TAVR with J•Valve™ Ausper System for Treatment of Pure ......TAVR with J•Valve Ausper System...
Transcript of TAVR with J•Valve™ Ausper System for Treatment of Pure ......TAVR with J•Valve Ausper System...
TAVR with J•Valve™ Ausper System for Treatment of Pure Aortic Regurgitation
and Aortic Stenosis First-in-human China clinical trial
Jian (James) Ye, MD, FRCSC (On behalf of Trial Investigators)
Clinical Professor
Division of Cardiovascular Surgery
St. Paul’s Hospital and Vancouver General Hospital
University of British Columbia, Vancouver, Canada
Potential conflicts of interest
Speaker's name: Jian (James) Ye
I have the following potential conflicts of interest to report: Consultant: Edwards Lifesciences JC Medical Inc.
J·ValveTM Bioprosthesis
-Woven polyester fabric
-Porcine aortic valve
-Nitinol clasper to locate and anchor the valve
-Stent frame -suture
J·ValveTM Ausper system
Ausper Delivery Device
Control Knob 1
Control Knob 2
Control Knob 3
Release Control Knob
Main Handle – Stationary Handle Grip
Nose Cone
Sheath
Confidential Property of JC Medical, Inc.
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AI Case Treated with JValve
Principal Investigators
Guo, YingQiang, MD West China Hospital, Chengdu, China Shi, YingKang, MD Wei, Lai, MD ZhongShan Hospital, Shanghai, China Wang, ChungSheng, MD Wang, Wei, MD Fuwai Hospital, Beijing, China Wang, Xin, MD
Trial Design
• Study Design:
Prospective, multi-center, non-randomized, single-arm observational study
• Primary Endpoint:
All cause mortality at 30-days and 12 months
• Secondary Endpoint:
- cardiac function, NYHA at 30 days, 6 and 12 month follow-up
• Main Inclusion Criteria:
- symptomatic severe AS or moderate-severe AI
- high risk determined by heart team or EuroSCORE ≥20%
Other Important Endpoints
• Safety
Cardiac mortality
MI
Stroke
Acute kidney injury
Major vascular complication
Life threatening bleeding
Repeat AV intervention or reopration
Endocarditis
Permanent pacemaker
• Echo Valve Performance
Mean transaortic pressure gradient
Effective orifice area
LVEF
Paravalvular regurgitation
Patient Characteristics
Characteristic
Age (years) 74.4±5.2
Male (%) 54.2%
EuroSCORE (%) 27.5±8.3
NYHA Class III or IV (%) 97.2
Cerebravascular disease (%) 6.5
PVD (%) 52.3
CAD (%) 18.7
Prior CABG (%) 1.9
Atrial fibrillation (%) 19.6
DM (%) 15.0
Mortality
All Cause Mortality All patients
N=107 (64 AS and 43 AI)
Intraoperative death (%) 0
30-day mortality (%) 4.67
6-month mortality (%) 5.65
12-month Mortality (%) 5.65
Complications
Complications 30 days 12 months
CVA (%) 0 3.1
MI (%) 0 0
Acute kidney injury (%) 1.0 n/a
Pacemaker(%) 2.8 4.3
Reoperation(%) 0.9 2.4
0%
20%
40%
60%
80%
100%
Before-Op 30 Day 6 M 12 M
Pre- and Post-Op NYHA Class
I II III IV
Mean Transaortic Pressure Gradient
0
20
40
60
80
Before-Op During-Op Post-Op 7 Day 30 Day 6 M 12 M
mmHg
AS
AI
Paravalvular Leak
7 Days 30 Days 6 M 12 M
2,00% 0,00% 0,00% 0,00%
29,00% 33,68% 30,77% 27,87%
32,00% 31,58% 29,67%
26,23%
37,00% 34,74% 39,56% 45,90%
Moderate Mild Trivial None
Survival
0,0
0,2
0,4
0,6
0,8
1,0
0 60 120 180 240 300 360
Days following TAVR
Surv
ival
rat
e
94.4%
Conclusions
• All-cause 30-day mortality: 4.67%
• One-year survival: 94.4%
• NYHA class I-II in 98% of patients at 30-day post-TAVR
(NYHA class III or VI in 97.2% patients at baseline)
• Technical success rate: 93.3%
Device success rate: 89.5% at 30-day post-TAVR
Paravalvular leak less than mild in 98% of patients
• J·ValveTM system: reliable, safe and efficacious for the
treatment of both aortic stenosis and pure aortic
regurgitation
Thanks