Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up
ObjectiveThe aim was to evaluate the safety and efficacy of TTVR in patients with severe TR at the 1-year follow-up.Materials and methodsThis project was a single-center, observational study. From September 2020 to May 2021, 15 patients with severe or extremely severe TR at high risk of traditional...
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| Format: | Article |
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Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1019813/full |
| _version_ | 1811320512689733632 |
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| author | Yu Mao Lanlan Li Yang Liu Mengen Zhai Yanyan Ma Chennian Xu Ping Jin Jian Yang |
| author_facet | Yu Mao Lanlan Li Yang Liu Mengen Zhai Yanyan Ma Chennian Xu Ping Jin Jian Yang |
| author_sort | Yu Mao |
| collection | DOAJ |
| description | ObjectiveThe aim was to evaluate the safety and efficacy of TTVR in patients with severe TR at the 1-year follow-up.Materials and methodsThis project was a single-center, observational study. From September 2020 to May 2021, 15 patients with severe or extremely severe TR at high risk of traditional surgery were enrolled. All patients had preoperative imaging assessments to evaluate the tricuspid valve and the anatomy of the right heart. All patients were planned to treated with the LuX-Valve (Ningbo Jenscare Biotechnology, Ningbo, China). The LuX-Valve was implanted under the intraoperative guidance of TEE and X-ray fluoroscopy. Data were collected at baseline, before discharge, and at 30 days, 6 months, and 1 year postoperatively.ResultsThe LuX-Valves were successfully implanted in all 15 patients. TR was significantly reduced to ≤ 2 +. One patient died on postoperative day 12 of a pulmonary infection that was considered unrelated to the procedures or the devices. The remaining 14 patients (100.0%) reached the primary end point. One patient (7.1%) was rehospitalized during 1-year follow-up because of device thrombosis. The number of patients who survived at 1 year with New York Heart Association (NYHA) functional class II was higher than that before TTVR (11/14 vs. 0/15, P = 9.11 × 10–4). Patients with peripheral edema and ascites decreased from 100.0 to 46.7% at baseline to 28.6% and 14.3% at 1 year (P = 1.57 × 10–3 and 2.53 × 10–2).ConclusionTTVR is associated with RV remodeling, increased cardiac output, and improvement in NYHA functional class. Using the LuX-Valve for TTVR to treat patients with severe TR is a feasible and relatively safe method with reliable clinical results. Further studies are needed to determine long-term outcomes. |
| first_indexed | 2024-04-13T13:00:55Z |
| format | Article |
| id | doaj.art-a8db93f525d74352b91d1dd79f807c5e |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-13T13:00:55Z |
| publishDate | 2022-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-a8db93f525d74352b91d1dd79f807c5e2022-12-22T02:45:56ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-12-01910.3389/fcvm.2022.10198131019813Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-upYu MaoLanlan LiYang LiuMengen ZhaiYanyan MaChennian XuPing JinJian YangObjectiveThe aim was to evaluate the safety and efficacy of TTVR in patients with severe TR at the 1-year follow-up.Materials and methodsThis project was a single-center, observational study. From September 2020 to May 2021, 15 patients with severe or extremely severe TR at high risk of traditional surgery were enrolled. All patients had preoperative imaging assessments to evaluate the tricuspid valve and the anatomy of the right heart. All patients were planned to treated with the LuX-Valve (Ningbo Jenscare Biotechnology, Ningbo, China). The LuX-Valve was implanted under the intraoperative guidance of TEE and X-ray fluoroscopy. Data were collected at baseline, before discharge, and at 30 days, 6 months, and 1 year postoperatively.ResultsThe LuX-Valves were successfully implanted in all 15 patients. TR was significantly reduced to ≤ 2 +. One patient died on postoperative day 12 of a pulmonary infection that was considered unrelated to the procedures or the devices. The remaining 14 patients (100.0%) reached the primary end point. One patient (7.1%) was rehospitalized during 1-year follow-up because of device thrombosis. The number of patients who survived at 1 year with New York Heart Association (NYHA) functional class II was higher than that before TTVR (11/14 vs. 0/15, P = 9.11 × 10–4). Patients with peripheral edema and ascites decreased from 100.0 to 46.7% at baseline to 28.6% and 14.3% at 1 year (P = 1.57 × 10–3 and 2.53 × 10–2).ConclusionTTVR is associated with RV remodeling, increased cardiac output, and improvement in NYHA functional class. Using the LuX-Valve for TTVR to treat patients with severe TR is a feasible and relatively safe method with reliable clinical results. Further studies are needed to determine long-term outcomes.https://www.frontiersin.org/articles/10.3389/fcvm.2022.1019813/fulltricuspid regurgitationtranscatheter tricuspid valve replacementLuX-Valvefollow-uptricuspid valve |
| spellingShingle | Yu Mao Lanlan Li Yang Liu Mengen Zhai Yanyan Ma Chennian Xu Ping Jin Jian Yang Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up Frontiers in Cardiovascular Medicine tricuspid regurgitation transcatheter tricuspid valve replacement LuX-Valve follow-up tricuspid valve |
| title | Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up |
| title_full | Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up |
| title_fullStr | Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up |
| title_full_unstemmed | Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up |
| title_short | Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up |
| title_sort | safety efficacy and clinical outcomes of transcatheter tricuspid valve replacement one year follow up |
| topic | tricuspid regurgitation transcatheter tricuspid valve replacement LuX-Valve follow-up tricuspid valve |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1019813/full |
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