1. Transcatheter Aortic Valve Intervention 3 rd 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 AVR High risk for surgery Complications 30-40% do not undergo Sx Advanced age LV dysfunction Multiple co-morbidities Pt. preference Physician assessment 30-40% do not undergo Sx Advanced age LV dysfunction Multiple co-morbidities Pt. preference Physician assessment “Symptomatic Severe Aortic Stenosis” Prohibitive risk Inoperability ~3% mortality (STS, EuroSCORE) ~2% Stroke ~11% prolonged ventilation Organ failure Thromboembolic Complications Bleeding Prosthetic valve Dysfunction ~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 Intervention Indications & Pre-procedural work up Dr. Nithin P G

6. Indications A 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 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 Intervention Procedure & Hardware Dr. Nithin P G

13. Procedure & Hardware 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 Percutaneous or Cut-down technique J. Am. Coll. Cardiol. 2012;59;1200-1254 Modified from www.edwards.comwww.edwards.com Dr. Nithin P G

14. Procedure & Hardware 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] TEE- Mid esophageal long axis view J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

15. 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 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 BAV Valve implantation MMCTS.2007.003077 Dr. Nithin P G

16. Procedure & Hardware Balloon aortic valvuloplasty: 20x30 mm (for # 23) or 23x30 mm (for # 26)  Appropriate angiographic projection in line with the plane of annulus [LAO20 0 /Cran20 0 ]  midpoint of balloon at the annular level  PACE  INFLATE  CHECK  DEFLATE  stop pacing Balloon aortic valvuloplasty video MMCTS.2007.003077 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 Cardiol Clin 29 (2011) 211–222 Superior hemodynamics Lower risk for PPM Superior hemodynamics Lower risk for PPM Dr. Nithin P G

18. Procedure & Hardware CrimperDilator setInflation device www.edwards.com Dr. Nithin P G

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

20. Procedure & Hardware Pressure tracings before and after TAVR European Heart Journal (2011) 32, 140–147 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 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 cm 2 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 Dr. Nithin P G

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

25. 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 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 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 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 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 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] 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) 211–222 Dr. Nithin P G

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

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

32. Complications & Management 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 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 Dr. Nithin P G

33. Complications & Management Significant annular rupture Ventricular perforation Significant annular rupture Ventricular perforation Pericardial drainage, auto-transfusion Conversion to open surgical closure Pericardial drainage, auto-transfusion Conversion to open surgical closure Device malposition Device embolization Device malposition Device embolization Overlapping ‘valve in valve’ Urgent endovascular/ surgical management Overlapping ‘valve in valve’ Urgent endovascular/ surgical management Major ischemic stroke Minor ischemic stroke Hemorrhagic stroke Major ischemic stroke Minor ischemic stroke Hemorrhagic stroke Catheter-based, mechanical embolic retrieval Aspirin, anticoagulants Anticoagulation reversal, coagulopathy correction Catheter-based, mechanical embolic retrieval Aspirin, anticoagulants Anticoagulation reversal, coagulopathy correction J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

34. Complications & Management Atrial fibrillation Rate control/ rhythm control via pharmacological or electrical cardioversion Shock, low cardiac output Major bleeding Vascular complications 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 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 Intervention Review of evidence Dr. Nithin P G

36. Review of Evidence Registry data 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 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 Dr. Nithin P G

37. Review of Evidence PARTNER Trial Design Cohort A 84 yrs N=699 Cohort A 84 yrs N=699 Cohort B 83 yrs N=358 Cohort B 83 yrs N=358 J. Am. Coll. Cardiol. 2012;59;1200-1254www.nejm.org 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? a)Expected survival >12 months b)Severe PAH c)Severe aortic disease d)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 a)TEE b)Angiography c)CMR d)MDCT Dr. Nithin P G

42. MCQ’s 3. Preferred access route in case of septal hypertrophy? a)Transfemoral b)Transapical c)Transaortic d)Subclavian Dr. Nithin P G

43. MCQ’s 4. TAVR using ‘CoreValve’ device is not done via a)Transfemoral b)Transapical c)Transaortic d)Subclavian Dr. Nithin P G

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

45. MCQ’s 6. ‘Device success’ is not achieved if a)AVA =1.2 cm 2 b)mean AV gradient= 30 mm Hg c)peak velocity =2.75 m/s d)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 a)Rapid RV Pacing b)Gentle probing with catheter c)Prepare for urgent AVR d)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 a)RV pacing induced VF b)Vascular complications c)Device malposition d)Moderate AR Dr. Nithin P G

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

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

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