1. Vascular Disease: Update on Testing and Management Daniel B. Walsh, M.D. Professor of Surgery, Dartmouth Medical School Vice-Chair, Department of Surgery, Dartmouth-Hitchcock Medical Center

2. Vascular Disease: Update on Testing and Management Improvements in imaging techniques Screening for mesenteric ischemia Screening for hypertension and renal insufficiency Lower extremity revascularization Endovascular aortic grafts Carotid stents

3. Mesenteric Duplex Accurately identifies mesenteric arterial occlusive disease May also identify anatomic variants of the mesenteric circulation

4. Mesenteric Duplex

5. Dartmouth Criteria for Celiac Reversed Flow in Common Hepatic ALWAYS indicates severe celiac stenosis or occlusion EDV > 55 cm/sec Sensitivity 93% Specificity 100%

6. Dartmouth Criteria for SMA EDV > 45 cps retrospective study Sensitivity 100% Specificity 92% EDV > 45 cps in prospective analysis Sensitivity 90% Specificity 91%

7. Renal Duplex Accurately identifies correctable renal vascular atherosclerosis which causes global renal ischemia, hypertension and secondary renal insufficiency

8. Renal Duplex

9. Can durable lower extremity revascularization be performed based solely on duplex ultrasound arteriography? Success = plan the procedure, demonstrate technical adequacy, achieve patency comparable to standard contrast arteriography The Question

10. Duplex for Operative Planning Patients requiring tibial or peroneal artery bypass Preop DU, Preop CA Operating Surgeon DU Surgeon Reviewer (retrospective) CA Surgeon Reviewer (retrospective) DU Target CA Target Actual Bypass Recipient

11. Patient Demographics Patients38 Extremities40 Mean Age72 (range, 44-82) Sex Male53% Female47% Risk Factors Smoking39% Hypertension92% Diabetes74% Clinical Manifestation Rest Pain35% Tissue Loss65% Co-Morbid Illnesses Coronary Artery Disease55% Chronic Renal Insufficiency18%

12. Tibial or Peroneal Arteries Seen DU CA Seen Not Seen Total (%) 11010 (8%) 119 1 (1%) ATA 382 (5%) 39 1 (2%) PER 328 (20%) 40 0 PTA 400 40 0 40 lower extremities from 38 Pts. 110/120 arteries seen by DU and CA DU and CA agreement in evaluation of vessels seen was 81% (CI range 73% - 87%)

13. DU & CA Artery Selection DU and CA agreement in evaluation of target arteries was 85% (95% CI 71-93%). CA Occluded Patent, Not Target CA Target Occluded 363 3 (3) DU Patent, Not Target 818 3 DU Target 4 (1) 1 34

14. DU vs. CA Selection of Actual Bypass Recipient Artery DU vs. CA p=.59 ATA111211 (92%)99 (88%) PER1055 (50%)109 (88%) PTA192319 (83%)2119 (91%) Total404035 (88%)4037 (93%) Actual Bypass Artery # DU Targets #, (%) Correct # CA Targets #, (%) Correct

15. To Confirm Long-Term Patency

16. Primary Patency

17. Limb Salvage

18. Duplex to Confirm Technical Adequacy From 1996 to 2000, 45 primary infragenicular vein bypass grafts with completion duplex ultrasound 20 thrombosed within 12 months (44%) Time to thrombosis: 1 to 361 days mean 88  19 days (  SEM) Bypass graft thrombosis led to 7 amputations (35%)

19. 35 30 25 20 15 10 5 0 Distal EDV (Cm/Sec) EDV 8 cm/sec Distal Bypass EDV, cm/sec ThrombosedPatent

20. Distal Bypass, EDV EDV  8 cm/sec Sensitivity, 76% Specificity, 75% PPV, 71% NPV, 78% EDV = 0 cm/sec Sensitivity, 40% Specificity, 100% PPV, 100% NPV, 66%

21. Discussion DU selects tibial level bypass recipients as often as CA In 20% of patients, peroneal is not adequately visualized

22. Discussion “DU First” Approach 80% of patients avoid CA DU has no morbidity Allows focused CA DU accuracy - operator dependent

23. Conclusions DU and CA typically agree in selection of tibial artery bypass recipient If PER is seen by DU, CA unlikely to alter procedure

24. Durable lower extremity revascularization can be performed based solely on duplex ultrasound arteriography! Success = plan the procedure, demonstrate technical adequacy, achieve patency comparable to standard contrast arteriography The Answer

25. Carotid Endarterectomy Clinical Trials NASCET: (NEJM, 1991), decreased stroke from 24% to 7% VA Cooperative Study Group: (NEJM, 1993), decreased overall neurologic event rate from 21% to 8% in asymptomatic patients ACAS: (JAMA, 1995), 5 year stroke rate was decreased from 11% to 5% in asymptomatic patients. Benefits not as great for females (17% risk reduction) than males (66% risk reduction)

26. Pre Stent placement Following Predialation with 3 mm balloon 8X24 Wall stent 5 mm PTA

28. 78 y/o male with aSx L ICA >95% stenosis and R vocal cord paralysis

29. 8X24 wall stent, 5mm PTA

31. Multi-center Trials Comparing CEA vs CAS CREST : NIH sponsored, randomized, prospective CARESS: Society of Endovascular Specialists sponsored, non-randomized

32. Dartmouth – Hitchcock Experience with Carotid Stenting N= 31 patients 23 performed with cerebral protection None would have been eligible for NASCET 1/31 minor strokes: No TIA, major stroke or death No cases of restenoses, though follow- up is short

33. Summary Results of CAS improving ? Impact of neuro-protection device Results of CAS approaching those of CEA but will need multi-center clinical trials to confirm efficacy/safety. Patients better served by CAS: Neck radiation Recurrent stenosis High bifurcation(C-2) Associated comorbidities Contralateral cranial nerve injury

34. EVG Preoperative Imaging Accurate measurements are essential for EVG planning and implantation CT Scan Diameter; Extent of AAA Angiography Length; Iliac Access Electronic measurements are better than those made from hard-copy CT. may not be perpendicular to the vessel Angiographic measurements tend to underestimate length compared to CTAngio* Computer Aided Measurement, Planning & Simulation (CAMPS) Software – Preview ® *SemVasc Surg, Vol12, No4, Dec.1999

35. 3D-CAMPS Software

36. Methods Retrospective Review 203 consecutive EVG repairs 6/96 –12/01 6 early repairs used pre-operative angiography for decision making and were excluded Last pre-operative angiogram, 12/1998 197 remain for analysis in which 3D-CAMPS sole pre-operative imaging modality Mean follow-up 17.5 months

37. Cases selected for angiography: Prediction of Difficult Access 3D CAMPS predicted difficult access in 14 of the first 82 cases (17%) Angiography: 4 most severe cases (3D- CAMPS suggested access failure likely) 3/4 angiograms falsely reassuring the only cases of femoral access failure in these 82 patients 197 procedures have been performed relying on 3D-CAMPS alone, with no access failures.

38. EVG Types & Configurations 5 Bifurcated 6 Tube 3 AUI 14 EVT (Ancure) 42 Bifurcated 42 Excluder 1 Tube 1 Talent 2 Tube 2 Lifepath 26 Bifurcated 4 Tube 30 Vanguard I 98 Bifurcated 3 Tube 8 AUI 109 AneuRx

39. Operative Results General Anesthesia 74% Technical success 98.5% 3 immediate conversions early in series Fluoroscopy Time 37±17min Adjunctive procedures n=53 patients (27%) 23 Coil Occlusions of Branch Vessel 16 Common Femoral Artery reconstructions 8 Fem-Fem Bypass for Aortouniliac (AUI) grafts 6 Iliac Stent 5 Retroperitoneal/ Flank incision 3 Brachial Access

40. Perioperative Results 30-Day Mortality 0.5% Mean LOS 2 ± 3 days 9 (5%)Patients Requiring ICU Stay 2 (1%)Peripheral Neurologic Injury 2 (1%)Limb Occlusions 3 (1.5%)Respiratory Failure 1 (0.5%)Hemodialysis 12 (6%)Creatinine Increase > 0.5 mg/dL 3 (1.5%)Myocardial Infarction

41. Patient Survival Time (months) 0.2.4.6.8 1 Survival 010203040506070 No deaths were AAA related

42. Endoleaks 168 130 121 69 Total at Risk II I III Percent of Total No patients with AAA enlargement

43. Freedom from Re-Intervention Non FDA Approved Ultimately FDA Approved 0.2.4.6.8.8 1 Freedom from Secondary Intervention 010203040506070 Time (months) Logrank (Mantel-Cox) p = 0.02 No open conversions Two late ruptures

44. Freedom from Re-Intervention DHMC vs EUROSTAR* * Eurostar Data Registry, Jan.2001 Freedom from Re-Intervention 0.2.4.6.8 1 010203040506070 Time (months) DHMC, entire series EUROSTAR*

45. Reported Series NR 87 % 1 % 24 % 75 % 98.4 % 27 EUROSTAR 2001 Report 98.5 %98.6 %94 %Technical Success 17.518 Mean Follow-Up (mos.) 1 %0.8 %0Rupture Rate 88 % NR 86 %Survival (2yrs) 01.3 %2 %AAA Related Mortality 7 % NR 25 %*Endoleak Rate at 2yrs 90 % NR 75 %Freedom from Secondary Intervention (2yrs) Datillo et al JVS 2002 MGH Bush et al JVS 2001 Emory Low Risk Grp Multiple Graft Types Pre-Operative Angiography DHMC NR = not reported, *=based on “continuing clinical success” DHMC

46. Single Device Series 99.4 %100 %98 %90-96 %Technical Success 15(14-17)1824Mean Follow-Up (mos.) 0 %000Late Rupture Rate 88 %87 %76 %94 %Survival 000.3 % NR AAA Related Mortality 6 %20 %13 % (1yr)20 %Endoleak Rate at 2yrs 95 %86 %90 % NR Freedom from Secondary Intervention (2yrs) DHMC Matsumura et al. EXCLUDE R (Phase II) Zarins et al. J Endovasc Ther 2001 ANEURX (FLEX) Makaroun JVS 2001 ANCURE (Bifurcated) Single Device Series Pre-Operative Angiography DHMC NR = not reported

47. Conclusion 3D-CAMPS eliminates the need for pre- operative contrast arteriography. Accurate patient selection Accurate Graft Sizing Equivalent results to best series using pre- operative angiography Additional advantages Less invasive Does not require CT workstation Less expensive Less radiation & contrast exposure