Adjusting your level of competence to the difficulty of a CTO

Yves Louvard, Massy, France

Euro CTO club meeting, hotel Melia Castilla, Madrid, september 24-25, 2014

How to adjust ?

• Adapt the patient difficulty to the skillness of the operator = patient selection

- predictors of success - scores - operator’s experience as a predictor of success

• In case of excessive difficulty - surgery (LM, LAD) ? - referral inside / outside the group - proctoring

PCI of CTO’s and the Learning Curve

74 72 6760

70 7257

86

67

91

67

29 25

100

0102030405060708090

100

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Primary success rate (%)

% n= 292 250 118 77 76 72 49 22 12 11 9 7 4 1

Succes rate / operator: 2004-2009

ICPS CTO Database

Success rates and failure predictors / years

Year n Success rate (%)

Previous CABG (%)

No visible stump (%)

Calcification (0-3)

Lesion length (mm)

2004 107 67.3 2.9 7.5 0.96+0.97 17.9+14.6

2005 165 67.9 4.3 16.6 1.07+1.01 18.7+13.2

2006 195 69.7 7.7 18.0 1.15+1.00 20.6+14.4

2007 178 68.5 8.4 22.9 0.92+0.98 22.7+21.2

2008 161 72.7 6.3 25.9 1.08+0.98 21.4+16.1

2009 194 73.2 8.4 32.5 0.86+1.09 23.2+19.8

ICPS CTO Database

PCI of CTO’s and the Learning Curve

Patient’s selection

Predictors of outcome

Tortuosity <0.001 5.45 ( 2.05-14.51)Calcification 0.003 3.64 ( 1.56-8.48 )Bridging collateral 0.089 0.41 ( 0.14-1.15 )Long lesion 0.091 1.92 ( 0.90-4.07 )Abrupt type 0.161 1.92 ( 0.77-4.80 )Occl. Age (>3Mo) 0.409 1.68 ( 0.49-5.79 )Side branch 0.572 0.78 ( 0.33-1.86 )

Multivariate analysis of procedural failure

Determinants of procedural failure in CTO

Period IV P value Odds ratio (95% CI)

Mitsudo et al. CCT 2002

Prospective Registry started in 2004 European CTO club definition Ischaemia and/or viability in the index territory Patients not considered for surgery as a 1st option 14 operators, Team approach CK measured 12-24 hours post PCI Lesion characteristics defined by one operator

ICPS Registry

PCI of CTO’s and the Learning Curve

ICPS CTO Database

Predictors of Success / Failure of CTO PCIn= 1000

Success predictors: multivariate

OR 95% CI pNo visible stump 0.61 0.39-0.96 0.031Previous CABG 0.44 0.23-0.86 0.015Calcifications (0-3) 0.78 0.65-0.94 0.009Operator experience (1-6) 1.24 1.08-1.42 0.002Occlusion length (mm) 0.98 0.97-0.99 0.000

Louvard, Hayashida, ESC, AHA 2010

Predictors of success in CTO PCI (1)

 Successful PCI Univariate OR Multivariate OR Age(per 5 years increase)

0.96(0.89, 0.98)

p=0.009

0.94(0.89, 0.99)

p=0.048Lesion length(per 1 mm increase)

0.98(0.97, 0.98)

p<0.001

0.97(0.97, 0.98)

p<0.001Calcification(increasing thresholds of mild, mod-severe, and massive)

0.72(0.65, 0.80)

p<0.001

0.74(0.66, 0.84)

p<0.001No visible stump 0.66

(0.52, 0.85)p=0.001

0.62(0.46, 0.84)

p=0.002Tapered morphology 1.58

(1.26, 1.99)p<0.001

1.24(0.94, 1.63)

p=0.12

Leong, Louvard, ESC, AHA 2012

N= 1508

Predictors of success in CTO PCI (2)

 Successful PCI Univariate OR Multivariate OR Tortuosity 0.73

(0.56, 0.97)p=0.03

0.68(0.50, 0.93)

p=0.015Intraluminal channel 2.32

(1.59, 3.40)p<0.001

1.89(1.27, 2.83)

p=0.002Previous MI 0.60

(0.47, 0.78)p<0.001

0.66(0.50, 0.87)

p=0.003Previous CABG 0.40

(0.27, 0.58)p<0.001

0.42(0.28, 0.65)

p<0.001Operator experience(per 50 cases increase)

1.08(1.03, 1.13)

p=0.002

1.11(1.05, 1.18)

p=0.001

Leong, Louvard, ESC, AHA 2012

N= 1508

Predictors of success in CTO PCI: Lesion length

Leong, Louvard, ESC, AHA 2012

Higher Probability of Successful PCI in Patients With CTO of the LAD Compared to non LAD CTO PCI: Single Center Study

of 1,819 Consecutive Procedures

Alessandrino, Louvard, TCT 2014

Non LAD-CTO-PCI OR 95%CI P value

DM 0.6979 0.5277 to 0.9230 0.0117

Length>20 mm 0.4522 0.3489 to 0.5862 <0.0001

Severe Calcification 0.3523 0.2372 to 0.5233 <0.0001

Previous CABG 0.6152 0.4048 to 0.9349 0.0229

Previous MI 0.6903 0.5090 to 0.9360 0.0171

Tapered Stump 1.7297 1.3327 to 2.2450 <0.0001

LAD-CTO-PCI OR 95%CI P value

Dyslipidemia 0.5734 0.3560 to 0.9236 0.0222

Length>20 mm 0.5542 0.3496 to 0.8785 0.0120

Severe Calcification 0.4630 0.2453 to 0.8739 0.0175

Previous CABG 0.1039 0.0403 to 0.2682 <0.0001

Previous MI 0.5801 0.3477 to 0.9677 0.0370

Intra CTO tortuosity 0.4172 0.1859 to 0.9365 0.0341

LAD-CTO-PCI had a higher procedural success rate compared to non LAD (78.8% vs 69.7%, p<0.0001).

Scores

Morino et al. JACC Interv 2011; 4: 213-221

Wire crossing within less than 30 minutes

Predictors of success: the J-CTO score

PCI sucess

Morino et al. JACC Interv 2011; 4: 213-221

J-CTO score

%

P<0.001

Predictive value of the J-CTO score in percutaneous coronary interventions for chronic total occlusions: observed failure rate

Failure rate

Ferrante, Louvard, TCT 2012

Predictive value of the J-CTO score in PCI for CTO: Predictive value of the J-CTO score

1.95

3.47

4.57

P=0.003

P<0.001

P<0.001

Ferrante, Louvard, TCT 2012

Predictive value of the J-CTO score in PCI for CTO: Predictive value of the J-CTO score: discrimination

True

pos

itive

rate

False positive rate

AUC

0.77 (0.75-0.80) vs. 0.71 (0.69-0.74),P< 0.001

Ferrante, Louvard, TCT 2012

Influence of case load on individual succes rate

Learning Curve index

PCI of CTO’s and the Learning Curve

1: First 50 cases included in the study by 1 operator

2: 50 to 100

3: 100 to 150

4: 150 to 200

5: 200 to 250

6: > 250

ICPS CTO Database

Multi-operator success / Case volume

Operator case volume categories

1481 CTO-lesions 1260 patients

% P=0.038

Tora Leong

*

**

OR

of s

ucce

ss

* p=0.01 * * p<0.001† p= 0.014

2.1 (95% CI 1.2-3.7)

2.9 (95% CI 1.9-4.4)

†

J-CTO score

G. Ferrante, Y. Louvard, TCT 2012

Success rate of CTO PCI vs individual case load

Patient’s selection: conclusion• Case load is a factor of success in CTO PCI: - dedicated operators - individual case selection - refer / refuse too « complex » patients - how to select patient: score, ideally including operator’s experience • But: - predictors of failure are changing, scores ? - case load influence on success rate is very unlikely to be linear and much probably vary between individuals - dedicated operators ?: how to traine new operators in new centers and more difficult in same center to face the case-load increase or operator retirement …

How to improve the success rate in patients with CTO PCI ?

IndividualSuccess Rate

Team Interaction

New TechniquesNew Devices

Patient selection

PCI of CTO’s and the Learning Curve

ICPS CTO Database

Case load

Intrinsic operator quality

Impact of novel guide wire “Fielder XT” on CTO PCI success rate (ICPS, 2 operators)

Before Fielder XT After Fielder XT P

CTO n= 83 83

Fielder XT use (%) 1.2 80.7 0.000

Second attempt (%) 6.0 7.2 0.38

Procedural duration (min) 110 + 58 106 + 51 0.31

Contrast medium volume (cc) 258 + 137 290 + 147 0.08

Dissection (%) 24.7 12.2 0.02

Success rate (%) 67.5 84.3 0.005

Hayashida, Eur Heart J 2010; 31 (Suppl 1)

- extensive didactic training - on-site proctorship- routine determination of case appropriateness- adherence to procedural safety guidelines- 2-operator/case approach

Team approach

Proctoring, thanks to …

• Invited operators during local workshops (Japanese famous operators, Euro CTO members …)

• Invited operators for live transmissions (PCR, mainly on previously failed cases)

• « Private » proctoring for new devices ( James Spratt for StingRay and hybrid strategy, Peter O’Kane for Laser …)

Database

• To individual success rate in well described lesions

• To know the procedural complications

• To help case distribution inside a group and referral outside

• To re validate the scores

  Overall PopulationUnivariate Analysis

Stepwise Logistic regression P<0.0001

  Failure(455)

Success(1202)

p Odds Ratio 95% CI p

Hypertension, n (%) 301 (66,1) 694 (57,7) 0,0022      Previous MI n, (%) 128 (28,1) 224 (18,63) <0,0001 1,5633 1,1955 to 2,0443 0,0011

Previous PCI n, (%) 196 (43) 429 (35,7) 0,0067      Previous CABG n, (%) 58 (12,7) 66 (5,5) <0,0001 2,2809 1,5299 to 3,4005 0,0001

Multivessel CAD n, (%) 279 (61,3) 647 (53,8) 0,007      Non LAD n (%) 105 (23) 401 (33,3) <0,0001 1,5821 1,2135 to 2,0626 0,0007

Blunt Stump (%) 273 (60) 602 (50) 0,0004 1,5738 1,2444 to 1,9905 0,0002

Tortuous lesion n, (%) 84 (18,4) 167 (13,9) 0,009      Severe Calcification n, (%) 79 (17,3) 82 (6,8) <0,0001 2,9569 2,0815 to 4,2005 <0,0001

Lesion Lenght >20 mm n, (%) 214 (47) 366 (30,4) <0,0001 2,0480 1,6204 to 2,5884 <0,0001

Multivariable analysis

A Clinical And Angiographic Scoring system to predict the probability of successful first- attempt PCI in patients with total CTO

G. Allessandrino, T. Lefevre, Y. Louvard, submitted

Independent Variables Odds Ratio Score

Severe Calcified lesion 2,95 + 2

Previous CABG 2,28 + 1,5

Lesion Length ≥ 20 mm 2.0 + 1,5

Previous MI 1,56 + 1

Blunt Stump 1,57 + 1

Non LAD CTO location 1,58 + 1

Independent predictive variables scored according to OR

A Clinical And Angiographic Scoring system to predict the probability of successful first- attempt PCI in patients with total CTO

G. Allessandrino, T. Lefevre, Y. Louvard, submitted

Procedural success rate according to CL-SCORE value

A Clinical And Angiographic Scoring system to predict the probability of successful first- attempt PCI in patients with total CTO

G. Allessandrino, T. Lefevre, Y. Louvard, submitted

Conclusions• Individual CTO case load and experience are factors of CTO

PCI success.

• To increase the institution success rate, selection of case based on actualized predictors and scores, selection of operator and team interaction / proctoring are important

• Database including lesion analysis, outcome, and individual success rate can be used to select the operators for specific cases