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Transcatheter Aortic Valve Intervention

Transcatheter Aortic Valve Intervention. 3 rd April 2012 Dr Nithin P G. Overview. Introduction Procedure Indications & Pre-procedural work up Procedure & Hardware Post-op care, Complications & Management Review of evidence Conclusions. Introduction.

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Transcatheter Aortic Valve Intervention

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  1. Transcatheter Aortic Valve Intervention 3rd April 2012 Dr Nithin P G Dr. Nithin P G

  2. Overview • Introduction • Procedure • Indications & Pre-procedural work up • Procedure & Hardware • Post-op care, Complications & Management • Review of evidence • Conclusions Dr. Nithin P G

  3. Introduction “Symptomatic Severe Aortic Stenosis” Prohibitive risk High risk for surgery Inoperability AVR • 30-40% do not undergo Sx • Advanced age • LV dysfunction • Multiple co-morbidities • Pt. preference • Physician assessment Complications • ~3% mortality (STS, EuroSCORE) • ~2% Stroke • ~11% prolonged ventilation • Organ failure • Thromboembolic Complications • Bleeding • Prosthetic valve Dysfunction J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  4. Introduction Alternatives • Balloon Aortic Valvuloplasty • Palliation • Bridge to AVR • Medical management • TAVI Dr. Nithin P G

  5. Transcatheter Aortic Valve InterventionIndications & Pre-procedural work up Dr. Nithin P G

  6. Indications J. Am. Coll. Cardiol. 2012;59;1200-1254 A Symptomatic severe calcific Aortic Stenosis[trileaflet] who have aortic and vascular anatomysuitablefor TAVR and a predicted survival>12 months, and who have a prohibitivesurgical riskas defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factorssuch as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease. TAVR is a reasonable alternativeto surgical AVR in patients athigh surgical risk (PARTNER Trial Criteria: STS >8) Dr. Nithin P G

  7. Indications Patient selection in clinical trials Logistic EuroSCORE >20% or STS Score > 10. J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  8. Indications J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  9. Requisites • ‘Heart team’ approach • Specific team leader • Close communication • ‘Preplanning procedure’ • Large cathlabs/ ‘hybrid’ rooms • Fluoroscopic imaging • TEE capabilities • GA/ CPB • Vascular intervention • Urgent AVR, CABG, Vascular complications • Anesthesia • Conscious sedation/ GA • CPB facility • Hemodynamic monitoring and management Dr. Nithin P G

  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 (>8mm), Atheroma burden, calcification • Other valvular disease, sub aortic obstruction • LV function • Vascular anatomy from access site to annulus • Cerebro vascular imaging Dr. Nithin P G

  11. Work up Role of imaging in pre-procedural and post procedural assessment J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  12. Transcatheter Aortic Valve InterventionProcedure & Hardware Dr. Nithin P G

  13. Procedure & Hardware Percutaneous or Cut-down technique J. Am. Coll. Cardiol. 2012;59;1200-1254 www.edwards.com Modified from www.edwards.com • LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg / MAP >75 mm Hg] • Vascular access • Sites • Transfemoral • Transapical • Left ant. thoracotomy • More direct, shorter catheter • Septal hypertrophy • Ascendra2, Sapien valve • Transaortic • Upper partial sternotomy • Mini-sternotomy 2/3 RICS • Aorta 5 cm above valve • Less painful, familiar approach • Manipulation of ascending aorta • Subclavian Dr. Nithin P G

  14. Procedure & Hardware TEE- Mid esophageal long axis view J. Am. Coll. Cardiol. 2012;59;1200-1254 • Pacing leads – Trans venous or epicardial • Anticoagulation • Large sheaths • Heparin [ACT>300] • 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] Dr. Nithin P G

  15. Procedure & Hardware Valve implantation BAV MMCTS.2007.003077 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 Therapeutic arterial access: Percutaneous puncture/surgical preparation standard diagnostic J 0.035 Guidewire +14F long (24 cm) 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 extrastiff 0.035, 260 cm length Guidewire Dr. Nithin P G

  16. Procedure & Hardware MMCTS.2007.003077 Balloon aortic valvuloplasty: 20x30 mm (for # 23) or 23x30 mm (for # 26)Appropriate angiographic projection in line with the plane of annulus [LAO200/Cran200]  midpoint of balloon at the annular level PACE INFLATE CHECK DEFLATE stop pacing Balloon aortic valvuloplasty video Dr. Nithin P G

  17. Procedure & Hardware • ‘Sapien XT’ device ‘CoreValve’ device Self expandable Nitinol frame Porcine Pericardial Tissue European Heart Journal (2011) 32, 140–147 • Superior hemodynamics • Lower risk for PPM Cardiol Clin 29 (2011) 211–222 Dr. Nithin P G

  18. Procedure & Hardware Dilator set Inflation device Crimper www.edwards.com Dr. Nithin P G

  19. Procedure & Hardware www.edwards.com • ‘Sapien’ Deployment video • ‘Sapien XT’ video • ‘CoreValve’ Deployment video Dr. Nithin P G

  20. Procedure & Hardware European Heart Journal (2011) 32, 140–147 Pressure tracings before and after TAVR Dr. Nithin P G

  21. 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 Dr. Nithin P G

  22. Procedure & Hardware European Heart Journal (2011) 32, 140–147 Dr. Nithin P G

  23. Procedure & Hardware J. Am. Coll. Cardiol. 2012;59;1200-1254 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 Dr. Nithin P G

  24. Transcatheter Aortic Valve InterventionPost-op care, Complications & Mx Dr. Nithin P G

  25. Post-Operative Care & Monitoring J. Am. Coll. Cardiol. 2012;59;1200-1254 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 Dr. Nithin P G

  26. Complications & Management Dr. Nithin P G

  27. 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) 211–222 J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  28. Complications & Management J. Am. Coll. Cardiol. 2012;59;1200-1254 • 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 Dr. Nithin P G

  29. 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] Cardiol Clin 29 (2011) 211–222 J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  30. Complications & Management 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’ Paravalvular AR Central valvular AR J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  31. Complications & Management Rapid Pacing for stabilization Reduction of diastole ‘Valve in Valve’ Implantation Cardiol Clin 29 (2011) 211–222 Dr. Nithin P G

  32. Complications & Management • 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 Cardiol Clin 29 (2011) 211–222 J. Am. Coll. Cardiol. 2012;59;1200-1254 Causes of hypotension after TAVI Dr. Nithin P G

  33. 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 Catheter-based, mechanical embolic retrieval Aspirin, anticoagulants Anticoagulation reversal, coagulopathy correction Major ischemic stroke Minor ischemic stroke Hemorrhagic stroke J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  34. Complications & Management Rate control/ rhythm control via pharmacological or electrical cardioversion Atrial fibrillation 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 Dr. Nithin P G

  35. Transcatheter Aortic Valve InterventionReview of evidence Dr. Nithin P G

  36. Review of Evidence • Age> 80 years • EuroSCORE [> 23 ‘Sapien’, >16 ‘CoreValve’] • Route of implantation no difference in procedural success rate b/w TF & TA accesses • Major bleeding more in TA vs. more vascular complications in TF J. Am. Coll. Cardiol. 2012;59;1200-1254 Registry data Dr. Nithin P G

  37. Review of Evidence PARTNER Trial Design Cohort A 84 yrs N=699 Cohort B 83 yrs N=358 www.nejm.org J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

  38. Conclusion Evolving field, may be used in lower risk patients, bicuspid AoV ‘Criteria to screen eligible patients’ dynamic 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, AVR Sx remains the standard treatment Dr. Nithin P G

  39. Thank You Dr. Nithin P G

  40. MCQ’s 1. Which of the following is not a contraindication for TAVI? • Expected survival >12 months • Severe PAH • Severe aortic disease • LVEF<20% Dr. Nithin P G

  41. MCQ’s 2. Best investigation for planning the precise coaxial alignment of the stent-valve along the centerline of the aortic valve and aortic root • TEE • Angiography • CMR • MDCT Dr. Nithin P G

  42. MCQ’s 3. Preferred access route in case of septal hypertrophy? • Transfemoral • Transapical • Transaortic • Subclavian Dr. Nithin P G

  43. MCQ’s 4. TAVR using ‘CoreValve’ device is not done via • Transfemoral • Transapical • Transaortic • Subclavian Dr. Nithin P G

  44. MCQ’s 5. Advantages of Sapien XT include all except- • Lesser calcification • Longer stent size • More radial strength • Lesser risk for AR Dr. Nithin P G

  45. MCQ’s 6. ‘Device success’ is not achieved if • AVA =1.2 cm2 • mean AV gradient= 30 mm Hg • peak velocity =2.75 m/s • mild prosthetic valve AR Dr. Nithin P G

  46. MCQ’s 7. Patient undergoes transfemoral TAVI with ‘Sapien’ valve, immediate post procedure angio noticed to have moderate AR, SBP-100 mm Hg; first response would be • Rapid RV Pacing • Gentle probing with catheter • Prepare for urgent AVR • IABP Dr. Nithin P G

  47. MCQ’s 8. Patient undergoes successful transfemoral TAVR with ‘CoreValve’ device, immediate post procedure angio & TTE good device position and function, after sheath removal and shifting to ICU pt goes into shock, most likely cause • RV pacing induced VF • Vascular complications • Device malposition • Moderate AR Dr. Nithin P G

  48. MCQ’s 9. For TAVR optimum annulus to coronary artery distance should be • >4mm • >5mm • >8mm • >10mm Dr. Nithin P G

  49. MCQ’s 10. After uncomplicated TAVR routine post-op care and discharge advice does not include • Early extubation and ambulation • Control of Post-op hypertension • Pre-discharge TTE • OAC Dr. Nithin P G

  50. MCQ’s 11. Which is false regarding TAVI • PPM is less likely compared to surgical bioprosthesis • ‘Valve in valve’ implantation is an acceptable option in patients with high risk for surgical AVR and post procedural moderate AR • AR after TAVR is usually paravalvular • Patients with post procedural AR at 1 year follow up 90% of pts show a gradual increase in severity Dr. Nithin P G

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