• 30 Day Outcomes from The PARTNER II Trial for Transapical and Transfemoral 29mm TAVR in Inoperable Patients with the Edwards SAPIEN XT

    30 Day Outcomes from The PARTNER II Trial for Transapical and Transfemoral 29mm TAVR in Inoperable Patients with the Edwards SAPIEN XT- PARTNER II, Nested Registries 5 & 6 Inoperable Cohort Vasilis Babaliaros, MDon behalf of The PARTNER Trial Investigators and the PARTNER Publications Office Consulting Fees/Honoraria Bard Medical, DirectFlow Medical, Intervalve 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 Disclosure Statement of Financial Interest Vasilis Babaliaros, MD In the nested registries of The PARTNER II Trial, a 29mm Edwards SAPIEN XT was available to treat inoperable patients by either a Transfemoral or Transapical (TA) approach. Background TA TAVR 29mm SAPIEN XT TF TAVR 29mm SAPIEN XT n = 50 per NR The PARTNER II Inoperable CohortStudy Design (Nested Registries 5 & 6) ASSESSMENT- 3D Annulus Size (CT or TEE) Inoperable ASSESSMENT by Heart Valve Team 29mm Valve ASSESSMENT- TF or TA Endpoints presented today are 30 day and mid-term follow up 6 months. Primary Endpoint NYHA class QOL instruments 6-minute walk test Days alive out-of-hospital ICU and index hospital LOS Other Secondary Important EndpointsVARC 2 Definitions SAFETY EFFICACY ECHO VALVE PERFORMANCE Mean and peak AV gradient Effective orifice area LV function (ejection fraction) Paravalvular and total AR Structural valve deterioration Cardiovascular mortality Major vascular complications All strokes and TIAs Peri-procedural Mis Acute kidney injury Life-threatening or disabling bleeding No. of transfusions New permanent pacemakers New onset atrial fibrillation = 2 THV implants Repeat intervention Endocarditis • Severe AS- Echo-derived AVA < 0.8 cm2 (or AVA index < 0.5 cm2/m2) and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/s • Cardiac Symptoms- NYHA Functional Class = II “Inoperable”- Risk of death or serious irreversible morbidity as assessed by a cardiologist and two surgeons must exceed 50% Anatomical- 3D assessment of annulus (CT or TEE) Aortic annulus diameter compatible with a 23 or 26mm valve Iliac-femoral anatomy precluding safe sheath insertion (vessel size >7 mm diameter for TF TAVR) Severe LV dysfunction (LVEF < 20%) Untreated CAD requiring revascularization Anatomic- Serum Cr > 3.0 mg/dL or dialysis dependent Acute MI within 1 month CVA or TIA within 6 months Hemodynamic instability Clinical- FRAME Size 29 mm and 660 mm2 DELIVERY SYSTEM NovaFlex+ and Ascendra+ SHEATH TF- 20 Fr esheath (8mm OD expands up to 9.9mm OD) TA- 26 Fr SAPIEN XT THV Cobalt-chromium NovaFlex+ Ascendra+ Every case reviewed by web-based conference callbefore enrollment Primary analysis performed by as-treated (AT) analyses Event rates as Kaplan-Meier estimates Composite analyses pre-specified 100% data monitoring of clinical events at 30 days All 30-day events CEC adjudicated (>99%) 6 month mid-term endpoint events = CEC adjudicated (54%) Baseline Patient Characteristics-Vasculopathy (AT) Baseline Patient Characteristics-Inoperable Co-morbidities (AT) Baseline Echocardiography (AT) Procedural Factors (AT) Primary Endpoint Events-At 30 Days (AT) *Rehospitalization or prolonged index hospitalization Other Clinical Outcomes-At 30 Days (AT) Vascular and Bleeding Events-At 30 Days (AT) Group2 - TF 29mm SAPIEN XT Group3 - TA 29mm SAPIEN XT Disabling Stroke or Disabling Stroke (%) Group1 - TF 23/26mm SAPIEN XT Group2 - TF 29mm SAPIEN XT Group3 - TA 29mm SAPIEN XT All-Cause Mortality or Rehospitalization or Disabling Stroke TF TA 2.0 cm2 2.2 cm2 7.7 mmHg Paravalvular AR Total AR At 30 days, All-cause mortality and disabling strokes were low (Mortality- TF TAVR 5.0% vs. TA TAVR 4.4%; Strokes- TF TAVR 0.0% vs. TA TAVR 2.2%) Echocardiographic endpoints were similar with AVA = 2.0 cm2 and mean gradients = 7.7 mmHg In an inoperable cohort of The PARTNER II Trial, requiring a 29mm Edwards SAPIEN XT valve by a transfemoral or transapical approach… At 6 months, The combination of all-cause mortality, disabling strokes, and re-hospitalizations were comparable to that with TF 23 and 26mm SAPIEN XT In an inoperable cohort of The PARTNER II Trial, requiring a 29mm Edwards SAPIEN XT valve by a transfemoral or transapical approach… Acceptable 30-day morbidity and mortality Acceptable mid-term clinical outcomes compared with 23 and 26mm SAPIEN XT The 29mm SAPIEN XT represents an important addition to the 23 and 26mm SAPIEN XT for inoperable patients requiring a larger THV. In an inoperable cohort of The PARTNER II Trial, requiring a 29mm Edwards SAPIEN XT valve by a transfemoral or transapical approach…

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