Chapter 39 Transcatheter Aortic Valves: Types of Available Valves

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1 Chapter 39 Transcatheter Aortic Valves: Types of Available Valves G. SENGOTTUVELU RAGHUL GANESAPANDI INTRODUCTION Aortic stenosis (AoS) is the commonest degenerative heart disease in the world 1. Incidence of AoS is increasing due to improved life expectancy throughout the world due to advanced health care systems. Severe AoS has very rapid downhill course after symptom onset with death rates of 50.7% at 1 year and 68% at 2 years 2. Transcatheter aortic valve replacement (TAVR) has become a boon and a part of advanced health care systems, which prolongs survival even in inoperable patient and we have abundant data even in high-risk and intermediate-risk category patients. TAVR IN GUIDELINES 2017 AHA/ACC FOCUSED UPDATE OF VALVULAR HEART DISEASE GUIDELINE AORTIC STENOSIS Recommendation for TAVR among high-risk patients with severe, symptomatic AS (stage D) is Class I (LOE A) after consideration by a heart valve team. TAVR is a reasonable alternative to surgical AVR for patients with severe, symptomatic AoS (stage D) and intermediate surgical risk after consideration by a heart valve team is Class IIA, (LOE B-R) TAVR EVOLUTION showed TAVR was possible but it could not prove to be effective due to various limitations and hence human application was not feasible. Andersen 7 and his group developed the concept of balloon-expandable valve system, where they used endovascular stent to mount the prosthesis and reported their work in porcine model but it did not progress to human model. Alain Cribier and his team initiated their studies for TAVR from 1990 and succeeded in implanting the first TAVR valve in April which made TAVR a possible treatment option and paved way for further advancements. Edwards Lifesciences acquired valve model from Alain Cribier and resulted in development Edwards SAPIEN Transcatheter heart valve system, which preceded multicentre clinical trials and the pivotal randomized PARTNER study revelling a large data on TAVR valves 9, 10. Grube and colleagues 11 implanted the self- expanding CoreValve developed by Medtronic in US CoreValve pivotal trials showed the safety and the efficacy of the valve 10,12. Since then Edwards and Medtronic have developed new models of transcatheter valves and delivery systems, producing a significant improvement in results and a decreased rate of complications. Several other types of transcatheter valves have been launched by various companies. TAVR VALVES BALLOON EXPANDABLE VALVES VS SELF EXPANDABLE VALVES The basic valve systems available for TAVR are balloonexpandable and self-expanding valve systems. These valve systems were available after a long research and development process. The research on TAVR started as early as in The first animal study was done by Davies in Further data came from Moulopoulos 4, Phillips 5 and Matsubara 6 in 1971, 1976 and 1992, respectively. The research TAVR Valves Self Expanding Balloon expandable Retrivable Non Retrivable 321

2 322 SECTION IV Interventional Cardiology BALLOON-EXPANDABLE VALVE Balloon-expandable valve was developed using bioprosthetic valve used for surgical aortic valve replacement (SAVR). The valve haemodynamics, valve design and profile are similar to SAVR valves. Advantage These valves are smaller compared to self-expanding valves. The data so far from trials have showed lesser incidence of conduction abnormality needing pacemaker implantation, and the incidence of paravalvular regurgitation is also less. Disadvantages These valves need rapid ventricular pacing for implantation which is not tolerated in patients with left ventricular dysfunction. Implantation of balloon-expandable valve in challenging aortic valve anatomy due to eccentric calcification can be difficult. These valves are not retrievable and repositionable, hence planning should be very precise. SELF-EXPANDING VALVES Self-expanding valves are built on a platform which by design is different from the SAVR valves. Advantages The aortic annulus is not circular and does not have uniform shape. These valves have unique feature of conforming the shape of native annulus due its self- expanding nature. They do not need rapid ventricular pacing. They can be repositionable and retrievable, hence can achieve perfect positioning and good result. They can be used in challenging anatomy. Disadvantages The data so far from trials have showed slightly higher incidence of conduction abnormality needing pacemaker implantation. The risk of coronary artery occlusion is higher and future coronary artery intervention is difficult due to the supra-annular position of the valve. We will describe about various valves currently available for TAVR in detail. Balloon-Expandable Valves 1. Edwards SAPIEN THV system 2. Edwards SAPIEN XT 3. Edwards SAPIEN S3 (current generation) 4. MyVal (in pipeline) 5. Direct Flow 6. Colibri 7. Braile Inovare Self-Expanding Valves 1. CoreValve 2. CoreValve Evolut R 3. CoreValve Evolut Pro (current generation) 4. Portico 5. Lotus 6. Edwards Self-Expanding CENTERA 7. JenaValve 8. ACURATEneo 9. The Medtronic Engager valve prosthesis 10. Venus A-Valve 11. Optimum TAV 12. Heart leaflet technology 13. Trinity valve 14. Hydra Aortic valve 15. VitaFlow 16. Allegra 17. Triskele 18. PercValve Balloon-Expandable Valves CRIBIER EDWARDS VALVE. The world s first TAVR was performed by Cribier in 2002 with the Cribier Edwards valve in a 57-year-old patient with calcific AoS. This valve consisted of three equine pericardial leaflets mounted within a tubular, slotted, stainless steel balloon-expandable stent. SAPIEN VALVE. This is the first-generation transcatheter heart valve system from Edwards Lifesciences. The prosthesis is made up three bovine pericardial leaflets, mounted on a stainless steel platform. A polyethylene terephthalate (PET) fabric cuff is placed on the ventricular side valve which enable a seal with the calcified valve, and there by prevents paravalvular leak. Since it is a balloon-expandable valve, the valve is crimped around the catheter using Edwards Crimper. The valve was deliverable by both retrograde and antegrade approaches. The valves were bigger and the height of these valves varied between 14 mm and 19 mm. The 23-mm valve requires a 22 French (Fr) Sheath for delivery and the 26-mm valve requires a 24 Fr Sheath and

3 Chapter 39 Transcatheter Aortic Valves: Types of Available Valves 323 used RetroFlex delivery system. The SAPIEN valve ( Fig ) got the US Food and Drug Administration (FDA) approval in October Placement of AoRTicTraNscathetER Valve (PART- NER) I Clinical Trial showed the valve to be superior to standard medical therapy in high-risk nonoperative patients in cohort B of the trial. SAPIEN XT VALVE. The further advancement of SAPIEN valve was the SAPIEN XT valve ( Fig ). The stainless steel frame which is not MRI safe was replaced by cobalt chromium which was MRI conditional and in the meantime helped in achieving thinner frame which was stronger and compressible then the previous valve. The improvement in the valve design resulted in achieving a smaller valve then the previous generation and smaller novo flex delivery system, 16 Fr for the 23-mm valve and 19 Fr for the 26-mm valve allowing for implantation in patients with smaller vessels and reducing the risk of vascular injury 13. The device got FDA approval in PARTNER II Trial showed TAVR with SAPIEN XT valve system was similar to surgical aortic valve replacement with respect to the primary end point of death or disabling stroke. SAPIEN 3. The Edwards SAPIEN 3 valve ( Fig ) is the current generation advancement of SAPIEN transcatheter heart valve system. It is FDA approved since June The valve leaflets were made of bovine pericardium. The bioprosthesis is treated Valve Balloon Catheter Valve Reroflex delivery system Figure First-generation SAPIEN valve. Valve Valve Figure SAPIEN XT valve.

4 324 SECTION IV Interventional Cardiology Frame design Enhanced frame geometry for ultra-low delivery profile High radial strength for circularity and optimal hemodynamics Flexion based on arch Commander delivery system Low frame height Respects the cardiac anatomy Bovine pericardial tissue Leaflet shape optimized for hemodynamics and durability Carpentier-Edwards ThermaFix* process intended to reduce the risk of calcification Distal end with easy adjusments Outer skirt Designed to minimize paravalvular leak E sheath Figure SAPIEN 3. with ThermaFix tissue treatment which will reduce early valve degeneration and valve calcification. The major changes from previous generations are that the frame struts are wide angled and consist of four rows and four columns at the top of the valve which significantly increases the radial strength. The advantage of the valve design helps in making a smaller valve which can use low-delivery profile catheter, and at the same time because of increased radial strength, it helps in maintaining circular shape of valve profile postdeployment 14 ; the other major change is usage of PET material as an outer skirt of the valve which helps in reducing the incidence of paravalvular leak significantly 15. The prosthesis is available in four sizes 20, 23, 26 and 29 mm and uses a low-profile 14 F e-sheath which has an advantage of expanding to prevent resistance for valve delivery. It uses commander delivery system which can be flexed based on aortic arch curvature. The device can be used through transfemoral, transaortic and transapical accesses. The device got FDA approval in 2015 for use in high-risk patients and in 2016 FDA extended its approval to use in intermediate-risk patients. PARTNER IIA Trial demonstrated use of SAPIEN 3 TAVR in intermediate-risk patients, which resulted in low 1-year rates of all-cause mortality (7.4%), all stroke (4.6%) and moderate or severe aortic regurgitation (1.5%). The conclusions from the PARTNER IIA randomized trial and this propensity score analysis provide strong evidence that in intermediate-risk patients with severe AoS, SAPIEN 3 TAVR compared with surgery improves clinical outcomes and is the preferred therapy. The PARTNER III Trial The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients with AoS started in April 2016 and preliminary data will be available by The trial after completion may result in significant change in guidelines in the management of severe AoS. MYVAL. It is the first Indian transcatheter aortic valve which is essentially a balloon-expandable valve with a nickel cobalt alloy frame, trileaflet bovine pericardial valve made of single pericardial tissue valve, and PET fabric which is self-skirting with tissue valve, which minimizes number of stitched segments thereby eliminating stresses from the system. Animal studies have been completed in a porcine model and were performed at the Skirball Center for Cardiovascular Research, NY, which showed successful satisfactory results. MyVal-1 First in-human study is all set begin by the middle of 2017, in which we are one of the participating centres. It is a prospective, multicentre, single arm, open label study of MyVal ( Fig. 39-4A ) TAVR system in the treatment of severe symptomatic native aortic valve stenosis which is a 5-year study which will be completed by the end of 2017 and the 1-year data will be available by DIRECT FLOW. The Direct Flow valve ( Fig. 39-4B ) is a unique valve. Its totally nonmetallic frame with a double-ring design, one ring on the upper side of the valve in the aortic end and other ring in the

5 Chapter 39 Transcatheter Aortic Valves: Types of Available Valves 325 A. Myval valve B. Direct flow valve C. Colibiri valve D. Braile Inovare Figure Balloon-expandable valve. lower side which is towards left ventricle interconnected by a tubular bridging system, can be inflated independently through two of the three position-fill lumens. The valve is made up of bovine pericardium attached to a polyester fabric cuff which conforms the shape of the native aortic annulus. The valve is present in between the two inflatable rings. These rings can be inflated with similar mechanism of balloon catheter, which allows precise positioning, repositioning, assessment of valve performance until a final position is achieved. Once the valve is positioned optimally, contrast-saline mixture is exchanged for a polymer and the valve is implanted with a final inflation with the pressure of 12 atm. Once the polymer solidifies, the device is no longer retrievable. The advantage of the valve is that it does not need rapid ventricular pacing and the inflatable rings use contrast media helping in positioning the valve; hence, the contrast load can be minimized during the procedure 16. The Discover trial was the first multicentre nonrandomized study of the Direct Flow valve as used in routine clinical practice, and was effective and safe in the short-term follow-up, with low rates of mortality, stroke, vascular complications and aortic regurgitation. TranScatheter Aortic Valve RepLacement System US Feasibility (SALUS) trial data, which will be available by 2017, will give a report on the valve performance and haemodynamics. COLIBRI. It is a balloon-expandable valve system which uses only transfemoral approach ( Fig. 39-4C ). The valve is made up of porcine pericardium leaflets with minimal stitches. It is premounted on stainless steel platform, precrimped and prepackaged ready-to-use valve. The valve is implanted using custom-made noncompliant, high pressure dual balloon-expandable delivery system which uses 14F Sheath. The device is currently available in 24-mm size. The first-in-man case was presented in 2012 (see ref 17 ). BRAILE INOVARE. The valve ( Fig. 39-4D ) is made up of single sheet of bovine pericardium mounted on a cobalt chromium frame with three radiopaque markers and has a 20-mm height. It is delivered only by transapical approach with a 24 Fr introducer system. The valve is available for commercial use; data from the trials are awaited.

6 326 SECTION IV Interventional Cardiology Self-Expanding Valves COREVALVE. The bioprosthesis leaflets and skirt are manufactured by using a single layer of porcine pericardium mounted onto a self-expanding, multilevel and radiopaque frame made of Nitinol. The stent is composed of shape-memory alloy, acquiring its final shape once released. The bioprosthesis is processed with alpha-amino oleic acid, which is an antimineralization treatment derived from oleic acid, a naturally occurring long-chain fatty acid. The device ( Fig ) was delivered using AccuTrak 18 F delivery system by transfemoral approach. The CoreValve US Pivotal Trial Extreme- Risk cohort was a prospective, nonrandomized, unblinded, multicentre investigational study comparing TAVR versus SAVR, which showed superior survival of TAVR. The valve received FDA approval in January COREVALVE EVOLUT R VALVE. The Medtronic CoreValve Evolut R ( Fig ) is advancement of the CoreValve. It is made up of supra-annular trileaflet porcine pericardial leaflets, and porcine pericardium fabric skirt which prevents paravalvular leak. The valve is mounted on a radiopaque self-expanding Nitinol support frame, which is self-anchoring and conforms and seals to the noncircular annulus. The frame cell is design in such a way that it can accommodate a 10 Fr catheter for coronary access. The overall height of the prosthesis is 10% shorter than the previous CoreValve, thereby preventing conduction disturbances. The device is designed to enable recapturability and repositionability until a satisfactory position is achieved. The valve used transfemoral approach and a 14 Fr Enveo R Delivery System In-Line Sheath. The valve is available in 23, 26, 29 and 31 mm; annulus sizes from 18 mm to 29 mm can be treated. The EnVeo R DCS s capsule flare and flexible catheter design enable uniform and controlled valve expansion and self-centering of the valve in the annulus and provides the option to recapture and reposition up to three times until 80% deployment. The valve got FDA approval TAVR with a self-expanding prosthesis or SAVR in intermediate-risk patients: The SURTAVI Clinical Trial demonstrated that Evolut R valve was safe and an effective treatment for patients with symptomatic severe AS at intermediate risk for surgical mortality. FDA expanded the approval for use in intermediate-risk category patients in COREVALVE EVOLUT R PRO. The Evolut Pro prosthesis is built on the Evolut R s platform with various advancements with porcine pericardial leaflets with a self-expanding Nitinol frame with its supraannular valve position. Evolut Pro ( Fig ) device features a unique valve design with a biocompatible porcine pericardial tissue wrap which is present in the outer surface of the valve that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance and decrease the paravalvular leak. The Evolut Pro is indicated for vessel diameter less than 5.5 mm and is available in 23, 26 and 29 mm sizes in the USA, delivered via Provides controlled and accurate deployment via self-expanding Nitinol frame Optimizes hemodynamics with supra-annular valve function Minimizes paravalvular leak (PVL) with conforming frame and sealing skirt 12 mm Maintains coronary access Annulus range mm Delivers low rate of major vascular complications with 18Fr profile Figure The first-generation CoreValve.

7 Chapter 39 Transcatheter Aortic Valves: Types of Available Valves 327 Figure The Evolut R valve with Enveo R delivery system. Figure The Evolut Pro valve with an outer skirt. EnVeo R delivery catheter system by transfemoral approach. It is retrievable and repositionable until 80% deployment. The US Evolut PRO Clinical Study, which included 60 patients, showed 30-day outcomes 1.7% mortality, 1.7% stroke, 10% permanent pacemaker and 0% paravalvular leak, 6.4 mm Hg mean gradient with mean EOA 2.0 cm 2. Medtronic has secured approval from the FDA for its CoreValve Evolut Pro transcatheter valve to treat severe AoS In March PORTICO. It is a self-expanding valve ( Fig. 39-8A ) made up of bovine and porcine pericardium mounted on a Nitinol stent. The Nitinol stent frame has a wide open strut at the aortic level to prevent coronary artery occlusion. The valve treated with Linx anticalcification technology to prevent early degeneration. The valve is implanted at the annular level and hence prevents conduction abnormality. The stent can be retrieved and repositioned until 80% of deployment. The valve uses 18 F delivery system. TAVR with the Abbott Vascular Portico valve: First-in-Human Experience (2015) revealed data which showed Portico valve implantation is feasible, with good short-term clinical and haemodynamic outcomes. St. Jude temporarily halted the implementation of valves worldwide for safety issues and evaluation of reduced valve leaflet mobility reported on CT scans. However, the issue seemed not to occur specifically in the Portico; moreover, it was described as a class problem, including surgical prosthesis. As a result, in June 2015, the FDA cleared St. Jude Medical (now Abbott vascular) to resume further study of the Portico valve. LOTUS. It is a self-expanding valve ( Fig. 39-8B ) and is made up of three bovine pericardial leaflets mounted on a braided Nitinol frame with locking mechanism with an adaptive seal designed to minimize paravalvular leakage. It is designed to be fully recapturable at 100% deployment prior to release, and can be redeployed and repositioned at any time during the procedure. It is a -reloaded system, with central positioning marker and intuitive handle designed for ease of use. It is only used for transfemoral approach. The valve was evaluated in REPRISE I, II, RESPOND and REPRISE III trials and got approval for human use in September EDWARDS CENTERA. It is a self-expandable prosthesis ( Fig. 39-8C ), made up of bovine pericardium mounted on a Nitinol frame with an outer skirt made up of PET to prevent paravalvular leak. It has a low frame height similar to Edwards SAPIEN 3 valve, thus minimizing the risk for conduction disorders and does not extend to ascending aorta for anchoring. It has a motorized delivery system for stable deployment and singleoperator use. It is repositionable, available in 23, 26 and 29 mm, and delivered through a 14 Fr e-sheath through transfemoral and subclavian

8 328 SECTION IV Interventional Cardiology A. Portico valve B. Lotus valve C. Edward Centera valve D. Jena valve E. Acurate Neo valve F. Medtronic Engager G. Venous valve H. Optimum valve I. HLT valve J. Trinity valve L. Vita Flow M. Allegra valve N. Triskele valve 50-mm 0-mm K. Hydra valve Figure Self-expanding valve.

9 Chapter 39 Transcatheter Aortic Valves: Types of Available Valves 329 approaches. The first in-human study Safety and Performance Study of the Edwards CENTERA Self- Expanding Transcatheter Heart Valve (CENTERA-1) will be completed by the end of JENAVALVE. This self-expanding valve ( Fig. 39-8D ) is made up of three native porcine aortic valve mounted on a Nitinol frame, with a clipping system which fixates the stent to diseased native valve leaflets. This device can be repositioned multiple times before the release of clipping system. This valve is designed for transapical approach successfully evaluated in JenaValve FIM Trial. An 18 F transfemoral delivery system has been developed and animal studies have been completed. It is the only prosthesis that received CE (Conformite Europeene) mark for aortic regurgitation in September ACURATENEO. It is a self-expandable prosthesis ( Fig. 39-8E ), made up of porcine pericardium mounted on a Nitinol frame with inner and outer impermeable skirt to prevent paravalvular regurgitation. The prosthesis is implanted at the level of supracoronary position which has stabilization arches at the upper and lower levels of the valve for adequate fixation. It uses a separate transapical delivery system and an 18 F delivery system for transfemoral approach. Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA): 6-month outcomes showed a 30-day device success rate of 92.5%, with two valve-in-valve procedures and one moderate leakage after implantation. At 6-month follow-up, 96.7% demonstrated either none/trivial or mild paravalvular regurgitation. MEDTRONIC ENGAGER. The self-expanding prosthesis ( Fig. 39-8F.) is made up of bovine pericardial leaflets mounted on a Nitinol frame and also has a polyester skirt to prevent paravalvular leak. The prosthesis contains three control arms to support and fix the prosthesis in ideal position. It is used for transapical approach with transapical delivery system which is available in 23 and 26 mm size. European pivotal trial was conducted with a total of 61 patients. Overall device success was achieved in 94.3%. All-cause mortality was 9.9% at 30 days. VENUS A-VALVE. The Venus A-valve ( Fig. 39-8G ) is the Chinese valve which is made with porcine pericardial leaflet. It is a self-expanding valve which is implanted at supra-annular level. It is delivered by using F delivery systems. It has a retrievable system and can be deployed using transfemoral, transaortic or transaxillary/ subclavian route. The data from Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis (Venus-A) will give exact haemodynamic profile of the valve. OPTIMUM. The Optimum TAVR system or the Thubrikar TAVR ( Fig. 39-8H ) is a self-expanding prosthesis made up of bovine pericardium leaflets mounted on a Nitinol frame with skirt preventing paravalvular leak. It is delivered by using an 18 F delivery system. Currently, a 23-mm prosthesis is available. Till date, animal studies, durability testing and human cadaver studies have been completed with success. HEART LEAFLET TECHNOLOGY. It is a self-expandable prosthesis ( Fig. 39-8I ) which is made up of porcine pericardial tissue with Nitinol elastic frame. The valve is implanted at the annular level. The valve has unique design where the Nitinol frame is elastic in nature and helps in anchoring the valve at the annular level by adapting the native annular shape. It also has an integrated braided polyester liner which prevents paravalvular leak. TRINITY. It is a self-expanding prosthesis ( Fig. 39-8J ) where leaflets are made from bovine pericardium which is mounted on a nickel titanium alloy frame. This prosthesis is completely repositionable and retrievable. TRINITY heart valve system completed animal studies in 2010 and completed human studies at the end of The device is available for use either by transapical or transarterial route. HYDRA AORTIC VALVE. This prosthesis is made up of bovine pericardial leaflets mounted on a Nitinol stent frame ( Fig. 39-8K ). It has a unique design composing three tentacles at the outflow area of the prosthesis which helps in anchoring the prosthesis and adapting the shape of the aorta. It can be delivered by using an 18 F delivery system. It is retrievable until 70% of deployment. VITAFLOW. It is a self-expanding valve ( Fig. 39-8L ) developed in China, which is made up of bovine pericardial leaflets with standard anticalcification treatment process. The frame which valve is mounted is made up of low-density cells, which provide better alignment during deployment; the large cells allow more space for coronary access if needed for future coronary intervention. The extended inner and outer skirt may reduce paravalvular leak. The delivery system is available in 16 F and 18 F, which is motorized which can facilitate single-operator valve delivery. A prospective, multicentre trial aiming at assessing the safety and efficacy of VitaFlow TAVR valve in the treatment of severe AoS has been initiated in China. Data will be available soon. ALLEGRA. The prosthesis is made up of bovine pericardium which is mounted on Nitinol frame

10 330 SECTION IV Interventional Cardiology with PermaFlow technology ( Fig. 39-8M ). The valve functions early even before full valve implantation by using the PermaFlow technology, thereby preventing LV outflow obstruction during implantation. It can be delivered using by an 18 F femoral route. TRISKELE. This is a self-expanding valve, which is fully repositionable and retrievable ( Fig. 39-8N ). The valve leaflets are made up of biocompatible polymer which has increased durability and higher resistance to calcification and degeneration. The prosthesis mounted on a stent made up of nickel titanium alloy. This valve is still under research. PERCVALVE. This is a self-expandable prosthesis which is not repositionable and retrievable. Leaflets are made by nano-synthesis technology. The valve is mounted on a nickel titanium alloy frame. The prosthesis compared to other valves is smaller and can be delivered by using a 10 F delivery system. Animal studies have been completed and showed successful valve haemodynamics, post implantation with reduced thrombotic events. Human trials are awaited. SUMMARY Prosthesis Indication Valve Material Balloon-Expandable Approach Edwards AS Bovine pericardium Balloon-expandable Transfemoral/transapical/ 2007 SAPIEN transaortic Edwards AS Bovine pericardium Balloon-expandable Transfemoral/transapical/ 2011 SAPIEN XT transaortic Edwards AS Bovine pericardium Balloon-expandable Transfemoral/transapical/ 2014 SAPIEN 3 transaortic MYVAL AS Bovine pericardium Balloon-expandable Transfemoral 2017 Direct Flow AS Bovine pericardium Inflation of ring Transfemoral 2006 Medical balloons Colibri Heart AS Porcine pericardium Balloon-expandable Transfemoral 2012 Valve Braile Inovare AS Bovine pericardium Balloon-expandable Transapical approach 2008 Prosthesis Indication Valve Material Self-Expandable Approach First in Human First in Human Core Valve AS Porcine pericardium Self-expandable Transfemoral 2012 Evolut R Core valve AS Porcine pericardium Self-expandable Transfemoral 2016 Evolut R Pro Portico AS Porcine pericardium Self-expandable Transfemoral 2011 Lotus Valve AS Bovine pericardium Self-expandable Transfemoral 2007 system Edwards AS Bovine pericardium Self-expandable Transfemoral and 2011 CENTERA subclavian approach Jena Valve AR Porcine native Self-expandable Transfemoral/transapical 2009 aortic valve leaflets Venus A-valve AS Porcine native Self-expandable Transfemoral, 2010 aortic valve leaflets transaortic or Trans axillary/subclavian Optimum AS Bovine pericardium Self-expandable Trans-femoral, subclavian artery, Trans-apical Heart leaflet AS Porcine pericardium Self-expandable Trans-femoral 2009 technology Trinity valve AS Bovine pericardium Self-expandable Transfemoral/transapical 2014 Hydra Aortic AS Bovine pericardium Self-expandable Transfemoral 2017 Valve VitaFlow AS Bovine pericardium Self-expandable Transfemoral 2016 Allegra AS Bovine pericardium Self-expandable Transfemoral Triskele AS biocompatible polymer Self-expandable Transfemoral Under research Perc Valve AS Nano-synthesized Self-expandable Transapical Under research

11 Chapter 39 Transcatheter Aortic Valves: Types of Available Valves 331 CONCLUSION TAVR is rapidly evolving; devices are becoming more compact with increased efficiency making the procedure simpler and effective one. Due to various advancements in the devices and increased technical skills of the operator, complication rates have decreased significantly. In future, TAVR may possibly be an equal alternative for SAVR. Out of all the TAVR valves mentioned, SAPIEN 3, Evolut R valve, Portico valve, Braile valve, Venus valve, MyVal and Hydra valve have been deployed in India. REFERENCE 1. Ross, J., Jr., & Braunwald, E. ( 1968 ). Aortic stenosis. Circulation, 38, Varadarajan, P., Kapoor, N., Bansal, R. C., & Pai, R. G. ( 2006 ). Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Annals of Thoracic Surgery, 82, Davies, H. ( 1965 ). Catheter mounted valve for temporary relief of aortic insufficiency. Lancet, 285, Moulopoulos, S. D., Anthopoulos, L., Stamatelopoulos, S., & Stefadouros, M. ( 1971 ). Catheter-mounted aortic valves. Annals of Thoracic Surgery, 11, Phillips, S. J., Ciborski, M., Freed, P. S., Cascade, P. N., & Jaron, D. ( 1976 ). A temporary catheter-tip aortic valve: Hemodynamic effects on experimental acute aortic insufficiency. Annals of Thoracic Surgery, 21, Matsubara, T., Yamazoe, M., Tamura, Y., Ohshima, M., Yamazaki, Y., Suzuki, M., et al. ( 1992 ). Balloon catheter with check valves for experimental relief of acute aortic regurgitation. American Heart Journal, 124, Andersen, H. R., Knudsen, L. L., & Hasenkam, J. M. ( 1992 ). Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. European Heart Journal, 13, Cribier, A., Eltchaninoff, H., Bash, A., Borenstein, N., Tron, C., Bauer, F., et al. ( 2002 ). Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: First human case description. Circulation, 106, Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., et al. ( 2010 ). Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. New England Journal of Medicine, 363, Smith, C. R., Leon, M. B., Mack, M. J., Miller, D. C., Moses, J. W., Svensson, L. G., et al. ( 2011 ). Transcatheter versus surgical aortic-valve replacement in highrisk patients. New England Journal of Medicine, 364, Grube, E., Laborde, J. C., Gerckens, U., Felderhoff, T., Sauren, B., Buellesfeld, L., et al. ( 2006 ). Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: The Siegburg first-in-man study. Circulation, 114, Popma, J. J., Adams, D. H., Reardon, M. J., Yakubov, S. J., Kleiman, N. S., Heimansohn, D., et al. ( 2014 ). Transcatheter aortic valve replacement using a selfexpanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. Journal of the American College of Cardiology, 63, Webb, J. G., & Wood, D. A. ( 2012 ). Current status of transcatheter aortic valve replacement. Journal of the American College of Cardiology, 60, Bleiziffer, S., Ruge, H., Hörer, J., Hutter, A., Geisbüsch, S., Brockmann, G., et al. ( 2010 ). Predictors for newonset complete heart block after transcatheter aortic valve implantation. JACC Cardiovascular Interventions, 3, Wendt, D., Al-Rashid, F., Kahlert, P., Eißmann, M., El-Chilali, K., Jánosi, R. A., et al. ( 2015 ). Low incidence of paravalvular leakage with the balloon-expandable sapien 3 transcatheter heart valve. Annals of Thoracic Surgery, 100 ( 3 ), Schofer, J., Colombo, A., Klugmann, S., Fajadet, J., DeMarco, F., Tchétché, D., et al. ( 2014 ). Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. Journal of the American College of Cardiology, 63, Fish, R. D., Paniagua, D., Ureña, P., & Chevalier, B. ( 2013 ). The Colibri heart valve: Theory and practice in the achievement of a low-profile, pre-mounted, prepackaged TAVI valve. EuroIntervention, 9 ( Suppl ), S111 S114.

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