1. Transcatheter Aortic Valve Replacement Using the Lotus Valve with Depth Guard First Report from the RESPOND Extension Study
Nicolas M Van Mieghem, MD, PhD
Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands
Daniel J Blackman, MD; David Hildick-Smith, MD; Adam Witkowski, MD; Saib S Khogali, MD; Marek Grygier, MD; Dominic J Allocco, MD; Keith D Dawkins, MD

2. Disclosure
I, Nicolas Van Mieghem, MD, PhD, has received research grant support from
Abbott Vascular
Boston Scientific
Claret Medical
Medtronic
PulseCath Inc.

3. Pericardium in Nitinol Frame
The Lotus™ Valve
Controlled mechanical expansion for precise placement
Repositionable & fully retrievable
Functions early in deployment to provide hemodynamic stability
Adaptive seal conforms to irregular anatomical surfaces to minimize paravalvular leak
Bovine
Pericardium in Nitinol Frame
Radiopaque Marker
To aid precise positioning
Adaptive Seal

4. RESPOND Post-Market Study
Lotus Valve used in routine clinical practice
1014 patients; 41 centers (EUR, NZ, LAT AM); 3 valve sizes (23mm, 25mm, 27mm)
Percentage of Patients
Paravalvular Leak at Discharge (N=934)
Moderate
None/Trace
Mild
No patients with severe PVL
Core Lab-Adjudicated Data
Permanent pacemaker implantation, 0 to 30 days: 30.0%

5. Depth Guard™ Technology
Designed to reduce LVOT interaction and lower PPM rates
Lotus™ Valve
Lotus Valve with Depth Guard™
Deeper LVOT Interaction
Anchors early during deployment
Enables more predictable placement
Minimizes depth of valve frame
Depth Guard technology enables the valve to deploy differently than the Lotus Valve.  It is a technology modification that minimizes how deep the frame extends into the LVOT before anchoring, limiting potential interaction with the conduction system.  
As you can see in the Lotus illustration on the left, the valve is deploying in a funnel shape. This funnel deploys deeper into the LVOT, causing interaction with the conduction system. The funnel shape also prevents it from having an early “anchoring” or securement to the leaflets in the annulus.
As you look to the picture on the right, you can see that Lotus with Depth guard deploys in a wider, more bell shaped fashion. This enables it to have a larger section of the valve anchor – or secure itself - to the wall of the valve at an earlier point in time. Because of this deployment, physicians will have a better idea of where this will land, giving it more predictable placement. Finally, the Depth Guard valve deploys in a way that limits how deep the valve frame goes into the LVOT. This minimizes the interaction with the conduction system.

6. LOTUS with Depth Guard™
LOTUS Edge
+ Depth Guard
Lotus Valve
System
Depth Guard optimizes valve deployment:
Anchors early during deployment
Minimizes depth of valve frame, reducing interaction with the LVOT & conduction system
When used in combination with modifications to valve implant technique, may reduce the need for new pacemaker implantation

7. RESPOND Extension Study
Study Objective
Assess clinical and device performance outcomes with the Lotus Valve (23mm & 25mm) combined with Depth Guard
Enrollment
50 patients enrolled at 6 European study centers (NL, UK, PL)
Primary Endpoint
All-cause mortality 30 days post procedure
Additional Endpoints
Device performance
VARC-2 clinical efficacy and safety through 30 days
New conduction disturbances and the need for PPM implantation
Grade of pre-discharge PVL (core lab-adjudicated)

8. Baseline Characteristics
Demographics & Clinical Characteristics (N=50)
Age (Years)
80.9 ± 8.2
Gender (Female)
54%
Diabetes, medically-treated
30%
Prior pacemaker
10%
NYHA Class III or IV
52%
STS Score (v 2.73; %)
4.4 ± 3.1
Katz Index (frail if <6)
5.9 ± 0.4
Indications for TAVI (Site-Reported)
Tricuspid aortic valve stenosis
94%
Bicuspid aortic valve stenosis 6%
Low flow/low gradient 0%
TAV-in-Valve
Echocardiographic Measurements
(Core Lab Assessment, N=44)
AVA (cm2)
0.7 ± 0.2
Mean gradient (mmHg)
39.1 ± 13.0
Peak gradient (mmHg)
63.0 ± 18.6
AR (mod/severe)
15.9%
MR (mod/severe)
4.7%
LVEF (%)
50.2 ± 9.3

9. Device Performance & Success
Successful vascular access, delivery and deployment, and successful retrieval of the delivery system
100% (50/50)
Repositioning attempted
32% (16/50)
Successful repositioning (ie, partial or complete resheathing, and redeployment in a more accurate position within aortic valve annulus)
100% (16/16)
Valve Systems Implanted
23 mm
34% (17/50)
25 mm
66% (33/50)
Vascular Access
Transfemoral
96% (48/50)
Transaortic
4% (2/50)
Device Success (VARC-2 Metrics)
No procedural mortality
100%
Correct positioning of one valve in proper location
Mean aortic valve gradient <20 mmHg
94%
Peak velocity <3 m/s
No moderate/severe prosthetic valve regurgitation
*Total prosthetic aortic valve regurgitation (central and paravalvular) per VARC-2 definition; core-lab adjudicated.

10. Safety Outcomes at Discharge
% (n)
All-cause mortality
0% (0)
Cardiovascular mortality
All stroke
6% (3)
Disabling stroke
4% (2)
Life-threatening or disabling bleeding
Major vascular complications
2% (1)
Myocardial infarction
Acute kidney injury (Stage 2 or Stage 3)
Repeat procedure for valve-related dysfunction
Prosthetic aortic valve thrombosis
Prosthetic aortic valve endocarditis
Permanent pacemaker implantation
All patients (n=50)
16% (8)
Pacemaker-naïve patients (n=45)
17.8% (8)
All patients (n=50)
16% (8)
Pacemaker-naïve patients (n=45)
17.8% (8)

11. Mean Aortic Gradient & EOA
Mean Effective Orifice Area (cm2)
Mean Aortic Gradient (mmHg)
39.1 ± 13.0 (n=44)
0.7 ± 0.2 (n=43)
11.7 ± 4.4 (n=34)
Baseline
Discharge
Core Lab-Adjudicated Data

12. Paravalvular Aortic Regurgitation
Paravalvular Leak (PVL)
Aortic Regurgitation
None
Trace
Mild
Moderate
Severe
Percentage of Evaluable Echocardiograms
(n=44)
(n=34)
Core Lab-Adjudicated Data

13. Percentage of Patients
NYHA Functional Class
P<0.001 I II
III IV
NYHA Class
Percentage of Patients
(n=49)
(n=41)
Among patients for whom NYHA Class was recorded and with follow-up data available for the given time points; P-value is from generalized McNemar’s test.

14. RESPOND & RESPOND Extension
At A Glance: Hospital Discharge
RESPOND Ext (LOTUS + Depth Guard, n=50)
RESPOND (Lotus Valve, n=996)
Percentage of Patients
All-cause mortality
Cardiovascular mortality
All stroke
Disabling stroke
Major vascular complications
Life-thrt/
disabling bleeding
Pacemaker implantation*
≥Mild
PVL
RESPOND: 0% severe PVL; 0.3% moderate PVL
RESPOND Extension: 0% moderate or severe PVL
*Among patients without a prior pacemaker at baseline (RESPOND, n=864; RESPOND Ext, n=45).

15. Conclusions
The RESPOND Extension study establishes the early safety and efficacy of TAVI with the Lotus Valve with Depth Guard
0% mortality at discharge/7 days
Low paravalvular regurgitation (core lab-adjudicated)
85.3% of patients with no/trivial PVL
No patients with moderate or severe PVL
Permanent pacemaker implantation (0-7d/discharge)
16% among all patients; 17.7% among pacemaker-naïve patients
11:35 – 11:45
Data on 30-day outcomes from RESPOND Extension are expected to be reported at EuroPCR 2017