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
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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
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
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
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 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
e ng th o f Sta y: 20.604%
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
ST S >11% T F
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
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%
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
1000 Pa tie nts in 71 c e nte rs Sa pie ns 3 va lve use d Sa pie ns 3 Ultra b e ing te ste d in a sma ll c o ho rt o f pts. ST S= 1.9% >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. 15.1% p=0.001 30 da y o utc o me s stro ke p=0.02 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
E vo lut R E vo lut Pro 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
NE JM 380; 18 Ma y 2 , 2019 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
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.
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 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 l2017;2:1197-206, J Am Co ll Cardio l2019;73:546-53
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
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%
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
Re prise I I I 912 pa tie nts ra ndo mize d b e twe e n L
syste m Pa ra va lvula r re g urg ita tio n le ss in L
p<0.001) Pa c e ma ke r impla nts mo re in L
19.6% p< 0.001)
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
N Engl J Med 2011; 364:1395-1406 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
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%
September 23, 2018 DOI: 10.1056/NEJMoa1806640 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
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
Clinic a l tria ls a b o ut to sta rt
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
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
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
T e tra lo g y o f F a llo t: with prio r surg e ry with ste no sis o r re g urg ita nt pulmo na ry va lve Othe r Pulmo na ry va lve re pla c e me nts with de g e ne ra tio n: Ho mo g ra fts o r b io pro sthe tic va lve Me lo dy va lve a nd Sa pie ns XT F DA a ppro ve d
The Tric Valve device The TriCinch system Trialign device The Forma system
71 yo pa tie nt with c hro nic Afib , s/ p AV junc tio n a b la tio n a nd PPM impla nt HT N, CK D, CHF , COPD GI b le e ding with iro n de fic ie nc y a ne mia CHA2DS2-VASc sc o re 5 (6.7% ye a rly risk o f stro ke )
PROT E CT AF tria l He mo rrha g ic stro ke re duc e d PRE VAI L tria l Wa tc hma n no n-infe rio r o ve ra ll
Ab b o tt de vic e US tria l o ng o ing AMPL AT ZE R Amule t Ob se rva tio na l Po st-Ma rke t Study: 1088 pt. no n- va lvula r AF . CHAD2Va sc risk> 6%. 1yr 2.9% stro ke
Struc tura l he a rt dise a se ha s mo re pe rc uta ne o us tre a tme nt o ptio ns no w tha n e ve r b e fo re Ma ny o ptio ns a re e q uiva le nt o r supe rio r to tra ditio na l surg ic a l tre a tme nt
he c o st o f pe rc uta ne o us tre a tme nt ma y b e le ss tha n surg ic a l Rx. Dura b ility o f tre a tme nt is pro b a b ly b e tte r tha n so me o f the surg ic a l tre a tme nts Ma ny o ptio ns a re a va ila b le in pa tie nts who a re NOT surg ic a l c a ndida te s Mo st o f the a ppro ve d tre a tme nts a re re a dily a va ila b le in o ur pro g ra m;
c o nve nie nc e Sta y tune d fo r ne w inte rve ntio ns a nd inve stig a tio na l de vic e s