Original Title: Efectividad y seguridad de los sistemas de reparación percutánea para el tratamiento de la insuficiencia de la válvula tricúspide

Authors' objectives: Assessment of safety, efficacy and cost-effectiveness of percutaneous tricuspid valve repair versus conventional surgery or optimal medical treatment

Authors' results and conclusions: RESULTS: The literature search identified 29 studies, 6 on the MitraClip device (Abbott Vascular), 4 on FORMA (Edwards Lifescience), 3 on SAPIEN (Edwards Lifescience), 3 on Cardioband (Edwards Lifescience), 3 on PASCAL (Edwards Lifescience), 2 on TriClip (Abbott Vascular), 1 on TriAlign (Mitralign), 1 on Mistral (Mitralix), 1 on EVOQUE (Edwards Lifescience), 1 on Lux-Valve (Ningbo Jenscare Biotechnology), a comparative study between MitraClip and PASCAL. In addition, three studies on the outcomes of the TriValve clinical registry were identified, one of which focused on the outcomes of coaptation devices. Safety Overall, percutaneous devices for the treatment of tricuspid regurgitation were shown to be safe, with a mortality rate ranging from 57% to 0.A randomized control trial of the SAPIEN device showed the highest mortality rate (57%) due to a higher number of device dislocations, leading to discontinuation of the trial. Regarding the annuloplasty devices, the Cardioband device showed a 30-day mortality of 7.6%. While the TriAlign and TriCinch devices showed a 0% mortality rate. The very serious adverse event rate for Cardioband was 13.3%, with one death, one case of devicecaused cardiac tamponade and one non-device related stroke. For TriAlign, the serious adverse event rate was 6.7%, due to one case of distal right coronary artery narrowing in the plication region that was associated with ST-segment elevations on the electrocardiogram. Coaptation devices showed mortality rates of 33-5% for FORMA, 19-5% for MitraClip and 7.1% for PASCAL. One study that analyzed coaptation devices included in TriValve Register, reported an estimated mortality for coaptation devices of 20.3% after one year of follow-up and a mortality plus re-hospitalisation rate for heart failure of 34.7. None of the studies reported any cases of myocardial infarction or cardiac tamponade in any of the devices studied, and only two reported one case of stroke, respectively. Effectiveness All included studies reported statistically significant reductions in tricuspid annulus diameter. On the other hand, statistically significant improvements were also observed in the reduction of the width of the vena contracta and the effective area of the regurgitant orifice. Statistically significant improvements in functional status outcomes, as measured by NYHA and 6MWD, and patient quality of life, as measured by MLHFQ and KCCQ, as well as improvement in the degree of edema, were also observed for all devices studied. However, in the only randomized clinical trial included, these results of improvement in tricuspid regurgitation were not superior to those observed in the medically treated group. CONCLUSIONS: The available evidence does not yet allow establish conclusions on the efficacy and safety of percutaneous devices for the treatment of tricuspid insufficiency. More robust clinical studies with larger numbers of patients, comparators and longer follow-up time are needed to draw conclusions about which technique is more effective and whether they are superior to standard clinical treatment. Better information is needed on both the epidemiology of tricuspid pathologies and the results of this type of intervention.

Authors' methods: A system review of the scientific literature in different databases has been carried out using the research question based on the PICO concept (Patients, Intervention, Comparators, Outcomes-Results). We included original articles from studies of any design and without limitation of sample size that met the criteria of the PICO question. Editorials, abstracts, conference papers, editorials, letters to the editor and nonsystematic reviews were excluded. The risk of bias of randomized clinical trials was assessment with tool RoB2 of Cochrane and cuality of nonrandomized studies was assessed using the tool designed by the Institute of Health Economics in Canada.

Project Status: Completed

Year Published: 2022

URL for published report: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=1039

Requestor: Spanish Ministry of Health

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: <p>Agencia de Evaluacion</p>