Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

NCT ID: NCT03259945

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2022-12-12

Brief Summary

The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients.

Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.

The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time.

More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.

However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject.

The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.

Conditions

Patients With a Sutureless Aortic Valve

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Data collection

demographic and clinical data

Intervention Type: OTHER

Review of ECGs

nature and frequency of proven conduction disorders

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite Edwards or Perceval S Liva Nova)

Exclusion Criteria

• patients with a pacemaker
• patients who underwent double valve replacement

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

References

Bouchot O, Petrosyan A, Morgant MC, Malapert G. Technical points for aortic valve replacement through right anterior minithoracotomy. Eur J Cardiothorac Surg. 2018 May 1;53(suppl_2):ii24-ii26. doi: 10.1093/ejcts/ezy105.

Reference Type: RESULT

PMID: 29718234 (View on PubMed)

Other Identifiers

BOUCHOT 2017

Identifier Type: -

Identifier Source: org_study_id