trans-radial interventions

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.

5.3%

2.1%

4.00%

0.7%0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

Non-obese Obese

Femoral Radial

P= 0.048 P= 0.040

Cox, N. Am J Cardiol 2004; 94 1174-1177

Risk of vascular complications associated with femoral and radial access

Retrospective review of 5,234 cath and PCIVascular complications by BMI: lower rate of vascular complications using TR vs.

TF approach for obese and non obese patients

Jolly SS et al.Am Heart J 2009;157:132-40

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

NSTE-ACS and STEMI(n=7021)

Radial Access(n=3507)

Femoral Access(n=3514)

Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days

Randomization

RIVAL Study Design

Key Inclusion: • Intact dual circulation of hand required

• Interventionalist experienced with both (minimum 50 radial procedures in last year)

Jolly SS et al. Lancet 2011.

Blinded Adjudication of Outcomes

Baseline CharacteristicsRadial

(n =3507)Femoral (n =3514)

Mean Age (years) 62 62

Male (%) 74.1 72.9

Diabetes (%) 22.3 20.5

Diagnosis at presentation

UA (%) 44.3 45.7

NSTEMI (%) 28.5 25.8

STEMI (%) 27.2 28.5

Jolly et al, Lancet 2011

Primary and Secondary Outcomes

Radial(n=3507)

%

Femoral (n=3514)

%HR 95% CI P

Primary OutcomeDeath, MI, Stroke, Non-CABG Major Bleed

3.7 4.0 0.92 0.72-1.17 0.50

Secondary OutcomesDeath, MI, Stroke 3.2 3.2 0.98 0.77-1.28 0.90


Other Outcomes

Radial(n=3507)

%

Femoral (n=3514)

%HR 95% CI P

Major Vascular Access Site Complications

1.4 3.7 0.37 0.27-0.52 <0.0001

Major Bleeding

TIMI Non-CABG Major Bleeding

0.5 0.5 1.00 0.53-1.89 1.00

ACUITY Non-CABG Major Bleeding

1.9 4.5 0.43 0.32-0.57 <0.0001


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 Jolly et al, Lancet 2011

Primary endpoint - NACE

Non CABG major bleeding

Death, MI, Stroke or non-CABG major Bleed Subgroups: Primary OutcomeR I V A L

0.25 1.00 4.00Radial better Femoral better

Hazard Ratio (95% CI)

<75 ≥75

FemaleMale

<2525-35>35

≤7070-142.5>142.5

Lowest TertileMiddle TertileHighest Tertile

NSTE-ACSSTEMI

Age

Gender

BMI

Radial PCI Volume by Operator

Radial PCI Volume by Centre

Diagnosis at presentation

Overall

0.786

0.356

0.637

0.536

0.021

0.025

Interactionp-value


Other Outcomes Radial(n=3507)

Femoral (n=3514) P

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

Persistent pain at access site >2 weeks (%) 2.6 3.1 0.22

Patient prefers assigned access site for next procedure (%)

90 49 <0.0001

• No differences in PCI success rate

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

(2012–2007)

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 2007to 16.07% in the 3rd quarter of 2012 (P<0.01).

Outcomes

Main Findings

1. Use of ↑ r-PCI X13 over 6 yrs in the US2. Lower risk of bleeding and vascular

complications with r-PCI3. Underuse of r-PCI at ↑ risk groups for

bleeding (older, women, ACS)4. 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

5. r-PCI associated with longer fluoroscopy times

Q2_07

Q4_07

Q2_08

Q4_08

Q2_09

Q4_09

Q2_10

Q4_10

Q2_11

Q4_11

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

femoralradial

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

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 maneuversNeed 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 Right Arm Approach For Lesions in LCA For Lesions in LCA

- XB 3.5 - JL 3.5 - JL 4 - XB/EBU 3.0

- Kimny - Kimny For Lesions in RCA For Lesions in RCA

- JR 4 - JR 4 , 3DRC- AL I or AL II - HS1, AL I

- HS 1 & 2 - Barbeau - Kimny - Kimny

Sheathless Catheters

Patent Haemostasis

N=57• Dedicated and better TR access tools

hydrophilic sheathsSheathless guiding cathetersSingle catheter diagnostics (e.g. Tiger)

• 5 French compatible PCI equipment• Ability to perform complex interventions

STEMI, bifurcations, CTO, LM, long lesions etc.

Developments with trans-radial equipment

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 ProceduresAsymptomatic radial occlusion

4.7%Symptomatic radial occlusion

0.2%Significant hematoma

0.2%Significant pseudoaneurysm

0.2%• Worst Complication

Perforation →Compartment Syndrome 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

trans-radial interventions

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