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Does Valve size Impact Hemodynamic, Left Ventricular Mass Regression and Prosthetic Valve Deterioration with a Sutureless Aortic Valve?

Published:January 23, 2023DOI:https://doi.org/10.1016/j.jtcvs.2023.01.017
Does Valve size Impact Hemodynamic, Left Ventricular Mass Regression and Prosthetic Valve Deterioration with a Sutureless Aortic Valve?
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      Abstract

      Objective

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

      Methods

      Data was obtained from a multicenter European and a U.S. IDE trials. Echocardiography data were analyzed by an echocardiography core lab. Mixed-effects regression model assessed relationship between hemodynamic outcomes, time from procedure and valve sizes. VARC-3 definition for bioprosthetic valve failure was applied.

      Results

      The sutureless valve was implanted in 970 patients. The median age was 77.8 years, 57.2% of the patients were female, the median Society of Thoracic Surgeons predicated risk of mortality (STS PROM) was 3.3% [2.1; 6.2], and 33.4 % had concomitant procedures. Median clinical follow-up was 45.7 months [28.2; 76.1]. Small (S) and medium (M) valve sizes were implanted more commonly in women (16.9% versus 1.9% for S and 55.1% versus 19.5% for M, p<0.001). The mean aortic valve gradients decreased significantly post implant and remained stable across all valve sizes throughout the follow up period. All patients were free from severe patient prosthesis mismatch (with EOA/m2 of > 0.8). Significant left ventricular mass regression was documented regardless valve sizes, plateaued at - 9.1% at 5-years. Freedom from structural valve deterioration and reintervention were 95.2% and 96.3% at 5-years and were independent of implanted valve size (p=0.22). 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, low structural valve degeneration and re-intervention rates across all valve sizes.

      Graphical abstract

      Figure thumbnail fx1
      Graphical Abstract

      Keywords

      Abbreviations:

      AS (aortic stenosis), ASA (acetylsalicylic acid), AVR (aortic valve replacement), CABG (Coronary artery bypass grafting), CE (European conformity), CEC (Clinical Events Committee), CI (confidence intervals), DSMB (Data Safety Monitoring Board), EOA (effective orifice area), FDA (Food and Drug Administration), HR-QoL (health related quality of life), ICU (intensive care unit), IDE (Investigational Device Exemption), IRB (Institutional Review Board), KCCQ (Kansas City Cardiomyopathy Questionnaire), LV (Left Ventricle), LVOT (left ventricle outflow tract), NSVD (non-structural valve dysfunction), NYHA (New York Heart Association), PMI (pace-maker insertion), PVL (paravalvular leak), STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality)
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      Article info

      Publication history

      Accepted: January 16, 2023
      Received in revised form: December 22, 2022
      Received: September 16, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Disclosure Statement

      Gabriel S. Aldea: nothing to disclose

      Christopher R. Burke: nothing to disclose

      Theodor Fischlein: consultant CORCYM and BioStable

      David A. Heimansohn: nothing to disclose

      Axel Haverich: nothing to disclose

      Rakesh M. Suri: nothing to disclose

      Niv Ad: Atricure Inc.- Consulting; LivaNova – Consulting; Medtronic-Speaker, VGS- Advisory Board; Left Atrial Appendage Occluder LLC- Co-Founder

      Funding: The CAVALIER trial and the PERCEVAL IDE Trial were funded by CORCYM S.r.l.

      Clinical trial registry number: CAVALIER-NCT01368666; PERCEVAL IDE-NCT01810679

      Central Picture legend: Mean aortic valve gradients over study period

      Central message

      Perceval valve showed low and stable gradients at 5-year follow-up with low rates of bioprosthesis degeneration and reintervention across all valve sizes.

      Perspective

      Mid-term (5 year) clinical and echocardiographic performances of the Perceval sutureless valve was assessed prospectively using detailed Core-lab evaluations. The valve exhibited low and stable gradients, significant LV mass regression, low structural valve degeneration (VARC-3) and re-intervention rates for all valve sizes.

      Identification

      DOI: https://doi.org/10.1016/j.jtcvs.2023.01.017

      Copyright

      © 2023 Published by Elsevier Inc. on behalf of The American Association for Thoracic Surgery

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