IMPROVE CRT RESPONSE WITH MPP AND SYNCAV CRT

reported that in 21% of cases with bipolar LV leads, the first pacing site chosen was not suitable due to lead instability and high pacing thresholds... Lead instability and high pacing

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Adj Assoc Prof David Foo Head of Department, Senior Consultant Tan Tock Seng Hospital

Singapore

IMPROVE CRT RESPONSE WITH MPP AND

SYNCAV CRT

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CRT and Heart Failure

• Improvement in 6 minute walk test

• Improvement in NYHA functional class - most

trials approx 1 class

• Improvement in left ventricular function and

mitral regurgitation

• Average decrease in Mn Living with Heart Failure

Score of approx 10 points

• Fairly consistent on secondary endpoint of

decreased hospitalization for CHF

• Improvement in mortality and morbidity

Challenges in patient selection, procedural and

programming

30% Non responder

rate

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Anatomical Challenges

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1 Lead instability and high pacing thresholds

2 Phrenic Nerve Stimulation

3 Lead Revision

Cardiac Resynchronization – Bipolar Clinical Challenges

Duray, et al J of Cardio Electro, 2008

Duray et al reported that in 21% of cases with bipolar LV leads, the first pacing site chosen was not suitable due to

lead instability and high pacing thresholds

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1 Lead instability and high pacing thresholds

2 Phrenic Nerve Stimulation

3 Lead Revision

Cardiac Resynchronization – Bipolar Clinical Challenges

Biffi et al reported 37% of CRT patients experience

Biffi M, et al CICEP, 2009

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1 Lead instability and high pacing thresholds

2 Phrenic Nerve Stimulation

3 Lead Revision

Cardiac Resynchronization – Bipolar Clinical Challenges

Leon et al reported that 8% of CRT patients required

lead revision

Leon AR, et al J Am Coll Cardiol, 2005

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1 Lead instability and high

pacing thresholds

Cardiac Resynchronization – Bipolar Clinical Challenges

How can we overcome these 3 most common CRT problems?

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Quadripolar pacing technology would address the pacing complications and provides

greater CRT efficiency during implant and follow up

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1 Lead stability and high pacing thresholds

2 Phrenic Nerve Stimulation

3 Lead Revision

Quadripolar Pacing Technology

Duray, et al J of Cardio Electro, 2008 Has shown that with Quartet™ lead.The distal tip

can be advanced close to apex to ensure lead stability while retaining pacing at a

preferred location

Distal Proximal

CS anatomy prior to

LV lead placement

LV lead’s distal tip advanced close to the apex

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1 Lead instability and high pacing thresholds

2 Phrenic Nerve Stimulation

3 Lead Revision

Quadripolar Pacing Technology

Forleo GB, et al Heart Rhythm, 2011 Study outcome show that 6 of 7 quadripolar LV lead patients

with PNS were successfully managed without lead repositioning

Five of 23 patients in the bipolar group had PNS requiring a retraction or a repositioning of the lead to

a different vein

Forleo GB, et al Heart Rhythm, 2011

Single-center, prospective, controlled,

PNS testing at implant

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1 Lead stability and high pacing thresholds

2 Phrenic Nerve StimulationStimulation

3 Lead Revision Revision

Quadripolar Pacing Technology

Quartet™ Lead Meta Analysis

• No re-interventions for PNS

• No re-interventions for high threshold or loss of capture

• 98.8% success rate at 30 days

Quartet Lead Meta Analysis

Publication Quadra

Patients

Implant Success

30-day Dislodgement

Intractable PNS

High Threshold

Osca A, et al

Europace 2011 27 27 0 0 0 Forleo GB, et al

Heart Rhythm 2011 22 22 0 0 0

Viani SM, et al

Europace 2011 18 18 0 0 0 Tomassoni G, et al

No reinterventions for high threshold or loss of capture

No reinterventions for PNS

 Quadripolar LV lead is a potential alternative to lead adjustment or

discontinuing CRT

 Provides options to manage common CRT pacing complications

 Phrenic nerve stimulation

 High pacing thresholds

 Provides more options to pace at a preferred LV stimulation site without compromising lead stability

 While pacing at non-apical positions

Quadripolar Pacing Technology

•Multiple admissions for Congestive Cardiac Failure

•despite optimal medical therapy

•NYHA III

Implant Data

Device: Promote Quadra™ CD3239-40

Atrial lead : Tendril™ ST Optim™ 1888TC/46

RV lead: Durata™ 7120/60

LV lead : Quartet™ 1458Q/86

Procedure time: 2 hours

Final LV lead position: Branch of posterior lateral vein

Case Study

Quartet™ LV Lead - Benefits of Having More Pacing Vectors Under Limited Vein Choices

Implant Experience

• Patient had only one narrow branch at lateral

side, which did not allow for a lead [Figure 1]

• The posterior-lateral vein was chosen as the

target site of left ventricular lead placement This

branch was the only choice as the anterior

branch was not beneficial to the patient [Figures

2 and 3]

• After successful positioning of the lead in the

target location, diaphragmatic stimulation and

thresholds were tested at all ten configurations

[Table 1]

• Acceptable configurations included M2,

M3-P4, M3-RV coil

• The best configuration was chosen to be M3-RV

coil with a pacing threshold of 2.2 V at 0.5ms

and no diaphragmatic stimulation at 10 V

Figure 1: AP view: Small Lateral Branch

Figure 2: AP view: Posterior-Lateral Branch

Case Study

Quartet™ LV Lead - Benefits of Having More Pacing Vectors Under Limited Vein Choices

Conclusion

Having multiple pacing options when there is no appropriate target

vein is highly beneficial as it allows the physician to choose the best

lead location without compromising lead stability and avoiding

diaphragmatic stimulation In this case, diaphragmatic stimulation

was efficiently and effectively managed as a result of quadripolar

pacing capabilities

All acceptable vectors included the Mid 3 electrode, unique to the

quadripolar lead Furthermore, this case could not have been

completed with a traditional bipolar lead due to high pacing

thresholds and phrenic nerve stimulation (PNS)

Figure 3: RAO view: Final Position

The Need for Effective Therapy: CRT Non-Response

therapy

In a study (n = 302), 43% of CRT patients could be classified as non-responders

Daubert, J.C., Saxon, L., Adamson, P.B., Auricchio, A., Berger, … Torp-Pedersen, C.T (2012) 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management Europace, 14(9):1236-86

SUBHEAD GUIDE MULTIPOINT PACING SUBHEAD GUIDE

Introducing MultiPoint™ Pacing

MultiPoint™ Pacing is a FDA approved feature, 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

D1

M3 P4 M2

MULTIPOINT™ PACING

Introducing MultiPoint™ Pacing

MultiPoint™ Pacing is a FDA approved feature, 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 VS MULTIPOINT PACING

MultiPoint™ Pacing Goals

By pacing from TWO LV Sites it is designed to capture

more tissue to improve:

2 Potentially improve engagement of areas

LV1 LV2

Ability to pace from 2 LV sites with

LV1 LV2

RV

+

MultiPoint™ Pacing from a Single CS Branch

MultiPoint™ Pacing Flexible Programming Options

- Pacing Sequences and Delays

RV

 



* Animated activation pattern

Possible Patterns of Wavefront Propagation* with conventional LV Pacing vs MPP in HF, Scarred Heart

Improved Activation Propagation and Minimized Functional Block(s)

Ryu, K., Ghanem, R N., Khrestian, C M., Matsumoto, N., Goldstein, R N., Sahadevan, J., Dorostkar, P C., Waldo, A L (2005) Comparative effects of single- and linear triple-site rapid bipolar pacing on atrial activation in canine models Am J Physiol Heart Circ Physiol 289: H374–H384.

MultiPoint™ Pacing acute data 14 Study Detail:

Menardi, E., Ballari, G P., Goletto, C., Rossetti, G., & Vado, A (2015) Characterization of ventricular activation pattern and acute hemodynamics during multipoint left ventricular pacing Heart Rhythm, 12(8), 1762-9

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

 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

MultiPoint Pacing

Single Site Pacing

Hemodynamic Mechanical

Electrical

MPP™ technology reduced QRS duration by 50% and

decreased total endocardial activation time by 60%

Italian MPP™ pacing Registry Data Study Detail:

Forleo, G.B., Santini, L., Potenza, D., Di Stolfo, G., Locatelli, A., Baracca, E., Zanon, F (2015) Impact of multi-point left ventricular pacing on QRS duration and left ventricular ejection fraction: preliminary results from a multicenter prospective study Heart Rhythm, 12(5) PO04-183

Methods

• N = 436 patient, 73 center Italian registry

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

• 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 QRS Duration and Echo Changes

Capture Threshold in Both Vectors

Unmatched CRT Response with MultiPoint ™ Pacing

3

2

Hemodynamic, mechanical and electrical benefits with acute data1,2,3

19%

improvement

in responder rates

at 12 months4

44% relative reduction in non-responders4

Improved

LV function among CRT non-responders and CRT responders5

Unmatched CRT Response

SUBHEAD GUIDE MULTIPOINT PACING™ TECHNOLOGY US IDE SUBHEAD GUIDE

STUDY

Study Detail:

Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., Niazi, I (2016) Safety and efficacy of multipoint pacing

in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study 2016 Heart Rhythm Society, LBCT 01-03

Objective:

of MPP technology in heart failure (HF) patients

indicated for a CRT-D

Design:

Randomized, blinded non-inferiority trial

at 3 & 9 mo using Clinical Composite Score (CCS)

Patient Global Assessment (PGA), HF events, and cardiovascular death

Study enrollment (n=506)

CRT Implants (n=506)

(Trad BiV for 3mths)

Acute Echo Test (VTI)

(MPP > BiV)

NO YES

MPP N=201

22 Patients not randomized (PNS, Lead displacement, medically unstable etc)

9mths

Assess

Response

Assess Response

MULTIPOINT™ PACING TECHNOLOGY (MPP)

IDE STUDY RESULTS

MPP™ Technology IDE Study Results: Importance of MPP Programming

Post-hoc sub-analyses were conducted to determine the influence of MPP programming

on CRT response (199 pts*):

Sub-group 1 Sub-group 2 Sub-group 3

< 30 mm (n=115)

RV

Electrode Separation (≥ 30 mm) &

TD > 5 ms

LVd LVp

RV

Electrode Separation (< 30 mm)

LVd LVp

RV

Electrode Separation (≥ 30 mm) &

TD = 5 ms

CRT 9 month Response – optimal MPP™ technology

> 30mm Electrode spacing 5ms timing delay (n=52)

Converting Non Responders To responders

MPP IDE Conclusions

programmed with wide LV electrode spacing and short intraventricular delay

responder rates

Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., Niazi, I (2016) Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study 2016 Heart Rhythm Society, LBCT 01-03

SUBHEAD GUIDE SYNCAV™ CRT SUBHEAD GUIDE

What is SyncAV ™ CRT?

• New algorithm

• Designed to allow physicians to make CRT

more individualized

• Dynamic algorithm that works to make

parameter changes out of clinic

AVAILABLE ON THE FOLLOWING

Why SyncAV ™ CRT?

• SyncAV™ CRT HIGHLIGHTS

– Automatic measurement of intrinsic AV

conduction intervals

– Programmable SyncAV™ CRT Delta

shortens the programmed AV

delays for a set number of cycles

– Continuous 256 cycle search window

– Programming steps are simple

– Complimentary to MultiPoint™ pacing

4

2

When enabled, SyncAV™ CRT continuously monitors the patient’s intrinsic AV

conduction intervals and dynamically adjusts CRT parameters to changes in the

patient’s conduction

DESIGNED TO PROVIDE

on a patient to patient basis

patient activity level, heart rate, conduction status, drugs, etc

SUBHEAD GUIDE PROGRAMMING SyncAV™ CRT SUBHEAD GUIDE

4

3

AV conduction interval

2

Review &

Program SyncAV™ CRT settings

3

DDD or VDD modes ONLY

SyncAV™ CRT: Continuous rhythm monitoring

Time to

256 Cycles (min)

SyncAV™ CRT Dynamically Tailored to the patient’s beat

• New dynamic timing feature for

quadripolar CRT devices, it can

complement Multipoint™ Pacing

• Individualize and dynamically

adjust timing (AV Delays) based on

intrinsic patient rhythm

• Drive fusion with intrinsic rhythm for

improved electrical synchrony and

narrower QRS¹

RV

Intrinsic Conduction LV/RV Pacing

MultiPoint™ Pacing with SyncAV™ CRT

technology

QRS Reduction with SyncAV™ CRT technology

• Acute Data from Cleveland Clinic

shows the value of dynamic timing

optimization and fusion pacing 1

• Using a delta value of -50ms,

fusion pacing was achieved and

provided a 20% improvement in

QRS width

• Methodology improved QRS

duration over traditional fixed

AV delays and LV only pacing

• Incremental QRS narrowing can

be achieved by fine-tuning delta

value, programmable only in

SJM™ SyncAV feature

• Data uses Neg-Hys predicate

version of SyncAV™ CRT feature¹

QRSd 142 ± 18 ms 131 ± 12 ms 123 ± 10 ms 140 ± 15 ms

P < 0.01

P < 0.01 P < 0.01

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• MPP shown to be beneficial for CRT patients, overcomes implant limitations and increases responder rates

• SyncAV further fine tunes individual needs

to biventricular pacing, allowing maximum derivation of CRT benefit in daily activities

Conclusions

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