TAVR Education Basics For The Cardiologists

TAVR education

1. TAVR Education: The Basics Ashish Rastogi, MD

2. Outline Review of Aortic Stenosis Treatment Options Pre-procedure Planning Procedure Steps Post-procedure Management

3. Aortic Stenosis

4. Aortic stenosis is a common condition affecting about one out of eight people over the age of 75 Severe aortic stenosis is often caused by calcification of the aortic valve’s leaflets — and can be progressive resulting in degenerative calcific aortic stenosis Over time, the leaflets become stiff, resulting in limitation of the normal opening during systole, causing stress and increasing the risk of heart failure Images courtesy of Renu Virmani MD at the CVPath Institute Aortic valves with severe aortic stenosis

5. Images displayed are representative of aortic valves Mild Moderate Severe Healthy Aortic stenosis is a buildup of calcium deposits on the valve, which causes it to narrow and reduce blood flow to the rest of the body.

6. The symptoms of aortic disease are commonly misunderstood by patients as ‘normal’ signs of aging. Many patients initially appear asymptomatic, but on closer examination up to 32% exhibit symptoms. Shortness of breath Syncope or presyncope Angina Fatigue Rapid or irregular heartbeat Difficulty when exercising Swollen ankles and feet Palpitations (an uncomfortable awareness of heart beating rapidly or irregularly) LINK: Aortic Valve Stenosis – Symptoms and Causes

7. Treatment is critical for survival Survival after onset of symptoms for severe aortic stenosis (AS) is as low as 50% at two years and 20% at five years. 1 50% at two years 20% at five years Malaistie S, et al. Mortality While Waiting for Aortic Valve Replacement. Ann Thorac Surg 2014;98:1564–71

8. The longer your severe aortic stenosis patients wait for treatment, the higher their risk of mortality 11.6% at six months post recommendation for AVR Probability of death while waiting for treatment is 4% while undergoing assessment for treatment After onset of symptoms there is a 50% survival rate at two years Probability of death in routine clinical practice is

9. PK Shah. Circulation. 2012;126:118–125

10. Treatment Options

11. Surgical Valve Replacement (SAVR)

12. ULTRA Transcatheter Valve Replacement (TAVR)

13. Low delivery profile & high radial strength Bovine pericardial leaflets Facilitates future coronary access Approximately 40% increased outer skirt height 1 Textured material. Similar biocompatible PET material as the SAPIEN 3 valve. 14F sheath compatibility 2 Taller, Textured Outer Skirt Same Frame and Leaflet Design 1 EDWARDS Sapien 3 Ultra Valve

14. Medtronic Evolut R / PRO Valve

15. EDWARDS Sapien 3 Ultra Medtronic Evolut R/PRO

16. Pre-Procedure Planning

17. 2020 ACC/AHA Guidelines Patient with Severe AS Surgical Risk Assessment TAVR High or Prohibitive Life Expectancy with acceptable QOL >1 year Palliative Care Low to Intermediate Patient Age SAVR Mechanical (2a) Pulmonic Autograft (2b) Mechanical OR Bioprosthetic (2a) SAVR TAVR TAVR SAVR (2a) transfemoral transfemoral YES NO < 50 years 50 - 65 years 65 - 80 years > 80 years Class I Indication Class 2a Indication

18. Favor SAVR Young patient, potential for Mechanical Valve Another reason for surgery + CABG + MVR/ MVr + Ascending/Root enlargement Aortic Regurgitation Endocarditis Higher risk TAVR Low coronary height / small root Difficult access Unfavorable anatomy based on CT When to do SAVR?

19. Workup CT scan (Cardiac CT w/ 3D morphology and Chest/Abd/Pelvis) Coronary angiogram +/- RHC Interventional Cardiology Consult Frailty Assessment Cardiac Surgery Consult

20. Access Options for TAVR Transaortic (access through arch of the aorta) Transaxillary (access through the axillary artery) Adapted from possible catheter access sites image at www.mayoclinic.org Transapical (access through tip of heart) Transfemoral (access through femoral artery) If transfemoral access is not feasible, alternative access sites may be considered depending on regional approvals and operator experience Carotid (access through carotid artery) PREFERRED

21. HEART VALVE TEAM MEETING

22. Procedure Steps

23. Day of Procedure Nursing Pre-procedure EKG Pre-procedure neuro check Bilateral DP/PT pulse checks with Doppler if needed Consented by physicians and form signed 325 mg Aspirin

24. Foley catheter Transvenous pacing wire Central Line General Anesthesia +/- Intubation Radial a-line 14-16 F Arterial access 6 F Arterial access +/- 6F Radial sheath Anesthesia IC/ Surgeron Nursing PIV

25. Edwards SAPIEN 3 Ultra System Pink Green Purple Orange 20 mm THV 23 mm THV 26 mm THV 29 mm THV Crimper Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (20, 23, 26 mm only) OR Inflation Devices Color Coded System The Edwards Balloon Catheter for balloon aortic valvuloplasty is not included with the 20, 23 and 26 mm systems. NOTE: Edwards SAPIEN 3 Transcatheter Heart Valve (29 mm only) Edwards eSheath Introducer Set Edwards Commander Delivery System Edwards Balloon Catheter

26. IC CTS A P DPL CCL Staff OR Staff

27. EDWARDS Table Interventional Equipment

28. PREPPED PATIENT

29. Edwards Sapien Valve Procedure

30. Post-Procedure Management

31. Foley catheter Transvenous pacing wire Central Line General Anesthesia +/- Intubation Radial a-line 14-16 F Arterial access 6 F Arterial access +/- 6F Radial sheath Anesthesia IC/ Surgeron Nursing PIV

32. +/- Transvenous pacing wire (20% of cases) +/- TR BAND PIV Perclose sutures I’m hungry! If left in, 75% removed next day 5-10% of all patients may need pacemaker

33. Potential Complications of TAVR Stroke Heart Block Vascular Bleeding/Occlusion Cardiac Tamponade Acute Kidney Injury STEMI Infection

34. Stroke ~1% CAUSE SIGNS NURSING INTERVENTIONS Bulky calcium on aortic valve Atherosclerosis of Aorta Balloon Valvuloplasty /Valve Deployment Sudden numbness, weakness, paralysis of face, arm and/or leg, especially unilateral Sudden slur or difficulty with speech and/or understanding words/phrases Sudden unilateral loss of vision Call Dr. Rastogi emergently to discuss symptoms Often times vague symptoms can be related to anesthesia True unilateral weakness/paralysis/numbness will require Stroke Code activation

35. Heart Block ~6% CAUSE SIGNS NURSING INTERVENTIONS Valve pressing on inter-ventricular septum Risk factors: pre-existing heart block, older age, valve size Bradycardia Hypotension Faitgue /Dizziness Syncope Call Dr. Rastogi immediately STAT EKG Pacer Pads on patient if no temporary pacemaker already May nee permanent pacemaker during admission

36. Vascular Complication ~5% CAUSE SIGNS NURSING INTERVENTIONS Large caliber sheath in artery Heavily calcified illeo -femoral arteries Perclose closure device issues Patient not adhering to bedrest requirements Raised Hematoma Tachycardia/Hypotension Absent distal pulses Significant pain in groin with Bruit on exam Call Dr. Rastogi Manual pressure if Hematoma IV fluids +/- Pressors for hypotension Serial pulse checks May need to go to cath lab for treatment Hematoma Pseudoaneurysm RP Bleed Occluded Artery Most issues can be treated in the C ath L ab

37. Cardiac Tamponade < 1% CAUSE SIGNS NURSING INTERVENTIONS Rupture of Aortic Annulus by TAVR Perforation of LV or RV by wires Bradycardia Hypotension Elevated JVP Chest pain / SOB Call Dr. Rastogi immediately STAT ECHO May require pressor support May require emergent pericardiocentesis vs pericardial window

38. Acute Kidney Injury <1% CAUSE SIGNS NURSING INTERVENTIONS Contrast Hypotension Bleeding Decreased urine output Confusion IV fluids post-TAVR (as per orders) Minimize hypotension Monitor urine output

39. Other Potential Complications STEMI INFECTION Coronary obstructed by Valve or Calcium STAT EKG if Chest Pain Call Dr. Rastogi if STEMI suspected Patient will get pre and post antibiotiocs Patients also need antibiotic prophylaxis in future for dental procedures 90-95% of patients should have minimal issues and walk out of the hospital on POD1

40. POD 0 Nursing Post-procedure EKG IV fluids x 4-6 hours Telemetry Pacer pads on patient Bedrest overnight Head of bed to 30 degrees after 4 hours Q4 hour neuro checks Q15-30 min groin and pulse checks in first few hours Medications PRN Tylenol and Norco POD 1 Nursing Ambulate by 6AM Medications Aspirin 81mg Labs/Tests CBC/BMP Echocardiogram Post Procedure DISCHARGE on POD1 with 1 week and 4 week follow-up!