PMID- 34034378
OWN - NLM
STAT- MEDLINE
DCOM- 20210527
LR  - 20210527
IS  - 0253-3758 (Print)
IS  - 0253-3758 (Linking)
VI  - 49
IP  - 5
DP  - 2021 May 24
TI  - [Safety and efficacy of transcatheter tricuspid valve replacement with LuX-Valve 
      in patients with severe tricuspid regurgitation].
PG  - 455-460
LID - 10.3760/cma.j.cn112148-20210125-00091 [doi]
AB  - Objectives: To evaluate the safety and efficacy of LuX-Valve on the treatment of 
      severe tricuspid regurgitation (TR). Methods: This is a prospective observational 
      study. From September 2018 to March 2019, 12 patients with severe TR, who were 
      not suitable for surgery, received LuX-Valve implantation in Changhai Hospital. 
      LuX-Valve was implanted under general anesthesia and the guidance of 
      transesophageal echocardiography and X-ray fluoroscopy. Access to the tricuspid 
      valve was achieved via a minimally invasive thoracotomy and transatrial approach. 
      Main endpoints were surgery success and device success. Surgery success was 
      defined as successful implanting the device and withdrawing the delivery system, 
      positioning the valve correctly and stably without severe or life-threatening 
      adverse events. Device success was defined as satisfied valve function (TR 
      severity reduction >/= 2 grades, tricuspid gradient </= 6 mmHg (1 mmHg=0.133 kPa)), 
      absence of malposition, valve failure and reintervention, major adverse events 
      including device related mortality, embolization, conduction system disturbances 
      and new onset shunt across ventricular septum at day 30 post implantation. 
      Results: A total of 12 patients with severe to torrential TR were included in 
      this study. The age was (68.5+/-6.9) years and 7 were female. All patients had 
      typical right heart failure symptoms. Procedural success was achieved in all 
      cases, there was no intraprocedural mortality or transfer to open surgery. TR 
      significantly improved after LuX-Valve implantation (none/trivial in 8 patients, 
      mild in 3 patients and moderate in 1 patient). The average device time was 
      (9.2+/-4.2) minutes. Intensive care unit duration was 3.0 (2.0, 4.8) days. One 
      patient died at postoperative day 18 due to non-surgery and device reasons. 
      Transthoracic echocardiography at 30 days after operation showed that TR was 
      significantly reduced (none/trivial in 8 patients, mild in 2 patients and 
      moderate in 1 patient) and device success was achieved in 11 cases. All survived 
      patients experienced a significant improvement in life quality with significantly 
      improvement in New York Heart Association (NYHA) classification (Ⅰ and Ⅱ: 6/11 
      post operation vs. 0/11 before operation, P=0.012) and there were no device 
      related complications in this patient cohort. Conclusions: LuX-Valve implantation 
      is feasible, safe and effective for the treatment of patients with severe TR.
FAU - Ning, X P
AU  - Ning XP
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - An, Z
AU  - An Z
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Qiao, F
AU  - Qiao F
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Cai, C L
AU  - Cai CL
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Han, L
AU  - Han L
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Song, Z G
AU  - Song ZG
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Li, B L
AU  - Li BL
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Zhou, G W
AU  - Zhou GW
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Wang, J
AU  - Wang J
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Xu, Z Y
AU  - Xu ZY
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
FAU - Lu, F L
AU  - Lu FL
AD  - Department of Cardiovascular Surgery, Changhai Hospital, Naval Medical 
      University, Shanghai 200433, China.
LA  - chi
GR  - 2016YFC1100900/Key Research and Development Program of National Science and 
      Technology Ministry/
GR  - 17441901800/Science and Technology Commission of Shanghai Municipality/
GR  - 2018B10092/Major Science and Technology Innovation 2025 projects of Ningbo 
      Science and Technology Bureau/
PT  - Journal Article
PT  - Observational Study
PL  - China
TA  - Zhonghua Xin Xue Guan Bing Za Zhi
JT  - Zhonghua xin xue guan bing za zhi
JID - 7910682
SB  - IM
MH  - Aged
MH  - Cardiac Catheterization
MH  - Female
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
MH  - Tricuspid Valve/diagnostic imaging/surgery
MH  - *Tricuspid Valve Insufficiency/diagnostic imaging/surgery
EDAT- 2021/05/26 06:00
MHDA- 2021/05/28 06:00
CRDT- 2021/05/25 22:33
PHST- 2021/05/25 22:33 [entrez]
PHST- 2021/05/26 06:00 [pubmed]
PHST- 2021/05/28 06:00 [medline]
AID - 10.3760/cma.j.cn112148-20210125-00091 [doi]
PST - ppublish
SO  - Zhonghua Xin Xue Guan Bing Za Zhi. 2021 May 24;49(5):455-460. doi: 
      10.3760/cma.j.cn112148-20210125-00091.