Direct Flow Medical Experience with a Conformable, Repositionable Retrievable Percutaneous Aortic Valve Reginald Low MD University of California, Davis.

Slides:

Advertisements

Similar presentations

” سبحانك لا علم لنا إلا ما علمتنا إنك أنت العليم الحكيم “

Advertisements

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA,

Three-year clinical and echocardiographic follow-up of aortic stenosis patients implanted with a self-expending bioprosthesis Sabine Bleiziffer German.

ACC 2015 Jae K. Oh, MD On Behalf of the US CoreValve Investigators Remodeling of Self-Expanding Transcatheter Aortic Valve Is Responsible for Regression.

ACC 2015 Michael J Reardon, MD, FACC On Behalf of the CoreValve US Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic.

Long-Term Outcomes Using a Self- Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-Year Results From.

Preliminary results from the C-Pulse OPTIONS HF European Multicenter Post-Market Study Holger Hotz, CardioCentrum Berlin, Berlin, Germany; Antonia Schulz,

Between May 2013 and June 2014, we implanted the C-Pulse device in 7 male and 1 female patients with a mean age ± SD of 61.1 ± 9.4 years. Four had ischemic.

University Heart Center Hamburg

TAVR Pearls Addressing the Shortcomings of the Current TAVR Generation

Trans-catheter Aortic Valve Replacement: a UK update. Dr Martyn Thomas Guys and St Thomas’ Hospital.

Axel Linke University of Leipzig Heart Center, Leipzig, Germany Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital.

Techniques in Valve-in-Valve TAVR Vinod H. Thourani, MD Professor of Surgery and Medicine Chief of Cardiothoracic Surgery, Emory Hospital Midtown Co-Director:

Trancatheter Aortic Valve Implantation (TAVI)

UC c EN. Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125.

Transcatheter Cardiovascular Therapeutics 2008 (October 12-17, 2008 · Washington, DC) First-in-Human Report: Initial Experience with a Stentless and Retrievable.

EXPANDING INDICATIONS OF TRANSCATHETER HEART VALVE INTERVENTIONS. JACC CARDIOVASCULAR INTERVENTION. DR.RAJAT GANDHI.

Twelve Months and Beyond: Long-Term Results of the Direct Flow Medical Repositionable and Retrievable Pericardial Valve for Percutaneous Aortic Valve Replacement.

Date of download: 9/19/2016 Copyright © The American College of Cardiology. All rights reserved. From: Percutaneous Aortic Valve Replacement Will Become.

Longest Follow-up After Implantation of a Self-Expanding Repositionable Transcatheter Aortic Valve: Final Follow-up of the Evolut R CE Study Stephen Brecker,

VSD post TAVR: Mechanisms, Presentation and Management

TAVR for the Treatment of Pure Native Aortic Valve Regurgitation

PERCUTANEOUS PULMONARY VALVE REPLACEMENT:

August 9th 2016 Structural Heart Live: ND, 89 yr.F

Extending the Boundaries of TAVR: Future Directions

Highlights From the SAPIEN 3 Experience in Intermediate-Risk Patients Vinod H. Thourani, MD on behalf of the PARTNER Trial Investigators Professor.

The Medtronic Ventor EngagerTM TAVI System

TAVR Medtronic CoreValve® Subclavian Approach Clinical Data

Is Transoesophageal Echocardiography during TAVR Essential?

The Lotus Device Design & FIM Experiences with a Repositionable Self Expanding Percutaneous Aortic Valve Ian T. Meredith MBBS, BSc(Hons), Ph.D, FRACP,

Imaging and Quantification of Aortic Regurgitation after TAVI

Transcatheter Aortic Valve Replacement Using the Lotus Valve with Depth Guard First Report from the RESPOND Extension Study Nicolas M Van Mieghem, MD,

Raj R. Makkar, MD On behalf of The PARTNER Trial Investigators

Design & Product Development Larry L Wood

Direct Flow Medical Experience with a Conformable, Repositionable, Retrievable, Percutaneous Aortic Valve Reginald Low MD University of California,Davis.

Updates From NOTION: The First All-Comer TAVR Trial

Mitralign Program Update

EVOLUT R, Next Generation, and Future

Portico™ Transcatheter Aortic Valve Replacement Program CRT 2013

Review of the Latest OUS Data from the Self-Expanding Valve Studies

First Report of One-Year Outcomes of the REPRISE I Feasibility Study of the Repositionable Lotus Aortic Valve Replacement System Ian T. Meredith.

30-Day Safety and Echocardiographic Outcomes Following Transcatheter Aortic Valve Replacement with the Self-Expanding Repositionable Evolut PRO System.

Trans-Apical Aortic Valve Implant:

Endurant: A New Generation Endograft

First Report of Three-Year Outcomes With the Repositionable and Fully Retrievable Lotus™ Aortic Valve Replacement System: Results From the REPRISE I.

Early Outcomes with the Evolut R Repositionable Self-Expanding Transcatheter Aortic Valve in the United States Mathew Williams, MD, For the Evolut R US.

Optimizing Valve Sizing: Role of CT vs. Echo

Giuseppe Tarantini MD, PhD

Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement Harold L. Dauerman, MD; Michael J. Reardon,

TAVI „Catch me if you can!“

The Impact of Live Case Transmission on Patient Outcomes during Transcatheter Aortic Valve Replacement: Results from the VERITAS Study Dr. Ron Waksman.

Keith Dawkins MD FRCP FACC FSCAI Global Chief Medical Officer

Two-Year Outcomes With the Fully Repositionable and Retrievable Lotus™ Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe.

Panel Discussion: What Should Be the Optimal Design for Percutaneous Aortic Valve Therapy? Raoul Bonan, MD Institut de Cardiologie de Montreal.

Opportunities to Study Valve Iterations and Modifications in the US

Longevity of transcatheter and surgical bioprosthetic aortic valves in patients with severe aortic stenosis and lower surgical risk Lars Sondergaard,

CRT 2010 Washington DC, January 21, 2010

Progress with the Sadra Medical Lotus™ Valve System

Axel Linke University of Leipzig Heart Center, Leipzig, Germany

The XIENCE V EXCEED Study

One Year Outcomes in Real World Patients Treated with Transcatheter Aortic Valve Implantation The ADVANCE Study Axel Linke University of Leipzig Heart.

Second Generation Valves: What Will Be Different?

REPRISE I The Sadra Lotus Valve for TVAR

University Heart Center Hamburg

S.G. Worthley, MB, BS, PhD., S. Redwood, MD, PhD.,

Balloon-Expandable Transcatheter Valve System : OUS Data

TRANSCATHETER MITRAL VALVE IMPLANTATION FOR SEVERE MITRAL REGURGITATION: THE TENDYNE GLOBAL FEASIBILITY TRIAL 1 YEAR OUTCOMES David WM Muller, MBBS,

Samir R. Kapadia, MD On behalf of The PARTNER Trial Investigators

Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER 1 Trial Michael J. Mack, MD.

Structural Heart Live Cases

Presentation transcript:

Direct Flow Medical Experience with a Conformable, Repositionable Retrievable Percutaneous Aortic Valve Reginald Low MD University of California, Davis Sacramento, California

Disclosures Abbott Vascular - Consultant Boston Scientific - Consultant Direct Flow Medical - Consultant UC Davis

Introduction Feasibility, safety, and efficacy of TAVR with Edwards-Sapien and Medtronic CoreValve have been well demonstrated Large Effective Orifice Area Durability Securement No coronary obstruction Multiple sizes Delivery profile Opportunities for improvement Reduction of paravalvular insufficiency Improved access Profile, flexibilty and trackability Assess function before final deployment Precise positioning Repositioning Retrievable UC Davis

Direct Flow Medical Percutaneous Aortic Valve Design Features Bovine Pericardium Leaflets (anti-calcification treatment) Balloon Frame covered with Polyester Fabric Initial deployment - inflate frame with Saline/Contrast When acceptable final position and function are confirmed, Polymer media is infused to replace saline/contrast 18 French deliviery system Valve sizes - 25 mm, 27 mm treats annulus diameter 21 - 26 mm 3 check valves Valve is immediately functional when unsheathed and distal ring is inflated UC Davis

Direct Flow Medical Percutaneous Aortic Valve Design Features Delivery System Polymer nylon sleeve Multi-lumen catheter 3 position and fill wires 1 guide wire lumen Flexible nose cone Non-metallic delivery system and valve Flexible and trackable Precise positioning Retrievable with deflation and withdrawl into retrieval basket Position & Fill Lumens Aortic Ring Ventricular Ring Guidewire Lumen UC Davis

Direct Flow Medical Percutaneous Aortic Valve Valve loaded in Delivery System Valve Unsheathed Valve Inflated & Steering System Valve in Retrieval Basket UC Davis

Inflation, Deflation & Media Exchange UC Davis

Positioning & Securement UC Davis

Deliverability & Sealing UC Davis

Complex Valve and Vascular Anatomy 87 year old male Euroscore = 36.2 Moderately Calcified Leaflets &Native Annulus Extensive Calcification Marked Tortuosity 6 Month CT Current Status: 52 Months Post-Procedure Final Position UC Davis

Tracking - Aortic Arch Deliverable and precisely positionable in any arch configuration including Horizontal Arch UC Davis

Case Review: 009-01-003 (Cali) Access Summary No Complications UC Davis

Balloon Aortic Valvuloplasty UC Davis

Annulus and Procedure Results Systole Symmetric Calcium Score 1051 Diastole UC Davis

Case Summary UC Davis

Echo Pre Procedure Post TAVR Procedure UC Davis

Important Feature No significant paravalvular leak - aortic insufficiency UC Davis

Important Feature No significant paravalvular leak - aortic insufficiency UC Davis

Important Feature Important Feature No significant paravalvular leak - aortic insufficiency UC Davis

Important Feature No significant paravalvular leak - aortic insufficiency UC Davis

Important Feature No significant paravalvular leak - aortic insufficiency UC Davis

22 French Early Experience University Medical Center, Hamburg-Eppendorf (n=25) Helios Heart Center - Siegburg (n=6) High risk patients for cardiac surgery Patients Enrollment Number 31 / 22 Implants / 2 Surgical Conversions Age 82 ± 4 years Female/Male 16/15 NYHA III – IV 71% Logistic EuroSCORE 29 ± 7% Mean transvalvular gradient 49 ± 14 mmHg Aortic valve area 0.54 ± 0.13 cm2 LVEF 53 ± 15% UC Davis

22 French Early Experience 2 Year Data Effective orifice area - 1.5 cm2 Mean Echo gradient - 18.7 Functional Class I (75%) or II Aortic insufficiency - 73% none & 27% minimal 2 year survival - 69% CT - No change in position, diameter and orifice area over time Echo - Gradient 50.1±11.3 to 19.6±5.7 at 30 days - No change over time AVA - Baseline 0.57±0.15 cm2 to 1.47±0.35 cm2 at 30 days - No change over time UC Davis Bujuklic K et al. Circ Cardiovasc Interv. 2011 Dec 1;4(6):595-601

Present Studies Latest iteration (18 Fr) improved profile, positioning, valve loading into delivery sheath, radial force, valve competence, & simplified media exchange IP 009-01 South America - Colombia Study IP 010-01 European CE March Trial France, Germany, Italy UC Davis

Summary Direct Flow Medical Percutaneous Aortic Valve Non-metallic fabric covered balloon supported bovine pericardial valve with excellent trackability and deliverability Precise positioning, repositionable and retrievable Mechanical securement with conformability and sealing to minimize paravalvular leak Formed in-situ with exchange polymer media Design permits functional and hemodynamic assessment before final deployment Feasibility, safety and efficacy demonstrated with 22 F system European study with longest implant of 4.3 years CE Mark and South American (Colombia) trial enrolling No or trace paravalvular leak & no screening failures for peripheral access UC Davis

University of California Davis Medical Center Thank You University of California Davis Medical Center

UC Davis