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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
such as high thresholds and phrenic nerve stimulation 5

1.

Paparella G, et al. Pacing Clin Electrophysiol. 2010

2.

Cleland JG, et al. N Engl J Med. 2005

3.

Anand IS, et al. Circulation. 2009

4.

Tang AS, et al. N Engl J Med. 2010

5.

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 negativeresponders 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

uniform ventricular

contraction

SINGLE SITE

PACING

MULTIPOINT™ PACING

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

to

capture more tissue to improve:
 Pattern of depolarization1
LV2

 Potentially improve engagement
of areas around scar tissue2

LV1

 Hemodynamics3
 Resynchronization4
RV

MultiPoint™ Pacing allows pacing from
1.

Theis C. et al. Journal of Cardiovascular Electrophysiology 2009

2.

Pappone C, et al. Heart Rhythm, 2015

3.

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

4.

Thibault B, et al. J Card Fail., 2014

two LV sites through just one CRT lead.

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
Vector

LV1

LV2

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

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


ACUTE CLINICAL EVIDENCE
International Experience


MultiPoint™ Pacing acute data

Electrical

Mechanical

Methods

Hemodynamic

Single Site
Pacing

 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

MultiPoint
Pacing

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 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
Ts-SD (ms)

•

40

30
20
10
0
BiV Simul

p < 0.001

Best MPP feature
(of 8 tested)

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

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

tracking radial strain)
Improvement in EF with MultiPoint


Pacing

SJM-MLP-0416-0052 | Item approved for U.S. use only. | 10
Osca, J., et al. Heart Rhythm, 2015


MultiPoint™ Pacing

Electrical

acute data

Mechanical

Methods

Hemodynamic

140

Best
Best MPP™
MPP™ Config

 This study evaluated the acute impact of

Best CONV (Quad)

MultiPoint™ Pacing (MPP™) on hemodynamic response in CRT-D patients (n =
44).

RV Only

105

Results


The best MPP technology intervention significantly

and ejection fraction as compared to the best conventional pacing intervention.



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



LV Pressure (mmHg)

increased the rate of pressure change (dP/dt [max]), stroke work, stroke volume,

70

35

Results showed that CRT with MPP technology can
significantly improve acute LV hemodynamic parameters compared to
conventional pacing.

0
150

175

200

225

LV Volume (mL)
Pappone, C., et al. Heart Rhythm, 2014

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

250


CHRONIC CLINICAL EVIDENCE
International Studies


MultiPoint™ Pacing 12-month



follow-up

International

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.



Pappone, C., et al. Heart Rhythm. 2015.

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

data


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

from

Conventional

CRT

to

MPP™ Technology
Methods


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

rs

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

148 patients with 6-mo follow-up



67 with MPP™ technology ‘ON’, 81 with MPP
technology ‘OFF’

0

40

-5

30

 During implant Capture Thresholds were
-10

measured (CTs) and presence of PNS
Results


-15

10
P < 0.000

MultiPoint™ Pacing was programmable in
97% of patients



20

-20

0

At follow-up QRS was reduced and EF improved with MultiPoint Pacing

% DeltaQRS Biv

% DeltaQRS MPP

EF baseline

relative to conventional BiV

MultiPoint™ Pacing Programmability

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
Programmability

98

97

89

89

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

Forleo, et al. Europace 2015.

EF Biv

EF MPP


Multiple

quadripolar

lead

options

to the right target

vein

to deliver

MultiPoint™

Pacing

Quartet™ 1458Q
S-curve
20-30-47 mm

Original

SJM Advanced
Quadripolar

Quartet ™ 1456Q

Solutions

Quartet ™ 1458QL
S-curve

Small S-curve

20-47-60 mm

20-30-40 mm

Quadra Assura™ MP C
Quadra Allure MP™ RF CRT-P

RT-D
SJM-MLP-0416-0052 | Item approved for 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,



MultiPoint™ Pacing compared

to

the single

mortality
site

pacing

through

Quadra Assura™ CRT-D

Quadra Assura MP™

Quadra Allure MP™ RF

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