The Journal of Thoracic and Cardiovascular Surgery
AdultDoes valve size impact hemodynamic, left ventricular mass regression, and prosthetic valve deterioration with a sutureless aortic valve?
Graphical abstract
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.
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Cited by (0)
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.