CIPG Transcatheter Aortic Valve Replacement- When Is Less, More?
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1 CIPG 2013 Transcatheter Aortic Valve Replacement- When Is Less, More? James D. Rossen, M.D. Professor of Medicine and Neurosurgery Director, Cardiac Catheterization Laboratory and Interventional Cardiology
2 Disclosure Site investigator for Edwards LIS PARTNER-2 TRIAL
3 Aortic Stenosis- Symptoms Asymptomatic phase Symptoms Angina Heart failure Syncope
4 Symptomatic Aortic Stenosis- Prognosis From Ross Jr J et al. Circulation 1993;87:61
5 Symptomatic AS- Prognosis with AVR From Schwartz F et al. Circulation 1982;66:1105
6 Open AVR (OAVR) Treatment of choice for calcific AS US 40,000 + OAVR yearly Last two decades Increasing patient age AVR with concomitant CABG Redo surgery Mortality 4%: isolated SAVR 15%: reoperations with multiple valves Risk factors: age, female, CABG, redo AVR, CHF, renal failure, cerebrovascular disease Ann Thorac Surg 2000;70:1939
7 Aortic Valve Replacement Age > 80 Yrs Perioperative morbidity, 245 patients (%) Intra op/post op IABP 5 Reoperation for bleeding 9 Myocardial infarction 1 Atrial arrhythmia 45 CVA (permanent) 3 Renal failure 12 Prolonged ventilation day hospital mortality 9 All hospital mortality 10 Spencer JM et at. Annals Thor Surg 2007;83:1651
8 Transcatheter Aortic Valve Implantation TAVI = TAVR Access: Femoral artery- TF TAVR Apex of left ventricle- TA TAVR Ascending aortic- TAo TAVR
9 Educational Goals of Talk Describe TAVR Summarize data- Inoperable patients High risk patients Review UIHC Experience Future
10 TAVR Timeline Anderson: stent mounted porcine valve into pigs Bonhoeffer: transcatheter pulmonic valve in human patient Cribier: transcatheter aortic stent-valve in humans CE Mark approval SAPIEN valve Webb published first large TAVR series First PARTNER Trial published US FDA approves SAPIEN valve for inoperable patients
11 Edwards Sapien Valve
12 TAVR Patient Requirements Native aortic trileaflet senile calcific valve stenosis Suitable annulus size (18-25 mm) Transfemoral- aortic and iliac artery anatomy 22 or 24 F sheaths used 7 or 8 mm minimum iliac artery diameter Or- transapical, transaortic
13 TAVR Evaluation Testing Transthoracic echo: stenosis severity, morphology CT angiogram: annulus size, aorta, ilio femoral artery size/anatomy Transesophageal echo: annulus size, valve morphology Catheter angiogram: Coronaries, iliacs Operative risk assessment STS mortality risk score (>8 10%) Frailty PHTN, porcelain aorta, bypass grafts, immunocompromised etc.
14 Aortic Valve Gross Patho-Anatomy Normal Bicuspid Senile Calc Tricuspid Senile Calc Tricuspid RF
15 Ao V Annulus Measurement
16 Aortoiliac CT Angiogram
17 TAVR and Iliac Artery Anatomy
18 Transfemoral TAVR Procedure General anesthesia, ET intubation Transesophageal echocardiography Percutaneous access or femoral cutdown Sheath placement Balloon valvuloplasty Valve positioning guided by angiography and echo Valve implantation during rapid ventricular pacing Access site closure
19 Aortic Balloon Valvuloplasty
20 Valve Implantation
21 Transfemoral TAVR Access Site
22 PARTNER Trial (Cohort B) Patients with severe symptomatic AS Inoperable- risk >50% Randomized to transfemoral implant of Edwards Sapien valve vs standard therapy Primary endpoint- death from any cause 358 pts enrolled Leon MB et al. N Engl J Med 2010;363:1597
23 Partner 1B Trial Primary Outcome Leon MB et al. N Engl J Med 2010;363:1597
24 PARTNER 1B 1 Year Outcomes TAVR Std Rx P Death any cause (%) <.001 Repeat hospitalization (%) <.001 Stroke or TIA(%) Major stroke (%) Minor stoke (%) Death or major stroke (%) <.001 Leon MB et al. N Engl J Med 2010;363:1597
25 PARTNER 1B Symptoms
26 PARTNER 1B Quality Of Life Months Reynolds M R et al. Circulation 2011;124:
27 PARTNER 1B Prosthesis Performance Makkar RR et al. N Engl J Med 2012;366:1696
28 PARTNER 1B Aortic Regurgitation and Mortality Makkar RR et al. N Engl J Med 2012;366:1696
29 PARTNER 1B STS Risk and Mortality Makkar RR et al. N Engl J Med 2012;366:1696
30 PARTNER 1B Cost-Effectiveness TAVR Std Rx P TAVR hospitalization cost, $ Follow-up hospitalizations $78,542+33, <.001 Total F/U costs 29, ,542 53,621+53,301 <.001 Total 12 mo costs 106,076+60,206 53,621+53,301 <.001 Cost-effectiveness ratio- $50,200 per year of life gained Reynolds MR et al. Circulation. 2012;125:1102
31 PARTNER Trial (Cohort A) Patients with severe symptomatic AS Operable with surgical risk >15% Randomized to transfemoral or transapical Edwards Sapien valve vs open AVR Non-inferiority trial with primary endpoint- death from any cause 699 pts enrolled Smith CR et at. N Engl J Med 2011;364:2187
32 PARTNER 1A Primary Outcome
33 PARTNER 1A 30 Day Outcomes TAVR Open AVR P Death (%) Stroke or TIA (%) Death or major stroke (%) Major vasc comp (%) <.001 Major bleeding (%) <.001 New atrial fibrillation (%) Smith CR et at. N Engl J Med 2011;364:2187
34 PARTNER 1A 1 Year Outcomes TAVR Open AVR P Death (%) Stroke or TIA (%) Death or major stroke (%) Major vasc comp (%) <.001 Major bleeding (%) <.001 New atrial fibrillation (%) Smith CR et at. N Engl J Med 2011;364:2187
35 TF TAVR vs AVR, TA TAVR vs AVR Transfemoral TAVR Open AVR Death at 1 yr (%) Transapical TAVR Open AVR Death at 1 yr (%) P P
36 PARTNER 1A Stoke at 2 Years
37 PARTNER 1A Subgroup Analysis Smith CR et at. N Engl J Med 2011;364:2187
38 TAVR, Gender and Mortality Karin H et at. J Am Coll Cardiol 2012;60:882
39 PARTNER 1A Symptoms Smith CR et at. N Engl J Med 2011;364:2187
40 PARTNER 1A Aortic Regurgitation TAVR Open AVR Paravalvular AR- Moderate-severe 1 years (%) < years (%) <.001 P
41 PARTNER 1A AR and TAVR Mortality Kodali S et al. N Engl J Med 2012;366:1686
42 PARTNER Prosthesis Performance
43 Medtronic CorValve Nitinol self expanding 18F delivery sheath Repositionable Suitable for aortic regurgitation AV block risk US pivotal trial in progress
44 TAVR at UIHC Started December, 2011 with Edwards Sapien THV First commercial TAVR in Iowa First transapical TAVR in Iowa 53 implants- 46 transfemoral, 7 transapical 30 day mortality 5.7% Survival 87% Stroke 3.8% Vascular complications 17%
45 TAVR- The Future CMS reimbursement for high risk patients FDA approval for transapical and transaortic access TAVR in moderate risk AS PARTNER 2A- randomized TAVR vs OAVR TAVR single arm (soon) Improvements in current device Smaller delivery system Expanded sizes Valve-in-valve for failed bioprosthesis CorValve commercial availability
46 TAVR- The Future New TAVR systems Smaller caliber delivery systems Smaller crossing profile Precise positioning Repositionable Improved annular seal
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