10. Devices Therapy for Advance HF - dr Yoga Yuniadi SpJP.pptx

Devices Therapy for Advanced

Heart Failure Yoga Yuniadi

Department of Cardiology and Vascular Medicine, FMUI, and National Cardiovascular

Center Harapan Kita, Jakarta

Outline 1.Electrical Remodeling in Heart

Failure – Mechanisms of electrical remodeling – Ventricle dyssynchrony – Clinical Consequence 2.Cardiac Resynchronization Therapy

– Mechanisms of cardiac synchronization – Clinical Evidences 3.When to Perform CRT Implantation

– Refractory Heart Failure – Guidelines Directed Medical Treatment 4.Who will be Benefited from CRT

– Impact of QRS duration – Overt vs. Mild Heart Failure – Sinus Rhythm vs. Atrial Fibrillation

Normal Heart Conduction

Left Bundle Branch (LBB)

Posterior Fascicle of LBB

Anterior Fascicle of LBB

Right Bundle Branch (RBB)

Cardiac Electrical Remodeling Primary Secondary

Remodeling Remodeling

Causes Ventricular Pac'rrig Myocardial Infarction Conduction System !Dysfunction Hypertrophy

Heart Failure

Eiectrophysiology Changes

Mechanisms

APD Prolongation

echani c a I Stretch AngiotensiOn II Electroton US

APD Prolongation Conduction Slowing E-C Coupling Changes

Complex Signaling Pathways

Ionic Changes Ito, 'ca., and Cx43 4' h. IkT, and Cx43 E-C coupling proteins 4'<-0Bta

IINcvtitcx RyR and SERCA2a

Cutler et al. Trends Pharmacol Sci. 2011 ; 32(3): 174-180

Cardiac Memory

Rosenbaum et al. Am J Cardiol.1982; 50(2):213–22.

Electrophysiological Remodeling in

Heart Failure

Tomaselli GF et al. Cardiovascular Research.1999;42:270–283

II

11

A

Electrical Remodeling 7

a V I V2

a V V3

(

I 1

III

LBBB, QRS duration 180 ms, PR interval 240 ms

Vi

V6

Electrical Remodeling Results in Mechanical Dyssynchrony

Prevalence of Ventricular Dyssynchrony in

Heart Failure Left Bundle Branch Block More Prevalent

with Impaired LV Systolic Function Preserved LVSF

(1) 8%

Impaired LVSF (1) 24%

Moderate/Severe HF (2) 38%

1.Masoudi, et al. JACC 2003;41:217-23

2.Aaronson, et al. Circ 1997;95:2660-7

Clinical Consequences of Ventricular Dyssynchrony

Prognosis of Electrical Remodeling

1 Year Mortality Long-term (45 Mo) Mortality

P < 0.001

P < 0.001

11% QRS < 120 ms

49%

QRS > 120 ms

16%

QRS > 120 ms

34%

QRS < 120 ms

Baldasseroni S, et al. Eur Heart J 2002;23:1692-98 Iuliano et al. AHJ 2002;143:1085-91 N=5,517 N=669

Outline 1.Electrical Remodeling in Heart Failure

– Mechanisms of electrical remodeling – Ventricle dyssinchroni – Clinical Consequence 2.Cardiac Resynchronization Therapy




Cardiac Resynchronization Therapy

Cardiac Resynchronization

Mechanisms of Improvement

1" dP/dt, 1" EF, 1" CO L MR (1" Pulse Pressure)

Intraventricular Synchrony

L LVESV L LVEDV

Cardiac Resynchronization

Reverse Remodeling

Atrioventricular Synchrony

L LA Pressure

1" LV Diastolic Filling

Interventricular Synchrony

1" RV Stroke Volume

Yu CM et al. Circulation 2002;105:438-445

Metaanalysis of the effects of CRT on morbidity and mortality

All.r.ause

6 12 15 24 30 42

Subjtat. a1 RSA.

Number of months post-implant

CRT: 2023 167$ /331 1155 SKI 737 586 416 286. 205 CDirtrod: 1549 144 116. 1433 1395 6136 532 369 24T 10E

B All-cause martalityti -IF hospitalization

4 0 '

12 18 24 50 36 42 4.E. 54

Subjects at Risk

Number of morrrh.9 pc/RI-implant

CRT: 2023 1592 1234 11344 771 54.3 4D1 306 234 169. Control:1549 1320 1027 am 43f.7 409 332 240 184 137

CRT- M RT-D CDiback-up pacing Hazard Ratio 0.66(95% CI a 57-11771

-

Hazard Ratio O. 5 (95% CI 0.5B-4.74]

CRT-P/CRT-10 0 hi TIC 09ek-up paci r4g

BO uJ

50 -

7.90 9 80 La

:If 70

Cleland et al. Eur Heart J. 2013;34:3547-3556

How Low Can You Go?

Mann Dl et al. Circulation. 2005;111:2837-2849

Number Need To Treat

·CRT: – All cause mortality: 25 (Cochrane 2009) – Hospitalization for HF: 11 (Cochrane 2009) ·ACEI: – Heart failure mortality: 24 (Am Fam Phys 2004) – HF mortality and hospitalization: 11 (Am Fam Phys

2004) – Non-HF mortality: 720 (Am Fam Phys 2006)






Comparison of ACCF/AHA Stages of HF and

NYHA Functional Classifications

Guidelines Directed Medical Treatment

Yancy et al. ACCF/AHA Guidelines for Management of HF. Circulation. 2013;128:e240-e327.

The effect of CRT in pre-specified subgroups on death or heart failure hospitalization

Subjects with events/total subjects Hazard ratio (95% confidence intervals) .(11:E2/3872)

Group ovcrBil

1CD subject

(3C11dCr

A ge

Vcs (6824'2437) Nromon435)

Melo (87113004) Female (21 li8681

<5g (211,4400) 58-66(242.967) 66-725 (311./964) >72.5 (318)960

NYI-LA 11(441.1'1877) Ill (577/1849) IV (64/146)

LVEF <15 (1.30196.5) 16-20(248)784)

Co0DT2162) (571318)

>35 1271174)

Morphology LBIEID (8210036) R131'01(11 5T346) Neilher (123,467)

Systolic BP <WS (316/976) 106-116 mmHg (281'961) 117-130 mmHg (297111681 3-130 mmHg (151051)

Ischaemic Yea. (72242232) (3613/1640)

Elem•Nuckers Yes (7993006) No (28318144

cLea (4-$7., 0,76) 0.157 (151, 0,79) 0,52 W31 o,r)

0.59 (141, 13.8.3) 0,56 0.43, 171 (115, 0_83) 0,69 (0-4, I . k 7) 0.56(06, 1.23)

0,61 (0.53, 0.7) 0,94 (045. 1,37)

1.36).

up (0.57. 0.871 0,68 (034, 0,86) 0.56 (0.44, 0.71) 0.61 0.44, (I,83)

0.69 (0.6, 0.8) 0.54 (144, 0.157)

0.65 (0..56, 0,74)

1-6.8 (0.54 0 57)

15 2

0.155 (158, 0.74)

1170 (0126,10_52) 0.58 (147, 0.71)

0.159 (16, 0.761) 0.50 (0.37. I/661

0.131 11146, 0,g1) 1110 .131.54, 119) 0.65 (152, 0.52) 0,62 (149., 0,78)

0.2 0.5

—M—

·

■

Resyrichronization better OMT ± ICD bulbar


Indications for CRT therapy algorithm Patient with oarciomyopathy on GDMT for me or on GDMT and X40 d after MI, or

with implantation of pacing or defibrillation device for special indications

V

LVEF

V

Comorlaidities and/or frailty

limit survival with good functional capacity to <1 y

Continue GDMT ..vithout implanted device

Evaluate general health status

V

Acceptable noncardiac health

V

Evaluate NYHA clinical status

NYHA class II

·LVEF 35% ·ORS X150 ms ·LBBB pattern ·Sinus rhythm ·LVEF .35% ·ORS 120-149 ms ·LBBB pattern ·Sinus rhythm ·LVEF .35% ·ORS 1-2150 ms ·Non-LBBB pattern ·Sinus rhythm ORS .c[50 ms Non-LBBB

pattern

NYHA class Ill & Ambulatory class IV

·LVEF s35% ·OHS -2150 ms ·LBBB pattern ·Sinus thythim ·LVEF •35% ·ORS 120-149 ms ·LBBB pattern ·Sinus rhythm ·LVEF •35% ·ORS 2150 ms ·Non-LBBB pattern ·Sinus rhythm ·LVEF s35% ·ORS 120-149 ms ·Non-LBBB pattern ·Sinus rhythm

Special CRT Indications

·Anticipated to require frequent ventricular pacing (.40%)

·Atrial fibrillation, if ventricular pacing is required and rate control will result in near 100% ventricular pacing with CRT

V

NYHA class I

·LVEF -30% ·ORS X150 ins ·LBBB pattern ·lschemic

cardiameathy Ems .150ms Non-LBBB pattern

GOR

I l a

III: Na Benefit

Yancy et al. ACCF/AHA Guidelines for Management of HF. Circulation. 2013;128:e240-e327.






Impact of QRS Duration on Clinical Event Reduction With Cardiac Resynchronization Therapy

Figure 2. Effect of cardiac resynchronization therapy (CRT) on composite clinical events in patients with severely prolonged ORS interval (n=3624: 12=32.1%, fixed-effect model). CARE-HF indicates Cardiac Resynchronization-Heart Failure''; Cl. confidence interval; COMPANION, Comparison of Medical Therapy, Pacing. and Defibrillation in Heart Failureth: CRT, cardiac resynchronization therapy: MADIT-CRT, Multicenter Automatic Defibrillator Implantation Trial—Cardiac Resynchronization Therapy2'; RAFT, Resynchronization-Defibrillation for Ambulatory Heart Failure Trial22; REVERSE, Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction': RR, risk ratio.

Statistics for each study

RR (95% CI) zValue P Value

COMPANION (ORS, 148-168 rns, n=314) 0/8 (0.59-1.04) —1.70 .09

COMPANION (ORS, >168 ms, n=287) 0.66 (0.47-0.93) —2.35 .02

CARE-HF QRS, >159 ms, n=505) 0.60 (0.46-0.79) —3/0 <.001

REVERSE (ORS, >151 ms: n=307) 0.42 (0.22-0.81) —2.61

.009

MADIT-ORT (ORS, >149 ms, n=1175) 0.48 (0.37-0.63) —5.41 x.001

RAH (QRS, >149 ms, n=1036) 0,59 (0.48-0.73) 493 c.001

Me1a•anal'siS 0.60 (0,53167) —8.67 <.001

0.2 0.5 2 5

CRT Better Control Better

Sipahi et al. Arch Intern Med. 2011;171(16):1454-1462.

Impact of QRS Duration on Clinical Event Reduction With Cardiac Resynchronization Therapy

Sipahi et al. Arch Intern Med. 2011;171(16):1454-1462.

CRT in Narrow QRS complex (EchoCRT)

A Prirnari Composite Outcome B Death from Any Cause.

P=0.02

Patient with [vent (%)

9

7 6 C 5 C 4 C 3 C i C : C

CRT

Control

Patient with Event (%)

0.5 1.0 1.5 2.0

Years since Random

2.5

ation

3.0 3.5

0.5 1.0 1.5 2.0

Years since Random

2.5

ation

3.0 3.5

No. at Risk

No. at Risk

CRT 404 297 223 155 103 65 42 19 CRT 404 334 267 199 132 84 56 25 Control 405 302 236 166 119 71 44 15 Control 405 335 269 195 141 87 62 27

Ruschzkita et al. N Engl J Med 2013;369:1395-405.

Models showing the effects of CRT vs. control with QRS duration

Mortality endpoint

1 0 0 11 0 1 2 0 1 3 0 1 4 0 1 5 0 1 6 4 1 7 0 1 0 0 1 9 0 2 0 0 2 1 0 2 2 0 2 3 0 2 4 0 2 5 0

ORS duration

Mortarty1HFII endpoint

10 0 110 12 0 130 1 40 15 0 1 6o - 170 1 80 1 94 2 00 2 1 0 2 20 23 0 2 40 25 0 ORS duration

— Smoothed est imate 95% tootatrap confidence bounds

6 –

Smoothed estimate BM bootstrap confidence bounds

_ - -

Hazard ratio for CRT

Hazard ratio for CRT


Role of CRT in Overt vs. Mild HF Mortality; study group,* rain

study camcD ICD RR (95% CII

NYHA class I and It

MIRACLE OM II, 200423 2/85 21101 1.19 (0.17-8.26)

REVERSE, 2008,* 9/419 3/191 137 (037-4.99)

MA.DIT-CRT, 2.00929 74/10.59 531731 0.94 (0-67-1.32)

RAFT (claw FP), 20101A 110,1703 154130 0.74 (0-59-0.94

Subtotal 195/2301 212)1753 0,80 (0 67-0.96)

11, = 0

111Y11Adais111and IV

Lozano at al.,. 200013 51109 10/113 0.52 (0A 8-1.47)

MIRACLE ICI), 200322 14/187 15/182 0.91 (0_45-1.83)

RHYTHM 1CD. 200435 6/119 2/60 1.51 (0_31-7.27)

RAFT {{lass I 201014 761186 82/174 0.87 (0,69-1.10)

Subtotal 101/601 109/5.29 0.86 18.168-1.0))

P=0

Overall 295/2902 321/2282 0,B3 032-0.96)

0.1 0.2 0.5 1 2 r, 10 RR (95% CI)

idVOLEr5 CRT

Favc;I..15 car Pp! -'

Meta-analysis: CRT for Less Symptomatic HF or 171:mloci G amp, a-

-

11f4:10--

Iiis F. Rally 1J5 9c lF i.

Study. Via, Sc restanci5 E iambs 14:441 Primbs ittal

Pradom I narAT FNMA [lass L.1

al MFALC LE 1 CID II.. 2064 4•34Z1 2 HS 2 101 113

1.1-9 CO.1 T-15_2 al-

FLEW EF:Sa 20011111} S 419 3 1-91 117 1.37 CO. 3 7-4_99 I-

AA A.G. EE--CFET. ] 009 11 2 F 3.1 18:69 53 73 1 S_7 0.94 C0.62-1321 -E- RAFT. ...91 II C 13 5 1 SE 394 23.6 904 99_6. O. 311 CO. 57-11941

G Fatlia-E.T.A Mi. zari a c-L-7 1 51 2 SO 63

O. 9-3 03. 14-.6_7-ifF

van Calclarp at al 2 MEI 4265 6 19 I) 13

51c4 750 [nib la

54arIcKal 1 95 % C:1) 2557 2 (PDS 5115 O. El 3 (.:t 77-11 9b-1.

Torii Ever= 233 29.6

Fiata,newic!y: Tug' = CI. IX:t cla- squaw = 1.46 : P = 0!23: .1 k = O's

Tsat 10r twill 1 aiTerlz 2 = 2 .43 : P = a01

1.-narlorni naney WM.& [Las s M.. IV ill ILFSEIC S R. 2.501 C313 5 1 a

34 -0_1

3.06 90.17- 707A)

il Mr.A.CLE 2002 431} 12 273 1S 2 2_1 0.7A {0. 35 1931

PATH -C HE 2 E. 13 1) 2 14 I:: 1 7 -0_1 3.00 CO.10-70541

Jil ILPSTIC AF_ 2 002 C3) 1 75 6 1L EL1 7 lli. MOS-95_9 3) .

VI 11144 C LE I CO 2E03 CI S.5 SA 197 1 5 . 152 23 0.91 CO. 45- 1_1E1 F

H liahres at al 2E03 43143 11 2.15 1.6 2AS 211 0. SS CO. 3 7- 1_4 5 1

P.4151-1- E H F R. 711413 [9111 2 43 3 {3

0_4 Q67 C0.12-379F

C CAI Pa[ill c 2-004 .13 7) 121 217 77 363 1 KS O.95 CO. 93- 1_094

R H ITH.1.11 I CEI C29) .6 113 2

. .bXIS

95 65 1.51 CO. 3 1

-7271.

WaL-1-7-L 7315 a 51 1 53 1 47 0_1

O. 156 CO. cps- 1 a _4433

C ARE- 11F. 2 609 4-313 32 •1E9 126 494 137 0.57 CO. 5 5-6. Sal-

H CIS M.1.:CF. 2046 1 1.5 1

1387

1.5 112 1.136 CO. 0 7-14516

El ELJ PWE . 2006 C2 3 5 •E 37 3 37 0.7 ].O6 CO. 54- 7_40 1

Rate. 3 007 12 11 5 57 2 HS 6_4 2.44 [0. 41.-12 -1

PD-CI-FF. 2 007 14 DI 2 32 A 32 04

O. 50 CO. 115-2_ 451 0.55 .53.1 3- 1_191:

ID E :IR EA 5EF_ 2 957 : 2 5 i -a 26S 5

-H

169 1113

Plapti ol al. 2001. 17 4 1 7 44 5 AS. 13 0.39 CO. 3 5-a2 GI

13-LEFT FF. 7131E1 (171- E. 9. 41 HS 0.1

.5.11 CO. 01 - 1_{.11 1 O.5{' CO. 1 0- 2_41:11

C CM 1141-. 21] 0 QM: 2 27 A 27 II .4

54451443.1 4 95 X C 2 51 3 1997 495 0711 90. 57-43_94 F 4111P

Total s4.0rr9 291 251

FirtorDamalily: 7au2 = O.0t Era • squaw- = 11 _fi 1 : P = 0 . 117; J3 = 0%

Tait 1or oriial 1 41144th .5 =3.1: P = 11001

Tel {SS 3 CI) S 0110 4002

1989O. 3 1 CO. 72-6-9.0 F 4

1-0101 ErFs-n fs 5fi5 577 ■

' 1:1 Famers. E9: F 3A:ors Corrl r•=4

FAO. Pato 057. CR

H lalarneanarry_ Tana] = O.OR :=111 --pauari = 13.4 Cc P = 0 94 J T = O 'X To.= Its -ow:rail an 1:-•=r_ = 4.OU .P K a . [c•-! Tani as cuts-row 3 Hiarances : J44:11.

Al Majed et al. Ann Intern Med. 2011;154(6):401-412.

JACO Heats Patine VoL I, No. 6, 21:11 2013 by rho Annelimn. CAI-go of Cardiology Foundation ISSN 2213-] 779336.00

FubLshti by Elsevic r http JO I Eiljje hi-2013.06.003

Cardiac Resynchronization Therapy in Patients With Atrial Fibrillation The CERTIFY Study (Cardiac Resynchronization Therapy in Atrial Fibrillation Patients Multinational Registry)

Maurizio Gasparini, MD,* Christophe Leclercq, MD, PHD,f Maurizio Lunati, MD,t Maurizio Landolina, MD, Angelo Auricchio, MD,I Massimo Santini, D, Giuseppe Boriani, MD,# Barbara Lamp, MD,' Alessandro Proclemer, MD,tt Antonio Curnis, Catherine Klersy, MD, MSM Francisco Leyva, MDR

Results Median follow-up was 37 months. Toll mortality (6.B vs. 6.1 per 100 personyearsi and cardiac mortality 14.2 vs. 4.0) were similar for patients with AF AVJIA and patients in SR (both p NS). In contrast. the AF drugs group had a higher total and cardiac mortality than the SR group and the AF • AVIA group {11.3 and al. respectively; p 0.001). On multivariable analysis. AF AVM had total mortality (hazard ratio [HR]: 0.93, 95% confidence interval [CI]: 0.74 to 1.67) and cardiac mortality (HR: 0.9.R, 95% CI: 0..66 to 1.17) similar to that of the SR group, independent of known confounders. The AF • drugs group, however. had a higher total mortality (MR: 152. 95% GI: 1.26 to 1.82) and

cardiac mortality (HR: 1.57, 95% CI: 1.27 to 1.94) than both the SR group and the AF AVJA group (both p 0.001).

Conclusions Longterm survival after CRT among patients with AF • AVM is similar to that observed among patients in SR. Mortality is higher for AF patients treated with rate-slowing drugs. (1 Am Coll Cardiol MF 2013;1:500-7) .1',1 2013 by the American College of Cardiology Foundation

Survival After CRT

Gasparini et al. J Am Coll Cardiol HF 2013;1:500–7

Left Ventricular Reverse Remodeling

After CRT

Gasparini et al. J Am Coll Cardiol HF 2013;1:500–7

Rev Fort Cardiot. 2014;33(11):717-725

REVIEW ARTICLE

Cardiac resynchronization therapy in patients with atrial fibrillation: A meta-analysis

11:1!D CrossM ark

Study or subgrow

AF Events ID Lai

SR Events Total Weight

Odds ratio M-1-1, random, 95% CI

Cid& ratio M-H, random; 95% CI

Ferreira eta]-1G 1'3 53 2 78 5.6% 8.84 [1.8542_211

Gaspa.rirli et al.lic :34 243 135 1042 34.1% 1.09 [073.1-641

Khadjooi et al.113 24 86 45 209 24.8% 1.41 [039, 2.511

—M—

Linde et al-37 10 64 10 67 11816 1.06 [0-41.2-741

Moihoek et al.g 6 30 3 30 6.1% 2. [0.51, 9,991

Nas8irnento et al. 10 12 19 264 16.6% 1.0g [0.4g, 2A-21

Total (g5% CI)

604

16g0 100.0% 1.36 [0.9Z 2.011

• Total events 94

214

Heterogeneity-. Taut =0.07; ohl-squiare.. 7.46,11=5 (r11-11g); 12= 88%

CI.01 0.1 1 1CI 1 CI Test for overall effect: 2=1.55 (p=0,002) In favor of AF In favor of SR

Cardiovascular mortality for patients with atrial fibrillation versus sinus rhythm.

ELSEVIER DOYIVIA

Revista Portuguesa de

Cardiologia Portuguese journal of Cardiology

www,revportcardiol.org

Non Responders in AF Patients

AF SR Study or sublgroup Events Total Events Total Weight Molhoek et al.9

11 30 6 30 3.1% Gasparini et al. 4° 65 162 158 511 31.3% Delnov et al.18

13 96 28 167 8.3% Buck et al.12

24 56 26 58 7.7% Ferreira et al.1° 17 53 16 78 6.6% Tolosana et al.15

52 126 103 344 23.4% Kim et al.13

6 26 22 96 4.0% WiiCon et al.17

11 19 31 67 4.0% Wo et al.11

8 13 16 40 3.1% Tolosana et al." 16 46 43 156 8.5%

Total (95% Cl) 630 1547 100,0%

Total events 223 449

Fletengeneitrau2z 0.00; chi-square .14, d 9 (p41.73); Test for overall effect:Z=328 (p=0.001)

Odds ratio MA-I, random: 95° CI

2.32 [0.72, 7.411 1.5011.04, 2.16i 0.78 [0.38, 1.581 0.92 10.44, 1.941 1.83 [0.82, 4.06J 1.64 [1.08, 2.511 1.01 p.36, 2.821 1.60 [0.57; 4.47J 1.50 [0.47, 4.821 1.40 [0.70; 2.93]

Odds ratio M-H. random, 95% CI Year

2004 2006 2007 2008 MEI 2008 2009 2011 2011 2012

I

0.01 0.1 1 10 100 In favor of AF In favor of SR

141 [1.15,1.731

crk

Lopes et al. Rev Port Cardiol. 2014;33(11):717-725

Role of AV Junction Ablation in AF patient with CRT

Lopes et al. Rev Port Cardiol. 2014;33(11):717-725

Role of CRT to AF

New Onset AF Persistent and Permanent AF Conversion to SR after CRT

Fung et al. Am J Cardiol. 2005;96:728–731 D’ascia et al. IŶt J CliŶ Pract. 2011;65:1149–1155

· lower incidence among CRT than controls matched for age, sex, and EF (8.3% vs. 30.6%, HR 0.23, 95% CI 0.09–0.76) · lower among CRT

responders compared with non-responders (50.0% vs. 15.0%, odds ratio (OR) 5.67, 95% CI 1.36–23.59)

Parachute Implant System

Costa et al. Circ Heart Fail. 2014;7:752-758

Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

Three-Year Outcomes of the PARACHUTE First-in-Human Study

Marco A. Costa, MD, PhD; Ernest L. Mazzaferri Jr, MD; Horst Sievert, MD; William T. Abraham, MD

LV n i t

LV ESVit 60% —

Cardiac output,

LV erigth, ecii

EF, %

Stroke volume, r 2096

6

•••

6M 12M 24M 36M

P Value*

4) 0.0095 ·Death

111TransplantiVAD 10) 0.4792 la IV 3) 0.0299

m 1) <0.0001

a" 9) 0.0132 of

7.0.0012

9) 0.2893

8.0.5020

1 6 1 . M . - 0 1

Head rate, Ppm

Lki mass, g 0,4

Initial Evidences PUBLISHED PAPERS AND ABSTRACTS

Bozdag-Turan, I., Berrnaoui, B. and Turan, R.G. et al. Left ventricular partitioning device in a patient with chronic heart failure: Short-term clinical follow-up. International Journal of Cardiology. 2013, 163 (1): el-e3. htitp:livirww.ncbi.nlm.nih_oovipubmedi22824252

Mazzaferri, E.L. Jr., Gradinac, S. and Sagic, D. et al. Percutaneous Left Ventricular Partitioning in Patients with Chronic Heart Failure and a Prior Anterior Myocardial Infarction: Results of the PARACHUTE Trial. American Heart Journal. 2012,163 (5): 812-820. htto://virmv.ncbi.nlm.nih_oovipubmedi22807859

Sagic, D., Otasevic, P. and Sievert, H. et at Percutaneous Implantation of the Left Ventricular Partitioning Device for Chronic Heart Failure: A Pilot Study with 1-Year Follow-p_ European Journal of Heart Failure_ 2010; 12 (6): 600-606. hftp:ilvirmw.ncbi.nlm.nih_oovibubmedi20400453

ONGOING STUDIES

ClinicarTrials_gov. A Multinational Trial To Evaluate The Parachute Implant System (PARACHUTE) NCT01286116_ http:hrwmv.clinicaJtrials.clovict2ishowINCT01286116?term=Parachute&rank=1_ Accessed 2B February 2013.

Clinicaffrials.gov. Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients (PARACHUTE) NCT00573560. http:Iformv.clinicaltilals.00vrict2ishow7term=Parachute&rank=3. Accessed 28 February 2013.

Clinicaffrials.gov. A Multinational Trial to Evaluate the Long-term Safety of the Parachute Implant System (PARACHUTE Ill) NCT01297296. ica1tlials.00vict2ishow?term=Parachute&rank=4. Accessed 28 February 2013.

Clinicaffrials_gov. A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV) NCT01614652_ http:Ifwvindv.clinicaltrials.00vict2ishow?terrn=Parachute&rank=5. Accessed 28 February 2013.

Decision tree for elective mechanical

circulatory support

Low RV

High RV

High RV Low RV Failure Risk

Failure Risk Failure Risk

Failure Risk after LVAD

after LVAD after LVAD

after LVAD

■

Consider Consider

LVAD as BIVAD or TAH

Low LVAD

High LVAD

Supportive

BTT as BTT

Imptant Risk

Implant Risk Cardiology

If revorsible risk

(eg, infection

Cons ider ...... AKI, rnalmutritioril

DT LVAD

Transplant Candidate Not Eligible

for Transplant

HF Symptoms Limiting Daily Functioning and Quality of Life

Optimal Pharmacologic and Resynchronization Therapy >3mos

Stewart et al. Circulation. 2012;125:1304-1315

Devices in Evolution

VINIIMAIM t flr. morn vairnarp

PtiO/Fr Ware HVAD Jarvik 2000

Ir i tnyr oppl

,ar-tWare Jarvik Heart

lus (centrifugal) Continuous (axial)

ricardium Pericardium

Electric Electric

160g 90g

50 rnL 25 mL

IDE IDE

ion; HVAD, HeartWare ventricular assist e.

14birtililm I LIMB SOW' 4574tillse

Stewart et al. Circulation. 2012;125:1304-1315

Implantable LVADs in Euro

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g

Manufacturer Thoratec

Flow profile Pulsatile

Implant site Abdomen

Driver Electric

Weight 1150 g

Displacement 400 rnL

FDA approval BTT, DT

BTT indicates bridge to transp device; IDE: investigational devil *Thoratec PVAD is the same

Conclusion · Electrical remodeling and ventricle dyssynchroniy are nor rare in patient with heart failure and drive to worse prognosis

· CRT is the only therapeutic modality to correct electrical remodeling

· Patient selection is utmost important to achieve better reponse of CRT implantation

· Mild HF and AF patients are also benefited from CRT implantation

· Some new promising devices are under investigation to be available in the market soon

Take Home Message ·CRT is covered by BPJS ·Always think for CRT Implantation

when dialing with HF characterized by: – Low EF ч 35% – LBBB – QRS duration ш ϭ5Ϭ ms

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Tachycardia.

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Fix The Rhythm And M.dintain The Pulse

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SYMPOSIA Robotic Ahl tion Sudden Cardiac Dent

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Syncope Arrhythmia

Drugs Who, Interpr t'ng Unknown

WORKSHOP

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ed ECG ·Pediatric Anhyth rtoa Advanced Par ornaltaT (Guru,

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nd Pier Fibr i Ilation r Hoe rondinarnit and E I actris.a I CADdig'FVF5i411

·Sudden Cardiac Death ·taordnvacive Rhythm Monitoring SyrnWpo

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Atrial Pharrnacotherap

Ablation blation

Type of Respons to CRT ·Responders – Expected Normal Responders – Super Responders

·Non Responders – Icl. Negative Responders

Documents

10. Devices Therapy for Advance HF - dr Yoga Yuniadi SpJP.pptx