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Does valve size impact hemodynamic, left ventricular mass regression, and prosthetic valve deterioration with a sutureless aortic valve?

https://doi.org/10.1016/j.jtcvs.2023.01.017Get rights and content

Abstract

Objective

To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes.

Methods

Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 definition for bioprosthetic valve failure was applied.

Results

A Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2% were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3% (range, 2.1%-6.2%), and 33.4% had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9% vs 1.9% for small and 55.1% vs 19.5% for medium; P < .001). The mean aortic valve gradients decreased significantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient–prosthesis mismatch (with an effective orifice area/m2 of >0.8). Significant LV mass regression was documented regardless valve sizes, plateaued at -9.1% at 5 years. Freedom from SVD and reintervention were 95.2% and 96.3%, respectively, at 5 years and were independent of implanted valve size (P = .22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8% at 5 years.

Conclusions

The Perceval valve demonstrated low and stable mean gradients, significant LV mass regression, and low SVD and reintervention rates across all valve sizes.

Section snippets

Method

The protocol was approved by the Institutional Review Board or Medical Ethics Committee at each center. All patients provided written informed consent.

Results

The Perceval aortic valve was implanted in 970 patients in the CAVALIER and Perceval IDE Trials. Inclusion and exclusion criteria were the same for the 2 trials and are reported in Table E1, and study assessments are summarized in Table E2. The median patient age was 77.8 years, 57.2% of the cohort was female, the median STS-PROM was 3.3% (range, 2.1%-6.2%), 56.2% were NYHA grade ≥3, and 33.4% had a concomitant procedure (Tables 1 and 2). The distribution of valve size by sex is shown in Table 3

Discussion

Our analyses of the combined CAVALIER1,2 and US IDE trials3 aimed to better understand the physiologic significance of hemodynamic performance on intermediate-term (5-year) outcomes (Figure 4). Longer-term hemodynamic benefits of this valve design were overshadowed by prior reports that focused on postimplantation gradients, the ease and speed of implantation, the short learning curve, and good safety profile of Perceval valve implantation with both sternotomy and minimally invasive approaches

Conclusions

In conclusion, the Perceval valve has demonstrated stable hemodynamic and physiologic performance with an intermediate 5-year follow up. If these results are confirmed with longer-term (ie, 10-year) follow-up, this valve would be a great adjunct to our surgical options.

References (22)

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The CAVALIER trial and the Perceval IDE trial were funded by CORCYM.

ClinicalTrials.gov identifiers: CAVALIER, NCT01368666; Perceval IDE, NCT01810679.

The study protocol was approved by the Institutional Review Board or Medical Ethics Committee at each center. All patients provided written informed consent.

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