1. Holger Thiele, MD on behalf of the SOLVE-TAVI Investigators
A 2x2 Randomized Trial of Self-Expandable vs Balloon-Expandable Valves and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation
Holger Thiele, MD
on behalf of the SOLVE-TAVI Investigators

2. Disclosure Statement of Financial Interest
I, Holger Thiele DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. Background I
TAVR is developing as standard strategy for symptomatic patients with severe aortic stenosis at high to intermediate risk.
TAVR device design led to relevant technical and clinical improvements (e.g. pacemaker rates, paravalvular leakage, vascular complications).
There is limited evidence for direct valve comparisons (CHOICE, REPRISE III) in particular for latest generation valve designs.
Abdel-Wahab et al. JAMA 2014;311:
Feldman et al. JAMA. 2018;319:27-37 2

4. Background II – Anesthesia Strategy
- In clinical routine TAVR is performed in ≈50% using general or local anesthesia with conscious sedation.
Registry data suggest
lower mortality
lower morbidity
shorter ICU and hospital stay
shorter procedure times with local anesthesia.
There is a lack of adequately powered randomized trials.
Villablanca et al. Catheter Cardiovasc Interv. 2017;1–13 3

5. Symptomatic Aortic Stenosis with TAVR Indication
SOLVE-TAVI Program
Symptomatic Aortic Stenosis with TAVR Indication
1:1
CoreValve Evolut R
Valve Strategy
Edwards Sapien 3
1:1
Local Anesthesia
General Anesthesia
Anesthesia Strategy

6. Hypotheses
I) Self-expanding CoreValve Evolut R is equivalent to balloon-expandable Sapien 3 (Edwards) valve
II) Local anesthesia with conscious sedation is equivalent to general anesthesia
in symptomatic aortic stenosis patients undergoing transfemoral TAVR.

7. Endpoints – Valve Strategy
Primary Study Endpoint:
30-day composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation.
Secondary Study Endpoints:
Individual components of the primary endpoint at 30 days, 6 and 12 months, 2 and 5 years
Device success (VARC-2 criteria*)
Early safety at 30 days (VARC-2 criteria*)
Clinical efficacy at 30 days (VARC-2 criteria*)
Time-related valve safety (VARC-2 criteria*)
Cardiovascular mortality at 30 days, 6 and 12 months, 2 and 5 years
Mean length of primary hospital stay
Quality of life according to the EuroQuol-5 questionnaire (EQ-5D) at 30 days, 6 and 12
months, 2 and 5 years
Device time
Total procedural time
*Kappetein et al. Eur Heart J 2012;33:2403–2418

8. Endpoints – Anesthesia Strategy
Primary Study Endpoint:
30-day composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury.
Secondary Study Endpoints:
Individual components of the primary endpoint at 30 days, 6 and 12 months, 2 and 5 years
Postinterventional occurrence of acute delirium assessed according to CAM-ICU criteria
Device time
Total procedural time
Need and doses of vasopressors and inotropes
Mean length of primary hospital stay
Mean length of primary stay at the ICU
Moderate or severe moderate or severe prosthetic valve regurgitation at 30 days
Cardiovascular mortality at 30 days, 6 and 12 months, 2 and 5 years
Quality of life according to the EQ-5D-questionnaire at 30 days, 6 and 12 months, 2 and
5 years

9. Methodology – Sample Size
Valve Strategy - Equivalence Testing
Postulated event rate for both valves 15%
Lower
limit -
Upper
limit +
Equivalence
zone -D +D
Anesthesia Strategy - Equivalence Testing
Postulated event rate for both anesthesia strategies 13%
Lower
limit -
Upper
limit +
Equivalence
zone -D +D
Sample Size:
Valve strategy: 2-sided test Chi2-test; power: 90%, α=0.05 for final analysis → 438 patients
Anesthesia strategy: 2-sided test Chi2-test; power: 80%, α=0.05 for final analysis → 388 patients
To compensate losses in follow-up → 444 patients

10. Investigator-initiated German multicenter trial; 1:1 randomization
SOLVE-TAVI Trial
Investigator-initiated German multicenter trial; 1:1 randomization
Leipzig
Berlin
Rostock
Kiel
Lübeck
Bremen
Giessen
PI:
Holger Thiele
Study Coordination: Suzanne de Waha-Thiele
University Heart Center Lübeck:
Thomas Kurz, Roza Meyer-Saraei
Ingo Eitel, Matthias Heringlake
Klinikum Links der Weser Bremen:
Rainer Hambrecht, Harm Wienbergen
Heart Center Leipzig:
Hans-Josef Feistritzer, Steffen Desch
Marcus Sandri, Mohamed Abdel-Wahab
David Holzhey, Michael Borger
Yvonne Rückert, Jörg Ender
University of Giessen:
Holger Nef, Oliver Dörr
Charité Berlin:
Alexander Lauten, Sascha Treskatsch
University of Rostock:
Hüseyin Ince, Mohamed Sherif
University Schleswig-Holstein, Campus Kiel:
Norbert Frey, Derk Frank
Funding:
CROs: 9

11. Study Flow Chart - Valve Strategy Primary endpoint analysis
447 randomized
Allocation
225 randomized to Evolut R
4 withdrawal of informed consent
1 death prior to TAVI procedure
1 medical treatment (no aortic stenosis)
222 randomized to Sapien 3
2 withdrawal of informed consent
1 death prior to TAVI procedure
Intervention
219 undergoing TAVI procedure
216 Evolut R as allocated
1 cross-over Sapien 3
1 conventional AVR
1 balloon valvuloplasty only
219 undergoing TAVI procedure
218 Sapien 3 as allocated
1 cross-over Corevalve Evolut R
Follow-up
219 eligible for 30-day follow-up
2 missing data for primary endpoint
219 eligible for 30-day follow-up
1 withdrawal of informed consent
3 missing data for primary endpoint
Primary endpoint analysis
217 primary endpoint analysis
215 primary endpoint analysis

12. Baseline Characteristics – Valve Strategy
Evolut R
(n=219)
Sapien 3
Age (years); mean ±SD
81.7 ± 5.3
81.5 ± 5.7
Male sex; n/total (%)
105/219 (47.9)
109/219 (49.8)
Risk scores
STS score (%); mean ±SD
7.7 ± 7.2
7.6 ± 7.4
Log. EuroScore I (%), mean ±SD
18.4 ± 12.1
18.3 ± 13.1
EuroScore II (%), mean ±SD
6.1 ± 5.5
5.4 ± 4.9
Frailty; n/total (%)
93/216 (43.1)
80/217 (36.9)
Peripheral arterial disease; n/total (%)
28/219 (12.8)
27/219 (12.3)
Prior myocardial infarction; n/total (%)
Prior PCI; n/total (%) 
Prior CABG; n/total (%)
Atrial fibrillation; n/total (%)
Pacemaker/ICD; n/total (%)
19/219 (8.7)
84/219 (38.4)
26/219 (11.9)
103/219 (47.0)
24/218 (11.0)
22/219 (10.1)
79/219 (36.1)
18/219 (8.2)
93/219 (42.5)
23/219 (10.5)
Prior stroke; n/total (%)
25/219 (11.4)
26/218 (11.9)
Renal insufficiency; n/total (%)
177/216 (81.9)
184/214 (86.0)
Pulmonary hypertension; n/total (%)
106/216 (49.1)
105/218 (48.2)
COPD; n/total (%)
30/219 (13.7)
29/217 (13.4)
Cardiovascular risk factors
Diabetes; n/total (%)
Arterial hypertension; n/total (%)
HLP; n/total (%)
Current smoking; n/total (%)
79/218 (36.2) 
193/219 (88.1)
118/218 (54.1)
8/218 (3.7)
68/219 (31.1) 
204/219 (93.2)
10/219 (4.6)

13. Treatment – Valve Strategy
Characteristic
Evolut R
(n=219)
Sapien 3 P
Pre echo data
AVA; cm2
AVA index; cm2/m2
Mean gradient; mmHg
Peak gradient; mmHg
TAPSE; mm
LVEF >55%; n/total (%)
LVEF 45-54%; n/total (%)
LVEF 35-44%; n/total (%)
LVEF <35%; n/total (%)
0.76 ± 0.19
0.41 ± 0.12
39.5 ± 14.4
63.9 ± 22.9
20.6 ± 4.6
114/203 (56.2)
56/203 (27.6)
21/203 (10.3)
12/203 (5.9)
0.77 ± 0.20
0.43 ± 0.12
64.2 ± 26.4
19.9 ± 5.7
114/201 (56.7)
52/201 (25.9)
16/201 (8.0)
19/201 (9.5)
0.60
0.39
0.52
0.37
0.49
Valve size
23 mm; n/total (%)
1/215 (0.5)
51/218 (23.4)
26 mm; n/total (%)
56/215 (26.2)
120/218 (55.1)
29 mm; n/total (%)
108/215 (50.2)
47/218 (21.6)
34 mm; n/total (%)
50/215 (23.3)
Pre dilatation; n/total (%)
83/219 (37.9)
86/216 (39.8)
0.68
Post dilatation; n/total (%)
77/219 (35.2)
50/218 (22.9)
0.006
Recapturing; n/total (%)
55/204 (27.0)
<0.001
Contrast agent, ml
119 ± 44
98 ± 33
Fluoroscopy time, min
14.2 ± 12.8
12.0 ± 6.1
0.02

14. Primary Endpoint – Valve Strategy
All-cause mortality, stroke, moderate or severe prosthetic valve regurgitation,
permanent pacemaker implantation at 30 days
Rate difference -1.14
90%CI – 5.87
Pequivalence=0.02
Psuperiority=0.83
27.2%
26.1% %

15. Endpoints – Valve Strategy Individual components primary endpoint%
Pacemaker implantation
Moderate/severe valve regurgitation
Pequivalence<0.001
Psuperiority=0.77
2.8%
2.3%
Pequivalence=0.003
Psuperiority=0.01
0.5%
4.7%
Psuperiority>0.99
1.9%
1.4%
Pequivalence=0.06
Psuperiority=0.34
22.9%
19.0%
■ Evolut R
■ Sapien 3

16. Secondary Endpoints – Valve Strategy
Evolut R
(n=219)
Sapien 3
Rate difference
Pequivalence
Psuperiority
Device time, min
63 ± 32
64 ± 43
0.80
Total procedural time, min
118 ± 48
117 ± 52
0.40
Cardiovascular mortality, n (%)
1/216 (0.5)
4/218 (1.8)
1.37 (-2.27 ─ 5.01)
<0.001
0.37
Hospital stay, days
9 ± 7
0.97
VARC-2 criteria:
Device success, n (%)
203/216 (94.0)
200/218 (91.7)
-2.24 (-6.91 ─ 2.43)
0.002
0.46
Early safety, n (%)
24/217 (11.1)
33/219 (15.1)
4.01 (-1.57 ─ 9.59)
0.03
0.26
Clinical efficacy, n (%)
74/216 (34.3)
80/217 (36.9)
2.61 (-4.94 ─ 10.15)
0.05
0.61
Time-related safety, n (%)
41/217 (18.9)
58/219 (26.5)
7.59 ( )
0.27
0.07

17. Subgroup Analysis – Valve Strategy Primary Endpoint Event
Rate difference
P Value for
Corevalve Evolut R
Sapien 3
(90% CI)
Interaction
No. of patients with event/total no. (%)
Sex
Female
28/113 (24.8)
33/107 (30.8)
6.1 (-3.9 ─ 16.0)
0.08
Male
31/104 (29.8)
23/108 (21.3)
-8.5 (-18.4 ─ 1.4)
Age
<80 years
18/69 (26.1)
16/73 (21.9)
-4.2 (-16.0 ─ 7.7)
0.59
≥80 years
41/148 (27.7)
40/142 (28.2)
0.5 (-8.2 ─ 9.2)
Coronary artery disease
Yes
34/126 (27.0)
34/115 (29.6)
2.6 (-7.0 ─ 12.2)
0.37 No
22/80 (27.5)
21/94 (22.3)
-5.2 (-16.0 ─ 5.7)
Frailty
Mild
52/202 (25.7)
53/204 (26.0)
0.2 (-6.9 ─ 7.4)
0.99
Moderate
4/12 (33.3)
3/9 (33.3)
0.0 (-34.3 ─ 34.4)
Chronic renal failure
49/175 (28.0)
46/182 (25.3)
-2.7 (-10.4 ─ 5.0)
0.44
10/39 (25.6)
9/28 (32.1)
6.5 (-12.1 ─ 25.1)
Left ventricular ejection fraction
<35 %
3/12 (25.0)
4/19 (21.1)
-4.0 (-30.1 ─ 22.2)
0.86
≥35 %
52/189 (27.5)
47/179 (26.3)
-1.3 (-8.9 ─ 6.4)
Body mass index
<25 kg/m²
25/69 (36.2)
22/76 (29.0)
-7.3 (-20.1 ─ 5.5)
0.57
25-30 kg/m²
20/95 (21.1)
22/90 (24.4)
3.4 (-6.8 ─ 13.6)
≥30 kg/m²
13/52 (25.0)
12/49 (24.5)
-0.5 (-14.7 ─ 13.7)
STS score
<10%
43/149 (28.9)
36/157 (22.9)
-5.9 (-14.2 ─ 2.3)
0.02
≥10%
9/49 (18.4)
18/50 (36.0)
17.6 (2.8 ─ 32.5)
Logistic EuroScore
<20%
36/142 (25.4)
33/141(23.4)
-2.0 (-10.4 ─ 6.5)
0.71
≥20%
22/74 (29.7)
23/74 (31.1)
1.4 (-11.1 ─ 13.8)
Aortic stenosis
Normal flow, high gradient
23/98 (23.5)
0.0 (-10.0 ─ 10.0)
0.29
Low flow, low gradient
19/50 (38.0)
13/50 (26.0)
(-27.4 ─ 3.4)
Paradoxical low flow low gradient
7/32 (21.9)
13/41 (31.7)
9.8 (-7.8 ─ 27.4)
ScO2 prior to intervention
<50%
42/158 (26.6)
45/165 (27.3)
0.7 (-7.5 ─ 8.8)
1.00
≥50%
5/15 (33.3)
0.0 (-30.2 ─ 30.2)
Mode of anesthesia
General anesthesia
32/111 (28.8)
22/107 (20.6)
-8.3 (-18.0 ─ 1.5)
0.09
Local anesthesia
27/106 (25.5)
34/108 (31.5)
6.0 (-4.2 ─ 16.2)
Equivalence margin
Corevalve Evolut R better
-20
-15
-10 -5 5 10 15 20
Sapien 3 better

18. Study Flow Chart - Anesthesia Strategy
222 randomized to local anesthesia
3 withdrawal of informed consent
1 death prior to TAVI procedure
447 randomized
225 randomized to general anesthesia
1 medical treatment (no aortic stenosis)
218 undergoing TAVI procedure
217 local anesthesia
13 bailout general anesthesia
1 elective cross over general anesthesia
220 undergoing TAVI procedure
219 general anesthesia
1 elective cross-over to local anesthesia
218 eligible for 30-day follow-up
1 withdrawal of informed consent
2 missing data for primary endpoint
220 eligible for 30-day follow-up
215 primary endpoint analysis
220 primary endpoint analysis
Intervention
Follow-up
Primary endpoint analysis
Allocation

19. Baseline Characteristics – Anesthesia Strategy
Local Anesthesia
(n=218)
General Anesthesia
(n=220)
Age (years); mean ±SD
81.8 ± 5.3
81.4 ± 5.7
Male sex; n/total (%)
107/218 (49.1)
107/220 (48.6)
Risk scores
STS score (%); mean ±SD
6.9 ± 6.2
8.3 ± 8.2
Log. EuroScore I (%), mean ±SD
17.8 ± 12.6
18.9 ± 12.5
EuroScore II (%), mean ±SD
5.5 ± 4.8
6.0 ± 5.6
Frailty; n/total (%)
91/214 (42.5)
82/219 (37.4)
Peripheral arterial disease; n/total (%)
29/218 (13.3)
26/220 (11.8)
Prior myocardial infarction; n/total (%)
Prior PCI; n/total (%) 
Prior CABG; n/total (%)
Atrial fibrillation; n/total (%)
Pacemaker/ICD; n/total (%)
24/218 (11.0)
92/218 (42.2)
22/218 (10.1)
98/218 (45.0)
13/218 (6.0)
17/220 (7.7)
71/220 (32.3)
22/220 (10.0)
98/220 (44.6)
20/220 (9.1)
Prior stroke; n/total (%)
24/217 (11.1)
27/220 (12.3)
Renal insufficiency; n/total (%)
179/213 (84.0)
182/217 (83.9)
Pulmonary hypertension; n/total (%)
100/216 (46.3)
111/218 (50.9)
COPD; n/total (%)
27/216 (12.5)
32/220 (14.6)
Cardiovascular risk factors
Diabetes; n/total (%)
Arterial hypertension; n/total (%)
HLP; n/total (%)
Current smoking; n/total (%)
70/218 (32.1) 
199/218 (91.3)
92/216 (42.6)
9/218 (4.1)
77/219 (35.2) 
198/220 (90.0)
88/219 (40.2)
9/219 (4.1)

20. Treatment – Anesthesia Strategy
Characteristic
Local Anesthesia
(n=218)
General Anesthesia
(n=220) P
O2 saturation at start of anesthesia; %
92.7 ± 25.0
91.6 ± 27.3
0.08
Minimal O2 saturation during anesthesia; %
88.0 ± 27.4
93.3 ± 21.8
<0.001
O2 saturation at end of anesthesia; %
83.2 ± 36.7
81.9 ± 38.2
0.42
Conversion to general anesthesia
Agitation; ; n/total (%)
Emergency surgery; n/total (%)
Respiratory insufficiency; n/total (%)
Hemodynamic reasons; n/total (%)
13/218 (5.9)
3/13 (23.1)
5/13 (38.5)
2/13 (15.4)
Transesophageal echocardiography; n/total (%)
8/210 (3.8)
73/217 (33.6)
Anesthesia medication
Remifentanyl; n/total (%)
Propofol; n/total (%)
Dexmedetomidine; n/total (%)
Sufentanyl; n/total (%)
Fentanyl; n/total (%)
Piritramide; n/total (%)
Other non-benzodiazepine drugs; n/total (%)
18/218 (8.3)
56/218 (25.7)
111/218 (50.9)
63/218 (28.9)
13/218 (6.0)
7/218 (3.2)
213/220 (96.8)
198/220 (90.0)
3/220 (1.4)
7/220 (3.2)
9/220 (4.1)
6/220 (2.7)
0.39
0.79
Zahlen bei agitation und emergency.

21. Primary Endpoint – Anesthesia Strategy
All-cause mortality, stroke, myocardial infarction,
infection requiring antibiotic treatment, acute kidney injury at 30 days
Rate difference -1.52
90%CI – 5.42
Pequivalence=0.02
Psuperiority=0.74
27.0%
25.5% %

22. Endpoints – Anesthesia Strategy
Individual components primary endpoint %
■ Local anesthesia
■ General anesthesia
Pequivalence=0.005
Psuperiority>0.99
21.0%
21.0%
Pequivalence<0.001
Psuperiority>0.99
Pequivalence<0.001
Psuperiority=0.77
Pequivalence=0.002
Psuperiority>0.99
Pequivalence<0.001
Psuperiority>0.99
8.9%
9.2%
2.8%
2.3%
2.4%
2.8%
0.5%
0.5%
Myocardial infarction
Infection requiring antibiotics
Acute kidney
injury

23. Secondary Endpoints – Anesthesia Strategy
Local Anesthesia
(n=218)
General Anesthesia
(n=220)
Rate difference
Pequivalence
Psuperiority
Cardiovascular mortality, n (%)
2/214 (0.9)
3/220 (1.4)
0.43 (-3.16 ─ 4.02)
<0.001
>0.99
Moderate/severe valve
4/209 (1.9)
3/212 (1.4)
-0.5 (-4.20 ─ 3.20)
0.72
Delirium, n (%)
28/211 (13.3)
32/215 (14.9)
1.61 (-4.13 ─ 7.36)
0.007
0.68
Device time, min
61 ± 27
65 ± 45
0.76
Total procedural time, min
116 ± 50
119 ± 49
0.43
Need for catecholamines, n (%)
137/218 (62.8)
214/220 (97.3)
34.43 (27.84 ─41.02)
1.00
Hospital stay, days
9 ± 7
0.74
ICU stay, hours
51 ± 84
47 ± 65
0.59
regurgitation, n (%)

24. Subgroup Analysis – Anesthesia Strategy
Primary Endpoint Event
Rate difference
P Value for
Local anesthesia
General anesthesia 3
(90% CI)
Interaction
No. of patients with event/total no. (%)
Sex
Female
30/109 (27.5)
32/113 (28.3)
0.8 (-9.1 ─ 10.7)
0.56
Male
28/106 (26.4)
-4.0 (-13.7 ─ 5.8)
Age
<80 years
19/71 (26.8)
13/72 (18.1)
-8.7 (-20.3 ─ 2.9)
0.21
≥80 years
39/144 (27.1)
43/148 (29.1)
2.0 (-6.7 ─ 10.6)
Coronary artery disease
Yes
36/124 (29.0)
33/118 (28.0)
-1.1 (-10.6 ─ 8.5)
0.89 No
20/80 (25.0)
22/96 (22.9)
-2.1 (-12.8 ─ 8.7)
Frailty
Mild
53/201 (26.4)
49/208 (23.6)
-2.8 (-9.9 ─ 4.2)
0.20
Moderate
3/10 (30.0)
6/11 (54.6)
24.6 (-10.9 ─ 60.0)
Chronic renal failure
54/176 (30.7)
50/182 (27.5)
-3.2 (-11.1 ─ 4.7)
0.41
4/34 (11.8)
6/35 (17.1)
5.4 (-9.2 ─ 20.0)
Left ventricular ejection fraction
<35 %
5/15 (33.3)
3/16 (18.8)
-14.6 (-40.6 ─ 11.5)
0.37
≥35 %
48/186 (25.8)
48/185 (26.0)
0.1 (-7.4 ─ 7.6)
Body mass index
<25 kg/m²
22/78 (28.2)
20/68 (29.4)
1.2 (-11.2 ─ 13.6)
25-30 kg/m²
22/87 (25.3)
22/100 (22.0)
-3.3 (-13.6 ─ 7.0)
≥30 kg/m²
14/50 (28.0)
14/51 (27.5)
-0.6 (-15.2 ─ 14.1)
STS score
<10%
44/159 (27.7)
37/150 (24.7)
-3.0 (-11.3 ─ 5.3)
0.97
≥10%
13/42 (31.0)
16/57 (28.1)
-2.9 (-18.3 ─ 12.5)
Logistic EuroScore
<20%
37/147 (25.1)
32/138 (23.2)
-2.0 (-10.4 ─ 6.4)
0.91
≥20%
21/68 (30.9)
24/81 (29.6)
-1.3 (-13.7 ─ 11.2)
Aortic stenosis
Normal-flow, high-gradient
30/85 (31.6)
27/103 (26.2)
-5.4 (-16.0 ─ 5.2)
0.71
Low-flow, low-gradient
15/49 (30.6)
15/51 (29.4)
-1.2 (-16.3 ─ 13.9)
Paradoxical low-flow, low-gradient
7/38 (18.4)
8/35 (22.9)
4.4 (-11.3 ─ 20.1)
ScO2 prior to intervention
<50%
49/167 (29.3)
41/159 (25.8)
-3.6 (-11.7 ─ 4.6)
0.87
≥50%
3/10 (30)
4/17 (23.5)
-6.5 (-36.0 ─23.0)
Type of valve
Sapien 3
28/110 (25.5)
25/108 (23.2)
-2.3 (-11.9 ─ 7.3)
0.85
Corevalve Evolut R
30/105 (28.6)
31/112 (27.7)
-0.9 (-11.0 ─ 9.2)
Equivalence margin
General anesthesia better
-20
-15
-10 -5 5 10 15 20
Local anesthesia better

25. Summary and Conclusions I
In patients with symptomatic aortic stenosis undergoing transfemoral TAVR the self-expanding Corevalve Evolut R valve is equivalent to the balloon-expandable Edwards Sapien 3 with respect to the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days.
The rate of relevant valve regurgitation was low whereas permanent pacemaker rates are still relatively high.
There may be a higher stroke rate with the balloon-expandable valve.

26. Summary and Conclusions II
Local anesthesia with conscious sedation is equivalent to general anesthesia with respect to the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury.
General anesthesia is associated with a higher rate of catecholamine use but does not affect procedure times, valve-related outcome, or clinical outcome.

27. Acknowledgement and Thank You
SOLVE-TAVI Patients and Investigators
Steering Committee
Holger Thiele, MD (Chair)
Steffen Desch, MD
Suzanne de Waha-Thiele, MD
Thomas Kurz, MD
Holger Nef, MD
Rainer Hambrecht, MD
Norbert Frey, MD
Alexander Lauten, MD
Hüseyin Ince, MD
Michael Borger, MD
David Holzhey, MD
Matthias Heringlake, MD
Jörg Ender, MD
DSMB
Gerhard Schuler, MD
Steffen Schneider, PhD
Bernd Böttiger, MD
Funding
German Heart Research Foundation
Echo Core lab
Heart Center Leipzig::
Georg Stachel, MD
Suzanne de Waha-Thiele, MD
CRO
Leipzig Heart Institute:
Yvonne Rückert
Anne-Kathrin Funkat, PhD
Ina Wagner
IMBS Lübeck
Inke König, PhD
Reinhard Vonthein, PhD
Jördis Stolpmann
ZKS Lübeck:
Arne Schreiber, PhD
Alicia Illen