Transcatheter Aortic Valve Implantation (TAVI): Current Evidence

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1 Transcatheter Aortic Valve Implantation (TAVI): Current Evidence Davy C. H. Cheng, MD MSc FRCPC FCAHS CCPE Distinguished University Professor & Chair / Chief Department of Anesthesia & Perioperative Medicine Professor, Critical Care Medicine, Department of Medicine Western University London, Ontario, Canada davy.cheng@lhsc.on.ca

2 Department of Anesthesia & Perioperative Medicine LHSC (UH-VH) $1.1 Billion SJHC London $500 Millions 42 OR (3-4 Cardiac OR/d, 1,350 cardiac surgery/yr) 68 ICU beds (14 CSRU) 88 Anesthesia Faculty 20 Fellows 47 Residents

3 DISCLOSURE No Industries Conflict of Interest Ministry of Health and Long-Term Care AFP Innovation Fund (MOHLTC) Canadian Institutes of Health Research Co-Chair ISMICS Consensus Conferences Co-Chair ECTS Consensus Conference Acknowledgement: Janet Martin

4 OBJECTIVES 1. Consensus Conference in TAVI versus SAVR and Medical Management 2. TAVI Outcomes and Current Evidence 3. TAVI Learning Curve

5 AVR in Octogenarians Author City n 30 day Mort. % Journal (2007-8) Melby SJ St Louis Annals Thorac Surg Roberts WC Dallas Am J Cardiol Bose AK Newcastle J Cardiothorac Surg Urso S Conventional SAVR surgery San Sebastian J Heart Valve Dis is the Gold Standard Kolh P Liege Eur J Cardiothor Surg Mohr FW Leipzig Eur J Cardiothor Surg, submitted

6 Surgery was denied in 33% of elderly patients with severe, symptomatic AS

7 Aortic Valve Replacement Homograft 1962 Mechanical aortic valve, 1962 First PVT animal implantation A. Cribier First Corevalve animal implantation JC. Laborde Transvascular Porcine valve, 1965 Pericardial tissue valve, 1969 First Edwards/PVT Transapical Beating Heart AVR Webb, Lichtenstein Nov 29, 2005 PARTNER Trial First plastic ball valve - TDA, 1952 Charles Hufnagel First PVT Transcatheter AVR by Antegrade Approach Alain Cribier First CoreValve Percutaneous AVR by Retrograde Approach Oct 12, 2006 Serruys, DeJaegere, Laborde Surgery First CoreValve Transcatheter AVR by Retrograde Approach Laborde, Lal, Grube July 12, 2004

8 Transcatheter Aortic Valve Implantation (TAVI) Trans Subclavian Trans Subclavian Trans Aorta Trans Apical Trans Femoral approach 8

9 INTERNATIONAL SOCIETY FOR MINIMALLY INVASIVE CARDIOTHORACIC SURGERY ISMICS 2012 EXPERT CONSENSUS PANEL MEMBERS Paris April 20-22, 2012 Gregory Fontana, Chair Davy Cheng, Co-Chair Janet Martin Anson Cheung Todd Dewey Gino Gerosa John Knight Francesco Maisano Raj Makkar Ganesh Manoharen Alan Menkis Nicolo Piazza Carlos Ruiz Vinod Thourani Thomas Walther Olaf Wendler Mat Williams New York, USA London, Canada London, Canada Vancouver, Canada Dallas, USA Padova, Italy Adelaide, Australia Milano, Italy LA, USA Belfast Winnipeg, Canada Montreal, Canada New York, USA Atlanta, USA Bad Nauhaim, Germany London, UK New York, USA

10 TAVI vs SAVR CC Objectives 1. TAVI vs SAVR To assess TAVI (TF and TA) improves clinical and resource-related outcomes in AS patients eligible for conventional open SAVR 2. TAVI vs MM To assess TAVI (TF) improves clinical and resource-related outcomes compare with medical management (MM) in AS patients ineligible for open SAVR

11 The PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 (A) High Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered (B) Inoperable N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

12 Partner B Trial N Engl J Med 2010;363:

13 Partner A Trial N Engl J Med 2011;364:

14 Partner B Trial Follow up N Engl J Med 2012 May

15 Partner A Trial Follow up N Engl J Med 2012 May

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18 Meta-Analysis of TAVI: Level A/B Citations Screened: N = 3630 (up to April 2012) Non-relevant Trials Excluded before Retrieval: n = 3136 Potentially Relevant Level A/B Retrieved: N = 986 Relevant Level A/B studies: N = 495 Included Level A/B studies N = 44 (3 RCTs, 41 NRCTs) Potentially -relevant Trials Excluded after Retrieval: n = 491 Relevant trial Excluded from after retrieval: n = 335

19 TAVI vs SAVR

20 TAVI vs SAVR: All-Cause Mortality at 30 days Group by Comparison Study name Subgroup within study Comparison Outcome Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit p-value N Dallas_Dewey 08 MIXED N death, 30d N Paris_Descoutures 08 TF N Death, 30d N Malaga_CaballeroBorrego 11 TF N death, 30d N Catania-Pedara_Tamburino12 MIXED N Death, 30d N Vancouver_Higgins11 unmatched TA N death, 30d N Pisa_DeCarlo 10 TF N death, 30d N Milan-Pisa_Ranucci 10 MIXED N death, 30d N Rotterdam-Cali-Bogota_Nuis 12 TF N death, 30d N Cleveland_Kapadia 09 vs SAVR MIXED N death, 30d N Salzburg_Motloch 12, all MIXED N death, 30d N Bern-Rotterdam_Piazza 09 MIXED N death, 30d N Bochum_Strauch 12 TA N Death, 30d N Bern_Amonn 12 TA N Death, 30d N RCT STACCATO_Nielson 12 TA RCT Death, 30d RCT PARTNER A_Smith 11, all MIXED RCT Death, 30d RCT Y Hamburg_Conradi 12 MIXED Y Death, 30d Y Monzino Milan_Fusari 12, matched MIXED Y Death, 30d Y Frankfurt_Zierer 09 TA Y Death, 30d Y Milan-Pisa_Guarracino10 TF Y Death, in-hospital Y Aachen_Stohr11 MIXED Y Death, 30d Y Leipzig_Holzhey12 TA Y death, in hospital Y Vancouver_Higgins11, matched TA Y death, 30d Y Nord_Steigen 11 MIXED Y Death, 30d Y BERMUDA triangle MIXED Y Death, 30d Y Overall I 2 =61% Lower with TAVI Lower with SAVR

21 TAVI vs SAVR: Stroke at 30 days Study name Subgroup within study Comparison Outcome Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio limit limit p-value Dallas_Dewey 08 MIXED N Stroke, 30d Catania-Pedara_Tamburino12 MIXED N CVA Vancouver_Higgins11 unmatched TA N CVA, postop Essen_Kahlert 10, TF TF N stroke/tia, 30d London SGH_Jahangiri 11 vs SAVR MIXED N stroke/tia, 30d Salzburg_Motloch 12, all MIXED N stroke, 30d Bochum_Strauch 12 TA N Stroke, 30d Bern_Amonn 12 TA N Stroke, 30d STACCATO_Nielson 12 TA RCT stroke, 30d PARTNER A_Smith 11, all MIXED RCT Stroke, any, 30d Hamburg_Conradi 12 MIXED Y Stroke, 30d Leipzig_Holzhey12 TA Y cerebral ischemia, postop Vancouver_Higgins11, matched TA Y CVA, postop Nord_Steigen 11 MIXED Y Stroke, 30d Favours TAVI I 2 =8% Favours SAVR

22 OUTCOMES: TAVI vs SAVR SIMILAR INCREASED DECREASED Mortality Stroke A Fibrillation MI AR Bld Tx ARF PPM Reexploration

23 Stroke (TA and TF) Miller et al. J Thorac Cardio Surg 2012: 143:

24 Major VC were frequent after TF-TAVI in the PARTNER trial using first-generation devices and were associated with high mortality.

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27 N Engl J Med 2012;366:

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34 TAVI vs SAVR TAVI vs SAVR Outcomes

35 TAVI vs Medical Management

36 Senile Aortic Valve Stenosis Medical managed patients survival rate (62% 1-yr, 32% 5-yr, 18% 10-yr). It is worse in the presence of advanced age, LV dysfunction, heart failure, and renal failure

37 A Tradeoff between Stroke and Death For every 100 patients treated with TAVI instead of medical mgt, there will be 20 additional survivors at 1 year, but at a cost of 6 more stroke/tias 6 strokes/tias 20 deaths 33 symptom-free survival 6 stroke/tia 20 deaths 33 symptom-free survival TAVI MM (+/-BAV)

38 Cost-Effectiveness Analysis at LHSC

39 Incremental Cost-Effectiveness Ratio of TAVI vs Medical Management? COST QALY ICER TAVI $192, STD CARE $ 78, $ 38,448 ($32,000-44,000) ICER = C/ E = ($192,639 - $78,837) = $38,448/QALY ( )

40 ISMICS Recommendation: TAVI vs MM In severe AS patients who are ineligible for SAVR, it is reasonable to perform TAVI. The choice between TAVI and MM involves a trade off between the increased risk of stroke with TAVI vs improved 1 yr survival, clinical status and resource utilization. [Class IIa, level B]

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43 TAVI vs MM TAVI vs MM

44 Logit event rate Learning Curve & Death at 30d Martin J, Chu M, Cheng D, et al Regression of Experience on Logit event rate p= Experience Within increasing experience, 30-day all-cause mortality declines (p= )

45 Take Home Messages

46 TAVI: LHSC Hybrid Operating Room (with Fluoroscopy )

47 LHSC: TAVI (Total 168, May 2015) TransFemoral 92 Core Valves (Medtronic) TransApical 55 Sapiens (Edwards), Accurate TA valves (Symetis), Engagers (Medtronic) Direct Aortic 19 - Core Valves (Medtronic) TransAxillary 2 Core Valves (Medtronic) Total mortality : 8.9% LOS in Hospital 7.1±

48 TAVI vs SAVR TAVI vs SAVR Outcomes

49 TAVI vs MM TAVI vs MM

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