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

Overview Vascular Closure Device(VCD) in Japan

From: Vascular Closure Devices: The Second Decade J Am Coll Cardiol. 2007;50(17):1617-1626. doi:10.1016/j.jacc.2007.07.028

VCD 2000 2003 2004 2007 2012 94 95

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

Reinbursement Issues (2004) Only for 7F Intervention AND next day discharge then, but http://www.naihoren.jp/youbou/4kaitei/p128-141.htm 136 16 7 2 7 6 QOL 6

Reinbursement Issues (2004) Only for 7F Intervention AND next day discharge then, but http://www.naihoren.jp/youbou/4kaitei/p128-141.htm 136 16 7 2 7 2 6 7 6 QOL 6

PCI in JAPAN (2006) TRI, TBI 87,000/year PCI 202,000/year TFI 115,000/year 2002 2.5 Closure Device 50,000/year (43%/TFI)

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

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

PCI in JAPAN (2002-2012) Approach Sites TRI TBI TFI

PPI (2012)

2013 VCD (R&D 2013)

VCD Failure Recent literature

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

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

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

Two Main Roads Suture-Based or Collagen Plug

Suture-Based? or Collagen Plug?

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

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

Suture-Based VCD Perclose-Family

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;57:297-302) 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.

Suture-Based VCDs Evolution cost saving

Prostar TM Needles

Closer S TM Needles Foot

Closer S TM Clincher

Perclose AT TM

Perclose AT TM 1min, really?

Perclose ProGlide TM Monofilament

ProGlide vs. AT Different Sutures

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

Suture Braided ( ) 3.0

Suture Braided

Suture Monofilament 3.0

Suture Monofilament

Suture Monofilament vs. Braided ( 1/5)

Suture Monofilament

Perclose ProGlide Detail

Instruction DVD

mm 0.038inch Terumo Corporation

( ) Terumo Corporation

Terumo Corporation

Quick Cut

45 70 45

2 24 5 1 1 4-5kg 2 ( ) 5 Terumo Corporation 61/9

(2012 10 1 1. ( 2. 5Fr 3. 4. 1 Terumo Corporation 62/9

Perclose ProGlide For PPI cases

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

http://www.cvc-ohno.or.jp

http://www.cvc-ohno.or.jp Perclose ProGlide 1,163 (1/1/2010 1/28/2014)

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

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

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

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

Summary Take-Home Messeges

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

From: Vascular Closure Devices: The Second Decade J Am Coll Cardiol. 2007;50(17):1617-1626. doi:10.1016/j.jacc.2007.07.028 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.

J Am Coll Cardiol. 2007;50(17):1617-1626. doi:10.1016/j.jacc.2007.07.028

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

Vascular Closure Device(VCD) 1994 Vasoseal (1994.9.2) Proster (1995.1.30) Closer (2000.5.29) Angioseal (2003.8.8) Perclose AT (2004.7.21) Angioseal STS PLUS (2007.6.7) Perclose Proglide (2007.7.9) Angioseal Evolution (2009.8.6) 2014 Exoseal (2012.2.21)

AngioSeal Proglide Proglide AngioSeal (STS Plus)

Closer S TM

Prostar TM

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

Suture Monofilament 1. 2. 3. 4.

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

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