Skip to main content
Download PDF
Download ePub

Early and late clinical outcomes and cost-effectiveness of aortic valve replacement using the Inspiris Resilia bioprosthesis

A systematic review and meta-analysis

Journal of Cardiothoracic Surgery volume 20, Article number: 117 (2025) Cite this article

Abstract

Background

The present study aimed to critically revise the published literature on clinical outcomes and cost-effectiveness of Inspiris Resilia valve.

Methods

This work was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Full text research articles discussing clinical or cost-effectiveness aspects of Inspiris Resilia bioprosthesis published in English were included in this analysis. Studies were excluded if they weren’t exclusively conducted on patients submitted to surgical aortic valve replacement using the Inspiris Resilia bioprosthesis.

Results

The technical success rate was almost perfect in all studies. Reported complications included severe prosthesis-patient mismatch, reoperation, endocarditis, and paravalvular leak. In almost all studies, there were significant improvement of NYHA at the end of follow up as compared to baseline. In all studies, there were significant improvement of one or more hemodynamic parameters at the end of follow up as compared to baseline.

Conclusions

Surgical aortic valve replacement using Inspiris Resilia tissue valve appears to be safe and effective with low rate of aortic valve and systemic complications and mortality. Its performance appears to be equal to or better than many other bioprosthetic valves. As compared to mechanical valves, its use is suggested to be more cost-effective.

Peer Review reports

Introduction

Aortic valve disease (AVD) is the third common cause of cardiovascular disease with significant impact on patients’ quality of life and survival. Surgical aortic valve replacement (SAVR) has been widely regarded as a reliable and safe technique. It remains the standard of care for AVD management [1]. Over the last two decades, minimally invasive aortic valve replacement has increasingly gained solid grounding as a safe and effective treatment modality in comparison to open and transcatheter approaches [2].

The choice between mechanical and bioprosthetic valves usually respects the current American College of Cardiology/American Heart Association (AHA/ACC) and European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/ EACTS) guidelines that recommend which type of aortic valve prosthesis should be used according to different clinical and surgical criteria [3, 4]. Use of mechanical valves is hampered by the need for lifelong anticoagulation therapy with its related side effects especially in younger patients. In contrast, biological valves are disadvantaged by the shorter durability attributed to the high risk of structural valve deterioration (SVD) and subsequent need for reoperation [5,6,7]. SVD is attributed to valve calcification and destruction of connective tissue caused by mechanical stress, lipid and inflammatory cells infiltration and immune system activation [8].

Many attempts have been done to improve the durability of biological valves with many innovations and technologies developed to achieve this target [9, 10]. The Carpentier-Edwards Perimount Magna Ease valve is a third-generation bioprosthesis used for SAVR with satisfactory safety profile and sustained hemodynamic and functional performance at the long-term [11]. More recently, a new generation bioprosthetic valve -the Inspiris Resilia- was introduced and approved for use in many countries across Europe, North America and Asia. Inspiris Resilia (Model 11000, Edwards Lifesciences, LLC) is made of tri-leaflet bovine pericardial tissue mounted underneath a flexible frame. It was built upon the Carpentier-Edwards Perimount Magna Ease valve design. It is characterized by three magnificent features: First, the valve tissue is biologically selected to reduce calcium deposition via blockade of aldehyde groups and thus increasing durability. Second, the stent frame is supplemented with as expansion feature (V-Fit) that facilitates further valve-in-valve procedures particularly in patients with small annuli. The frame is designed to be compliant at the orifice as well as at the commissures. The wire form is made from cobalt–chromium alloy to improve spring efficiency and fatigue-resistance. Third, glycerolisation treatment inhibits oxidation of the valve tissue which preserves the structural integrity of the collagen matrix during non-liquid storage [12].

Preclinical [13, 14] and early clinical [12] studies showed adequate safety profile and good clinical performance. Subsequently, multiple clinical trials and registries were initiated to assess the long-term outcome of the newly introduced technology including the COMMENCE trial [15], the RESILIENCE trial [16], the INDURE registry [17] and the IMPACT registry [18].

The present work aimed to critically revise the published literature on clinical outcomes and cost-effectiveness of Inspiris Resilia valve.

Methods

The present study was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.

Inclusion and exclusion criteria

Full text research articles discussing clinical or cost-effectiveness aspects of Inspiris Resilia bioprosthesis published in English were included in this analysis. Studies were excluded if they weren’t exclusively conducted on patients submitted to SAVR using Inspiris Resilia bioprosthesis.

Search strategy

Three biomedical databases were searched: Pubmed, Scopus and Web of Science Core Collection. Used keywords included aortic valve, aortic valve replacement, bioprosthetic aortic valve replacement and Inspiris Resilia aortic valve. Multiple word combinations were made using the Boolean operators AND/OR to maximize the search results. Search settings were adjusted to retrieve journal articles published in English up to May 1, 2024.

Collected data

Data collected from the cohort studies included baseline data (type of study, number of patients, age, sex distribution, surgical risk scores, and left ventricular ejection fraction), aortic valve pathology (bicuspid aortic valve, aortic stenosis, aortic regurgitation, aortic prosthetic dysfunction), operative parameters (valve size, surgical access, number of patients with isolated aortic valve replacement), early and late aortic valve outcome (technical success, severe patient-prosthesis mismatch (PPM), reoperation for valve replacement, valve endocarditis, valve explanation, valve thrombosis, structural valve deterioration, non- structural valve deterioration, significant paravalvular leak: > 2+), early and late systemic complications (arrhythmia, use of permanent pacemaker, thromboembolic complications, bleeding requiring surgical revision, hemolysis), mortality (all-cause and valve-related), functional performance (NYHA) at baseline and at the end of follow up and hemodynamic parameters at baseline and the end of follow up.

Risk of bias assessment

Risk of bias in comparative studies included in the meta-analysis component was assessed using the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool. This tool evaluated bias in non-randomized studies regarding 7 domains (bias due to confounding, bias in selection of participants into the study, bias in classification of interventions, bias due to deviations from intended interventions, bias due to missing data, bias in measurement of outcomes and bias in selection of the reported result) with overall risk of bias judgement [19].

Statistical analysis

Data were presented as number, mean and standard deviation or median and interquartile range. Meta-analysis of comparative studies was performed using Review Manager 5.4.1 (Cochrane Collaboration, UK). Studies included in meta-analysis were tested for heterogeneity of the estimates using Cochran’s Q chi square test and I-square (I2) index. Binary outcomes across included studies were calculated using the Mantel-Haenszel methods and were expressed as log odds ratio with 95% confidence limits (95% CI). P-value < 0.05 was considered statistically significant.

Results

Search results

Search of the three databases identified 240 records which were reduced to 144 records after removal of duplicates. Screening of titles and abstracts resulted in exclusion of 116 records. Among the 28 full-text articles assessed for eligibility, 5 articles were excluded because they didn’t exclusively study the Inspiris Resilia valve. The remainder 23 studies were systemically revised and 5 comparative studies were advanced to further meta-analysis to compare the overall prevalence of early thromboembolic events and all-cause mortality between Inspiris Resilia valve and other bioprosthetic valves (Fig. 1).

Risk of bias in studies included in meta-analysis

Using the ROBINS-I tool, studies included in meta-analysis for early thromboembolic events and mortality were judged to have low risk of bias.

Clinical findings in the included cohort studies

  1. 1.

    Overview of included cohort studies.

In this section, 18 studies are included. The study of Sadowski et al. [12] is the first clinical study to assess the Inspiris Resilia performance. The same group published more three articles with more patients and/or longer follow up duration [20,21,22]. The studies of El-Sayed Ahmad et al. [18] and El-Sayed Ahmad et al. [23] respectively described the one-year and mid-term outcomes of patients from the IMPACT trial. The studies of Puskas et al. [24], Johnston et al. [25], and Beaver et al. [26]. respectively reported two-year, mid-term and seven-year outcomes from the Commence trial. Other studies are listed in Table 1. The follow up duration in the included studies ranged from time to hospital discharge [27] to 5.3 ± 2.2 years [26]. Trial/Registry/Setting, country of origin, number of included centers and number of included patients are shown in Table 1.

Table 1 Included cohort studies (n = 18)
Full size table
  1. 2.

    Baseline data in the included cohort studies.

Among the included studies, there were 10 prospective and 8 retrospective studies. Number of included patients ranged from 20 [12] to 689 [24,25,26]. Patients’ age ranged from 53.5 ± 6.9 years [28] to 75.1 ± 4.5 years [29]. Sex distribution of included patients, EuroSCORE, Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score and left ventricular ejection fraction (LVEF) are shown in Table 2.

Table 2 Baseline data in the included cohort studies (n = 18)
Full size table
  1. 3.

    Aortic valve pathology in the included cohort studies.

Presence of bicuspid aortic valve (BAV) and the prevalence of pure or combined aortic stenosis (AS) and regurgitation (AR) are shown in Table 3.

Table 3 Aortic valve pathology in the included cohort studies (n = 18)
Full size table
  1. 4.

    Operative data in the included studies.

Valve size 21 was the most commonly used valve size by 5 studies while valve size 23 was the most commonly used size by 11 studies. The most commonly or only used surgical access was full sternotomy in 12 studies while right anterior mini-thoracotomy (RAMT) was the main or only surgical access used in two studies (Table 4).

Table 4 Operative data in the included cohort studies (n = 18)
Full size table
  1. 5.

    Early and late aortic valve outcome in the included cohort studies.

Six studies didn’t report the technical success rate. The technical success rate was almost perfect in other studies. Reported complications included severe PPM, reoperation, endocarditis, and PVL (Tables 5 and 6).

Table 5 Early aortic valve outcome in the included cohort studies (n = 18)
Full size table
Table 6 Late aortic valve complications in the included cohort studies (n = 16)
Full size table
  1. 6.

    Early and late systemic complications and mortality in the included cohort studies.

Reported systemic complications included arrhythmia which sometimes required permanent pacemaker implantation, thromboembolic complications, major bleeding and mortality including valve-related mortality (Tables 7 and 8).

Table 7 Early systemic complications and mortality in the included cohort studies (n = 18)
Full size table
Table 8 Late systemic complications and mortality in the included cohort studies (n = 16)
Full size table
  1. 7.

    Functional performance (NYHA) at baseline and at the end of follow up in the included cohort studies.

In all studies, there were significant improvement of NYHA at the end of follow up as compared to baseline (Table 9).

Table 9 Functional performance (NYHA) at baseline and at the end of follow up in the included cohort studies (n = 18)
Full size table
  1. 8.

    Hemodynamic parameters at baseline and the end of follow up in the included cohort studies.

In all studies, there were significant improvement of hemodynamic parameters at the end of follow up as compared to baseline (Table 10).

Table 10 Hemodynamic parameters at baseline and the end of follow up in the included cohort studies (n = 18)
Full size table

Inspiris Resilia performance after bicuspid aortic valve replacement

One study [30] compared the clinical outcomes of bicuspid and tricuspid SAVR using the Inspiris Resilia valve. The valve showed excellent outcomes at 5 years with no structural valve deterioration and very low rates of paravalvular (0.7%) and transvalvular regurgitation (2.9%).

Comparison between Inspiris Resilia and other bioprosthetic valves

Six studies compared the clinical outcomes between Inspiris Resilia valve and other bioprosthetic valves (Tables 11, 12, 13, 14, 15 and 16). Bartus et al. [31] noted significantly lower rate of structural valve deterioration (SVD) in Inspiris Resilia tissue-based SAVR as compared to other contemporary prothesis while Bernard et al. [32] found that use of Inspiris Resilia valve is associated with lower rate of cardiovascular readmissions. Also, Bernard et al. [32] and Shala et al. [33] identified lower mean transvalvular gradient at follow up in the Inspiris Resilia valve and the study of Maeda et al. [34] recognized that effective orifice area in the Inspiris Resilia group was significantly larger than those in the Magna group. They also noted that patient-prosthesis mismatch at discharge was significantly lower in the Inspiris Resilia group than in the Magna group. In contrast, the study of Chiariello et al. [35] reported that use of Avalus valve is associated with better left ventricular mass reduction. Individual studies and overall analysis showed comparable outcomes between Inspiris Resilia valve and other valves regarding thromboembolic events (Fig. 2) and all-cause mortality (Fig. 3).

Table 11 Early aortic valve outcome in Inspiris Resilia versus other bioprosthesis in comparative studies (n = 5)
Full size table
Table 12 Late aortic valve complications in Inspiris Resilia versus other bioprosthesis in comparative studies (n = 5)
Full size table
Table 13 Early systemic complications and mortality in Inspiris Resilia versus other bioprosthesis in comparative studies (n = 5)
Full size table
Table 14 Late systemic complications and mortality in Inspiris Resilia versus other bioprosthesis in comparative studies (n = 4)
Full size table
Table 15 Functional performance at the end of follow up in Inspiris Resilia versus other bioprosthesis in comparative studies (n = 5)
Full size table
Table 16 Hemodynamic parameters at the end of follow up in Inspiris Resilia versus other bioprosthesis in comparative studies (n = 5)
Full size table
Fig. 1
figure 1

Flow chart of search strategy

Full size image
Fig. 2
figure 2

Thromboembolic events in Inspiris Resilia and other bioprosthetic valves

Full size image
Fig. 3
figure 3

All-cause mortality in Inspiris Resilia and other bioprosthetic valves

Full size image

Cost-effectiveness of Inspiris Resilia

Three studies [36,37,38] performed cost-effectiveness analysis of SAVR using Inspiris Resilia valve. In the study of Carapinha et al. [36], a budget impact analysis was performed to compare the Inspiris Resilia and mechanical valves in aortic stenosis (AS) patients > 65 years up to five years postoperative in Saudi Arabia. The authors concluded that Inspiris Resilia tissue valves are overall budget saving commencing in year 1 and savings gradually increase year-on-year when compared with mechanical valves. They further explained that the higher costs of the initial procedure, reoperation, and additional monitoring (echocardiogram tests and visits) associated with Inspiris Resilia tissue valves are counterbalanced by savings in warfarin use, disabling strokes, major bleeding, and anticoagulation complications [36].

In another study, Keuffel et al. [37] performed economic evaluation to quantify the expected long-run savings of bioprosthetic valves with RESILIA tissue relative to mechanical valves given 5-year clinical results and expected performance through year 15 using data of 10,000 American patients. They found that relative to mechanical SAVR, expected net savings after 5 years for one patient are $9,110 and in 15 years horizon are $20,744.

In addition, Malcolm et al. [38] from the United Kingdom developed a decision-analytic model to evaluate the potential cost-effectiveness of SAVR using Inspiris Resilia tissue versus mechanical valves. They found that SAVR using Inspiris Resilia valves is potentially associated with higher quality-adjusted life years and potential cost savings that were greatest for those aged 55–64 years.

Discussion

The present work critically analyzed the published research articles on SAVR using the Inspiris Resilia bioprosthetic valve. Like other bioprosthetic valves, the main target of Inspiris Resilia development is to increase valve durability and minimize SVD observed in similar valves. Apparently, Inspiris Resilia valve can be regarded as a promising option in this aspect not only due to the low rates of SVD noted by different studies but also due the evidence shown by a long-term and large sample size comparative study of Bartus et al. [31] In their study, the authors compared SVD between full and matched cohorts from the COMMENCE and PARTNER 2 A trials. The COMMENCE trial used the RESILIA valve for SAVR while other non-Resilia valves were used in the PARTNER 2 A. At 5 years, the rates of SVD were 1.8 versus 3.5% in full cohorts and 1.0% and 4.8% in the matched cohorts in the COMMENCE and PARTNER 2 A trials respectively. Considering the fact that most patients in the PARTNER 2 A trial were managed using various versions of Carpentier–Edwards PERIMOUNT that lack the Inspiris Resilia tissue. Findings of that study support the suggestion that the Inspiris Resilia valve may provide better performance than other valves even in longer follow up duration.

Probably, one of the most debatable issues in SAVR using Inspiris Resilia valve is the appropriate selection of the suitable candidates. In fact, selection of suitable candidates for the procedure remains undetermined as shown by the wide variation of the inclusion and exclusion criteria in the analyzed studies and the baseline clinical and surgical characteristics of the included patients. For example, in El-Sayed Ahmad et al. [18] study, pregnancy was the only exclusion criteria and valve selection was based on many criteria such as lifestyle choice, desire for pregnancy, and/or contraindication for anticoagulation therapy while in another study by the same authors, patients with endocarditis and redo SAVR were excluded [22].

These criteria contradict the stricter conditions required by earlier studies. As expected, the initial clinical study of Sadowski et al. [12] restricted patients’ eligibility to those with aortic valve disease requiring isolated replacement and excluded many patients including those with low LVEF, active endocarditis; concomitant valve disease and recent history of myocardial infarction.

Technically, SAVR using Inspiris Resilia tissue was mainly performed using full sternotomy surgical access. However, minimally invasive approaches were safely and effectively used in some studies. Like other aortic valve surgeries, the outcome of minimally invasive aortic valve replacement using Inspiris Resilia can benefit from additional technological advances e.g. video-assisted thoracoscopic surgery which can result in better procedural safety and performance, shorter cross-clamping and CBP time and shorter ICU and hospital stay as suggested by the study of El-sayed Ahmad et al. [18]

It has been also shown that use of Inspiris Resilia was associated with very low frequency of early and late aortic valve and systemic complications. The main reported complications included patient-prosthesis mismatch, reoperation for valve replacement, valve endocarditis, valve thrombosis, significant paravalvular leakage, arrhythmia, use of permanent pacemaker, thromboembolic complications and bleeding requiring surgical revision. Moreover, there was significant improvement of the functional performance as expressed by the NYHA classification and hemodynamic performance.

In a sub-analysis of the COMMENCE trial, it was shown that patients with bicuspid aortic valve had excellent 5-year safety outcomes after SAVR using the Inspiris Resilia valve with outcomes similar to patients with tricuspid aortic valve indicating that valve morphology is minimally related to the outcome of SAVR using the Inspiris Resilia. In fact, it was reported that bicuspid aortic valve may be associated with higher rates of PVL because of the asymmetrical annulus [39].

Comparison between the Inspiris Resilia valve and other bioprosthetic valves showed variable results. In one study comparing Inspiris Resilia and Magna Ease valves, no significant difference in short-term outcomes was observed, survival was similar at 30 months, but freedom from readmission was higher in the Inspiris Resilia group. Moreover, it was found that Inspiris Resilia valves had a lower mean gradient at discharge, 1–3 months and 24 months [31]. In another study, Maeda et al. [34] demonstrated that peak velocity and mean pressure gradient in the Inspiris Resilia group were comparable, while the effective orifice area in the Inspiris group was significantly larger than those in the Magna group. A patient-prosthesis mismatch at discharge was significantly lower in the Inspiris Resilia group than in the Magna group. Also, it was shown that Inspiris Resilia group tended to have lower trans-prosthetic pressure gradients, reduced trans-prosthetic blood flow acceleration and increased permeability indices as compared to the Magna Ease group [33]. In another study, however, early and late outcomes were found to be comparable between the Inspiris Resilia and Avlus valves regarding valve-related mortality, prosthetic endocarditis, reoperation, SVD or significant paravalvular leak [35]. Similar conclusions were reported by the study of Francica et al. [40] which compared Perimount Magna Ease and Inspiris Resilia Valve.

In respect to the cost-effectiveness, findings of studies suggested that Inspiris Resilia tissue valves proved to be cost-effective as compared to versus mechanical valves [36,37,38]. While these studies acknowledged the fact that SAVR using Inspiris Resilia is initially more expensive, they explained that other long-term costs related to mechanical valves including warfarin use, disabling strokes, major bleeding, and anticoagulation complications are much more costly.

Conclusions

In conclusion, SAVR using Inspiris Resilia tissue valve appears to be safe and effective with low rate of aortic valve and systemic complications and mortality. As compared to mechanical valves, its use is suggested to be more cost-effective.

Data availability

No datasets were generated or analysed during the current study.

References

  1. Costache VS, Moldovan H, Arsenescu C, Costache A. Aortic valve surgery of the 21st century: sutureless AVR versus TAVI. Minerva Cardioangiol. 2018;66(2):191–7.

    PubMed  Google Scholar 

  2. Kirmani BH, Akowuah E. Minimal Access aortic valve surgery. J Cardiovasc Dev Dis. 2023;10(7):281.

    PubMed  PubMed Central  Google Scholar 

  3. Writing Committee Members, Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice guidelines. J Thorac Cardiovasc Surg. 2021;162(2):e183–353. Epub 2021 May 8. PMID: 33972115.

    Article  Google Scholar 

  4. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, 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.

    PubMed  Google Scholar 

  5. Jiang Y, Wang S, Bian J, Chen S, Shao Y. Mechanical versus bioprosthetic aortic valve replacement in Middle-aged adults: a systematic review and Meta-analysis. J Cardiovasc Dev Dis. 2023;10(2):90.

    PubMed  PubMed Central  Google Scholar 

  6. Sigala E, Kelesi M, Terentes-Printzios D, Vasilopoulos G, Kapadohos T, Papageorgiou D, et al. Surgical aortic valve replacement in patients aged 50 to 70 years: mechanical or bioprosthetic valve? A systematic review. Healthc (Basel). 2023;11(12):1771.

    Google Scholar 

  7. Vankayalapati DK, Segun-Omosehin O, El Ghazal N, Suresh Daniel R, El Haddad J, Mansour R, et al. Long-term outcomes of mechanical Versus Bioprosthetic aortic valve replacement: a systematic review and Meta-analysis. Cureus. 2024;16(1):e52550.

    PubMed  PubMed Central  Google Scholar 

  8. Côté N, Pibarot P, Clavel MA. Incidence, risk factors, clinical impact, and management of bioprosthesis structural valve degeneration. Curr Opin Cardiol. 2017;32(2):123–9.

    Article  PubMed  Google Scholar 

  9. Agathos EA, Tomos PI, Kostomitsopoulos N, Koutsoukos PG. A novel anticalcification treatment strategy for bioprosthetic valves and review of the literature. J Card Surg. 2019;34(10):895–900.

    Article  PubMed  Google Scholar 

  10. Qi SS, Kelly RF, Bianco R, Schoen FJ. Increased utilization of bioprosthetic aortic valve technology:Trends, drivers, controversies and future directions. Expert Rev Cardiovasc Ther. 2021;19(6):537–46.

    Article  CAS  PubMed  Google Scholar 

  11. Tsui S, Rosenbloom M, Abel J, Swanson J, Haverich A, Zacharias J, et al. Eight-year outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT magna ease valve. J Card Surg. 2022;37(12):4999–5010.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Sadowski J, Bartuś K, Kapelak B, Chung A, Stąpor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317–22.

    Article  PubMed  Google Scholar 

  13. De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, et al. Advanced Integrity Preservation Technology reduces Bioprosthesis Calcification while preserving performance and safety. J Heart Valve Dis. 2015;24(1):101–9.

    PubMed  Google Scholar 

  14. Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149(1):340–5.

    Article  PubMed  Google Scholar 

  15. Bavaria JE, Griffith B, Heimansohn DA, Rozanski J, Johnston DR, Bartus K, et al. Five-year outcomes of the COMMENCE Trial investigating aortic valve replacement with RESILIA tissue. Ann Thorac Surg. 2023;115(6):1429–36. Epub 2022 Jan 20. PMID: 35065065.

    Article  PubMed  Google Scholar 

  16. Pibarot P, Borger MA, Clavel MA, Griffith B, Bavaria J, Svensson L, et al. Study design of the prospective non-randomized single‐arm multicenter evaluation of the durability of aortic bioprosthetic valves with RESILIA tissue in subjects under 65 years old (RESILIENCE trial). Struct Heart. 2020;4(1):46–52.

    Article  Google Scholar 

  17. Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwöger M, Laufer G, et al. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020;15(1):119.

    Article  PubMed  PubMed Central  Google Scholar 

  18. El-Sayed Ahmad A, Salamate S, Amer M, Sirat S, Akhavuz Ö, Bakhtiary F. The First 100 cases of two innovations combined: video-assisted minimally invasive aortic valve replacement through right anterior mini-thoracotomy using a novel aortic prosthesis. Adv Ther. 2021;38(5):2435–46.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919. https://doiorg.publicaciones.saludcastillayleon.es/10.1136/bmj.i4919. PMID: 27733354; PMCID: PMC5062054.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Bartuś K, Litwinowicz R, Kuśmierczyk M, Bilewska A, Bochenek M, Stąpór 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(3):618–24.

    Article  PubMed  Google Scholar 

  21. Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, et al. Intermediate-term outcomes after aortic valve replacement with a novel RESILIATM tissue bioprosthesis. J Thorac Dis. 2019;11(7):3039–46.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg. 2021;59(2):434–41.

    Article  PubMed  Google Scholar 

  23. Ahmad 23E-S, Giammarino A, Salamate S, Fehske S, Sirat W, Amer S. Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center. J Card Surg. 2022;37(12):4833–40.

    Article  Google Scholar 

  24. Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017;52(3):432–9.

    Article  PubMed  Google Scholar 

  25. Johnston DR, Griffith BP, Puskas JD, Bavaria JE, Svensson LG. COMMENCE Trial investigators. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg. 2021;162(5):1478–85.

    Article  PubMed  Google Scholar 

  26. Beaver T, Bavaria JE, Griffith B, Svensson LG, Pibarot P, Borger MA et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2023:S0022-5223(23)00873-5.

  27. Useini D, Schlömicher M, Haldenwang P, Naraghi H, Moustafine V, Bechtel M, et al. Early results after aortic valve replacement using last Generation Bioprosthetic aortic valve. Heart Surg Forum. 2021;24(6):E598–962.

    Article  PubMed  Google Scholar 

  28. Meuris B, Roussel JC, Borger MA, Siepe M, Stefano P, Laufer G, et al. Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years – 1-year follow-up from the prospective INDURE registry. Interdiscip Cardiovasc Thorac Surg. 2023;37(4):ivad115.

    Article  PubMed  PubMed Central  Google Scholar 

  29. Fukunaga N, Yoshida S, Shimoji A, Maeda T, Mori O, Yoshizawa K, 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(4):323–8.

    Article  PubMed  Google Scholar 

  30. Bavaria JE, Mumtaz MA, Griffith B, Svensson LG, Pibarot P, Borger MA, et al. Five-year outcomes after bicuspid aortic valve replacement with a novel tissue bioprosthesis. Ann Thorac Surg. 2023:S0003. 4975(23)01298-5.

  31. Bartus K, Bavaria JE, Thourani VH, Xu K, Keuffel EL. Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses. J Comp Eff Res. 2023;12(3):e220180.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Bernard J, Georges G, Hecht S, Pibarot P, Clavel MA, Babaki S, et al. Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the magna ease. Interdiscip Cardiovasc Thorac Surg. 2023;37(1):ivad117.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Shala M, Niclauss L. Early results of the Resilia Inspiris aortic valve in the old age patients - a retrospective comparison with the Carpentier Edwards Magna Ease. J Cardiovasc Thorac Res. 2020;12(3):222–6.

    Article  PubMed  PubMed Central  Google Scholar 

  34. Maeda K, Shimamura K, Yoshioka D, Inoue K, Yamada S, Yamashita K, et al. Midterm outcomes after surgical aortic valve replacement with the INSPIRIS RESILIA from a multicenter AVR registry. J Cardiol. 2023;82(4):261–7.

    Article  PubMed  Google Scholar 

  35. Chiariello GA, Villa E, Bruno P, Pasquini A, Nesta M, Ferraro F, et al. Two innovative aortic bioprostheses evaluated in the real-world setting. First results from a two-center study. J Cardiovasc Surg (Torino). 2023;64(3):338–47.

    PubMed  Google Scholar 

  36. Carapinha JL, Al-Omar HA, Aluthman U, Albacker TB, Arafat A, Algarni K, et al. Budget impact analysis of a bioprosthetic valve with a novel tissue versus mechanical aortic valve replacement in patients older than 65 years with aortic stenosis in Saudi Arabia. J Med Econ. 2022;25(1):1149–57.

  37. Keuffel EL, Reifenberger M, Marfo G, Nguyen TC. Long-run savings associated with surgical aortic valve replacement using a RESILIA tissue bioprosthetic valve versus a mechanical valve. J Med Econ. 2023;26(1):120–7.

  38. Malcolm R, Buckley C, Shore J, Stainthorpe A, Marti B, White A, et al. An exploratory cost-effectiveness analysis of a novel tissue valve compared with mechanical valves for surgical aortic valve replacement in subgroups of people aged 55–64 and 65 + with aortic stenosis in the UK. Expert Rev Pharmacoecon Outcomes Res. 2023;23(9):1087–99.

  39. Husso A, Airaksinen J, Juvonen T, et al. Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve. Clin Res Cardiol. 2021;110:429–39.

    Article  PubMed  Google Scholar 

  40. Francica A, Tonelli F, Rossetti C, Galeone A, Perrone F, Luciani GB, et al. Perimount MAGNA ease vs. INSPIRIS resilia valve: a PS-Matched analysis of the hemodynamic performances in patients below 70 years of age. J Clin Med. 2023;12(5):2077.

    Article  PubMed  PubMed Central  Google Scholar 

  41. Porto A, Stolpe G, Badaoui R, Boudouresques V, Deutsch C, Amanatiou C, et al. One-year clinical outcomes following Edwards INSPIRIS RESILIA aortic valve implantation in 487 young patients with severe aortic stenosis: a single-center experience. Front Cardiovasc Med. 2023;10:1196447.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

None.

Funding

Not applicable.

Author information

Authors and Affiliations

  1. Cardiothoracic Surgery Department, Ain Shams University, Cairo, Egypt

    Ahmed Ahmed

  2. Dubai Hospital, Dubai, United Arab Emirates

    Tarek A. Abdel Aziz, Mohannad M. R. AlAsaad, Motaz Majthoob & Kamaleldin Ahmed Altahmody

  3. Cardiology Department, Tanta University, Tanta, Egypt

    Kamaleldin Ahmed Altahmody

Authors
  1. Ahmed Ahmed
    View author publications

    You can also search for this author inPubMed Google Scholar

  2. Tarek A. Abdel Aziz
    View author publications

    You can also search for this author inPubMed Google Scholar

  3. Mohannad M. R. AlAsaad
    View author publications

    You can also search for this author inPubMed Google Scholar

  4. Motaz Majthoob
    View author publications

    You can also search for this author inPubMed Google Scholar

  5. Kamaleldin Ahmed Altahmody
    View author publications

    You can also search for this author inPubMed Google Scholar

Contributions

Design of the study: AA, TA, MMR, MM, KA; Data management and analysis: AA, TA, MMR, MM, KA; AA; TA, MMR, MM, KA AT prepared the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Ahmed Ahmed.

Ethics declarations

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Material 1

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ahmed, A., Aziz, T.A.A., AlAsaad, M.M.R. et al. Early and late clinical outcomes and cost-effectiveness of aortic valve replacement using the Inspiris Resilia bioprosthesis. J Cardiothorac Surg 20, 117 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s13019-024-03269-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s13019-024-03269-7

Keywords

Journal of Cardiothoracic Surgery

ISSN: 1749-8090

Contact us