safety and efficacy of distal superficial femoral artery ... · tatsuya nakama, y yamamoto, a...

Safety and Efficacy of

Distal Superficial Femoral Artery Puncture for

Femoropopliteal Occlusive Lesions

~Result form the Multicenter RIVERside registry~

○Tatsuya Nakama,

Y Yamamoto, A Matsui, T Doijiri, M Fujihara, N Hayakawa, T Michinao,

S Ozaki, Y Tsubakimoto, M Utsunomiya, D Kaomoi, Y Imoto, M Kimura,

H Anzai, Y Ohno, M Sugihara, N Fujimura, K Suzuki, N Kaneko, Y Iwata,

H Ando, K Urasawa, Y Yokoi and Y Shibata

On behalf of REVERside registry investigators

Speaker name: Tatsuya Nakama MD.

.................................................................................

I have the following potential conflicts of interest to report:

Consulting: Boston Scientific Japan, Century Medical Inc.

Employment in industry: None

Stockholder of a healthcare company: None

Owner of a healthcare company: None

Other(s): Honoraria recieved from

Abbot Vascular, Asahi Intecc., Boston Scientific, COOK, Cordis

Cardinal Health, Goodman, KANEKA, Lifeline, Medikit, Medtronic,

Orbus Neichi, Terumo,

Disclosure

• Distal SFA puncture (DSFAP: OMOTE-pan) has been widely

spread as an alternative retrograde access technique.

Backgrounds

A Schmidt et al. J Endovasc Ther. 2012; 19:23-29

• Retrograde approach is important technique in percutaneous

endovascular revascularization for FPA occlusion.

• Popliteal artery puncture (PAP: URA-pan) is already

established as a conventional retrograde approach.Kawarada O. et al. J Endovasc Ther. 2010; 17: 255-258

Femoropopliteal artery: FPA, Superficial femoral artery: SFA,

Complications of DSFAP

Fujihara M. et al. LINC2017

• Retrograde access site complications, such as hematoma,

re-bleeding, pseudoaneurysm and hemostatic difficulty were

sometimes observed during daily clinical practice.

Kenji O. et al. LINC2017

Pseudoaneurysm

Thrombin injection

required

Frequent re-bleeding

Covered stent deployment

Multicenter registry was planned

Retrospective analysis for the clinical value of retrograde

access technique in endovascular therapy for

femoropopliteal occlusions

To investigate the safety and efficacy of the DSFAP

technique in EVT for FP occlusions.

Purpose

Distal SFA puncture (OMOTE-pan)

○ Study type

・ Retrospective, multicenter study (18 site)

○ Study period

・ January 2012 to July 2016 ( 30 months )

○ Number of patients

・ 609 retrograde procedure for SFA occlusion

○ Study patients・ Symptomatic PAD patients who underwent EVT for SFA

occlusion using retrograde approach

Backgrounds

RIVERside registry

Iwaki Kyoritsu General Hp.

Miyazaki Medical

Association Hp.

Kasukabe Chuo General Hp.

Yamato

Seiwa Hp.

Kishiwada

Tokushukai Hp.

Kokuho Asahi Chuo Hp.

Tokeidai

Memorial Hp.

Itabashi Chuo Medical Center

Japanese Red Cross

Kyoto Daini Hp.

Tokyo Rosai Hp.

Nagoya

Kyoritsu Hp.

Fukuoka Wajiro Hp.

Japanese Red Cross

Kyoto Daiichi Hp.

Ota

Memorial Hp.

Chiba University Hp.

Fukuoka University Hp.

Tokyo Saiseikai Central Hp.

Retrospective analysis for the clinical value

of retrograde access technique in

endovascular therapy for femoropopliteal

occlusions

・ Trans-collateral approach (n=41)

・ Tibial or peroneal puncture (n=51)

・ Antero-lateral P3 puncture (n= 26)

Procedural success & complication rate

609

_

Popliteal puncture

(PAP cohort)

142 patients

Methods

Patients underwent percutaneous FPA-CTOs

recanalization with retrograde approach

Distal SFA puncture

(DSFAP cohort)

349 patients

Baseline characteristics

Overall(n= 491)

PAP cohort(n= 142)

DSFAP cohort(n= 349) P value

General Status

Age, years 73.2 ± 8.6 72.9 ± 8.0 73.3 ± 8.9 0.578

Male, n (%) 350 (71.3) 247 (70.8) 103 (72.5) 0.696

Ambulatory status on admission 0.797

Independent gait, n (%) 354 (72.1) 101 (71.1) 253 (72.5)

Walk with stick, n (%) 47 (9.6) 12 (8.5) 35 (10.0)

Non-ambulatory status, n (%) 90 (18.3) 29 (20.4) 61 (17.5)

Wheel chair use, n (%) 71 (14.5) 22 (15.5) 49 (69.0)

Bed-ridden, n (%) 19 (3.9) 7 (4.9) 12 (3.4)

Limbs status

Critical limbs ischemia, n (%) 159 (32.4) 53 (37.3) 106 (30.4) 0.136

With ischemic wounds, n (%) 114 (23.2) 34 (23.9) 80 (22.9) 0.808

ABI before intervention 0.52 ± 0.25 0.52 ± 0.29 0.52 ± 0.23 0.719

ABI after intervention 0.89 ± 0.20 0.89 ± 0.19 0.88 ± 0.21 0.622

Baseline characteristics

Overall(n= 491)

PAP cohort(n= 142)


Risk factors

Hypertension, n (%) 422 (85.9) 118 (83.1) 304 (87.1) 0.247

Dyslipidemia, n (%) 310 (63.1) 88 (62.0) 222 (63.6) 0.733

Diabetes mellitus, n (%) 273 (55.6) 87 (61.3) 186 (53.3) 0.107

Smoking history, n (%) 232 (47.3) 72 (50.7) 160 (45.8) 0.328

Regular hemodialysis, n (%) 99 (20.2) 31 (21.8) 68 (19.5) 0.557

History of ischemic heart disease, n (%) 208 (42.4) 76 (53.5) 132 (37.8) 0.001

History of cerebrovascular disease, n (%) 106 (21.6) 29 (20.4) 77 (22.1) 0.689

Medication

Aspirin, n (%) 407 (82.9) 122 (85.9) 285 (81.7) 0.396

Clopidogrel, n (%) 353 (71.9) 105 (73.9) 248 (71.1) 0.570

Cilostazol, n (%) 175 (35.6) 48 (33.8) 127 (36.4) 0.560

DAPT, n (%) 427 (87.0) 124 (87.3) 303 (86.8) 0.665

Anticoagulation therapy, n (%) 63 (12.8) 15 (23.8) 48 (13.8) 0.411

DAPT + anticoagulation therapy, n (%) 52 (10.6) 13 (9.2) 39 (11.2) 0.528

Angiogram characteristics

Overall(n= 491)

PAP cohort(n= 142)


Angiographic characteristics

TASC D, n (%) 397 (80.9) 109 (76.8) 288 (82.5) 0.141

De novo lesion, n (%) 462 (94.1) 134 (94.4) 328 (94.0) 0.870

Lesion length, mm 248 ± 82 235 ± 82 253 ± 81 0.024

Vessel calcification <0.0001

None, n (%) 101 (20.6) 27 (19.0) 74 (21.2)

Mild, n (%) 165 (33.6) 26 (18.3) 139 (39.8)

Moderate, n (%) 93 (18.9) 33 (23.2) 60 (17.2)

Severe, n (%) 132 (26.9) 56 (39.4) 76 (21.8)

Moderate to severe calcification, n (%) 225 (45.8) 89 (62.7) 136 (39.0) <0.0001

PACCS score <0.0001

0, n (%) 115 (23.4) 26 (18.3) 89 (25.5)

1, n (%) 109 (22.2) 17 (12.0) 92 (26.4)

2, n (%) 48 (9.8) 20 (14.1) 28 (8.0)

3, n (%) 74 (15.1) 25 (17.6) 49 (14.0)

4, n (%) 145 (29.5) 54 (38.0) 91 (26.1)

EVT procedures

Overall(n= 491)

PAP cohort(n= 142)


Antegrade approach site

Crossover, n (%) 302 (61.5) 71 (50.0) 231 (66.2) 0.004

Sheathless technique for retro site, n (%) 366 (74.5) 68 (47.9) 298 (85.4) <0.0001

Guidewire crossing technique <0.0001

Retrograde direct cross (%) 81 (16.5) 38 (26.8) 43 (12.3)

Kissing wire, n (%) 32 (6.5) 12 (8.5) 20 (5.7)

Wire rendezvous, n (%) 320 (65.2) 66 (46.5) 254 (72.8)

CART/ reverse CART, n (%) 51 (10.4) 23 (16.2) 28 (8.0)

Retrograde access site hemostasis

Tamponade with PTA balloon, n (%) 418 (85.1) 85 (59.9) 333 (95.4) <0.0001

Size of PTA balloon, mm 4.87 ± 0.66 4.69 ± 0.60 4.91 ± 0.67 0.004

Use of compression devices, n (%) 78 (15.9) 49 (34.5) 29 (8.0) <0.0001

Thrombin injection required, n (%) 37 (7.5) 6 (4.2) 31 (8.9) 0.076

Time to complete hemostasis, min 26.6 ± 57.7 71.9 ± 97.0 9.7 ± 6.7 <0.0001

Primary efficacy outcomes

0

10

20

30

40

50

60

70

80

90

100

All cohort POPA cohort DSFAP cohort

98.6% 97.9% 98.9%

P=0.612

All cohort PAP cohort DSFAP cohort

Retro puncture

success rate 99.0% 100.0% 98.6%

Procedural success rate (%)

(URA-pan) (OMOTE-Pan)(Overall)

Primary safety outcomes

5

6

7

8

9

10

11

12



9.8% 9.9% 9.7%

Incidence of overall complications (%)

P=0.637

Puncture related complications

0

1

2

3

4

5

6

7


Overall Antegrade Retrograde

4.0%

2.0%

5.7%

3.3%

1.4%

3.5%

2.4%

4.9%

6.0%

Puncture relataed complication rate


0

1

2

3

4

5

6

7



4.0%

2.0%

5.7%

3.3%

1.4%

3.5%

2.4%

4.9%

6.0%

P=0.637All puncture site


0

1

2

3

4

5

6

7



4.0%

2.0%

5.7%

3.3%

1.4%

3.5%

2.4%

4.9%

6.0%

P=0.324

Antegrade puncture site


0

1

2

3

4

5

6

7



4.0%

2.0%

5.7%

3.3%

1.4%

3.5%

2.4%

4.9%

6.0%

P=0.141

Retrograde puncture site

0

2

4

6

8

All cohort POPA cohort DSFAP cohort


6.2% 7.6% 5.6%

Secondary outcomes

Incidence of 30-days adverse event (%)

P=0.637

Summary of presentation

• Retrograde puncture success rate

• PAP: 100% vs. DSFAP: 99%

• Procedural success rate

• PAP: 98% vs. DSFAP: 99%

Summary of presentation

• Overall complication rate

• PAP: 9.9% vs. DSFAP: 9.7%

• Puncture related complication rate

PAP: 4.9% vs. DSFAP: 6.0%

• Retrograde site complication rate

• PAP: 1.5% vs. DSFAP: 4.0%Included 1% blood

transfusion

Conclusions

• Both retrograde access technique, PAP and DSFAP,

were feasible and safe technique in percutaneous

endovascular revascularization for complex FPA

occlusions.

• Safety and efficacy of DSFAP, which was called

“OMOTE-pan” in Japan, is not inferior compared to

conventional PAP, which called “URA-pan”.

Safety and Efficacy of

Distal Superficial Femoral Artery Puncture for

Femoropopliteal Occlusive Lesions

~Result form the Multicenter RIVERside registry~

○Tatsuya Nakama,

Y Yamamoto, A Matsui, T Doijiri, M Fujihara, N Hayakawa, T Michinao,

S Ozaki, Y Tsubakimoto, M Utsunomiya, D Kaomoi, Y Imoto, M Kimura,

H Anzai, Y Ohno, M Sugihara, N Fujimura, K Suzuki, N Kaneko, Y Iwata,

H Ando, K Urasawa, Y Yokoi and Y Shibata

On behalf of REVERside registry investigators

safety and efficacy of distal superficial femoral artery ... · tatsuya nakama, y yamamoto, a...

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