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MultiPoint™ Pacing from a Single CS Branch10 CRT-D or 14 CRT-P VectSelect Quartet™ Vectors Ability to pace from two LV sites with independent impulses and programmable delays LV1 LV2 SJ

MULTIPOINT™ PACING

Benefits of Cardiac Resynchronization Therapy

CRT benefits heart failure patients with a wide QRS and low LVEF

 Compared to RV (right ventricular) only pacing, CRT:

Improves EF, NYHA class and 6 MWT results1

Decreases hospitalizations1,4

Reduces the risk of death2







 Compared to optimal pharmacological therapy, CRT:

Reduces rates of all-cause, cardiac, and HF hospitalization3



Quadripolar CRT Systems have represented a new opportunity to

improve CRT implant success and avoid common CRT complications

1.

2.

3.

4.

5.

Paparella G, et al Pacing Clin Electrophysiol 2010

Cleland JG, et al N Engl J Med 2005

Anand IS, et al Circulation 2009

Tang AS, et al N Engl J Med 2010

Tomassoni G, et al Heart Rhythm 2012

SJM-MLP-0416-0052 | Item approved for U.S use only | 2

CRT Challenge: Non-responders

43%

43% of CRT patients classified as non-responders or

negative-responders by LVESV after 6 months (N = 302)

Ypenburg, C., et al Journal of the American College of Cardiology 2009

SJM-MLP-0416-0052 | Item approved for U.S use only | 3

MultiPoint™ LV Pacing

MultiPoint™ Pacing, exclusively from St Jude Medical,

delivers two pulses from the Quartet™ LV lead per pacing

cycle, resulting in a more effective

LV1

P4 M3 M2 D1

LV2

SJM-MLP-0416-0052 | Item approved for U.S use only | 4

Goals of MultiPoint™ Pacing

Pacing from TWO LV sites is designed

capture more tissue to improve:

to

Pattern of depolarization 1

Potentially improve engagement

of areas around scar tissue 2

Hemodynamics 3

Resynchronization 4



LV1





RV

MultiPoint™ Pacing allows pacing from two LV sites through just one CRT lead.

1.

2.

3.

4.

Theis C et al Journal of Cardiovascular Electrophysiology 2009

Pappone C, et al Heart Rhythm, 2015

Rinaldi CA, et al J Interv Card Electrophysiol., 2014

Thibault B, et al J Card Fail., 2014

SJM-MLP-0416-0052 | Item approved for U.S use only | 5

MultiPoint™ Pacing from a Single CS Branch

10 CRT-D or 14 CRT-P VectSelect Quartet™

Vectors

Ability to pace from two LV sites with independent

impulses and programmable delays

LV1

LV2

SJM-MLP-0416-0052 | Item approved for U.S use only | 6

Vector Cathode to Anode

1 D1  M2

2 D1  P4

3 D1  RV Coil

4 M2  P4

5 M2  RV Coil

6 M3  M2

7 M3  P4

8 M3  RV Coil

9 P4  M2

10 P4  RV Coil

11 D1  Can

12 M2  Can

13 M3  Can

14 P4  Can

ACUTE CLINICAL EVIDENCE

International Experience

MultiPoint™ Pacing acute data

Electrical Mechanical Hemodynamic

Methods

 This study evaluated the effect of MultiPoint™ Pacing

(MPP™) on the left ventricular (LV) activation pattern

and hemodynamics in the same patient population

 A total of 10 patients with non-ischemic cardiomyopathy

underwent an acute pacing protocol that included 2

biventricular (BiV) and up to 9 MPP technology

interventions

Results

 Compared with BiV, MPP technology significantly increased

LV dP/dtmax (30 ±13% vs 25 ±11%, P = 0.041); reduced

QRS duration (22 ±11% vs 11 ±11%, P = 0.01) and

decreased total endocardial activation time (25 ±15% vs 10

± 20%, P= 0.01).

MPP technology also captured significantly greater LV mass

during the first 25 ms and first 50s of pacing, suggesting

faster wavefront propagation throughout the LV



 MPP technology improved acute hemodynamic parameters,

QRS duration and activation patterns in comparison to BiV

Menardi, E., et al Heart Rhythm, 2015

SJM-MLP-0416-0052 | Item approved for U.S use only | 8

MultiPoint Pacing Single Site Pacing

MultiPoint™ Pacing acute data

Electrical Mechanical Hemodynamic

Methods

•

•

Multi-center, 41 patient study

Tissue doppler imaging to assess mechanical

dyssynchronny

Results

• MultiPoint™ Pacing reduced mechanical dyssynchrony relative to conventional biventricular

pacing

Reduced Mean Dyssynchrony with MPP™ feature

80 70 60 50 40 30 20 10 0

(of 8 tested)

p < 0.001

SJM-MLP-0416-0052 | Item approved for U.S use only | 9

Rinaldi, C A., et al Journal of Cardiac Failure, 2013

MultiPoint™ Pacing acute data

Electrical Mechanical Hemodynamic

 Methods

 N = 25 consecutive patients

implanted with an MultiPoint™

Pacing capable CRT device

 Echo evaluation performed at

first follow-up

Results



 Reduction in dyssynchrony with

MultiPoint Pacing (AS-to-P wall

delay with speckle tracking radial

strain)

Improvement in EF with

MultiPoint

Pacing

Dyssynchrony Evaluation: AS-Post wall delay (Speckle-Tracking):



SJM-MLP-0416-0052 | Item approved for U.S use only | 10

Osca, J., et al Heart Rhythm, 2015

MultiPoint™ Pacing acute data

Electrical Mechanical Hemodynamic

140

Methods

Best MPP™ Config Best CONV (Quad)

 This study evaluated the acute impact of

MultiPoint™ Pacing (MPP™) on

hemodynamic response in CRT-D patients (n

Results

 The best MPP technology intervention significantly

increased the rate of pressure change (dP/dt

[max]), stroke work, stroke volume, and

ejection fraction as compared to the best

conventional pacing intervention 70

 ƒThe best MPP technology intervention

improved

acute diastolic function, significantly decreasing

- dP/dt (min), relaxation time constant, and end-

diastolic pressure as compared to the best

conventional intervention

35

 Results showed that CRT with MPP technology can

significantly improve acute LV hemodynamic

parameters compared to conventional pacing 0

LV Volume (mL)

Pappone, C., et al Heart Rhythm, 2014

SJM-MLP-0416-0052 | Item approved for U.S use only | 11

Best MPP™

Best CONV

RV Only

CHRONIC CLINICAL EVIDENCE

International Studies

MultiPoint™ Pacing 12-month

Methods

44 consecutive patients were randomized to receive

pressure-volume (PV) loop optimized MPP™

technology or Conventional CRT (CONV) at a single

center in Italy

The primary endpoint was the change in end systolic

volume (ESV) and ejection fraction (EF) from baseline

to 12 months in the MPP technology group vs the

CONV group

Response to CRT was defined as alive status and ≥

15% decrease in ESV relative to the baseline

Results

ESV and EF increase relative to baseline were

significantly greater with MPP technology than with

CONV (ESV: median –25% vs median –18%, P =

0.03; EF: median +15% vs median +5%, P < 0.001)

At 12 months, 76% (16/21) of patients in MPP

technology group were classified as CRT responders

compared with 57% (12/21) in the BiV group

The CRT response rate in the MPP technology group

remained consistent at 76% from 3-month to 12-month

follow-up

PV loop-guided MPP technology resulted in greater LV

reverse remodeling and increased LV function at 12

months compared with similarly optimized

Conventional CRT

follow-up International data



















Pappone, C., et al Heart Rhythm 2015.

SJM-MLP-0416-0052 | Item approved for U.S use only | 13

MPP™ Technology 12-Month Follow-Up Study Methods

Improvement in the degree of response over 12-months

SJM-MLP-0416-0052 | Item approved for U.S use only | 14

Pappone, C., et al Heart Rhythm 2015.

Benefits of Switching

MPP™ Technology

Methods

from Conventional CRT to

 The aim of this study was to evaluate if patients

receiving conventional CRT (CONV) would receive

additional benefit by switching CRT programming to

MPP technology (n = 8)

 Patients implanted with a CRT 12 months post implant

had their CRT programming switched to MPP

technology after echo and NYHA class assessment

and classified as responders (6/8) or non-responders

(2/8) based on echo comparison to baseline

 Responder was defined as ESV ≥15% relative to

baseline

Results

 The two non-responders to CONV became responde

with MPP technology with reduction in ESV and

improvement in EF relative to the 12 month exam

 The remaining 6 patients classified as responders to

CONV also experienced additional reduction in ESV

and improvements in EF

 The study results suggest that activating MPP

technology may be a potential strategy to

convert non- responders to responders or

further improve response in patients already

responding to conventional therapy

Pappone, C., et al European Heart Journal Supplements, 2015 SJM-MLP-0416-0052 | Item approved for U.S use only | 15

MultiPoint™ Pacing Registry

Methods

 N = 436 patient, 73 center Italian registry QRS Duration and Echo Changes





148 patients with 6-mo follow-up

67 with MPP™ technology ‘ON’, 81 with

MPP

 During implant Capture Thresholds were

measured (CTs) and presence of PNS

Results

 MultiPoint™ Pacing was programmable in

97% of patients

At follow-up QRS was reduced and EF

improved with MultiPoint Pacing relative

to conventional BiV

MultiPoint™ Pacing Programmability

SJM-MLP-0416-0052 | Item approved for U.S use only | 16

Forleo, et al Europace 2015.

CT in both CT in both Vectors CT in both CT in both

Vectors Vectors < 5V < 5V and Without PNS Vectors < 3V < 3V and without

PNS

% MultiPoint Pacing

P < 0.000

SJM-MLP-0416-0052 | Item approved fo

Quadra Assura™ MP CRT-D

Multiple quadripolar lead options to the right target vein to deliver MultiPoint™ Pacing

S-curve

20-30-47 mm

Original

SJM Advanced Quadripolar

S-curve

20-47-60 mm

Quartet ™ 1456Q Small S-curve

20-30-40 mm

Quadra Allure MP™ RF CRT-P

r U.S use only | 17

Multipoint™ Pacing

U.S IDE study demonstrated safety and efficacy of MultiPoint Pacing

 Primary endpoint: Safety and efficacy





Response defined by composite score of Hospitalization, LVEF, mortality

MultiPoint™ Pacing compared

Quadra Assura™ CRT-D

to the single site pacing through

Quadra Assura MP™

Quadra Allure MP™ RF

SJM-MLP-0416-0052 | Item approved for U.S use only | 18