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Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study

Published:January 13, 2021DOI:https://doi.org/10.1016/j.jtcvs.2020.12.109

      Abstract

      Objective

      The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve.

      Methods

      Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years.

      Results

      The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years.

      Conclusions

      This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.

      Graphical abstract

      Key Words

      Abbreviations and Acronyms:

      AVR (aortic valve replacement), CAVALIER (Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark), CEC (Clinical Event Committee), CI (confidence interval), NYHA (New York Heart Association), PARTNER (Placement of Aortic Transcatheter Valve Trial), STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality)
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      Linked Article

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          Transcatheter aortic valve replacement (TAVR) has been approved for patients with severe aortic stenosis at all levels of risk, and is now performed in more than 700 centers. In fact, annual TAVR volume, for the first time in 2019, exceeded the total number of surgical AVR procedures.1-4 At least in part to make the surgical approach more palatable to patient preference compared with TAVR, access through smaller, less invasive hemisternotomy or right thoracotomy incisions has increased, with excellent outcomes.
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      • Commentary: The truth is out there
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          We are focusing on the new, we are distracting from the old. The rapid development of transcatheter devices and the subsequent flourishing of randomized clinical trials and large registries have shown not only the feasibility and good results of new technologies but have also brought to light that something is missing, rigorous data on surgical aortic valve replacement (SAVR).1,2 A critical appraisal of recent randomized clinical trials can suggest that incidence of end points in the SAVR arm are abnormally high compared with the real world; nonetheless, looking for high-quality data supporting this hypothesis, we stay with a fistful of flies in hand as there are no strong updated mid- and long-term outcomes confirming surgery as the gold standard for the treatment of aortic valve disease, until proven otherwise.
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