What will be the TAVI's future? Which developments can we still expect in the forthcoming years?

Transcription

1 What will be the TAVI's future? Which developments can we still expect in the forthcoming years? Patrick Serruys, MD, PhD Christos V Bourantas, MD, PhD Yoshinobu Onuma, MD Nicolo Piazza, MD, PhD Nicholas Van Mieghem, MD 10:30-10:50, Room Tbilisi - Central Village

2 I have nothing to disclose.

3 Aortic Valve Replacement Homograft 1962 First PVT animal implantation A. Cribier First Corevalve animal implantation JC. Laborde Mechanical heart valve 1962 SURTAVI 2010 PARTNER Cohort B Porcine valve 1965 Pericardial tissue valve 1969 First Edwards/PVT Transapical Beating Heart AVR Webb, Lichtenstein Nov 29, Surgery First TAVI animal implantation H. Andersen First PVT human TAVI by Antegrade Approach A. Cribier First CoreValve TAVI by Retrograde Approach Laborde, Lal, Grube July PARTNER Cohort A PARTNER 2

4 The Future of TAVI Patients selection Futility Category For both TAVI/ SAVR 0-4% Low 4-10% Interm 10-15% High >15% Very High Inoperable In addition to the specific risk factors that can prohibit patients from undergoing TAVR or SAVR, operative risk assessment is also important to identify patients who will not benefit from either TAVR or SAVR (so called futility category ). A prohibitive operative risk by at least 2 surgeons from a tertiary center of excellence. Serruys et al. TVT 2012

5 Patients selection TAVI current status

6 #2 TAVI vs. SAVR Part I (high risk patients) The Future of TAVI Patients selection Ongoing studies Medtronic Corevalve pivotal US High risk: non inferiority study randomizes at 1:1 basis 790 pts with a predicted risk of operative mortality 15% to TAVI and SAVR Partner II Intermediate risk non inferiority study, randomizes at 1:1 basis 2000 pts with a STS 4 to TAVI with the Sapien XT and SAVR. Pts with CAD and SYNTAX score <33 will be included SURTAVI Non inferiority study randomizes 1800 intermediate risk pts with an STS 4 at 1:1 basis to TAVI with the CoreValve and SAVR. Pts with CAD and SYNTAX score <23 will be included

7 Key aspect of non-inferiority: durability I Accelerated Structural Valve Degeneration of bioprosthesis with younger age at implantation II Event free life expectancy after SAVR III Structural valve Degeneration of porcine (blue) or bovine pericardial (red) bioprosthesis Huang et al. Circulation 2011

8 #2 TAVI vs. SAVR Part I (high risk patients) Durability The Future of TAVI Limited data with regards the durability of the available valves Reports with mid-long term follow-up (3y) have confirmed the durability of the available valves Echocardiographic examination showed low gradients and moderate AR in 6% CT scan confirmed the absence of stent fracture, a small reduction in the AV area and structurally normal valves Gurvitch et al. Circulation 2011 Post-mortem examination at 3 year follow-up demonstrated a structurally and a functionally normal valve Further data are required to evaluate the durability of the available valves

9 Bioprosthetic Valve Failure Given that there have been over Pannus Thrombus Calcification 100,000 implantations, case reports of transcatheter valve failure are scarce Wear and tear Endocarditis Hammerstingl et al. Catheter Cardiovasc Interv 2012

10 Valve in valve The Future of TAVI Current data are restricted in small case series Though feasible, its long term efficacy is unclear A small case series of 20 pts showed a high success rate The mortality rate was 15% (1MI due to LMS obstruction, 1 stone heart and 1 due to severe PV leak and cardiogenic shock) Piazza et al. JACC Cardiovasc Interv 2011

11 #2 TAVI vs. SAVR Part I (high risk patients) Durability The Future of TAVI In SURTAVI the CoreValve bioprosthesis has been processed for the first time with an antimineralization treatment of alpha-amino oleic acid (AOA) a compound derived from oleic acid, a naturally occurring long-chain fatty acid This is expected to increase the endurance of the device

12 #2 TAVI vs. SAVR Part I (high risk patients) The Future of TAVI: Cell seeding Durability Autologous living heart valves from bone marrow derived MSCs are expected to emerge in the near future The first autologous prosthesis developed, consisted of a bioresorbable frame which was covered by bone marrow derived MSC The device has been tested in animal models Although the device required surgical implantation and the follow-up period was small, the first results were promising Sutherland et al. Circulation 2005

13 The Future of TAVI: Cell seeding Durability Recently an autologous tissue engineering heart valve was developed that was seeded with bone marrow MSCs The valve was implanted transapically in six baboons Echo confirmed a functional prosthesis and mild/moderate AR in 50% of the treated cases Explantation at 4m demonstrated endothelialization of the prosthesis but shrinked leaflets Webber et al. Eur H J 2011

14 Future valves The Future of TAVI Nanosynthesis of Metal atmosphere to eliminate Contaminants Ion excitement/bombardment of pure metal (Nickel and Titanium ions) Ratio of deposition of ions determined by internal chamber characteristics Can incorporate multiple ionic species Allows variable thickness and size based upon central mandrel Nanosynthesis of Metal

15 The Future of TAVI Future valves ABPS NiTi enitinol Membranes Variable Leaflet Configuration

16 The Future of TAVI Future valves Thin film enitinol membrane PercValve monolithic structures Heart Valve Venous Valve 10 Fr 4.8 Fr

17 The Future of TAVI PercValve TM Aortic Implants Future valves In Vivo Aortic View Ventricular View

18 Heart Team The Future of TAVI Patients assessment

19 The Heart Future Team of TAVI Patients assessment Risk stratification Patient assessment is based on a multidisciplinary team approach Euroscore A TAVI risk score similar to STS or Euroscore is not available The traditional risk score does not take into account known risk factors (Porcelain aorta, Frailty, Liver failure etc) Tomas et al. Circulation 2010 An extrapolation of the risk estimated by the known surgical risk score to TAVI may give a rough estimation of the patient morbidity but cannot be considered as accurate

20 The Heart Future Team of TAVI The TAVI risk score should also take into consideration the anatomical suitability of the patients Presence of PVD Tortuosity of the iliofemoral arteries Assessment of the AV annulus Evaluation of the AV complexity Study of coronary anatomy A valid and accurate risk stratification would facilitate the decision making process and permit more objective selection of the appropriate patients Piazza et al. Arch Cardiovasc Dis 2012

21 #2 TAVI vs. SAVR Part I (high risk patients) The Future of TAVI TAVI access routes Crube et al. Circulation 2006 Latsios et al Cathet Cardiovasc Interv 2010 Direct Aortic Subclavian Transapical Ye et al. J Thor Cardiovasc Surg 2006 Transfemoral Cribier et al. Circulation 2002

22 Advances in imaging 3D ECHO The Future of TAVI Husser et al. Catheter Cardiovasc Interv 2012

23 Advances in imaging The Future of TAVI 3D reconstruction from angiography (conventional and rotational) Tzikas et al. Catheter Cardiovasc Interv 2010 Meyhoher et al. Catheter Cardiovasc Interv 2012

24 The Future of TAVI Advances in imaging CT and CT like reconstruction during TAVI Dyna CT Developed by Siemens Heart Navigator 3D reconstruction of the aorta Correct sizing of the prosthesis Able to overlay CT on angiography Selection of the optimal view Creation an overlaying image showing the aortic view in relation to the aorta Utilize data acquired by rotational angiography to reconstruct the aorta The obtained model can be superimposed on the aorta and facilitate optimal device implantation Kempfert et al. J Am Coll Cardiol 2011

25 2 nd generation valves Bourantas, Farooq, Onuma, Piazza, van Mieghem, Serruys. Eurointervention 2012

26 The Future of TAVI Future valves Medtronic Engager TM valve Scalloped bovine pericardial leaflets Arms positioned over native leaflets Polyester Skirt Dedicated commissural posts for valve positioning Self-expanding Nitinol frame

27 The Future of TAVI Future valves Direct Flow DFM valve Aortic ring inflatable Bovine pericardial tissue Positioning wires Retrievable and repositionable Ventricular ring inflatable Check valves

28 CE mark The Future of TAVI Future valves JenaValve JenaValve Self expanded nitinol stent Porcine aortic root valve Jena Clip anchoring mechanism Retrievable and repositionable

29 CE mark The Future of TAVI Future valves Symetis Acurate Self expanding nitinol stent Stabilization arms Porcine tissue valve

30 The Future of TAVI Future valves Boston The Lotus Valve Locking mechanism enables operator control of implant Adaptive seal designed to minimize paravalvular leaks Retrievable and repositionable Nitinol frame designed for retrieval and repositioning Bovine pericardium long-term proven material

31 The Future of TAVI Future valves St Jude Portico valve Self expanding stent Bovine pericardial valve with anti-ca technology Large stent cell design allows access to coronaries Tissue cuff designed to minimize PV leak Low placement of leaflets/cuff within the stent frame minimal protrusion into the LVOT Retrievable and repositionable

32 Centera The Heart Future Team of TAVI Motorized delivery system provides stability and allow single operator valve deployment 14F delivery system bovine pericardial leaflets The valve anchors the annulus Repositionable Sapien III 14F delivery system bovine pericardial leaflets Includes a customized sealing cuff which reduces the PV leak Has anchors that embrace the annulus

33 The Heart Future Team of TAVI The next generation device should address the following limitations Paravalvular leak Suboptimal deployment Cuffs that cover the device Repositionable Retrievable Repositionable Retrievable Anchoring systems that embrace the annulus Conduction disturbances Limit the risk of coronary ostium obstruction Easy to use Low placement of the leaflets in the prosthesis for minimal protrusion of the valve in the LVOT Large stent cell design Motorized delivery systems Markers to facilitate deployment

34 Antiplatelets Anticoagulants Stroke Conundrum Embolic Protection New Onset AF

35 Claret CE Pro Heart Team The Future of TAVI Cerebral protection devices Cerebrovascular adverse events are well recognized complications of TAVI and the Partner trial reported a 6.7% event rate in high risk patients and a 5.5% event rate in patients with increased co-morbidities Claret CE Pro Inserted through the right radial artery Has 2 filters which protect the brachiocephalic and the left common carotid artery The device was tested in a small feasibility study in 40 pts Debris detected in 54% of the filters Naber et al. Eurointervention 2012

36 Claret CE Pro SHEF The Heart Future Team of TAVI Heparinized filter that is placed in the aortic arch and operates as a debris deflector Can stay in position for months The device was tested in a small study in 15 pts There was a 50% reduction in the cerebral lesions detected with MRI comparing to the control group Embrella embolic deflector Protects the brachiocephalic and left carotid Delivered through the right radial The device was evaluated in 18 pts The new lesions detected by MRI were reduced comparing to those reported in the literature

37 Claret CE Pro The Heart Future Team of TAVI New delivery systems E-sheath The esheath allows for transient sheath expansion during valve delivery Has a diameter 16F and expands to 18F allowing smooth delivering of the valve and then returns to its initial status Solopath The Solopath sheath is balloon expandable Has a diameter of 14F and expands to 18F facilitating delivering of the valve The 2 nd generation sheath will allow deflation of the sheath post valve deployment

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40 Claret CE Pro Heart Team Conclusions Cumulative evidence has demonstrated the value of TAVI in the treatment of pts with severe symptomatic aortic stenosis TAVI therapy should today be restricted to symptomatic inoperable or high risk patients As we become more familiar with this treatment and the new technologies in valve design and enabling TAVI devices are likely to change its future role and increase TAVI applications This can be achieved only if we: Demonstrate its safety and superiority over SAVR in lower risk population Confirm the durability of the device

41 Claret CE Pro Heart Team Conclusions Facilitate the identification of the appropriate pts for treatment Improve the design of the available devices and TAVI enabling systems and reduce the risk of complications Implement advanced imaging modalities for better treatment planning Confirm its cost effectiveness Advances in these fields are likely to enhance the applications of TAVI and probably allow its implementation in the treatment of other valvular pathologies

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44 Aortic PercValve tm Deployment The Future of TAVI Future valves