PREDICTORS OF PERI-PROCEDURAL OUTCOMES OF CAS A REAL WORLD EXPERIENCE

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1 PREDICTORS OF PERI-PROCEDURAL OUTCOMES OF CAS A REAL WORLD EXPERIENCE 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) Rhys Daniel, MBBS, Chem.Eng Jackie Wong, MPH

2 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

3 INTRODUCTION - PPPH-CAS 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): % Registries: 0-12%

4 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

5 INTRODUCTION - PPPH-CAS Hemodynamic alterations such as bradycardia or hypotension are wellrecognized 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 Oct;10(5): 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 Nov;34(11):

6 DEFINITION OF 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: T. NONAKA, S. OKA, S. MIYATA, T. BABA, T. MIKAMI, K. HOUKIN. Risk Factors of Postprocedural Hypotension Following Carotid Artery Stenting Jan; 12(Suppl 1):

7 INTRODUCTION - PPPH-CAS

8 PIVAR PPPH-CAS Atropine Sulfate (0.5 mg) ivi Or Glycopyrrolate (300 ug) ivi OR Persistence of Bradycardia and Hypotension SBP > 90mmHg 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) Continue with IVI crystalloid fluid Admit to HDU for monitoring and continuous management

9 STUDY AIM 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)

10 STENT CHOICE : PPPH-CAS PRECISE PRO RX CAROTID STENT SYSTEM 1. 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 SYSTEM 1. 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 STENT The 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.

11 PATIENT DEMOGRAPHIC CHARACTERISTICS No PPPH-CAS (n=123) PPH-CAS (n=37) Age (mean ± SD) ± ± Total (n=160) ± 9.77 CHARACTERISTICS No PPPH-CAS (n=123) PPH-CAS (n=37) Total (n=160) Smoking no. (%) 32 (26.0) 15 (40.5) 47 (29.4) 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) 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) INDICATION FOR INTERVENTION Hypertension no. (%) 102 (82.9) 29 (78.4) 131 (81.9) CHARACTERISTICS No PPPH-CAS (n=123) PPH-CAS (n=37) Total (n=160) Hyperlipidemia no. (%) 69 (56.1) 26 (70.3) 95 (59.4) 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) 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)

12 LESION CHARACTERISTICS AT BASELINE CHARACTERISTIC No 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) Type II 59 (48.0) 19 (51.3) Type III 2 (1.6) 2 (5.4) Bovine Arch 9 (7.3) 1 (2.7) 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) % 45 (36.6) 14 (37.8). Occluded 3 (2.4) 0 (0). LESION LENGTH (MM) MEAN ± SD ± ±

13 CLINICAL CHARACTERISTICS AT BASELINE CHARACTERISTIC No PPPH-CAS (n = 123) PPH-CAS (n= 37) P-value SBP pre-procedure (mmhg) ± ± SBP after stent implantation (mmhg) ± ± 4.0 < Hb, g/l (pre-procedure) ± ± Hb, g/l (post-procedure) ± ± 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 ± ± Modified Rankin Scale (99.2) 37 (100) (0.8) 0 LOS-ICU (days) 1.16 ± ± 0.88 < LOS-Hospital (days) 2.88 ± ± 1.86 < 0.001

14 DEVICE AND PROCEDURAL CHARACTERISTICS AT BASELINE CHARACTERISTIC No PPPH-CAS (n = 123) PPH-CAS (n= 37) P-value PRIMARY STENTING 38 (30.9) 17 (45.9) 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) < Xact Carotid Stent 50 (40.6) 5 (13.5) Cristallo Ideale 20 (16.3) 4 (10.8) Other stents** 9 (7.3) 1 (2.7) STENT DIAMETER 8.36 ± ± NUMBER OF STENT USED 1.07 ± ± VOL. OF CONTRAST USED (ML) ± ± PROCEDURE DURATION (MIN) ± ± * FLUOROSCOPY TIME (MIN) ± ± DOSE AREA PRODUCT (μgym 2 ) Median (IQR) ( ) ( ) *Other Embolic protection device (EPD): Mo.Ma device, SpiderFX **Other stents: Carotid WALLSTENT, Acculink carotid stent, Advanta V12 Sten

15 UNIVARIATE AND MULTIVARIATE ASSOCIATIONS BETWEEN CLINICAL CHARACTERISTICS AND OCCURRENCE OF PPPH-CAS VARIABLES UNIVARIATE ANALYSIS MULTIVARIATE ANALYSIS OR (95% CI) P-VALUE OR (95% CI) P-VALUE Age 0.97 (0.93, 1.01) (0.94, 1.06) 0.95 Sex, Male 1.03 (0.45, 2.36) (0.33, 2.61) 0.89 Smoking 1.94 (0.90, 4.19) (0.90, 7.71) 0.08 Diabetes Mellitus 1.77 (0.83, 3.77) (0.47, 3.61) 0.60 Arrhythmia 1.07 (0.42, 2.75) (0.37, 4.47) 0.70 CAD 0.65 (0.30, 1.39) (0.22, 1.95) 0.46 Hypertension 0.74 (0.30, 1.86) (0.32, 3.49) 0.94 Hyperlipidemia 1.85 (0.84, 4.08) (0.75, 6.15) 0.15 CVA 0.81 (0.25, 2.59) (0.23, 5.00) 0.92 CRF 0.14 (0.02, 1.10) (0.01, 1.00) 0.05 PVD 0.88 (0.42, 1.85) (0.40, 2.97) 0.86 SBP pre-operative 0.97 (0.3, 1.00) (0.94, 1.03) 0.42 Volume of Contrast 1.02 (1.01, 1.02) (1.00, 1.02) Symptomatic vs asymptomatic 0.86 (0.41, 1.81) (0.31, 2.14) 0.68 Arch type 0.95 (0.59, 1.53) Degree of Carotid lesion Calcification 2.09 (1.18, 3.69) Stent Type 0.45 (0.26, 0.78) EPD type 1.30 (0.87, 1.93) 0.194

16 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) XACT CAROTID STENT 0.23 (0.07, Cristallo Ideale 0.26 (0.06, 1.06) 0.06 Other stents 0.15 (0.01, 1.94) 0.15 MULTIVARIATE ASSOCIATIONS EPD TYPE AND OCCURRENCE OF PPPH-CAS EPD TYPE OR (95% CI) P-VALUE FILTERWIRE 0.76 (0.35, 1.65) 0.49 EMBOSHIELD NAV (0.14, 1.10) 0.07 ANGIOGUARD 3.13 (1.45, 6.75) Other EPD 0.35 (0.04, 2.92) 0.329

17 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- value 1 PPPH-CAS risk score weight Univariate C-statistic Multivariate C-statistic Δ C- statistic Age (<60 years) (1.45, 25.7) p-value 2 Volume Contrast > (0.65, 5.17) > (1.52, 12.54) Calcification (0.89, 9.67) (1.10, 16.82) Stent type Cordis Precise (1.49, 9,26) From multivariate binary logistic regression. 2 For C-statistic : C-statistics indicate diagnostic accuracy. PIVAR

18 DIAGNOSTIC ACCURACY FOR PPPH-CAS RISK SCORE: RECEIVER OPERATING CURVE (ROC) Sensitivity Specificity Area under ROC curve = The area under the ROC for the final model is showing fairly good diagnostic accuracy based on our risk score.

19 DISTRIBUTION OF PPPH-CAS RISK SCORES AMONGST PATIENTS WITH AND WITHOUT PPPH-CAS (N=160) Frequency No PPPHCAS (n=123) PPPHCAS (n=37) 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 although there are also quite a few patients that develop complications with a lower score SPECIFICITY IS GOOD BUT SENSITIVITY IS NOT SO GOOD.

20 PREDICTED PROBABILITY OF PPPH-CAS ACCORDING TO CALCULATED RISK SCORE (N=160) Probability of PPPHCAS (%) e.g PPPHCAS 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).

21 VARIATION OF SBP P= P= P= P=

22 DISCUSSION 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 ±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.

23 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.

24 CONCLUSION 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.

25 PREDICTORS OF PERI-PROCEDURAL OUTCOMES OF CAS A REAL WORLD EXPERIENCE 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) Rhys Daniel, MBBS, Chem.Eng Jackie Wong, MPH