SOLVE-TAV. Holger Thiele, MD on behalf of the SOLVE-TAVI Investigators
|
|
|
- Ashley White
- 5 years ago
- Views:
Transcription
1 SOLVE-TAV A 2x2 Randomized Trial of Self-Expandable vs Balloon-Expandable Valves and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation Holger Thiele, MD on behalf of the SOLVE-TAVI Investigators
2 Disclosure Statement of Financial Interest I, Holger Thiele DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
3 Background I Abdel-Wahab et al. JAMA 2014;311: Feldman et al. JAMA. 2018;319: TAVR is developing as standard strategy for symptomatic patients with severe aortic stenosis at high to intermediate risk. - TAVR device design led to relevant technical and clinical improvements (e.g. pacemaker rates, paravalvular leakage, vascular complications). - There is limited evidence for direct valve comparisons (CHOICE, REPRISE III) in particular for latest generation valve designs.
4 Background II Anesthesia Strategy - In clinical routine TAVR is performed in 50% using general or local anesthesia with conscious sedation. - Registry data suggest a) lower mortality b) lower morbidity c) shorter ICU and hospital stay d) shorter procedure times with local anesthesia. - There is a lack of adequately powered randomized trials. Villablanca et al. Catheter Cardiovasc Interv. 2017;1 13
5 SOLVE-TAVI Program Symptomatic Aortic Stenosis with TAVR Indication 1:1 CoreValve Evolut R Valve Strategy Edwards Sapien 3 1:1 Local Anesthesia Anesthesia Strategy General Anesthesia
6 Hypotheses I) Self-expanding CoreValve Evolut R is equivalent to balloon-expandable Sapien 3 (Edwards) valve II) Local anesthesia with conscious sedation is equivalent to general anesthesia in symptomatic aortic stenosis patients undergoing transfemoral TAVR.
7 SOLVE-TAVI Trial Investigator-initiated German multicenter trial; 1:1 randomization Bremen Kiel Rostock Lübeck Giessen Berlin Leipzig PI: Holger Thiele Study Coordination: Suzanne de Waha-Thiele University Heart Center Lübeck: Thomas Kurz, Roza Meyer-Saraei Ingo Eitel, Matthias Heringlake Klinikum Links der Weser Bremen: Rainer Hambrecht, Harm Wienbergen Heart Center Leipzig: Hans-Josef Feistritzer, Steffen Desch Marcus Sandri, Mohamed Abdel-Wahab David Holzhey, Michael Borger Yvonne Rückert, Jörg Ender University of Giessen: Holger Nef, Oliver Dörr Charité Berlin: Alexander Lauten, Sascha Treskatsch University of Rostock: Hüseyin Ince, Mohamed Sherif University Schleswig-Holstein, Campus Kiel: Norbert Frey, Derk Frank Funding: CROs:
8 Study Flow Chart - Valve Strategy 447 randomized 225 randomized to Evolut R 4 withdrawal of informed consent 1 death prior to TAVI procedure 1 medical treatment (no aortic stenosis) 219 undergoing TAVI procedure 216 Evolut R as allocated 1 cross-over Sapien 3 1 conventional AVR 1 balloon valvuloplasty only 219 eligible for 30-day follow-up 2 missing data for primary endpoint Allocation Intervention Follow-up 222 randomized to Sapien 3 2 withdrawal of informed consent 1 death prior to TAVI procedure 219 undergoing TAVI procedure 218 Sapien 3 as allocated 1 cross-over Corevalve Evolut R 219 eligible for 30-day follow-up 1 withdrawal of informed consent 3 missing data for primary endpoint Primary endpoint analysis 217 primary endpoint analysis 215 primary endpoint analysis
9 Baseline Characteristics Valve Strategy Characteristic Evolut R (n=219) Sapien 3 (n=219) Age (years); mean ±SD 81.7 ± ± 5.7 Male sex; n/total (%) 105/219 (47.9) 109/219 (49.8) Risk scores STS score (%); mean ±SD 7.7 ± ± 7.4 Log. EuroScore I (%), mean ±SD 18.4 ± ± 13.1 EuroScore II (%), mean ±SD 6.1 ± ± 4.9 Frailty; n/total (%) 93/216 (43.1) 80/217 (36.9) Peripheral arterial disease; n/total (%) 28/219 (12.8) 27/219 (12.3) Prior myocardial infarction; n/total (%) Prior PCI; n/total (%) Prior CABG; n/total (%) Atrial fibrillation; n/total (%) Pacemaker/ICD; n/total (%) 19/219 (8.7) 84/219 (38.4) 26/219 (11.9) 103/219 (47.0) 24/218 (11.0) 22/219 (10.1) 79/219 (36.1) 18/219 (8.2) 93/219 (42.5) 23/219 (10.5) Prior stroke; n/total (%) 25/219 (11.4) 26/218 (11.9) Renal insufficiency; n/total (%) 177/216 (81.9) 184/214 (86.0) Pulmonary hypertension; n/total (%) 106/216 (49.1) 105/218 (48.2) COPD; n/total (%) 30/219 (13.7) 29/217 (13.4) Cardiovascular risk factors Diabetes; n/total (%) Arterial hypertension; n/total (%) HLP; n/total (%) Current smoking; n/total (%) 79/218 (36.2) 193/219 (88.1) 118/218 (54.1) 8/218 (3.7) 68/219 (31.1) 204/219 (93.2) 80/217 (36.9) 10/219 (4.6)
10 Primary Endpoint Valve Strategy All-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, permanent pacemaker implantation at 30 days Rate difference %CI P equivalence =0.02 P superiority =0.83 % % 26.1% 10 0 Evolut R Sapien 3
11 Endpoints Valve Strategy Individual components primary endpoint Evolut R Sapien 3 % P equivalence <0.001 P superiority = % 2.3% P equivalence =0.003 P superiority = % 4.7% P equivalence <0.001 P superiority > % Moderate/severe valve regurgitation Mortality Mortality Stroke Valve Stroke regurgitation 1.4% P equivalence =0.06 P superiority = % 19.0% Pacemaker implantation Pacemaker implantation
12 Study Flow Chart - Anesthesia Strategy 447 randomized 222 randomized to local anesthesia 3 withdrawal of informed consent 1 death prior to TAVI procedure 218 undergoing TAVI procedure 217 local anesthesia 13 bailout general anesthesia 1 elective cross over general anesthesia 218 eligible for 30-day follow-up 1 withdrawal of informed consent 2 missing data for primary endpoint Allocation Intervention Follow-up 225 randomized to general anesthesia 3 withdrawal of informed consent 1 death prior to TAVI procedure 1 medical treatment (no aortic stenosis) 220 undergoing TAVI procedure 219 general anesthesia 1 elective cross-over to local anesthesia 220 eligible for 30-day follow-up Primary endpoint analysis 215 primary endpoint analysis 220 primary endpoint analysis
13 Baseline Characteristics Anesthesia Strategy Characteristic Local Anesthesia (n=218) General Anesthesia (n=220) Age (years); mean ±SD 81.8 ± ± 5.7 Male sex; n/total (%) 107/218 (49.1) 107/220 (48.6) Risk scores STS score (%); mean ±SD 6.9 ± ± 8.2 Log. EuroScore I (%), mean ±SD 17.8 ± ± 12.5 EuroScore II (%), mean ±SD 5.5 ± ± 5.6 Frailty; n/total (%) 91/214 (42.5) 82/219 (37.4) Peripheral arterial disease; n/total (%) 29/218 (13.3) 26/220 (11.8) Prior myocardial infarction; n/total (%) Prior PCI; n/total (%) Prior CABG; n/total (%) Atrial fibrillation; n/total (%) Pacemaker/ICD; n/total (%) 24/218 (11.0) 92/218 (42.2) 22/218 (10.1) 98/218 (45.0) 13/218 (6.0) 17/220 (7.7) 71/220 (32.3) 22/220 (10.0) 98/220 (44.6) 20/220 (9.1) Prior stroke; n/total (%) 24/217 (11.1) 27/220 (12.3) Renal insufficiency; n/total (%) 179/213 (84.0) 182/217 (83.9) Pulmonary hypertension; n/total (%) 100/216 (46.3) 111/218 (50.9) COPD; n/total (%) 27/216 (12.5) 32/220 (14.6) Cardiovascular risk factors Diabetes; n/total (%) Arterial hypertension; n/total (%) HLP; n/total (%) Current smoking; n/total (%) 70/218 (32.1) 199/218 (91.3) 92/216 (42.6) 9/218 (4.1) 77/219 (35.2) 198/220 (90.0) 88/219 (40.2) 9/219 (4.1)
14 Primary Endpoint Anesthesia Strategy All-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, acute kidney injury at 30 days Rate difference %CI P equivalence =0.02 P superiority = % 25.5% % Local anesthesia General anesthesia
15 Endpoints Anesthesia Strategy Individual components primary endpoint Local anesthesia General anesthesia 30 P equivalence =0.005 P superiority >0.99 % P equivalence <0.001 P superiority = % Mortality P equivalence =0.002 P superiority > % 2.4% 2.8% Stroke P equivalence <0.001 P superiority >0.99 Mortality Stroke Myocardial infarction 0.5% 0.5% Myocardial infarction 21.0% 21.0% Infection requiring requrning antibiotics P equivalence <0.001 P superiority > % 9.2% Acute kidney kidney injury injury
16 Summary and Conclusions I In patients with symptomatic aortic stenosis undergoing transfemoral TAVR the self-expanding Corevalve Evolut R valve is equivalent to the balloon-expandable Edwards Sapien 3 with respect to the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. The rate of relevant valve regurgitation was low whereas permanent pacemaker rates are still relatively high. There may be a higher stroke rate with the balloon-expandable valve.
17 Summary and Conclusions II Local anesthesia with conscious sedation is equivalent to general anesthesia with respect to the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury. General anesthesia is associated with a higher rate of catecholamine use but does not affect procedure times, valverelated outcome, or clinical outcome.
18 Acknowledgement and Thank You SOLVE-TAVI Patients and Investigators Steering Committee Holger Thiele, MD (Chair) Steffen Desch, MD Suzanne de Waha-Thiele, MD Thomas Kurz, MD Holger Nef, MD Rainer Hambrecht, MD Norbert Frey, MD Alexander Lauten, MD Hüseyin Ince, MD Michael Borger, MD David Holzhey, MD Matthias Heringlake, MD Jörg Ender, MD DSMB Gerhard Schuler, MD Steffen Schneider, PhD Bernd Böttiger, MD Funding German Heart Research Foundation Echo Core lab Heart Center Leipzig:: Georg Stachel, MD Suzanne de Waha-Thiele, MD CRO Leipzig Heart Institute: Yvonne Rückert Anne-Kathrin Funkat, PhD Ina Wagner IMBS Lübeck Inke König, PhD Reinhard Vonthein, PhD Jördis Stolpmann ZKS Lübeck: Arne Schreiber, PhD Alicia Illen
Incorporating the intermediate risk in Transcatheter Aortic Valve Implantation (TAVI)
Incorporating the intermediate risk in Transcatheter Aortic Valve Implantation (TAVI) Larry S. Dean, MD, MSCAI Past President SCAI Professor of Medicine and Surgery University of Washington School of Medicine
TAVI After PARTNER-2 : The Hamilton Approach
TAVI After PARTNER-2 : The Hamilton Approach James L. Velianou MD FRCPC Interventional Cardiology Hamilton General Hospital St Catharines General Hospital Associate Professor of Medicine McMaster University
1-YEAR OUTCOMES FROM JOHN WEBB, MD
1-YEAR OUTCOMES FROM JOHN WEBB, MD ON BEHALF OF THE SAPIEN 3 INVESTIGATORS UNIVERSITY OF BRITISH COLUMBIA VANCOUVER, CANADA Potential conflicts of interest Speaker's name: John Webb I have the following
Aortic valve implantation using the femoral and apical access: a single center experience.
Aortic valve implantation using the femoral and apical access: a single center experience. R. Hoffmann, K. Brehmer, R. Koos, R. Autschbach, N. Marx, G. Dohmen Rainer Hoffmann, University Aachen, Germany
Peri-operative results and complications in 15,964 transcatheter aortic valve implantations from the German Aortic valve RegistrY (GARY)
Peri-operative results and complications in 15,964 transcatheter aortic valve implantations from the German Aortic valve RegistrY (GARY) Thomas Walther, Christian W. Hamm, Gerhard Schuler, Alexander Berkowitsch,
University of Leipzig Heart Center
Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock Holger
30-Day Outcomes Following Implantation of a Repositionable Self-Expanding Aortic Bioprosthesis: First Report From the FORWARD Study
30-Day Outcomes Following Implantation of a Repositionable Self-Expanding Aortic Bioprosthesis: First Report From the Study Stephan Windecker Department of Cardiology Bern University Hospital - INSELSPITAL
Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis or Surgical Aortic Valve Replacement in Intermediate-Risk Patients:
Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis or Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 1-Year Results from the SURTAVI Clinical Trial Nicolas M. Van
LOW RISK TAVR. WHAT THE FUTURE HOLDS
LOW RISK TAVR. WHAT THE FUTURE HOLDS Michael J. Reardon, M.D. Professor of Cardiothoracic Surgery Allison Family Distinguish Chair of Cardiovascular Research Houston Methodist DeBakey Heart & Vascular
TAVR IN INTERMEDIATE-RISK PATIENTS
TAVR IN INTERMEDIATE-RISK PATIENTS K. Lampropoulos MD, PhD, FESC, MEAPCI Interventional Cardiologist Evangelismos General Hospital The Burden of Valve Disease Prevalence Survival NATURAL HISTORY OF AS
30-day Outcomes of The CENTERA Trial a New Self-Expanding Transcatheter Heart Valve. Didier Tchétché, MD On Behalf of the CENTERA Investigators
30-day Outcomes of The CENTERA Trial a New Self-Expanding Transcatheter Heart Valve Didier Tchétché, MD On Behalf of the CENTERA Investigators Speaker's name: Didier Tchétché, MD I have the following potential
Paris, August 28 th Gian Paolo Ussia on behalf of the CoreValve Italian Registry Investigators
Paris, August 28 th 2011 Is TAVI the definitive treatment in high risk patients? Impact Of Coronary Artery Disease In Elderly Patients Undergoing TAVI: Insight The Italian CoreValve Registry Gian Paolo
TAVI: The Real Deal? Marc Pelletier, MD Head, Department of Cardiac Surgery New Brunswick Heart Centre
TAVI: The Real Deal? Marc Pelletier, MD Head, Department of Cardiac Surgery New Brunswick Heart Centre Disclosure St. Jude Medical: Consultant and Proctor Edwards Lifesciences: Proctor Medtronic: Research
Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction the Randomized SHOCK-COOL Trial
Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction the Randomized SHOCK-COOL Trial Georg Fuernau, Johannes Beck, Steffen Desch, Ingo Eitel, Christian Jung, Sandra Erbs, Norman Mangner,
Le TAVI pour tout le monde?
Le TAVI pour tout le monde? Thierry Lefèvre Institut Cardiovasculaire Paris Sud, Massy Disclosure Statement of Financial Interest I currently have, or have had over the last two years, an affiliation or
Aortic Stenosis: Background
Transcatheter Aortic Valve Replacement in Low Surgical Risk Patients Barry George, MD The Ohio State University Structural Heart Disease Course May 19 th, 2017 Aortic Stenosis: Background Severe Symptomatic
Igor Palacios, MD Director of Interventional Cardiology Massachusetts General Hospital Professor of Medicine Harvard Medical School
Aortic Stenosis: Current State of Percutaneous Therapies, Emerging Technologies and Future Directions Igor Palacios, MD Director of Interventional Cardiology Massachusetts General Hospital Professor of
Outcomes in the Commercial Use of Self-expanding Prostheses in Transcatheter Aortic Valve Replacement: A Comparison of the Medtronic CoreValve and
Outcomes in the Commercial Use of Self-expanding Prostheses in Transcatheter Aortic Valve Replacement: A Comparison of the Medtronic CoreValve and Evolut R platforms in the Society of Thoracic Surgeons/American
Aortic Stenosis: Open vs TAVR vs Nothing
Aortic Stenosis: Open vs TAVR vs Nothing Wilson Y. Szeto, MD Associate Professor of Surgery Surgical Director, Transcatheter Cardio-Aortic Therapies Associate Director, Thoracic Aortic Surgery Division
TAVR in Intermediate Risk Populations /Optimizing Systems for TAVR
TAVR in Intermediate Risk Populations /Optimizing Systems for TAVR Saibal Kar, MD, FACC, FAHA, FSCAI Professor of Medicine Director of Interventional Cardiac Research Smidt Heart Institute, Cedars-Sinai
German Aortic Valve RegistrY
German Aortic Valve RegistrY C. W. Hamm, F.W. Mohr, H. Möllmann, D. Holzhey, A. Beckmann, H.-R. Figulla, J. Cremer, K.-H. Kuck, R. Lange, R. Zahn, S. Sack, G. Schuler, T. Walther, F. Beyersdorf, M. Böhm,
TAVI- Is Stroke Risk the Achilles Heel of Percutaneous Aortic Valve Repair?
TAVI- Is Stroke Risk the Achilles Heel of Percutaneous Aortic Valve Repair? Elaine E. Tseng, MD and Marlene Grenon, MD Department of Surgery Divisions of Adult Cardiothoracic and Vascular and Endovascular
An Update on the Edwards TAVR Results. Zvonimir Krajcer, MD Director, Peripheral Intervention Texas Heart Institute at St.
An Update on the Edwards TAVR Results Zvonimir Krajcer, MD Director, Peripheral Intervention Texas Heart Institute at St. Luke s Hospital Disclosures On the speaker s bureau for Endologix, TriVascular,
TAVR-Update Andrzej Boguszewski MD, FACC, FSCAI Vice Chairman, Cardiology Mid-Michigan Health Associate Professor Michigan State University, Central
TAVR-Update Andrzej Boguszewski MD, FACC, FSCAI Vice Chairman, Cardiology Mid-Michigan Health Associate Professor Michigan State University, Central Michigan University 1 Disclosure Chiesi Pharma- Consultant
Deutsches Aortenklappenregister German Aortic Valve RegistrY
Deutsches Aortenklappenregister German Aortic Valve RegistrY C. W. Hamm, F.W. Mohr, H. Möllmann, D. Holzhey, A. Beckmann, H.-R. Figulla, J. Cremer, K.-H. Kuck, R. Lange, R. Zahn, S. Sack, G. Schuler, T.
Is TAVR Now Indicated in Even Low Risk Aortic Valve Disease Patients
Is TAVR Now Indicated in Even Low Risk Aortic Valve Disease Patients Saibal Kar, MD, FACC, FAHA, FSCAI Director of Interventional Cardiac Research Cedars Sinai Heart Institute, Los Angeles, CA Potential
Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis
Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III On Behalf of the CoreValve US Clinical Investigators
TAVR today: High Risk, Intermediate Risk Population, and Valve in Valve Therapy
TAVR today: High Risk, Intermediate Risk Population, and Valve in Valve Therapy Alan Zajarias, MD FACC Structural Interventional Fellowship Director Associate Professor Medicine Cardiovascular Division
CULPRIT-SHOCK: A Randomized Trial of Multivessel PCI in Cardiogenic Shock. Holger Thiele, MD on behalf of the CULPRIT-SHOCK Investigators
CULPRIT-SHOCK: A Randomized Trial of Multivessel PCI in Cardiogenic Shock Holger Thiele, MD on behalf of the CULPRIT-SHOCK Investigators Disclosure Statement of Financial Interest Within the past 12 months,
Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement Jesse Jorgensen, MD Medical Director, Cardiac Catheterization Laboratory Greenville Health System Greenville, South Carolina, USA January 30, 2016 Aortic Stenosis
CIPG Transcatheter Aortic Valve Replacement- When Is Less, More?
CIPG 2013 Transcatheter Aortic Valve Replacement- When Is Less, More? James D. Rossen, M.D. Professor of Medicine and Neurosurgery Director, Cardiac Catheterization Laboratory and Interventional Cardiology
Five-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in Inoperable Patients With Severe Aortic Stenosis: The PARTNER Trial
Five-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in Inoperable Patients With Severe Aortic Stenosis: The PARTNER Trial Samir R. Kapadia, MD On behalf of The PARTNER Trial Investigators
Indication, Timing, Assessment and Update on TAVI
Indication, Timing, Assessment and Update on TAVI Swedish Heart and Vascular Institute Ming Zhang MD PhD Interventional Cardiology Structure Heart Disease Conflict of Interest None Starr- Edwards Mechanical
For the SURTAVI Investigators
Neurological complications after transcatheter aortic valve implantation with a self-expanding bioprosthesis or surgical aortic valve replacement in patients at intermediate-risk for surgery A. Pieter
Multicentre clinical study evaluating a novel resheatable self-expanding transcatheter aortic valve system
Multicentre clinical study evaluating a novel resheatable self-expanding transcatheter aortic valve system Preliminary Results: Acute and 1-year Outcomes Ganesh Manoharan, MBBCh, MD, FRCP Consultant Cardiologist
Predictors, incidence and outcomes of patients undergoing transcatheter aortic valve implantation complicated by stroke
Predictors, incidence and outcomes of patients undergoing transcatheter aortic valve implantation complicated by stroke From the CENTER-Collaboration Wieneke Vlastra, MD Heart Center, Amsterdam UMC, University
The Role of TAVI in high-risk and normal-risk Patients
The Role of TAVI in high-risk and normal-risk Patients Joachim Schofer Hamburg University Cardiovascular Center and Department for percutaneous treatment of structural heart disease Albertinen Heart Center
3 years after introduction of TAVI in QEH. Michael KY Lee On Behalf of QEH TAVI Heart Team Queen Elizabeth Hospital Hong Kong
3 years after introduction of TAVI in QEH Michael KY Lee On Behalf of QEH TAVI Heart Team Queen Elizabeth Hospital Hong Kong HA Convention 2014 Introduction Aortic Stenosis most common valvular heart disease
Vinod H. Thourani, MD, FACC, FACS
Considering SAVR in the TAVR era: Surgical Implications of TAVR Vinod H. Thourani, MD, FACC, FACS Professor of Cardiothoracic Surgery and Medicine Chief of Cardiothoracic Surgery, Emory Hospital Midtown
Evolving and Expanding Indications for TAVR
Evolving and Expanding Indications for TAVR Wilson Y. Szeto, MD Associate Professor of Surgery Surgical Director, Transcatheter Cardio-Aortic Therapies Associate Director, Thoracic Aortic Surgery Division
Debate: SAVR for Low-Risk Patients in 2017 is Obsolete AVR vs TAVI
Debate: SAVR for Low-Risk Patients in 2017 is Obsolete AVR vs TAVI Joseph E. Bavaria, MD Roberts-Measey Professor of Surgery Vice Chair, Division of Cardiovascular Surgery University of Pennsylvania Immediate
SAPIEN 3: Evaluation of a Balloon- Expandable Transcatheter Aortic Valve in High-Risk and Inoperable Patients With Aortic Stenosis One-Year Outcomes
SAPIEN 3: Evaluation of a Balloon- Expandable Transcatheter Aortic Valve in High-Risk and Inoperable Patients With Aortic Stenosis One-Year Outcomes Howard C. Herrmann, MD on behalf of The PARTNER II Trial
Outcome of Next-Generation Transcatheter Valves in Small Aortic Annuli: A Multicenter Propensity-Matched Comparison
Outcome of Next-Generation Transcatheter Valves in Small Aortic Annuli: A Multicenter Propensity-Matched Comparison Mauri, V. et al.: Circ Cardiovasc Interv. 2017;10:e005013 All trademarks are the property
How to Prevent Thromboembolic Complications in TAVI
How to Prevent Thromboembolic Complications in TAVI PETER WENAWESER, MD Swiss Cardiovascular Centre, University Hospital, Bern, Switzerland Potential Conflicts of Interest Proctoring and lecture fees from
In Process, Unpublished STS/ACC TVT Registry Manuscripts
In Process, Unpublished STS/ACC TVT Registry Manuscripts The following pages list current research and publications proposals that have been recently approved, are under analysis, are under manuscript
Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data
Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data Echo Florida 2013 Jonathan J. Passeri, M.D. Co-Director, Heart Valve Program Director,
THE PERCUTANEOUS MANAGEMENT OF VALVULAR HEART DISEASE DR JOHN RAWLINS CONSULTANT INTERVENTIONAL CARDIOLOGIST UNIVERSITY HOSPITAL SOUTHAMPTON
THE PERCUTANEOUS MANAGEMENT OF VALVULAR HEART DISEASE DR JOHN RAWLINS CONSULTANT INTERVENTIONAL CARDIOLOGIST UNIVERSITY HOSPITAL SOUTHAMPTON INTRODUCTION History of heart valve intervention Current indications
TAVR: Review of the Robust Data from Randomized Trials
TAVR: Review of the Robust Data from Randomized Trials Nicholas J. Ruggiero II, MD,FACP, FACC, FSCAI, FSVM, FCPP Director, Structural Heart Disease and Non-Coronary Interventions Director, Jefferson Heart
Minimalist Transcatheter Aortic Valve Replacement (MA-TAVR)
Minimalist Transcatheter Aortic Valve Replacement (MA-TAVR) Jensen HA, Condado JF, Devireddy C, Binongo JN, Leshnower BG, Babaliaros V, Sarin EL, Lerakis S, Guyton RA, Stewart JP, Syed AQ, Mavromatis K,
Appropriate Use of TAVR - now and in the future. A Surgeon s Perspective. Neil Moat Royal Brompton Hospital, London, UK
Appropriate Use of TAVR - now and in the future A Surgeon s Perspective Neil Moat Royal Brompton Hospital, London, UK Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner
Aortic Valve Practice Guidelines: What Has Changed and What You Need to Know
Aortic Valve Practice Guidelines: What Has Changed and What You Need to Know James F. Burke, MD Program Director Cardiovascular Disease Fellowship Lankenau Medical Center Disclosure Dr. Burke has no conflicts
TAVR: Intermediate Risk Patients
TAVR: Intermediate Risk Patients Oscar A. Mendiz.MD.FACC.FSCAI Director Cardiology & Cardiovascular Institute (ICyCC) Chief Interventional Cardiology Department Board of Directors Hospital & Favaloro University
2/15/2018 DISCLOSURES OBJECTIVES. Consultant for BioSense Webster, a J&J Co. Aortic stenosis background. Short history of TAVR
TRANSCATHETER AORTIC VALVE REPLACEMENT IN 2018: IS IT NOW THE STANDARD OF CARE? 22 ND ANNUAL COASTAL CARDIAC & VASCULAR CONFERENCE FEBRUARY 17, 2018 R. David Anderson, MD, MS, FACC, FSCAI Professor of
Transcatheter Aortic Valve Implantation. SSVQ November 23, 2012 Centre Mont-Royal 15:40
Transcatheter Aortic Valve Implantation SSVQ November 23, 2012 Centre Mont-Royal 15:40 Nicolo Piazza MD, PhD, FRCPC, FESC, FACC McGill University Health Center German Heart Center Munich 1 First-in-Human
RANDOMISED TRIALS TAVI WITH SAVR STEPHAN WINDECKER AORTIC VALVE DISEASE COMPARING
AORTIC VALVE DISEASE RANDOMISED TRIALS COMPARING TAVI WITH SAVR STEPHAN WINDECKER DEPARTMENT OF CARDIOLOGY SWISS CARDIOVASCULAR CENTER AND CLINICAL TRIALS UNIT BERN BERN UNIVERSITY HOSPITAL, SWITZERLAND
Strokes After TAVR Reasons for Declining Frequency
Strokes After TAVR Reasons for Declining Frequency Samir Kapadia, MD Professor of Medicine Director, Cardiac Catheterization Laboratory Cleveland Clinic Disclosure NONE Second Generation Valves Newer
Transcatheter Aortic-Valve Implantation for Aortic Stenosis
Transcatheter Aortic-Valve Implantation for Aortic Stenosis Policy Number: 7.01.132 Last Review: 6/2018 Origination: 2/2012 Next Review: 2/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC)
A new option for the Diagnosis and Management of Valvular Heart Disease. Oregon Comprehensive Valve Center
A new option for the Diagnosis and Management of Valvular Heart Disease Oregon Comprehensive Valve Center I have no disclosures Oregon Comprehensive Valve Center Weekly multidisciplinary case conferences
PARTNER 2A & SAPIEN 3: TAVI for intermediate risk patients
O P E N A C C E S S Department of Cardiology, Aswan Heart Centre *Email: ahmed.elguindy@aswanheartcentre.com Lessons from the trials PARTNER 2A & SAPIEN 3: TAVI for intermediate risk patients Ahmed ElGuindy*
Edwards Sapien. Medtronic CoreValve. Inoperable FDA approved High risk: in trials. FDA approved
Transcatheter Aortic Valve Replacement Symptomatic Aortic Stenosis Asymptomatic Juan Crestanello, MD Interim Director, Division of Cardiac Surgery Associate Professor Division of Cardiac Surgery The Ohio
Medical Policy An independent licensee of the Blue Cross Blue Shield Association
Transcatheter Aortic Valve Implantation for Aortic Stenosis Page 1 of 37 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Transcatheter Aortic Valve Implantation
Transcatheter aortic valve implantation for severe aortic valve stenosis with the ACURATE neo2 valve system: 30-day safety and performance outcomes
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions
After PARTNER 2A/S3i and SURTAVI: What is the Role of Surgery in Intermediate-Risk AS Patients?
After PARTNER 2A/S3i and SURTAVI: What is the Role of Surgery in Intermediate-Risk AS Patients? Vinod H. Thourani, MD Professor of Surgery and Medicine Emory University Disclosure Statement of Financial
Valve Disease in Patients With Heart Failure TAVI or Surgery? Miguel Sousa Uva Hospital Cruz Vermelha Lisbon, Portugal
Valve Disease in Patients With Heart Failure TAVI or Surgery? Miguel Sousa Uva Hospital Cruz Vermelha Lisbon, Portugal I have nothing to disclose. Wide Spectrum Stable vs Decompensated NYHA II IV? Ejection
The Heart Team and the minimalist approach to TAVR today Is there a conflict? G T Stavridis MD FETCS Onassis Cardiac Surgery Ctr.
The Heart Team and the minimalist approach to TAVR today Is there a conflict? G T Stavridis MD FETCS Onassis Cardiac Surgery Ctr. DISCLOSURES Conflicts of interest: none Minimalist approach (MA) Cath lab
TAVR SPRING 2017 The evolution of TAVR
TAVR SPRING 2017 The evolution of TAVR Matthew Johnson, MD Disclosers None Evolution of the Balloon- Expandable Transcatheter Valves Cribier 2002 SAPIEN 2006 SAPIEN XT 2009 SAPIEN 3 2013 * Sheath compatibility
Ian T. Meredith AM. MBBS, PhD, FRACP, FCSANZ, FACC, FAPSIC. Monash HEART, Monash Health & Monash University Melbourne, Australia
Two-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results From the REPRISE II
Results of Transfemoral Transcatheter Aortic Valve Implantation
Results of Transfemoral Transcatheter Aortic Valve Implantation Saudi Heart Association, February 21-24 Rüdiger Lange, MD, PhD Nicolo Piazza, MD, FRCPC, FESC German Heart Center, Munich, Germany Division
Appropriate Patient Selection or Healthcare Rationing? Lessons from Surgical Aortic Valve Replacement in The PARTNER I Trial Wilson Y.
Appropriate Patient Selection or Healthcare Rationing? Lessons from Surgical Aortic Valve Replacement in The PARTNER I Trial Wilson Y. Szeto, MD on behalf of The PARTNER Trial Investigators and The PARTNER
The Case for Multivessel Revascularization in Shock
The Case for Multivessel Revascularization in Shock Emmanouil S. Brilakis, MD, PhD Minneapolis Heart Institute 9.37 9.49 am Disclosures Consulting/speaker honoraria: Abbott Vascular, American Heart Association
Transcatheter Therapies For Aortic Valve Disease. March 2017 Brian Whisenant MD
Transcatheter Therapies For Aortic Valve Disease March 2017 Brian Whisenant MD Introduction I got into this field to protect my turf. I must say, I have come full circle... - Kent W. Jones I got into this
Trend and Outcomes of Direct Transcatheter Aortic Valve Replacement from a Single-Center Experience
Cardiol Ther (2018) 7:191 196 https://doi.org/10.1007/s40119-018-0115-0 BRIEF REPORT Trend and Outcomes of Direct Transcatheter Aortic Valve Replacement from a Single-Center Experience Anthony A. Bavry.
Is TAVR the treatment of choice for high risk diabetic patients with aortic stenosis? Insights from the FRANCE2 Registry
Is TAVR the treatment of choice for high risk diabetic patients with aortic stenosis? Insights from the FRANCE2 Registry E Van Belle, E Teiger, F Juthier, A Vincentelli, B Iung, H Eltchaninoff, J Fajadet,
Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients
Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients Susheel Kodali, MD on behalf of The PARTNER Trial Investigators
Transcatheter aortic valve replacement is considered investigational for all other indications.
Medical Policy Original Policy Date: March 30, 2012 Effective Date: July 1, 2018 Section: 7.0 Surgery Page: Page 1 of 33 Policy Statement Transcatheter aortic valve replacement with an U.S. Food and Drug
The FORMA Early Feasibility Study: 30-Day Outcomes of Transcatheter Tricuspid Valve Therapy in Patients with Severe Secondary Tricuspid Regurgitation
The FORMA Early Feasibility Study: 30-Day Outcomes of Transcatheter Tricuspid Valve Therapy in Patients with Severe Secondary Tricuspid Regurgitation Susheel Kodali, MD Director, Structural Heart & Valve
Transcatheter Aortic-Valve Implantation for Aortic Stenosis
Transcatheter Aortic-Valve Implantation for Aortic Stenosis Policy Number: 7.01.132 Last Review: 2/2019 Origination: 2/2012 Next Review: 2/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC)
Emergency TAVI: Does It Exist? Is the Risk Higher?
Emergency TAVI: Does It Exist? Is the Risk Higher? Gerald Yong MBBS (Hons) FRACP FSCAI Interventional Cardiologist Royal Perth Hospital Western Australia APCASH 12 October 2014 Disclosure Statement of
Cardiac Valve/Structural Therapies
Property of Dr. Chad Rammohan Cardiac Valve/Structural Therapies Chad Rammohan, MD FACC Medical Director, El Camino Hospital Cardiac Catheterization Lab Director, Interventional and Structural Cardiology,
Early Experience of Transcatheter Mitral Valve Replacement Results from the Intrepid Global Pilot Study
Early Experience of Transcatheter Mitral Valve Replacement Results from the Paul Sorajja, MD for the Investigators Presenter Disclosure Information Within the past 12 months, I or my spouse/partner have
Corrado Tamburino, MD, PhD
Paravalvular leak: acceptable or not Corrado Tamburino, MD, PhD Full Professor of Cardiology, Director of Postgraduate School of Cardiology Chief Cardiovascular Department, Director Cardiology Division,
Transcatheter Aortic-Valve Implantation for Aortic Stenosis
Transcatheter Aortic-Valve Implantation for Aortic Stenosis Policy Number: Original Effective Date: MM.06.019 10/01/2012 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 05/26/2017
Prof. Dr. Thomas Walther. TAVI in ascending aorta / aortic root dilatation
Prof. Dr. Thomas Walther TAVI in ascending aorta / aortic root dilatation nn AorticStenosis - Guidelines TAVI and aortic aneurysm? Few data published. EJCTS 2014;46:228-33 TAVI and aortic aneurysm? Few
TAVR 2018: TAVR has high clinical efficacy according to baseline patient risk! ii. Con
TAVR 2018: TAVR has high clinical efficacy according to baseline patient risk! ii. Con Dimitrios C. Angouras, MD, FETCS Associate Professor of Cardiac Surgery National and Kapodistrian University of Athens,
Prognostic Value of Intramyocardial Hemorrhage Detected by Cardiac Magnetic Resonance Imaging in Acute Reperfused ST-Elevation Myocardial Infarction
Prognostic Value of Intramyocardial Hemorrhage Detected by Cardiac Magnetic Resonance Imaging in Acute Reperfused ST-Elevation Myocardial Infarction Holger Thiele, MD; Konrad Kubusch, BSc; Steffen Desch,
Valvular Intervention
Valvular Intervention Outline Introduction Aortic Stenosis Mitral Regurgitation Conclusion Calcific Aortic Stenosis Deformed Eccentric Calcified Nodular Rigid HOSTILE TARGET difficult to displace prone
Valve Replacement without a Scalpel Transcatheter Aortic Valve Replacement (TAVR) Charles T. Klodell, M.D.
Valve Replacement without a Scalpel Transcatheter Aortic Valve Replacement (TAVR) Charles T. Klodell, M.D. Professor, Thoracic and Cardiovascular Surgery University of Florida klodell@surgery.ufl.edu Disclosures
The Future of TAVR: Minimalist Fast Track
The Future of TAVR: Minimalist Fast Track Zvonimir Krajcer, MD Program Director- Peripheral Vascular Interventions Department of Cardiology, St. Luke s Episcopal Hospital and Texas Heart Institute, Houston,
The safety of introducing a new generation TAVR device: one departments experience from introducing a second generation repositionable TAVR
Bjursten et al. BMC Cardiovascular Disorders (2017) 17:25 DOI 10.1186/s12872-016-0466-1 RESEARCH ARTICLE Open Access The safety of introducing a new generation TAVR device: one departments experience from
Incidence And Predictors Of Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
Incidence And Predictors Of Left Bundle Branch Block After Transcatheter Aortic Valve Implantation Ömer Aktug 1, MD; Guido Dohmen 2, MD; Kathrin Brehmer 1, MD; Verena Deserno 1 ; Ralf Herpertz 1 ; Rüdiger
Neal Kleiman, MD Houston Methodist DeBakey Heart and Vascular Institute
Neal Kleiman, MD Houston Methodist DeBakey Heart and Vascular Institute Despite a 33 fold growth in the first five years, there is still tremendous variability among penetration in different countries
Update interventional Cardiology Hans Rickli St.Gallen
Update interventional Cardiology 2012 Hans Rickli St.Gallen 26.11.2012 Review of Literature ESC-Highlights TCT/AHA-Highlights Update interventional cardiology 2012 Structural Heart Disease Transcatheter
Matthew R. Reynolds, M.D., M.Sc. On Behalf of the PARTNER Investigators
Lifetime Cost Effectiveness of Transcatheter Aortic Valve Replacement Compared with Standard Care Among Inoperable Patients with Severe Aortic Stenosis: Results from the PARTNER Trial (Cohort B) Matthew
Measuring the risk in valve patients Lessons learnt from the TAVI story? Bernard Iung Bichat Hospital, Paris, France
Measuring the risk in valve patients Lessons learnt from the TAVI story? Bernard Iung Bichat Hospital, Paris, France Faculty disclosure Bernard Iung I disclose the following financial relationships: Consultant
In Process, Unpublished STS/ACC TVT Registry Manuscripts
In Process, Unpublished STS/ACC TVT Registry Manuscripts The following pages list current research and publications proposals that have been recently approved, are under analysis, are under manuscript
TAVI in Korea, How to Avoid Conduction
TAVI in Korea, How to Avoid Conduction Disturbance after CoreValve Seung-Jung Park, MD, PhD Professor of Medicine, University of Ulsan College of Medicine, Heart Institute, Asan Medical Center, Seoul,
TAVR for Complex Aortic Valvular Conditions
TAVR for Complex Aortic Valvular Conditions Wilson Y. Szeto, MD Professor of Surgery Chief, Cardiovascular Surgery at Penn Presbyterian Surgical Director, Transcatheter Cardio-Aortic Therapies Associate
Aortic Stenosis Background and Breakthroughs in Treatment: TAVR Update
Aortic Stenosis Background and Breakthroughs in Treatment: TAVR Update Howard J Broder MD Interventional Cardiology DaVita Medical Group/ Healthcare Partners Cardiology Disclosures for Howard J Broder
TAVI in Rabin Medical Center -
Long-Term Outcomes of 560 Consecutive Patients treated with TAVI and Propensity Score Matched- Analysis of Early Versus New Generation Valves Amos Levi, MD, Uri Landes, MD, Abid R Assali, MD, Katia Orvin,
TAVI: Nouveaux Horizons
TAVI: Nouveaux Horizons EUAPI580i 432HQ14NP02353 Institut de Cardiologie de la Pitié-Salpêtrière jean-philippe.collet@psl.aphp.fr www.action-coeur.org Objectifs Les recommandations Le TAVI en chiffre La