1. Patients Characteristics
Outcomes of aortic valve replacement with bioprosthetic or mechanical valves in end-stage renal disease patients Taro Nakatsu, Kyoto University Graduate School of Medicine, Japan.
Objectives
The durability of bioprosthetic valves adapted to end-stage renal disease (ESRD) patients and the impact of bleeding events associated with life-long warfarinization in ESRD patients given mechanical valves remain unknown. 　
This study aimed to analyze the long-term outcomes after aortic valve replacement (AVR) for ESRD patients, based on comparing Bioprosthetic valves and Mechanical valves.
Methods
● Study design 　 Multicenter (18 centers) retrospective cohort study.
● Subjective　 N=366(ESRD patients underwent AVR between 2008 and 2015), Group B (Bioprosthetic valves 260) vs Group M (Mechanical valves 106)
● Follow up 2.4±2.0 years (Max 8.3 years), 99% completeness
Results
Patients Characteristics
Group M
Group B
p=0.92
5-year survival
43.0% vs 50.0%
Overall Survival
Time from AVR　(years)
Survival
No. at risk
Group M　
Group B
p<0.01
5-year valve-related survival
87.2% vs 74.3%
Freedom from Valve-Related Deaths
Group M
Freedom from valve related deaths
No. at risk
Time from AVR　(years)　　　
p=0.80
5-year freedom from bleeding events
73.9% vs 74.1%
Freedom from Bleeding Events
Freedom from bleeding events
Time from AVR　(years)
Group M
Group B
No. at risk
Thank you for the great opportunity to present our recent work in this conference.
I’d like to show you outcomes comparing bioprosthetic valves and mechanical valves after aortic valve replacement for end-stage renal diseases patients.
This study involved 366 ESRD patients after Aortic valve replacement between 2008 and 2015 from 18 centers in Japan.
Group B consists of 260 patients with bioprosthetic valves, and Group M has 106 patients with mechanical valves.
Patients’ follow up were completed in 99% of patients.
Telling about patients background, Group B was older, shorter history of dialysis, and more diabetes patients than Group M. Then other factors were not so different.
No differences were found in concomitant operations between the two groups.
Approximately 10% of the patients in both groups were lost in-hospital.
These are the overall survival curves showing no differences between the two groups. Approximately only 50% of patients were alive at 5 years after AVR.
Focus on the valve related deaths, Group B had significant better outcomes than Group M.
Valve related deaths involves deaths from bleedings, embolisms, prosthetic valve endocarditis, or sudden deaths.
Group M had more sudden deaths, especially in these components.
These are freedom from bleeding events curves. No differences were found between the two groups. Importantly, 26% of patients in both groups had bleeding events in 5 years after AVR.
No differences were described between the two groups in thromboembolic events, or reoperations. These events were revealed not so common.
This study revealed AVR with bioprosthetic valves contribute better outcomes in valve related survivals.
Among these patients, bleeding events were common, however thromboembolic events were not so common.
We recognized that no benefits receiving the mechanical valves were identified in ESRD patients whose prognosis were so poor,only 50% of patients were alive at 5 years after surgery.
This is our conclusion.
On the view points of valve related survivals, high incidences of bleeding events and no benefits with mechanical valves, Patients with ESRD undergoing AVR might benefit most from choosing bioprosthetic valves.
Group B (N=260)
Group M (N=106) p　
Age
73.7±6.9
64.0±10.0
<0.01
Men
170
65.4% 69
65.1%
1.00
Dialysis history (years)
9.6±7.7
12.0±8.0
Diabetes mellitus
104
40.0% 30
28.3%
0.04
Hypertension
215
82.7% 76
71.7%
0.02
Dyslipidemia
29.2% 31
Infective endocarditis 15
5.8% 6
5.7%
0.81
PAD 79
32.2% 33
32.4%
0.74
Shock 13
5.0% 1
0.9%
0.15
NYHA class
2.1±0.9
1.9±0.9
0.29
Preoperative EF (%)
56.6±13.5
55.3±15.7
0.01
AR grade
1.5±1.1
1.6±1.2
0.06 AS
231 91
85.8%
0.54
AVA( cm2)
0.75±0.25
0.75±0.23
0.72
MR grade
1.6±1.1
TR grade
1.0±0.9
1.1±1.0
0.07
Operative Variables
Valve-Related deaths
Group B 13
Group M 17
Bleeding events 6 5
Thromboembolic events 1
Prosthetic valve endocarditis 3
Sudden deaths 4 8
Freedom from Thromboembolic events
p=0.82
5-year freedom from thromboembolic events
91.5% vs 96.4%
Time from AVR　(years)
Freedom from thromboembolic events
Group M
Group B
No. at risk
Freedom from Reoperation
Group M
Group B
p=0.81
5-year freedom from reoperation :
91.5% vs 94.9%
No. at risk
Time from AVR　(years)
Freedom from reoperation
Group B (N=260)
Group M (N=106) P
Emergency 9
3.5% 5
4.7%
0.57
Operation time
361±143
395±136
0.75
CPB time
163±80
198±73
0.88
Aortic cross-clamp time
109±56
130±49
0.76
CABG 93
35.8% 33
31.1%
0.47
CABG graft number
1.9±1.0
1.7±1.0
0.77
Aortic valve size
21±1.8
20.5±2.1
＜0.01
Mitral valve surgery 55
21.2% 31
29.2%
0.11
Tricuspid valve repair 24
9.3% 14
13.2%
0.26
Maze procedure 17
6.8% 7
6.6%
0.15
Early Outcomes
Group B (N=260)
Group M (N=106) p　
In-hospital death 32
12.3% 10
9.4%
0.48
Reoperation for bleeding 13
5.1% 6
5.8%
0.96
Stroke 7
6.8%
0.83
Sepsis 27
10.7% 12
11.7%
Atrial fibrilation 94
37.3% 26
25.2%
0.09
Warfarin at discharge
182
70.0% 92
86.8%
＜0.01
Discussion
AVRs with bioprosthetic valves for ESRD patients contribute better to outcomes in terms of valve related survivals.
Bleeding events were common, though thromboembolic events were not particulary common in ESRD patients after AVR.
No benefits of employing mechanical valves were identified in ESRD patients with a very poor prognosis. (only 50% were alive at 5 years)
Conclusion
Patients with ESRD undergoing AVR might benefit from the use of bioprosthetic valves.