Associate Professor Walter W. Buckley Endowed Chair in Research Cleveland Clinic Lerner College of Medicine-CWRU. Houston Aortic Symposium 2017
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1 Matthew J. Eagleton, MD Associate Professor Walter W. Buckley Endowed Chair in Research Cleveland Clinic Lerner College of Medicine-CWRU Houston Aortic Symposium 2017
2 Aortica: Advisory Board Centerline Biomedical: Advisory Board FEVAR l February 25, 2017 l 2
3 Roy Greenberg, MD initiated IDE trial 2001
4 IDE Enrollment : 1257 Patients Increasing Complexity
5 Type IV JRAA Type I Type III Type II
6
7 Aortic Aneurysms treated with F/B-EVAR: PS-IDE, CMD: High Risk Patients JRAA and Type I, II, III Type IV TAAA TAAA
8 Single center, prospective study: patients 258 Juxtarenal 349 Type IV TAAA Fenestrations and scallops varying degrees of coverage (Renals, SMA, Celiac) Mean FU: 8 years Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61:
9 5-Year Survival: 50% 8-Year Survival: 20% 8-Year Freedom from Aneurysm-Related Mortality: 98% Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61:
10 ~65% at 5 years Secondary Procedures Branch Occlusions Stent Migration Endoleak Aneurysm Growth Spinal Cord Ischemia Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61:
11 2 o Procedures (Vascular/Aortic): 26.4% Spinal Cord Ischemia: 1.16% Mean coverage above celiac w/ SCI: Mean coverage above celiac w/o SCI: 52 ± 21 mm 33 ± 21 mm Stent Fracture: 2.2% Stent Migration: 0.16% Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61:
12 30 (1.9%) branch occlusions 1/109 (1%) celiac stents 3/333 (1%) SMA stents 12/558 (2.2%) left renal artery stents 12/553 (2.2%) right renal artery stents Mastracci TM, J Vasc Surg 2013; 57:
13 SMA: 26 (4%) 13 endoleak 13 stenosis/thrombosis Renals: 58 (5%) 28 endoleak 30 stenosis/thrombosis Mastracci TM, J Vasc Surg 2013; 57:
14 Freedom from secondary in nterventions Day: 98% (96-99%) 1-Yr: 94% (92-96%) 5-Yr: 89% (78-90%) No factor showed association w/ increased risk 0 for 2 re-intervention Years of follow up Mastracci TM, J Vasc Surg 2013; 57:
15 Endoleak - Type 1 - Type 3 Total 3% 4.6% Supra- Celiac SMA or Renal or celiac Scallop lower lower 3.4% 10% 1.1% 5.2% 2.1% 2.7% 10.4% 9.3% Aneurysm Growth Aneurysm Rupture 3.6% 5.2% 2.1% 4.6% 2.6% 2.3% 5.2% 1.1% 2.8% 1.3% More complex grafts More endoleak potential Less extensive grafts More endoleak potential Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61:
16 Higher Rates: - Most type 1 leaks occurred late - Most occurred from patients early in our experience - Landing zone - Shorter - Involved fewer visceral vessels O Callaghan A, et al; J Vasc Surg 2015; 61:
17 Courtesy T. Mastracci
18 O Callaghan A, et al; J Vasc Surg 2015; 61:
19 O Callaghan A, et al; J Vasc Surg 2015; 61:
20 354 TYPE II AND III TAAA REPAIRS Eagleton, et al; J Vasc Surg 2016; 63:
21 Device Configuration: 1320 Target Vessels 274 Patients (77.4%) Fenestrations Only 45 Patients (12.7%) Single Branch with Fenestrations 35 Patients (9.9%) Double Branches with Fenestrations Eagleton, et al; J Vasc Surg 2016; 63:
22 Overall technical success rate: 91.2% Branch-specific technical success rates: Celiac 96.3% SMA 100% Right Renal Left Renal 99% 99% 30-Day/In-Hospital Mortality: 4.8% Eagleton, et al; J Vasc Surg 2016; 63:
23 Renal Failure: 2.8% Type II: 5.5%* Type III: 1.3% Spinal Cord Ischemia (Permanent): 4% Type II: 7.8%* Type III: 1.8% Adjuncts to reduce last 3 years for type II < 4% * P<0.0.5 Eagleton, et al; J Vasc Surg 2016; 63:
24 Endoleak 67 (18.9%) Branch Occlusion or Stenosis 27 (7.6%) Aortic-Related Re-interventions 9 (2.5%) Component Separation (without endoleak) Access Site Pseudoaneurysm 5 (1.4%) Chronic Lower Extremity Ischemia 3 (0.8%) Iliac Aneurysm Expansion 1 (0.2%) 4 (1.1%) Eagleton, et al; J Vasc Surg 2016; 63:
25 SMA Celiac SMA Patency Rates Celiac Patency Rates Months Right Renal Patency Rates Left Renal Patency Rates 12 Right Renal Left Renal Months Months Months Eagleton, et al; J Vasc Surg 2016; 63: Primary Patency Secondary Patency
26 36-Month Values: Overall: 57% 36-Month Freedom from Type II: 46% Aneurysm-Related Mortality 91% TypeisIII: 62% p=0.01 Eagleton, et al; J Vasc Surg 2016; 63:
27 Concern for high long-term mortality rates in our series : 1091 patients from the IDE 522 patients died after F/B-EVAR Mean follow-up: 2.8± 2.4 yrs (median 2.3 yrs) 3084 patient-years available for analysis Beach et al., SAVS January 2017
28 100 US Life Matched 80 Survival: day: 1-year: 2-year: 3-year: 5-year 7-year: 97% 93% 75% 64% 46% 30% High-risk, untreated Years Beach et al., SAVS January 2017
29 50 Early Phase (0-4 mos) 40 Constant Phase 30 Late Phase (> 4 mos) Years Beach et al., SAVS January 2017
30 Risk Factors for Death: Type I/II or III repair Lower Systolic Blood Pressure (preoperative) Higher BUN* Smaller renal artery diameter No preop antiplatelet use Thrombocytopenia (preoperative) * Not on di aly si s Beach et al., SAVS January 2017
31 Risk Factors for Death: (entire post-op period) Larger maximum aortic diameter Lower BSA COPD Higher heart rate Lower Ejection Fraction Lower hemoglobin (preoperative) More severe renal artery disease Beach et al., SAVS January 2017
32 Risk Factors for Death: Type I/II TAAA repair Older Age Higher weight (BMI) Congestive Heart Failure No preop antiplatelet use Longer prothrombin time Beach et al., SAVS January 2017
33 Increased Risk Death at 2-Years Congestive heart failure COPD Renal dysfunction Anemia Coagulation disorders Type I/II repair and larger aneurysms Beach et al., SAVS January 2017
34 Clinical Scenario Case 1: 65yo M, no CHF, COPD, or renal disease, normal blood counts, on antiplatelet, type IV repair Case 2: 75yo M, with CHF, COPD, and mild anemia and thrombocytopenia, mild renal dysfunction, type I/II repair Predicted 2 year survival 76.5% vs 29.3% Beach et al., SAVS January 2017
35 Data represents an evolution in devices and techniques F/B-EVAR is a good alternative for patients with aortic aneurysms but will require reintervention Keys to success: Routine monitoring and early re-intervention for stenosis and endoleaks Careful selection of proximal and distal aortic landing zones
36 Outcomes will continue to improve with Experienced providers refining its application Improvements in technology Attention to patient medical care affect long-term survival
37
38 Survival: Open v. F/B-EVAR (estimates) Survival Simulated OR CCF F/B-EVAR Time (months)
39 Survival: Open v. F/B-EVAR (estimates) Survival Simulated OR CCF F/B-EVAR Time (months)
40 Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61:
41
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