Dataset Information

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

ABSTRACT:

Objectives

Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.

Methods

This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5?years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory.

Results

Mean patient age was 65.3?±?13.5?years, with 34 patients (25.6%) ?60. The mean follow-up was 4.2?±?1.5?years. Early (?30?days) and late (>30?days) all-cause mortality were 2.3% (N?=?3) and 3.2%/late patients-years (N?=?18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5?years, mean gradient was 14.8?±?7.6?mmHg and effective orifice area was 1.4?±?0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5?years.

Conclusions

The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5?years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue.

Clinical trial registration number

NCT01651052.

SUBMITTER: Bartus K

PROVIDER: S-EPMC7850021 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

Bartus Krzysztof K Litwinowicz Radoslaw R Bilewska Agata A Stapor Maciej M Bochenek Maciej M Rozanski Jacek J Sadowski Jerzy J Filip Grzegorz G Kusmierczyk Mariusz M Kapelak Boguslaw B

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20210101 2

<h4>Objectives</h4>Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.<h4>Methods</h4>This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 s ...[more]

PMID: 33141188

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Project description:BackgroundThe past decade has witnessed an ever-increasing momentum of transcatheter aortic valve replacement (TAVR) and a subsequent paradigm shift in the contemporary management of severe aortic stenosis (AS). We conducted a multi-centric TAVR registry based on Chinese patients (the China Aortic valve tRanscatheter Replacement registrY [CARRY]) to delineate the clinical characteristics and outcomes of Chinese patients who underwent TAVR and compare the results between different valve types in different Chinese regions.MethodsCARRY is an all-comer registry of aortic valve disease patients undergoing TAVR across China and was designed as an observational study that retrospectively included all TAVR patients at each participating site. Seven hospitals in China participated in the CARRY, and 1204 patients from April 2012 to November 2020 were included. Categorical variables were compared using the chi-squared test, and continuous variables were analyzed using a t test or analysis of variance (ANOVA) test. The Kaplan-Meier curve was used to estimate the risk of adverse events during follow-up.ResultsThe mean age of the patients was 73.8 ± 6.5 years and 57.2% were male. The median Society of Thoracic Surgeon-Predicted Risk of Mortality score was 6.0 (3.7-8.9). Regarding the aortic valve, the proportion of bicuspid aortic valve (BAV) was 48.5%. During the hospital stay, the stroke rate was 0.7%, and the incidence of high-degree atrioventricular block indicating permanent pacemaker implantation was 11.0%. The in-hospital all-cause mortality rate was 2.2%. After 1 year, the overall mortality rate was 4.5%. Compared to patients with tricuspid aortic valve (TAV), those with BAV had similar in-hospital complication rates, but a lower incidence of in-hospital mortality (1.4% vs. 3.3%) and 1 year mortality (2.3% vs. 5.8%).ConclusionsTAVR candidates in China were younger, higher proportion of BAV, and had lower rates of post-procedural complications and mortality than other international all-comer registries. Given the use of early generation valves in the majority of the population, patients with BAV had similar rates of complications, but lower mortality than those with TAV. These findings further propel the extension of TAVR in low-risk patients.Trial registrationhttps://www.chictr.org.cn/ (No. ChiCTR2000038526).

Dataset Information

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

Objectives

Methods

Results

Conclusions

Clinical trial registration number

Publications

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

Similar Datasets

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