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