Original article
Adult cardiac
Sutureless Aortic Valve Replacement: First-Year Single-Center Experience

Presented at the Forty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–Feb 1, 2012.
https://doi.org/10.1016/j.athoracsur.2012.04.024Get rights and content

Background

Sutureless aortic bioprostheses bear the potential of easy implantation, reduced ischemic time, and surgical trauma in aortic valve replacement. We herein show our clinical and echocardiographic results after a 1-year experience with a new sutureless bioprosthesis.

Methods

The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center.

Results

The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a “J” sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10. ± 7.5%, mean aortic cross-clamp time was 43.8 ± 20.8 minutes (36 ± 12.7 minutes for isolated procedures). Mean implantation time was 8 ± 3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5 ± 4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0 ± 0.6. Mean transprosthetic gradients were 13.4 ± 2.8, 12.6 ± 2.3, and 10.8 ± 1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively.

Conclusions

The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time.

Section snippets

Patients

Between March 2010 and December 2011, 114 patients were selected in the European multicenter study “Cavalier,” finalized to the European approval of the Perceval S sutureless aortic bioprosthesis. Data from all centers are not already published or in plans to be published. Patients were eligible if they suffered from severe calcified native aortic valve stenosis and if they were 65 years of age or greater. Exclusion criteria were acute endocarditis and complex anatomic features; bicuspid valve

Results

The surgical procedures are listed in Table 2. We emended the original protocol, allowing the implantation of the sutureless Perceval S valve also in patients with bicuspid aortic valve, although these patients were originally excluded from the study. We felt that particular cases of bicuspid valve (7 patients) with symmetric sinuses of Valsalva and small annuli, where an appropriate fixation and a proper valve orientation were considered feasible, could have been included in the study. The

Comment

In the last few years, several models of valvular sutureless bioprosthesis have been developed [11]. We describe here our experience with the model of a sutureless aortic valve prosthesis currently tested in a European clinical trial and which is now routinely used in our center.

Our preliminary results demonstrate good clinical and hemodynamic outcomes. These data suggest the necessity of specific patient selection criteria and guidelines for the use of this procedure.

We demonstrated a

References (13)

  • L.G. Svensson et al.

    United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex

    Ann Thorac Surg

    (2008)
  • B. Bridgewater et al.

    Towards global benchmarking: the Fourth EACTS Adult Cardiac Surgical Database Report

    (2010)
  • M.L. Brown et al.

    Ministernotomy versus conventional sternotomy for aortic valve replacement: a systemic review and meta-analysis

    J Thorac Cardiovasc Surg

    (2009)
  • B. Martuza et al.

    Minimal access aortic valve replacement: is it worth it?

    Ann Thorac Surg

    (2008)
  • R. Zahn et al.

    Transcatheter aortic valve implantation: first results from a multi-centre real-world registry

    Eur Heart J

    (2011)
  • C. Smith et al.

    Transcatheter versus surgical aortic-valve replacement in high-risk patients

    N Engl J Med

    (2011)
There are more references available in the full text version of this article.

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Drs Santarpino and Pfeiffer contributed equally to this work.

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