PREDICTORS OF PERI PROCEDURAL OUTCOMES OF · Amaurosis Fugax 28 (22.8) 5 (13.5) 33 (20.6) CAS/CEA...
Transcript of PREDICTORS OF PERI PROCEDURAL OUTCOMES OF · Amaurosis Fugax 28 (22.8) 5 (13.5) 33 (20.6) CAS/CEA...
B. PATRICE MWIPATAYI, MMed, FCS (SA), FRACS, GD-CLINED (Melb)
Department of Vascular Surgery, RPH
School of Surgery, University of Western Australia Perth.
Director of Perth Institute of Vascular Research (PIVAR)
PREDICTORS OF PERI-PROCEDURAL OUTCOMES OF CAS
A REAL WORLD EXPERIENCE
Rhys Daniel, MBBS, Chem.Eng
Jackie Wong, MPH
DISCLOSURE
Speaker name: Prof. B. Patrice Mwipatayi
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
• RCTs have shown Carotid Intervention by CEA or CAS are efficacious
• Trend of improving CAS results with experience and newer devices
• 30-day STROKE or DEATH RATE
RCT (ICSS, EVA 3S, CREST, SPACE): 6.7- 9.6%
Registries: 0-12%
INTRODUCTION - PPPH-CAS
Kolkert JL, Meerwaldt R, Geelkerken RH, Zeebregts CJ. Endarterectomy or carotid artery stenting: The quest continues part two. Am J Surg, 2015 Feb ; 209(2):403-12
INTRODUCTION - PPPH-CAS
• Hemodynamic alterations such as bradycardia or hypotension are well-
recognized physiological responses during CAS, but most of these events are
transient and self-limiting in nature. 1, 2
• The incidence of hypotension during CAS ranges widely, from 14% to 28%, based
on available reports.1
• Nearly 60% of all hypotension patients developed during the procedure and 41%
after the procedure.
1. Mlekusch W, Schillinger M, Sabeti S, et al. Hypotension and bradycardia after elective carotid stenting: frequency
and risk factors. J Endovasc Ther. 2003 Oct;10(5):851-859..
2. McKevitt FM, Sivaguru A, Venables GS, et al. Effect of treatment of carotid artery stenosis on blood pressure: a comparison of
hemodynamic disturbances after carotid endarterectomy and endovascular treatment. Stroke. 2003 Nov;34(11):2576-2581
INTRODUCTION - PPPH-CAS
• Prolonged Post-Procedural Hypotension (PPPH-CAS) was defined as a FALL IN
SYSTOLIC BLOOD PRESSURE (SBP) OF >30MMHG FROM BASELINE WITHOUT EVIDENCE OF
HYPOVOLEMIA, WITH A SYSTOLIC PRESSURE (SBP) < 90 MM HG AT THE END OF CAS AND
LASTING AT LEAST 1-2 HOURS. 1, 2
• The concern about the POTENTIAL HARMFULNESS OF HYPOTENSION AND BRADYCARDIA
during or after CAS has enhanced the scientific interest about its risk factors.
• SO FAR, THE REPORTED PREDICTORS VARY FROM ONE STUDY TO ANOTHER.
•1. George Dangas,, John R. Laird, Jr, Lowell F. Satler et al. Postprocedural Hypotension after Carotid Artery Stent Placement: Predictors and Short- and Long-term
Clinical Outcomes. Radiology, Jun 2000, Vol. 215:677–683.
•2. T. NONAKA, S. OKA, S. MIYATA, T. BABA, T. MIKAMI, K. HOUKIN. Risk Factors of Postprocedural Hypotension Following Carotid Artery Stenting. 2006 Jan; 12(Suppl
1): 205–210.
DEFINITION OF PPPH-CAS
INTRODUCTION - PPPH-CAS
Atropine Sulfate (0.5 mg) ivi
Persistence of Bradycardia and Hypotension
Repeat Atropine (up to 0.04/kg)
Or
Repeat Glycopyrrolate (300 ug) ivi
Aramine: 0.5-5mg, follow by an adjusted infusion rate
(15-100mg/500ml N/S)
SBP > 90mmHg
Continue with IVI crystalloid fluid
Admit to HDU for monitoring
and continuous management
Or Glycopyrrolate (300 ug) iviOR
PIVAR
PPPH-CAS
To describe the predictors of persistent hypotension after CAS
placement.
To define the clinical outcome of patients with this
hemodynamic disturbance (stroke and death rate at 30 days)
STUDY AIM
PRECISE PRO RX® CAROTID STENT SYSTEM1. Micromesh geometry− ‘V’ pattern mesh structure − Peak-to-valley design − Optimal free-cell area 2. SAPPHIRE Trial(n=334)− Non-inferiority of PCAS vs CEA in high-risk patients − PCAS durability at 3 years follow-up
XACT® CAROTID STENT SYSTEM1. close cell design and a high radial force generated by the variable size of the cells.2. SECuRITY trial was a prospective, multi-center registry that reported on 305 high-risk patients at 30 sites
CRISTALLO IDEALE CAROTID STENTThe hybrid stent design is able to combine both the flexibility of an open-cell structure and the resistance to particle penetration of closed-cell structures.
STENT CHOICE : PPPH-CAS
CHARACTERISTICS No PPPH-CAS(n=123)
PPH-CAS(n=37)
Total(n=160)
Age (mean ± SD) 73.28 ± 9.08 70.46 ±11.66
72.63 ± 9.77
Age ≥ 65yr – no. (%) 105 (85.4) 26 (70.3) 131 (81.9)
Male sex - no. (%) 89 (72.3) 27 (73.0) 116 (72.5)
White race - no. (%) 117 (95.1) 36 (97.3) 153 (92.2)
CHARACTERISTICS No PPPH-CAS(n=123)
PPH-CAS(n=37)
Total(n=160)
Smoking – no. (%) 32 (26.0) 15 (40.5) 47 (29.4)
Diabetes Mellitus – no. (%) 37 (30.0) 16 (43.2) 53 (33.1)
Arrythmia – no. (%) 22 (17.9) 7 (18.9) 29 (18.1)
CAD – no. (%) 56 (45.5) 13 (35.1) 69 (43.1)
CABG – no. (%) 14 (11.4) 1 (2.7) 15 (9.4)
Hypertension – no. (%) 102 (82.9) 29 (78.4) 131 (81.9)
Hyperlipidemia – no. (%) 69 (56.1) 26 (70.3) 95 (59.4)
Previous CVA – no. (%) 16 (13.0) 4 (10.8) 20 (12.5)
CRF – no. (%) 20 (16.2) 1 (2.7) 21 (13.1)
PVD – no. (%) 57 (46.3) 16 (43.2) 73 (45.6)
Previous malignancy – no. (%) 9 (7.3) 4 (10.8) 13 (8.1)
Smoking – no. (%) 32 (26.0) 15 (40.5) 47 (29.4)
PATIENT DEMOGRAPHIC
INDICATION FOR INTERVENTION
CHARACTERISTICS No PPPH-CAS(n=123)
PPH-CAS(n=37)
Total(n=160)
TIA – no. (%) 33 (26.8) 10 (27.0) 43 (26.9)
Amaurosis Fugax 28 (22.8) 5 (13.5) 33 (20.6)
CAS/CEA 12 (9.7) 4 (10.8) 16 (10.0)
Pre-CABG CAS 5 (4.0) 1 (2.7) 6 (3.8)
Restenosis after surgery 9 (7.3) 0 (0) 9 (5.6)
Symptomatic – no. (%) 71 (57.7) 20 (54.0) 91 (56.9)
LESION CHARACTERISTICS AT BASELINE
CHARACTERISTICNo PPPH-CAS
(n = 123)PPH-CAS(n= 37)
P Value
LESION SIDE (%)Right side 67 (54.5) 17 (45.9) ….
ARCH TYPE (%)
Type I 53 (43.1) 15 (40.5) 0.851
Type II 59 (48.0) 19 (51.3) 0.718
Type III 2 (1.6) 2 (5.4) 0.197
Bovine Arch 9 (7.3) 1 (2.7) 0.309
LESION CALCIFICATION (%)
None - Mild 40 (32.6) 5 (13.5) ….
Moderate 69 (56.1) 21 (56.8) ….
Severe 14 (11.4) 11 (29.7) ….
DEGREE OF CONTRALATERAL CAROTID ARTERY STENOSIS (%)
Normal – mild disease 75 (61) 23 (62.2) ….
70 – 99% 45 (36.6) 14 (37.8) ….
Occluded 3 (2.4) 0 (0) ….
LESION LENGTH (MM) MEAN± SD 24.21 ± 4.06 24.24 ± 4.58 0.611
CLINICAL CHARACTERISTICS AT BASELINE
CHARACTERISTICNo PPPH-CAS
(n = 123)PPH-CAS(n= 37)
P-value
SBP pre-procedure (mmHg) 145.9 ± 10.7 141.6 ± 13.2 0.077
SBP after stent implantation (mmHg) 138.2 ± 14.5 85.5 ± 4.0 < 0.001
Hb, g/L (pre-procedure) 130.1 ± 15.9 132.6 ± 21.4 0.139
Hb, g/L (post-procedure) 119.5 ± 16.1 123.1 ± 20.5 0.211
ASA physical status
ASA 2 26 (21.1) 6 (16.2)
ASA 3 85 (69.1) 28 (75.7)
ASA 4 12 (80) 3 (8.1)
Number anti-Hypertensive Medications – mean (SD/range) 2.41 ± 1.29 2.11 ± 1.39 0.120
Modified Rankin Scale
0 - 2 122 (99.2) 37 (100)
3 - 5 1 (0.8) 0
LOS-ICU (days) 1.16 ± 0.43 2.32 ± 0.88 < 0.001
LOS-Hospital (days) 2.88 ± 1.84 4.16 ± 1.86 < 0.001
DEVICE AND PROCEDURAL CHARACTERISTICS AT BASELINE
CHARACTERISTICNo PPPH-CAS
(n = 123)PPH-CAS(n= 37)
P-value
PRIMARY STENTING 38 (30.9) 17 (45.9) 0.091
EMBOLIC PROTECTION DEVICE
FilterWire EZ™ 51 (41.5) 13 (35.1) …
Emboshield NAV6 35 (28.5) 5 (9.3) …
Angioguard™ 31 (25.2) 19 (51.4) …
Other EPD* 2 (1.6) 0 (0) …
STENT TYPE
Precise Pro Rx® Carotid Stent 44 (35.8) 27 (73) < 0.001
Xact® Carotid Stent 50 (40.6) 5 (13.5) 0.004
Cristallo Ideale ® 20 (16.3) 4 (10.8) 0.4190
Other stents** 9 (7.3) 1 (2.7) 0.3295
STENT DIAMETER 8.36 ± 0.691 8.19 ± 0.660 0.563
NUMBER OF STENT USED 1.07 ± 0.248 1.03 ± 0.164 0.379
VOL. OF CONTRAST USED (ML) 105.89 ± 39.50 141.57 ± 52.89 0.010
PROCEDURE DURATION (MIN) 49.27 ± 16.46 45.30 ± 13.12 0.135*
FLUOROSCOPY TIME (MIN) 14.96 ± 5.37 13.83 ± 5.17 0.253
DOSE AREA PRODUCT (μGym2) – Median (IQR)1144.700
(732.300 – 1626.800)1143.300
(653.600 – 2036.900)0.077
*Other Embolic protection device (EPD): Mo.Ma® device, SpiderFX™
**Other stents: Carotid WALLSTENT™, Acculink™ carotid stent, Advanta™ V12 Sten
VARIABLESUNIVARIATE ANALYSIS MULTIVARIATE ANALYSIS
OR (95% CI) P-VALUE OR (95% CI) P-VALUE
Age 0.97 (0.93, 1.01) 0.125 1.00 (0.94, 1.06) 0.95
Sex, Male 1.03 (0.45, 2.36) 0.941 0.93 (0.33, 2.61) 0.89
Smoking 1.94 (0.90, 4.19) 0.092 2.64 (0.90, 7.71) 0.08
Diabetes Mellitus 1.77 (0.83, 3.77) 0.138 1.31 (0.47, 3.61) 0.60
Arrhythmia 1.07 (0.42, 2.75) 0.089 1.28 (0.37, 4.47) 0.70
CAD 0.65 (0.30, 1.39) 0.265 0.66 (0.22, 1.95) 0.46
Hypertension 0.74 (0.30, 1.86) 0.529 1.05 (0.32, 3.49) 0.94
Hyperlipidemia 1.85 (0.84, 4.08) 0.127 2.15 (0.75, 6.15) 0.15
CVA 0.81 (0.25, 2.59) 0.723 1.08 (0.23, 5.00) 0.92
CRF 0.14 (0.02, 1.10) 0.062 0.10 (0.01, 1.00) 0.05
PVD 0.88 (0.42, 1.85) 0.740 1.09 (0.40, 2.97) 0.86
SBP pre-operative 0.97 (0.3, 1.00) 0.049 0.98 (0.94, 1.03) 0.42
Volume of Contrast 1.02 (1.01, 1.02) 0.0001 1.01 (1.00, 1.02) 0.048
Symptomatic vs asymptomatic 0.86 (0.41, 1.81) 0.693 0.81 (0.31, 2.14) 0.68
Arch type 0.95 (0.59, 1.53) 0.845
Degree of Carotid lesion Calcification 2.09 (1.18, 3.69) 0.010
Stent Type 0.45 (0.26, 0.78) 0.004
EPD type 1.30 (0.87, 1.93) 0.194
UNIVARIATE AND MULTIVARIATE ASSOCIATIONS BETWEEN
CLINICAL CHARACTERISTICS AND OCCURRENCE OF PPPH-CAS
EPD TYPE OR (95% CI) P-VALUE
FILTERWIRE 0.76 (0.35, 1.65) 0.49
EMBOSHIELD NAV6 0.39 (0.14, 1.10) 0.07
ANGIOGUARD 3.13 (1.45, 6.75) 0.003
Other EPD 0.35 (0.04, 2.92) 0.329
MULTIVARIATE ASSOCIATIONS EPD TYPE
AND OCCURRENCE OF PPPH-CAS
MULTIVARIATE ASSOCIATIONS STENT TYPE
AND OCCURRENCE OF PPPH-CAS
STENT TYPE OR (95% CI) P-VALUE
PRECISE PRO RX® STENT 3.71 (1.49, 9,26) 0.0006
XACT® CAROTID STENT 0.23 (0.07, 0.79 0.02
Cristallo™ Ideale 0.26 (0.06, 1.06) 0.06
Other stents 0.15 (0.01, 1.94) 0.15
PPPHCAS PREDICTION SCORING ALGORITHM USING CLINICAL CHARACTERISTICS AND STENT
PROCEDURE TYPE. RESULTS FROM MULTIVARIATE BINARY LOGISTIC REGRESSION ANALYSIS
(N=160) INCLUDING -COEFFICIENTS, ODDS RATIOS AND PPPHCAS COMPLICATION RISK
SCORE WEIGHTS.
Β coefficient OR (95% CI) p-value1
PPPH-CAS risk score
weight
Univariate C-statistic
Multivariate C-statistic
Δ C-statistic
p-value2
Age (<60 years) 1.81 6.11 (1.45, 25.7) 0.014 18 0.5549 0.5549 - -
Volume Contrast
0.6914 0.7066 0.1517 0.001
>100 0.61 1.83 (0.65, 5.17) 0.25 6
>150 1.48 4.37 (1.52, 12.54) 0.006 15
Calcification 0.6461 0.7596 0.053 0.11
2 1.07 2.93 (0.89, 9.67) 0.08 11
3 1.46 4.30 (1.10, 16.82) 0.04 15
Stent type 0.6860 0.7901 0.0305 0.26
Cordis Precise
1.31 3.71 (1.49, 9,26) 0.0006
1From multivariate binary logistic regression. 2For C-statistic : C-statistics indicate diagnostic accuracy.
PPPHCAS PREDICTION SCORING ALGORITHM USING CLINICAL CHARACTERISTICS AND STENT
PROCEDURE TYPE. RESULTS FROM MULTIVARIATE BINARY LOGISTIC REGRESSION ANALYSIS
(N=160) INCLUDING -COEFFICIENTS, ODDS RATIOS AND PPPHCAS COMPLICATION RISK
SCORE WEIGHTS.
PIVAR
DIAGNOSTIC ACCURACY FOR PPPH-CAS RISK SCORE:RECEIVER OPERATING CURVE (ROC)
0.0
00
.25
0.5
00
.75
1.0
0
Se
nsi
tivity
0.00 0.25 0.50 0.75 1.001 - Specificity
Area under ROC curve = 0.7901
The area under the ROC for the final model is 0.7901 – showing fairly good diagnostic accuracy based on our risk score.
DISTRIBUTION OF PPPH-CAS RISK SCORES AMONGST
PATIENTS WITH AND WITHOUT PPPH-CAS (N=160)
01
02
03
0
0 20 40 60 0 20 40 60
No PPPHCAS (n=123) PPPHCAS (n=37)F
req
ue
ncy
PPPHCAS risk score
This shows that a cut-point of 40 would work fairly well in terms of prediction i.e. you’re much more likely to have a complication with a score of 40+ - although there are also quite a few patients that develop complications with a lower score –
SPECIFICITY IS GOOD BUT SENSITIVITY IS NOT SO GOOD.
PREDICTED PROBABILITY OF PPPH-CAS ACCORDING TO
CALCULATED RISK SCORE (N=160)
0
20
40
60
80
100
Probability ofPPPHCAS
(%)
0 10 20 30 40 50 60 70PPPHCAS risk score
This shows there is a fairly gradual increase in risk of complications with gradually increasing risk score – rather than any very abrupt risk beyond a certain value (e.g. 40).
e.g. 40
VARIATION OF SBP
P= 0.0702 P= 0.0609P= 0.205
P= 0.2367
• 23% OF THE STUDY POPULATION DEVELOPED PHPCAS AT 30 DAYS POST-CAS.
• LOS is increased by 21% if patient develops PHPCAS [4.16±1.86 vs. 2.88
±1.84 (P < 0.01)]
• NO IMPACT ON MI. Only 1 patient had MI in the PHPCAS group vs none in
the PHPCAS group.
• NO IMPACT ON STROKE RATE: Stroke was observed in 1 patient (2.7%) with
PHPCAS vs. 3 patients (2.5%) in the no PHPCAS group.
DISCUSSION
• Patient was 4.37 times more likely to develop PHPCAS if VOLUME OF
CONTRAST WAS GREATER THAN 150ML
• STENT TYPE: 3.71 times more likely to develop PHPCAS with use of PRECISE
PRO RX® CAROTID STENT
• Two patients required pacemakers to be inserted within 72 hours
• There were no deaths at 30 days post-procedure.
DISCUSSION
• The hypothesis that remains to be proven is that an open cell stent design
conforms well with calcified anatomy and will continues to expand to the full
diameter resulting in an impact on the carotid body baroreceptor.
• The combination of Stent Design, the Degree of carotid Calcification and Contrast
Volume has predicted the occurrence of PPPH-CAS in our clinical setting.
• Our findings show that these episodes of sustained hypotension does not
translate to increased adverse clinical outcomes, including Stroke, MI and death.
CONCLUSION
B. PATRICE MWIPATAYI, MMed, FCS (SA), FRACS, GD-CLINED (Melb)
Department of Vascular Surgery, RPH
School of Surgery, University of Western Australia Perth.
Director of Perth Institute of Vascular Research (PIVAR)
PREDICTORS OF PERI-PROCEDURAL OUTCOMES OF CAS
A REAL WORLD EXPERIENCE
Rhys Daniel, MBBS, Chem.Eng
Jackie Wong, MPH