Current Status of Abdominal Aortic Stent Grafts. John R. Laird Professor of Medicine Director of the Vascular Center UC Davis Medical Center

Transcription

1 Current Status of Abdominal Aortic Stent Grafts John R. Laird Professor of Medicine Director of the Vascular Center UC Davis Medical Center

2 Autumn Greetings

3 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Consulting Fees/Honoraria Research Support Boston Scientific, Medtronic, Abbott, ev3, Bard Peripheral Vascular, Lutonix, AngioScore Atrium Medical, WL Gore Major Stock Shareholder/Equity (Modest) AngioScore, Angioslide, NexGen, NovoStent, Endoluminal Sciences Major Stock Shareholder/Equity (Significant) AccessClosure

4

5 AAA FACTS AAA affects 1-5% of population Most commonly diagnosed in the seventh decade 4:1 male to female Increasing incidence 12.2/100,000 to 36.2/100,000 10th leading cause of death Ernst C. NEJM 1993;328:1167

6 Abdominal Aortic Aneurysm Scope of Problem 25-41% risk of rupture at 5 years for untreated AAA > 5 cm > 90% mortality for out of hospital rupture > 50% mortality for in-hospital rupture Other complications: Distal embolization Compression syndromes

7 AAA Operative Mortality Modern Era # of Studies # of patients Operative Mortality Single Center Reports 7 2, % Multicenter Reports 5 10, % Population Based Studies 3 9, %

8 Endoluminal Stent-Graft Advantages Minimally invasive Reduced morbidity and mortality Less blood loss/need for transfusion Shorter hospital stay Quicker recovery time

9 FDA-approved Devices AnCure: Removed from the market Perioperative complications AneuRx: 99 Excluder: 02 Zenith: 03 Powerlink: 04 Talent: 08

10 AneuRx AAAdvantage Stent Graft System

11 AneuRx AAAdvantage Stent Graft Radial Force Self expanding, diamond shaped nitinol elements without barbs or hooks Flared limbs Graft Material MRI Compatible Nitinol exoskeleton High density polyester graft material

12 Gore Excluder AAA Device Sealing cuff Barbs

13

14 C3 Delivery System

15 Cook Zenith Endograft Modular bifurcated design two docking limbs Long suprarenal attachment Proximal attachment hooks 18Fr and 20Fr delivery catheters

16

17 Powerlink System (ENDOLOGIX) Bifurcated unibody system. Single wire Cobalt chromium stent. eptfe covered, sutured only at the ends. Neck diameters 25 & 28 mm. Lengths 135, 140 & 155 mm. Limbs 16 mm diameter.

18 Endurant Stent Graft

19 Aneurysm Morphology

20 Aneurysm Morphology

21 Endovascular Stent-Grafting Technique Critical Dimensions: Diameter and length of proximal neck Diameter of the common iliac arteries (attachment site) Diameter of external iliac and common femoral arteries (for device passage) Length from renal arteries to aortic bifurcation and iliac bifurcation (device selection)

22 Endovascular Procedure Cath Lab or OR Suite (Fluoroscopy) General, Epidural, or Local Anesthesia Bilateral Small Groin Incisions vs. Preclose technique Bifurcated Graft Discharge on post op day one or two

23 Current Practice of EVAR Complete Percutaneous Endovascular Aneurysm Repair 18F 12F Less time Lower cost Less complications Equal success Zvonimir Krajcer, MD

24 Current Practice of Percutaneous Exclusion of AAA Pulling on the rails of Perclose the sliding knots are advanced to the arteriotomy. The.035 hydrophylic guide wire remains in place until hemostais is achieved Zvonimir Krajcer, MD

25 Endoluminal Stent-Grafts 88 year old male History of COPD and pacemaker High surgical risk 6.5 cm AAA

26

27 Endoluminal Stent-Grafts Baseline CT Scan Following Stent-Graft

28 AAA Shrinkage

29 EVAR Complications Periprocedural Iliac dissection/rupture Embolization Mesenteric/renal ischemia Limb ischemia Late Endoleak Graft migration Graft failure Late Rupture

30 ACCESS ISSUES AORTIC ENDOGRAFTS Large sheath Inflexible devices DANGER!! Calcification Tortuosity Small iliacs (women)

31

32 Endoleak Type I Endoleak Proximal or distal attachment Type II Endoleak Retrograde branch flow Type III Endoleak Structural defect or junction Type IV Endoleak Trans-graft blush White, et al, JES, 1997;4: B-13

33 Endoleak: 2D + 3D Analysis

34 Type I Endoleak

35 Late Graft Failure Type III Endoleak

36 Management of Endoleak Type I or III: Correction by further endoluminal graft procedure or surgery Type II: Conservative (observation, with monitoring by repeat imaging) Embolization Conversion to open repair of aneurysm Type IV: No therapy required

37 Randomized Trials of EVAR vs. Open Surgical Repair DREAM Trial EVAR Trial

38 Outcome Operative mortality Operative mortality and severe complications Operative mortality and moderate or severe complications Major outcomes in DREAM Randomized trial of 345 patients with AAA>5.5cm Open repair (%) Endovascular repair (%) Relative risk (95% CI) 3.9 ( ) 2.1 ( ) 1.3 ( ) Prinssen M et al. N Engl J Med 2004; 351:

39 Preliminary Outcomes with EVAR (Endovascular Aneurysm Repair) 1082 pts randomized to either EVAR or Surgery for AAA >5.5cm Outcome EVAR Open repair In-hospital mortality (%) day mortality, intention-totreat (%) Secondary interventions (%) P EVAR investigators. Lancet 2004

40 N Engl J Med 2005;June 9, 352:

41 Early benefit lost in 1 Yr N Engl J Med 2005;June 9, 352:

42

43 EVAR vs Open Repair 45,660 medicare patients who underwent EVAR or open repair (22,830 in each group) from Mean age 76 years 20% women 10% had MI in previous 2 years

44

45

46

47

48 Open surgery vs EVAR: Patient preference Open surgery 4 days after Once you go Endo, you cannot come back Endovascular 4 hrs after T Ohki, MD

49 Investigational Devices Fenestrated and branch vessel devices TriVascular Ovation device Vascutek/Terumo Anaconda device Lombard Medical Aorfix with Securant staple Aptus Modular Endograft with Endovascular stapling system Nellix Endoluminal Sciences Others

50 Zenith Fenestrated AAA Endovascular Graft PROXIMAL GRAFT DISTAL GRAFT LEG EXTENSION GRAFT SCALLOP SMALL FENESTRATION

51 Ovation Abdominal Stent Graft System Tri-modular design Suprarenal stent with anchors for fixation Inflatable rings for optimal seal Low viscosity, radiopaque polymer fill Hydrophilic catheter coating 14F OD Aortic Body 13F OD Iliac Limbs CE Mark approved - August 2010 US Trial underway

52 Separation of Fixation and Seal ANCHORS FIXATION SEALING COLLAR SEALING RING SECONDARY SEALING RING SEALING ZONE Polymer filled sealing mechanism: water tight seal, even in short (down to 7 mm), calcified, and thrombotic necks.

53 Ovation Graft

54 Ovation Graft Pre Post

55 Endovascular Stapling

56 Deployment Steps

57 Final Result After Four EndoStaples

58 Summary EVAR is here to stay standard of care for AAA treatment when anatomy is suitable Lower profile devices on the horizon (13 16 Fr) Most cases can be done totally percutaneous Techniques for treating short or no neck (fenestrated grafts, snorkel technique) evolving