In September 2021, NICE published three Interventional Procedures Guidance (IPG):
- Transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis;
- Transapical transcatheter mitral valve-in-ring implantation after failed annuloplasty for mitral valve repair;
- Lateral elbow resurfacing for arthritis.
IPG is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.
NICE concluded that evidence on the safety of transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis and transapical transcatheter mitral valve-in-ring implantation after failed annuloplasty for mitral valve repair is adequate and shows some serious but well-recognized complications. Evidence on efficacy is inadequate or limited in quality. Therefore, both procedures should only be used with special arrangements for clinical governance, consent, and audit or research.
The following is recommended for both procedures:
- Patient selection should be made by a multidisciplinary team which must include interventional cardiologists experienced in the procedure, cardiac surgeons, an expert in cardiac imaging, and where appropriate, a cardiac anesthetist and a specialist in medicine for older people. The multidisciplinary team should determine the risk level for each patient and the device most suitable for them;
- The procedure is technically challenging and should only be done in specialized centers and only by clinical teams with special training and experience in complex endovascular cardiac interventions, including regular experience in transcatheter valve implantation procedures. Centers doing these procedures should have cardiac surgical support for emergency treatment of complications and subsequent patient care;
- NICE recommended further research that should include details on patient selection, type and size of valve used, functional outcomes (New York Heart Association functional class, mitral valve regurgitation), quality of life, patient-reported outcome measures, survival, and complications. Studies should report long-term follow-up of clinical outcomes and valve durability.
NICE concluded in recommendations that evidence on the safety and efficacy of lateral elbow resurfacing for arthritis is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. The procedure should only be done in specialist centers by surgeons who do elbow arthroplasty regularly and have training in this specific technique. Further research is recommended that could include case series with long-term follow-up, should report a range of motion, patient-reported outcomes, and complications.
See the full details here.
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