Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..
Due to a massive shift from mechanical to bioprosthetic valves with finite longevity, increasing numbers of patients are presenting with bioprosthetic mitral valve degeneration. Mitral valve reoperation, the standard therapy for the bioprosthetic failure in the past, often entails high risk due to age, multiple comorbidities et al. TMVR is an emerging treatment for the patients with bioprosthetic failure at high risk for conventional mitral valve surgery. Recent studies from US and Europe have demonstrated the safety and efficacy of TMVR in this population. However, there are limited data regarding clinical outcomes after TMVR from Asia-Pacific region. To evaluate the safety and efficacy of TMVR using balloon-expandable valve among those patients with high risk for redo surgery and those who refuse redo surgery after shared decision making even they have less than high risk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Transcatheter transfemoral mitral valve-in-valve replacement is an alternative surgery in patients with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The procedure is performed via femoral vein access. All procedures were carried out using intra-procedural TEE guidance to aid in transseptal puncture. After balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle and expanded in the mitral position during rapid ventricle pacing.
Yan Wang
Xiamen, Fujian, China
RECRUITINGall-cause mortality
The rate in all-cause mortality will be calculated from 0 month to 12 months.
Time frame: 12 months
Rate of New hospitalization for heart failure
Hospitalization for valve-related symptoms or worsening congestive heart failure
Time frame: 12 months
Technical success
Technical success was the primary safety endpoint at the time of patient exit from the cardiac catheterization laboratory, which was defined as the delivery and retrieval of the transcatheter delivery system being successful, the deployment of a single valve in the proper position in the mitral annulus, no need for surgery or additional reintervention, and the patient leaving the procedure room alive
Time frame: 24 hours
Procedure success
Procedure success defiened as adequate performance of the THV with residual MR grade \< 2 and mean MV gradient (MVG) \< 10 mm Hg.
Time frame: 12 months
all-cause mortality
The rate in all-cause mortality will be calculated from 0 month to 12 months.
Time frame: annual for five years
Rate of New hospitalization for heart failure
Hospitalization for valve-related symptoms or worsening congestive heart failure
Time frame: annual for five years
Rate of myocardial infarction
Time frame: annual for five years
Rate of neurological events
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All stroke, transient ischemic attack (TIA)
Time frame: annual for five years
Rate of Structural Valve dysfunction
as assessed by transthoracic echocardiography with residual MR grade \> 2 and mean MV gradient (MVG) ≥ 10 mm Hg.
Time frame: annual for five years
Clinical Benefit Endpoint
Change in New York Heart Association (NYHA) functional classification from baseline
Time frame: 30 days, 6 months, 12 months, annual for five years]