Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Coronary artery disease wikipedia , lookup
Marfan syndrome wikipedia , lookup
Turner syndrome wikipedia , lookup
Hypertrophic cardiomyopathy wikipedia , lookup
Lutembacher's syndrome wikipedia , lookup
Quantium Medical Cardiac Output wikipedia , lookup
Pericardial heart valves wikipedia , lookup
Transcatheter Aortic Valve Implantation (TAVI/R) for Severe Aortic Stenosis Dr Dylan G Wynne PhD, BSc (Hons), MBBS, FRACP Consultant Interventional Cardiologist 0562/SAH/1112/SAH Transcatheter Aortic Valve Implantation Overview • • • • • • • • Introduction TAVI historical perspective Pre-procedural assessment Review of evidence Complications & Management Indications and Current Guidelines Limitations and future directions Conclusions Clinical Course of Severe Aortic Stenosis • Causes – – – – Degenerative Congenital – mainly bicuspid Rheumatic Others – less common (including supra-aortic, subaortic) Open AVR – Mechanical and Bioprosthetic • Excellent operation • Surgical Risk 1 – 3% • Mechanical valve – Permanent need for anticoagulation with Warfarin • Bioprosthetic Valve – Valve degeneration over time – TAVI valve in valve an option • Growing Elderly surgically prohibitive population. The Majority of AS Patients Indicated Per Guidelines Remain Untreated Dr. Alain Cribier First-in-Man PIONEER • Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis • • First Human Case Description Alain Cribier, MD; Helene Eltchaninoff, MD; Assaf Bash, PhD; Nicolas Borenstein, MD; Christophe Tron, MD; Fabrice Bauer, MD; Genevieve Derumeaux, MD; Frederic Anselme, MD; François Laborde, MD; Martin B. Leon, MD Conclusions – “Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement.” April 16, 2002 TAVR: Where are we today ? A considerable worldwide expansion with huge potential 200 000 TAVR performed over 10 years Success based on innumerable registries and evidence based trials Evolution of TAVI European Cumulative Implants Australian Experience • • • • • Began 2008 18 (10) Centres. (Mostly NSW / VICT) 2100 total implants. Edwards, CoreValve, Lotus, Portico Academic breeding ground – New technologies – International Clinical Trial Involvement • Economic restraints of Conservative Health Care – last health care to get technology approved. Cine of Edwards case. CoreValve aortic valve replacement Balloon valvuloplasty 0562/SAH/1112/SAH CoreValve aortic valve replacement Balloon valvuloplasty 0562/SAH/1112/SAH CoreValve aortic valve replacement Balloon valvuloplasty Partial deployment 0562/SAH/1112/SAH CoreValve aortic valve replacement Balloon valvuloplasty Partial deployment Full deployment 0562/SAH/1112/SAH Tests Required + Pre-Procedure Assessment • TTE / TOE – Determine accurate annulus sizing – 3D TOE for annular sizing if CT prohibitive due to renal impairment • DSE in those with low EF / low gradient AS • Cardiac catheterization within past 6 months • Pulmonary function tests • Carotid duplex • Frailty assessment CT Assessment • Evaluate the ascending Aorta for calcification • Evaluate the femoral and iliac arteries for calcification • Annulus area determination Anatomical Contraindications Calcified + Tortuous ++ Diameter < 6.0 mm Calcifications + Tortuosities less control++ Multiple Access Sites THE EVIDENCE 0562/SAH/1112/SAH PARTNER 5-year FU in Lancet (March, 2015) Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER 1 Trial CoreValve US Pivotal Trial 48 month F/U A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed at Increased Risk for Surgery 2-Year Outcomes Complications & Management • Aorto / Iliac rupture • Conduction Disturbances • Annular Rupture • Device Embolization • Ventricular Rupture • Valve in Valve Malposition • Coronary Ostia Occlusion • AR and PVL • Stroke (Need for Surgical Bailout) Associated with Increase Mortality Coronary Occlusion Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve. Treated with CPB device explantation AVR Also PCI/CABG Cardiol Clin 29 (2011) 211–222 J. Am. Coll. Cardiol. 2012;59;1200-1254 Risk of ischaemic and bleeding complication after TAVI (<30days Post TAVI) Stroke post TAVI • Clinical stroke after TAVI: 2.7-6.7% – Increased risk of mortality 3x – Causes significant morbidity – 50% of stroke perioperative • Mechanisms: – – – – Athero-calcific embolism Thromboembolism Air embolism Valve thrombosis • Silent Brain Infarction common : 58100% • Predictors of early CVE – – – – Pre + post dilatation Procedural duration Valve repositioning Hx of stroke • Use of embolic protection devices. • New onset Atrial Fibrillation Thromboembolic recommendations Post Procedure Aortic Regurgitation Inaccurate deployment: too high/low Asymmetric calcification/annulus Undersized device Central: overdilated, leaflet injury Increased Mortality with Mod / Severe AR Moderate to Severe AR • Balloon Valve Dilatation • Percutaneous Closure • Valve in Valve Complete Heart Block and PPM Requirement • Incidence of CHB requiring permanent pacemaker implantation has been higher with the CoreValve (19.2% to 42.5%) than with the Sapien valve (1.8% to 8.5%) [larger profile and extension low into the LVOT • Occurrence of CHB/LBBB – BAV 46% – Balloon/prosthesis positioning &wirecrossing of the aortic valve 25% – Prosthesis expansion 29%. • Pre-existing RBBB risk factor for CHB J. Am. Coll. Cardiol. 2012;59;1200-1254 Clinical Indications • A Symptomatic severe calcific Aortic Stenosis [trileaflet] who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk as defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease. • TAVR is a reasonable alternative to surgical AVR in patients at high surgical risk (PARTNER Trial Criteria: STS >8) J. Am. Coll. Cardiol. 2012;59;1200-1254 Special Indications Bicuspid Aortic Valve TAVI within failed Bioprosthetic AVR Valve-in-valve procedures. A, A 26-mm CoreValve device (Medtronic) implanted inside a 25-mm Mitroflow valve (Sorin). B, A 23-mm Edwards SAPIEN (Edwards Lifesciences) implanted inside a 23-mm CarpentierEdwards porcine valve (Edwards Lifesciences). TAVI – Limitations of 1st Generation Devices Remaining Challenges and hopes for New Generation Devices Vascular access Smaller systems, dilatable sheaths Ease/certainty of deployment Novoflex, Accutrak delivery systems Aortic regurgitation Novel designs, larger devices Atheroembolic stroke Distal protection devices Need for pacemaker implantation Accurate placement Cost Reimbursement pending for Australia 0562/SAH/1112/SAH CE Mark Evolution Lotus Valve System - Advantages • Controlled mechanical expansion enables precise positioning • Central radiopaque marker to aid precise positioning • Functions early, enabling hemodynamic stability • Fully repositionable and retrievable • Adaptive seal designed to minimize paravalvular leak LOTUS Valve : Reprise II Clinical Trial • 120 patients > 70 yrs • STS score > 8% or deemed surgical high risk • Severe AS • Results • Access, delivery, deployment, system retrieval 100%. • Mean Aortic gradient – 46 to 11 mmHg • AVA 0.7 to 1.7 cm2 • Device success – Absence of mortality - 99.2%. • Valve embolization / migration / malpositioning - 0% • PPM rate remains high >25%. Guidelines (AHA/ACC/ECC 2012) • TAVI is accepted as a treatment option. • TAVI is indicated in pts. with symptomatic AS who are not suitable for AVR as assessed by a heart team (IB).Prerequisite: Improvement in quality of life is likely and life expectancy is > 1 year considering comorbidities. • Both, TAVI and AVR should be considered in surgical high risk patients with severe symptomatic AS (IIaB): No formal differential indication between TAVI and AVR. Decision by a heart team after careful consideration of the individual risk profile and anatomic suitability. Current TAVI Guidelines ESC/EACTS-GL 2012 Vahanian A et al Eur Heart J 2012;33:2451-96 Complexity of the Multidisciplinary Team The Severe AS-TAVI Population Old…very old… • Frail…very frail • Lots of co-morbidities… • Prior CABG (poor LV function) • CKD • Severe COPD • PVD • Chronic AF • Cancer in remission Favour TAVI for SAVR • Porcelain aorta • Hostile chest – Cobalt / mantle radiation • Liver disease / cirrhosis – MELD score < 8 – SAVR – MELD 8-20 – awake TAVI – > 20 palliation (BAV) • LIMA or RIMA across midline • Age > 90 years • More than 2 prior sternotomies • Severe lung disease(FEV1 <40% and FEV1 , 800mls • Redo AVR – TAVI if > 23 prior prosthesis. • ESRF – TAVI / Med Mx • Moderate Dementia • Frailty / debility / immobility Patient Selection Frailty Testing Select patients destined to die of Severe Aortic Stenosis rather than with AS Not currently Indicated Outstanding Issues of Cost Effectiveness and Reimbursement TAVI - CONCLUSIONS • Rigorous Evidence Based Research – Proven superiority to medical management in inoperable severe AS. – Equivalent to SAVR in high surgical risk patients. • • • • Strict Guidelines – Heart team and onsite Cardiothoracic Surgery Proven safety and efficacy. Cost effectiveness and Reimbursement? Move to intermediate risk populations. Improvements in prevention of Stroke, need for pacemaker, and PV leak will continue to develop. • Valve durability confirmed to five years and beyond? IBE / Thrombosis? • Aspects for frailty and futility are still to be determined Thank You. http://www.peninsulacardio.com.au/ Tel : 02 9971 7668