Radial_Catheterizations_2013 - Eli Lev MD - his

Report
Trans-Radial Interventions
Eli Lev, MD
Director of Interventional Cardiology
Hasharon Hospital, Rabin Medical Center
and Tel-Aviv University, Israel
Objectives
•
Learn the main scientific literature
supporting radial access for PCI
•
Learn the basic methodology in
performing trans-radial PCI
History



Transradial catheterization first described by Radner in
1948.
In 1989, Campeau et al revisited Radner’s idea &
reported on percutaneous entry into distal radial artery
for selective coronary angiography in 100 pts.
In 1992, Kiemeneij et al used Campeau’s work as the
basis for developing TRI.
1. Radner S. Thoracal aortography by catheterization from the radial artery; preliminary report of a new
technique. Acta radiol. 1948;29:178-80.
2. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc
Diagn. 1989;16:3-7.
3. Kiemeneij F, Laarman GJ, de Melker E. Transradial coronary artery angioplasty. Am Heart J.
1995;129:1-7.
Risk of vascular complications associated
with femoral and radial access
Retrospective review of 5,234 cath and PCI
Vascular complications by BMI: lower rate of vascular complications using TR vs.
TF approach for obese and non obese patients
6.0%
5.0%
5.3%
4.0%
4.00%
3.0%
2.0%
P= 0.048
P= 0.040
2.1%
1.0%
0.7%
0.0%
Non-obese
Obese
Femoral
Radial
Cox, N. Am J Cardiol 2004; 94 1174-1177
Radial versus femoral
access for coronary
angiography or PCI:
A systematic review and
meta-analysis of
randomized trials (total
of 4458 patients)
Jolly SS et al.
Am Heart J
2009;157:132-40
Radial vs. femoral access for coronary angiography or PCI:
A systematic review and meta-analysis of randomized trials
Jolly SS et al. Am Heart J 2009;157:132-40
RIVAL Study Design
NSTE-ACS and STEMI
(n=7021)
Key Inclusion:
• Intact dual circulation of hand required
• Interventionalist experienced with both (minimum 50
radial procedures in last year)
Randomization
Radial Access
Femoral Access
(n=3507)
(n=3514)
Blinded Adjudication of Outcomes
Primary Outcome: Death, MI, stroke
or non-CABG-related Major Bleeding at 30 days
Jolly SS et al. Lancet 2011.
Baseline Characteristics
Radial
(n =3507)
Femoral
(n =3514)
62
62
Male (%)
74.1
72.9
Diabetes (%)
22.3
20.5
UA (%)
44.3
45.7
NSTEMI (%)
28.5
25.8
STEMI (%)
27.2
28.5
Mean Age (years)
Diagnosis at presentation
Jolly et al, Lancet 2011
Primary and Secondary Outcomes
Radial Femoral
HR
95% CI
P
4.0
0.92
0.72-1.17
0.50
3.2
0.98
0.77-1.28
0.90
(n=3507)
(n=3514)
%
%
3.7
3.2
Primary Outcome
Death, MI, Stroke,
Non-CABG Major
Bleed
Secondary Outcomes
Death, MI, Stroke
Jolly et al, Lancet 2011
Other Outcomes
Radial Femoral
HR
95% CI
P
(n=3507)
(n=3514)
%
%
1.4
3.7
0.37 0.27-0.52 <0.0001
TIMI Non-CABG
Major Bleeding
0.5
0.5
1.00 0.53-1.89
ACUITY Non-CABG
Major Bleeding
1.9
4.5
0.43 0.32-0.57 <0.0001
Major Vascular
Access Site
Complications
Major Bleeding
1.00
Jolly et al, Lancet 2011
RIVAL study





7021 patients with
ACS undergoing PCI
No difference in
MACE – death, MI,
stroke
Trend for less major
bleeding with radial
access, depending on
the bleeding definition
Less vascular
complications with
radial access
Special benefit for
radial in STEMI pts
Primary endpoint - NACE
Non CABG major bleeding
Jolly et al, Lancet 2011
R I V A L Subgroups: Primary Outcome
Death, MI, Stroke or non-CABG major Bleed
Overall
Age
<75
≥75
Gender
Female
Male
BMI
<25
25-35
>35
Radial PCI Volume by Operator
≤70
70-142.5
>142.5
Radial PCI Volume by Centre
Lowest Tertile
Middle Tertile
Highest Tertile
p-value
Interaction
0.786
0.356
0.637
0.536
0.021
Diagnosis at presentation
NSTE-ACS
STEMI
0.025
0.25
Jolly et al, Lancet 2011
1.00
Radial better
4.00
Femoral better
Hazard Ratio (95% CI)
Other Outcomes
Radial
Femoral
(n=3507)
(n=3514)
Access site Cross-over (%)
7.6
2.0
<0.0001
PCI Procedure duration (min)
35
34
0.62
Fluoroscopy time (min)
9.3
8.0
<0.0001
2.6
3.1
0.22
90
49
<0.0001
Persistent pain at access site
>2 weeks (%)
Patient prefers assigned
access site for next
procedure (%)
• No differences in PCI success rate
P
RIFLE-STEACS study (Radial Versus Femoral Randomized
Investigation in ST-Elevation Acute Coronary Syndrome)
• 1001 pts with ST elevation ACS randomized TRI vs
TFI at high volume centers
• NACE at 30 days (cardiac death, stroke, MI, TVR,
bleeding): 13.6% TRI VS. 21% TFI (P=0.003)
• Cardiac mortality : 5.2% TRI vs. 9.2% TFI (P=0.02)
• Bleeding: 7.8% TRI vs. 12.2% TFI (p=0.026)
• Shorter hospital stay with TRI
Romagnoli et al JACC, 2012
Meta-analysis of Radial vs. Femoral in STEMI pts
Mortality
Access site complications
Bleeding
Mamas et al Heart 2012
Adoption of Radial Access and Comparison of Outcomes
to Femoral Access in Percutaneous Coronary
Intervention An Updated Report from the National
Cardiovascular Data Registry
)2007–2012(
Dmitriy N. Feldman DN et al, Circulation. 2013;127:2295-2306
NCDR registry, >2,800,000 patients, >1300 sites
Trends of use of r-PCI over time
The proportion of r-PCI procedures accounted
for 6.33% of total procedures (n=178,643),
increasing from 1.18% in the 1st quarter of 2007
to 16.07% in the 3rd quarter of 2012 (P<0.01).
Outcomes
Main Findings
1.
2.
3.
4.
5.
Use of ↑ r-PCI X13 over 6 yrs in the US
Lower risk of bleeding and vascular
complications with r-PCI
Underuse of r-PCI at ↑ risk groups for
bleeding (older, women, ACS)
The greatest benefit of r-PCI in terms of the
absolute reduction of bleeding & vascular
complications is seen in high-risk groups of
pts aged ≥75 years, women, & pts with ACS
r-PCI associated with longer fluoroscopy times
100%
90%
80%
70%
60%
femoral
radial
50%
40%
30%
20%
10%
Q2_07
Q3_07
Q4_07
Q1_08
Q2_08
Q3_08
Q4_08
Q1_09
Q2_09
Q3_09
Q4_09
Q1_10
Q2_10
Q3_10
Q4_10
Q1_11
Q2_11
Q3_11
Q4_11
0%
Frequencies of transradial and transfemoral interventions from
April 2007 until December 2011, Rabin Medical Center
G. Greenberg et al . A Comparative Matched-Analysis of Clinical Outcomes Between Transradial
versus Transfemoral PCI. Under Review…..
The Anatomy
The Anatomy
Allen’s Test - Can be performed ± Oximetry test
Peripheral vascular diseases. Edgar van Nuys Allen, MD and others with associates in the Mayo
Clinic and Mayo Foundation; 2nd edition, Philadelphia, Saunders, 1955.
Allen’s Test - Can be performed ± Oximetry test
We
recommend that, in the presence of an abnormal AT, the RA should not be
used for cardiac catheterization unless the risk of using the femoral approach is
excessive. Greenwood et al. JACC Vol. 46, No. 11, 2005, 2005:2013–7
Optimal Candidates for TR Access
•
•
•
•
Most of the population who have dual
circulation to the hand
Obese individuals who are at increased
risk of complications from TF access
Individuals with severe PVD or AAA
Diagnostic procedures (e.g. prior to
cardiac surgery)
Today TR is the default approach in many centers
Radial Access: proximal to styloid process
– Not really the wrist!
Technical Tips for
Successful Transradial Cannulation
•
•
•
Use a 21 G x 2.5 cm thin wall needle to cannulate the
radial artery
Advance a 0.025 inch guidewire through the needle
After the introducer is inserted, give “cocktail” of
Verapamil 2 mg diluted in saline, or 100-200 mcg of
nitroglycerine, with by 50 units/kg heparin bolus
Quesada et al, “Transradial Coronary Interventions”,
Interventional Cardiology Secrets, 2003, pp. 203-210
Sedation and Verapamil / Nitro Virtually
Eliminate the Spasm Problem
Before
After
Radial Loop and Radial Recurrent Artery
How do you deal with tortuousity?
•
•
•
•
•
Use a Benson or Wholey or Terumo wires into the
ascending aorta.
Pull the wire into the shaft of the catheter in order to
facilitate torquing for coronary cannulation.
Low threshold for crossing over to femoral
Always use a diagnostic catheter and then
exchange for a stiffer guiding catheter.
Use JR or MP as your initial catheter to access the
ascending aorta and then exchange for the PCI
catheter
Quesada et al, “Transradial Coronary Interventions”,
Interventional Cardiology Secrets, 2003, pp. 203-210
The Learning Curve: Transradial Pitfalls
•
•
•
•
•
•
•
Getting access
Radial Artery Spasm
 Prevention and management
Anatomical Variations
 Tortousity, vascular anomalies
Transversing the subclavian – Rt vs. Lt
 Respiration maneuvers
 Need for TF conversion
Catheter shape selection for cannulation
Catheter control and backup support
“Patent Haemostasis” after pulling out the sheath
Commonly Used
Guiding Catheter Shapes
Left Arm Approach
For Lesions in LCA
- XB 3.5
- JL 4
- Kimny
For Lesions in RCA
- JR 4
- AL I or AL II
- HS 1 & 2
- Kimny
Right Arm Approach
For Lesions in LCA
- JL 3.5
- XB/EBU 3.0
- Kimny
For Lesions in RCA
- JR 4 , 3DRC
- HS1, AL I
- Barbeau
- Kimny
Sheathless Catheters
Patent Haemostasis
Developments with trans-radial equipment
• Dedicated and better TR access tools
N=57
 hydrophilic sheaths
 Sheathless guiding catheters
 Single catheter diagnostics (e.g. Tiger)
• 5 French compatible PCI equipment
• Ability to perform complex interventions
 STEMI, bifurcations, CTO, LM, long lesions etc.
Transradial Access Site Complications
•
•
•
•
•
•
•
Radial artery occlusion (≈5%, higher rates
when routine doppler is used, mostly asympt.)
Forearm hematoma and/or pain
Radial artery pseudoaneuyrsm
Radial or brachial or artery perforation
Uncontrolled bleeding with resultant
compartment syndrome
Pain during catheter insertion
Need for femoral conversion (5-10%)
Radial Artery Occlusion Factors
•
•
•
•
•
Artery size: higher incidence with smaller artery
Larger catheter (>6 French)
Lack of heparinization or ↓ heparin dose
Artery spasm: pretreatment with verapamil / nitro
Hemostasis device: minimize over-compression
Ruo S, EHJ 2012
Radial Artery Complications
•
•
1372 Procedures
Asymptomatic radial occlusion
Symptomatic radial occlusion
Significant hematoma
Significant pseudoaneurysm
Worst Complication
Perforation →Compartment Syndrome
4.7%
0.2%
0.2%
0.2%
1 Case
GR. Barbeau, et.al. ACC 2006)
Radial Access - Disadvantages
•
•
•
•
•
•
Associated with a significant operator learning curve
Has limited compatibility with very large equipment
Elderly patients may have increased tortuousity of
the radial and subclavian arteries which makes the
procedure more challenging
May have limited guiding catheter support in most
challenging PCI scenarios (tortousity, heavy
calcifications, complex bifurcations)
Associated with upper limb arterial complications (rare)
Higher radiation exposure to the operator
Radial Access - The Advantages
• Decrease the incidence of major vascular complications
• Decrease the incidence of bleeding complications
• Appears to decrease MACE in patients with ACS
• Better control over vascular access and hemostasis for
obese and overall patients
• Decreased time to ambulation
• Improved patient movement and comfort
• Allows early discharge policy
• May decrease cost
Thank you

similar documents