TAVI

the uprise in transcatheter valvular interventions...

1. TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) Dr.Nagula Praveen, Final yr PG

2. Contents Introduction History Screening of the patients Description of Edwards Sapien Valve Approaches for TAVI Complications Corevalve Complications Newer devices Take home message

3. Introduction TAVI is the most exciting advancement (an inexorable march) in the field of interventional cardiology(percutaneous valve therapeutics). First TAVI was a bail out procedure in an extremely high surgical risk dying patient. TAVI as an indication for AS patients with low risk , intermediate risk for surgery is on uprise and will be available in the near future.

4. History Transcatheter valvular interventions - exciting area for research since 1960 s. Initial animal investigations were performed by Hywel Davies in 1965. Moulopoulos in 1971 Phillips in 1976 Matsubara in 1992. Temporary relief of aortic regurgitation. Concept of balloon expandable valvular prosthesis from the endovascular stents. In 1992, Andersen et al , porcine model, transluminal stented heart valve.

5. Transcatheter Aortic Valve Implantation (TAVI) 1992: Henning Andersen First description of valve sutured in stent Animal model(pig) Encountered major limitations Obstruction of coronary ostia Handmade wire frame to which was sewn a porcine valve.

6. 1994 – cadaver work – ability to deploy a palmaz stent in the aortic position and contributed to appropriate stent dimensions. 1999 – Percutaneous Valve Technologies , Fort Lee,NJ – an original catheter was developed and tested in the sheep model. In 2000, Bonhoeffer and coworkers – valve from bovine jugular vein mounted within an expendable stent -- native pulmonary valve of the lambs. Later first successful human percutaneous replacement of a pulmonary valve in an RV-PA prosthetic conduit with valve dysfunction.

7. First TAVI in a human was performed in 2002(April 16). Acquisition of PVT by Edwards Life Sciences in 2003 – Cribier Edwards and the EDWARDS-SAPIEN Heart valve further modifications of the original device was done. Feasibility of the TAVI in further studies. Grube et al - self expanding Core Valve Revalving system was reported 2005. 2010 – commercially available in Europe. Presently >50 procedures/week

8. Dr.Alain Cribier Dr.Helene Eltchaninoff Dr.John Webb

9. First human implantation: Alain Cribier April 16, 2002 ( France) Bovine pericardium valve 23mm in diameter

10. CE approval 2007. Edwards SAPIEN valve FDA approval Novmeber 2,2011. Edwards SAPIEN XT – 2014. Edwards SAPIEN 3 – June 17,2015. CE approval for Corevalve 2007 FDA approval for Corevalve 2014. Corevalve EVOLUT – CE mark -2012. Jena valve and ABSOLUT valve CE approval for TA approach.

11. Risk stratification High risk for surgical complications - age or comorbidities. High operative risk (scores in the upper decile for mortality or have a 30-day mortality >15%). Surgical risk is most commonly estimated by the Society of Thoracic Surgery Predicted Risk of Mortality (STS- PROM) and the European System for Cardiac Operative Risk Evaluation (Euro SCORE). Euro SCORE – validated in patients undergoing valve surgery. Logistic Euro SCORE – Persistently overestimate the mortality rate. the risk score divided by 3 – accepted true risk comparable to STS score.

12. STS PROM score Derived from the STS database. Voluntary registry of practice outcomes, which estimates the risks of mortality, morbidity, renal failure, and length of stay after valvular and nonvalvular cardiac surgeries. Underestimates the true mortality rate after the cardiac surgery. Truly reflects the operative and 30 day mortality for the highest risk patients undergoing aortic valve replacement. 2011 updated score – is especially for TAVR – includes liver disease assessed by MELD score,previous radiation therapy,porcelain aorta,oxygen dependence. http://riskcalc.sts.org/stswebriskcalc/#/calculate

13. Limitations of EuroSCORE Donot include certain characteristics that would complicate surgery and increase operative mortality, such as Previous mediastinal irradiation Presence of severe calcification in the thoracic aorta(porcelain aorta) Anatomic abnormality of the chest wall History of mediastinitis Liver cirrhosis Patient’s frailty Algorithms were calculated from patients who underwent surgery. Applicability to patients who were not surgical candidates ?

14. Frailty Index Modified Fried frailty index. 4 criteria ≥ 2/4 criteria among the following: ≥ 2/6 Activity of Daily Living (ADL) impairment Serum albumin < 3.5 g/dl Grip strength < 30 kg for male,< 18 kg for female 15 feet walk test ≥ 7 seconds. Each criterion is scored in quartiles (0-3) Total score 0-12 . Frailty score > 5 had a > 7 fold increase in 1 yr mortality after TAVR. Multicenter FRAILTY AVR study. 400 SAVR vs 400 TAVR >70 yrs age 7 frailty assessment tools Dr.Linda P. Fried

15. Screening of the patients PARTNER trial cohort Severe symptomatic AS High risk for surgical complications (STS risk score >10%) Have a greater than 1 yr survival with regard to their comorbidities, and might benefit from the valve replacement. EUROPE UNION COUNTRIES Patients with severe AS( valve area < 0.8 cm ² ) High surgical risk (Logistic Euroscore >20%) Contraindication to conventional AVR

16. Preliminary evaluation Screening echocardiography to document The severity of AS. Absence of other severe valvular disease Describe the valve anatomy and calcium distribution Determine the aortic annular diameter and left ventricular function. Right and left heart catheterization Presence of pulmonary hypertension and concomitant CAD If present need to be treated before valve implantation. Aortic angiography Correct orientation of the image intensifier during valve positioning Determine potential complicating factors in the aortic arch that may interfere during the procedure. Thoraco abdominal CT angiography Ilio femoral run off – anatomy of aorta,vessel diameter ,calcification and tortuosity.

17. Oversizing relative to the aortic annulus Anchoring to prevent migration sealing to prevent paravalvular aortic regurgitation proper valve functioning to prevent patient-prosthesis mismatch

18. Vascular screening Route of implantation needs to be determined. Both delivery methods are comparable in success and complication rates. Selection depends upon the tortuosity, calcification and internal diameter of the femoral,external iliac and common iliac arteries. Presence of abdominal aortic aneurysm or history of their repair - - - use of the trans apical approach or the subclavian approach. Vascular complications – significant mortality. Contrast angiography – appropriate screening tool for route selection. Core Valve Revalving system Femoral Subclavian approach Edwards SAPIEN heart valve Trans apical Trans femoral

19. Vascular screening Detailed determination of the vascular anatomy is not possible with contrast angiography. Insertion of a guidewire across the iliac arteries – the degree that the vessels will straighten can be evaluated. If the arteries persist with tortuosity – TA or subclavian approach can be preferred. CTA – degree, extent and localisation of vascular calcification. 3D vessel reconstruction and cross sectional imaging – precise determination of vessel lumen diameter . Minimal luminal diameter and the length of the segment with the MLD are the main considerations for selecting the delivery approach IVUS – invasive way of measuring the arterial diameter. – image obliquity.

20. Vascular screening Valve size Sheath size Minimal arterial diameter Edwards SAPIEN 23 mm 22 French (F) 7 mm 26 mm 24 F 8 mm Edwards SAPIEN XT 23 mm 18F 6 mm 26 mm 19F 6.5 mm Medtronic Core valve 18 F 6 mm

21. Recent developments MDCT – reliable and reproducible imaging modality for optimal prosthesis sizing, especially in patients with an eccentric annulus. CT imaging > TEE > TTE – annular diameter. 3D TEE – risk of significant AR post operatively Annular area – prosthesis area = prosthesis annular discongruence . 3D rotational angiography Paieon C THV system 3 mensio valve system Dyna CT of SIEMENS – processing of 2D iamges acquired in the cath lab by a C ARM system.

22. Vascular access sites TRANSFEMORAL TRANSAPICAL TRANSAORTIC TRANS SUBCLAVIAN TRANSAXILLARY TRANSSEPTAL RETROPERITONEAL TRANSCAROTID Are the latest access sites applicable for TAVI

23. Can be repositioned Easy deployment Less risk of conduction disturbances Less risk of PVR 14 F sheaths

24. Valve Academic Research Consortium Outcomes Recently updated VARC 2 definitions Eur J Cardiothorac Surg.  2012 Nov;42(5):S45-60. doi : 10.1093/ ejcts /ezs533. Epub 2012 Oct 1. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2)

25. EDWARDS LIFE SCIENCES TRANSCATHETER HEART VALVE (THV) Edwards Life Sciences,Irvine,California .

26. Cribier -Edwards percutaneous valve. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved. Laser cut stainless steel tubular frame Within which was sewn valve leaflets Constructed from equine pericardium, with the inflow covered with a fabric sealing cuff.

27. EDWARDS SAPIEN VALVE Consists of a bioprosthetic valve, the balloon catheter on which it is mounted, the retroflex catheter and the crimping tool. Tri leaflet bioprsothesis Bovine perciardium Balloon expandable stainless steel stent. Pre treated to decrease calcification and functional deterioration .

28. Fabric cuff – on the ventricular side Covers one half of the frame Limits stent expansion Decreases perivalvular insufficiency Oversizing to the aortic annulus – post deployment stability – lack of a sewing ring. Durability of the valve > 10 yrs Advantages : larger effective orifice area, lower hemodynamic profile compared with corresponding surgically implanted valves, Disdavantage : higher incidence of perivalvular insufficiency. 23 mm stent height 14.5 mm 26 mm height 16 mm

29. EDWARDS SAPIEN XT Currently commercially available in Europe. Cobalt chromium alloy. Same radial strength while reducing the valve profile. Approved for the TF approach and is under investigation for the TA approach. In the future,21 mm and 29 mm valves will be available.

30. EDWARDS SAPIEN 3

31. Figure 2. A, Femoral sheath and dilator . B , The deflection catheter facilitates delivery of the prosthetic valve to the aortic annulus. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved.

32. Balloon catheter Custom made balloon 30 mm in length. Balloon diameters corresponding to the sizes of prostheses,and ends in a nose cone that facilitates crossing the native valve. Its inflation profile decreases movement during inflation.

33. The crimping tool Used to manually and symmetrically compress the overall diameter of PHV – from expanded size to minimal deliver profile. A cylindrical gauge is used to confirm the collapsed profile of the delivery system to ensure that it will move smoothly through the introducer sheath. A measuring ring is used to calibrate the balloon inflation to its desired size and to determine the amount of saline – contrast mixture in the syringe necessary for the proper inflation at the time of deployment.

34. Retroflex Guiding catheter Initially developed by Webb. An innovation to facilitate the PHV passage across the aortic arch from the retrograde approach. Deflectable tip - changes direction when activated by the rotation of an actuator incorporated in the handle. Provides a less traumatic passage to the valve delivery system. Asssits in centering and supporting the valve as it crosses the calcified and stenotic native valve. Precise positioning at the aortic annulus.

35. Novaflex catheter Newer generation catheter Allows loading the Edwards- SAPIEN XT prosthesis onto the balloon while in the body, decreasing the sheath size dramatically.

36. Ascendra delivery system Delivery system used for the trans apical route. Easy valve manipulation to improve the orientation of the prosthesis.

37. Delivery sheath 25 cm hydrophilic coated sheath. Extends into the abdominal aorta to decrease vascular complications. Transfemoral delivery Sheaths are equipped with a hemostatic mechanism to decrease blood loss. Transapical delivery sheath is 26F in diameter, is shorter,and has a flexible tip to decrease trauma when placed in the LV. EDWARDS SAPIEN 23 mm 22F 26mm 24F EDWARDS SAPIEN XT 18F NOVOFLEX 19F

38. Expandable sheaths “Snake swallowing the prey concept” esheath (Edwards) Allows the valve delivery system to stretch within the sheath as it is advanced through the femoral and iliac artery, until it reaches the abdominal aorta. Sheath Valves enclosed 16Fr 23 mm SAPIEN XT 18Fr 26 mm SAPIEN XT 20Fr 29 mm SAPIEN XT

39. TRANS FEMORAL VALVE IMPLANTATION

40. Steps of the Procedure Patient preparation Equipment Antibiotic prophylaxis. Venous and arterial access Imaging RVP BAV TAVI Post procedure assessment

41. Room requirements: Cardiac cath lab or hybrid operating room. Fixed flouroscopy unit – high image quality, ability to store reference images for roadmapping . Cardiopulmonary bypass machine should be accessible. Equipment to treat vascular or coronary complications. Anaesthesia: General anaesthesia if simultaneous TEE is performed. Conscious sedation and local anaesthesia if no TEE. Continuous hemodynamic monitoring required. Vasopressores should be used judiciously,as vasoconstrictiors may interfere with the insertion and removal of the arterial sheath – vascular complications.

42. Infection and antithrombotic prophylaxis: IV antibiotics before procedure – 48 hrs later ( Vancomycin,cefazolin ). Aspirin 160 -325 mg and clopidogrel 300 mg are administered alteast 24 hours before the procedure. After procedure,clopidogrel 75 mg daily is continued for 1 to 6 months and daily apsirin 75mg indefinitely.

43. Venous and arterial access: Ipsilateral leg Femoral arterial access 5F or 6F pigtail catheter Aortic angiography Femoral vein access RVP Contralateral leg Percutaneously Two suture mediated devices Surgical cut down Common femoral artery not to be completely dissected in the posterior aspect Sheath insertion is easier Percutaneously 10 F device Edwards SAPIEN X T device

44. Aortic angiography: Ideal projection is all of the aortic cusps in line and perpendicular to the image intensifier. Temporary Pacemaker Placement: 6F Soloist lead is placed in the right ventricle. RVP at a rate of 180 -220 bpm . Crossing the aortic valve: After anticoagulation with heparin and a therapeutic ACT is confirmed,the native aortic valve is crossed using an AL-2 catheter and a straight guidewire . Extrastiff IA is then exchanged through the AL-2 . Catheter withdrawn distal wire position is maintained in the LV. Pigtail catheter is advanced and the valve gradient is then obtained.

45. Delivery sheath insertion: With guidewire in LA,the previously inserted 8F sheath is removed. Serial dilatation of the femoral and iliac arteries are performed with arterial dilators of increasing size(16F-25F). Delivery sheath is inserted and positioned in the descending aorta. Balloon aortic valvuloplasty : under RVP,before TAVI. Valve prosthesis should be ready to be inserted before the completion of the BAV in case severe AR and hemodynamic instability develop. 20 mm Balloon 23 mm Valve 23 mm Balloon 26 mm valve

46. Figure 3. A, The prosthesis could not be advanced around the aortic arch. B , Active deflection allowed redirection around the arch and access to the ascending aorta. Fluoroscopy in the left anterior oblique projection may aid in negotiating the aortic arch. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved.

47. Valve insertion and deployment: Prosthesis and the delivery system are then inserted in the sheath over the extra stiff guide wire. Once the delivery system reaches the aortic arch,the retroflex catheter is activated,allowing the safe passage of the delivery system across the aortic arch. System advanced to ascending aorta. In the same projection as before(aortic annulus is perpendicular to the screen,the valve is positioned in the aortic position,maintaining a 60%:40% ratio of ventricular :aortic positioning. Midline of the stent frame level with aortic annulus Appropriate location with angiography and TEE – the valve is deployed under RVP.

48. Figure 4. A, The prosthesis could not be advanced through the commissure of the native valve. B, The active deflection catheter facilitates redirection through the valve orifice. C , The prosthesis is carefully positioned adjacent to the calcified native aortic valve. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved.

49. The valve is deployed after the confirmation that the systemic blood pressure has reached and maintained its nadir. Balloon inflation is held 3-5 seconds before deflation. RVP is then stopped to avoid traction on the prosthesis while the balloon catheter is being withdrawn. RVP run generally does not last longer than 15 seconds. Delivery system is straightened and withdrawn. Trans valvular gradient is measured and paravalvular leaks are evaluated by angiography and echocardiography.

50. ECG and femoral arterial pressure monitor display. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved. ECG and femoral arterial pressure monitor display . Rapid right ventricular pacing reduces transvalvular pulsatile flow during balloon inflation. In this case, initial 2:1 capture is followed by delayed 1:1 capture with a greater fall in arterial pressure.

51. Figure 6. A, Balloon-mounted prosthetic valve positioned adjacent to native valve calcification . B , Partial inflation of the deployment balloon. C , Full inflation of the deployment balloon. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved.

52. Ascending aortograms obtained in the posteroanterior projection. After prosthetic valve implantation. The prosthesis is positioned below the ostia of the coronary arteries. There is no aortic insufficiency. John G. Webb et al. Circulation. 2006;113:842-850 Copyright © American Heart Association, Inc. All rights reserved.

53. Sheath Removal and Arteriotomy closure: Sheath is withdrawn with careful monitoring of blood pressure and simultaneous contrast administration through the pigtail catheter placed at the level of the iliac bifurcation. A precipituous drop in BP or extravasation of contrast media indicates vascular rupture. Complication treated by – covered stent or surgical repair. Immediate tamponade of the ruptured vessel with large sheath,closure of the iliac artery or abdominal aorta with a large size balloon – before arterial repair. Arteriotomy site –closed surgically or percutaneousl y

54. Postmortem photograph showing the prosthetic stent adjacent to a bulky, calcified native leaflet excrescence. John G. Webb et al. Circulation. 2006;113:842-850

55. Transfemoral Approach Sapien Valve 77 RetroFlex 3 introducer Sheath Set Edwards SAPIEN THV RetroFlex Balloon Catheter RetroFlex Dilator Kit

56. Hardware Crimper Dilator set Inflation device

57. Hardware

58. Transfemoral Approach Valve Deployment Aortic Pressure RV pacing : 200/min

59. Edwards SAPIEN implantation

60. Edwards SAPIEN implantation

61. TRANS APICAL APPROACH

62. Differences A small left lateral thoracotomy is performed. Planes are dissected until the left ventricular apex is visualised. Purse string suture is placed in a muscular segment of the apico lateral wall. Direct puncture of the LV after anticoagulation and therapeutic ACT achieved, a 7F or a 8F sheath is inserted into the LV. 0.035 inch J tipped guidewire,then advanced through the valve into the descending aorta while being guided with JR curve catheter. The wire must be free of the papillary muscles or mitral chordal structures to avoid complications after insertion of the delivery sheath. The wire exchanged for an extra stiff wire, the amplatz 0.035 inch,270cm long guidewire and the JR catheter is removed.

63. Sheath is exchanged for a 26 F delivery sheath – inserted 3-4 cm into the LV. Under RVP,a BAV is performed with a 20 cm retroflex balloon. Ascendra delivery system is advanced into the sheath and de aired. The valve catheter ensemble is advanced into the aortic position, maintaining a ratio of 50:50 aortic :ventricular positioning. RVP and a patient breath hold are initiated. Valve is deployed as blood pressure is at its nadir. Balloon is deflated and withdrawn. Ventricular sheath is removed after assessing the AR. Thoracotomy is closed over a drain.

64. Ascendra ™ Transapical Approach Edwards SAPIEN ™ THV Ascendra ™ Introducer Sheath Set Ascendra ™ Delivery System Crimper Atrion Inflation Device Ascendra ™ Valvuloplasy Catheter

65. Transapical Approach Direct left ventricular puncture Placement and valve deployment

66. Transapical Approach

67. Apical access devices in pipeline APICA system Coiling device to anchor to the apex. Sealing cap to close or reaccess the access site. PERMA seal Sutureless device Collapsible polymers to spontaneously close the apex after the TA delivery system is removed.

68. TRANSAORTIC Most direct access to the aortic valve. Advantages: Avoids thoracotomy which potentially impedes pulmonary function (COPD pts ). Avoids injury to the myocardium and apex (low LVEF pts ) Sheath placement easier and safer. Compatible with SAPIEN and Corevalve . Rapid cannulation of aorta and initiation of CP bypass. C/I – significant aortic calcification. MDCT mandatory before procedure. Upper hemisternotomy and right anterior mini thoracotomy. Certitude system is the latest for TAo implantation

69. TRANSCAROTID First done in Emory university 3 patients Edwards Retroflex 3 system was used. Corevalve implantation via left carotid artery done in 12 patients. Left carotid diameter > 7.5 mm adequate.

70. Stroke Heart block and arrhythmias Renal dysfunction Severe aortic insufficiency Valve embolization Vascular complications Coronary obstruction Complications

71. Stroke General incidience is 2.5-4.2% . Lower with trans apical approach(assumption). Subclinical cases high with MRI screening. Cerebral embolization can occur during Passage of the valve across the aortic arch. During the attempt to traverse the aortic valve During BAV During valve implantation. Cerebral embolic protection devices during TAVI are being evaluated.

72. Embolic protection device

73. Heart block Incidence of CHB requiring PPI 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 &wire-crossing of the aortic valve 25% Prosthesis expansion 29%. Pre-existing RBBB risk factor for CHB

74. Other AF is seen in approx 12% after TAVI. CHB that requires pacemaker – 5.7% LBBB – 12% First degree AV block – 15%. Cause: Trauma to conduction tissue –transient Myocyte necrosis in the IVS –permanent block.

75. Renal dysfunction AKI seen in 12%- 28%. Renal replacement therapy in 1.4%. Hypertension (OR 4.66) COPD (OR2.64) Transfusion requirement (OR 3.47) Mortality risk is increased (28% vs 7%) AKI and dialysis were less compared to surgery (9.2% vs 25% , 2.5% vs 8.7%)

76. Severe AR VALVULAR PERIVALVULAR Valvular most commonly caused by guidewire and disappears once wire is removed. Prosthetic malfunction – rare. Interference of native valve leaflets with prosthetic function. Placement of a new valve inside the previously placed valve.

77. Perivalvular insufficiency. Inappropriate sizing Malposition Stent underexpansion Post procedure dilatation with a large balloon size will cause flaring of the aortic portion of the stent, conformation of the ventricular portion is changed –worsens the AR. Stent skirt prevents further expansion.

78. Aortic Regurgitation Typically paravalvular mild or mild-moderate severity Most of AR disappears or reduces at 1 yr follow-up [13% absent, 80% mild AR]

79. Date of download: 9/15/2015 Copyright © The American College of Cardiology. All rights reserved. From: A Practical Guide to Multimodality Imaging of Transcatheter Aortic Valve Replacement J Am Coll Cardiol Img. 2012;5(4):441-455. doi:10.1016/j.jcmg.2011.12.013 Grading Criteria for Paravalvular AR
(A) Schematic and illustrated representation of the short-axis view at the level of the aortic valve by echocardiography. (B) Echocardiographic and schematic illustrations of the short-axis view of the aortic valve. Paravalvular aortic regurgitation (AR) can be graded according to the circumferential extent of the regurgitant jet. Paravalvular AR can be graded as mild, moderate, or severe on the basis of a circumferential extent of <10%, 10% to 20%, or >20%, respectively. See Leon et al. (55). RV, right ventricle. Image credit: CC Patrick J. Lynch and C. Carl Jaffe, Yale University, 2006. Figure Legend:

80. Measures to decrease perivalvular AR Decreased congruence between the aortic annulus and device diameter. Low cover index. 100 *(prosthesis diameter – TEE annulus diameter ) /prosthesis diameter.  AR index = [(DBP − LVEDP)/SBP] × 100 . Echocardiographic calcification score index Aortic annulus, sinotubular junction, and aortic valve commissures Each commissure and cusp is given score. Score of 0 – 8.  

81. Valve embolization Malposition Undersizing of the prosthesis. Inappropriate capture during RVP. Embolization to LV – fatal. Aortic embolization occurs – not to remove the guidewire – distal aorta. Inverted valve –does not allow passage of blood through it. Uniformly fatal. Aortic dissection chances are more after valve manipulation

82. Vascular complications 6.6% of cases. Transfemoral approach 8% vs 3.6% Fatal with transapical approach. Small dissection Vascular perforation Vessel avulsion. Aortic annular tear - dissection

83. Causes of hypotension after TAVI Vascular complications—iliac rupture Ventricular rupture Acute valve dysfunction Coronary artery obstruction Multiple rapid pacing episodes in pts with poor LV function ‘Suicidal’ LV in severe LVH [After removing AV obstruction LV decompresses to such an extent that the subvalvular hypertrophy obstructs outflow] treated with fluids & avoiding diuretics

84. Coronary obstruction Subcoronary position 0.6% cases Emergency revascularization

85. Coronary obstruction Displacing an unusually bulky, calcified native leaflet over a coronary ostium height of the coronary ostia, and dimensions of the sinus of Valsalva. ostia should be minimally located 14 mm away from the leaflets insertion .

86. Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve. Treated with CPB  device explantation  AVR Also PCI/CABG

87. Left main coronary artery occlusion resulting from a bulky leaflet displaced over the ostium . Successful percutaneous intervention restored left coronary flow.

88. transvenous , transseptal approach antegrade apical approach : avulsion of a mitral chordae ventricular end of a transcatheter prosthesis can be expected to contact the anterior mitral curtain Mitral valve injury

89. Complications & Management Significant annular rupture Ventricular perforation Pericardial drainage, auto-transfusion Conversion to open surgical closure Device malposition Device embolization Overlapping ‘valve in valve’ Urgent endovascular/ surgical management Major ischemic stroke Minor ischemic stroke Hemorrhagic stroke Catheter-based, mechanical embolic protection Aspirin, anticoagulants Anticoagulation reversal, coagulopathy correction

90. MEDTRONIC SELF EXPANDING CORE VALVE Dr.Eberhard Grube

91. Three generations of the Corevalve Revalving systems have been developed. Self expanding valve . Delivery catheter First generation 25 F Nitinol frame Bovine pericardial valve Second generation 21 F Nitinol frame Porcine pericardial valve Scalloped inflow portion – better flow hemodynamics Third generation 18 F Nitinol frame Skirt and leaflet into six independent sections Sections sewed onto nitinol frame CE MARK approval in 2007 >10,000 impantations worldwide

92. Low profile ,increased durability

93. 3 components Self expanding nitinol support frame – cells configured in a diamond cell design, - anchors a trileaflet porcine pericardial tissue valve. 18 F delivery catheter. Disposable loading system. Aortic annular size 26 mm 20-23 mm 29 mm 24-27 mm

94. Nitinol frame Radial and hoop strength. upper third (outflow) - low radial force : sits prosthesis in the aortic root Parallel to the flow through the valve middle third(constrained center portion ) high hoop strength,valve leaflets are attached avoid impinging the coronaries. (SUPRA ANNULAR VALVE LEAFLETS) It is concave – allows coronary cannulation after implantation. lower third (inflow) - high radial expansive force and sits within the left ventricular outflow tract /aortic annuluar location. Prevents annular recoil Allows to conform to the noncircular shape of the aortic annulus. Prevents frame migration Minimizes paravalvular leaks

95. The three leaflet elements – long commissures –suspension bridge –uniform distribution of the aortic pressure overload to the valve leaflets and the commissural posts. Angled take off of the posts further reduces stress and optimizes leaflet motion. The ability to maintain functionality in a non round shape at the inflow is a critical feature of CRS,constrained part maintains the circular configuration.

96. Anatomic pathologic findings after corevalve implantation 4 patients 350 days after implantation Fibrin deposition and inflammation occur early after implantation. Neointimal coverage and progressive regression of the inflammatory response over time. Neointimal tissue covers the most of the frame struts in contact with aortic wall but in areas of high velocity of blood flow. No excessive pannus formation occuring over the valve leaflets. No fractures of the nitinol frame struts upto 2 yrs – angiographic imaging.

97. Patient selection Clinical contraindications to Corevalve placement – Sepsis Active endocarditis Uncontrolled AF Severe MR,TR,PR Life expectancy less than 1 yr. Relative – Gastritis,peptic ulcer disease, severe renal insufficiency,uncontrolled bleeding diathesis, symptomatic CAD, abdominal or thoracic aortic anuerysm . LVEF < 20%

98. Anatomic criteria Careful evaluation of the aortoannular complex with imaging studies before the procedure. TTE,TEE – preliminary CTA – true aortic annular area. Vascular criteria access vessel diameter > 6 mm. Severe calcification and vessel tortuosity,the access vessel diameter > 7 mm. CTA is the best for evaluation

99. Diagnositc findings Recommended Not recommended LVH Normal to moderate 0.6-1.6 cm Severe >1.7 cm CAD None;mid or distal >70% Proximal lesions >70% Aortic arch angulation Large radial turn Sharp turn Aortic root angulation <30 degrees 30-45 degrees Aortic and vascular disease No or light vascular disease Moderate vascular disease Vascular access diameter >6 mm Calcified and elongated >7 mm Sinus of valsalva width ≥27 mm (26 mm corevalve ) ≥29 mm (29 mm corevalve ) <27 mm <29 mm Sinus of valvsalva height ≥15 mm <15 mm Ascending aorta diameter ≤40 mm ≤43 mm >40 mm >43 mm Annulus diameter 20-23 mm 24-27 mm <20 or >23 mm <24 or >27 mm No atrial or ventricular thrombus No subaortic stenosis LVEF >20% <2 + MR

100. Procedure Pretreatment with aspirin,clopidogrel Antibiotic coverage atleast 1 hr before the procedure. General anaesthesia or conscious sedation. Temporary 5F pacing lead in RV. Arterial access is then obtained on the contralateral side to the planned 18 F sheath for the CRS. Ultrasounded and angiographic guide for arterial puncture. ACT of 250 seconds or more. Pigtail catheter in NCC of the aorta. LAO projection. Angiographic catheter –advance over the standard j tip guide wire into the ascending aorta. Guidewire is exchanged with the straight tip wire to cross the aortic valve - catheter into LV. Extras stiff wire is passed into the LV –positioned at LV apex.

101. Balloon valvuloplasty is performed under RVP. 1:1 sizing (minimal aortic annular diameter by CTA,echo ) Maximum size is 25mm balloon. Corevalve advanced over the 0.035 inch guidewire and positioned across the aortic valve. Aortography to assess the most inferior aspect of the valvular plane. Inflow portion of the corevalve within the aortic annulus.(<6mm below the annulus). Inflow portion flaring out is assessed by sequential aortography Residual stenosis and AR. Removal of vascular sheath – percutaneous closure Cardiac ICU monitoring for 48 hours. Aspirin , clopidogrel combination for 3 months after procedure.

102. Vascular sites Subclavian access Italian National Registry 54 cases 100% procedural success noted with Core Valve. No specific complications noted No deaths at 30 days in the series. 6 month mortality was 9.4%(same as transfemoral approach). Adequate vessel caliber is needed –dissection ,left arm paralysis. Transaortic

103. Valve in Valve Degenerative bioprosthetic valve Stenotic 21mm aortic bioprosthesis Has been successfully implanted in patients with prior mechanical mitral valve prosthesis.(previously considered as a contraindication.

104. Recent trends in using THV Valve in transcatheter valve Valve in aortic bioprosthetic valve Valve in mitral valve Valve in double valve Valve in tricuspid valve Valve in ring

105. TAVI in Degenerated Bioprostheses Aortic Capable with CoreValve and Sapien Bioprosthesis only Annular/Size diameter CoreValve : not in annulus < 21mm Mitral Transapical approach Sapien only Pulmonary

106. TAVI in a patient with a history of mitral valve replacement

107. Valve-in-valve TAVI in both Stented and stentless bioprosthetic valve dysfunction

108. Complications The Valve Academic Research Consortium (VARC) has developed standardized definitions for outcome after TAVI These criteria will form the evidence base for studies in the future. Complications (VARC) Strokes and Transient Ischemic attacks Aortic Regurgitation Vascular access complications Conduction system disturbances Coronary artery occlusion Acute renal failure

109. Strokes and TIA Approximately 5% of patients after traditional surgical AVR. Similar rates after CoreValve placement. Etiology of CVAs after TAVI – Embolization of atherothrombotic material during advancement of the device to and across the aortic valve. Microembolization is common after TAVI. Clinical strokes are infrequent (2.9% -5.1%). If TIAs are included the rate may increase. Novel embolic protection devices to protect the cerebral circulation are under development.

110. Aortic Regurgitation Determination of the etiology of AR after Corevalve placement is an important factor in determining both its significance and its treatment. Paravalvular leaks – uncommon after CoreValve TAVI. Low positioning of the CoreValve frame Incomplete expansion of the frame into the eccentrically shaped annulus Rigidity of the underlying aortic annulus caused by calcification Undersizing of the valve relative to the aortic annular size. Post deployment valvuloplasty may be useful. Retraction of the frame loops using a retrieval snare.

111. Complications & Management Paravalvular AR Central valvular AR Post-deployment balloon dilation, rapid RV pacing for stabilization, ‘valve in valve’ implantation Usually self-limited, Gentle probing of leaflets with a soft wire or catheter Delivery of a 2 nd TAVR device, ‘valve in valve’

112. Higher degrees of post implantation AR (>2+) - worse clinical outcome - low cardiac output, respiratory failure delirium, new onset LBBB, in hospital death.

113. Vascular access complications Because of the relatively large 18F caliber sheath. Incidence varied from 4% to 13%. 91 consecutive patients – 13 patients (13% ) vascular events 7 events were related to incomplete arteriotomy closure with the Prostar device. Meticulous pre procedural screening using CTA Use of vascular ultrasound guidance for arterial access Use of alternative access ( subclavian )

114. Conduction system disturbances Latent and manifest conduction disease in the bundle of His and the tri fascicular conduction system. More extensive with calcified valves and greater valve obstruction. Location of the AV node and origin of the left bundle adjacent to the junction of the RCC and NCC, irritation of membranous septum can affect AV conduction. a  | The anatomy of the aortic root, valve, and conduction system in the normal heart.  b  | Leaflet fusion, as seen with aortic stenosis, results in reduced (annular) attachment of the valve, with reduction of the interleaflet triangle size.  c  | Position of the Medtronic CoreValve ®   system in the native aortic valve. Abbreviations : L, left coronary sinus; LBB, left bundle branch; LFT, left fibrous trigone ; MS, membranous septum; MV, mitral valve; N, noncoronary sinus; R, right coronary sinus; RFT, right fibrous trigone ; STJ, sintotubular junction; VAJ, ventriculoarterial junction; VS, ventricular septum. Permission obtained from Wolters Kluwer Health © Khawaja , M. Z.  et al . Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative).  Circulation  123  (9), 951–960 (2011).

115. Coronary occlusion Rare <1% Distance between the aortic annulus and coronaries are reduced in patients with AS.

116. Differences between two valves head to head comparison

117. Other Prostheses Second generation trans catheter aortic valve prototypes Lotus 117( Sadra Medical,Saratoga,CA ) AorTx (Palo Alta,CA ) Jenna Valve Direct Flow (Santa Rosa,CA ) Paniagua

118. Newly approved TransApical devices

119. Future directions Catheter based valve implantation to treat bioprosthetic valve dysfunction. New stent anchoring systems may be developed to treat aortic insufficiency as well. Development of embolic protection devices In vivo prosthetic valve durability Clinical consequences of chronic perivalvular insufficiency will be answered.

120. Conclusion Catheter based treatment of aortic stenosis is improving. Restenosis after valvuloplasty has been overcome after development of TAVI. Indications for TAVI can be expanded after the availability of follow up of patients of the cohort. Team approach for successful procedure. Training required for performance of TAVI and dedicated imaging instruments. Patient selection is complex.

121. Take home message Selection of patients, evaluation is more extensive in TAVI, procedure is complex – but good results. Surgical AVR still is the treatment of choice for patients with severe symptomatic AS. In inoperable or high risk patient,TAVI is a reality, may be extended to intermediate risk and low risk patients.