TAVI PROGRAM CHANGING THE EDMONTON LANDSCAPE...
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1 TAVI PROGRAM CHANGING THE EDMONTON LANDSCAPE... Benjamin Tyrrell MD, FRCPC Co-Director TAVI Program Northern Alberta CK HUI Heart Centre NOV 29, 2014
2 Disclosures None related to this talk
3 Objectives Brief Review of TAVI Rationale for TAVI Local Data Future Directions
4 Case 85 year old female with SOB on exertion with murmur High functioning Mild Renal Insufficiency DM diet controlled Remote smoker quit 30 years ago TIA
5 Physical Exam Systolic Murmur Diamond-Shaped, harsh, left sternal border to right intercostal spaces, neck and apex Late peak, obliteration of S2 Pulses Parvus Tardus Delayed and Low Volume Carotid Pulse
6 Symptoms of Aortic Stenosis Angina Syncope or Presyncope Dyspnea
7 ECHO
8 ECHO
9 ECHO
10 ECHO
11 ECHO
12 Hemodynamics
13 Aortic Stenosis - Etiology Bicuspid Inflammatory/ Rheumatic Degenerative/ Calcific
14 Pathophysiology AS develops gradually over 4me LV adapts to pressure overload with concentric hypertrophy
![Prognosis of AS Survival ayer onset of symptoms is 50% at two years and 20% at five years 1 Surgical interven4on [for severe AS] should be performed promptly once even minor symptoms occur 2 Source:](/docs-images/78/78236755/images/15-2.jpg "1 S.J. Lester et al., The Natural History and Rate of Progression of Aor4c Stenosis, Chest 1998. 2 C.M. OMo, Valve Disease: Timing of Aor4c Valve Surgery, Heart 200 Chart: Ross J Jr, Braunwald E.")
15 Prognosis of AS Survival ayer onset of symptoms is 50% at two years and 20% at five years 1 Surgical interven4on [for severe AS] should be performed promptly once even minor symptoms occur 2 Source: 1 S.J. Lester et al., The Natural History and Rate of Progression of Aor4c Stenosis, Chest C.M. OMo, Valve Disease: Timing of Aor4c Valve Surgery, Heart 200 Chart: Ross J Jr, Braunwald E. Aor4c Stenosis. Circula4on. 1968;38(Suppl 1):61-7.
16 Standard Therapy
17 Medical RX Beta Blockers Diuretics Supplemental Oxygen Statin? Aortic Valvuloplasty
18 What is TAVI?
19 What is TAVI? Transcatheter Aortic Valve Implantation invented in first in man (Dr. Cribier)
20 What is TAVI? Transcatheter Aortic Valve Implantation invented in first in man (Dr. Cribier)
21 What is TAVI? Transcatheter Aortic Valve Implantation invented in first in man (Dr. Cribier)
22 September 22, 2010 on NEJM.org
23 PARTNER Study Design
24 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened
25 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened Total = 1058 patients n= 700 High Risk 2 Parallel Trials: Inoperable n=358 Individually Powered
26 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened Total = 1058 patients n= 700 High Risk 2 Parallel Trials: Inoperable n=358 Individually Powered ASSESSMENT: Transfemoral Access High Risk TF High Risk TA 1:1 Randomization 1:1 Randomization TAVI Trans femoral VS Surgical AVR TAVI Trans femoral VS Surgical AVR Primary Endpoint: All Cause Mortality (1 yr) (Non-inferiority)
27 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened Total = 1058 patients n= 700 High Risk 2 Parallel Trials: Inoperable n=358 Individually Powered ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access High Risk TF High Risk TA 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study TAVI Trans femoral VS Surgical AVR TAVI Trans femoral VS Surgical AVR TAVI Trans femoral VS Standard Therapy (usually BAV) Primary Endpoint: All Cause Mortality (1 yr) (Non-inferiority) Primary Endpoint: All Cause Mortality over length of trial (Superiority)
28 All Cause Mortality Standard Rx TAVI All-cause mortality (%) Months Numbers at Risk TAVI Standard Rx
29 All Cause Mortality Standard Rx TAVI at 1 yr = 20.0% NNT = 5.0 pts All-cause mortality (%) 50.7% 30.7% Months Numbers at Risk TAVI Standard Rx
30 All-Cause Mortality (ITT) Crossover Patients Censored at Crossover Standard Rx (n = 179) TAVR (n = 179) 80.9% 87.5% 93.6% All-Cause Mortality (%) 50.8% 30.7% 68.0% 43.0% 53.9% 64.1% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < % Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%.
31 TAVR Mortality Stratified by Age (ITT) 96.0% 91.8% 73.5% 70.4% Mortality (%) Months
32 Median Survival 11.1 Months p (log rank) < Months Months
33 Repeat Hospitalization (ITT) Standard Rx (n = 179) TAVR (n = 179) 83.0% 87.3% 72.5% 75.7% Rehospitalization (%) 53.9% 34.9% 43.1% 46.3% 47.6% 27.0% HR [95% CI] = 0.40 [0.29, 0.55] p (log rank) < Months
![Subgroup Analysis All-Cause Mortality Hazard Ratio [95% CI] Overall (N=358) 0.50 [0.39-0.65] Age < 85 (N=186) 0.46 [0.33-0.66] Age 85 (N=172) 0.56 [0.39-0.79] Male (N=166) 0.46 [0.32-0.](/docs-images/78/78236755/images/34-0.jpg "66] Female (N=192) 0.55 [0.40-0.78] BMI 25 (N=170) 0.58 [0.41-0.84] BMI > 25 (N=188) 0.44 [0.31-0.63] STS 11 (N=170) 0.52 [0.36-0.76] STS > 11 (N=187) 0.53 [0.37-0.74] EF 55 (N=173) 0.47 [0.33-0.")
34 Subgroup Analysis All-Cause Mortality Hazard Ratio [95% CI] Overall (N=358) 0.50 [ ] Age < 85 (N=186) 0.46 [ ] Age 85 (N=172) 0.56 [ ] Male (N=166) 0.46 [ ] Female (N=192) 0.55 [ ] BMI 25 (N=170) 0.58 [ ] BMI > 25 (N=188) 0.44 [ ] STS 11 (N=170) 0.52 [ ] STS > 11 (N=187) 0.53 [ ] EF 55 (N=173) 0.47 [ ] EF > 55 (N=171) 0.61 [ ] Pulmonary Hypertension No (N=136) 0.56 [ ] Yes (N=103) 0.51 [ ] Mod / Sev MR No (N=261) 0.58 [ ] Yes (N=77) 0.30 [ ] Oxygen Dependent COPD No (N=270) 0.46 [ ] Yes (N=88) 0.68 [ ] Prior CABG or PCI No (N=182) 0.55 [ ] Yes (N=176) 0.46 [ ] Interaction p-value
35 Primary Endpoint: All-Cause Mortality at 1 Year TAVR AVR No. at Risk TAVR AVR Months
36 Primary Endpoint: All-Cause Mortality at 1 Year TAVR AVR No. at Risk TAVR AVR Months
37 Primary Endpoint: All-Cause Mortality at 1 Year TAVR AVR 26.8 HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = No. at Risk TAVR AVR Months
38 Both TAVR and AVR were associated with important but different periprocedural hazards: Major strokes at one year (5.1% vs. 2.4%, p=0.07) major vascular complications were more frequent with TAVR (11.0% vs. 3.2%, p<0.001) Major bleeding (9.3% vs. 19.5%, p<0.001) and new onset atrial fibrillation (8.6% vs. 16.0%, p<0.001) were more frequent with AVR TAVR and AVR are both acceptable therapies in these high-risk patients
39 Worldwide Transcatheter Aortic Valve Implantation First implantable aortic valve ,000 TAVI annually worldwide Market estimates 200,000 TAVI candidates representing $2B market by 2014
40 Inception of Heart Team TAVI team Multidisciplinary combining Interventional Cardiology and Cardiac Surgery Regional collaboration between CK Hui and MAHI Directors: Welsh,Tyrrell and Meyer Echo Dr. Shanks CT Drs. Butler & Sidhu
41 Pa4ent Journey Pt severe AS Clinical Visit Anatomy Tavi Review Open AVR Medical RX 29
42 SCREENING for TAVI
43 All SAPIEN XT Valve Sizes Available
44 All SAPIEN XT Valve Sizes Available
45 TAVR Transfemoral and Transapical Transfemoral Transapical
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50
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54 Percutaneous Closure
55 LOCAL DATA 140" 120" 100" 80" 60" 40" 20" 0" TAVI%CLINIC%REFERRALS% 79 to AVR 108 Rejected All" 31)Dec)09" 31)Dec)10" 31)Dec)11" 31)Dec)12" 31)Dec)13" 31)Dec)14" 1)Jan)09" 1)Jan)10" 1)Jan)11" 1)Jan)12" 1)Jan)13" 1)Jan)14" 531 patients in total
56 All Across Canada Edmonton Rural Sask Manitoba BC NWT NFLD YUKON
57 Local Data 45" 40" 35" 30" 25" 20" 15" 10" 5" 0" Completed)Cases)/)Fiscal)Year)Total) 31(Mar(11" 31(Mar(12" 31(Mar(13" 31(Mar(14" Completed"Cases"/"Fiscal" Year"Total" 1(Apr(10" 1(Apr(11" 1(Apr(12" 1(Apr(13" 173 completed TAVI
58 Cases By Age 85.50% 85.00% Mean%Age% % 84.00% 83.50% Mean%(all)% 83.00% 82.50% 82.00% Both% TF% TA% Range 54 to 98 years of Age
59 Procedural DATA 98.8% successful implants 5.8% pacemaker implant rate <1% clinical significant stroke 1 peri-procedural death at day 3 post TAVI
60 Approach for TAVI Majority are Trans-femoral 60.06% male TF 14% TA Size%Total% 86% 23#mm#(total)# 23#mm#(valve-in-valve)#AV# 26#mm#(total)# 26#mm#(valve-in-valve)#AV# 29#mm#(total)# 29#mm#(valve-in-valve)#AV#
61 Mortality 180" 160" 140" 120" 100" 80" 60" 40" 20" 0" Completed" Vital&Status&Total& Alive" Decease"(0+"days)"TOTAL" Decease"(0>7"days)" Decease"(7>30"days)" Decease"(0>30"days)" Decease"(>30"days)" Vital"Status"Total"
62 Mortality 35" 30" 33 25" 20" 15" 10" 5" " Decease"(0-7"days)" Decease"(7-30" days)" Decease"(0-30" days)" Decease"(>30"days)"
63
64 Mortality All#Cases# TA# 1" 2" Completed) Alive) TF# 1" 2" 18.5% mortality
65 Length of Stay 2011 TAVI%to%Discharge% (Average)% 25# 20 20# 15# 10# 5 8 TF#(F)# 13 TA#(M)# TA#(F)# 5# TF#(M)# 0# TF#(M)# TF#(F)# TA#(M)# TA#(F)#
66 AVG LOS POST TAVI 2014 POST TAVI NON TAVI ALL TF TA
67 Reducing Complica4ons BeMer technology BeMer case selec4on Experience BeMer results 50
68 Edwards esheath Expandable Introducer Sheath
69 Dynamic Expansion Mechanism Allows the sheath to expand, then return to a reduced profile once the valve has passed through the sheath Unexpanded Expanded Reduced Profile
70 CVA Risk age>70 DM HTN Hyperlipidemia Aor4c Calcifica4on Aortic Artheroma 53
71 Embrella Embolic Deflector Porous membrane designed to deflect embolic debris Nitinol Frame & Shaft Polyurethane Porous Membrane Hydrophillic coating with antithrombogenic properties 3 Radiopaque Markers 54
72 Cerebral vessel coverage
73 Variety of Captured & Removed Emboli 56
74 BeMer Valve Skirt to reduce Paravalvular leak Procedural planning and sizing using CT 57
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76 3M Approach to TAVR A Multidisciplinary, Multimodality, but Minimalist (3M) approach to Transfemoral TAVR facilitates safe next day discharge in high risk patients Safe next day discharge after minimally invasive heart valve surgery
77 Less is more Maximize objective functional and anatomical screening followed by a Minimalist procedure
78 3M Approach to TAVR Functional Screening 25% Procedural Expertise 50% Anatomical Screening 25%
79 3M TAVR Functional Assessment* Frailty >5 TUG Functional > 20 seconds Screening 5 metre > 6 seconds 25% MMSE < 26 ADL > 1 IADL > 2 Home Supports 3M Approach to TAVR Procedural Expertise 50% Anatomical Screening 25%
80 3M TAVR Functional Assessment* Frailty >5 TUG Functional > 20 seconds Screening 5 metre > 6 seconds 25% MMSE < 26 ADL > 1 IADL > 2 Home Supports 3M TAVR Procedural Coaxial Checklist valve plane Adequate TTE images (pvl and complications) Area based Anatomical CT sizing Screening with root assessment (adequate 25% images) Iliofemoral assessment (CT) No Foley Minimize Lines (Anesthesia) Early Mobilization 3M Approach to TAVR Procedural Expertise 50%
81 3M TAVR Discharge Criteria No persistent IVCD (if present, consider POD 2 discharge) Mobilizing at baseline (access sites) Follow up blood work Day 3 and Day 5 (Hgb < 100, egfr < 30) TTE (POD 1) Home Supports Contact Information (30 days)
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83 30 Day VARC 2 Outcomes (n = 60)
84 30 Day VARC 2 Outcomes (n = 60) Death 1 (1.7%) MI 0 (0%) CVA (All) 0 (0%) Major 0 (0%) Minor 1 (1.9%) Major 0 (0%) Minor 2 (3.3%) AKI 0 (0%) PPM 2 (3.3%) Device 58 (97%)
85 Parting Words Just because something is a class 3 indication doesn t mean you should stop doing it... Dr. Randy Williams Canadian Cardiovascular Congress Nov 2014
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