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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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Hermiller JB. ACC i2 Boot Camp 2009
Too Low Stick
Profunda or SFA puncture • PSA – not compressible • AV fistula • Occlusion/Thrombosis
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Hermiller JB. ACC i2 Boot Camp 2009
Too High Stick
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Hermiller JB. ACC i2 Boot Camp 2009
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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Hermiller JB. ACC i2 Boot Camp 2009
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!
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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.
Saito S et al. Cathet Cardiovasc Interv 1999; 46: 173-178.
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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
Saito S et al. Cathet Cardiovasc Interv 1999; 46: 37-41.
Saito S et al. Cathet Cardiovasc Interv 1999; 46: 173-178.
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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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TRI vs. TFI Systematic Overview and Meta-Analysis of 12 Randomized Trials
(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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TRI vs. TFI Systematic Overview and Meta-Analysis of 12 Randomized Trials
(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”.
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