- Email: [email protected]
Czech TAVI registry – Hospital outcome
cor et vasa 59 (2017) e51–e56
Available online at www.sciencedirect.com
ScienceDirect journal homepage: http://www.elsevier.com/locate/crvasa
Original research article – Special issue: Structural heart disease – Aortic and mitral valves
Czech TAVI registry – Hospital outcome Petr Kala a,*, Milan Blaha b, Martin Mates c, Michael Želízko d, Marian Branny e, Viktor Kočka f, Martin Třetina g, JIří Jarkovský b, Petr Němec g, Josef Šťásek h, Pavel Červinka i a
Department of Internal Medicine and Cardiology, Medical Faculty of Masaryk University and University Hospital Brno, Jihlavska 20, Brno, Czechia b Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czechia c Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic d Department of Cardiology, of Cardiovascular and Experimental Medicine, Prague, Czechia e Cardiocenter Hospital Podlesi, a.s., Trinec, Czech Republic f 3rd Department of Internal Medicine - Cardiology, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czechia g Cardiovascular and Transplant Surgery Centre, Brno, Czechia h 1st Department of Cardioangiology, Faculty of Medicine in Hradec Kralove, Charles University in Prague and University Hospital Hradec Kralove, Hradec Kralove, Czechia i Department of Cardiology, Krajska zdravotni, a.s., Masaryk Hospital in Ústí nad Labem, o.z. and UJEP in Ústí nad Labem, Usti n. Labem, Czechia
article info
abstract
Article history:
The first TAVI in the Czech Republic was performed in 2008 and since then, more than 90% of
Received 9 February 2017
TAVI procedures have been involved in the online all comers Czech TAVI Registry. 1532 TAVI
Accepted 10 February 2017
procedures from 2008 till June 2016 in a high risk population with symptomatic severe aortic
Available online 24 February 2017
stenosis (logistic EuroSCORE 18.2, median age 80 years) were relatively safe (in-hospital mortality 3.9%, severe paravalvular aortic regurgitation after TAVI 1.0%) and highly effective
Keywords:
(index of aortic valve area before versus after TAVI was 0.4 cm2/m2 versus 1.0 cm2/m2,
TAVI
respectively). Majority of patients (83.7%) underwent TAVI because of their high risk for
Registry
surgery assessed by the Heart team discussion and 71.9% of them were discharged home.
Czech
© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
Aortic valve implantation High risk
Introduction The first transcatheter aortic valve implantation (TAVI) in the Czech Republic was performed in 2008, i.e. six years after
the first TAVI provided by A. Cribier and his team [1]. To assess the in-hospital and outcome data after TAVI, the Czech Association of Interventional Cardiology (former Working Group of Interventional Cardiology) of the Czech Society of Cardiology in collaboration with the European
* Corresponding author at: Department of Internal Medicine and Cardiology, Medical Faculty of Masaryk University and University Hospital Brno, Jihlavska 20, Brno, Czechia. E-mail address: [email protected] (P. Kala). http://dx.doi.org/10.1016/j.crvasa.2017.02.002 0010-8650/© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
e52
cor et vasa 59 (2017) e51–e56
0
2
518
486
466
321 368
288
249
149 170
108
81
52
200
13 39
400
220
600
420
780
732
669
800
567 625
1000
850 903
1079
1200
1000
1400
1197
Date of operation Fig. 1 – Czech TAVI Registry – enrollment in time.
N = 1532
Dyspnea NYHA (%):
Angina CCS (%): 20
0
40
60
I - No limitation of physical activity = normal statys
46.1
No angina I - No limitation of physical activity
19.0
II - Slight limitation of ordinary activity
IV - Symptoms at rest or minimal activity
1.1
IV - Symptoms at rest or minimal activity
Unknown
0.3
Unknown
60
80
15.3
III - Marked limitation of ordinary physical activity
13.1
40
3.2
II - Slight limitation of ordinary activity
20.4
III - Marked limitation of ordinary physical activity
20
0
80
69.1 12.3 0.1
Presyncope/syncope (%): 2.0
18.7
Critical pre-operative status was found in 12 patients (0.8%). Yes No Unknown
79.4
Fig. 2 – Symptoms before TAVI. CCS – Canadian classification score; NYHA – New York heart association.
1532
1457
Complete records (included in the analysis); N=1532
1246 1368
1600
20 08 -1 20 2 09 20 -3 09 2 0 -6 0 20 9-9 09 20 12 10 20 -3 10 20 -6 10 2 0 -9 10 -1 20 2 11 20 -3 11 20 - 6 1 20 1-9 11 -1 20 2 12 20 - 3 12 2 0 -6 1 20 2-9 12 -1 20 2 13 2 0 -3 13 20 -6 1 20 3-9 13 20 12 14 2 0 -3 14 20 -6 14 20 -9 14 -1 20 2 15 20 -3 15 2 0 -6 15 2 0 -9 15 -1 20 2 16 20 -3 16 -6
Cumulative number of patients
1800
e53
cor et vasa 59 (2017) e51–e56
N = 1532
Primary reason for TAVI by age:
2.0
14.3 N = 48 N = 92 N = 194 N = 337 N = 533 N = 294 N = 31
100% 2.1%
1.0%
1.8%
2.3%
3.1%
87.1%
84.3%
83.5%
84.0%
90.3%
11.9%
13.9%
14.3%
12.9%
9.7%
70-74
75-79
80-84
85-89
>= 90
90% 80% 70% 64.6%
Patients (%)
83.7
Formally turned down for surgery Assessed as high risk for surgery Patient refused surgery
60%
82.6%
50% 40% 30% 20%
33.3%
10%
17.4%
0% < 65
65-69
Age Fig. 3 – Primary reason for TAVI.
Time of procedure (min): 50
Patients (%)
40 30
Mean
Median
112
111
Site of implantation (%):
5th-95th percentile 40-197
0.3
Min-Max 17-465
Not available for 0.9%.
23.1
N = 1532
Cath Lab
20.1
20
9.9
12.3
Operation room
43.3 9.5
6.9
10
6.1
3.8
8.5
Hybrid room Unknown
<
75 75 -8 9 90 -1 04 10 511 9 12 013 4 13 514 9 15 016 4 16 517 9 >= 18 0
0
55.9 0.5
Length of procedure (min)
Anaesthesia (%):
Periprocedural imaging (%): 20
0
60
30.5
None
80
0
100
None 55.2
TOE
20
40
60
80
100
1.0 58.1
General
12.5
TTE Other
40
1.4
Unknown 0.3
Local
40.5
Unknown 0.3
Fig. 4 – Implantation procedure I. TOE - transoesophageal echocardiography, TTE - transthoracic echocardiography.
e54
cor et vasa 59 (2017) e51–e56
Contrast amount (ml): Patients (%)
60
Mean
Median
192
180
Min-Max
0.3
10-700
Not available for 0.6%.
40
29.7
29.0 21.8
N = 1532
Type of contrast (%):
5th-95th percentile 90-350
Non ionic
21.1
20
9.5
6.6
5.9
Ionic 3.3
2.8
Isoosmolar
3.9
66.1
Unknown
<
10 10 0 014 15 9 019 20 9 024 25 9 029 30 9 034 35 9 039 9 >= 40 0
0
Contrast amout (ml)
Diameter of largest balloon (mm):
Patients (%)
60
Mean
Median
22
22
5th-95th percentile 18-25
16-40
15.7
0.1 0.3
Not available for 6.3%.
36.2
40
Aortic Balloon Valvuloplasty (%):
Min-Max
Completed
24.9
Not done
16.4
20
13.4
Failed
7.2
Unknown
1.4
0.5
0.1 0 < 20
20
21
22
23
24
25
83.8
> 25
Diameter (mm)
Fig. 5 – Implantation procedure II. Observational Registries' Program (EORP) of the European Society of Cardiology founded a national online all comers Czech TAVI Registry in 2009. All Czech TAVI centres, except one, have been participating in the Registry representing more than 90% of all TAVI procedures in the Czech Republic. All data are anonymized and collected at the Institute of Biostatistics and Analyses of Masaryk University in Brno, Czech Republic. Based on the Czech law, there has been no need for the patients' informed consent. Description of the Czech TAVI program [2] development from 2008 till June 2016 and the in-hospital outcome after these exciting and lifesaving procedures for patients with symptomatic severe aortic stenoses is the aim of this analysis. Data from the
Czech TAVI Registry was included in several EORP TAVI Registry publications [3–5].
Results Total of 1532 TAVI procedures was enrolled (Fig. 1). Patients' characteristics is as follows: median age 80 years [67–89], females (53%), hypertension (88.1%), smoking (3.7%), diabetes (43.9%), ischemic heart disease (47.8%), history of acute myocardial infarction (22.9%), history of stroke and/or transient ischemic attack (17.3%), pulmonary disease (25.3%), previous cardiac surgery (27.7%) and percutaneous
N = 1532
Sheath size (French) (%):
Delivery approach (%): 0
20
40
60
80 70.8
Femoral – percutaneous 13.8
Transapical
6.5
100
0
20
< 18 18-19
2.7
Subclavian
22-23
2.0
Transthoracic
3.8
24-25
Axillary 0.1
≥ 26
80
74.2
20-21
Transaortic 0.5
60
9.9
4.0
Femoral – surgical
40
7.6 3.1
Unknown 0.4
Unknown 0.5
Fig. 6 – Implantation procedure III.
100
e55
cor et vasa 59 (2017) e51–e56
N = 1532
Aortic regurgitation (by echo) (%): 20
0
40
60
80
Complications: 100
C o mpl i c a t ion
26.0
None
50.1
Mild
5.8
Moderate
Severe 0.7
17.4
Unknown
Aortic regurgitation (by angio) (%): 0
20
40
60
80
100
N (%)
Permanent pacemaker requirement
52 (3.4%)
Major vascular injury
48 (3.1%)
Cardiogenic shock
34 (2.2%)
Tamponade
16 (1.0%)
Myocardial Infarction (clinically clear)
14 (0.9%)
Conversion to valve surgery
14 (0.9%)
Bailout PCI
10 (0.7%)
CVA (cerebrovascular attack)
6 (0.4%)
Major apical cannulation complications
3 (0.2%)
33.0
None
48.8
1
14.9
2 3+4
1.4
Unknown
2.0
Fig. 7 – Immediate procedural outcome and complications.
coronary intervention (31.9%). The presence of symptoms and primary reasons for TAVI are shown in Figs. 2 and 3. The median logistic EuroSCORE of TAVI patients was 18.2 [5.1–48.5%] representing the predictive 30 day risk of death if the patient would undergo cardiac surgery. Median left ventricle ejection fraction (LVEF) was 60% and 18.4% of patients had LVEF 40% or less. Tricuspid aortic valve was found in majority of cases (89.6%), bicuspid aortic valve in 4.9% and in 5.5% there is a lack of data. Implantation
procedures are described in Figs. 4–6. Median and index aortic valve areas before versus after TAVI were 0.7 cm2 [0.1–1.1] and 0.4 cm2/m2 versus 1.9 cm2 [0–3.1] and 1.0 cm2/m2 [0–1.7], respectively. Immediate procedural outcome and complications are shown in Figs. 7 and 8, 5.3% of patients suffered severe mitral regurgitation after TAVI, severe paravalvular leak was detected in 1.0% of patients. In-hospital mortality was 3.9% and the reasons for death are described in Fig. 9. Majority of patients (71.9%) was discharged home.
N = 1473* *59 patients deceased before discharge
Post implant aortic leakage Central (%):
Post implant aortic leakage Peri-prothesis (%):
0
0
20
40
60
80
100 89.3
None
8.9
Grade 1
20
Grade 2 Grade 3+4
1.0
1.4
Unknown
1.4
40
100
7.9 1.1
No 51.5
Yes
22.1
Grade 2
Unknown
80
13.8
19.5
None Grade 1
Grade 3+4
60
100
Pericardial effusion (%):
Mitral regurgitation (%): 20
80
52.5
Grade 1
Grade 3+4 0.1
0
60
31.4
None
Grade 2 0.4
Unknown
40
Unknown
5.3 1.6 91.0
Fig. 8 – In-hospital aortic leakage and mitral regurgitation after TAVI.
e56
cor et vasa 59 (2017) e51–e56
N = 1532
Classification of death:
In-hospital mortality: 3.9
Yes No
96.1
Cause Classification of death Cardio-vascular causes Non cardio-vascular causes Unknown Cardio-vascular causes Heart failure Myocardial infarction Cardiac pathway disturbances Cardiac arrhythmia Acute arterial ischemia Other Non cardio-vascular causes Multi-organ failure Infection Renal failure Other
N = 59 42 14 3 16 4 4 2 2 14 7 5 1 1
Fig. 9 – In-hospital mortality after TAVI.
Conclusion The TAVI program in the Czech Republic has shown its safety and high effectivity in the treatment of patients with symptomatic severe aortic stenoses. Despite a high-risk patients' population with a median logistic EuroSCORE 18.2, there was a relatively low in-hospital mortality 3.9%. The online all comers Czech TAVI Registry provides a nationwide reliable data that serve the TAVI operators to improve the quality of care.
Conflict of interest The authors declare no conflict of interest related to this publication.
Ethical statement Authors state that the research was conducted according to ethical standards.
Informed consent I declare, that informed consent requirements do not apply to this manuscript.
Acknowledgement All operators and centres participating in the Czech TAVI Registry are acknowledged for their hard and enthusiastic help and work.
Funding body Supported by MH CZ - DRO (FNBr, 65269705).
references
[1] A. Cribier, H. Eltchaninoff, A. Bash, et al., Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description, Circulation 106 (2002) 3006–3008. [2] M. Bláha, P. Kala, D. Klimeš, et al., The user's reporting from the national registry of catheter aortic valve implantations (Czech TAVI Registry): the possibilities of the analytical reports based on the database system TrialDB2, Vnitrní Lékarství 60 (2014) 837–845. [3] C. Di Mario, H. Eltchaninoff, N. Moat, et al., The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients, EuroIntervention: Journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 8 (2013) 1362–1371. [4] G. Dall'Ara, H. Eltchaninoff, N. Moat, et al., Local and general anaesthesia do not influence outcome of transfemoral aortic valve implantation, International Journal of Cardiology 177 (2014) 448–454. [5] M. Gilard, M. Schlüter, T.M. Snow, et al., The 2011–2012 pilot European Society of Cardiology Sentinel Registry of Transcatheter Aortic Valve Implantation: 12-month clinical outcomes, EuroIntervention: Journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 12 (2016) 79–87.
Available online at www.sciencedirect.com
ScienceDirect journal homepage: http://www.elsevier.com/locate/crvasa
Original research article – Special issue: Structural heart disease – Aortic and mitral valves
Czech TAVI registry – Hospital outcome Petr Kala a,*, Milan Blaha b, Martin Mates c, Michael Želízko d, Marian Branny e, Viktor Kočka f, Martin Třetina g, JIří Jarkovský b, Petr Němec g, Josef Šťásek h, Pavel Červinka i a
Department of Internal Medicine and Cardiology, Medical Faculty of Masaryk University and University Hospital Brno, Jihlavska 20, Brno, Czechia b Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czechia c Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic d Department of Cardiology, of Cardiovascular and Experimental Medicine, Prague, Czechia e Cardiocenter Hospital Podlesi, a.s., Trinec, Czech Republic f 3rd Department of Internal Medicine - Cardiology, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czechia g Cardiovascular and Transplant Surgery Centre, Brno, Czechia h 1st Department of Cardioangiology, Faculty of Medicine in Hradec Kralove, Charles University in Prague and University Hospital Hradec Kralove, Hradec Kralove, Czechia i Department of Cardiology, Krajska zdravotni, a.s., Masaryk Hospital in Ústí nad Labem, o.z. and UJEP in Ústí nad Labem, Usti n. Labem, Czechia
article info
abstract
Article history:
The first TAVI in the Czech Republic was performed in 2008 and since then, more than 90% of
Received 9 February 2017
TAVI procedures have been involved in the online all comers Czech TAVI Registry. 1532 TAVI
Accepted 10 February 2017
procedures from 2008 till June 2016 in a high risk population with symptomatic severe aortic
Available online 24 February 2017
stenosis (logistic EuroSCORE 18.2, median age 80 years) were relatively safe (in-hospital mortality 3.9%, severe paravalvular aortic regurgitation after TAVI 1.0%) and highly effective
Keywords:
(index of aortic valve area before versus after TAVI was 0.4 cm2/m2 versus 1.0 cm2/m2,
TAVI
respectively). Majority of patients (83.7%) underwent TAVI because of their high risk for
Registry
surgery assessed by the Heart team discussion and 71.9% of them were discharged home.
Czech
© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
Aortic valve implantation High risk
Introduction The first transcatheter aortic valve implantation (TAVI) in the Czech Republic was performed in 2008, i.e. six years after
the first TAVI provided by A. Cribier and his team [1]. To assess the in-hospital and outcome data after TAVI, the Czech Association of Interventional Cardiology (former Working Group of Interventional Cardiology) of the Czech Society of Cardiology in collaboration with the European
* Corresponding author at: Department of Internal Medicine and Cardiology, Medical Faculty of Masaryk University and University Hospital Brno, Jihlavska 20, Brno, Czechia. E-mail address: [email protected] (P. Kala). http://dx.doi.org/10.1016/j.crvasa.2017.02.002 0010-8650/© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
e52
cor et vasa 59 (2017) e51–e56
0
2
518
486
466
321 368
288
249
149 170
108
81
52
200
13 39
400
220
600
420
780
732
669
800
567 625
1000
850 903
1079
1200
1000
1400
1197
Date of operation Fig. 1 – Czech TAVI Registry – enrollment in time.
N = 1532
Dyspnea NYHA (%):
Angina CCS (%): 20
0
40
60
I - No limitation of physical activity = normal statys
46.1
No angina I - No limitation of physical activity
19.0
II - Slight limitation of ordinary activity
IV - Symptoms at rest or minimal activity
1.1
IV - Symptoms at rest or minimal activity
Unknown
0.3
Unknown
60
80
15.3
III - Marked limitation of ordinary physical activity
13.1
40
3.2
II - Slight limitation of ordinary activity
20.4
III - Marked limitation of ordinary physical activity
20
0
80
69.1 12.3 0.1
Presyncope/syncope (%): 2.0
18.7
Critical pre-operative status was found in 12 patients (0.8%). Yes No Unknown
79.4
Fig. 2 – Symptoms before TAVI. CCS – Canadian classification score; NYHA – New York heart association.
1532
1457
Complete records (included in the analysis); N=1532
1246 1368
1600
20 08 -1 20 2 09 20 -3 09 2 0 -6 0 20 9-9 09 20 12 10 20 -3 10 20 -6 10 2 0 -9 10 -1 20 2 11 20 -3 11 20 - 6 1 20 1-9 11 -1 20 2 12 20 - 3 12 2 0 -6 1 20 2-9 12 -1 20 2 13 2 0 -3 13 20 -6 1 20 3-9 13 20 12 14 2 0 -3 14 20 -6 14 20 -9 14 -1 20 2 15 20 -3 15 2 0 -6 15 2 0 -9 15 -1 20 2 16 20 -3 16 -6
Cumulative number of patients
1800
e53
cor et vasa 59 (2017) e51–e56
N = 1532
Primary reason for TAVI by age:
2.0
14.3 N = 48 N = 92 N = 194 N = 337 N = 533 N = 294 N = 31
100% 2.1%
1.0%
1.8%
2.3%
3.1%
87.1%
84.3%
83.5%
84.0%
90.3%
11.9%
13.9%
14.3%
12.9%
9.7%
70-74
75-79
80-84
85-89
>= 90
90% 80% 70% 64.6%
Patients (%)
83.7
Formally turned down for surgery Assessed as high risk for surgery Patient refused surgery
60%
82.6%
50% 40% 30% 20%
33.3%
10%
17.4%
0% < 65
65-69
Age Fig. 3 – Primary reason for TAVI.
Time of procedure (min): 50
Patients (%)
40 30
Mean
Median
112
111
Site of implantation (%):
5th-95th percentile 40-197
0.3
Min-Max 17-465
Not available for 0.9%.
23.1
N = 1532
Cath Lab
20.1
20
9.9
12.3
Operation room
43.3 9.5
6.9
10
6.1
3.8
8.5
Hybrid room Unknown
<
75 75 -8 9 90 -1 04 10 511 9 12 013 4 13 514 9 15 016 4 16 517 9 >= 18 0
0
55.9 0.5
Length of procedure (min)
Anaesthesia (%):
Periprocedural imaging (%): 20
0
60
30.5
None
80
0
100
None 55.2
TOE
20
40
60
80
100
1.0 58.1
General
12.5
TTE Other
40
1.4
Unknown 0.3
Local
40.5
Unknown 0.3
Fig. 4 – Implantation procedure I. TOE - transoesophageal echocardiography, TTE - transthoracic echocardiography.
e54
cor et vasa 59 (2017) e51–e56
Contrast amount (ml): Patients (%)
60
Mean
Median
192
180
Min-Max
0.3
10-700
Not available for 0.6%.
40
29.7
29.0 21.8
N = 1532
Type of contrast (%):
5th-95th percentile 90-350
Non ionic
21.1
20
9.5
6.6
5.9
Ionic 3.3
2.8
Isoosmolar
3.9
66.1
Unknown
<
10 10 0 014 15 9 019 20 9 024 25 9 029 30 9 034 35 9 039 9 >= 40 0
0
Contrast amout (ml)
Diameter of largest balloon (mm):
Patients (%)
60
Mean
Median
22
22
5th-95th percentile 18-25
16-40
15.7
0.1 0.3
Not available for 6.3%.
36.2
40
Aortic Balloon Valvuloplasty (%):
Min-Max
Completed
24.9
Not done
16.4
20
13.4
Failed
7.2
Unknown
1.4
0.5
0.1 0 < 20
20
21
22
23
24
25
83.8
> 25
Diameter (mm)
Fig. 5 – Implantation procedure II. Observational Registries' Program (EORP) of the European Society of Cardiology founded a national online all comers Czech TAVI Registry in 2009. All Czech TAVI centres, except one, have been participating in the Registry representing more than 90% of all TAVI procedures in the Czech Republic. All data are anonymized and collected at the Institute of Biostatistics and Analyses of Masaryk University in Brno, Czech Republic. Based on the Czech law, there has been no need for the patients' informed consent. Description of the Czech TAVI program [2] development from 2008 till June 2016 and the in-hospital outcome after these exciting and lifesaving procedures for patients with symptomatic severe aortic stenoses is the aim of this analysis. Data from the
Czech TAVI Registry was included in several EORP TAVI Registry publications [3–5].
Results Total of 1532 TAVI procedures was enrolled (Fig. 1). Patients' characteristics is as follows: median age 80 years [67–89], females (53%), hypertension (88.1%), smoking (3.7%), diabetes (43.9%), ischemic heart disease (47.8%), history of acute myocardial infarction (22.9%), history of stroke and/or transient ischemic attack (17.3%), pulmonary disease (25.3%), previous cardiac surgery (27.7%) and percutaneous
N = 1532
Sheath size (French) (%):
Delivery approach (%): 0
20
40
60
80 70.8
Femoral – percutaneous 13.8
Transapical
6.5
100
0
20
< 18 18-19
2.7
Subclavian
22-23
2.0
Transthoracic
3.8
24-25
Axillary 0.1
≥ 26
80
74.2
20-21
Transaortic 0.5
60
9.9
4.0
Femoral – surgical
40
7.6 3.1
Unknown 0.4
Unknown 0.5
Fig. 6 – Implantation procedure III.
100
e55
cor et vasa 59 (2017) e51–e56
N = 1532
Aortic regurgitation (by echo) (%): 20
0
40
60
80
Complications: 100
C o mpl i c a t ion
26.0
None
50.1
Mild
5.8
Moderate
Severe 0.7
17.4
Unknown
Aortic regurgitation (by angio) (%): 0
20
40
60
80
100
N (%)
Permanent pacemaker requirement
52 (3.4%)
Major vascular injury
48 (3.1%)
Cardiogenic shock
34 (2.2%)
Tamponade
16 (1.0%)
Myocardial Infarction (clinically clear)
14 (0.9%)
Conversion to valve surgery
14 (0.9%)
Bailout PCI
10 (0.7%)
CVA (cerebrovascular attack)
6 (0.4%)
Major apical cannulation complications
3 (0.2%)
33.0
None
48.8
1
14.9
2 3+4
1.4
Unknown
2.0
Fig. 7 – Immediate procedural outcome and complications.
coronary intervention (31.9%). The presence of symptoms and primary reasons for TAVI are shown in Figs. 2 and 3. The median logistic EuroSCORE of TAVI patients was 18.2 [5.1–48.5%] representing the predictive 30 day risk of death if the patient would undergo cardiac surgery. Median left ventricle ejection fraction (LVEF) was 60% and 18.4% of patients had LVEF 40% or less. Tricuspid aortic valve was found in majority of cases (89.6%), bicuspid aortic valve in 4.9% and in 5.5% there is a lack of data. Implantation
procedures are described in Figs. 4–6. Median and index aortic valve areas before versus after TAVI were 0.7 cm2 [0.1–1.1] and 0.4 cm2/m2 versus 1.9 cm2 [0–3.1] and 1.0 cm2/m2 [0–1.7], respectively. Immediate procedural outcome and complications are shown in Figs. 7 and 8, 5.3% of patients suffered severe mitral regurgitation after TAVI, severe paravalvular leak was detected in 1.0% of patients. In-hospital mortality was 3.9% and the reasons for death are described in Fig. 9. Majority of patients (71.9%) was discharged home.
N = 1473* *59 patients deceased before discharge
Post implant aortic leakage Central (%):
Post implant aortic leakage Peri-prothesis (%):
0
0
20
40
60
80
100 89.3
None
8.9
Grade 1
20
Grade 2 Grade 3+4
1.0
1.4
Unknown
1.4
40
100
7.9 1.1
No 51.5
Yes
22.1
Grade 2
Unknown
80
13.8
19.5
None Grade 1
Grade 3+4
60
100
Pericardial effusion (%):
Mitral regurgitation (%): 20
80
52.5
Grade 1
Grade 3+4 0.1
0
60
31.4
None
Grade 2 0.4
Unknown
40
Unknown
5.3 1.6 91.0
Fig. 8 – In-hospital aortic leakage and mitral regurgitation after TAVI.
e56
cor et vasa 59 (2017) e51–e56
N = 1532
Classification of death:
In-hospital mortality: 3.9
Yes No
96.1
Cause Classification of death Cardio-vascular causes Non cardio-vascular causes Unknown Cardio-vascular causes Heart failure Myocardial infarction Cardiac pathway disturbances Cardiac arrhythmia Acute arterial ischemia Other Non cardio-vascular causes Multi-organ failure Infection Renal failure Other
N = 59 42 14 3 16 4 4 2 2 14 7 5 1 1
Fig. 9 – In-hospital mortality after TAVI.
Conclusion The TAVI program in the Czech Republic has shown its safety and high effectivity in the treatment of patients with symptomatic severe aortic stenoses. Despite a high-risk patients' population with a median logistic EuroSCORE 18.2, there was a relatively low in-hospital mortality 3.9%. The online all comers Czech TAVI Registry provides a nationwide reliable data that serve the TAVI operators to improve the quality of care.
Conflict of interest The authors declare no conflict of interest related to this publication.
Ethical statement Authors state that the research was conducted according to ethical standards.
Informed consent I declare, that informed consent requirements do not apply to this manuscript.
Acknowledgement All operators and centres participating in the Czech TAVI Registry are acknowledged for their hard and enthusiastic help and work.
Funding body Supported by MH CZ - DRO (FNBr, 65269705).
references
[1] A. Cribier, H. Eltchaninoff, A. Bash, et al., Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description, Circulation 106 (2002) 3006–3008. [2] M. Bláha, P. Kala, D. Klimeš, et al., The user's reporting from the national registry of catheter aortic valve implantations (Czech TAVI Registry): the possibilities of the analytical reports based on the database system TrialDB2, Vnitrní Lékarství 60 (2014) 837–845. [3] C. Di Mario, H. Eltchaninoff, N. Moat, et al., The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients, EuroIntervention: Journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 8 (2013) 1362–1371. [4] G. Dall'Ara, H. Eltchaninoff, N. Moat, et al., Local and general anaesthesia do not influence outcome of transfemoral aortic valve implantation, International Journal of Cardiology 177 (2014) 448–454. [5] M. Gilard, M. Schlüter, T.M. Snow, et al., The 2011–2012 pilot European Society of Cardiology Sentinel Registry of Transcatheter Aortic Valve Implantation: 12-month clinical outcomes, EuroIntervention: Journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 12 (2016) 79–87.