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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 stimulation5
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
 Potentially improve engagement
of areas around scar tissue2
 Hemodynamics3
 Resynchronization4

LV2

LV1

RV

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

MultiPoint™ Pacing allows pacing from
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
Ability to pace from two LV sites with independent
impulses and programmable delays

10 CRT-D or 14 CRT-P
VectSelect Quartet™ Vectors
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
 This study evaluated the effect of MultiPoint™ Pacing
(MPP™) on the left ventricular (LV) activation pattern and
hemodynamics in the same patient population.

Hemodynamic
Single Site
Pacing

 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).

MultiPoint
Pacing

 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

Ts-SD (ms)

•

80
70
60
50
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 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

 This study evaluated the acute impact of
MultiPoint™ Pacing (MPP™) on hemodynamic
response in CRT-D patients (n = 44).

 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.
 ƒ
The best MPP technology intervention improved
acute diastolic function, significantly decreasing dP/dt (min), relaxation time constant, and enddiastolic pressure as compared to the best
conventional intervention
 Results showed that CRT with MPP technology can
significantly improve acute LV hemodynamic
parameters compared to conventional pacing.

LV Pressure (mmHg)

Results

Best CONV (Quad)

RV Only

105

70

35

0
150

175

200

225

250

LV Volume (mL)
Pappone, C., et al. Heart Rhythm, 2014
SJM-MLP-0416-0052 | Item approved for U.S. use only. | 11


CHRONIC CLINICAL EVIDENCE
International Studies


MultiPoint™ Pacing 12-month follow-up International data


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


MPP™ Technology 12-Month Follow-Up Study Methods
Improvement in the degree of response over 12-months

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

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


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 responders
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 nonresponders 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

0

40

-5

30

 During implant Capture Thresholds were
measured (CTs) and presence of PNS

-10

20

Results

-15

10




148 patients with 6-mo follow-up
67 with MPP™ technology ‘ON’, 81 with MPP
technology ‘OFF’

 MultiPoint™ Pacing was programmable in
97% of patients

P < 0.000

-20

 At follow-up QRS was reduced and EF
improved with MultiPoint Pacing relative to
conventional BiV

0
% DeltaQRS Biv

% DeltaQRS MPP

EF baseline

EF Biv

EF MPP

MultiPoint™ Pacing Programmability

% MultiPoint Pacing
Programmability

CT in both
Vectors < 5V

CT in both Vectors
< 5V and Without PNS

CT in both
Vectors < 3V

CT in both Vectors
< 3V and without PNS

98

97

89

89

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

Forleo, et al. Europace 2015.


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

Quartet™ 1458Q
S-curve
20-30-47 mm

Original

Quartet ™ 1456Q
Small S-curve

SJM Advanced
Quadripolar
Solutions

Quartet ™ 1458QL
S-curve
20-47-60 mm

20-30-40 mm

Quadra Assura™ MP CRT-D
Quadra Allure MP™ RF CRT-P
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, mortality
 MultiPoint™ Pacing compared to the single 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