Perclose Suture-Based VCD: For PPI as well as PCI Yamashita T, MD, PhD, FACC Vice-Chairman Cardiology CV Ctr Hokkaido Ohno Hospital Sapporo, JAPAN

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1 Perclose Suture-Based VCD: For PPI as well as PCI Yamashita T, MD, PhD, FACC Vice-Chairman Cardiology CV Ctr Hokkaido Ohno Hospital Sapporo, JAPAN

2 Perclose Suture-Based VCD: For PPI as well as PCI Yamashita T, MD, PhD, FACC Vice-Chairman Cardiology CV Ctr Hokkaido Ohno Hospital Sapporo, JAPAN

3 Overview Vascular Closure Device(VCD) in Japan

4 From: Vascular Closure Devices: The Second Decade J Am Coll Cardiol. 2007;50(17): doi: /j.jacc

5 VCD

6 VCD

7 VCD

8 PCI in JAPAN (2002) TRI, TBI 30,000/year PCI 150,000/year TFI 120,000/year Closure Device 20,000/year (16%/TFI)

9 Reinbursement Issues (2004) Only for 7F Intervention AND next day discharge then, but QOL 6

10 Reinbursement Issues (2004) Only for 7F Intervention AND next day discharge then, but QOL 6

11 PCI in JAPAN (2006) TRI, TBI 87,000/year PCI 202,000/year TFI 115,000/year Closure Device 50,000/year (43%/TFI)

12 PCI in JAPAN (2002 vs 2006) Approach Sites TRI TBI TFI

13 PCI in JAPAN (2012) PCI 245,000/year TRI, TBI 164,000/year TFI 81,000/year Closure Device 60,000/year (74%/TFI)

14 PCI in JAPAN ( ) Approach Sites TRI TBI TFI

15 PPI (2012)

16 2013 VCD (R&D 2013)

17 VCD Failure Recent literature

18 Total=23,813 (JACC Intv 2012;5:837-44) 78% 10% 13%

19 Vascular Closure Device Failure in Contemporary Practice (Vidi VD, et al. JACC Intv 2012;5:837-44) Predictors of VCD Failure

20 Vascular Closure Device Failure in Contemporary Practice (Vidi VD, et al. JACC Intv 2012;5:837-44) Deployment Failure Vascular Complication Suture-Based VCD Learning Curve

21 Two Main Roads Suture-Based or Collagen Plug

22 Suture-Based? or Collagen Plug?

23 Suture-Based vs. Collagen Plug Perclose ProGlide AngioSeal (STS Plus)

24 Suture-Based vs. Collagen Plug Suture-based Perclose ProGlide AngioSeal (STS Plus)

25 Suture-Based VCD Perclose-Family

26 Comparison of Costs and Safety of a Suture-Mediated Closure Device With Conventional Manual Compression After Coronary Artery Interventions (Rickli H, et al. CCI 2002;57: ) Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.

27 Suture-Based VCDs Evolution cost saving

28 Prostar TM Needles

29 Closer S TM Needles Foot

30 Closer S TM Clincher

31 Perclose AT TM

32 Perclose AT TM 1min, really?

33 Perclose ProGlide TM Monofilament

34 ProGlide vs. AT Different Sutures

35 糸 モノフィラメント糸 材質 3.0 ポリプロピレン 色 青 軸糸 白 ブレード糸 材質 3.0 ポリエステル 色 緑 軸糸 白 糸の切断 クイックカットで切断 ハサミでも可 ハサミで切断 糸の締め込み 白糸も操作 最後に締め込む トリマーは青糸 白糸両方 にかける ワンハンドテクニックで青糸の みを引いてノットを押し込む 最後に白糸を引き しっかりと ノットを締め込む 白糸には触らない 緑糸のみにトリマーをかけ テンションをかけながら十 分に締め込む スーチャートリマー の操作

36 Suture Braided ( ) 3.0

37 Suture Braided

38 Suture Monofilament 3.0

39 Suture Monofilament

40 Suture Monofilament vs. Braided ( 1/5)

41 Suture Monofilament

42 Perclose ProGlide Detail

43 Instruction DVD

44

45 mm 0.038inch Terumo Corporation

46 ( ) Terumo Corporation

47 Terumo Corporation

48

49

50 45

51 /

52

53 Quick Cut

54

55 GW

56

57

58

59

60

61 kg 2 ( ) 5 Terumo Corporation 61/9

62 ( ( 2. 5Fr Terumo Corporation 62/9

63 Perclose ProGlide For PPI cases

64 Vascular Closure Device Failure in Contemporary Practice (Vidi VD, et al. JACC Intv 2012;5:837-44) Predictors of VCD Failure

65

66 Perclose ProGlide 1,163 (1/1/2010 1/28/2014)

67 Gender PPI Procedure Diagn 154/1163 (13%) 64/1163 (6%) 8F 4/1163 (0.3%) Size 5F 103/1163 (6%) 64/1163 (9%) 6F

68 Perclose ProGlide Experience Overall - PCI & PPI FAILURE 26/1163 (2%) Device failures: 26 Capture loss 23 Incomplete hemostasis 3 Vascular complications: 0 Infection 0 Occlusion 0 Stenosis 0 3 Angioseal 23 Manual compression Complete Hemostasis

69 Perclose ProGlide Experience PCI FAILURE 17/945 (2%) Device failures: 17 Capture loss 15 Incomplete hemostasis 2 Vascular complications: 0 Infection 0 Occlusion 0 Stenosis 0 3 Angioseal 14 Manual compression Complete Hemostasis

70 Perclose ProGlide Experience PPI FAILURE 7/154 (4%) Device failures: 7 Capture loss 6 Incomplete hemostasis 1 Vascular complications: 0 Infection 0 Occlusion 0 Stenosis 0 0 Angioseal 7 Manual compression Complete Hemostasis

71 Summary Take-Home Messeges

72 Perclose Suture-Based VCD: For PPI as well as PCI Yamashita T, MD, PhD, FACC Vice-Chairman Cardiology CV Ctr Hokkaido Ohno Hospital

73 Perclose Suture-Based VCD: For PPI as well as PCI Yamashita T, MD, PhD, FACC Vice-Chairman Cardiology CV Ctr Hokkaido Ohno Hospital

74

75

76 From: Vascular Closure Devices: The Second Decade J Am Coll Cardiol. 2007;50(17): doi: /j.jacc Figure Legend: Overview of Vascular Closure Device Types Vascular closure methods are: 1) passive and delayed manual compression with assistance (Femostop) or enhancement (patches); and 2) active and immediate collagen-based with or without anchor and suture, suture-based, and staple/clip-mediated.

77 J Am Coll Cardiol. 2007;50(17): doi: /j.jacc

78 PCI in JAPAN (2012) PCI 245,000/year TFI 81,000 (33%) TRI 164,000 (67%) TERUMO 2012

79 Vascular Closure Device(VCD) 1994 Vasoseal ( ) Proster ( ) Closer ( ) Angioseal ( ) Perclose AT ( ) Angioseal STS PLUS ( ) Perclose Proglide ( ) Angioseal Evolution ( ) 2014 Exoseal ( )

80 AngioSeal Proglide Proglide AngioSeal (STS Plus)

81

82

83

84 Closer S TM

85 Prostar TM

86 AngioSeal Proglide Learinig Curve VCDs : Vascular Closure Devices Deployment Failure Rates of Different VCDs Vascular Complication Rates of Different VCDs Reference; J Am Coll Cardiol Intv 2012;5:837-44

87 Suture Monofilament

88 Puncture Site Puncture Site Puncture Site Puncture Site Teru 88/6

89

90 Results FAILURE 26/1163 (2%) Device failures: 44(3.7%) Failure to deploy 29 Incomplete hemostasis 15 Vascular complications: 0 Infection 0 Occlusion 0 Stenosis 0 6 Angioseal 38 Manual compr

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