Objective Tricuspid regurgitation (TR) is a common valvular heart disease with unsatisfactory medical therapeutics and high surgical mortality. The present study aims to evaluate the safety and effectiveness of transcatheter tricuspid valve replacement (TTVR) in high-risk patients with severe TR.
Methods This was a compassionate multicentre study. Between September 2018 and November 2019, 46 patients with TR who were not suitable for surgery received compassionate TTVR under general anaesthesia and the guidance of trans-oesophageal echocardiography and fluoroscopy in four institutions. Access to the tricuspid valve was obtained via a minimally invasive thoracotomy and transatrial approach. Patients’ data at baseline, before discharge, 30 days and 6 months after the procedure were collected.
Results All patients had severe TR with vena contracta width of 12.6 (11.0, 14.5) mm. Procedural success (97.8%) was achieved in all but one case with right ventricle perforation. The procedural time was 150.0 (118.8, 180.0) min. Intensive care unit time was 2.0 (1.0, 4.0) days. 6-month mortality was 17.4%. Device migration occurred in one patient (2.4%) during follow-up. Transthoracic echocardiography at 6 months after operation showed TR was significantly reduced (none/trivial in 33, mild in 4 and moderate in 1) and the primary safety end point was achieved in 38 cases (82.6%). Patients suffered from peripheral oedema and ascites decreased from 100.0% and 47.8% at baseline to 2.6% and 0.0% at 6 months.
Conclusions The present study showed TTVR was feasible, safe and with low complication rates in patients with severe TR.
- valve disease surgery
- transcatheter valve interventions
- tricuspid valve disease
Statistics from Altmetric.com
F-LL, ZA and YM contributed equally.
Contributors FQ and Z-YX are responsible for the study design and concept. F-LL, ZA and YM wrote the first draft of the manuscript and all authors have substantially contributed to the design, conduct, data collection, data analysis, writing and revision of this study.
Funding This work was supported by the Science and Technology Commission of Shanghai Municipality (No. 17441901800 to F-LL), the Ningbo Science and Technology Bureau (No. 2018B10092 to F-LL) and the Key Research and Development Program of National Science and Technology Ministry (No. 2016YFC1100900 to Z-YX).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study was approved by the ethics committee of the four centres and all implantations were approved under compassionate grounds. Medical devices were allowed to be used under compassionate grounds after passing the test of the National Medical Products Administration and getting the permission of the ethics committee of the hospital in China. All procedures were conducted in accordance with the Declaration of Helsinki and written informed consent was obtained.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.