Issue: March 2016
January 08, 2016
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Expert consensus panel issues recommendations on sutureless, rapid deployment valves for surgical AVR

Issue: March 2016
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A panel of experts has issued recommendations relating to the use of sutureless and rapid deployment valves for surgical aortic valve replacement.

“With the use of sutureless valves, there are a range of advantages, including the fact that surgical procedures can be performed faster, with reduced total time in the operating room, and shorter cross-clamp time,” panelist Rakesh M. Suri, MD, DPhil, from the department of thoracic and cardiovascular surgery at Cleveland Clinic and chief of medical operations at Cleveland Clinic Abu Dhabi, said in an interview with Cardiology Today. “Some studies have reported shorter stays in the ICU and less blood loss using this technology. … Because sutureless valve implantation is technically straightforward and requires less time than traditional valves, they may be of benefit in certain circumstances, such as during complex surgeries.”

Rakesh A. Suri, MD, DPhil

Rakesh M. Suri

The 31-member panel issued consensus recommendations based on literature related to two sutureless valves (Perceval, Sorin; and 3f Enable, Medtronic/ATS Medical) and one rapid deployment valve (Intuity, Edwards Lifesciences). The 3f Enable was recently withdrawn from the market by its manufacturer due to slow sales.

The recommendations include:

  • Individual proctoring and institutional-level training are necessary to begin using sutureless valves.
  • Sutureless or rapid deployment valves should be considered as an alternative to stented valves in patients who require AVR with a biological valve, especially if the patient requires a redo or has a delicate aortic wall condition.
  • Sutureless or rapid deployment valves should be the first choice of valve prosthesis for patients who require concomitant procedures or have a small aortic annulus.
  • Transesophageal echocardiography should be performed during procedures with sutureless or rapid deployment valves.
  • Oversizing with sutureless valves should not be done because it can have negative consequences for the patient.
  • Suitable annular sizes are 19 mm to 27 mm after decalcification.
  • Complete decalcification of the aortic root, performed carefully, is recommended to avoid paravalvular leakage, but extensive decalcification could create annular defects.

“With expert advice now available regarding who should be treated with sutureless valves, along with the outcomes and benefits, I believe that they will increasingly be considered as viable options to treat patients with heart diseases requiring biologic aortic valve substitutes,” Suri said. “[The recommendations] will be tremendously beneficial for those who are not familiar with this technology to allow a better understanding of the indications, technical details and outcomes of sutureless valves compared with more traditional options.” – by Erik Swain

Disclosure: The panel was convened by Sorin, but the panelists received no payment except housing and catering. Suri reports being reimbursed by Sorin for expenses related to service as principal investigator of the U.S. trial for Perceval, and having research agreements with Abbott and St. Jude Medical. See the full statement for a list of the other panelists’ relevant financial disclosures.