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Quality of life in 3875 patients after Transcatheter Aortic Valve Implantation

1-year-data from the German Aortic Valve Registry

Deutsches Aortenklappenregister

German Aortic Valve RegistrY

EACTS 2014 Milan

R. Lange, A. Beckmann, T. Neumann, M. Krane, R. Zahn, J. Cremer, W.

Hamm, F.W. Mohr

on behalf of the GARY Registry

(2)

2

Deutsches Aortenklappenregister

German Aortic Valve RegistrY

Executive Board Steering Committee

joint project

German Society of Thoracic and Cardiovascular Surgery

German Society of Cardiology

supported by:

German Heart Foundation

Agreement of participation

data managment

Informed consent

hospitals

patients

(3)

EQ-5Dimension – 3 Level

Best

imaginable health status

= 100%

Worst

imaginable health status

= 0%

Visual analogue scale (VAS)

Quality of Life Measurement

EQ-5D – 3 Level and VAS

no complains mild complains severe complains

(4)

http://www.euroqol.org/fileadmin/user_upload/Documenten/PDF/Produc ts/Sample_UK__English__EQ-5D-3L.pdf

Best

imaginable health status

= 100%

Worst

imaginable health status

= 0%

4

X X

X

X

X

X

X

X

X

X X

X

Pre-OP 1-Year-FU

Quality of Life Measurement

EQ-5D – 3 Level and VAS/pre-OP and 1-year FU

(5)

Included patients

Patient distribution

N=14220

included patients 01/01/2011 – 31/12/2011

N=360 Ross OP/David OP

N=3875

TAVI (TV and TA)

N=6523 SAVR

N=3462 SAVR+CABG

N=2694

TAVI - TV

N=1181

TAVI - TA

53 cardiac surgery units 69 cardiology units

(6)

1 year follow-up: 3875 patients

6

Parameter TAVI-TV

(n=2694)

TAVI-TA (n=1181)

EQ-5D (pre OP) 2553 (94.8%) 1136 (96.2%)

EQ-5D (1-year FU) 1782 (66.1%) 715 (60.5%)

FU denied 98 (3.6%) 32 (2.7%)

Patient alive (national population register) 179 (6.6%) 74 (6.3%)

1-year mortality 565 (21%) 328 (27.8%)

lost to FU 70 (2.6%) 32 (2.7%)

(7)

Preoperative patient

characteristics

(8)

8

Procedural Patient

characteristics

(9)

Postoprative Patient

characteristics

(10)

VAS Score

Changes: pre-OP  1-year-FU

pre-OP 1-year FU

V A S score (%)

48 50 52 54 56 58 60

TAVI_TV TAVI_TA

p<0.001 p<0.001

(11)

EQ-5D – 3 Level

Changes: pre-OP  1-year-FU

no complains mild complains severe complains

Difference pre-OP/1-year FU (%)

TAVI-TV

7,6

-6,4

-1,2

-10 -8 -6 -4 -2 0 2 4 6 8

10

TAVI-TA

3,5

-3,8

0,3

-10 -8 -6 -4 -2 0 2 4 6 8 10

Mobility

(12)

12

EQ-5D – 3 Level

Changes: pre-OP  1-year-FU

no complains mild complains severe complains

Difference pre-OP/1-year FU (%)

TAVI-TV TAVI-TA

(13)

Results from

The German Heart Center

physical summary score

mental summary score

pre TAVI

3 months post TAVI 12 months post TAVI

Krane et al, 2010, AHJ

(14)

14

Summary

GARY provides a large study population with completed follow-up

improved VAS Scores in both groups with higher values in TAVI-TV

Treatment of aortic valve disease by TAVI leads to significant improvement of QoL shown by:

increased patient numbers in the EQ-5D dimensions mobility and usual activity within Level I

 The dimensions pain/discomfort and depression/anxiety showed significant increases for patient numbers in the Level III reflecting a worsening of QoL in these dimensions

The limited improvement of QoL after TAVI within mental score groups like pain/discomfort and depression/anxiety is a reported phenomenon in TAVI patients.

(15)

Thank you!

(16)

EACTS Advanced Course on the Mitral and Tricuspid Valves at the

German Heart Center Munich

German Heart Center Munich

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