Device Monitoring and Managing Heart Failure

7/21/2019 Device Monitoring and Managing Heart Failure

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DEVICE MONITORING ANMANAGING HEART FAILUBRAUNWALD READING



INTRODU

• In the year 2001 a new era o !"#$anta%$e &e'!(e thera#"ana*e"ent o heart a!$+re wa) !n!t!ate& w!th FDA a##ro'a&e'!(e or (ar&!a( re)yn(hron!-at!on thera#y .CRT/

• ICD) %e(a"e !n&!(ate& or the #r!"ary #re'ent!on o a$$(a+) re&+(t!on !n the !n(!&en(e o )+&&en (ar&!a( &eath !n #a

heart a!$+re an& re&+(e& ee(t!on ra(t!on)• Co"%!ne& CRTICD &e'!(e) were )hown to re&+(e "or%!&!ty an

!n heart a!$+re #at!ent) w!th a re&+(e& ee(t!on ra(t!on .'entr!(+$ar &y))yn(hrony



VENTRICULAR D3443NCHRON35 THE TARGET OF CARDIAC RE43NCHRONI THERA73

• Ventr!(+$ar &y))yn(hrony 5 a #ro$on*e& 8R4 &+rat!on9 *enera$$ythan 120 "!$$!)e(on&)9 on the )+ra(e e$e(tro(ar&!o*ra"

• Ventr!(+$ar &y))yn(hrony "ay now %e a&&re))e& w!th #a(!n* tthro+*h the !"#$antat!on o #a(!n* $ea&) !n %oth the r!*ht an&

'entr!($e)

CRT



RANDOMIZED CONTROLLED TRIALS OFCARDIAC RESYNCHRONIZATION THERAPYPATIENTS WITH NEW YORK HEART

ASSOCIATION CLASS III AND IV HEART FA• MU4TIC .M+$t!)!te 4t!"+$at!on !n Car&!o"yo#athy/ )t+&y

• MIRACLE .M+$t!(enter In4yn( Ran&o"!-e& C$!n!(a$ E'a$+at!on/

• MIRACLE ICD tr!a$

• CONTA: CD tr!a$

• CAREHF .Car&!a( Re)yn(hron!-at!on !n Heart Fa!$+re/ tr!a$

• COM7ANION .Co"#ar!)on o Me&!(a$ Thera#y9 7a(!n* an& De,!n Heart Fa!$+re/ Tr!a$



MULTISITE STIMULATCARDIOMYOPATHY TRIALS (M

• To e'a$+ate the )aety an& e;(a(y o CRT !n #at!ent) w!th a&'a!$+re9 'entr!(+$ar &y))yn(hrony9 an& e!ther nor"a$ )!n+) rhyt,%r!$$at!on

• The #r!"ary en&#o!nt) 5 e<er(!)e to$eran(e a) a))e))e& %y "eo #ea= VO2 or the >"!n+te ha$$ wa$= te)t an& ?+a$!ty o $!e a&eter"!ne& %y +)!n* the M!nne)ota L!'!n* w!th Heart Fa!$+re .M

?+e)t!onna!re

• 4e(on&ary en&#o!nt) 5 reho)#!ta$!-at!on an&@or "o&!,(at!on) !nthera#y or wor)en!n* heart a!$+re



MULTISITE STIMULATCARDIOMYOPATHY TRIALS (M

RE4ULT4 5

• The "ean &!)tan(e wa$=e& !n > "!n+te) wa) 2 *reater w!th w!tho+t CRT

• 4!*n!,(ant !"#ro'e"ent wa) a$)o )een !n ?+a$!ty o $!e an& N3+n(t!ona$ ($a)) ran=!n*

• Fewer ho)#!ta$!-at!on) o((+rre& &+r!n* a(t!'e re)yn(hron!-at!o



MULTICENTER INSYNC RANDOCLINICAL EVALUATION (MI

• The ,r)t #ro)#e(t!'e9 ran&o"!-e&9 &o+%$e%$!n&9 #ara$$e$(ontrotr!a$ &e)!*ne& to e'a$+ate the %ene,t) o CRT

• 7r!"ary en&#o!nt) 5 N3HA ($a))9 ?+a$!tyo$!e )(ore an& >wa$= &!)tan(e

• 4e(on&ary en&#o!nt) 5 A))e))"ent o a (o"#o)!te ($!n!(a

(ar&!o#+$"onary e<er(!)e #eror"an(e9 (ar&!a( )tr+(t+re an&'ar!ety o "ea)+re) o wor)en!n* heart a!$+re9 an& (o"%!nean& "orta$!ty




RE4ULT4 5

• 7at!ent) ran&o"$y a))!*ne& to CRT &e"on)trate&

• I"#ro'e"ent !n ?+a$!tyo$!e )(ore .10 'er)+) 0 #o!nt)9P

• >"!n+te wa$= &!)tan(e . 'er)+) 10 "eter)9 P 000/9

• N3HA +n(t!ona$ ($a)) ran=!n* .10 'er)+) 00 ($a))9 P 0001/

• Trea&"!$$ e<er(!)e t!"e .1 'er)+) 1 )e(on&)9 P 0001/9 #e.11 'er)+) 01 "L@=*@"!n9 P 001/

• LVEF .J> 'er)+) 029 P 0001/

• Fewer #at!ent) !n the CRT *ro+# re?+!re& ho)#!ta$!-at!on . 'or !ntra'eno+) "e&!(at!on) .K 'er)+) 1/ or the treat"entwor)en!n* heart a!$+re .%oth P 00/



re&+(e& en&&!a)to$!( an& en&)y)to$!( 'o$+"e)9 re&+(e& 'entr!(+$ar "a))9 !n(rea)e& ee(t!on ra(t!on9 re&+(e& "!tre*+r*!tant %$oo& ow9 an& !"#ro'e& "yo(ar&!a$ #eror"a!n&e<


•

The MIRACLE tr!a$ a$)o #ro'!&e& #er)+a)!'e e'!&en(e )+##orto((+rren(e o re'er)e $et 'entr!(+$ar re"o&e$!n* w!th (hron!(

)er!a$ Do##$er e(ho(ar&!o*ra") were o%ta!ne& at %a)e$!ne an& "onth) !n a )+%)et o 2 #at!ent) CRT or > "onth)

•



MULTICENTER INSYNC IMPLANTABLE CARDIOVERDEFIBRILLATOR RANDOMIZED CLINICAL EVALUAT(MIRACLE ICD)

• 7ro)#e(t!'e9 "+$t!(enter9 ran&o"!-e&9 &o+%$e%$!n&9 #ara$$e$(o($!n!(a$ tr!a$ !nten&e& to a))e)) the )aety an& e;(a(y o a (o"ICD )y)te" !n #at!ent) w!th &!$ate& (ar&!o"yo#athy an& an !n&an ICD



MULTICENTER INSYNC IMPLANTABLE CARDIOVERDEFIBRILLATOR RANDOMIZED CLINICAL EVALUAT(MIRACLE ICD)

RE4ULT4 5

• I"#ro'e"ent !n "e&!an ?+a$!ty o $!e )(ore .1K 'er)+) 1002/ an& +n(t!ona$ ($a)) .1 'er)+) 09 P 000K/ than &!& (o

• No &!erent ro" (ontro$) !n the (han*e !n &!)tan(e wa$=e& !n >. 'er)+) "eter)9 P 0>/

• 7ea= o<y*en (on)+"#t!on !n(rea)e& %y 11 "L@=*@ "!n !n there)yn(hron!-at!on *ro+# 'er)+) 01 "L@=*@"!n !n (ontro$) .P

• D+rat!on o trea&"!$$ e<er(!)e !n(rea)e& %y > )e(on&) !n the Can& &e(rea)e& %y 11 )e(on&) !n (ontro$) .P 0000>/



CONTAK CD

• Enro$$e& 1 )y"#to"at!( heart a!$+re #at!ent) w!th 'entr!(+$a&y))yn(hrony an& "a$!*nant 'entr!(+$ar ta(hyarrhyth"!a) (or ICD

• RE4ULT4 5

• 4!*n!,(ant !"#ro'e"ent) !n #ea= o<y*en +#ta=e an& ?+a$!ty o $!re)yn(hron!-at!on *ro+# !n (o"#ar!)on to (ontro$ )+%e(t) a$th

?+a$!ty o $!e wa) !"#ro'e& on$y !n N3HA ($a)) III an& IV #at!ent)

r!*ht %+n&$e %ran(h %$o(=

• Let 'entr!(+$ar &!"en)!on) were a$)o re&+(e&9 an& LVEF) !n(rea



CARDIAC RESYNCHRONIZATIOHEART FAILURE TRIAL (CARE-HF

• To e'a$+ate the ee(t) o re)yn(hron!-at!on thera#y w!tho+t"or%!&!ty an& "orta$!ty !n #at!ent) w!th N3HA ($a)) III or IV han& 'entr!(+$ar &y))yn(hrony

• 1 #at!ent) w!th an LVEF o or $e)) an& 'entr!(+$ar &y))y

• J0J #at!ent) were ran&o"$y a))!*ne& to re(e!'e o#t!"a$ "e&!(a$

a$one

• J0 #at!ent) to o#t!"a$ "e&!(a$ thera#y #$+) re)yn(hron!-at!on t



CARDIAC RESYNCHRONIZATION HEART FAILURE TRIAL (CARE-HF

RE4ULT4 5

• The r!)= or &eath ro" any (a+)e or +n#$anne& ho)#!ta$!-at!on(ar&!a( e'ent wa) )!*n!,(ant$y re&+(e& %y K !n the treat'er)+) (ontro$ )+%e(t)

• Re)yn(hron!-at!on thera#y a$)o )!*n!,(ant$y re&+(e& th

+n#$anne& ho)#!ta$!-at!on or a "aor (ar&!a( e'ent %y "orta$!ty #$+) ho)#!ta$!-at!on or heart a!$+re %y J>9 an& hoor heart a!$+re %y 2



COMPARISON OF MEDICAL THERAPY,AND DEFIBRILLATION FOR HEART FA(COMPANION)

• To (o"#are &r+* thera#y a$one w!th &r+* thera#y !n (o"%(ar&!a( re)yn(hron!-at!on !n #at!ent) w!th &!$ate& (ar&!o"y!ntra'entr!(+$ar (on&+(t!on &ee(t9 N3HA ($a)) III or IV heart no !n&!(at!on or a &e'!(e

• The #r!"ary en&#o!nt 5 a (o"#o)!te o a$$(a+)e "orta$!ty an& ho)#!ta$!-at!on

• 4e(on&ary en&#o!nt) 5 a$$(a+)e "orta$!ty an& a 'ar!ety o "ea(ar&!o'a)(+$ar "or%!&!ty



COMPARISON OF MEDICAL THERAPY,AND DEFIBRILLATION FOR HEART FA(COMPANION)

RE4ULT4 5

• The (o"%!ne& en&#o!nt o "orta$!ty or ho)#!ta$!-at!on or hearwa) re&+(e& %y !n #at!ent) re(e!'!n* CRT an& %y J0 !n #re(e!'!n* CRTICD (o"#are& w!th "e&!(a$ thera#y a$one

• For the "orta$!ty en&#o!nt a$one9 CRT #at!ent) ha& a 2J re&+

an& CRTICD #at!ent) e<#er!en(e& a > re&+(t!on !n r!)= whew!th o#t!"a$ "e&!(a$ thera#y



RANDOMIZED CONTROLLED TRIALS OF CARESYNCHRONIZATION THERAPY IN PATIENWITH NEW YORK HEART ASSOCIATION CLA

AND II HEART FAILURE

• REVER4E .Re)yn(hron!-at!on Re'er)e) Re"o&e$!n* !n 4y)to$!(Ventr!(+$ar Dy)+n(t!on/ tr!a$

• MADITCRT .M+$t!(enter A+to"at!( De,%r!$$ator I"#$antat!on TCar&!a( Re)yn(hron!-at!on Thera#y/

• RAFT .Re)yn(hron!-at!on@ &e,%r!$$at!on or A"%+$atory Heart F Tr!a$/



RESYNCHRONIZATION REVERSES REMODELING SYSTOLIC LEFT VENTRICULAR DYSFUNCTION TR(REVERSE)

• To a&&re)) the %ene,t o CRT 'er)+) o#t!"a$ "e&!(a$ thera#y aheart a!$+re "or%!&!ty !n #at!ent) w!th "!$& heart a!$+re

• The #r!"ary en&#o!nt 5 a ($!n!(a$ (o"#o)!te heart a!$+re )(ore

• Be(a+)e the *oa$ o the )t+&y wa) to &eter"!ne the ee(t o C#re'ent!n* &!)ea)e #ro*re))!on9 a wor)ene&P )tat+) wa) (on)ne*at!'e o+t(o"e



RESYNCHRONIZATION REVERSES REMODELING SYSTOLIC LEFT VENTRICULAR DYSFUNCTION TR(REVERSE)

RE4ULT4 5

• A )!*n!,(ant %ene,t o CRT wa) note& !n !"#ro'e"ent !n 'ent)tr+(t+re an& +n(t!on an& !n heart a!$+re "or%!&!ty9 w!th a re$at!'e r!)= re&+(t!on !n the t!"e to ,r)t heart a!$+re ho)#!ta

REVER4E wa) the ,r)t $ar*e ran&o"!-e&9 "+$t!(tr!a$ to &e"on)trate the #otent!a$ or CRT to )

#ro*re))!on o &!)ea)e thro+*h re'er)e re"o&e$#at!ent) w!th N3HA ($a)) I an& II heart a!$+re a

'entr!(+$ar &y))yn(hrony



MULTICENTER AUTOMATIC DEFIBRILLATOR IMPLATRIAL WITH CARDIAC RESYNCHRONIZATION THER(MADIT-CRT)

• To a&&re)) the #otent!a$ )+r'!'a$ an& "or%!&!ty %ene,t o CRTw!th N3HA ($a)) I an& II heart a!$+re %y a))e))!n* the re&+(t!o&eath an& nonata$ heart a!$+re e'ent) !n th!) #o#+$at!on

• 7ro#hy$a(t!( CRT (o"%!ne& w!th an ICD wa) (o"#are& w!th a

!n 120 #at!ent) w!th an LVEF o 0 or $ower9 8R4 &+ra"!$$!)e(on&) or $on*er9 an& e!ther an !)(he"!( .($a)) I #at!e.($a)) II #at!ent)/ (a+)e



MULTICENTER AUTOMATIC DEFIBRIMPLANTATION TRIAL WITH

RESYNCHRONIZATION THERAPY (MA

RE4ULT4 5

• The #r!"ary en&#o!nt o &eath ro" any (a+)e or a nonata$ e'ent o((+rre& !n 1K2 o the CRTICD *ro+# 'er)+) 22 o *ro+#

• Th!) )!*n!,(ant %ene,t wa) &r!'en %y a J1 re&+(t!on !n heart a.1 'er)+) 22/

• Both the !)(he"!( an& non!)(he"!( *ro+#) )howe& %ene,t w!th CR*reater %ene,t wa) note& !n wo"en than !n "en an& !n #at!ent)&+rat!on o 10 "!$$!)e(on&) or $on*er

• 7at!ent) %ene,t!n* "o)t ha'!n* $et %+n&$e %ran(h %$o(= .LBBB/

MADIT-CRT led !e FDA " e#$%&d !e '&d"* CRT " NYHA l%++ II "* '+!e' $%'e&+ '! %& LVEF " le++ !%& ./0, d2*%'"& l"&3e* !%& 4./ 'll'+e"&d+, %&d

"* !e de5'e+ e5%l2%ed '& !'+ +2d67



RESYNCHRONIZATION8DEFIBRIFOR AMBU

HEART FAILURE TRIA

• RAFT wa) the ,r)t to )how a "orta$!ty %ene,t o (o"%!ne& CRan ICD a$one an& a re&+(t!on !n "orta$!ty w!th the a&&!t!on o #at!ent) w!th N3HA ($a)) II heart a!$+re

• RE4ULT4 5

• 4how a "orta$!ty %ene,t o (o"%!ne& CRTICD o'er an ICD a$one

re&+(t!on !n "orta$!ty w!th the a&&!t!on o CRT !n #at!ent) w!th NII heart a!$+re

• The year a(t+ar!a$ &eath rate wa) $ower .2> 'er)+) J>t!"e +nt!$ &eath wa) $on*er !n the CRTICD #at!ent) than !n the I

T!e *e+2l+ *" RAFT %&d REVERSE *e+2le!e FDA e#$%&d'&3 !e '&d'%'"& "* e*%'&

de5'e+ " '&l2de $%'e&+ '! 'ldl6+6$"%' !e%* %'l2*e (NYHA l%++ II), %LVEF " ./0 "* l"e*, LBBB, %&d % 1RS d2*%" 4./ 'll'+e"&d+ "* l"&3e*7



INDICATIONS FOR CARDIAC RESYNCHRONIZTHERAPY IN PATIENTS WITH HEART FAILUR



SUDDEN CARDIAC DEATH IN PATIENTS WHEART FAILURE

• 7at!ent) w!th heart a!$+re an& $et 'entr!(+$ar )y)to$!( &y)+n(t!n(rea)e& r!)= or 4CD

• 4CD !) the $ea&!n* (a+)e o "orta$!ty !n #at!ent) w!th heart a!$o((+r) at a rate )!< to n!ne t!"e) that )een !n the *enera$ #o#+

• Lan&"ar= tr!a$) e)ta%$!)h!n* a ro$e or ICD) a) #r!"ary #re'ent"orta$!ty !n heart a!$+re #at!ent)

• MADIT II .M+$t!(enter A+to"at!( De,%r!$$ator I"#$antat!on Tr!a$ II/

• DEFINITE .7ro#hy$a(t!( De,%r!$$ator I"#$antat!on !n 7at!ent) w!th D!$ate& Car&!o"yo#athy/ tr!a$

• The Nat!ona$ In)t!t+te) o Hea$thQ)#on)ore& 4CDHeFT .4+&&en C

DeathQHeart Fa!$+re Tr!a$/



MULTICENTER AUTOMATIC DEFIBRILIMPLANTATION TRIAL II (MADIT II)

• To a))e)) the )+r'!'a$ %ene,t o ICD) !n a #o#+$at!on o #o)t!nar(t!on #at!ent) w!th re&+(e& ee(t!on ra(t!on) .0/

• RE4ULT4 5

• A$$(a+)e "orta$!ty rate) were 1 !n the (on'ent!ona$ thera

1J2 !n the ICD *ro+#

•

The ee(t o ICD thera#y on )+r'!'a$ wa) )!"!$ar !n )+%*ro)trat!,e& a((or&!n* to a*e9 )e<9 ee(t!on ra(t!on9 N3HA ($a))9

!nter'a$

• The ,n&!n*) )+**e)te& that heart a!$+re #at!ent) w!th "!$& )y"#to") an& "o&erate to )e'ere re&+(t!on) !n LVEF "ay %en

ro" a #ro#hy$a(t!( ICD



PROPHYLACTIC DEFIBRILLATOR IMPLANTATION PATIENTS WITH NONISCHEMIC DILATEDCARDIOMYOPATHY TRIAL (DEFINITE)

• The ,r)t ran&o"!-e& tr!a$ o #r!"ary #re'ent!on thera#y w!th a#at!ent) w!th non!)(he"!( (ar&!o"yo#athy

• Entry Cr!ter!a

• RE4ULT4 5

• I"#$antat!on o an ICD y!e$&e& a non)!*n!,(ant re&+(t!on !n

any (a+)e an& )!*n!,(ant$y re&+(e& the r!)= or )+&&en &eath %yre"ar=a%$e 0

• In the )+%*ro+# o N3HA ($a)) III #at!ent)9 a$$(a+)e "orta$!ty wa))!*n!,(ant$y &e(rea)e& !n the ICD ar"



SUDDEN CARDIAC DEATH9HEARFAILURE TRIAL

• 4CDHeFT wa) a threear" tr!a$ !n wh!(h treat"ent w!th an ICD(o"#are& w!th a"!o&arone an& #$a(e%o

• 4CDHeFT a&&re))e& at $ea)t two !"#ortant !))+e) !n heart a!$"ana*e"ent5

• E"#!r!( a"!o&arone thera#y )a'e) $!'e) !n we$$treate& #at!ent) w($a)) II an& III heart a!$+re an& no arrhyth"!( !n&!(at!on or the &

• A #ro#hy$a(t!( ICD )a'e) $!'e) !n )+(h #at!ent) w!th heart a!$+re an !)(he"!( or non!)(he"!( (a+)e



SUDDEN CARDIAC DEATH9HEARFAILURE TRIALRE4ULT4 5

• Morta$!ty rate) !n the ICD9 a"!o&arone9 an& #$a(e%o *ro+#) we2J9 an& 22 at year) an& 29 J19 an& 9 re)at year)

• An ICD wa) a))o(!ate& w!th a )tat!)t!(a$$y )!*n!,(ant 2 re&+(a+)e "orta$!ty !n (o"#ar!)on to #$a(e%o

• 4!"!$ar &e*ree) o %ene,t w!th an ICD were note& !n #at!ent) w!)(he"!( .21 re&+(t!on !n "orta$!ty/ an& non!)(he"!( .2K r"orta$!ty/ heart a!$+re



INDICATIONS FOR PROPHYLACTIC IMPLANTATIONIMPLANTABLE CARDIOVERTER-DEFIBRILLATORS INPATIENTS WITH HEART FAILURE



CRITERIA DICARDIOM3O

• LVEF

• Let 'entr!(+$ar en&&!a)to$!( &!"en)!on SLVEDD ""

• N3HA ($a)) III or IV heart a!$+re

• 'entr!(+$ar &y)yn(hrony .8R4 10 "!$$!)e(on&)/



ENTR3 CRITERIA DEFINITE

• Ee(t!on ra(t!on o or $e))

• A h!)tory o )y"#to"at!( heart a!$+re9

• The #re)en(e o a"%!ent arrhyth"!a &e,ne& a) an non)+)ta!ne& 'entr!(+$ar ta(hy(ar&!a or at $ea)t 10 #re"at+re(ontra(t!on) #er 2Jho+r #er!o& &+r!n* (ont!n+o+)

e$e(tro(ar&!o*ra#h!( "on!tor!n*

Documents

Device Monitoring and Managing Heart Failure