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transcatheter aortic valve replacement with Lotus valve: results of - - PowerPoint PPT Presentation
transcatheter aortic valve replacement with Lotus valve: results of - - PowerPoint PPT Presentation
Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with Lotus valve: results of the RELEVANT study. Potential conflicts of interest Speaker's name: Rocco Antonio Montone I do not have any potential
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RELEVANT Study
REgistry of Lotus valvE for the treatment of aortic VAlve steNosis with Tavr University Hospital Padova GVM Cecilia Maria Hospital Cotignola University Hospital Pisa IRCCS San Raffaele Hospital
Italian prospective multicenter registry
IRCCS Policlinico San Donato
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Lotus aortic valve
Characteristics
- Second-generation TAVR device
- Fully repositionable and retrievable
- Adaptive seal designed to minimize
paravalvular leak
- Controlled mechanical expansion
to obtain a precise positioning
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RELEVANT Study
Study design
Patients with severe aortic stenosis Local Heart Team
High risk patients (mean STS score 8.5)
TAVR with Lotus aortic valve
N = 208 patients
Discharge and 30-day outcome
208 patients enrolled
- From December 2013 to March 2016
- 30-day follow-up
Primary endpoint:
All-cause mortality
Secondary endpoints (VARC definition):
- Stroke
- Vascular complication
- Bleeding
- New pacemaker implantation
- Emergent cardiac surgery
Site-reported events
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Variable n (%) or mean ± SD Age, years 83.2 ± 6.4 Male 100 (48.1) Diabetes 56 (26.9) Chronic pulmonary disease 70 (33.6) Previous cerebrovascular disease 35 (16.8) Previous cardiac surgery 49 (23.6) Atrial fibrillation 51 (24.5) Pulmonary hypertension 73 (35.0) Euroscore II 7.1 ± 5.9 Logistic Euroscore 17.8 ± 6.8 STS score (mortality) 8.5 ± 5.3 Left ventricular ejection fraction >50% 132 (63.5) 30%-50% 55 (26.4) <30% 21 (10.1) Coronary artery disease 73 (35.0) Etiology of aortic valve disease Degenerative 196 (94.3) Bioprosthesis 4 (1.9) Bicuspid 8 (3.8)
RELEVANT Study
Baseline characteristics
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Variable n (%) General Anaesthesia 39 (18.8) Access route Trans-femoral 203 (97.6) Trans-subclavian 5 (2.4) Lotus valve size 23 mm 78 (37.5) 25 mm 82 (39.4) 27 mm 48 (23.1) Pre-implant balloon valvuloplasty 143 (68.8) Successful Lotus device deployment 208 (100.0) Access site closure Percutaneous 193 (92.8) Planned surgical 12 (5.8) Unplanned surgical 3 (1.4)
RELEVANT Study
Procedural details
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Endpoint Discharge, % 30-day, % Primary endpoint All-cause mortality * 2.4 2.9 Secondary endpoints Stroke 1.9 2.4
Major 0.5 1.0
Vascular complications 5.8 5.8
Major 2.0 2.0
Bleeding 10.1 11.5
Major or life-threatening 2.4 2.4
New pacemaker implantation 26.4 27.4 Emergent cardiac surgery 1.9 1.9
RELEVANT Study
Clinical outcomes
* In-hospital mortality: 5 patients (3 sepsis, 1 aortic rupture, 1 heart failure) 30-day mortality: 1 more patient (major stroke)
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RELEVANT Study
Echocardiographic outcomes
Mean aortic gradient (mmHg) Baseline Discharge 30-day
10 20 30 40 50
45.6 11.3 11.6
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Baseline Discharge 30-day
20% 51% 24% 5% 68% 67% 31% 32% 1% 1%
Aortic regurgitation Aortic gradient
none mild moderate severe
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RELEVANT Study
Comparison with other registries
RELEVANT
(208 patients)
REPRISE II
(120 patients)
2.9% 4.2%
All-cause 30-day mortality
RELEVANT
(208 patients)
REPRISE II
(120 patients)
1.0% 1.0%
30-day more-than-mild AR
2.0% RESPOND
(500 patients - interim)
0.4% RESPOND
(500 patients - interim)
RELEVANT
(208 patients)
REPRISE II
(120 patients)
30-day new pacemaker implantation
27.4% 28.6% RESPOND
(500 patients - interim)
36.5% RELEVANT
(208 patients)
REPRISE II
(120 patients)
2.4% 5.9%
30-day all stroke
3.9% RESPOND
(500 patients - interim)
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RELEVANT Study
Conclusions
RELEVANT study is one of the largest real world TAVR registry
- f Lotus valve device.