A total of 281 PTA procedures were recorded,
207 performed using standard balloons and 74 using cutting angioplasty balloons
The demographic characteristics of the population are presented in Table 1.
There were no significant differences in characteristics between the two treatment groups.
The characteristics of the fistulas are presented in Table 2.
Cutting balloon showed a better PP,
SP and APP compared to standard balloons (p=0,046; 0,002 and 0,001 respectively).
Kaplan-Meier graphs of PP,
SP and APP are provided in Figure 1.
Technical success was reached in 240 over 264 procedures,
171 over 194 treated with standard balloon,
69 over 70 treated with cutting balloon (p=0.009 Pearson Chi-Square ).
Median recoil for standard balloon venoplasty was 40% (±15.9 SD),
whereas cutting balloon suffered minor recoil 25.6% ( ±17.1 SD; p<0.001).
Considering the single treatment,
the patency rates at the intervention,
6,
13,
26 and 52 weeks were respectively 93%,
79%,
77%,
70%,
69% for the standard balloon group and 100%,
89%,
88%,
70%,
58% for the cutting balloon group (table 3).
In keeping with literature,
cutting balloon showed a better secondary patency at 6 months compared to standard balloon angioplasty (p=0.029 - Pearson Chi-Square)(14).
According to the US follow-up,
cutting balloon showed a significant improvement in the patency of the fistula only after the intervention (p=0.005),
with no significant difference at the following scans at 6,
13,
26 and 52 weeks (0.067,
0.09,
0.992 and 0.315 respectively).
Linear regression analysis showed a strong correlation between the outcome and the stenosis recoil,
wherein a better outcome was found in procedures with less stenosis recoil.
A direct correlation was found between the kind of balloon and the stenosis recoil (p<0.001),
showing that the use of cutting balloon has a reduced stenosis recoil percentage.
Table 1
Characteristics
|
Standard Balloon (n)
|
Cutting balloon (n)
|
p value
|
Native
|
207
|
74
|
|
Primary patency,
days (median±SD)
|
119,0±127,2
|
180,5±122,2
|
0,046
|
Age at intervention,
years (median±SD)
|
70,3±13,1
|
70,9±14,4
|
0,458
|
% of residual stenosis (median±SD)
|
33,3±19,1
|
17,4±17,5
|
<0,001
|
% of recoil (median±SD)
|
40,0±16,0
|
28,6±17,2
|
<0,001
|
Table 2
Characteristic
|
Sandard balloon
|
Cuting balloon
|
p value
|
Native fistulas
|
88
|
50
|
|
Secondary patency mean days ±SD
|
268±297
|
433±375
|
0,001
|
Type of fistulas
|
|
|
|
bb
|
75
|
37
|
|
bc
|
95
|
27
|
|
rc
|
37
|
10
|
|
Left side
|
141
|
54
|
|
Right side
|
66
|
20
|
|
Male
|
124
|
41
|
|
Table 3
Patency of the AVF (n)
|
Standard balloon
|
Cutting balloon
|
After the procedure
|
188/202
|
72/72
|
6 weeks
|
153/194
|
63/71
|
13 weeks
|
110/142
|
51/58
|
26 weeks
|
71/101
|
33/47
|
52 weeks
|
40/58
|
15/26
|