CTO and LV assist devices Alfredo R. Galassi, Catania, Italy 10th Experts „Live“ CTO Workshop - Day2

1. EURO CTO CLUB
Toulouse 2018
Alfredo R. Galassi MD, FESC, FACC, FSCAI
CTO and LV assist device
Department of Clinical and Experimental Medicine,
University of Catania, Italy and
University Insel Hospital of Cardiology, Bern, Switzerland

2. EURO CTO CLUB
Toulouse 2018
I, Alfredo R Galassi 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
Disclosure Statement of Financial Interest

3. Hospital Mortality or MACE
Stratified by LVEF and CHF
Wallace TM et al. Am J Cardiol 2009

4. Potential time-dependent pathway of
dysfunctional myocardium
Wilcox JE et al, JACC 2015

5. Viability / Ischemia Assessment
Preserved LVEF
CTO territory
Necrotic or ischemic non-CTO related territory
Symptoms
QOL
Prognosis
Impaired LVEF
Symptoms
QOL
Prognosis

6. Indications for percutaneous
Mechanical Circulatory Support MCS
ACC/AHA/SCAI Guidelines for PCI 2015

7. History of Mechanical Circulatory Support

8. Thiele et al, Eur Heart J 2015
Schematic drawings of Percutaneous
Ventricular Circulatory Support
IABP=Intra Aortic Balloon Pumping, Impella-Tandem Heart-iVAC=Percutaneous LV assist
devices; ECLS/ECMO=ExtraCorporeal Life Support/ ExtraCorporeal Membrane Oxigenator

9. Thiele et al, Eur Heart J 2015
Technical features of currently percutaneous
Mechanical Circulatory devices

10. Main Indications for Mechanical Circulatory Support

11. Industry Assembly
6th European Live Summit on
Retrograde CTO Revascularization
April 28-29, 2017 - Zurich, Switzerland
Course Directors Course Vice Director & Coordinator
Alfredo R. Galassi , MD, FACC, FESC Oliver Gaemperli, MD, FESC
Thomas F. Luscher, MD, FACC, FESC
George Sianos, MD, PhD, FESC
CTO PCI in patients with
low LVEF<35%
7.2
6.5 6.8 7.1
0
2
4
6
8
10
2014 2015 2016 2017
%

12. Industry Assembly
6th European Live Summit on
Retrograde CTO Revascularization
April 28-29, 2017 - Zurich, Switzerland
Course Directors Course Vice Director & Coordinator
Alfredo R. Galassi , MD, FACC, FESC Oliver Gaemperli, MD, FESC
Thomas F. Luscher, MD, FACC, FESC
George Sianos, MD, PhD, FESC
%
Angiographic success of CTO PCI
in patients with low LVEF<35%
83.5
89.5
84.7 88
0
20
40
60
80
100
2014 2015 2016 2017

13. 3 VD CTO PCI by Fielder XTR and ECMO
in a patient survived VF and AMI (EF 18%)
Galassi et al Eur Heart J 2014

14. Case Summary
Clinical presentation: unstable angina + dyspnea NYHA III
Risk factors: smoker, diabetes type II, hypertension
2 D Echo: LVEF 24% midventricular inferolateral akinesia
global hypokinesia in the other segments
Target vessel: Mid RCA CTO
Septal collaterals from LAD and epicardial collaterals from LCx for RCA
Ostial LM stenosis Mid LAD stenosis
Ostial and proximal stenosis of OM2
62 year-old male

15. Ventriculography
LVEF 20-25%

16. Ischemia / Viability Assessment
Ischemia in LAD and RCA areas with
preserved viability
Stress/Perfusion Late Gadolinium
Inferolateral scar (distal segment)

17. Treatment Strategy
Euroscore 6
Logistic Euroscore II 2.4%
Syntax score 35
J-CTO score for CTO lesion 3
Heart Team Decision Surgical revascularization
However the patient refused surgery
 staged PCI was proposed

18. RCA CTO revascularization
Double femoral 7Fr access
IABP Support

19. Failed Initial Antegrade Approach
Finecross (Terumo)
Fielder XT-R(Asahi)
1 DES implantation in proximal RCA

20. 1 DES implantation in LM
Retrograde Approach
(Hybrid Approach)

21. Retrogradely
Corsair (Asahi)
Sion (Asahi)
Antegradely
Finecross (Terumo)
Fielder XT-R (Asahi)
Stent Facilitated Reverse CART Technique
Retrograde Approach
(Reverse CART technique)

22. Final Result
3 DES implantation

23. LAD PCI
Optimization of LM
stenting by IVUS
Final Result

24. Baseline At 6 months
LVEF 24% LVEF 36%
Follow-up LV Angio
Uneventful 6 month follow-up period
No angina, dyspnea (from NYHA III to NYHA II)

25. Hamad General Hospital, Doha, Qatar, 7 September 2018

26. Case Summary
Past history: CABG 2015, LIMA on LAD, Venous graft to D1 and MO
Risk factors: smoker, diabetes type II, hypertension
2 D Echo: LVEF 35% anteroseptal akinesia, inferolateral hypokinesia
viable and ischemic myocardium (nuclear scan)
58 year-old male
Present hystory: LIMA on LAD and graft on MO occluded, graft on D1 patent

27. In the attempt to revascularize CX, perforation occurred and
graft master stent was implanted in LM

28. After 6 months clinical conditions worsen even further and
PCI was planned; EF decreased to 24 - 26%
Ostial LM CTO Ostial graft to D1 CTO
Patent RCA last remaming vessel

29. Despite no guiding back up, attempt was made to insert
antegrade wire in LM

30. Retrograde approach was performed from epicardial collateral of last
remaining vessel, by the use of caravel with SUOH 3 wire and assisted by
IABP plus dopamine infusion during second part of procedure
2 DES were implanted; fluoroscopy time 60 mins; contrast load 280 ml; radiation dose 4470 mGy

31. Tajstra M et al, JACC Intv 2016
CTOs and Outcome in Systolic Heart Failure (12-month mortality)

32. Tajstra M et al, JACC Intv 2016
After a multivariate adjustment for differences in baseline characteristics, the
presence of CTO remained significantly associated with higher 12-month mortality

33. Cardona M et al, Journal of Cardiovascular Magnetic Resonance 2016

34. Toma A et al, Am J Cardiol 2017
January 2005 - December 2013 N. 2002 pts undergoing PCI for CTO
Death, MI, TVR

35. Toma A et al, Am J Cardiol 2017

36. From January 2013 to December 2015
839 CTO patients attempted percutaneously
in a prospective multicenter study (Italy, Switzerland and Germany)
LVEF≥50%
552 patients (65.8%)
LVEF 35-50%
215 patients (25.6%)
LVEF≤35%
72 patients (8.6%)
Successful CTO PCI
66 patients (91.7%)
Failed CTO PCI
6 patients (8.3%)
Clinical follow-up
66 patients (100%)
17.6±10.2 months
Angiographic follow-up
49 patients (74.2%)
Galassi AR et al, JACC Intv 2017

37. All
839 patients
LVEF≥50%
552 patients
(Group 1)
LVEF 35-50%
215 patients
(Group 2)
LVEF≤35%
72 patients
(Group 3)
Age, years, mean ± SD 64.6 ± 10.5 63.8 ± 10.2 65.8 ± 11.3* 66.4 ± 10
Age ≥ 75 years, n (%) 163 (19.4) 85 (15.4) 58 (27)* 20 (28.8)†
Males, n (%) 736 (87.7) 475 (86.1) 195 (90.7) 66 (91.7)
Diabetes, n (%) 252 (30) 152 (27.5) 67 (31.2) 33 (45.8)†‡
Smokers, n (%) 447 (53.3) 289 (52.4) 116 (54) 42 (58.3)
Hypertension, n (%) 695 (82.8) 455 (86.1) 179 (83.3) 61 (84.7)
Dyslipidemia, n (%) 607 (72.3) 385 (69.7) 174 (80.9)* 48 (66.7)†‡
BMI , kg/m2 , mean ±SD 28.6 ± 4.5 28.6 ± 4.5 28.9 ± 4.4 27.3 ± 4.2‡
Peripheral artery disease, n (%) 129 (15.4) 66 (12) 46 (21.4)* 17 (23.6)†
Chronic kidney disease, n (%) 130 (15.5) 68 (12.3) 44 (20.5)* 18 (25)†
Prior MI, n (%) 358 (42.7) 197 (35.7) 118 (54.9)* 43 (59.7)†
Prior PCI, n (%) 287 (34.2) 186 (33.7) 84 (39.1) 17 (23.6)‡
Prior CABG, n (%) 141 (16.8) 77 (13.9) 50 (23.3)* 14 (19.4)
Prior stroke, n (%) 13 (1.5) 6 (1.1) 5 (2.3) 2 (2.8)
Three-vessel disase, n (%) 370 (44.1) 211 (38.2) 117 (54.4)* 42 (58.3)†
> 1 CTO, n (%) 40 (4.7) 18 (3.2) 13 (6.9)* 9 (12.5)†
* Group 1 vs. Group 2, p<0.05 / † Group 2 vs. Group 3, p<0.05 / ‡ Group 1 vs. Group 3, p<0.05
Clinical characteristics
Galassi AR et al, JACC Intv 2017

38. All
839 patients
LVEF≥50%
552 patients
(Group 1)
LVEF 35-50%
215 patients
(Group 2)
LVEF≤35%
72 patients
(Group 3)
Target CTO artery, n (%)
LAD
LCx
RCA
222 (26.5)
123 (14.7)
494 (58.9)
151 (27.4)
76 (13.9)
325 (58.9)
55 (25.6)
30 (14)
130 (60.4)
16 (22.2)
17(23.6)
39 (54.2)
Blunt Stump, n (%) 506 (60.3) 330 (59.8) 126 (58.6) 50 (69.4)
Bending >45°, n (%) 265 (31.6) 180 (32.6) 64 (29.8) 21 (29.2)
Severe Calcifications, n (%) 234 (27.9) 155 (28.1) 59 (27.4) 20 (27.8)
CTO length, mm, mean ± SD 42.2 ± 29.2 42.6± 29.6 42.5 ± 29 39 ± 27.3
CTO length ≥20mm, n (%) 674 (80.3) 441 (79.9) 179 (83.3) 56 (77.8)
Ostial location, n (%) 111(13.2) 68 (12.3) 31 (14.4) 48 (66.7)
In-stent CTO, n (%) 56 (6.7) 33 (6) 15 (7) 8 (11.1)
Previous attempt, n (%) 255 (30.4) 190 (34.4) 49 (22.8) 16 (22.2)†
Collateral filling Rentrop 2-3, n (%) 574 (68.4) 388 (70.3) 148 (68.8) 38 (52.8)†‡
J-CTO score ≥3, n (%) 402 (47.9) 273 (49.5) 97 (45.1) 32 (44.4)
ORA score ≥3, n (%) 103 (12.3) 53 (9.6) 35 (16.3)* 15 (20.8)†
Angiographic characteristics
* Group 1 vs. Group 2, p<0.05 / † Group 2 vs. Group 3, p<0.05 / ‡ Group 1 vs. Group 3, p<0.05
Galassi AR et al, JACC Intv 2017

39. Success rate and procedural details according LVEF
Galassi AR et al. JACC Intv 2017

40. All
839 patients
LVEF≥50%
552 patients
(Group 1)
LVEF 35-50%
215 patients
(Group 2)
LVEF≤35%
72 patients
(Group 3)
Procedural Time, min, mean ± SD 118.1 ± 75.5 119 ± 75.3 118.1 ± 79.2 110.5 ± 61.9
Fluoroscopy time, min, mean ± SD 57.1 ± 39.2 57 ± 38.2 57.9 ± 43 54.8 ± 35.3
Contrast Load, ml, mean ± SD 358 ± 206.5 369.9 ± 213.9 349.1 ± 197.7 295.6 ± 159 †‡
Radiation Dose, mGy, mean ± SD
3497.2 ± 2539 3578.8 ± 2574.6 3341.9 ± 2299.4 3335.3 ± 2854.6
Procedural Details
* Group 1 vs. Group 2, p<0.05 / † Group 2 vs. Group 3, p<0.05 / ‡ Group 1 vs. Group 3, p<0.05
Galassi AR et al, JACC Intv 2017

41. All
839 patients
LVEF≥50%
552 patients
(Group 1)
LVEF 35-50%
215 patients
(Group 2)
LVEF≤35%
72 patients
(Group 3)
Coronary Perforation, n (%) 34 (4) 25 (4.5) 6(2.8) 3 (4.2)
Tamponade, n (%) 13 (1.5) 8 (1.4) 5 (2.3) 0
Death, n (%) 0 0 0 0
Non Q wave MI, n (%) 7 (0.8) 3 (0.5) 4 (1.9) 0
Q wave MI, n (%) 2 (0.2) 2 (0.4) 0 0
Stent thrombosis, n (%) 2 (0.2) 1 (0.2) 1 (0.5) 0
Stroke, n (%) 0 0 0 0
Need for emergency CABG, n (%) 1 (0.1) 1 (0.2) 0 0
In-Hospital Outcome
Galassi AR et al, JACC Intv 2017
All p=NS

42. 8 2
IABP ECMO
CTO Patients with EF<35%
LV assistance device
62pts
86.2%
10pts
13.8%
No LV assistance device LV assistance device
Galassi AR et al, JACC Intv 2017
No impact on mid-term outcome
(HR: 1.10; 95% CI: 0.13 to 8.96; p=0.929)

43. Mid-term Outcome
Mean clinical follow-up of 16.3 ± 8.2 month
Overall Successful CTO PCI Failed CTO PCI
MACE = cardiac death, MI, stroke and further revascularization
Galassi AR et al, JACC Intv 2017

44. Predictors of MACE
Galassi AR et al, JACC Intv 2017

45. Patients CTO Patients with EF<35%
successfully revascularized
Improvement in LVEF
29.1
41.6
0
10
20
30
40
50
before CTO PCI after CTO PCI
FU 17.6 ± 10.2 months
P<0.001
Range
(17 – 34)
%
Galassi AR et al, JACC Intv 2017

46. Changes in symptoms 6 months after CTO
PCI according to LVEF
Galassi AR et al, JACC Intv 2017

47. Danek et al. J Inv Cardiol 2018
MCS was used in 91 patients (out of 1598
procedures) 5% of patients undergoing CTO-PCI

48. Danek et al. J Inv Cardiol 2018

49. Major bleeding and vascular access-site bleeding , incidence
of bleeding, classified according to the type of MCS,
including both elective and urgent use
Danek et al. J Inv Cardiol 2018

50. Conclusions
 PCI represents an efficient as well as safe strategy in pts with
CTO and low LVEF (Low LVEF does not represent an independent
predictor of MACCE at follow-up)
 MCS is used in the majority of cases with prior heart failure, prior
CABG, lower LVEF and angiographic characteristics necessitating
use of advanced crossing techniques (last remaining vessel)
 PCI CTO is very often the last remaining option and sometime
these patients are refused by surgery
 Successful CTO PCI improves
- LVEF
- Symptoms
 Successful CTO PCIs improves mid-term clinical outcome

51. Thank You
For Your Attention
www.alfredogalassi.com