1. Adult Spinal Deformity What’s new in treatment?
Emre Acaroglu MD
Ankara Spine center
Ankara, Turkey

2. Scheme What is the best treatment? Do complications affect results?
A new score to decrease the rate of mechanical complications

3. European Spine Study Group
Identifying The Best Treatment in Adult Spinal Deformity: A Decision Analysis Approach
Emre Acaroglu1, Aysun Cetinyurek Yavuz2, Umit Ozgur Guler1, Selcen Yuksel3, Yasemin Yavuz4, Selim Ayhan1, Montse Domingo-Sabat5, Ferran Pellise6, Francisco Javier Sanchez Perez-Grueso7, Ahmet Alanay8, Ibrahim Obeid9, Frank Kleinstück10, European Spine Study Group-ESSG
1 Ankara Spine Center, Ankara, Turkey
2 Biostatistics, ClinIST-eu, Nijmegen, Netherlands
3 Biostatistics, Yildirim Beyazit University School of Medicine, Ankara, Turkey
4 Biostatistics, Ankara University School of Medicine, Ankara, Turkey
5 Fundacio Institut de Recerca Vall d’Hebron, Barcelona, Spain
6 Spine Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain
7 Spine Unit, Hospital Universitari La Paz, Madrid, Spain
8 Comprehensive Spine Center, Acibadem Maslak Hospital, Istanbul, Turkey
9 Spine Unit, Bordeaux University Hospital, Bordeaux, France
10 Spine Center, Schulthess Klinik, Zürich, Switzerland
12/7/2018
European Spine Study Group

4. European Spine Study Group
Purpose
To identify the best (optimum) treatment in ASD
Using a statistical “decision analysis” model
Hypotheses:
Surgery may yield better overall clinical results
Surgery is associated with more complications and overall burden
To construct a statistical decision analysis (DA) model to identify the optimum overall treatment in ASD.
12/7/2018
European Spine Study Group

5. European Spine Study Group
Patients and Methods
International multicentre prospective database
ASD Patients
Overall n=968
Included n=535 (1 year f-up)
non-surgical (NS): 371
surgical (S): 164
From an international multicentre database of ASD patients with a total of 968 pts at the time of analysis, 535 who had completed 1 year follow-up (371 non-surgical –NS), 164 surgical –S), constitute the population of this study.
12/7/2018
European Spine Study Group

6. European Spine Study Group
Patients and Methods
Decision Analysis
Baseline
Outcome probabilities
improvement (↓ in ODI > 8pts)
no change
deterioration (↑ in ODI > 8pts)
Death / complete paralysis
The values of preference – utilities
Combine information and assign quality adjusted life expectancy (QALE)
No improvement
DA was structured in two main steps of: 1) Baseline analysis (Assessing the probabilities of outcomes, Assessing the values of preference –utilities-, Combining information on probability and utility and assigning the quality adjusted life expectancy (QALE) for each treatment) and 2) Sensitivity analysis.
12/7/2018
European Spine Study Group

7. European Spine Study Group
Results
Pooled outcome probabilities of patients (n=472)
Surgery presented with a higher chance of improvement (54.2%) compared to conservative treatment
12/7/2018
European Spine Study Group

8. Life Expectancy (default)
Results
Baseline and final utilities; QALE of patients
Treatment
(all)
Baseline Utility
Final Utility p
(baseline vs. final)
Life Expectancy (default)
QALE (healthy years)
Surgery
0.56
0.60
<0.0001
100 60
Non-Surgical
0.65
0.2692 65
0.0038
The non-surgical group demonstrated better final outcomes although this group had also started with higher QALE. There were improvements in overall QALE in both groups but this was significant only in the surgical group.
12/7/2018
European Spine Study Group

9. European Spine Study Group
Conclusions
No single best treatment
Conservative treatment
Higher QALE (up to 6%)
Secondary to higher baseline QALE
Surgical treatment
Significantly higher increase in QALE
Chances of improvement at first year significantly better than non-surgical
 This study demonstrated that a single best treatment modality for ASD may not exist. Conservative treatment appears to yield higher (up to 6%) QALE when compared to surgery, probably secondary to a higher baseline QALE. On the other hand, surgery provides a significantly higher increase in QALE and chances of improvement at 1st year
12/7/2018
European Spine Study Group

10. Effect of Treatment Complications on Outcomes in Adult Spinal Deformity: A Decision Analysis Approach
Emre Acaroglu1, Umit Ozgur Guler1, Aysun Cetinyurek Yavuz2, Selcen Yuksel3, Yasemin Yavuz4, Selim Ayhan1, Montse Domingo-Sabat5, Ferran Pellise6, Francisco Javier Sanchez Perez-Grueso7, Ahmet Alanay8, Ibrahim Obeid9, Frank Kleinstück10, European Spine Study Group-ESSG
1 Ankara Spine Center, Ankara, Turkey
2 Biostatistics, ClinIST-eu, Nijmegen, Netherlands
3 Biostatistics, Yildirim Beyazit University School of Medicine, Ankara, Turkey
4 Biostatistics, Ankara University School of Medicine, Ankara, Turkey
5 Fundacio Institut de Recerca Vall d’Hebron, Barcelona, Spain
6 Spine Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain
7 Spine Unit, Hospital Universitari La Paz, Madrid, Spain
8 Comprehensive Spine Center, Acibadem Maslak Hospital, Istanbul, Turkey
9 Spine Unit, Bordeaux University Hospital, Bordeaux, France
10 Spine Center, Schulthess Klinik, Zürich, Switzerland

11. Results Number of complications associated with each treatment arm
Surgery
n (%)
Non-surgical
Total
None
112 (68.3)
330 (89.0)
442 (82.6)
NLT
39 (23.8)
39 (10.5)
78 (14.6) LT
10 (6.1)
2 (0.5)
12 (2.2)
Death
3 (1.8)
3 (0.6)
Total Complications
52 (31.7)
41 (11.1)
535
All 535 patients (371 NS, 164 S) could be analysed in regard to complications. Overall, there were 78 NLT and 12 LT complications and 3 death/paralysis. Surgical treatment was significantly more prone to complications (31.7% vs. 11.1%, p<0.001)
p<0.001

12. European Spine Study Group
Results
Distribution of outcomes by complications
Surgery
Non-Surgical n
Detoriorate
n (%)
No Change
Improve
None
112
8 (9.4)
27 (31.8)
50 (58.8)
330
47 (17.5)
184 (68.7)
37 (13.8)
NLT 39
2 (7.4)
13 (48.1)
12 (44.4)
6 (15.4)
26 (66.7)
2 (17.9) LT 10
1 (12.5)
4 (50)
3 (37.5) 2
1 (50)
On the other hand, presence of complications did not necessarily decrease the chances of improvement, surgical patients tending to rate better in this respect (Table 1b).
02-04.September.2015
European Spine Study Group

13. European Spine Study Group
Conclusions
Surgical treatment of ASD
more likely to cause complications
Presence of complications
Negative impact on clinical improvement
Do not affect QALE at the first year
 This study has demonstrated that surgical treatment of ASD is more likely to cause complications compared to non-surgical treatment. On the other hand, presence of complications although has a negative impact on the likelihood of clinical improvement, it does not affects the QALE at the first year detrimentally.
02-04.September.2015
European Spine Study Group

14. European Spine Study Group
Impact of Resolved Early Major Complications on Two-Year Outcome Following Adult Spine Deformity Surgery
Núñez S, Pellisé F, Vila A, Domingo M, Haddad S, Sánchez Pérez-Grueso F, Acaroglu E, Alanay A, Obeid I, Kleinstück F
European Spine Study Group

15. Aim
To investigate the impact of early major complications, considered to be resolved at 6 months, on PROMs and on the likeness of reaching MCID two-years after adult deformity surgery.

16. Baseline demographics
CG (151)
MCG (24)
Mean (SD)
Age
48.5 (19.1)
62.3 (16.8)
n (%)
Female
118 (78.2%)
13 (54.2%)
Previous Surgery
35 (23.2%)
12 (50%)
ASA≥2
81 (53.6%)
18 (75%)

17. Baseline deformity parameters
CG (151)
MCG (24)
Mean (SD)
Major Cobb
41.28 (23.4)
38.78 (21.1)
SVA
21.82 (55.5)
72.69 (69.4)
Global Tilt
21.02 (15.8)
31.0 (17.2) PI
52.26 (11.1)
54.25 (10.6) PT
18.89 (10.5)
23.83 (9.7) SS
33.27 (10.8)
30.42 (10.2) LL
(21.0)
(18.8)

18. Baseline HRQOL CG mean (SD) MCG mean (SD) ODI 37.69 (20.6)
CG mean (SD)
MCG mean (SD)
ODI
37.69 (20.6)
44.75 (14.1)
SF-36 PCS
36.19 (9.3)
32.98 (6.3)
SF-36 MCS
43.98 (11.4)
42.13 (10.9)
SRS-22function
3.15 (0.91)
2.95 (0.93)
SRS-22mental health
3.24 (0.8)
3.18 (0.92)
SRS-22pain
2.75 (0.98)
2.65 (0.89)
SRS-22satisfaction
3.0 (1.1)
3.0 (1.0)
SRS-22self image
2.53 (0.73)
2.43 (0.63)
SRS-22subtotal
2.91 (0.7)
2.79 (0.7)

19. Surgical characteristics
CG mean (SD)
MCG mean (SD)
Estimated Blood Loss
(1155.8)
(1225.7)
Surgical Time
310.1 (174.2)
364.0 (148.7)
CG n (%)
MCG n (%)
3 Column Osteotomies
25 (16.6%)
5 (20.8%)
Patients on the revision group had longer, more complex surgeries

20. Major Complications
27 major complications in 24 patients, 18 reoperations + 1 cholecystectomy

21. Change Over Time and MCID/SCB
Control Group
Baseline
2 years
Change
MCID
SCB
ODI
37.68
23.1
-14.58
-12.8
-18.8
SF-36 PCS
36.44
43.8
7.36
4.9
6.2
SRS-22 subtotal
2.91
3.67
0.76
0.43
0.69
MCID for ODI, SF-36 Copay 2008 J Spine, SCB Glassman 2008 JBJS
MCID for SRS-22 Crawford III 2015 Spine, SCB Crawford 2016 Spine Deformity

22. Change Over Time and MCID/SCB
Major Complication Group
Baseline
2 years
Change
MCID
SCB
ODI
44.75
32.92
-11.83
-12.8
-18.8
SF-36 PCS
33.48
38.49
5.31
4.9
6.2
SRS-22 subtotal
2.82
3.45
0.63
0.43
0.69
MCID for ODI, SF-36 Copay 2008 J Spine, SCB Glassman 2008 JBJS
MCID for SRS-22 Crawford III 2015 Spine, SCB Crawford 2016 Spine Deformity

23. Conclusions Patients with major complications;
If resolved six months after surgery,
achieved a significant improvement reaching MCID values for SF-36 and SRS-22 at two years.

24. A score to predict/prevent mechanical complications

25. Background: Sagittal Plane Analysis
There is a need for a new look
into the ‘ideal’ sagittal plane
Spinal curvatures and alignment
must be viewed in light of each other
Chain of correlations
PI influences SS
SS influences LL
LL influences TK
TK influences CL
Pelvic incidence
is a (relatively) constant morphological parameter
that describes the ‘pelvic size’ for any given person
PI = A signature
All sagittal plane parameters
Should be evaluated
Proportional to PI
(rather than absolute numeric)
To assess disproportion compared with the calculated ideal

26. Methods From the ESSG database 222 patients randomly assigned to
≥4 levels posterior fusion
≥2 years follow up
222 patients (168F, 54M) were included
Mechanical Complications
PJK / PJF
DJK
Rod breakage
Implant related complications
Screw loosening, fracture, pull out
Interbody, hook or set screw pull out
222 patients randomly assigned to
derivation (n = 148, 66.7%)
and validation (n = 74, 33.3%) cohorts
Mean age
52.2 ± 19.3 (range 18-84)
Mean follow-up
28.8 ± 8.2 (24-62) months

27. Global Alignment & Proportion : GAP Score
New Method of Analyzing Sagittal Plane
Offers individualized sagittal plane analysis
Instead of population norms & mean values
Uses PI-based proportional radiographic parameters
Instead of absolute numerical values
Denotes “normal” and “pathologic”
standing sagittal alignment and shape
as a single score for every magnitude of pelvic incidence.
Radiographic parameters
RPV: Relative Pelvic Version (Measured-Ideal SS)
RLL: Relative Lumbar Lordosis (Measured-Ideal LL)
LDI : Lordosis Distribution Index (L4-S1 / L1 – S1 x100)
RSA : Relative Spinopelvic Alignment (Measured-Ideal GT)
Age Factor

28. Mechanical Complication
Results
Mechanical Complication - +
n (%) 2 P
RPV
Anteversion
5 (62.5)
3 (37.5)
2(3)=39.1
0.000
Aligned
50 (78.1)
14 (21.9)
Moderate Retroversion
22 (44)
28 (56)
Severe Retroversion
3 (11.5)
23 (88.5)
RLL
Hyperlordosis
1 (16.7)
5 (83.3)
2(3)=37.4
63 (75)
21 (25)
Moderate Hypolordosis
13 (36.1)
23 (63.9)
Severe Hypolordosis
3 (13.6)
19 (86.4)
LDI
Hyperlordotic Maldistribution
3 (10.7)
25 (89.3)
2(3)=36.2
69 (71.1)
28 (28.9)
Moderate Hypolordotic Maldistribution
6 (37.5)
10 (62.5)
Severe Hypolordotic Maldistribution
2 (28.6)
5 (71.4)
RSA
Negative Malalignment
2 (50)
2(3)=43.8
44 (77.2)
13 (22.8)
Moderate Positive Malalignment
30 (62.5)
18 (37.5)
Severe Positive Malalignment
4 (10.3)
35 (89.7)
Age
<60 years
51 (66.2)
26 (33.8)
2(1)=9.6
0.002
≥60 years
29 (40.8)
42 (59.2)
Risk Factors
β regression coefficient (SE) OR
(95% CI) P
Statistical Weights
RPV
Anteversion
0.762 (0.790)
2.1 (0.5 – 10.1)
0.335 1
Aligned -
Moderate Retroversion
1.514 (0.415)
4.5 (2.0 – 10.3)
0.000 2
Severe Retroversion
3.310 (0.684)
27.4 (7.2 – 104.7) 3
RLL
Hyperlordosis
2.708 (1.124)
15 (1.7 – 135.8)
0.016
Moderate Hypolordosis
1.669 (0.429)
5.3 ( )
Severe Hypolordosis
2.944 (0.670)
19 ( )
LDI
Hyperlordotic Maldistribution
3.022 (0.655)
20.5 ( )
Moderate Hypolordotic Maldistribution
1.413 (0.563)
4.1 ( )
0.012
Severe Hypolordotic Maldistribution
1.818 (0.866)
6.2 ( )
0.036
RSA
Negative Malalignment
1.219 (1.049)
3.4 (0.4 – 26.4)
0.245
Moderate Positive Malalignment
0.708 (0.434)
2.0 (0.9 – 4.7)
0.103
Severe Positive Malalignment
3.388 (0.615)
29.6 (8.8 – 98.9)
Age
<60 years
≥60 years
1.044 (0.341)
2.8 ( )
0.002

29. GAP Score
The GAP score, calculated by adding the scores for relative pelvic version, relative lumbar lordosis, lordosis distribution index, relative spinopelvic alignment, and the age factor, ranged from 0 to 13 points.
A GAP score of 0 to 2 was categorized as indicating a proportioned spinopelvic state; 3 to 6, as moderately disproportioned; and ≥7, as severely disproportioned.

30. GAP SCORE (Global Alignment and Proportion)
PARAMETERS
SCORING
CATEGORIES
Relative Pelvic Version ( RPV = Measured - Ideal Sacral Slope * )
RPV Subgroups Score
The parameters column includes a scale-based view of the subgroups of each parameter using the cutoff points.
The scoring column includes the statistical weights of the parameter subgroups.
The categories column includes the categorization of the GAP score.
Severe
Retroversion
Moderate
Retroversion
Aligned
Anteversion
< -15 :
-15 – -7.1 :
-7 – 5 :
> 5 :
Severe Retroversion
Moderate Retroversion
Aligned
Anteversion 3 2 1
-15o
-7o
+5o
* Ideal Sacral Slope = PI x
Total Score : 0 – 2
Relative Lumbar Lordosis ( RLL = Measured - Ideal Lumbar Lordosis ✢ )
RLL Subgroups
Proportioned
Severe
Hypolordosis
Moderate
Hypolordosis
Aligned
Hyperlordosis
< -25 :
-25 – :
-14 – 11 :
> 11 :
Severe Hypolordosis
Moderate Hypolordosis
Aligned
Hyperlordosis 3 2
-25o
-14o
+11o
✢ Ideal Lumbar Lordosis = PI x
Total Score : 3 - 6
Lordosis Distribution Index ( LDI = L4-S1 Lordosis / L1- S1 Lordosis x100 )
LDI Subgroups
Moderately
Disproportioned
Severe
Hypolordotic
Moderate
Hypolordotic
Aligned
Hyperlordotic
< 40 % :
40 – 49 % :
50 – 80 % :
> 80 % :
Severe Hypolordotic Maldistribution
Moderate Hypolordotic Maldistribution..
Aligned
Hyperlordotic Maldistribution 2 1 3
40%
50%
80%
Total Score  7
Relative Spinopelvic Alignment ( RSA = Measured - Ideal Global Tilt † )
RSA Subgroups
Severely
Disproportioned
Severe
Positive
Moderate
Positive
Aligned
Negative
> 18 :
18 – 10.1 :
10 – -7 :
< -7 :
Severe Positive Malalignment…………….
Moderate Positive Malalignment………..
Aligned……………
Negative Malalignment 3 1
+18o
+ 10o
-7o
† Ideal Global Tilt = PI x – 15
Age Factor
Age Subgroups
Elderly
Adult
< 60 years :
≥ 60 years :
Adult…………………………………......
Elderly Adult...…… 1 60

31. Mechanical Complication & Revision Rates
GAP Score in predicting
mechanical complications
GAP Score
GAP Categories

32. Conclusion
GAP score
is a new PI-based proportional method of analyzing
the individualized sagittal plane
is an all-inclusive single score
that offers a ‘one-size fits all’ solution
for every size of pelvic incidence
Preoperative planning & setting surgical goals in the sagittal plane
on the basis of the individualized proportional indices reflected by the GAP score
may decrease the rate of mechanical complications.

33. Summary What’s new in ASD treatment?
Surgery has been shown to be a better treatment modality over non-surgery
Within indications
Surgery has been shown to be more prone to complications
That affect outcomes
Yet provide significant HRQoL improvements
GAP score appears to be highly predictive of mechanical failures
A quantification of the ‘proportional’ sagittal alignment
May potentially be used as a planning tool