RANDOMISED TRIALS TAVI WITH SAVR STEPHAN WINDECKER AORTIC VALVE DISEASE COMPARING

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1 AORTIC VALVE DISEASE RANDOMISED TRIALS COMPARING TAVI WITH SAVR STEPHAN WINDECKER DEPARTMENT OF CARDIOLOGY SWISS CARDIOVASCULAR CENTER AND CLINICAL TRIALS UNIT BERN BERN UNIVERSITY HOSPITAL, SWITZERLAND

2 TAVI VERSUS SURGERY RANDOMISED EVIDENCE INTERMEDIATE RISK PATIENTS TAVI LIMITATIONS

3 PCI VS. CABG AND TAVI VS. AVR PCI vs. CABG TAVI vs FIRST DESCRIPTION OF CABG (FAVOLARO) 1977 CORONARY ANGIOPLASTY (GRÜNTZIG) YEARS TO THE FIRST COMPARISON 9 YEARS TO THE FIRST COMPARISON 1992 FIRST DESCRIPTION OF A TRANSCATHETER HEART VALVE (ANDERSEN) 1995 CABRI n=1054 CABG/PCI AVR STENTS INTRODUCED 1994 EAST n=392 CABG/PCI 2002 FIRST IN MAN TAVI (CRIBIER) 1998 RITA n=1011 CABG/PCI 1996 BARI n=1829 CABG/PCI (1%BMS) 2002 AWESOME n=454 CABG/BMS (54%) 2005 ARTS I n=1205 CABG/BMS (98%) 2005 ERACI II n=450 CABG/BMS 2007 MASS II n=611 CABG/BMS (68%) 2008 LE MANS n=105 CABG/DES (35%) 2008 SOS n=988 CABG/BMS (97%) 2010 PARTNER B n=358 TAVI / MED 2009 SYNTAX n=705 CABG/DES 2011 LEIPZIG n=201 CABG/DES 2011 PreCOMBAT n=600 CABG/DES 2011 PARTNER A n=699 TAVI / AVR 2010 CARDia n=510 CABG/DES+BMS 2012 PARTNER 2 SurTAVI RECRUITING TAVI / AVR

4 10 YEARS OF DEVELOPMENT THE PROCEDURE 2012 ANTEGRADE TF ACCESS PATIENT - ADAPTED ACCESS SITE SELECTION Direct Carotid RETROGRADE ACCESS Axillary ACCORDING TO INDIVIDUAL ANATOMICAL CHARACTERISTICS

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6 PROCEDURAL SUCCESS COREVALVE EDWARDS SAPIEN 100 % 80 72,6 91,2 97,2 98,2 97,6 77, ,1 95, Büllesfeld Buellesfeld Grube 2008 Piazza Petronio Gilard Webb Webb Webb Thomas Gilard S&E MCV Circ Interv EIJ Circ Interv NEJM Circulation Circulation Circulation Circulation NEJM JACC N=126 N=136 N=646 N=514 N=1143 N=18 N=50 N=113 N=463 N=2107

7 PARTNER B Leon et al. N Engl J Med 2010 Oct 21;363(17): INOPERABLE PATIENTS WITH SYMPTOMATIC AS MEDICAL TREATMENT TAVI n = 358 Randomized n = 179 n = /85 patients 100% followed at 1 Yr 46/46 patients 100% followed at 2 Yrs 19/19 patients 100% followed at 3 Yrs Cross over 11 pts Cross over 9 pts 124/124 patients 100% followed at 1 Yr 101/102 patients 99.0% followed at 2 Yrs 80/82 patients 97.6% followed at 3 Yrs

8 TAVI VS. MEDICAL TREATMENT IN INOPERABLE PATIENTS 3 YEAR F/U LEON MB ET AL. NEJM 2010; PRESENTED AT TCT 2012, MIAMI PARTNER B ALL CAUSE DEATH CARDIAC DEATH 100% HR [95% CI] = 0.53 [0.41, 0.68] p (log rank) < Standard Rx TAVI 100% HR [95% CI] = 0.41 [0.30, 0.56] p (log rank) < % 60% 40% 20% 0% 50.8% 20.1% 30.7% NNT=5.0pts 80.9% 68.0% 26.8% Months 25.0% 54.1% NNT=3.7pts 43.0% NNT=4.0pts 80% 60% 40% 20% 0% 74.5% 62.4% 33.1% 44.6% 31.7% 41.4% 24.1% NNT=3.0pts 30.7% 20.5% NNT=3.2pts NNT=4.1pts

9 MORTALITY STRATIFIED BY STS SCORE (ITT) LEON MB ET AL. NEJM 2010; PRESENTED AT TCT 2012, MIAMI PARTNER B STANDARD RX TAVI 100% 80% STS: STS: STS % 100% 80% 100% = 66.8% = 22.3% = 20.8% NNT = 1.5 pts NNT = 4.5 pts 77.5% NNT = 4.8 pts 80% 86.6% MORTALITY (%) 60% 40% 33.2% 60% 40% 55.2% 60% 40% 65.8% 20% 20% 20% 0% Numbers at Risk % % Months Months Months Standard Rx TAVR

10 INOPERABILITY CONDITIONS BY STS RISK SCORE Makkar et al. N Engl J Med 2012;366: PARTNER B Frailty % Porcelain Aorta Radiation Chest Deformities Respiratory Disease

11 MANAGEMENT OF SEVERE AORTIC STENOSIS ESC GUIDELINES ON VALVULAR HEART DISEASE 2012 Severe AS No LVEF < 50% Symptoms Yes No Yes Contraindication for AVR No Physically active Symptoms or fall in blood pressure below baseline No Yes Exercice test Yes No High risk for AVR No Yes Yes Short life expectancy No Yes Presence of risk factors and low/intermediate individual surgical risk TAVI Med Rx No Yes Re-evaluate in 6 months AVR AVR or TAVI TAVI Eur Heart J doi: /eurheartj/ehs109 & EurJ Cardiothorac Surg doi: /ejcts/ezs455).

12 TAVI VERSUS SURGERY RANDOMISED EVIDENCE INTERMEDIATE RISK PATIENTS TAVI LIMITATIONS

13 TAVI VS. SURGERY ALL CAUSE DEATH Kodali et al. N Engl J Med 2012;366: PARTNER A INTENTION TO TREAT POPULATION AS TREATED POPULATION

14 TAVI VS. SURGERY ALL CAUSE DEATH Smith C et al. N Engl J Med 2011;364: PARTNER A AS TREATED PATIENT POPULATION % P=0.33 P= , P=0.05 8,2 P=0.79 8,7 7,6 21,3 25,2 25,3 TF TAVI TF SAVR TA TAVI TA SAVR 5 3, Days 12 Months AT

15 TAVI VS. SURGERY SUBGROUP ANALYSES OF TREATMENT EFFECT Smith C et al. N Engl J Med 2011;364: PARTNER A

16 TAVI VS. SURGERY ECHOCARDIOGRAPHIC FINDINGS Kodali et al. N Engl J Med 2012;366: PARTNER A AORTIC VALVE AREA MEAN AORTIC GRADIENT TAVI SAVR TAVI SAVR

17 6 MINUTE WALK TEST (MEDIAN DISTANCE (M)) TAVI VS. SURGERY EFFECT OF TAVI ON QOL AT 12 MONTHS Reynolds MR et al. J Am Coll Cardiol 2012;50: PARTNER A FUNCTIONAL CAPACITY NYHA FUNCTIONAL CLASS TAVI AVR p=0.73 p= p= p= P=1.00 P<0.001 P=0.05 P=0.74 NYHA Baseline 30 Day 6 Month 1 Year TAVI AVR TAVI AVR TAVI AVR TAVI AVR

18 ROLE OF TAVI IN ROUTINE CLINICAL PRACTICE Wenaweser P et al. J Am Coll Cardiol 2011;58: Medical Surgical TAVI 0 No. at risk N=452 All cause death All Cause Mortality 56.4% 20.6% 20.6% Medical Surgical TAVI p=<.0001 Medical Treatment, N=78 (18%) Surgical AVR: adj. HR = 0.51 ( ) N=107 (24%) TAVI: adj. HR = 0.34 ( ) N=257 (58%) Follow-up, months

19 ESC RECOMMENDATIONS FOR THE TREATMENT OF VALVULAR HEART DISEASE Eur Heart J doi: /eurheartj/ehs109 & EurJ Cardiothorac Surg doi: /ejcts/ezs455).

20 TAVI VERSUS SURGERY RANDOMISED EVIDENCE INTERMEDIATE RISK PATIENTS TAVI LIMITATIONS

21 TAVI VS. SAVR CEREBROVASCULAR ACCIDENTS (ITT) Primary EP: Mortality Retrospective Assessment of stroke severity Age = 85±6 EuroScore = 29±16 Atrial fibrillation: 43% Cerebrovascular dz: 27% SYNTAX (CABG group) Stroke = 1 year p=0.12 Age = 65±10 EuroScore = 4±3

22 TRANSCATHETER AORTIC VALVE IMPLANTATION AND CEREBROVASCULAR EVENTS STORTECKY S, WINDECKER S CIRCULATION 2012;126:2921-4

23 EMBOLIC PROTECTION DEVICES EMBOLIC DEFLECTOR DEVICES EMBOLIC FILTER DEVICE RADIAL ACCESS FEMORAL ACCESS RADIAL ACCESS

24 AORTIC STENOSIS AND ATRIAL FIBRILLATION IN PATIENTS UNDERGOING TAVI STORTECKY S ET AL. CIRC CARDIOVASC INTERV FEB 2013; [EPUB AHEAD OF PRINT] BERN TAVI REGISTRY N=389; AGE 83±6 YEARS; 58% FEMALE GENDER

25 MECHANISMS OF AORTIC REGURGITATION Buellesfeld L et al. JACC Cardiovasc Interv 2012;5:578-81

26 TAVI VS. MEDICAL TREATMENT ECHOCARDIOGRAPHIC OUTCOMES TAVI COHORT Makkar et al. N Engl J Med 2012;366: PARTNER B PARAVALVULAR AR TRANSVALVULAR AR 100% 80% 0,7 0 11,8 4,5 p= ,9 0,7 4,5 27,8 p= ,9 60% 52,1 31,3 Severe Moderate Mild 38,9 49,3 40% Trace 20% 0% 20,1 34,3 15,3 30 DAYS 2 YEARS None 32,6 28, DAYS 2 YEARS

27 AORTIC REGURGITATION AND IMPACT ON OUTCOMES Kodali SK et al. N Engl J Med. 2012;366: PARTNER A PARAVALVULAR AR OVERALL AR DEATH FROM ANY CAUSE (%)

28 2-Year Death (%) PARTNER 1 NRCA ONLY MORTALITY & PARAVALVULAR LEAK NRCA-TF - None or Trace PVL at 30D NRCA-TF - Mild PVL at 30D NRCA-TF - Mod or Sev PVL at 30D % % 20.2% 10 Log Rank P= < Time in Days Number At Risk None or Trace PVL Mild PVL Mod or Sev PVL * Events adjudicated to one year

29 NEW GENERATION TAVI DEVICES EFFECT ON PARAVALVULAR AR? EDWARDS SAPIEN 3 MEDTRONIC ENGAGER SEALING CUFF TECHNOLOGY NATIVE VALVE CLIPPING MECHANISM

30 RELATIONSHIP OF THE AORTIC VALVE AND THE CONDUCTION SYSTEM EPSTEIN A ET AL. N ENGL J MED 2007;357:2706 PIAZZA N ET AL. CIRC CARDIOVASC INTERV 2008;1:74-81

31 PERMANENT PACEMAKER IMPLANTATION % 40 COREVALVE EDWARDS SAPIEN 35 33,3 35, ,2 16,3 24,2 PARTNER B: 3.4% PARTNER A: 3.8% 15 11, ,4 6 6,7 0 Büllesfeld S&E Grube Sgb Petronio Ital Avanzas Spai Gilard Fran2 Webb Web7 Webb Web9 Himbert Thomas Fran2 Gilard S&E MCV Circ Intv Circ Intv Rev Esp NEJM Circulation Circulation JACC Circulation NEJM JACC Card N=126 N=136 N=514 N=108 N=1043 N=50 N=113 N=51 N=463 N=2107

32 IMPACT OF PERMANENT PACEMAKER IMPLANTATION ON CLINICAL OUTCOMES AFTER TAVI BUELLESFELD L ET AL. J AM COLL CARDIOL 2012;60: COREVALVE ADVANCE PRESENTED BY BAUERNSCHMITT R. AT EUROPCR 2012

33 TAVI VERSUS SURGERY RANDOMISED EVIDENCE INTERMEDIATE RISK PATIENTS TAVI LIMITATIONS

34 HEART TEAM DECISION STS - SCORE ALL CAUSE 30 DAYS % ,4 11,4 11,4 7, ,2 5, , , Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

35 BERMUDA PATIENT FLOW PIAZZA N ET AL. JACC CARDIOVASC INTERV. 2013; AHEAD OF PRINT Assessed for eligibility (n= 3666) TAVI= 782 (21.3%) SAVR= 2884 (87.7%) Unmatched: n= 2856 TAVI= 377 SAVR= 2479 PS matched patients with TAVI (n= 405) Lost to follow-up (n=4) PS matched patients with SAVR (n= 405) Lost to follow-up (n=10), Patient declined (n=2) Not eligible for SURTAVI (n= 150) STS <3: n= 99 STS >8: n= 51 Not eligible for SURTAVI (n= 150) STS <3: n= 99 STS >8: n= 51 PS matched patients with TAVI eligible for SURTAVI (n= 255) Lost to follow-up (n=3) PS matched patients with SAVR eligible for SURTAVI (n= 255) Lost to follow-up (n=8)

36 All Cause Mortality (%) BERMUDA TRIANGLE TAVI IN INTERMEDIATE RISK PATIENTS PIAZZA N ET AL. JACC CARDIOVASC INTERV. 2013; AHEAD OF PRINT All Cause 30 Days PROPENSITY SCORE MATCHED PATIENT POPULATION TAVI (N=255) VS. SAVR (N=255) All Cause 12 Months 20 HR (95% CI): 1.12 ( ); p= HR (95% CI): 0.90 ( ); p= Days after TAVI NO. AT RISK TAVI SAVR TAVI Months after TAVI SAVR

37 SURTAVI STUDY DESIGN STS mortality risk 4% and 10% Randomized 1:1, noninferiority study Heart Team Evaluation Confirm Inclusion/Exclusion & Intermediate Risk Classification Up to 75 worldwide centers Europe Canada United States Randomization Stratified by need for revascularization Approx 2,000 total number of trial subjects Medtronic CoreValve TAVI N = ~2,000 patients SAVR Long-term follow-up through 5 years

38 PARTNER II TRIAL UPDATE LEON MB, PRESENTED AT TCT 2012

39 NEW GENERATION TAVI DEVICES

40 TAVI IN INTERMEDIATE RISK PATIENTS PRIORITY SURTAVI & PARTNER II HEART TEAM APPROACH MULTIDSCIPLINARY CONSULTATION Cardiologist Surgeons and cardiologists must work as a team to select appropriate candidates, perform the procedure, and, finally, Technician Imaging Specialist evaluate the results. Vahanian A et al. Eur Heart J. 2008;29: Anesthesiologist Surgeon

41 10 YEARS TAVI WHAT DID WE LEARN FROM CLINICAL TRIALS TAVI IMPROVES PROGNOSIS TAVI is superior compared to medical treatment and non-inferior compared to surgical aortic valve replacement. STROKE AFTER TAVI IS AN ISSUE Cerebrovascular events are frequent early after TAVI and have a substantial impact on outcomes VALVE DURABILITY is maintained beyond 2 years of follow-up Aortic regurgitation impacts on outcomes and needs to be improved HEALTH RELATED QUALITY OF LIFE TAVI effectively alleviates symptoms and improves health-related quality of life

42 10 YEARS TAVI WHAT DID WE LEARN FROM CLINICAL TRIALS TAVI IS SAFE TAVI is superior compared to medical treatment and non-inferior compared to surgical aortic valve replacement. STROKE AFTER TAVI IS AN ISSUE Cerebrovascular events are frequent early after TAVI VALVE DURABILITY is maintained beyond 2 years of follow-up Aortic regurgitation impacts on outcomes and needs to be improved HEALTH RELATED QUALITY OF LIFE TAVI effectively alleviates symptoms and improves health-related quality of life

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44 HEART TEAM APPROACH PATIENT WITH COMPLEX AORTIC VALVE DISEASE

45 10 YEARS OF TAVI INTERMEDIATE RISK PATIENTS TAVI VERSUS SURGERY RANDOMISED EVIDENCE COST EFFECTIVENESS TAVI LIMITATIONS

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