Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes.

@article{Bartus2018PrimarySA,
  title={Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes.},
  author={Krzysztof Bartus and Radosław Litwinowicz and Mariusz Kuśmierczyk and Agata Bilewska and Maciej Bochenek and Maciej Stapor and Sebastian Woźniak and Jacek R{\'o}żański and Jerzy Sadowski and Bogusław Kapelak},
  journal={Kardiologia polska},
  year={2018},
  volume={76 3},
  pages={
          618-624
        }
}
BACKGROUND Structural valve deterioration (SVD) is a major obstacle to lifetime durability for bioprosthetic heart valves. A bio-prosthetic valve created with RESILIA™ tissue was designed to produce long-term resistance to SVD. AIM The objective of this study was to evaluate the safety and performance of this new class of RESILIA™ tissue aortic bio-prosthesis. METHODS A nonrandomised, prospective, multi-centre, single-arm, observational study was performed in 133 patients who underwent… 

Tables from this paper

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis
  • K. Bartus, R. Litwinowicz, B. Kapelak
  • Medicine, Biology
    European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery
  • 2020
TLDR
The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up, and encouraging outcomes warrant additional investigation of this novel tissue.
Intermediate-term outcomes after aortic valve replacement with a novel RESILIATM tissue bioprosthesis.
TLDR
The aortic bioprosthesis with novel RESILIATM tissue demonstrated excellent hemodynamic performance and safety outcomes over 4 years, and the New York Heart Association functional class had improved from baseline in 54.5% of patients.
Early Results after Aortic Valve Replacement Using Last Generation Bioprosthetic Aortic Valve
TLDR
The use of the INSPIRIS RESILIA aortic valve in a young, low-risk population is safe and associated with very good early clinical and hemodynamic outcomes.
Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry
TLDR
The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60’years who undergo surgical AVR using the INSPiris RESILia aortic valve.
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)
TLDR
The RESILIENCE trial is the first prospective study to associate both clinical and imaging definitions of SVD with long-term (11 years) bioprosthetic valve durability.
Mid-term follow-up after suture-less aortic heart valve implantation.
TLDR
Long term echocardiographic hemodynamic outcomes of the Enable sutureless bioprosthesis are presented with excellent outcomes and hemodynamic profile which remained stable during the follow-up period.
Bioprosthetic or mechanical heart valves: prosthesis choice for borderline patients?-Results from 9,616 cases recorded in Polish national cardiac surgery registry.
TLDR
Patients aged 60-70 years represent more than one-third of all AVR patients and between 2006 and 2016, the proportion of implanted prostheses has changed dramatically, with BVs implanted in nearly 75% of AVR cases, three times more often than in 2006.
Clinical outcome and hemodynamic performance of St. Jude Trifecta aortic prosthesis: short-term follow-up and risk factors analysis.
TLDR
Third generation Trifecta aortic prosthesis should be considered as one of the best options in the setting of the aorti valve replacement surgery and hemodynamic performance, due to low incidence of PPM and low peak and mean trans-prosthetic aortsic valve gradients.
Changing trends in aortic valve procedures over the past ten years-from mechanical prosthesis via stented bioprosthesis to TAVI procedures-analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database.
TLDR
In the last ten years, the number of AV procedure has doubled and TAVI procedure rapidly grew in popularity, and there was a significant increase in the use of bioprosthesis.
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References

SHOWING 1-10 OF 29 REFERENCES
Long-Term Clinical and Echocardiographic Follow-Up of the Freestyle Stentless Aortic Bioprosthesis
TLDR
Aortic valve replacement with the Freestyle bioprosthesis in a subcoronary position provides good long-term clinical and echocardiographic outcomes for patients >60 years of age.
Aortic valve replacement with a novel anti-calcification technology platform.
TLDR
This early clinical experience using an aortic bioprosthetic valve treated with a novel anti-calcification tissue processing technology demonstrated excellent valve performance, durability, and safety.
Survival and long-term outcomes following bioprosthetic vs mechanical aortic valve replacement in patients aged 50 to 69 years.
TLDR
The findings suggest that bioprosthetic valves may be a reasonable choice in patients aged 50 to 69 years undergoing aortic valve replacement, and there was no significant difference in 15-year survival or stroke.
Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.
Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position.
Hemodynamic performance of the Medtronic Mosaic and Perimount Magna aortic bioprostheses: five-year results of a prospectively randomized study.
Long-term results of aortic valve replacement with mechanical prosthesis or carpentier-edwards perimount bioprosthesis in Japanese patients according to age.
TLDR
The use of BP is suitable in patients aged ≥70 years, while the use of bileaflet MP is preferable in Patients aged <60 years, because of the lower incidence of anticoagulant-related events and the equivalent long-term survival.
One-year hemodynamic comparison of Perimount Magna with St Jude Epic aortic bioprostheses
TLDR
Findings suggest that in a series with relatively low indexed effective orifice areas, the peak and mean gradients obtained were acceptable and more clinical follow-up of these patients is required to assess the true impact of prosthesis patient mismatch.
Clinical outcomes and hemodynamics of the 19-mm Perimount Magna bioprosthesis in an aortic position: comparison with the 19-mm Medtronic Mosaic Ultra Valve.
TLDR
Use of the 19-mm Magna bioprosthesis appears to provide satisfactory clinical results and the present data suggest that PPM is not related to reduction in the LV mass index.
...
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