Venogram Versus Intravascular Ultrasound for Diagnosing and Treating Iliofemoral Vein Obstruction (VIDIO)

Transcription

1 Venogram Versus Intravascular Ultrasound for Diagnosing and Treating Iliofemoral Vein Obstruction (VIDIO) Report From a Multicenter, Prospective Study of Iliofemoral Vein Interventions Paul J. Gagne, MD, FACS, RVT: Global VIDIO Principal Investigator (On Behalf of the VIDIO Investigators) American Venous Forum 28 th Annual Meeting February 24-26, 2016 Orlando, Florida

2 Disclosure Consultant and Global Principal Investigator: Philips Volcano 2

3 VIDIO Investigators Investigator Institution Paul J. Gagne, MD, RVT, FACS Robert W. Tahara, MD, FACS Carl P. Fastabend, MD Lukasz Dzieciuchowicz, MD, PhD William A. Marston, MD Suresh Vedantham, MD Windsor Ting, MD Mark D. Iafrati, MD, RVT, FACS Marzia Lugli, MD Antonios P. Gasparis, MD Steve A. Black, MD, FRCS, Ed, FEBVS Patricia E. Thorpe, MD, FSIR Marc A. Passman, MD Norwalk Hospital and Southern CT Vascular Center; Norwalk and Darien, CT Allegheny Vein & Vascular; Bradford, PA Imperial Health; Lake Charles, LA Szpital Kliniczny Przemienienia Panskiego Uniwersytetu; Poznan, Poland University of North Carolina; Chapel Hill, NC Washington University; St. Louis, MO Mount Sinai Hospital; New York, NY Tufts Medical Center; Boston, MA Hesperia Hospital Clinic; Modena, Italy Stony Brook Medicine; Stony Brook, NY St. Thomas Hospital; London, UK Arizona Heart; Phoenix, AZ University of Alabama; Birmingham, AL Vascular Surgeon, Interventional Radiology & Cardiology 3

4 Study Administration Study Administration Core Lab Imaging Over-reads and Biostatistics Data Management Electronic Data Capture Study Sponsor Syntactx (Led by Kenneth Ouriel, MD) Contract Research Organization New York, NY Regulatory and Clinical Research Institute (RCRI) Minneapolis, MN Merge Healthcare eclinicalos Chicago, IL Volcano Corporation (Now Philips Volcano) San Diego, CA 4

5 Is Venography Alone Adequate to Evaluate the Deep Veins? We develop strategies to compensate for the shortcomings of venography and convince ourselves it s adequate. Peter Neglén, MD, Ph.D. Venogram poor diagnostic sensitivity 1 34% of pts. w/ chronic venous symptoms had iliac vein obstruction and normal venogram 2 Collaterals, 43% of limbs that were stented Negus D, Fletcher EW, Cockett FB, Thomas ML. Compression and band formation at the mouth of the left common iliac vein. Br J Surg 1968;55: Raju S, Neglén P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg 2006;44: Raju S, Darcey, Neglén P. Unexpected major role for venous stenting in deep reflux disease. J Vasc Surg 2010;51: /001

6 Shortcoming of 2-D Imaging Great for round vessels (arteries); Poor for elliptical vessels (veins) Straight AP 60 o LAO 18 mm 3 mm 6

7 Study Objectives Primary Objective 1. Prospectively compare multiplanar venography vs.intravascular Ultrasound (IVUS) for diagnosing treatable iliac/common femoral vein obstruction (ICFVO) 2. Characterize the patient response to iliofemoral venous intervention [Venous Clinical Severity Score (VCSS) and Quality of Life (QoL) measures] over 6-month follow-up 3. Assess the presence and significance of associations between venography and IVUS findings and symptom resolution. 7

8 Study Objectives Primary Objectives 1. Prospectively compare the diagnostic performance of multiplanar venography and Intravascular Ultrasound (IVUS) for diagnosing treatable iliac/common femoral vein obstruction (ICFVO) 2. Prospectively compare clinical decision making regarding treatment based on multiplanar venography vs. IVUS 3. Charecterize the patient response to iliofemoral venous stenting [Venous Clinical Severity Score (VCSS) and Quality of Life (QoL) 6-month follow-up 8

9 Study Design Prospective, multi-center, single-arm 14 Sites: US (n = 11) and Europe (n = 3) 100 patients CEAP 4-5, n=50; CEAP 6, n=50 Follow-up visits: 1m and 6m ^ For subjects with C6 disease 9

10 Study Design Venogram Standardized: (CIV, EIV, CFV) Catheter (6Fr sheath) at cranial Femoral V 20cc half-strength contrast (Opacify Veins) Hand injection AP, 30 0 RAO and 30 0 LAO views Significant Stenosis : Venogram: 50% Diameter reduction IVUS: 50% CSA reduction 10

11 Baseline Clinical Characteristics Characteristic N = 100 Gender (female:male) 43:56 Index leg (left:right) 63:37 Age (mean ± SD, range) 62 ± 12 (30 85) Race (Caucasian) 86 % BMI (kg/m 2 ) 33.6 ± 7.5 CEAP N (by protocol) 4a 33 4b

12 Sample Case

13 Multiplanar Venography VIDIO Case Demographics 84 y/o male patient BMI = 25.8 History Prior R leg DVT Prior L leg PTA (6 months prior to this procedure) Diagnostic Venography: AP Views Physical Exam Study Leg: Left CEAP C6: 10 x 14 mm Ulcer, present for > 12mos 13 Case details, images, and footage courtesy of Paul Gagne, MD /002

14 Multiplanar Venography VIDIO Case Demographics 84 y/o male patient BMI = 25.8 History Prior R leg DVT Prior L leg PTA (6 months prior to this procedure) 30 o RAO View 30 o LAO View Physical Exam Study Leg: Left CEAP C6: 10 x 14 mm Ulcer, present for > 12mos Iliac Vein 14 Case details, images, and footage courtesy of Paul Gagne, MD /002

15 Intravascular Ultrasound VIDIO Case Diagnosis: Non-Thrombotic Iliac Vein Lesions (NIVL) x2 CIV Reference CIV Tightest Stenosis Common Iliac Vein 58% Cross-Sectional Area Reduction Tightest Stenosed Area of 72mm 2 External Iliac Vein 38% Cross-Sectional Area Reduction Tightest Stenosed Area of 88mm 2 EIV Reference Reference Iliac Vein EIV Tightest Stenosis /002

16 Baseline Imaging: Venogram and IVUS (Site-Reported) Venogram and IVUS Findings Veins Segment* Percent of Lesions Total Segments Assessed % Lesion on IVUS but not Venogram % Lesion on Venogram but not IVUS 5 1.7% Lesion on both Venogram and IVUS % No appreciable stenosis, Venogram or IVUS % *Common Iliac, External Iliac, and Common Femoral veins IVUS more sensitive for ICFVO Stenosis vs. Venogram 16

17 IVUS vs. Venogram: Diameter (Core Laboratory) Multiplanar Venography underestimates the degree of diameter stenosis compared to IVUS. Venogram missed 26% of >50% diameter-reduction lesions IVUS determined stenoses, in general, were 10.9% more severe (mean) than by Venogram (P <.001) 17

18 IVUS vs. Venogram: Area (Core Laboratory) Surprisingly, multiplanar venography allows a relatively accurate assessment of area reduction / stenosis when compared to IVUS. However, even with 3 view venograms,, 17.7% of significant CSA lesions (defined by >50% area reduction) were missed. 18

19 Procedure Decision Making Site Investigator: Venogram vs. IVUS -> Stent? Decision To Stent: Changed 60/100 (60%) pts. due to IVUS Stent Number, n=50 pts., Increased from 0->1 stent or 1->2 stents due to IVUS Without IVUS, undertreat ICFVO! 19

20 Ulcer Size: Stented vs. Non-stented Subjects 20 Time Point Mean in Stented Subjects (N = 36) Mean in Non-Stented Subjects (N=14) Subjects 36 (72%) 14 (28%) Baseline 34.6 cm cm 2 1 month 26.0 cm cm 2 6 months 27.5 cm cm 2 Baseline vs. 1 month P =.002 P =.021 Baseline vs. 6 months P =.017 P = Month vs. 6 months P =.855 P =.202 Wilcoxon Signed Ranks Test Ulcer Size: Non Stented > 6 months Ulcer Recurring at 6 mos.?

21 Patient with Pain Quality of Life: SF-36 v.2 Patients who had stents placed for ICFVO: Pt. Pain improved, baseline at 1 mos. (p=0.001) Pt. Pain improved, baseline at 6 mos. (p>0.001) Pts. Feel better when lesions identified / treated 21

22 VIDIO: Results Stent Placement with IVUS determined: 50% CSA/diameter reduction generally predicts clinical improvement (VCSS) 61% CSA diameter stenosis may be better cutoff for predicting clinical improvement w/ compression lesions Gagne et al, Journal of Vascular Surgery: Venous and Lymphatic Disorders Volume 5, Number 1, abstracts, p /002

23 Conclusions Primary Endpoint: (CEAP4-6 pts.) IVUS vs. Multiplanar Venogram IVUS more sensitive for identifying ICFVO IVUS better define degree of CSA / diameter Stenosis IVUS best guide for Stent Intervention 23

24 Conclusions Secondary Endpoints (CEAP4-6 pts.) QOL / Clinical improvement when stent ICFVO Not all patients improve after stenting ICFVO Appropriate patient / lesion / stenosis: require further investigation Different Vein Pathology ( i.e. compression vs. PTD) may have different treatment thresholds More Work to be Done!!!! 24

25 Thanks for Your Attention

26 VIDIO: Conclusions Further studies - define the degree of stenosis required to treat for predictable clinical improvement Different Vein Pathologies ( i.e. compression vs. PTD) may have different treatment thresholds /002

27 Venous IVUS interpretation made easy with the American Venous Forum Venous IVUS ipad app Now available on the App Store. Search for Venous IVUS.

28 Venous Clinical Severity Score (rvcss): By Ulcer and By Stent Time Point No Ulcer (N = 50) Ulcer (N = 50) Stent (32) No Stent (18) Stent (36) No Stent(14) 28 Baseline 11.0 ± ± ± ± month 7.1 ± ± ± ± months 7.3 ± ± ± ± 5.5 Baseline vs. 1 month P <.001 P =.008 P <.001 P =.008 Baseline vs. 6 months P <.001 P =.004 P <.001 P < Month vs. 6 months P =.757 P =.336 P =.001 P =.537 No Ulcer / Ulcer No Stent: Pt. VCSS improve by 1 mos. Ulcer Stent: Pt. w/ continuous improvement 1->6 mos.

29 Ulcer Size (N=50 at Baseline) Time Point Mean Baseline 30.7 cm 2 1 month 22.6 cm 2 6 months 24.9 cm 2 Baseline vs. 1 month P <.001 Baseline vs. 6 months P = Month vs. 6 months P = Ulcers No Ulcers Median size of the ulcers decreased from 30.7 cm 2 at baselined to 22.6 cm 2 at 1 mos. The decrease in ulcer size was statistically significant. 24% of ulcers healed at 1 mos. 50% were healed at 6 mos Baseline 1 Month 6 Months 12 29

30 Study Objectives Secondary Objectives 1. Prospectively compare the diagnostic performance of multiplanar venography and Intravascular Ultrasound (IVUS) for diagnosing treatable iliac/common femoral vein obstruction (ICFVO) 2. Prospectively compare clinical decision making regarding treatment based on multiplanar venography vs. IVUS 3. Characterize the patient response to iliofemoral venous stenting [Venous Clinical Severity Score (VCSS) and Quality of Life (QoL) measures (SF-36 6-month follow-up 30

31 Patient Quality of Life: SF-36 Time Point Physical Function Physical Health Emotional Limitations Energy / Fatigue Emotional Well-Being Social Function QoL improvement was greater in stented patients than non-stented patients. Improvement in Stented Patients persisted and was statistically greater at 6 months Pain General Health Baseline Stented 51 ±27 48 ±27 72 ±28 52 ±22 72 ±18 68 ±25 48 ±22 56 ±19 Non-Stented 59 ±28 59 ±27 75 ±28 59 ±22 78 ±17 75 ±23 59 ±25 62 ±16 P Value, Stent vs. No stent Change: Baseline to 1 month Stented 8 ±23 11 ±30 2 ±25 7 ±25 5 ±19 7 ±22 10 ±25 7 ±15 P Value, Stented Subjects <.001 Non-Stented 0 ±22 5 ±23 6 ±25 1 ±17-2 ±15 8 ±21 3 ±18 6 ±12 P Value, No Stent Change: Baseline to 6 months Stented 9 ±19 14 ±30 7 ±31 9 ±21 5 ±15 10 ±22 12 ±25 9 ±17 P Value, Stented Subjects < <.001 <.001 Non-Stented -1 ±14 7 ±23 8 ±34 3 ±15 0 ±16 12 ±27 2 ±23 6 ±15 P Value, No Stent

32 Venogram Versus Intravascular Ultrasound for Diagnosing and Treating Iliofemoral Vein Obstruction (VIDIO) Report From a Multicenter, Prospective Study of Iliofemoral Vein Interventions Paul J. Gagne, MD, FACS, RVT: Global VIDIO Principal Investigator (On Behalf of the VIDIO Investigators) American Venous Forum 28 th Annual Meeting February 24-26, 2016 Orlando, Florida