Maintaining 3 Month Blood Flow Strategy...0 20 40 60 80 100 0 200 400 600 800 1000 After 2012 APRIL...

JET 2017February 18th, 2017 13：20～14：50

Garden City Shinagawa The 4th hall (Anemone)

Maintaining 3 Month Blood Flow Strategy

Ikeda Vascular Access Dialysis and Internal Medicine Clinic

Kiyoshi Ikeda M.D.

Today Topics

#1 VAIVT Results

#2 Expansion Technique Examination : Animal model

#3 DW Consideration

#4 Others

Fig.1 : AVF Patency rate 2003-2010

(%)

0

10

20

30

40

50

60

70

80

90

100

0 200 400 600 800 1000 1200

Patency ratio

Patency period

(%)

(days)

Ave. atm Ave. balloon size

A 6.84±2.11 4.62±0.68

B 7.65±3.06 5.18±0.72

C 9.09±9.92 5.31±5.37

〔mean±SD〕

―A group：NSE (n: 63)―B group：Angio Sculpt (n: 45)―C group：DORADO (n:202)

A vs B (n.s.)A vs C (n.s.)B vs C (p<0.01)

Fig.2 : Comparison of Patency period

0

20

40

60

80

100

0 200 400 600 800 1000

After 2012 APRIL (140 cases)

Before 2012 APRIL (240 cases)

(Days)

(%)

※

※： LOGRANK P<0.001

(Kaplan-Meier method)

No.9Ikeda Vascular Access/Dialysis/Internal Medicine Clinic no.9

Fig.3 : Primary Patency of VAIVT in AVF Cases

0

20

40

60

80

100

0 200 400 600 800 1000

After 2012 APRIL (140 cases)

Before 2012 APRIL (240 cases)

※： LOGRANK P<0.05

※

(Days)

(Kaplan-Meier method)

(%)

No.10Ikeda Vascular Access/Dialysis/Internal Medicine Clinic no.10

Fig.4 : Secondary Patency of VAIVT in AVF Cases

Period : 1/1/2016 - 12/31/2016

VA trouble539

PTA : 380 Surgery : 159

AVF : 294 AVG : 86

PTA 20 (52.6％)

Thrombus + PTA18 (47.4％)

Obstruction : 38

PTA 6 (37.5％)

Thrombus + PTA10 (62.5％)

Obstruction : 16

Cuff type catheterization5 cases (13.2％)

Thrombus removal + reconstruction7 cases (18.4％)

Reconstruction 10 cases (26.3％)Thrombus removal 7 cases (18.4％)

(the following : hybrid surgery)Thrombus removal ⇒ PTA ⇒ reconstruction

1 case (2.6％)Thrombus removal ⇒ reconstruction ⇒ PTA

3 cases (7.9％)

Thrombus removal + PTA 5 cases (13.2％)

Obstruction : 38

70.5% 29.5%

77.4% 22.6%23.9%

18.6%12.9%

Fig.5 : Breakdown of access trouble patients treated

Fig.6 :Area of PTA patients introduced from other medical institutions

Period : 2016.1 - 12

Our clinic patients : 33 people , average : 1.9 times

Our clinic63cases

17%

Other hospital317cases

83%

Fukuoka-city

246cases

78%

Other than Fukuoka-city

49cases15%

Other Prefecture

22cases7%

Table1 : The Ratio of the number of VAIVT required within 3 months

PeriodThe number of

cases

The number of VAIVT within 3 months

(number of medical service fee)

Ratio(％)

AVF

2010/9/1 - 2012/3/31 199 56 28.1

2012/4/1 - 2013/3/31 179 34 19.0

2013/4/1 - 2013/12/31 146 39 26.7

2014/1/1 - 2014/12/31 286 131 45.8

2015/1/1 - 2015/12/31 271 66（36） 24.3（13.3）

2016/1/1 - 2016/12/31 294 60（40） 20.4（13.6）

AVG

2010/9/1 - 2012/3/31 137 44 32.1

2012/4/1 - 2013/3/31 98 16 16.3

2013/4/1 - 2013/12/31 64 20 31.2

2014/1/1 - 2014/12/31 96 48 50.0

2015/1/1 - 2015/12/31 92 12（7） 13.0(7.6)

2016/1/1 - 2016/12/31 86 21（15） 24.4(17.4)

Period : 2010.9-2016.12

Fig.7 : The number of Surgeries and PTA

73

267

315 323

399376 380

27

91

96 98

117118 126

2

14

12 17

1218 33

0

100

200

300

400

500

600

2010/9/1-12/31 2011/1/1-12/31 2012/1/1-12/31 2013/1/1-12/31 2014/1/1-12/31 2015/1/1-12/31 2016/1/1-12/31

PTA (2,133) Surgery (673) Catheter (108)(cases)

Today Topics

#1 VAIVT Results

#2 Expansion Technique Examination : Animal model

#3 DW Consideration

#4 Others

【Subject & Methods】

Experimental model, Japanese white rabbit♂（3-4kg）（n=6）

Ikeda method (n=3), High pressure single extended (n=3)

－－－－－－－－－－－－－－－－－－－－－－－－－－－－1. Make an arteriovenous anastomosis using side-to-side technique between Right common carotid

artery and Right external jugular vein.

2. After 2 weeks, make a stenosis to the venous heart side using Sugita clip.

3. Using a diameter 3.5mm Sugita clip and then make a stenosis about 65%.

4. After 4 weeks, remove the Sugita clip.

5. High pressure single extended type (20atm 30seconds) using 10mm Conquest balloon. Extended by Ikeda method.

6. After 4 weeks in PTA, terminate for pathological examination

4 weeks

Side-to-side anastomosis to Right common carotid artery and Right external jugular vein

Make an AVF Make a Stenosis

Using 5mm Sugita clipMaking a stenosis about 65%

Remove a clip Terminate

2 weeks

PTA

Extend by 10mm balloon(20atm 30seconds)

4 weeks

Make an AVF

artery

anastomosis vein

Make an arteriovenous anastomosis using side-to-side techniquebetween Right common carotid artery and Right external jugular vein.

After 2 weeks make a AVF

Enlarged anastomosis : diameter 10mm

anastomosis

Make a stenosis using a Sugita clip

make a stenosis about 65%

After 2 weeks, make a stenosis to the venous heart side using Sugita clip.Using a diameter 3.5mm Sugita clip and then make a stenosis about 65%.

Remove Sugita clip after 4 weeks making a stenosis

Using a diameter 3.5mm Sugita clip and then make a stenosis about 65%.After 4 weeks, remove the Sugita clip.

Expand by 10mm balloon

Conquest balloon

High pressure single extended type (20atm 30seconds) using 10mm Conquest balloon. Extended by Ikeda method.

＜Ikeda method＞＜High pressure

single expansion＞

Fig.8

Make an AVF, put a Sugita clip on the heart V-side for 2 weeks

After 4 weeks, PTA

Terminate after 4 weeks

Fig.9 : Comparison of blood flow

AVF作成前 AVF作成後 2w後狭窄前2w+4w後クリッ

プ解除前2w+4w後拡張後

2ｗ+4ｗ+4ｗ屠

殺時

15-02 41 208 277 139 274 28015-13 32 105 358 510 335 4015-20 40 126 199 182 105 25515-01 37 128 256 256 22515-12 30 98 212 285 685 29015-19 46 115 252 462 314 500

0

100

200

300

400

500

600

700

800

Hig

hLo

w

Blockade perfectly

Before AVFAfter 2 weeks, before stenosisAfter AVF

After 2+4 weeks, before remove a

clip

After 2+4 weeks, before extended

After 2+4+4 weeks, slaughter

High pressure single expansion15-02_9EM×1.25

15-13_9EM×1.25

15-02_9EM×20

15-13_9EM×20

Intimal thickening

High pressure single expansion15-02_9HE×1.25

15-13_9HE×1.25

15-02_9HE×20

15-13_9HE×20

intimal thickening

intimal thickening

invasion of the smooth muscle

intimal thickening

Ikeda method15-01_7EM×1.25

15-12_10EM×1.25

15-01_7EM×20

15-12_10EM×20

Ikeda method15-01_7HE×1.25

15-12_10HE×1.25

15-01_7HE×20

15-12_10HE×20

【Results】

1) One case of occlusion was observed in the Single Expansion group.

2) Evidence of Intimal thickening and invasion of the smooth muscle was present in the Single Expansion group.

3) Ikeda Method group showed a clear difference of intimal thickening compared to Single Expansion group.

4) Even when pressure was increased from 20 to 30 standard atmospheres using the Ikeda Method, membrane damage was minimal.

【 Conclusions】1) In an animal experiment, frequent expansion using low pressure (Ikeda method) and single expansion using high pressure were performed.

2) Remarkable intimal thickening and thrombotic adhesion were observed after four weeks in high pressure single expansion case.

3) Using Ikeda Method, Neither intimal thickening nor invasion of the smooth muscle even with pressurization of 20 standard atmosphere were observed.

Future policy

Pathological results showed that using frequent gradual pressure increase (Ikeda Method) was more effective and less damaging than Single High Pressure Expansion Method. Increase in Patency Period was also a benefit of using Ikeda Method.

Today Topics

#1 VAIVT Results

#2 Expansion Technique Examination : Animal model

#3 DW Consideration

#4 Others

VAIVT：Docter decides devices and therapy’ method

VA management: Periodical check using ultrasound

Strategy to extend patency period

【Background 1】

※Management using ultrasound to evaluate VA condition does not contribute to extend primary patency period.

※ Determining Hemodialysis Patient’s DW in dialysis unit is very important.

【Background 2】

#1 CTR#2 Blood Pressure#3 Measurement of IVC after hemodialysis

#4 BCM examination

ＤＷ Determination Factors

ＢＣＭ is an analysis device using the principle of electric resistance.A faint electric current flows through the body, giving an up-to-date measurement of body water, body fat and muscle mass.

BCM（BodyCompositionMonitor）

BCM : made by Fresenius Medical Care AG & Co. KGaA, Germany

Electric flow varies depending on water amount. ・High fat content (low muscle mass) = high electric resistance・Low fat content (high muscle mass) = low electric resistance

Using BCM analysis we can determine ideal body weight.

<Input of Personal information>1) Height2) Weight3) Age4) Sex

BCM（BodyCompostionMonitor）

【Objects】

Number of Hemodialysis Patients: 110

Period : Jan.2014-Dec.2015

BCM Examination : PTA(-) 261 times vs PTA(+) 139 times

-3

-2

-1

0

1

2

3

Ａ値 Ｂ値

mean±SE

PTA(-)(n=261)+0.13Kg

PTA(+)(n=139)-0.96Kg

P=NS

Fig.10 : Comparison of BCM results （DW－Ideal BW）PTA(-) vs PTA(+)

2015；74.2%

2014；39.6%

p:ns

Patency ratio

【Results】

Fig.11 : Primary Patency Period

DAYS

Today Topics

#1 VAIVT Results

#2 Expansion Technique Examination : Animal model

#3 DW Consideration

#4 Othersa) Milking Methodb) Firapy

【Pressure ＶＡ Massage（PVM）】

～Points～

PVM is done by pushing blood to stenotic area using both hands.

①One hand stops shunt flow on the down flow side.

②The other hand presses vein from up flow side.

This method stretches stenotic area.

【Results 1】

1.46

0.63

1.16

1.89

0.570.94

0

1

2

3

4

5

6

7

狭窄径（mm） FV（mL/min） RI PI

1.57

0.420.57

2.04

0.33 0.41

0

1

2

3

4

5

6

狭窄径（mm） FV（mL/min） RI PI

490

610

420

480

（+29.5%）

（+24.5%）

（+9.5%）（+19.5%）

（+29.9%）

（+14.3%）

（+21.4%） （+28.1%）

Results after examination.

Case1 Case2

Diameter (mm) Diameter (mm)

Before PVMAfter PVM

Fig.12 : Ultrasound Examination Data

58.6

111

0

20

40

60

80

100

120

VAマッサージ開始前 VAマッサージ開始後

70

124

0

20

40

60

80

100

120

140

VAマッサージ開始前 VAマッサージ開始後

n=6 n=4

Case1 Case2

This method contributed to 3 month rule.

VA massage before the start VA massage after the start VA massage before the start VA massage after the start

【Results 2】Fig.13 : Patency period (days)

What FIRAPY can do for vascular access

Improve AVF Maturation for early use

Increase Blood Flow

Maintain VA Patency

The practice of Far-Infrared Therapy Unit

92% Hemodialysis centers use FIRAPY in Taiwan

>90%

HD centers

equipped with FIRAPY

in Taiwan

The HD situation in Taiwan

• Area: 36,000 square km

• Population: 23 million

• Dialysis Patients: 80,000

• HD centers: 600 1/287

1 -year Survival Curves for Unassisted

Patency of AVF between the two HD Groups

J Am Soc Nephrol. 2007; 18:985-992

Nephrol Dial Transplant 2013 May; 28(5): 1284-93

5-year Survival Curves for Unassisted Patency of AVF between the two HD Groups

Parameter Control GroupFIRAPY

Groupp

No. starting study 73 72 -

Patients with new AVF malfunction (%) 22 (30.1%) 9 (12.5%) <0.01

Patients with thrombosis of AVF 6 (8.2%) 2 (2.8%) 0.15

Patients with intervention of AVF 16 (21.9%) 7 (9.7%) 0.044

Total observations (patients-months) 802.4 812.6 -

New episodes of AVF malfunction during

study30 12 -

Episode of AVF malfunction/patient-months 1/26.7 1/67.7 0.03

Far-infrared Therapy reduce the malfunction of fistula after 1 year treatment

J Am Soc Nephrol. 2007; 18:985-992

#1 Existing devices limit potential for extending patency period.

#2 Existing devices have potential for extending patency period if expansion technique is used.

#3 The accuracy of DW management helps to avoid VA trouble.

#4 ① VA massage is possible on vein close to surface.② There are reports that use of ultraviolet rays on VA is

beneficial.

【 Conclusions】