In September 2020, a completed mini-method assessment for the MitraClip for percutaneous mitral valve repair was issued within the New Methods framework, which was established in Norway in 2013. In this framework, all innovations should undergo health technology assessment (HTA) before being funded. The Oslo University Hospital carried out the assessment.
MitraClip is used for percutaneous mitral valve repair in patients with primary and secondary mitral insufficiency (MI), who are technically suitable for the method and have a high risk or are prohibited for open heart surgery.
MitraClip was compared with current treatment methods - open heart surgery, conventional heart failure treatment, with the focus on safety and effectiveness. Mortality, admissions for heart failure, and degree of residual mitral insufficiency were considered as outcomes.
The following conclusions were made in relation to the effectiveness:
- In patients with high MI, MitraClip significantly reduces it with a low risk of complications
- In primary MI, the method is less effective than open heart surgery but has a low risk of complications and is a good treatment alternative for patients who have a high surgical risk and are technically suitable for MitraClip
- In the case of functional MI insufficiency, MitraClip reduces the mortality risk and readmission for heart failure if patients are technically fit and previously received conventional treatment for their heart failure
Regarding safety, the following statements were provided:
- The most common undesirable outcomes are failure to reduce mitral leakage due to suboptimal clip implantation or valve apparatus damage
- The procedural success of placing clips and reducing mitral insufficiency is about 95% in various registry studies
- Other complications risk is low - 1-3% in various studies (e.g., stroke, cardiac tamponade, bleeding from the injection site, wound infections
The key conclusion is that the MitraClip has a good level of efficacy and safety in comparison with the current treatment, and should be introduced as part of the clinical routine in the hospitals.
See the full details in Norwegian here.
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