Abdominal and thoracic aneurysm repair

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1 Abdominal and thoracic aneurysm repair William A. Gray MD Director, Endovascular Intervention Cardiovascular Research Foundation Columbia University Medical Center

2 Abdominal Aortic Aneurysm Endografts

3 AAA is under diagnosed and under treated Prevalence of AAA in the U.S. Versus Diagnosis The prevalence of AAA in men is 4.5% and in women is 1.0% (data from SAVE screenings) 1,152,294 patients living with AAA Prevalence = 1,152,294 Diagnosed = 172,900 Total Treated = 69,300 Treated w/ EVAR = 22,300 15% are diagnosed 6% are treated

4 Abdominal Aortic Aneurysm Diameter < 4 cm 4-5 cm 5-6 cm 6-7 cm 7-8 cm > 8 cm Annual Risk of Rupture 0 % % 3-15 % % % % J Vasc Surg 2003;37:

5 Threshold to intervention Prophylactic treatment decisions can be difficult (asymptomatic patients) Major considerations are operative mortality and life expectancy compared to risk of rupture In general, AAA s s cms in reasonable risk patients should be repaired AAA s s exceeding the expected rate of growth of 10% per year warrant repair EVAR may lower the threshold to treat

6 Elective open repair AAA Major surgical procedure Mortality 2% to 5% Complications Pseudoaneurysms Erectile dysfunction Aortoenteric fistula Graft thrombosis Graft infection Recovery period 6 weeks to 4 months

7 Functional Outcomes Following Open AAA Repair 154 consecutive elective AAA repairs Operative mortality 4% Mean hospital stay 10.7 days Mean ICU stay 4.57 days 11% of pts transferred to skilled nursing facility Mean stay 3.66 months Only 64% of patients experienced complete recovery Mean time 3.9 mos 33% were not fully recovered at mean f/u of 34 mos 18% said they would not undergo AAA repair again knowing recovery process Oregon Health Sciences Center J Vasc Surg 2001;33:913-20

8 Endovascular Repair Proven benefits Minimally invasive Reduced morbidity Reduced hospital stay Early return to function Typically 2 to 4 weeks for full recovery

9 Currently Available Devices (U.S.) Medtronic AneuRx US Trial Implants 1193 Gore Excluder US Trial Implants 235 Cook Zenith US Trial Implants 352 Endologix Powerlink US Trial Implants 192

10 Device profiles Device profiles woven woven polyester polyester infrarenal infrarenal 21F 21F 20,22,24, 20,22,24, 26,28 26,28 aneurx aneurx medtronic medtronic eptfe eptfe infrarenal infrarenal 18F 18F 23,26, 23,26, excluder excluder gore and gore and associates associates eptfe eptfe infrarenal infrarenal 21F,22F 21F,22F 25,28 25,28 power powerlink link endologix endologix woven woven polyester polyester suprarenal suprarenal 20F,23F 20F,23F 22,24,26, 22,24,26, 28,30,32 28,30,32 zenith zenith cook cook graft graft material material fixation fixation location location outer outer diameter diameter neck neck diameter diameter device device company company

11 Anatomic considerations/limitations Endovascular Stent Grafts Proximal aortic neck Diameter of device oversized 10-20% Length 1.5cm for all FDA approved devices Angulation/tortuosity Short angulated necks, short wide necks, & severe AAA tortuosity can lead to suboptimal outcomes Iliac access Large enough to accommodate 18F-24F delivery systems (7-8mm for bifurcated devices)

12 Preoperative Imaging CTA (3mm cuts) Infrarenal neck Aneurysm with thrombus Iliac access

13 Iliac aneurysms

14 INTRAOPERATIVE ANGIOGRAM

15 Completion angiogram (<60 minutes) shows aneurysm exclusion Groins repaired or percutaneously closed (90% of cases) Follow-up CTA reveals thrombosis of AAA sac

16 Endoleaks

17 Follow-Up Imaging CTA to assess endoleak and size 1 month 6 months 12 months Annually Graft separation

18 Alternatives to CT scanning Ultrasound with or without contrast agent Cardiomems device to assess endotension May be more sensitive than other methods Allows for direct measurement of pressure within the excluded sac Need data to support endotension as a predictor of delayed rupture Requires specialized monitoring equipment

19 Outcomes with EVAR: Lifeline Registry Freedom from aneurysm-related related issues 2664 EVAR vs. 334 open repairs K-M M analysis at 6 years: 99% freedom from rupture 98% freedom from aneurysm-related related death 95% freedom from surgical conversion

20 As aneurysms grow in size, proximal necks can become shorter and more angulated which may preclude patient from being good anatomic candidate for stent graft

21 Small vs. large AAA 2 year clinical outcomes following EVAR Type 1 Endoleak Migration Conversion Aneurysm Related Death 24 months Small < 5.5 cm 1.4 % 4.4 % 1.4 % 1.5 % 86 % Large > 5.5 cm 6.4 % 13 % 8.2 % 6.1 % 71 % Ouriel et al J Vasc Surg 2003;37:

22 PIVOTAL Trial Positive Impact of endovascular options for treating aneurysms Randomization of close to 1700 patients with 4-5cm 4 AAA s s to EVAR or continued follow up AAA s s must exceed double the diameter of the reference aorta and meet inclusion criteria for the AneuRX device Patients who become symptomatic, exceed 5.0 cms or experience rapid growth will be offered repair

23 Improvements in Cath Lab imaging DynaCT acquisition

24 Extending applicability: Cook fenestrated

25

26 Extending applicability: branch grafts Common Iliac Aneurysm

27 Thoracic endograft (TEVAR)

28 Thoracic aortic aneurysm: size vs. rupture Yearly risk > 3.5cm >4.0cm >5.0 cm > 6.0cm Rupture 0.0% 0.3% 1.7% 3.6% Dissection 2.2% 1.5% 2.5% 3.7% Death 5.9% 4.6% 4.8% 10.8% Any of the above 7.2% 5.3% 6.5% 14.1%

29 Gore thoracic endograft: : pivotal trial 140 TAG vs. historical/concurrent surgical control of 94 Safety endpoint: 1 year MAE (non-inferiority) Death, repeat hospitalization, permanent sequelae, repeat procedure/surgery Efficacy endpoint: 1 year freedom from device-event event (superiority) At 2 years, TAG resulted in less LOS/ICU use, lower paraplegia (3% vs. 14%) lower CVA (5% vs. 10%) fewer re-op (4% vs. 10%) less aneurysm-related related death (97% vs. 90%) No difference in all-cause mortality (26% vs. 28%)

30 Completing the Elephant trunk repair for arch aneurysm or dissection

31 Completing the Elephant trunk repair for arch aneurysm or dissection Surgical clips on graft

32 Completing the Elephant trunk repair for arch aneurysm or dissection First segment

33 Completing the Elephant trunk repair for arch aneurysm or dissection Final segment

34 Completing the Elephant trunk repair for arch aneurysm or dissection

35 Completing the Elephant trunk repair for arch aneurysm or dissection Preclose

36 TEVAR considerations: Paraplegia Coverage of graft from zones 2-72 usually does not result in paralysis Coverage from zones may be associated with higher risk of paraplegia Precedent AAA surgery increased risk To address risk of paraplegia: Spinal drainage Maintain adequate blood pressure

37 TEVAR Considerations: covering subclavian If covering the subclavian to mitigate a short neck is considered, ask: Is there a LIMA bypass? Is dominant vertebral flow derived from the subclavian? Does carotid stenosis present a risk factor? Obtain a full carotid angiogram to assess carotid flow Be prepared to do subclavian bypass if indicated

38 TEVAR considerations: Angulation 65 degrees

39 Extending TEVAR: Penetrating ulcer

40 Extending TEVAR: Thoracic dissection Type A: Surgical repair Type B: Surgery for type B aortic dissection 14% to 67% risk of irreversible spinal cord injury or postoperative mortality Medical management for uncomplicated dissection with aggressive antihypertensive therapy ~85% of patients survive initial hospital stay Long-term outcome is unsatisfactory ~25% late expansion of the false lumen at 4 years formation of a thoracic aneurysm with inherent risk of rupture or to retrograde progression of dissection with involvement of the proximal aorta with even higher mortality 50% mortality at 5 years

41 Endografting for dissection: INSTEAD trial European trial Patients with uncomplicated Type B dissection Randomized to medical or endo Rx Endpoint: all cause mortality at 2 years Preliminary outcomes at 1 year: no difference in mortality

42 Evolution of Endovascular Indications Thoracic Branch Standard AAA Fenestrated

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