The FIFA (FiveFrenchInACS) protocol – feasibility of 5F sheath as radial standard for ACS - Johannes Feuerbach

1. Klinikum Hanau GmbH | Leimenstraße 20 | 63450 Hanau | johannes_feuerbach@klinikum-hanau.de | www.klinikum-hanau.de @JFeuerba
Neubau: Architektur M-Gebäude 2. BA (heute HB-Gebäude) Architekten Witan Russ Lang GbR Frankfurt
The FIFA (FiveFrenchInACS) protocol –
feasibility of 5F sheath as radial standard for ACS
Johannes Feuerbach
Medizinische Klinik I
Klinikum Hanau
Germany

2. The FIFA protocol FiveFrenchInACS AIMRadial 2017 2
Disclosure
• I, Johannes Feuerbach DO NOT have a financial
interest/arrangement or affiliation with one or
more organizations that could be perceived as a
real or apparent conflict of interest in the
context of the subject of this presentation

3. The FIFA protocol FiveFrenchInACS AIMRadial 2017 3
• Radial access now in guidelines
• High radial quota in dedicated centers possible1,
rare complications
• Radial artery occlusion (RAO) possible
complication, less clinical significance2
• Sheath size contributing factor
• 6F sheath standard in many centers for ACS
• Our single center data shows the feasibility of
5F
1 Feuerbach J, Weinbrenner C, The forgotten side - left radial approach permits high radial quota in ACS patients,Clin Res Cardiol
105, Suppl 1, March 2016
2 Rashid M, Kwok CS, PancholyS et al., Radial Artery Occlusion After Transradial Interventions: A Systematic Review and
Metaanalysis, J Am Heart Assoc. 2016;5:e002686

4. The FIFA protocol FiveFrenchInACS AIMRadial 2017 4
Methods
• Primary PCI center for population of 150.000
• RadialFirst center (~95% radial approach)
• May 2016 decision to use 5F as standard in
ACS(STEMI+NSTEMI)
• Sep 2016 introduction of formal protocol
• Analysis May 2016- April 2017 374 ACS
radial
362
5Fsheath
300
PCI
244
Angio only
56
6F sheath
62
PCI
54
Angio only
8
femoral
12

5. The FIFA protocol FiveFrenchInACS AIMRadial 2017 5
Total
May 16 – Apr 17
Start-up period
(May 16-Sep16)
Protocol period
(Sep16- Apr 17)
All operators 300/362 (82,9%) 106/155 (68,4%) 194/207 (93,7%)*
Operator 1 17/17 (100%) 1/1 (100%) 16/16 (100%)
Operator 2 12/14 (85,7%) 3/4 (75%) 9/10 (90%)
Operator 3 5/6 (83,3%) 5/6 (83,3%)
Operator 4 29/64 (45,3%) 10/37 (27,0%) 19/27 (70,4%)
Operator 5 56/73 (76,7%) 12/27 (44,4%) 44/46 (95,7%)
Operator 6 80/84 (95,2%) 39/42 (92,9%) 41/42 (97,6%)
Operator 7 101/104 (97,1%) 36/38 (94,7%) 65/66 (98,5%)
0.00%
20.00%
40.00%
60.00%
80.00%
100.00%
120.00%
0 1 2 3 4 5 6 7 8
5F sheath by operator
protocol period
start up period
* p< 0,01

6. The FIFA protocol FiveFrenchInACS AIMRadial 2017 6
PCI after diagnostic angio:
5F (244/300) 81,3%
6F (54/62) 87,1%
0 5 10 15 20 25 30 35 40
post CPR, on ventilation
on ventilation
known complex anatomy
shock
IVUS option
“better do it 6f”
reasons for primary choice 6F sheath (n=62)
start up
protocol

7. The FIFA protocol FiveFrenchInACS AIMRadial 2017 7
0 5 10 15 20
complex anatomy
bifurcation
IVUS
Upsize before PCI (n=27)
27
273
0
0all 5F 27
217
00
5F PCI only

8. The FIFA protocol FiveFrenchInACS AIMRadial 2017 8
Upsize during PCI necessary in 8/217 (3,6%) cases
Reason in all cases: need für increased backup
Thoughts:
• Give up wire position ? Exchange over long
0,014´´wire possible, but troublesome
• Complete dislocation => right time to upsize ?

9. The FIFA protocol FiveFrenchInACS AIMRadial 2017 9
Procedural success
0
50
100
150
200
250
5F (n=209) 6F incl upsize (n=89)
PCI not successful
PCI successful
Procedure considered successful when PCI could be performed as intended and no re-intervention scheduled for target vessel
94,3% 85,2%

10. The FIFA protocol FiveFrenchInACS AIMRadial 2017 10
Discussion/Summary - 1
• 5F feasible in most ACS
• Huge difference between operators regardless
of volume => dedication is the key
• Introducing a formal protocol can be helpful
• Post CPR/on ventilation no reason for 6F
(shock?)
• Procedural success comparable (no
randomisation)

11. The FIFA protocol FiveFrenchInACS AIMRadial 2017 11
Discussion/Summary - 2
• Need to/timing of upsize important
 Formal protocol + learning curve
• Limitation:no routine follow-up for RAO
performed, advantage shown in previous
studies
@JFeuerba