P, Bakhtiary F and Doss M.

Journal of Cardiac Surgery. 2022; 37: 4833–40

Key points:

The mid-term follow-up results of this single- centre study, in a patient population with a mean age of 56.8 years, indicate favourable procedural outcomes, with adequate durability and no cases of structural valve deterioration (SVD).
At Year 3, haemodynamic performance was stable and adequate.
INSPIRIS RESILIA aortic valve may represent a bioprosthesis suitable for younger patients, giving excellent results.

Background information

Surgical aortic valve replacement (SAVR) using bioprosthetic valves is becoming increasingly popular in younger patients.
The INSPIRIS RESILIA aortic valve features a tri-leaflet bovine pericardial tissue mounted under a flexible frame and has been developed to reduce calcification, therefore, increasing durability.

Aim

To analyse mid-term follow-up data in patients who underwent SAVR with an INSPIRIS RESILIA bioprosthetic heart valve at the Heart Centre in Siegberg-Wuppertal.

Type of study

A single-centre, non- randomised retrospective study.

Endpoints

The primary endpoint was the haemodynamic properties of the RESILIA tissue valve at mid-term follow-up.
Secondary objectives included mortality and valve-related complications (according to Valve Academic Research Consortium-3 criteria).¹

Limitations

This is a retrospective, non- randomised, single-centre study with a small sample size and no control group.

Methods

All patients with aortic valve disease who received an INSPIRIS RESILIA aortic valve between April 2017 and December 2019 at the Division of Cardiac Surgery, Heart Centre Siegberg-Wuppertal, University Witten- Herdecke, Germany (n=154) were included.
Follow-up data were collected in the clinic or by telephone during the 3-month closing interval ending in April 2021.
Echocardiographic data were collected twice a year.

Results

Study population

Mean (± standard deviation) patient follow-up was 2.05 ± 0.77 years.
Baseline characteristics are listed in Table 1.

Mortality and valve-related complications

30-day, 1-year and 3-year freedom from mortality were 98.7%, 97.3% and 87.7%, respectively; the rate of valve-related mortality was 0%.
There were no cases of SVD or valve-related thrombosis and one (0.6%) case of reoperation due to endocarditis.

Table 1: Patient baseline characteristics

Haemodynamic properties

At last follow-up:
– Effective orifice area was 1.9 cm².
– Peak gradient was 23.6 mmHg.
– Mean gradient was 13.9 mmHg.
Figure 1 shows peak and mean gradients at 3-year follow-up by valve size.

Figure 1: Peak and mean gradients at 3-year follow-up for each valve size

Conclusions

The INSPIRIS RESILIA valve shows adequate mid-term durability and haemodynamic performance.
Further studies are required to assess long-term durability and efficacy, especially in younger patients.

Reference

Genereux P, Piazza N, Alu MC et al. Valve Academic Research Consortium 3: Updated endpoint definitions for aortic valve clinical research.
Eur Heart J. 2021; 42: 1825–57

This document is a summary of the El-Sayed Ahmed A et al. paper and covers key information including aim, type of study, methods, results and conclusions.

The full abstract is available at:

doi: 10.1111/jocs.17198

Abbreviations

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center

Authors: El-Sayed Ahmad A, Giammarino S, Salamate S, Fehske W, Sirat S, Amer M, Bramlage P, Bakhtiary F and Doss M.

About

From early development to practical use, through durability assessment and real-world data

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Overview

Part 1: Tissue technology
Part 2: Clinical Trials and Studies
Part 3: Biological valve in Young Patient Population
Part 4: Lifetime management
Part 5: Health economics
Part 6: Live in a box
Part 7: Single-center experiences