AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
Conditions
Keywords
TAVR, real-world, aortic valve stenosis, Sapien 3
Brief summary
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
Detailed description
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis (AS). Currently TAVR indication has expanded to intermediate and low-risk patients from inoperable or high-risk patients, through a rigorous series of clinical trials comparing TAVR with surgical aortic valve replacement (SAVR). Despite 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommended SAVR for patients with symptomatic severe AS aged \<65 years, the previous data from United States nationwide Vizient Clinical Data Base and Northern New England Cardiovascular Disease Group Consortium (NNECDSG) registry demonstrated dramatic growth in TAVR utilization in younger patients aged \<65 years from 2015 to 2021/2022, which is possibly driven by increased TAVR utilization in low surgical risk patients. However, TAVR has never been systematically tested in young (\<65 years old), low-risk patients, with many unanswered questions, especially the safety and effectiveness of TAVR in patients with bicuspid aortic valves and the durability of transcatheter heart valves. Furthermore, we noticed that the patients between 65 years old and 70 years old accounted for 23.3% of all the TAVR patients and this patient subgroup were underrepresented in the previous study, which makes it necessary to also explore the interested endpoints in this subgroup. The aim of this study is to establish the safety and efficacy of Sapien 3 TAVR in young (50\ 70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population and to explore the durability performance of Sapien 3 in this cohort.
Interventions
PROCEDURETranscatheter Aortic Valve Replacement (TAVR)
TAVR procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. Vascular access site will be through transfemoral on the basis of pre-procedural evaluation of access site vessel. The procedure will be performed under local or general anesthesia and per clinical practice standard.
Sponsors
Xijing Hospital
Shanghai Zhongshan Hospital
Fu Wai Hospital, Beijing, China
West China Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet ALL of the following inclusion criteria to be eligible for participation: * 50 years of age or older but ≤70 years old at time of consent. * Severe AS, defined as follows: a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%. * Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT. * The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. * Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant. * The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Exclusion criteria
Subjects are NOT eligible for participation if they meet ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | At 5 years | The primary end point is the 5 year all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite of all-cause mortality, stroke and rehospitalization | At 30 days, 1, 3, 5 years | The composite of all-cause mortality, stroke, rehospitalization (procedure, valve and heart failure related) at 30 days, 1, 3, 5 years |
| The composite of device success | At 30 days | The composite of device success at 30 days comprising the following: freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication, intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation), according to the VARC-3 definition |
| The durability performance of Sapien 3 | At 1, 3, 5 years | The durability performance of Sapien 3 at 1, 3, 5 years: bioprosthetic valve dysfunction (BVD, including SVD, non-SVD, endocarditis and thrombosis), moderate or severe hemodynamic valve deterioration (HVD), bioprosthetic valve failure (BVF) according to the VARC-3 definition, EOA/mean gradient (MG) change over follow up |
| Annular rupture | At 1 day of discharge | The incidence of annular rupture |
| Paravalvular leakage | At 1 day of discharge, 30 days, 1, 3, 5 years | The incidence of paravalvular leakage |
| Technical success | At exit from procedure room | Technical success (at exit from procedure room): * freedom from mortality * successful access, delivery of the device, and retrieval of the delivery system * correct positioning of a single prosthetic heart valve into the proper anatomical location * freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication |
| Procedural success | At 30 days | Procedural success at 30 days defined as meeting all of the following: * Device success * No device or procedure related SAE's as follows: 1. Life-threatening bleed (BARC 3b or greater) 2. Major vascular or cardiac structural complications requiring unplanned reintervention or surgery 3. Stage 2 or 3 AKI (includes new dialysis) 4. MI or need for PCI/CABG 5. Severe heart failure or hypotension requiring IV inotrope \>12 hours, ultrafiltration or mechanical circulatory support 6. Prolonged intubation \> 48 hours 7. Need for a permanent pacemaker implant or continuous, new onset atrial fibrillation |
| Mortality (all cause & cardiovascular) | At 30 days, 1, 3, 5 years | The incidence of mortality (all cause \& cardiovascular) |
| Stroke (disabling and nondisabling) | At 30 days, 1, 3, 5 years | The incidence of stroke (disabling and nondisabling) |
| Rehospitalization (procedure, valve and heart failure related) | At 30 days, 1, 3, 5 years | The incidence of rehospitalization (procedure, valve and heart failure related) |
| Major vascular complication | At 30 days, 1, 3, 5 years | The incidence of major vascular complication |
| Major or life-threatening bleeding | At 30 days, 1, 3, 5 years | The incidence of major or life-threatening bleeding |
| Myocardial infarction | At 30 days, 1, 3, 5 years | The incidence of myocardial infarction |
| Acute kidney injury stage 2 or 3 | At 30 days, 1, 3, 5 years | The incidence of acute kidney injury stage 2 or 3 |
| Need for a permanent pacemaker | At 30 days, 1, 3, 5 years | The incidence of permanent pacemaker implantation |
| New onset atrial fibrillation | At 30 days, 1, 3, 5 years | The incidence of new onset atrial fibrillation |
| Valve endocarditis | At 30 days, 1, 3, 5 years | The incidence of valve endocarditis |
| Valve thrombosis | At 30 days, 1, 3, 5 years | The incidence of valve thrombosis |
| New York Heart Association class | At 30 days, 1, 3, 5 years | The changes in New York Heart Association class |
| Patient-prosthesis mismatch | At 30 days, 1, 3, 5 years | The incidence of patient-prosthesis mismatch |
| Health status as evaluated by Quality of Life questionnaires - KCCQ | At baseline, 30 days, 1, 3, 5 years | The changes in Health status as evaluated by Quality of Life questionnaires - KCCQ |
Countries
China
Contacts
CONTACTJian Yang, MD, PhD
CONTACTMeng en Zhai, PhD
PRINCIPAL_INVESTIGATORJian Yang, MD, PhD
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
Outcome results
None listed