TAVI procedure review with cases

• 1. Cath Conference Abdelkader Almanfi, MD, MRCP-UK 04/24/2014 Trans-catheter Aortic Valve Implantation

2. Overview Introduction Procedure Indications & Pre-procedural work up Procedure & Hardware Post-op care, Complications & Management Clinical cases Conclusions 3. Introduction AVR High risk for surgery Complications 30-40% do not undergo Sx Advanced age LV dysfunction Multiple co-morbidities Pt. preference Physician assessment Symptomatic Severe Aortic Stenosis Prohibitive risk Inoperability ~8% mortality (STS, EuroSCORE) ~2% Stroke ~11% prolonged ventilation Organ failure Thromboembolic Complications Bleeding Prosthetic valve DysfunctionJ. Am. Coll. Cardiol. 2012;59;1200-1254 4. Introduction Alternatives Balloon Aortic Valvuloplasty Palliation Bridge to AVR Medical conservative management poor prognosis TAVI - (TAVI) was developed to address this unmet need, After the demonstration of feasibility of TAVI in 2002. now widely practiced, with >50 000 patients treated worldwide, and the technique has been recommended as an alternative strategy for patients in high-risk surgical groups. 5. Transcatheter Aortic Valve Intervention Indications & Pre-procedural work up 6. Indications . 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 7. Indications Patient selection in clinical trials Logistic EuroSCORE >20% or STS Score > 10. J. Am. Coll. Cardiol. 2012;59;1200-1254 8. Contraindications 9. Requisites Heart team approach Specific team leader Close communication Preplanning procedure Large cathlabs/ hybrid rooms Fluoroscopic imaging TEE capabilities General Anesthesia / CPB Vascular intervention for vascular complications Urgent AVR, CABG, Hemodynamic monitoring and management 10. Work up Pre-anesthetic work up Cardiothoracic evaluation [access, AVR, risk assessment] Imaging AS severity, morphology, calcification, annular size and shape Aortic root, annulus to coronary ostia distance (>8mm), Atheroma burden, calcification Other valvular disease, sub aortic obstruction LV function Vascular anatomy from access site to annulus 11. Work up Role of imaging in pre-procedural and post procedural assessment J. Am. Coll. Cardiol. 2012;59;1200-1254 12. MDCT imaging for arterial calcification. Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087 2008 European Association for Cardio-thoracic Surgery 13. MDCT imaging for calculation of the dimension of the aortic annulus. Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087 2008 European Association for Cardio-thoracic Surgery 14. MDCT imaging 3D reconstruction of iliac artery. Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087 2008 European Association for Cardio-thoracic Surgery 15. Transcatheter Aortic Valve Intervention Procedure & Hardware 16. Procedure & Hardware LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg / MAP >75 mm Hg] Vascular access Sites Transfemoral. Less invasive, can be done LA Transapical Left ant. Thoracotomy, more invasive More direct, shorter catheter, easy delivery Septal hypertrophy Ascendra2, Sapien valve Transaortic Upper partial sternotomy Mini-sternotomy 2/3 RICS Aorta 5 cm above valve Less painful, familiar approach to surgeons Manipulation of ascending aorta Subclavian Percutaneous or Cut-down technique J. Am. Coll. Cardiol. 2012;59;1200-1254 www.edwards.com 17. Procedure & Hardware Pacing leads Trans venous or epicardial Anticoagulation Large sheaths Heparin [ACT>250] Intra-procedural TEE Guidewire placement Valve placement Stable position No coronary obstruction No interference with mitral valve function No conduction system impingement No overhanging native aortic leaflets Avoidance of aortic root complications (rupture & dissection) Post deployment assessment [MR, AR] TEE- Mid esophageal long axis view 18. Procedure & Hardware Balloon Aortic Valvotomy Prepping and draping Anesthesia diagnostic arterial access: C/L FA access with 6F sheath pigtail catheter for C/L iliofemoral angiography, location of puncture marked Femoral vein access: I/L to diagnostic access with 7F sheath, for RHC and pacing leads BAV Valve implantation MMCTS.2007.003077 19. Procedure & Hardware Therapeutic arterial access: Percutaneous puncture/surgical preparation standard diagnostic J 0.035 Guidewire +18 or 24F long sheath, heparin Valve crossing : AL1 into ascending aorta exchanged with straight tip 0.035 Guidewire to cross AV AL1 into LV & wire exchanged with Amplatz extra stiff 0.035, 260 cm length Guidewire Balloon aortic valvuloplasty: 20x40 mm balloon Appropriate angiographic projection in line with the plane of annulus [LAO/Cran ] (or you can obtain this angle from CT scan images) midpoint of balloon at the annular level PACE INFLATE CHECK DEFLATE stop pacing MMCTS.2007.003077 20. Procedure & Hardware Sapien XT device CoreValve device Self expandable Nitinol frame Porcine Pericardial Tissue European Heart Journal (2011) 32, 140147 Cardiol Clin 29 (2011) 211222 Superior hemodynamics Lower risk for PPM 21. Procedure & Hardware CrimperDilator set Inflation device www.edwards.com 22. Valve Preparation Table Normal saline Heparinized Saline Papaverine & KY Gel Mineral oil 0.035 J Wire Inflation Device Edwards Rep & Interventional Cardiologist 23. Progressive Arterial Dilation 18,20,22,23,25 & 28 French dilators 25F Outer Diameter Sheath for 23 mm valve 24. Valve Prep 25. Valve Prep & Delivery 26. Balloon aortic valvuloplasty 27. Procedure & Hardware Pressure tracings before and after TAVI European Heart Journal (2011) 32, 140147 28. Procedure & Hardware Sapien device Balloon deployment Transapical deployment also Leaflets in open mode, more chance for AR CoreValve device Partially repositionable Larger annular size Higher chance for CHB Sapien XT device Lesser calcification [reduction of 98% calcium binding sites] Shorter stent size More radial strength grater durability More closed form, less chance for AR www.edwards.com www.medtronic.com 29. Procedure & Hardware European Heart Journal (2011) 32, 140147 30. Device success Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system Correct position of the device in the proper anatomical location Intended performance of the prosthetic heart valve (AVA >1.2 cm2 and mean AV gradient < 20 mm Hg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) Only 1 valve implanted in the proper anatomical location J. Am. Coll. Cardiol. 2012;59;1200-1254 31. Transcatheter Aortic Valve Intervention Post-op care, Complications & Mx 32. Post-Operative Care & Monitoring Immediate or early extubation, early mobilization Adequate analgesia, control postoperative hypertension, monitor for any bleed Monitor vital parameters including fluid balance, renal status, and AV conduction system. Pre-discharge TTE, DAPT J. Am. Coll. Cardiol. 2012;59;1200-1254 33. Complications & Management 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) 211222 J. Am. Coll. Cardiol. 2012;59;1200-1254 34. Complications & Management 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 &wire-crossing of the aortic valve 25% Prosthesis expansion 29%. Pre-existing RBBB risk factor for CHB J. Am. Coll. Cardiol. 2012;59;1200-1254 35. Case # 1 DB is a 87 year old Male with symptomatic severe AS Ischemic CMP NYHA 4 BSA 1.83 Cr 1.09 Hb 14.5 High Risk due to following Frailty CAD (CABG) PCI (2 months ago) ICMP (LVEF 25-30%) CHF (Class IV) CKD with (B/L renal stents) 39 STS 21.2 Euro Score II 39.02 Procedure Name Isolated AVRepl Risk of Mortality 21.276% Morbidity or Mortality 55.053% Long Length of Stay 35.812% Short Length of Stay 4.059% Permanent Stroke 3.397% Prolonged Ventilation 46.630% DSW Infection 0.913% Renal Failure 23.626% Reoperation 22.903% 36. Echocardiography TEE performed Required Measurements AVA 0.7 cm2 Peak Velocity 3.17 m/s AVA index Annulus Diameter 21 mm Mean Gradient 25 mmHg Ejection Fraction 25-30% Findings aortic valve calcification Severe AR Mild MR Mild TR None 40 37. Echocardiography 22.0 cm Proposed 26mm Sapien 38. Echocardiography 39. Echocardiography 40. CT MIP 41. Vitrea View of Gated CTA of Aortic Annulus 329 mm2 42. CTA : Small AAA Aortic bifurcation Proximal common iliacs Bilateral common iliac dissection Bilateral renal stents Distal Aorta 43. CTA : External iliac arteries 44. CTA : CFA (Axial Views) 45. Procedural Plan Annulus Diameter Measurement THV Valve Size Proposed Femoral Access Side Proposed Smallest Vessel Diameter Measurement TEE 24x17 Gated CTA 26 mm TA 7 mm Special Case ConcernsReduced EF 25-30% 46. Videos for TAVI procedure 47. Complications & Management 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] J. Am. Coll. Cardiol. 2012;59;1200-1254 Cardiol Clin 29 (2011) 211222 48. 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 2nd TAVR device, valve in valve J. Am. Coll. Cardiol. 2012;59;1200-1254 49. Complications & Management Rapid Pacing for stabilization Valve in Valve Implantation Reduction of diastole Cardiol Clin 29 (2011) 211222 50. Case # 2 BH is 80 years old female with symptomatic severe AS NYHA 3 BMI 42.7 Cr 0.91 Hb 13.3 PLT 164 High risk due to following CAD-CABG DM COPD Morbid obesity (BMI 42.7) CHF 54 STS 16.5 Euro Score II 9.1 Procedure Name Isolated AVRepl Risk of Mortality 16.524% Morbidity or Mortality 46.470% Long Length of Stay 34.552% Short Length of Stay 5.796% Permanent Stroke 3.058% Prolonged Ventilation 43.166% DSW Infection 1.663% Renal Failure 24.814% Reoperation 12.086% 51. Echocardiography TEE Required Measurements AVA 0.9 cm2 Peak Velocity 3.7 m/s AVA index Annulus Diameter 21 mm Mean Gradient 35 mmHg Ejection Fraction 60% Findings aortic valve calcification Moderate AR Moderate to severe MR Mild to moderate TR Mild to moderate 55 52. Echocardiography 22.0 cm Proposed 23mm Sapien 53. Echocardiography 54. Coronary Angiography Coronary Angiography 11/20/13 Coronary Artery Disease Severe Prior revascularization (CABG or PCI) CABG Additional Revascularization Indicated No 55. CT of Aortic Annulus 500 mm2 56. Aortic Annulus 329 mm2 57. CTA : Distal aorta Aortic bifurcation Common iliacs 58. CTA : External iliac arteries 59. Peripheral Sizing CT Angio Minimal Luminal Diameters Right Left Common Iliac 8 mm Common Iliac 8 mm External Iliac 7 mm External Iliac 7 mm Common Femoral 6-7 mm Common Femoral 6-7 mm 60. Procedural Plan Annulus Diameter Measurement THV Valve Size Proposed Femoral Access Side Proposed Smallest Vessel Diameter Measurement 21 TEE 21x21 Gated CTA 23 mm mm Special Case ConcernsAccess 61. Videos for the TAVI procedure 62. Complications & Management Causes of hypotension after TAVI Vascular complicationsiliac 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 J. Am. Coll. Cardiol. 2012;59;1200-1254 63. 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 retrieval Aspirin, anticoagulants Anticoagulation reversal, coagulopathy correction J. Am. Coll. Cardiol. 2012;59;1200-1254 64. Complications & Management Atrial fibrillation Rate control/ rhythm control via pharmacological or electrical cardioversion Shock, low cardiac output Major bleeding Vascular complications Careful systemic pressure management, inotropic support, IABP, or CPB Hemodynamic support, blood transfusion Urgent endovascular repair/surgery J. Am. Coll. Cardiol. 2012;59;1200-1254 65. Case # 3 RM is 88 years old Male with severe symptomatic AS NYHA 4 BSA 1.75 Cr 1.22 Hb 11.5 PLT 181 High risk due to following CAD (CABG x2 & multiple PCIs) MR CA prostate 69 STS 12 EuroScore II 5.94 Procedure Name Isolated AVRepl Risk of Mortality 11.994% Morbidity or Mortality 39.912% Long Length of Stay 20.333% Short Length of Stay 8.877% Permanent Stroke 3.041% Prolonged Ventilation 32.088% DSW Infection 0.447% Renal Failure 12.706% Reoperation 12.550% 66. Echocardiography TEE performed Required Measurements AVA 0.7 cm2 Peak Velocity 3.3 m/s AVA index Annulus Diameter 20 mm Mean Gradient 30 mmHg Ejection Fraction 45% Findings aortic valve calcification Moderate AR Mild MR Moderate TR Mild 70 67. Echocardiography 22.0 cm Proposed 26 mm Sapien 68. Echocardiography 69. Coronary Angiography Coronary Angiography 1/29/14 Coronary Artery Disease Severe Prior revascularization (CABG or PCI) Multiple CABG & PCIs Additional Revascularization Indicated Ostial LAD SVG 70. Coronary Angiography Ostial SVG to LAD stenosis 71. CT of Aortic Annulus 500 mm2 72. CT 3D 329 mm2 73. CTA : Distal aorta Aortic bifurcation Common iliacs 74. CTA : External iliacs 75. CTA : CFA (Axial Views) 76. Peripheral Sizing CT Angio Minimal Luminal Diameters Right Left Common Iliac 10 mm Common Iliac 8-9 mm External Iliac 8 mm External Iliac 8 mm Common Femoral 8 mm Common Femoral 7 mm 77. Procedural Plan Annulus Diameter Measurement THV Valve Size Proposed Femoral Access Side Proposed Smallest Vessel Diameter Measurement 20 TEE Gated CTA 26 mm Right 7 mm Special Case ConcernsLAD-SVG stenosis 78. Videos for TAVI procedure 79. Conclusion Evolving field, may be used in lower risk patients, and bicuspid AoV What is the durability? .. role of TAVI in low-gradient AS? Which institutions should be qualified to perform TAVI? TAVI for prosthesis degeneration? With refinement in procedures and newer improved hardware may become an attractive alternative to AVR, repeat procedure possible However for Severe symptomatic AS with low risk for surgery, Surgical AVR remains the standard treatment 80. Thank You