Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mechanical Heart Valve Prosthesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
As part of the follow-up in the Day Hospital in the national reference center for Marfan syndrome and related disorders, each consultant benefits from a psychological interview. During these psychological interviews, it is noticed that some patients with a mechanical heart valve prosthesis are bothered on a daily basis by the noise caused by this valve. Some patients also mention the fact that the noise of their mechanical heart valve prosthesis causes discomfort to their partners. Indeed, preoperatively to aortic surgery, the need for aortic valve replacement is evaluated and the patient must receive a clear and detailed explanation of the advantages and disadvantages associated with a mechanical heart valve prosthesis and a biological heart valve prosthesis so that he or she can make an informed choice. Nevertheless, during their psychological interviews, it was noted that the memory of the information concerning the noise associated with mechanical heart valve prostheses is not systematically delivered preoperatively. While there are studies in the literature showing that the noise of the mechanical valve prosthesis has harmful consequences on the quality of life and sleep of the patient and/or those around them, no study has determined whether giving information on the noise associated with the mechanical valve preoperatively will have consequences on the post-operative quality of life of the patient and those around them.
Detailed description
During cardiac surgery in people with Marfan Syndrome, it is not uncommon for an aortic or mitral valve replacement to be performed. Several types of valve substitutes exist, each with its advantages and disadvantages: biological valve prostheses made with animal tissue and mechanical valve prostheses made of synthetic materials (pyrolytic carbon and titanium) are mainly implanted.
Heart valve surgery is necessary on average before the age of 40 in Marfan syndrome, i.e. at a younger age than in other heart valve pathologies.
The recommendations are to prefer a mechanical valve prosthesis in subjects under 60 years of age because these mechanical prostheses have a longer lifespan than biological prostheses, especially in young subjects. However, the implantation of a mechanical valve prosthesis has two main disadvantages compared to the biological prosthesis:
1. the need to take anticoagulant treatment with Anti Vitamin K for life 2. the noise generated by the wings of the mechanical prosthesis when they close
Data from the literature confirm that this noise is potentially harmful to patients' quality of life, since one to three-quarters of patients are regularly bothered by the noise generated by the mechanical prosthesis and that this noise can disturb patients during the day but also during their sleep. However, it appears that most patients are not informed preoperatively that a mechanical prosthesis generates a noise that they will be able to hear.
A study that involved nearly 1200 patients with mechanical prostheses reported that valve noise is felt more negatively in women and patients under 60 years of age.
Based on data from the literature, it appears that the noise generated by mechanical valves can be harmful to some patients and impact the quality of life of some patients.
On the other hand, the frequency and effect on quality of life of providing information to the patient preoperatively on the advantages and disadvantages of the different types of valve replacement has not been studied, or very little.
This study wants to determine whether the recall of preoperative information about the noise caused by the mechanical valve has consequences on the postoperative quality of life of patients.
Primary outcome measures
- Post-operative quality of life assessed by the answers to the SF36 questionnaire [Time frame: 1 year]
Secondary outcome measures (7)
- Gender (male) [Time frame: 1 year]
- Gender (female) [Time frame: 1 year]
- Percentage of patients who would have chosen not to receive mechanical valves [Time frame: 1 year]
- Operation in an emergency [Time frame: 1 year]
- Scheduled surgery [Time frame: 1 year]
- Patients who were operated on before 2004 [Time frame: 1 year]
- Patients who were operated on after 2004 [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients with an aortic mechanical valve who have consulted from 1995 to date at the reference center.
- Patients affiliated to a social security scheme
Exclusion criteria
- Patient who does not speak French
- Hearing or hearing impaired patient.
- Patient without a phone: Interviews will take place over the phone.
- Patient who has been individually informed and objects to participate in this research
- Patient not affiliated to a social security scheme or CMU (Universal health coverage)
- Adult patients protected by law
- Patient on AME (State medical aid)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Hôpital Bichat-Claude Bernard — Paris
Identifiers
NCT: NCT07304115 · APHP240701 · 2024-A01122-45