• A Randomized Comparison of Vascular Complications after TAVR Comparing the SAPIEN vs. The Lower-Profile SAPIEN XT System in Inoperable Aortic Stenosis Patients

    A Randomized Comparison of Vascular Complications after TAVR Comparing the SAPIEN vs. The Lower-Profile SAPIEN XT System in Inoperable Aortic Stenosis Patients Augusto D. Pichard, MD on behalf of The PARTNER Trial Investigators and The PARTNER Publications Office A PARTNER 2 Substudy Analysis Proctor for Edwards Lifesciences 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 Disclosure Statement of Financial Interest In inoperable patients with severe aortic stenosis, major vascular complications (VC) after TAVR are common and associated with unfavorable outcomes. The use of large diameter catheters with the first generation devices and the high-risk characteristics of the treated population have been implicated as potential causes. The frequency and impact of VC with the newer second generation, low-profile SAPIEN XT valve and delivery system is unknown. HR (Major VC vs. No Major VC- 2.16 [95% CI- 1.19,3.93]) Log-Rank p= 0.009 Major Vascular Complication (n=31) No Major Vascular Complication (n=146) Mortality (%) Time in Months 26.7% 48.4% Mortality with Major Vascular Complications in PARTNER 1B (TF) Généreux et al. JACC 2012 33% reduction in CSA NovaFlex RetroFlex 3 To examine the effect of device type on vascular complications after TAVR To characterize the incidence and nature of vascular complications after TAVR To evaluate the impact of major vascular complications on 1 year all-cause mortality To determine the predictors of major vascular complications after TAVR As-treated analysis of inoperable patients undergoing TF-TAVR in the PARTNER 2 Cohort B trial with either SAPIEN or SAPIEN XT Inclusion/exclusion criteria, data collection and monitoring were similar to PARTNER I Cohort B Trial Key exclusion criteria- Iliac-femoral anatomy precluding safe sheath insertion (vessel size <7 mm for 23 mm valve or < 8 mm for 26 mm valve. 8 and 9 mm for heavily calcified vessels). Aortic annulus diameter (echo measurement) < 18 mm or > 25 mm Significant aorto-iliac disease, including marked tortuosity Events were adjudicated by an independent CEC Major and minor vascular complications as defined by Valve Academic Research Consortium-2 criteria Event rates are presented as Kaplan-Meier estimates Multivariable analyses were performed to identify predictors of major vascular complications using Cox proportional hazards models Major Vascular Complications Any aortic dissection, rupture, left ventricular perforation, or new apical aneurysm/pseudo-aneurysm Access site or access-site related vascular injury (dissection, perforation, stenosis, hematoma, etc.) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment Distal embolization requiring vascular surgery, amputation, or irreversible end organ damage Unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischemia, or neurological impairment Any new ipsilateral lower extremity ischemia Surgery for access site-related nerve injury Permanent access site-related nerve injury Minor Vascular Complications Access site or access-site related vascular injury (dissection, perforation, stenosis, hematoma, etc.) NOT leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment Distal embolization treated with embolectomy and/or thrombectomy and NOT resulting in amputation or end organ damage Unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft Source- Kappetein, et al. JACC 2012 TF TAVR SAPIEN XT TF TAVR SAPIEN Primary Outcome- Major Vascular Complications at 30 days 1-1 Randomization VS n = 560 Randomized Patients The PARTNER II Inoperable CohortAs-Treated Population Study Flow ASSESSMENT- Transfemoral Access Inoperable ASSESSMENT by Heart Valve Team n = 282 n = 271 30 Day Outcomes – Major Vascular Complications 30 Day Outcomes – Minor Vascular Complications p=0.33 n=105 17.1% 14.3% <1% 3.8% 4.8% 10.5% Percentage p=0.003 p=0.04 p=0.10 No Major VC Major VC Females 69.6% Females 49.6% Males 53.1% Female sex was statistically significant for major vascular complications at 30 days (HR 2.34, CI 1.40-3.91, p=0.001) Major VC SAPIEN XT Major VC SAPIEN Females 71.4% Females66.7% Males 33.3% There was no statistical significance between device type and gender on 30 day major VC rate (p=0.67). XT + VC Sapien + No VC Sapien + VC XT + No VC Multivariable analysis* demonstrated only two statistical significant predictors- Female sex (HR 2.34, CI 1.40-3.91, p=0.0001) SAPIEN THV (HR 1.64, CI 1.01-2.67, p=0.043) Interaction testing between gender and device type was not statistically significant for 30 day major vascular complications. *Baseline Covariates- Age, gender, BMI, STS score, diabetes, smoker, peripheral arterial disease, renal insufficiency, and device type In this randomized evaluation of SAPIEN vs. the lower profile SAPIEN XT system- SAPIEN XT patients had a lower rate of major vascular complications, disabling bleeding and transfusions The most common vascular complications were dissection, perforation, and hematoma, which were all lower with SAPIEN XT Major vascular complications resulted in increased 1 year mortality Female sex was associated with a greater likelihood of developing major vascular complications at 30 days (independent of device type). CT scans, angiograms, and peripheral ultrasound performed prior to randomization was not available in case report forms. Information regarding operator experience, and strategies to prevent and/or treat major vascular complications was unavailable at the time of this analysis. The newer low-profile SAPIEN XT and NovaFlex delivery system demonstrated markedly lower major vascular complications rates. SAPIEN XT should be the preferred transcatheter valve to minimize morbidity from major vascular complications in inoperable patients undergoing TAVR. p=0.03 p=0.28 p=0.07 p=0.005 p=0.55 p=0.41 p=0.65 40 Major+minor VC MajorVC Vascular Dissection Access Site Hematoma Vascular Perforation Pseudo- aneurysm Retro-peritonal 35 30 32.8 25 20 15 10 Cohort B-TF Cohort A-TF 5 0 23.2 17.5 13.7 17.1 10.7 12.6 5.1 6.8 5.4 2.9 1.7 1.7 2.3 Généreux P et al. J Am Coll Cardiol 2012;60-1043–52 PARTNER I Cohort A and B Vascular Complications p < 0.0001 p < 0.0001 *Based on VARC 1 Definitions Major Bleeding

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details