1. University Heart Center Hamburg
Transcatheter valve-in-valve therapy using six different devices in four anatomic positions – clinical outcomes and technical considerations
Conradi L, Silaschi M, Seiffert M, Lubos E, Blankenberg S, Reichenspurner H,
Schäfer U, Treede H
University Heart Center Hamburg 1 1

2. Disclosures Proctorship: - JenaValve Technology GmbH, Munich, Germany
- Medtronic, Inc., MA, USA
- Symetis SA, Ecublens, Switzerland
Consultancy:
- Edwards Lifesciences, Inc., CA, USA

3. Background
88% biological valves
in 2014!

4. Development of aortic valve procedures University Heart Center Hamburg
Background
Development of aortic valve procedures University Heart Center Hamburg
Primary procedures
Redo procedures
48.4%
52.4%
51.6%
47.6%

5. TAVI procedures at UHC Hamburg
Edwards Sapien (XT)
598
TF 295
TA 301
TS/Ax 1
TAo 1
V-i-V 31
Edwards Sapien 3
243
TF 183
TS/Ax 5
TA 54
V-i-V 7
Medtronic CoreValve
178
TF 168
TS/Ax 6
TAo 4
V-i-V 28
JenaValve
160
TF 6
TA 154
V-i-V 2
Symetis Acurate
161
TF 47
TA 114
Medtronic Engager 86
TA 81
TAo 5
Directflow Medical 18
TF 18
Boston Scientific Lotus 23
TF 23
V-i-V 3
SJM Portico 5
TF 5
Biotronik Biovalve 12
TF 12
n = 1484
31/03/2015

6. Baseline demographics I
Results
Baseline demographics I
Baseline demographics
All ViV
(n=75)
Aortic
(n=54)
Mitral
(n=17)
Pulmonary
(n=2)
Tricuspid
Age (years)
74.1±12.9
77.9±8.0
69.6±14.5
37-60
28-44
Male gender, n (%)
38 (50.7)
31 (57.4)
4 (23.5)
1 (50)
2 (100)
BMI
26.2±4.8
26.6±4.3
24.9±6.8
24-26
25-26
Logistic EuroSCORE I (%)
26.2±17.8
28.4±18.3
23.0±15.2
8-11
1-5
STS Score (%)
8.8±7.4
8.7±7.7
10.7±8.2
1-2
Diabetes mellitus, n (%)
10 (13.3)
7 (13.0)
3 (17.6)
Peripheral vascular disease, n (%)
22 (29.3)
20 (37.0)
2 (11.8)
Creatinine (mg/dl)
1.4±1.2
1.5±1.3
1.2±0.4
Atrial fibrillation, n (%)
12 (16.0)
7 (12.9)
5 (29.4)
Previous stroke / TIA, n (%)
15 (20.0)
8 (47.1)
Left ventricular ejection fraction
- normal (>50%), n (%)
- moderate reduction (30-50%), n (%)
- severe reduction (<30%), n (%)
68 (90.7)
4 (5.3)
3 (4.0)
47 (87.0)
4 (7.4)
3 (5.6)
17 (100)
NYHA functional class, n (%)
- I/II
- III/IV
8 (10.7)
67 (89.3)
5 (9.3)
49 (90.7)
1 (5.9)
16 (94.1)

7. Baseline demographics II
Results
Baseline demographics II
Baseline demographics
All ViV
(n=75)
Aortic
(n=54)
Mitral
(n=17)
Pulmonary
(n=2)
Tricuspid
> 1 previous valve replacement, n (%)
7 (9.3)
4 (7.4)
3 (17.6)
Interval to index procedure (years)
9.3±4.9
9.8±4.9
8.8±5.1
1-3
6-8
Type of previous valve, n (%)
- stented
- stentless
- unknown
64 (85.3)
10 (13.3)
1 (1.3)
45 (83.3)
8 (14.8)
1 (1.9)
17 (100)
2 (100)
1 (50)
Size of previous valve, n (%)
- ≤21mm
- 23mm
- ≥25mm
- Unknown
12 (16.0)
27 (36.0)
35 (46.7)
12 (22.2)
27 (50.0)
15 (27.8)
2 (100.0)
Mode of deterioration, n (%)
- stenosis
- regurgitation
- mixed
29 (38.7)
28 (37.3)
18 (24.0)
24 (44.4)
19 (35.2)
11 (20.4)
4 (23.5)
8 (47.1)
5 (29.4)
Valve gradient (mmHg) -
35.9±16.9
14.0±6.5
34-47
8-9
Valve regurgitation ≥ moderate, n (%)
43 (57.3)
26 (48.2)
14 (82.4)
1 (50.0)

8. Results Procedural data I Periprocedural results All ViV (n=75) Aortic
Mitral
(n=17)
Pulmonary
(n=2)
Tricuspid
Procedure time (minutes)
104.3± 47.2
101.7±50.8
110.4±33.2
55-100
Flouroscopy time (minutes)
15.5±12.4
13.3±12.7
15.5±10.2
35-38
14-33
Contrast agent (ml)
119.6±89.6
114.1± 81.6
93.9±80.5
Access route
- transapical, n (%)
- transvascular, n (%)
- direct aortic, n (%)
40 (53.3)
33 (44.0)
2 (2.7)
23 (42.6)
29 (53.7)
2 (3.7)
17 (100)
2 (100)
THV type, n (%)
- all Sapien
- Sapien (XT)
- Sapien 3
- all CoreValve
- CoreValve
- CoreValveEvolut
- St. Jude Portico
- Boston Lotus
- Medtronic Engager
- JenaValve
39 (52.0)
31 (41.3)
8 (10.7)
26 (34.7)
12 (16.0)
14 (18.7)
3 (4.0)
21 (38.9)
16 (29.6)
3 (5.6)
26 (48.1)
12 (22.2)
14 (25.9) -
14 (82.4)
12 (70.6)
2 (11.8)
3 (17.6)
1 (50)

9. Case examples
Tricuspid V-i-V
RV Angiography

10. Case examples
Mitral V-i-V
Lotus 25 mm in Hancock 27 mm

11. VARC-2 acute clinical outcome
Results
VARC-2 acute clinical outcome
30-day clinical outcomes
All ViV
(n=75)
Aortic
(n=54)
Mitral
(n=17)
Pulmonary
(n=2)
Tricuspid
Length of stay ICU (days)
2.2±1.7
2.2±1.8
2.3±1.6
1-3 1
Duration of hospital stay (days)
7.4±13.7
6.5±15.6
10.7±6.2 6
4-7
Immediate procedural mortality (<72h), n (%)
2 (2.7)
1 (1.9)
1 (5.9)
All-cause death, n (%)
6 (8.0)
3 (5.6)
3 (17.6)
Cardiovascular death, n (%)
Any stroke, n (%)
Myocardial infarction, n (%)
1 (1.3)
Major vascular complication, n (%)
4 (5.3)
Major/life-threatening bleeding, n (%)
Acute kidney injury type II/III, n (%)
3 (4.0)
Permanent pacemaker implantation, n (%)
8 (10.7)
6 (11.1)
2 (11.8)
Early Safety, n (%)
12 (16.0)
7 (13.0)
5 (29.4)
Clinical efficacy, n (%)
49 (65.3)
31 (57.4)
14 (82.4)
2 (100)

12. Results
Valve regurgitation

13. Acute hemodynamic outcomes
Results
Acute hemodynamic outcomes
Acute hemodynamic outcomes
All ViV
(n=75)
Aortic
(n=54)
Mitral
(n=17)
Pulmonary
(n=2)
Tricuspid
Valve area (cm²) -
1.5±1.4
2.4±0.9
n.a.
Peak gradient (mmHg)
34.1±14.2
14.2±8.2
22-29
8-12
Mean gradient (mmHg)
20.1±7.1
4.7±3.1
12-15
4-9
Paravalvular regurgitation no/trace, n (%)
51 (68.0)
33 (61.1)
14 (82.4)
2 (100)
Paravalvular regurgitation mild, n (%)
24 (33.8)
21 (38.9)
3 (17.6)
Paravalvular regurgitation moderate/severe, n (%)

14. Residual transvalvular gradients
Aortic V-i-V

15. Resultant indexed EOA
Aortic V-i-V

16. Kaplan-Meier Survival
Results
Kaplan-Meier Survival

17. Valve-in-valve therapy
Conclusions
ViV therapy well established for treatment of SVD in aortic and mitral positions
Technical feasibility demonstrated in tricuspid and pulmonary positions
Multiple types of THV available for aortic and mitral ViV
Excellent hemodynamic outcome regarding PVL
Concern: elevated transvalvular gradients after aortic ViV, especially in valves ≤ 23 mm
Open questions: - Suitability of respective THV types?
- Balloon-expandable or self-expanding?
- Patient selection: ViV vs. redo surgery
Increasing importance of ViV can be anticipated (more bioprostheses in younger patients)

18. Thank you for your attention!

19. THV deployment (Sapien3 26 mm in Shelhigh 31 mm)
Case examples
Tricuspid V-i-V
THV deployment (Sapien3 26 mm in Shelhigh 31 mm)

20. Case examples
Mitral V-i-V
Lotus 25 mm in Hancock 27 mm

21. Case examples
Mitral V-i-V
Lotus 25 mm in Hancock 27 mm