Better Understanding Safety Related to Vascular Access: A ...Agostoni P., et al. Radial versus...

NPO TRI International

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Shigeru Saito, MD, FACC, FSCAI, FJCC

ShonanKamakura General Hospital, Kamakura, Japan

Better Understanding Safety

Related to Vascular Access:

A Global Need

Shigeru SAITO, MD, FACC, FSCAI Kamakura & Sapporo, JAPAN


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Hermiller JB. ACC i2 Boot Camp 2009

Femoral Access Problems

Magnitude of the problem

Over 10,000 million percutaneous arterial

procedures in 2007

Over a million coronary interventions

performed a per year

The most common complications of

coronary intervention result from access

problems


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Chandrasekar CCI 2001 – 11,821 procedures

How often complications occur!


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Complications Associated with Femoral Artery Access

Bleeding

Pseudoaneurysm

AV Fistula

Retroperitoneal hematoma

Arterial occlusion

Infection


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Anatomy of Femoral Artery


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Schnyder G, et al. Cath Cardiovasc Intervent 2001;53:289-295.

Bifurcation of Femoral Artery

Anatomy of femoral artery is varying among patients!


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Too Low Stick


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Too Low Stick

Profunda or SFA puncture • PSA – not compressible • AV fistula • Occlusion/Thrombosis


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Too High Stick


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A typical case after TFI

Big subcutaneous hematoma after TFI in AMI


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Grier D, Br J Radiol. 1990;63:602

Traditional Landmark for Femoral Puncture

Skin Crease

Maximum Femoral

Pulse

Boney Landmarks


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Schnyder G, et al. Cath Cardiovasc Intervent 2001;53:289-295.

Bifurcation of Femoral Artery

13% underwent puncture into vessel other than CFA 5% EIA 6% in SFA 2% Profunda

15% Below inferior border of femoral head 26% Below center of CFH

Traditional Landmark for Pucture is not reliable!


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Complications on Femoral Access

0

0. 1

0. 2

0. 3

0. 4

0. 5

0. 6

0. 7

0. 8

0. 9

RP Bl eed PSA Hemat oma

%

0.19%

0.62%

0.89% Indiana Heart Institute: -

2002-2006

n=47,587

AV fistula <0.1% Arterial occlusion <0.1%


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Complications on Femoral Access

Indiana Heart Institute: -2002-2006

n=47,587

AV fistula <0.1% Arterial occlusion <0.1%

0

0. 2

0. 4

0. 6

0. 8

1

1. 2

RP Bl eed PSA Hemat oma

Dx Cat h

PCI

%

0.14

0.46

0.76

0.28

0.86

1.2


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Thus, Always Fluoro is the most important!


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Procedure (see figure):

1. Fluoro the groin in the AP position and mark the bottom of the femoral head on

the skin with a clamp.

2. Palpate the artery and puncture the skin as marked, approaching the femoral

artery at a 45 degree angle. A 30 degree angle may be used if the skin is

entered 1 finger breath below the femoral head.

3. A “front wall” entrance techniques should be used.

4. If the artery is not entered, and bone is not hit (periosteal pain), repeat

fluoroscopy should be performed to be sure the needle tip is not above the

femoral head. Further successful needle adjustment can be accomplished

using the femoral head as a landmark and remembering the typical course

of the femoral artery.

Fluoro-Guided Femoral Puncture


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Fluoro-guided Femoral Puncture & Vascular Complications

Fitts J, et al. Fluoroscopy-guided femoral artery puncture reduces the risk of PCI-related vascular complications. J Interv Cardiol 2008; 21: 273-8.

Pseudoaneurysm

Any Arterial Injury

Bleeding

Length of Hospital Stay

p = 0.017

p < 0.01

p < 0.01 p = 0.69 Still, Fluoro-guidance cannot

prevent Access Site Complication!


Network Moscucci, M. et al. Eur Heart J 2003 24:1815-1823

Adjusted OR for mortality associated with major bleeding = 1.64 (CI 1.18-2.28)

Adjusted OR associated with PCI = 1.63 (CI 1.36-1.94)

How often bleeding complications occur in ACS? - GRACE registry


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Data from NHLBI Registry (6,656 pts)

Incidence (%) Adjusted analysis

Outcome No HRT HRT P-value

Death (in-hospital) 1.2 9.90 0.001

Death (1-year) 4.7 18.8 0.048

HRT, hematoma requiring transfusion

Yatskar L. et al. Access Site Hematoma Requiring Blood Transfusion Predicts Mortality in Patients Undergoing Percutaneous Coronary Intervention. Catheter

Cardiovasc Interven. 2007; 69: 961–966.


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Major bleeding increased 1-year mortality after PCI in 6,001 pts

Feit F et al. Predictors and Impact of Major Hemorrhage on Mortality Following Percutaneous Coronary Intervention from the REPLACE-2 Trial

Am J Cardiol. 2007; 100:1364-9

Time from Randomization (days)

Cumulative

mortality

(%)

P<0.001

1.9%

8.7%


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Kaplan-Meier estimates of mortality between 30 days and 6 months among patients who developed and those who did not develop major bleeding, excluding deaths that occurred during the first 30 days or

within 30 days of a major bleed

Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Eikelboom JW, et al. Circulation. 2006 Aug 22;114:774-82.


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Access Site Bleeding increases Mortality

M.O.R.T.A.L Study (Mortality benefit Of Reduced Transfusion after PCI via the Arm or Leg):

38,872 procedures in 32,822 pts

1,134 pts (3.5%) received transfusion

Absolute increase in 1-year mortality by transfusion: 6.78%

TRI is better than TFI (OR 0.71/0.83 for 30-day/1-year mortality)

Chase AJ, et al. Heart 2008; 94: 1530-2.


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Vendor Product Closure Method Abbott Vascular Perclose AT Suture Perclose Proglide Suture Perclose ProStar XL 10 Suture Starclose SE Nitinol clip Access Closure Mynx Extravascular PEG sealant Cardiva Medical Boomerang Arteriotomy tampanode St Jude Medical Angio-Seal Evolution Mechanical seal Angio-Seal VIP Angio-Seal STS Plus Sutura Super Stitch Suture and knot Vascular Solutions Duett Pro Thombin/collagen pro-coagulant

Current FDA Approval Vascular Closure Devices


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Suture To Ambulate aNd Discharge (STAND II) Trial

Baim DS et al. Am J Cardiol 2000; 85: 864-9.

More frequent local complications after using hemostasis devices.

Transfemoral Diagnosis or

Intervention

Arterial Sheath Size >= 5 Fr (>

8Fr: 7-8%)

515 Patients

Proster-Plus (Perclose)

8 or 10 Fr Devices

251 Patients

Overall major complication: 2.4%

Surgical repair: 1.2%

Transfusion: 1.2%, Severe

infection: 0.8%

Pseudoaneurysm: 0.8%

Overall minor complication:

3.6%

Hematoma: 2.4%

Superficial infection: 1.6%

Manual or Mechanical Compression

Sheath Removal at ACT < 180 Sec.

264 Patients

Overall major complication: 1.1%

Surgical repair: 0.4%

Transfusion: 0.4%, Severe

infection 0.4%

Psuedoaneurysm: 1.1%

Overall minor complication:

1.1%

Hematoma: 1.1%

Superficial infection: 0%

Baim DS, Knopf WD, Hinohara T, Schwarten DE, Schatz RA, Pinkerton CA, Cutlip DE, Fitzpatrick M, Ho KK, Kuntz RE. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the

suture to ambulate aNd discharge (STAND I and STAND II) trials. Am J Cardiol 2000; 85: 864-9.


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Complication of Femoral Artery Closure Devices is not rare!

Carey D, Martin JR, Moore CA, Valentine MC, Nygaard TW. Complications of femoral artery closure devices. Cathet Cardiovasc Interv 2001; 52: 3-7.

Current femoral artery closure devices need to be improved much more.

Consecutive transfemoral

From 1996 to 1999

3699 Patients

Manual compression

1019 Patients

Acute FA Occlusion: 0%

Infection: 0%

Total Comp: 0.5%

control

Vasoseal

937 Patients

Acute FA Occlusion: 0%

Infection: 0.3%

Total Comp: 1.5%

p=0.02

Angioseal

742 Patients

Acute FA Occlusion: 0.7%*

Infection: 0.3%

Total Comp: 2.6%

p=0.0002

Techstar

1001 Patients

Acute FA Occlusion: 0.1%

Infection: 0.4%*

Total Comp: 0.8%

NS


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Transradial Coronary Intervention

(TRI)

The total solution to reduce access site complication is:


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Transradial Approach

No major nerve

adjacent

Median nerve in carpal tunnel

Ulnar nerve runs with ulnar artery

Dual circulation –

Allen test (>90%)

Easy compression –

less PSA, hematoma

Tight space – less

PSA


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Comparisons between TRI and TFI

TRI TFI

Success rate of

Puncture (/pts) 2632 (99.6%) 793 (100%) NS

Cannulation (/pts) 2344 (98.8%) 793(100%) NS

Procedure (/lesions) 2959 (94.9%) 948(98.1%) NS

Saito S et al. Cathet Cardiovasc Interv 1999; 46: 37-41.



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Comparisons between TRI and TFI

TRI TFI Death 6 (0.3%) 3 (0.4%) NS Q-MI 5 (0.2%) 4 (0.6%) NS Urgent CABG 3 (0.1%) 1 (0.2%) NS Urgent PCI 13 (0.5%) 5 (0.8%) NS Major vascular access site complications 2 (0.1%) 21 (3.3%) <0.0001




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TRI vs. TFI Systematic Overview and Meta-Analysis of 12 Randomized Trials

(n=3,224)

Agostoni P et al. J Am Coll Cardiol 2004;44:349 –56


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(n=3,224)

Agostoni P., et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures: Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol 2004; 33: 349-356.

Entry (Bleeding) Complication is less in TRI!


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(n=3,224)

MACE is similar!

Agostoni P., et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures: Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol 2004; 33: 349-356.


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Jolly SS, et al. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized

trials. Am Heart J. 2009; 157: 132-40.

Metaanalysis for TRI vs TFI

Major Bleeding is less in TRI!


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Jolly SS, et al. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized

trials. Am Heart J. 2009; 157: 132-40.

Metaanalysis for TRI vs TFI

Success rate is similar!


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Schiahbasi A et al. Am J Cardiol 2009; 103:796-800.

PCI for Non-ST elevation Acute Coronary Syndrome (PRESTO-ACS Trial)

Death/Myocardial Infarction and Access Site Bleeding Complication

TRI TFI p N 307 863 In-Hp Death/MI 2.6% 2.9% 0.79 Death/MI at 1 Y 4.9% 8.3% 0.05 In-Hp Bleeding 0.7% 2.4% 0.05


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End point Transradial PCI, n=307 (%)

Femoral access PCI, n=863 (%)

p

Death/MI, in hospital 2.6 2.9 0.79

Death/MI at 1 y 4.9 8.3 0.05

Bleeding, in hospital 0.7 2.4 0.05

Schiahbasi A et al. Am J Cardiol 2009; 103:796-800.

PCI for Non-ST elevation Acute Coronary Syndrome (PRESTO-ACS Trial)

Death/Myocardial Infarction and Access Site Bleeding Complication


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PCI with Iib/IIIa inhibitors for ACS

TFI TRI p

N 130 531

Success 93.1% 91.0% >0.2

Bleeding 29.2% 8.7% <0.0001

Transfusion 7.7% 0.8% <0.0001

Death 1.5% 0.4% >0.2

1-yr Death 10.0% 4.7% 0.02

1-yr MACE 20.8% 14.1% 0.06

Marco De Carlo et al. Cathet Cardiovasc Interv 2009; 74: 408-415.


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Prevalence of Transradial Coronary Intervention in 2004 in Japan

0 200 400 600 800 1000 1200 1400 1600

Annual No. of PCI

0%

20%

40%

60%

80%

100%

%T

RI u

se

TRI is performed in 251 hospitals (73.6%) and 24,400 procedures (43.4% of cases)


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Steady Increase in the Penetration of TRI in Japan

According to the Annual Surveillance by Japanese Society of Interventional Cardiology


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TRI can provide safer PCI to everybody

Just TRY It! Just TRI It!


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Don’t be as bellow!

TRI TR哀 “哀” is a famous Chinese character and means “Sad”. Also, Its pronunciation is same as “I”.


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TRI is the basic and standard techniques in PCI.

Love and Start TRI!

TRI TR愛 “愛” is a famous Chinese character and means “Love”. Also, Its pronunciation is same as “I”.

Better Understanding Safety Related to Vascular Access: A ...Agostoni P., et al. Radial versus...

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