German Aortic Valve RegistrYC. W. Hamm, F.W. Mohr, H. Möllmann, D. Holzhey,
German Aortic Valve RegistrY
A. Beckmann, H.-R. Figulla, J. Cremer, K.-H. Kuck, R. Lange,
R. Zahn, S. Sack, G. Schuler, T. Walther, F. Beyersdorf,
M. Böhm, G. Heusch, A.-K. Funkat, T. Meinertz, T. Neumann,
K. Papoutsis, S. Schneider, A. Welz for the GARY-Executive Board
Christian W. HammChristian W. HammKerckhoff Heart and Thorax Center Bad Nauheim and
Medical Clinic I, University of Giessen, Germany
DisclosuresKERCKHOFF HERZ- UND THORAXZENTRUMuniversitätsklinikum giessen
Speaker’s name: Christian W. Hamm
Affili ti /Fi i l R l ti hi C
I have the following potential conflicts of interest to report:
Affiliation/Financial Relationship Company
1. Honoraria for lectures Medtronic, Edwards
2. Honoraria for advisory board activities Medtronic
3. Participation in clinical trials Medtronic, Edwards, Symetis, Jena Valve
4. Financial shares and options: no
RationaleRationale
N ti id l t f ti t ith ti• Nationwide complete survey of patients with aortic valve disease undergoing invasive procedures:• surgical (AVR), replacement/reconstruction• catheter-based (TAVI) transfemoral • catheter-based (TAVI) transapical• valvuloplasty.
• To evaluate catheter-based procedures in i t i l ti l l tcomparison to surgical aortic valve replacement.
• Develop criteria for an adequate patient selection of p q pbest treatment modality.
Designg
• Prospective, controlled, multicenter registry.
All ti t d i i i th f• All patients undergoing an invasive therapy for acquired aortic valve disease consecutively included; 88 active centers/ 7 inactive
The only exclusion criterion: no informed consent• The only exclusion criterion: no informed consent.• Follow-up: in-hospital, 1, 3, 5 years
Data Management and SponsorshipData Management and Sponsorship
D t t• Data management: BQS – Institut für Qualität & Patientensicherheit.
• Sponsorship: p pInvestigator initiated study with unrestricted grant from:Edwards, Medtronic, Jena Valve, Symetis, St Jude, Sorin, , , y , ,
•Support:ppGerman Cardiac Society (DGK)German Society for Thoracic and Cardiovascular SurgeryGerman Society for Thoracic and Cardiovascular SurgeryGerman Heart Foundation
Patients with Written Consent2010 ntil 02/20132010 until 02/2013
Patients with Written Consent
40000
45000
35564 36961 38616
30000
35000
40000
20000
25000
Num
ber
16904
10000
15000
19870
5000
End Dec 2010 End Dec 2011 End Dec 2012 Jan 2013 Feb 2013
6Month
BQS-Institut - Database: 28.02.2013
Patients(360 Ross and David excluded )
Inclusion from 01/01/2011 to 31/12/2011
53 cardiac surgery units 69 cardiology units
Inclusion from 01/01/2011 to 31/12/2011
53 cardiac surgery units 69 cardiology units
13.860 patientsp
6.523 surgical AVR 3.462 surgical 2.694 transvascular 1.181 transapical
without CABG AVR with CABG TAVI TAVI
Baseline Characteristics
AVR AVR Transvasc TransapicalwithoutCABG
withCABG
Transvasc. TAVI
TransapicalTAVI
CAD 18.6 97.1 53.6 56.1
LV-EF <30% 3.1 5.1 9.3 7.5<30%
A. fib. 15.9 15.0 28.9 29.5
Art. HT 79.5 86.1 86.4 90.0
Pulm. HT 10.8 11.1 39.8 23.4
COPD 10.0 12.2 19.8 20.5
IDDM 8.2 12.9 13.3 17.5
all p<0.001
Baseline CharacteristicsBaseline Characteristics
100% n=6517 n=3458 n=2689 n=1177
86,3% 84,0%80% Patients > 75 years
40%
60%
33,3%
44,9%
20%
40%
0%
20%
0%without CABG with CABG transvascular transapical
Surgical AVR TAVI
TAVI Valve Typeyp
transapicaltransvascular transapicaltransvascular
Others
Others
n = 1.181 O e s
n = 2.695
Results – Outcome
9 0% n=6517 n=3458 n=2689 n=1177
7 7%8,0%
9,0%Mortality (in-hospital)
7,7%
6,0%
7,0%
4,5%5,1%
4,0%
5,0%
2 1%2,0%
3,0%
2,1%
0,0%
1,0%
without CABG with CABG transvascular transapical
Surgical AVR TAVI
Results – ProcedureResults ProcedureNew Pacemaker
25%n=6517 n=3458 n=2689 n=1177
23,7%20%
9 9%
15%
4,6% 3 9%
9,9%
5%
10%
, % 3,9%
0%
5%
without CABG with CABG transvascular transapical
Surgical AVR TAVI
1 year follow-up: 13.860 patients
• 2011: 13.860 patients included
• Follow-up: 13.595 patients 98,1 %Follow up: 13.595 patients 98,1 %
• direct follow-up: 89,5 %direct follow up: 89,5 %• indirect follow-up: 8,6 %
(National population register)
• Unknown: 1,9%13
Kaplan-Meier mortality-rate by procedure
Death AVR AVR+CABG
TV TAVI
TA TAVI
Hospital 2.1% 4.5% 5.1% 7.7%
30 Days 2 4% 4 5% 5 6% 9 0%
log-rank testp-values (GH: <0.001)
AVR+CABG
TV TAVI
TA TAVI
AVR < 0.001 < 0.001 < 0.00130 Days 2.4% 4.5% 5.6% 9.0%
180 Days 5.2% 9.2% 14.7% 20.4%
365 Days 6.7% 11.0% 20.7% 28.0%
AVR+CABG < 0.001 < 0.001
TV TAVI < 0.001
14
Kaplan-Meier mortality-rate by procedureAge: < 75 years; >= 75 years
Age: < 75 years Age: >= 75 years
Age: < 75 years; > 75 years
Age: < 75 years Age: >= 75 years
No. at Risk
Day 0
Day 30
Day 180 Day 365
AVR 2168 2089 1971 1925
AVR
No. atRisk
Day 0
Day 30
Day 180 Day 365
AVR 4349 4251 4112 4050
AVR
Death AVR AVR+CABG
TV TAVI TA TAVI
30 Days 2.0% 3.9% 4.6% 11.2%
Death AVR AVR+CABG
TV TAVI
TA TAVI
30 Days 3.4% 5.3% 5.8% 8.6%
15
+CABG 1553 1467 1351 1316
TV TAVI 2321 2176 1918 1781
TA TAVI 989 896 768 687
+CABG 1905 1823 1725 1697
TV TAVI 368 352 314 289
TA TAVI 188 165 141 133
180 Days 4.0% 7.7% 14.2% 22.7%
365 Days 5.1% 9.2% 21.6% 27.1%
180 Days 7.7% 11.1% 14.8% 19.9%
365 Days 9.7% 13.3% 20.5% 28.0%
Kaplan-Meier mortality by procedureEuroSCOREEuroSCORE
16
Kaplan-Meier mortality by procedureEuroSCOREEuroSCORE
log-rank test AVR+CABG
TV TAVI
TA TAVI
log-rank test AVR+ TV TA p-values (GH: <0.001)
ABG TAVI TAVI
AVR < 0.001 < 0.001 < 0.001
AVR+CABG < 0.001 < 0.001
TV TAVI 0.376
p-values (GH: =0.001) CABG TAVI TAVI
AVR 0.041 0.200 < 0.001
AVR+CABG 0.282 0.135
TV TAVI 0.003
log-rank test AVR+ TV TAlog-rank testp-values (GH: <0.001)
AVR+CABG
TV TAVI
TA TAVI
AVR 0.005 < 0.001 < 0.001
AVR+CABG 0.162 < 0.001
TV TAVI 0.011
log rank testp-values (GH: <0.001)
AVRCABG
TV TAVI
TA TAVI
AVR 0.164 0.103 < 0.001
AVR+CABG 0.836 0.012
TV TAVI < 0.001
17
German Aortic Valve Disease ScoreAKL Score“„AKL-Score
:
Age (5 risk classes) LV-EF (2 risk classes)
Gender (female) Redo-procedureGender (female) Redo-procedure
Body mass index (2 risk classes) Infection (endocarditis)
Heart failure (NYHA) Peripheral arterial disease
Myocardial infarction within last Chronic obstructive lung diseaseythree weeks
g(2 risk classes)
Critical preoperative status Renal failure
Pulmonary hypertension Emergency
Rh th ( i h th )Rhythm (no sinus rhythm)
http://www.bqs-outcome.de/2008/ergebnisse/leistungsbereiche/hch
AKL Score Distribution
TAVISurgical AVR
WithoutCABG
transvasculartransvascular
WithCABG
transapical
Kaplan-Meier mortality by procedureGerman AV-Score (AKL-Score)German AV Score (AKL Score)
20
Kaplan-Meier mortality by procedureGerman AV-Score (AKL-Score)German AV Score (AKL Score)
log-rank test AVR+ TV TA log-rank test AVR+ TV TA p-values (GH: <0.001) CABG TAVI TAVI
AVR < 0.001 < 0.001 < 0.001
AVR+CABG < 0.001 < 0.001
TV TAVI 0.203
p-values (GH: <0.001) CABG TAVI TAVI
AVR 0.156 0.185 < 0.001
AVR+CABG 0.692 0.024
TV TAVI 0.001
log-rank test AVR+ TV TAlog-rank testp-values (GH: <0.001)
AVR+CABG
TV TAVI
TA TAVI
AVR 0.001 0.007 < 0.001
AVR+CABG 0.358 0.056
TV TAVI 0.004
log rank testp-values (GH: =0.003)
AVRCABG
TV TAVI
TA TAVI
AVR 0.984 0.790 0.026
AVR+CABG 0.770 0.047
TV TAVI < 0.001
21
1-year follow-up: interviewed patients
StrokeStroke
1-year follow-up: interviewed patientsyStroke
5%Minor Stroke
n = 5421 n = 2718 n = 1782 n = 715
2,8%2,1%
4%
Minor StrokeMajor Stroke
1,3%
1,8%3%
1,7%
2,3%2,0% 1,8%
1%
2%
0%
1%
22without CABG with CABG transvascular transapical
TAVISurgical AVR
1-year follow-up: interviewed patients
NYHA l ifi ti
1 year follow up: interviewed patients
NYHA-classification
72 to 85 % in NYHA I or II
3 4% 1 0%
Surgical AVR TAVI
1-year follow-up: interviewed patientsHeart failure - NYHA I - NYHA IV
72 to 85 % in NYHA I or II
48 6%
13,7%
0,9% 0,4% NYHA I
NYHA II
NYHA III
3,4% 1,0%
38,0%23,2%
48,6%
36,4%NYHA IV
N/A 34,4%
0,3%
14 9%
1,1% 2,1%1,4%
without CABG transvascular
36,6%47,2%
14,9%
34,4%22,8%
39,3%
with CABG transapical
23
1-year follow-up: interviewed patients
Current state of health vs state of health before procedure
1 f ll i t i d ti t
Current state of health vs. state of health before procedure
60 % b tt th b fSurgical AVR TAVI
1-year follow up: interviewed patientsCurrent state of health in comparison to state of health before procedure
~ 60 % better than before
0,4%
12,1%better
same
0,4%
14,8%
26,6% 60,9%worse
N/A61,8%23,0%
13 4%
0,4% 0,3%without CABG transvascular
24,2%61,9%
13,4%
57,8%23,8%
18,2%
with CABG transapical
24
1-year follow-up: interviewed patientsPatient satisfaction 1 year after intervention
1-year follow-up: interviewed patients
a e sa s ac o yea a e e e o
93 96 % satisfied with procedure
3 3% 0 8% 2,9% 1,3%
Surgical AVR TAVI
1 year follow up: interviewed patientsPatient satisfaction 1 year after intervention
93 – 96 % satisfied with procedure
8,0%
3,3% 0,8% very good
good
satisfactory
2,9% ,
50,2%
9,0%
55,2%32,6% unsatisfactory
N/A36,5%
0,6%
9,1%
3,9% 6,3%0,8%
without CABG transvascular
35,9% 50,5%
, %
43,1%
35,9%
13,8%
,
with CABG transapical
25
SummarySummary
• First large scale registry on comparing surgical & catheter based procedures with 1 year follow-up.
• Continuous increase in mortality after hospital discharge, predominately in high risk groups.
• In low and intermediate risk groups, surgical AVR (no CABG) group has better outcome than TAVI.
• TV-TAVI and conventional surgery have equal outcome in patients EURO Score > 20%, AKL Score > 6%.
• Good one year clinical outcome (QoL) and high patient satisfaction across all groups.
26
ConclusionConclusion
• Score > 20% or AKL Score > 6% and age > 75 yrs good cut-offs
• Mortality equal (TA-TAVI) or better (TV-TAVI) than PARTNER A.
Limitations: • Voluntary participation of centers• The AV risk score is derived predominately from patientsThe AV risk score is derived predominately from patients
with surgery, a separate risk score for TAVI is under development
27
Grazie!Grazie!Danke!
28
Kaplan-Meier mortalityTAVI: residual aortic insufficiencyTAVI: residual aortic insufficiency
Death none / trace
mild / severe
30 Days 6.1% 8.8%
180 Days 15.5% 23.6%
365 Days 22 3% 26 9%365 Days 22.3% 26.9%
log-rank testp-value
0.063
29
p value
Kaplan-Meier mortalityTAVI: residual aortic insufficiencyTAVI: residual aortic insufficiency
Death none trace mild severe
30 Days 6 0% 6 2% 6 7% 37 5%30 Days 6.0% 6.2% 6.7% 37.5%
180 Days 14.7% 16.3% 21.7% 50.0%
365 Days 21.2% 23.3% 25.3% 50.0%
30
1-year follow-up: interviewed patients
Myocardial InfarctionMyocardial Infarction
1-year follow-up: interviewed patientsyMyocardial Infarction
5%n = 5421 n = 2718 n = 1782 n = 715
4%
3%
1%
2%
0,4% 0,6% 0,7%0,7%0%
1%
31without CABG with CABG transvascular transapical
TAVISurgical AVR
1-year follow-up: interviewed patients
StrokeStroke
1-year follow-up: interviewed patientsyStroke
5%n = 5421 n = 2718 n = 1782 n = 715
4,8%4,5%
4%
3,0%
3,6%3%
1%
2%
0%
1%
32without CABG with CABG transvascular transapical
TAVISurgical AVR
1-year follow-up: interviewed patients
CABG after discharge from hospitalCABG after discharge from hospital
1-year follow-up: interviewed patientsyCABG after discharge from hospital
5%n = 5421 n = 2718 n = 1782 n = 715
4%
3%
1%
2%
0,1%0,3%
0,4% 0,4%0%
1%
33without CABG with CABG transvascular transapical
TAVISurgical AVR
1-year follow-up: interviewed patients
PCI after discharge from hospitalPCI after discharge from hospital
1-year follow-up: interviewed patientsyPCI after discharge from hospital
5% n = 5421 n = 2718 n = 1782 n = 715
4%
3%
1,9%1,5%
1%
2%
0,5%
1,1%
0%
1%
34without CABG with CABG transvascular transapical
TAVISurgical AVR
1-year follow-up: interviewed patientsPatients with hospital stays after procedurep y pbecause of: complications of procedure; cardiovascular problems
1 f ll i t i d ti t1-year follow-up: interviewed patientsPatients with hospital stays after the procedure
50%
34 4%
40,2%
45,5%
40%
50%AVR without CABGAVR with CABGTAVI - transvascularTAVI transapical
29,6%
34,4%
30%
TAVI - transapical
11,3%12,3%15,4%
8 3%
16,9%20%
6,5% 6,5%4,4%
8,3%
0%
10%
35
%
Hospital stays Hospital stays for complications of the procedure
Hospital stays for cardiovascular problems