ΠΑΡΑΣΚΕΥΗ 12 ΔΕΚΕΜΒΡΙΟΥ 2014, 13:00-14:30 Γ’ Στρογγυλό Τραπέζι: Διακερκιδική προσπέλαση

Διακερκιδική vs. διαµηριαίας προσπέλασης

Γεώργιος Χάχαλης, Αναπληρωτής Καθηγητής Πανεπιστηµίου Πατρών

Καµία σύγκρουση συµφερόντων σχετικά µε αυτή την οµιλία

• TransRadial versus TransFemoral

• TransRadial versus TransUlnar

• TransRadial versus TransFemoral

• TransRadial versus TransUlnar

RIVAL: Primary and Secondary Outcomes

Radial (n=3507)

%

Femoral (n=3514)

% HR 95% CI P

Primary Outcome Death, MI, Stroke, Non-CABG Major Bleed

3.7 4.0 0.92 0.72-1.17 0.50

Secondary Outcomes Death, MI, Stroke 3.2 3.2 0.98 0.77-1.28 0.90 Non-CABG Major Bleeding 0.7 0.9 0.73 0.43-1.23 0.23

(Jolly SS: Lancet 2011)

Transradial vs.r transfemoral…

0.25 1.00 4.00 16.00 Radial better Femoral better

High Medium Low

High Medium Low

High Medium Low

High Medium Low

High Medium Low

0.021

0.013

0.538

0.019

0.003

Interaction p-value HR (95% CI)

Primary Outcome

Death, MI or stroke

Non CABG Major Bleed

Major Vascular Complications

Access site Cross-over

Results stratified by High*, Medium* and Low* Volume Radial Centres

R  I  V  A  L

No significant interaction by Femoral PCI center volume

Tertiles of Radial PCI Centre Volume/yr

*High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)

Transradial vs.r transfemoral…

-80% (n=2845)

-64% (n=7014)

-62% (n=1001) -79%

(<75 year)

-56% (>75 yr)

(n=7804 / 585290)

US-Registry 2004-07

(Rao: JACCIntrv 2008)

RIFLE-STEACS STEMI Patients (Romagnoli E:

Presented at TCT San Francisco 2011)

RIVAL-Trial (Jolly: Lancet 2011)

Agostoni Meta-analysis (Vorobcsuk: JACC

2004)

Less access site Complications Transradial vs.r transfemoral…

-31% (>75 year)

-67% (<75 year)

(n=7804 / 585290)

US-Registry 2004-07

-62%% (n=1001)

RIFLE-STEACS STEMI Patients

-58% (n=13499)

PCI-single center

(Eichhoefer:AHJ2008 RIVAL

-68% (n=3324)

STEMI Meta-analysis

† Large hematomas ‡ Similar rates of non-CABG TIMI major bleedings

Less incident access site Bleeding

Possibly less Contrast volume US-Registry

2004-07 (Rao: JACCIntrv 2008)

(n=7804 / 585290)

-6.0% (n=489)

STEMI -Canada (Arzamendi: AJC 2010)

-12% (n=13499)

PCI-single center (Eichhoefer: AHJ 2008)

-12.5% (n=1021)

UK-STEMI (Hetherington Heart 2009)

(n=7021)

0%

RIVAL (Jolly:

Lancet 2011)

Excess of Fluoroscopy time (All P<0.05)

Higher Crossover rates: Successful access rate TF vs. TR: 98% vs. 93%

Agostoni Meta-analysis (JACC 2004)

RIVAL Trial

(Jolly SS:Lancet 2011)

+330% (7.2 vs 2.4%)

(n=2845)

+280% (7.6 vs 2.0%)

(n=7014)

Transradial vs.r transfemoral…

0%

+14% (n=2970)

+17% (n=3324)

P<0.00001

+16% (n=7014)

+19% (n=307)

+19% (n=7804 / 585290)

US Registry 2004-07

(Rao: JACCIntrv 2008)

Patients >75 y.o. (Aschenbach: CathCV Intv

2009)

RIVAL-Trial (Jolly: Lancet 2011)

STEMI Meta-analysis

(Vorobcsuk: AHJ 2009)

Agostoni Meta-analysis (JACC 2004)

+28% r-PCI (n=178 643)

f-PCI (n=2 642 231

NCDR 2007-12

(Feldmann: Circulation 2013

+360% (6,1 vs 1,7%)

(n=1800)

SAFE-PCI In women

(TCT 2013)

Transradial better Transfemoral better 1.0

Death, MI, Stroke-RIVAL (Radial Experts)

Death, MI, Stroke-RIVAL

OR: 0.98 [0.76-1.28]

Death-RIVAL

OR: 0.86 [0.58-1.29]

RIVAL

OR: 0.50 [0.27-0.92]

(Jolly SS. Lancet April 4, 2011 DOI:10.1016/S0140-6736(11)60404-2)

Transradial vs.r transfemoral…

Transradial better Transfemoral better 1.0

OR: 0.81 [0.59-1.10]

Death

OR: 0.85 [0.64-1.11]

MI

1.04 [0.57-1.89] Stroke

Meta-analysis 2011 (post-RIVAL)

(Jolly SS. Lancet April 4, 2011 DOI:10.1016/S0140-6736(11)60404-2)

Transradial vs.r transfemoral…

Adjusted Association Between r-PCI and Primary Outcomes (f-PCI as Reference)

OR (95% CI) P Value

Adjusted for National Cardiovascular Data Registry bleeding risk score, sex (female as reference), body mass index, GPI use, unfractionated heparin use, direct thrombin inhibitor use, history of congestive heart failure, and peripheral vascular disease

* greater procedural success for r-PCI (n=178 643) over f-PCI (n=2 642 231)

*

Feldman D, et al. Circulation. 2013;127:2295

An Updated Report from the National Cardiovascular Data Registry (2007–2012)

Operator experience in RIVAL (in number of procedures per year)

Mehta SR et al. JACC 2012;60:2490

P<0.001 P<0.001

N per year

Mortality Mortality

A Registry-Based Randomized Trial Comparing Radial and Femoral Approaches In Women

Undergoing Percutaneous Coronary Intervention:

The Study of Access site For Enhancement of PCI for Women (SAFE-PCI for Women) Trial

Sunil V. Rao MD, Connie N. Hess MD, Britt Barham, Laura H. Aberle BSPH, Kevin Anstrom PhD, Tejan B. Patel MD, Jesse P. Jorgensen MD, Ernest L. Mazzaferri MD, Sanjit S. Jolly MD, Alice Jacobs MD, L. Kristin Newby MD, C. Michael Gibson MD, David F. Kong MD, Roxana Mehran MD, Ron Waksman MD, Ian C. Gilchrist MD, Brian J. McCourt, Eric D. Peterson MD MPH, Robert A. Harrington MD, Mitchell W. Krucoff MD on behalf of the

SAFE-PCI for Women Investigators

TCT 2013

Study design

Female patient undergoing PCI or cardiac cath w/poss. PCI

Best background medical therapy Bivalirudin, P2Y12 inhibitors

2b3a at investigator’s discretion

Radial Femoral N=3000 pts randomized for 1800

PCI pts Patent hemostasis required

Vascular closure devices allowed

Primary Efficacy Endpoint (72 hrs or hospital discharge): BARC Types 2, 3, or 5 bleeding or Vascular Complications requiring intervention Primary Feasibility Endpoint: Access site crossover Secondary endpoints: Procedure duration, total radiation dose, total contrast volume, 30-day death/vascular complications/unplanned revascularization

SAFE-PCI for Women

TCT 2013

Results – Primary efficacy and feasibility endpoints PCI cohort

•  Most common reason for needing to convert from radial to femoral access to complete the procedure was radial artery spasm (42.9% of crossovers)

Radial (N=345)

Femoral (N=346)

OR (95% CI)

P

BARC 2, 3, 5 bleeding or Vasc Complications

1.2% 2.9% 0.4 (0.1-1.3) 0.12

SAFE-PCI for Women

TCT 2013

Results – Primary efficacy and feasibility endpoints Total randomized cohort

Radial (N=893)

Femoral (N=894)

OR (95% CI)

P

BARC 2, 3, 5 bleeding or Vasc Complications

0.6% 1.7% 0.3 (0.1-0.9) 0.03

SAFE-PCI for Women

TCT 2013

• Spasm • Bleeding • Hematoma • Compartment syndrome • Perforation, laceration, dissection • Evulsion of artery • Arterio-venous fistula • Pseudo-aneurysm • Subcutaneous granulomatous reaction (hydrophilic coating) • Cutaneous infection • Occlusion • Digital ischemia • Accelerated atherosclerosis • Transient vocal cord paralysis • Mediastinal hematoma • Delayed reflex sympathetic dystrophy

Vascular Complications Associated With Forearm Artery Catheterization

Caputo R et al. Cath and Cardiov Interventions. 2011;78: 823–839. doi: 10.1002/ccd.23052

SCAI Guidelines 2011

Transradial vs.r transfemoral…

RA

Flow

Ulnar AV-Fistula Ulnar artery pseudoaneurysm

Compartment syndromes

Conservative Tx Surgical Tx

Case report: Abnormal Allen’s test, Patent Hemostasis (1)

Allen’s test: Abnormal

Patent hemostasis:

YES

Ulnar pulse: 1/10

Radistop; No ulnar artery compression

Compression of the Right Ulnar Artery

Plethesmography of the Right RA

Right Radial artery

Right Ulnar artery

Pre-procedural angio

The Day After: Occluded Right Radial Artery with Thrombus

Patent Right Ulnar Artery

Thrombus Thrombus

Radial artery Occlusion, Absence of Hand Ischemia (2) Case report: Abnormal Allen’s test, Patent Hemostasis

Spasm: “Aggressive Prevention” is Necessary

Radial artery Ulnar artery Spasm Spasm

N=54

12%

N=78

17% P=0.06

• Independent predictor of artery occlusion

• Main reason for crossover in the transradial group

l1Deftereos S et al. . Cath and Cardiov Interventions 2011 2Deftereos S, …Hahalis G, et al. . Cath and Cardiov Interventions 2012 (in press)

• Correlates with radial1 and ulnar2 endothelial dysfunction

In the Aura-of-Artemis trial:

Incidence of Radial Artery Occlusions (RAO) 1997-2014

Incidence of Radial Artery Occlusions (RAO) 1997-2014

• Class IIa • To decrease access site complications (Level of Evidence: A)

• Particularly appealing in patients with: Coagulopathy Elevated INR Morbid obesity

2011 AHA/ACC Guidelines for PCI Transradial vs.r transfemoral…

• TransRadial versus TransFemoral

• TransRadial versus TransUlnar

Crossover Rates by quartiles in the Ongoing AURA-OF-ARTEMIS Randomized Study

Operator G Hahalis Ulnar

Overall N=250

1st N=62 2nd N=62 3rd N=63 4th N=63 p-value

75(30%) 20(32.3%) 16(25.8%) 21(33.3%) 18(28.6%) 0.8

Operator G Hahalis Radial

Overall N=186

1st N=44 2nd N=45 3rd N=47 4th N=47

9(4.8%) 2(4.3%) 1(2.2%) 2(4.3%) 4(8.5%) 0.6

Tranulnar vs.r transfemoral…

No learning curve of transulnar access rates

among experienced radialists

10.4%

Ulnar group

(n=462)

8.9%

Radial group

(n=440)

P=NS

Forearm artery occlusions: RAO vs. UAO

Hahalis et al. Circulation CV Intrvn 2013

60 αρτηριακές αποφράξεις (10.2%) σε 589 ασθενείς

Τυχαιοποίηση σε 2 δόσεις ηπαρίνης & 5F στεφανιογραφία

Hahalis G, et al. submitted. ΑΙΜ-RADIAL, New York, Sept 2013 & TCT, S. Franscisco Oct. 2013

• Κερκιδικό µόσχευµα για ΕΑΣΠ: Δυνητικό αίτιο ισχαιµίας στο χέρι µετά από τοποθέτησης φίστουλας για αιµοκάθαρση1

1 Asif A, et al. Semin Dial 2013 May-Jun;26(3):E17-9. doi: 10.1111/sdi.12084. Epub 2013 Mar 25 2 Wang S, Asisf A. Semin Dial 2013 May-Jun;26(3):E20-9. doi: 10.1111/sdi.12044. Epub 2012 Nov 22.

• Fistula First Breakthrough Initiative : Σύσταση για αποφυγή διακερκιδικής προσπέλασης για στεφανιογραφίες σε ασθενείς µε Χ.Ν.Α.2

Πολλοί στεφανιαίοι ασθενείς πάσχουν από Χ.Ν.Α. ….και αρκετοί είναι υποψήφιοι για µελλοντική αιµοκάθαρση

Διαγνωστική στεφανιογραφία, αρχικά σε άνδρες, µετά σε γυναίκες. Καλός κερκιδικός σφυγµός, <70 σ.α.λ.

PCI σε επιλεγµένους σταθερούς

ασθενείς

Διαγνωστική στεφανιογραφία σε όλους (ηλικιωµένοι, κοντοί, µετά

ΕΑΣΠ)

PCI σε όλους τους

σταθερούς ασθενείς

ΝΣΤΕΜΙ-Ο.Σ.Σ.

SΤΕΜΙ

0.25 1.00 4.00 16.00

Radial better Femoral better

High Medium

Low

0.003

Cross-over

HR (95% CI) Interaction P-value

Μελέτη RIVAL: Σηµασία του όγκου περιστατικών

Θάνατος, ΟΕΜ, ΑΕΕ High

Medium Low

Jolly SS, et al. Lancet 2011;377:1409 Hammon M, et al. Eurointervention 2013;January

Δεξιά

έσω

µαστική

αρτηρία

Αριστερή έσω

µαστική

αρτηρία

Ευχαριστώ για την προσοχή σας…

Καταγραφή NCDR (CathPCI Registry 2007-12) στις Η.Π.Α.

Χρήση κερκιδικής (ΚΑ) -n=178 643- & µηριαίας (ΜΑ) -n=2 642 231 - αρτηρίας

10.6%

KA

18.9%

MA

KA

MA 1.1%

3.0%

STEMI Καρδιογενής καταπληξία

P<0.01

P<0.01

Feldman DN, et al. Circulation 2013;127:2295

Yonetsu T, et al. Eur Heart J (2010) 31, 1608

Οπτική συνεκτική τοµογραφία (OCT) της κερκιδικής αρτηρίας

Αµέσως µετά από στεφανιαίες επεµβάσεις

Patent Hemostasis Technique for Post-procedural Hemostasis

1. Apply hemostasis device 2. Place pulse oximeter on ipsilateral index finger or thumb 3. Tighten hemostasis device and remove sheath 4. Occlude ipsilateral ulnar artery 5. Loosen hemostasis device until plethysmographic signal returns

or bleeding occurs If bleeding occurs, use manual compression If hemostasis is maintained in the presence of the plethysmographic signal, then leave hemostasis device in place for 2 h

6. Check for maintenance of plethysmographic signal every hour

(From Rao SV et al. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. JACC 2010;55)