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Update on TAVR
Howard C. Herrmann, MD, FACC, MSCAI
John Bryfogle Professor of Cardiovascular Medicine and SurgeryHealth System Director for Interventional Cardiology
Director, Cardiac Cath Labs, Hospital of the Univ of PA
Perelman School of Medicine University of Pennsylvania
Philadelphia
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Disclosure Statement of Financial InterestWithin the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Discussion may include unapproved and off-label devices, procedures, and indications
Equity
MicrointerventionalDevices
Consulting Fees/Honoraria
Edwards LifesciencesBayerWells FargoLeering
Grant/Research Support
Abbott Vascular Edwards LifesciencesSt. Jude MedicalMedtronicGoreSiemens
BayerBoston SciCorviaCardiokinetxUniv Laval
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Status of TAVI by Surgical Risk LevelTrial Device Risk Outcome
PARTNER 1B SAPIEN Inoperable TAVR > Medical TherapyPARTNER 1A SAPIEN High Risk TAVR = SAVRPARTNER 2A SAPIEN XT Intermediate Risk TF TAVR > SAVRPARTNER S3i SAPIEN 3 Intermediate Risk TAVR > SAVR
PARTNER 3 SAPIEN 3 Low Risk Enrolling
ValveTechnology
SAPIEN SAPIEN XT SAPIEN 3
Sheath Compatibility 22-24F 16-20F 14-16F
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Take-Home Messages:
1. In intermediate risk patients with severe symptomatic AS, TAVR is non-inferior to SAVR for death/disabling stroke at 2 years
2. Will likely change the guideline to class I from IIa
• Randomized comparison of TAVR and SAVR in severe symp AS at intermediate risk for surgery• 1660 patients• STS PROM 4.5%• SAVR: more AKI, AF, Transfusion• TAVR: more AR, PPM, lower grads
Reardon et al, NEJM 2017;378:1321-1331
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6.3%5.2%
3.7%4.5%
3.5%2.2% 1.6% 1.1% 1.1%
0%
5%
10%
15%
20%
P1B (TF) P1A (All) P1A (TF) P2B (TF) P2B XT (TF) S3HR (All) S3HR (TF) S3i (All) S3i (TF)
All-Cause Mortality at 30 DaysEdwards SAPIEN Valves (As Treated)
175 344 240 271 282 583 491 1072 947
SAPIEN SXT SAPIEN 3
PARTNER 1 and 2 Trials(Overall and TF Patients)
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Estimated Global TAVR Procedure Growth
SOURCE: Credit Suisse TAVI Comment –January 8, 2015. ASP assumption for 2024 and 2025 based on analyst model. Revenue split assumption in 2025 is 45% U.S., 35% EU, 10% Japan, 10% ROW
In the next 5 years, TAVR growth will doubleIn the next 10 years, TAVR will increase X4!
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Penn TAVR Program: Growth in Procedures
~2000
Chart1
Total FY08
Total FY09
Total FY10
Total FY11
Total FY12
Total FY13
Total FY14
Total FY15
Total FY16
Total FY17
# Transcatheter cases
Penn Medicine Transcatheter Total Volume FY08-current
10
27
39
79
193
212
270
324
391
414
HUP
FY08Jul-07Aug-07Sep-07Oct-07Nov-07Dec-07Jan-08Feb-08Mar-08Apr-08May-08Jun-08commtrialn=10
Commercial0000000000000TF000Sapien 110
Trial00002111004110TA000Sapien XT0
Total00002111004110TAO000Sapien 30
Trial randomized SAVR01010CoreValve0
Aborted-not counted10
FY09Jul-08Aug-08Sep-08Oct-08Nov-08Dec-08Jan-09Feb-09Mar-09Apr-09May-09Jun-09commtrialn=27
Commercial0000000000000TF000Sapien 127
Trial21321232441227TA000Sapien XT0
Total21321232441227TAO000Sapien 30
Trial randomized SAVR02727CoreValve0
Aborted-not counted27
FY10Jul-09Aug-09Sep-09Oct-09Nov-09Dec-09Jan-10Feb-10Mar-10Apr-10May-10Jun-10commtrialn=34
Commercial0000000000000TF000Sapien 134
Trial60342332215334TA000Sapien XT0
Total60342332215334TAO000Sapien 30
Trial randomized SAVR03434CoreValve0
Aborted-not counted34
FY11Jul-10Aug-10Sep-10Oct-10Nov-10Dec-10Jan-11Feb-11Mar-11Apr-11May-11Jun-11commtrialn=68
Commercial0000000000000TF000Sapien 168
Trial35855476685668TA000Sapien XT0
Total35855476685668TAO000Sapien 30
Trial randomized SAVR06868CoreValve0
Aborted-not counted68
FY12Jul-11Aug-11Sep-11Oct-11Nov-11Dec-11Jan-12Feb-12Mar-12Apr-12May-12Jun-12commtrialn=152
Commercial00000018167111760TF47047Sapien 10
Trial991310781050314492TA12012Sapien XT0
Total99131078111316102521152TAO101Sapien 30
Trial randomized SAVR6092152CoreValve0
Aborted-not counted152
FY13Jul-12Aug-12Sep-12Oct-12Nov-12Dec-12Jan-13Feb-13Mar-13Apr-13May-13Jun-13commtrialn=159
Commercial1417812119131341046121TF7328101Sapien 11278839
Trial51113431039738TA38846Sapien XT3232
Total1918913141316144131313159TAO10212Sapien 30
Trial randomized SAVR11121120311312138159CoreValve0
Aborted-not counted2131 open TAVRAVR (Trial)13
FY14Jul-13Aug-13Sep-13Oct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14commtrialn=173
Commercial785124047119161093TF7068138Sapien 167
Trial810237101012146780TA16925Sapien XT30
Total1518715111014913232318173TAO628Sapien 348
Trial randomized SAVR33121000000010LSC112CoreValve28
Aborted-not counted119380173AVR (Trial)10
FY15Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15commtrialn=213
Commercial21141119101710171219915174TF15730187Sapien 10
Trial97132200054639TA8311Sapien XT103
Total302112221219101712241321213TAO505Sapien 35
Trial randomized SAVR0000110000002LSC404CoreValve79
Aborted-not counted11001003158322076Lotus1
AVR (Trial)2
FY16Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15Jan-16Feb-16Mar-16Apr-16May-16Jun-16commtrialn=253thru 6/30
Commercial132016231915182021161219212TF14231173Sapien XT8
Trial36332414536141TA101Sapien 3172
Total162619262119192426191820253(+40)TAO314CoreValve12
TMVRLSC808Evolut R50
Trial randomized SAVR0000000000000trans-septal202Lotus4
Aborted-not counted020000000000215632188Portico7
AVR (Trial)0253
FY17Jul-16Aug-16Sep-16Oct-16Nov-16Dec-16Jan-17Feb-17Mar-17Apr-17May-17Jun-17Totalscommtrialn=241thru 5/31
Commercial1112221422202428231727220(+27)TF19517212Sapien XT7
Trial5530111301121(-19)TA213Sapien 3168
Total1617251423212531231828241(+8)TAO314CoreValve0
Mitraspan100000000001SCA15015Evolut R50
CardiaQ100000000001trans-septal617Evolut-Pro6
Compassion00000000010122120241Lotus1
TMVR (off label v-in-v)000100111015AVR (Trial)01Portico6
Trial randomized SAVR000010001002Mitraspan1
Aborted-not counted000000000224CardiAQ1
Compassion1
241
Calendar 2013Jan-13Feb-13Mar-13Apr-13May-13Jun-13Jul-13Aug-13Sep-13Oct-13Nov-13Dec-13n=149
Commercial131341046785124086Sapien 1862013 & 2014
Trial3103978102371063Sapien XT47n=365
Total1614413131315187151110149Sapien 314Sapien 1120
Trial randomized SAVR11203133121018CoreValve2Sapien XT115
Aborted-not counted0Sapien 364
CoreValve66
Calendar 2014Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14n=216
Commercial471191610211411191017149Sapien 134
Trial1012146797132264Sapien XT68
Total14913232318302112221219216Sapien 350
Trial randomized SAVR0000000000112CoreValve64
Aborted-not counted11
n=76
Calendar 2015Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15TotalSapien XT33
Commercial10171219915132016231915188Sapien 339
Trial00054636332436CoreValve34
Total101712241321162619262119224(+8)
Trial randomized SAVR0000000000000
Aborted-not counted1001000200004
JulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY1200000018167111760check
Commercial FY131417812119131341046121
Commercial FY14785124047119171195
Commercial FY1521141119101710171219915174
Commercial FY16132016231915182021161219212(+ 38)
Commercial FY171112221422202428231727220(+27)
JulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Trial FY0800002111004110
Trial FY0921321232441227
Trial FY1060342332215334
Trial FY1135855476685668
Trial FY12991310781050314492
Trial FY1351224631039743
Trial FY14810237101022146781
Trial FY1597132200054639
Trial FY1636332414536141
Trial FY175530111301121(-19)
JulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Total FY0800002111004110
Total FY0921321232441227
Total FY1060342332215334
Total FY1135855476685668
Total FY1299131078111316102521152
Total FY1319181014151516144131313164
Total FY141518715111014913232318176
Total FY15302112221219101712241321213
Total FY16162619262119192426191820253
Total FY171617251423212531231828241(-9)
Total FY0810
Total FY0927
Total FY1034
Total FY1168
Total FY12152
Total FY13164
Total FY14176
Total FY15213
Total FY16253
Total FY17241
Trial FY0810
Trial FY0927
Trial FY1034
Trial FY1168
Trial FY1292
Trial FY1343
Trial FY1481
Trial FY1539
Trial FY1641
Trial FY1721
Commercial FY1260
Commercial FY13121
Commercial FY1495
Commercial FY15174
Commercial FY16212
Commercial FY17220
TrialCommercialTotal
Total FY0810010
Total FY0927027
Total FY1034034
Total FY1168068
Total FY129260152
Total FY1343121164
Total FY148195176
Total FY1539174213
Total FY1641212253
Total FY1721220241
4568821338
FY13FY14FY15FY16FY17
Transfemoral101138193233212
Transapical46251123
Transaortic128554
Transaxillary0241215
Trans-Septal00017
Total159173213253241
*TAVR/TMVR
n=159
Sapien 1127(FY2013)
Sapien XT32
Sapien 30
CoreValve0
Total159
n=173
Sapien 167(FY 2014)
Sapien XT30
Sapien 348
CoreValve28
Total173
n=213(FY 2015)
Sapien XT103
Sapien 330
CoreValve79
Lotus1
Total213
n=253(FY 2016)30-Jun
Sapien XT8
Sapien 3172
CoreValve12
Evolut R50
Lotus4
Portico7
AVR (Trial)0
Total253
n=241(FY 2017)31-May
Sapien XT7
Sapien 3168
CoreValve0
Evolut R50
Evolut-Pro6
Lotus1
Portico6
Mitraspan1
CardiAQ1
Compassion1
Total241
AVR (Trial)1
JulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY131417812119131341046121
Commercial FY14785124047119171195(-26)
Commercial FY1521141119101710171219915174(+79)
Commercial FY16132016231915182021161219212(+38)
Commercial FY171112221422202428231727220(+27)
Trial FY1351224631039743
Trial FY14810237101022146781(+38)
Trial FY1597132200054639(-42)
Trial FY1636332414536141(+2)
Trial FY175530111301121(-19)
Total FY1319181014151516144131313164
Total FY141518715111014913232318176(+12)7%
Total FY15302112221219101712241321213(+37)17%
Total FY16162619262119192426191820253(+40)16%
Total FY171617251423212531231828241(+8)
JulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Total FY15302112221219101712241321213
Total FY16162619262119192426191820253
Total FY171617251423212531231828241(+8)
HUP
2013 & 2014 TAVR Model Distribution
TAVR Valve Model # Utilization
HUP 2013 & 2014 TAVR Model Distribution
PPMC
2013-2015 (bottom-top)
HUP Calendar Year 2013-2015 TAVR Model Distribution
HUP-PPMC
HUP FY14 Valve Model Distribution
Physician %
HUP FY15 Valve Model Distribution
For Herrmann
HUP FY16 Valve Model Distribution
HUP-PPMC MAC-GA
HUP FY17 Valve Model Distribution
HUP TAVR Cath Data
Transfemoral
Transapical
Transaortic
Transaxillary
Trans-Septal
Access Totals
Transcatheter Volume
Transcatheter Valve Replacements by Access (FY13-FY17 current)
Sheet1
Trial
Commercial
# Commercial vs Trial
HUP Transcatheter Distribution 2007-current
Sheet2
FY Transcatheter Growth
# Transcatheter cases
HUP Overall Transcatheter Volume FY07-current
Sheet3
FY10Jul-09Aug-09Sep-09Oct-09Nov-09Dec-09Jan-10Feb-10Mar-10Apr-10May-10Jun-10commtrialtotaln=5
Commercial0000000000000TF055Sapien 15
Trial0000110011015TA000Sapien XT0
Total0000110011015TAO000Sapien 30
Trial randomized SAVRCoreValve0
Aborted-not counted5
FY11Jul-10Aug-10Sep-10Oct-10Nov-10Dec-10Jan-11Feb-11Mar-11Apr-11May-11Jun-11commtrialn=11
Commercial0000000000000TF088Sapien 111
Trial10121120111011TA033Sapien XT0
Total10121120111011TAO000Sapien 30
Trial randomized SAVR0110CoreValve0
Aborted-not counted11
FY12Jul-11Aug-11Sep-11Oct-11Nov-11Dec-11Jan-12Feb-12Mar-12Apr-12May-12Jun-12commtrialn=41
Commercial00000010339319TF12921Sapien 130
Trial33231420121022TA61319Sapien XT11
Total332314304510341TAO101Sapien 30
Trial randomized SAVR192241CoreValve0
Aborted-not counted41
FY13Jul-12Aug-12Sep-12Oct-12Nov-12Dec-12Jan-13Feb-13Mar-13Apr-13May-13Jun-13commtrialn=48
Commercial26322345431136TF18927Sapien 136
Trial01001101004412TA18321Sapien XT12
Total27423446425548TAO000Sapien 30
Trial randomized SAVR361248CoreValve0
Aborted-not counted1148
FY14Jul-13Aug-13Sep-13Oct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14commtrialn=94
Commercial43461011439339TF233760Sapien 131
Trial422488830102455TA131326Sapien XT17
Total85610989441311794TAO257Sapien 338
Trial randomized SAVRLSC101CoreValve8
Aborted-not counted39559494
FY15Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15commtrialn=111
Commercial846108799757686TF672491Sapien 10
Trial15010000278125TA9514Sapien XT53
Total996118799912157111TAO404Sapien 325
Trial randomized SAVRLSC606CoreValve33
Aborted-not counted8028115111
FY16Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15Jan-16Feb-16Mar-16Apr-16May-16Jun-16commtrialn=112
Commercial1161081251199111111114TF8720107Sapien XT7
Trial22231421031324TA303Sapien 377
Total138121113913109141214138(+27)TAO415CoreValve9
Trial randomized SAVRLSC909Evolut R27
Aborted-not counted124Lotus4
124
FY17Jul-16Aug-16Sep-16Oct-16Nov-16Dec-16Jan-17Feb-17Mar-17Apr-17May-17Jun-17commtrialn=1735/31/17
Commercial2111141412131112181716159(+56)TF14814162Sapien XT3
Trial4302210101014(-7)TA202Sapien 3110
Total2514141614141113181816173(+49)TAO202CoreValve0
TMVR010010000002LSC505Evolut R46
Trial randomized SAVRseptal202Evolut-Pro8
Aborted-not counted15914173Lotus6
173
Calendar 2010Jan-10Feb-10Mar-10Apr-10May-10Jun-10Jul-10Aug-10Sep-10Oct-10Nov-10Dec-1010/30/15
Commercial000000000000
Trial0011011012119S3i CAP39Lotus5
Total0011011012119S3 interm22TF Lotus5
Trial randomized SAVRS3 HR23TA Lotus0
Aborted-not countedTotal S376TAO Lotus0
SC Lotus0
Calendar 2011Jan-11Feb-11Mar-11Apr-11May-11Jun-11Jul-11Aug-11Sep-11Oct-11Nov-11Dec-11S3i CAP39TF Evolut1
Commercial000000000000TF33TA Evolut0
Trial20111033231421TA4TAO Evolut0
Total20111033231421(+12)TAO2SC Evolut0
Trial randomized SAVR
Aborted-not countedS3 interm22
TF18
Calendar 2012Jan-12Feb-12Mar-12Apr-12May-12Jun-12Jul-12Aug-12Sep-12Oct-12Nov-12Dec-12TA4
Commercial10339326322337TAO0
Trial20121001101110
Total304510327423447(+26)S3 HR23
Trial randomized SAVRTF12
Aborted-not countedTA8
TAO3
Calendar 2013Jan-13Feb-13Mar-13Apr-13May-13Jun-13Jul-13Aug-13Sep-13Oct-13Nov-13Dec-13
Commercial45421143461035Total S376
Trial01004442248837TF56
Total564255856109873(+26)TA16
Trial randomized SAVRTAO4
Aborted-not counted
P2B30
Calendar 2014Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14TF24
Commercial114393846108764TA4
Trial830102415010034TAO2
Total94413117996118798(+25)
Trial randomized SAVRP2A10
Aborted-not countedTF6
TA4
Calendar 2015Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15TAO0
Commercial99757611610812595
Trial00278122231432P127
Total999121571381211139127(+29)TF14
Trial randomized SAVRTA13
Aborted-not countedTAO0
Calendar 2016Jan-16Feb-16Mar-16Apr-16May-16Jun-16Jul-16Aug-16Sep-16Oct-16Nov-16Dec-16P31
Commercial1199111111211114141211145TF1
Trial21031343022122TA0
Total13109141214251414161412167(+40)TAO0
Trial randomized SAVRSAVR0
Aborted-not counted
Calendar 2017Jan-17Feb-17Mar-17Apr-17May-17Jun-17Jul-17Aug-17Sep-17Oct-17Nov-17Dec-17P31
Commercial111218171674(+13)TF1
Trial010102(-5)TA0
Total111318181676(+18)TAO0
Trial randomized SAVR00000SAVR0
Aborted-not counted
JulyAugSeptOctNovDecJanFebMarAprilMayJune
Commercial FY1200000010339319
Commercial FY1326322345421135
Commercial FY1443461011439339
Commercial FY15846108799757686
Commercial FY161161081251199111111114
Commercial FY172111141412131112181716159(+56)
JulyAugSeptOctNovDecJanFebMarAprilMayJune
Trial FY080000000000000
Trial FY090000000000000
Trial FY100000110011015
Trial FY1110121120111011
Trial FY1233231420121022
Trial FY1301101101004413
Trial FY14422488830102455
Trial FY1515010000278125
Trial FY1622231421031324
Trial FY174302210101014(-7)
JulyAugSeptOctNovDecJanFebMarAprilMayJune
Total FY08
Total FY09
Total FY100000110011015
Total FY1110121120111011
Total FY12332314304510341
Total FY1327423446425548
Total FY1485610989441311794
Total FY15996118799912157111
Total FY16138121113913109141214138
Total FY172514141614141113181816173(+49)
Total FY080
Total FY090
Total FY105
Total FY1111
Total FY1241
Total FY1348
Total FY1494
Total FY15111
Total FY16138
Total FY17173
Trial FY080
Trial FY090
Trial FY105
Trial FY1111
Trial FY1222
Trial FY1313
Trial FY1455
Trial FY1525
Trial FY1624
Trial FY1714
Commercial FY1219
Commercial FY1335
Commercial FY1439
Commercial FY1586
Commercial FY16114
Commercial FY17159
TrialCommercial
Total FY0800
Total FY0900
Total FY1050
Total FY11110
Total FY122219
Total FY131335
Total FY145539
Total FY152586
Total FY1624114
Total FY1714159
169452605
includes off-label TMVRFY10FY11FY12FY13FY14FY15FY16FY1731-May
Transfemoral5821276081121162
Transapical031921261232
Transaortic00107252
Transaxillary00001695
Transseptal00000052
Total511414894101143173
JulyAugSeptOctNovDecJanFebMarAprilMayJune
Commercial FY1200000010339319
Commercial FY1326322345421135(+16)
Commercial FY1443461011439339(+4)
Commercial FY15846108799757686(+47)
Commercial FY161161081251199111111114(+28)
Commercial FY172111141412131112181716159(+56)
Trial FY1233231420121022
Trial FY1301101101004413(-9)
Trial FY14422488830102455(+42)
Trial FY1515010000278125(-30)
Trial FY1622231421031324(-1)
Trial FY174302210101014(-7)
Total FY12332314304510341
Total FY1327423446425548(+7)15%
Total FY1485610989441311794(+46)49%
Total FY15996118799912157111(+17)15%
Total FY16138121113913109141214138(+27)20%
Total FY172514141614141113181816173(+49)
JulyAugSeptOctNovDecJanFebMarAprilMayJune
Total FY15996118799912157111
Total FY16138121113913109141214138
Total FY172514141614141113181816173(+49)
FY16 PPMC
n=124
Sapien XT7
Sapien 389
CoreValve9
Evolut R29
Lotus4
138
FY17 PPMC
n=173
Sapien XT3
Sapien 3110
CoreValve0
Evolut R48
Evolut PRO6
Lotus6
Mitraspan0
CardiAQ0
173
Sheet3
PPMC FY16 Valve Model Distribution
FY Transcatheter Valve Growth
# Transcatheter Cases
PPMC Overall Transcatheter Growth FY07-current
Trial
Commercial
# Trial vs commercial
PPMC Transcatheter % Distributation FY07-current
Transfemoral
Transapical
Transaortic
Transaxillary
Transseptal
Access by FY
# of cases by access
PPMC Transcatheter Access FY07-current
PPMC FY17 Valve Distribution
FY13FY14FY15FY16FY17AS OF 5-31-17
Transfemoral128198285351374includes mitral v-in-v
Transapical67512055
Transaortic12159106
Transaxillary03102020
Trans-Septal00059
total207267324391414
PPMCHUPTotal
Total FY0801010
Total FY0810Total FY0902727
Total FY0927Total FY1053439
Total FY1039Total FY11116879
Total FY1179Total FY1241152193
Total FY12193Total FY13481642129%
Total FY13212Total FY149417627021%
Total FY14270Total FY1511121332417%
Total FY15324Total FY1613825339117%
Total FY16391Total FY17173241414(+40)
Total FY1741462113381959
thru 5-31-2017
Trial FY0801010
Trial FY0902727
Trial FY1053439
Trial FY11116879
Trial FY122292114
Trial FY13134356
HUPJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotalTrial FY145581136
Total FY15302112221219101712241321213Trial FY15253964
Total FY16162619262119192426191820253(+40)Trial FY16244165
Total FY171617251423212531231828241(-2)Trial FY17142135(-26)
PPMCJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Total FY15996118799912157111Commercial FY12196079
Total FY16138121113913109141214138(+27)Commercial FY1335121156
Total FY172514141614141113181816173(+51)Commercial FY143995134
Commercial FY1586174260
Commercial FY16114212326(+66)
Commercial FY17159220379(+83)
n=391(FY 2016)30-Jun
Sapien XT15
Sapien 3263
CoreValve21
Evolut R77
Lotus8
Portico7
n=414(FY 2017)31-May
Sapien XT10
Sapien 3279
CoreValve0
Evolut R94
Evolut-Pro14
Lotus7
Portico7
Mitraspan1
CardiAQ1
Compassion1
414
*double valve case
TrialCommercial
Total FY1179079
Total FY1211479193
Total FY1346156202
Total FY14136134270
Total FY1564260324
Total FY1665326391
Total FY1735379414
53913341873
PPMCHUPTotal
62113381959
Penn Medicine FY16 Valve Distribution
Transfemoral
Transapical
Transaortic
Transaxillary
Trans-Septal
FY Transcatheter Access Volume
# Transcatheter Cases
Penn Medicine Transcatheter Access FY13-current
# Transcatheter cases
Penn Medicine Transcatheter Total Volume FY08-current
Penn Medicine FY17 Valve Distribution
Trial
Commercial
Total volume
Penn Medicine % Distribution FY11-current
FY15Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Total%FY15%
Bavaria142123121200199Bavaria9
Szeto6547343315244722Szeto22
Desai151069512585991210548Desai48
Vallabhajosyula9624543569256028Vallabhajosyula28
Atluri01010001011052Atluri2
21719 JEB1009 JEB100
FY15Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15FY15%
Herrmann1284941026514388539Herrmann39
Anwaruddin12105998697771110046Anwaruddin46
Giri6433023203423215Giri15
217100100
FY16Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15Jan-16Feb-16Mar-16Apr-16May-16Jun-16Total%FY16%
Bavaria010120120120104Bavaria4
Szeto2434563244134116Szeto16
Desai6141013119111112581012048Desai48
Vallabhajosyula68583351089667730Vallabhajosyula30
Atluri211021012131156Atluri6
2539 JEB1004 JEB100
FY16Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15Jan-16Feb-16Mar-16Apr-16May-16Jun-16FY16%
Herrmann8461099691010769437Herrmann37
Anwaruddin5189118512121166911244Anwaruddin44
Giri3545451353554819Giri19
254100100
FY17Jul-16Aug-16Sep-16Oct-16Nov-16Dec-16Jan-17Feb-17Mar-17Apr-17May-17Jun-17Total%FY17%
Bavaria10301012113135.3Bavaria5.3
Szeto41120242121208.3Szeto8.3
Desai1011167121112218131914058.1Desai58.1
Vallabhajosyula15751078613387330.3Vallabhajosyula30.3
Atluri1010111210083.3Atluri3.3
24113 JEB1004.7 JEB100
FY17Jul-16Aug-16Sep-16Oct-16Nov-16Dec-16Jan-17Feb-17Mar-17Apr-17May-17Jun-17FY17
Herrmann6584871013111068836.6Herrmann36.6
Anwaruddin91011101181014671411045.6Anwaruddin45.6
Giri126046546184317.8Giri17.8
241100100
%
FY15 TAVR DISTRIBUTION
%
FY15 TAVR DISTRIBUTION
%
FY16 TAVR DISTRIBUTION
%
FY16 TAVR DISTRIBUTION
%
FY17 TAVR DISTRIBUTION
FY17Jul-16Aug-16Sep-16Oct-16Nov-16Dec-16Jan-17Feb-17Mar-17Apr-17May-17Jun-17
Herrmann6584871013111082
Anwaruddin910111011810146796
Giri126046546135
Li25141416141411131818157
Raza000000000000
370
HUPJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Total FY171617251423212531231828241
PPMCJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Total FY172514141614141113181816173
AccessFY17AS OF 5-31-17
Transfemoral334includes mitral v-in-v
Transapical5*includes 1 combined TAVR/v-in-v TMVR, therefore Access total is +1 from HUP/PPMC total
Transaortic5
Transaxillary18
Trans-Septal8
Total370
n=370(FY 2017)31-May
Sapien XT9*double valve case
Sapien 3247
CoreValve0
Evolut-R90
Evolut-Pro8
Lotus7
Portico6
Mitraspan1
CardiAQ1
Compassion1
370
FY17 TAVR DISTRIBUTION
2014201520162017thru 2/3/17201420152016
MAC4013619124MAC87188
GA17689496GA230118
MAC-GA CONV110
2014 accurate
add 2015 HUP
2016 accurate
20142015
MAC4771
GA5134
add nov-dec 2015 data
add 2016 data
48% MAC
68% MAC
MAC
GA
PPMC MAC vs GA 2014-2015
MAC
GA
HUP/PPMC MAC vs GA 2014-2015
27% MAC
61% MAC
MAC
GA
HUP/PPMC MAC vs GA 2014-2015
19% MAC
60% MAC
80% MAC
MAC
GA
calendar Year (January-December)
# TAVR cases per calendar year
HUP MAC calendar year 2014-2016
TAVR casesHUP cathCCH cathPAH cathPPMC cathUPHS cathnon-UPHS cath
FY15218126611114474
FY16158871210010949
as of 2/11/16
HUP cathCCH cathPAH cathPPMC cathnon-UPHS cath
FY15126611174
FY16871210049
UPHS cathnon-UPHS cath
FY1514474
FY1610949
HUPPPMCthru 2/29
Commercial FY1260Commercial FY1219
Commercial FY13121Commercial FY1335
Commercial FY1495Commercial FY1439
Commercial FY15174Commercial FY1586
Commercial FY16144Commercial FY1672
HUPJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY1200000018167111760check
Commercial FY131417812119131341046121
Commercial FY14785124047119171195
Commercial FY1521141119101710171219915174
Commercial FY161320162319151820144(+25)
PPMCJulyAugSeptOctNovDecJanFebMarAprilMayJune
Commercial FY1200000010339319
Commercial FY1326322345421135
Commercial FY1443461011439339
Commercial FY15846108799757686
Commercial FY1611610812511972(+11)
PENN MEDICINEJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY12000000281910202079
Commercial FY13162311141312171881257156
Commercial FY141111918505815122614134
Commercial FY15291817291824192619241621260
Commercial FY162426263131202929216(+36)
Penn Medicine Q1 13-16Total
FY120
FY1350
FY1431
FY1564
FY1676
Sapien 3 impact to TVT
HUPJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY1521141119101710171219915174
Sapien 3 Intermediate96000000054529
Total302011191017101712241320203
HUPJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY1613201649
Sapien 3 Intermediate44210
Total17241859
HUP/PPMC w/ HUP S3iJulyAugSeptOctNovDecJanFebMarAprilMayJuneTotal
Commercial FY15291817291824192619241621260
Sapien 3 Intermediate96000000054529
Total382417291824192619292026289
HUP/PPMC w/ HUP S3iJulyAugSeptOctNovDecJanFebMarAprilMayJune
Commercial FY12000000281910202079
Commercial FY13162311141312171881257156
Commercial FY141111918505815122614134
Commercial FY15382417291824192619292026289
Commercial FY1628302583
HUP/PPMC w/ HUP S3iTotals
Commercial FY1279
Commercial FY13156
Commercial FY14134
Commercial FY15289
Commercial FY1683
PENN MEDICINETotal
Commercial FY1279
Commercial FY13156
Commercial FY14134
Commercial FY15260
Commercial FY16216
Commercial FY12
Commercial FY13
Commercial FY14
Commercial FY15
Penn Medicine Commercial TAVR Growth
Total
Quarter 1 Fiscal Volume Comparison
# commercial TAVR
Penn Medicine 1st Quarter Comparison Commercial TAVR
Commercial FY12
Commercial FY13
Commercial FY14
Commercial FY15
Penn Medicine Commercial + HUP S3i TVT Volume
Commercial FY12
Commercial FY13
Commercial FY14
Commercial FY15
Commercial FY16
Commercial FY12
Commercial FY13
Commercial FY14
Commercial FY15
Commercial FY16
Calendar 2014Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14
Commercial471191610211411191017149
Trial1012146797132264
Total14913232318302112221219216
Trial randomized SAVR0000000000112
Aborted-not counted11
Calendar 2015Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15
Commercial1017121991513201623154
Trial000546363330
Total10171224132116261926184(-1)
Trial randomized SAVR00000000000
Aborted-not counted10010002004
Calendar 2014Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14Oct-14Nov-14Dec-14
Commercial114393846108764
Trial830102415010034
Total94413117996118798
Trial randomized SAVR
Aborted-not counted
Calendar 2015Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15Oct-15Nov-15Dec-15
Commercial99757611610878
Trial002781222327
Total999121571381211105(+22)
Trial randomized SAVR
Aborted-not counted
HUPPPMCPAHCCH
Monthly Cardiac Cases0611018
HUPPPMCPAHCCH
FY16-current cases04381018
Jan-16HUPPPMCPAHCCH
CABG1857
Valve1144
Valve/ CABG502
TAVR1400
Aortic810
VAD100
ECMO400
Other005
Transplant000
FY16 to dateHUPPPMCPAHCCH
CABG11057
Valve12044
Valve/CABG3802
TAVR7900
Aortic4210
VAD600
ECMO3500
Other805
Transplant000
HUP
PPMC
PAH
CCH
January 2016 Case Breakdown
Monthly Cardiac Cases
Campuses
Monthly Volume
January 2016 Cardiac Cases
FY16-current cases
Campuses
FY16 to date volume
HUP
PPMC
PAH
CCH
FY16-current Case Breakdown
-
• Hybrid OR
• Heart team intact (Anesthesia, CV Surgery, Cardiology)
• MAC predominately (vs CS)
• Peripheral access (no PA catheter, no RIJ line)
• Percutaneous access
• Fast track to floor
• D/C home POD # 2-3
TAVR at Penn Today ≈ 500 Cases Annually
“It Takes a Village!”
-
• Lower the rate of complications to those of SAVR:
• Vascular complications
-
10
Lotus Deployment
-
Medtronic TAVR EnVeo R
Evolut Pro
-
New valves will likely provide trade-offs between vascular complications (size), sealing (PVL), and need for PPM.
Assuming all of these are undesirable, which do you consider to be the worst?
1. Vascular complications
2. Mild AR/PVL
3. PPM
-
14
Meredith, et al., presented at PCR London Valves 2014; Adams, et al., N Engl J Med 2014; 370: 1790-8; Leon, et. al. presented at ACC 2013; Lefevre et al., J Am Coll Cardiol 2016; 1:; Popma, et al., J Am Coll Cardiol 2014; 63: 1972-81; Linke, et. al. presented at London Valves 2015; Van Mieghem, et al., presented at EuroPCR 2015; Kodali, et al., presented at ACC 2015; Holmes, et al., JAMA 2015; 313: 1019-28; Meredith, et al., presented at ACC 2015, 1 Williams, et. al. presented at ACC 2016; Thourani, et al, presented at ACC 2016
4.0% 3.9%
5.5%
6.8% 7.0%
0.0%
3.3%
4.1%
2.5%
4.9%4.3%
1.5%
2.7%
5.5%
0%
1%
2%
3%
4%
5%
6%
7%
8%
CoreValveExtreme
RiskN=489
LOTUSRESPOND
N=500
PorticoCE StudyN=103
LOTUSREPRISE II
+ ExtN=249
Direct FlowDISCOVER
N=75
Evolut RCE Study
N=60
Evolut RIDE N=241*
SAPIENPARTNER
IIBN=276
SAPIENTVT HR
N=12182
CoreValveHigh Risk
N=390
SAPIEN XTPARTNER
IIBN=284
SAPIEN 3PARTNER II
HRN=583
SAPIEN 3PARTNER II
S3iN=1078
SAPIEN XTPARTNER
IIAN=1011
% P
atie
nts w
ith S
trke
at 3
0 Da
ys
Extreme Risk Extreme/High Risk High Risk Intermediate Risk
* Disabling Stroke
Incidence of CVA after TAVI remains clinically significant, particularly in high risk patients
-
15
• 68-100% of TAVI patients affected1-11
• Most patients have multiple infarcts• “Silent” infarcts associated with12-14
• 2-4-fold risk of future stroke• >3-fold risk of mortality• >2-fold risk of dementia• Cognitive decline• Dementia
New cerebral lesions are found in the vast majority of patients following TAVI
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Rod
es-C
abau
2011
Gha
nem
201
0
Arno
ld 2
010
Kahl
ert 2
010
Asta
rci 2
011
DEF
LEC
T III
cont
rol a
rm20
15
Biju
klic
201
5
CLE
AN-T
AVI
cont
rol a
rm
PRO
TAVI
-C
Neu
roTA
VR
MIS
TRAL
-C
% of TAVI patients with new cerebral lesions on DW-MRI
Ghanem, et. al, JACC 2010
1. Rodes-Cabau, et al., JACC 2011; 57(1):18-282. Ghanem, et al., JACC 2010; 55(14):1427-323. Arnold, et al., JACC:CVI 2010; 3(11):1126 –32
4. Kahlert, et al., Circulation. 2010;121:870-8785. Astarci, et al., EJCTS 2011; 40:475-96. Lansky, et al., EHJ 2015; May 19
7. Bijuklic, et al., JACC: CVI 20158. Linke, et al., TCT 20149. Vahanian, TCT 201410. Lansky, et al. London Valves 2015
11. van Mieghem N, et al. EuroIntervention2016;12:499-507 12. Sacco et al., Stroke 201313. Vermeer et al., Stroke 200314. Vermeer et al., New Engl J Med 2009
-
Background
• The Claret MontageTM dual-filter Cerebral Protection System was developed to protect the brain from injury caused by embolic debris.
• Randomized controlled trial data showing the efficacy of any embolic protection device in TAVR are missing.
-
SENTINAL TRIAL:Primary Efficacy Endpoint
42.2% reduction [95% CI: -3.2,67.6)
p = 0.33
New
Les
ion
Volu
mes
in
Prot
ecte
d Te
rrito
ries (
mm
3 )
350
300
250
200
150
100
50
0Control(N=98)
178
Median ± 95% Confidence Limit
Treatment(N=91)
102.8 0%10%20%30%40%50%60%70%80%90%
100%
-
Are small emboli that do not cause disabling or clinical strokes bad?
1. Very bad
2. Only a little bad and a reasonable trade-off for avoiding surgical recovery
3. Only a little bad, but would persuade me to have surgery if I was intermediate or low risk
4. Not bad at all
-
When an embolic protection device is avail in my hospital (cost ~1.5-3K), I will use it in…:
1. All patients
2. No patients
3. Selected patients based on device
4. Selected patients based on my assessment of stroke risk
-
Valve Leaflet Abnormalities
Diastole
Systole
Makkar, et al. 2015
-
New TAVR Pharmacology Trial
PIs: Dangas, G.Windecker, S.
US PI:Herrmann, H.
-
In 5 years all patients receiving bio AVR (TAVR and SAVR) will be treated for 3-6 months with:
1. Dual anti-platelet therapy (current standard of care)
2. Warfarin anticoagulation to INR 2-3
3. DOAC
4. Reduced dose warfarin (INR goal 1.5-2.5)
5. Reduced dose DOAC (rivaraxaban [10 mg] or apixaban [2.5 bid])
6. Echo (TEE) or CT guided therapy
-
Commercial AVR (TAVR or SAVR), Clinical Trial (P3), etc.
Symptomatic N=1,000 ptsPositive stress test
ScreeningNot eligible if 10
Asymptomatic Severe, Calcific AS
Asymptomatic N=1,109 ptsNegative stress test OR confirmation via med history*
TF- TAVR Clinical Surveillance
Registry
Primary Endpoint (superiority): 2-year composite of all-cause death, all stroke, and
unplanned cardiovascular hospitalization
Clinical and Echo Follow-up: 30 days (TAVR only), 1, 2, 3 and 5 years Telephone Follow-up:
1, 2, 3 and 5 years
Randomization 1:1Stratified by ability to perform stress test
Principal Investigator:Philippe Généreux, MD,
Chair: Martin B. Leon, MD
NCT03042104; 1st patient consented March 16th
-
InternationalMulticenter
Randomized
TAVR-UNLOAD Trial Design
Heart FailureLVEF < 50%
NYHA ≥ 2Optimal HF
therapy(OHFT)
Moderate AS
TAVR UNLOAD
Trial
R
TAVR + OHFT
OHFT Alone
Follow-up:1 month6 months
1 year
Clinical EndpointsSymptomsEcho QoL
Primary EndpointHierarchical occurrence of:
All-cause death Disabling stroke Hospitalizations for
HF, aortic valve disease, or non-disabling stroke
Change in KCCQ
Reduced AFTERLOADImproved LV systolic and diastolic function
-
New indications for TAVR. I recommend TAVR for which of these patients:
1. Asymptomatic AS only if very severe (mean gradient >50 mmHg)
2. Asymptomatic AS if severe (mean gradient >40 mmHg)
3. Moderate AS (AVA >1.0 cm2) if symptomatic with LV dysfunction
4. 1 and 3
5. 2 and 3
-
TAVR Durability IssuesSome of the problems associated
with this type of analysis…• 2 center experience, ultra-sick patients,
earliest versions of the Sapien THV• Incorrect statistical methods - THV
degeneration is a time-dependent “process”, not a clinical “event”
• Competing risks of frequent deaths in these patients with multiple co-morbidities creates censoring problems
• Echo data are incomplete - ascertainment and interpretation, and definitions used were spurious - creates significant biases
• No. at risk after 5 years drops precipitously - tail shape unreliable• “Clinical” SVD - freedom from re-intervention - never discussed
-
27
Longitudinal Hemodynamics in Partner 1
• All patients with evaluable echoes over time at core lab
N= 2482 TAVR patients
• Median F/U 3.1 years (Max 5 years)
• Main findings:
• Stable hemodynamics
• Only 5 patients had re-intervention for SVD (0.8%)
• Mod/severe AR 3.7% (slight increase over time)
Douglas et al, JAMA Cardiology 2017 (in press)
-
Regarding durability, pick the statement you most agree with:
1. TAVR valves will not be as durable as surgical prostheses, but the
difference will be small and won’t influence procedure selection
2. TAVR valves will be less durable and will make surgery preferable in
patients
-
Low Risk TAVR Trials
* Source: Clinicaltrials.gov
Sponsor Edwards (NCTO2675114)* Medtronic (NCTO2701283)*
Device Sapien 3 Evolut R / EnVeo R
Design Prospective, randomized Prospective, randomized
Comparator 1:1 to SAVR 1:1 to SAVR
Analysis Non-inferiority Non-inferiority
N 1228 1250
Inclusion Heart team risk
-
Regarding low risk patients, pick the statement you most agree with:
1. TAVR will eventually replace surgery in most patients, including those
at low risk due to the procedural advantages and patient preference
to avoid surgery
2. Despite likely non-inferiority in the low risk trials, surgery should still
be preferred due to lack of even mild PVL and known durability.
3. Risk is less important to me than age. Eg., a low risk 78 yo should get
TAVR and an intermediate risk 70 yo should get SAVR.
Update on TAVRDisclosure Statement of Financial Interest�Status of TAVI by Surgical Risk LevelTake-Home Messages:�� 1. In intermediate risk patients with severe symptomatic AS, TAVR is non-inferior to SAVR for death/disabling stroke at 2 years� 2. Will likely change the guideline to class I from IIaAll-Cause Mortality at 30 Days�Edwards SAPIEN Valves (As Treated) Slide Number 6Penn TAVR Program: Growth in ProceduresTAVR at Penn Today ≈ 500 Cases Annually What additional evidence is required to make �TAVR suitable for everyone?Lotus DeploymentSlide Number 11Slide Number 12Slide Number 13Incidence of CVA after TAVI remains clinically significant, �particularly in high risk patientsNew cerebral lesions are found in the vast majority of patients following TAVIBackgroundSENTINAL TRIAL:�Primary Efficacy EndpointSlide Number 18Slide Number 19Valve Leaflet Abnormalities Slide Number 21Slide Number 22Slide Number 23TAVR-UNLOAD Trial Design Slide Number 25Slide Number 26Longitudinal Hemodynamics in Partner 1Slide Number 28Low Risk TAVR TrialsSlide Number 30