T he ro le o f T ra nsc uta ne o us ve rsus Surg ic a l I nte - PDF document

T he ro le o f T ra nsc uta ne o us ve rsus Surg ic a l I nte rve ntio ns fo r Struc tura l He a rt dise a se s R ohit Sr ivastava MD F ACC F SCAI Asso c ia te Pro fe sso r UCSF F re sno Co -Dire c to r Ca rd ia c Ca the te riza tio n L a b o ra to ry Co mmunity Re g io na l Me dic a l Ce nte r F re sno , CA Disc lo sure s  No industry a ffilia tio n  I will b e disc ussing no n-F DA a ppro ve d de vic e s/ tre a tme nts

Ob je c tive s  Disc uss the pe rc uta ne o us struc tura l c a rdia c inte rve ntio ns a ppro ve d a nd in the pipe line  Disc uss the a ppro pria te indic a tio ns fo r no ve l Struc tura l Ca rdia c I nte rve ntio ns  Disc uss the ro le o f Surg ic a l pro c e dure s in va lvula r a nd o the r struc tura l c a rdia c diso rde rs g o ing fo rwa rd Surg ic a l Ao rtic Va lve re pla c e me nt

T ra nsc a the te r Ao rtic Va lve Re pla c e me nt Ca n we re pla c e the Ao rtic va lve pe rc uta ne o usly with e q ua l o r b e tte r o utc o me s a s c o mpa re d with SAVR?

Ca se pre se nta tio n: No n-surg ic a l/ hig h risk SAVR c a ndida te  65 yo pa tie nt with CAD (a the re c to my o f RCA), PVD, CK D (Cre a tinine 2.7), PVD (Rt AK A), mo rb id o b e sity (BMI 37), COPD with a c tive smo king  L VE F no rma l, Critic a l AS (Me a n g ra die nt 42, AVA 0.5 c m2)  Cla ss 3 DOE  Whe e lc ha ir b o und Risk: ST S sc o re Risk o f Mo rta lity: 7.048% Re na l F a ilure : 38.075% Pe rma ne nt Stro ke : 1.110% Pro lo ng e d Ve ntila tio n: 28.554% DSW I nfe c tio n: 0.287% Re o pe ra tio n: 3.655% Mo rb idity o r Mo rta lity: 44.810% Sho rt L e ng th o f Sta y: 12.776% L o ng L e ng th o f Sta y: 20.604%

Pa rtne r tria l: I no pe ra b le c o ho rt B. 358 pt. T AVR vs. Me dic a l Rx Stro ke 13.3% vs. 5.5% Ve ry la rg e b o re de live ry syste m: 24 F (6F is inte rve ntio na l she a th) N E ng l J Me d 2012;366:1696-704 Pa rtne r tria l: Hig h risk c o ho rt A. 699 pt. T AVR vs. SAVR ST S >11% T F vs. T A 30 d o utc o me s Va sc ula r c o mplic a tio ns: 11% vs. 3.2% p<0.001 Ma jo r b le e d: 9.3% vs. 19.5% p<0.001 Afib : 8.6% vs. 16% p=0.006 1 yr o utc o me s Ma jo r Stro ke : 13% vs. 7% p=0.07 Pa c e ma ke r 3.8% vs. 3.6% N E ng l J Me d 2011;364: 2187-98

Pa rtne r 2 tria l: I nte rme dia te risk. 2032 pt. T AVR vs. SAVR ST S= 5.8% 76.3% T ra nsfe mo ra l Sa pie ns XT 30 da y o utc o me s Va sc ula r c o mplic a tio ns: 7.9% vs. 5.8 % p=0.008 Ble e ding :10.4% vs 43.4% p<0.001 Ac ute kidne y injury: 1.3% vs. 3.1% p=0.006 Afib : 9.1% vs. 26.4% p<0.001 Pa c e ma ke r: 8.5 vs. 6.9% p=0.17 N E ng l J Me d 2016;374:1609-20 ST S= 1.9% Pa rtne r 3: L o w risk pt. >90% T ra nsfe mo ra l Sa pie ns 3 1 ye a r o utc o me s Prima ry e nd po int 8.5% vs.  1000 Pa tie nts in 71 c e nte rs 15.1% p=0.001 30 da y o utc o me s  Sa pie ns 3 va lve use d stro ke p=0.02  Sa pie ns 3 Ultra b e ing te ste d in a sma ll c o ho rt o f pts. de a th/ stro ke p=0.01 a tria l fib p<0.001 No diffe re nc e in Va sc ula r c o mplic a tio ns Pa c e ma ke r impla nt N E ng l J Me d. 2019 Ma r 17

Me dtro nic Se lf E xpa nding va lve I ndic a te d fo r hig h risk a nd inte rme dia te risk pa tie nts Re c e nt lo w risk tria l with b e tte r o utc o me s tha n SAVR E vo lut R E vo lut Pro Co re Va lve L o w risk tria l T AVR SAVR De a th o r Disa b ling 5.3% 6.7% NS Stro ke a t 2 yrs 30 day Disa b ling stro ke 0.5% 1.7% Ble e ding 2.4% 7.5% AK I 0.9% 2.8% Afib 7.7% 35.4% Mo de ra te o r se ve re AR 3.5% 0.5% Pa c e ma ke r impla nt 17.4% 6.1% 1 year Gra die nt 8.6mmHg 11.2mmHg Orific e a re a 2.3c m2 2.0c m2 NE JM 380; 18 Ma y 2 , 2019

Co st E ffe c tive ne ss o f T AVR vs. SAVR  T AVR vs. SAVR de vic e c o st: $32,000 vs. $5,000  Qua lity-a djuste d life -ye a rs (QAL Ys)  I nc re me nta l c o st-e ffe c tive ne ss ra tio (I CE R) is o b ta ine d b y dividing diffe re nc e in c o st b y diffe re nc e in QAL Ys  I CE R < $50,000/ QAL Y g a ine d re pre se nts hig h e c o no mic va lue , a n  I CE R b e twe e n $50,000 a nd $150,000/ QAL Y re pre se nts inte rme dia te va lue  I CE R > $150,000/ QAL Y re pre se nts lo w va lue within the US he a lthc a re syste m J Am Co ll Cardio l 2014;63:2304-22. Co st e ffe c tive ne ss  I no pe ra b le c o ho rt: Ac c e pta b le $61,889/ QAL Y g a ine d (I nte rme dia te )  Hig h risk c o ho rt: Ac c e pta b le $76,877/ QAL Y g a ine d (I nte rme dia te )  I nte rme dia te risk, se lf e xpa nda b le va lve : $55,090/ QAL Y g a ine d  I nte rme dia te risk, b a llo o n e xpa nda b le va lve : Re duc tio n in c o st b y $9-11,000  Re a so ns fo r lo we r c o st:  Sho rte r ho spita liza tio n  MAC vs. Ge ne ra l a ne sthe sia  Pe rc uta ne o us a c c e ss  Re duc e d c o mplic a tio ns inc luding b le e ding Circ ulatio n 2012;125:1102-9, J Am Co ll Cardio l 2012;60:2683-92, J Am Co ll Cardio l 2016;67:29-38, Circ ulatio n 2019;139:877-88

Dura b ility o f T AVR vs. SAVR  Dura b ility o f T AVR is a s g o o d o r b e tte r tha n SAVR  L ike a ll b io pro sthe tic va lve s, d ura b ility o f T AVR is unlike ly to b e b e tte r tha n me c ha nic a l va lve s JAMA Cardio l 2017;2:1197-206, J Am Co ll Cardio l 2019;73:546-53 I n 2019 a nd g o ing fo rwa rd is the re a ro le o f SAVR  Pa tie nts with pure Ao rtic re g urg ita tio n: no c a lc ific a tio n to a nc ho t the tra nsc a the te r va lve  Yo ung e r pa tie nts with b ic uspid a o rtic ste no sis who a re b e st se rve d with me c ha nic a l a o rtic va lve  Pa tie nts who ne e d c o nc o mita nt CABG o r o the r va lve re pa ir o r re pla c e me nt

Ca n we re pla c e a ma lfunc tio ning b io - pro sthe tic Ao rtic va lve ?  87 yo VA pa tie nt with b io pro sthe tic va lve in 2007, CABG 2007, 3.7 c m AAA, c la ss 3 SOB  Pro sthe tic AV me a n g ra die nt 47 mmHg , g ra fts pa te nt, L VE F 30%  T urne d do wn fo r T AVR a t VA Pa lo Alto At fo llo w up a ppt, pa tie nt d o ing we ll, no SOB, L VE F 55%

Ca n we re pla c e a ma lfunc tio ning b io - pro sthe tic Mitra l va lve ?  83 yo VA pa tie nt with b io pro sthe tic Mitra l va lve re pla c e me nt, se ve re MR, pulmo na ry HT N c la ss 3 SOB  No t a g o o d c a ndida te fo r re do -ste rno to my

Ne we st a ppro ve d T AVR de vic e : Bo sto n Sc ie ntific L o tus va lve Re prise I I I 912 pa tie nts ra ndo mize d b e twe e n L o tus a nd Co re va lve syste m Pa ra va lvula r re g urg ita tio n le ss in L o tus (0.9% vs. 6.8% p<0.001) Pa c e ma ke r impla nts mo re in L o tus (35.5% vs. 19.6% p< 0.001)

Ca n we re pa ir a se ve re ly re g urg ita nt Mitra l va lve pe rc uta ne o usly? Ca se pre se nta tio n: De g e ne ra tive Mitra l Re g urg ita tio n  70 ye a r o ld mo rb idly o b e se ma n with c la ss 3 CHF , se ve re MR  HT N, DM, CK D (Cre a t 3 mg / dL ), a ne mia , PVD, CABG 5 ye a rs a g o (g ra fts pa te nt), mild/ mo d MR a t time o f surg e ry: ma na g e d me dic a lly, L VE F 55%, prio r stro ke , COPD  E c ho : Se ve re De g e ne ra tive MR  ST S 13.9% (<3% lo w risk, 3-8% inte rme dia te risk, >8% hig h risk

Mitra l Va lve re g urg ita tio n Pe rc uta ne o us Mitra l Va lve re pa ir: E ve re st I I tria l. 279 pt. 2:1 ra ndo miza tio n Alfie ri stitc h Curre nt I ndic a tio n fo r Mitra c lip: De g e ne ra tive MR, sig nific a nt CHF sympto ms Pro hib itive risk fo r MV surg e ry N Engl J Med 2011; 364:1395-1406

Ca se pre se nta tio n: F unc tio na l Mitra l Re g urg ita tio n  70 ye a r o ld with c la ss 3 CHF , se ve re MR  HT N, CK D, PVD, CABG 5 ye a rs a g o (g ra fts pa te nt), mild/ mo d MR a t time o f surg e ry: ma na g e d me dic a lly, L VE F 25%  E c ho : F unc tio na l MR  ST S 8% Co a pt tria l: 614 pt. Mitra c lip vs. Me dic a l Rx. E F 20-50% with mo d-se ve re / se ve re se c o nda ry MR a nd CHF Sx de spite Me dic a l Rx I sc he mic CMP: ~60% ST S 8.2% RE SHAPE HF -2 tria l pe nding (2021) September 23, 2018 DOI: 10.1056/NEJMoa1806640

Mitra F R tria l: 304 pt. Mitra c lip vs. Me dic a l Rx. Se ve re Se c o nda ry MR: E F 15-40% Critic ism: 9.2% tre a tme nt pt. did no t g e t the de vic e Ve ry sic k pa tie nts e nro lle d Mo re mo de ra te MR pa tie nts e nro lle d L e ss e xpe rie nc e d o pe ra to rs with mo re re sidua l MR Aug ust 27, 2018 DOI : 10.1056/ NE JMo a 1805374 E dwa rds Pa sc a l syste m Clinic a l tria ls a b o ut to sta rt

Ca rdio b a nd pe rc uta ne o us a nnulo pla sty ring Ca n we re pla c e the Mitra l va lve pe rc uta ne o usly?  Ye s we c a n, Co mme rc ia lly, in a fe w ye a rs!  T MVR inve stig a tio na l a t this time

T ra nsc a the te r Mitra l Va lve re pla c e me nt: I ntre pid Va lve (Me dtro nic ) I nve stig a tio na l de vic e , no t a ppro ve d fo r c linic a l use APOL L O tria l sta rte d T ra nsc a the te r Mitra l Va lve re pla c e me nt: T e ndyne (Ab b o tt) I nve stig a tio na l de vic e , no t a ppro ve d fo r c linic a l use Summit tria l sta rte d

E me rg ing T MVR de vic e s Ca n we tre a t rig ht side d va lve dise a se pe rc uta ne o usly?