EVAS is Associated with Lower All-Cause Mortality

Transcription

1 EVAS is Associated with Lower All-Cause Mortality Marc L Schermerhorn, MD Chief, Division of Vascular and Endovascular Surgery Beth Israel Deaconess Medical Center Professor of Surgery Harvard Medical School

2 Disclosure Speaker name: Marc Schermerhorn, MD... I have the following potential conflicts of interest to report: Receipt of grants/research support X Receipt of honoraria and travel support Participation in a company sponsored speakers bureau Employment in industry Shareholder in a healthcare company Owner of a healthcare company I do not have any potential conflict of interest

3 5y Survival of Patients with AAA 67% Freedom from Mortality vs. 81% Matched Control 86% Freedom from CV Events vs. 93% Matched Control Karthikesalingam et al EJVES 2014; 46: 533 AAA, N=19,505 / Control, N=75,260

4 Factors Affecting Survival Aneurysm Size Statin and Antiplatelet Therapy 5y survival and AAA diameter O Donnell et al JVS 2018 Bahia et al BJS 2016; 103: 1626

5 Mortality Following EVAR and Open Repair EVAR Confers No Mortality Advantage over Open Repair 50% of EVAR patients are alive at 8 years Schermerhorn et al. NEJM 2015

6 EVAR Mechanism

7 Association of Aneurysm Sac Behavior with Long-Term Survival Following EVAR Sac behavior associated with new endoleaks, reintervention, and longterm mortality. Even Stable Sacs Associated with Lower Survival Association between sac behavior and long-term mortality persisted in patients without endoleaks, and was not modified by reintervention O Donnell et al. Accepted to JVS 2018 All patients (n=14,827) undergoing EVAR the Vascular Quality Initiative (VQI),

8 Association of Aneurysm Sac Behavior with Long-Term Survival Following EVAR Sac expansion was independently associated with late mortality, regardless of presence or absence of endoleak. Vascular Study Group of New England (VSGNE) Registry Deery et al. J Vasc Surg 2018;67:157-64

9 Might EVAS be Associated with a Difference in Mortality Compared to EVAR?

10 EVAS Mechanism: Active Sac Management

11 EVAS The Story Thus Far Steep initial learning curve on procedure to 2016 Good early clinical results in challenging patient cohorts Low rate Type II endoleak Failure modes apparent at 2y (migration and sac expansion) Root cause analysis and refinement of IFU Excellent clinical outcomes but reduced applicability Confirmatory IDE study underway

12 2Y Mortality Signals with EVAS: All-Cause and CV EVAS FORWARD IDE (US) EVAS FORWARD Global Registry (OUS) IDE: Carpenter et al, SVS 2017 / Registry: Holden et al Veith 2016

13 All Cause Mortality Stratified by Aneurysm Size ANEURYSM SIZE (mm) EVAS 1 n=610 EVAR 2 n=874 < % 87% >50 D < % 90% >55 D < % 79% > % 70% 1. Composite EVAS FORWARD IDE and Global Registry. Endologix Inc. Data on file. 2. Huang et al. J Vasc Surg 2017;65: NOTE: 36 Month rates estimated using provided survival plots.

14 EVAS and Systemic Inflammatory Response Syndrome (SIRS) EVAS (63) EVAR (41) PIS (%) (106) (123) CRP (mg/l) WCC MAE (%) Cardiac MAE 0 11 Endoleaks Berg et al. JEVT 2017; 24: 670 Stenson et al Veith 2017

15 All Cause Mortality: Propensity Weighting EVAS METHODS Test Group: 333 EVAS IDE patients treated in Control: 15,431 EVAR patients from the U.S. Vascular Quality Initiative (VQI) treated in Applied IDE exclusion criteria: hemodialysis, creatinine > 2.0 mg/dl, or rupture Calculated propensity scores, weighted for AAA and CV risk factors Applied inverse probability weighting to compare risk adjusted longterm survival using Kaplan-Meier and Cox regression

16 Methods (cont d) Calculated egfr utilizing CKD-EPI formula Categorized chronic kidney disease into none, glomerular filtration rate (GFR) and GFR < 30 Coronary artery disease consisted of a history of CAS, previous MI, angina, arrhythmia, CABG, or PCI Primary outcome: overall survival in propensity-weighted cohort Secondary analysis: overall survival stratified by aneurysm size

17 All Cause Mortality VQI Propensity Weighting EVAS 93% EVAS 88% EVAR After weighting, EVAS patients experienced higher 3y survival than EVAR Corresponds to 41% lower risk of mortality for EVAS (HR 0.59 [ ], P =.02)

18 All Cause Mortality, AAA < 5.5 cm VQI Propensity Weighting EVAS 94% EVAS 91% EVAR No difference in survival between patients with aneurysms < 5.5cm treated with EVAS vs EVAR (P = 0.25)

19 All Cause Mortality, AAA 5.5 cm VQI Propensity Weighting EVAS 92% EVAS 86% EVAR EVAR patients with aneurysms > 5.5 cm experienced twice the rate of mortality as those treated with Nellix (HR 2.01, P =.01)

20 Conclusion EVAS is associated with higher long-term survival than traditional EVAR EVAS and higher survival was strongest in patients with aneurysms > 5.5 cm Biology of AAA post EVAS may play a role Further study needed Comparison of cardiovascular events Clinical benefits support continuation of therapy

21 INDICATIONS FOR USE: The Nellix EndoVascular Aneurysm Sealing System can be used in patients who have an infrarenal abdominal aortic or aortoiliac aneurysm (AAA) with suitable anatomy as indicated: Iliac and femoral artery access that allows for atraumatic device introduction, Aortic proximal neck diameter range of 18mm to 28mm, minimum aortic proximal neck length 10mm, with diameter change 10%, proximal aortic neck angulation of 60, aortic aneurysm with a blood lumen diameter 70 mm, ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.4, iliac artery blood lumen diameter range of 9 mm to 35 mm outside the distal seal zone, and distal seal zone with length of 10mm and diameter range of 9mm to 25mm CONTRAINDICATIONS: The Nellix EndoVascular Aneurysm Sealing System is contraindicated for patients who have a condition that threatens to infect the implant and patients with sensitivities or allergies to the implant materials. Note: Nellix System (Catheter delivery and Implant) are not made with natural rubber latex. CAUTION: The Nellix EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System has not been approved in any geography for treatment of juxta/pararenal aneurysm. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Rx only. Note: Endologix products and associated components are not available in all countries or regions. Please consult with your Endologix representative for details regarding product availability. CE marked. Please refer to current product instructions for use. This analysis has not been submitted to FDA. Endologix is a registered trademark of Endologix, Inc. in United States, Europe and Japan and Nellix is a registered trademark of Endologix, Inc. in United States, Argentina, Brazil, Europe, and Japan. All other trademarks are the property of their respective owners Endologix, Inc. All rights reserved.