new tavr technology: j-valvetm ausper system...age 74.2 ± 5.2 female gender 21% weight 52.3 ± 7.6...
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New TAVR Technology: J-ValveTM Ausper System
Anson Cheung, MD
Clinical Professor of Surgery
St. Paul’s Hospital
University of British Columbia
Vancouver, Canada
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• St. Jude Medical• HeartWare Inc• Abiomed Inc• Edwards LifeSciences
• Kardium Medical• Entourage Medical• Neovasc Inc
Within the past 12 months, I or my spouse/partner have had a
financial interest/arrangement or affiliation with the organization(s)
listed below.
Affiliation/Financial Relationship Company
Disclosures
JC Medical - J-ValveTM Ausper System
• Second generation Transapical TAVR system
• Nitinol based, self-expanding valve stent
• Porcine aortic valve
• Clasper – independently operated 3D ring that corresponding to the native sinuses, orients the valve stent and capturing the native leaflets
• 27F sheathless delivery catheter with a flexible tip
JC Medical – J ValveTM
JC Medical - J-Valve TAVR System
• 4 sizes (21, 23, 25 and 27) – Annular range of 19 to 27mm
• Unique mechanism
• Able to treat patient with AS and AI
Courtesy of Dr. Y. Guo
Clinical Experience with
J-Valve Ausper System
• FIM implant at West China Hospital in Chengdu,
China by Dr. Yingqiang Guo in March 2014
• Chinese SFDA regulatory trial completed
March 2014 to July 2015
107 patients with severe symptomatic AS or AR
J•Valve™ Ausper System China Study
• Study Design:
Prospective, multi-center, observational study
• Primary Endpoint:
Mortality rate from all causes 30 days after surgery
• Secondary Endpoint:
Improvement of cardiac function, NYHA functional
classification at 30 days, 6 months, and 12 months
• Inclusions:
High risk symptomatic patients with AS or AR
EuroSCORE > 20%
Patient Demographics
Characteristics
Number of Patients Enrolled 107
Age 74.4 (61-87)
Male 54%
Logistic EuroSCORE 27.5% (20-63.2)
Annular Size 22.5 mm (17-27)
NYHA Class III or IV 97.2%
Aortic Stenosis 59.8%
Aortic Insufficiency 40.2%
Patient Pre-operative Characteristics
Number (%)
Hypertension 63.6%
Diabetes 15.0%
CAD 18.7%
COPD 55.1%
Atrial Fibrillation 19.6%
Congestive heart failure 25.2%
Peripheral vascular disease 52.3%
Stroke/TIA last 3 months 6.5%
Device Success
Number of Patients 107
Procedural Mortality 0
Incorrect Positioning 5
Second Valve Implanted 2
Conversion to Surgery 5
Device Success Rate: 93.5%
Clinical Outcomes
30 day
(n=107 )
All-cause Mortality 4.7%
MI 0%
Urgent cardiac surgery or repeat
intervention0.9%
Stroke 0%
New Pacemaker 2.8%
Major adverse cardiovascular and cerebrovascular events (MACCE)1defined as any emergency surgical or transapical catheter intervention procedures that
repair, otherwise alter, adjusts, or replaces a previously implanted valve
0
20
40
60
80
100
120
Pre-OperationITT
Treated
Nu
mb
er
of
pat
ien
ts
I II
III IV
30 days Post-op
Clinical Outcomes-NYHA
Mean Aortic Gradient – AS vs AI
Perivalvular Leak (PVL)
ITT: Intend to treat
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre-Implant 30 Day
Severe
Moderate
Mild
Trivial
None
J-Valve in AI patients (N=33)
Clinical Factors
Age 74.2± 5.2
Female Gender 21%
Weight 52.3 ± 7.6 kg
Peripheral Vascular disease 36%
COPD 55%
Prior Cerebrovascular disease 36%
NYHA Class II 18%
III 52%
IV 30%
Logistic EuroSCORE I 24.4 ± 5.1%
LVEF < 50% 42%
Mean gradient 10.0 ± 5.7 mmHg
AR Grade III 21%
Grade IV 79%
J-Valve in AR patients (N=33)VARC-2 Defined Endpoints
Cerebrovascular event 0
Myocardium infraction 0
Access site complication
Minor 3%
Major 0%
Paravalvular leakage (>2+) 3%
Acute kidney injury 3%
Permanent pacemaker implantation 6%
ICU stay (days) 2 ± 1
In-hospital stay (days) 12 ± 4
Device success 97%
All-caused mortality 3%
Cardiac mortality 3%
Degree of Aortic Regurgitation
0%
25%
50%
75%
100%
Pre Implant 30 Day 6 Month
Severe
Moderate
Mild
Trace
None
N=33 N=31 N=31
Summary
• J-ValveTM Ausper system is a 2nd generation
TAVR system with unique mechanism
• Able to treat patients with AS or AI
• Excellent device, clinical success and
performance, especially in AR patients
Future Direction
• Preparing CE Mark submission
• Planning stage for US IDE trial
• Retrograde delivery systems in development
Discussions